How the Same Study with Different Conclusions Could Spell Disaster for Unborn and New-Born Babies

Last year (2012) the British Medical Journal (BMJ) published a study from 5 Nordic countries (Denmark, Finland, Iceland, Norway, and Sweden) based on more than 1.6 million infants born after gestational week 33 between 1996-2007.

This year (2013) JAMA published a report based on a study from all Nordic countries (Denmark, Finland, Iceland, Norway, and Sweden) at different periods from 1996 through 2007, also based on over 1.6 million births. So it’s a safe bet that the two studies are one.

BMJ Study Jan 2012. Here.

Jama Study Jan 2013. Here.

The first study concluded that the risk of persistent pulmonary hypertension of the new-born doubled when the mother was using an SSRI. This year the same study concluded that SSRIs do not increase the risk of infant deaths. Articles, like this one, which stated that “Recent research has cancelled the claims by saying that SSRIs do not pose any sort of risk” are at risk of wrongly giving the impression that these drugs are safe to take in pregnancy. Wrong! Stating that this is ‘recent research’ further gives the impression that this is a recent study, suggesting new findings. Also wrong!

The study was undertaken by a group of researchers from the Karolinska University Hospital, Stockholm, and initially warned that pregnant women who are taking SSRIs could be doubling the risk of having a baby with serious birth defects. This year though, the same researchers (bar one, Örjan Ericsson) presumably played with the stats, and concluded “Taking SSRIs during pregnancy do not up the risk of infant death.”

What the JAMA study actually found was that women who took an SSRI did have higher rates of stillbirth and infant death than those who did not. Although according to co-author Dr. Olof Stephansson, “this was because of an increased proportion of smokers, older [maternal] age, diabetes and hypertensive disease.” That’s not quite the same as saying ‘SSRIs do not pose any sort of risk’.

What the researchers failed to take into account is that SSRIs are in fact linked to increased rates of voluntary terminations. This may be because of the ‘disinhibiting’ effect of SSRIs but more importantly, the findings could be due to Nordic women terminating pregnancies with significant birth defects. In 2001 a woman wrote to GlaxoSmithKline, asking whether it was possible for her to have a healthy baby while using their drug Paxil (Seroxat). She had terminated her first pregnancy after discovering the baby had a serious heart defect (truncus arteriosus) and was unlikely to survive. Internal GSK documents were found to have stated that this baby’s heart defect was ‘almost certainly linked to Paxil’. Drug companies including GSK and Lundbeck have had no choice but to admit that Paxil and Celexa can have teratogenic effects, so it begs the question, why are these researchers putting babies lives at risk?

It seems that even the drug companies will admit that their drugs can cause harm, yet these dangerously misleading articles are published without restraint. This excerpt is from a meeting in Lundbeck’s head office. I initially asked them if Citalopram and Escitalopram (same product) was a teratogen:

Leonie:  Can it (Citalopram and Escitalopram) cause harm?….. to unborn babies?

Dr. Madsen:  Anything can cause harm, can cause harm in any dose.

Leonie:  So, yes it can.

Dr. Madsen:  Depending on dose.

Despite Lundbeck admitting that Citalopram and Escitalopram can cause harm, they then went on to say that it is up to doctors to warn pregnant women, not the pharmaceutical companies. So now we go round and round in circles and no-one accepts the blame for the dead and harmed babies.

According to Professor David Healy, 1 in 10 pregnant Irish women are on antidepressants, leading to about 40 extra babies with significant birth defects and 200 extra miscarriages each year. So in the last 20 years, antidepressants have caused birth defects in 800 Irish babies and 4000 miscarriages. How many babies have died unnecessarily worldwide?  That’s some discrepancy in the figures! Can a pregnant woman afford to take the risk?

Whatever the reasons for the Karolinska researchers coming to the conclusion that SSRIs do not increase baby deaths, and I can think of a few, extreme caution needs to be advised. Interestingly, the Karolinska institute (which along with the Karolinska University Hospital form an academic health science centre), has recently been involved in dubious research findings on antidepressants and suicide, here.

Dr. Adam Urato, assistant professor of maternal-fetal medicine at Tufts University Boston, on prescribing SSRIs to pregnant women, stated ”The situation amounts to ‘a large scale human experiment.” So it begs the question, if some doctors and even the pharmaceutical industry are admitting that these drugs are teratogens, surely medicals researchers, at the very least, should err on the side of caution? In my opinion, in these circumstances, the benefits do not outweigh the risks!