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Footnotes & Sources - Prescription Drug Ads - ProCon.org

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Prescription Drug Ads Footnotes & Sources

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Legal Claims in Accutane Lawsuits

According to court documents, plaintiffs in Accutane lawsuits claim: "The pharmaceutical drug Accutane (also known as Roaccutane and generically as isotretinoin) is defective, dangerous to human health, unfit and unsuitable to be marketed and sold in commerce, and lacked proper warnings as to the dangers associated with its use."

The majority of plaintiffs in Accutane litigation claimed Accutane caused inflammatory bowel disease (IBD) - a condition that involves chronic inflammation of the gastrointestinal tract. IBD typically manifests in one of two diseases: ulcerative colitis or Crohn's disease. IBD is a permanent condition.

Hoffman-LaRoche had knowledge of a link between gastrointestinal symptoms and Accutane, according to lawsuits. Before the FDA approved Accutane in 1982, it raised concerns about these issues. Despite this, Roche did not include any warnings about the risk of IBD.

Suicide and Depression Claims

Other plaintiffs allege that Accutane can cause psychosis, depression and suicide. These lawsuits allege that Roche manufactured an unsafe product.

In 2002, Julia Bishop filed suit against Roche after her 15-year-old son Charles Bishop crashed a Cessna into the 28 th floor of the Bank of America Building in Tampa, Florida. Bishop claimed Accutane caused her son to commit suicide and demanded $70 million from Roche, USA Today reported.

"Our suit alleges that Hoffman-La Roche has known that this drug causes spontaneous suicide and depression but they have refused to accept responsibility," Bishop's attorney Michael Ryan told USA Today.

Also in 2002, Carla Gray of Ada, Oklahoma, took her Accutane depression case to trial. She asked for $3 million because Riche failed to warn about depression. A jury denied her claim.

In 2007, Bishop dropped her case against Roche. Her attorney said she was physically and emotionally unable to continue in the difficult litigation.

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Accutane Litigation - Status, Legal Claims & Verdicts

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According to court documents, plaintiffs in Accutane lawsuits claim: "The pharmaceutical drug Accutane (also known as Roaccutane and generically as isotretinoin) is defective, dangerous to human health, unfit and unsuitable to be marketed and sold in commerce, and lacked proper warnings as to the dangers associated with its use."

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Consumer Drug Advertising Should Be Banned

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The decision to start long-term medication should be motivated by observations of patients and physicians, not stimulated by rosy ads.

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35 FDA-Approved Prescription Drugs Later Pulled from the Market - Prescription Drug Ads - ProCon.org

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35 FDA-Approved Prescription Drugs Later Pulled from the Market - Prescription Drug Ads - ProCon.org

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35 FDA-Approved Prescription Drugs Later Pulled from the Market - Prescription Drug Ads - ProCon.org

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FDA approved prescription drugs such as Quaalude and Vioxx that have been pulled off the market over safety concerns

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Are Prescription Drug Ads Good for Consumers? - The New York Times

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Are Prescription Drug Ads Good for Consumers? - The New York Times

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DAN JAFFE

Exec. V.P., Government Relations

Association of National Advertisers

Washington
To the Editor:
As observers of prescription drug use for more than 30 years, we appreciate the strong stand against direct-to-consumer advertising of prescription drugs made recently by the American Medical Association. We agree and say "turn the volume off!"

The advice of David Vladeck, a former director of the Bureau of Consumer Protection at the Federal Trade Commission, for a two-year moratorium on direct-to-consumer advertising of new prescription products could no doubt be helpful but doesn't go far enough.

Experience with prescription drug safety leads us to prefer the advice of Dr. Sidney M. Wolfe, the founding director of Public Citizen's Health Research Group: We should wait at least seven years from the date of release to take any new drug unless it is one of those rare "breakthrough" drugs that offer a documented therapeutic advantage over older, proven drugs.

We favor a flat-out prohibition on direct-to-consumer prescription drug advertising, which would return us to the 1985-87 Food and Drug Administration moratorium that restricted such advertising. It would also put us in sync with the rest of the Western world's drug policies and reduce unnecessary demand for prescription drugs.

JULIE M. ZITO

DANIEL J. SAFER

Baltimore
Dr. Zito is a professor of pharmacy and psychiatry at the University of Maryland, Baltimore. Dr. Safer is a professor of psychiatry and pediatrics, Johns Hopkins Medical Institutions.

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Opinion | Are Prescription Drug Ads Good for Consumers?

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DAN JAFFE Exec. V.P., Government Relations Association of National Advertisers Washington To the Editor: As observers of prescription drug use for more than 30 years, we appreciate the strong stand against direct-to-consumer advertising of prescription drugs made recently by the American Medical Association. We agree and say "turn the volume off!"