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Legal pressure is rising to force drug makers to disclose all studies, good or bad, that shed light on the safety of medicines they sell. On June 2, New York State Attorney General Eliot Spitzer charged GlaxoSmithKline with concealing data about the safety of its antidepressant Paxil. His suit appears to be the first to argue that a drug maker’s failure to publicize negative safety data constitutes fraud. New York v. GlaxoSmithKline PLC, No. 04-401707. A Glaxo spokeswoman objected to the premise of Spitzer’s case, saying her company disclosed the data to regulatory agencies. Yet doctors most likely couldn’t learn about the safety findings. The Food and Drug Administration generally treats data submitted by drug makers as proprietary. Even if Glaxo’s argument works in court to rebuff Spitzer, another lawsuit filed in February in Washington aims to end drug makers’ practice of treating the regulatory process as a shelter. This case, filed by the nonprofit group Public Citizen, has already succeeded in extracting evidence of safety risks for a popular medicine that Pfizer sells as Bextra. The Spitzer and Public Citizen cases signal that drug companies may need to reassess how they talk to regulators, and that lawyers are likely to play a prominent role in these discussions. The effort to expose the Bextra data was launched after the manufacturer announced that it had asked the FDA to approve Bextra for four purposes. The FDA approved three, rejecting it as a treatment for acute pain. Then a journal published an article concluding that Bextra did help fight pain, and Public Citizen asked the FDA for the evidence that persuaded it to reject Bextra for pain treatment. At first, the FDA gave to Public Citizen material that hid the safety data as confidential. After the group filed suit, the FDA partially reconsidered, revealing that Bextra wasn’t approved in part because it had caused heart trouble in some patients who were given it for pain. Public Citizen has filed several suits over whether safety studies are confidential business information. The manufacturers won a round in 1999, when a court ruled that safety data may remain confidential if attached to an abandoned drug candidate. The logic: Revealing this failure may give competitors an advantage by helping them avoid mistakes. Public Citizen lawyer Allison Zieve said that with a product already on the market, such confidentiality is even less justifiable. The drug makers face limited choices on how to keep information confidential. “The result can’t be that they stop submitting the information,” said Philip Katz of Washington-based Crowell & Moring. Rather than addressing how to interact with regulators, said Arnold & Porter partner William Vodra, “Lawyers will get involved in a different set of questions: Do you want to do this study?”

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