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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

#141

Post by Alex3917 »

refurb wrote: post #123
Alex3917 wrote: post #99

Earlier quoted context omitted.

> If you sit on an FDA panel you need to declare all conflicts of interest. Panel members usually recuse themselves under those circumstances. I don't care if you work for the pharma, but please don't keep posting demonstrably false comments shilling for the industry: "Since the lion's share [of FDA user fees] can only go to expedite approvals, that area of the agency has grown while staffing and resources in other p…

Once again, "conflict of interest" is not a binary thing. People can have weak conflicts of interest (owning pharma stock in their 401k) and strong conflicts of interest (sitting on the board of a pharma company). The FDA needs to balance that with getting the best folks they can on their advisory committees. So yes, some folks who have conflicts of interest remain on the committees. I don't think it's something that…

> many folks who have strong conflicts of interest usually recuse themselves from those discussions.

Cite?

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

#142

Post by hga »

benrapscallion wrote: post #116
MichaelGG wrote: post #78

A related and very interesting story is this article[1] on Ranbaxy. Basically this company was corrupt and fraudulent from the top down. Falsifying data, copying competitor information as their own, etc. Or encouraging internationally traveling employees to privately import medicines to India for them. Or asking doctors on staff to write prescriptions for everyone in the office to boost sales figures. The FDA applied…

Importantly, in the meantime the original promoters Shivinder Singh and Malvinder Singh quickly sold the company to Daiichi Sankyo to wash their hands off the mess that they had created.

Sort of, that sale was back in 2008 and they retained a 36% stake (see my other recent comment for the sale to Sun Pharma). But they of course knew their company was a fraud, as the Fortune article makes clear.

Let me put in a word for Indian English: the usage of "promoters" for that class of businessmen is perfect.

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

#143

Post by Alex3917 »

oldmanjay wrote: post #119
Alex3917 wrote: post #65

Earlier quoted context omitted.

EBM involves using science to determine the safety and efficacy of any given treatment. Oftentimes multiple studies are combined using metaanalysis, an approach that has both strengths and weaknesses. SBM, despite the name, believes that using science to study medical treatments is often a waste of money regardless of whether a treatment is very effective or completely ineffective; their claim is that there will alwa…

Is the racism necessarily part of it? Or do you feel like white people are deserving of any indirect scorn you wish to heap on them?

> Is the racism necessarily part of it? Or do you feel like white people are deserving of any indirect scorn you wish to heap on them?

I mean a large part of medical research is basically appropriating plant medicine from indigenous cultures and then sending people to prison for using the same medicine in plant form. So yes, racism does play a large part in the medical system.

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

#144

Post by ska »

refurb wrote: post #129
ska wrote: post #122

Earlier quoted context omitted.

Academia already does much of the fundamental research. It's mostly the "D" part of the "R&D" that is expensive, and shapes the pharma industry. Some of this could be addressed by making clinical trials cheaper to operate and initialize, but it's always going to be quite expensive.

I agree that most fundamental (chemistry, biology) research is done in academia. But fundamental research doesn't deliver new drugs, it only supports discovery. About 24% of new drugs are discovered in academia.[1] The remainder come from industry. I think offloading all discovery to academia, plus the "D" part of R&D would be something academia would struggle with. [1] http://pipeline.corante.com/archives/2010/11/04…

Sure, a lot of discovery is done in industry too (and, as you note, is supported by academic outputs). But that's not the expensive part which is what I was trying to say -- obviously not clearly enough.

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

#145

Post by tomaskafka »

thisIsNotMikey wrote: post #130

The problem with the FDA is it usurps liability from the manufacturer and responsibility from the consumer. Most Americans will grant more time to a free app review, than to a nutrition label. We have a false sense of security that food and drugs are FDA "approved." This same problem exists in banking because of the FDIC. How many people know what's on their bank's balance sheets?

You could say that they purposefully created a single point of failure - just like every other agency with monopoly over some area.

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

#146

Post by acdha »

thisIsNotMikey wrote: post #136
acdha wrote: post #131

Earlier quoted context omitted.

How many consumers are capable of evaluating drug safety and have time to do so? This is a real problem requiring time from a limited number of highly skilled professionals and easy proposed solutions are naive.

The consumers directly don't. But as a consumer I don't know how to evaluate an automobile, a smart-phone, or other products. But there is a market that provides the relevant data to consumers. Before I buy a car, I check out USNews, or Edmunds; before I buy any product I check out the relevant resources. Because of the way the FDA is structured, not much non-FDA research and reviews are being done. Lol. I didn't pro…

… and those markets have a long history of being gamed despite enjoying much larger numbers of people who can check the work. The drug market is huge and extremely lucrative which ensures that any successfully started review service would be under attack from multiple fronts – lawsuits, attempts to hire people away or buy influence, setting up “competing” groups which try to sound legitimate but exist only to attack the other group’s claims, etc.

Read the history of what happened with say the financial ratings companies during the 2000s for one side (regulatory capture) and the tobacco or fossil fuel industry for the dirty tricks version. There's no reason to think that wouldn't keep happening, all of which dramatically increases the cost and likelihood of failure.

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

#147

Post by emcrazyone »

Scaevolus wrote: post #54
graeme wrote: post #52

How much of this could be solved by replication? Some sort of rule where we say, formally, not to take any study seriously unless it's been replicated? On the one hand, it's very bad that the FDA has covered this up. But on the other hand, there was science before the FDA. I may be interpreting the article wrong, but it seems as though the FDA is merely failing to prevent bad science. Presumably, journals that cited…

Clinical trials are very expensive to run. The only people financially interested in running them are the pharmaceutical companies trying to make new products available. Replication is hard enough to achieve in hard sciences where replicating a study might cost tens of thousands of dollars. Finding the money to replicate or refute a clinical trial for millions of dollars is very difficult.

@Scaevolus so very true. I use to work in this field. I was the IT director for a small pharmaceutical company that produced prescription creams and ointments and worked with a nearby university to work on new drugs.

My role was to develop the custom software that ran on laptops we gave to hospitals involved in the clinical trial. In the drug manufacturing world, anytime computer software is used in a clinical trial or in the tracking of drug production, you have to have the software validated.

Software validation is basically a process by which you hire an outside company to go over what your software does. Similar to an ISO certification. The folks & companies you hire are very clueless... They know enough buzz words to ask good questions but they often over look things.

Anyway, long story short, the whole process of just collecting data is riddled with security problems. None of this, as far as I know, is exposed to the public either. So if buggy software is, somehow, corrupting test results, there is not feedback loop to correct or discard the data. Companies like the one I worked for at the time, would throw out the data as a policy and start over. Hence, very expensive situation and very crucial to make sure your systems do the right thing the first time.

This was in the late 90s and in one situation I was in charge of some software that we were developing that was expected run past Y2K. Back then there was a lot of hoopla about the Y2K century roll over and what it would do to computer systems.

The company we hired validated our software for Y2K use cases but they often over looked basic things like data encryption, plain text storage of user passwords, etc...

I imagine the validation companies have gotten better over the years but in the end I learned that software validation is nothing more than a big CYA tactic. It's a paper trail to try and claim we did our due diligence if the shit were to hit the fan.

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

#148

Post by bduerst »

thisIsNotMikey wrote: post #137
bduerst wrote: post #135

Earlier quoted context omitted.

FDIC insurance exists so you do not need to keep checking in on your bank's integrity. It is set up this way by design. Should the bank run with your money or fold, you get your money back. How you extrapolate FDA regulations and faith in it to banking is a bit beyond me, because if you get diabetes the FDA is not insurance you can use to treat it.

Moral hazard. It is a simple concept.

So simple it doesn't apply. This isn't automobile insurance.

You're no less risky with your money because the FDIC backs your bank account - in fact, you're more likely to leave it there with less risk.

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

#149

Post by hueving »

thisIsNotMikey wrote: post #137
bduerst wrote: post #135

Earlier quoted context omitted.

FDIC insurance exists so you do not need to keep checking in on your bank's integrity. It is set up this way by design. Should the bank run with your money or fold, you get your money back. How you extrapolate FDA regulations and faith in it to banking is a bit beyond me, because if you get diabetes the FDA is not insurance you can use to treat it.

Moral hazard. It is a simple concept.

Not simple enough for you to understand I suppose. For a bank to get FDIC insurance, it needs to follow a lot of regulations. Even during the financial crisis, look how many times the FDIC insurance was triggered. It worked exactly as intended and kept banks from messing with depositor money.

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

#150

Post by thisIsNotMikey »

bduerst wrote: post #148
thisIsNotMikey wrote: post #137

Earlier quoted context omitted.

Moral hazard. It is a simple concept.

So simple it doesn't apply. This isn't automobile insurance. You're no less risky with your money because the FDIC backs your bank account - in fact, you're more likely to leave it there with less risk.

Banks are more risky. Your right, this isn't a simple concept for some.
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