Amy Tenderich is a leading online voice for diabetes advocacy. She is author of the popular blog, Diabetes Mine, and has type 1 diabetes herself. I caught up with Amy recently to discuss her concerns about a potential slowdown in diabetes research due to an increasingly risk-adverse FDA. You may listen to our conversation here, or read my summary below.
Dr. Val: I understand that there’s a new petition asking the FDA to better serve the needs of people with diabetes. What is your role in that?
Tenderich: The petition represents the collective online voice of the diabetes community. It was spearheaded by Kelly Close, Manny Hernandez, and myself in response to what seems to be an increasing climate of extreme risk aversion on the part of the FDA. Patients generally don’t know much about the FDA’s actions, so we bloggers are stepping in to raise awareness.
Dr. Val: What do you think is making the FDA so risk-adverse?
Tenderich: As noted by Rebecca Killion, one of the few Patient Representatives who works directly with the FDA (and also has Type 1 diabetes), we’ve seen intensified regulatory issues in the post 9-11 era due to an increasing culture of fear. In addition, this country is so litigation happy, that everyone is trying to cover themselves. The media tends to dramatize things and they come out with headlines like “diabetes drugs will kill you.” In reality, certain drugs may be very helpful to millions of people, with caution only required for those in high risk groups. We need to counteract some of this fear and exaggeration by having patients speak up. We can’t just be yanking whole classes of drugs off the market because of a risk found in a small subgroup of potential users.
Dr. Val: Can you explain how the FDA’s new safety requirements might stymie diabetes research?
Tenderich: The FDA is adding additional cardiovascular research requirements to the development of all new oral diabetes drugs. This will have a chilling effect on innovations in diabetes care. As Rebecca has pointed out, it’s pretty unreasonable to require cardiac testing in phase II and phase III drugs that have not given us any reason to believe that they may pose a cardiac risk. The additional expense and time lag caused by testing the drugs for potential cardiac side effects will slow down the whole process and makes some research cost-prohibitive for smaller companies. It takes thousands of additional study subjects to rule out the possibility of cardiac harm, which can add up to tens of millions of dollars.
Patients put a lot of faith in the FDA and they just assume that it’s looking out for their best interest – both in terms of mitigating risks and also in regard to encouraging research in the right areas. However, the FDA can be very political – with individual researchers driving their own agendas, without specific regard to patient needs. The diabetes community would definitely like to see a stronger patient voice at the FDA.
Dr. Val: So in a perfect world, what changes are you hoping that the next FDA Commisioner will make?
Tenderich: We’d like to see the new Commisioner remove excessive research hurdles to pave the way for new drugs and innovations. Of course we want the FDA to keep safety in mind and issue warnings to appropriate at-risk populations, but we don’t want them to remove patient and physician choices. We’d like to see the FDA help (rather than hinder) the development of new technologies to improve quality of life, such as continuous glucose monitors. These devices can make a huge difference in diabetes management, but insurance companies are pushing back hard on coverage for them because of the high up-front costs for a long term gain.
The purpose of the petition is to implore the FDA to set up a Diabetes Advisory Council made up of patients, researchers, and physicians “in the trenches” and actively engaged in diabetes care on a day-to-day basis. That way the decisions made by the FDA will be more in tune with the needs of real patients.
To sign the petition, please go to www.healthefda.com.
For more information, please check out Amy’s blog post at Diabetes Mine.