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.
David_Healy says
Just after this was posted, my attention was drawn to an uncritical editorial in the Lancet, praising the research of R Gibbons.
http://www.thelancet.com/journals/lancet/article/PIIS0140-6736(12)60331-6/fulltext
This editorial ignores the extensive criticism of this research in multiple places (see Coincidence a fine thing – for a critique) and elsewhere:
http://1boringoldman.com/index.php/2012/02/29/after-all/
This Lancet comment is matched by an editorial from Fiona Godlee in the BMJ last week casting doubt on Irving Kirch’s findings
http://www.bmj.com/content/344/bmj.e1322
http://www.bmj.com/highwire/filestream/569679/field_highwire_article_pdf/0.pdf
“This evidence counters widely publicised claims made in a meta-analysis, published in PLoS Medicine in 2008, that they had little or no effect except in people with the most severe depression. Such claims may well have dissuaded
patients and some clinicians from considering or continuing antidepressants. It’s good to see them countered here”.
So doctors waiting for the guillotine to fall can comfort themselves with the friendly faces of Richard Horton and Fiona Godlee knitting.
pacificpsych says
Thanks for the alert abut 60 minutes.
The APA is a joke. “Oh noes [closing eyes tight and placing hands over ears] people’s saying bad stuff. They’re wrong wrong wrong”.
The links in your comment, btw are not set correctly.
Thanks for keeping the flame going for us Anusim.
http://www.amazon.com/review/R44BVGOXA9CW9/ref=cm_cr_rdp_perm
Neil Carlin says
Dr. Healy, why is it that in in most of the Gibbons et al. papers Dr. J. John Mann is listed as the last author? My understanding is that in academia, being listed as last author in a scientific paper is significant. Is this true?
Dr. Mann appears s to have a close relationship with the pharmaceutical industry re clinical trials of psychiatric drugs. How can we then trust the objectivity of anything written by Gibbons et al. where Mann is a co-author?
ie. CMAJ February 3, 2009 vol. 180 no. 3
J. John Mann holds a research grant from GlaxoSmithKline for a positron emission tomography study of amyloid protein levels in the brains of patients with Alzheimer disease and mild cognitive impairment. He also holds a research grant from Novartis for a positron emission tomography study of mGluR5 receptors in depression.
Your help in understanding this is appreciated.
Neil Carlin
Oakville, ON
Canada
David_Healy says
I don’t put a great deal of store by conflict of interest – I think we are all biased. The progress of science depends not on purity of motive but access to the data and the ability of a wide range of people with mixed backgrounds and motives to scrutinize the data. The major problem is we don’t have access to the data. A second problem as recent posts have tried to point out is our blind faith in controlled trials especially trials done in patients with an illness. Pfizer, whom John Mann has also consulted for, had no problem detecting the agitating and aggression inducing effects of Zoloft when given to healthy volunteers – see Mystery in Leeds. Having made all these points, I have to say John Mann is one of the few people in recent years who have been prepared to engage with me in public debate on the issues
Anne Morrison says
Great article. I have always remembered a tutor I had when training to be an RMN, who stated that most people suffering from depression will get better within about 6 years………without medication. Hopefully, that could be reduced by some quality, timely therapeutic intervention not involving medication. ( I have no idea where he got his figures from I’m afraid) The trouble is that we ( society) want a quicker “fix” and therefore Anti-depressants have become the norm. I have often wondered if a placebo would have worked just as well and be far less dangerous!
David_Healy says
The mean time to recovery in melancholia/psychotic depression before the availability of antidepressants and other treatments was of the order of 5-6 months. See Harris, M., et al., The incidence and prevalence of admissions for melancholia in two cohorts (1875–1924 and 1995–2005), J. Affect. Disord. (2011), doi:10.1016/j.jad.2011.06.015
Altostrata says
Dr. Healy , when you stated:
“The American Psychiatric Association statement should have read: ‘The American Psychiatric Association believes that Psychiatrists save lives.””
you encapsulated the problem for U.S. psychiatrists and, by extension, psychiatrists all over the world. Psychiatry professional organizations have sold psychiatrists’ birthright of providing medical care for a mess of pottage from pharmaceutical companies.
The APA can’t claim psychiatrists save lives (if only this were true) because for 20 years it’s worked to promote psychiatric drugs as invariably safe, no-brainer prescriptions.
Why go to a psychiatrist rather than a GP for psychiatric care? To make a case for a value-add for themselves, psychiatrists would have to demonstrate they provide safer and more effective treatment than non-psychiatric doctors, nurses, or physician assistants. Which is to say, they’d have to point out adverse effects and health dangers of psychiatric drug prescription and inaccuracy of diagnosis as provided by others.
Unfortunately, psychiatry can’t make that case. Most psychiatrists act as no-brainer drug distributors, no better than GPs, and psychiatry professional organizations are, indeed, driving psychiatry clinicians out of business.
One wonders why any psychiatrist who wants to truly practice medicine and help patients continues to pay dues to the APA. All should sign the DSM-5 petition at http://www.ipetitions.com/petition/dsm5 and withhold dues in protest.
Fid says
Anything on record of placebo causing the ‘electric-like zaps’ associated with SSRi discontinuation [withdrawal]?
I know suicide attempts have been reported on placebo but I’ve not come across any reports of the zaps. Then again, my access to clinical trial results is restricted.
Ana says
The DSM-5 petition has a video that explains a lot but psychiatrists don’t want to get involved.
I don’t know but it seems to me that even the psychiatrists that are fighting all of this are having difficulty in uniting and spreading the word.
You work alone, the others work alone, have sites, are at Facebook and only those who are aware of what is happening comment.
What is the use of preaching for the converted?
Many patients and serious people, like Charles Medawar, gave up fighting.
I’m one of them. I have a blog but I stop publishing like I did in the first two years.
Now I’m dedicated to this blog.
The Phase 4 of clinical trials is not being done and the words of those who took these drugs is considered as anecdote evidence and we are put in disbelief by the pharmaceutical industry astroturfers that is everywhere.
The clinical experience is not reported as a source of data. How can it be that the suffering of the patients is not relevant?
I never saw any psychiatrist claiming that one, two or zero of their patients committed suicide or an homicide because of drug-induced violent behavior.
Quoting SSRI stories, even though Rosie is doing a great job, is not enough since it can’t be used as evidence and psychiatrists working for the Big Pharma say that they laugh when visit this site.
Charles Medawar database is closed and I remember the numerous people telling their struggle with withdrawal.
This is sad and… blah blah blah…
David_Healy says
You’ve outlined one of the reasons for Rxisk.org. The arguments often work for Pharma because they appear to have data and others just have anecdotes. The data offers a focus for people who may have very disparate opinions. On the other side there has been no data for people to unite around and critics have tended to fall out over nuances of meaning – as you hint. Rxisk.org will offer data rather than individual points of view and this hopefully will make a difference.
jsw says
My friend who lost her daighter to Celexa tried to bring the information revealed in these articles to the attention of her physician, who refused to acknowledge that it might be valid, and insists that antidepressants are helpful. Jeannie, who died, was an anolmaly in her view. There is enormous resistance by doctors who have invested years believing in these drugs to understanding the lessons that dispassionate analysis of the evidence reveals.
Ana says
I did a post about one of my suicide attempts when I was tapering Effexor.
For 18 months I tapered 225 mg of Effexor. It was hell. In the end of the process I discovered that I could not function without Effexor any more.
I’ve been on the drug for too long.
For three months I was not able to function… but this is another story.
I take 150 mg now. I wish I knew that the last dose, 37,5 mg, would be harder to withdraw.
If I knew that I would have taken 37,5 mg for a long period of time. Months or even years before withdrawing it.
But what I want to share is that real suicide ideation is very different from the drug-induced. This is my story:
“I said that I had suicidal ideation while tapering Effexor. What I didn’t say is that I’ve tried to kill myself twice. I thought about it on a wide scale of degrees. Four times it was very hard to cope with it and for two times I’ve tried.
I’ll tell you about one of these times.
I was in a normal day, tapering Effexor. All of a sudden, an idea was planted in my brain: “-I have to kill myself.” Just like that. Unexpectedly, no reason for it, I was happy and then this idea appeared.
You don’t think about anything else. You only think that you have to kill yourself. I wrote some notes for four people, and was thinking at the back of my mind: “-This is withdrawal, this is withdrawal, this is withdrawal…; call your therapist, call a friend, do something!”
Strangely enough you don’t call anybody. You do not care. All you have to do is… kill yourself.
I have a dog. So I could not do anything at home for I could not harm her or make something that could kill her, like gas – my second attempt was with gas -, and you keep on wandering how are you going to do it without making any fuss and avoiding the scandal of being found dead in your place. Good, at least there’s room to think about a dignified exit!
I had many samples of psychiatric drugs, drugs that I tried, and, at the forth pill had to stop… I had an arsenal of psychiatric drugs of many kinds.
Therefore, I took them all and put them in two bottles of Depakote – by that time it was sold in bottles not in blister. “-It’s withdrawal, it’s withdrawal, it’s withdrawal… do something; call someone; call your therapist, please!” “-Nope! I have to kill myself.”
I’ve phoned a hotel and ask for a bedroom. I’ve dressed myself with care and took a big bag pretending to be coming from a near town. I have put some clothes in this bag and a bottle of Jack Daniels to have the pills, Rohypnol was in the cocktail which is very helpful and was once used by the site Exit . They used to sell a packed for those who wanted to do euthanasia and I’ve discovered that one of the three items was Rohypnol. They are back now but with another proposal.
“-It’s withdrawal, it’s withdrawal, it’s withdrawal… do something; call someone; call your therapist, please!” “-Nope! I have to kill myself.”
It was 9 pm. I went away from my building, took a cab, and told the driver to go to the hotel. He left me there.
When I was in front of the hotel, I felt thirsty and did not want to appear as if I was out of my mind. I went to a place and asked for a bottle of water.
I thought that the man could not hear me. By miracle, he gave me the bottle of water. I took it and, miracle, I’ve paid for this and he smiled at me. He smiled at me!
So people could see me! “-It’s withdrawal, it’s withdrawal, it’s withdrawal… do something; call someone; call your therapist, please…
Isn’t it good!
I’m alive! I started walking. I’ve walked, walked, walked, and started to sweat.
Nice feeling! I was sweating and feeling all my body, my legs, my arms, my head, my hands, my toes…
“-It’s withdrawal, it’s withdrawal, it’s withdrawal…”
What am I doing here? Why will I kill myself? I don’t want to kill myself.
My dog is home! She must be feeling sad. I have to go back home to see her and call my friends and family.”
“I want to thank Charles Medawar, SocialAudit. There was a man on his site whose nick was “Anon”. He helped everybody and one of the things I’ve remembered was he saying that we should never become a statistics and if we killed ourselves “they” were winning another time.
He said other valuable things that was on my mind beside the “-It’s withdrawal…”
Fortunately I don’t remember anymore and I’m glad to be able to talk about it without crying and now I am feeling that it’s in the past.
The only thing I fear is that even spending 19 months tapering Efexor when I reached the end of the process I felt so bad that I had to go back to the drug.
I’ll talk about it later.
If I miss I pill I have nightmares. I fear missing the amount of dose and feel it again.
You can see that it’s very easy to kill me if someone has the intention.
I also lost my freedom because I cannot make a trip or go anywhere without Effexor in my purse.””
I hope it helps someone. PLEASE BE AWARE THAT DRUG-INDUCED SUICIDE IS REAL.
The whole post is here: http://justana-justana.blogspot.com.br/2012/01/psychiatric-drug-induced-suicide.html
BE SAFE!