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

As for Sun, who knows? In 2008 Ranbaxy managed to pawn off 64% of the company to Japan's Daiichi-Sankyo for $7 billion. Sun bought that stake in 2014 for $4 billion ... in Sun shares, i.e. a firesale price, at least compared to the original. And Ranbaxy has lots of plants outside India which to my knowledge and recent research can still ship to the US.

Although I'm not sure how many of those actually synthesize the raw stuff as these Indian plants did, then again Sun is probably best off with them shut down; that they didn't proactively deal with the Ranbaxy's cancer ... well, you can see why I'm nervous about that drug I'm taking.

Somebody has to be first.

That said, is an interesting question.

If it's done according to the scientific method, then it can be called scientific research.

If not, it's just research.

I also presume that there is a more important aspect. If society believes that homeopathy works and that vaccines cause autism, that would be good cause to conduct very rigorous, credible (and above all media-friendly) experiments testing those beliefs.

If society believes that eating too many eggs is bad for you, test it. If we believe drinking red wine is good for you, test it. If we believe reptilian aliens are using sodium fluoride in the water supply as an adjuvant for their mind control rays, test it.

I presume, without knowing, that this particular aspect of SBM is very much about countering all the junk science hucksters stowing away on the gravy train, just because no one bothers to grab their freeloading asses and throw them off. So when Dr. Selschupplementsondeside (who may or may not be inspired by an actual person) touts a miracle cure on his cable television show, you put that on your list for potential testing and start tracking the hype versus scientific credibility ratio. If too many people start believing without knowing, you need some experimental results.

We can't test everything, so focus on testing the unanswered questions. Test the home remedies and traditional cures. Debunk the junk science.

For example, homeopathy states that a remedy becomes stronger the more dilute it becomes - i.e. the lower the dose, the stronger the effect. This defies the dose-response relationship between an active ingredient and its effect. Further, it states that even when no more of the active ingredient remains, it can still have an effect.

SBM would say homeopathy isn't worth studying because it has no plausibility based on what we know of medicine and physics.

EBM would say let's test it and see what we get.

The problem is that if you test the same thing enough times, or measure enough variables, and then discard the ones that don't meet your desired outcome, you can gather "evidence" for basically anything.

SBM would say weak evidence for a claim like homeopathy is meaningless, as the claim is extraordinary (it overturns physics), so you need stronger evidence than you might accept for a less exceptional claim. EBM doesn't make that judgment, it treats all evidence as equally valid.

There is a treatment for trauma (PTSD etc.) called EMDR (Eye Movement Desensitization and Reprocessing) which has over 20 years of statistical evidence backing up it's efficacy. To date, no-one really knows how it works (there are a few good theories, and hopefully modern neuroscience can help here).

Currently, it's "EBM". There is a huge amount of evidence to show it works, but no proven theory as to why.

It's not "SBM" yet, as there still isn't a demonstrable mechanism or theory that describes why it works.

homeopathy, antivaxers and scientoligists don't even have any evidence to show they work. They don't even count as "EBM".

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 don't have to agree with or like things to see them coming you know.

> Plus, the public does not have access to the synthesis or new materials

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.

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.

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.

The testimony: """ After considering the fact that the investigation results were preliminary and we had not received formal recommendations about how to take the results into account in review of the application, and the fact that only in very rare cases do inspection results from individual sites lead to the exclusion of an entire large clinical trial, FDA decided to hold the Advisory Committee meeting as planned. The Agency made this decision, knowing that any advice from the Committee would have to be later taken into account in the context of additional information about the integrity of data from Study 3014. It is not unusual for more information to come to FDA for review after an Advisory Committee meeting is held about an application. The Advisory Committee voted that the safety and efficacy of the requested indications had been demonstrated, based on the information it was provided, including Study 3014, and limited international post-marketing data provided at the meeting. Although the Advisory Committee recommended approval, on January 23, 2003, (two weeks after the Advisory Committee meeting) FDA issued another approvable letter to the sponsor because of the remaining questions about the safety of Ketek. The letter specifically noted the unresolved data integrity issues associated with Study 3014 (issues confirmed in the final clinical inspection summary of the Agency's audits of the first three clinical trial sites) and the incomplete post- marketing safety data from foreign countries. FDA noted that the final decision regarding approval of each indication would be made after a review of the information and analyses requested in this letter. On March 3, 2003, during a closed session of the Advisory Committee convened to discuss other matters, FDA briefly explained that an approvable letter was issued because the Agency wanted to see more information about data from Europe and Latin America. With regard to Study 3014, FDA explained that there were unresolved inspectional issues. Third Cycle. The sponsor submitted a complete response to the approvable letter in October 2003. The October 2003 submission addressed issues of Study 3014 and included post- marketing reports for spontaneous adverse events for approximately four million prescriptions for patients in other countries where Ketek had already been approved. Upon completing the review of the sponsor's October submission, including the findings from the additional audits of clinical trial sites summarized in a March 2004 memorandum from the Division of Scientific Investigations, the Agency decided that it could not rely on Study 3014 to support approval of Ketek because of the systemic failure of the sponsor's monitoring of the clinical trial to detect clearly existing data integrity problems. Accordingly, Study 3014 was dropped for consideration in making the decision whether to approve Ketek. The Agency considered data from other clinical trials and the international post-marketing experience to conclude there was adequate evidence of safety. """

I'm all for allowing patents to access unproven medicines, but why should the companies be allowed to run billion dollar marketing campaigns saying that they work?

>The FDA is clearly catching these companies doing wrong, so why are they covering it up?

This deserves more research. Don't get distracted by "big pharma", ask why the FDA aren't doing anything about the wrong-doing they're uncovering.

Occam's razor cuts towards lack of funding.

Next question: Who is in charge of FDA funding? How can this be changed?

So the usual handwavy appeal to "regulation" that is so common I'm comfortable implicitly reading it into the above criticism despite it not explicitly containing it is not enough.

I'm generally libertarian, but behind that libertarianism is not the belief that the government "can't do anything", but more the observation that a lot of people go through the following process:

    1. Identify a problem. Maybe. (Accuracy is optional at this stage.)
    2. Claim we need "regulation". No details given.
    3. Case closed!

Nope, it's a hard problem. It's a lot of hard problems, and people who just attack industry and handwave haven't even properly engaged with the problems, let alone solved anything. The fact that there is such widespread belief in the airy handwaves of "regulation" is itself a primary cause of things like this sort of dysfunction... it becomes a political attack to claim that the regulation has a problem because of course it's working, how can it not? It is literally inconceivable, and to emphasize, I mean, literally not expressible in the relevant neurons in people's brains. People treat it as an atomic entity that can not be further investigated, rather than as a complicated mechanism in a complicated system that requires systemic analysis, and the resulting possibility that on occasion, yes, the regulatory agents will be broken.

(From a positive perspective, my libertarianism comes from the observation that markets are freaking powerful and regulatory regimes, since they are created by people whose thinking is biased into an "us vs. markets" modality rather than the aforementioned "systemic analysis" often screw up, either by missing chances to harness the power of the market, or by fighting them in ineffective or inefficient (in the usual sense of the term, not EMH) ways. This blindness results in regulatory regimes that start from day one by first dropping their most powerful tool on the ground. Unsurprisingly, this often results in less effective regulation. We need regulation because not even I want to live in a raw market-dominated world, but nobody wins when it's done stupidly because of preconceived moralistic notions about markets, which are in many ways best conceived of and treated as natural forces rather than demonic embodiments of pure evil or something equally silly, and thus something best harnessed properly, not fought and pilloried. In this case, I'd suggest that a more market-comprehending regulatory regime would understand that transparency and openness are key to properly keeping the system functioning properly, and that the top priority the first time they received any information like this should have been getting word out to people. But, that's not part of how they think, because the idea that this could have been nipped in the bud much earlier by harnessing the power of information flows in a market simply isn't in their DNA. In all likelihood they wouldn't hardly have needed to do much of anything else, but instead the inevitable logic of a market-fearing regulator, through several steps I'm not explaining, leads to this sort of coverup with distressing frequency.)

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.

Define "nutritional equivalent" and "natural products"?

Do you just want the same levels of carbs/fat/protein as Soylent has, or do you want to also get the same levels of iron, sodium, vitamins, etc.? The more demanding you make that condition, the closer you get to just replicating Soylent. ("We could replace this artificial ingredient with that natural one, but the natural one has less salt, so to make up for that we have to...")

And it hardly seems fair to compare Soylent against a natural equivalent of Soylent, which doesn't currently exist to my knowledge, instead of against people's actual real-life diets.

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 have VERY researched positive impact on public health. If government were a private corp then hell yes they would require vaccinations.

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

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

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 parts of the FDA have been relatively starved. As drugs enter the market faster, it becomes increasingly difficult for the FDA to perform its other functions -- including monitoring drug safety, ensuring manufacturing standards, and regulating marketing. [...]

Furthermore, the FDA is subject to industry pressures through its eighteen standing advisory committes, which consist of outside experts in various specialties, are charged with reviewing new drug applications and making recommendations to the agency about approval. The FDA almost always takes their advice. Many members of these committees have financial connections to interested companies. Although there are conflict of interest rules that prohibit participation in such cases, the agency regularly waives them on the unlikely grounds that someone's advice is indispensable. USA Today examined FDA hearing records in 2000 and found that 'at 92 percent of the meetings at least one member had a financial conflict of interest,' and 'at 55 percent of meetings, half or more of the FDA advisers had conflicts of interest.'

Members of FDA advisory committees are said to command unusually high consulting fees from drug companies. They are certainly in a position to do so. They probably don't even have to say, 'Pay me if you want your drugs approved.' According to the Washington Times reporter August Gribbin, 'One drug company executive who asked not to be identified referred to the advisory committee members' approaches for obtaining [consulting] work as 'shakedowns' because a company that refused to yield to such requests could doom products that cost tens of millions of dollars to develop.'" Source: The Truth About Drug Companies, p. 209

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.

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.

The FDA's own website contradicts you here:

http://www.fda.gov/Food/DietarySupplements/

The FDA, on their own website, says it's their job to make sure that supplements are unadulterated and not mislabeled. If 80% of supplements are in fact completely fake, then I don't see how you're using the problems of the supplement industry to show how well the drug industry is regulated in comparison.