It’s “a zombie at this point. Completely irrelevant, except in a negative sense.” How a Trump admin $21M gambit to see if Pepcid worked as a COVID remedy fizzled. rplardner and JHDearen’s AP story
This June 15, 2020 photo shows a bottle and tablets of Pepcid antacid in Washington. The U.S. government's Pepcid project has revealed what critics describe as the Trump administration’s disregard for science and anti-corruption rules meant to guard against taxpayer dollars going to political cronies or funding projects that aren’t rigorously designed.
That contract is now under scrutiny after a government whistleblower accused a senior administration official of rushing the deal through without the scientific oversight necessary for such a large federal award. And the doctors who initially promoted the Pepcid idea are locked in a battle for credit and sniping over allegations of scientific misconduct.
“And I’ve been very critical of this approach to the COVID-19 epidemic, which I’ve likened to throwing spaghetti at the wall and seeing what sticks. I consider trials like this one to be largely a waste of time and money when they’re very unlikely to show positive results.”The story of how an over-the-counter heartburn remedy garnered top-level government interest as a COVID-19 medicine began several months ago in eastern China. Or maybe it was in rural Virginia -- even that point is in dispute.
When the virus hit in late 2019, Callahan was already in Wuhan working with Chinese infectious disease researchers. Callahan said he and the Chinese doctors analyzed the medical records of more than 6,000 hospitalized patients, 1,100 of whom had severe COVID-19 disease, according to information released by researchers conducting the clinical trial.
Science and political impatience clashed quickly, documents show. A week after Trump’s emergency declaration, Kadlec received a blunt warning from the White House. Federal pandemic response scientists at the Biomedical Advanced Research and Development Authority, or BARDA, were shut out of these early conversations about famotidine. Rick Bright, BARDA’s director at the time, would later file a whistleblower complaint alleging unethical conduct by agency leadership, and point to the Pepcid trial as a key example.
Their concerns were ignored, according to Bright’s complaint and government records. Kadlec oversees Bright’s agency, and wanted the Pepcid contract approved. Fast.The fast-moving Pepcid proposal, however, snared the interest of the HHS’s senior leadership, including Secretary Alex Azar, according to the internal emails.
“We don’t have enough small studies to show that this is a drug worth pursuing,” said Dr. George Abraham, chair of the American Board of Internal Medicine’s infectious disease group. “It is my understanding that ADM Giroir and Secretary Azar have been briefed and express interest in supporting a randomized clinical trial to determine the safety and potential efficacy for the use of famotidine in COVID-19,” Tracey wrote in the email to Kadlec.
Northwell spokesman Libassi disputed that Malone took control of preparing the contract proposal and said he became “difficult to work with” as the plans for trial progressed. Northwell’s Libassi declined to comment on the allegations of misconduct in Bright’s whistleblower complaint. “With respect to the famotidine trial, we are confident it is based on sound science and we look forward to completing it,” he said.
Still, Kadlec said through a spokeswoman he would choose to fund the trial again. “If it could save lives, yes.”About two weeks after the Pepcid contract was awarded, Science Magazine published an article describing the deal. In the piece, Callahan was credited as the “first to call attention to the drug in the United States.
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