August 8, 2009

GSK Marketed Paxil Heavily to Pregnant Women Though It Causes Birth Defects

This isn't a diabetes story, but I am writing about it because the manufacturer involved in this case, GlaxoSmithKline (GSK), is the same company that sells and promotes Avandia and Avandamet to people with diabetes. The behavior of GSK in the way it is promoting blockbuster profit maker Paxil is very similar to what we saw with Avandia: complete disregard for the damage the company's drug caused patients.

You can read an excellent discussion of the problems with Paxil in this story published in today's Guardian. It's important to note that these stories appear in a British publication, not a US publication. The reason may have something to do with the fact that US print publications rely heavily on drug company advertising which is illegal in the UK.

Antidepressants once seen as miracle drugs: now risks are becoming evident US courts to hear claims that insufficient attention was paid to dangers to foetus.

What is most disturbing here is that the company specifically marketed Paxil, an SSRI which is notoriously difficult to quit, to pregnant women and women of childbearing age, even when there was growing evidence that the drug caused severe withdrawal symptoms in newborns and possibly was causing heart defects.

Even now the company spokesmen continue to downplay the dangers.

This is the same company that used threats of lawsuits to silence those who attempted to inform the public of the heart-attack potential of Avandia. While intelligent people can debate the facts about Avandia's link to heart attack, the heavy handed Mafia-like tactics the company employed to prevent that discourse from taking place speaks far louder than any research study about what the company really knew about Avandia's side effect profile.

If you are taking any SSRI and are thinking about becoming pregnant or have friends or relatives in that situation, you need to read this article and get the word out about what SSRIs may do to a baby. These drugs can be extremely difficult to stop (which in my youth was the definition of "addictive drug"--a definition which the SSRI manufacturers have managed to change). So women on these drugs should get their doctor's help to detox months before becoming pregnant.

And the rest of us have one more reason to distrust drug companies who prove month in and month out that they are willing to boost profits even if it means ruining the lives of innocent men, women, and now it appears, children.

7 comments:

Liss said...

Jenny my doctor pressed me to take Pristiq for depression despite my plans for pregnancy. I did enough research to confirm my suspicions that this would be foolish. I'm taking Wellbutrin instead, but am not fully comfortable that it's safe for pregnancy. Have you run into any research that discusses the effects of norepi-dopamine reuptake inhibitors on fetuses? My instincts tell me to discontinue this med.

Jenny said...

Lisa,

I don't keep a close eye on the depression meds except for the well-known ability of some to worsen insulin resistance in many people.

When I was pregnant I even cut out coffee because it wasn't clear if it was harmful to the fetus. Given the huge amount of obfuscation and manipulation of study data re all the antidepressants, I personally would avoid them all. My guess is that they have a lot to do with why we have so many obese toddlers and children because they are powerful drugs that do get into babies. They may not be causing defects visible at birth, but who is to say what subtle effects they are having on the developing brain of the baby.

Most people don't need antidepressants. They are over prescribed for the normal sadness and emotional turmoil that have always been part of growing up and that most of us grew out of in the old days. Quite a few studies, suppressed by the manufacturers show them working no better than placebo.

A sugar pill might be a lot healthier for your baby.

Jenny said...

One more point. There are drugs that are necessary--usually those prescribed for severe conditions, like lithium, where if you stop taking them you can lose contact with reality and behave in ways that are dangerous to yourself and others.

If you have that kind of mental condition, you may have to take drugs to avoid psychotic break. But I saw almost every one of my teenaged daughters upper middle class peers put on antidepressants after normal "depressing" events like breaking up with their first serious boyfriend. I personally consider that drug abuse, and I am appalled at the doctors and parents who addicted their teens to powerful drugs rather than giving them the support they needed to deal with emotional growth.

Susanne said...

I took Paxil from 1992-2000. Getting off Paxil required a 4 year (!!) withdrawal process. Every tiny reduction in dose resulted in headaches, nausea, extreme vertigo and mental instability. When I was down to one pill every eight days, I quit completely and went through three months of disabling hell. I had a friend who went to Russia and forgot his Paxil at home, and he was in such bad shape within a few days that he paid $400 US to get a few bootleg Paxil pills to get him home. This drug is the devil!

Peter Atwood said...

Thanks for drawing attention to this story. The ramifications of these drugs on our world are not fully understood but something tells me you are on the right trail once again.

Scott said...

Did you catch Fed Chief Margaret Hamburg's speech the other day about enforcement? (see http://www.fdli.org/conf/09/fda-commissioner/ for both a webcast and a transcript) ... it is clear that for too long, thanks to the 1992 User-Fee Act which reallocated a majority of funds to come from industry rather than taxpayers, the FDA has viewed itself as a "partner" to the drug and biotechnology industries, not as an agency tasked with ensuring public health. Just look at the staffing in departments of the FDA: new drugs, growth of 300%, post-market analysis and enforcement, -50%. Although the new leadership has much to clean up, I am hopeful that they have their priorities straight, but we need to remember that the motto "let the buyer beware" to be how we view FDA-approved products, because at the moment, that isn't as good as a Good Housekeeping Seal of Approval!

Jenny said...

Scott,

Actually I had read about her speech.

But you are right that after a decade of completely ignoring the patient's interests, there are many dozens of drugs on the market and it would take years for even the best intentioned regulators to figure out which ones are harming people.

And the money pouring in from the drug companies to congress may well result in legal changes that do an end run around those regulators, far away from where the public even hears about it.

I have to go easy reading the health news lately because I get so infuriated it isn't healthy for ME. My blood pressure is fine if I don't visit Huff Post for the latest outrage. So I have to ration just how much I take in so that I can keep doing my big to help people with diabetes get by.