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Letter from the Editor, #705: Avandia and FDA Approvals

Nov 29, 2013

This week the FDA reversed its previous decision on Avandia (see this week’s Item #1). All the hype and bad press that Dr. Steven Nissen of the Cleveland Clinic put out about the drug and its side effects led to the near demise of the drug and the TZD class as a whole. Although GSK could ramp up their sales force and try to win back prescribers, it would be an exercise in futility as pioglitazone (Actos) is now available generically and so there would not be many formularies that Avandia would be on. Although this is tragic for GSK, they will survive. The real issue is what Dr. Nissen did for diabetes drugs as a whole. We know that all drugs have some risk of side effects or complications but it seems like since the Avandia debacle, the FDA has forgotten to look at the benefits of drugs versus the complications.
Based on the comments made on almost every other drug for diabetes, one has to wonder how many people have suffered because of the additional cardiovascular studies required for all potential diabetes drugs.

I was reviewing payments for clinic and emergency room visits at hospitals and found something that seems to conflict with the goals of pay for quality care. CMS will no longer allow clinics to bill for patient visits based on the severity of the problem. Providers used to be able to bill for 10 levels of care related to the complexity of the patient’s problem. Now they have decided to change to one code fits all. Whether the visit is for something as simple as a sore throat or as complicated as a metabolic syndrome patient’s issues, the reimbursement is the same. What makes it worse is that emergency rooms are exempt from this so they can still bill for levels of complexity. This new concept flies straight in the face of trying to cut down on the most expensive patient visits, those that occur in the ER. 


From "dLife demystifies sweeteners and sugar substitutes. Plus, how one woman got past denial to take control of her health. And, a heroic mother fighting diabetes in her son’s memory shares her difficult and emotional story." Sundays live online at at 7 PM ET, 6 PM CT, and 4 PM PT. Keep up on the latest dLife news at

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Dave Joffe, Editor-in-chief