WASHINGTON: As the coronavirus began its deadly march through the world, two well-respected American doctors identified a possible, but seemingly unlikely remedy: Pepcid, the heartburn medication found on drugstore shelves everywhere.
There were no published data or studies to suggest that famotidine, the active ingredient in Pepcid, would be effective against the novel coronavirus. In early April, when government scientists learned of a proposal to spend millions in federal research funding to study Pepcid, they found it laughable, according to interviews, a whistleblower complaint and internal government records obtained by The Associated Press.
But that didn’t stop the Trump administration from granting a $21 million emergency contract to researchers trying it out on ailing patients. The Food and Drug Administration gave the clinical trial speedy approval even as a top agency official worried that the proposed daily injections of high doses of famotidine for already sick patients pushed safety “to the limits,” internal government emails show.
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.
Meantime, the trial itself is on pause due to a shortage of hospitalised Covid-19 patients in New York, delaying it indefinitely. A vaccine or effective treatment could be available before the study is complete.
The Pepcid project has underscored what critics describe as the Trump administration’s casual disregard for science and anti-corruption rules that are meant to guard against taxpayer dollars going to political cronies or to fund projects that aren’t rigorously designed.
“The evidence used to support the trial is extremely weak,” said Dr Steven Nissen, a Cleveland Clinic cardiologist who has been a frequent adviser to the FDA. “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.”