This from Vera Hassner Sharav at the Alliance for Human Research Protection.
An excellent OpEd in today’s New York Times by psychiatrist, Dr. Daniel Carlat pulls no punches about the corruption of accredited medical education–which is nothing more than a forum for drug marketing.
“According to the most recent data available from the national organization in charge of accrediting the courses, drug-industry financing of continuing medical education has nearly quadrupled since 1998, from $302 million to $1.12 billion. Half of all continuing medical education courses in the United States are now paid for by drug companies, up from a third a decade ago. Because pharmaceutical companies now set much of the agenda for what doctors learn about drugs, crucial information about potential drug dangers is played down, to the detriment of patient care.”
On paper, the guidelines prohibit companies from paying doctors who teach continuing medical education courses directly. But given the corruption of medicine at every institutional level–including academia–companies they have found a money laundering way to circumvent the guidelines: They hire for-profit “medical education communication companies” to organize the courses. “These companies receive millions of dollars from drug companies to create course work and to pay doctors to deliver the content. Sometimes, they pay doctors to give lectures to other doctors. Other times, prominent doctors are paid to be listed as the authors of journal articles that are written by ghost writers, a practice that was extensively documented in court records from a lawsuit against Pfizer.”
The remedy? Dr. Carlat has a simple solution: “The solution could hardly be simpler: any continuing medical education that is paid for by the drug industry should not be accredited.”
Yesterday’s Times editorial, Misdirected Studies on Avandia, notes: “One disturbing possibility is that Glaxo has designed tests that have the effect of meeting the company’s marketing objectives while minimizing risks. The F.D.A. may have allowed itself to be outmaneuvered, approving designs that won’t fully answer key safety questions.”
The editorial writer is under the illusion that faulty clinical test designs such as the one Glaxo used to test Avandia, is unusual. The fact is, FDA officials at the Center for Drug Evaluation (CDER) routinely approve clinical trial designs which ensure that the drug’s serious risks will NOT be readily detected–lest they harm the marketing prospects of the drug.
An investigation of the FDA approval of the second generation antipsychotics will show that CDER officials have been approved the drugs despite the “inappropriate” trial designs which did not answer key safety questions. Indeed, the antipsychotic failed to demonstrate clinical efficacy. Furthermore, although antipsychotics now carry black box warnings about drug-induced deaths–those warnings remain hidden from consumers. FDA officials have not required manufacturers to provide consumers with MedGuides for antipsychotics. Instead, FDA is fast-tracking approval of antipsychotics for teenagers.