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0 pointshwillis3y ago0 comments

In 1938, the FDA started reviewing and approving drugs.

In 1960, Richardson-Merrell applied for approval for a drug called Thalidomide, a cancer treatment. They had clinical trials that included pregnant women. They were rejected six times.

In the UK, The Distillers Company (Biochemicals) Ltd, a subsidiary of Distillers Co. Ltd marketed thalidomide as Distaval, a remedy for morning sickness. Their advertisement claimed that "Distaval can be given with complete safety to pregnant women and nursing mothers without adverse effect on mother or child ... Outstandingly safe Distaval has been prescribed for nearly three years in this country."

By 1962, over 10,000 children (most in west germany) were born with crippling disabilities caused by thalidomide. Over 2,000 died.

Frances Oldham Kelsey was awarded the medal for Distinguished Federal Civilian Service by President John F. Kennedy for rejecting the drug.

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missedthecue3y ago

I remember reading an archived copy of the FDA press release after they finally approved beta-blockers, a medicine that had been approved and widely distributed in Europe for some ten years. In the press release, the FDA was proud to announce that as a result of their approval, beta blockers would save the lives of an estimated 10,000 Americans every year.

That is to say, the inefficiency of the FDA was, in the words of the FDA itself, directly responsible for the premature deaths of 100,000 Americans. And that was for beta-blockers alone.

I laughed when watching an FDA press conference during covid, where the spokesman said that the agency was streamlining approval measures to get covid vaccines approved faster. A journalist asked if this would negatively impact the safety or efficacy of the vaccine to which the FDA head confidently replied that it would have zero material impact. It makes you wonder, if they are capable of quickly making approval decisions without sacrificing safety or efficacy standards, why is that not standard operating procedure? There are no answers that don't lead one to conclude that the FDA is a bloated, bureaucratic, wasteful mess.

hwillisOP3y ago

> A journalist asked if this would negatively impact the safety or efficacy of the vaccine to which the FDA head confidently replied that it would have zero material impact. It makes you wonder, if they are capable of quickly making approval decisions without sacrificing safety or efficacy standards, why is that not standard operating procedure?

That's easy. The normal process has multiple trials:

Phase 1: 50 people Phase 1: 200 people Phase 3: 100,000 people

Normally, you pass each phase before exposing a larger number of people to risk. More people means you can find rarer and smaller effects, but if you haven't tested on <50 people first then you might really endanger the group of 200 or 100k.

The expedited process tests it on 100,250 people at once. THOSE people are exposed to more risk, but the safety of the vaccine is the same. And because the vaccine was proven safe, those people were not negatively impacted any more than if they had followed the normal process.

> There are no answers that don't lead one to conclude that the FDA is a bloated, bureaucratic, wasteful mess.

No, you're just not actually looking.

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