The threat to the integrity of the drug approval process

IN SUMMARY: Under no circumstances can or should the US drug approval process come under questioning by the press or patients. This administration has shelved science and replaced it with politics and pseudoscience which endangers us all.

According to the Times “Americans and American biomedical researchers have often prided themselves on conducting the best clinical research in the world. Yet with over six million Covid-19 cases and almost 183,00 deaths, the United States has produced little pathbreaking clinical research on treatments to reduce cases, hospitalizations, and deaths. Even one of the most important U.S. studies to date, which showed that the antiviral drug remdesivir could reduce the time Covid-19 patients spent in the hospital to 11 days from about 15, had too few patients to demonstrate a statistically significant reduction in mortality”.

Yet the clinical research is being questioned. STAT News said “seventy-eight percent of Americans worry the Covid-19 vaccine approval process is being driven more by politics than science, according to a new survey from STAT and the Harris Poll, a reflection of concern that the Trump administration may give the green light to a vaccine prematurely.

With trust in government so low we can’t afford, as a nation, to allow the FDA to become a political pawn. When people start to doubt the effeciveness of new drugs we all, as a nation, suffer.

It’s gotten so bad that Medscape posted an open letter to the FDA commissioner saying “Dear Commissioner Hahn: Tell the Truth or Resign”.

Here is some of what that letter said…

You posted this data-dredging subgroup analysis on the FDA website with the headline statement “Another Achievement in Administration’s Fight Against Pandemic.”

That is a grossly insufficient correction and does not represent the truth. Here’s what you didn’t say:

  1. There are no data or evidence from prospective, randomized trials for convalescent plasma to support any survival benefit.
  2. The data I am citing are from a subgroup analysis from a preprint, which is intended to formulate a hypothesis without any definitive findings or conclusions.
  3. The 35% survival benefit, and 35 people’s lives saved per 100 sick with COVID-19, was completely off-base. If the preprint data held up in a proper randomized controlled trial, it would be avoiding deaths of 3 or 4 people per 100 who would have died. We know that fewer than 1 out of 100 people who have a COVID-19 infection die, so it is impossible to save 35 people’s lives of 100 people sick with COVID-19. I made a terrible, monstrous error and I deeply apologize for that.
  4. It is frankly unlikely for there to be a major survival benefit of convalescent plasma, as it contains a broad admixture of patient antibodies, most of which are not neutralizing — that is having no effect against the virus. We need randomized trials to determine if there is any benefit and, if so, what is the magnitude of benefit. Such trials are ongoing and need robust support and participation.
  5. There are still potential safety issues of convalescent plasma that are unresolved, such as transmission of a virus or immune reaction.

This is unnerving to say the least.

Taken all together we can clearly read that the FDA has decided to bow to politics rather than do its job. It’s compounded by the fact that the current administration is the most corrupt and unqualified government in our lifetime.

Where is pharma? Their silence is deafening. Perhaps they are afraid of retribution if they speak up but for God’s sake grow some balls! Stop worrying about sales and start worrying about the very integrity of our drug approval process.