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a d v e r t i s e m e n t
 

HEALTH NEWS

Drug Safety Is a Mainstream Issue in Post-Vioxx World

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 08 June, 2005  07:37 GMT

drug safety panel
'From the media's perspective, side effects are now up there with burning houses and disappeared children and the Jackson case as things that are of interest to the readers and viewers.'
An independent panel named by the Institute of Medicine, an arm of the National Academies, is meeting to discuss how the Food and Drug Administration can improve the safety of drugs taken by millions.

But before the study committee makes a single suggestion, others with vested interests are already conducting their own research into drug safety.

Analysts with doctorate and medical degrees are becoming commonplace on Wall Street. They are charged with uncovering safety concerns posed by drugs, including those still in clinical trials, and steering investors away from drug company stock they consider too risky.

Academic researchers have also become more proactive. Some are publishing journal articles that discuss side effects not revealed by the FDA, like the risk of death posed by the heart failure drug Natrecor. After articles in March and April questioned the drug's safety, the FDA said Scios Inc., a Johnson & Johnson subsidiary, would add the mortality risk data to the drug's label.

Swift Label Revisions

These days, even an article in an obscure journal pointing to drug risks -- like one in the March issue of the Journal of Neuro-Ophthalmology detailing seven new cases of vision problems suffered by men after taking the erectile dysfunction drug Viagra -- can prompt swift drug label revisions.

Dr. Howard D. Pomeranz, who wrote the article, said his case study gained more notice because a patient discussed his vision problems on national television.

"You suddenly have a patient to kind of hang this on, so to speak, as opposed to this sort of abstract paper that's kind of floating out there," said Pomeranz, a University of Minnesota researcher who grew up in Woburn.

On May 27, the same day the Viagra article was making news, the FDA said it was in discussions with manufacturers of erectile dysfunction drugs to add uniform wording to labels that notes the rare vision problems.

Post-Vioxx World

Just a few years ago, a similar paper pointing to heart risks associated with popular painkillers did little to slow sales of the drugs, said Harvard Medical School's Dr. Jerry Avorn, author of "Powerful Medicines."

"This is really the post-Vioxx world. Many things are different now," Avorn said, referring to the painkiller that was removed from the market last fall by Merck & Co. "From the media's perspective, side effects are now up there with burning houses and disappeared children and the Jackson case as things that are of interest to the readers and viewers."

On Wall Street, a growing number of analysts with scientific training -- and related college degrees -- are closely scrutinizing issues once considered closer to the realms of science and medicine than finance, such as the mechanism drugs use to cure maladies. New generation painkillers like Celebrex and Vioxx, for example, target a specific enzyme linked to swelling and pain.

Kevin Hrusovsky, president and chief executive of Caliper Life Sciences, a company that creates tools to speed drug discoveries, said Wall Street attention to medical matters is "going to be an emerging area because, overnight, there could be so much value lost based on side effects."

Hrusovsky noted Wall Street's increasing interest in hiring analysts with doctorates when he moderated a May 26 Massachusetts Biotechnology Council panel on drug safety.

From Optimistic to Somber

Wall Street analysts are even paying keen attention to the tenor of company announcements, such as Elan Corp's comments about Tysabri's return to market, which turned from optimistic to somber after the multiple sclerosis drug last week was linked to a fourth possible case of a potentially deadly brain disease. Elan is a partner with Cambridge-based Biogen Idec on Tysabri.

"There was a noticeable change, absolutely," said Mark Augustine, a biotechnology analyst at Credit Suisse First Boston. Augustine's research update last week included the newest patient's symptoms, the current scientific abstract for a competing MS drug and a projection of "substantially diminished future sales" should Tysabri return.

Today's Institute of Medicine panel begins amid calls by consumer groups to ban one of its members, Andy Stergachis, former vice president and chief pharmacist at drugstore.com, because of his consulting agreements with the drug industry.

Greg French, a drugstore.com spokesman, declined to comment.

Christine Stencel, an Institute of Medicine spokeswoman, said she did not know whether the conflict of interest allegations would prevent Stergachis from serving on the panel.

The committee will gather information in coming weeks on how the FDA tracks the safety of drugs after they're approved, and eventually issue a report including recommended changes for the FDA, laws that govern its actions, and the amount of money it receives to improve safety.

In addition to the institute, the National Academies is comprised of the National Academy of Engineering, the National Academy of Sciences and the National Research Council.




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