As noted, I’m not so interested in the worth -– or market potential –- of this new drug from Amylin Pharmaceuticals as I am in the actual value to patients. I was initially excited and intrigued by this first new offering to help Type 1 diabetics since insulin in the 1920s. Yet after querying several doctors and a number of patients who chose to stay on Symlin after participating in a study, I must say I still don’t get it.
Apparently the main benefit is requiring less insulin. BUT these patients are now injecting yet another substance – another synthetic hormone, no less — into their bodies that could easily lead to side effects or long-term effects worse than those of insulin. So what is the real VALUE of Symlin to the patient, to offset this risk?
Two things seem to appeal: Symlin works as an appetite suppressant, so it helps people lose weight. It also reduces BG levels in the three hours after eating, so that the diabetic never hits those highs that a healthy person’s system can avoid naturally. Some patients also clearly feel that it is important to participate in clinical studies for the greater good, i.e. to “be part of the solution” doing their part working toward a cure. I totally respect this, but can’t understand why people already dealing with an insulin pump would be willing to continue the Symlin treatment, requiring multiple injections throughout the day. It seems like massive inconvenience with a lot of as-yet-unknown risk.
What’s more, the vast majority of Type 1’s are children, the way I understand it. In order to push approval of this drug, the FDA allowed the manufacturer to put off studying the drug’s effect on children until September 2007. The FDA Approval letter, of which I have a copy, lists a number of precautionary requirements, including a Surveillance Plan for hypoglycemic events, and the establishment of a 24/7 nationwide call center “to assist patients and physicians with the use of Symlin.”
Sounds like the Powers That Be have their doubts about this drug as well. Maybe the idea is to let consenting adults be the guinea pigs for the first few years (?)
If anyone knows better on Symlin, I’m all ears!