Things have looked bad for GlaxoSmithKline’s flagship antidepressant for a fair amount of time now. But bad press continues to plague the SSRI and its manufacturer, both in and out of the legal arena.
First, one must consider the extensive lawsuits filed against GSK, alleging that Paxil is responsible for the formation of birth defects in children born to mothers who were taking Paxil during their pregnancies. These defects included heart malformations, PPHN, and mis-formed body parts such as incompletely formed anal openings, clubbed feet and over- or under-sized craniums. A large chunk of these lawsuits recently was settled for several billion dollars in damages.
Next, there is the continuing evidence that Paxil causes aggravated feelings of suicide in younger patients — and this despite the fact that the FDA hasn’t approved the drug for use in younger patients. The evidence includes a controversial study that recently was performed in Japan in children as young as 7 years old. Stranger still, Paxil is required to carry a black box warning indicating that it can aggravate suicidal thoughts in children; the condition and effect are already known. So now Paxil is doing yet another study to see if this is true. Why?
Last, but perhaps not least, is the recent conviction of Dr. Maria Carmen Palazzo. GSK hired Palazzo to perform a series of clinical tests on Paxil patients 10 years ago. A few weeks ago, Palazzo pleaded guilty to numerous counts of fraud, confessing that her studies were almost entirely falsified. She performed tests on children based on diagnoses that were patently untrue, claiming that the children suffered from conditions such as major depressive disorder when it was abundantly clear they did not have any such affliction.
In essence, there has been no seriously good news for GSK or Paxil for several months at this point. Admissions of defeat and deceit alike continue to come in, raising serious questions about the long-term viability of Paxil in this image-conscious market.