Here is the title of a scientific paper that will make your eyes glaze over
‘Randomized Phase II Study of 5-Fluorouracil Hepatic Arterial Infusion with or without Antineoplastons as an Adjuvant Therapy after Hepatectomy for Liver Metastases from Colorectal Cancer.’ http://journals.plos.org/plosone/article?id=10.1371/journal.pone.0120064
It was published in the Public Library of Science (PLOS) on the 19th of March, and I danced a little jig of happiness. For I helped these researchers get this paper published, a battle that has taken well over a year. Just to blow my trumpet a little, here are the Acknowledgements:
‘We thank all patients who consented to participate in this study and Dr SR Burzynski for free supply of antineoplastons for this study. We appreciate greatly the editorial assistance provided by Dr. Malcolm Kendrick, Central and Eastern Cheshire Primary Care Trust, UK.’
In truth, my wife did most of the heavy lifting in editing the paper, whilst I took all the credit. Oh well, such is life. I shall buy her a bunch of flowers from the local petrol station.
I realise that, at this point, you have not the slightest idea what I am talking about, so I shall step you back in time. Three years ago, or thereabouts, I was speaking to Pete Cohen. He is a life coach and health guru, and all round good guy. He told me about his partner who had developed a brain tumour, gliobastoma. I hasten to add I am not giving away patient confidentiality here, Pete has written about this, and blogged about it many times. http://www.teamhannah.com/
Hannah had received orthodox treatment in the UK, but the prognosis was still very poor. These tumours are very difficult to eradicate, and usually recur quite quickly. To quote a recent paper ‘Median survival times of all patients diagnosed in the 2000-2003 and 2005-2008 periods were 8.1 and 9.7 months.’ 1
An ‘average’ survival time of about nine months is a very depressing thought. (Although it tends to be a bit longer in younger patients). Pete then spent a great deal of time effort, and eventually money, trying to find an alternative treatment. An oncologist, who will never be named, suggested Pete looked at the results from Dr Burzynski’s clinic in Texas.
The results certainly looked impressive, and Pete’s partner started on infusions of antineoplastons, which Burzynski has been using for patients with glioblastomas for many years. Some of you may have heard of Burzynski, for he is regularly condemned as being a complete dangerous maverick. A man who plays on parent’s desperate need for someone to help their children suffering from terminal brain cancer etc.
If you look Burzynski up on the internet there is a complete diatribe of vitriol rains down upon him. Put him in the Andrew Wakefield camp. The BBC assassinated his character in a half hour programme a couple of years ago. To read what is written of him, you would think he is the sort of man who would happily pitchfork babies into the back of a lorry.
However, as someone who is regularly attacked for being a maverick myself, I consider attacks from mainstream medicine, and the media to be a badge of honour, and I pay little attention to such things. I like to look into things myself, and make my own mind up. Clearly some of those attacked for being dangerous mavericks are, indeed, dangerous mavericks. Others are not. Into which camp did Burzinski fall, I wondered?
The first thing about Burzynski’s treatment was that, in Hannah’s case, it seemed to be working. The tumour had gone. As least it was no longer detectable on MRI scans. It has still gone, and Hannah remains well. Will it remain in remission forever? I know not.
Of course a single case is not proof, never is, never will be. But recurrence free survival of several years is extremely uncommon in Gliobastoma, so a single case is rather more powerful evidence than in many other conditions. I then communicated with Burzynski and gained access to his many, many, case histories. Whilst many patients did die, a significant number were surviving longer than would be expected. In some cases patients were alive twenty years later.
I agreed to write up a number of his case histories and got some of them published here and there. It was always a battle do so, batting away objection after objection. Have no doubt that the ‘authorities’ know exactly who Burzinski is, and they do what they they can to stop anything he does being published, anywhere. Often there was just blank refusal to publish anything, once the name was seen.
I was then contacted by someone, who shall currently remain nameless, who told me that a group of Japanese researchers had done work on antineoplastons as adjuvant (add-one) therapy for patients with liver metastases following colorectal cancer. They did not know how, or where, to publish it. So I agreed to look at it, and try and get it published in a peer-reviewed journal.
They were turned down by Lancet Oncology (no surprise), and a couple of other journals. I suggested PLOS (Public Library of Science), which has a high impact and tends to be a bit more open to non-mainstream articles. So we sat down to write, rewrite, edit, alter and adapt.
To be honest, I have never, ever come across so many objections by the peer reviewers. Stuff that was so trivial, so difficult to answer. Re-write, re-write, re-write. Water down the conclusions. I thought by the end of it, nothing would be left, although the most important points did, just about, survive.
Of course this was not a study on gliobastoma, but it was a carefully controlled (not placebo controlled, as that would be impossible) study of high quality. Setting out to answer the question, can antineoplastons benefit patients suffering late stage cancer?
The answer is that they can. They work. They are not a miracle cure; they are not the answer to cancer. But they have clear and clinically significant benefits. So Burzinski is not a maverick… well, he is a maverick, but his (terribly named) antineoplastons significant effects in cancer. So he is the right sort of maverick, in that he is challenging the status quo – and he is right.
Will his work now be accepted, will Burzynski ever be allowed to treat patients again? Probably not. So, a victory, but probably a small one. Meanwhile, in the UK, Charles Saatchi’s efforts to allow ‘mavericks’ to try and treat cancer are being well and truly crushed. ‘We have enough innovation’ is the cry – by the establishment – that most innovative of groups.
I would counter-argue that innovation by large University departments, and pharmaceutical companies, is not really, innovation at all. They just plough the same old furrows, looking to unearth the occasional goody that was missed in the past.
Their most fervent wish is to cry ‘Eureka’ (I have found it – the thing that I knew was there). The true maverick, however, is on a restless quest for ‘that’s funny.’ For only in the ‘that’s funny’ moments does science truly progress.
Dr. Malcolm Kendrick 
So, Dr Kendrick, is this treatment available anywhere and, if so, at what cost? We have a dear friend who has 2 (small they say) recurring mets (liver and lung), late 40s got back to full fitness following colo- rectal and liver surgery 3 years ago. He has embraced lifestyle changes (quit smoking and drinking, long walks daily, back to work, positive attitude) but, to my mind made the wrong dietary choices (loads of fruit juice, low fat etc). I have sent his wife info on the Ketogenic diet and she is researching it. Before I send them this blog post thought I’d ask.
This is Dr Burzynski’s website:
http://www.burzynskiclinic.com/
Huuuuum… Odette
Envoyé depuis un mobile Samsung
“Dr. Malcolm Kendrick” a écrit : Dr. Malcolm Kendrick posted: “Here is the title of a scientific paper that will make your eyes glaze over Randomized Phase II Study of 5-Fluorouracil Hepatic Arterial Infusion with or without Antineoplastons as an Adjuvant Therapy after Hepatectomy for Liver Metastases from Colore”
Congratulations on your patience and persistence. What’s the establishment objection to this work? Will it provide cheaper, non-big-pharma-magic-bullet treatment?
From today’s tabloid press: http://www.dailymail.co.uk/wires/pa/article-3007167/Proton-therapy-saved-Ashyas-life.html
This family seem to have their media strategy sorted since the beginning. At least other approaches are getting coverage through them. It reminds me of the helicobacter docs and their tabloid approach to getting published when shunned by medical journals.
Congratulations! But my favorite part was the buying of flowers at the gas station. Very funny stuff, and exactly how it gets done in our household.
Tesco has a better range of flowers, but my other half laughed when she saw an exact copy of her anniversary bunch sitting in someone else’s window!
Flowers are flowers no matter what or where. But I remarried after my husband died and we are still somewhat considered newlyweds.. I get flowers a lot but it is a joke in our house. When he asks me what I want for a specific occasion my pat answer is “Don’t come in this house with a gift that does not have a mineral content!” It is our little joke, but I get flowers when I least expect still, mostly just because. If my late husband had his say, this is the man he would have hand picked as a marital partner for me and as a stepdad for our son. He was there for me when I had to raise a teenager. He ought to get the flowers with a few medals of honor thrown in.
They sell flowers at your gas stations? Good idea. Could probably decrease the divorce rate in the states. Dr. Kendrick you are lucky to have a good wife and children.
I am glad to see another doctor (other than Mercola who sadly mixes cutting edge medicine with utter quackery) discussing the results from Burzynski’s antineoplaston treatments.
Their selective ‘turning off’ of particular oncogenes (& ‘turning on’ of other genes) is something cancer researchers have been hunting forever! Here we have a first generation of molecules that appear do be doing just that and they’re poo-pooed – tragic.
Dr.Kendrick, were oxidative phosophorylation measures ever taken in the context of before & after antineoplaston treatments?
Thanks
Not that I am aware of, but I can check
Congratulations Dr K. wonderful effort. I tried to get a paper by Dr Graveline into PLOS on the subject of adverse reactions based on Medscape data. I would have thought that with the rise in SARs and Dr G’s reputation that it would make the grade. But NO! My response to PLOS was short but still printable.
It is a battle, an endless battle.
I’ve read the paper. I notice a couple of odd things about it, and I’d be grateful if you could comment on them.
First, it took an awful long time to recruit the patients. 6 years for just 65 patients. Do you know why? It makes me wonder if there were in fact many other patients who were considered for inclusion in the study but were not actually included. It would be very informative to understand how many such patients there are and what the reasons for non-inclusion were.
Second, the study has a very odd primary outcome measure. A cynic might suggest that the primary outcome measure was originally overall survival, but the investigators changed their mind and pretended that “cause specific survival” was the primary outcome measure all along when they discovered that in fact the drug had no statistically significant effect on overall survival. Normally, we could look at the trial registration details to find out what the original primary outcome measure was, but I note that the trial wasn’t registered until after it had been completed. How can we know with certainty what the original primary outcome measure was?
Third, and perhaps most importantly (especially in light of my first point), there was no mention of allocation concealment. Do you know if the investigators had access to the randomisation list when recruiting patients? I’m sure I don’t need to explain to you how that would completely invalidate the results of the study if they did.
Many strange things, and phrases, were forced upon us. if you wish, I shall pass your comments onto the researchers involved. I do not wish to make any statements that might cause them problems. I would only comment that, unless you have a ‘patentable’ compound, and a hundred million dollar budget, compromises are required in recruitment. you might also wish to investigate how many studies are actually being registered. Ben Goldacre doesn’t believe it is happening – as supposedly required.
So to clarify, was the failure to mention anything about allocation concealment forced on you?
And was the choice of primary outcome measure forced on you?
May I ask you to clarify why you are asking these questions? What is the purpose behind them? I am always keen to establish the context of any discussion.
I think we may have a “maverick basher”. I wonder whether he supported Dr Poldermans guidelines which were a truly massive fraud.
I’m asking these questions because given the history of fraud around antineoplastons, I think it’s important to establish whether this trial was conducted honestly.
And frankly, your evasiveness in answering them isn’t filling me with confidence.
I am not being evasive, just trying to ensure that I understand exactly where someone is coming from before responding. You have made it very clear what your starting position on this is, fine. What I would suggest is that, if you have detailed questions about this study, you contact the trial investigators directly. They are in a far better position to answer your technical questions than I am. I also know that if I make the slightest error this will be pounced upon instantly, and I do not want to get the Japanese into any trouble by getting something wrong. In short, please direct your questions at PLOS or the Japanese. And if you think that is evasive, fine. I have nothing whatsoever to hide. I have no financial interests (though I was paid by the Japanese investigators for my editorial input/time) in Burzinski’s clinic or work. My only interest was to highlight another side to this story after meeting someone who’s partner, Hannah, is still alive and very well indeed. I am also aware that once the mob starts to howl, the world can become a very scary place indeed.
Nice to see you are tweeting already. Have to say @malcolmken’s responses to my questions about the ANP trial are less than 100% reassuring bit.ly/1DNVSco #Burzynski. I haven’t actually responded to your questions yet. So, which bit would not be reassuring?
The fact you hadn’t responded was kind of the point.
I note you now say you are unable to answer my questions. Well, fair enough. It wasn’t your trial, even if you did feel that you were qualified to write it up.
But again, nothing here reassures me that the trial was conducted honestly.
Let me re-phrase your wording. You obviously believe that the trial was dishonest. Why? Also, I am not unable to answer your questions (and I did not say this). I said that the investigators are far better place to answer your questions… as they have all the trial data to hand, and this is also supposed to be how one does things. Do you think, in some way, this is a cover-up? You can still find all the answers you want.
So it seems to me we all agree Dr Kendrick is not in position/not the best person to answer statsguyuk’s questions. So, statsguyuk, I’m hoping you’ll follow up with the researchers and update us on your findings?
In the meantime, while I understand statsguyuk doesn’t find the reassurance he’d like as to the validity of the findings (hopefully, he’ll find it once he gets in touch with the research team), I also don’t see he’s got enough to go by to dismiss the research. The statement that there has supposedly been a lot of fraud in this area doesn’t seem very convincing in itself. After all, many valid findings have been dismissed as fraud and quackery. That’s History of Medicine 101. We all agree on this point, too, right?
Anyway, this is not to say that I dismiss statsguyuk’s hunch. I have no reason to believe he has any other agenda than trying to arrive at the truth. (Well, that and some Twitter fame, perhaps.) But, statsguyuk, your hunch is clearly based on your bias, which I hope you’re aware of. Again, not attacking you here, as we all have biases. But trying to remain objective is hard work, and I hope you’ll make the effort.
For example, if the study was about something less controversial, would you actually believe that if it lacks allocation concealment (*if*, because we don’t know yet that it does), it is *completely* invalidated? “Completely”? Sure, the fact might lessen the quality of the evidence, but it doesn’t completely invalidate the findings. Here’s a good exercise in objective thought. Are there any good things about the study that you are able to acknowledge? My personal bias is that I believe most published research findings are false. (Thanks, Dr Ionnidis.) So as an exercise I’m looking for the good here. And there’s a lot of it, to be honest. For example, the fact that the paper is very clearly written and that it presents all the numbers in a highly comprehensible fashion. The researchers don’t see to have much to hide. Also, they have no financial conflicts of interest, another very good sign.
Trials conducted honestly
How many are or have you not read J.P. Ioannidis’ paper (PLoS Medicine | http://www.plosmedicine.org 0696
Essay “Why Most Published Research Findings
Are False Open access, freely available online
August 2005 | Volume 2 | Issue 8 | e124)
or Prof Gotzsche’s book Deadly Medicines and Organized Crime. It seems to me that many, many medical studies suffer from the complaints you make about this paper whiich was not done by Burzinski. In the statin field there are many that have been published but are flawed and should not have been published. Read Dr Michel de Lorgeril’s book on this subject and many others (Ravnskov, Graveline, Roberts, Sinatra et al to name a few.
OK, my bad. You’re not unable to answer my questions, merely unwilling.
Ola, I’ve asked my questions as a comment on the journal article. Let’s see if the authors respond.
Thank you for not making any assumptions about my agenda. I am indeed just trying to get to the truth, and I hope I’m aware of my biases (yes, you’re right, we all have them!)
You ask me if I can point to anything good about the study, and perhaps the best thing about it is that Dr Burzynski, who let’s be clear, is a total crook, was not one of the investigators. However, the investigators in the current study are not completely independent. Dr Tsuda appears in one of the Burzynski movies (essentially over-long adverts for the clinic). It seems they have been collaborating since the 1990s. So I’m afraid we have to treat this study with some scepticism. Perhaps there is no financial conflict of interest (or perhaps there is and it just hasn’t been declared, I don’t think we can know), but even if there isn’t, it seems that the Japanese researchers have at least some intellectual investment in the therapy.
The point about allocation concealment is actually a really serious one. It’s all the more so in this case where there has been such a history of malpractice. It means that you can pick the healthy looking patients and assign them to antineoplaston therapy and pick the sick looking patients and assign them to the control group. In effect, it means the study isn’t really randomised at all. That’s a big deal.
You say “many valid findings have been dismissed as fraud and quackery”. Well, some valid findings have been dismissed as fraud and quackery. But the vast majority of stuff that’s been dismissed as fraud and quackery is, in fact, fraud and quackery. As Carl Sagan once put it: “They laughed at Columbus, they laughed at Fulton, they laughed at the Wright brothers. But they also laughed at Bozo the Clown.”
It’s not as if antineoplastons are a new idea that are just waiting to be proved given time. Burzynski has been researching them since the 1970s. He’s done loads of research, but has never managed to produce any evidence that they work. Doesn’t that tell us something?
Anyway, remember that the present study, despite all the huge potential for bias, still didn’t manage to show a statistically significant effect on overall survival.
Hi, Adam —
Thank you for asking the questions. Today is the first day I’ve ever heard of Dr Burzynski, so I have some catching up to do, and I’m curious to find out more. And – of course – good point on fraud and quackery often being just fraud and quackery. Dr Kendrick has said pretty much the same thing many times before, and also in this current post (“Clearly some of those attacked for being dangerous mavericks are, indeed, dangerous mavericks.”) So just like I believe that your primary goal is figuring out what the truth is, I believe the same about Dr Kendrick. The interesting part is that you both set out to find out the truth but arrived at different conclusions. This is, BTW, a gold mine for readers like me who like to be exposed to different sides of the story before making up their mind. The challenge is often finding representatives of the two sides who are reasonably unbiased and rational. (I’m hoping I’ve found them in this case!)
So, how does one find out if someone is a fraud? In order to figure this out, Dr Kendrick communicated with Burzynski and looked at his case histories. I don’t know yet how you’ve arrived at your conclusion that Burzynski is a quack, but after having read your comments on the Japanese paper, I’m looking forward to reading the blog posts you’ve mentioned you have written. And I’ll definitely do it before watching the Burzynski “infomercial” to know what to look out for. (I also hope you’ll indulge some questions I might ask on your blog at that point!)
As to antineoplastons not being a new idea and lack of research, it’s definitely a valid concern. (For the record, I have little background here, but it seems to me from my today’s reading that there has been *some* evidence, just not of the highest quality (RCT) – up until this Japanese study.) On the other hand, isn’t it also a valid concern that researchers have issues getting their research published (like the Japanese researchers we’re talking about here?) And I’m really not trolling you, but the argument Dr Kendrick made elsewhere in the comments sounds compelling as to why a bigger study hasn’t been funded: “However, to do a phase III study, when you cannot patent your product is the preserve of the curious billionaire. Just say I, or you, or Burzynski wished to do such a thing. It would cost millions, probably tens of millions. If it were positive then you could never, ever, get this money back. For a generic company can breeze along, start manufacturing and selling your product, that you did the clinical studies on, and you could do nothing whatsoever about it. Whatever money you spent on the trial would be gone – forever.”
Alright, so back to the research at hand. I have had some more time to look at it after getting off work, and I see that I was wrong in thinking the allocation concealment question couldn’t be addressed by reading the paper itself. In the “Patients and Methods” section there is a link to the S1 Protocol, which describes the minimization method the authors used. Now, you’re the stats guy, so correct me if I’m wrong, but the question of allocation concealment is not relevant when it comes to minimization methods, right? Because, by definition, there can be no allocation concealment in minimization? Now, I still think there’s potential to ask questions here. For example, you can question the exact minimization method used (and described) by the authors. Or maybe, as a stats guy, you can actually argue that minimization shouldn’t be “considered methodologically equivalent to randomized trials” or that it doesn’t “maintain a better balance than traditional blocked randomisation”, which seems to be the current mainstream view (quotations from “How to Report Statistics in Medicine” by Lang/Secic and Wikipedia.) Now, I don’t have enough background in statistics (yet) to have an opinion, so I’ll go with the default mainstream view for now. Also, I’ll assume there’s nothing suspicious about the authors using a mainstream statistical method.
Finally – what I personally care the most about: the overall survival. Again, you, as the stats guy, might have to correct me here. The OS was longer in the AN arm than in the control (64.5 months vs 39 months), but the result was deemed not statistically significant, because the p-value was 0.105. This means that the probability that the observed effect is attributable to chance is 10.5%. In other words, there was an observed effect, and the probability of it being real is 89.5%, right? Now, given the small sample size (it’s a Phase II trial, after all), isn’t that actually pretty encouraging? Seems like maybe we just haven’t thrown the dice enough times here to achieve significance? We can’t prove an effect, but let’s not forget we can’t disprove it either. There’s definitely enough here to encourage further research and bigger studies. (Given low toxicity and the other outcomes.) I’m also wondering why the researchers didn’t focus on what cancer researchers usually focus on – the 5-year survival? Most other cancer drugs are evaluated based on the 5-year survival outcome, so why are they setting the bar so high for this treatment? If the research team really wanted to deceive, they could have done just that: tout the stunning 60% vs 32% OS difference and bury the 10-year OS somewhere deep in the footnotes.
Thank you Ola. I had been hoping that someone else (not me) would defend this paper. I would just like to say that I consider the Japanese authors to be just about the most ‘straight up’ people I have communicated with. As far as I am aware nothing about this study can be considered ‘dishonest’ in any way. The fact that the investigators met with Burzynski hardly seems to disqualify them from doing a study. The main problem was the lack of statistical significance in overall survival. As you point out, this is primary due to the small numbers studied. In short, every question statsguy used to discredit this paper, was actually answered in the paper. I await his reply to your analysis with interest.
I think that some of the posters here epitomise the way that researchers are bullied in science today – particularly, it would seem, medical science.
Dr Kendrick has not exercised his right as moderator to remove simply these posts, and we can see the sort of pressure that is applied:
Answer the following questions instantly (even though you are not an author of the relevant paper) or I will assume you have a sinister motive.
Any excuse is good enough, such as a supposed history of fraud around antineoplastons! OK there is no logic to such an assertion – surely a history of fraud can only be associated with one or more persons, not a medical technique – but heck it will do!
One way that a “history of fraud” may surround a subject, is if repeated attempts are made to discredit an idea, but they all fail!
Likewise, I imagine, one reason why it may take a long time to handle enough patients for a trial may be that obstructing tactics make it hard to recruit patients to a study.
David. Indeed.
Ola, thank you for your detailed comment. It is clear to me you are approaching this with an open mind in the spirit of honest enquiry. I have a lot of time for that sort of thing.
So, to answer your questions:
“So, how does one find out if someone is a fraud?”
You could start by looking at the court documents. Now, Burzynski has been in court many times, and he’s often got off, often on technicalities. He has a very good lawyer. But even his lawyer couldn’t save him from one verdict of fraud against him, where the court found that he’d defrauded a health insurance company. More details on his Wikipedia page.
Of course, just because he’s been involved in financial fraud doesn’t necessarily mean he’s also a medical fraud, though I think it does say something about his character. There are various strands of evidence that have convinced me he’s a medical fraud.
First, his treatments are not licensed, and yet he charges people huge sums of money for them. That’s highly unusual. Patients are not usually charged money for participating in clinical trials. Certainly not the life-changing sums that Burzynski charges. He is only allowed to administer antineoplastons as part of clinical trials, as they’re not licensed drugs. The trials are not really clinical trials in any meaningful sense: they are simply a ruse to allow him to carry on treating patients. Even his own lawyer, Robert Jaffe, admitted as much.
So what about these clinical trials? If you look on clinicaltrials.gov, you’ll find that he has registered over 60 trials, many as far back as the 1990s, and yet he’s only published a handful, and most of those only in the last year or so. Does that seem like the act of a legitimate researcher?
“I’m looking forward to reading the blog posts you’ve mentioned you have written”
Sadly, they are mostly on a site that’s now defunct. But plenty of other people have blogged about Burzynski. Probably the most worth reading is David Gorski, who writes on the Science Based Medicine blog. He’s written loads about Dr B.
“it seems to me from my today’s reading that there has been *some* evidence, just not of the highest quality (RCT)”
The evidence so far is very far from the highest quality RCT. Burzynski has published a small number of phase II studies. They have no control group, so it’s difficult to draw conclusions. But invariably, the vast majority of patients in his trials die. The results seem to me to be entirely consistent with no beneficial activity at all.
“Just say I, or you, or Burzynski wished to do such a thing. It would cost millions, probably tens of millions”
Yes, it’s expensive to do clinical trials. And yet Burzynski has done loads of them and just not published them. The marginal cost of publishing a trial once you’ve done it is tiny, so I don’t think it’s really cost that’s putting him off. And remember Burzynski is a very wealthy man.
“In the “Patients and Methods” section there is a link to the S1 Protocol, which describes the minimization method the authors used.”
Oh, well spotted, I hadn’t noticed that. But I think it raises more questions than it answers. If the study did use minimisation instead of randomisation, that’s actually inconsistent with what was written in the publication. Also, minimisation is quite a complex method, and far more details than are given there would be needed to make sense of exactly what they did. To be fair, it’s quite common not to describe such methods in detail in the protocol, as you don’t want investigators to know too much about them while the trial is ongoing. But there is no reason to omit those details from the publication.
“so correct me if I’m wrong, but the question of allocation concealment is not relevant when it comes to minimization methods, right?”
I shall indeed correct you. Allocation concealment is all the more important for minimisation. The thing about minimisation is that it’s not completely random (possibly not at all random: the degree of randomness is actually variable, and that’s one of the details I would have expected to see). If the minimisation algorithm is reasonably straightforward, it might be possible for the investigator to know what the next treatment is even if there are quite good attempts at allocation concealment. In fact I would say that it is never appropriate to use minimisation for a single centre study for precisely that reason.
The important thing to realise is that there is huge potential for bias if the investigator can predict what treatment the next patient might have before the next patient is officially recruited. An investigator might, for example, choose not to recruit a patient at all if that patient looked severely ill and would have been recruited to the antineoplaston group.
“Or maybe, as a stats guy, you can actually argue that minimization shouldn’t be “considered methodologically equivalent to randomized trials” or that it doesn’t “maintain a better balance than traditional blocked randomisation”, which seems to be the current mainstream view ”
I’m actually quite a fan of minimisation. But as stated above, only for multicentre trials. This was a single centre trial, which makes minimisation inappropriate.
“The OS was longer in the AN arm than in the control (64.5 months vs 39 months), but the result was deemed not statistically significant, because the p-value was 0.105.”
Correct
“This means that the probability that the observed effect is attributable to chance is 10.5%. In other words, there was an observed effect, and the probability of it being real is 89.5%, right?”
Wrong. But you’re in good company: it’s a very common misunderstanding of what P values mean. What it means is that if antineoplastons were completely ineffective, there is a 10.5% chance you would see a survival difference of the magnitude observed in the study. That’s subtly, but importantly, different to saying there is a 10.5% probability that antineoplastons have no effect.
“Seems like maybe we just haven’t thrown the dice enough times here to achieve significance?”
Burzynski has thrown the dice many times. But he has only published a small subset of his results. You have to wonder what he has to hide about the ones he hasn’t published.
“We can’t prove an effect, but let’s not forget we can’t disprove it either.”
Sure, we can’t disprove it. But Dr B has been trying to prove it for over 40 years and has yet to provide any good evidence his treatment works. I think that tells us quite a lot.
“There’s definitely enough here to encourage further research and bigger studies. (Given low toxicity and the other outcomes.) ”
I’m afraid the low toxicity is a bit of a myth. Antineoplastons are highly toxic. In fact the FDA made Dr B stop using them a couple of years ago after one of his patients died as a direct result of their toxicity.
Google “the other Burzynski patient group” for more stories of the hideous side effects of the drugs.
Hi, Adam —
Thank you for taking the time to answer my questions. I know these online discussions don’t tend to be very productive in general, starting off like this: https://xkcd.com/386/ and ending in weariness and exasperation. But I’ve had a lot of good experience, too, where both parties get to understand each other’s points of view and are able to determine exactly where the disagreement lies. At which point it usually comes down to someone saying, “OK, I need to do more research” or “OK, we will have to wait for more research to emerge.” I think I’m close to identifying some of these points for this discussion.
Anyway, back to the paper, and let me start with what I consider to be your most important point:
Allocation concealment in minimization: I went back to the original Pocock/Simon paper from 1975 and skimmed through some follow-up papers as well. I now think I understand how allocation concealment is relevant in minimization. I agree/see all of your points about the predictability of the outcome. My initial fallacy was to assume that since the algorithm that does the assignment is set by the investigators at the very start, and precisely because of the predictability you point out, there is – sadly – nothing we can conceal any more. (Basically, what this guy says: http://www.ncbi.nlm.nih.gov/pmc/articles/PMC2930067/.) Again, correct me if I’m wrong, but here’s what I now think would be one way of satisfying the allocation concealment condition in minimization (i.e. that “group assignment of patients are not revealed prior to definitively allocating them to their respective groups.”) We could achieve this, for example, if the people who accept the patients into the study and gather the subjects’ relevant information (the algorithm input) are not aware of how the allocation algorithm works.
So, to summarize, yes, I understand and agree with your point about how lack of allocation concealment would mean potential for bias in this study. I still don’t agree that it would completely discredit this study, but let me get to that later.
NB, if allocation concealment (for example, as described above) is in place, is it still not appropriate – in your opinion – for a single center study to use minimization?
Onto the p-value. Thank you for the correction. The point I was trying to make still stands, although perhaps it was unclear: small studies are likely to report non-significance even if there are real effects. (I don’t think this is a very controversial statement.) I would like to see bigger studies. I’m pretty sure you wouldn’t mind seeing bigger studies, either, although I know you’ll be very critical of them, especially if they do turn out significant. Which brings me to the next point.
Dr Burzynski and his character. I’m so glad you mentioned looking at court documents! I was doing some reading on the subject of another alleged quack not so long ago, and at some point I concluded that unless I can look at the court documents myself, I won’t be able to figure out the truth. I suspect that if I do some more digging on Dr Burzynski, I might arrive at the same conclusion. Not sure if this digging is going to happen on my part anytime soon (but if it does, I’ll probably stop by your blog to say hi and ask questions.) If you’ve looked at the court documents yourself, I’ll rely on your word for now. (To be clear, you have personally looked at them, right?) Then, again, I’ll also rely on Dr Kendrick’s word, who has looked at Dr Burzynski’s clinical data and has communicated with the man directly.
Another good point you’ve made: the involvement in financial fraud not meaning clinical fraud, but also saying something about Dr Burzynski’s character. Yep. This actually brings me to one of those points in the discussion where I think we will have to “agree to disagree”. Les Rose (in a comment below) summarized it well: “My first thought on perusing this long exchange is that those who know the background to the Burzynski saga are bound to require even more assurances regarding any claims associated with him and his business.” Adam, you’re one of those people who have the background, I am not. And until I have it, if I ever do, I can’t contribute much to the Burzynski character discussion. (I still think we can have – and indeed have had – a good exchange about the Japanese paper itself.)
Now, elsewhere in the comments you say that this discussion is about Burzynski, and not about drug companies. Actually, I initially thought that the discussion was about the Japanese paper, not about Burzynski, but I do agree that Burzynski’s character is not irrelevant.
At the same time, and in the same way, I also have a background which informs me. That background is in studying the inaccuracies and deceit common in medical research funded and influenced by the pharmaceutical industry. I know you disagree, but I believe this context is as relevant to the discussion of the Japanese paper as the context of Burzynski’s character. To explain why, I’ll go back to what I said above about how I won’t dismiss this study completely even if we show potential for bias via lack of allocation concealment.
In an ideal world all studies would be conducted perfectly, all biased minimized. I’m sure we agree we don’t live in such a world. If, indeed, there is a lot of legitimate research with small potential for bias in some area, then sure, let’s dismiss all of the studies in the same area that show big bias potential. Now, given my background, I don’t believe that cancer research is one of those areas. So I will not reject a study outright because of its potential for bias. What I will do is simply rank it lower than relevant studies that show less bias potential. So as much as I understand that your knowledge about Burzynski makes you more critical of the Japanese paper than you might be with a paper on some other subject, I also hope that you see (not agree with me, but just understand) how my background informs me, and why – for now – I will give the Japanese the benefit of a doubt.
Hi Ola
I’m finding it increasingly difficult to navigate into the depths of this subthread, so shall reply to your points in a new thread at the bottom of this post.
I’ve only skimmed the paper so far, so these are my preliminary thoughts. I’ll definitely be reading it in detail when I’m off work, since it looks well written and comprehensible as opposed to much of what gets published in medical journals today.
I think statsguyuk raises some good questions. The first of his questions seems to be answered in the paper itself. There were 73 patients total assessed for eligibility, 8 excluded. 6 declined to participate, 2 didn’t meet inclusion criteria (listed in “Patients and Methods”) section.
The second question is exactly the same question I had when I first skimmed the paper! (I have recently read an excellent book on medical research that taught me that if overall survival hasn’t changed, I probably shouldn’t care about the outcome of the study at all.) So I was intrigued, and dug a little deeper. Why wasn’t this trial registered? Well, again, turns out the question is answered in the paper itself: “It was not registered previously because enrollment for this study finished in 2003 before the start of mandatory official registration for clinical trials in Japan (UMIN- CTR) in 2006. The authors confirm that all ongoing and related trials for this drug are registered.” So for the cynics and skeptics among us, that’s great news. Soon we will – hopefully – see the results of the follow-up studies, which I’m sure will add to our discussion. (Unless the follow-up findings are blocked from being published, which – unfortunately – seems likely, given the struggle MK described in his post.)
The third question is excellent, and I can’t find an answer to it by just looking at the paper. Would be interested to hear the researchers’ comment on this point.
Now, going back to worried me the most about the paper – the overall survival being unchanged at the 10-year follow-up point. I’m wondering if the fact that patients included in the study were 60 years old on average and have undergone invasive procedures may have something to do with it.
Ola. I think I shall same thing to everyone. The researchers themselves are far better place to answer such highly technical questions. I did not do the study, I only assisted in getting it published. And as you have found, some of statsguy’s questions are, in fact, available in the paper itself. However, I appreciate you taking the time and effort to study the paper properly.
Dr.K, being something of a fan, have all your books etc., and no twitter audience or similar, I must admit I am finding this item a little disturbing. Simple minded I may be at times, but, whilst I entirely appreciate the value and also applaud the value in helping the worthwhile work of mavericks see the light of day, to triumphantly promote a paper with which you were fairly intimately involved but then seem to be refusing to engage, in your own blog, with its content on the level/basis/sceptical principles you yourself advocate does appear a little inconsistent? Other papers get discussed ok it seems, and in this case you would seem to be more than averagely qualified to comment! Your own interpretations and comments could always be caveated. With “Don’t shoot me I was only the editor” perhaps? Or what am I missing?
What you are missing, I think, is that I am not the lead investigator, and I cannot speak on his behalf (I could, I suppose, but I don’t wish to) Nor do I have all the information required to answer certain questions. I could say, ‘I can ask the investigators and get back to you.’ but it is rather more simple, I feel, to ask those who want more detailed information to go to the source, and ask away. As you may have noticed, Adam Jacobs was very critical of this study not being registered. This was answered, in the paper itself. The trial started before there was any requirement to register trials in Japan. Oh, perhaps he didn’t read that bit.
To be frank, I also know that whatever questions are answered, Adam Jacobs (and many others) will always believe it was fraudulent. Any question answered will be followed by another question, and another question, ad infinitum. At some point, as with any trial, there will be imperfections. I know from past experience, that if I make the slightest error, this is leapt upon and used to discredit everything I have to say, on any matter. I spent a year trying to sort out detailed questions about this study. I really, really, do not want to spend another year doing so. Especially when it will make not the slightest difference. Those who disbelieve this study will continue to do so. No matter what. It is the nature of the thing. Please do not confuse weariness with evasiveness – or any other motivation that you may feel is lurking beneath the surface here. Just because someone demands that I answer questions does not mean that I have to do so.
In retrospect I made a tactical error. I should have just said. If you have detailed questions please contact the lead author, or direct questions through the journal. End of.
This is exactly the type of pedantry that stifles all scientific advances. if it is deemed that it has a potential, against near overwhelming vested interest negative pressure, it will be further investigated and refined. It would be better to let it run and develop either way before one starts throwing bricks at it. To do so at this stage sends my suspicion index right off the clock.
Better a little hope than Bob Hope, he’s dead.
Let us also be mindful of Burzynski’s compounds most of them are unpatentable so there’ll be no interest from the drug companies, in fact quite the opposite, they will be discredited at every opportunity, that is until the active ingredients can be isolated, synthesised and patented.
Burzynski’s patient base is mainly comprised of people who have been abandoned by conventional medical treatments often arriving post chemo, radio and surgical interventions.
The fact that he has any success at all is remarkable.
This is a response to Adam Jacobs, it seems to have been misplaced.
And who wouldn’t turn to Burzynski when the conventional therapy being offered gives NO hope? From what I read, Dr B has about a 25% remission rate on these desperate cases. Seems a no brainer (no pun intended), to me.
Even in our NHS there have been surgeons whose stats showed them to be at the lower end of the ‘successful outcomes’ continuum. That’s because they were willing to give a fellow human being a sporting chance….as against the ‘cherry pickers’ who preferred to operate on lower risk cases. Such league table comparisons are just plain barmy.
Anyhow Adam, (and I don’t mean this to sound nasty) where will you turn to when everything is stacked against you….God forbid! I would quite like to know why you are so aggressive in your quest to get at ‘the truth’ as you see it. I reckon you should come clean as to your motives.
In reply your query, Adam Jacobs, as to why Dr Burzynski has registered so many trials but only published a handful, do you know if he has submitted them all to publication or has actually not tried to publish the majority? As Dr Kendrick says above, “Have no doubt that the ‘authorities’ know exactly who Burzinski is, and they do what they they can to stop anything he does being published, anywhere. Often there was just blank refusal to publish anything, once the name was seen.”
According to ‘Bad Pharma’ (Dr Ben Goldacre) research papers are not published for many reasons; sometimes because the outcome wasn’t good, but also because they might ‘rock the boat’ of the medical establishment. Being as Dr Burzynski’s antineoplastons are not patentable and given that the majority of medical journals are ‘controlled’ to a large extent by pharmaceutical companies, they won’t be rushing to print his papers.
Patients such as Hannah (who so far seems to be doing exceptionally well) would undoubtedly have died – of course nobody is saying Dr B’s treatments cure everyone, and I’m sure he suffers from the same problem that places like the Bristol Homeopathic Hospital do, in that people only end up there when they are desperate after having had the conventional treatments. They are in quite an advanced state of disease and so they are likely to skew the figures adversely as regards mortality.
I am sure Dr B needs quite a lot of money to fund his own trials too, so the treatments are considered expensive but people seem to be criticising this as if he’s just raking it in for his own personal benefit. Nobody seems to mind pharmaceutical companies are raking in the money above and beyond what they seem to need – otherwise they wouldn’t make such huge profits (and it wouldn’t be so tempting to those medical and political individuals who greatly influence our health policies to be so closely associated with them.)
I don’t know how many of his trials he’s submitted for publication.
But even if he did submit trials for publication and got rejected (which would probably be because the trials are too low quality to be of interest: the idea that the pharmaceutical industry controls the majority of medical journals is, I’m afraid, a conspiracy theory with little basis in fact), there is absolutely nothing to stop him posting the results on clinicaltrials.gov, which allows results to be posted no matter what the quality of the trial was.
That he has not done so suggests the reason why he hasn’t published the results is that he has something to hide.
…the idea that the pharmaceutical industry controls the majority of medical journals is, I’m afraid, a conspiracy theory with little basis in fact),
For goodness sake, read Prof Gotzsche’s book, “Deadly Medicines and Organised Crime”. He has a whole chapter on this issue. He is also an eminent member and leader in the Cochrane Collaboration and, personally, I would prefer to believe him than your ad hoc, unsupported and biased assertion.
I have read his book. I don’t remember reading credible evidence about the majority of medical journals being controlled by the pharmaceutical industry. Can you remind me which page that’s on?
Or if you believe that evidence exists that the majority of medical journals are controlled by the pharmaceutical industry, perhaps you could point me to the primary source?
I think I’m pretty clear about which is the unsupported assertion here.
He may not have, but Richard Horton (Editor of the Lancet, has stated the following). “‘Journals have devolved into information laundering operations for the pharmaceutical industry’, wrote Richard Horton, editor of The Lancet, in March 2004. That is a quote from my book, by the way.
Oh, and by the way, Mike, I note you haven’t responded to my point that no matter how many journals are controlled by the pharmaceutical industry, there is nothing to stop him posting his results on clinicaltrials.gov.
Do you believe that that is controlled by the pharmaceutical industry as well?
I note you did not make any response to my posting of the abstract of a recent phase II clinical study?
That is obviously a choice but probably has minimal impact. If it was that useful Big Pharma would use it. Save them millions in reprint costs.
I think that you have read none of the following; Gotzsche’s book “Dangerous Medicines……” or “Risk Savvy” by Gigerenzer, or “The Truth about Drug Companies……..” by Dr Marcia Angell and several others, all of which are entirely relevant to my view point. These are excellent reviews, well referenced by eminent authors.
I have tried over several decades to keep an open mind as a researcher should and over the last couple of decades I have observed flawed research being presented as infomercials to sell drugs by both allopathic and naturopathic interests; though I do find the supporters allopathic drugs (sorry Les Rose) to be far more closed mind than naturopathic MD NDs.
If I used what appears your criteria for calling an individual a “crook”, there would be a several, eminent names involved. It is however easier to say they are grossly mistaken.
Morning Adam. Just had a look at Bad Pharma, can’t say which page it’s on as it’s on my Kindle, but near the beginning (in the ‘Intro’), Goldacre says, “Regulators see most of the trial data, but only from early on in a drug’s life and even then they don’t give this data to doctors or patients, or even to other parts of government. This distorted evidence is then communicated and applied in a distorted fashion. In their forty years of practice after leaving medical school, doctors hear about what works through ad hoc oral traditions, from sales reps, colleagues or journals. But those colleagues can be in the pay of drug companies – often undisclosed – and the journals are too. And so are the patient groups. And finally, academic papers, which everyone things of as objective, are often covertly planned and written by people who work directly for the drug companies, without disclosure. Sometimes whole academic journals are even owned outright by one drug company.”
Admittedly he doesn’t say ‘the majority’ but then I didn’t directly say in my comment that he had. That was merely the impression I have got having read several similar books by people ‘in the know’ over the past few years. I’m afraid I cannot furnish you with which ones they were as they were loaned to me by various friends and colleagues.
Oh, another thought crossed my mind. I have worked in hospitals for much of my working life and I know how busy doctors there are and how they are mailed directly with ‘physical’ journals. So they are less likely to have the time to scour the internet for papers published online unless they are doing some particular research, but they are more likely to be sitting in the coffee room or wherever browsing through the ‘journals’ that have been piling up there; I’ve seen that for myself.
While not a human doctor, much the same applies in the veterinary field. Cofee breaks are also useful for discussion. To undertake a search on a particular subject takes a lot of time though these days there are excellent search engines available. Pubmed is good for “retirees” (at 78 3 years ago) that do not have BigPharma or University backing.
When I see reviews like Dr K’s “Doctoring Data” and the reference list I wonder how he manages his practice and still has time to write both informative and entertaining books.
Malcolm, when Richard Horton said that, he wasn’t talking about stopping people outside the pharma industry from publishing, just about biased reporting from pharma companies.
So unless someone can show me actual evidence that anyone in the pharmaceutical industry has stopped Burzynski’s research from being published, then I’m still filing that notion under “crazy conspiracy theories”.
And I repeat: even if you do believe that every single medical journal in the world is controlled by the pharma industry, then there is still nothing to stop Dr B posting his results on clinicaltrials.gov.
As for the abstract you posted of the anaplastic astrocytoma study, you’re right, I haven’t commented on it. You said you’d blog about it specifically, and I thought I’d save my comments for then, rather than derailing this discussion further. Let me know when you’ve written that blogpost and I’ll be delighted to stop by and comment on it. If you tweet @ me I’ll see your tweet.
One of the computers I use at work comes up with a message. ‘User inactivity detected.’ To which I always mutter. You cannot detect inactivity.
At which point, no doubt, everyone would hold their hands in synthetic anguish and cry ‘His trials are so rubbish that the only place he can make them public is on clinicaltrials.gov.’
Hi Anglosvizzera
I’ve dug out my copy of Bad Pharma. The passage you mentioned is on page xi. I’m afraid he doesn’t offer any evidence for it. He merely states it as a fact with no citation of evidence.
Still waiting for actual evidence, rather than opinion, that pharma companies control significant numbers of medical journals.
Try Marcia Angell’s Truth about Drug Companies. Some time since I read it but it is probably in chapters
7. The Hard Sell . . . Lures, Bribes, and Kickbacks This describes the ways and means getting Drs and journal support
11. Buying Influence—How the Industry Makes Sure It Gets Its Way this chapter describes the ways and means of influencing the US Govt.
Angell, Marcia (2004-08-24). The Truth About the Drug Companies: How They Deceive Us and What to Do About It Random House Publishing Group. Kindle Edition.
“‘His trials are so rubbish that the only place he can make them public is on clinicaltrials.gov”
That may well be true. But at the moment, the conclusion I am drawn to is that the trials are so rubbish that they’re not even good enough for clinicaltrials.gov
I’m afraid the only person to blame for Burzynski’s trials not being in the public domain is Burzynski himself. The really is no evidence that he’s tried but failed to get things published.
How could anyone possibly know if someone tried, and failed, to get something published. The only reason I know is because Pete Cohen asked me if he could help to get things published, because Burzynski was failing to do so. As I wrote back at the time (sic). I don’t know if he is not getting published because his data are rubbish, his name is Burzynski, or he cannot write clinical papers. As it turned out his data were a bit all over the place and, how can I put this politely, his writing style was forceful rather than scientific. But we have now got two important papers published – which kind of negates your comment, Adam, that the trials are so rubbish that they’re not even good enough for clinicaltrials.gov.
He’s registered about 60 trials. I don’t think he’s published more than about 10 of them. That leaves a lot of trials with huge question marks over them.
“He’s registered about 60 trials. I don’t think he’s published more than about 10 of them. That leaves a lot of trials with huge question marks over them.”
I wonder how that compares with the number of unpublished trials registered by pharmaceutical companies. I suspect it’s not particularly unusual although, of course, I won’t be spending my valuable time trying to find that answer.
“I wonder how that compares with the number of unpublished trials registered by pharmaceutical companies. ”
Well, we have pretty good data with which to answer that question. There’s been quite a lot of research on how much of the research done by the pharma industry gets disclosed. It’s improved quite a lot over the years. Back in the bad old days (1980s and 1990s), it was quite common for pharma trials not to be published. Probably only about half of them were. That’s still better than 10/60, of course.
But in recent years things have been improving quite dramatically. The most recent paper that I know of to look specifically at publication rates from pharma found that about 90% of trials were disclosed.
http://informahealthcare.com/doi/abs/10.1185/03007995.2013.860371
Of course, that’s 10% too low, but it’s a damn sight better than what Burzynski manages.
The most recent paper that I know of to look specifically at publication rates from pharma found that about 90% of trials were disclosed.
Problem: Can one believe them? Ioannidis’ report would suggest NO!
Ah, but how can you believe what Ioannidis says? You are assuming that everything written in published papers is wrong, yes? So given that Ioannidis made his points in a published paper, how can you believe them?
More seriously, if you’re just going to say everything in the scientific literature is wrong, then how are you going to come to any conclusions about anything? All you are left with then is opinion, which is just going to conform to your prejudices rather than being informed by evidence.
Adam, You raise a very good, and difficult to answer point. I am hovering on the edge of ‘I don’t believe any medical research anymore,’ yet still trying to cling on. There comes a point, I know now where it is, whereby enough research is falsified/horribly manipulated that the entire structure must collapse. I have looked at certain papers, that I know to be wrong (have proven to be wrong) that have been cited and cross-referenced many times. The ‘wrong’ evidence has now permeated the ‘structure’ of the edifice. Paper A cites paper B, paper C cites paper A, paper D cites A and C – without ever having seen B. Even if you strip B out of the system. A and C and D will still have come to conclusions, partially based on paper B. Multiply this up a few thousand times and you have the equivalent of a computer virus replicating itself in the system. I will use one specific example.
People with low cholesterol levels after the age (you can argue about the exact age) of 55 have a higher mortality rate. A researcher called Iribarren wrote a paper in which he hypothesized that the low cholesterol was ’caused’ by underlying illnesses and it was therefore the underlying illness that killed people, not the low cholesterol [A reasonable ad-hoc hypothesis, but unsupported by any studies]. Several long-term studies have disproven this hypothesis. Yes, severe liver disease and end-stage cancer does lower blood cholesterol levels – to name but two. But if you remove these people from your studies the association between low cholesterol and increased mortality rates remains – albeit attenuated. So, there is no evidence to support Iribarren’s hypothesis. In short, it is wrong. However you will see this hypothesis, or variations thereof, stated as ‘fact’ in paper after paper. Most authors of such papers appear unaware that Iribarren’s original was only a hypothesis [in fact I am perfectly certain they have no idea where the idea actually originated], also that when it has been studied in, say the Honolulu trial, or Voralberg (to name but two studies of hundreds of thousands of people) it has been contradicted.
Where does this leave us. I know, because I have read more damned papers on CVD than is good for my brain, that low cholesterol is associated with increased mortality [in all groups except men under the age of 50]. Yet the vast ‘weight of the evidence’ would tell me otherwise. Therefore, yes, I do make my own decisions about which ‘evidence’ I believe and which evidence I do not. I think I have to, for I cannot believe everything. But I do not think this is a good state of affairs. I would much rather not have to look a paper, look who wrote it, look what institutions they work for, search for their conflicts (declared or otherwise) and then start from the positron of (in many cases) distrust. There are certain researchers/authors whose papers I do not even bother to read, as I know they will be so biased as to be worthless. And no, I am not going to tell you who they are, because the laws of libel in the UK are extraordinarily punitive.
Interesting thoughts, Malcolm. I think we can all agree that much published research is unreliable. But how to tell which is which?
For me, it’s all about replication. Things become more believable if they’ve been replicated by independent researchers. It’s very hard ever to believe a single study that hasn’t been replicated.
Of course, if you’re looking at epidemiological research (and the cholesterol examples you mention, which I really don’t want to get into discussing on this thread as it’s already straying far enough from the point of this post on antineoplastons, though I’d truly love to discuss with you another day if you ever blog about cholesterol) things become much more complex, as there are so many biases inherent in epidemiological studies. I believe the finding that HRT protects against cardiovascular disease had been widely replicated, but of course we now know that it was wrong because of the RCT evidence.
Interpreting epidemiological research is much trickier.
Dement Geriatr Cogn Disord 2009;28:75–80
DOI: 10.1159/000231980 Can be downloaded in full.
Midlife Serum Cholesterol and Increased Risk of Alzheimer’s and Vascular Dementia Three Decades Later
Alina Solomon et al.
The patient records were available for many possible factors such as age, sex, race, education and other medical conditions (Table 1) but not the therapeutic records. This is unbelievable; patient records without treatment details implies either gross incompetence or negligence or that the records were withheld DELIBERATELY
Tables 2-4 row titles were given as blood cholesterol levels. Change these levels to official US guideline therapy. This does not affect numbers or stats but allow an alternative interpretation, namely that long term usage of statins leads to Alzheimer’s(AD). This paper is very rarely (if ever) cited by reports claiming benefits for statins in AD. I suspect that NHS trusts have the data to repeat this study but that will probably never happen. Just another example of biased/selective research.
Have to agree about the blind repetition of “facts” garnered second- or third-hand from the published research. I read and edit medical papers for a living (primarily eye research). Most of the papers I read are written by foreign researchers. Because of the language difficulties, I sometimes go looking for the original papers they have cited just to figure out what they are trying to say. In comparing what the original paper said to what the current paper says, it’s often clear that the researcher has read only a second-hand account of the results or, at best, has read only the abstract. I must say, the 20+ years I’ve spent at this job have made me a lot less trusting of the published research.
Adam Jacobs – join the dark side, you know you want to!
Unfortunately all scientific research is fallible. Even if we have a million subjects and a double blind placebo study, in the end we have to rely on the honesty of the researchers that they followed these protocols to the letter, reported everything of relevance.
However, blatant dishonesty is probably not the biggest problem in science. It is the dishonesty that is unconscious that permeates all research, hypothesis and conclusion: it is this that weaves the tangled webs. Most people believe in what they do and even the most corrupt people seem to believe in the integrity of their work. I have never heard of a politician caught with a blatant conflict of interest not say – oh yes, but my ties to Big-Multi-Nat had no bearing on the decisions I made!
It is interesting that Mr Jacobs points out that Dr B has been ‘trialing’ this wonder drug since the 1970’s but has never published a single paper. My conclusion from this is that Dr B most certainly believes in this treatment he has pioneered, and is as alleged probably using the ‘trial’ status as a means to keep the treatment going. The reason he keeps these ‘trials’ going would be two-fold. One, it is earning him a good income – and in the US, I assume scientists are less likely to feel ashamed by being rich! But, the other reason would be that he really believes he is giving his patients good value for what they pay. His commitment to the treatment regime is good cause to believe he believes in it himself – otherwise I would assume he would have moved onto to new snake-oil by now. This does not mean his treatment works, just that he is probably no less honest than most scientists who believe in their own hypothesis.
I understand we like to designate ideas and people to the good and bad categories, but I come to the conclusion that this is a false dilemma. The only issue that really matters in all this is whether the treatment really works, and maybe it is the question Adam Jacobs and Malcolm Kendrick might have some background to pursue. Of course, if we pursued every ‘quack’ cure to cancer, we would be searching for needles in the haystack, so some sort of skepticism is needed to help us. However, skepticism that says, ‘there are no needles in any haystacks – needles can only be found in 100% certified needle shops’ is the type of thinking that sees witches, quacks, heretics, geniuses and haystacks all getting burned!
Dr Kendrick dreams of a world where scientific objectivity can be assumed – but I think it is both a false hope and maybe even not the best outcome. In the end, it is our human subjectivity that in the end gets results. It is our dogmatic beliefs and stubborn refusal to admit defeat that leads to triumphs. History beatifies the winners and those that pursued an incorrect path become the villains. How should we judge them now? what makes the maverick scientist wrong and the scientist on the University pay role right? Is it the end result that matters or the means they pursued their ideas?
Congratulations on your success, but can you explain why Burzynski has become labelled a maverick?
The pattern seems so common in science – anyone with an inconvenient message becomes ostracised, and their research shut down!
I think you just answered your own question
Is Burzynski delivering an “inconvenient message” the only reason you are aware of Dr Kendrick?
Yes, but what exactly was inconvenient about his message?
Malcolm – you are my favourite blogger – a relentless fighter!
Congratulations to this victory – raises my appetite!
Bravo Dr Kendrick – Yes, am aware of Burzynski’s work – impressive. And would like to draw your attention to : Cancer: The Forbidden Cures – YouTube http://www.youtube.com A fascinating series of youtube presentations. In addition, there is the work of Royal Rife and his Rife frequencies. Many do regard Rife as more snake oil, but check it out.
In the main, the cure for cancer is certainly right now in our hands, unfortunately invested interests keep much of the world from accessing these cures. Appalling. But one day, and not, I hope, in the too far distant future, the amazing breakthroughs by brilliant minds will be openly acknowledged, and ALL will have access to not only these cancer cures but to the other technologies and information that have been suppressed by overly weighty and totally self-interested powers.
Kendrick – thank the Lord for your bravery and assertiveness – a breath of fresh air in the overly-stifled atmosphere of self-interest that sits under the banner of ‘medicine’ and ‘care’…quelle misnomer ! Best to you sir –
MEC
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Here is a better link to the youtube documentaries : https://www.youtube.com/results?search_query=cure+for+cancer+conspiracy and this is the full documentary – superb presentation of what is assuredly a medical dictatorship directed by vested interests : https://www.youtube.com/watch?v=s7J0nW7w4tY
MEC
Excellent youtube documentary on the work of Burzynski – https://www.youtube.com/watch?v=2BH9XTxb290
Let the documentary speak for itself, am sure everyone will be appalled at the actions of the FDA backed up by the pharmaceutical industry –
I refuse to support in any way ‘cancer research’ but the work of Burzinski should be supported by all.
MEC
I have followed Burzynski for a while now and I do think he is an unscrupulous person who does exploit the desperate.
Well, I suppose he might be. But I have met him a couple of times and, whilst he can come across in a certain way, I do not have any doubt that he believes that he is trying to help people. One of the greatest problems in medicine/science is trying to establish what is true from what is nonsense. The history of medicine is stuffed full of people ridiculed as charlatans who were later vindicated. The history of those challenging the radical mastectomy is particularly depressing, as was the fate of Semmelweiss. Gregor Mendel died disbelieved, as did John Snow etc. etc.
I would trust your judgement on his motives. You are more my kind of maverick though, not making money from unproven treatments.
Yes, but we all need to make money somehow or another. I am lucky enough to be comfortable without having to sell anything to anyone – currently. I hope that making money does not preclude you from also being someone who seeks the truth? I have, after all, got a book to sell.
It’s just that if you have cancer with a poor prognosis, you are going to be vulnerable and desperate. You are going to believe a Burzynski if he tells you he can cure you. Of course you are. But if that cure is unproven and may even cause more harm, like antineoplastons in my opinion, and expensive – to be brutally frank you are still going to die. But your estate is going to be a lot poorer.
This is a million miles away from selling an informative book.
Did not stop Big Pharma with some of their psychiatric drugs which have been shown to be little better than placebos (The Cochrane Collaboration I believe) and inventing conditions that can be “treated” with their drugs. An excellent book on risk is Gigerenzer, Gerd (2014-04-17). Risk Savvy: How To Make Good Decisions (p. 49). Penguin Books Ltd. Kindle Edition. A useful chapter on survival.
Oh yes! I certainly believe in challenging all research which I have done with several organizations such as NICE, DoH, MHRA and sundry charities. They never answer because the can’t; their solution is to ignore all reports and data that is contrary to their belief. If that is medical science today the Dr Ioannidis is absolutely right – most research is flawed and it not just the “mavericks”
Fergus
I fully agree with Malcolm. There are no good options to earn a living in a way so you can live with what you are doing. I wonder how you manage that if you at the same time are fully aware that you are doing your patients harm by subscribing numerous drugs. Is it possible?
Perhaps that is why most GPs close their eyes and ears and follow the ‘rules’ – and then completely suppress any inquisitive tendencies.
Prof
I know it’s a cliche but two wrongs don’t make a right.
As I understand it many, if not most of his patients are those that allopathic medicine has failed. It may well be a last chance, good or bad, that those patients seek and have every right to seek. Unfortunately conventional medical journals use experts as referees who are interested in maintaining their status and the status quo. If his results are refused publication no one knows what is happening. We do know that published papers are indeed flawed but nobody is accusing the authors of “exploiting patients” which they are in fact doing.
Fergus, “It’s just that if you have cancer with a poor prognosis, you are going to be vulnerable and desperate” Trust me, I’ve been there but I refused to be either vulnerable nor desperate.
Burzynski has been hauled before the courts on numerous occasions on the premise that his treatments were harmful, they failed to show harm and convict on every appearance, believe me they tried. In fact they tried every angle and failed to get a conviction from any direction.
Another thing often cited is the cost to the patient, what they don’t tell you is some of the mainstream cancer drugs prescribed can be in excess of £6k per month, so we’re talking serious money here.
A hope in itself can have curative properties just as no hope can achieve the opposite.
I am neither a proponent or endorsee of Burzynski’s treatments, he may well be a charlatan and a crook, I don’t think he is, I think he’s looking at a problem from an unconventional angle.
Let it run and see what the conclusion is, if there’s anything in it they will find a way of patenting it. If it gets buried it’s either wrong or there is no credible way to monetise it.
Throwing bricks at it at this stage isn’t the way forward. If the establishment had it’s way we’d still be resectioning stomachs for ulcers.
My gut prophecy would be, some form of his therapy will be adopted but he’ll get no credit for it, he’s damned if he’s right and damned if he isn’t. Let it run.
Flyinthesky
Obviously not everyone will be vulnerable and desperate – you weren’t. I was being conversational. However lots of people will, especially parents of sick children. In my opinion these are who Burzynski relies on (he may or may not believe he is helping).
Burzynski has never been taken to court. The Food and Drug Administration (FDA) pulled him up for administering drugs over many years that had not been through proper trials for efficacy and also had not been tested for safety. He was banned from using antineoplastons until these trials had been done – they never were.
Fergus. And what trials were done on CABG? None. And what trials were done on penicillin? None. And what trials were done on hip replacements? None. And what trials were done on nitrates? None. And what trials were done on thiomersal? None. And what trials were done on HRT? None. And what trials were done on breast screening? None. And what trials were done on kidney transplants? None….And what trials were done on….etc. The vast majority of medical interventions were introduced with no studies done. In the UK OoF was introduced with no trials done. Was there ever a controlled clinical trial on smoking… Most of what we do as doctors has no evidence base to support it. So, what do we do? Pick and choose what we like, who we like? Stop doing everything that has not been subject to a controlled clinical trial? I don’t know the answer to this by the way, but I think we must accept that massive controlled clinical trials cannot be the only evidence base we can pay any attention to.
The FDA, with its revolving door policy with Big Pharma has been described as “not fit for purpose” Time and again the leadership has reversed decisions of its own experts. I refer you to the case of VIOXX and Dr David Graham and Senator Grassley. Prof. Gotzsche has a whole chapter on the failures of the agencies designed to protect the general public but spend more time protecting the interests of Big Pharma. ..
Malcolm
Everything you say is correct.
However for specific drugs these days you need to jump through hoops to get to market- 6 or 7 years. We are talking about an anti cancer drug here. It needs to be shown to have some effect and reasonable safety. Otherwise anybody could start selling any harmful product. If Burzynski’s drug is effective why did he only publish phase 1. Why not go through the hoops to phase 2 and 3? IMO because they don’t work.
Well, you may be interested to know that I am just looking at a phase two study on antineoplastons, published five days ago. So, hoops have been jumped through, and I shall be writing about victory number II shortly. However, to do a phase III study, when you cannot patent your product is the preserve of the curious billionaire. Just say I, or you, or Burzysnski wished to do such a thing. It would cost millions, probably tens of millions. If it were positive then you could never, ever, get this money back. For a generic company can breeze along, start manufacturing and selling your product, that you did the clinical studies on, and you could do nothing whatsoever about it. Whatever money you spent on the trial would be gone – forever. Looking at another area, there is very strong evidence that IL2 can be enormously effective in limiting brain damage in stroke. IL2 cannot be patented, no-one was willing to do the trial. I think some money has now been found (this has nothing to do with Burzynski, or me). The sad fact is this. First you need to patent your compound, then you can do the clinical trials – that can cost hundreds of millions to do. They you have to have a massive marketing machine behind you to sell the drug around the world. The only organisations that have the financial power, and infrastructure, to do this are pharmaceutical companies. By creating the system we have, we have fallen into a terrible trap – and I do not know how to get out of it.
Your point about patents and the cost of Phase III trials is absolutely correct. The ALLHAT study that tested the 50 year-old chorthalidone against three new comers for BP as you know is an example. Despite the fact it was the best, it came last in the usage lists because of advertising and promotion. I think it was Dr Marcia Angell who drew my attention to this absurdity
Phase 2…? You’ve got my attention.
So either you have millions of pounds to do full trials or we have to trust someone who says “Take this. It works honest” Neither seems to work.
Yes, phase II. Fergus, I think the main point here is that Burzynski has not said – ‘do not use conventional cancer treatments, come to me and I shall treat you with antineoplastons instead.’ As far as I know all (at least the vast majority) of his patients had been through conventional treatments and had either been told ‘there is nothing more we can do’ or the patient had said ‘I am not undergoing any more radio/chemo.’ He has tended to be the last chance saloon. A child with a gliobastoma will always have had surgical treatment, usually radiotherapy and/or chemotherapy. I think this is important – at least it is to me.
Thank you for posting that link. A very powerful documentary.
Congratulations on the successful publication of the paper – not an easy task, I’m sure. I recognised the name of Dr Burzynski from Ty Bollinger’s documentary series ‘The Quest for The Cures’ which seeks to enlighten the public about which successful treatments (other than cut, poison and burn) are available, as well as how to prevent cancer in the first place and ways you can help yourself combat the disease. He is an amazing guy, battling on despite enormous opposition, as are the other specialists featured in the series. I learned an awful lot about ‘the cancer industry’ and how so many successful and far less dangerous treatments are helping people to survive for many, many years when they would otherwise have been long gone by now had they taken the orthodox route.
If anyone is interested in watching this series for free (which I highly recommend) they are being shown again, one per evening, from 31 March till 9 April. See this link where you can register:
http://thetruthaboutcancer.com/quest/?utm_source=NewsletterVol10&utm_medium=email&utm_campaign=Newsletter
It did take a while to convince people that the world is round and that it revolved around the sun. It took a long time to convince hospitals that stritct sanitary conditions was vital for patient survival and health. The beds that were use for corpses were used for women who were having babies. A doctor made a connection and discovered this. He tried telling people about it, but everyone thought he was nuts and they locked him up. There was no such thing as bacteria, there was no such thing as bacteria. Dr.Kendrick I think you can you wilk have nice laugh after reading this article: http://mobile.nytimes.com/2015/03/23/opinion/the-myth-of-high-protein-diets.html?_r=0#_=_
http://www.typesofbacteria.co.uk/how-when-were-bacteria-discovered.html
Indeed, there are many such examples; blood letting, hifat diets for weight reduction (Banting – circa 1860s), infections, six weeks bed rest for heart attack, stress for GI ulcers (H. pylori) and so on and on. Most of these “wrong-uns” supported by the medical establishment of the time to maintain their status (and no doubt their income). Big Pharma and its KOLs have little to be proud of, were the truth known.
In my opinion, high fat diets are great for weight reduction (and overall health). Banting wasn’t part of the “establishment” and instead was an undertaker.
http://bantingdiet.org/
As such, he’s more like a Gary Taubes, — a total outsider telling the “establishment” they are wrong (or at least not scientifically sound).
Mike, Banting refused to take any profit from his best-selling book. He wanted others to benefit from what he’d learnt. We’d be a lot better off if we’d followed his guidance rather than the high carbohydrate diet promoted from 1983 to reduce heart disease. It’s been a disaster. You might be right about the rest, but you misjudge the principled undertaker Mr Banting.
Stephen
I am afraid you or I misread my intention. I am a strong supporter of him; he was way ahead of his time and an example of how facts can be ignored. Ancel Keys set the hicarb/lofat bandwagon rolling by using a SELECTED 7 countries to prove his belief. An early example of grossly flawed research while Yudkin was providing evidence that sugar was BAD (Pure, White and Deadly circa 1972) was totally ignored by the medical establishment as usual. And guess what, researchers now say sugar is BAD and is promoted by individuals who were probably not out of infant school at the time.
Mike, I couldn’t agree more with your clarified comments about Banting. John Yudkin seems to have been the ignored hero from that period, who suffered at the hands of Ancel Keys. I understand that when Keys was looking for a reason for heart disease, he didn’t even consider smoking. He was clearly a dominant figure who gradually silenced opposition. As you no doubt know, Nina Teicholz has spoken eloquently about this.
It’s astonishing that the high carb/low fat is still official policy. It’s incredible that diabetics are still given this terrible advice. It’s hard to see how it could have been a bigger failure, but these things take on a life of their own. I understand that guidance from 1820 – 1980 warned that carbohydrates increased weight.
A desperately sad aspect of human nature that I’ve seen many times is the refusal of experienced practitioners to abandon bad policy. If you’ve spent most or all of your professional career promoting harmful guidelines, admitting the error is just too painful. Most people prefer to continue with bad policy rather than acknowledge their involvement in a huge mistake. Nutrition stands out in this regard but I’ve seen this in other fields.
Nina Teicholz’s book is an indictment of those who continue to support the HCLF advice, but there is a long list of authors who have criticized this advice with well referenced books; Taubes and Groves spring to mind.
Frrankly, I no longer believe any research supported by Big Pharma money and technical expertise. Money and status have replaced scientific integrity. This is unfortunate to say the least. I have, some decades ago, worked with pharmaceutical companies with no problems. One did the research, wrote the report and, out of courtesy, let the company see it; no attempt to influence the results or conclusions. Sadly, these companies have been swallowed up in take-overs managed by the a-ethical money men who only are concerned with money and to h*ll with everything else.
Congratulations on getting the paper published. I haven’t read it, and probably won’t as I don’t have an interest in the subject, but I do wonder did why peer reviewing means research has to conform to current confirmation bias before publication can take place. No wonder research moves on at a snail’s pace.
And when did the term maverick become pejorative? Maverick:
“A person who shows independence of thought and action, especially by refusing to adhere to the policies of a group to which he or she belongs.”
Maverick, that’s the point I’m trying to make, there has been no progress, from the middle ages, that hasn’t been proposed by a “maverick”, an analogous definition of consensus would be stagnation. There is no possibility of progress within the constraints of consensus.
In the middle ages the consensus was to confer power, control and influence. In modern times we have the multiplying factor, money.
Max Planck is reputed to have said that: Science progresses funeral by funeral. In short science is about maintaining the status quo and the status of the experts. Lots of examples
Response to Fergus “if you have cancer with a poor prognosis you are going to be vulnerable and desperate”. Really. Do you know that from experience or is that just your opinion? As a person who has a disease which is progressive and untreatable, with a prognosis of a couple of years, I think I can speak for many in the same situation who don’t feel “vulnerable and desperate” but in fact look for hope where hope is available. If orthodox medicine offers no hope or help, it really doesn’t have the right to stand on it’s lofty eminence and sneer (and worse) at unorthodox treatments. It is not “vulnerable and desperate” to see just what we can do for ourselves by researching the options. It sure is better than just accepting what the doctors say and doing nothing to help ourselves. We may take action which gives us some control and empowerment over our situation and if that action involves accepting treatment from doctors working outside the mainstream, then that is solely our decision. Having a terminal diagnosis does not mean our brains turn to mush and we go running about saying “save me! save me!” , most of us are perfectly capable of researching and planning our strategies so please, don’t patronise.
I watched the movie about Hannah and her trip to Texas. I was profoundly moved and am so very happy it worked for her. Towards the end of the movie her partner asked her how she felt about the skeptics now. She replied that she wondered how they would feel, to be told that they had a short time left. And that is so true, it results in a very different view of things, than just having an intellectual opinion of what it it might be like. I don’t know anything about Dr. Burzynski or his clinic, but clearly Hannah benefitted from his treatment, much more so than the conventional treatment that she had.
Maureen
How do you know I haven’t also got a progressive and untreatable disease?
If as you state you don’t know anything about Dr Burzynski why are you defending him?
OK Fergus. Do you have a progressive and untreatable disease, or do you perhaps have an agenda?
Maureen, I’m with you all the way. You speak very eloquently.
So Fergus….just what does your sharp response to Maureen add to this discussion? Her point was valid, and maybe came over as rhetorical, rather than requiring a personal statement about your own health.
I seem to recall you may be a GP? If so….enough said.
I have had my fill of being stiffled by conventional, dyed in the wool GPs. Maureen is perfectly entitled to seek unorthodox treatments as much as she wants to, without answering to anyone else. She does not have to justify why she chooses that pathway.
I have gone 180 degrees against NHS advice, and know what it is to come up against clever dicks who think they can wriggle out of situations by using the tack of boomeranging back as you did. I never tell people to copy me by abandoning convention, I merely tell my story, as Maureen does.
Some retorts on this blog have incensed me today….where’s that bottle of whisky!
The problem for the layman is sorting out the deluded from the original thinker, the David Tredinnick from the John Snow.
I regard homeopathy as laughable nonsense, but plenty of people believe in it, supported by a few doctors and a ‘maverick’ Tory MP David Tredinnick, who also thinks astrology is useful and apparently charged the taxpayer £755 for special astrology software. This Right Honourable Gentleman sits on a parliamentary select committee for health! Professor Robert Winston described Tredinnick’s views as ‘lunatic’ in a Daily Mail online article and I would agree and feel safe in putting Mr Tredinnick in the fruitcake category. Mr Tredinnick is quoted as saying, “some scientists refuse to accept the principles of homeopathy despite the fact that homeopath doctors have been regulated by an Act of Parliament since 1950.” Just some scientists refuse to accept homeopathy? I think the overwhelming majority would be more accurate.
People have a right to believe in homeopathy, but I object strongly when they claim it’s supported by science, as they frequently do. It’s not, as Ben Goldacre amusingly explained in ‘Bad Science’. It’s nonsense built upon absurdity.
Perhaps a sceptical but open mind is the only way to proceed. When I first began to question the diet-heart hypothesis, I encountered this website and after reading and checking a great deal of material I gradually became convinced that statins were close to useless and that we’d all been conned and harmed by Ancel Keys and the disastrous dietary guidelines that followed.
I recently abandoned the low fat diet and moved to a low carbohydrate, higher fat diet. Within a short time I felt more energetic and mentally alert. This leads me to wonder how much obesity, diabetes and mental ill health have been caused by the needless fat phobia of the last thirty years? It is truly astonishing that the NHS is still telling diabetics to eat a high carbohydrate diet, which convert into glucose inside the body. People who can’t properly process glucose are effectively told to eat glucose? Am I missing something? It seems wrong-headed to an extent that almost defies description.
There seems to be a worrying connection between statins, a low-fat diet and memory loss/anxiety/depression. Stephanie Seneff certainly links statins and a low fat diet with Alzheimer’s. Research, naturally, is concentrating on finding a drug solution when the answer might be an awful lot simpler.
The problem is that once you realize that there is one area where “experts” are wrong (such as a low fat diet), you’ll then begin questioning everything. Therein lies madness. I used to believe in low fat diets, everything my doctor told me, flu shots, homeopathy is bad, etc. Once I went on a high fat, low carbohydrate diet and realized I felt fantastic even though all the experts told me I “needed” carbohydrates for energy, I confronted everything I thought I knew was correct. Now, I’m on a high fat diet, don’t believe anything my doctor (or dentist) tells me (unless independent study confirms it), don’t take flu shots, think at least some homeopathy is OK, etc. I can’t whether I’m free or just some crazy loon who no longer trusts anyone.
Bob, I agree that once we discover the fallibility of experts the door is open to further scepticism. I fully agree with those who value the importance of “That’s funny” as a crucial moment that provokes the curious.
You’re not a crazy loon. However, I’m more likely to believe in Santa Claus and fairies before homeopathy. “Please explain how it works?” is the best way of debunking this subject. The answer is ridiculous beyond words.
I too am skeptical about homeopathy but please explain the placebo effect. A sugar pill is hardly an allopathic drug. I like to see the data but observationally there are “cures” that I have seen but cannot explain. Mind over matter perhaps. I do not know but I do know that I was taught at the LSH&TM to keep an open mind.
Re ‘placebo effect’. According to Professor Peter Gøtzsche, having reviewed the data, antidepressants are barely more effective, if at all, than a placebo. Yet they are prescribed at the drop of a hat and patients claim they get better on them. Nobody seems to take issue with that. Yet if, for example, homeopathy is accused of merely being placebo effect, there is uproar even though the latter has no side effects and patients get over their depression whereas the former may be addicted to their drugs, suffer long-term sexual dysfunction, weight gain/loss, potential permanent effects to the brain and plenty of other unpleasant effects. Some people go to a homeopath to get over their addiction to antidepressants and succeed. I’d rather use a ‘safe’ placebo than something that permanently messes up my brain!
anglosvizzera
Indeed that is correct – for many there are no benefits using anti-depressants. For others they do work. This is why I would like to see a drug description that gives the probabilities of benefit, non-benefit and adverse reactions for the individual rather than relative percentage rates. After all a reduction of fatality from 2/million to 1/million is a 50% reduction but totally irrelevant as a measure of benefit.
There is an element of hypocrisy in the attack on homeopathy and other forms of alternative medicine – the placebo effect is acknowledged but homeopathy et al are criticised.
mikecawdery
It is difficult to know whether antidepressants do actually help anyone – again, according to Dr Gøtzsche, most cases of depression resolve in an average time of 8 months. So even if someone feels the drug is helping, this may have been the illness resolving on its own or placebo effect.
What is not disputed, however, are the adverse effects (eg sexual dysfunction, sometimes permanent) that so many people have with them. And the potential for permanent adverse changes in the brain (which has been demonstrated in animal studies) particularly in children and young people, and the ‘withdrawal’ symptoms which mimic ‘dependency’ and occur in healthy test subjects who develop anxiety and depression when withdrawing, although they never had those symptoms before the drug.
Sorry, got carried away again…..:-(
Another case of the probability of adverse reactions versus the probability of benefit for the individual.
Unfortunately many doctors either don’t know or don’t care that the actual adverse effects that patients experience are not listed on data sheets, nor reported back to the drug companies very often – so for an individual to judge purely on what information they are given by the prescribing doctor about whether to go ahead with the antidepressant is rather difficult. They wouldn’t be told of the likelihood that any response is probably placebo either. The website (connected in some way with Professor David Healy) http://www.rxisk.org, gives patient feedback on their experience of drugs. Of course, anyone who doesn’t have an issue won’t have contributed so it’s still a bit biased. But having a 16 year old daughter who is currently on antidepressants (2 at once!) because she is deemed old enough to decide for herself based solely on the patient information leaflet, it is a cause for concern to me.
Germanwings co-pilot had serious depressive episode: Bild newspaper
One wonders
mikecawdrey
Yes, I too wondered about the pilot. There are countless cases of suicide/homicide linked with antidepressants. It seems that Robin Williams was on Mirtazapine at the time of his death by suicide (which doesn’t fill me with confidence as my daughter is taking that one!). Professor Gøtzsche, with whom I have recently corresponded, pointed out to me in his email that any change of dose, either up or down, can bring on the risk of suicide/homicide so people are at risk even when trying to wean themselves off the drugs.
We have no idea if the co-pilot was, or was not, on an anti-depressant
Indeed. Or statins leading to TGA . I wonder if the truth will ever be known. It seems that he did have medical problems.
No, we don’t. We’ll probably never know either.
Stephen Town
Very good comment to me since my own way to complete disbelief in the school medicine followed actually the same path as you indicate.
The problem arises for any guy trained in the hard core natural sciences when it comes to benefits of things like homeopathy. The problem is not that there are believers but when the claim is that there are firm scientific proofs of a ‘drug action’ when there is no drug taken or rather just the ‘memory’ of one. This is really revolting to my mind which still does not exclude me from believing in the neuropsychological effects generally accepted as the placebo effects and well documented.
Thank you, Goran.
Don’t we need to take a balanced view and avoid swinging from one extreme to another? The current medical orthodoxy is clearly sometimes wrong, but I don’t assume it’s always wrong. When it’s wrong it seems to be because of a fixed paradigm or because of a vested interest. Statins, of course, are a classic example of the latter.
If I break a leg I think I’ll accept the doctor’s treatment. If I’m going to be prescribed a drug for the rest of my life, I think I’ll look into it.
Stephen
Indeed a balanced view is essential but it has to be based on honest research and OPEN ACCESS. At $30+ for a few pages of a downloaded pdf file is disgraceful.
In the wider context of this discussion Dr James LeFanu’s book The Rise and Fall of Modern Medicine is an excellent review of the advances and failures (post 1980??) of medical research. My own objection is the so-called “Social Theory” which followed from Bradford-Hill’s work and the advent of computers which allowed huge quantities of data, relevant and irrelevant, to be processed with a guaranteed report and conclusion at the end. You know the sort of thing – eggs good-bad-good.
But more importantly, this leads to what I call “Diagnosis by Herd”; the individual patient no longer exists. If he/she is defined by a test (or tests) to be in a “herd”, treatment follows even when the probability of benefit is tiny, wwith the only beneficiaries being the drug makers. The nearest the experts get to this individual probability is the NNT which is frequently not given and hidden behind a relative rate.
Since the subject of alternative treatments of cancer is the subject for the present blog I must here commit that I have lost all confidence that the orthodox ‘evidence based medicine’ has much to do with any kind of natural science I am used to (metallurgy) specifically because you are refrained from scientifically scrutinise the test data behind all these ‘wonderdrugs’ for cancer.
With that lost confidence alternative medicine turns more interesting and if I myself would get serious cancer I would for sure test safe alternative methods before subject myself to chemotherapy or the knife who are without any ‘side effects’ and I tell you what I think would be my pick.
– An ‘extrem’ ketogenic diet with the blood ketone glucose ratio larger than one
– Drink a very diluted kolloidal silver solution
There are evidently a lot more alternatives around, including the texas doctor, which I should look at.
Anyway, I am writing chronicles on a Swedish ‘controversial’ GP-blog and the present chronicle is actually about an alternative treatment of cancer. I have never had so many comments (almost 200 !) – so the subject is definitely ‘hot’ – surprisingly no hostile comments so far. The title of my chronicle is appropriately “The sensitive subject about cancer”
For those here not mastering Swedish you may press the translation button to get an idea in case of interest.
I watched this 20 20 special on line about the use of Polio virus to fight cancer. There has been a lot of similar treatments being tested. Spontaneous remission of cancer and also the use of infection to treat cancer is not new.
http://www.cbsnews.com/videos/cancer-free-after-one-dose-of-polio-virus/
Click to access Report-Bugs.pdf
http://www.nature.com/bjc/journal/v92/n3/full/6602386a.html
“Their most fervent wish is to cry ‘Eureka’ (I have found it – the thing that I knew was there). The true maverick, however, is on a restless quest for ‘that’s funny.’ For only in the ‘that’s funny’ moments does science truly progress.”
I think you’re paying them a kindness, as I’m not so sure pharmaceutical companies want a real Eureka. There’s probably not as much money in that as there is in stringing along patients with endless rounds of chemo drugs and radiation.
Fergus, your comment: “how do you know I don’t have a terminal progressive disease?”. I don’t. You didn’t answer me when I asked if you had any experience for your previous comment. So, do you?
I’m not defending anyone, simple noting that Hannah, the woman who visited Dr. B’s clinic, had a positive outcome.
Maureen
I do have a terminal progressive disease. But I have never had terminal cancer. I re-read your post and you were’t defending Burzynski. Apologies.
Hannah is not the only woman to visit Dr B’s clinic. She’s just one of the very, very few who are still alive. Dr B has treated thousands of patients. Most of them died. He shouts from the rooftops about Hannah because he doesn’t want you to pay too much attention to all the thousands of others.
Yes, most of them died. Your point being? Most people who took part in the HPS study, who took statins, are also dead.
Surprised you feel the need to ask that question, Malcolm. If you’re claiming to be able to cure cancer, I would say it’s rather a big flaw in the claim if most of your patients die, isn’t it?
Adam, you claim to be the stats guy? Burzynski has never, ever, claimed that he cures everyone. Do you think a treatment has to cure everyone to be sold as a ‘cure?’ That’s an impossibly high bar. All (almost all) chemotherapeutic agents (for cancer) are measured on increase in median survival – not cure rates. You must know this. If Burzynski doesn’t cure most of his patients he is a fraud. But if pharmaceutical companies launch products, with great fanfare, that increase medial survival by three months that is OK?
By the way, are you happy that all of your questions about the paper have now been answered. Or are you just going to keep changing the subject.
I should also point out that all of my patients will always die. That is inevitable. All we can do, in medicine, is to keep people alive for longer – or reduce morbitity (hopefully both). Perhaps you feel Burzynski’s treatments should make us immortal.
It is rather like Vitamin D. Not patentable but with wide benefits to health. Big Pharma supporters try regularly to discredit this and other vitamins by using trivial doses while their experts try and get vitamins defined as “medicines” in WHO.
Unfortunately, by using “survival rates” and “relative rates” allopathic medicine is doing precisely what you are complaining of; flawed medical advice. I, as a patient, want to know the probability that I will benefit from treatment. Statements like “treat 3 million (with statins-Collins) and 10,000 lives will be saved every year” means to me that I will have a probability of 0.003 of benefiting and a probability of 0.997 of NOT BENEFITING with a probability of ~0.2 of suffering adverse reactions. As as statistician I hope you appreciate my concern.
I never claimed that Burzynski says he can cure everyone. But he does say he can cure some people, and there is simply no evidence of that.
I would agree that a cancer drug that can improve median survival by 3 months is of limited benefit. But we have yet to see evidence that Burzynski can improve median survival at all.
And no, I’m not happy that all my questions have been answered, because my most important questions haven’t been. I merely accepted your response that you weren’t going to answer them, so I have refrained from labouring the point. I’ve asked the same question of the authors as a comment on the published paper, and we’ll see what happens if and when they answer.
Obviously Burzynski can’t make people immortal. But I don’t think it’s that unreasonable that if he’s going to charge such eye-wateringly large sums of money for his treatment, he should at least have some evidence that they have some benefit. He doesn’t.
By the way, Malcolm, I also want to say thanks for entering a discussion in the spirit of genuine debate. This is undoubtedly the most sensible discussion I have ever had with any supporter of Burzynski’s treatment. We may disagree, and I suspect we’ll end up in a position where we still disagree, but I feel that so far we are doing so honestly.
So thank you.
Indeed, thank you. I do try to keep and open mind and keep debate going. I think it is important. As a fellow traveler said to me. In science we should be playing tennis, but everyone seems to be playing golf.
Adam, I’d never heard of Burzynski before reading this item. You clearly have background knowledge that leads you to have strong feelings on the subject. You describe Burzynski as a crook, not mistaken or misguided. You believe that he’s not just wrong but dishonest. Can you tell us what makes you think this? With no prior knowledge, I read Dr Kendrick’s entries as someone who is simply keeping an open mind. I think that’s usually a good thing until evidence is presented that requires a change of mind. Perhaps you could explain your reasons for regarding Burzynski as a crook?
“Perhaps you could explain your reasons for regarding Burzynski as a crook?”
An excellent question, Stephen. When I first heard of Burzynski and realised that things were not as they should be, I really couldn’t decide whether he genuinely believed what he was doing was helping people but was just so mired in confirmation bias he couldn’t see that he wasn’t, or whether he was actively dishonest. It’s very hard to tell, and while I now lean strongly towards the dishonesty explanation, I can’t be 100% sure.
But what finally made up my mind was the BBC Panorama programme on Burzynski, in which they interviewed him. The way he answered the interviewer’s questions was really very hard to reconcile with someone who was just trying his best but not terribly good at research.
My suspicions were then made stronger by seeing the reports of his FDA inspections. Destroying clinical trial records could just be an honest mistake, but that doesn’t seem like the most likely explanation to me.
Adam, I must say that I wonder why you don’t turn your undoubted brainpower onto the pharmaceutical industry. Attacking Burzynski, OK, you can attack whomsoever you like. But if you are talking about significant harms, and distortion of evidence… Burzysnski could harm, maybe ten thousand people, in total. Dan Poldermans, by falsifying his research on beta-blockers, then writing the guidelines on the use of beta-blockers in the peri-operative period could have killed 800,000 – not my estimate. Roche will not release their data on Tamiflu, the CTT will not release adverse effect data of statins, the JUPITER study was stopped early, before reaching pre-specified end-points, the recent study on Ezetimbe doubled the study population as they were not reaching statistical significance with the original study population. I could go on, and on, and on. Why don’t you go and look at some real data distortion that could affect tens of millions of people? To be honest, there are probably enough people attacking Burzinski, it would be nice to spread the attacks around a bit. Perhaps you could help me in my attempts to attack the bloated cholesterol lowering industry.
Survival rates are inflated by setting the time of diagnosis earlier. Contrary to what many people have been told, there is no evidence that early detection and subsequent treatment of prostate cancer prolongs or saves lives.
Gigerenzer, Gerd (2014-04-17). Risk Savvy: How To Make Good Decisions
This book provides an excellent interpretation of “risk” in medicine and how it (risk) is used to “fool” the general public. Well worth reading
Malcolm
You said:
“Adam, I must say that I wonder why you don’t turn your undoubted brainpower onto the pharmaceutical industry.”
This is the question I constantly ask ferocious attackers on alternative medicine. I just wonder why they are using all that high level energy fighting alternative treatments which at worst are innocent from a side effect perspective. To fight the corruption of Big Pharma as you do is a far more challenging task and definitely less rewarding and therefore worth admiration at least from me.
I wonder e.g. if and how Adam would attack professor Seyfried’s research showing that a strict high ketogenic diet has a tremendous potential to make cancer regress.
Looks like a phase 3 trial is on the way – http://www.anpcoalition.org/fda-clinical-hold-on-antineoplastons-lifted/
Adam, I must say that I wonder why you don’t turn your undoubted brainpower onto the pharmaceutical industry.
Because he works/worked for the pharmaceutical industry.
Oops, didn’t realise.
I have never worked for a pharmaceutical company, though in the interests of full disclosure I don’t mind telling you that I’ve spend most of my career working for companies that have pharmaceutical companies as clients. I currently work for a contract research organisation.
Anyway, I’m more than happy to criticise the pharmaceutical industry when they do bad things. But this discussion is not about the pharmaceutical industry. It’s about Burzynski. I prefer not to be distracted from a specific discussion. Maybe I’ll stop by this blog another day when the subject is actually the pharmaceutical industry, and we’ll see what happens then. But today, the subject is Burzynski.
Oh, well then, here is something for you to have a look at
A Phase II Study of Antineoplastons A10 and AS2-1 in Adult Patients
With Newly-Diagnosed Anaplastic Astrocytoma
Final Report (Protocol BT-08)
Stanislaw R. Burzynski1, Tomasz Janicki1, Gregory S. Burzynski1 & Ania Marszalek1
1 Burzynski Clinic, 9432 Katy Freeway, Houston, Texas 77055, USA
Correspondence: Stanislaw R. Burzynski, M.D., Ph.D., Burzynski Clinic, 9432 Katy Freeway, Houston, Texas
77055, USA. Tel: 713-335-5697; Fax: 713-935-0649. E-mail: srb@burzynskiclinic.com
Received: November 25, 2014 Accepted: January 5, 2015 Online Published: March 15, 2015
doi:10.5539/cco.v4n1p28 URL: http://dx.doi.org/10.5539/cco.v4n1p28
Abstract
The paper reports the evaluation of efficacy and safety of Antineoplastons A10 and AS2-1 (ANP) in a phase II
study of newly diagnosed patients with anaplastic astrocytoma (AA). The study was designed as a single-arm,
two-stage, phase II trial of ANP as monotherapy. The primary endpoint, was to determine the overall response
rate (confirmed complete response (CR) or partial response (PR)) to ANP, based on disappearance or more than
50% reduction of tumor size by contrast-enhanced magnetic resonance imaging (MRI). The goal of the study
was a response rate to ANP of not less than 10% or 4 patients. 19 patients (12 men, 7 women) ages 22-60 years
(median age, 44) were treated. The patients received ANP daily every four hours (median dose of A10 5.3 g/kg/d
and AS2-1 0.3 g/kg/d). The duration of ANP ranged from 3 to 175 weeks. A complete response was documented
in 21%, and stable disease in 26% of patients. The study was closed for enrollment after 19 of its subjects had
been admitted, because the goal of trial had been accomplished. Progression-free survival and overall survival at
2 years was 16% and 37% and at 10 years was 5% and 14% respectively. Only 11% of patients reported grade 3
toxicities consisting of hypokalemia and fatigue, and 11% reported grade 4 toxicities consisting of hypernatremia
and hypokalemia. There was no chronic toxicity and there was a high quality of life. ANP shows efficacy with
very good toxicity profile in patients with newly diagnosed AA.
Keywords: anaplastic astrocytoma, antineoplastons, glioma, phase II clinical trial
Cancer and Clinical Oncology; Vol. 4, No. 1; 2015
ISSN 1927-4858 E-ISSN 1927-4866
Published by Canadian Center of Science and Education
P.S. Acknowledgments
The authors express their appreciation to the additional physicians involved in the care of the patients: Robert A.
Weaver, M.D., Robert I. Lewy, M.D., Eva Kubove, M.D., Barbara Szymkowski, M.D., and Mohammad Khan,
M.D. Preparation of the manuscript was provided by Elizabeth Cleveland, Carolyn Powers and Jennifer Pineda.
Editorial assistance was provided by Malcolm Kendrick, M.D.
I will be blogging about this study shortly with full study attached.
Adam, if you work for a CRO the it would surely be more accurate to say that you do work for pharmaceutical companies? After all, they are the ones that pay the CROs – are they not? Or perhaps I misunderstand that relationship?
I think we’re in danger of losing sight of the main topic: the paper successfully published by the Japanese researchers, which has enabled this discussion.
I’ve spend most of my career working for companies that have pharmaceutical companies as clients. I currently work for a contract research organisation.
Sounds like you are paid indirectly by Big Pharma like Collins.
Dr K has written many blogs about drugs, drug companies and drug studies that are flawed but I do not remember your name supporting him.
“if you work for a CRO the it would surely be more accurate to say that you do work for pharmaceutical companies?”
Well, yes, indirectly I work for pharmaceutical companies. By the same token, employees of pharmaceutical companies work for the government, as the government is the main client of pharmaceutical companies.
Anyway, I’m not really sure any of this is relevant. We are in danger of being distracted from the topic at hand, namely the Japanese study.
And talking of which, I noticed something else rather odd about the Japanese study. The protocol that is linked to in in the paper is dated February 2003. It also contains the information that patients were recruited to the study between April 1998 and August 2004.
Does anything strike you as odd about that?
Yes indeed but then the EXCEL study (vytorin vv. simvastatin) was only registered after the study was complete and the publication itself was some 2 years late. And what about the many negative studies never published? Personally, I prefer to see a study published so that it can be judged on the data and criticized on that basis as you yourself have done in this case. But because you disagree does not give you the right to call the man a crook. Only the courts have that right
I referred above to the EXCEL study. I am sorry – slip of the pen. The study was ENHANCE which has been extensively reviewed by Dr Michel de Lorgeril in his book “Cholesterol and Statins…” Chapter 2. Worth reading!
” But because you disagree does not give you the right to call the man a crook. Only the courts have that right”
Fair point. On reflection, I must agree with you that the only proper source of such categorisations are the courts. And of course, the courts would seldom use such non-specific language as “crook”. So you’re right, it was unfair of me to call him a crook.
Let’s stick with what the court said. Can we agree that a more appropriate description of Burzynski is “proven fraudster”?
If that is what the courts said OK, but then I hope that you will agree that all the Big Pharma companies that have been severely fined ($multi-million up to $billions) by the US courts are equally guilty of “fraudulent” hiding of serious (fatal) adverse reactions; far more serious because they involve tens (at least) of thousands of patients. The AMA admits that 106,000 die each year from pharmaceutical drugs, properly prescribed and properly used. By a rough estimate this would suggest 20,000 dying in the UK each year based on relative population size.
Mike, yes I would completely agree that pharma companies have sometimes engaged in fraudulent behaviour, and there is no excuse for that. As you point out, some of them have been fined huge sums of money. In my view, that’s not enough, and when pharma companies break the law like that, the directors really ought to be held personally liable, right up to jail time if the offences are serious enough.
But of course that doesn’t mean it’s OK for Burzynski to be a fraudster. 2 wrongs don’t make a right.
“The AMA admits that 106,000 die each year from pharmaceutical drugs, properly prescribed and properly used”
That statistic is rather misleading. It counts only the harms of drugs, and not the benefits. There’s quite a good discussion of some similar statistics here:
http://www.sciencebasedmedicine.org/death-by-medicine/
It is estimated that Vioxx probably killed between 60,000 to 120,000 in the USA before being withdrawn. Had Merck not, very deliberately, redacted the CV safety data prior to publication of their trial data in the NEJM this would NOT have happened. Whilst two wrongs don’t make a right, most people would probably try to take action against organisation/actions that kill tens of thousands before moving onto someone like Burzynski who, as far as I am aware, has never been found guilty of killing anyone. At the very worst he may have charged people a lot of money for no benefit.
That is the point. !06,000 deaths a year but over 1 million harms. Take the HPS study as an example. 3/1000 treated “saved” per year; 15/1000 died despite treatment. 997/1000 not “saved” probability of no benefit to two decimal places = 1.00. probability of suffering harms 100-200/1000 per year, All this is hidden in the relative rate = 17% (156/937*100). I want to know the probability that a) I will benefit p=0.003 and/or the probability I will suffer a harm p=0.1-0.2. Alternatively the probability that I will not benefit.
I am NOT a herd, just an individual. Unfortunately statistics do not deal with individuals and diagnosis by herd (aka risk) is not suited to diagnosis of the individual except possibly when the risk is very high and death/morbidity is high and/or very serious. I was researching this back in the 1950s.
Adam has given his reasons for why he think Burzynski is a crook and, agree or disagree, his occupation doesn’t seem relevant to that discussion. If Adam does work for the pharmaceutical industry, I’d be interested in his views on the appalling scandals that Dr Kendrick raises. An insider could have valuable insights if he’s willing to share them. I have often disagreed with my employer’s policies and there must be people like that working for pharma.
There are indeed. I have been known to warn my clients about good practice breaches, and actually blew the whistle on one of them. I’m not aware that the regulator did anything.
Les Rosie and Adam,
Rose, you only blew the whistle on one? What do you do on the job…sleep? As I read yours and Adam’s attack of Burzynski’s practices, I could not help but chuckle. The amount of people pharmaceutical companies have maimed, killed, and cheated out of years of quality of life makes Burzynski look like the Mother Theresa of Healthcare. The reason Adam here has decided to “stop by” is that he thought he found ONE ARGUMENT he might win. If either of you had any courage or integrity, you would have voiced some opinion long ago about the problems with pharmaceutical companies. It is not like this blog is any big trade secret. Adam seems to think we are now waiting with baited breath for him to “stop by” and wow us with his views. He is apparently no scholar and certainly not much of a statistician either.
Dr. Kendrick don’t show up at your house to give your wife some flowers from the petro station, show up with something with a mineral content!! She deserves the best!!
Well done. We need more of that. The recent track record of regulators in this country isn’t encouraging, but we can at least hope that the failures at Mid Staffs and Morecambe might have taught people that ignoring inconvenient truths is wrong and can come back and bite hard. All these scandals could have been avoided if people had understood the folly of burying the truth. The problem is short-tem thinking. Get this year’s target met and ignore the bigger picture.
My first thought on perusing this long exchange is that those who know the background to the Burzynski saga are bound to require even more assurances regarding any claims associated with him and his business. I’m perfectly happy to declare my career of almost 40 years in the pharma industry, two thirds of that as a contractor in one form or another. In all that time, I have never seen anything approaching the catalogue of professional and ethical violations that are a matter of Buzynski’s public record. I won’t pepper this comment with links to all that, I’m sure you are perfectly capable of searching the FDA site for the various inspection reports. Also I have never heard of anyone else charging patients to enter a `clinical trial’; not just modest amounts, but vast sums requiring huge fundraising efforts, and involving inflated prices for routine procedures. How does he get away with that? Well his ethics committee (IRB) is not independent of his business.
It really is a cheap playground trick to try to divert attention from all this by raising the spectre of the pharma industry’s many shortcomings. As Adam quite rightly says, that’s not what this discussion is about. However poor the drug companies’ track records, which I don’t deny, Burzynski is in a class of his own for his abuse of good clinical practice and research ethics. He only survives because of his friends in Congress.
Let me correct a few errors here. Burzynski has not been hauled over the medical regulatory coals regarding his products, it’s because of his disregard for professional practice. Just read the Texas Medical Board material. It’s also a widely used fallacy to declare that many other established treatments have never had clinical trials, thus excusing a new treatment. Trials are only needed when we are in equipoise, ie the outcome of the treatment is in doubt. We don’t need trials of splinting broken legs, and probably not for hip replacements either. But do get your facts right. HRT was widely thought to reduce the risk of CHD, on the basis of observational data, until a huge RCT was carried out (The Women’s Health Initiative Study). This reversed the previously received wisdom. My point is that when there is doubt about the outcome, as there was with HRT safety (and there certainly is with antineoplastons) a randomised controlled trial is essential.
Oh, and when somebody uses the word `allopathic’ I stop reading. I know you didn’t Malcolm, but it did save me some time when it leapt out of some comments here.
Les Rose – Definitely some good points made, especially in the first paragraph.
Now, I completely disagree that Dr Kendrick is guilty of the errors you accuse him of.
You say:
“It’s also a widely used fallacy to declare that many other established treatments have never had clinical trials, thus excusing a new treatment.Trials are only needed when we are in equipoise, ie the outcome of the treatment is in doubt. We don’t need trials of splinting broken legs, and probably not for hip replacements either.”
No one has committed this fallacy here: you read too much into Dr Kendrick’s comment. As to the broken legs, etc, you’ll be happy to know that Dr Kendrick has actually gone on record saying the following: “No-one did clinical trials on hip replacements – which are a fantastic operation. No-one did clinical trials on penicillin – you didn’t really need to, dying soldiers were given penicillin and stopped dying. No-one has done a controlled clinical study on the damage that smoking does – but you don’t really need to.”
Also, let’s be clear here, Dr Kendrick has got his facts perfectly straight when it comes to HRT. Again, he has written about it in detail in other places. While I appreciate you don’t have to have read Dr Kendrick’s other writings to express an opinion on the subject at hand, it would be nice if you did the person hosting this discussion the courtesy of not putting words in his mouth. I suggest you go re-read his comment above. He is not equating HRT/CABG and the like to hip replacements, broken knees and the like. They all appear in his comment because they were all medical interventions that were introduced with no trials done. That’s all he’s saying there. He is also *not* saying, as you seem to have assumed/misread that if there is doubt about the outcome, trials are not desirable.
Now, since I’m running the risk of doing the exact same thing I’ve just accused you of (the bit about putting words in Dr Kendrick’s mouth), I’m going to say no more.
To end on a positive note, I’m happy to see you’ve acknowledged it wasn’t Dr Kendrick using the “a” word.
In my defence, I haven’t read Malcolm’s other writings on clinical trials and have to comment on how what he says here came across to me. He seemed to be justifying Burzynski’s reliance on case series rather that RCTs for evidence of effectiveness. He actually said: ” And what trials were done on HRT? None”.
Les Rose
As a researcher in the hard core natural sciences for many years I was also a firm believer that BigPharma was involved in the same type of natural science as I was until about 15 years ago when I was badly hit by a severe heart attack and started scratching on the surface of this shining empire state building of medicine and today I can only see the debris in front of me.
My distrust has actually now reached such a low mark that when I find a big “Quack watch warning” sign around some alternative medical practice I really start to get interested. The bitter but victorious fight of BigPharma against any innocent low profit alternatives has, as I understand this, been clearly won by BigPharma and with the main battle basically around the 1950th. This can in my eyes only be understood from the simple business perspective where the sacrifices of human lives, as Malcolm often points out, counts not in hundreds, or thousands but in millions and counts for nothing.
The ferocity of the attacks from BigPharma may also be understood when you start realising how much money there is to belost when the evident corruption inside the shining surface, e.g. well documented about the statins to name just one drug, is fully exposed to the public. That is why you have to ‘kill’ people like Malcolm one way or the other. They really constitute a profound threat to you.
To me BigPharma is today, unfortunately, just about very sophisticated quackery and where the alternative quacks appear in this perspective as incredibly small peanuts but where the treatments anyway in contrast won’t harm you – not many lives on their conscience as far I know.
To me, as a ‘scientist’, I am today just disgusted to have realised, though apparently so late in my life, how the public have been deceived by the medical establishment in the name of corporate profits. As long as you hide the test data I personally don’t believe that you are involved in anything I would consider to be scientific. You may also call this unscientific attitude unethical.
It seems to me that BigPharma desperately needs to be structured in a more sensible way. Where else would an industry spend decades developing a ‘product’ that would be endlessly tested, but those tests could not lead to any improvement of the ‘produce’ (because it is a specific molecule), but simply potentially to its abandonment – with huge losses to the company. I don’t want to excuse them for what they do, but doesn’t society bear a lot of the blame for creating such a daft model?
Society should pay for research to be done – maybe by reformed pharmaceutical firms – and then pay other chemical manufacturers to create the final product at cost price.
Paying for research might sound expensive, but we pay already through the price of the drugs, and also through our health because the drug companies are focused on their profits, not on the welfare of the population.
I think the entire structure of medical research has become a mess. Pharmaceutical companies claim that it costs ~ $500m to bring a drug to market. [This figure does seem endlessly adaptable – though it is clearly does cost a lot]. No individual can possibly afford this. Especially not if they are studying a product that cannot be patented – therefore cannot make any profit. There are many examples of substances that look promising, which are never put through complex phase I,II, III studies, for the money is not there. Who is going to invest in a hugely expensive clinical trial that cannot possibly make any money. Warren Buffet perhaps? Pharmaceutical companies put billions into research, on the prospect that they will get more billions out at the other end. They do not, for example, try to find new antibiotics. Why not? Because antibiotics are taken for a week (usually), so you need a hell of a lot to be prescribed to make significant profit. Also, if do manage to product a new, fabulous, antibiotic then microbiologists will only use it when all other antibiotics have failed (to stop resistance to it developing). So, if you research antibiotics you cannot (or are very unlikely) to make a profit. If it is effective against, say, MRSA, it will hardly ever be prescribed.
One cannot blame the pharmaceutical industry for acting this way. If they don’t a profit, they go bust and die. [BTW, the only way Burszynski can make enough money to continue, is to charge patients, even if they are taking part in a clinical trial]. We have to look at the system of funding, profit etc. and work out a better way to move forward. We are creating a situation whereby the pharmaceutical industry is being seen, by many, as the enemy. This is a bad thing. Although the industry has done some pretty terrible things, that cannot be excused by anyone, in general the world would be a worse place if pharmaceutical products did not exist. I, for one, would be dead. We need to try to use the great skills and expertise that exist within pharmaceutical companies and utilize these as effectively as possible – for the good of society as a whole. I don’t know how this could be done, but some form of shared risk/partnership between Govts and the industry must be achievable, in some way.
Dr Kendrick,
I agree absolutely with you. Many years ago I was involved in getting a dog medicine authorized in Ireland and the UK (the preclinical and clinical aspects). It is very effective in dogs, cats, horses, pigs and has even been used in birds for the claimed condition. It is also effective in humans but because of the costs and the fact that it is not patentable (too long on the human market for another purpose) it is not worth doing the necessary Phase III studies. It was removed from the market for one condition, on the grounds of safety, because the Pharma Co. had patented another drug from which they could charge far more. It is still on the market in parts of the EU and is remarkable safe. But the regulators take Big Pharma advice (Gotzsche)! There is a dire need to reform the system both in terms of research and treatment
Thanks Dr Kendrick for that very detailed response.
I wonder if part of the problem is that the whole drug trials process has become far too complex. Suppose a new antibiotic that was ready for human trials, was instead given to doctors to use as a dug of last resort, on the understanding that they would keep notes on every patient they used it on.
This would not be perfect, but if the patient were about to lose his/her life (or even just a limb), it might be better than specifying elaborate trials that simply mean the product is never brought to market at all!
A simpler method to bring really useful drugs to market might also incentivise companies to focus on such drugs rather than ‘me too’ products, or statins!
Allopathic. Indeed most, if not all supporters of pharmaceutical drugs dislike it. I use it because, over the last nearly 60 years I have worked with drug companies, large and small, but it is only in the last 30 years that the money men have taken over with the sole purpose of making huge profits. But then I suspect that you haven’t noticed the development of “me-too” with no comparison of them them against a competitor only against a “sugar pill”, the use of advertising to promote a less effective drug etc., etc. Dr Marcia Angell highlighted all this as has Dr Kendrick, Prof. Peter Gotzche et al. and what about thhe AMA’s admition that pharmaceutical drugs, properly prescribed and properly used, kill 106,000 Americans every year. No wonder you do not like the word “allopathic” – bit too close to the truth perhaps?
Can’t we just pass all the responsibility for conducting any future studies evaluating the efficacy and safety of Antineoplastons to Sir Professor Rory Collins? All results would naturally be top secret and he alone would pass or fail the results and make positive recommendations. I’m sure that the couple of hundred million pounds we’d promise to pay him wouldn’t sway him one way or the other. He’s been trusted with the statin trials so I can’t see why we shouldn’t trust him with Antineoplastons.
Regarding any adverse effects, we can empower him to have a think about those when the patents run out.
I have to say, the way that this man seems to be being hounded makes me more interested in his work. I have an uncle who was a whistleblower and he ended up being criticised by many in the establishment. In fact he was criticised because he didn’t shut up. Later on he was criticised because he didn’t go public earlier. They may sure you can’t win either way. He was vindicated in the end and recognised as a leader in his field. He was awarded an honour in recognition of services to women’s health.
maryl@2015, I only blew the whistle on one because that was the only breach I encountered that was a clear violation of the regulations. You seem to assume that on balance the pharma industry has done more harm than good. Remember that if you ever get pneumonia.
Anyway I am not going to engage further in off-topic debate, especially when personal attacks are involved.
Les, in a debate like this, emotions will run fairly strongly. If I may point you to an earlier post: ‘It really is a cheap playground trick to try to divert attention from all this by raising the spectre of the pharma industry’s many shortcomings.’ Perhaps accusing someone of a cheap fairground trick could be construed as a personal attack? What is sauce for the goose?
Although, in general, I do agree that we should avoid personal attacks (for example accusing Burzynski of being a crook?) My finger has hovered over the delete button a few times. However, at present I have allowed all comments to go live. I would just recommend, to everyone, that we avoid personal attacks if at all possible.
Point taken Malcolm. I hope you can accept my apology, and I do appreciate your reluctance to use the delete key.
Apology accepted. I have developed a monumentally thick skin over the past few years. Personally, I like a good robust debate, and the occasional personal insult goes with that territory. I am mainly concerned that others leave the arena if they feel it becomes too much like a croc-pit. If we did not get emotionally involved, and care, and eff and blind a bit, there wouldn’t be much point to it all. I spend quite a lot of time deleting my own posts, when I get too horrible. [I always leave it a few minutes, and re-read, before posting].
Sorry Malcolm, my heart hurts for those I see suffer. And I have seen a lot of it. I apologize to you Dr. Kendrick but turn around is fair play. I now am honored to learn of this marvelous physician who dares to try to make the lives of cancer victims better. I would pay for it and I would also donate to one who needed it. Thank God there are good people in the world who believe in giving of themselves and their finances to help others. You have to admit, it has been a lively discussion though. I think I need a good night’s rest.
In response to Ola’s comment on March 25, 2:43 am:
Love the kxcd reference!
Anyway…
“precisely because of the predictability you point out, there is – sadly – nothing we can conceal any more”
Yes, and the paper you link to makes some good points, although there are ways to get round some of those problems. But crucially, I think you can only really get round them in multicentre trials. Those criticisms are absolutely spot on for a single-centre trial, such as this one.
“We could achieve this, for example, if the people who accept the patients into the study and gather the subjects’ relevant information (the algorithm input) are not aware of how the allocation algorithm works.”
In theory, perhaps. But given that the algorithm is described in the protocol, it’s simply not plausible to suggest that anything like that happened here.
“NB, if allocation concealment (for example, as described above) is in place, is it still not appropriate – in your opinion – for a single center study to use minimization?”
I would never, ever recommend minimisation for a single centre study. The procedure you describe would involve having to conceal elements of the study design from the investigators that it would probably not be reasonable to conceal, and even if you tried, the potential for breaches of operational security that would compromise the allocation concealment is huge.
“I’m pretty sure you wouldn’t mind seeing bigger studies, either”
I think I’d be quite concerned about the ethics of a treatment with known serious toxicities and little realistic prospect of benefit. Maybe if Burzynski would disclose the data on the thousands of patients he’s treated, we could make a better decision about the ethics of such a trial. But while he keeps his data secret, I simply don’t believe any more ANP trials would be ethical.
“To be clear, you have personally looked at them, right?”
Not all of them. Burzynski has been in court a lot! But I have personally looked at the ruling of the appeal court judges who confirmed the fraud case against him.
“I also hope that you see (not agree with me, but just understand) how my background informs me, and why – for now – I will give the Japanese the benefit of a doubt”
I’m glad you’re not expecting me to agree, because I don’t. But I’m not even sure I understand. If I’ve understood correctly (and perhaps I haven’t), you are arguing that because a lot of other research is flawed (which it certainly is: I agree with you there) we shouldn’t be too hard on the Japanese researchers just because their research is also flawed. Well, no. To me that doesn’t follow. Two wrongs don’t make a right, and all that.
Hi, Adam —
Thank you for your opinion on minimization in one center trials. I appreciate it. And great to hear you did look at the court documents yourself. Awesome.
Now, I agree two wrongs don’t make a right. I wasn’t clear. Let me try one more time. I don’t argue we should apply lesser standards to the Japanese paper, I argue we shouldn’t apply stricter standards, or – in other words – we should apply the same standards we apply to other papers. (Which, to be clear, I have no reason to believe you are personally not doing. But I do have reason to believe that other people/”the powers that be”, etc are doing just that.)
Anyway, so what I think you are proposing is to value the quality of the evidence of the Japanese paper at (close to) 0 because they used minimization without (potentially) proper allocation concealment and in a one-center study, which means that there is big potential for bias. (I definitely agree with the potential of bias bit, to be clear.) So just like you, I will discount the weight of the evidence given the imperfections. But the difference is that I won’t discount it as much as you do. I won’t say it’s (close to) zero. I am also stressing that I will apply similar discounting to other relevant research in the area. In the end, it might well turn out that the quality of the Japanese paper, even though discounted, is still higher than the quality of other similar research, in which case – yes – I will pay great attention to it. I do hope you see reason in this approach, and I think the disagreement point is in the exact weighing procedure and/or in how we see the probability of most other relevant research scoring lower on the reliability scale.
Ok, that was some dense prose, thanks for reading, hope I made myself clearer.
At this point I’d like to take a moment to encourage you to continue engaging people like me in discussions. There’s value in it. In this particular instance, thanks to your answers, I have appreciated the value of allocation concealment (it’s something that I will from now on pay close attention to when looking at papers). I also understood more about what minimization is and how it is/should be used, as well as got some ideas as to where to look if I continue reading about the Dr Burzynski subject. So thanks again and maybe see in the comments section in your blog in the future!
OK, I think I understand your point of view better now, though I still don’t agree. I don’t think we should rate the credibility of a study based on how well designed it is in comparison with other studies. I think we should consider it purely on its own merits. The design of other studies only becomes relevant if other studies have attempted to answer the same question.
But for me, if the pharmaceutical industry have done studies with dreadful designs on antidepressants (and they have!), then that gives us zero information with with to judge the Japanese ANP study.
Anyway, think you as well. I am delighted you have approached this discussion with an open mind and in a spirit of honest debate, and that this hasn’t turned into a “someone is wrong on the internet” discussion.
Adam, I agree completely: only studies that answer similar questions should be considered. This is, btw, what I meant by the “relevant” in talking about “discounting other relevant research”. I admit I could have made it clearer.
P.S. Would it perhaps be more on point to state in your comment on the Japanese researchers’ paper what you believe about single-center minimization studies as opposed to asking them about allocation concealment procedures? After all, I think you believe no allocation concealment could have taken place there, and even if it has taken place, you will still not recommend applying minimization in a single center study. So regardless of how they reply, you will still discredit the study on this basis. (Which is your right and you make some good arguments for it as far as I can tell.) It would probably save both you and them time if you get to your bottom line point right away?
Ola, I like your style
Well, the only problem with minimisation in single centre studies is the difficulty of allocation concealment, so given I’ve already asked them about allocation concealment, I think we pretty much have that covered.
If they can actually give a good answer to the question of allocation concealment, then I would have no objection to their having used minimisation. However, the fact that they have used minimisation makes me think it’s extremely unlikely they’re going to be able to give a good answer. But we shall see.
OK, so let me try to summarize your position to make sure I understand. You believe using minimization in a single center setting is always inappropriate, but you admit there’s a slight chance that the Japanese researchers will answer your question in such a way as to convince you that this view is wrong. Is that right? If so, let me make a suggestion. A better forum for you to argue your general position regarding minimization in single center trials would be a biometrics journal or even the comments section on a paper dealing primarily with the minimization method. I think it’s unreasonable to place the sole burden of arguing for the validity of what is widely considered best practice on the Japanese. If you don’t agree it is considered best practice, please provide some sources that explicitly state minimization is not appropriate in single center trials. And if you do agree it is considered best practice, but think it shouldn’t be, again, why not take it up with the bodies that set these standards and those who argue for them.
You make convincing arguments that there is potential for selection bias here. No doubt. Does that mean the study should be dismissed on this basis? It doesn’t. It would be much more meaningful if we understood the magnitude of the problem, not just that the problem exists. The probability of selection bias is almost never zero, even in the best protocols. What I’d like to see is some research analyzing the magnitude of the effect of selection bias inherent to single-center studies with minimization. If you’re not aware of such research, that’s fair, but then perhaps at least suggest how selection bias could be minimized while maintaining the minimization protocol’s other advantages in a study like this one (given that it’s a single-center study with sequential assignment.) Or suggest specific protocol improvements. Currently it seems to me like you’re almost dismissing the study because it’s not perfect. I want to be convinced that you’re dismissing it because it’s actually bad, and one way of convincing me would be to list ways of how the researchers could have meaningfully improved their protocol design given their constraints.
Another problem with the question you submitted to the authors is that it clearly shows you haven’t thoroughly read the paper. You missed something posted in the first sentence of the “Patients and Methods” section. Now, this is not a major issue in a casual blog discussion like this one. But if I were a researcher working on important problems (treating cancer) I’m not sure I’d waste my time answering the questions of someone who hasn’t even bothered spending half an hour reading the paper properly. This is not to say you can’t go ahead an ask any questions you want. But it is to say your question would be much more likely to lead to something productive if you reworded it.
Bottom line for me here is that if the major objection to the paper is that the researchers followed what’s considered a best practice protocol, even if there’s some potential for selection bias, I think the paper is looking pretty solid. And, yes, of course, if in the future a different research team attempts to answer the same question and uses a better protocol, I’m going to value that future paper more. It’s hard for me to accept that someone with zero background on Dr Burzynski prior to reading the paper – like me – would honestly argue the paper is of poor quality based just on reading the paper itself. I might be wrong, but I’m not sure how to verify it given that it seems most of the people interested in the discussion do know about Burzynski and are either his critics or supporters. Perhaps this discussion can’t be had outside of the Burzynski’s character context. In which case, I’ll have to re-join once I’ve done more reading on the doctor.
I await a response with interest. Thank you Ola for doing this careful analysis… We had all this x 20 with the peer reviewers. They did, in the end, publish. Had this compound been called anything other than antineoplastons, with the immediate link to Burzynski, this paper would have been published far, far, sooner. I cannot prove that, but it would exceedingly difficult to convince me otherwise. My valedictory title for the blog reflects, I admit, the fact that we did get it published at all. Something which I advised, at the start, was highly unlikely. Not because the study was done poorly, or dishonestly, or that the results were not interesting. No, it was because, virtually the entire cancer research community condemns Burzynski, and considers him a fraud and a crook. I looked at his case histories, and the research he had done (which was far from perfect), and felt that his results were interesting. I thought they deserved an airing, and a discussion. When I learned of the Japanese trial I agreed to help in trying to get their results published. I was, and remain, fully aware that to stick my head over the parapet in this area would result in, pretty much, blanket condemnation from the ‘establishment.’ But I cannot resist my Maverick urges. I hate seeing people crushed. I hate it when the pack starts baying for blood.
Hi, Dr Kendrick —
This discussion is an excellent exercise to accompany the reading of your latest book. Thank you for following my convoluted arguments: your comments assure me that this is the nature of the beast and not anything specific to what I’ve said. It’s good to know I’m not going mad. I appreciated it on an intellectual basis already, but I now also have a more visceral understanding of what you’re up against. It’s been an interesting experience to get thrown into the camp of “crazy conspiracy theorist” from the get-go, assigned views I don’t subscribe to, and then trying to dig my way out one painfully slow argument at a time.
Most importantly, while I am just posting comments on the Internet, from the safety of anonymity, and on a subject that’s not relevant to my career, you are indeed sticking your head over the parapet. It’s incredibly admirable. Thank you for that. Maybe at some point I’ll figure out how I can contribute to the good fight. In the meantime I’m trying remain optimistic. After all – with apologies to Professors Feldman and Marks – the fact remains that we’re still living longer, healthier lives despite all that is terribly wrong in medicine today.
Yes, I keep trying to view this as an exercise is seeing what, if any, arguments can work. I keep my Poppers selections on my desk to remind myself of the various ways that can be used to refute ideas. Refuting is, of course, simple. Confirming…. not so easy. Changing people’s minds… not sure that I have ever done this. Certainly not where someone has a great deal to lose from changing their mind. So, I can easily convince a lay audience that LDL/cholesterol does not and cannot cause CVD. But the same facts have not the slightest impact on research cardiologists. You could say that is because they know far more (than me), and can more easily refute what I have to say. However, none of them have ever refuted my facts directly, they simply widen the argument to the point where they just say – well it is a multifactorial disease. Or words to that effect. This is the ultimate destination of the ad-hoc hypothesis. I will not bore your further, but when you end up discussing whether or not Swiss cows, by eating on high pastures, synthesize longer chain saturated fats, which is why the Swiss, despite having a very high saturated fat diet – and high cholesterol levels – have such a low rate of CVD… You feel that you have kind of ended up in an intellectual cul-de-sac, wondering if there can be no end to the objections thrown in your way.
well it is a multifactorial disease. A tacit admission that you might be right but they don’t really KNOW!
Ola,
May I suggest from the age of 82, that in general we are living longer because, as Dr James LeFanu put it, we, certainly I, lived through the RISE of modern medicine. It remains to be seen whether those living through the FALL will continue to extend life span. There are studies in the literature that suggest otherwise.
Dr James LeFanu: The Rise and Fall of Modern Medicine. well wort reading – particularly the FALL!
Well, there goes my optimism then!
Thank you for the recommendation. I put the book on my list: it looks very interesting.
Hi Ola
” but you admit there’s a slight chance that the Japanese researchers will answer your question in such a way as to convince you that this view is wrong”
Yes, though I have to say at the moment I see it as a very slight chance indeed.
” I think it’s unreasonable to place the sole burden of arguing for the validity of what is widely considered best practice on the Japanese.”
Well, it’s most certainly not widely considered best practice to use minimisation in single centre studies. But it’s the Japanese researchers who used it in their trial, so I think it’s completely appropriate to place the burden of arguing for its validity on them. If they didn’t think it was valid, they shouldn’t have done it.
“Does that mean the study should be dismissed on this basis? It doesn’t. It would be much more meaningful if we understood the magnitude of the problem, not just that the problem exists. ”
Yes, it’s true that we don’t understand the magnitude of the problem. Personally, I tend not to trust the results of clinical trials if I know they are bad, and I don’t know how bad they are. Maybe the allocation was only a little bit biased. But we can’t know that. Though in any case, remember that the trial didn’t show a significant effect on overall survival, so even it the treatment allocation was completely fair, we still have no good evidence that ANPs are beneficial.
“What I’d like to see is some research analyzing the magnitude of the effect of selection bias inherent to single-center studies with minimization. If you’re not aware of such research, that’s fair”
I’m not aware of any such research. I would guess that single-centre studies with minimisation are so rare that it’s hard to research them. However, there is empirical research showing that poor allocation concealment more generally leads to bias:
Pildal J, Hróbjartsson A, Jórgensen KJ, Hilden J, Altman DG, Gøtzsche PC. Impact of allocation concealment on conclusions drawn from metaanalyses of randomized trials. Int J Epidemiol 2007;36:847-57.
Wood L, Egger M, Gluud LL, Schulz KF, Jüni P, Altman DG, et al. Empirical evidence of bias in treatment effect estimates in controlled trials with different interventions and outcomes: meta-epidemiological study. BMJ 2008;336:601-5.
“one way of convincing me would be to list ways of how the researchers could have meaningfully improved their protocol design given their constraints”
Sure. For a start, the trial could very easily have been double-blinded. The treatment was administered by infusion, and it’s really easy to create a placebo infusion.
If for some reason I’m not aware of that wasn’t possible, then the judgements about causes of death and progression could have been made by an independent investigator who was blinded to treatment.
And, of course, they could have implemented a more robust randomisation method involving proper allocation concealment. That’s really not difficult to do. For example, the randomisation list could have been prepared independently and held by a third party, with randomisation codes only released for specific patients once they’ve definitely been enrolled.
“Another problem with the question you submitted to the authors is that it clearly shows you haven’t thoroughly read the paper. You missed something posted in the first sentence of the “Patients and Methods” section.”
Well, if true, that was very careless of me. What do you think I missed?
“Bottom line for me here is that if the major objection to the paper is that the researchers followed what’s considered a best practice protocol, even if there’s some potential for selection bias”
I really disagree that they followed what’s considered a best practice protocol. The lack of allocation concealment is a very serious flaw.
We await the judgement of Adam
Hi, Adam —
In an unexpected turn of events as far as arguing on the Internet goes, I think I have finally managed to see the problem from your perspective.
“Personally, I tend not to trust the results of clinical trials if I know they are bad, and I don’t know how bad they are. Maybe the allocation was only a little bit biased. But we can’t know that.”
Of course I cringed at the “bad” label. (If I agreed the study was bad, we wouldn’t be having this conversation.) Otherwise, though, this is fair enough.
“I would guess that single-centre studies with minimisation are so rare that it’s hard to research them.”
Sounds right, at least based on what I’ve gathered over the past couple of days from skimming through relevant literature. And thank you for the citations re: the general allocation concealment problem.
Re: making the study double-blinded/using independent investigator
Why the study wasn’t blinded is definitely a good question to ask. I sure wish it had been. While I’m sure we can think of some possible reasons, it’d be much more insightful to hear an answer from the authors.
Re: randomization lists prepared independently.
This is the bit that made me realize I just don’t understand enough about the protocol the Japanese used. In their “S1 Protocol” document they say “minimization”, so I assumed they meant the method described here: http://www.ncbi.nlm.nih.gov/pubmed/1100130. Seemed clear enough initially. They further explained they were using two factors with two levels each. But then *you* kept talking about randomization lists. I didn’t understand why you kept bringing those up given that in minimization the random element is introduced via the biased-coin procedure, and randomization lists are not set up in advance (this appeared clear to me from reading the Pocock/Simon paper and is re-iterated in the SPIRIT checklist.) But what I can’t reconcile is this bit: “Randomization used 50:50 weighting to the two arms and was established by computed macro program in Microsoft Excel 97.” How is 50:50 a biased coin? Does this mean they were using true randomization? Maybe you, as the stats guy, have figured this out? Anyway, this made me realize I don’t understand the protocol, so my assumption as to the the nature of their method may be wrong.
“Well, if true, that was very careless of me. What do you think I missed?”
Sorry, that comment was unnecessary on my part. I was referring to you having missed the bit about minimization in “S1 Protocol”. And the whole thing about how you ask them about randomization lists even though randomization lists aren’t set up in advance in minimization. But my assumption about the nature of their protocol just went out the window, so what you asked them, might, in fact, be relevant. Furthermore, if the protocol is indeed unclear (and it’s not just my lack of background that stops me from understanding it), the fact that you’ve framed your question about allocation concealment in general terms seems appropriate.
“But it’s the Japanese researchers who used it in their trial, so I think it’s completely appropriate to place the burden of arguing for its validity on them. If they didn’t think it was valid, they shouldn’t have done it.”
I agree that they should have an understanding of why the method was appropriate for their study.
“I really disagree that they followed what’s considered a best practice protocol.The lack of allocation concealment is a very serious flaw.”
Given my uncertainty as to their actual protocol, this question might turn out to be irrelevant. Still, it’s interesting. I’m going by what these guys say: http://www.spirit-statement.org/sequence-generation/
“Minimisation offers the only acceptable alternative to randomisation, and some have argued that it is superior.” I don’t see them saying “…unless it’s a single-center study, in which case the method is complete rubbish.”
NB, to reduce potential for bias, SPIRIT recommends that trial investigators “do not provide full details of a restricted randomisation scheme (including minimisation) in the trial protocol.”
Anyway, bottom line, I understand now how you find this study to be very unconvincing, especially given your beliefs on Dr Burzynski. To me, personally, it is still a “wow, this is interesting” moment. As to determining the quality of the evidence, I need to wait until I find out more about the protocol and the reasoning behind it. We’ll see. Most importantly, I am looking forward to seeing more research published on Dr Burzynski’s treatment in the future.
Dr Kendrick
It’s funny what people start to consider about why there is a paradox in some countries. Swiss cows probably eat a far healthier diet whether up in the pastures or not, compared with where our dairy produce comes from. However, maybe the ‘Swiss Paradox’ is also partly explained by the fact that Switzerland was, in 2013, the 3rd happiest country in the world! (Although that doesn’t explain the French Paradox, as they only managed to come 25th, to our 22nd…..so that hypothesis doesn’t necessarily work – so multifactorial reasons are even more compelling)
Sorry, you await my judgement on what? Did I miss something?
Hi Ola
“Does this mean they were using true randomization? Maybe you, as the stats guy, have figured this out? ”
No, I have to confess I haven’t figured it out at all. The description of how treatments were allocated sounds inconsistent and confusing. I’m hoping that the authors of the paper will respond to my comment on the paper and shed some light on this. No response yet, though. But unless they can come up with a good explanation, my working assumption is that the process was flawed.
A bit off topic but it does highlight the huge area of medicine that has “got it wrong” through, flawed, fabricated, manipulated research and statistics.
Unclean
http://high-fat-nutrition.blogspot.co.uk/
then CTRL”f” unclean
Nissen of course is a very eminent US cardiologist and statinist which makes these quotes eminently interesting but means that the experts have been wrong for decades.
__________________________________________________
People may have seen this quote on Facebook. Lovely to see Steven Rentaquote Nissen publicly acknowledging that the death toll from cardiovascular medicine’s lethal low fat diet has finally been halted by a couple of investigative journalists. Thank you Mr Taubes and Ms Teicholz. Oh, he missed that bit…… Here’s the quote:
Steven Nissen, chairman of cardiovascular medicine at the famed Cleveland Clinic: For years, “we got the dietary guidelines wrong. They’ve been wrong for decades.”
Advice to avoid foods high in fat and cholesterol led many Americans to switch to foods high in sugar and carbohydrates, which often had more calories. “We got fatter and fatter,” Nissen says. “We got more and more diabetes.”
“Recent studies even suggest that longtime advice on saturated fat and salt may be wrong, Nissen says.
Personally I feel a little contaminated, unclean, by Nissen’s falling in to line with what any sensible person with a laptop and net access realised fourteen years ago. Yeugh. Anyway: I thought I would help out by sketching out his next press release:
Steven Nissen, chairman of cardiovascular medicine at the famed Cleveland Clinic: For years, “we got the cholesterol guidelines wrong. They’ve been wrong for decades.”
Advice to take drugs to lower cholesterol led many Americans to pay for statins which made them diabetic and increased their cancer risk. “We got sicker and sicker,” Nissen says. “We got more and more dementia.”
“Recent studies even suggest that longtime advice in favour of statins was a bad as that against saturated fat and salt“, Nissen says.
Y’all know it’s coming! You saw it here first.
Peter
I am really confused by Dr Steven Nissen’s apparent sudden turnaround where statins are concerned. In the USA AARP Magazine for February/March he writes a full page article extolling the need for cholesterol lowering with statins or with the about to be released PSK9 Inhibitors or the new drug LCZ696. I quote one worrying comment from him (there are many others) “Those of us who treat older patients were appalled by the recent guidelines suggesting that you should not give statins to people 75 or older. That is just medically wrong” I heartily disagree with him (Uffe Ravnskov and others). Where is the man coming from?
he is coming from the new world of PCSK9 inhibitors, for here is where the vast marketing budgets are now being spent
Where is he coming from? Foxes me too. The official doctrine, status, fear of admitting he was wrong, I don’t know. But with class actions against statin makers rapidly increasing……..
Sadly so very true.
http://cen.acs.org/articles/93/i13/Cholesterol-Lowering-PCSK9-Inhibitors-Near.html
I recall some years ago hearing a discussion of world population and planetary resources to sustain them. I think it was on Radio 4 morning news with John Humphries. The person with the ‘ology’ said that “for the Earth’s population to be sustainable it should be decimated” JH said “you mean we need a 10% reduction from where we are now” (I paraphrase), “no” the ‘ology’ said, “decimate means ‘reduce to a tenth'”.
Do you think someone was listening to him?
Time and again I come up against this meme that innovative treatments are being attacked by Big Pharma. I have never been offered any evidence to support it. For many years I have been asking alternative medicine supporters questions – simply that. I don’t try to prove them wrong, I just ask them for evidence that they are right. Nobody pays me to do this. It has never been even mentioned by any of the drug companies I have served. This is what Adam and I are doing with Burzynski. The difference between his operation and a properly regulated drug development programme is this. Notwithstanding the dreadful abuses within the pharma industry, no drug company will ever charge a patient to enter a clinical trial. A phase II trial (which Burzynski says are most of his trials) will be properly controlled, either placebo or active, it will be intensively monitored and audited, the data will be quality assured and reviewed before breaking the randomisation, the statistics will be planned in advance and conducted to comply with the plan, and ALL adverse events will be captured irrespective of presumed causality. Of course, things can go wrong despite all this, by accident or design, especially when the data get into the hands of the marketing people. But Burzynski’s `trials’ are not actually trials at all, they are case series. The FDA inspection reports clearly raise many issues, including definition of outcome criteria, accountability for patients in the trial, major protocol violations (especially with regard to ANP dosages which were grossly elevated in some patients). These are breaches which would get a company’s R&D closed down here in the UK. Meanwhile Burzynski gets rich. I think you can see why Adam and I need more convincing over this Japanese trial.
Over all these years I have simply tried my best to ensure that the companies I worked for did things right. That’s what the vast majority of people in the industry do. Decades ago I tried to stop a company from doing something I saw as unethical. Guess who was the first victim of `downsizing’? In subsequent years no doubt I missed other opportunities, in which case mea culpa. But I do react to the suggestion that Big Pharma and orthodox medicine are evil and on balance harmful. They are not, but they need to be much better. My support for that is on record: https://majikthyse.wordpress.com/2012/10/22/is-pharma-all-bad/
Time and again I come up against this meme that innovative treatments are being attacked by Big Pharma
No they leave to people like Dr Stephen Barrett et al of Quackwatch and such like or through their llinks with the FDA.
And
Decades ago I tried to stop a company from doing something I saw as unethical. Guess who was the first victim of `downsizing’?.
First can I congratulate you on your action.
Second, surely I take that to be the reason why most people in a position to “whistle-blow” do not.
The US has a system whereby whistle-blowers get a percentage of the fine!
And evidence of “wrong doing” is the massive fines the US courts have imposed on many of the Big Pharma companies but they are never convicted. Were they to be, US law would ban them from supplying Medicare and Medicaid. Just imagine what the result of that would be.
I have just read your item “Is pharma all Bad” An interesting item and worth reading.
Of course not! But it has many flaws, mostly arising since the companies were reduced to a few massive ones managed by “money men” like the Banks. The ones that were involved in Dr LeFanu’s “Rise……” are now long gone having been merged to the huge money generating firms of today. The Rise included the sulphas, the antibiotics, cortisones, surgical procedures and the like; all enhancing health from infections, accidents etc.
But now the attention has been turned to the chronic diseases and their “diagnosis” often leading to overdiagnosis, overtreatment and “herd” therapy. Shortage of new antibacterials – well there is no real profit therein. Big Pharma now relies on “medicines for life” not a “quickie” cure, with drugs with very low efficacy rates, high NNTs that require huge costly trials to demonstrate the tiny benefits. And therein lies the problem.
You mention Ben Goldacre’s “Bad Pharma” and you know about his campaign to provide greater access to research data. But he is one of many that are writing and publishing well referenced works on the failings (and politics) of the pharmaceutical industry. In this discussion I have named a few that are in this category, some well versed in research publication, such as editors of the NEJM and BMJ and others with a long pedigree of research. To ignore their views is simply a “head in sand” approach that is unworthy of scientific integrity
As you wrote, I quote:
I was trained to present clinical evidence in the best possible light.” admirable Yes But in many cases this has become subject to excessive advertising using relative rates and similar tactics.
Don’t disagree with anything you say here. But again we are badly off-topic. I just wanted to dismiss the claims that Burzynski is being hounded by Big Pharma. On the contrary, he is getting away with far more, on a small scale, than Big Pharma ever could. Dropping out of this now as I have other more pressing tasks.
On the contrary, he is getting away with far more, on a small scale, than Big Pharma ever could
Even the $billion fines imposed without a conviction? Sorry but I cannot agree with you on that. See Prof Goran’s comment and my reply.
My I thank you for your contribution though – I enjoy a debate with different views. I believe that is often more fruitful than one with those of a similar viewpoint.
Les, thank you. It’s interesting and helpful to hear something from inside the industry. The serious worries about statins, blood pressure medication and lots more is important and growing, but we surely accept that we need pharma? I’d be rather happy if they could come up with a new antibiotic. But we need companies like Mike describes from thirty years ago. That was when people in banks were highly respected! I wonder at what level in the industry things start to go wrong? Just at the very top or is it much wider? Organisations develop a culture and, when it’s fundamentally good, abuses tend to be exposed. I don’t remember much of that from inside the industry. Banks lost their way and reputation by a short-term obsession with profit and bonuses and I think pharma has gone a long way, or further, in the same direction. When pharma does wrong, suffering goes way beyond people’s pockets, which is why we need proper regulation. Sadly, it often looks like the regulator is too small and compromised to be effective.
Have to agree with this too. Corporate systems worked OK when shareholders were individual investors, but now they are mostly huge power blocs like pension funds and venture capitalists. Pharma companies are beholden to them.
Oh dear, I said I was dropping out of this! Really must get on with other stuff now.
Les, I hope to see you back soon. I treasure that alternative view, I always fear that we too readily listen to those we agree with, and dismiss those we do not. (To quote) ‘To become an extremist, hang around with people you agree with.’
Cass Sunstein — co-author of the hugely influential Nudge and an adviser to President Obama — unveils his new theory of ‘group polarisation’, and explains why, when like-minded people spend time with each other, their views become not only more confident but more extreme.
I’m getting bored now!
Perhaps you can understand my reluctance to get involved in the debate initially.
Yes, Dr. K, I can certainly understand anyone’s reluctance to get involved in debates like this, even though I suspect this is an exceptionally mild and respectful one compared to many others. I must admit I have enjoyed this particular one, annoying though some bits have been, it has given me food for thought, for sure. (thanks for the apology, by the way Fergus). When I started my own “research” into various health aspects, I made some rules for myself, one of them was to be wary of sites that indulged in character assassinations, insults, jeers and sneers, They may have some points and/or valuable info, but to wade through the crap to find it, made it unpleasant. The similarity to politics strikes me. I used to check in with Dr. Barrett’s “Quackwatch” from time to time, plus a couple of others sceptical of “Alternative Medicine” (their quotes, not mine”), but finally I was repulsed by a blog of “Orec”, a sort of obituary after Dr. Servan Schreiber died. Orec acknowledged that the type of cancer Dr. Schreiber had, was a particularly nasty one with a prognosis of months. Dr Shreiber survived for nineteen years. He (Dr. S) credited the two surgeries he had in the first five year, as saving his life, unfortunately the cancer returned a third time. He credited his extra nineteen years as being the result of his research into various food and lifestyle effects on cancer. “Orec”, while acknowledging that to survive 19 years with this particular cancer was inexplicable, pooh poohs the idea that it was anything to do with Dr. Schreibers treatment of himself. But the truly offensive thing about this blog, was the snide and dismissive tone about a man who had just died and who had beat the odds by a hundred miles.
http://scienceblogs.com/insolence/2011/08/02/rip-david-servan-schreiber/
Maureen
I fully agree in your wise decision to keep away from ‘unpleasant’ blogs, you are just losing energy if you try to say something reasonable among people who are throwing rocks on one another.
Though, serious blogs, like Malcolm’s, I find encouraging in my present state of dystopic views on medicine.
I just can’t resist passing on this gem, on Orec’s “Respectful Insolence” blog, re Dr. David Servan Schreiber. (where the respect comes in I have no idea)….” Unfortunately, like many promoters of alternative medicine testimonials, David Servan-Schreiber too has passed away:” I’m sure he didn’t think that one through.
To me as quantitative finance geek who professionally bets on market phenomena identified with fairly scant evidence, the difference in the 5 year survival rate reported in the paper is showing a big buy signal that I would bet on! Obviously, scientists have a much higher bar hurdle, but the results do look promising. I look forward to seeing the follow up studies.
John
You should read Gigerenzer, Gerd (2014-04-17). Risk Savvy: How To Make Good Decisions Penguin Books Ltd. Kindle Edition. He is a statistician who has lectured on Risk for amny years I suggest that it is right up your street. The section on medicine considers survival time.
The case he uses as I remember was prostate cancer. While survival times were far better in the US due to early diagnosis than in the UK, the actual DEATH rates in the two countries were virtually identical. In short, in the US you live longer knowing you have cancer but death is just as inevitable as the UK.
Let us just switch gears just for a minute. All these subjects are complicated particularly for those of us who are not physicians or researchers. However, I found a great test I used for high school and college bound students to give them a little insight on how they best learn I think it could help each of us and/or our children. It is an online test called the Index of Learning Styles Questionnaire. It is free and only has 44 multiple choice questions. After you take it online, it gives the option to automatically score your test. After, you can refer to the section that gives the definitions of learning styles. You will be surprised about how and under what specific conditions you learn best. I love this little test and my clients did too. Have fun!!
I am trying hard to understand what ‘medicine is all about’, from a natural science perspective, since a few years now, and I think I now do have some understand of some basic facts – I love basics and the ‘thicker’ and more fundamental the textbooks the better for me. Seriously! I actually think I am ‘in love’ with the basic understanding – a dangerous path though from a philosophical point of view.
Since this thread is all about alternative treatments of cancer, although a specific one, I think it is very appropriate for me bring up, and stress, the least ‘quacky’ book I have come across so far on the subject of cancer.
It is a book by Thomas N. Seyfried who is a professor at Boston College and who has conducted serious research for many, many years about the energy metabolism, and especially in the the mitochondria, of cancer cells. His research for me refutes, in a clearly ‘Popper’ way, the established and almost dogmatic view of cancer as a ‘genetic only’ disease.
The titel of his 2012 book is “Cancer as a Metabolic Disease” and is to me now great profound reading on alternative medical treatments on cancer. The only bad thing with the book was the price tag but such often come with serious books. What I actually nowlearn from this reading is that I, myself, first would go for an extremely strictly ketogenic diet if I would get a cancer diagnosis and look at the result after a few months with the help of those who ‘know’ the dogmas. Nothing to lose here even if it is a very challenging task to refrain from ALL carbs.
I can hardly imagine that it can be possible for BigPharma to put a ‘quack’ stamp on such a prominent researcher although what he has arrived at is so fundamentally threatening their multibillion business. The only option I find to such a stamp is the same old silencing we have seen before when other ‘firm’ dogmas have been profoundly challenged.
Many Thanks for the info about metabolism and cancer. Unfortunately the price tag, even for the Kindle version, is to high at £60+
I did find Tripping Over the Truth: The Metabolic Theory of Cancer8 Oct 2014
by Travis Christofferson which is more in my price range
Sixty quid! Blimey, I am undercharging for my book, obviously.
Indeed but look at the pleasure you bring to the many that can afford it!
Well, well – I might be a very special metallurgist but, as I stated, I love the basic stuff. Still, now reading chapter 4, “Energetics of Normal Cells and Cancer Cells”, this book is quite a challenge to me – these little ‘intelligent’ mitochondria with their tricky physical chemistry pathways throwing all those ATP high value coins all around the cytoplasm to be used wherever needed in the cells! Constantly I have to consult Guyton and Hall “Medical Physiology” as well as Alberts et al. “Molecular Biology of THE CELL” not to lose the grip of what I am reading although I think I pretty much understand the basic thermodynamics involved. And it didn’t hurt that I have read Alberts twice as well as Guyton years before digging my teeth into Seyfrieds book now.
About the price tag on the book (equals two bottles of the greatest scotch whisky 🙂 ) it is to me actually the price tag on a life of a serious researcher who obviously early turned into a sceptic towards the cancer dogma as is partly evident, not only from what he himself claims but, mostly from the literally thousands of references in his book. Seyfried is a well read researcher in my opinion.
“Doctoring Data” is to me an equally great book but working at a significantly higher and on a more accessible level at the same time for a ‘lay’ person and I am also more than convinced that Malcolm is selling many more copies than Seyfried but both of you are trying to change the world in the right direction. Your efforts really impresses on me looking in this from the outside and who otherwise just see the debris of science in medicine.
Prof Goran,
I passed on the information to my guru Dr Graveline.
1) even Nissen seems to think cancer is involved with diet
2) Dr Graveline is believes that ROS causes mitochondrial DNA damage and also nuclear DNA damage because of the depletion of CoQ10 by statins.
3) Statins are known to be carcinogenic in rodents; may be this is biochemical route that is responsible.
4) Dr Ravnskov also believes that statins are carcinogenic.
All this seems to be leading to an interesting development in the statin/cancer/metabolic association. I hope I will not bbe accused of quackery
There is a nice account of the concept of the idea of a metabolic cause of cancer here:
http://healthinsightuk.org/2015/04/02/governments-are-spending-hundreds-of-millions-researching-cancer-genes-is-it-all-a-big-waste-of-time/
Thanks. It goes right back to Chritsofferson’s book on Wagner, Pedersen and Seyfried’s book. But the concept is gaining ground. May be chasing “chaotic” genetic associations should be reviewed and replaced by a fact that effects many, if not most, cancer types as demonstrated by the PET scan, in short mitochondrial disease.
‘The number of targeted therapies tested in patients with cancer in the past decade was seven hundred, yet no patients with solid tumour have been cured by targeted therapies over the same time period.’
Question: is this any worse or better that Dr Burzynski’s results? Seems to me these results are protected because they have been done in pursuit of approved OFFICIAL theory. 700 failures out of 700 attempts could not be any worse.
I take this to be an example of the closed mind
Dr Georgia Ede has written a three part article about the book here:
http://www.diagnosisdiet.com/what-causes-cancer/
Thank you for the link.
As Dr Ede says Seyfried’s book is expensive but Christofferson’s, simplified review is cheap and can be read for free on Kindle.
Thank you for the link.
While Seyfried’s book is expensive and very detailed, Cristofferson’s review is cheap and can actually be read for free on Kindle
Following from Prof Goran’s reference to “Thomas N. Seyfried Cancer as a Metabolic Disease”
The bottom line [to the cause of cancer] is this: damage to mitochondria happens first, then genomic instability, and then mutations to DNA. The upshot, according to Seyfried, is that the mutations to DNA, thought to precipitate and drive the disease, are only a side effect, sending researchers on a multidecade, multibillion-dollar wild goose chase.
Extract from: Christofferson, Travis (2014-10-26). Tripping Over the Truth: The Metabolic Theory of Cancer . . Kindle Edition.
Now there is a nice but different view of the cause of cancer and possibly to a treatment.
Well, it sounds interesting. I shall read Christofferson’s book (once I have prized the kindle away from my wife). Then see how I feel about shelling out vast sums of money for a book.
Dr K …get her her own Kindle in place of flowers….or both would be even better…..you know she deserves it.
Inter-library loan not an option?
For KIndle users, the Christofferson book can be read for free!
Moved to write in response to one of Mike Cawdery’s earlier posts (I’m catching up again after a couple of days) where it was suggested that “some of the posters here epitomise the way that researchers are bullied in science today . . . Answer the following questions instantly (even though you are not an author of the relevant paper) or I will assume you have a sinister motive”. This may or may not have had me in mind as one of that bullying ‘some’ but I’d urge all the usual cautions in interpreting the tone and motivations of people based on a few words in a format like this when it often has as much to do with the reader as the writer!
The burning discussion may now be dying down somewhat but I’m sorry MK seemingly denigrates it as boringly predictable (or how to interpret the response to Maureen Berry? – though probably just understandable tiredness…) as for me this has been a useful discussion, albeit somewhat dispiriting – though that seems to go with the territory.
It has certainly given me pause for thought, and as others have said this blog and forum seems a genuine and valuable one, and which supports people in making their own informed judgements. In helping break down the walls of excessive authoritarian institutional medicine it is part of a positive process of widening participation in science – though of course that brings a greater variety of people into the mix with varying backgrounds, experience and levels of refinement in thinking in this area.
So what did I learn..? It seems that the original blog post was trumpeting a victory in getting an outsider’s work published in spite of the establishment status quo, and this as being good for the advancement of medical science. As I now interpret it it was not really making any particular claim for the value of the specific medical content of the paper beyond it being worthy of publication and consideration on a more equal footing, and/or that this forum was not appropriate to dig into it.
If the value of specific medical content is being claimed, then the claimant being asked to defend or at least further articulate that claim would generally seem reasonable.
Tactical errors are accepted, gawd knows I know them well, and not proof of bad motivations, similarly the possible complications of involvements with various parties are appreciated.
Nonetheless I still think it is very easy to read the original blog post as suggesting a quite strong endorsement of the value of the technical medical content (“they can”, “they work”, “he’s right” etc.) even if it was not intended to be the key point, and taken in the context of Dr.K’s stance against medical nonsense then questioning the outcomes statistics etc would hardly seem in itself a repressive bullying or otherwise unreasonable or surprising response in this forum, and where these are scientific questions then it should not make any difference what prejudices the questioner may have.
The chaotic forces of mass communication, social, political, commercial eco-systems etc however are what makes it so hard to see what is really good, bad, indifferent (that and bandwidth and stupidity..). It’s precisely because of the skewing effects of these that the scientific, logical and statistical evaluation aspects are especially vital to hang onto. I signed up for this blog almost as soon as I saw Karl Popper and falsification mentioned!
The thing this discussion has really got me chewing over is what is a better approach to safely foster innovation and medical progress. One could consider positive discrimination but I’m not not sure I can swallow the idea that bad papers should get a leg up to make up quotas, nor can I accept that a bad paper is more worth looking at because there are already a load of bad mainstream papers which get published. It comes down to whether or not its a good paper (or theory or whatever), but we need a more level evaluation playing field.
A long response and in danger an existential crisis.
( Oh – and all power to Ola’s elbow and vigour to Dr.K !)
Um, no easy answers. I think, in general, we have become so unwilling to accept ‘risk’ that we will perhaps crush all innovation. If someone has a headache, I would not recommend drilling a hole in their skull to see if it does any good. If someone is dying of cancer, and has tried almost everything the mainstream has to offer, we need to be more willing to do take the shackles off. There are no absolutes here, only different shades of right and wrong, risk vs. reward. It is why, I suppose, I do not get bothered by homeopathy. Whether it works, or not – and I tend to favour ‘not’ it cannot do much harm. The only harm can be those who refuse conventional treatment, clinging to homeopathic treatment for so long, that they then die of something that could have been cured. I don’t know how often, if at all, this has ever happened. But homeopaths treat their patients nicely, make them feel good, and I am sure homeopathy has a strong positive effect because of this.
Equally, when someone is almost certain to die, quite soon, though cancer mainly, I feel that we need to completely readjust the level of risk we are willing to take. But we really don’t. Maurice Saatchi has been trying to drive a bill through parliament in the UK, which would allow more ‘experiment’ in such situations. He will fail. The massed ranks will close against him. They will all claim they are innovative enough, and there is no need for the bill (they have already done this). ‘They’ being high level scientists surrounding by major teaching institutions where, almost by the nature of the thing, innovation is strangled at birth. No doubt if any of them ever reads this blog they would howl me down on this point. But I still think it is true.
Malcolm,
I fully agree here.
Thank you for being (relatively) kind about homeopathy. There are some other inexplicable outcomes from homeopathic treatment though such as odd, temporary, unexpected symptoms that occur shortly after the administration of an apparently inert extremely dilute ‘sugar pill’ (itchy rash, craving for white wine for example) which last for maybe one or two days but are found to be related to the remedy picture upon investigation. Or temporary worsening of symptoms. Or the fact that animals get better, even from something as difficult to treat as pemphigus in dogs, for example. Sorry – I went a bit off-topic there…..couldn’t help it 😉
I only put thoughts into one of three places. Probable, possible, unlikely. I try never, ever, to dismiss anything out of hand. I like ‘that’s odd’. At present, however, I have not seen any evidence for homeopathy that, I believe, could not be explained by observer effect and/or placebo effect. Perhaps I need to look again.
Here’s an RCT of elderberry syrup for lessening influenza symptoms:
http://www.ncbi.nlm.nih.gov/pubmed/15080016
I assume using elderberry (“sambucus” in the US) syrup would qualify as “homeopathic”? Compare this outcome with the outcome for Tamiflu:
http://community.cochrane.org/features/tamiflu-relenza-how-effective-are-they
I do not believe the RCT of elderberry syrup has been (attempted to be) replicated.
So, there is some scientific evidence that some treatments, such as Sambucus, do work. It’s just there’s not a lot of money to perform initial or further studies.
As an N=1 study, I used Sambucus every time this year when I felt any amount of cold/flu coming on. I had only very minor “colds” (it’s impossible to know what I actually contracted), even though both my children were sick multiple times. What does this prove? Nothing, unfortunately. But I will continue to use Sambucus next year too.
I used to be adamantly against homeopathy, but then I realized my belief in high carb, low fat diets was completely misplaced. After that, it’s been a steady slide down into accepting “alternative” “medicine” and rejecting (most) “real” “medicine”.
Hi BobM
I think you may be in danger of confusing herbal medicine with homeopathy to some extent. Just to clarify….
For a medicine to be called ‘homeopathic’ it has to follow the principle of ‘like curing like’, in that the symptoms created either by the substance itself (often toxic), or by the ‘proving’ (testing on healthy people) of the diluted medicine, correlate with the symptoms present in an individual who is diseased. Usually, though not always, the homeopathic medicine is diluted, and vigorously shaken at each stage of dilution, to various degrees, which is how the controversy arises as to the mechanism of action.
Confusion is not uncommon, because many remedies used in homeopathy are made from plant sources and can be prescribed as a ‘mother tincture’ (ie undiluted) but would only be considered ‘homeopathic’ if used as stated above. There is a slight ‘overlap’, of course, between herbal medicine and homeopathic if tinctures are used undiluted – here is an example of the homeopathic ‘remedy picture’ for Sambucus Nigra (Elder)
http://www.homeoint.org/books/boericmm/s/samb.htm
which, when you look at the respiratory symptoms, would probably match many people’s experience of the flu. A homeopath would check the flu patient’s actual symptoms before prescribing a medicine, which may not indicate Sambucus as the best option in their case, and therefore may not have much, or any, healing effect. They would also take any other seemingly non-related symptoms, characteristics of the patient generally and past medical history into account (hence why it is considered ‘holistic’) and use those to find the medicine that best matches all aspects of the patient’s expression of disease.
Beautifully stated, Dr. Kendrick. Beautifully stated.
No easy solutions for sure. Institutional risk aversion sems not necessarily a bad thing of course where an institution is responsible somehow for public health…
Given that we probably do not want a Wild West (no Burzynski joke intended) then we need independent scrutiny/licencing/control even if we somehow increase independent alternatives and individual choice – which might foster more diverse approaches – and we will probably still want the central scrutiniser to err on the side of caution.
Perhaps conscionable safe zones for institutional risk taking can be identified, where the patient’s situation is desperate, as suggested, the Saatchi initiative etc. makes absolute sense but compared to the breadth of medicine this would seem to be a relatively narrow zone to work in. (Not meaning unimportant or not worthwhile pursuing.)
I caught a small part of a BBC radio 4 program in passing earlier this week which was discussing how to get antibiotic developments moving forward to tackle the growing resistance problem – not sure exactly what the program was I’m afraid. Anyway, an idea was being discussed – dubbed ‘delinkage’ – where the NHS/government would pay pharma a whopping one-off price for a developed product depending on its medical merit, and on the basis that the drug is then licensed for free manufacture and distribution at minimal unit cost so value becomes decoupled from volumes.
For antibiotics this would support an aim of prescribing as few as possible of course whilst getting the development done, but similarly for other drugs it could help dismantle the system geared up to promoting frequent medication as a way of life, and turn the attention away from propping up existing ideas – as they’ve already paid for themselves (to a greater extent at least). Hence more innovation might perhaps be unleashed.
Sounds tricky and I’m not optimistic about the chances sadly – but its about the only positive concrete suggestion that does get to one of the the hearts of the matter that has passed through my orbit recently. On the positive side it is not that strange from a business perspective – not really much different to paying a consultancy firm to help with the development of something. But I’m afraid the sums of money will just look too big. It becomes a pretty high-stakes game for the government/NHS purchasers, and another facet of risk averseness will manifest itself no-doubt.
Another problem I suppose will be that pharma will calculate, in a proportion of cases, that they will probably make more money from volume related sales compared to that which they can get hard-working politicians to squeeze out of their budgets – and therefore the old game will continue. But that’s a bit defeatist – it seems a very positive approach to pursue really.
(ok – I’ve now found the program details if anyone interested: “Restarting the antibiotic pipeline” and there seems to have been two episodes.)
HenryL,
You seem to have quoted part of one of my posts, rather than Mike Cowdery.
My comments referred in particular to one poster here, but it was not you.
It also applied more generally. For example, Sir Rory Collins stated in the Guardian that “Doctor’s fears over statins may cost lives”. This is a particularly devious and unscientific way to argue a technical issue – avoid the minuscule apparent benefit of statins, or the considerable harm that these drugs can do (I have experienced these, and I count myself lucky to have escaped intact!) and appeal to the gut. I would call this bullying. I mean lots of medical arguments may potentially cost lives, but that isn’t the point – the point is which side is right.
My comments were also meant to apply more generally, because there really do seem to be a number of non-medical ‘scientific consensuses that are held together by bullying and coercion rather than a genuine near universal acceptance of the validity of the supposed truth.
David Bailey & Mike Cawdery – sincere apologies for mixing your names up. By the time I got to the bottom of the accumulated posts it had (evidently!) gone too far over my memory horizon.
David, thanks for your response and I appreciate the feedback that I did not come over in a way I did not intend; though I was also addressing what I perceived as the
general situation here on the blog debate. Your comment seemed targeted at posters here rather specifically, more than the scientific world at large. None of the questions raised by people on the blog seemed unreasonable to me following from the original post, even if they had clear prejudices, as I argued somewhat.
Anyway, I quite agree with you over bullying (and other heartless and selfish attitudes) evident in the wider scheme of things, in the history of science up to today. The motivations for it may be all too familiarly human, but it is startling in an ostensibly scientific context.
….they had clear prejudices, as I argued somewhat.
As indeed you do yourself. Surely that is the whole point of science to get at what is the truth. Without debate nothing changes. The “six weeks strict bed rest” guideline post-MI lasted until NASA research (Dr Graveline) showed that total rest resulted in cardiac damage. The “harms” (more deaths) were not offset by any benefits.
David this is so true. I recall recently that Rory Collins said something to the effect that he would have to review the “safety of statins”, I guess to lull people (for the time) into a sense of confidence that he is trying to do the right thing. He certainly cannot deny the mounting evidence. But…according to guidelines with regards to pharmaceuticals, shouldn’t he have been doing this all along? Why now? That is where he has been derelict in his duties and in his position. That is what makes those of us who have suffered terrible side effects of statins not understand his position and become angry. How can you have such a huge responsibility toward others and not do you job?
If am hardwired to believe in God, I make no apologies for it. Perhaps going to private Catholic school and college and graduate school had something to do with it. But, I do have faith in things I don’t understand and there is no doubt that even Steven Hawking does not know it all. There are many mysteries in science and life. We do not have the capacity as humans to understand it all, though we try. It made me kind of sad when I saw you say at 20, you gave up on a belief in God. It is as though intellectuals think believers are pagans. I see all the strides in science we have made up to this point as being consistent with God. They go hand in hand pretty well for me. Nothing is impossible.
HenryL
With Karl Popper it is easy that we now slide over to the question on what constitute science in medicine. Popper is just one of my favourite tools in the box of now trying to understand what I see as ‘only debris of science’ in medicine and which has made me more and more openminded towards alternative medicine which I, as obviously most ‘medicine men’ today, earlier just frowned at.
About the subject of this blog post, put simply, any alternative procedure, although not approved FDA, that works is fine with me and should not be killed.
I really don’t have a problem with RCT’s – it is the way they are carried out in the hands of Big Pharma or, more often than not, not carried out for the same obvious reason which is ‘killing’ medicine as ‘a science’ to me and also makes it corrupt i my eyes.
It is not convincing for me to hide the test data and make incredible profits on such a procedure.
I am also much more open minded about alternative science ideas now that I see just how much conventional science has veered from honesty.
Yes, I am open to alternative forms of medicine, if I were to need them. I tried acupuncture while I had the statin problems, but I can’t possibly know if it contributed to my recovery – which I mainly attribute to stopping Simvastatin, and exercise.
It is interesting that some of the great men of science – such as Wolfgang Pauli, and David Bohm seemed to have seriously considered mystical/psi ideas. I suppose much of alternate medicine would fit into that bracket.
I like your phrase “debris of science”, which I am sure has a much wider application than medicine. Those parts of modern science that are absolutely pinned down by experiment and preferably actual gadgets, are honest, but the rest is probably a mess. Think how much cosmology rests on Hubble’s law, and yet there was (he died recently) a student of Hubble, Halton Arp, who became a ‘maverick’ by collecting evidence that galaxies could acquire red shifts in other ways than the Doppler shift associated with the expansion of the universe! Dotted through science are people who were formerly respected members of the science community, who are ostracised for their inconvenient ideas.
@ Professor Göran Sjöberg
Thank you for pointing me in the direction of Thomas N. Seyfried and his research. Just watched a video on YouTube based on his book, “Cancer as a Metabolic Disease” which I would urge everyone to watch. The interview with Dr Mercola fills in some of the gaps as well. The fundamental problem with his research and why it will be ignored is simple: there’s no real money to be made regardless of how effective the therapy is.
Just to clarify my point I am, with my background, almost allergic against all ‘supernatural’ claims of religious nature that often ‘pops up’ in the alternative medicine realm and at the same time advocate ‘science’ in support. Still you have to be openminded and if something works it works and then you may start searching for a rational natural scientific explanation for this if you are inclined to such endeavours. But you can also stay ‘happy’ with ‘when it works it works’ as most of us tend to do with most things in our lives – more a kind of ‘individual clinic observation’ together with a ‘religious belief’ in what works works – might be the ‘life’ placebo effect at work here.
I am here also in full support of Malcolm’s views on this.
To be frank, and you don’t need to be well read either, medicine and religion has travelled hand in hand since the very beginning of ‘civilisation’ and probably long before agriculture made us ‘civilised’ and that most of these supernatural believes are actually hardwired into the neurological systems in the frontal lobes of our brains if I now should believe what professor David Lewis-Wililams, who have studied these connections extensively, tries to tell me and I actually tend to believe him. Essentially, therefore, religious beliefs are hardwired into our brains once you have got them and they are then extremely difficult to ‘un-wire’ and that is the main point here. This is also what I see among the ‘debris of science’ in ‘orthodox medicine’.
Nowadays, quite naturally with my new Lewis-Williams perspective on this, I also wonder how ‘hardwired’ my belief in LCHF actually could be in my brain. Think if it is all placebo irrespective of what the blood glucose meter is telling me in digital numbers.
Science i a really tricky thing when you start thinking deep about the subject so the best thing is perhaps to stay clear from this kind of thinking if you want to preserve you ‘faith’ in traditional medicine.
Professor Göran Sjöberg,
I must admit that although I am not a religious person, I do baulk at the idea that certain religious ideas have simply been hard-wired into our brains!
I was, in fact a Christian until age 20, and I seemed to have no difficulty un-wiring that line of thought while at university!
We probably should not clog up Dr Kendrick’s blog with more discussion of this topic, but if you want, we can discuss our respective ideas by email.
It’s a long time since I actually read Popper I must confess, Göran, and I should be careful waving him about like a banner given the recalcitrant nature of my grey cells… but at the time I encountered his work it made resounding sense to me as a logical framework for science. I was studying physics and philosophy and one of the physics lecturers increased the speed of my personal falling out of love with physics (at that time) by banging the table and telling us we had to remember that “although it may not look like it, it actually IS made of atoms and molecules”. At which point I stumbled from the room (in the Broadway version) muttering “it’s just a MODEL isn’t it, even if it’s a good one”. So I was rather at home with verisimilitude. I also think Kuhn’s paradigms and revolutions angle and Feyerabend’s ‘anything goes’ equally captured important aspects of the reality of the scientific ‘process’, regardless of conflicts arising between these views. As to what constitutes medical science – well whatever it is I’d say the culture seems rather more Feyerabendian than Popperian right now!
Medical research is not a world of falsificationalists, that’s for sure.
David Bailey
“I must admit that although I am not a religious person, I do baulk at the idea that certain religious ideas have simply been hard-wired into our brains!”
I think that you, with your stated background, might enjoy Lewis-Williams writing on this subject. Anyway it was an intrigued with my mind as a natural scientist.
When I am now using the term ‘hard wiring’ it is actually a phrase I borrowed from Lewis-Williams who uses it to explain the neurologically ‘hard wired’ ability of the human, Homo Sapiens, mind to experience revelations, mostly of religious kinds, and which by such revelations tend to gets ‘stuck’ with unquestionable dogmas. From this perspective you may be able to explain why people get so fanatically defensive in their different beliefs – I think, with Lewis-williams, that this ability is just hard wired in us.
In medicine I find this attitude very strongly and unfortunately in almost every branch I have happened to jump into; heart disease, diabetes, mental ‘disorders’ and nutrition to name the most prominent. Here I truly see orthodox ‘medicine men’ claiming the possibility of walking on water in the name of ‘science’.
E.g:
“By-pass surgery is fine!”
“It is good for diabetics to eat sugar.”
“Psycopharmaca will heal your mind.”
“Saturated fat is bad for you.”
I am sorry that forgot the main medical topic relating to this post on my list, cancer and the “walking on water” dogma:
“Cancer is a genetic disease.”
Having read the early history of cancer chemotherapy by Cristofferson, there seems to have been a lot of ad hoc experimentation with biocidal chemicals and cocktails thereof. The resultant harms and failures were extensive but because they were following an approved, official medical theory, there was no demonisation. One can only hope that the largely forgotten work of Warburg and its derivatives are more successful in the future. I fear that the medical status quo may well slow the process down.
HenryL
“Feyerabend’s ‘anything goes’ equally captured important aspects of the reality of the scientific ‘process’”
Postmodernism, heavily endorsed by the establishment today, might have some allure to some ‘modern’, ‘humanistically’ inclined people who see a number of ‘real realities’ around in the cultural context. I, though, see this postmodernist influence, to my disgust, now infiltrates even the hard core natural sciences at universities. What surprises me is that they really can get away with it.
I, myself, adhere to the more traditional ‘simplistic’ view that we have one physical reality, and only one (however complex), about which we by definition must have different opinions. How could anything else be possible?
BigPharma has one opinion about statins or cancer – me another for sure!
I also believe that my present opinion about medical things like these is closer to the ‘one’ physical reality in medicine than the ‘ignorant’ one I had 15 years ago.
Talking about atoms and ‘verisimilitude’ it is an interesting fact the even a ‘die hard’ positivist as Mach, after having ‘assasinated’ Boltzman’ many years before, died admitting the existence of our atoms – unbelievable! Today you can, by the way, see the atoms one by one in the microscopes and fewer thus doubt their existence than a hundred years ago.
A positivist has the benefit of never being able to be wrong about anything – he will always be a winner. As with the postmodernists there is always another option for a positivist but there are fewer of the latter kind around today while the former are multiplying. I guess Wittgenstein would turn in his grave if he should know about what is going on.
HenryL
First you have misquoted me. The phrase that you disliked was in fact made by David Bailey.
In helping break down the walls of excessive authoritarian institutional medicine it is part of a positive process of widening participation in science
I agree with you entirely on that statement; excessive authoritarian institutional medicine is in fact the major problem. It reflects closed minds and leads to “directives” aka guidelines that are frankly wrong as Dr Nissen has suggested. It is that which I personally cannot condone as “science, evidence-based medicine” or call it what you will. To me scientific integrity is paramount; hiding negative data involving deaths as was done with VIOXX and AVANDIA is anathema. This raises the query: “What other drugs have hidden data of this nature? Can we, the general public/patients trust Big Pharma when we know they have done this? Regretfully, I am afraid that I cannot; they will have to prove themselves again by transparency and ipen access. I support Ben Goldacre and others in their attempts to axhieve this objective but I am not hopeful. Money and status are too powerful.
Oh, hi, Henry – I saw my name, so I thought I’d stop by this sub-thread to say hello. What a poetic rant and great attempt (really) at summarizing the various threads of this discussion! Initially I was tempted to join in with the other voices here and underscore that I wasn’t saying what I think you think I was saying. But that would detract from the main point, which is that I see validity in pretty much everything in your comment.
This is on a tangent, but it’s so interesting to me how polarized these discussions are. Once someone says anything remotely supportive of Dr Burzynski, they are labeled as crazy conspiracy theorists and the arguments against them assume so many things about where they are coming from and what they believe. (This works in the other direction, too, I’m sure.) There’s been some interesting research in the US recently on how “partyism” trumps racism as a source of prejudice (http://www.bloombergview.com/articles/2014-09-22/partyism-now-trumps-racism). So this is a powerful mental phenomenon, and it’s difficult to remain immune to it. Knowing that the other side really does see the dress as white and gold has kept me from becoming too exasperated. Not sure what has helped you, but yours is one of the most balanced comments I’ve seen here.
Ola, I’ve been accused of various things but rarely poetry!
Thanks for your kind words, but/and it seemed to me you were/are doing a fine balancing act yourself, whilst digging into the underlying substance into the bargain.
The polarisation phenomenon is fascinating and somewhat horrifying. Association with groups is clearly a deep innate mental tendency indeed.
I was struck by an account some years ago from a woman who lived through the breakdown in former Yugoslavia. She described how she had been living a comfortable pretty middle-class life with an integrated group of ethnically diverse friends, they would meet up for dinner etc., but ended up trying to kill each other (not during the dinner). Other ethnically based examples might spring to mind.
It seems the group-association tendency has an unfortunate and sometimes dangerous positive-feedback loop. You are associated with a group somehow, members of another group attack this group in some way, you are then inclined to see other people associated with the attacking group (even if they were not attacking you) as an enemy, and so on. Stating the obvious perhaps.
However, ‘partyism trumps racism’ – a triumph reflecting a diminished concern with race and that peoples political views are more of a threat!?
(ps re group-association just saw MK’s reference to Cass Sundstein and group polarisation in another subthread – maybe this is offering an explanation of or alternative to the positive-feedback loop idea)
Ola
I have really enjoyed this discussion. I stopped posting as I was annoying people but I have kept following it.
You and Malcolm and others have shown how to argue without antagonising. Excellent stuff.
Fergus, you cannot have fire without friction, so if all agreed and did not feel a sense of combativeness at times, things won’t get done. That is not the worst thing that can happen. Although I am a bit feisty at times, it has serves me well when I needed to shake things up a bit.
Oh! But you are definitely wrong about the dress!!
=)
In response to Mike Cawdery above (can’t seem to insert this response in the right place) –
you say
“….they had clear prejudices, as I argued somewhat.(my words)
As indeed you do yourself. Surely that is the whole point of science to get at what is the truth.(your words)”
I of course have predispositions, but I had no pre-existing judgement, or bias, with respect to Burzynski or his field of activity as I knew nothing about him or it. Perhaps especially because of that I was predisposed to see a scientific debate on the content of the work 🙂
I guess I’m unclear on your point and we may be at cross-purposes here somewhat.
YouTube has a very detailed and explicit video about Burzynski and what he has endured over several years of harassment by the FDA. He has spent millions in his defense and the taxpayers millions upon millions more as a result of these vicious attacks on Burzynski. I think it is important to view this film for all to understand how contradictory the FDA can be when it comes to alternate means of curing certain cancers for those who CHOOSE his treatment as a last resort or because they suffer far fewer debilitating side effects. As a real slap in the face, one large pharmaceutical company actually tried to steal his patent. Yet, he has stood solid and never wavered in his determination to fight to the end. I think everyone here should watch it.
http://www.burzynskimovie.com
The FDA has long lost my respect. With its “revolving door” policy with Big Pharma and its attempts to besmirch Dr David Graham over the VIOXX disaster and other incidents of the top brass over-riding decisions of its own experts makes it unfit for purpose.
You know the Burzynski Movie is just an over-long advert for the clinic, right? It may not necessarily be completely factual. There’s a nice review of it here:
Re Cancer
http://thetruthaboutcancer.com/fall_quest1.php?a_aid=1619624#
along with Dr Steyfried
A reason for an open mind???
Agree Mike open mind. Although I still believe cancer is a game of chance dependent on mutations caused by many sources, I of course could be proven wrong. We shall see.
Homeopathy/water however , no chance.
if homeopathy produce a satisfactory outcome in an INDIVIDUAL for whatever reason, so be it. The problem with what James LeFanu calls the “Social Theory” in modern medical thinking only concerns a defined herd and often but a tiny fraction of that herd benefits. In short, the individual patient is no longer of concern, just the herd and the concept of “First do harm” has been forgotten.
On homeopathy; probably would not consider it but herbal medicine is something else; quinine cures malaria and muscle cramp.
OOPs! First do NO, harm. My mistake
Fergus,
I am not really wanting to promote the idea of homoeopathy, so much as to counter the excessive certainty which seems to abound nowadays in scientific pronouncements.
The whole thrust of this blog (and Dr Kendrick’s book) is to point out just how disastrous that approach has been. I like Dr Kendrick’s comment:
“I only put thoughts into one of three places. Probable, possible, unlikely”
This makes it less likely that something really valuable will be scornfully discarded.
Regarding homoeopathy, I’d be happy to see it with the ‘unlikely’ classification, but it is sobering to remember that Quantum Mechanics, that underpins matter,can only be applied to individual molecules (more or less), and that a drop of water contains, at least 10^20 molecules – yet we glibly assume that we understand all its properties and can rule out homoeopathy a-priori, and even despite some evidence to the contrary.
Given the state of medical science, I find that arrogance quite unjustified.
Back in 1989 two chemists (one of them English) reported on a way to bring about nuclear fusion in a test-tube – cold fusion. This was seen as a tremendous threat to hot fusion which has absorbed vast sums of money, and even now has delivered no electricity. Cold fusion was not placed into Dr Kendrick’s ‘unlikely’ character, but totally ruled out – as if someone could prove a theorem that it was impossible.
Nowadays, Cold Fusion is studied under the name LENR (Low Energy Nuclear Reactions), and if you explore this on GOOGLE you will see that the topic is hotting up (sorry about the pun). You can, for example, watch a whole series of lectures on the subject by a number of MIT professors!
Whether this ever delivers or not, did it really help to downgrade Cold Fusion from ‘unlikely’ to ‘impossible’?
Many conventional treatments do many times more harm than good. So little is known about cancer is wise to investigate well before choosing any type of treatment. Because even not all oncologist believe that cancer should be treated the same way.
http://www.wired.com/2009/05/cancercompromise/
OK Charlie. But remember cancer survival has improved dramatically in the last 20 years. Eg childhood acute lymphoblastic leukaemia, 20 years ago 20% cure to almost 90% now. Due to oncolgy.
True. And one must not fall into the trap of dismissing everything someone does, because some things are wrong. I think we must always recognize that good people/systems can do bad things and vice versa. For example, I care not if Burzynskis is a fraud, a crook, a cheat, a wife beater…. I would hope he is not. But these facts have no relevance to the ‘truth’ or otherwise of his work, no relevance at all. Equally, the pharmaceutical industry has done some inexcusable things that would easily all into the fraud, crook, cheat, category. But one cannot deny that many good things have come from this industry. I suppose one could look to the end of the Second World War where some felt that the medical research of the Nazis should be destroyed, for it came from utterly unethical research e.g. dropping people in freezing water to see how long it took them to die. Others felt that to destroy such work would be pointless. We could learn much from what they did to help people now, and in the future. Whilst I feel utter distaste for how this research was done, and those that did it, I fall firmly into the second camp. To destroy valid research, because you cant stand the people that did it, is pointless.
Fergus
As far as I understand, Seyfried’s main point is that the ‘curing’ outcome of the present orthodox cancer treatments are at best meagre but they are nevertheless dire and it is therefore ‘unforgivable’ that the establishment cling to the present fundamental ‘dogmas’ about cancer. The definition of ‘survival’ seems i addition to be in the hands of the medical business as usual – doesn’t instil trust in me. No one can, from the statistics of the last 20 years, claim that the ‘war on cancer’ has progressed if judged by the number of dead victims..
With utmost interest I am now reading, in Seyfried’s book, how in detail, what he calls, the ‘substrate level oxidation’ of glucose and glutamine takes place and actually interact in the mitochondria through the ‘corrupted’ citric acid cycles, of different kinds, characterising all cancer cells, and how enough ATP still is produced for the cell survival and proliferation in a fermentation mood irrespective of the presence of oxygen – and here Seyfried certainly knows what he is talking about. This is an extremely interesting and scrutinising analysis of the metabolism to me since it is here, as I see it, and in all its ‘devilish’ details, where the understanding of the ‘riddle’ of cancer harbours. This actually seems to be the key point of the controversy that goes back to the days of Otto Warburg.
Malcolm
I fully agree again.
What you say reminds me of what my ‘favourite’ physiologist, and perhaps the most famous ever, Claude Bernard, accomplished during the 19th century and he is to me also one of the very few true scientists in medicine while he tried, but actually failed, to wash out the medieval, scholastic and religious attitudes permeating the medicine of his day and due to his faliure on this point these prejudices still exist today, as I see it. Bernard had deep and influential thoughts about fundamental experimental science in general which I fully adhere to. Though, it is a fact that Bernard’s wife left him partly due to his insensitivity to the sufferings of the test animals during his experimentations.
Seyfried might be a modern variant of Bernard and he is actually complaining about the ‘thwarting’ ethical restrictions today imposed on the experimentation with animals which makes the progress of science in cancer research very expensive and slow to his opinion.
And what you say also reminds me of profound attitudes of philosophers of science like Sir Francis Bacon.
I can remember all those years ago when Burzynski’s clinic was first raided. I was keeping an eye on events in news articles. It brought out the passion in many I recall. A number of people who felt his treatment had helped fight different cancers rallied to his support. I remember later buying a book about him and his cancer ideas. It had me thinking if I was unfortunate enough to develop cancer I would visit his facilities. It might not be the first stop I made, but somewhere along the way I’d make an appointment, if possible. Nice to see the published study on Burzynski.
Here in America saw a PBS special is soon to be be shown on the history of cancer treatments. I don’t have plans to watch it, and imagine if Burzynski is mentioned he likely will be highlighted in a poor light. That seems to be the nature of things. A little bit about the show can be read at ~
“Cancer’s most controversial surgery”
https://news.yahoo.com/cancer-emperor-of-all-malodies-cancer-s-most-controversial-surgery-221909086.html
In short is anything published right? In many reports I have read Ioannidis’ view has been confirmed and This view is supported by Dr K’s “Doctoring Data”, Gotzsche’s “Deadly Medicines…” and many, many other studies. What about GSK’s hiding deadly data on Avandia, the Poldemann affair, the VIOXX disaster and many others?
Of course much research is good but when $billions are involved, I personally believe skepticism is the appropriate approach. Are YOU prepared to take a drug when the probability of YOU benefiting is 0.003 and the probability of suffering adverse reactions may be as high as 0.2? That is the question we all have to answer for ourselves unless of course you are prepared to be an insignificant member of a statistical herd.
So I take it you would apply your sceptical approach to the Japanese ANP study, right?
Of course
To clarify: to be skeptical does NOT mean that a given theory is wrong which seems to be your view. It means that further supportive evidence from an independent source is required.
To condemn a theory on its failures is wrong. If that is your view, this would immediately condemn the genetic theory of cancer because of the litany of failures that it has accumulated.
What Causes Cancer?
Part I
http://www.diagnosisdiet.com/what-causes-cancer/
Cancer as a Metabolic Disease by Thomas Seyfried
Thomas Seyfried PhD, a brain cancer researcher with over 25 years of experience in the field, gave a groundbreaking presentation about cancer at the Ancestral Health Symposium held at Harvard Law School this past August. The three main take-home points of his talk (spoiler alert!):
1. Cancer is not caused by genetic mutations
2. Cancer is a mitochondrial disease
3. Cancer can be treated with ketogenic diets
OOPS! If this is correct will the current cancer chemotherapists to demonised like Dr B? I hope not; they like Dr B are probably genuinely trying their best to solve an intractable problem. Time will tell who is right and who wrong or may be Dr Seyfried is right and the rest wrong.
Mike
If cancer is a metabolic disease why do mutagens of DNA cause cancer? Also why do individuals with DNA repair mutations suffer from lifetime cancers eg blooms syndrome fanconis etc. The theory would have to explain these sort of issues.
May I suggest you read Thomas N. Seyfried Cancer as a Metabolic Disease £60 on Kindle
or
Christofferson, Travis (2014-10-26). Tripping Over the Truth: The Metabolic Theory of Cancer . . Kindle Edition. Free to read for Kindle subscribers £7.50 Kindle edition to buy. This is a layicised review of Seyfried’s book.
The reasons are explained in a very cogent and detailed manner with the “chaotic” gene results leading through to Watson’s (of DNA helix fame) U-turn in favour of the metabolic concept of cancer from the genetic.
Well here’s my, probably unwelcome, twopennorth. We are no further forward today in the field of cancer research than we were twenty years ago despite the statistics to the contrary. Let’s not forget these are based on five year survival rates not cure. The earlier we find it the more it conforms to the five year survival rate.
99% of the research done is, and has to be done for funding, within the constraints of consensus, to me terms like mutagens of DNA cause cancer and individuals with DNA repair mutations suffer from lifetime cancers confers the illusion of “knowing” the empowerment factor.
We know almost nothing about it and within the constraints of consensus we never will.
We have come up with ever more creative ways to excise it, poison it and burn it in it’s earliest stages, that indeed has influenced the statistics but play the game, care of consensus, we’re not even on the field yet.
Bloom’s syndrome and Fanconi anemia cause a lot of abnormalities and I’d be really surprised if they didn’t incur metabolic defects (in fact I’d regard anemia as exactly that.)
Most mutagens are also quite directly toxic, interfering with cell respiration and damaging them resulting in metabolic problems. Some mutagens like those discovered in soot also exhibit estrogen like functions. Excesses of estrogen and its analogues have been implicated in lots of cancers.
For example some people carry certain genes that are said to make an individual more sensitive to estrogen, increasing the likelihood of cancers of a certain type. However, these aren’t damaged genes but normal ones the person inherited. The environment changed (more estrogen) and the individual developed a cancer without changes to their genetics.
However I personally wouldn’t say that DNA damage can’t cause cancer. If acquired genetic damage results in a metabolic derangement, that also provides a metabolic pathway for a ‘DNA induced’ cancer.
Maybe the mitochondrial damage causes the observed “chaotic” genetic mutations resulting in the failure to establish consistent genetic associations within types and individual cancers?
Mike
Thanks for that book recommendation (Christofferson’s) – at first glance that looks like yet another area of medical science that may be wrong! I noticed that James Watson is involved in the rethink.
It is interesting that Peter Duesberg (he of alternative theories of AIDS) wrote an article in Scientific American about the strange aspect of cancers – that the genome of cancerous cells become spectacularly scrambled.
F.I.T.S.
“We are no further forward today in the field of cancer research than we were twenty years ago”
I disagree. eg chronic myeloid leukaemia (CML). We know the fundamental cause, a translocation between chromosomes 9 and 22. We know the abnormal protein this translocation causes, a fusion gene bcr-abl. A drug was manufactured to bind with this protein and stop it causing CML. Brilliant.
There are lots of these targeted therapies now and with the new genomics sequencing various tumours more and more of these advances will be made.
Can you explain why with “survival time” increasing, the actual death rate from cancer continues to increase and is expected to become the No 1 killer in the near future? Dr.
Gigerenzer, in Risk Savvy shows how survival times hides the reality in terms of death rate; prostate cancer was his example. I also refer you to LeFanu’s book “The Rise and Fall of Modern Medicine”
Mike
The standard answer to your question is that we are living longer. As we live longer the number of genetic “hits” increases and builds up to make it more likely as we get older that you will get cancer and therefore the rate of cancer increases.
I am not sure that the metabolic basis of cancer idea is dismissed to the degree you think as a lot of cancer specialists are taking the idea seriously. As you may have guessed I still have to be convinced. I think that most cancer is caused by DNA damage caused by many things, just living being one of them. Some cancer no doubt is caused by metabolic problems also.
mikecawdery
Since I brought Seyfried into this thread and am reading his book with great interest just now I must admit that I recently found serious critic of his advocating a very strict ketogenic diet as a cure for cancer. Evidently it works to regress the cancer but not as a cure for good as far as I understand it just now – the cancer will hit back!
As with everything when you start digging into it turns out to be much more complicated than when you just started to look into the ‘problem’.
This would however not refrain me from seriously looking into alternative, ‘innocent’, treatments – there are a number of ‘anecdotes’ around and possibly you can go ‘low cost’ by working on your own. Doesn’t hurt with a research background when you start looking around but this is hardly any strict requirement.
Indeed, and thank you for doing so. The fact, apparently known about since Wagner 80 years ago that ALL cancers provide evidence of reversion to energy production by the anarchic fermentation process is common seems to me serious evidence of mitochondrial damage. Watson’s view on this and apparent support plus the “chaotic” genetic “associations” appear to direct attention to this.
That the cancer can “hit back” does not surprise me; cancers have “hit back” against conventional therapies as well! The rate of cancer deaths, despite the claims of better “survival” is still increasing and there are estimates that it will soon be the major killer. I believe that there are squadrons of black swans confounding current, official dogma on cancer
Many thanks for the link. I am delighted to see that Otto Warburg’s work on cancer is receiving interest after these many years. I saw recently that Stephanie Seneff of MIT is interested in the possibility that the body creates tumors in vestigial organs – such as the breast in post-menopausal women and the prostate in older men) as part of its effort to fight off disease and she, too, quotes Warburg’s research. Following up on Dr. Kendrick’s earlier comment about using German research during WWII, It may be possible that Warburg’s work was not followed up sufficiently by the scientific community simply because he did not do “the right thing” and leave Germany during the war.
Hej Prof.S.
In response to your comment a couple of days ago (again I can’t see how to insert this in the right place..):
I was a bit surprised at your sweeping dismissive categorisation of Kuhn and Feyerabend (or perhaps just Feyerabend actually, reading your words again) as a postmodernist and therefore obviously beneath contempt. I’ve never looked into postmodernism per se and am not really sure what it is, I just read Feyerabend’s book ‘Against Method’ during studies in my youth and thought it had some interesting observations and angles in it, perhaps as Burzynski might have have something worth looking closer at?
With my usual caveat that I have not been paddling in the philosophy of science for a long time and the limbs are rather stiff:
To me Popper gave a strong logical account of scientific knowledge and low-level methodology.
I fall back to it, somewhat loosely perhaps, as representing a kind of hard logical back-stop, as well as a banner to rally around. Practically, in medical science more focus on falsifiability to reduce the excessive hold some ideas seem to get (with associated dogma), more transparency and tracking of the auxiliariness of hypotheses would seem and a good thing, and absence of truth might promote humility.
Kuhn’s paradigms/revolutions would seem to fit extremely well with medical science. The diet-heart and cholesterol hypotheses look pretty much like paradigms to me. Feyerabend went a step or two further and argued that not only did science not proceed in a nice cumulative way it was much more messy than that. One of his central arguments was that the history of science really exhibits no consistent methodology and involves all kinds of dubious manouevres in the heart of progress – hence ‘anything goes’ (or went) – and then IIRC he argued furthermore that it was overall more productive not to prescribe a methodology but to allow diverse approaches, and attacked overbearing scientific dogma as stifling this.
A lot of the discussions on this forum cite social and commercial factors (money, status etc.) and overbearing institutions and orthodoxies as major problems affecting the quality of medical science, adversely affecting patients, stifling creativity and so on. And considering the apparently woeful state of notionally scientific medical research output, dodgy practices, political and commercial manoeuverings and so on, ‘anything goes’ seems to fit the overall picture pretty well. Consequently I’m less inclined to dismiss Feyerabend’s digging in this area out of hand. The slight frisson of anarchism might appeal to MK too 🙂
On a lighter note, I too am quite happy with the notion of one physical reality, at least within a given co-working scientific group! But as to being able to see atoms, I’d respectfully suggest that one cannot. One may build a machine which creates an image that can be attributed to the existence of atoms based on the model that is being used.
HenryL
Thank you for pondering my thoughts!
There is a lot to say about ‘the way’ to look at different diseases with associated cures and, not least, how these views has shifted with time. Since you mention Thomas Kuhn it is interesting to note that he gives full credit to a predecessor to his own main ideas about how scientific revolutions take place. This happens to be a ‘forgotten’ deep thinking ‘medicine man’, Ludwick Fleck, who in 1935 wrote a brilliant monograph named “Genesis and Development of a Scientific Fact”. I think that you, if you like, can here find connections in Fleck’s book with the ‘social’ views of Feyerabend and perhaps also with the thoughts of Susan Sontag in her book “Illness as a Metaphor”.
Since you still seem to have a deep sceptic view on the ability to ‘see’ atoms, one by one, with modern electron microscopes I guess you tend to line up with those guys who didn’t want to consult the telescope of Galileo or perhaps even more seriously consider Schopenhauer’s views of seeing, building concepts and not least what is meant by understanding is sheer nonsense. I hope I am wrong!
And about postmodernism I myself consider it as a societal incurable brain cancer and which not even Burzynski could do anything about.
Göran, you have stimulated some dormant areas, and your impressive learning and energy is most invigorating!
I am sceptical but perhaps not in a pigeonhole sense. I suppose from a Popperian perspective neither the atomic model nor any other can ever be known to be the final truth, however well it hangs together. A two dimensional image of something looking like out-of-focus ping-pong balls (or whatever) can only be understood to be a representation of ‘atoms’ by means of a huge theoretical edifice, it’s not just some kind of ‘raw seeing’. I think Kuhn also made a related point about the way the paradigm shapes the observations that are made. I am certainly convinced that perception in general is ‘theory-laden’. They may be incredibly useful, powerful and (so far..) reliable theories/models, in many cases – widely inductively corroborated thus we may feel confident in applying them, but still models.
We might have to just agree to disagree here I guess 🙂
Medical/biological science seems harder than physics, the problem being the variabiity, complexity and interconnectedness of biological interactions, bordering on chaotic, which makes the problem look more like long-range weather forecasting.
Anyway, the value in remembering that our ‘knowledge’ is just a model is that we are then more open for the consideration of alternative models and ideas. That way more progress might me made. Though we still want testable ones!
(In the interests of seeing whether I have completely misremembered Feyerabend I have now got down my copy of ‘Against Method’ and transferred it to the teetering bedside reading pile… )
Henry L
You seem to me to be genuinely interested – I like that.
When you say : “I am certainly convinced that perception in general is ‘theory-laden’” I am happy to note that this is exactly what Schopenhauer is teaching about perception and understanding although he here prefers the word concept. Basically it is impossible to approach the ‘one’ external physical world without your own ‘prejudices’ – you would very soon die by misjudgments. (It is irrelevant to me if you use the word concepts or models for the ‘pictures’ you build of this ‘one world’ you happen to see.)
My point about seeing, which Schopenhauer really elaborates on, is that our visual perception system is quite complex (it was well known already in the middle of the 19th century that you have to ‘learn’ to see and build concepts of our external ‘one world’ to make your vision work. Still I agree with you that the todays extremely sophisticated ‘microscopic’ means of physics to ‘image’ the minute details of the material world involves a strong subjective element – I have myself argued with students of metallurgy who were displaying ‘impressive’ colour images of this ‘real reality’.
And when I read “I am sceptical but perhaps not in a pigeonhole sense. I suppose from a Popperian perspective neither the atomic model nor any other can ever be known to be the final truth, however well it hangs together.” I realise that nothing is here new since Xenophanes.
Anyway, when I am now reading the 6th edition of the “Molecular Biology of THE CELL”, Alberts et al., I tend to ‘believe’ that those intricate images created, by various really sophisticates X-ray means, of the intricate structure of our proteins are rather accurate in reflecting the ‘real’ material ‘one world’ involved.
When you state: “Medical/biological science seems harder than physics, the problem being the variabiity, complexity and interconnectedness of biological interactions, bordering on chaotic, which makes the problem look more like long-range weather forecasting.” I more than fully agree with you.
Actually, today, when I was helping my last Ph.D. student to put the final touch to his thesis I actually used Albert’s book to point to the overwhelming complexity of the organic world in comparison with the inorganic one which is our own field of research in order to bring in some perspective on his work.
It is realising this very complexity which tend to make me almost allergic to any categoric statements from ‘medicine men’, but dogmas have always been the norm here and that is also the main reason for me considering medicine more of a religion than to have anything to do with science.
When you start thinking ‘deep’ about what is ‘science’ you, for sure, arrive at realising that RCT’s is just something ‘screwed up’ by Big Pharma and that there is much, much more in the ‘science of medicine’.
That is also why I don’t have a real problem with guys like Burzynski – it may work!
Henry L,
Your comment:
“When you start thinking ‘deep’ about what is ‘science’ you, for sure, arrive at realising that RCT’s is just something ‘screwed up’ by Big Pharma and that there is much, much more in the ‘science of medicine’.”
reminds me of a comment made by Jerome Burne, over at http://healthinsightuk.org/ .
“Evidence based medicine has reached a point similar to what was happening in banking before the crash, which was relying on what turned out to be toxic debt packages tied up with complex mathematics.”
The more I think about that statement, the more I like it.
In both cases the maths works on tiny effects (price differences, or health outcomes), but in theory it can’t fail.
In both cases, despite all the maths, it does fail – basically because the mathematicians make assumptions that aren’t necessarily true, but which end up totally buried.
In both cases, hardly anyone really understands both the maths and the other discipline (finance or medicine).
In both cases the technical obscurity hides massive corruption.
David
goransjoberg2015
“…that perception in general is ‘theory-laden’” I am happy to note that this is exactly what Schopenhauer is teaching about perception and understanding…”
Again a long time since I read (small portions of) Schopenhauer, but I have vague fond memories!
“It is irrelevant to me if you use the word concepts or models…” – me too, in this case, I was not making any particular distinction.
You said “My point about seeing, which Schopenhauer really elaborates on, is that our visual perception system is quite complex (it was well known already in the middle of the 19th century that you have to ‘learn’ to see and build concepts of our external ‘one world’ to make your vision work. Still I agree with you that the todays extremely sophisticated ‘microscopic’ means of physics to ‘image’ the minute details of the material world involves a strong subjective element ”
I think the word ‘subjective’ is a tricky one in this context.
I hesitated to back up this far during my own previous comments but, as you cite, our fundamental perception of the world is a construction, and we are in the delicious circle or recursion of the fact that our neuro/physiological model of perception by means of which our experience of a world is created based on sputtering nerve impulses is itself a figment within that created world.
It can seem bordering on insanity to some people to back out to the edges and even entertain such ideas as ‘matter (or substance) is invisible and just a concept to organise our perception of the behaviour of surfaces’, or ‘causation is purely a concept to group the regularity of certain kinds of experienced coincidences’. In some sense it *is* insane as it is outside of the normal lower level regions of a substantially stable shared model/language/world which we normally inhabit and interact within. But I think the practical upshot of this in the context of this forum is to shake the dogma and increase openness to new/alternative ideas.
One should ensure one’s BS detectors are fully charged but on the other hand should avoid throwing the baby out with the bathwater. (This applies as much within the mainstream as the outer reaches of course.)
A good example of an alternative model here perhaps could be the (a?) traditional chinese medical model? I don’t pretend to have any grasp of it, I have not inhabited it, however I have been treated under this model and the diagnostic and advice experience was interesting enough to make me proceed (whereas I more or less rapidly jettisoned a number of other alternatives explored). It may have been co-incidence, placebo etc. but nonetheless my own ominously worsening condition soon turned the corner and started improving after embarking on this treatment – starting around one year into the illness (having fallen off the map of conventional western medicine which seemed to have nothing more to say).
A key thing which made me stay with it was that the chinese medical practitioner I saw, apart from seeming commendably sane and honest and not exaggerated in his claims, told me a couple of things I had not noticeably told him or indeed seen clearly myself (could have been some ‘cold reading’ perhaps somehow I suppose if one was being super-sceptical, but it did not seem so), and which suddenly fitted with my experience. He told me (predicted) that certain things would probably tend to exacerbate the condition – and lo and behold I saw that I had indeed been doing just this kind of thing and it did indeed seem to correspond with worsening of the symptoms. So I stayed, and recovered.
I’m sure there has been a lot of work somewhere looking into chinese medicine from various perspectives and I have not sought any of it. At the time this was to a large extent due to a kind of delegation philosophy ‘I don’t have time to become expert enough to assess this in detail so no point even starting’, but also I suspect this reflected a dilemma that many people more or less consciously face when dealing with their own health in some greater or lesser degree of desperation – that you want to believe it could work, and you are only likely to convince yourself of the opposite by looking too hard! A kind of subconsciously self-administered placebo perhaps.
Anyway, I have the unscientifically tested impression that many alternative treatments and ideas suffer from the problem of trying to go too far and becoming incredible. It seems they may often be based on some noticed patterns of genuine interest, starting from a ‘that’s funny’ perhaps, enough of it accrues to become a nugget of something but then the attempt to generalise it into a wider conceptual framework – which is of course a scientific enough aim in itself – is where it is prone to come adrift. Our old friends, those with various kinds of vested interests, step into the breach to help shore it up in various dubious ways. Also there is a tendency to try to stretch the concepts too far, to try to cover all ills and this can become ridiculous. This leads to religiosity and I suspect leads to the rejection of core nuggets and viewpoints that may be worth more of a look.
As you also said: “It is realising this very complexity [of medical science] which tend to make me almost allergic to any categoric statements from ‘medicine men’, but dogmas have always been the norm here and that is also the main reason for me considering medicine more of a religion than to have anything to do with science.”
Indeed…
My bottom-line suggestion about ‘alternative’ treatments is that if there is a number of ‘anecdotes’ around, the ‘school-medicine’ treatments dire and with limited prospects of ‘curing’, while the anecdotal treatments are innocent and with some ‘hope’ of success, why should you not try these alternative first. I would do it myself and if these innocent treatment then works they do even if Big Pharma is losing at lot of money on your refusal to follow the dire line.
Then, often you hear you doctor say: “What ever you do continue with it!” and he will not ask any further questions not to lose his job. Although my ‘own’ cardiologist, proclaiming´ that he was following the ‘guide lines’, considered what I had done during 15 years to reach the “success” with my heart disease was “almost criminal” but I hope that his attitude is still a rare one among GP’s.
Raising the issue of “black swans” again both Einstein and Prof. Hawking have made similar comments. The trouble is that many of the edicts/directives issuing from the medical establishments are subject, not to one “black swan” but to squadrons of them, all totally ignored.
You need to see this. There was an episode of 60 minutes on US television concering some research work which has been ongoing for years at Duke University to treat brain tumors (to kill brain tumors, more exactly) by directly injecting a modified polio virus into the tumor. This report can be see at
http://www.cbsnews.com/news/polio-cancer-treatment-duke-university-60-minutes-scott-pelley/
It was truly exciting to see the results of such excellent scientifically driven research evolve.
The issues of using antineoplastons may disappear.
This was so amazing!!! It goes to show how keeping a very open mind can benefit even the worst deadly diseases.
For anyone that’s interested, “The Quest for The Cures Continues” series is now available to watch for free again, as of 30 March. There are 12 one hour programmes which are showing once a day until 9 April. Dr B does appear in some episodes as do many other doctors and specialists who are trying to prevent and treat cancer in ways other than the usual cut, poison and burn. Many of the patients featured have gone down the orthodox route to start with, but this series covers many different ways that people have successfully ‘regressed’ their cancer or survived many years longer than they would normally have done. The host, Ty Bollinger, is obviously a Christian, but don’t let that put you off – he doesn’t make a big deal of it.
Anyone open-minded enough will no doubt find some nuggets of interest in the series – and possibly help themselves to avoid succumbing to the disease.
Episode one is here: – https://www.youtube.com/watch?v=Rc1rtIxvkao
Episode two: – http://thetruthaboutcancer.com/spring15/episode2/
Episode three: http://thetruthaboutcancer.com/spring15/episode3/
The subsequent episodes will be available to watch again as they are broadcast daily – so episode 4 will be available later tonight.
Should be interesting how this works out. I saw Forbes had a few articles about the CBS cancer report.
“Here’s What ’60 Minutes’ Didn’t Tell You About The ‘Miracle’ Glioblastoma Treatment”
http://www.forbes.com/sites/arleneweintraub/2015/03/30/heres-what-60-minutes-didnt-tell-you-about-the-miracle-glioblastoma-treatment/
&
“What ’60 Minutes’ Got Right And Wrong On Duke’s Polio Virus Trial Against Glioblastoma”
http://www.forbes.com/sites/davidkroll/2015/03/30/60-minutes-covers-dukes-polio-virus-clinical-trial-against-glioblastoma/
I feel very sad writing this, but having spent Easter weekend looking at the Burzynski movie and a whole lot more, it would appear to me that the “Powers that Be” do not want to rock the boat and actually acknowledge there might be a cure for cancer. It could mean the collapse of the whole “cancer industry”. I really would like to see them prove me wrong. I do hope the time is right for something positive and humanitarian to happen.
Thankyou for your truth and insight into the status quo.With all your adversaries it’s a wonder you have not been shot at dawn. My GP has been pleading with me to take statins for some time in his case as a duty of care to me as his patient. . I worked in a busy doctors practice for five years and have seen the side effects they have caused. Also like you I was running a muck when swine flu hit town but no way was anyone coming at me with a shot of tamuflu even though I was in the front line. That’s not to say there was the Spanish flu “a real catastrophe”after the 1914 war so I was using common sense. Thankyou for the cholesterol con. I am now nearly at the end of doctoring data. My husband died in a car accident in 1997 and happened to work on the factory floor of Roche,but I am not going to feel guilty where my pension comes from. Carry on the good work. You are a shining light. Your sense of humour makes all those facts and figures so readable. The way of the Truth……
The Cancer Giants & History’s Greatest Crime. In Germany, in the Octobers of 1881 / 1883, two children were born, who were to become the leaders in the area of cancer research and treatment : Otto Warburg and Maximillian Gerson.
ln 1931, Dr Otto Warburg was awarded the Nobel Prize , Physiology or Medicine , for research carried out on cancer’s basic mechanism . He defined cancer as a condition where the respiration of oxygen in the normal cell is replaced by the fermentation of glucose . In ” The Metabolism of Tumours “, he stated that cancer is characterized by two basic conditions : hypoxia and acidosis . ” Lack of oxygen and acidosis are two sides of the same coin: where you have one, you have the other. .. All normal cells have an absolute requirement for oxygen, but cancer cells can live without oxygen – a rule without exception. … Deprive a cell 35% of its oxygen for 48 hours and it may become cancerous.”
Cancer starts with a single cell , doubling, in number , whilst the immune defences are down : after, on average, around 10 years,a tumour may form : then, cells may then metastasise to the rest of the , already , cancerous body . In a genuine – as opposed to a misdiagnosed false-positive – case of cancer, the tumour is not part of a localised condition : metastasis is not the spreading of cancer to previously-healthy tissue . The Warburg research was in line with the previous – 1892 – Scientific American piece which concluded “ Cancer is most frequent where meat-eating habits prevail.” : acidosis , due to an unbalanced animal / plant dietary intake , leading to hypoxia and then to changes at cellular level and to cancer . Other studies including the D.C. Campbell 1980s 8,000 – component China Study , confirmed the link .
As the human dietary consumption ratio gradually flipped from around 85/90% pure plant + 10/15% pure animal … to 10/15% poisoned plant + 85/90 % poisoned animal .. plus the carcinogenic , immuno-suppressive synthetic-saturation of the environment , cancer changed from being rare to being endemic within the developed world .
When the 1931 prize was announced , the cancer industry , nothing like today’s trillion-dollar enterprise but growing rapidly and looking forward to a hugely-financially-rewarding future, faced a short-lived dilemma.
There were three main options : challenge the research – this would need Nobel-level contradictory-research : out of the question : switch to safe , effective , inexpensive non-patentable nutritional therapy based on the science: out of the question : ignore the Gold Standard Science research as though it had never happened.
The politicians , the regulatory authorities and controlled-media allowed The Cancer Business to do just that.
In 1966, after his work had been suppressed for over thirty years , Dr Warburg addressed a meeting of his fellow Nobel Laureates and declared “ there is no disease , whose prime cause is better known, than cancer .”
If this was not recognised “ millions must die , unnecessarily. “ Now, billions .
Max Gerson was a young medical student whose career was threatened , before it started , by crippling migraine . He had been, since a young child , devoted to the soil and its inhabitants and studied their behaviour , when faced with the un-natural : as in the incidence of earth worms , avoiding areas , chemically fertilised.
He believed the answer to his problem lay in the food and its purity : after two years of research , his illness was gone and he then qualified as a doctor and , at first , concentrated on migraine .
One of his patients reported that , not only was his migraine cured but also his skin tuberculosis : Dr Gerson contacted Dr Ferdinand Sauerbruch , Germany’s leading orthodox practitioner , in the field of skin TB .
A trial was set up , involving 450 patients : Dr Sauerbruch would have been surprised and pleased if any showed improvement : 446 recovered .
After leaving Nazi Germany to protect his family – his seven siblings stayed and perished- Dr. Gerson travelled to the USA , by way of living for a time in England . He turned to cancer , using , as with the other conditions , the same raw , organic, alkalising , oxygenating , plant regime , which Dr Warburg had pointed towards , as a preventative / treatment . His highly successful treatment led to him testifying to a Senate committee on July 1,2,3 1946 , presenting 10 of his cases .
The Pepper-Neely Anti-Cancer Bill, doc. 8947, to allocate $100 million dollars – at 1950s rates – to research a cure for cancer, was heading in the direction of The Gerson Therapy.
In the evening of July 3 1946 , US network ABC anchorman, Raymond Swing, announced to the whole nation, that
“ For the first time in history , a cure for cancer has been found ” : Swing was fired , two weeks later , after 30 years with the ABC .
Intense lobbying by the American pharmaceutical , medical and research organisations , aided by two senators , who were also doctors , resulted in the Bill being lost by 4 votes .
The Bill is still gathering dust in the US Printing Office archives .
Dr. Gerson fell ill during the preparation of his “ A Cancer Therapy : results of 50 cases “ : on recovering he found that the manuscript had been stolen : it took him a year to re-write . After publishing , he fell ill again , tested positively for arsenic poisoning and died in 1959 .
The Gerson legacy has lived on and is now going ever-stronger at the Gerson Centre and at various practices , around the world .
Case histories , in the hundreds of thousands , from the multiple US / Mexican etc. holistic clinics are all based on the work , theoretical and practical , of the two cancer giants – Warburg and Gerson .
Many, if not most, of the patients are in a similar state to those, who our NHS are sending to the hospice.
The first UK cancer research organisation was founded in 1902 : a rival group began in 1923 . They have a combined 200 years of fund-raising.
Cancer research has always strictly avoided any and all threats to The Cancer Business : the proven safe, effective , natural, inexpensive therapies are inside a ring-fenced , strictly-no-go area .
” A solution to cancer would mean the termination of research programmes, the obsolescence of skills, the end of dreams of personal glory. triumph over cancer would dry up contributions to self-perpetuating charities…it would mortally threaten the present clinical establishment by rendering obsolete the expensive surgical, radiological and chemotherapeutic treatments in which so much money,training and equipment ls invested…’ and, as for a natural, non-patentable approach …” the new therapy must be disbelieved, denied, discouraged and disallowed at all costs, regardless of actual testing results .. preferably, without any testing at all.” The Houston/Null Analysis.
The year ending April, 2015 saw £621 million collected by Cancer Research UK : salaries,social security pensions, alone for the 3,964 office staff cost £131 million . If Race for Lifer, wearing her Pink Bunny costume and her ” Cancer , We’re coming to get you ” T-shirt raises £100 , this will keep the CRUK office staff paid / pensioned for 25 SECONDS .
Fatuous slogans : ” l’m all clear…l shouldn’t be here “, coupled with other total fabrications keep the cash flowing in
ln the early 70s, treatments developed through CRUK funding were killing half of the patients within a year : a policy change resulted in less doses of lethal drugs and longer dying times : this led to CRUK slogans –
” Thanks to improved treatments more women..are now being successfully treated .. Survival rates have doubled .. Each year thousands of people beat cancer thanks to Cancer Research UK ” from a group, supremely confident, with very good reason, that it can put out whatever fantasy it chooses without any threat of regulation, civil or criminal : “ It is a crime to knowingly or recklessly provide false or misleading information ”.: sec. 60(1Xb) of the Charities Act 2011 . The Met. police were not interested : neither were the – Derbys. – locals.
Michael Pragnell led the creation of Syngenta, of bee-killing pesticide fame : it became world leader in ” crop protection “, following the merger of the agrochemicals / plant bio-science businesses of AstraZeneca and Novartis.
” Organic food is highly toxic, …sticking to an organic regime just puts plants under greater and greater strain – and life for farmers in the UK is only going to get more difficult as the result of organic farming.” Pragnell , D. Telegraph . He retired in 2007 after a 39-year career in the chemical, genetic-modification and bio-technology industries. As the ideal choice , Michael Pragnell was made Chairman of Cancer Research UK .
ln the year 2015, in the UK, there were 162,000 deaths of people , diagnosed with cancer , including some 12,000 deaths of women, diagnosed with breast cancer : these were people who , typically, did as they were told, before the diagnosis and who, overwhelmingly , did as they were told , after it . They ate The Dept. of Health Balanced Diet, with all that it promotes and allows – animal produce , complete with antibiotic/vaccine/pesticide/herbicide residues , “ 5-a-day “ , grown in dead soil and sprayed 20 times is alright, aspartame , MSG and the whole range of synthetic food-additives .. : they had the recommended vaccines, the antibiotics, the anti-coagulants, the anti-depressives the antivirals .. the anti-everything, .. the statins, .. the steroids …the CT scans, the mammograms ..
When they were diagnosed, they were coerced into the tumour-attack package of surgery, cytotoxic drugs – * chemical warfare, radioactivity … a highly carcinogenic, immuno-suppressive , liver / heart / kidney / lung – destructive regime , diametrically opposed to that , needed for survival , with the inevitable result .
On the numbers : the untold millions of deaths , the tens of billions of “ research “ dollars/pounds, clawed-in, no other crime is in the same league as the suppression of the work of the Drs. Warburg and Gerson .
My requests , under the British Freedom of Information Act , 2000 , for ” peer-reviewed , scientifically-valid evidence of a correlation , connection , cause-effect relationship between , on the one hand , the use of surgery, cyto-toxic drugs and radiation , in the treatment of cancer and on the other hand , increased patient survival : as opposed to the patients , not being treated , at all ” were submitted to NHS England and NIHCE .
Both provided the same answer – too costly and time consuming to find out if they have that information .
Notably they had not ” found the evidence “, but , very wisely , decided not to look for it , as all of the available evidence shows that the untreated live – often much – longer . An Oxford Uni. study put the total -all factors considered- cost to the UK at £16 billion per year – and rising .
* During WW II a ship carrying sulphur mustards -chemical warfare- was bombed. Before they died,the troops and crew developed depleted bone marrow and lymph systems , which have cells that naturally divide faster than other cells. The cancer industry saw the possibility of mustard gas being used in the treatment of cancer cells that also divide faster : in 1942/3, Memorial Sloan-Kettering and Yale Univ. began secret trials on breast cancer patients .
As now, no-one was cured but since the tumours shrunk , the trials were declared to be a ” success ” and cyto-toxic drugs were developed : the first drugs were nitrogen mustards : the “ chemotherapy ” industry was born.
Patrick Rattigan N.D.1974 email hera@nemesisawake.com 2017