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The FDA buries evidence of fraud in medical trials. My students and I dug it up

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11–20 of 177 posts

Re: The FDA buries evidence of fraud in medical trials. My students and I dug it up

#11

The 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?

The issue here is slightly different. As the law works, there is absolutely a lot wrong with lying, cheating, stealing and killing if you are poor or black.

White billionare? Nope. You can literally rape your toddler daughter and go free because the judge feels you would "not fare well in prison." (DuPont heir).

Large corporation? Lol. The attorney general will argue on your behalf instead of bringing a case against you. (JP Morgan).

Re: The FDA buries evidence of fraud in medical trials. My students and I dug it up

#12
post #5
post #4

Earlier quoted context omitted.

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.

Setup by the SEC. The incentives are structured, by the government, in the most ridiculous way possible. Pointing at the failure of government mandated and monitored rating agencies as a failure in private enterprise is just stupid.

Re: The FDA buries evidence of fraud in medical trials. My students and I dug it up

#14
post #6

I 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.

Most likely self-experimenting and community based "trials" are gonna be much more prevalent in the coming years, due to bio hacking opening up. Gonna be even trickier to regulate and navigate.

Re: The FDA buries evidence of fraud in medical trials. My students and I dug it up

#15
post #2

In 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…

Except the major drugs are brought to both markets usually and largely made by multinationals. Many drugs get approval in Europe first before they are tested in the US.

Re: The FDA buries evidence of fraud in medical trials. My students and I dug it up

#16

The 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.

Maybe as a condition of hire, the appicliant, if hired by the FDA, couldn't seek future employment in any aspect of the Pharmacutical industry?

I belonged to a union that flat out told apprentices that they were forbidden from going through the program and opening up a non-union shop. I've always wondered about the legality of putting conditions on a job? I know the formentioned union still has the clause in it's bylaws, and it's a union in a huge city.

Re: The FDA buries evidence of fraud in medical trials. My students and I dug it up

#17
post #2

In 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 )

How about the Singapore model? Pay government bureaucrats huge salaries and pensions so they don't have to structure their career around getting a private sector cash out after they retire from regulating.

Re: The FDA buries evidence of fraud in medical trials. My students and I dug it up

#18
To clarify: I'm not calling for less regulation from the FDA. Far from it. Rather, I'm pointing out that in the follow instance where more regulation is being called for, a major influence is again Big Pharma and the motivation is, to my eyes and reading, not primarily consumer protection.

----

There is also the other "half" of this FDA saga. "Supplements" and herbal treatments are a mixed bag, and there are fraudulent manufacturers and suppliers in this market as well. However, there are repeated pushes to get the FDA to more or less outlaw all of them and/or to regulate this marketplace out of existence.

I'm someone who, along with more than a bit of grief from pharmaceutical industry products, has actually found some significant results in the "natural" marketplace. I've had to be careful, and I've had to find manufacturers who actually deliver what they say. But the idea of one of these knee jerk, "ban 'em all" reactions taking these items away from me, scares me in no small measure.

The FDA appears no longer to be an effective regulator; it has become ever more an economic and political tool of the most moneyed private interests. (Where a focused Big Pharma far outweighs the broader field of smaller supplement providers, for example.)

To be somewhat repetitive, I don't want to discount the significant problems with the "supplements" marketplace. But I have been able to achieve results with it that I have not found in the pharmaceutical marketplace. I am unwilling to cede this territory to the pharmaceutical companies, as they seek to have it shut down -- for their own economic self-interest, rather than the public interest.

Re: The FDA buries evidence of fraud in medical trials. My students and I dug it up

#19
I feel like we're so deep in the mire now, of this kind of corruption and control by wealthy people/interests/entities, it'll be tough, if not impossible, to dig out of.

Being a fairly selfish person, that's not for my own self interest. Its a recipe for disaster. We need a massive overhaul.

Edit: Lobbying and the ability for a fiat currency to control decisions, and revolving door setups, seems like the obvious first step to me. But the people that can make that happen are the people that benefit from it currently. Bring on a new planet, without those types of people.

Re: The FDA buries evidence of fraud in medical trials. My students and I dug it up

#20
post #6

I 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.

The oped piece you cited does not support your assertion that the "FDA is incompetent and corrupt". They may be, but that is a pretty hefty accusation and requires more evidence.

Nor, honestly, does it support the "getting a drug approved is more dependent on how much money you want to spend than on whether it works" claim, or the "some drugs that may be effective are delayed for years and years".

Developing a drug is an incredibly complex operation. The FDA requires evidence that a drug will not kill people before it will approve it, which means that most drugs need to be tested in thousands of people. That requires outsourcing clinical trials to hospitals, which are then paid per patient to take on the extra work.

The original link cites corruption at the hospital level, which does seem like the weakest link in the system. The hospitals/doctors get paid based on getting patients through the trial protocol, or at least saying they did. Much of the cost born by pharmaceutical companies is actually auditing this process, to make sure it happens correctly.

Just yelling about the FDA will not change the corruption practices of a hospital in China.

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