Wall Street Journal Examines FDA Approval Process for Diabetes Drug

Main Category: Diabetes
Article Date: 30 Oct 2005 - 13:00 PDT

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The Wall Street Journal on Wednesday examined the "battle" over FDA approval for Amylin Pharmaceutical's diabetes drug Symlin, which "provides an inside look at the FDA drug-review process and how the agency balances the benefits and risks of new products." Symlin, which is injected before meals and used with insulin, is a synthetic version of a hormone called amylin that diabetics are deficient in or lack. Amylin Pharmaceutical, which is named after the hormone, said Symlin can help diabetics control their blood sugar and reduce the risk of complications. FDA approved Symlin on March 16 after several years of consideration. One of the two reviewers who originally was assigned to the Symlin case -- Robert Misbin, a former University of Florida professor -- raised concerns about the efficacy and safety of the drug early in the review process. He particularly was concerned that trial participants taking Symlin with insulin experienced an increased rate of hypoglycemia, which could lead to blackouts and car accidents. At a July 2001 meeting, Misbin called the safety data "alarming," adding that he believed the drug's long-term benefits were trivial and diabetic patients should continue taking insulin alone. He subsequently sent a personal letter to Orville Kolterman, a pharmacist at Amylin who had worked on Symlin for nearly 10 years, explaining his reasons for making such a statement. According to the Journal, Kolterman and Misbin had met "socially several times over the years through a mutual friend." After a complaint from Amylin about the letter, Misbin was removed from FDA's Symlin evaluation team and "mostly stayed out of deliberations" for the next several years, the Journal reports.

Approval
The drug was rejected again in December 2003 because of safety concerns but then approved in March after the company submitted results from studies in which diabetic patients knew they were taking Symlin and could adjust doses of the drug and insulin to avoid hypoglycemia. In a review completed in February, reviewer Dragos Roman said the drug's risks had been "identified and addressed" through the new research, adding that if patients did not drive for two or three hours after taking Symlin, the risk of car accidents resulting from hypoglycemia would "be practically eliminated." Amylin also agreed to ban consumer ads for Symlin, conduct an additional safety study and place a black box warning on the drug's label notifying consumers about the hypoglycemia risks. Misbin -- who is "one of a few FDA officials who have criticized the agency's decisions when they believed life-or-death health issues were at stake" -- said he was surprised by the approval because he believed Symlin's risks could not be eliminated, the Journal reports. He also believed the black box warning did not adequately describe the risks. According to the Journal, in recent months Misbin has "swung into action," notifying the staff of Senate Finance Committee Chair Chuck Grassley (R-Iowa) of his concerns and requesting that Mothers Against Drunk Driving publish the black box warning label from Symlin on its Web site. FDA declined to comment on Misbin's recent activities, and Amylin said it was unaware of his efforts (Wilde Mathews, Wall Street Journal, 10/26).

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