Senators Ron Johnson and Ted Cruz Demand FDA and NIAID Come Clean on Promising New Treatment for Late-Stage COVID-19
On Thursday 3 March, United States Senators Ron Johnson and Ted Cruz dispatched a letter to NIAID Director Anthony Fauci and FDA Director Robert Califf demanding to know why access to potentially life-saving treatment for COVID-19 is being withheld from seriously ill patients.
The treatment in question is ZYESAMI, an injectable form of Vasoactive Intestinal Peptide, manufactured by NRx Pharmaceuticals. According to Senators Johnson and Fauci, twenty patients suffering from Acute Respiratory Distress Syndrome from COVID-19 whose conditions did not improve after receiving Remdesivir were treated with the new drug. No serious adverse events were reported, and sixteen of the twenty patients improved sufficiently that they were able to leave the hospital. Mortality rate for patients with ARDS typically is on the order of forty percent. However, with ZYESAMI the rate dropped to ten percent.
Despite these seemingly promising results, the FDA has refused to review the data for an Emergency Use Authorization of ZYESAMI until clinical trials are completed this year.
The two senators wrote:
Two years into a pandemic with a death toll exceeding a reported 900,000 Americans, it is unacceptable that the FDA and NIAID are needlessly delaying a treatment for late-stage COVID-19 with a remarkable track record of success.
The FDA’s disparate review processes for different treatments that appears to favor large manufacturers is troubling.
The senators demanded Drs. Fauci and Califf provide a timeline of FDA and NIAID actions to review ZYESAMI as an emergency treatment for COVID-19, as well as documentation of any communications between FDA or NIAID and physicians currently using ZYESAMI as treatment under Right to Try rules. They also demanded to know why the FDA refuses to review ZYESAMI data until clinical trials are completed, and asked for the FDA’s and NIAID’s current treatment recommendations for COVID-19 patients who have proved refractory to steroids and Remdesivir.