September 26, 2012

Should Diabetes be on the Agenda of Upcoming FDA Public Meetings?

Please share your voice. Ask the FDA to include diabetes in their public meeting process. 

The FDA is asking for public comments on twenty topics in meetings on patient-focused drug development. The FDA says the idea is a systematic way of getting patient views on the severity and treatments for a set of disease areas. They have a preliminary list of nominated diseases. Diabetes per say and the specific types of diabetes are not on the list. Two specific diabetes complications are; diabetic ulcers and diabetic foot infections. 

Twenty diseases and diabetes isn't on the list. That does not seem balanced. I think the DOC should get diabetes on the FDA's list. 

I would like to see this PDUFA effort consider diabetes in a manner similar to how they propose treating cancer. If you do too please comment to the FDA.

The proposed cancer areas are a more divers perspectives. For example the draft offers to consider; melanoma, lung cancer, cancer and young patients, cancer treatment in pregnancy, cancer and sexual dysfunction, cancer and depression. So how about T1D, T2D, diabetes and young patients, Gestational and other diabetes and pregnancy, diabetes and sexual dysfunction, diabetes and depression.

If the FDA is holding meeting on twenty diseases one topic should be diabetes. The FDA is open to diseases not on the proposed preliminary list. They ask when offering an additional disease for condition for consideration the following criteria be used:
  • Disease areas that are chronic, symptomatic, or affect functioning and activities of daily living;
  • Disease areas that reflect a range of severity;
  • Disease areas for which aspects of the disease are not formally captured in clinical trials;
  • Disease areas that have a severe impact on identifiable subpopulations (such as children or the elderly);
  • Disease areas that represent a broad range in terms of size of the affected population; or
  • Disease areas for which there are currently no therapies or very few therapies, or the available therapies do not directly affect how a patient feels, functions, or survives.

There is a public meeting. More information is available in the Federal Register: 
Comments can also be sent before Nov 1 2012.!submitComment;D=FDA-2012-N-0967-0001

My comments are:

I thank the FDA for this opportunity to share views as a patient on the development of medications. I am a parent of two type 1 teens and a pre type 2 patient myself. We are just few of the over 25 million Americans that the CDC estimates live with diabetes.  I urge the FDA to consider a wide perspective on diabetes in this PDUFA meeting process. Specifically I hope the FDA will dedicate one of the twenty planned disease topics to diabetes. That should include at all forms of diabetes and their related complications. Specifically diabetes should be viewed by its different types, Type 1, Type 2 LADA and gestational. 

Type 1 and LADA are chronic autoimmune diseases that have a significant impact on patients’ lives. All forms of diabetes require daily behavioral changes. Bond et. al. write in the May/June 2010 Diabetes Educator, “Despite advances in treatment regiments now available for care, the self management activities of diabetes remain complex, with treatment recommendations difficult to incorporate into existing lifestyles. The daily management of diabetes can be overwhelming.”1 

The severity of changes to live with diabetes vary. For some, like myself, healthy activity and diet may manage blood sugar. For other, including my teens, significant effort is required through out every day to replace insulin destroyed in the autoimmune form of the disease. For all there are significant life changes.

Innovative medications offer the promise of better outcomes. Glucose responsive insulins (GRI) may help minimize potentially fatal hypoglycemic risk of using insulin. The FDA should be preparing the expertise needed to efficiently evaluate this innovation. By doing so the agency can expeditiously consider GRI applications.

The FDA can help foster evaluation of better treatments for the very young T1D patients. Little children respond to very small amounts of insulin. Their developing communication skills make it difficult for them to share with parents and care givers when they are experiencing hypoglycemia. Many children and adolescents are not aware of theses symptoms. 

Mental Health issues are more common with people with diabetes.2,3,4  Van Bastelaar et al site estimations that as many as “20% of diabetes patients suffer from clinical depression.”

Diabetes is a significant public health issues. As such, I hope the FDA will consider a board evaluation of the issues diabetes patients face in the PDUFA meeting process. 

1 Bond, G. E., R. L. Burr, F. M. Wolf, and K. Feldt. "The Effects of a Web-Based Intervention on Psychosocial Well-Being Among Adults Aged 60 and Older With Diabetes: A Randomized Trial." The Diabetes Educator 36.3 (2010): 446-56. Print. 

2 Van Bastelaar, Kim, Pim Cuijpers, François Pouwer, Heleen Riper, and Frank J. Snoek. "Development and Reach of a Web-based Cognitive Behavioural Therapy Programme to Reduce Symptoms of Depression and Diabetes-specific Distress." Patient Education and Counseling 84.1 (2010): 49-55. Print. 
3 Anderson RJ, Freedland KE, Clouse RE, Lustman PJ. The prevalence of comorbid depression in adults with diabetes: a meta-analysis. Diabetes Care 2001;24:1069–78.
4 Mosaku K, Kolawole B, Mume C, Ikem R. Depression, anxiety and quality of life among diabetic patients: a comparative study. J Natl Med Assoc 2008;100:73– 8


  1. Note that the announcement claims "FDA will conduct public meetings for 20 different disease areas. The meetings will focus on the patient perspective regarding two key considerations in FDA’s regulatory decision-making: the severity of the disease and the currently available treatment options." The FDA perception is undoubtedly that a) the "severity" of diabetes is relatively low given that there ARE effective treatments for all types of diabetes. Again, the idea that patients' failure to meet treatment goals is not indicative of an ineffective treatment, rather they point to issues such as noncompliance, lack of patient education, etc. but the treatments themselves are not questioned. Again, I believe that the focus on diabetes-related complications, rather than the disease itself, is a mistake on the part of the FDA in this case. Most (but not all) diabetes complications can be avoided with proper management, but the FDA is considering patient input on treatments for complications, but not for treatments (insulin, biotech drugs, medical devices) for diabetes itself.

    I'd like to see just how the FDA responds to the question about the selection of disease states they are focusing on. Perhaps a call to the Office of Special Health Issues is in order here?

  2. My Comment Tracking Number: 8112a57c

  3. Comment Tracker 1jw-816l-dnlh.

    Thanks Bennet!