811 deaths and counting

There is a doctor in the USA called Duane Graveline who I know well. He trained as an astronaut, when such things were seen as exciting. He was very much mainstream in his prescribing and thinking about medicine, until he was started on statins. He took them happily, until he suffered an episode of transient global amnesia. A complete loss of memory, re-booting his brain to the age of about eight.

On the first occasion he had no idea what had happened. He thought he could have had a stroke, but after investigations nothing was found. He asked if the statin could have caused this, and was told no – not a chance. So he started on statins again, and suffered another episode, the same as the last.

He then started investigating and found that thousands of others had suffered from episodes of transient global amnesia whilst on statins. A very, very, rare thing to happen to anyone, but increasingly common nowadays. I wonder why? Dr. Graveline then started to develop a neuromuscular disease, similar to amyotrophic lateral sclerosis (ALS) which he attributes to the statin. Statins can certainly cause neuropathy – but I shall say no more on this issue at present.

Dr. Graveline is not so keen on statins now, nor does he believe that cholesterol causes heart disease – having looked at the evidence again with a fresh eye. For those who do not know, he has a website www.spacedoc.com. Here are listed all of the many adverse effects of statins, and the suffering of many thousands of people.

He believes that the authorities are, basically, turning a blind eye to the many and varied problems with statins. So he has laboriously gone through the Food and Drug Administration (FDA) database of Adverse Drug Events (Medwatch), to find out just exactly how many deaths statins have caused.

This is extremely difficult to analyse as the coding system in Medwatch is complex, poorly linked and many things – frankly – do not seem to make sense. Whilst going through this stuff is an absolute nightmare, it can be done – although you have to make some assumptions along the way.

What Dr. Graveline did was to look for case of rhabdomyolysis (catastrophic breakdown of muscle tissue) linked to statins. Rhabdomyolysis is a pretty specific, and well-accepted, adverse effect of al statins. However, it is considered as so vanishingly rare as to be not worth bothering about by most doctors.

Rhabdomyolysis carries a very high mortality rate, because the waste products of dissolving muscles travel to the kidneys, where they block up the nephrons, causing acute kidney failure. In around ten per-cent of cases rhabdomyolysis is fatal. So you can assume, with reasonable accuracy, that for every ten reported cases of rhabomyolysis, you will get one death. You will also get a number of people with destroyed kidneys who end up on dialysis – hey ho.

At this point I should also point out that adverse drug events are widely known to be a massively under-reported. It is difficult to be certain on the exact figures. However, having read many papers on this subject the general feeling is that about 1 – 5% of all events are actually reported by anyone – ever. Which means that any figures in Medwatch can be pretty reliably multiplied by twenty to one hundred? Which is a topic for another day.

Anyway, with this pre-amble out of the way, I have copied Dr. Graveline’s blog on statins (with his full permission). What he has found is that, over a six year period there were 8,111 cases of rhabodmyolysis reported to Medwatch associated with statins. This represents, at least, 811 deaths in this period. [If you were to multiply this figure by twenty, this is 16,200. Multiply by one hundred and you have 81,110.]

A few years ago one of the statins called Baycol was rapidly removed by the FDA after sixty people died from rhabdomyolysis whilst taking statins. Well, all statins can cause rhabdomyolysis. Hundreds have died, probably more, since Baycol was yanked from the market. Yet there is absolute radio silence on this issue.

Below is Dr. Graveline’s blog…

Relative risk of Statin Associated Rhabdomyolysis

A recent study comparing the relative risks of muscle problems with the use of the various statin drugs has recently been reported. Generally the risk of muscle adverse effects varies with the strength of the statin used except for the statin fluvastatin (Lescol). Lescol, usually considered to be the weakest of the commonly used statins now shares with rosuvastatin (Crestor), the strongest of the statins, in being consistently linked to higher adverse muscle events relative to the other commonly used statins. Atorvastatin (Lipitor) and simvastatin (Zocor) showed intermediate risks and pravastatin (Pravachol) and lovastatin (Mevacor) had the lowest risk rates. Designating rosuvastatin’s and fluvastatin’s relative risk as 100%, comparative rates for atorvastatin, simvastatin, pravastatin, and lovastatin were, respectively, 55%, 26%, 17%, and 7.5%.

     There were a total of 186,796 case reports listed within the Adverse Event database (Medwatch) during the study period 1 Jul 2005 to 31 Mar 2011. Choosing rhabdomyolysis as one of the more discrete and credible of the muscle diagnoses, a total of 8,111 cases of rhabdomyolysis were reported during this study period, averaging 1,350 cases yearly. Sidney Wolfe MD has previously estimated the statin associated rhabdomyolysis death rate to be 10 percent (giving a total of 811 deaths during this 6 year 4 month time period). Of the total number of rhabdomyolysis cases, fluvastatin was involved in 164, rosuvastatin in 1146, simvastatin in 3395, atorvastatin in 1641, pravastatin in 267 and lovastatin in 161.

     Returning to the death rate estimate of 811, this strikes me as extraordinarily high and I cannot believe I am just now discovering this. Back in the Baycol crisis of 2004, sixty deaths caused FDA to rise up and Bayer to take its problematic product off the shelves. Six years later, 811 deaths do not even deserve a mention. What has happened? Where is the media uproar that we had back in 2004? I knew the Medwatch figures for Lipitor because I had obtained a copy of the Medwatch data and counted the rhabdomyolysis cases myself. I counted 2731 cases of rhabdomyolysis from the period 1997 to 2011 from Lipitor alone which fits quite well with this recently published work. So I had a heads up. I predicted the total rhabdomyolysis cases would be 6,000 for all the statins never suspecting I would underestimate by several thousand.

     Medwatch exists for FDA to monitor these outrageous post marketing events and report back to the medical community. Where is the FDA report? This is incredible!

14 thoughts on “811 deaths and counting

  1. Stuart Mcdonagh

    A close friend of mine has read the Drs book and we have both read yours,this friend has familialhypercholesterlemia (don’t think that’s the right spelling but you get the idea) but refuses to take statins due to the information given by you two Drs and much more he has researched.
    I myself feel proud that I have talked at least 3 people out of taking statins and have recommended your book to anyone that talks about or thinks about taking statins.
    Keep the info coming we need to keep trying to save lives while the GP’s blindly try to take them.

    1. David Bailey

      I am curious as to how much freedom the medical profession gives you when it comes to advising patients about statins and cholesterol – can you follow your conscience or do you end up prescribing statins to people who don’t need them?

      1. Dr. Malcolm Kendrick Post author

        I let everyone know my views. I do not start statins, but I do not stop them either, unless the patient is clearly suffering from statin related side-effects. So far, no-one has a major problem with this. Doctors, or patients.

  2. Chris

    I too was diagnosed with familialhypercholesterlemia, and still I refuse to take statins an now have gone so far as to not even let them test my cholesterol. I have had two heart attacks in the past 12 years and am a female under the age of 50. I eat a whole foods diet and am just a bit overweight. Also, at the time of both heart attacks, I was under a tremendous amount of stress. What do the doctors say caused my heart attack? Cholesterol! Are they willing to look at anything else? Nope! My feeling is this, I would rather have these heart attacks and recover quickly (or die, right away) rather than dying of some long term illness caused by the medications I take. Now, I do take one medication for RA (Rheumatoid Arthritis) that has some increased risks of cancer, but without it, I wouldn’t be able to get out of bed. But to take a drug that has very sketchy evidence that it even works, or worse yet, as such a high risk of dying from the side effects (not to mention that I believe lowering your cholesterol too much is also detrimental), no thanks. I’ll live with the risks.

  3. mo79uk

    My GP once pondered putting me on statins at the age of 27 for what was average total cholesterol.
    I realised this was a rigged game as I already had been generally following dietary and exercise recommendations; so either most people have inherited a non-profitable quirk while still having teeth designed for meat, or the lipid hypothesis is a joke.

    If a commercial reference is allowed to be made, I documented my cholesterol story in an independent book at prescsun.com.

  4. celia

    Have you read Dr Mintz blog;responding to space doc? An apparently earnest young American who is determined to extol the virtues of statins. I wondered why he was fighting so hard for them till I pulled up his disclosures. Sure enough, he has given talks on behalf of various drug companies, and also given advice to some of them. Need I say more?

  5. GG

    Thankfully I am not on statins (wouldn’t take them if offered) but I know people who were put on statins and then it was discovered they didn’t need to take them (oh good) but their doctor left them on a low ‘maintenance dose’ because it is a good idea. What is that all about? It is bad enough that people take these drugs because it is thought that they need them but to take them for no reason is madness.

  6. LaurieLM

    I decided to take my elderly Dad off statins, AMA, 3 years ago. He’s old, and getting older by the hour. He’s passed his sell-by date and his warranty is up and I know he will succumb sooner rather than later. His gout disappeared, his practically every other month unwelcome visits to hospitals stopped, his cataracts eased, his CHF (heart failure) went away (really and that surprised me most), the constant coughing and colds ended, he was able to stop his kidney meds, and he generally looks pretty okay, is active and perky- for 89. He will die of course, but not from being driven insane and descending into depression and having his body waste away and with one organ system after another degrading and falling off-all complements of Lipitor -though.

  7. dearieme

    An ancient aunt (90-ish) of a friend of ours was recently admitted to hospital after a nasty fall. They put her on statins. How many anecdotes does it take to constitute data?

  8. GG

    Once again statins are making headline news in the press. This time they are claiming that statins may facilitate lowering the risk of dementia. One wants to shout – is there anything that statins cannot do?

  9. Suzanne Looms

    I give people information about statins and some stop taking them, but others are in thrall to the white coats. I understand from many sources (Uffe Ravnskov included) that statins have no effect on women, but am meeting increasing numbers of women who have statins prescribed ‘because of high cholesterol’.


Leave a Reply

Fill in your details below or click an icon to log in:

WordPress.com Logo

You are commenting using your WordPress.com account. Log Out /  Change )

Facebook photo

You are commenting using your Facebook account. Log Out /  Change )

Connecting to %s