Dr James LeFanu writes

Drug companies need reining in

There is rather more than is readily apparent to the massive £1.9 billion fine imposed recently by a US District Court in Boston on Britain’s largest and most reputable pharmaceutical company, GlaxoSmithKline.

The regulatory authorities require, as we all know, that drugs must first be thoroughly evaluated in a series of clinical trials before being approved for public use. The catch, however, is that those trials are not just paid for, but also designed and implemented by the drug companies themselves.

This, one might infer, could have some bearing on their outcome, as indeed proved to be the case with Glaxo’s antidepressant Paxil (or Seroxat). The drug’s promotion for the treatment of depression in adolescence entailed, the court heard, costly “educational” conferences in exotic locations such as Hawaii, with the added inducement of deep-sea fishing expeditions and hot-air balloon rides.

The evidence in Paxil’s favour seemed compelling enough, based on the findings of a large multi-centre clinical trial demonstrating its “remarkable efficacy and safety”. In reality, as it subsequently emerged, the situation was precisely the contrary – Paxil proved no better than the placebo with which it was compared, while paradoxically increasing the risk of suicide threefold.

In his recent book, Pharmageddon, the British psychiatrist Prof David Healey, of Cardiff University, describes in detail how this came about. The crucial point is that the control exerted by drug companies over the trials of their drugs extends to analysing the data and interpreting what it shows. This allows them to select the good bits, omit the less favourable, and gloss over the hazards by, for example, categorising those subjects reporting suicidal thoughts as “non-compliant” or “emotionally liable”.

GlaxoSmithKline then arranged for this imaginative reinterpretation of the original data to be written up as a scientific paper, which was duly “signed off” by the psychiatrists involved in the study – and arrangements made for it to be published in the prestigious Journal of the American Academy of Child and Adolescent Psychiatry.

Prof Healey illustrates the inevitable tragic consequences of this, with the testimony at a public hearing of a mother whose daughter, Beth, consulted her family doctor over her anxiety and sleeping problems: “He prescribed Paxil and said she would feel better within a couple of weeks. Seven days later, Beth took her own life.”

The sort of practices revealed by the Paxil saga were, at one time, and indeed may still be, pervasive throughout the pharmaceutical industry, with implications for the presumed safety and efficacy of many commonly prescribed drugs that are almost too fearful to contemplate.

http://www.telegraph.co.uk/health/9401390/Drug-companies-need-reining-in.html