However, documents obtained under the Freedom of Information Act reveal that FDA regulators were fully aware of the recoding but, says Healy, told the pharma industry that they did not see the SSRI–suicide connection as “a real issue, but rather as a public relations problem”.
And yet, no fewer than four clinical studies published between 1990 and 2000 have shown SSRIs to cause “an increased risk of suicidality”, culminating in a British report entitled ‘Deliberate Self-Harm and Antidepressant Drugs’. This was a survey of the Accident & Emergency case notes from one UK hospital area that revealed a five-and-a-half times extra risk of suicides among people taking SSRIs (Br J Psychiatry, 2000; 177: 551–6).
Healy showed that there has been collusion between the authorities and the drug companies in putting as good a gloss on the data as possible.
For example, the FDA had a back-door agreement with Pfizer that the sertraline suicide data should be analysed as if it were a constant hazard, even though they knew the evidence clearly shows that suicides peak in the first few weeks of use.
This averaging-out is outright “manipulation of data”, says Healy, because it disguises the true extent of the suicide problem. His own analysis shows that the latest data for paroxetine indicates as much as a fivefold increase in suicide risk, a statistic consistent with previous findings.
Another area of concern is children. Astonishingly, SSRIs have been given to kids as young as two years old, and the figure is rising exponentially for older children, too. For example, sertraline prescriptions for youngsters aged two to 19 tripled in just the 10 years from 1988 to 1998—from 40 million prescriptions to 120 million—after the introduction of fluoxetine (Pediatrics, 2002; 109: 721–7).
Equally surprisingly, very few SSRIs have actually been formally licensed for use by children, so all of this prescribing to them has been ‘off-label’. This term is used to describe when doctors prescribe drugs that have been officially approved for one purpose to treat other, unauthorized conditions.
In fact, few drugs are ever tested
on children. The reasoning behind this practice is that children are simply ‘little adults’, so the hazard profile of a drug may safely be applied to them so long as the appropriate reductions in dosage have been made to accomodate their smaller size.
But this is not necessarily true. For example, Ritalin—the infamous hyper-activity drug—appears to act as a depressant in children, but is a stimulant when taken by adults.
So we know that children can react totally differently from adults, particularly when mood-altering drugs are concerned.
Indeed, in the case of SSRIs, it was largely children’s violently self-harming reactions to the drugs that alerted psychiatrists to the suicide problem in the first place.
In 1991, Yale University doctors reported the case notes of six children, aged 10 to 17, who developed “intense self-injurious ideation or behaviour” while taking Prozac. For example, after three weeks on the drug, one 14-year-old girl, who had never been suicidal before, began cutting and otherwise injuring herself. She told hospital staff, “I’m just waiting for the opportunity to kill myself,” and chanted, “Kill, kill, kill; die, die die; pain, pain, pain” (J Am Acad Child Adolesc Psychiatry, 1991; 30: 179–86).