Because the FDA’s irrational fear of COVID-19, it has refused to do inspections required to approve a new drug (effective against non-Hodgkin’s lymphoma). The result: The drug company’s application will expire on November 16, meaning that they will have to start all over, a process that could take years, while tens of thousands die annually unnecessarily.
Liso-cel, manufactured by Bristol-Myers Squibb, originally had its Food and Drug Administration (FDA) application accepted in February, but has yet to have one of its contracted manufacturing sites undergo FDA inspection due to the coronavirus pandemic. Not only is the drug’s approval contingent on the facility inspections from the FDA, according to multiple company executives, but its application expires on Nov. 16, meaning that if the plant is not inspected in the coming days Bristol-Myers may have to completely resubmit the drug’s application as a result.
While the first of two facility inspections occurred, the planned inspection of Bristol-Myers’ contracted Houston facility has not “due to COVID travel restrictions and health risks,” according to a Sept. 8 conference call with Citi biopharma analysts and the company’s chief medical officer.
…The drug, which in clinical trials triggered a positive response in 73% of patients and remission in 53% of patients, according to Bristol-Myers, must receive FDA approval by Nov. 16. If it fails to be approved, it must resubmit its application, further delaying its approval by months, if not years, potentially costing thousands of lives as a result.
Each year, approximately 77,000 Americans are diagnosed with non-Hodgkin’s lymphoma, and about 20,000 Americans die, according to the American Cancer Society.
I promise you, this story is one of many. A cold rational look at the unnecessary deaths caused by the thoughtless fear of COVID-19 would find without doubt that the cure was much worse than the disease. We are killing many more people from other far more serious illnesses because of our unreasonable terror at something quite comparable to the ordinary flu.
Readers! My Quick November Fund-Raiser for Behind the Black is now over
I cannot thank the numerous people who so generously donated or subscribed to Behind the Black during this fund drive. The response was remarkable, and reflected the steady growth and popularity of the work I have been doing here for the past ten-plus years.
Thank you again!
Though the find-raising campaign is officially over, and I am no longer plastering the main page with requests for help, if you like what you have read you can still contribute, by giving either a one-time contribution or a regular subscription, as outlined in the tip jar below. Your support will allow me to continue covering science and culture as I have for the past twenty years, independent and free from any outside influence.
Regular readers can support Behind The Black with a contribution via paypal:
If Paypal doesn't work for you, you can support Behind The Black directly by sending your donation by check, payable to Robert Zimmerman, to
Behind The Black
c/o Robert Zimmerman
Cortaro, AZ 85652