On September 14th, 1989, Joseph Wesbecker walked into his workplace in Louisville, Kentucky, produced an AK47, shot eight people dead, wounded 12 others and finally killed himself.
It transpired that Wesbecker had a long history of depression and had been put on Prozac just one month before the killings.
Relatives of his victims took a civil case against pharmaceutical giant Eli Lilly, makers of Prozac, arguing the drug was responsible for Wesbecker's murderous rampage. Just last month, documents which should have been produced by Eli Lilly during that case have finally emerged. What they show has sent shockwaves around the world, calling into question the safety of one of the most widely prescribed anti-depressants internationally.
Relatives of the Louisville shooting victims had lost their case in 1994. Eli Lilly made full use of its victory, declaring it had been "proven in a court of law. . . that Prozac is safe and effective". Not only did Eli Lilly withhold damning evidence from the court, however, but it failed to disclose it had in fact already made a secret settlement with victims and relatives during the trial. The judge presiding eventually struck out the verdict that had been so useful to Eli Lilly.
The documents which have now emerged were sent anonymously to the British Medical Journal last month. They include reviews and memos showing possible links between Prozac and suicidal behaviour. They indicate that Eli Lilly was aware of these side effects as far back as the 1980s and sought to suppress the information. The BMJ has now passed on the documents to the US Food and Drug Administration, the all-powerful licenser of medical drugs. It had approved fluoxetine (the pharmacological name for Prozac) in 1987. But Dr Richard Kapit, the FDA clinical reviewer who approved the drug, has said he was not given the Eli Lilly data that has only now emerged.
He told the BMJ last month: "If we have good evidence that we were misled and data were withheld then I would change my mind [ about the safety of fluoxetine]. I do agree now that these stimulatory side effects, especially in regards to suicidal ideation and homicidal ideation, are worse than I thought at the time that I reviewed the drug." This is potentially devastating news for anyone on Prozac. While anxiety about its effects and those of a range of similar anti-depressants has been growing in both the US and the UK, there has been relatively little discussion about the safety of these drugs in this country.
We are major consumers of anti-depressants, with roughly 1.5 million prescriptions issued in 2003 with about a quarter of a million people in Ireland on anti-depressants. Because of the way in which these figures are presented, it is difficult to be precise on numbers.
But we know that roughly 30,000 Irish people took Prozac during 2003, with similar numbers prescribed Seroxat and Efexor. All three of these anti-depressants have been identified as producing worrying side-effects. In addition to concerns about suicide risk, Seroxat has been reported as causing serious dependency. Efexor is recommended to be prescribed only by psychiatrists because of possible toxic effects on the heart. Despite this, it is important to note anti-depressants have been shown to be enormously beneficial to large numbers of those suffering from depression, and have been taken safely by many patients.
Dr Dermot Walsh, former Inspector of Mental Hospitals, has recently raised the issue of over-prescription, however, and the possible links to increased rates of suicide. He notes there is no evidence that these drugs have decreased the incidence of depression. "Worryingly, the rise in suicide mirrors almost exactly the increased use of anti-depressants", he said last month. With our high rate of suicide, there is clearly a need to take Dr Walsh's remarks seriously. Proper, independent research is needed either to prove or disprove any link between the increase in our anti-depressant drug consumption and our incidence of suicide, particularly among the young. What makes this all the more urgent is that it is precisely this group that is most at risk from suicidal and self-harm behaviour when taking some of the anti-depressants. Because of this, the UK and the US recommend that none except Prozac is suitable for those under 18. The European Medicines Agency has recently recommended that not even Prozac should be prescribed for children. Figures for the numbers of Irish children on anti-depressants are not published. Sources indicate, however, that as many as 1,000 children around the country are being given these drugs. Once again, in many cases this is doubtless found to be both beneficial and safe.
But in a world where it is clear that some major pharmaceuticals have been less than forthright about the side-effects of their drugs, it is imperative that we in Ireland should begin seriously to question our high rate of prescription of anti-depressants for adults and children.