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.
My July fund-raising campaign for 2021 has now ended. Thank you all for your donations and subscriptions. While this year’s campaign was not as spectacular as last year’s, it was the second best July campaign since I began this website.
And if you have not yet donated or subscribed, and you think what I write here is worth your support, you can still do so. I depend on this support to remain independent and free to write what I believe, without any pressure from others. Nor do I accept advertisements, or use oppressive social media companies like Google, Twitter, and Facebook. I depend wholly on the direct support of my readers.
If you choose to help, you can contribute via Patreon or PayPal. To use Patreon, go to my website there and pick one of five monthly subscription amounts, or by making a one-time donation. For PayPal click one of the following buttons:
If Patreon or Paypal don'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