On November 5th of this year, Pfizer (via an independent board) decided to end the trials for its antiviral pill Paxlovid prematurely out of ethical concerns. Paxlovid was expressly designed to combat an active COVID-19 infection and showed a reduction in hospitalization & death of 89%.
The aforementioned ethical concerns were triggered because the drug was so amazingly effective and should move forward with approval for public use ASAP.
This post lays out the ridiculous paradox we find ourselves in right now. Here’s an extended quote, but I encourage you to read the
whole piece.
“The trial was stopped due to ‘ethical considerations’ for being too effective. You see, we live in a world in which:
- It is illegal to give this drug to any patients, because it hasn’t been proven safe and effective.
- It is illegal to continue a trial to study the drug, because it has been proven so safe and effective that it isn’t ethical to not give the drug to half the patients.
- Who, if they weren’t in the study, couldn’t get the drug at all, because it is illegal due to not being proven safe and effective yet.
- So now no one gets added to the trial so those who would have been definitely don’t get Paxlovid, and are several times more likely to die.
- But our treatment of them is now ‘ethical.’
- For the rest of time we will now hear about how it was only seven deaths and we can’t be sure Paxlovid works or how well it works, and I expect to spend hours arguing over exactly how much it works.
- For the rest of time people will argue the study wasn’t big enough so we don’t know the Paxlovid is safe.
- Those arguments will then be used both by people arguing to not take Paxlovid, and people who want to require other interventions because of these concerns.
- FDA Delenda Est.”
We are now >1 month since this trial was cut short. A new variant is causing significant worldwide concern, and a considerable winter wave of cases is beginning. Do you know what might be nice to have right now? THE SUPER-EFFECTIVE PILL SITTING ON SHELVES.
What’s maybe even more frustrating to me: this is just okay with us. There is open disdain for individuals who choose not to be vaccinated, but this is orders of magnitude more impactful, yet we…just don’t care.
What if you or someone you loved contracted COVID and died in the next few weeks, despite an effective treatment sitting on shelves waiting for bureaucrats to approve it?
Our institutions are still failing us.
I propose the Law of Efficacy, which states that the requirement to halt a trial due to a drug being ‘too effective’ is that the drug has been approved for public use by the regulatory authorities.
If it’s so damn obvious that the drug is safe and effective that we don’t need more data, then the authorities can make that determination. Until then, no halting trials.
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