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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

#61

Post by gerry_shaw »

graeme wrote: post #56
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.

So can we still call it science, or not? And if not, what do we call it?

If all the steps are made available in the paper to reproduce the experiment I would consider it science. Just because people don't replicate the study because of other factors like time or money shouldn't take away from the first experiment.

Somebody has to be first.

That said, is an interesting question.

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

#62

Post by molyss »

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 ab and FDA. The only things that I would think apply would be internal FDA comm, and patient names. None of the things I cited sound like : - national security threats - internal rules - breaking federal law - trade secrets, commercial or financial info - inter/intra agency comm - personal privacy (if we exclude patient names) - law enforcement info - supervision of financial institutions (that's an interesting exception to see BTW) - geological info on wells (totally off topic, but I'm kind of curious about this one).

It looks like the author si as baffled by the assumption that misconduct fall into the "commercial info" exception...

Really scary also is the whole orange book thing. I thought generics were actually the exact same molecule, as in "we've done a mass spectrometry of the stuff, and it's the same shit, only cheaper". It looks it's not at all the case... Reading the wikipedia talks on generic drugs, it looks like there was confusion there as well (http://en.wikipedia.org/wiki/Talk%3AGeneric_drug#Orange_book). As of today, there's only one reference to the word molecule in the wikipedia article ("[...] most small molecule drugs are accepted as bioequivalent if[...]), which doesn't seem to address the confusion.

Assuming (and it's a pretty big assumption) that insurances really want you to get better, it would then look like the should tell you _not_ to use generics, rather than pushing you to. Argument could be made that you only depend on them for a limited time. I guess the same argument could be made for public healthcare systems (like France), in the sense that you're less expensive dead on generics than alive on the real stuff, but I sound a bit cynical, even to myself.

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

#63

Post by austinz »

wanion wrote: post #59
austinz wrote: post #53

Earlier quoted context omitted.

Question (not being sarcastic): what's the difference between 'science-based medicine' and 'evidence-based medicine'? I did a quick Wikipedia search, but the former just redirects to the latter.

Science Based Medicine is a movement to improve Evidence Based Medicine with a stronger focus on scientifically rigorous evidence. It's not in opposition to EBM. To quote the SBM blog's about page: "Good science is the best and only way to determine which treatments and products are truly safe and effective. That idea is already formalized in a movement known as evidence-based medicine (EBM). EBM is a vital and posit…

Thanks! Exactly what I was looking for.

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

#64

Post by refurb »

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…

How much of this could be solved by replication?

The FDA won't approve a drug without at least two positive phase III trials (some exceptions for oncology and other fatal diseases).

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

#65

Post by Alex3917 »

austinz wrote: post #53
Alex3917 wrote: post #33

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 (contr…

Question (not being sarcastic): what's the difference between 'science-based medicine' and 'evidence-based medicine'? I did a quick Wikipedia search, but the former just redirects to the latter.

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 always be some studies that say the treatment works and other studies that say the treatment doesn't work, and spending more money will just yield more unreliable data. They therefore believe that the bulk of scientific resources should be dedicated to research reinforces society's prior beliefs, and that research on the efficacy of any given drug should be weighted based on society's prior beliefs. You can read more about this philosophy here:

http://www.sciencebasedmedicine.org/hello-world/

If it seems somewhat muddled and handwavy as to how exactly prior beliefs and evidence should be weighted, well, this is why I personally think of SBM as the 'white person stamp of approval' approach to medicine. But certainly they have a point that a lot of medical research is complete crap.

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

#66

Post by CodyBZ »

Statins are the most widely prescribed drug on earth. The drug company's report that myopathy occurs in 1% of the population. Field reports show that number is around 20%. One in five people statin intolerant due to muscle disorders. Its common knowledge these drugs can cause serious muscle problems, yet most doctors are unaware.

http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3463373/ "It is impossible to discern the true incidence of mild muscle complaints because these problems typically are not examined in pharmaceutical sponsored trials and because of study design. In HPS, for example, subjects were not randomized to simvastatin or placebo until they had successfully tolerated simvastatin 40 mg for a 5 week introductory period (17), and most trials report muscle symptoms only when CK values exceeded 10 times upper limits of normal."

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

#67

Post by chaostheory »

chris_va wrote: post #57
chaostheory wrote: post #48

Earlier quoted context omitted.

> 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…

"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 words they enforce the law. Also I'm not sure how the agency has to hide whole bogus studies to protect confidential information. It's not like they can't redact sensitive portions (things like drug names and misconduct don't count) of it instead of just hiding the whole thing. Am I wrong?

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

#68

Post by logn »

kibibu wrote: post #55
logn wrote: post #44

Earlier quoted context omitted.

I can't think of many industries pushing for laws to force you to ingest their product. Eating McDonald's is not a prerequisite for admittance to pre-school.

This is one of those bizarre comments that arise, I think, from a society being halfway between socialism and full-blown privatized capitalism. Consider: Eating McDonalds could certainly be a prerequisite for admittance to McPreSchool, the worlds largest hypothetical private preschool system. Consider also: your government operating as a corporation. Public health is a massive drain on government resources. Vaccines…

> VERY researched

Except for double-blind placebo controlled trials, which are apparently unethical.

... in addition to the article here which casts doubt on all drug research.

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

#69

Post by hurin »

refurb wrote: post #28
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 u…

> (as someone coming from the industry)

What do these particular failings referred to in the article have to do with the FDA's lack of resources?

From what I can see all you are doing is trying to change the subject of discussion away from the industry.

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

#70

Post by logn »

jamestnz wrote: post #58
logn wrote: post #51

Earlier quoted context omitted.

I'm pointing out that pharma can either be treated like every other company and held to similar standards or they can act like scientists if they want mandated use of their products. And yes, pharma does lobby for laws to mandate vaccinations. edit: obviously lobbying is not 100% responsible for all vaccinations laws, but it's partly so and increasing.

Fine, but obviously it's not only the vaccine manufacturers who are pushing for things like mandatory vaccinations for public school enrolment (except where unable, e.g. immunocompromised children unable to tolerate the vaccination itself). It's also, y'know, people with an interest in promoting public health, people who understand the concept of herd immunity, and people who have a reasonably tuned sense of social r…

I don't really disagree with you too much except that lobbying is relevant when considering regulatory capture.

And if you want hard numbers to analyze the impact of lobbying, you're not going to get it, because lobbyists have lobbied against transparency laws. Anyhow, the impact is real such as with Merck and Gardasil. Further, it's not only laws that matter but court precedent and CDC policies.

But certainly you're right that many unbiased/disinterested people agree with pharma. It's definitely not an issue only related to profits.

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