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Comment by Fede_V | Hacker News Reader

The best part of the article:

"Dr. Curtis Wright, who led the agency’s medical review of the drug, declined to comment for this article. Shortly after OxyContin’s approval, he left the FDA and, within two years, was working for Purdue in new product development, according to his sworn testimony in a lawsuit a decade ago."

Says it all doesn't it?

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Yup.

Regulatory capture: https://en.wikipedia.org/wiki/Regulatory_capture

Cultural capture: https://baselinescenario.com/2016/04/22/cultural-capture-in-...

The revolving door between government and the private sector: http://dealbook.nytimes.com/2013/11/11/slowing-the-revolving...

What does it say?

It strongly implies he received favoritism in hiring after a Purdue drug was approved. It's a revolving door problem between regulators and industries they regulate.

It is the appearance of impropriety, straight out of any corporate anti-bribery ethics training. In this case, it appears they offered a cushy job to a government official in exchange for favorable regulatory treatment, leading a very lucrative business. It appears dirty but maybe can't be proven.

Another way to look at it was in working with Purdue, he was able to demonstrate his ability to define and walk around FDA approvals by understanding and guiding product language to get approval.

This is a valuable skill. Purdue probably wanted someone like that on their product development team who could influence drug design early on which would make it less costly and more efficient to get drugs approved in the future.

It's all business. Every actor wants more money and power, and are willing to play to their strengths to get there. No malice, obvious corruption, or bribery would even need to take place. Just smart motivated people trying to make a ton of money .... (without caring about the consequences).

> Another way to look at it was in working with Purdue, he was able to demonstrate his ability to define and walk around FDA approvals by understanding and guiding product language to get approval.

Isn't subverting the system like that almost as improper as doing it from the other side? Not as obviously, possibly not as strongly, but from having been in research myself, knowing the little details like that is often good enough to get things through all by itself, completely without regard for whether your research works.

I don't think so because the government created a regulatory environment that requires drug companies to find people like this that know how to get their drugs approved.

> a regulatory environment that requires

the regulatory environment only "requires" this if your drug doesn't work as advertised. The other way to get your drug approved is to, you know, not make phony claims about its efficacy.

If you don't know how and when and where and exactly what format to file your documents, you don't get approval. Simply working isn't sufficient. It's a complex process and having well connected experts is of extreme value.

Happens ALLLLLLLL the time, though. Improper or not, look around at corporate America and you'll find a lot of people who were regulating a company as a government agent, then soon there after, work for the firm they were regulating.

Of course it does. If you've got two organizations competing for the experts, you'll get a lot of back and forth.

I don't disagree that it creates the appearance of impropriety, but I'm not quite sure how'd you'd avoid it. Force people at the beginning of their career to chose one or another?

another way of looking at it is, working at the FDA means he is capable and qualified individual. Why would a pharmaceutical company not hire him? Let's not put 100% confidence level into guilt by insinuation. Did he do something specifically improper?

FDA approval shouldn't be determined by your ability to write product language effectively, but by your ability to do valuable research and to produce a useful product.

If the FDA is approving drugs based on their advertising budget or methodology, then they're worthless.

Just like your salary compensation should be determined by the value you bring to your company, instead of how well you negotiate and get people to identify you as "one of us".

Just like presidents should be decided by issues instead of how good looking they are. http://paulgraham.com/charisma.html

The other agents in all of our interactions are humans. Fallible, emotional creatures, guided by an unimaginably complicated, overlapping, self-contradicting set of heuristics optimized over millions of years to make us as effective as possible at creating more humans.

View any behavior approaching rationality as something to be treasured and appreciated, rather than the norm-- _Even within ourselves_. Even very smart people need prolonged introspection/mindfulness practice to become aware of how rarely we actually act as a rational being.

Wishing things were one way has no bearing on whether they are that way. We do ourselves a disfavor if we act as if the world worked the way we want it to rather than the way it does.

All true, but I think a good measure of "brokenness" of a regulatory apparatus is the extent to which you need someone on the inside in order to understand what you need to do to get approval, as opposed to being able to find that information from easily discoverable documents as an outsider.

So yes, humans are fallible, but the extent of this reliance on "knowing the right people" is the extent of the fallibility.

> Another way to look at it was in working with Purdue, he was able to demonstrate his ability to define and walk around FDA approvals by understanding and guiding product language to get approval.

Well, he was working for the FDA at that point. So that would have been a fail.

Had he denied the application it could just as easily be said to have shown his expertise in the regulatory approval process by detecting and rejecting a dangerous drug.

And yet, I don't think that display of competence would have landed him a job at Purdue.

https://en.wikipedia.org/wiki/Revolving_door_%28politics%29

That the revolving doors work well.

Quid pro quo. You scratch my back and I'll scratch yours 2 years later.

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