Healthy Skepticism Library item: 784

Warning: This library includes all items relevant to health product marketing that we are aware of regardless of quality. Often we do not agree with all or part of the contents.

Publication type: news

Associated Press.
Acne Drug Memos Kept Secret Despite Suits
Associated Press 2005 Jan 28

Full text:

Lawyers suing the makers of Accutane over allegations the acne drug increases the risk of suicide cannot share the company’s internal memos and other documents with the public or federal regulators, a judge ruled Friday.

The attorneys had sought to make public as many as 1 million documents produced by Hoffman-La Roche Inc., saying the disclosure was needed as Accutane’s safety comes under increased scrutiny by the U.S. Food and Drug Administration.

U.S. District Judge James Moody rejected the request, saying attorneys could ask the court to open up records if they discover a matter of public safety as they prepare their cases. But in a victory for the plaintiffs, he said the drug maker cannot redact documents before handing them over to the attorneys.

Moody, based in Tampa, is presiding over the management of dozens of lawsuits filed nationwide over Accutane, used by about 5 million Americans.

The drug, which has been dispensed in the United States since 1982, 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.

Hoffman-La Roche contends the drug is safe, although it recommends that users be screened for depression. The company notes that teenagers and young adults, the groups most likely to use the drug, have higher suicide rates than the general population.

The documents at issue include internal company discussions about the safety of the drug and how to handle allegations of an increased suicide risk.

Hoffman-La Roche attorney Ed Moss said the company fought the release of the documents mostly out of concern for protecting Accutane’s “recipe,” and that federal officials already have internal documents relating to the drug’s safety.

“We are not trying to hide documents from the public,” Moss said. “We have given everything in the world to the FDA.”

FDA scientist 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.

Among the Accutane cases is a $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 Inc., based in Nutley, N.J., is the United States prescription drug unit of the Swiss drug maker Roche Group.