Operator Speaking by Zachary Constantine
 

Snake Oil, Lies, and Forgery: Effective Placebos, Biased Drug Trials, Ghostwriting for Doctors

2009-08-30 01:58:35 // The Operator
 

Dr. Robert Goodman, an internist in New York City, says the real force behind skyrocketing antidepressant prescription rates is pharmaceutical marketing to doctors and to consumers. “You put those two together and you get a lot of prescriptions for antidepressants,” he said.

- CDC: Antidepressants most prescribed drugs in U.S.
by Elizabeth Cohen for CNN Health

With 47%CDC of all Americans taking some variety of prescription drug and antidepressants being one of the most commonly issued prescriptions, it’s somewhat depressing to consider the fact that pharmaceutical companies may be building their fortunes on the placebo effect, manipulating research studies, and publishing self-serving reports under the guise of real (well-compensated) physicians.


Deglutiatur Fallācia

It looked like every pharma executive’s dream: a new kind of medication that exploited brain chemistry in innovative ways to promote feelings of well-being. The drug tested brilliantly early on, with minimal side effects, and Merck touted its game-changing potential at a meeting of 300 securities analysts.

Behind the scenes, however, MK-869 was starting to unravel. True, many test subjects treated with the medication felt their hopelessness and anxiety lift. But so did nearly the same number who took a placebo, a look-alike pill made of milk sugar or another inert substance given to groups of volunteers in clinical trials to gauge how much more effective the real drug is by comparison. The fact that taking a faux drug can powerfully improve some people’s health—the so-called placebo effect—has long been considered an embarrassment to the serious practice of pharmacology.

- Placebos Are Getting More Effective
by Steve Silberman for WIRED

Gloomy folk just need a faith healer and some sugar pills, really.


Comminiscorem artem esse medicinam

More and more, research is funded by commercial entities, which deem any results proprietary. And even among fair-minded academics, the pressures of time, tender, and tenure can make openness an afterthought. If their research is successful, many academics guard their data like Gollum, wringing all the publication opportunities they can out of it over years. If the research doesn’t pan out, there’s a strong incentive to move on, ASAP, and a disincentive to linger in eddies that may not advance one’s job prospects.

- Freeing the Dark Data of Failed Scientific Experiments
by Thomas Goetz at Wired.com, 2007.09.25

Discovery is not the right word for the meta-analysis which has been making the rounds lately, however, it is without a doubt of great import to health providers and health consumers in the United States that FDA drug trials do not provide representative data on the putative claims which become associated with pharmaceuticals as they hit the market.

Worse? Doctors are buying the hype and even adding to pharma’s coffers with off-label prescriptions based upon similar falsehood:

The omission of a requirement that companies pursue approval for the off-label uses they promote “eliminates any incentive for industry to invest in studies beyond those necessary to earn preliminary approval.” The effect of this policy change, they say, could be quite radical. “The FDA might be left out of the regulatory loop for many of the indications for which companies market drugs to physicians.”

- Harms of promoting off-label uses to doctors
by Gavin Yamey for PLoS

FDA approval is a license sell panaceas – just like the old days!


… and, while we’re at it, let’s start prescribing dangerous anti-psychotics to children to make a buck …

The families of many children injured or sickened by the antipsychotic drugs they’d been prescribed are calling for the testimony of a prominent child psychiatrist whose endorsement of such drugs led to a 40-fold (4,000%) increase in diagnoses of pediatric bipolar disorder between 1994 and 2003. A recent Congressional investigation revealed a very lucrative association between the doctor and the pharmaceutical giant that manufactures one of the most-prescribed drugs for treating the disorder.

- Is Financial Fraud Behind Dramatic Spike in Pediatric Antipsychotics?
at MedHeadlines.com

Can’t be as bad as giving them laudanum, right?


Consilium de rebus cælestibus

The early days of Prozac were euphoric, with statistics indicating that over 70 per cent of people taking those drugs were helped dramatically. While there were very few randomized, double-blind experiments with such drugs, anecdotal and other types of articles appeared that touted these high rates of cure. Instrumental in this mix were the ghost-written articles with the names of well-known experts in the field published in significant and prestigious journals.

- Ghostwritten Medical Articles Cast Doubt on Reliability of Psychiatric Drugs
Psychology Today

Apparently ghost-writing isn’t just for thesis papers…


Addendum

… and apparently the ills of this system are being outed just as well by those on the inside:

If the overuse of Lamictal was due to hiding negative studies, does he think its rapid decline in the past two years has been due to the release of these studies? Did we stop using Depakote because we all finally read the article from 2000?

They went generic. That’s all. And it’s not the absence of reps that made docs forget about these drugs; it’s the absence of “studies” and reviews in all the journals telling us, over and over, to use them.

The problem of psychiatry isn’t the hiding of negative studies– even if they were available, it would make no difference, because we’re not prescribing based on science, we’re prescribing– like Ghaemi’s colleague– on word of mouth. Psychiatry is politics, and we basically toe the party line, no matter what common sense, logic, or even science tell us.

- Unpublished Lamictal Studies Left Us Thinking It Was An Antidepressant
The Last Psychiatrist
2009-09-08

Ghostwriters rattling chains defeat the science (or is it an art?) of clinical medicine yet again.

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