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JAMA scandal and Ketek approval raise questions about big pharma's influence

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No sooner did Dr. Catherine DeAngelis, JAMA's editor in chief, disclose that the physician authors defending antidepressants during pregnancy in the Feb.1 issue had ties to antidepressant manufacturers than it happened again.

This time the physician authors linking migraines with auras to cardiovascular disease [CVD] in the July 19 issue had their own links: to migraine and heart medication manufacturers.

Even the mea culpas sounded the same.

"While we believe that we have no financial interests, relationships, or affiliations that would be relevant to our describing a biological link between migraine and cardiovascular disease," wrote Tobias Kurth, MD, lead author in a follow-up letter to JAMA, "we are disclosing all nonfederal relationships of every coauthor." He goes on to list 53 irrelevant financial relationships the six physician authors have with drug companies.

"Dr. Urato suggests the financial associations of the 9 physician authors constituted a conflict of interest," Dr. Lee Cohen, lead author of the discredited antidepressants/pregnancy study wrote in a follow-up letter to JAMA. "However we did not view those associations as relevant to this study for the following reasons." Cohen then lists, in addition to his reasons, 76 irrelevant financial relationships the nine physician authors have with drug companies.

And there was more. In JAMA's May 17 issue, physician authors Dr. Eric Matteson and Dr. Tim Bongartz who wrote about arthritis drug side effects had undisclosed--and no doubt irrelevant--financial relationships with Abbott and Centocor Pharmaceuticals.

Of course these aren't the only docs who can't make a living discharging their Hippocratic oath and take a pharmaceutical dive. The physician authors who told us Vioxx and HRT were safe also presumably couldn't make ends meet.

That's why a lot of us hear big pharma behind the JAMA studies saying "Hey what if we scared women with migraines into taking drugs for CVD risks?" And "Hey--we're losing antidepressant sales to pregnancy!"

And that's why we also hear big pharma behind FDA's controversial approval of the antibiotic Ketek, blamed in the death of four and liver injury or failure in 37 others since 2004.

Like Vioxx, Ketek's potential deadly side effects were known to its French manufacturer Sanofi-Aventis early in clinical trials and covered up. Like Vioxx, it has no advantage over existing drugs except a slick ad campaign, including full page color ads in JAMA. And like Vioxx, Dr. David Graham of the Food and Drug Administration's drug safety office has outed it.

"It's as if every principle governing the review and approval of new drugs was abandoned or suspended where telithromycin [Ketek] is concerned," he recently wrote in an internal document, recommending the drug's "immediate withdrawal."

But the FDA, which was about to recommend Vioxx use in children when Merck voluntarily recalled it--another use; another revenue stream!--disagreed.

"Every issue or question raised during the Ketek review process and subsequently since approval has been rigorously reviewed by the nation's best physicians, statisticians and epidemiologists both internal and external to the FDA," said FDA spokeswoman Susan Bro in her best wordchain governmentspeak. "We're in bed with Sanofi-Aventis," would have been simpler.

Still Senator Charles E. Grassley, R- Iowa, chairman of the Finance Committee, who has been investigating the circumstances surrounding Ketek's approval smells a rotten beaker.

"It's no surprise to learn that the FDA didn't listen to Dr. Graham on the dangers of Ketek" he says. "The FDA has made it their business to discredit Dr. Graham and others who aren't willing to cater to the drug companies."

In July, Grassley asked the Health and Human Services Department to probe whether the FDA's own Dr. Brian Harvey conspired against Graham by providing Merck details about his upcoming Vioxx presentation to better help them refute it says the Associated Press.

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Martha Rosenberg is an award-winning investigative public health reporter who covers the food, drug and gun industries. Her first book, Born With A Junk Food Deficiency: How Flaks, Quacks and Hacks Pimp The Public Health, is distributed by Random (more...)
 

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