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Sunday, September 20, 2020

Pepcid as a virus remedy? Trump admin’s USD 21M gamble fizzled

The Pepcid project underscores what critics describe as the Trump administration's casual disregard for science and anti-corruption rules, regulations meant to guard against taxpayer dollars going to political cronies or funding projects that aren't based on more rigorous science.

By: AP | Washington | July 24, 2020 4:45:09 pm
New York eases visitor ban aimed at curbing virus in nursing homes Government whistle blower Rick Bright filed a complaint accusing a senior administration health official of rushing the deal through without the scientific oversight necessary for such a large federal award. (AP Photo/Ted Shaffrey) (Representational)

A nearly USD 21 million government-funded study to see if a popular, over-the-counter heartburn medication could be a COVID-19 remedy has fizzled amid allegations of conflicts of interest and scientific misconduct, according to interviews, a whistleblower complaint and internal government records obtained by The Associated Press.

In mid-April, the Trump administration funded a study of famotidine, the main ingredient in Pepcid, despite a lack of published data or studies to suggest heavy doses would be effective against the novel coronavirus. When government scientists learned of the hastily produced proposal to spend millions in federal funding on the research, they considered it laughable.

Now, the Pepcid project faces an uncertain future. Northwell Health, the New York health care provider hired to conduct the testing at its hospitals, put the trial on hold due to a shortage of hospitalized COVID-19 patients in that state. Northwell is partnered with Alchem Laboratories, the Florida-based pharmaceutical company that received the contract.

The Pepcid project underscores what critics describe as the Trump administration’s casual disregard for science and anti-corruption rules, regulations meant to guard against taxpayer dollars going to political cronies or funding projects that aren’t based on more rigorous science.

It was harshly criticized by a government whistleblower, Rick Bright. He filed a complaint accusing a senior administration health official of rushing the deal through without the scientific oversight necessary for such a large federal award.

The government had very little data on which to base a funding decision about Pepcid and COVID-19, critics say; there was no high-grade research on famotidine’s coronavirus-fighting potential to underpin a clinical trial involving hundreds of patients.

“The evidence used to support the trial is extremely weak”, said Dr. Steven Nissen, a Cleveland Clinic cardiologist and a frequent adviser to the Food and Drug Administration.

“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.”

Northwell Health spokesman Matthew Libassi declined to comment on Bright’s whistleblower complaint. “With respect to the famotidine trial, we are confident it is based on sound science”, he said.

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