Consider This

A jury trial begins this week in New Jersey to hear charges that AstraZeneca failed to warn patients of the dangerous side effects of its blockbuster drug Seroquel. This is the latest in a series of allegations that as early as 1997 the British drug giant ignored internal reports that the drug caused significant weight gain beyond the six-week period of drug trials. Documents obtained by Furious Seasons indicate company insiders debated what they should tell doctors who asked about weight gain, and whether there was a marketing advantage they could devise against competitors with similar complications. Company memos show they considered arguing weight gain as a benefit. Substantial weight gain carries the risk of diabetes, heart disease, disability and early death.

Well timed for the trial is the release of a new TV ad for SeroquelXR. This message, ostensibly about bipolar depression, shows people literally fading into the background, just as the narrator predicts. They become the upholstery on the couch, the milk containers at the supermarket, and the back seat of the bus. They watch life pass them by while we are entertained with a catchy rhythm and upbeat sound of guitar and xylophone that keep you humming. The company claims the ad provides "insight that patients with bipolar depression often feel consumed by their illness." As a message, it's certainly flawed. One person wrote on the Yahoo message board, "I am not sure what the ad on tv is supposed to say. Is that what is feels like to take seroquel? Or is it the other way around?"

AstraZeneca.jpgThis example of direct-to-consumer advertising, and the upcoming trial, coincide with peak cynicism about pharmaceutical companies marketing new drugs and creating spin for second-generation anti-psychotics (SGA). The trial will address the clinical consequences of side effects, while it renews attention to what psychiatrist blogger Dan Carlat calls "accusation fatigue" including (but not limited to) professional conflicts-of-interest, ghost writers, and assigning blame to patients, rather than a drug, for conditions leading to metabolic disorders.

Seroquel was marketed to treat schizophrenia in 1997, later approved for bipolar disorder, mania, and depression. The extended release version, featured in the ad, was approved by the FDA in 2008, adding years to the patent. Now, Seroquel is one of the SGAs at the heart of legal, ethical and medical debates about "who knew what when." As in the case of Eli Lilly (Zyprexa), internal documents have shown that AstraZeneca was aware of side effects. The former medical director told the BBC that he was "pressured" into accepting the company's claims despite efforts to convince them differently.

More than 26,000 people have filed suits against AstraZeneca claiming debilitating or life-threatening side effects associated with Seroquel. More than half of the television ad, 50 of 90 seconds, lists them. And they sound pretty frightening if you pay more attention to the words than to the music. The BBC recently profiled how side-effects affected patients taking this drug. AstraZeneca maintains it conducted the proper clinical tests before the drug was approved. More than 22 million people have taken it since.

Last year the drug earned $4 ½ billion dollars and law suits have already cost $650 million. But the jury trial for Seroquel is a first. Meanwhile, the company appears to be appealing to the court of public opinion. In addition to the ad, last week, from corporate headquarters in Delaware it announced "that it provided $769.6 million in savings to 507,475 patients in the United States last year through its AZ&Me™ Prescription Savings programs."

It's too early to tell what the verdict will be in either court. In the meantime, we'll stay glued to the box.


Comments (1)
David:

Noone contacted me about how Seroquel affected me over a two year period of taking it. And I certainly was not told about the expected weight gain nor the chances of developing type2 diabetes from taking this drug. In a two year period I gained right at 30 lbs. and afetr going off the drug by my own choice, I was diagnosed as a type2 diabetic. High blood sugar had never been a problem for me prior to taking Seroquel. My doctor only told me that it would help me to sleep and it would control my moodiness. Moodiness?? I thin it's a terrible shame that their drug can cause me to have life-long problems while I have only two years to prove them liable for my new, unwanted condition. I haven't heard anything from any lawyers....only what I read here online. This is how I found out about the bad side effcts that Seroquel causes. Meanwhile I have to take Metformin twice daily and stick my fingers twice daily and it's just not a problem for Astra-Zeneca. I hope that others have a better relationship with their doctors and they don't just talk in circles as mine did. Then diagnose them as a type2 diabetic once they stop taking that drug. I don't live on fast foods and I was not pre-disposed to getting diabetes. It doesn't run on either side of my family. Good luck to all you potential litigants.

Posted by David | September 16, 2011 4:47 AM
Post a Comment

MIWatch would love to hear your thoughts. Please join the discussion.


characters left

Phyllis Vine

Consider This

by Phyllis Vine

Relevant Sites

Featured Videos

Watch videos at Vodpod and politics videos and more of my videos

MIWatch Archives

This website is certified by Health On the Net Foundation. Click to verify. This site complies with the HONcode standard for trustworthy health information:
verify here.



Search only trustworthy HONcode health websites:



Top 50 Wellness Guru Award
Accredited Online Colleges