Thursday, October 19, 2006

Credible Source (?) on Paxil

I was reading through Evelyn Pringle's latest article on GlaxoSmithKline, which I will excerpt in a moment. It struck me that she may also have a significant conflict of interest here, but some points bear mentioning nonetheless.

Much of the piece focused on Paxil.

Glaxo's latest escapade was revealed on October 5, 2006, when Bloomberg News reported that Glaxo conducted a recall of Paxil CR, a selective serotonin reuptake inhibitor antidepressant, last month because some of the pills may lack an active ingredient, but that the company did not warn patients who may be taking the useless pills.

Doctors told Bloomberg that patients who either abruptly stop taking Paxil or get inactive pills, can face the risk of suicidal thoughts, shooting pains and flu like symptoms.

The Paxil CR pills are the highest dose sold, and can cause severe withdrawal symptoms, according to Dr Stephen Ellen, a psychiatrist from the University of Massachusetts Medical School in Worcester. "If it is true that patients might have gotten dummy pills without knowing it, it is outrageous," he said.

According to Glaxo, the FDA knew about the problem and approved the limited recall plan, but FDA spokeswoman, Susan Cruzan, told Bloomberg that she did not know the details of the September Paxil CR recall.

This incident is even more outrageous because back on March 4, 2005, the government cited Glaxo for the exact same wrongdoing when the FDA and the Department of Justice initiated the seizure of Paxil CR tablets after Glaxo failed to meet the standards laid out by the FDA to ensure product safety, strength, quality and purity.

Among the violations noted then by the FDA, was the finding that the tablets could split apart and patients could receive a portion of the tablets that lacks any active ingredient, or alternatively a portion that contains active ingredient and does not have the intended controlled-release effect."

So Glaxo was selling an unknown amount of Paxil without the active ingredient and not letting anyone know that they were, in fact , receiving placebo. Oops! Granted, Paxil ain't much more effective than a placebo, but the withdrawal effects are certainly a concern, especially when people don't know they are withdrawing.

What I don't like about this piece is the frequent mentions of the Baum Hedlund law firm. Maybe the folks at this firm really are tireless consumer advocates -- I have no idea. But it does read as a bit of an infomercial for the firm. I suppose that makes sense in the context that the end of the article states "Written as part of the Paxil Litigation Monthly Round-Up, Sponsored by Baum Hedlund's Pharmaceutical Antidepressant Litigation Department."

As y'all know, I'm not in the antidepressant fan club, as evidenced by posts such as this, this, this, and this. It just seems that this particular article comes across as a bit too much in favor of lawsuits. I suppose her counterargument may be that there are few other avenues to pursue recourse and convince manufacturers to change poor practices given that the FDA is toothless. If that were her response, I would have no rebuttal.

All that being said, I could find nothing that really contradicted the original report at Bloomberg, which can be found here.

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