Avandia: DREAM Killer

Yes, yes, yes, Dear Readers, I have read about Avandia causing heart attacks. (Thank you all kindly for the tips.) But what I keep saying is, this is not news; they just have more concrete evidence now for flaws in the drug that were obvious since at least last August.

So much for GlaxoSmithKline‘s “DREAM Study” last Fall, ay? That drugmaker-backed study — the largest D-prevention study ever conducted, in fact — apparently “showed convincing evidence that the insulin sensitizer drug rosiglitazone (Avandia)… appears to cut the risk of developing Type 2 diabetes by more than half.”

Killer_drugs

But even back then, analysts were warning of “troubling results regarding congestive heart failure and weight gain.”

Now a new study by the Cleveland Clinic is showing that the widely prescribed drug may have caused heart attacks in “tens of thousands of people.” (OK, the numbers are scary!) The study showed that patients on Avandia had a 43% higher risk of heart attacks, and a 64% increase in cardiovascular death.

Consumer advocacy groups are calling foul play, too, because GSK seems to have quietly informed the FDA of the risk last August, but neither party warned the public.

Instead of apologizing, the company is on the defensive, “strongly objecting to the results and defending use of the drug.” They claim that they’ve been “fully transparent” and provided ample evidence that the drug is safe.

But what about those tens of thousands of people having heart attacks? You tell me…

In any case, please let’s stem the widespread panic here… My visiting mother, for example, brandished the newspaper from the breakfast table this morning, asking (well, kind of yelling): “Oy Gott, is this what I’m taking?!”

“No mom, that’s Metformin.”

“But is that the generic name or something?”

“No mom, you’re taking Metformin, a different drug.”

“Aww, they make all these diabetes drugs in the same vat, don’t they?

Oy Gott, I hope not…

******** UPDATE: ********
Is the media blowing the Avandia scare totally out of proportion? Some people think so.

See also: “What Choices Do You Have If You’re Taking Avandia?

6 Responses

  1. Felix Kasza
    Felix Kasza May 22, 2007 at 10:40 pm | | Reply

    I am happy to report that the “42%” and so on numbers are typical newspaper garbage. They represent an increase in _relative risk_ — if, formerly, two person out of hundred thousand got some condition, a 43% increase in RR would mean that three persons would be afflicted afterwards.

    As for why GSK and FDA didn’t inform the public, there may be several reasons — but I suspect that the tendency of media (and blogs) to blow things out of proportion played a major role.

    Cheers,
    Felix.

  2. Big_Dave_T
    Big_Dave_T May 23, 2007 at 9:25 am | | Reply

    Thanks for doing this article. As a regular reader of your blog, I hope to keep abreast of major developments in the treatment of diabetes. I knew this was one you wouldn’t miss.

    Good blog, good links. Thanks again.

  3. Jolene
    Jolene May 23, 2007 at 10:02 am | | Reply

    This was my first medication when diagnosed T2, and didn’t do squat for me, so moved on to Actos — which isn’t any better I might add. Glad I’m on either now. I don’t trust a single drug company PERIOD! Even the one that makes my beloved Armour Thyroid.

  4. Andrea
    Andrea May 24, 2007 at 6:15 pm | | Reply

    I suggest author Gretchen Becker’s post for another perspective on all this:
    http://www.healthcentral.com/diabetes/c/5068/9750/perspective/

    This Business Week article also presents the other side:
    http://www.businessweek.com/technology/content/may2007/tc20070523_162460.htm

  5. wschaf
    wschaf May 27, 2007 at 10:13 pm | | Reply

    There may be more conflicts of interest here than the one that is obvious. The lead investigator from the Cleveland Clinic, Dr Nessen, has performed clinical trials for just about every big drug company except GSK. Therefore, he may have a conflict of interest in finding fault with anything GSK produces. Another problem is that the study was a meta-analysis, where similar studies are pooled to try to increase the accuracy of any conclusions that can be made. Something that is crucial to an honest meta-analysis is including as much as possible for statistical analysis. The Nissen study found 48 studies of Avandia, but did not include six studies where no deaths occurred because of the statistical method used can’t work with data with a zero result. This could certainly skew the resulting statistics. These, and other complaints come from a rant by the angry pharmacist, http://www.theangrypharmacist.com/archives/2007/05/avandia_oh_why.html.

  6. Ann-Marie
    Ann-Marie May 31, 2007 at 9:12 am | | Reply

    The word definitely needs to spread about some of the harmful side effects of these drugs.

    http://www.imtypefree.com

    Recent article:

    Heart attacks, broken bones and rapid weight gain, sounds like the consequences of neglecting your health; but a recent FDA study suggests that those side effects may be the result of treating Type 2 Diabetes (T-2) with Avandia® (rosiglitazone) a medication prescribed to T-2 diabetics for the past eight years.

    According to many health professionals and advocates for diabetics, prescription drugs alone may not be the best treatment for diabetes.

    “Treating diabetes with drugs such as Avandia® may have hidden health costs,” said Ann-Marie Stephens, the co-founder of ImTypeFree.com, a diabetes health education website. “Anyone recently diagnosed with impaired glucose tolerance (pre-diabetes) or diabetes should consult with their physician about managing this disease with nutrition and exercise either in conjunction with prescription medication or without,” she added.

    Most health professionals agree that nutrition and exercise are crucial in managing T-2 Diabetes or in reducing the risk of developing the disease. Studies have found that diet and exercise have effectively helped to manage T-2 Diabetes especially when overweight and/or obese diabetics commit to weight loss. Reducing waistline fat by 5% to 10% will reduce your risk of developing T-2 Diabetes by 25%.

    “Thirty minutes of moderate exercise can go a long way in our journey to winning the war against diabetes,” said Stephens. “But nutrition is also an important piece of the equation when reclaiming our health. Avoiding processed sugar, excessive fatty foods and alcohol are the first tiny steps you can take.”

    Type Free, LLC agrees with nutritionists who suggest a meal plan filled with whole grains, legumes, vegetables, fruit, nuts and seeds is the foundation of a healthy diet that can effectively help battle diabetes.

    ImTypeFree.com offers articles on proper nutrition and exercise regimens for diabetics. Visit the http://www.ImTypeFree.com forum and try the delicious diabetes recipes posted. Also sign up for the ImTypeFree newsletter, to receive health tips, diabetes news and timely information about winning the war against diabetes.

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