The FDA is supposed to protect Americans against unsafe drugs — drugs with bad side effects, for example. According to this interview with Ronald Kavanaugh, a former FDA employee who worked there 10 years, that is not what actually happens. Here are excerpts from the interview:
I think most people would be shocked at how malleable safety data is. Human studies are usually too short and the number of subjects in them too small to adequately characterize [= detect] the most dangerous risks.
Human clinical pharmacology trials are typically done in Europe, yet clinical pharmacology reviewers at FDA have been barred from analyzing this information prior to studies being conducted in the US.
If reviewers say things that companies don’t like, they will complain about the reviewer or they will call upper management and have the reviewer removed or overruled.
When you do raise potential safety issues, the refrain that I heard repeatedly from upper management was‚”where are the dead bodies in the street?” Which I took to mean that we only do something if the press is making an issue of it.
FDA’s response to most expected risks is to deny them and wait until there is irrefutable evidence postmarketing, and then simply add a watered down warning in the labeling.
Which is why bad side effects are sometimes discovered after FDA approval.
Thanks to Anne Weiss.
See also:
https://alison-bass.blogspot.com/2009/10/is-there-link-between-antidepressants.html
Yeah, it’s known as “regulatory capture”. It’s one of the primary criticisms of government regulatory efforts:
“Alternatively, it may be better to not create a given agency at all lest the agency become victim, in which case it may serve its regulated subjects rather than those whom the agency was designed to protect. A captured regulatory agency is often worse than no regulation, because it wields the authority of government. However, increased transparency of the agency may mitigate the effects of capture.”
https://en.wikipedia.org/wiki/Regulatory_capture
I did a post about this a while ago. One of the reasons the FDA was created was to prevent adulterants like sawdust (primarily composed of cellulose) from being added to foods. Now, the FDA actively promotes adding cellulose to foods, at the prompting of industry. The FDA’s not on the consumer’s side any more. And it resists all efforts at transparency.
“Sawdust and Ice Cream“
I have long wondered at the odd but common assumption on blogs that only American trials count – it hadn’t occurred to me that it carried the force of law. It would be far more sensible for the US to combine European data with US data taken on blacks and mestizos (spelling?) – that way you’d have a better chance of getting studies with enough of those two racial groups to give them some reasonable assurance of safety.
In fact, you could argue that the present US system carries needless risk for those two groups in particular.
And come to think of it, perhaps Asian racial groups too.
And women? Except in the case of something like a birth-control pill, studies are often done only on male subjects.
Elizabeth: really? How extraordinary.
The few scientists at the FDA who have the courage and conviction to report questionable practices in their agency now have their email monitoring. The whistle-blower act, which is supposed to protect government employees against reprisal for reporting illegal and dangerous practices at any agency is ineffective. Management and supervisors manipulate the system against whistle blowers, often leading to job loss.
I suppose these federal employees ought to resort to the US Postal Service to deliver their concerns to members of congress.