Researchers: FDA Slow To Approve Study Of Heart Attack Drug To Treat Coronavirus Patients
BOSTON (CBS) - We first told you about the drug tPA (tissue plasminogen activator) last week. Doctors at Beth Israel Deaconess Medical Center are using tPA off-label on critically ill COVID-19 patients and getting good results. Dr. Christopher Barrett said he is optimistic, but without a clinical trial, he can't be sure it works.
Researchers say the FDA has been slow to approve a study that would allow doctors to use tPA on other coronavirus patients.
In March, President Trump said the FDA would fast track potential drug treatments for COVID-19 and approve drug trials in just days.
But Dr. Earnest "Gene" Moore, who is working on the study with Barrett and others, said he is frustrated that the fast track has not been two days. He told WBZ the FDA, like other agencies, is not prepared to handle the surge of applications.
Doctors said they are also frustrated because tPA could potentially save lives now. The drug works by breaking up blood clots which physicians are seeing in the lungs of very sick COVID-19 patients. The promising treatment, doctors said, could help patients recover quicker and may even prevent the need for a ventilator - but without a study, researchers can't prove it.
Barrett said researchers are hopeful that's it is tPA that is helping them recover, but they need an FDA-approved study to move forward, and that is taking longer than they expected. Just this week, the FDA told Barrett and Moore in an email that it would get back to them with questions and comments the week of April 27.
The FDA said in a statement:
By law, the FDA generally cannot confirm, deny or comment on any potential interactions regarding any clinical trial for any drug. Quickly after the emergence of this virus, the agency began working directly with federal health partners, academia and industry to advance medical countermeasures against COVID-19. FDA staff continues to work across all sectors to expedite the development of numerous, innovative potential prevention and treatment approaches.
Michael
Michael Felberbaum
Senior Advisor
Office of Media Affairs
Office of External Affairs
U.S. Food and Drug Administration
Barrett is working with several others on the clinical trials, including Dr. Hunter Moore and Dr. Ernest Moore, of the University of Colorado, and Dr. Michael Yaffe of MIT and a surgeon at Beth Israel.
