Symlin Battle Reveals FDA Foul play

November 17, 2005

In 2001, Dr Robert Misbin, an FDA prescription drug reviewer lost sleep worrying about the serious side effects of a new drug called Symlin. Symlin, a drug used to control blood sugar and reduce the risk of complications in diabetic patients, can cause dangerously low blood sugar levels (hypoglycemia). When this serious Symlin side effect occurs, a patient may blackout, posing the risk of car accidents or other serious injuries. In light of this risk, Dr. Misbin voiced his concern, a decision which would get him kicked off the FDA review panel.

Dr. Misbin was so concerned about the significant threat of Symlin side effects he personally wrote a letter to his friend, Dr. Orville Kolterman, a pharmacist with Amylin, who makes Symlin. Dr. Misbin explained his stance on Symlin adding, "I ask that you recognize that as a medical officer at FDA, I get to count the bodies when things go wrong. I cannot forget the experience that I had in the not too distant past of receiving a letter (one of several letters) that said, 'My uncle was a wonderful man. Why did you approve a drug that killed him?'"

After this letter about Symlin risks was sent, the FDA received a letter from Amylin Pharmaceuticals saying the company was "very uncomfortable" about working with Dr. Misbin. Soon after this report, the FDA removed Dr. Misbin from the Symlin review committee. This move made a very bad statement about the FDA drug review process: If a medical expert disagrees with a drug's safety, they are taken out of the picture.

Employees like Misbin usually keep their jobs because the FDA does not want to appear adverse to whistle blowers. However, Dr. Misbin is one of a few officials who have criticized the FDA's decisions when they were concerned about the life-threatening risks associated with a prescription drug. This inside look at the FDA's drug review process begs the question: Just how many FDA reviewers have remained silent or been silenced about serious side effects associated with prescription drugs?

Symlin was debated and rejected for years before finally receiving FDA approval for consumer use. The drug was rejected in 2001 and again in 2003 because of safety concerns. Another generation of FDA reviewers appeared not to be as concerned about the known side effects associated with Symlin. Dragos Roman, an FDA reviewer of Symlin, said the drug's risks had been "identified and addressed" by new research. Other experts say Symlin's risks cannot be eliminated.

This truth is reflected in the concessions made by Amylin in order to receive FDA approval of Symlin. The pharmaceutical company agreed not to publish consumer ads for Symlin. They agreed to add a black box label warning to Symlin, the strongest warning the FDA can order, informing patients about serious and life-threatening risks associated with Symlin.

Dr. Misbin believes that the Symlin black box warning does not adequately convey important Symlin side effect information. For example, Dr. Roman stated that the risks of Symlin use could be mitigated if patients did not drive at all for two to three hours after taking this medication. This warning appears nowhere on the drug's warning label. Besides, some argue, that seems like an enormous drawback to this medication, compared to its supposed benefits.

Dr. Misbin has asked Mothers Against Drunk Driving to add the Symlin warning label to their website to inform consumers about the serious risks (of blacking out and causing car accidents) associated with this diabetes drug. He has also contacted members of the Senate to express his concerns about this medication. At least someone is looking out for the health and safety of consumers. Characteristically, the FDA and Amylin deny knowledge of Misbin's recent efforts to raise awareness about Symlin side effects.

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