Drug Withdrawal Symptoms-Antidepressant Drugs-Moderate Depression-Clinical Trials

60 Minutes Weighs In on Antidepressants

I was just checking out on line yesterday's "60 Minutes" segment--
http://www.cbsnews.com/video/watch/?id=7399362n&tag=contentBody;storyMediaBox
--that features a friend, Dr. Irving Kirsch of Harvard, a psychologist whose work on placebo effect and expectancy I have long admired. But the segment is only peripherally about placebo effect; it's rather about Kirsch's now oft-repeated finding that except for severe depression, the difference between antidepressants and placebos in clinical trials is negligible.
As seems typical, the news program featured as "gosh golly gee whiz" news stuff that we've been over in this blog many times before:

The serotonin theory of depression, on which most antidepressant therapy is based, is either only a part of the story or else dead wrong

The drug companies selectively publish the drug trials that show benefit and selectively hide the trials that don't

Several independent investigations have agreed with Kirsch's original work that in mild to moderate depression, there is hardly any difference between drug and placebo effects

What I personally found new was an interview with a British psychaitrist reporting that the UK National Health Service had independently replicated Kirsch's studies and found the same results. So they are now actively discouraging the use of antidepressant drugs for mild-to-moderate depression (the categories for which prescriptions in the US have exploded in the past 20 years) and are now busy working hard to implement--guess what--psychotherapy counseling and exercise programs which work just as well for those patients.
If I had any major quibble with the program, it was that the magic words "side effects" were first mentioned at around 11:30 of the 13:40 segment (by the British psychiatrist). Those words tell the whole story. Placebos might be equivalent to drug in regards to benefits--but certainly not with regard to adverse reactions. We have been incredibly slow (aided by aggressive drug company marketing) to realize in medicine that most of these "nonaddictive" drugs actually have serious withdrawal syndromes, such that the worsening symptoms when patients go off their antidepressants--interpreted by the drug companies as sure proof that they work--might just as well be drug withdrawal symptoms as recurrence-of-depression symptoms.
The other fun part of the program was watching the US psychiatrist (and of course, consultant for several drug firms) who was put on to defend the track record of these drugs. He naturally made no mention of side effects whatever, but he did insist that in his own independent studies, 14% of moderately depressed patients do better on drug than on placebo. (He admitted that it was a wash in mild depression.) In his mind this justified current practice. Can you believe it--14%??? For a condition where the drugs have serious side effects and where talk therapy or exercise work as well? And that's apparently the best rebuttal the drug industry can come up with?
I must here repeat the usual disclaimer--don't try this at home--if you're depressed see your doctor and do what the doctor says, and above all don't discontinue any drug without the doctor's advice. read more..

Pharmaceutical Companies-Research And Development-Pharmaceutical Company-Direct Marketing

How the Placebo Effect "Marketing Can Improve Health "Increase Pharma Profits

Big pharmaceutical companies are drastically cutting back on research and development. The economics just do not support the model that has been the driving force of the drug industry over the past 15 years.
According to a Forbes analysis reported by Matthew Herper, "The average drug developed by a major pharmaceutical company costs at least $4 billion, and it can be as much as $11 billion" (see "The Truly Staggering Cost Of Inventing New Drugs").
Some pundits suggest that lowering the cost of performing clinical trials will help get more drugs to market faster. Andrew von Eschenbach, former FDA Commissioner and now employed as chairman of conservative think tank Manhattan Institute's Project FDA initiative, suggested that instead of the FDA asking pharma companies to complete "laborious clinical trials proving efficacy, after proof of concept and safety testing, the product could be approved for marketing with every eligible patient entered in a registry so the company and the FDA can establish efficacy through post-market studies" (see here).
However, Herper points out that the "main expense is failure. AstraZeneca (AZ) does badly by this measure because it has had so few new drugs hit the market." AZ spent about $59 billion on R&D between 1997 and 2011, but only managed to get 5 new drugs approved. According to simple arithmetic, that means each of these 5 drugs cost about $11.8 billion to develop.
That's an interesting number. A very similar number came up during last night's 60 Minutes segment on "Treating Depression: Is there a placebo effect?" (see it here). It turns out that antidepressants sales in the U.S. bring in $11.3 billion a year to pharmaceutical companies that sell them -- including AstraZeneca!
Could it be that the drug industry is merely "breaking even" in the anti-depressant market?
I suspect they are probably making a pretty good profit -- but that profit may be diminishing as more and more anti-depressants go off patent. In fact, it has been suggested that 60 Minutes dared to air this expose -- four years after the research was first published -- because the "news" can no longer harm the drug companies that CBS depends upon for advertising -- most of the drugs mentioned are off patent (see “You’re telling me this now?” Why the news is suddenly critical of statins and antidepressants).
I did a blog post about antidepressants and the placebo effect two years ago in January 2010 (read "A Common Goal of Research and Marketing: Fool the Doctor"). In that post, it was noted that clinical evidence suggests these drugs are not any more effective than a placebo in patients with less severe depression. But drug company marketing to physicians does not mention this. Thus, physicians are led to believe that the drugs ARE effective for all patients with depression.
As pointed out in the 60 Minutes piece, "a clinician who cares, who takes the time, who listens to you, who asks questions about your condition and pays attention to what you say, that's the kind of care that can help facilitate a placebo effect." That goes double if the clinician actually believes what he or she is prescribing is a drug with proven efficacy.
Consequently, marketing to physicians along with direct marketing to consumers can play a huge role in "facilitating" a placebo effect. Which leads me to this idea: pharmaceutical companies should be in the business of developing placebos rather than dangerous, ineffective chemical compounds. There would be no need for expensive clinical trials and it would be easy for FDA to adopt von Eschenbach's idea to approve these new "drugs" before they are proven effective. It will be up to marketing to make them effective by facilitating the placebo effect!
Of course, to be successful, this new approach to drug development must be done surreptitiously and the FDA must conspire with the drug industry (not too much of a stretch there). After all, if everyone kn read more..