Drugs

Trump Holds Meeting on Another Unproven Covid-19 Therapy

President Trump reportedly has turned some attention to an extract from the oleander plant as an unproven cure for Covid-19, and he may be quietly urging FDA to help get the product on the market as a dietary supplement or a new drug, according to a report from Axios. “Senior administration officials familiar with the internal conversations around oleandrin have raised concerns about the way this botanical extract — pushed by Andrew Whitney of Phoenix Biotechnology — is being promoted at the highest levels of the Trump administration,” the report says.

Last month, Whitney got an Oval Office meeting with Trump at the urging of Housing and Urban Development secretary Ben Carson and MyPillow founder and CEO Mike Lindell, who told Axios that the president said FDA “should be approving it.” Lindell is such a believer in the botanical that he now has a financial stake in Phoenix Biotechnology. He said he has been taking the unapproved botanical and has shared it with his family and friends. He said he believes it has kept him from getting Covid-19. Whitney told Axios that oleandrin has been tested on humans for its efficacy against Covid-19 but said the study has not been published yet. He also said the lab study is in the process of being peer reviewed.

At Trump’s urging in March, FDA commissioner Stephen Hahn authorized hydroxychloroquine’s emergency use to treat Covid-19. But in June, that authorization was revoked due to data showing no benefits and risks to heart rhythm (see FDA Warning). So far, Hahn appears to be dismissing Whitney’s efforts, Axios says. “In a sign that has reassured some administration officials worried about the oleandrin campaign, Whitney has privately complained that the FDA has been dragging its feet,” it reports. Whitney described Hahn as “immensely professional” but added: “The process is too slow. ... We ought to be given an opportunity to test this. Call my bluff!”

Asked 8/17 whether he has pressed FDA to approve the product’s use, Trump said he hadn’t. “Is it something that people are talking about very strongly?” he asked reporters. “We’ll look at it... We’re looking at a lot of different things... I’ve heard that name mentioned. We’ll find out.”

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