But that’s just part of it. The companies fund, design and control the conduct of 80% of the drug studies done in the US. If studies don’t produce the “right” results, the companies, who own the information, don’t release the studies, or just release favorable parts of studies. They hire marketing companies to ghost write many – if not most – journal articles, then pay medical “opinion leaders” to sign on as authors. If they do get a positive study, they have ghost writers produce multiple articles based on the same study, so it appears that lots of research supports their drug.

Consumers can’t rely on the cruel joke of FDA drug approval, either. David Kessler, former head of the FDA, has publicly confirmed how bad the process is: to get a drug approved, all a company has to do is submit two controlled drug trials that show the drug has a statistically significant (not clinically significant) advantage over placebo. The company can (and often does) run many trials that show placebo equal to or better than the drug – that doesn’t matter as long as they get two that favor the drug. And drug trials usually last only 6 weeks, so we won’t know for years what all the adverse effects are (Kessler and others estimate that only 1 in 100 cases of adverse drug effects are actually reported to the FDA).

Case in point: Irving Kirsch, a bona fide academic, published in 2010 a meta-analysis of all antidepressant drug trials submitted to the FDA for approval of SSRI’s (he had to file a Freedom of Information Act request to get these). He found that about 1/2 of those trials did NOT show a statistically significant advantage for the drugs over placebo, and the average advantage, while statistically significant, was clinically meaningless. He concluded the drugs had no advantage in mild, moderate or severe depression, but showed a slight statistical (but not clinical) edge with very severe depression. A Duke Univ. review of the same information, publisihed in the January 2011 issue of JAMA, confirmed Kirsch’s conclusion.

This de-pantising of Pharma and bio-psychiatry is in stark contrast to the 20 years of rosy propaganda that emanated from Pharma’s and psychiatry’s noise machine: “Listening to Prozac,” consensus claims in medical journals, news articles, Physicians’ Desk Reference, drug reps’ sales pitches to doctors (most docs’ primary source of information on drugs), and Pharma-funded continuing medical education presentations to doctors.

Yet the very first trial Eli Lilly ever ran on Prozac showed no drug effect and shocking adverse effects – suicidality, agitation, etc. They kept at it ’til they got the two studies they needed for FDA approval; then they cranked up the PR, and off they went. Whistle blowers like Peter Breggin were scoffed at, ’til nearly 20 years later, the evidence was so overwhelming (even from Pharma’s thumb-on-the-scale drug trials) that the FDA issued a “black box warning” on all SSRI’s that they can cause suicidality in children, adolescents and young adults.

That’s some progress, but you know what? Despite the warning, and despite Kirsch’s and Duke University’s exposing the relative ineffectiveness of SSRI’s, PSYCHIATRISTS AND PRIMARY CARE DOCTORS STILL PRESCRIBE MASSIVE AMOUNTS OF SSRI’S (10% OF AMERICAN WOMEN ARE ON THEM) AND SALES ARE STILL IN THE BILLIONS. That’s what a $60 billion promotional budget will do for you.

Oh, and by the way – over 40% of the FDA’s budget for drug testing and approval COMES FROM THE DRUG COMPANIES THEMSELVES. Conflict of interest?

Dr. Angell mentioned a research publication on clinical trials of antidepressants in which the authors obtained protected information from the FDA by using the Freedom of Information Act. The upshot of the paper was that the pharmaceutical companies were/are promoting their products by presenting cherry-picked results from a body of data that was altogether underwhelming. Could you provide the reference so I can read that paper.

Somebody might…

This is not a minor quibble. “Everybody knows” that industry is rapacious yada yada. However, every time someone does something in an inefficient manner, that creates a market opportunity for someone else.

Furthermore, drug companies have good reasons to prefer to market a cure if at all possible.

Assuming they’re hedonically equivalent, the proper price for a cure is the discounted current value of the cost stream for the continuing therapy. However, pharma has an incentive to produce cures at this price rather than treatments, because pharma would severely discount potential profits from drugs that are due to go off patent. In other words, if $100 for a cure now is worth the same to the consumer as $10/year for 20 years for the ongoing therapy, they will be indifferent to whether to buy the cure or the therapy — but the drug company, who would get the whole $100 but who will only get a few years of the $10 because the drug will go off patent before 20 years are up, would hugely prefer the cure.

-dk

http://www.abcnews.go.com/Politics/wireStory?id=3277452