This from Professor David Healy writing in the Guardian today:
Doped and duped
Adverse effects of widely-prescribed drugs are often overlooked because there is so little truly independent academic evidence
Since 2005, the SSRI paroxetine, first marketed by GlaxoSmithKline as Seroxat, has carried warnings of risk of birth defects. In the US litigation in which I have been asked to give evidence, the plaintives will argue that, even before they were launched, there was good laboratory evidence that the SSRIs might cause problems, and, following their initial marketing, evidence emerged over a decade ago from clinical use that the drugs actually do cause problems.
Yet these drugs have been actively promoted, de facto primarily to women of child-bearing years. How could this happen?
Part of the problem is that having gone to their GP with a nervous problem, many women become dependent on a prescribed SSRI and find it impossible to stop using it whether they wish to get pregnant or if they find they are pregnant while on treatment. But few, if any, of these women will have been informed of either the risk of birth defects or the risk of becoming addicted. Why not?
What we are seeing here is the astonishing marketing power of pharmaceutical companies, which can now effect huge changes in medical culture within months. In this case, a great part of the scientific literature (the primary marketing tool of companies) on the use of antidepressants in pregnancy and on dependence on antidepressants is ghostwritten – just as virtually all literature on giving antidepressants to children was, at one point, company-written. Firms of medical writers are contracted to pharmaceutical companies to place in academic journals articles attributed to, but not actually authored by, university researchers.
Because of this, guideline makers like Nice, which can only go by the published literature, are trapped. Regulators, like the FDA and MHRA, which reflect a professional consensus rather than lead on issues like this, are likewise stuck. Doctors who believe their role is to follow Nice, the MHRA and the scientific evidence are in the same bind.
The process of manufacturing clinical consensus has become so slick that it is now almost impossible to find independent articles from academic physicians with no links to industry that will sound a note of caution about prescribing antidepressants to women of child-bearing years. This is a problem that increasingly applies across all of medicine – from the use of HRT, to drugs for osteoporosis, respiratory or gut problems, pain-relief, as well as all psychotropic drugs.
Where once drugs were seen as poisons to be used judiciously and with caution, they are now treated as fertilisers whose more or less indiscriminate use can only do good. Where once farmers knew to keep their cattle out of fields growing the serotonin reuptake inhibiting weed, St John’s Wort, as it caused miscarriages, under industry influence women have been herded by doctors in exactly the opposite direction.
So the question must remain just how much did Glaxo know and when did they know it?
Glaxo has a track record of hiding negative clinical trail data that would knock sales of its drugs – the story of Seroxat and Study 329 is truely shocking.
Let down by the MHRA… again