The authors better be careful or the next contact they have with government documents is notice of an IRS audit.
The FDA buries evidence of fraud in medical trials. My students and I dug it up
111–120 of 177 posts
Re: The FDA buries evidence of fraud in medical trials. My students and I dug it up
#112Earlier quoted context omitted.
Regulatory capture is pretty much inevitable. In almost any field, the skills needed for government regulators to evaluate claims are interchangeable with the skills needed to work in the field. The only thing that will help is strong whistleblower protections, to allow the ethical members of a profession to call bullshit without fear of repercussion. (This won't work in banking, for obvious reasons :P )
How about the Singapore model? Pay government bureaucrats huge salaries and pensions so they don't have to structure their career around getting a private sector cash out after they retire from regulating.
I'd wonder where the regulators are going to learn the skills needed to regulate. Drug development is not quite like academic research.
Re: The FDA buries evidence of fraud in medical trials. My students and I dug it up
#113I 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…
I was trying to think of an argument to disagree with you with but you're right. From the times of Woodrow Wilson's reign to John Edgar Hoover and Nixon to the NSA, there's never really been a time in the past hundred years some part of the government wasn't corrupt and power hungry. And probably even before 1900 too with slavery and subduing of the Indian tribes. The freest least corrupt point in USA government's history is probably July 2, 1776.
Re: The FDA buries evidence of fraud in medical trials. My students and I dug it up
#114Talk about this kind of journalism out of context (why you don’t trust a particular study, for instance) and you’ll be called a quack or conspiracy theorist.
Re: The FDA buries evidence of fraud in medical trials. My students and I dug it up
#115Earlier quoted context omitted.
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.
I think the point here is that it's pretty obvious that when people start beating up on "industry" they're basically calling for "more" regulation, but we have the regulation, the authority, the ability to assess penalties, everything you could possibly already want with "regulation". What's being done is already illegal and already being detected by an authority with the power to do something.
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.)
Re: The FDA buries evidence of fraud in medical trials. My students and I dug it up
#116A 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.
Re: The FDA buries evidence of fraud in medical trials. My students and I dug it up
#117Earlier quoted context omitted.
[deleted]
Fair enough; my comment was intended as an addition to your list of " 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 responsibility. " with examples in living history. Plus you can't get away from the concept of "good science" and people who don't accept the concept at all in this domain,…
Yes, I deleted my comment above shortly after leaving it because I figured it was a relevant discussion afterall unless I'm splitting hairs. (In the deleted comment I claimed this was all off topic to my original post).
Re: The FDA buries evidence of fraud in medical trials. My students and I dug it up
#118Earlier 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.
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…
Not knowing anything about the praxis of SBM, I presume that "prior beliefs and evidence" would be in the nature of noticing that people once used aspen bark tea to treat pain and fever, then determining through a series of experiments the exact molecule or group of molecules that produced the effect. At the end of the experiments, you determine that acetylsalicylic acid, ingested orally, is an effective remedy for pain and fever, with side effects stomach irritation etc.
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.
Re: The FDA buries evidence of fraud in medical trials. My students and I dug it up
#119Earlier 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.
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?
Re: The FDA buries evidence of fraud in medical trials. My students and I dug it up
#120I post a fair number of stories about regulation of medical treatments here on Hacker News. I see this one has attracted a lot of reader interest. The comments already posted as I post this comment point out that once someone sets up a regulatory program, the incentives become powerful to figure out ways to cheat the regulators. And, as usual, scientific research is hard (another topic I post a lot about here), and r…
> For natural supplements, the regulatory problem is far worse [...] So the better trade-off for the consumer here is to amend existing law so that as drugs go through clinical trials, disclosure and peer review of FDA inspection findings during the trials is a condition for marketing approval.
- The FDA already has the power to regulate supplements, for the most part they just choose not to. So the idea that supplements just need FDA regulation like 'regular drugs' is largely fallacious.
- Why should supplements need clinical trials for marketing approval when that isn't the standard for other any other comparable drugs on the market? I.e. almost all drugs that were in use before the 50s are allowed to be marketed without any testing for safety or efficacy, and since almost all supplements have a much longer history of human use, why should they be treated differently?