This is a contribution from a member of THINCS,
International Network of Cholesterol Skeptics
M. Kauffman, PhD, Professor of Chemistry Emeritus, University of the
John Abramson, MD, Overdo$ed America, New York, NY: HarperCollins,
2004. xvii + 332 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 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
As you can see, the problems posed by the excesses of Big Pharma are
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
. Trials that do not favor the drug are not published or reported to
. Advertisements for drugs ignore FDA warnings on over-promotion.
. Common conditions are elevated to pathological states to sell
. 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
. Physicians' prescribing habits can be purchased from
pharmacies to see whether the MDs have responded to sales
. 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
. 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
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 goads 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.
Joel M. Kauffman, PhD, Professor of Chemistry Emeritus,
University of the Sciences in Philadelphia -----5 Nov 04
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