Pepcid-COVID study raised red flags weeks after $21M grant

Two months after the Trump administration awarded $21 million to study whether a common heartburn drug was effective against COVID-19, government health officials raised serious concerns about patient safety and scientific integrity, according to internal documents obtained by The Associated Press.

The U.S. Department of Health and Human Services outlined a long list of concerns in a June 8 letter, concluding there was “a high probability” that the companies doing the research would fail to honor the terms of the deal to assess famotidine, the active ingredient in Pepcid, as a coronavirus treatment.

The AP reported Thursday that the contract with Florida-based Alchem Laboratories and its subcontractor, Northwell Health in New York, was the subject of ridicule by some government scientists who did not think the Pepcid study merited millions of federal research dollars. A federal whistleblower, Dr. Rick Bright, cited the contract as a key example of what he called unethical conduct by agency leadership in deciding how to spend taxpayer dollars to combat the coronavirus.

Despite the problems, the HHS office spearheading the federal response to the coronavirus crisis has not canceled the contract. Northwell, the state’s largest health care provider, told AP earlier this week that the famotidine trial has been paused indefinitely because of a shortage of new COVID-19 patients in New York.

In the four-page “cure notice,” HHS raised a litany of red flags about the Pepcid trial, which delivers a large dose of famotidine intravenously to patients in the study. Among them: a “lack of adequate documentation of good clinical practices related to ensuring patient safety.”

HHS’s letter also said the researchers failed to implement a system to track harm to patients, lacked an independent data monitor and failed to provide government scientists overseeing the contract with proper Food and Drug Administration documentation. “These are very serious concerns and are most shocking in the lack of attention to possible safety risks for what is a very high dose of famotidine, far above the FDA-approved dosing parameters for its currently-approved uses,” said Dr. Aaron Kesselheim, a Harvard Medical School professor who reviewed the the HHS letter for the AP.