Has The Avandia Controversy Scared Diabetics?

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scream.jpgOne leading wag says it has. In a research note, David Risinger, a Merrill Lynch analyst who follows the pharmaceutical industry, writes that the flap over the cardiovascular risks posed by Glaxo’s diabetes pill may have swung the pendulum a bit too far. After noting a drop in scrips written this year for all oral diabetes meds, he worries aloud that diabetics and their docs may be avoiding treatment altogether.

“We believe that scrutiny of Avandia may have harmed the US diabetic population by scaring some patients off of therapy. Avandia script declines have only been partially offset by increases in other oral diabetes medications. Although a small percentage of CV events may have been avoided, we worry that a large number of diabetes patients have less control of their blood glucose levels. Unfortunately, there is no way of assessing the relative benefit of how many CV events will be avoided over time relative to the incremental diabetic complications caused by individuals dropping oral drug therapy.

“Some patients appear to have simply been scared off of drug therapy rather than switching from Avandia to alternative oral medications. This is unfortunate, given lack of glucose control among diabetics and the growing diabetes epidemic in the country,” Risinger continues. He then notes that the year-over-year growth in scrips for diabetes pills went from 2 percent to 4 percent to a decline of the same magnitude.

“Although it is ‘in vogue’ for certain thought leaders and politicians to criticize drug safety, we believe these data highlight why it is critical for FDA to remind the public that all drugs carry benefits and risks, and risks should not be over-emphasized to the detriment of patients.”

Risinger makes a fair point. But a key issue raised by the Avandia episode, among others, is the extent to which safety data is fully disclosed, analyzed and assessed by those with the responsibility for doing so, whether it be drugmakers or regulators. Having all the info on the table - and a complete understanding of the implications - should always be ‘in vogue.’

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  1. Agree, Ed. Another way to say it is that _both_ benefits and risks are often extremely hard to (a) access fully and (b) communicate to pts, whether that be via their docs, DTC, etc..

    Maybe it wouldn’t help much, but I think everyone should have fluency re: relative risk and NNT numbers. To the degree that data are available, both the over-hype as well as the over-panic might at least be modulated.

  2. This would have been a much more interesting story if it was written by a physician rather than an industry investor analyst. Like he’s really concerned about the diabetics. Get real.

  3. Physician,.. now that’s funny..

  4. Rising’s “analysis” reads more like an editorial with cheerleading for the drug industry.

    Maybe the reason that there are less scrips for diabetics is because more of them actually DO understand the risks of medications and are trying to treat diabetes with exercise and diet change?

  5. Any time a drop in prescriptions is noted, someone is quick to claim that people are making uneducated and dangerous decisions regarding their health, while chosing to take the drug in the first place is no less dangerous.

    Its funny how the drug industry regards an educated public as dangerous.

  6. Thats not suprising Matt, given just how dangerous bad regulation of the drug industry is:

    Prescription for Disaster

  7. Thom,

    That’s funny — people are more concerned with diet and exercise. That’s rich. Have you looked around the grocery store? All I see are obese, sedentary people. But if you think a scare story about Avandia has created a huge change in the last month, you have a better eye than I do.

  8. I agree with the general view that diet, exercise, and other lfestyle options - and the gold-standard RCTS that support these approaches - have been mostly left out of public discussion of tx options.

    At the same time, I believe that some of the voices that figure in “Prescription for Disaster” should arouse as much suspicion as anything from pharma. The Life Extension Foundation, for example, is as full of self-interested hype as anything anywhere.

    And, in fact, it’s sometimes the same folks. A number of the supplement companies are now owned by big pharma. So….beware. Sometimes the “alternative” is genuine; sometimes it isn’t.

  9. OMG, if this is true then Merck’s Januvia is SO next. Check out the nearly 100 reader comments on this post:

    http://www.diabetesmine.com/2007/02/much_ado_about_.html

    Lots of nasty, as-yet-undocumented side effects.

  10. Although probably few consumers are looking at the evidence (they’re more likely swayed by the hype)the evidence on macrovascular outcomes for some other DM-2 treatments is disturbing. Among DM-2 pharmacologic agents only metformin and pioglitazone have any evidence of macrovascular benefit.

    As I documented in posts linked below, there is good and growing evidence that sulfonylureas are associated with not only macrovascular harm but also increased mortality. There is also weaker evidence that insulin may be associated with macrovascular harm in type 2 diabetes.

    Finally, although the TZDs are much maligned for their ability to cause macular edema, insulin causes it too.

    http://doctorrw.blogspot.com/2007/06/avandia-two-questions_8882.html

    http://doctorrw.blogspot.com/2007/09/avandia-and-actose-are-there-lessons.html

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