Jeffrey Dach on Lipitor and "The Dracula of Modern Technology"

Perhaps you have seen the Direct-to-Consumer TV and print advertisements with Robert Jarvik, the inventor of the Jarvik Heart, speaking on behalf of the Pfizer’s anti-cholesterol drug, Lipitor.  With 13 billion dollars in sales last year, Lipitor was the best selling statin drug, the best selling drug in the world, and most prescribed drug in the U.S. 

Jarvik is best known from the media circus surrounding the 1982 implantation of his Jarvik-7 into the Seattle dentist, Barney Clark.   Although the artificial heart continued to beat, Barney died of multi-organ failure 112 days after the operation, tethered to a dishwasher sized air compressor.  The heart device acted as a blender which chewed up the blood cells.  Recipients of the Jarvik-7 suffered horribly for months, finally succumbing to infections, strokes, convulsions and immune system failure with progressive decline in T cells, thus making the Jarvik-7 another cause of HIV negative AIDS.  During the ensuing media coverage, the New York Times dubbed the Jarvik Heart the  “Dracula of Medical Technology” (link) . Jarvik-7 patients had the Kevorkian option of assisted suicide, a small on-off button which allowed the mechanical heart to be stopped when too unbearable.  About 90 people received the Jarvik heart before it was banned.  The FDA recently approved  a revised mechanical heart September 5, 2006 for heart transplant candidates, intended for temporary humanitarian use to prolong the terminal patient while awaiting a suitable donor. 

Why would Pfizer select an MD like Jarvik as spokesman for their Direct to Consumer (DTC) campaign?   Jarvik himself doesn’t have the strongest of professional credentials, and apparently had difficulty gaining admission to a US medical school. Instead, he enrolled for the first two years at the University of Bologna in Italy, later returning for the MD degree at the University of Utah.  Jarvik never did an internship or residency, and never actually practiced medicine.  And the heart device had been invented by somebody else, Paul Winchell, the ventriloquist, who assigned the patent to the University.

Why does Jarvik’s “Dracula of Medical Technology” make him an expert on statin drugs? Eight controlled clinical trials have shown that statin drugs cause Coenzyme Q10 depletion by inhibition of HMG-CoA reductase, which is the rate limiting step in cholesterol and Coenzyme Q-10 biosynthesis. Coenzyme Q10 serves in the mitochondria as an electron carrier to cytochrome oxidase, the major  system for cellular energy production.  Heart muscle requires high levels of Co-Q10.  Side effects of Co-Q10 deficiency include muscle wasting, muscle pain, heart failure, neuropathy, amnesia, and cognitive dysfunction.  Deaths from heart failure have doubled nationwide since the introduction of statin drugs in 1987.  Statin induced heart failure can be prevented by supplementing with Co Enzyme Q10, a form of intervention considerably less expensive and less traumatic than an artificial heart operation followed by cardiac transplantation.

Perhaps Jarvik is not the best choice for the Lipitor campaign which has had mixed reviews.  Instead of Jarvik, a more convincing yet unlikely spokesman would be the popular Duane Graveline MD MPH, a former NASA astronaut, and author who was started on Lipitor during an annual astronaut physical at the Johnson Space Center, and 6 weeks later had an episode of transient global amnesia, a sudden form of total memory loss described in his book.    Graveline points out that 50 percent of the dry weight of the cerebral cortex is made of cholesterol, an important substance for memory and cerebral function.

Graveline also points out that statins are useful for secondary prevention of heart disease in patients with significant pre-existing coronary artery disease (link), however the benefit is independent of cholesterol response during statin use.  Contrary to the secondary prevention findings, no statin primary prevention study has ever shown a benefit in terms of all cause mortality in healthy men and women with only an elevated serum cholesterol, and no known coronary artery disease (link).  Patients with known heart disease are customarily placed on statin drugs by the medical system with no need for direct to consumer (DTC) advertising to this group.  DTC ads for Lipitor are clearly directed at the larger group of untreated primary prevention patients, for which there is no benefit in terms of all cause mortality. 

The J-Lit study actually showed higher mortality at the lowest serum cholesterol (both total and LDL-C), a paradox called the J-Shaped Curve.  The highest mortality was found at the lowest total cholesterol of 160 mg/dl, and lowest mortality at serum cholesterol around 240 mg /ml, exactly the opposite one would expect if cholesterol lowering was beneficial for health.  The authors state that the increased mortality at the lower cholesterol levels was due to increased cancer.  Another statin trial, CARE (Cholesterol And Recurrent Events), showed 1500 % increase in breast cancer among women in the statin treated group, explained as merely a statistical aberration. This is disputed by Uffe Ravnskov who feels that the difference is significant, and points to rodent studies showing statin drugs cause cancer in animals.

The Honolulu Heart Study of elderly patients showed the lowest serum cholesterol predicted the highest mortality. A study by Krumholz found lack of association between cholesterol and coronary heart disease mortality and morbidity in persons older than 70 years.  Jenkins (BMJ) states that no statin drug study has ever shown an all cause mortality benefit for women. 

The Jarvik-Lipitor ad campaign is a perfect example of why prescription drug ads are dishonest, do not promote public health, increase unnecessary prescriptions, increase costs to taxpayers, and can be harmful or deadly to patients.  New Zealand and the US are the only two industrialized nations to allow direct-to-consumer advertising for prescription drugs. Here in the USA, thirty nine public interest groups have proposed congressional legislation to ban DTC prescription drug ads. 

Two more unlikely spokesmen for the Lipitor ad campaign include Mary Enig and Uffe Ravnskov.  Should either one be selected as Lipitor spokesman, I myself would run down to the corner drug store to buy up the drug.  It seems unlikey that even Pfizer’s deep pockets could ever induce them to recant their opposing position on the cholesterol theory of heart disease.   Mary G. Enig writes, ”hypercholesterolemia is the health issue of the 21st century. It is actually an invented disease, a problem that emerged when health professionals learned how to measure cholesterol levels in the blood.  Uffe Ravnskov MD PhD, who can easily be regarded as the “Duesberg” of the Lipid Hypothesis, is spokesman for Thincs, The International Network of Cholesterol Skeptics, and author of “The Cholesterol Myths, Exposing the Fallacy That Saturated Fat and Cholesterol Cause Heart Disease”.  His controversial ideas have angered loyal cholesterol theory supporters in Finland who demonstrated by burning his book on live television. 

Last week I paid a condolence call to a dear friend who just lost her mom to Alzheimer’s.  Our kids have grown up together and we shared family events for the last 15 years.  A few months ago, during one such occasion, the conversation touched on her mom’s mental decline in a nursing home, and I mentioned that sometimes treatment for B12 deficiency or hypothyroidism can help.  They had already tried that to no avail.  During the condolence call, we chatted about her mom’s life and the reason for the cognitive decline.  Apparently, her mom had been taking Lipitor for 15 years, and her daughter recalled in painful detail the initial episodes of transient global amnesia, followed by progressive dementia, and death attributed in retrospect to the drug.  How many demented nursing home patients will suffer from the adverse side effects of statin drugs?  We will never know.  People experiencing adverse side effects from statin drugs may share their experiences in discussion groups .  One such group has 3800 messages.

Jeffrey Dach M.D. is board certified in interventional radiology and a member of the Board of the American Academy of Anti-Aging Medicine. He retired from radiology two years ago, and is currently in private practice focusing on bio-identical hormone treatment.

Comments

[Patrick Schluter]

You forgot to mention another, great book concerning cholesterol, Anthony Colpo's "The great cholesterol con"

And here is another site with interesting articles about the subject.

[Henry Bauer]

A close personal friend has participated in CoQ10 studies. Several years ago, he proposed to Merck the marketing of a "super-statin" that would contain CoQ10. The idea was shot down by Merck's legal advisers, on the grounds that this would be an admission that they should earlier have been warning statin users to take CoQ10 supplements.

Shades of Vioxx, etc.

[DBrooks]

Very interesting post. I have always wondered about the efficacy of statin use. As you said, the use of statins is ubiquitous, but one wonders when the fine print always mentions that there are no studies that "prove" statins prevent heart disease, etc. I wonder about fenofibrates(Tricor) which lower cholesterol in a different manner. Do you have any thoughts, or literature recommendations, about Tricor?

[Steve Keppel-Jones]

Malcolm Kendrick, M.D., wrote an article on the relationship between cholesterol, diet, heart disease, and statin drugs. I found it to be very informative, well-written, entertaining, and most importantly not too lengthy.

The bottom line, after you get past all of the establishment shenanigans that we're very familiar with, is that statins do protect against heart disease, but this has nothing to do with cholesterol, lipoproteins, or diet. And the effect is not that large; it is comparable to that of aspirin, for approximately the same reasons, although I suspect aspirin is quite a bit safer.

[Joel M. Kauffman]

Great essay on Lipitor, better than I did myself a year ago in my book: Malignant Medical Myths.