Tampa judge keeps Accutane records secret

Published: Saturday, January 29, 2005 at 6:01 a.m.
Last Modified: Friday, January 28, 2005 at 10:55 p.m.
TAMPA - A federal judge refused Friday to make public as many as one million documents produced by the makers of Accutane, rejecting a request that attorneys suing the acne drug's makers said was needed as its safety comes under increased scrutiny.
The ruling by U.S. District Judge James Moody applies to dozens of lawsuits filed nationwide against Accutane's maker, Hoffman-La Roche Inc. It comes at a time when attorneys and federal regulators are posing new questions about whether Accutane plays a role in suicides, birth defects and other serious side-effects experienced by some users.
Among the cases is the $70 million lawsuit brought by the mother and grandmother of Charles Bishop, the 15-year-old who stole a small airplane and crashed into a Tampa high rise in January 2002. His family blames his use of the drug for bringing on the dramatic suicide, but the company contends that he was a troubled young man and it is not to blame.
Hoffman-La Roche contends the drug is safe. The company worked to uphold a current ruling that keeps most of its documents from public view as the cases prepare for trial.
Michael Ryan, who represents Bishop's mother and grandmother, said under the current confidentiality order, if he were to discover crucial safety information about Accutane he would not be free to share it with the Food and Drug Administration, which regulates drug safety, without first proving to a judge the material needs to be exposed.
But Moody also gave the plaintiffs something they wanted in the hearing, ruling that the drug maker cannot redact documents it gives attorneys for a central collection center which will then be made available for all cases.
Because their are so many lawsuits against Accutane, the federal court system has invoked a special rule appointing Moody to preside over the management of the cases. The Bishop case is expected to go to trial in summer 2006.
Ed Moss, a Miami attorney representing Hoffman-La Roche, said the company is mostly interested in protecting the ''recipe'' for Accutane and the government already has access to its internal documents which relate to the drug's safety.
''We are not trying to hide documents from the public,'' he said. ''We have given everything in the world to the FDA.''
The drug, used by about 5 million Americans, has been blamed for increased rates of suicide and gastrointestinal diseases in some users and birth defects in babies born to mothers who took Accutane. But Hoffman-La Roche disputes those claims.
FDA scientists David Graham testified before Congress last year that Accutane was one of five dangerous drugs that should be restricted or removed from the market. In November, federal regulators toughened rules on Accutane, requiring doctors and pharmacists who dispense the drug to register patients on a central database.
Few Accutane cases have drawn as much international attention, though, as Charles Bishop's case which came just months after the Sept. 11 terrorist attacks in what initially appeared to be a frightening copycat act.
Bishop left a note sympathetic to Osama bin Laden, an act his family later said was so irrational for the high-achieving, patriotic boy that it only could have been sparked by Accutane.
His mother and grandmother have said in court records there were no signs of depression before Charles Bishop's suicide.
Hoffman-La Roche has denied that Accutane is a dangerous drug or increases the risk of suicide among its users and notes it is often used by teenagers and young adults, who as a population have higher suicide rates than the general population. The company recommends that users should be screened for depression. Accutane has been dispensed in the United States since 1982.
''Accutane is the last resort for youngsters facing a lifetime of disgrace,'' Moss said.

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