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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

#21

Post by sanderjd »

marincounty wrote: post #16
CodeWriter23 wrote: post #9

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 byl…

It all comes down to the incentives. I doubt the FDA is beating away applicants as it is. If the FDA enacts your proposed policy, what do we do if they can't find qualified applicants?

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

#22

Post by ekianjo »

hurin wrote: post #13

Pharmaceuticals is a ridiculous industry, public health and scientific merit are on the lowest rungs of their list of priorities.

To be honest I can't think of many industries which place public health scientific merit at their top priorities either. You could say the same thing about the food and beverages industries, and Soylent too if you care about mentioning stuff that makes HN tick often.

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

#23

Post by ekianjo »

sjg007 wrote: post #15
guylhem wrote: 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.

Most drugs go first on the American Market, because that's the most profitable one by far. Any source for your claim ?

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

#24

Post by refurb »

guylhem wrote: 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…

The EMA isn't that much better. Just do a google search for Mediator a diet drug only sold in the EU.

There were multiple signs that the drug causes heart damage. It took years and years for it to eventually be pulled.[1]

[1]http://news.yahoo.com/france-drugmaker-trial-suspected-death...

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

#25

Post by ekianjo »

erkkie wrote: post #14
powera wrote: 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.

Oh really ? Is that Science, in a non-controlled environment, no supervision of health care professionals ? I doubt anything like that is going to happen any time soon. Plus, the public does not have access to the synthesis or new materials, and I doubt that people would actually inject themselves with drugs that have never been tested on animals in the first place.

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

#26

Post by ekianjo »

CodeWriter23 wrote: post #9

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.

> given that industry insiders go back and forth between jobs in Industry

Very true, and there is very little done to reveal "Conflicts of Interests". Public Officials should be completely transparent (sources of income, past and present relationships, etc) if not I am afraid we cannot exclude corruption at any level.

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

#27

Post by DigitalSea »

Both honestly and sadly, I think nobody is actually legitimately surprised by this. The pharmaceutical industry is a profit machine that will do anything to ensure that it remains profitable.

If anyone hasn't seen John Oliver's latest video, it's on the whole marketing to doctors thing and touches upon the pharmaceutical industry and I highly recommend watching it: https://www.youtube.com/watch?v=YQZ2UeOTO3I - he sums it up perfectly.

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

#28

Post by refurb »

DigitalSea wrote: post #27

Both honestly and sadly, I think nobody is actually legitimately surprised by this. The pharmaceutical industry is a profit machine that will do anything to ensure that it remains profitable. If anyone hasn't seen John Oliver's latest video, it's on the whole marketing to doctors thing and touches upon the pharmaceutical industry and I highly recommend watching it: https://www.youtube.com/watch?v=YQZ2UeOTO3I - he sum…

The pharmaceutical industry is a profit machine that will do anything to ensure that it remains profitable.

But this isn't about the pharmaceutical industry, it's about the FDA. The FDA is clearly catching these companies doing wrong, so why are they covering it up?

And if you think the FDA and the pharmaceutical industry are in bed with each other, I would have to disagree (coming from the industry). The company I used to work for would never mess with the FDA since you could be shutdown in an instant.

To be honest, I think a lot of the FDA failings come from a lack of resources. Most of the drugs people take in the US and EU are made in places like India and China. The FDA is just starting to think about inspecting those plants. They just don't have enough inspectors to make sure each and every manufacturer is doing things by the book.

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

#29

Post by refurb »

ekianjo wrote: post #26
CodeWriter23 wrote: post #9

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.

> given that industry insiders go back and forth between jobs in Industry Very true, and there is very little done to reveal "Conflicts of Interests". Public Officials should be completely transparent (sources of income, past and present relationships, etc) if not I am afraid we cannot exclude corruption at any level.

Very true, and there is very little done to reveal "Conflicts of Interests".

Sure there is. If you sit on an FDA panel you need to declare all conflicts of interest. Panel members usually recuse themselves under those circumstances.

The tough part is that you can't stop folks from moving between industry and the FDA. Both organizations are looking for the best folks. It reminds me of doctors being paid for clinical trials. Of course it's always the top doctors getting paid because if you're a company, do you want the crappy doctors running your trial?

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

#30

Post by erkkie »

ekianjo wrote: post #25
erkkie wrote: post #14

Earlier quoted context omitted.

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.

Oh really ? Is that Science, in a non-controlled environment, no supervision of health care professionals ? I doubt anything like that is going to happen any time soon. Plus, the public does not have access to the synthesis or new materials, and I doubt that people would actually inject themselves with drugs that have never been tested on animals in the first place.

> Oh really ? Is that Science, in a non-controlled environment, no supervision of health care professionals ? I doubt anything like that is going to happen any time soon.

You might've misread me as condoning this, not at all, but I think it's inevitably gonna happen and in fact already is, if you dig around a little bit (all kinds of life extension forums out there, not to mention the current nootropics trends). You don't have to agree with or like things to see them coming you know.

> Plus, the public does not have access to the synthesis or new materials

You wouldn't believe how much is possible to do in a home lab and dna/rna based techniques are becoming more and more accessible as well.

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