Topic: Drug company employee says, "Don't believe our studies."

[Obsequious]

http://www.newser.com/story/148059/drug-company-employee-dont-believe-our-studies.html

(Newser) – Bear this in mind the next time a drug company touts a serious study proclaiming the wonders of its product: A former employee of a "major" pharmaceutical company has written an essay in the British Medical Journal warning that the industry's scientific-sounding studies are sometimes rigged. “We occasionally resorted to ‘playing’ with the data that had originally failed to show the expected result,” he writes in the subscription-only essay. “This was done by altering the statistical method until any statistical significance was found.”

As Nature explains, the writer is referring to studies that get done after FDA approval, "research" that is subject to far less scrutiny. The companies pay doctors to enroll patients in studies, then massage the results until they're tailor-made for a commercial. The studies are "not designed to determine the overall risk:benefit balance of the drug in the general population," writes the anonymous whistle-blower. "They were designed to support and disseminate a marketing message."

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      Why would anyone lie just to make a billion dollars off of something that doesn't work as advertised?

[Citizen Skeptic]

There is a formal mechanism for drugs called post-market surveillance that is supposed to track this stuff. Also, messing with claims is against FDA regs. You can't make claims beyond what's been submitted. But I also don't doubt the marketing department heavily influences the positioning although all marketing literature also has to be submitted.

[Ajzzz]

On occasion they get a data set and divide it up until there's statistical significance found, basically messing with the nature of the sample and its randomness without changing any values, they then market these benefits to the general populace. They especially do this when they are competing with cheaper generics. It's similar to the publication bias that goes on. The studies are submitted with the claims, they're just not rigorously checked or independently reproduced, there's far less scrutiny on after-market modifications after a drug has already been approved.

[Anders]

I just want to assure everyone that this takes place outside drug company studies.

[Zytheran]

I think this is covered in the book "Being Wrong" by Kathryn Schultz. Book's at work so I'll check.
Seriously, if your life is happy don't try to find out the biases in medical trials, or even current medical practices like using stents.
You don't wan't to know.

Also referred to as file drawer effect or publication bias and is slowly getting addressed by ensuring all drug trials are openly stated before running them so the ones that don't work can't just disappear as if they never happened.

[jaypee]

How long will it take for the anti-pharma crowd to conflate "As Nature explains, the writer is referring to studies that get done after FDA approval" with "ZOMG THE DRUG COMPANIES COMPLETELY LIE ABOUT THE SAFETY AND EFFICACY OF THEIR DRUGS AND THE FDA IS TOTALLY COMPLICIT!L!@#!@#!@"

[David E.]

How long will it take for the anti-pharma crowd to conflate "As Nature explains, the writer is referring to studies that get done after FDA approval" with "ZOMG THE DRUG COMPANIES COMPLETELY LIE ABOUT THE SAFETY AND EFFICACY OF THEIR DRUGS AND THE FDA IS TOTALLY COMPLICIT!L!@#!@#!@"

Two weeks ago last decade; give or take a 1/2 century or more. 

"More proof that you should buy our stuff instead.  We don't lie about studies on our products, because we don't bother studying them!" 

[Citizen Skeptic]

I think the biggest pharma scam is chemo/cancer drugs. Talk about low efficacy and a ripe environment for cherry picking.