Prasad Being Forced Out of FDA is a Sad Day for Evidence-Based Medicine
I am sure we will have more to say about the forced resignation of Vinay Prasad over at Sensible Medicine. Adam and I will welcome our friend back.
Here are some initial thoughts.
Mainly I am sad.
Sad for Vinay because he told me how much he had learned in his short time. He was happy doing a job that had incredible meaning. You could see how much this new role meant to him in the FDA videos he did with Marty. It was a different Vinay.
I am also sad for FDA, because I had thought that this new leadership could make a difference. Marty and Vinay together had a chance to bring increased rigor and greater independence to drug and device regulation. WIth RFK Jr’s opinion on removing industry influence, I had thought that the new FDA would be less apt to approve dubious drugs and devices.
Yet Vinay’s rapid ouster turned this optimism into magical thinking.
His first tough stance—regarding Sarepta’s drug for Duchenne Muscular Dystrophy— brought anger from right wing influencers Laura Loomer and former senator RIck Santorum.
The question I have, and surely you do too, is why would political operatives care about a specific drug for a rare disease.
Surely everyone (no matter the political affiliation) would want an FDA that reacts cautiously to any drug that could cause death.
NYT reports that Rick Santorum “has ties to Sarepta.” Here is the paragraph from the article:
Dr. Prasad’s critics argued that his actions with Elevidys amounted to a crusade against Sarepta. Mr. Santorum, who has ties to Sarepta, also reposted an editorial lambasting Dr. Prasad on social media and called top officials at the White House to relay his concerns, according to a person familiar with the matter.
We don’t know what these ties were but it’s hardly a conspiracy theory to believe that industry may have influenced these attacks.
And if that were true, if industry could so easily extract an independent judge of evidence, then the only thing to feel is intense cynicism and hopelessness.
Gosh this is bad. I am not against medical industry. We have had great advances in this generation.
But society also needs independent judges to prevent profiteering of susceptible people with serious illness. That we had one, and he was removed this easily is simply awful. Trust is shredded.
I sense Vinay (who has ALWAYS called it "like it is" — albeit ALWAYS with evidence to back up his opinion, whether you always agree with him or not) — I sense Vinay was just "too much" for current appointees of current administration. But there are just too-many-to-count OTHER examples in detrimental, thoughtless, harmful (not to mention often cruel) changes that have been made (and/or are "in process" of being made) for us to be surprised by this. Very, very SAD. As per John Mandrola's last sentence — "that we had an independent judge to prevent profiteering ... and he was removed this eaily is SIMPLY AWFUL." My "trust" was SHREDDED long ago ... THANK YOU John, Adam & Vinay for STOP & THINK — and for ALL that you do to bring truth to the forefront.
As sad as this is, and as bad as it may feel in the moment, I do believe this is for the best. Dr. Prasad is incredibly intelligent and passionate, both of which are wasted in the FDA. Real change is affected from the bottom up, not from positions of power such as the FDA. Now, Dr. Prasad is free to return to the work which can actually affect long term change: educating others through his relentless pursuit of truth.
Welcome back, Dr. Prasad!