Diabetics' Hearts Beat with Avandia
The diabetes drug Avandia is once again making headlines as posing a possible cardiac risk for certain patients, but Forbes contributor and associate professor of medicine at George Washington University Medical Center, Dr. , is debunking the myths of recent reports.
The bottom line, says Mintz (who has ties with the drug's maker GlaxoSmithKline by way of consulting and speaking fees), is that Avandia does not cause heart attacks and there is no evidence that patients should take the recommended drug Actos (produced by Takeda Pharmaceuticals North America Inc.) instead.
"In all the media attention, no one is discussing the good that Actos and Avandia do, which is primarily prevent patients from needing insulin," Mintz told Tonic in an email interview.
Mintz is responding to the hubbub surrounding Friday's New York Times article, which leads with this scary statement: "Hundreds of people taking Avandia, a controversial diabetes medicine, needlessly suffer heart attacks and heart failure each month, according to confidential government reports that recommend the drug be removed from the market."
Those reports by Sens. Max Baucus, D-Mont., and Charles E. Grassley, R-Iowa, are the results of a two-year investigation into the FDA and GSK's handling of Avandia safety, and not the result of a clinical study. Mintz argues that recommendations for patients to take Actos instead of Avandia are based on comparison between two separate and unrelated studies, breaking what he calls a "cardinal" rule of evidence-based medical study. Doctors and the media, he says, should instead focus on head-to-head studies. Mintz says both Actos and Avandia are safe, but can cause "fluid retention, edema and osteoporosis and should be used with caution in certain patients."
In his Forbes article, Mintz says there's nothing new here. He writes: "The one thing NOT being discussed in all these reports is that the question of Avandia safety was answered this past July at the American Diabetes Association's annual meeting when the RECORD trial was presented which definitively showed that Avandia did not cause heart hospitalizations, cardiac deaths, or any heart problems."
Mintz tells Tonic that the real risk of this latest Avandia scare is that many patients will just quit their drugs cold, without even consulting their doctors: "In our own practice, many of our patients did this back during the first Avandia scare."
He adds that many patients become fearful of the class of drugs as a whole (called TZDs, short for Thiazolidinediones), including Actos, even though they have been instrumental in preventing diabetics from needing insulin. Most type 2 diabetics require more than one drug to manage their symptoms and the best combination is metformin and TZD. Avandia has a combination pill called Avandamet and Actos has ActoPlusMet (although Mintz says this is not as strong as Avandamet), which Mintz says patients and doctors will shy away from if they are fearful of potential heart risks.
"I could just give the two pills separately, except that is inconvenient for the patient and will also mean two co-pays instead of one (both GSK and Takeda give the metformin away for free in the combo pill)," Mintz says.
On the day that President Obama revealed his health care plan, the price of prescription drugs is more volatile a subject than ever before. Patients should refer to their physicians before negating their prescriptions. It not only may save lives but wallets as well.
Photo by shouldbecleaning via Flickr.



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