Clinicians, medical researchers, statisticians, and ethicists are urging the U.S. Food and Drug Administration (FDA) to expand the use of hydroxychloroquine (HCQ) in early outpatient treatment settings.
A consortium of physicians led by Peter McCullough, M.D. and Kevin Wheelan, M.D, at Baylor University Medical Center are circulating a petition stating the current protocol for the drug’s use is a “failure.” Treatment protocals based on FDA guidance require COVID-infected patients to wait at home until they experience shortness of breath and are admitted into a hospital.
“It is unrealistic to believe that a continuation of this doctrine will have any practical effect in halting the epidemiological spread and significantly reducing the mortality rate of COVID-19,” the petition states.
The signees are asking FDA to grant emergency use authorization for HCQ that would include allow physicians to prescribe the drug based on their clinical judgement; a continuation of studies that would include measuring the effect of HCQ before infection or symptoms appear, the establishment of a prophylactic HCQ program for health care workers, first responders and other high risk groups and permission to health care professionals to administer the drug during case-contact tracing.
“What we need is for the FDA to announce that the drug is safe and recommended for specific COVID situations,” says Meryl Nass, M.D., a board member of the Alliance for Human Research Protection. Nass says such an acknowledgement by the FDA would eliminate liability problems physicians would still face even under a new EUA.
—Staff reports
Internet info:
Support for the Request for Emergency Use Authorization of Hydroxychloroquine for Ambulatory, Prophylaxis and Treatment of COVID-19: https://hcqpetition.com