Healthy Skepticism Library item: 12461

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Publication type: news

Sector Snap: Antidepressant Makers Fall
Forbes.com 2008 Jan 17
http://www.forbes.com/feeds/ap/2008/01/17/ap4545826.html

Full text:

Shares of antidepressant drugmakers traded lower Thursday after a report in the New England Journal of Medicine cast doubt as to whether the drugs are as effective as the pharmaceutical industry claims.

The report, published Thursday, reviewed data from studies covering 12 antidepressants and found the majority of trials with negative outcomes weren’t published.

According to published literature, 94 percent of trials conducted on antidepressants generated positive results. But after reviewing Food and Drug Administration documents, which include unpublished material, only 51 percent of data was show to be positive.

“We found a bias toward the publication of positive results,” the NEJM report stated. “Not only were positive results more likely to be published, but studies that were not positive, in our opinion, were often published in a way that conveyed a positive outcome.”

The review was conducted by a team led by Dr. Erick H. Turner, a psychiatrist from the Oregon Health and Science University. The team culled information from both published and unpublished studies involving 12,564 patients.

Several of the best-selling antidepressants were included, such as Indianapolis-based Eli Lilly & Co.‘s Cymbalta, which had sales of $1.3 billion in 2006. The company, which also sells Prozac, saw shares fall $1.23, or 2.2 percent, to close at $54.84.

Meanwhile, shares of Kenilworth, N.J.-based Schering-Plough Corp. fell to a new 52-week low of $20.55 during the trading session, closing down $1.87, or 8 percent, at $21.62. Its subsidiary Organon sells Remeron. Shares of U.K.-based GlaxoSmithKline PLC fell 91 cents to $50.70. The company sells Wellbutrin and Paxil, the latter of which had sales of $154 million in the first half of 2007.

The NEJM report said failed studies didn’t necessarily mean the drugs were ineffective, and all proved more effective than placebo. But, the true magnitude of their effectiveness appears to be less than what has been touted.

“It might be argued that some trials did not merit publication because of methodologic flaws, including problems beyond the control of the investigator,” the report states. “However, since the protocols were written according to international guidelines for efficacy studies and were carried out by companies with ample financial and human resources, to be fair to the people who put themselves at risk to participate, a cogent public reason should be given for failure to publish.”

The review only considered studies to be “published” if they were the sole subject of an article. When reached for comment, Organon said it is still reviewing the report, but has already found several studies that were either published or part of published reports. Remeron has been off-patent since 2002.

Eli Lilly spokeswoman Tammy Hull also said data from two Cymbalta studies that NEJM reviewers deemed “unpublished” was published in conjunction with other results and also was presented at one or more medical conferences at which abstracts were required to undergo peer review.

Hull objected to implications that Eli Lilly has been disingenuous in desseminating its data, asserting that the company has been an industry leader in transparency and was in fact the first drug maker to launch an online clinical trial registry which includes data from all Lilly-sponsored registration clinical trials for its marketed products going back to 1994.

David Shern, president and chief executive of advocacy organization Mental Health America, said the report doesn’t necessarily change what is know about the effectiveness of antidepressants.

“Their point was that physicians are only looking at published studies and probably getting a much rosier picture,” he said in an interview.

New York-based Pfizer Inc., which makes Zoloft, saw shares fall 44 cents to $22.96. Shares of Madison, N.J.-based Wyeth, which makes Pristiq and Effexor, fell $1.97, or 4.3 percent, to $44.17.

Shares of New York-based Forest Laboratories Inc., which makes Lexapro, rose 23 cents to finish at $40.13.