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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

#31

Post by hurin »

ekianjo wrote: post #22
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.

Of course - but the food and beverage industry can't serve you amphetamine-salts in your coke (well not anymore) just because it's profitable.

I don't know what soylent is (beyond just searching it in google). Wikipedia says:

Soylent is a nutritional drink, intended to cover all human nutritional requirements for an adult so that it may serve as main or sole food

There should be a very obvious test for this right? I think a large-scale controlled study would likely show negative effects compared to a randomly sampled population consuming the nutritional equivalent in natural products. This is actually part of the problem - you'll never read about such a study. Why? Because there is no profit incentive for anyone to finance a large-scale study that proves soylent or hypothetical product X to be useless or harmful.

If soylent (or company X) finances a study of their product and the results are contrary to their expectations (assuming the researches are honest and do not engage in fraud) - they can simply shelve that material - and if eventually study i++ is successful they can publish that (without ever referencing any number of past unpublished studies).

The FDA is wasting my money and yours (if you are a US citizen), in a way that normally should address this imbalance of selective interest in research. That it does not - hardly surprises me.

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

#32

Post by vijayr »

littletimmy wrote: post #11
themartorana wrote: post #10

Earlier quoted context omitted.

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…

not fare well in prison

Jeez - I thought you were joking, but nope :(

http://www.cnn.com/2014/04/02/justice/delaware-du-pont-rape-...

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

#33

Post by Alex3917 »

Tokenadult,

Out of curiosity, given that you've said in your previous comments that you believe medical questions are best answered with 'science-based medicine', which is a philosophy that explicitly rejects evidence-based medicine: do you believe that the FDA covering up scientific fraud is bad, or do you agree with the FDA's argument that it's justified?

Also, do you still believe that "It's an exaggeration (contradicted by thoughtful comments by drug industry researchers who have already posted replies in this thread) to say that the enterprises that develop new drugs for prescribed medical treatment are corrupt in general [...]."?

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

#34

Post by littletimmy »

sanderjd wrote: post #21
marincounty wrote: post #16

Earlier quoted context omitted.

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?

Raise the salary.

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

#35

Post by ekianjo »

erkkie wrote: post #30
ekianjo wrote: post #25

Earlier quoted context omitted.

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…

> 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.

Sure, but combine the lack of such equipment for most people with the fact that your experiments will have small n size (because of lack of pilot plant scale to do proper large batches of drugs) and the significance of the home trial drops to nil.

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

#36

Post by ekianjo »

hurin wrote: post #31
ekianjo wrote: post #22

Earlier quoted context omitted.

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.

Of course - but the food and beverage industry can't serve you amphetamine-salts in your coke (well not anymore) just because it's profitable. I don't know what soylent is (beyond just searching it in google). Wikipedia says: Soylent is a nutritional drink, intended to cover all human nutritional requirements for an adult so that it may serve as main or sole food There should be a very obvious test for this right? I…

> There should be a very obvious test for this right?

Yes, definitely, but I'm pretty sure it won't happen, and such a solution should not be allowed to make such claims ("intended to cover all human nutritional requirements for an adult") without any data supporting it, or at least a clear indication of the risks people take on it. In any case, some data is needed before you sell this kind of stuff to the public.

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

#37

Post by Alex3917 »

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.

And this article doesn't even cover 95% of the problems with the FDA, many of which are as bad or worse. But on this topic, here is a good example that the article missed:

http://www.washingtonpost.com/wp-dyn/articles/A9802-2004Sep9...

Basically the FDA ordered pharma companies bury the research showing that antidepressants were ineffective in children and could lead to suicide, because they were worried that parents would stop spending money on them.

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

#38

Post by 1123581321 »

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.

You're missing the big trend. In addition to the availability of DIY hardware and more ways for patients to find each other and communicate, other developed or developing countries are approving treatments before the FDA. The size of the US market still holds back medical research, but at some point in this century, the size of the "early adopter" markets with sufficient buying power will be big enough that it won't matter.

Signed, one American Type 1 diabetic who is tired of the FDA letting us die by keeping the best tools out of our hands.

P.S. If an analogy helps you, think about how music piracy ended up giving us Spotify, and how it had to come from Europe to break into the US market, and how it blocked Americans to avoid getting shut down in its early days. Or, think about how Jobs essentially tricked the labels into allowing iTunes. The traditional record label publishing model is analogous to the FDA's drug trial model. The FDA can make any number of arguments about how their method is more rigorous and beneficial, but at some point, newer methods of getting similar results are coming along, and at some point after that, those methods will be backed by a power with the resources and inclination to bring the benefits of rigor to the new methods without resorting to the old methods.

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

#39

Post by mirimir »

littletimmy wrote: post #34
sanderjd wrote: post #21

Earlier quoted context omitted.

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?

Raise the salary.

The US pharmaceutical industry is too wealthy for that to be workable. The game is to make friends while working at the FDA, and then to cash in. In order to serve the public interest, drug discovery and testing ought to occur in academia. The pharmaceutical industry should play no role in that, and should merely manufacture approved drugs.

Edit: Please see The Truth About Drug Companies, by Marcia Angell, M.D., formerly an editor of the New England Journal of Medicine.

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

#40

Post by erkkie »

ekianjo wrote: post #35
erkkie wrote: post #30

Earlier quoted context omitted.

> 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…

> 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. Sure, but combine the lack of such equipment for most people with the fact that your experiments will have small n size (because of lack of pilot plant scale to do proper large batches of drugs) and the significance of the home trial drops to nil.

That's to be seen, and it becomes an analytics problem to separate signal from noise more than anything else.

For preview google about the current issues around people 3d printing their own dental braces (or prosthetics).

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