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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

#121

Post by logfromblammo »

static_noise wrote: post #74
chris_va wrote: post #60

Earlier quoted context omitted.

Well, technically they are replicating the study over 50+ different hospitals until they reach some confidence interval on the safety data. If you get fraud in a small fraction of them, it should not (and if you read the actual testimony, does not) impact the net result.

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 outperform a gratis placebo are only producing that effect because the act of charging more for them makes them better placebos?

If that's the case, the fraud would only be needed to eliminate evidence of harm to get approval for a bogus remedy. All the effectiveness would come from magnified placebo effect.

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

#122

Post by ska »

refurb wrote: post #42
mirimir wrote: post #39

Earlier quoted context omitted.

The US pharmaceutical industry is too wealthy for that to be workable. The game is to make friends while working at the FDA, and then to cash in. In order to serve the public interest, drug discovery and testing ought to occur in academia. The pharmaceutical industry should play no role in that, and should merely manufacture approved drugs. Edit: Please see The Truth About Drug Companies , by Marcia Angell, M.D., for…

In order to serve the public interest, drug discovery and testing ought to occur in academia. Where do the funds for R&D come from? Getting academia to discover drugs is not a workable solution.

Academia already does much of the fundamental research.

It's mostly the "D" part of the "R&D" that is expensive, and shapes the pharma industry. Some of this could be addressed by making clinical trials cheaper to operate and initialize, but it's always going to be quite expensive.

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

#123

Post by refurb »

Alex3917 wrote: post #99
refurb wrote: post #29

Earlier quoted context omitted.

Very true, and there is very little done to reveal "Conflicts of Interests". Sure there is. If you sit on an FDA panel you need to declare all conflicts of interest. Panel members usually recuse themselves under those circumstances. The tough part is that you can't stop folks from moving between industry and the FDA. Both organizations are looking for the best folks. It reminds me of doctors being paid for clinical t…

> If you sit on an FDA panel you need to declare all conflicts of interest. Panel members usually recuse themselves under those circumstances. 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 p…

Once again, "conflict of interest" is not a binary thing. People can have weak conflicts of interest (owning pharma stock in their 401k) and strong conflicts of interest (sitting on the board of a pharma company). The FDA needs to balance that with getting the best folks they can on their advisory committees.

So yes, some folks who have conflicts of interest remain on the committees. I don't think it's something that can be avoided. The point is that the FDA is trying to address the issue and many folks who have strong conflicts of interest usually recuse themselves from those discussions.

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

#124

Post by refurb »

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…

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.

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

#126

Post by refurb »

hga wrote: post #106
refurb wrote: post #28

Earlier 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…

" The FDA is just starting to think about inspecting those plants. " Fortunately it's a lot better than that. They have been inspecting them for a long time, but infrequently and preannounced, and even then caught some in the act. After the gross, top to bottom fraud of Ranbaxy, they started doing unannounced visits, which has resulted in every one of their plants in India being shut down: https://news.ycombinator.co…

Your are correct. My statement was an exaggeration. The FDA has been inspecting foreign plants, but from what I've read they only have enough inspectors to inspect any given plant maybe once every few years. Certainly not ideal. The FDA is looking to ramp up hiring so that they can get much better coverage.

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

#127

Post by tokenadult »

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.

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 resisted more effective and rational regulation.

[1] http://www.sciencebasedmedicine.org/big-supp-resists-giving-...

[2] http://www.sciencebasedmedicine.org/fda-versus-big-supp-rep-...

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

#128

Post by logfromblammo »

kirsebaer wrote: post #92
zaroth wrote: post #45

Earlier quoted context omitted.

Soylent is not intended to diagnose, treat, cure, or prevent any disease. FDA be damned, people are actually allowed, with great level of discretion, to choose what they eat. There are controls on what they can put it in, it must have an accurate ingredient list, a nutritional label, etc., but medicine it is not.

Soylent is intended to prevent malnutrition. It is advertized as fullfilling _all_ of your nutritional needs. (Why would they call it Soylent? The name comes from a sci-fi movie where Soylent is a food made from human corpses. Using that name is an indication that there is a lack of judgement in the Soylent team.)

Prevention of malnutrition is not the same as treatment of nutritive deficiency diseases. Prevention of malnutrition is more simply termed "eating food".

Products like Soylent or Plumpynut are foods, not drugs. Replacing one's entire diet with Soylent is logically equivalent to choosing to eat a banana rather than an apple with your lunch today.

If you have kwashiorkor or beriberi or scurvy or pellagra, it is unlikely that you could be effectively treated with Soylent, because it is formulated to satisfy daily needs, rather than to correct a deficiency that may have taken many months to manifest symptoms. It is designed to be a complete food, using a recipe.

And if you watched the movie (it doesn't hurt all that much), you would know that only Soylent Green was made from people, rather than algae, as was claimed. The Soylent company sold other types of food products, and everyone ate mostly Soylent-brand foods, because they could not afford anything better. In the film, all the extras got most of their nutrition from Soylent Orange or Soylent Blue, or whatever those grubby-looking flakes were in the bins. Soylent Green always sold out early, and was in short supply.

Still... not the best naming decision. Most people haven't seen any more of the movie than the scene where Heston cries "You've gotta tell 'em. Soylent Green is people!"

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

#129

Post by refurb »

ska wrote: post #122
refurb wrote: post #42

Earlier quoted context omitted.

In order to serve the public interest, drug discovery and testing ought to occur in academia. Where do the funds for R&D come from? Getting academia to discover drugs is not a workable solution.

Academia already does much of the fundamental research. It's mostly the "D" part of the "R&D" that is expensive, and shapes the pharma industry. Some of this could be addressed by making clinical trials cheaper to operate and initialize, but it's always going to be quite expensive.

I agree that most fundamental (chemistry, biology) research is done in academia. But fundamental research doesn't deliver new drugs, it only supports discovery.

About 24% of new drugs are discovered in academia.[1] The remainder come from industry. I think offloading all discovery to academia, plus the "D" part of R&D would be something academia would struggle with.

[1]http://pipeline.corante.com/archives/2010/11/04/where_drugs_...

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

#130

Post by thisIsNotMikey »

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?
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