Another study carried out 10 years later again found that SSRIs increased suicidal behaviour in children (J Am Acad Child Adolesc Psychiatry, 2001; 40: 1364–5).
And yet, it wasn’t until 2003 that the British Medicines and Healthcare Products Regulatory Agency (MHRA) finally recommended that SSRIs not be given to children—and this only after being shamed into action by media reports of teen suicides caused by Seroxat.
Why did they take so long? According to Healy, there were two main reasons: a “lack of statistical expertise” on the part of the MHRA (and the FDA, too); and a mindset which “overstates the benefits and underestimates the risk of drugs”.
As a result, both the British and the American regulatory bodies, he says, insist on such cast-iron statistical proof of harmful effects that they demand “an all but unreachable threshold”.
The crowning irony of this official intransigence came in May of this year, when GlaxoSmithKline themselves sent a letter to doctors, warning them that paroxetine could cause a sixfold increase in the risk of suicides—a figure that neither the FDA nor the MHRA has so far acknowledged.
“Many people expect drug companies to be slow to concede that a drug causes hazards,” commented Healy dryly, “but we do not expect
our regulators to be even slower.”
Excess suicides are just the beginning. There are also major issues of side-effects and efficacy. After 20 years of experience with SSRIs, it now turns out that these super-sophisticated drugs that were once hoped to be relatively free of side-effects are, in fact, potentially more dangerous than the crude tricyclic antidepressants (TCAs) of the 1950s they were meant to surpass (see box, page 6).
But the SSRI scandal stretches even beyond that. The only reason SSRIs were allowed onto the market in the first place was that the drug companies claimed they were far superior to the existing TCAs. In the heady days of the 1980s, figures of 80 per cent effectiveness were confidently bandied about—this was three times better than with TCAs, said SSRI manufacturers.
But those claims have since turned out to be highly optimistic. Study after study has shown that SSRIs are actually little better than the TCAs. Recently, researchers have pulled together 15 to 20 years’ worth of statistics, including previously sup-pressed data amassed by the drug companies themselves, as a sort of final overall verdict on the SSRI experience.
These huge clinical ‘meta-analyses’ have looked at SSRI use by a variety of patient groups. Here, for example, are direct quotes from what researchers have found in three different types of patients:
So the truth is finally revealed: SSRIs have never worked any better than the drugs they were intended to replace.
- people with mild depression: “. . . no differences between TCAs and SSRIs” (Cochrane Database Syst Rev, 2000; 4: CD001130)
- depression in general: “There are no clinically significant differences in effectiveness between SSRIs and TCAs” (Cochrane Database Syst Rev, 2000; 2: CD001851)
- The elderly: “. . . SSRIs and TCAs are of the same efficacy” (Cochrane Database Syst Rev, 2006; 1: CD003491).
The anger in response to this revelation among the psychiatric profession is now palpable. Even normally conservative medical journals have spoken out against the drugs. An article in a major psychiatric journal recently concluded that drug-company-sponsored research is no longer reliable: “Caution is needed in interpreting drug company sponsored trials given the evidence of selective reporting and publication bias” (Curr Opin Psychiatry, 2005; 18: 21–5).