December 7

Despite Accutane Suicide Risk, Judge Refuses to make company Memos Public

Despite Accutane Suicide Risk, Judge Refuses to make company Memos Public

Mon, 31 Jan 2005

Judge James Moody, A federal judge in Tampa, Florida, ruled against plaintiff lawyers who sought to share internal documents belonging to Hoffman-LaRoche that show the company knew about the increased suicide risk associated with the acne drug, Accutane.

The company’s own safety experts had recommended in 1997 changing the US label to reflect the evidence that Accutaine "probably caused" depression and other psychiatric illnesses in some patients." USA Today reported (December 7, 2004) that Hoffman’s head of regulatory affairs testified in court that the marketing division argued that such a warning would "impact on marketing strategy and product liability." The marketing division prevailed and no such warning was issued. (see: )

Accutane is one of five drugs that FDA’s senior safety officer, Dr. David Graham, named in his Senate testimony as a possible candidate for withdrawal from marketing.

USA Today published a chronology of Accutane findings:

For example, in 1999, Roche told the FDA that none of the 168 reports of suicidal behavior can be directly linked to Accutane.

In 2000, during an FDA dermatology committee meeting, the agency confirmed that 147 suicides were linked to patients taking Accutane.

In 2002, Janet Woodcock, director of FDA’s Center for Drug Evaluation and Research, told a congressional committee that the agency had received reports of 3,104 adverse psychiatric events involving Accutane and that the FDA knew of 173 suicide reports associated with Accutane.

Furthermore, USA Today reported that in 1988, Godfrey Oakley, director of the Division of Birth Defects and Developmental Disabilities at the Centers for Disease Control, wrote that “40 infants born alive after first trimester exposure to Accutane have died … because of the developmental errors that Accutane caused.” Oakley argued that “we simply need to remove the drug from the market.”

In 2004, The Alliance for Human Research Protection asked Keith Altman, Adverse Drug Reaction Statistics Analyst, to analyze FDA’s Medwatch database for drug-linked suicides by children under 18 years of age.

He found that between 1989 and June 2003, there were 216 reported drug-linked suicides in under 18 year olds. Of these, 72 suicides were linked to Accutane. The next highest number of suicides – 55 – involved Prozac.

Since MedWatch reflects approximately 1% of actual adverse drug events, 72 Accutane suicide reports represent 7,200 suicides. And 55 Prozac-related suicide reports represent 5,500 suicides.

The judge indicated that attorneys could ask the court to open up records if they discover a matter of public safety as they prepare their cases. One wonders what standard the judge uses to determine when a drug hazard is "a matter of public safety?"

One also wonders why the FDA had failed to require disclosure to physicians that Accutane posed an increased suicide risk?

Contact: Vera Hassner Sharav

Acne Drug Memos Kept Secret Despite Suits
January 28, 2005 8:49 PM EST

TAMPA, Fla. – 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.

Copyright 2004 Associated Press

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