Salmon

Other injuries could have been added in the last year or so that I may not have heard about, but I think I would have.

Question: do any of these lawsuits involving “birth defects” mention neurodevelopmental problems in the children (or did they focus specifically on cardio defects)?

I raise this question because of the newest concern that SSRIs may be associated with autism (by disrupting 5HT homeostasis during early brain development).

Almost exactly 2 years ago, Dr. Rick Lin and his colleagues at the University of Mississippi’s Autism Spectrum Disease Research Group (ASDRG) were awarded a prestigious four-year, $1.2 million grant from NIH, known as a grant from the EUREKA program (Exceptional, Unconventional Research Enabling Knowledge Acceleration Program). This grant addresses an unconventional and compelling idea that the *rise in autism may be due (in part?) to the rise in the use of SSRI anti-depressant drugs.* Clearly, NIH paid attention.

“The group’s central hypothesis (from data based initially on rat moms and their pups) is that abnormal regulation of serotonin (5HT) during early brain development compromises oligodendrocyte function and interferes with the establishment of normal interhemispheric connections.” – from their website at http://www.umhc.com/wtn/Page.asp?PageID=WTN000064

This group hypothesizes that abnormal levels of serotonin during pregnancy (as a consequence of the pregnant human mom taking SSRIs) may be “the key environmental factor contributing to the recent surge of autism not only in the United States, but also in other highly developed, industrialized countries.”

Out of interest, you wouldn’t happen to know whether this “spokeswoman” was Mary-Anne Rhyne would you, Ed?

Anyway, importantly, an out-of-court settlement permits denial of all responsibility (as would a civil decision in favour of a plaintiff patient, in truth), and any further questions may be dismissed with “that’s all settled, so you can forget about it, because we have,” and the Company won’t have to change the way it operates, at all, as though everything really were settled. Great system!

Mind you, the issue of side effects, whilst I wouldn’t wish to diminish it, is secondary to whether the drug works, because if it doesn’t actually make people better, then the question of side effects should never arise. So, as a parting shot, does GSK believe that its drug has a level of efficacy that outstrips placebo, outside that presumed to be present solely on the basis that it has a marketing authorization (licence)? Because, obviously, GSK is big into beliefs, and is confident in putting its beliefs forward for scrutiny. So, let’s have at it, I say.

Matt