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Posted March 9, 2008
Extracting medical knowledge from advertising
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public health policy, closely analyzing FDA fast-track approval of painkillers including Celebrex in 1998 and the now withdrawn Vioxx in 1999 'pages 23-38' and NIH revisions to cholesterol guidelines in 2001 'pages 129-148'.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 t
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