It’s somehow eerily fitting that the bellwhether trial case for GlaxoSmithKline’s (GSK) Paxil is taking place in Philadelphia—the nation’s birthplace. You can’t really think of such a trial going on in Philly without recalling a few excerpts from the Declaration of Independence—and not just the more famous lines about unalienable rights but also some lesser quoted phrases like ”Such has been the patient sufferance of these Colonies”; substitute the word “mothers” for “colonies” and you’ve just advanced 233 years to be talking about Paxil.
At the heart of the trial that’s now underway is GSK’s allegedly knowing—and failing to warn patients—that its anti-depressant drug, Paxil, could cause birth defects.
All eyes are on this first case which centers on Lyam Kilker, now 3, who has suffered life-threatening heart defects since birth. According to bloomberg.com (9/11/09), Michelle David, Lyam’s mother, was quoted as saying that:
…she was prescribed Paxil during her first trimester to treat mild anxiety. Lyam was born with defects including two holes in his heart as a result of taking the drug, she said in court papers. The infant underwent multiple surgeries within six months of his birth, she said.
She said wouldn’t have taken Paxil if she knew of the risk and contends that Glaxo failed to warn her or her doctors.
“All of Ms. David’s physicians who prescribed Paxil just prior to and during her pregnancy with Lyam have testified that had they been warned that Paxil could increase the risk of cardiovascular heart defects, they would not have prescribed it to her,” according to court papers.
Needless to say, GSK’s position is that there’s no mea culpa; however, reports estimate at least 600 additional cases waiting in the pipeline for the outcome of this trial to say just whose culpa it is. For the sake of legacy of our forefathers, let’s hope prudence prevails.
Depression during pregnancy is a health risk not only for the mother, but also for her baby, yet it’s not widely publicized. According to information on the March of Dimes website—the March of Dimes being a leading non-profit organization for pregnancy and baby health—two of every 10 women experience symptoms of depression during pregnancy. That’s considerable.
So where’s the health risk to the baby? You get a prescription for an antidepressant and hope for the best, right? Wrong. The fallback treatment for depression has become antidepressant drugs, the most common type being selective serotonin reuptake inhibitors or SSRIs. SSRIs, such as Paxil (paroxetine) which are associated with serious cardiovascular malformations, primarily ventricular septal defects (VSDs) and atrial septal defects (ASDs). The risk for these birth defects is so serious that GlaxoSmithKline’s (the maker of Paxil) own publicly available literature states:
For women who intend to become pregnant or are in their first trimester of pregnancy, paroxetine should only be used after consideration of the other available treatment options.
In a June 24, 2009 letter, Senator Chuck Grassley asked 23 medical schools for information about their policies for conflicts of interest and requirements for disclosure of financial relationships between faculty members and the pharmaceutical industry.
“I recently learned from an American Medical Student Association report, AMSA PharmFree Scorecard 2009, that your institution either had “no response” or “declined to submit policies” when asked to supply conflicts of interest policies,” he said in the letter.
Grassley asked the Universities to respond by no later than July 15, 2009.
Of the 149 schools asked, 126 provided information to the AMSA. The Scorecard 2009 was released on June 16, 2009. Thirty-five schools, or 23%, received an F. Seventeen got a D, 18 received a C, 36 were graded B, and only 9 schools received an A.
“There’s a lot of skepticism about financial relationships between doctors and drug companies,” Grassley said in a press release. “Disclosure of those ties would help to build confidence that there’s nothing to hide.”
“Requiring disclosure is a common sense reform based on the public dollars and public trust at stake in medical training, medical research and the practice of medicine,” he added.
Nearly every year, researchers on drug company payrolls publish some ridiculous study with claims that more people may be dying from suicide due to a black box warning about an increased risk of suicide in young people on the labels of SSRI and SNRI antidepressants as a ruse to increase sales of drugs.
Judging from a new study out this month, with a June 2, 2009 headline on WebMD stating: “Are Antidepressant Warnings Causing Harm?”, apparently this year is no exception even though in the US there were 164.2 million prescriptions dispensed for antidepressants in 2008, compared to 143 million in 2004, according to IMS Health, a healthcare information company.
The study, published in the Archives of General Psychiatry, claims there has been a drastic drop in the diagnosis of depression in adults and kids.
Although the adverse effects of women taking psychiatric drugs while pregnant related to birth defects and infant withdrawal syndrome are often discussed or reported, the serious adverse effects on the sex lives and reproductive systems of millions of young couples are rarely mentioned.
Whatever the reason, due to the ever widening marketing campaigns by the psycho-pharmaceutical industry, young people need to be warned before they get conned into taking psychiatric drugs.