Biologics

Makary Blames NIH for Covid Virus

During a 7/30 NewsNation interview, FDA commissioner Martin Makary promoted a popular right-wing conspiracy theory by saying that under its former leadership, the National Institutes of Health (NIH) funded the lab that created the Covid-19 virus. The Hill reports that Makary made the comment in response to a question about the longevity of the Trump administration’s changes to federal health agencies. “We are planning to change our health agencies for a generation or longer,” Makary responded.

He said that when the new NIH director Jay Bhattacharya arrived, the agency “was a mess. Fourteen percent of the grants were descriptive studies on health equity, and the NIH had just funded a lab that brewed up a virus that killed 20 million people worldwide.”

The Hill notes the Trump administration has favored the Chinese lab leak theory and has replaced the government Covid Web site that had provided resources and information on the virus with a page promoting the conspiracy theory.

“The theory is that the coronavirus accidentally escaped from a lab in Wuhan, China, which was funded by the NIH,” The Hill says. “Most scientists believe the virus occurred naturally in animals and then spilled over to humans.”

The story says HHS did not respond to a request for comment on Makary’s assertion.

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