Furious Seasons

September 22, 2009

AstraZeneca Denied Seroquel Diabetes Link After Warning Of It In Japan

Bloomberg is reporting today on documents recently unsealed in federal court in Florida in the ongoing case against AstraZeneca concerning claims that the company did not properly notify the public of risks (principally, diabetes and weight gain) associated with its antipsychotic Seroquel, now one of the top selling drugs in the world

"Nancy White, the saleswoman, and a colleague met in July 2006 with an unidentified doctor who reported 'getting a lot of flak' from patients about Seroquel’s diabetes links, according to a note unsealed as part of a lawsuit. AstraZeneca wrote in November 2002 to Japanese doctors that it received a dozen reports of diabetes-related cases tied to Seroquel 'where causality with the drug could not be ruled out.'
"White said in the 2006 note that she told the physician that 'there has been no causative effect' found between Seroquel and diabetes. The doctor 'said he would not quit writing' prescriptions for Seroquel 'due to this at this time,' White reported."

Issuing a warning in Japan while not issuing one in the US probably won't play out really well for AZ at trial. The behavior is reminiscent of Lilly warning Japanese doctors of similar diabetes problems with Zyprexa in 2002 while months later in the US claiming the drug was perfectly safe as it rolled out a huge sales campaign aimed at PCPs.

Tufts psychiatrist Danny Carlat echoes what I wrote in 2007 about Zyprexa:

"'It’s pretty clear that if a drug poses a diabetes risk in one country, it poses that risk in others,' Dan Carlat, a psychiatrist at Tufts University in Boston who writes a blog about the health-care industry, said in an interview. 'I don’t think it’s ethical to warn doctors in Japan about this drug and then downplay or ignore the risk in the U.S.'"

Unethical? I'd say it should be illegal and the FDA ought to look into how it can reconcile US labeling to conform to warnings on the same drugs in other countries.

In other documents, AZ sales reps are reportedly working to downplay docs concerns about weight gain in Seroquel users, in effect flat out lying about the issue when Seroquel was known to be producing rapid weight gain in some patients, a potential precursor to diabetes.

An AZ spokesman told Bloomberg:

"'The heart of these cases are unproven claims that Seroquel caused diabetes,' Tony Jewell, an AstraZeneca spokesman in Wilmington, Delaware, said in an e-mailed statement. 'The evidence does not back up the allegations that Seroquel was responsible for the plaintiffs’ alleged injuries.'"

That remains to be seen.

Posted by Philip Dawdy at September 22, 2009 12:51 PM

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Comments

I can't hardly believe this! You mean AZ and other PhARMA corporations outright lie and deceive the American public; while the FDA stands by and does absolutely nothing.

Obviously government needs to pass more laws to protect those poor corporations from justice. We need this evil gravy train to keep rolling down the tracks for our economy to remain strong after all.

Maybe a second trillion dollar stimulus plan and total preemption is now in order for Big PhARMA.

"84% Americans Blame Big Pharma for Healthcare mess"

http://www.ahrp.org/cms/content/view/636/110/

Say it ain't so?

Posted by: Ms. Piggy at September 22, 2009 05:46 PM

'It’s pretty clear that if a drug poses a diabetes risk in one country, it poses that risk in others."

So, if antidepressants pose a risk of violence in one country, it should be pretty clear they pose a risk in other countries.

http://www.ssristories.com/show.php?item=3356

First two paragraphs read: "'Is the antidepressant I'm taking safe?' I am hearing this question from my patients more and more. The reason? The media has recently reported that among antidepressant users, some develop increased feelings of hostility or anxiety, and have even committed sudden acts of violence against others."

"The Ministry of Health, Labor and Welfare in Japan has investigated the side-effects of antidepressants and has decided to revise the warnings on the medication, stating, 'There are cases where we cannot rule out a causal relationship with the medication'."

http://mdn.mainichi.jp/perspectives/news/20090521p2a00m0na011000c.html

No need to fear antidepressants if patients, doctors team up on diagnosis, treatment
Rika Kayama

Posted by: Rosie at September 22, 2009 09:11 PM

Just had two patients in a row asking specifically for Seroquel. (Despite the fact that their psychotic symptoms are well controlled on low-dose Risperdal and Geodon, respectively.) When I explained the risk of diabetes & wt gain (which they'd never heard of-- imagine that!) they withdrew their request.

This happens all the time. For every patient for whom I want to discontinue antipsychotics, there's another one asking for Seroquel by name. Yep, word on the street is it's a good drug.

Posted by: SteveBMD at September 23, 2009 10:58 AM

That's interesting Steve, and thanks for clarifying the doctors who take meds topic the other day.

just from curiosity...I would like know if when you tell patients about the diabetes risk, re: Geodon and Risperdal et al, do you tell them all side effects, such as the heart risk factors with Geodon? Just curious, because I have yet to find a psychiatrist who worked with my daughter stop and tell ALL side effects, let alone the obvious.

AstraZeneca promotes the use of this drug as far as the FDA will allow it, and there is the problem at hand.

Posted by: Stephany at September 23, 2009 12:34 PM

Loved my vacation in the Critical Care Unit fighting for my life from Seroquel induced Acute Pancreatitis/Diabetes.Had just seen my psychiatrist the day before and when I told me how awful I felt he replied it was simple stress.How can a medical professional NOT know what the drug prescribed side effects are???
Been off all psyche drugs for 7 years and feel so much happier, calm and enjoy mental clarity. Thank goodness.
I had bought the whole psyche drugs will work hook, line and sinker and then almost bought the farm as in dying.

Posted by: Shelby Sardis at September 27, 2009 11:03 PM

Shelby,
"Been off all psyche drugs for 7 years and feel so much happier, calm and enjoy mental clarity. Thank goodness."

Thank you for sharing this! May I ask how long it took to get to this point? Lot's of people struggling (a year or more off drugs) and looking for hope on paxilprogress.org. They'd love to hear your story.

Posted by: Damaged at September 28, 2009 04:28 AM

Shelby,
I, too, nearly died from psychotropics. I spent 25 years with undiagnosed hypothyroidism, for which I had a laundry list of classic symptoms. Instead of having this ailment diagnosed I was subjected to endless drugs, changes of drugs, 12 hospitalizations--two of which totalled six months of my life. I have done my time, have paid whatever debt I may have owed society (insert cognitive dissonance alert here). The first big leap in my recovery was to disconnect from the psychiatric "profession" and their drugs. The next was (du-uh) the proper reading of a simple blood test by my local physician's assistant which probably saved my life.

How, indeed, "can a medical professional NOT know what the drug prescribed side effects are???" Too busy counting their money, I guess.

Posted by: Sherry at September 28, 2009 07:49 AM