He’s quietly spoken, careful and sparing in his words — not at all the sort of man you would expect to arouse strong emotions. Yet over the past seven years David Healy, Reader in Psychological Medicine at Cardiff University, has been so outspoken about the safety of antidepressant drugs that he has made his fair share of enemies.
Now those who called him a maverick are having to admit that he had a point. This week, two American Government advisory committees acknowledged that the most commonly prescribed group of antidepressants could spur suicidal behaviour in teenagers, and recommended that they carry a severe warning. This follows a new announcement from the drug companies Merck and GlaxoSmithKline that they will start publishing the results of all drug trials — good or bad. On top of that, medical journal editors declared last week that selective reporting of clinical trials must end.
It is unlikely that any of this would have taken place had it not been for Healy making a nuisance of himself. His outspoken views on the dangers of SSRI (selective serotonin reuptake inhibitors) antidepressants — most prominently Prozac — prompted a complete reappraisal of their benefits for young people and have pushed drug companies into being more open about drug trial results. Healy didn’t set out to cause controversy. His interest in SSRIs — hailed since the 1980s as the safest, least addictive and most effective means of treating depression — began when he noted some of his patients having bad reactions. The first patient that he put on Prozac, in 1990, felt miserable and helpless on the pills, so Healy put him on another type of SSRI called Faverin which made him feel “beyond despair”.
Healy’s worries intensified as he read about anecdotal studies from the US that indicated that SSRIs might make people feel suicidal. He wrote letters to the Medicines Control Agency urging action. According to Healy, he got only bland reassurances in reply. In 1997 he became a central figure in the drama when he was engaged as an expert witness in an American case brought against Lilly, the makers of Prozac, by the family of a man who killed his wife and then himself while on the drug — a case that Lilly won in 1999. It was the first of a series of similar cases against SSRI manufacturers that Healy became involved in and the clout of the law gave him unparalleled access to the closely guarded research archives of drugs companies Pfizer and GlaxoSmithKline. It compounded his fears.
“The Pfizer archives contain healthy volunteer trials that show people became agitated and probably suicidal on Sertraline in the early 1980s,” Healy says. “In the GlaxoSmithKline archives, the data showed that they were concerned about people being hooked on Seroxat in the 1980s.” As he immersed himself in the subject, he realised that the reassuring messages about the safety of SSRIs had been based on a misconception.
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Most studies looking into their effects on healthy volunteers had never been published — in the case of Prozac, just 12 out of 53 had been reported on. Healy realised that these unseen trials were particularly important. That was because most of the published studies had used data looking at the effect of Prozac not on healthy people, but on people hospitalised with depression. But for years, Prozac and the like had been doled out to mildly depressed people — people whose brain chemistry was likely to be different from that of severely depressed people in hospital. No one had published studies about the side effects of SSRIs on Joe Public.
Healy decided to investigate for himself how SSRIs affect the quality of life of normal people. In 1999 he took a group of ten female and nine male volunteers — psychiatrists, nurses and ad- ministrative staff — and asked them to take anti-depressive pills for four weeks. For two weeks they were on the SSRI Sertraline, and for two weeks they were on Reboxetine — a different class of drug called a selective noradrenaline reuptake inhibitor. What Healy discovered was alarming.
While many of these normal people were happy with one of the two drugs, nearly two thirds of the group also felt significantly depressed or disturbed on one of the treatments. In other words, there was a 50-50 chance of a GP putting their patients on an unsuitable pill.
For two women the side effects were dramatic. Within days of going on Sertraline, Joanna became withdrawn and worried. Colleagues warned Healy that she was acting strangely, spending money impulsively. In the second week, for three successive nights, she dreamt of slitting her throat and bleeding to death in bed beside her partner. Healy withdrew the drugs from her, but that night she decided to go out and throw herself in front of a car or a train — without even thinking of her partner or child. She was on her way out of the door when the phone rang, and the trance was broken.
Reporting on such findings made Healy a contentious figure among colleagues unwilling to challenge the orthodox view, as well as with drug companies. He didn’t realise exactly how contentious until 2000 when he was offered a professorship by the University of Toronto — and then had the offer withdrawn within a week of making a speech in Canada airing his concerns about SSRIs. Healy says “it is widely believed” this was not unconnected with the fact that the university ‘s mental health centre had recently received a $1.5 million (£840,000) donation from the manufacturers of Prozac — although the university still denies this.
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In the past 12 months, a series of articles in the most respected medical journals and pronouncements by the drug regulating authorities in Britain and the United States have given backing to some of his most important claims.
“I can only assume that the hostility to me has reduced now that some major journals have said the kind of things I’ve been saying,” Healy says. “There are some people who once were friends and are now quite hostile to me. That won’t be changed by the fact that I got it right.”
The real breakthrough in the UK came late last year when the Committee for the Safety of Medicine warned that all SSRIs, apart from Prozac, should now not be used on teenagers and children. Like the Food and Drug Administration in the United States, it is reviewing the evidence about the safety and efficacy of all SSRIs for adults, too, and is expected to report soon.
Healy admits that a recent editorial in the Lancet gives him particular satisfaction. It condemned pharmaceutical companies and clinicians worldwide for encouraging the use of SSRIs on the basis of research that was “at best inconsistent”.
For all his battles, Healy bears remarkably little resentment against drug companies and remains the pragmatist. As a psychiatrist, he’s a great believer in the use of drugs, even SSRIs, in the treatment of depression and mental illness. The point is that everyone should be clear and explicit about the limitations of all drugs, and they should be carefully targeted at the right people. Bureaucratic systems and the way they allow commercial considerations to take precedent over clinical benefits are the root problem.
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“Until 20 or 30 years ago, all drug trials would have been run through the hospital system and everything was transparent. Now all the data goes back to the drug companies, so no one ever gets to see the full picture apart from them. That means you can be presented with a very positive picture, but when you see the raw data, it doesn’t look that positive,” Healy says. He knows a number of people in drug companies themselves who are very unhappy with this situation.
As it is, Healy believes that the way that we were sold the SSRI dream will be looked back on in the same light as the unfettered influence of the tobacco industry and the Thalidomide scandal.
Would the story have ever come out if he hadn’t gained access to the drug company archives? “There have been many others, apart from me, who have been raising the issues for a while, and some legal actions in the United States have also played a part. But if you’re asking me whether the truth could have been completely buried, it could. I think that we are fairly fortunate that it wasn’t. It has been touch and go.”
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