Drugs

Courts Let Companies Keep Drug Risks Secret: Reuters

A Reuters investigative report, based on confidential federal court documents that were exposed due to filing errors, says New York federal judge Brian Cogan, who is hearing multi-district litigation against Merck’s Propecia, allowed the company to keep medical secrets contained in documents marked confidential by the company out of public view. The lengthy news service report says that “such court-sanctioned secrecy has become the lethal norm in product liability litigation in the U.S…. As a result, hundreds of thousands of Americans have been killed or seriously injured by allegedly defective products — cars, drugs, guns, medical devices — while evidence that could have alerted consumers and regulators to potential danger remained under seal.”

The documents are part of court filings alleging that the company exaggerated Propecia’s safety record and that it knew about 20 years ago that sales of the hair-loss drug would suffer if the public became aware of its possible long-term effects on men’s sexual health and depression.

Merck has officially denied the allegations and in a statement to Reuters said it “stands behind the safety and efficacy of Propecia,” noting that it has been prescribed safely to millions of men since the late 1990s.

According to Reuters, judges generally are supposed to weigh a litigant’s request for secrecy against the broader public interest in being able to see the evidence, and they must explain on the record any decision in favor of secrecy. But, it says, they rarely do what they are supposed to do because secrecy is convenient for judges concerned about efficiency, corporate lawyers seeking to protect their clients’ reputations, and plaintiffs’ lawyers seeking speedy resolution for their clients.

Gupta Raises Concerns About Overton’s Independence, Ideology

FDA commissioner nominee Heidi Overton’s responses on vaccines, contraception and abortion medication during her 9/24 Senate confirmation hearing raise concerns that ideology could influence her decision-making if she takes over the agency, MSNBC senior medical analyst Dr. Vin Gupta said Friday. Gupta was particularly critical of Overton’

Overton Confirmation Remains Uncertain After Senate Hearing

FDA commissioner nominee Heidi Overton emerged from her Senate confirmation hearing Thursday (see earlier story) without resolving questions about whether she has enough Republican support to advance — and with a rapidly narrowing window for confirmation before the midterm elections. The Senate Health, Education, Labor and Pensions Committee hearing provided few

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA has classified Boston Scientific's recall of its Imager II Angiographic Catheters as Class I because a manufacturing problem could cause catheter tips to degrade and detach, potentially resulting in life-threatening complications. The agency announced the Class I classification 9/25, updating an Early Alert it issued

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome

FDA has approved Roche’s Gazyva (obinutuzumab) for reducing the risk of relapse in adults and children aged 2 and older with frequently relapsing or steroid-dependent, childhood-onset idiopathic nephrotic syndrome who are in remission. The expanded approval covers the use of the CD20-directed antibody beyond its existing

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Gupta Raises Concerns About Overton’s Independence, Ideology

Overton Confirmation Remains Uncertain After Senate Hearing

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome