I was wondering if anyone here has actually used Symlin? I'm interested, but would like to gather opinions from experienced users to see what their thoughts and experience has been. I have hear mixed reviews on this new treatment for type 1 diabetes, and so far, some doctors are taking a wait-and-see approach before offering it to their patients. Some patients have told me they think its been great, really improving control and reducing total insulin requirements, with only a minor side effect of naseau that seems to disappear after about 10 weeks of usage. Others have called it the most annoying drug ever created, so I am getting mixed reviews!
From a historical perspective, a disturbing article was published on the front page of the October 26, 2005 edition of
The Wall Street Journal (see:
http://online.wsj.com/article/SB113028992607079538.html to read the full article). Basically, the article highlighted a rogue FDA drug reviewer, Dr. Robert Misbin, and his efforts to see that Symlin did not get FDA approval, and his subsequent efforts to try and bypass his own boss and the agency's approval of Symlin by making an issue of hypoglycemia, an adverse effect that is only caused by insulin, not by Symlin alone. Dr. Misbin even went so far as to send a letter to Mothers Against Drunk Driving, urging the group to post the Symlin warning label on the MADD web site. In his letter to MADD, Dr. Misbin said the FDA removed him from the Symlin review "after I expressed concern that this drug might increase the risk of motor vehicle accidents."
Its entirely appropriate to raise red flags on flaws in the FDA approval process, especially given the problems the FDA had with its approvals for such drugs as Vioxx, which was associated with cardiovascular problems, but Dr. Misbin's actions do not seem justified, and there is a body of published data to support Symlin. A well-written, peer-reviewed article on amylin was published in the respected diabetes journal
Clinical Diabetes back in 2002 (see
http://clinical.diabetesjournals.org.../full/20/3/137 to read the article) suggesting that the idea of insulin alone to effectively treat diabetes may be flawed. There was also another article published in the journal
Diabetes Care entitled "
Impact of Pramlintide on Glucose Fluctuations & Postprandial Glucose, Glucagon & Triglyceride Excursions Among Patients w/ T1DM".
It appears that in this case, the FDA is working just fine, which is why Dr. Misbin's efforts failed to derail Symlin's approval. Most alarmingly, I found it troublesome that he tried to make comparisons between biomedicines and chemical drugs, even as far as adverse effects are concerned. In most cases, the dosage of a biopharmaceutical (such as insulin) can be adjusted, and the side effects are then mitigated. But the same cannot be said for chemical drugs, yet Dr. Misbin made direct comparisons between Symlin (a biopharmaceutical analog of the human hormone amylin) and the chemical drug known as Rezulin was developed as a treatment for type 2 diabetes which was ultimately pulled from the market. Rezulin was always a foreign, chemical substance which did not exist anywhere in nature, unlike amylin.
It is worth noting that the "adverse effect" Dr. Misbin is apparently so concerned about was hypoglycemia, ironically, something which Symlin by itself does not cause. Only insulin (either with or without Symlin) causes hypoglycemia, and Dr. Misbin made no effort to address this issue, not even with warnings on the MADD website addressing the risks of hypoglycemia associated with insulin alone. In fact, amylin (along with several other elements, such as c-peptide) are suspected to be missing pieces to the metabolic puzzle that have plagued doctors since insulin was discovered in the early 1920's. Apparently, Dr. Misbin disagrees. In fact, in written remarks presented to a July 2001 meeting of an FDA advisory committee, Dr. Misbin called the safety findings for Symlin "alarming" and Symlin's long-term benefits were "trivial." Diabetics would do just as well sticking to insulin alone, he wrote.
It is a known fact that amylin is a missing hormone in all patients with type 1 diabetes, and I think its clear that this hormone plays some role in metabolism, or it wouldn't be there in the first place. Why, then, was Dr. Misbin so hell-bent on derailing Symlin, which
The Wall Street Journal acknowledges was the first new treatment for type 1 diabetes since the discovery of insulin? The presentation Aymlin Pharmaceuticals made to the FDA regarding Symlin was apparently sufficient to obtain the agency's approval (see
http://www.fda.gov/ohrms/dockets/ac/..._01_amylin.ppt for more detail).
I believe the FDA is working fine, and Symlin's approval is a testament to this fact. But I also believe that Dr. Misbin stepped over the line of appropriate behavior. But aside from the history of Symlin, I'd also like to solicit feedback from people who have actually used it, so please let me know. Thanks!!
Anyone Using Symlin?! 
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