October 13, 2009

Glaxo Must Pay $2.5 Million In Paxil Birth Defects Case

A Pennsylvania jury earlier today found GlaxoSmithKline liable for heart defects caused to a young boy whose mother was taking the company's anti-depressant Paxil while pregnant. The jury awarded the boy's family $2.5 million. Plaintiff's attorneys had argued that Paxil had caused the defects and had failed to properly test the drug and, while knowing of its ability to cause defects, had failed to warn consumers properly.

This is a significant ruling because it's the first time GSK has been found liable in a birth defects case and because there are abut 600 more similar cases awaiting trial.

GSK's lawyers said they would appeal the verdict. The company issued a statement:

"'While we sympathize with Lyam Kilker and his family, the scientific evidence does not establish that exposure to Paxil during pregnancy caused his condition. Very unfortunately, birth defects occur in three to five percent of all live births, whether or not the mother was taking medication during pregnancy,' the company's statement said."

Good luck with that appeal.

Posted by Philip Dawdy at October 13, 2009 11:47 AM
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Comments

Great news! it is about time the drug companies paid for the harm these drugs do, ESPECIALLY when they knew the information before marketing the drug to innocent people!

Posted by: Stephany at October 13, 2009 01:44 PM

"'While we sympathize with Lyam Kilker and his family, the scientific evidence does not establish that exposure to Paxil during pregnancy caused his condition. Very unfortunately, birth defects occur in three to five percent of all live births, whether or not the mother was taking medication during pregnancy,' the company's statement said."

Quack, quack, oops. Wrong answer.

The question of causation is a thorny one, and is arguable ad nauseum, because as I pointed out recently, we would have to be able to transport ourselves back in time, shrink ourselves to atomic size and miraculously avoid Mrs Kilker's immune system, so that we could observe Lyam's foetal development, in order to prove or disprove definitively that paroxetine caused it. But this is not the point...

The point is that GSK's internal documents revealed that the Company had concerns (and, given that it is the only entity to have all the available clinical "evidence," who is better-placed to make a safety assessment?). The Company also sat on those concerns. These things are facts, not speculation.

What GSK is saying in this statement appears to be "yeah, we were satisfied that there was evidence of an issue, but nobody can prove it, so fuck off." Nice one, and "fuck off to you, too."

Matt

Posted by: Matthew Holford at October 13, 2009 03:28 PM

Hi Matthew and Stephany!

"...the scientific evidence does not establish that exposure to Paxil during pregnancy caused his condition."

How do they make the research to claim that?
Is there a double blind test for that?

I'm always amazed by the scientific evidence! It always rings to the shareholders pockets.

"To whom the scientific evidence tools?"
I'll write a book with this title.
No! It will take years to write and it will only sell 200 copies.
Mummy and pappy will not buy, 198 copies.
Not worthy.

Posted by: Ana at October 14, 2009 06:44 PM

Here is a study, in a prominent journal, seeking to detect these birth defects: American Journal of Psychiatry, March 16, 2009: Major depression and antidepressant treatment: Impact on pregnancy and neonatal outcomes. Lead author is Katherine Wisner.

Now: take a guess: how many births, to moms taking SSRIs, would you need to check in order to detect an increased incidence of birth defects?

Here, the Am J Psychaitry, and Wisner, were satisfied with a 48 women taking SSRIS during pregnancy.

Folks, this is NOT how you conduct a birth defect surveillance study. 48?

Posted by: medsvstherapy at October 15, 2009 06:37 AM

medsvstherapty wrote:
"...Folks, this is NOT how you conduct a birth defect surveillance study. 48?"

Warning: scathing sarcasm ahead

Let's assume that this extensive study was at least partially responsible for the statistic quoted in the GSK press release... That would mean that approximately 2 of the 48 women in the study gave birth to malformed babies? And where is the comparator study, which tells us what the "normal" figure is - the study that looked at the percentage of birth defects occurring more generally, irrespective of SSRI influence? All these unsubstantiated claims; not very scientific, is it?

But let's not forget: "these drugs have helped millions of people, around the world". What a bunch of liars.

Matt

Posted by: Matthew Holford at October 15, 2009 01:26 PM

"these drugs have helped millions of people, around the world"

Matt,

One lie repeated ten times becomes truth. I don't remember who said that.
Same for the "chemical imbalance". It's still the belief of many.

Posted by: Ana at October 20, 2009 04:54 PM
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