Drugs

‘Threadbare Evidence’ OK’d for Malaria Drug EUAs: Report

An FDA internal review obtained by BuzzFeed News through a Freedom of Information Act request says the agency issued emergency use authorizations for two anti-malaria drugs (hydroxychloroquine and chloroquine) touted by President Donald Trump to treat Covid-19 “based on threadbare evidence.” An online post says the review “also raised serious questions about shoddy practices at overseas factories that manufactured and donated the drugs for use in American hospitals.”

BuzzFeed says that the FDA review, conducted by six officials, “referred to only two studies of the malaria drug, which either showed negligible results or have since been called into question altogether.”

According to the review documents, the article says, officials briefly warned about the risks of giving the drugs to patients with heart problems as part of a longer section detailing Warnings and Precautions.

The review also found that the one million chloroquine tablets donated by Bayer were made at never-inspected factories in India with “a low reputation for quality.” The pills were made by a manufacturer in India whose other factories had failed previous FDA inspections, the reviewers said, adding that meant that “facilities used to manufacture this chloroquine are presumed to have even lower standards of quality.”

The reviewers concluded that “based on the scientific evidence available to FDA, it is reasonable to believe that these products may be effective in treating the serious or life-threatening disease Covid-19,” BuzzFeed reports.

The news organization adds that since the review was submitted, growing evidence has suggested that the drugs may do more harm than good.

Center for Science in the Public Interest CEO Peter Lurie says the review gives “some hints of what they were depending on. It still seems to be to be a thin reed and one is left with a question of whether the approval had something to do with pressure from the White House.”

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