There are a lot of things going on at the troubled Food and Drug Administration right now that could have a profound impact on the future of diabetes care, but most of us patients never hear about them. And that's a damn shame. Because we stand at a crossroads.
You may or may not be aware that the Obama Administration is about to appoint a new FDA Commissioner. The politics and personal leanings of this new leader could provide a complete change in the FDA's modus operandi, or just more of the same, according to outspoken Michigan Congressman Bart Stupak, who says: "Current senior FDA employees are too close with the industries they regulate, creating a question of who they are working for." Correct.
And here's why you should be concerned, as a person with diabetes:
1) One of the most prominent candidates for new FDA Commissioner is a certain cardiologist Dr. Steven Nissen. He's a long-time past member of the FDA's CardioRenal Advisory Panel and a brash industry critic who was at the center of the Avandia scandal. He's currently on record as saying: "We already have enough diabetes drugs that lower blood sugar, so why do we need any more?" So he's implying that older drugs like metformin and sulfonyreas are all anyone with diabetes needs? The fact is that new drugs and new technologies have a huge potential to prevent complications and extend and improve life with diabetes, so why stymie progress in drug development?
2) The FDA is indeed dragging its feet on new drug approval. They held an ill-publicized informational meeting in July to gather input into what should be required to get new diabetes drugs approved. Dr. Nissen was one of the experts invited to present, and — according to Rebcca Killion, a diabetic and the panel's one and only patient representative — he made a strong case that pharma companies should be required to present additional detailed data on all new diabetes drugs submitted for approval suggesting that they do not increase the risk of cardiovascular disease. While this sounds innocuous, forcing drug developers to rigorously jump through even more hoops puts an arguably uneccessary cost and logistical burden on them, which could chill the development of new diabetes drugs and do very little for patient safety in the long-run.
3) As a result of that meeting, the FDA actually issued a letter across the pharma industry calling for the additional research on cardiovascular factors prior to evaluation of any new diabetes treatments. This has already had a chilling effect, in that Amylin's new long-acting version of Byetta (LAR) (a once-weekly injection for Type 2 diabetes) and Novo Nordisk's liraglutide (a once-daily injection also for Type 2) are held up at the starting gate for FDA approval.
4) Approval of new diabetes technology is also being hindered. Here are some recent examples of treatment options currently NOT available to US patients due in large part to the FDA's "very conservative stance," according to the analysts at Close Concerns, publishers of diaTribe:
- A new pump with a low blood glucose sensor 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 will likely be available to patients in the UK will 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 this pump or would hold it up for a long time.
- Symlin is another drug from Amylin that has been used successfully to reduce glycemic variability (in particular, high blood-glucose levels after meals — the trickiest time for most of us). It's currently approved for both Type 1 and Type 2 patients who use mealtime insulin, but a clinical trial recently provided evidence that its also effective for Type 2 patients who currently use basal insulin only. This could be a pwerful treatment for many, but the FDA struck it down without even providing a reason. The data from the trial was published in the journal Diabetes Care, showing no safety issues. According to Close Concerns, the FDA won't return phone calls asking why Symlin hasn't been approved for this use.
The diaTribe group summarizes the issue this way:
"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 which could slow, stop, or cure disease come from innovation. We need to accelerate, not brake, innovation."
So What's A PWD to Do?
I'm currently working with Kelly Close of Close Concerns/diaTribe and Manny Hernandez of TuDiabetes to create a campaign that we, the Diabetes Community, can rally behind. It's somehow going to involve asking you all for signatures, so get prepared for that. Want to get more involved in this Call-to-Action? Let the three of us know what ideas you may have.
** UPDATE 12:50 pm **
The Health Care Blog announced a survey on "Who Should Obama Pick for FDA Commissioner?" today. Check it out to peruse the full list of candidates, and who appears to be in the lead currently.