Per my recent post on the troubles at the FDA, we’ve launched an online letter and petition titled, “Ask the FDA to Better Serve Diabetes Patients’ Needs,” that we’re asking everyone to sign. The website is fittingly called Heal-the-FDA. Please go and have a look.
You will see that we have a growing list of supporters, including politically-minded D-blogger Scott Strumello, who flagged this issue last summer; Dr. Steven Edelman, founder of TCOYD; pumping expert Virginia Valentine; fellow diabetes journalist David Mendosa; Dr. Irl Hirsch, Professor of Medicine at the University of Washington; Dr. Lois Jovanovic, CEO and Chief Scientific Officer of the Sansum Diabetes Research Institute; Dr. Francine Kaufman, Professor of Pediatrics at the Keck School of Medicine; and many other prominent physicians and patient community leaders. Why are we all putting our names to this appeal to the FDA?
Here’s the long and short of it:
You may have read that the FDA is now demanding that all new diabetes drugs be tested for cardiovascular risks. While this sounds reasonable on the surface, in the words of our appeal, what they’re actually doing is creating excessive regulatory hurdles that serve only to ensure the continued use of the very drugs and devices that have proven ineffective for so many patients.
“We see no value in the perfect diabetes drug or device, or even a very good one, if the regulatory costs are so great that the product never makes it to market. Therefore we hereby urge the new FDA leadership to make the rules reasonable! We urge them recognize that a greater emphasis needs to be placed on improving treatment options for diabetes. This can benefit patients without sacrificing their safety.”
What we’re actually asking is that FDA consider immediately creating a “Diabetes Advisory Council” whose goal would be to improve options for patients. This council would include practicing endocrinologists, diabetes educators and others communicating directly with patients. Rather than only taking advice from researchers entrenched in their respective “ivory towers,” we’re imploring the FDA to tap into the D-community’s experience, focus, and keen awareness of patient needs, as it faces the arduous process of evaluating new diabetes treatments. They are currently too far removed from actual patient concerns.
But don’t just take my word for it. Late last week I was lucky enough to chat with Rebecca Killion, one of a very small group of Patient Representatives who works directly with the FDA representing our needs (who’s now also a co-sponsor of the petition!). Rebecca has diabetes (a LADA like me) and sits on the FDA’s Endocrinology Advisory Committee; she was involved in both the controversial Avandia review and the meeting last summer about heart risk of diabetes drugs that is the issue here. She has this to say:
“Of course we don’t want a drug that is clearly harmful to patients to go to market, but… the FDA is operating in a climate of fear right now, so the pendulum has swung to the extreme of over-caution.”
“Mainstream media is all corporate-driven and sensationalized; they’re reporting ‘these drugs will kill you!‘ But in fact, it’s pretty unreasonable to require cardiac testing in Phase 2 and 3 trials for drugs that gave off no cardiac signals in Phase 1. Are we putting these burdens on other drugs?”
“There’s just no way this move is not going to create a chilling effect in terms of slowing development and delaying bringing new diabetes drugs to market. And we patients are the ones who are going to suffer from these unintended consequences…”
“So how do we counteract that? How do we as patients get our voices heard? Get your voice heard!”
[Editor's note: look for a more detailed personal interview with Rebecca Killion here soon]