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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

#131

Post by acdha »

thisIsNotMikey wrote: post #130

The problem with the FDA is it usurps liability from the manufacturer and responsibility from the consumer. Most Americans will grant more time to a free app review, than to a nutrition label. We have a false sense of security that food and drugs are FDA "approved." This same problem exists in banking because of the FDIC. How many people know what's on their bank's balance sheets?

How many consumers are capable of evaluating drug safety and have time to do so? This is a real problem requiring time from a limited number of highly skilled professionals and easy proposed solutions are naive.

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

#132

Post by Alex3917 »

tokenadult wrote: post #127
Alex3917 wrote: post #120

Earlier quoted context omitted.

> 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 supplem…

The FDA already has the power to regulate supplements, for the most part they just choose not to. No, the "natural supplements" industry has carved out for itself a huge exemption from most of the regulation that applies to drugs, on the one hand, or foodstuffs, on the other hand. See a group blog post on "Big Supp"[1] for more information about this. For years, that industry had a champion in Congress[2] who resiste…

> No, the "natural supplements" industry has carved out for itself a huge exemption from most of the regulation that applies to drugs, on the one hand

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.

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

#133

Post by spydum »

heliumcraft wrote: post #103
wanion wrote: post #84

Earlier quoted context omitted.

EBM is meant to be serious science, but there's been a real effort to co-opt it for quackery. SBM is an attempt to inject science back into it. The difference comes down to how they treat evidence. 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 e…

for the record: homeopathy does not do well with EBM either.. (as in quality double blind studies)

sure, but if researchers can cherry pick the data and studies, they just have to avoid those quality double blind studies. all of a sudden, their meta analysis of # studies shows significance!

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

#134

Post by Retric »

woodman wrote: post #12
Retric wrote: post #5

Earlier quoted context omitted.

US raiting agency's are setup to be corrupt as the seller pays the raiting agency so there going to look for the loosest respectable option. And the agency has little incentive to dig deep.

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.

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

#135

Post by bduerst »

thisIsNotMikey wrote: post #130

The problem with the FDA is it usurps liability from the manufacturer and responsibility from the consumer. Most Americans will grant more time to a free app review, than to a nutrition label. We have a false sense of security that food and drugs are FDA "approved." This same problem exists in banking because of the FDIC. How many people know what's on their bank's balance sheets?

FDIC insurance exists so you do not need to keep checking in on your bank's integrity. It is set up this way by design. Should the bank run with your money or fold, you get your money back.

How you extrapolate FDA regulations and faith in it to banking is a bit beyond me, because if you get diabetes the FDA is not insurance you can use to treat it.

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

#136

Post by thisIsNotMikey »

acdha wrote: post #131
thisIsNotMikey wrote: post #130

The problem with the FDA is it usurps liability from the manufacturer and responsibility from the consumer. Most Americans will grant more time to a free app review, than to a nutrition label. We have a false sense of security that food and drugs are FDA "approved." This same problem exists in banking because of the FDIC. How many people know what's on their bank's balance sheets?

How many consumers are capable of evaluating drug safety and have time to do so? This is a real problem requiring time from a limited number of highly skilled professionals and easy proposed solutions are naive.

The consumers directly don't. But as a consumer I don't know how to evaluate an automobile, a smart-phone, or other products. But there is a market that provides the relevant data to consumers. Before I buy a car, I check out USNews, or Edmunds; before I buy any product I check out the relevant resources. Because of the way the FDA is structured, not much non-FDA research and reviews are being done. Lol. I didn't propose a solution.

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

#137

Post by thisIsNotMikey »

bduerst wrote: post #135
thisIsNotMikey wrote: post #130

The problem with the FDA is it usurps liability from the manufacturer and responsibility from the consumer. Most Americans will grant more time to a free app review, than to a nutrition label. We have a false sense of security that food and drugs are FDA "approved." This same problem exists in banking because of the FDIC. How many people know what's on their bank's balance sheets?

FDIC insurance exists so you do not need to keep checking in on your bank's integrity. It is set up this way by design. Should the bank run with your money or fold, you get your money back. How you extrapolate FDA regulations and faith in it to banking is a bit beyond me, because if you get diabetes the FDA is not insurance you can use to treat it.

Moral hazard. It is a simple concept.

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

#138

Post by dragonwriter »

Alex3917 wrote: post #120
tokenadult wrote: post #101

I 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 supplem…

> The FDA already has the power to regulate supplements, for the most part they just choose not to.

The FDA has some power to regulate supplements, but the relatively light touch they use on them is not something the FDA chose independently, but a direct result of the limits on the scope of their power and the bases on which they may exercise it in the authorizing legislation, which Congress made very weak after a supplement-industry sponsored publicity campaign painting the effort to grant the FDA regulatory authority over supplements as an effort to "ban supplements".

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

#139

Post by hurin »

philh wrote: post #98
hurin wrote: post #31

Earlier quoted context omitted.

Of course - but the food and beverage industry can't serve you amphetamine-salts in your coke (well not anymore) just because it's profitable. I don't know what soylent is (beyond just searching it in google). Wikipedia says: Soylent is a nutritional drink, intended to cover all human nutritional requirements for an adult so that it may serve as main or sole food There should be a very obvious test for this right? I…

> compared to a randomly sampled population consuming the nutritional equivalent in natural products. 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…

I don't think I ever mentioned 'replicating soylent' - By nutritional equivalent in natural products I presumed a diet.

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

#140

Post by hga »

refurb wrote: post #124
hga wrote: post #104

Earlier quoted context omitted.

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…

When I checked on this about a month ago, it appeared that every Ranbaxy plant in India had been shut down. I'm not sure if they are shutdown, but the FDA has banned imports into the US from everyone of the Ranbaxy plants. Sun Pharma is in a bad situation with this since they can't sell into the US market from their new acquisition.

Initially they of course didn't shut down, that's not in Ranbaxy's DNA, but other parts of the world were none too pleased with the horrendous details of the FDA inspections, and that forced the shutdown of every one of their Indian plants at their 4 major locations.

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.

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