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4.5
In "Overdosed America" Dr. John Abramson is mainly concerned with accuracy of information about prescription drugs and about medical devices and procedures in the United States. He shows how drug and device makers manipulate information to present their products favorably. Dr. Abramson leverages experience in public health policy, closely analyzing FDA fast-track approval of painkillers including Celebrex in 1998 and the now withdrawn Vioxx in 1999 (pages 23-38) and NIH revisions to cholesterol guidelines in 2001 (pages 129-148). For those cases, Dr. Abramson provides detailed readings of published studies, showing how drug benefits were promoted and hazards minimized.Dr. Abramson's most egregious example concerns hazards of Vioxx. A key report about Vioxx appeared November 23, 2000, in the New England Journal of Medicine, then as now edited by Dr. Jeffrey Drazen. It included information about potential hazards. An apparently authoritative review article about Vioxx and Celebrex appeared August 9, 2001, in the same journal, with updated hazard information. The latter article said increased incidence of cardiovascular events associated with Vioxx "may reflect the play of chance." From data published in the latter article Dr. Abramson found that the cardiovascular hazard from Vioxx was statistically significant, unlikely to represent chance occurrences. However, FDA action on the information was delayed until September, 2004, when Merck withdrew Vioxx from the market because of its cardiovascular hazard. On December 8, 2005, the New England Journal of Medicine published a belated "Expression of Concern" saying authors of the November 23, 2000, article had omitted data which they then possessed, showing a greater incidence of cardiovascular events.Writing before the 2005 disclosure, Dr. Abramson was incensed. Poring over information made available to the public by the FDA, he had already found that the FDA knew of a substantial cardiovascular hazard when Vioxx was approved. Members of the medical community had little access to this knowledge, unless willing to spend hours in background research as Dr. Abramson did, and the general public knew even less. Articles appearing in a major medical journal had promoted benefits of Vioxx and minimized hazards. Dr. Abramson reports pressure from his patients to prescribe Vioxx, inspired by advertising. He accuses "commercial medical research" of "rigging medical studies, misrepresenting...results" and "withholding...findings" (page xvii).Dr. Abramson's proposed remedy is a new federal agency "to protect the public's interest in medical science" (page 250). It would set standards for "medical research," oversee development of "clinical guidelines," and initiate research "when important scientific evidence was lacking." While describing this new agency, Dr. Abramson does not say but appears to mean by "medical research" mainly "clinical trials" for prescription drugs and medical devices, not the basic research programs sponsored by the NIH and other agencies. The key power of the new agency over prescription drugs and medical devices would be certifications that clinical trials met its standards.Dr. Abramson makes three more general recommendations to improve health care: a "rebalanced" "mix of physicians," financial rewards to health care providers for "improving the health" of their patients, and "adequate, stable funding" of the FDA and NIH, replacing [prescription drug and medical device] "industry money" (pages 255-256). Dr. Abramson does not provide guidance for making such changes. Instead he calls for "courageous leadership" from someone else, inviting "public hearings" investigating the Celebrex and Vioxx approval processes and investigating "commercial bias in the 2001 update to the cholesterol guidelines."Despite the intensity of his investigations, Dr. Abramson does not seem to have spent comparable energy on his proposed remedies. Unlike many economists, he seems much impressed with the effectiveness of the Federal Reserve Board and wants to model his proposed agency after it. His proposed new agency appears similar in spirit to "science court," long advocated under different names by Dr. Arthur Kantrowitz, the physicist who founded Avco-Everett Research Laboratory in 1955 and later became a professor at Dartmouth.A key problem with "science court" was that it would duplicate functions of existing courts, with no clear way to resolve issues of jurisdiction. A key problem with Dr. Abramson's proposed agency is that it would duplicate functions already assigned to the FDA and the NIH, with no clear way to divide responsibilities. Since his core complaint is that those agencies failed, Dr. Abramson ought to have provided a history of how they came to fail and ought to have explored whether and how such failures could be remedied. Avoiding knowledge of failures invites their repetition, should Dr. Abramson's plan somehow be implemented.Dr. Abramson left his medical practice in 2002 to teach primary care at Harvard Medical School, where he wrote his book. In a January, 2005, interview published by Managed Care, he disclosed frustration trying to teach students to examine evidence critically: "it creates dissonance for them." He explains that "medical students want to learn indications, doses and side effects, because that's what they'll be graded on." Dr. Abramson is himself a primary care physician who did learn how to extract knowledge from muddled evidence and unwarranted conclusions. While his book does not try to deal with a wide range of problems in United States medicine, it is clear and convincing in describing the issues it takes on."Overdosed America" can be most closely compared with "Powerful Medicines" by Dr. Jerry Avorn -- both books first published in late summer, 2004. Like Dr. Abramson, Dr. Avorn is an internist who teaches at Harvard Medical School. Unlike Dr. Abramson, Dr. Avorn has spent most of his career in academic medicine, currently heading a group of sixteen scientists and physicians called the Division of Pharmacoepidemiology and Pharmacoeconomics at Brigham and Women's Hospital in Boston. Dr. Avorn describes many of the same examples of problem drugs as Dr. Abramson -- including Vioxx, statins and hormone replacement therapy -- but his attitude is different. Where Dr. Abramson is sometimes incensed, Dr. Avorn is philosophical. Faced with probabilities of drug hazards, Dr. Abramson estimates the number of his patients who may suffer. Dr. Avorn says about such issues, "I don't intuit them well" (page 167). Instead, he says he has "developed a passable prosthetic sense of such things."A policy professional will probably find Dr. Avorn's explorations of prescription drug issues interesting and helpful. Most potential readers will find more insight and motivation in Dr. Abramson's book. It is a long read, travelling through territories likely to be unfamiliar. At the end of the journey, a persistent reader will understand a major problem affecting medical care in the United States and will have some sense of what needs to be done to deal with and correct it.
