This
is a contribution from a member of THINCS,
The International Network of Cholesterol Skeptics
Home
Book
Review
by
Joel M. Kauffman, PhD, Professor of Chemistry Emeritus, University of the
Sciences in Philadelphia
John Abramson, MD, Overdo$ed America, New
York, NY: HarperCollins, 2004. xvii + 332J pp ISBN 0-06-056852-6
The subtitle: “How the Pharmaceutical
Companies Distort Medical Knowledge, Mislead Doctors, and Compromise Your
Health” tells what 2/3 of this book is about. Much more of the range of
the dismal effects of unbridled capitalism on medical treatment in the USA
is covered by this Harvard-educated family doctor who has returned to
Harvard to teach primary care. A quote from pp258-259 will illustrate:
“Government needs to be re-empowered,
and a good place to start might be public hearings that investigate the
commercial distortion of our medical knowledge. The first ‘case’ might
be an investigation of the process by which Celebrex and Vioxx, two drugs of
very limited clinical value, ...[which became] blockbusters in the United
States [sales over $1 billion per year] but not in the rest of the world (nearly
80% of all sales occurred in the United States). Such hearings could
publicly review the unproccessed data from from the manufacturers’ own
studies that have been submitted to the FDA; expose the discrepancies
between these data and the articles that reported the ‘scientific evidence’
about the two drugs, published in our two most respected medical journals;
inform the public about the finacial ties between each of the four authors
of the clinical practice guidelines issued by the American College of
Rheumatology in 2000, which recommended the use of these drugs, and at least
one of the manufacturers of Celebrex and Vioxx; show that in 2001 (when
these drugs were being established as the standard of care) they were the
two most heavily advertised to the public and two of the most heavily
marketed to doctors; show how drug company—funded continuing education has
persuaded doctors to prescribe these drugs; show how the FDA has known this
whole story since February 2001 and, despite issuing Warning Letters to the
manufacturers of both Celebrex and Vioxx about false and misleading
marketing, has not effectively corrected doctors’ and the public’s
erroneous beliefs about the true clinical value of these drugs; and, finally,
show how all these tactics were masterfully orchestrated to produce $5.3
billion of COX-2 inhibitor sales in the United States in 2003.”
As you can see, the problems posed by the
excesses of Big Pharma are staggering.
Here are some specific means Dr.
Abramson wrote about by which medical knowledge is distorted:
• A clinical trial result can be published
in a peer-reviewed journal where the results are not statistically
significant, yet claimed to be highly positive.
• Relative risk reduction (RRR) is used to
magnify results when the absolute risk reduction is small. If a drug, test,
or device cuts the subjects with the medical condition from 2 in a million
to 1 in a million, the RRR = 50%. But in such a case, why bother?
• Many clinical trials study mostly or
entirely men, but the results are applied to women as well.
• Subjects in clinical trials may be 40-60
years old to start, but the results are then applied to those 70-90 years
old and children.
• Key findings often are not in the
abstracts of the articles reporting on clinical trials.
• Review papers are often written by drug
industry experts to praise certain drugs.
• Clinical trials are stopped when the data
become bad for the drug, not when the original trial duration planned has
been reached.
• Trials that do not favor the drug are not
published or reported to the FDA.
• Advertisements for drugs ignore FDA
warnings on over-promotion.
• Common conditions are elevated to
pathological states to sell drugs.
• Surrogate endpoints (bone density, blood
pressure, cholesterol) are substituted for clinically certain endpoints
(death, cancer, heart problems, ability to walk).
• Internet sites claiming to be patient
focus groups are sponsored by drug companies.
• Continuing Medical Education seminars are
produced by drug, test and device makers to sell their products, not to
educate.
• Physicians are wined and dined to favor
certain corporate goals.
• Physicians’ prescribing habits can be
purchased from pharmacies to see whether the MDs have responded to sales
pressures.
• The FDA and the NIH are influenced by
industry by implanted employees and consulting agreements.
• Congress is lobbied by the biggest force
of any industry to pass favorable legislation.
• Rare comparison tests between drugs use
non-equivalent doses to favor the sponsor of the trial.
• Ghostwriters are hired to draft papers
for medical journals that will most favor the drug, device, or test.
• Physicians’ offices are routinely
invaded by “detail women” bearing biased literature, gifts, and food.
• Treatment guidelines are promulgated by
mostly industry lackeys, and made to seem as though the federal government
has backed the guidelines.
• The direct-to-consumer ads on TV destroy
the doctor-patient relationship.
In addition to the stated goal of this
book, Dr. Abramson also addresses medical school snobbery. An example is
that general internal medicine is too low in the pecking order compared with
neurosurgery, for example. He deplores the excesses of expensive treatment
vs. the lower cost of prevention; the Medicare Prescription Drug Improvement
and Modernization Act of 2003 as a give-away to the drug companies; the
failure of the FDA to use the power it has against Big Pharma. He is aware
that most major advances in treatment are developed in government or
academic laboratories, not by Big Pharma.
He was aware of the lack of evidence for the 2001 cholesterol level
guidelines, the financial conflicts of those who wrote them, and the teeny
benefits for statin drugs in most people who take them as the almost
ineveitable result of the guidelines. Too bad that Uffe Ravnskov, MD, PhD,
possibly the most accomplished and published cholesterol skeptic worldwide,
and the website he founded, www.THINCS.org, were not mentioned or referenced.
He did not emphasize that a number of common tests, other than
angiography and for C-Reactive Protein level, that are of little or no value
(Welch, 2004). He notes physicians’ ever-present fear of malpractice suits
as one of the roads to too much testing.
Dr. Abramson makes the very positive suggestion that evaluation of
medical science evidence and promulgation of treatment guidelines be given
to the Institute of Medicine of the National Academy of Sciences, and that
the experts to be on the panels of the IOM be insulated from Big Pharma
(p250). A second suggestion is that all clinical trials be pre-registered
with the intended protocol given, so that results of trials are harder to
hide.
*****
Well, no one is perfect, and there were some serious errors, the most
so being on diet. The low-fat, low saturated fat and cholesterol, high
complex-carbohydrate (whole grains even) diet dogma appeared — unscathed
by tons of evidence against it. Since so many ailments start with obesity,
syndrome X, and type-2 diabetes, the main cause beyond genetic
predisposition is excessive carbohydrate consumption (Mozaffarian et al.,
2004; Otttoboni et al., 2002; Ravnskov, 2000). The American Heart
Association was presented as a useful source of diet advice despite evidence
that it it is not (Kauffman, 2004). Type-2 diabetes was described as a
condition when too little insulin is produced by the body; this is correct
only in the late stages. Surprisingly prevalent grain allergies were not
addressed at all.
A great section on the myths of osteoporosis was dimmed a bit by
failure to recommend magnesium and trace elements, such as boron and
manganese, in addition to the usual calcium and vitamin D supplements
(Atkins, 1998).
Multiple recommendations for exercise do not make enough distinction
between moderate and extreme exercise. Dr. Abramson gives no warning that
the latter causes cardiovascular disease and arrythmias that lead to sudden
cardiac death. There is no placebo for exercise. People who are healthy do
more of it. Those who are unwell do less of it, and they are often
instinctively correct (Solomon, 1984). When accurate reporting of the
effects of even voluntary exercise on heart patients is examined, the
benefits are minimal (Hambrecht et al., 1993).
Dr. Abramson was frank about the side-effects of many classes of drugs,
but did not dwell on the fact that 3/4 of people taking statins and blood
pressure drugs stop within 2 years because of side-effects (Roberts, 1996;
Jackevicius et al., 2002; Pahor et al., 2000). Moreover, the drop in
mortality for patients who continue on either statins or blood pressure
drugs is quite small. Dr. Abramson does not address the failings of the
antihypertensive drugs.
His complete avoidance of recommendations for any sort of alternative
treatments or supplements, one hopes, was to maximize his credibility with
mainstream medical opinion leaders, and to avoid alienating his Harvard
Medical School colleagues.
*****
Only two other books I know of are in the same class for exposing the
tricks of exaggerating the results of clinical trials: The Cholesterol Myths
by Uffe Ravnskov, 2000; and Calculated Risks by Gerd Gigerenzer, 2002.
This book is well-written with an almost cheerful tone. It is easy to
read with meaningful chapter headings, sections and subsections. It is very
well referenced. The arrangement is chaotic, but builds steadily to a
powerful conclusion.
I hope that Overdo$ed America will join Marcia Angell’s The Truth
About the Drug Companies, 2004 and Merrill Goozner’s The $800 Million
Dollar Pill, 2004, in staving off the medical industry’s effort to
grab half of the gross national product of the USA. Dr. Abramson’s book
will be a treasured reference for the rest of my life.
Atkins RC (1998). Dr Atkins
Vita-Nutrient Solution, London, England: Pocket Books, Simon & Schuster.
Hambrecht R, Niebauer J, Marburger C,
et al. (1993). Various Intensities of Leisure Time Physical Activity in
Patients With Coronary Artery Disease: Effects on Cardiorespiratory Fitness
and Progression of Coronary Atherosclerotic Lesions. Journal of the American
College of Cardiology, 22:468-477.
Jackevicius CA, Mamdani M, Tu JV
(2002). Adherence With Statin Therapy in Elderly Patients With and Without
Acute Coronary Syndromes. J Am Med Assoc 288:462-467.
Kauffman JM (2004).
Low-Carbohydrate Diets, J. Scientific Exploration 18(1):83-134.
Mozaffarian D, Rimm EB, Herrington DM
(2004). Dietary fats, carbohydrate, and progression of coronary
atherosclerosis in postmenopausal women. Am J Clin Nutr 80:1175-84.
Ottoboni F, Ottoboni A (2002). The
Modern Nutritional Diseases, Sparks, NV: Vicente Press.
Pahor M, Psaty BM, Alderman MH et al.
(2000). Health outcomes associated with calcium antagonists compared with
other first-line antihypertensive therapies: a meta-analysis of randomised
controlled trials. Lancet, 356(9246):1949-1954.
Uffe Ravnskov U (2000). The Cholesterol
Myths , Washington DC: New Trends Press.
Roberts WC (1996). The underused
miracle drugs: the statin drugs are to atherosclerosis what penicillin was
to infectious disease. American Journal of Cardiology, 78:377-8.
Solomon HA (1984). The Exercise Myth,
Orlando, FL: Harcourt Brace Jovanovich.
Welch H (2004). Should I Be Tested for
Cancer? Maybe Not and Here’s Why, Berkeley, CA, USA: University of
California Press.
Home
|