Problems at FDA Prompting Slowdowns in Development (Continued)
Not only will the FDA requirement delay availability of new therapies for patients, but we believe the requirements will have a strong chilling effect on development of new drugs altogether, limiting treatment options. Small companies dedicated to diabetes therapy may be unable to gather the large resources needed, and in the current financial climate, many will fold. Large companies may be unwilling to take on the additional cost, time, and risk and move out of diabetes treatments, as we are now seeing with companies moving away from obesity treatments. If the new requirements had been in place, we probably would not have Byetta and Januvia available today.
All in all, patients lose. With a growing diabetes epidemic and under 50% of patients meeting treatment goals, it is clear that the current treatments are not enough. Many of the drugs available now have safety and tolerability issues, and we lose hope of replacing these with better alternatives. Diabetes is a chronic progressive disease, which currently is managed, not cured. Breakthrough therapies that could slow, stop, or cure this disease come from innovation. We need to accelerate, not brake, innovation.
Here are a couple of recent examples of promising new therapies, which are NOT available to US patients at present:
• A pump with a low blood glucose sensor is being developed in the UK. It automatically turns off insulin delivery when blood sugar levels get dangerously low. It will be submitted to the EU regulatory body and people in the UK will likely be able to get this pump sometime next year. Why is this pump not being developed in the US? No one will say officially, but we constantly hear that Washington is so risk-averse that it probably wouldn't approve it or would hold it up a long time.
• Symlin is a drug that has been used successfully to reduce glycemic variability (in particular, high blood-glucose levels after meals – a tricky time for many of us). It is approved for those that use mealtime insulin – type 1 and type 2 patients. A clinical trial involved type 2 patients who used basal insulin only with Symlin at mealtimes. This could be a good option (even the FDA patient advocate has publicly stated she uses this drug), but the FDA struck it down without a reason. The data from the trial has been published in Diabetes Care showing no safety issues. The FDA won't return phone calls asking why Symlin hasn't been approved for this use.
diaTribe is working with DiabetesMine and TuDiabetes in putting together a petition asking for recognition of patient need for better diabetes drugs and an approval process that balances this need with risk. We hope patients join with us to have our voices heard by the FDA.
Kelly Close is editor in chief of diaTribe (www.diaTribe.us), a free online newsletter for patients looking for more information on products and research.
NOTE: The information is not intended to be a replacement or substitute for consultation with a qualified medical professional or for professional medical advice related to diabetes or another medical condition. Please contact your physician or medical professional with any questions and concerns about your medical condition.
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