Since 2005, Paroxetine, first marketed by GlaxoSmithKline as Seroxat/Paxil, has carried warnings of birth defect risks. These risks led to litigation in the US – but not elsewhere. In the first case that went to court in the US in 2009, the Kilker case, the lawyers for Lyam Kilker argued that, even before Paxil was launched, there was good laboratory evidence that the SSRIs might cause problems, and, that following their initial marketing, further evidence had emerged steadily from 1998 onwards painting a consistent picture that the drugs actually do cause problems in clinical use, and of company efforts to hide this.
Yet since their launch Paxil and other SSRIs have been actively and increasingly promoted to women of child-bearing years. The company most committed to this and most effective at it was Glaxo. This is ironic in that the company began in New Zealand as the makers of formula milk for babies – from which they derived their name.
Women of child bearing years in particular who have nervous problems have been encouraged to go to their family doctors where they are all too readily put on an SSRI. These family doctors aren’t aware of the risks of dependence or birth defects, and so don’t warn. The patients become dependent on the SSRI and find it impossible to stop using it when they wish to get pregnant or if they find they are pregnant. In an age where most women will abstain from alcohol, nicotine, tea, coffee, soft cheeses or uncooked meats if they are thinking about becoming pregnant, few of these women would consent to treatment if informed of either the risk of birth defects or the risk of becoming addicted (see We need to talk about doctors).
What we are seeing here is the astonishing marketing power of pharmaceutical companies, which can now bring about 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 or ghost-written.
Because of this, even the most independent guideline makers like NICE, who can only go by the published literature, are trapped. Regulators, like the FDA in the US and MHRA in the UK, which reflect a professional consensus rather than lead on issues like this, are likewise maneuvered into a corner. Doctors, who should be leading and who until recently would have been hostile to the idea of taking antidepressants in pregnancy, believe their role is to follow NICE, the FDA and what appears to be the scientific evidence and have failed to spot how they are being groomed.
The process of manufacturing clinical consensus has become so slick that it is now almost impossible to find independent articles from academic physicians 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 drugs for osteoporosis, respiratory or gut problems, or for 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.
Eye of newt, toe of frog, leaf of Hypericum?
And here’s the rub. In these legal cases, the laywers for GlaxoSmithKline took care to ask any of the women who were suing whether they had had St John’s wort (Hypericum). If they had they were likely to face an action from the company to get their case thrown out on the basis that this serotonin reuptake inhibiting plant had been known for centuries to cause birth defects.
Farmers regard St John’s wort as a dangerous weed and know to keep their cattle and sheep out of fields in which the weed grows for fear of miscarriages. But under industry influence doctors have been used like the dogs a farmer uses to round up sheep to herd women in exactly the opposite direction.
How many birth defects, miscarriages and terminations?
There are roughly 700,000 births in the UK each year, 4 million in the USA. Close to 10% of these, 70,000 in the UK and 400,000 in the US, will now be to women on antidepressants. Normally 2% of women give birth to a baby with congenital defects. So there should be 1400 babies with congenital defects born to women on antidepressants in the UK, 8000 in the US, but in fact the figures show that 3% or more of the babies born to these mothers, 2,100 in the UK and 12,000 in the US, will have major congenital defects.
There are likely 50-60,000 miscarriages in UK each year, 400,000 in the USA. In women on antidepressants this rate appears close to doubled – so what would have been 5-6,000 miscarriages in women on antidepressants will more likely be 10,000 in the UK, and 40-50,000 becomes something closer to 80,000 in the USA.
There will also be a substantial increase in voluntary terminations of pregnancy. This can happen for a few reasons. In some countries, any evidence of neural tube defects or other major congenital abnormalities automatically leads to a termination (see American Woman and American Woman 2). In other instances, the disinhibiting effects of SSRIs may lead to a woman having a termination she might not otherwise have.
There are roughly 250 terminations per 1000 live births. In women on SSRIs this likely rises to somewhere around 400. A very high proportion of terminations after 16 weeks are likely to be women on or previously on SSRIs, for reasons outlined above.
Glaxo began life making baby milk. SmithKline were once SmithKline Beecham. Beecham made their early money out of Beecham’s Pills. Slightly over a hundred years ago they were censured by the British Government for apparently promoting their pills for “maladies of indiscretion” – they would induce miscarriages.