Black Tortoise Press Things

Open letter to Anderson Cooper and Sanjay Gupta

I’m big fans of yours. I hear you are concerned that 50% of Americans are reluctant to get a COVID-19 vaccine.

I am one of them.

I do not latch on to conspiracy theories. I am not an antivaxer.

I am a vaccine proponent. I grew up with children who were crippled with polio. I know how measles, mumps, and rubella can cause serious problems such as birth defects, neurological damage, and even death.

I get a flu vaccine every fall. I encourage others to do the same.

I have spent over 30 years in leadership roles as a Quality and Regulatory Affairs professional in FDA regulated industries, some of which include vaccine manufacturing.

. I trusted that over 100 years of FDA gave us career-lifers that weathered both Democratic and Republican political leaders. Scientist who held back approval of drugs like thalidomide, in spite of pressure to approve. The diligence of FDA reviewers saved American babies from crippling birth defects in exchange for morning sickness during their mothers pregnancies.

I trusted the methodical, systematic, science-based and rigorous approach to FDA’s approval process. I trusted guidance from FDA.

Not anymore.

To be fair, my trust in FDA eroded before COVID-19. In 2017, with President Trump encouragement, FDA announced an initiative to improve the approval rate if drugs. The “improvement” involved shortening or eliminating Phase III trials.

In recent years, there has been growing interest in exploring alternatives to requiring phase 3 testing before product approval, such as relying on different types of data and unvalidated surrogate endpoints….

…phase 2 results can inaccurately predict safety and/or effectiveness for medical products in a wide range of diseases and patient populations. These cases also help illustrate the potential public health implications of undue reliance on phase 2 studies and the benefits of conducting Phase III studies. As a result of the Phase III studies discussed in this paper, patients outside of clinical trials were not subjected to drugs that would not benefit them or to the risk of unnecessary serious toxicities, and did not suffer unnecessary financial expenditures.

FDA.gov (22 Case studies Where Phase 2 and Phase 3 Studies had Divergent Results.)

Please follow the link and read the entire report. It involves a wide range of FDA regulated products. When Phase III studies reveal results different from those predicted in Phases II, it save lives, it prevents unnecessary surgeries, it improves doctors’ ability to prescribe the most effective course of action.

And now we have a COVID-19 Pandemic

We didn’t have a treatment. We didn’t have a vaccine. We didn’t have reliable diagnostics. We had an emergency. And emergencies require quick action. So…

FDA released Hydroxychloroquine, PPE, ventilators, sanitizers, diagnostics, etc. by Emergency Use Authorization (EUA.) (For a complete list of COVID-19 related products FDA qualified for EUA release go here.)

In some cases, FDA used the EUA without reviewing any data. Just to be clear, an EUA release means, “it is reasonable to believe the product is effective.”

We still don’t have a single diagnostic or treatment that is approved. (Proven through scientific data to be safe and effective.) Instead we have:

  • Sanitizers that can poison us with methanol;
  • Diagnostic tests with somewhere between 25 and 66% false negative (as reported by Northwestern Medical COVID-19 hotline;)
  • Antibody tests that have a false positivity rate between 30 and 50%;
  • Treatments that no longer qualify for EUA. (like Hydroxychloroquine.)

Vaccine manufacturers plan to compress and accelerate the studies and FDA is prepared to release a vaccine using EUA authority. In the meantime, manufacturers plan to scale up production “at-risk.”

Preliminary studies show promise. Still, those preliminary studies involve a small number of people with some significant side-effects. Some of the studies lack peer review. Some studies involve vaccine technology yet unproven.

Dr. Fauci ensured us that the studies will be rigorous. I believe him. Still, those Phase III, the large-scale, randomized, double-blind studies, are often where many of the adverse effects are discovered.

I know you are reassuring us that the studies will be rigorous. That the manufacturing will be well controlled. That we should all feel confident in FDA.

These case studies demonstrate that large phase 3 [random/controlled studies] can generate critical evidence across all types of products, patients, and diseases. Both safety and efficacy failures occurred even when the phase 2 studies were relatively large (e.g., recombinant VIIa), and even when the product was already approved for another condition (e.g., aliskiren). In some cases, the phase 3 study revealed that short-term results found in the phase 2 study were not associated with a long-term benefit (e.g., bitopertin) or that the product had toxicity that was not uncovered in the phase 2 study (e.g., semagacestat).

FDA.gov (22 Case studies Where Phase 2 and Phase 3 Studies had Divergent Results.)

But no. My confidence is shaken.

I’m not interested in getting a vaccine for COVID-19. Not now.

Although low-tech, I’m confident that I will not suffer adverse medical events from the three Ws:

  • Wear a mask
  • Watch my distance
  • Wash my hands

I’ll wait and see what for the post-market reporting tell me. Maybe I’ll change my mind when the data gets published. In the meantime, someone else can be the guinea pig.