The ADA and diabetes technology
Generally, I'm pretty upbeat about diabetes. Don't get me wrong, I wouldn't wish it on anyone; but I do believe that if we get the right information and support, we can manage the disease and prevent many - if not all - the complications.
But two things have really depressed me of late.
First, at a recent diabetes technology conference, we heard a speech given by one of the most important figures in the field - Dr. Richard Kahn, the Chief Scientific and Medical Officer of the American Diabetes Association. We found much of his take on diabetes technology inexplicable and insensitive - not exactly what we expect from the ADA.
Specifically, Dr. Kahn cast doubt on the efficacy of technology to improve patient care. At one point, he said, "Self-monitoring costs taxpayers over $1 billion, even though there hasn't been a single randomized, control trial demonstrating benefit." The last time we checked, the DCCT and the UKPDS were two trials that demonstrated that tighter glycemic control resulted in fewer long term complications - and how would tighter control be achieved, without blood glucose monitoring? Dr. Kahn also derided pump technology, even though many people we know - including diaTribe managing editor James Hirsch and myself - find pump therapy a huge benefit.
We couldn't help but wonder - has Richard Kahn spoken to diabetic patients about these products? If he or one of his children were diagnosed with diabetes tomorrow, would he urge that child be limited to three glucose strips a day (the Medicare limit for those on insulin), and would he refuse to consider an insulin pump? And if the ADA's chief scientist doubts the value of these tools, how are we supposed to lobby for greater coverage from insurers? (We provide further details on this disappointing talk in our Conference Pearls.)
Here at diaTribe, we would like to work to be as constructive as possible to help improve care and coverage - we hope agencies such as the ADA will continue to advocate for patients as strongly as they have done historically in this new era of new drugs and technology. Yes, it is more spending upfront, but reducing complications to make everyone better off is the name of the game, no?
My other diatribe is aimed at the FDA. This government agency, charged with the scrutiny of new drugs and devices, recently rejected a drug called Symlin to be used with long-lasting, basal insulins, Lantus or Levemir, for type 2 patients. Symlin is already approved for those taking mealtime insulin, but in the US, that's only a couple of million patients out of 15 million diagnosed. The FDA is supposed to reject new drug applications when there are safety concerns, but there are none to be found with the published data for Symlin. So why the rejection? The FDA didn't say. We hope they will look at this again and reconsider.
It's possible that the FDA - which has been criticized for being too lenient with industry - is now overcompensating with excessive safety. But the price of caution is high - fewer alternative drugs that some, if not many, patients could use. We recognize that all therapies have a risk-benefit trade-off, but we find the FDA's unexplained timidity a setback for diabetes care.
Let's hope that in the near future, both Dr. Kahn and the FDA can offer more enlightened leadership for the very people whom they purport to represent.
Yours truly,
Kelly Close