On October 15, 2004, after FDA had put a Black Box Warning on antidepressants to draw attention to the risk that they can cause suicide, the American Psychiatric Association (APA) came out with a news release whose key statement was:
‘The American Psychiatric Association believes that Antidepressants save lives.”
This was perhaps the first professional suicide note in history, but there have been several since.
On January 31, 2005, US News and World Report ran a front cover featuring an attractive nurse in a white coat with a stethoscope around her neck with a strapline “Who Needs Doctors? Your future physician might not be an MD and you might be better off.”
If modern medicines like the antidepressants are pretty effective and relatively free of hazards, then who does need doctors — doctors who fail to keep to guidelines and treatment algorithms and who cost far more as prescribers than nurses or clinical psychologists or pharmacists would?
The American Psychiatric Association statement should have read:
‘The American Psychiatric Association believes that Psychiatrists save lives.”
If medicine is to survive we need to restore the professionalism it takes to manage risky drugs appropriately. If the drugs aren’t risky and things go wrong, it must be the prescribers who are risky. And if the prescribers are risky, they need to be constrained within guidelines and protocols; and if they don‘t keep to them…well, it‘s safer for the organization to sack them.
We are all rapidly becoming factory doctors now
Locked into the distribution channel for prescription-only drugs, hemmed in by the science, doctors increasingly resemble the employees of the occupational health department of a factory that in the course of business exposes its workers to disability-inducing chemicals.
These doctors are all too aware that their ongoing employment depends on keeping quiet about any problems the workers may be having and learning to recommend laying off workers at the first signs of any ill-health — having persuaded them that they aren’t fit for the job rather than conceding that job conditions might be the problem.
Factory doctors like this were traditionally portrayed as uncaring, as opposed to the best of family doctors, who care and speak out. But we are all rapidly becoming factory doctors now.
On February 19, 2012, 60 Minutes ran a program about antidepressants, featuring the work of Irving Kirsch whose central claim was that controlled trials showed minimal benefits for these drugs.
True to form, the APA reacted a few days later, on February 22, 2012, with this response:
“Claiming there is no effective difference between antidepressants and placebos is…not just wrong, but irresponsible and dangerous reporting.”
APA went on to say that FDA do not endorse the findings of the 60 Minutes program.
In fact, FDA’s assessment of the data from all placebo-controlled trials of antidepressants, as of 2006, is that these trials combined show an odds ratio for a benefit of antidepressant over placebo as follows:
- In 18–25 year olds: 1.54 (95% C.I., 1.34, 1.76)
- In 25–64 year olds: 1.84 (95% C.I., 1.77, 1.93)
- In 65 years and over: 1.39 (95% C.I., 1.24, 1.57)
These are figures that fit very well with Irving Kirsch’s position.
There are even documents from Pfizer expressing surprise that the regulator has not pushed them harder on the question of efficacy.
There is a raft of public domain documents in which FDA officials express doubts that drugs like Zoloft work at all. There are even documents from Pfizer expressing surprise that the regulator has not pushed them harder on the question of efficacy:
On the contrary, one of the things that seems wrong with Kirsch’s argument is the idea that antidepressants work for severe depression. It is widely known that companies did not study their drugs in hospital settings because they knew the drugs did not work in more severe cases.
What are APA doing hiding behind a group of bureaucrats (FDA)? This is a further abnegation of professionalism.
APA might have usefully said that, “Claiming there is no effective difference between antidepressants and placebo is not just wrong, but irresponsible and dangerous reporting— placebos do not come with a risk of suicide, homicide, birth defects, physical dependence, or sexual dysfunction. It takes an expert to know when to take these risks.”
In terms of professional survival, APA might have usefully said that, “Claiming there is no effective difference between antidepressants and placebo is not just wrong, but irresponsible and dangerous reporting — placebos do not come with a risk of suicide, homicide, birth defects, physical dependence, or sexual dysfunction. It takes an expert to know when to take these risks, and FDA badly mislead people by failing to warn of these hazards in the first place.”
In 2001, 60 Minutes backed down under pressure – The Insider II.
Meanwhile 60 Minutes had had their chance to save lives (and save psychiatry) 11 years earlier. Against the backdrop of the Miller case (see Zoloft Study: Mystery in Leeds), they approached the Millers and their lawyer, Andy Vickery. Vickery asked first if they would back down under pressure — as they had infamously done with Jeffery Wigand (“The Insider”). They said, No, it would be the death of 60 Minutes to ever do that again (See Vickery email).
The program had Pfizer documents in which the attempted suicide of an 8-year-old boy had been put down by Pfizer monitors to Zoloft-induced activation. It had entirely independent academics with nothing to do with the case reporting that Zoloft could definitely trigger suicide.
Ed Bradley interviewed me, the Millers, Andy Vickery, and others. More than $50,000 had been put into the making of this show, and, at that kind of money, few 60 Minutes segments are ever canned (which is why The Insider was so famous).
But the producers came under pressure not to air. The show had been waiting to air for more than eight months when 9/11 happened, and the producer contacted the Millers to say that this was the reason why it wouldn’t air.
The tapes probably still exist in some CBS storage room.
The difference in 2012 is that the antidepressants are off-patent… and it suits the pharmaceutical industry to have the antidepressants pushed aside in favor of mood-stabilizers.
The difference in 2012 is that the antidepressants are off-patent, and as long as 60 Minutes doesn’t cast doubt on the safety of psychotropic drugs in general, it suits the pharmaceutical industry to have the antidepressants pushed aside in favor of mood-stabilizers.
So the antidepressants weren’t quite as effective as we thought, and maybe insurance companies or the government paid over the odds for them. Where’s the big deal in that?
An autopsy on the body of professional medicine coming soon…
The next series of posts will undertake an autopsy on the body of professional medicine in an attempt to pinpoint the cause of its death.
Marks on the body suggest the cause of death may be more shocking than readers expect.