Ask FDA to Better Serve Diabetes Patient Needs
- van: Patients With Diabetes
- ontvanger: The new leadership at the FDA, HHS and the new Obama administration
We fear that innovation is slowing in diabetes despite the urgent need for new treatments -today, close to half of the 24 million Americans with diabetes do not meet recommended blood sugar goals.
The U.S. Food and Drug Administration's job is to protect the safety of patients and approve innovative medicines.
We are asking the new FDA leadership for two things:
1. To create a council of diabetes patients and healthcare professionals who can help the FDA assess new information and assimilate diverse opinions, including those of patients.
2. To make the rules reasonable for the sake of the patients, which can be done without sacrificing safety.
Please note: This petition is sponsored by a group of concerned patients, doctors and diabetes educators, not the drug industry.
The U.S. Food and Drug Administration's job is to protect the safety of patients and approve innovative medicines.
We are asking the new FDA leadership for two things:
1. To create a council of diabetes patients and healthcare professionals who can help the FDA assess new information and assimilate diverse opinions, including those of patients.
2. To make the rules reasonable for the sake of the patients, which can be done without sacrificing safety.
Please note: This petition is sponsored by a group of concerned patients, doctors and diabetes educators, not the drug industry.
We, the undersigned, appeal to the leadership of the U.S. Food and Drug Administration (FDA) to reduce barriers to innovation in diabetes treatment development, in the interest of public health.
The FDA's job is to protect the safety of patients in its use of drugs and medical devices and to advance public health by speeding innovations that make medicines and technology more effective, safer and more affordable. That is its mission.
But we believe the FDA has adopted a stance of excessive caution in its regulation of diabetes drugs and technology that is counter to its duty to serve patient needs.
Specifically, it has established new rules that will impair research and innovation into diabetes therapy. (A copy of the letter sent to manufacturers in November 2008 can be found at www.diatribe.us/fdaletter.)
This worries us. For example, new requirements for additional multi-year long-term outcome studies prior to approval for drugs with no cardiovascular signals will assuredly discourage research and innovation to the detriment of public health.
The need for improved treatments for the 24 million Americans with diabetes could not be clearer. Many of the drugs available now have tolerability issues [1]. Poorly controlled diabetes increases the risk of devastating long-term complications, including blindness, end-stage renal disease, amputation, and heart disease. Complications cost our country at least $58 billion per year [2] -over twice what is spent on technology and therapy annually [3].
Nearly 50 percent of patients in the US do not meet A1c goals [4] using current therapies and technologies. No therapy today stops diabetes from advancing. As patients are living longer with diabetes and therapies stop working, the need for new therapies increases. We need better technology and drugs that help slow or avoid long-term complications as well as more therapies that cause fewer side effects1 and last longer. And, despite the epidemic in the number of diabetic patients, no drugs are yet available that can prevent diabetes. Innovative, safe, and effective prevention is the key for people at risk and for cost savings to society.
Ironically, excessive regulatory hurdles ensure the continued use of the very drugs and devices that have proven ineffective for many patients.
There is no value in an ideal diabetes drug or device if the regulatory costs are so great that the product never makes it to market. Make rules reasonable.
Due to the very nature of the severity and prevalence of diabetes, the following leaders within the diabetes community, who have signed this petition, implore the FDA for the immediate creation of 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 and would supplement the current advisory committee. Our experience, focus, and keen awareness of the needs of the diabetes community would be an invaluable resource to the FDA as it faces the arduous process1 of evaluating new diabetes treatments. Our aim is to improve options for patients.
We urge the new FDA leadership to recognize the urgent need for more safe and effective treatment options for diabetes and to reduce barriers to innovation. More treatment options will benefit patients. The disease is progressive. Delays in the availability of new treatments will only result in tremendous cost to public health and the economy. Our recommendation can benefit patients without sacrificing their safety.
Please sign this petition and tell others about it. Make your voice heard!
Learn more about the issues here:
Problems at FDA prompting slowdowns in development - should patients accept this?
The FDA in Transition: Diabetes Treatment at Risk
The FDA Needs Your Input on Diabetes Medicines!
Petition sponsors:
Kelly Close: Editor, diaTribe
Manny Hernandez: President, Diabetes Hands Foundation; Founder, TuDiabetes
Amy Tenderich: Creator and Author, DiabetesMine
Nadia Al-Samarrie: Publisher, Diabetes Health magazine
Marston Alfred: Founder, SugarStats.com
Timothy S. Bailey, MD: Director, AMCR Institute Inc.
Allison Blass: Author, Lemonade Life
Jennifer Block, CDE: Stanford Medical Center, Stanford University
Nancy Bohannon, MD: Director of Clinical Research, CVD Risk Reduction Program, St. Luke's Hospital, San Francisco
Bruce Buckingham, MD: Professor of Pediatric Endocrinology, Stanford University
Stead Burwell: CEO, Alliance Health Networks, Inc.
Priscilla Call Essert: Author, My Life As A Pancreas
Gina Capone: Co-Founder, the Diabetes Talkfest Blog
Fran Carpentier: Author, Diabetes, Day-By-Day on Parade.com
Kitty Castellini: Founder, CEO, Producer and Host, Diabetes Living Today - Talk Radio
David Edelman: Co-Founder, Diabetes Daily
Steve Edelman, MD: Professor of Medicine, University of California, San Diego; Founder, Taking Control of Your Diabetes
Bernard Farrell: Author, the Diabetes Technology Blog
Martha M. Funnell, MS, RN, CDE: Diabetes Educator
Bob Hawkinson: Author, Joy of Diabetes
Debbie Hinnen ARNP, BC-ADM, CDE, FAAN: Diabetes Educator, Mid America Diabetes Associates
James S. Hirsch: Author, Cheating Destiny
Irl B. Hirsch, MD: Professor of Medicine, University of Washington
Lois Jovanovic, MD: CEO and Chief Scientific Officer, Sansum Diabetes Research Institute
Francine R. Kaufman, MD: Professor of Pediatrics, Keck School of Medicine, USC; Head, Center for Diabetes, Endocrinology and Metabolism, Childrens Hospital Los Angeles; former ADA President
Neal Kaufman, MD, MPH: Founder and CEO, Diabetes Prevention Source
Tom Karlya: Author, Diabetes Dad
Rebecca Killion: Diabetes advocate
Davida F. Kruger, MSN,APN-BC,BC-ADM, Nurse Practitioner: Diabetes, Henry Ford Health System, Detroit, MI
David Mendosa: Diabetes Journalist
Kerri Morrone Sparling: Author, Six Until Me
Linda Parks, CDE
Jenny Ruhl: Author, Blood Sugar 101
Gary Scheiner MS, CDE: Clinical Director, Integrated Diabetes Services
Lisa Shenson: Diabetes Parent & AdvocateScott Strumello: Author, Scott's Web Log
Jane Jeffrie Seley, CDE, BC-ADM, Diabetes Nurse Practitioner
Mollie and Jackie Singer: Authors, Curemoll.com
Howard Steinberg: CEO and Founder, dLife
Virginia Valentine: CNS, BC-ADM, CDE, CEO, Diabetes Network, Inc. Albuquerque, New Mexico
Michael A. Weiss: Diabetes Advocate, Former American Diabetes Association National Chair
Gloria Yee, RN, CDE: University of California San Francisco (UCSF) Diabetes Teaching Center
Notes:
[1] "Glycemic Durability of Rosiglitizone, Metformin, or Glyburide Therapy," New England Journal of Medicine, December 7, 2006. ADOPT, a four-year clinical trial of over 4,000 patients, was designed to test the how long diabetes therapies last. In this trial, 23% of those on sulfonylureas (SFUs) and 38% of those on metformin experienced nausea, diarrhea and/or vomiting from taking the drugs. 10% of those on TZDs, 11% on metformin, and 39% on SFUs experienced hypoglycemia. 7% and 14% of those on TZDs experienced weight gain and edema. 12% on women on TZDs experienced fractures. The trial also found that within five years of starting therapy, 15% of those on rosiglitizone (TZD), 21% on metformin, and 34% on glyburide (a sulfonylurea [SFU]) had fasting blood glucose over 180 (~ roughly equivalent to an 8% A1c), suggesting that even if patients could tolerate the therapy, it wouldn't last longer than a few years for many.
[2] "Economic Costs of Diabetes in the US in 2007," Diabetes Care, March 2008, page 13.
[3] "Economic Costs of Diabetes in the US in 2007," Diabetes Care, March 2008, page 13.
[4] "Is Glycemic Control Improving in US Adults?," Diabetes Care, January 2008, page 81.
petitie tekenenpetitie tekenenThe FDA's job is to protect the safety of patients in its use of drugs and medical devices and to advance public health by speeding innovations that make medicines and technology more effective, safer and more affordable. That is its mission.
But we believe the FDA has adopted a stance of excessive caution in its regulation of diabetes drugs and technology that is counter to its duty to serve patient needs.
Specifically, it has established new rules that will impair research and innovation into diabetes therapy. (A copy of the letter sent to manufacturers in November 2008 can be found at www.diatribe.us/fdaletter.)
This worries us. For example, new requirements for additional multi-year long-term outcome studies prior to approval for drugs with no cardiovascular signals will assuredly discourage research and innovation to the detriment of public health.
The need for improved treatments for the 24 million Americans with diabetes could not be clearer. Many of the drugs available now have tolerability issues [1]. Poorly controlled diabetes increases the risk of devastating long-term complications, including blindness, end-stage renal disease, amputation, and heart disease. Complications cost our country at least $58 billion per year [2] -over twice what is spent on technology and therapy annually [3].
Nearly 50 percent of patients in the US do not meet A1c goals [4] using current therapies and technologies. No therapy today stops diabetes from advancing. As patients are living longer with diabetes and therapies stop working, the need for new therapies increases. We need better technology and drugs that help slow or avoid long-term complications as well as more therapies that cause fewer side effects1 and last longer. And, despite the epidemic in the number of diabetic patients, no drugs are yet available that can prevent diabetes. Innovative, safe, and effective prevention is the key for people at risk and for cost savings to society.
Ironically, excessive regulatory hurdles ensure the continued use of the very drugs and devices that have proven ineffective for many patients.
There is no value in an ideal diabetes drug or device if the regulatory costs are so great that the product never makes it to market. Make rules reasonable.
Due to the very nature of the severity and prevalence of diabetes, the following leaders within the diabetes community, who have signed this petition, implore the FDA for the immediate creation of 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 and would supplement the current advisory committee. Our experience, focus, and keen awareness of the needs of the diabetes community would be an invaluable resource to the FDA as it faces the arduous process1 of evaluating new diabetes treatments. Our aim is to improve options for patients.
We urge the new FDA leadership to recognize the urgent need for more safe and effective treatment options for diabetes and to reduce barriers to innovation. More treatment options will benefit patients. The disease is progressive. Delays in the availability of new treatments will only result in tremendous cost to public health and the economy. Our recommendation can benefit patients without sacrificing their safety.
Please sign this petition and tell others about it. Make your voice heard!
Learn more about the issues here:
Problems at FDA prompting slowdowns in development - should patients accept this?
The FDA in Transition: Diabetes Treatment at Risk
The FDA Needs Your Input on Diabetes Medicines!
Petition sponsors:
Kelly Close: Editor, diaTribe
Manny Hernandez: President, Diabetes Hands Foundation; Founder, TuDiabetes
Amy Tenderich: Creator and Author, DiabetesMine
Nadia Al-Samarrie: Publisher, Diabetes Health magazine
Marston Alfred: Founder, SugarStats.com
Timothy S. Bailey, MD: Director, AMCR Institute Inc.
Allison Blass: Author, Lemonade Life
Jennifer Block, CDE: Stanford Medical Center, Stanford University
Nancy Bohannon, MD: Director of Clinical Research, CVD Risk Reduction Program, St. Luke's Hospital, San Francisco
Bruce Buckingham, MD: Professor of Pediatric Endocrinology, Stanford University
Stead Burwell: CEO, Alliance Health Networks, Inc.
Priscilla Call Essert: Author, My Life As A Pancreas
Gina Capone: Co-Founder, the Diabetes Talkfest Blog
Fran Carpentier: Author, Diabetes, Day-By-Day on Parade.com
Kitty Castellini: Founder, CEO, Producer and Host, Diabetes Living Today - Talk Radio
David Edelman: Co-Founder, Diabetes Daily
Steve Edelman, MD: Professor of Medicine, University of California, San Diego; Founder, Taking Control of Your Diabetes
Bernard Farrell: Author, the Diabetes Technology Blog
Martha M. Funnell, MS, RN, CDE: Diabetes Educator
Bob Hawkinson: Author, Joy of Diabetes
Debbie Hinnen ARNP, BC-ADM, CDE, FAAN: Diabetes Educator, Mid America Diabetes Associates
James S. Hirsch: Author, Cheating Destiny
Irl B. Hirsch, MD: Professor of Medicine, University of Washington
Lois Jovanovic, MD: CEO and Chief Scientific Officer, Sansum Diabetes Research Institute
Francine R. Kaufman, MD: Professor of Pediatrics, Keck School of Medicine, USC; Head, Center for Diabetes, Endocrinology and Metabolism, Childrens Hospital Los Angeles; former ADA President
Neal Kaufman, MD, MPH: Founder and CEO, Diabetes Prevention Source
Tom Karlya: Author, Diabetes Dad
Rebecca Killion: Diabetes advocate
Davida F. Kruger, MSN,APN-BC,BC-ADM, Nurse Practitioner: Diabetes, Henry Ford Health System, Detroit, MI
David Mendosa: Diabetes Journalist
Kerri Morrone Sparling: Author, Six Until Me
Linda Parks, CDE
Jenny Ruhl: Author, Blood Sugar 101
Gary Scheiner MS, CDE: Clinical Director, Integrated Diabetes Services
Lisa Shenson: Diabetes Parent & AdvocateScott Strumello: Author, Scott's Web Log
Jane Jeffrie Seley, CDE, BC-ADM, Diabetes Nurse Practitioner
Mollie and Jackie Singer: Authors, Curemoll.com
Howard Steinberg: CEO and Founder, dLife
Virginia Valentine: CNS, BC-ADM, CDE, CEO, Diabetes Network, Inc. Albuquerque, New Mexico
Michael A. Weiss: Diabetes Advocate, Former American Diabetes Association National Chair
Gloria Yee, RN, CDE: University of California San Francisco (UCSF) Diabetes Teaching Center
Notes:
[1] "Glycemic Durability of Rosiglitizone, Metformin, or Glyburide Therapy," New England Journal of Medicine, December 7, 2006. ADOPT, a four-year clinical trial of over 4,000 patients, was designed to test the how long diabetes therapies last. In this trial, 23% of those on sulfonylureas (SFUs) and 38% of those on metformin experienced nausea, diarrhea and/or vomiting from taking the drugs. 10% of those on TZDs, 11% on metformin, and 39% on SFUs experienced hypoglycemia. 7% and 14% of those on TZDs experienced weight gain and edema. 12% on women on TZDs experienced fractures. The trial also found that within five years of starting therapy, 15% of those on rosiglitizone (TZD), 21% on metformin, and 34% on glyburide (a sulfonylurea [SFU]) had fasting blood glucose over 180 (~ roughly equivalent to an 8% A1c), suggesting that even if patients could tolerate the therapy, it wouldn't last longer than a few years for many.
[2] "Economic Costs of Diabetes in the US in 2007," Diabetes Care, March 2008, page 13.
[3] "Economic Costs of Diabetes in the US in 2007," Diabetes Care, March 2008, page 13.
[4] "Is Glycemic Control Improving in US Adults?," Diabetes Care, January 2008, page 81.
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