Drugs

Should Pfizer Have Disclosed Enbrel Alzheimer’s Signal?

The Washington Post reports that Pfizer researchers found in 2015 that its blockbuster rheumatoid arthritis drug Enbrel (etanercept) appeared to reduce the risk of Alzheimer’s disease. However, the newspaper says, the company made a decision during three years of internal review that Enbrel did not show promise for Alzheimer’s prevention because it does not directly reach brain tissue, and thus did not conduct further research or publish or share its researchers’ findings.

“Science was the sole determining factor against moving forward,” a company spokesman told the Post.

However, some scientists contacted by the newspaper disagree with the company’s assessment that studying Enbrel’s potential in Alzheimer’s disease prevention is a scientific dead end. They said it could hold important clues to combating the disease and slowing cognitive decline in its earliest stages.

Some suggested that the fact that Enbrel was coming off patent and generic versions could become available influenced the company’s decision not to move forward.

Medical ethics experts told the Post that companies have a responsibility to publicize positive findings, although it is not as strong as an imperative to disclose negative findings.

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

Read more

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