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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

#151

Post by thisIsNotMikey »

hueving wrote: post #149
thisIsNotMikey wrote: post #137

Earlier quoted context omitted.

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.

The moral hazard is the FDIC, which arguably helped perpetuate the crisis. Banks are insured by the fed, lender of last resort, and individual accounts are insured by FDIC. Insurance, or assurance in the case of the FDA, is the moral hazard which causes risky behavior.

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

#152

Post by chris_va »

chaostheory wrote: post #67
chris_va wrote: post #57

Earlier quoted context omitted.

"FDA managers hid the evidence of fraud and misconduct from the advisory committee, which was fooled into voting for approval" -> Yes, that sounds super sketchy. The actual testimony doesn't, though it's one sided (below). The redactions are not surprising to me. The FDA is a regulatory agency that deals with very sensitive and confidential information. They are not a criminal agency, and this isn't some district att…

> The redactions are not surprising to me. The FDA is a regulatory agency that deals with very sensitive and confidential information. They are not a criminal agency, and this isn't some district attorney asking for the information. Yes the FDA is a regulatory agency. In my mind, it's similar to the IRS, SEC, or FBI. It ensures that specific people and organizations are complying with rules and regulations; in other…

Maybe... Technically it's not their study, it's the study of the company running the trial. That isn't public information.

Now, one could argue that all clinical and pre-clinical data used for the drug approval process should be public information. That is a very complicated argument (and I actually come down on the "public" side, but it would take a long time to explain).

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

#153

Post by woodman »

Retric wrote: post #134
woodman wrote: post #12

Earlier quoted context omitted.

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.

I think it's more nuanced than that. Private companies optimize for money, with the right incentives they work well, with poor incentives they become a pointless money sink. All too often you see the equivalent of “though the magic of the invisibly hand we will solve X.” But, without the proper incentives simply privatizing or reducing regulations are going to do little but line someone’s pockets.

> But, without the proper incentives simply privatizing or reducing regulations are going to do little but line someone’s pockets.

Well, that is true every system - including functions of government. It has nothing to do with privatization vs nationalization. The government mandates that certain financial instruments must be rated by a short list of companies that have been blessed to do so. So the government has limited competition among rating agencies, a laughable mistake in judgement. Then these companies only get paid by the folks trying to sell the instrument under review... another stupid move.

Many government programs, presumably setup with the best intentions, have serious negative consequences because the moron behind it didn't think more than one step ahead. This happens in private industry as well, the difference being that there the market corrects for mistakes by mercilessly crushing fools. In government the fools live on, and their plans are slow to change because it is now law.

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

#154

Post by MichaelGG »

hga wrote: post #104
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…

A bit more happened, last year the FDA started making unannounced visits to their production plants in India. When I checked on this about a month ago, it appeared that every Ranbaxy plant in India had been shut down. This Google search will provide a lot of info, https://www.google.com/search?q=Ranbaxy+flies that's "flies" as in those disease spreading insects. One of the articles had a picture of a man unloading du…

Wow, that's fantastic and unexpected news. Is the FDA doing surprise inspections all over? Like, Sun buying them, then letting things stay bad, pretty much indicates they rather complicit. Or is it thought they wanted a "dirty" division to try tricks in, while keeping an otherwise clean company?

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

#155

Post by Retric »

woodman wrote: post #153
Retric wrote: post #134

Earlier quoted context omitted.

I think it's more nuanced than that. Private companies optimize for money, with the right incentives they work well, with poor incentives they become a pointless money sink. All too often you see the equivalent of “though the magic of the invisibly hand we will solve X.” But, without the proper incentives simply privatizing or reducing regulations are going to do little but line someone’s pockets.

> But, without the proper incentives simply privatizing or reducing regulations are going to do little but line someone’s pockets. Well, that is true every system - including functions of government. It has nothing to do with privatization vs nationalization. The government mandates that certain financial instruments must be rated by a short list of companies that have been blessed to do so. So the government has lim…

'the moron behind it didn't think more than one step ahead'

I think many and possibly most of these are based on regulatory capture where elected officials / regulators are ‘given incentives’ to look the other way.

Lots of seemingly stupid decisions are completely reasonable from the person who made them. All it takes is for someone to be judged just on their little piece of what happens (how much do we spend on paper) and not judged based on how much their changes hurt the corporation/overall economy etc. And before you know it, we saved 1million in ink last year at the cost of 50 million in manpower.

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

#156

Post by woodman »

Retric wrote: post #155
woodman wrote: post #153

Earlier quoted context omitted.

> But, without the proper incentives simply privatizing or reducing regulations are going to do little but line someone’s pockets. Well, that is true every system - including functions of government. It has nothing to do with privatization vs nationalization. The government mandates that certain financial instruments must be rated by a short list of companies that have been blessed to do so. So the government has lim…

'the moron behind it didn't think more than one step ahead' I think many and possibly most of these are based on regulatory capture where elected officials / regulators are ‘given incentives’ to look the other way. Lots of seemingly stupid decisions are completely reasonable from the person who made them. All it takes is for someone to be judged just on their little piece of what happens (how much do we spend on pape…

> Lots of seemingly stupid decisions are completely reasonable from the person who made them.

Lol, good intentions are worth absolutely nothing. Your misallocation of resources story isn't really helpful either, if you think the SEC made a great move in structuring financial instrument ratings - explain it.

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

#157

Post by bsder »

1123581321 wrote: post #38
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.

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…

> 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.

If evidence helps, let's talk about Thalidomide. http://en.wikipedia.org/wiki/Thalidomide

Hacking doesn't always produce a positive result. Who is going to take responsibility for the negative results?

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

#158

Post by 1123581321 »

bsder wrote: post #157
1123581321 wrote: post #38

Earlier quoted context omitted.

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…

> 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. If evidence helps, let's talk about Thalidomide. http://en.wikipedia.org/wiki/Thalidomide Hacking doesn't always produce a positive result. Who is going to take responsibility for the negative…

I don't think you understand that if 20,000 diabetics die because they are banned from effective treatment, DIY treatments save 5,000 of them, and 500 of those 5,000 have a negative effect, then it is a big improvement in overall national health, even though a 10% failure rate is horrifying.

The article you linked about one drug in West Germany does not take into account the overall benefit to health of learning that information and allowing more beneficial drugs to also enter the market quickly.

You could quibble about the numbers but it's important to understand the principle before doing so.

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

#159

Post by [deleted] »

zaroth wrote: post #43
1123581321 wrote: post #38

Earlier quoted context omitted.

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…

Just got my son on a CGM last week. The receiver claims a range of 20 ft, but it won't pick him up from our bedroom a wall away. When the receiver fails, you silently lose the hypoglycemia alerts. I've already ordered a pack of Wixels to setup these throughout the house, backyard, and at his preschool: https://github.com/StephenBlackWasAlreadyTaken/wixel-DexDrip

[deleted]

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

#160

Post by mirimir »

ska wrote: post #144
refurb wrote: post #129

Earlier quoted context omitted.

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.

Reforming the current system would be difficult, no doubt. And perhaps it's unworkable. Big pharma also owns academia. Much of the peer-reviewed literature for many drugs has been ghostwritten by industry-funded consultants. Sometimes the authors don't even read their manuscripts, and in some cases haven't been informed of them. Some journals have been addressing this, but it's pervasive.

In any case, the current system isn't working. Incentives for fraud far outweigh those for improving public health. And there is virtually no accountability.

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