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.
Barney Clark, Jarvik Heart Recipient
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.(1)(2)
The Dracula of Medical Technology
Left Images: Bella Lugosi in Dracula 1931, and Robert Jarvik selling Lipitor on TV 2007.
During the ensuing media coverage, the New York Times dubbed the Jarvik Heart the “Dracula of Medical Technology” (link). (3)(4)
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.(5)
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.(6)
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.(7)
Why is Jarvik an Expert on Statin Drugs?
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.(8)
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.(9) Deaths from heart failure have doubled nationwide since the introduction of statin drugs in 1987. (10)
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.
Jarvik May not be the Best Choice for Spokesman
Duane Graveline MD
Perhaps Jarvik is not the best choice for the Lipitor campaign which has had mixed reviews.(11)
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.(12)(13)
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. (14)
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.(15)
Studies Cast Doubts
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.(16)
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.(17) 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.(18)(19)
The Honolulu Heart Study of elderly patients showed the lowest serum cholesterol predicted the highest mortality.(20) A study
by Krumholz found lack of association between cholesterol and coronary
heart disease mortality and morbidity in persons older than 70 years.(21) Jenkins (BMJ) states that no statin drug study has ever shown an all cause mortality benefit for women.(22)
DTC Advertising- A Bad Idea
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.(23)(24)
Mary Enig and Uffe Ravnskov- Unlikely Lipitor Spokesmen
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.(25) 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. (26)
Condolence Call
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. (27) One such group has 3800 messages.(28)
Next Chapter
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