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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

#161

Post by mirimir »

zerocrates wrote: post #76
molyss wrote: post #62

I'm just wondering something probably very stupid. Shouldn't an FOIA request turn back all information that the article claims the FDA is refusing to give away ? Looking at the FDA FOIA exemption list ( http://www.fda.gov/RegulatoryInformation/FOI/ucm390370.htm or http://www.foia.gov/faq.html#exemptions ), there's none that seems to match a drug name, a lab's name, a detail on a mistake or even communication between…

Generally, generics are required to have the same active ingredient as the brand-name, in addition to showing bioequivalence.

Biological availability is a key issue. Having the right molecule is pointless if it's not absorbed as efficiently. Conversely, more-efficient absorption could be dangerous. It's an especially critical issue for extended-release forms.

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

#162

Post by mirimir »

colechristensen wrote: post #83
harkyns_castle wrote: post #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 firs…

It is only with a false view of the past that today can be seen as more corrupt than any point in history. Of course there is an ebb and flow of where the corruption lies, and to what extent it takes hold. People tend to forget that we're living in the safest, most transparent, most free point in the whole of human history. We've been digging ourselves out of a pit of corruption for ten thousand years, don't let your…

Yes, not that long ago, it was not uncommon for sugar to be adulterated with lead acetate. Spiking alcoholic beverages with methanol is still all too common.

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

#163

Post by Retric »

woodman wrote: post #156
Retric wrote: post #155

Earlier quoted context omitted.

'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.

That's not what I meant. It's not 'good intentions' vs 'reality' it's 'selfish intentions' +'bad measurement' = 'WTF rules'.

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

#164

Post by woodman »

Retric wrote: post #163
woodman wrote: post #156

Earlier quoted context omitted.

> 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.

That's not what I meant. It's not 'good intentions' vs 'reality' it's 'selfish intentions' +'bad measurement' = 'WTF rules'.

Ah, well that is a consequence of poor planning by the well-intentioned. Here, I'll show you:

People are bad, therefor we need a government made of people are bad, therefor we need a government made of people are bad...

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

#165

Post by tangerine_beet »

This article really brings home the truth of how helpless we are in the face of corrupt government bodies like the FDA. You can just picture von Eschenbach and his group reading the piece, and then calculating whether a response is going to be needed: Maybe it will all blow over if we just stay quiet? What can one do as a citizen to fight this kind of corruption?

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

#166

Post by static_noise »

logfromblammo wrote: post #121
static_noise wrote: post #74

Earlier quoted context omitted.

If you need 50 experiments to actually show that the effect exists, then even a small fraction of fraudulent experiments can heavily skew the result when looking at confidence intervals. Think of selfhealing as a coin toss with 50/50 chance and a medication increasing this chance: a) Medication increases healing chances to 80% -> Only few experiments needed. b) Medication increases healing chances to 55% -> Many expe…

Don't forget the placebo effect. A major flaw I see in most medications studies is that the market prices for the experimental drug or placebo are not included in the study. My hypothesis is that a placebo described as costing $1000 per dose will produce a greater effect than a placebo described as costing $10 per dose, even if the patients are not asked to pay that cost. Could it be that those drugs that barely outp…

Current stdies should account and compensate for the placebo effect (double blind study).

I think there was a study which compared different placebos and the more expensive ones showed better effects. So your hypothesis may be right.

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

#167

Post by EpicEng »

emcrazyone wrote: post #147
Scaevolus wrote: post #54

Earlier quoted context omitted.

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…

I'm also in the medical device industry, though we don't farm our V&V work out. The bugs are supposed to be caught in the verification phase; validation is all about making sure that the software is functioning correctly from a user perspective? Are you just conflating the terms here for the sake of simplicity?

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

#168

Post by hueving »

thisIsNotMikey wrote: post #151
hueving wrote: post #149

Earlier quoted context omitted.

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.

Nope. The FDIC made sure they didn't do the crap they did with depositor money. It's the reason the FDIC insurance wasnt massively triggered during the crisis. The accounts that got screwed were investment accounts which were not insured by the FDIC.

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

#169

Post by g_mifo »

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…

Thank you for your inspirational efforts to take control of the quality of your medication. Patients need to empower themselves to become experts in their condition and treatment.

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

#170

Post by MaysonL »

chaostheory wrote: post #48
chris_va wrote: post #20

Earlier quoted context omitted.

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 i…

> The original link cites corruption at the hospital level, which does seem like the weakest link in the system. If corruption stopped at the hospital there, then this wouldn't happen at the FDA: > As David Ross, the FDA official in charge of reviewing Ketek’s safety, put it, “In January 2003, over reviewers’ protests, FDA managers hid the evidence of fraud and misconduct from the advisory committee, which was fooled…

Here's a New England Journal of Medicine article by Dr. Ross about the affair: http://www.nejm.org/doi/full/10.1056/NEJMp078032
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