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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

#41

Post by refurb »

Alex3917 wrote: post #37
powera wrote: post #6

I think we have to face that the FDA is incompetent and corrupt. Getting a drug approved is more dependent on how much money you want to spend than on whether it works. Some drugs that may be effective are delayed for years and years ( http://well.blogs.nytimes.com/2015/02/05/for-a-l-s-patients-... ) while other drugs that don't work are approved as being effective.

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 patients access to a potentially helpful therapy (antidepressants do help some patients) is better than just pulling the product off the market.

As for the suicide risk, again, there is data to suggest that antidepressants can increase the risk of suicide. However, that data isn't cut and dry. Over the last few years the FDA has actually loosened it's warning since the data is in question. Note that the FDA required all of these drugs to have a black box warning stating the risk of suicide (the most strict warning any drug can have).

Producing and testing drugs does not result in a binary outcome (drug good/drug bad). What the FDA does is look at the risk/benefit and makes a decision on that. Frankly I think they do a pretty good job at it.

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

#42

Post by refurb »

mirimir wrote: post #39
littletimmy wrote: post #34

Earlier quoted context omitted.

Raise the salary.

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.

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

#43

Post by zaroth »

1123581321 wrote: post #38
ekianjo wrote: post #25

Earlier quoted context omitted.

Oh really ? Is that Science, in a non-controlled environment, no supervision of health care professionals ? I doubt anything like that is going to happen any time soon. Plus, the public does not have access to the synthesis or new materials, and I doubt that people would actually inject themselves with drugs that have never been tested on animals in the first place.

You're missing the big trend. In addition to the availability of DIY hardware and more ways for patients to find each other and communicate, other developed or developing countries are approving treatments before the FDA. The size of the US market still holds back medical research, but at some point in this century, the size of the "early adopter" markets with sufficient buying power will be big enough that it won't…

Just got my son on a CGM last week. The receiver claims a range of 20 ft, but it won't pick him up from our bedroom a wall away.

When the receiver fails, you silently lose the hypoglycemia alerts.

I've already ordered a pack of Wixels to setup these throughout the house, backyard, and at his preschool:

https://github.com/StephenBlackWasAlreadyTaken/wixel-DexDrip

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

#44

Post by logn »

ekianjo wrote: post #22
hurin wrote: post #13

Pharmaceuticals is a ridiculous industry, public health and scientific merit are on the lowest rungs of their list of priorities.

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.

I can't think of many industries pushing for laws to force you to ingest their product. Eating McDonald's is not a prerequisite for admittance to pre-school.

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

#45

Post by zaroth »

hurin wrote: post #31
ekianjo wrote: 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…

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.

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

#46

Post by 1123581321 »

zaroth wrote: post #43
1123581321 wrote: post #38

Earlier quoted context omitted.

You're missing the big trend. In addition to the availability of DIY hardware and more ways for patients to find each other and communicate, other developed or developing countries are approving treatments before the FDA. The size of the US market still holds back medical research, but at some point in this century, the size of the "early adopter" markets with sufficient buying power will be big enough that it won't…

Just got my son on a CGM last week. The receiver claims a range of 20 ft, but it won't pick him up from our bedroom a wall away. When the receiver fails, you silently lose the hypoglycemia alerts. I've already ordered a pack of Wixels to setup these throughout the house, backyard, and at his preschool: https://github.com/StephenBlackWasAlreadyTaken/wixel-DexDrip

That's a good solution. I'm getting a Dexcom pretty soon (relatively recently diagnosed.) It's a bit depressing to compare the speed of the Dexcom hacker community to the speed of Dexcom's FDA-approved software releases, but at least we aren't still stuck with Medtronic.

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

#47

Post by ericd »

logn wrote: post #44
ekianjo wrote: 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.

I can't think of many industries pushing for laws to force you to ingest their product. Eating McDonald's is not a prerequisite for admittance to pre-school.

Are you trying to imply that vaccines being mandatory is the result of lobbying and not just because it's an extremely important tragedy of the commons problem?

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

#48

Post by chaostheory »

chris_va wrote: post #20
powera wrote: post #6

I think we have to face that the FDA is incompetent and corrupt. Getting a drug approved is more dependent on how much money you want to spend than on whether it works. Some drugs that may be effective are delayed for years and years ( http://well.blogs.nytimes.com/2015/02/05/for-a-l-s-patients-... ) while other drugs that don't work are approved as being effective.

The oped piece you cited does not support your assertion that the "FDA is incompetent and corrupt". They may be, but that is a pretty hefty accusation and requires more evidence. Nor, honestly, does it support the "getting a drug approved is more dependent on how much money you want to spend than on whether it works" claim, or the "some drugs that may be effective are delayed for years and years". Developing a drug i…

> The original link cites corruption at the hospital level, which does seem like the weakest link in the system.

If corruption stopped at the hospital there, then this wouldn't happen at the FDA:

> As David Ross, the FDA official in charge of reviewing Ketek’s safety, put it, “In January 2003, over reviewers’ protests, FDA managers hid the evidence of fraud and misconduct from the advisory committee, which was fooled into voting for approval.”

Corruption goes beyond the hospital level and it extends into the FDA itself.

> As part of the new drug application process, or, more rarely, when the agency gets a tipoff of wrongdoing, the FDA sends a bunch of inspectors out to clinical sites to make sure that everything is done by the book. When there are problems, the FDA generates a lot of paperwork—what are called form 483s, Establishment Inspection Reports, and in the worst cases, what are known as Warning Letters. If you manage to get your hands on these documents, you’ll see that, most of the time, key portions are redacted: information that describes what drug the researcher was studying, the name of the study, and precisely how the misconduct affected the quality of the data are all blacked out. These redactions make it all but impossible to figure out which study is tainted.

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

#49

Post by zipfle »

I find it really interesting to juxtapose this situation with the current furor over Brian Williams' not actually having been in a helicopter he said he was in.

It's odd, but not too surprising, that the only job you can actually get fired from for lying is "propaganda mouthpiece."

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

#50

Post by bgun »

zipfle wrote: post #49

I find it really interesting to juxtapose this situation with the current furor over Brian Williams' not actually having been in a helicopter he said he was in. It's odd, but not too surprising, that the only job you can actually get fired from for lying is "propaganda mouthpiece."

the only job you can actually get _publicly shamed and publicly_ fired from for lying is "propaganda mouthpiece."

Someone being fired for lying, and someone you heard about getting fired for lying, are very different things.

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