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.
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