Conflict of Interest at the CTT?

What is a conflict of interest? One definition is thus: ‘A conflict of interest is a set of circumstances that creates a risk that professional judgement or actions regarding a primary interest will be unduly influenced by a secondary interest.’

Or, in my simple world. ‘Someone pays you money. You then say or do things that you would not have said or done, if they hadn’t.’ The secondary interest doesn’t have to be directly monetary. It could be a promise of a promotion, or an invitation to be chairman of an important committee, or a chance to meet someone famous, or watch a world cup final, or suchlike.

However, for the sake of keeping things simple, we are talking about money here. We are talking about pharmaceutical companies paying money to medical ‘experts’, who may then say or do things that they would not otherwise have said or done.

The first problem is, thus. How do you know they would not have said or done it anyway? If the dairy industry paid me a million pounds to say ‘Dairy foods do not cause heart disease.’ This would be a bonus. Because it is what I believe, it is what I say already, and you really don’t need to pay me a million pounds to say it. [Although I am open to offers].

However, if I was paid a million pounds and I then said ‘dairy foods to do not cause heart disease’, and you discovered that the dairy industry had paid me a million pounds, what would you think? I know exactly what you would think. ‘I trusted him, now it turns out he is just lining his wallet, the same as everyone else.’ Some would state this more vehemently than others. However, any reputation that I have would never be the same again. There would always be that loss of trust. That doubt.

The people we admire and trust the most do not take backhanders. Pity.

For many years, pharmaceutical companies paid doctors ‘honoraria’, which is just a posh word for money. The doctors happily stuffed said honoraria into their bank balances, and no-one seemed much bothered. You did not need to declare any financial interests, and the only limitation on how much you got paid was your perceived value to the companies.

Your value was measured in a few different ways:

1. Ability to influence other doctors – your status as an ‘opinion leader’
2. Your quality as a speaker at meetings and/or ability to set up and run clinical trials
3. Your influence within the healthcare system i.e. do you advise Governments on treatment, do you sit on committees that advice NICE, or the Food and Drugs Administration (FDA)
4. Your position on Guideline committees. Can you play a key role in writing the guidelines that other doctors have to follow e.g. drug x a must be used first line in all patients with condition y.

These things are, of course, all linked. As an expert you start on rung one and two, and then move onto three and four. Your progress up this ladder requires very close links with the industry. You cannot influence other doctors if you haven’t done research, and it is very difficult to do research without industry funding. If not impossible.

At a certain point in the process, you become exceedingly important to the industry. In fact there are companies who support the pharmaceutical industry whose entire raison d’etre is to manage Key Opinion Leaders (KOLs).

According to Dan Mintze, senior director, heartbeat experts, “The management of KOLs needs to be broader than identifying, segmenting, influence mapping and working with clinicians in order for products to gain clinical approval. Rather a comprehensive KOL solution which includes the identification and appropriate engagement of KOLs who impact market access decisions e.g. KOLs who serve as Government or payer advisory board members (see figure 3) should be adopted.” Such pharma-KOL engagement will lead to the development of value messages that can help pharma to access the market faster, gain quicker product adoption, and increase bottom line performance.’ [my words in bold]  Original PDF here

The more you increase bottom line performance, the more you are worth, and the more you get paid. Strangely, some left-wing commies a.k.a ‘people’ began to object to this cosy relationship. A bit too much potential for the situation whereby… a primary interest will be unduly influenced by a secondary interest.

Luckily this problem was instantly solved, amid scenes of wild rejoicing, by ensuring that doctors who did major studies, or wrote articles and suchlike, must disclose their conflicts of interest. Once this had been done there was nothing to worry about, ever again. [joke]
Although, what we are supposed to do with a disclosure of interest has never really been explained. As a Swedish doctor wrote to me:

‘While we are at this: I have often wanted to ask the purpose of revealing possible/probable conflicts of interest. Just what are we supposed to do with that editorial caveat? Does it mean the data might be suspect? If the editors want us to know it is suspect then why do they publish it?

If it means we should interpret the data with caution, can someone tell me how one is to be cautious. Does it mean one believes none of it or does one believe some of it? If the latter then which part do we believe and/or which do we not believe. Just how are we supposed to judge these things, after having been warned to beware?

Indeed, what are we supposed to do? The other problem is that, whilst doctors are meant to declare their conflicts, quite often they do not. Here is an addendum taken from the Journal of the American Medical Association.

It was in response to an article which was written by a number of authors, who did not see to need report any of their conflicts. Some eagle eyed readers wrote in to complain, and the journal responded thus [I put in bold those companies who would have benefitted financially from the original paper]:

Unreported Financial Disclosures in: ‘Association of LDL Cholesterol, Non–HDL Cholesterol, and Apolipoprotein B Levels With Risk of Cardiovascular Events Among Patients Treated With Statins: A Meta-analysis.’

….the following disclosures should have been reported: “Dr Mora reports receipt of travel accommodations/meeting expenses from Pfizer; Dr Durrington reports provision of consulting services to Hoffman-La Roche, delivering lectures or serving on the speakers bureau for Pfizer, and receipt of royalties from Hodder Arnold Health Press; Dr Hitman reports receipt of lecture fees and travel expenses from Pfizer, provision of consulting services on advisory panels to GlaxoSmithKline, Merck Sharp & Dohme, Eli Lilly, and Novo Nordisk, receipt of a grant from Eli Lilly, and delivering lectures or serving on the speakers bureau for GlaxoSmithKline, Takeda, and Merck Sharp & Dohme; Dr Welch reports receipt of a grant, consulting fees, travel support, payment for writing or manuscript review, and provision of writing assistance, medicines, equipment, or administrative support from Pfizer, and provision of consultancy services to Edwards, MAP, and NuPathe; Dr Demicco reports having stock/stock options with Pfizer; Dr Clearfield reports provision of consulting services on advisory committees to Merck Sharp & Dohme and AstraZeneca; Dr Tonkin reports provision of consulting services to Pfizer, delivering lectures or serving on the speakers bureau for Novartis and Roche, and having stock/stock options with CSL and Sonic Health Care; and Dr Ridker reports board membership with Merck Sharp & Dohme and receipt of a grant or pending grant to his institution from Amgen. (original JAMA correction here.)

As you can see, Paul Ridker had board membership with Merck Sharp and Dohme, and simply forgot the mention it. The authors’ collective punishment? Well, you have just seen it. Essentially, there is no punishment. A bit of momentary embarrassment, soon forgotten. [Although not by everybody, guys].

However, the steady pressure for doctors to provide disclosures of interest has had one major impact. It has made it a bloody site more difficult to know where the conflicts of interest might actually lie.

For it has been decreed….I don’t know who decreed, or agreed it, that if you are paid money directly by a pharmaceutical company, or say a PR company working for the industry, you have a financial conflict of interest that you must/should declare.

However, if you work for an organisation such as the Cleveland Clinic, or the Clinical Trials Research Unit (CTSU) in Oxford things are different. The clinic is paid money by the industry, and then the clinic pays you. This means that you are not conflicted in any way. You need not declare anything. Why?

I don’t know who stated that this is acceptable. As with most things in this area we are in a shadow world full of ghostly apparitions that elude your grasp. ‘They said it was fine.’ And who, exactly, are they. There is no oversight committee here, no investigations carried out, no rulebook, no punishment. Just a very woolly gentlemen’s agreement amongst the great and the good of medical research.

However, because it has been agreed, in some mysterious way, that ‘second hand’ payments are fine, it means that those working at the Cleveland Clinic, the CTSU, and suchlike, feel able to state that they have no financial conflicts – at all. Even if the organisation they work for earns hundreds of millions, or billions, in industry funding.

If those working at the CTSU do, somehow, find themselves working directly with the industry, they now give any money they might have eared to charity. To quote their rules on the matter:

Guidelines for CTSU staff with respect to honoraria and any
other payments offered and share ownership

——-

d: If an honorarium is declined, the intended CTSU recipient can still mention that a
corresponding amount might be donated to a specific charity.

A corresponding amount to a specific charity. What charity?

‘I guess if I had any advice for reporters, I would say, ask your local university if they’ve set up any associated [non-profit organizations]; many universities have an associated charity or foundation through which they solicit donations from corporate sponsors to support medical research. Find out about who those corporate sponsors are. Unfortunately, many universities set up these associated charities and foundations in such a way that they don’t have to disclose much publicly – ask about that, you know, try to push.’  (original article here)

Push away, but I don’t expect you will get very far.

Anyway, we are now supposed to believe that highly qualified and very influential KOLs, who work at the CTSU in Oxford, carry out work on behalf pharmaceutical companies for no payment, whatsoever. This is just charity work. Helping impoverished pharmaceutical companies is the same, really, as helping starving orphans in Africa.

Strangely, it appears that the CTSU doesn’t mind in the least that their staff are spending large chunks of their professional life helping pharmaceutical companies – out of the goodness of their hearts. The CTSU gets nothing; the pharmaceutical companies get nothing, other than a warm glow in their hearts. Meanwhile a ‘specific charity’ is doing rather well. Whatever that specific charity may be?

Of course the CTSU itself does rather well from the industry. Just for carrying out one of their many studies, REVERSE, they received £96million ($155million) from Merck Sharp and Dohme.

Yet, despite the huge sums of industry money sloshing about in the CTSU there are absolutely no conflicts of interest going on here. We are told this by none other than the CTSU itself. No-one is paid money directly by the industry in any way. So that is fine.
As Robbie Burns said: ‘O, wad some Power the giftie gie us to see oursels as others see us. It wad frae monie a blunder free us.’

As a sort of footnote to this blog, you may be interested to know that the Cholesterol Treatment Triallists Collaboration (CTT) in Oxford is probably the most influential organisation in directing the management of CV disease around the world.
The ACC/AHA guidelines launched last year in the US are based on the latest CTT meta-analysis; as are the latest NICE guidelines in the UK. The Cochrane Collaboration, which is also highly influential world-wide, changed their guidance on the use of statins in primary prevention, based on the CTT meta-analysis.

In short, if you want to identify a group of KOLs who can truly increase ‘bottom line performance’, you will not find any organisation more powerful than this. Best of all, CTT have absolutely no conflicts of interest with the pharmaceutical industry either. If you want to contact the CTT about any of this, you can e-mail them at: CTT@ctsu.ox.ac.uk

19 thoughts on “Conflict of Interest at the CTT?

  1. mikecawdery

    From wikipedia
    http://en.wikipedia.org/wiki/Heart_Protection_Study
    “The CTSU branch of Oxford has been criticized for not releasing all group study data about deaths and for inappropriately combining dissimilar endpoints and groups to suggest benefit for all. Having received over £m105 ($m200) from cholesterol-lowering drug manufacturers in addition to the funding from the sources listed above, their objectivity has been questioned.”
    http://blogs.wsj.com/health/2008/09/18/statistics-smackdown-experts-duel-over-vytorin-cancer-data/

    Now, if this were untrue it would be challenged by both Merck and the Oxford CTSU. So it probably is true but could be much higher if investigated (another reason not to chaallenge)

    Reply
  2. offshoretinker

    What is really scary is the pervasive cosiness, with good people in fear of the whole rotten deal watching helpless from the sidelines
    Why aren’t the righteous among the medical community raising merry hell? Because I guess sticking your head above the parapet is scary – as evidenced by the deeply entrenched fear of becoming a whistle blower in the NHS. Even today after all the hoo-ha of politicians ‘supporting those drawing attention to iniquity’ it’s career suicide to let conscience override personal interest.
    All that is necessary for evil to triumph is for good men to do nothing – Edmund Burke.

    Reply
  3. jojo

    I work in the NHS and its easy to see why most employees, right from the top dont ever question (maybe they do in their heads???) anything. Its all about guidelines and ticking boxes. If you dont adhere to them, it ruins the statistics and you’re very much on your own – we do as we are told and our job and reputation are safe. and we get good grades!!!!!

    Reply
  4. Spokey

    That’s amazing. Money ruins everything in the end. Well, apart from hookers, fast cars and heroin addiction, obviously, apart from those things, money ruins everything.

    Seriously though thanks for explaining the situation, I was having some trouble following the finer points of the cash flow!

    It’s ridiculous, it shouldn’t be easier to understand the failure of the cholesterol hypothesis than the medical community’s bank statements.

    Reply
  5. thetinfoilhatsociety

    If they are paid by the organization for which they work, because of the research they do for the pharmaceutical companies, and the pharmaceutical companies ‘donate’ money to the organization to support the research, then they *are* in fact being paid by the pharmaceutical companies. If they were mafia dons it would be called “money laundering” and be a felony. Why it’s not in this context I’m really not sure. White coats versus Armani suits? Who knows.

    Reply
    1. celia

      “Money laundering”! Can we accuse them of this publicly? Is there a difference? Well put. They need to be very publicly named and shamed. Unfortunately, I fear most of the public are too gullible to notice. We need to get to the politicians. I wonder why they seem to be unconcerned by all of this. Maybe the tax income is too good, or maybe their investments might suffer. I can only speculate.

      Reply
    2. amieres

      The whole CTSU organization has a clear conflict of interest. Can they say that conflict does not translate to it’s members as well? What fantastic isolation mechanism do they have that can prevent their researchers from being affected?

      It must be nice for the experts having the discretionary power to assign nifty sums of money to the organizations of their choice. That must make them pretty important to certain people who I’m sure know how to show their gratitude.

      Reply
  6. Tom Welsh

    “A bit too much potential for the situation whereby… a primary interest will be unduly influenced by a secondary interest”.

    Indeed the secondary interest may even become the primary interest! It seems to me that the traditional set-up was underpinned by the idea that doctors were such saintly altruistic people that they would never, ever allow financial considerations to affect their medical opinions in the slightest. With the obvious exception of Dr Kendrick, I am slightly sceptical about this belief.

    Reply
    1. Flyinthesky

      If we go to a tier immediately above the “health care professionals” the secondary interest has always been the primary.
      The phenomenon often goes way beyond medicine, if a position is wanting endorsement, any position on any subject, wheel in a doctor, It must be so “he’s a doctor”.
      If you question this position as a lot of people do, you should question everything else as it all works the same way, I don’t recommend it as it’s a tortuous route.

      Reply
  7. NickM (@bokkiedog)

    “thetinfoilhatsociety”: Money laundering is a very apposite way of putting this. Indeed, the whole system is so radically corrupted, that it is rational to be highly sceptical about even the minor benefits attributed to statins.

    Mark my words: as time goes on, and the immediate pressures of specific corruption fade, there’ll be the usual regression to the mean. Shock of shocks, we’ll find that statins in fact pretty much didn’t work at all. For anyone. High risk or otherwise. This has actually happened a number of times with, for example, depression drugs which were considered “miraculous” and then, as patents fell by the wayside, suddenly dissolved into placebos (at best).

    Reply
    1. Stephen Rhodes

      Very true. This http://www.trialsjournal.com/content/12/1/249 is comment on the misbehaviour of the drug companies in the running of trials and includes the following;

      The British House of Commons Health Committee examined the drug industry in detail in 2004 to 2005 and found that its influence was enormous and out of control [113,119]. However, although the Members of Parliament felt that the UK Medicines Agency was not competent to undertake its duties as a guardian of public health, the Government declined a public hearing.

      Many violations of the law in the context of clinical research or marketing have been documented [11,38-41,92,107,110,111,128-137]. A 2010 study showed that the drug industry was the biggest defrauder of the US Government under the False Claims Act and that the civil and criminal settlements had increased dramatically in the past five years [138].

      Pfizer agreed in 2009 to pay US$2.3 billion to settle charges of fraud and civil and criminal liability over its promotion of off-label use of four drugs [139]. The US Department of Justice said it was the largest healthcare fraud settlement in the Department’s history and the largest criminal fine ever. Even so, this was reported to be equivalent to less than three weeks of Pfizer sales.

      Well worth listening to Peter C Gøtzsche the author of ‘Deadly Medicine and Organised Crime – How Big Pharma is Corrupting Healthcare’ and Director of the Nordic Cochrane Centre

      Reply
  8. GG

    This sort of thing is rife in the world today. Being permeated throughout the commercial and research world does not make it right, far from it. Patients suffer from diseases or medical conditions that are misunderstood (due to lack of research or dare I say ‘common sense’) or ignored by much of the medical profession because they are not the trendy conditions that big pharma are interested in and therefore willing to pay big bucks for. Money governs big pharma and therefore those they directly or indirectly employ to give them the results they need to plough ahead with turning more and more of us into pill-popping zombies.

    Perhaps all research should state clearly where both the direct and indirect funding comes from and how these organisations or individuals might benefit now and in the future from such research.

    There are still many people who will be completely guided by the medical world without considering the influences from big pharma and others behind the diagnoses and decisions made about their health and treatments offered.

    Any committee or group of ‘experts’ creating guidelines for health and medical purposes MUST be transparent. That means that each and every member of the committee or group must have their name published along with all of their affiliations to big pharma and any other organisations, institutions, governments or individuals that could possibly influence their opinions about the matters dealt with. There are ludicrous situations currently where committees have been formed (and then disbanded once the job done) to create guidelines or in the case of the RCP, ‘statements’ (apparently statements are not guidelines and so doctors do not need to uphold them but one has to ask why create them if they can be ignored and so many doctors uphold them believing that they have to?) and no-one seems to know (or they are refusing to say) the names of the individuals on these committees making the decisions that negatively influence the lives of so many. Now is it that they are just too stupid to realise that by refusing to say who made the decisions that they are contributing to the condemnation of patients to a unhealthy, unhappy and miserable existence? Or is it that they are deliberately covering up the influences on these committees because they know that it will not look good for the RCP when it comes out that the reason patients are condemned to a miserable life has roots in big pharma and their profits? I know what I believe.

    Reply
  9. Richard Painter

    Dear Malcolm

    Another great article and I find it nothing short of scandalous that very bodies supposedly set up to safeguard us, be it for medical treatments or food and nutrition, are so tainted by such blatant financial inducements that their judgements and neutrality must be in doubt.

    Even if the money goes to a charity, this is just a kind of “Money laundering” cut-out and if anything shows a wilful attempt to obfuscate and hide these payments. Are they (the CTT) subject to the requirements of the Freedom of Information Act to release information if asked?

    Scandalous – keep up the great work!

    Regards

    Richard

    Reply
  10. jojo

    of course there is the other way of looking at this (although, probably not popular or factual). Could it be that those who work for the big pharma and are responsible for broadcasting their “amazing statins” etc. Do actually believe in them and thats why they are doing this work????

    ………. I’ll get my coat ….

    Reply
    1. Dr. Malcolm Kendrick Post author

      There is not doubt that many of those promoting statins do believe in them, and need no financial incentives to promote them. Not everything is to do with money, by any measure. Ideas are the most powerful thing of all, and they will be defended with all of the powers at our disposal.

      “Why do people insist on defending their ideas and opinions with such ferocity, as if defending honour itself? What could be easier to change than an idea?” ― J.G. Farrell, The Siege of Krishnapur.

      I stood in the middle of the Temples of Karnak three years ago and shouted. ‘The pharoah is not a God, he is just a man in a silly hat.’ As I told my children (my highly embarrassed children). ‘I couldn’t have done that three thousand years ago.’

      Reply

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