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The US Department of Health and Human Services presented a long list of concerns in a June 8 letter, concluding that there was “a high probability” that the companies carrying out the research would fail to honor the terms of the l agreement to evaluate famotidine, the active ingredient in Pepcid, as a treatment for coronavirus.Alchem ​​Laboratories and its subcontractor, Northwell Health in New York, have been ridiculed by some government scientists who did not believe the Pepcid study deserved millions of dollars in federal research. Federal whistleblower Dr Rick Bright cited the contract as a key example of what he called unethical conduct by the management of an agency in deciding how to spend taxpayer dollars to fight the coronavirus.

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

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

The letter from HHS also said the researchers did not implement a system to track patient damage, did not have an independent data monitor to ensure the integrity of the trial results, and did not failed to provide the government scientists overseeing the contract with the appropriate documentation from the Food and Drug Administration.


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