The FDA buries evidence of fraud in medical trials. My students and I dug it up
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Re: The FDA buries evidence of fraud in medical trials. My students and I dug it up
#2In healthcare, there are many skeletons in the closet - and many closets.
This FDA story is sad, but not surprising. The article seems to suggest the European equivalent (the EMA) is way better. Maybe it did behave better on this case, but as a rule of thumb, I strongly doubt it is much better.
The only advantage Europe has is how it works: if you want to bring a drug to the market, you either have it to get it accepted in one member state (then you can sell it everywhere) or go to the EMA. That's moderate competition. It may works slightly better, but it's still limited by the number of countries and regulatory agencies.
The only conclusion we should make from such stories is that there should be no public bodies susceptible to regulatory capture, but various independent organizations doing that.
See that as adding redundancy - if one was found to cheat and lie, it wouldn't be too big to fail, and a competitor would be glad to update its rating on say the 40 generics whose bioequivalence ratings are based on cooked data. That's a bit like how I trust Michelin guides more than any government evaluation of restaurants.
EDIT: I noticed a comment about financial ratings agencies. You realize there are only 3 big ones (Moody's, S&P, Finch) and that they have very strong ties to some governments, right? I predict they give you more quality that the FDA (because it's a legal monopoly), but less than what more competition could bring.
Re: The FDA buries evidence of fraud in medical trials. My students and I dug it up
#3Maybe we aught to stop allowing corporations to run our media and arbitrarily censoring facts they don't like.
Re: The FDA buries evidence of fraud in medical trials. My students and I dug it up
#4In healthcare, there are many skeletons in the closet - and many closets. This FDA story is sad, but not surprising. The article seems to suggest the European equivalent (the EMA) is way better. Maybe it did behave better on this case, but as a rule of thumb, I strongly doubt it is much better. The only advantage Europe has is how it works: if you want to bring a drug to the market, you either have it to get it accep…
Because the financial ratings agencies have proved to be such a huge success?
Re: The FDA buries evidence of fraud in medical trials. My students and I dug it up
#5In healthcare, there are many skeletons in the closet - and many closets. This FDA story is sad, but not surprising. The article seems to suggest the European equivalent (the EMA) is way better. Maybe it did behave better on this case, but as a rule of thumb, I strongly doubt it is much better. The only advantage Europe has is how it works: if you want to bring a drug to the market, you either have it to get it accep…
Because the financial ratings agencies have proved to be such a huge success?
US raiting agency's are setup to be corrupt as the seller pays the raiting agency so there going to look for the loosest respectable option. And the agency has little incentive to dig deep.
Re: The FDA buries evidence of fraud in medical trials. My students and I dug it up
#6I think we have to face that the FDA is incompetent and corrupt. Getting a drug approved is more dependent on how much money you want to spend than on whether it works. Some drugs that may be effective are delayed for years and years ( http://well.blogs.nytimes.com/2015/02/05/for-a-l-s-patients-... ) while other drugs that don't work are approved as being effective.
Re: The FDA buries evidence of fraud in medical trials. My students and I dug it up
#7In healthcare, there are many skeletons in the closet - and many closets. This FDA story is sad, but not surprising. The article seems to suggest the European equivalent (the EMA) is way better. Maybe it did behave better on this case, but as a rule of thumb, I strongly doubt it is much better. The only advantage Europe has is how it works: if you want to bring a drug to the market, you either have it to get it accep…
Regulatory capture is pretty much inevitable. In almost any field, the skills needed for government regulators to evaluate claims are interchangeable with the skills needed to work in the field.
The only thing that will help is strong whistleblower protections, to allow the ethical members of a profession to call bullshit without fear of repercussion. (This won't work in banking, for obvious reasons :P )
Re: The FDA buries evidence of fraud in medical trials. My students and I dug it up
#8In healthcare, there are many skeletons in the closet - and many closets. This FDA story is sad, but not surprising. The article seems to suggest the European equivalent (the EMA) is way better. Maybe it did behave better on this case, but as a rule of thumb, I strongly doubt it is much better. The only advantage Europe has is how it works: if you want to bring a drug to the market, you either have it to get it accep…
Because the financial ratings agencies have proved to be such a huge success?
Perhaps this proposed drug testing regime would be more comparable to auditing firms.[1] Arthur Andersen went under after it lost credibility in the eyes of shareholders, as a result of the Enron scandal. On the other hand, from everything I have read the ratings agencies were simply 'going through the motions', and cashing in on their government mandated service. No large investors trusted the ratings agency to begin with, the investors were all gaming the system, and the agencies were playing along to get a piece of the action.[2]
[1] http://en.wikipedia.org/wiki/Big_Four_(audit_firms)
[2] http://en.wikipedia.org/wiki/Big_Three_%28credit_rating_agen...
Re: The FDA buries evidence of fraud in medical trials. My students and I dug it up
#9The misconduct itself is not surprising, given that all drug studies required for drug approval are performed by the company seeking the approval. The cover-ups are also not surprising, given that industry insiders go back and forth between jobs in Industry, and running the FDA.
Re: The FDA buries evidence of fraud in medical trials. My students and I dug it up
#10The misconduct itself is not surprising, given that all drug studies required for drug approval are performed by the company seeking the approval. The cover-ups are also not surprising, given that industry insiders go back and forth between jobs in Industry, and running the FDA.
And more importantly, given that no one is ever held responsible. No one goes to jail. Again.
Punishment is supposed to be disincentive to crime. With no punishment, what's wrong with lying, cheating, stealing, and killing?