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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

#91
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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).

Two positive trials, but if there are additional negative trials those can be ignored. There is no requirement to combine all available trials in a meta-analysis. Very easy for the pharm company to come up with some excuse to throw away "bad" data.

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

#92
post #45
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…

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.)

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

#93
post #69
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…

> (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 personally think @refurb asked exactly the right question (whether he's from the industry or not).

>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?

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

#94
post #56

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?

You can call it research.

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

If not, it's just research.

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

#95
post #26

The misconduct itself is not surprising, given that all drug studies required for drug approval are performed by the company seeking the approval. The cover-ups are also not surprising, given that industry insiders go back and forth between jobs in Industry, and running the FDA.

> given that industry insiders go back and forth between jobs in Industry Very true, and there is very little done to reveal "Conflicts of Interests". Public Officials should be completely transparent (sources of income, past and present relationships, etc) if not I am afraid we cannot exclude corruption at any level.

This doesn't really reflect my understanding of the matter. In fact, the onerous restrictions required to work for the FDA (or any discretionary government agency, really) are one of the biggest reasons that people move to private industry...

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

#96
post #23

Earlier quoted context omitted.

Most drugs go first on the American Market, because that's the most profitable one by far. Any source for your claim ?

I worked for a client that was trying to develop a medical device (stents). I was told it was cheaper and faster to get approval in Europe.

Medical devices are not drugs. They do not follow the same regulations. And in Europe the medical device registration can be very fast depending on the type of medical device (they have standard classifications for fast review, and some are self-certification type of registration).

You should never make a parallel between medical devices and drugs because those are just two very different markets. And unless you have a better source for your first point, I stand by my position that the US gets most of the approval first, worldwide. And most of the large pharma industries are American.

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

#97
post #69

Earlier quoted context omitted.

> (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 personally think @refurb asked exactly the right question (whether he's from the industry or not). >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…

I'd expect uncovering the evidence to be the hard part - but then I remember how messed up the USA legal system is ...

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

#98
post #31
post #22

Earlier quoted context omitted.

To be honest I can't think of many industries which place public health scientific merit at their top priorities either. You could say the same thing about the food and beverages industries, and Soylent too if you care about mentioning stuff that makes HN tick often.

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 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.

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

#99
post #29
post #26

Earlier quoted context omitted.

> given that industry insiders go back and forth between jobs in Industry Very true, and there is very little done to reveal "Conflicts of Interests". Public Officials should be completely transparent (sources of income, past and present relationships, etc) if not I am afraid we cannot exclude corruption at any level.

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 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

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

#100
post #41

Earlier quoted context omitted.

And this article doesn't even cover 95% of the problems with the FDA, many of which are as bad or worse. But on this topic, here is a good example that the article missed: http://www.washingtonpost.com/wp-dyn/articles/A9802-2004Sep9... Basically the FDA ordered pharma companies bury the research showing that antidepressants were ineffective in children and could lead to suicide, because they were worried that parents…

The FDA's actions in this case are understandable. Proving that CNS drugs work is a huge pain in the ass and the FDA knows this. There is a huge placebo effect (that is interestingly increasing over time) and the our tools to measure depression frankly suck (too subjective). Yes, a number of antidepressant trials failed to show efficacy. However, a few of the trials did show improvement. The FDA decided that allowing…

> The FDA decided that allowing patients access to a potentially helpful therapy (antidepressants do help some patients) is better than just pulling the product off the market.

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?

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