The Whack Pack's Perverse Priorities on Drug Safety

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  • 06/28/2007
You have to love the way the NEJM and the NY Times treat the issue of drug safety. Steve Nissen runs a crappy meta-analysis of Avandia's supposed dangers and it's rushed to e-print in advance of a Senate hearing and the close of the markets. The NYTmakes it front page news.

A careful study that shows a very low risk of birth defects among women taking anti-depressants while pregnant...? Why, the very same NEJM sees no reason to stop the presses. No Congressional hearings. No publicity whores running to Nightline to talk about the number of suicides and depressed women who affected by the lack of treatment.

And the NY Times? No front page articles linking anti-depressants to "suicides." Because this time it's for real and this time it's a case of telling pregnant women it's ok to take them. (Kudos to http:// for being one of the first on the web with the good news)

It's page A16, next to a silly story about a congressional proposal setting up a mandatory registry of all "gifts" drug companies provide to doctors. Listen to how the NY Times reports on this NEJM article:

The findings, appearing in two studies in The New England Journal of Medicine, support doctors’ assurances that antidepressants are not a major cause of serious physical problems in newborns.

"But the studies did not include enough cases to adequately assess risk of many rare defects; nor did they include information on how long women were taking antidepressants or at what doses. The studies did not evaluate behavioral effects either; previous research has found that babies suffer withdrawal effects if they have been exposed to antidepressants in the womb, and that may have implications for later behavior.

“These are important papers, but they don’t close the questions of whether there are major effects” of these drugs on developing babies, said Dr. Timothy Oberlander, a developmental pediatrician at the University of British Columbia, who was not involved in the studies. “There are many more chapters in this story yet to be told.”

Meanwhile, in responding to a similar study last year Oberlander said: "At present, probably the effect of not treating the women's clinical depression is a much bigger issue for mothers and their infants."

Maybe we should do a study looking at the effect of being interviewed by the NYT on the quotes researchers give to reporters. We could call it the Nissen Doomsday Effect.

I digress. Notice all the caveats? Now here's the NYT on Avandia:

"The analysis, based on a review of more than 40 existing clinical studies involving nearly 28,000 patients, showed that Avandia significantly increased the risk of heart attacks, compared with other diabetes drugs or a placebo.

Both the study’s lead author and the editors of The New England Journal of Medicine, in which the article appeared, cautioned that the research method used left the findings open to interpretation. But they said the study nevertheless raised important concerns.

And the publication of the study on the journal’s Web site prompted the Food and Drug Administration to issue a public safety alert and advise users of the drug — an estimated million people in this country and two million worldwide — to consult their doctors about the potential cardiovascular risks.

The journal’s editor in chief, Dr. Jeffrey M. Drazen, said: “We view this as the best publicly available data on a very important question. It shows what we regard as a preliminary, but worrisome, signal about cardiovascular toxicity of this drug.”

No bias in the media on drug safety. None at all. In light of the increase in teen suicide due to a decline in SSRI use which was triggered by biased reporting, makes you wonder what would happen if drug companies weren't around to provide responsible, peer-reviewed and regulated information about the benefits of their products. And I AM serious about that.

Center for Medicine in the Public Interest is a nonprofit, non-partisan organization promoting innovative solutions that advance medical progress, reduce health disparities, extend life and make health care more affordable, preventive and patient-centered. CMPI also provides the public, policymakers and the media a reliable source of independent scientific analysis on issues ranging from personalized medicine, food and drug safety, health care reform and comparative effectiveness.

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