Today, close to half of the 24 million Americans with diabetes do not meet recommended blood sugar goals.

Ask FDA to Better Serve Diabetes Patient Needs

Target:
The new leadership at the FDA, HHS and the new Obama administration
Sponsored by: 
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.
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.
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.
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We signed the "Ask FDA to Better Serve Diabetes Patient Needs" petition!
# 4,384:
11:52 pm PST, Nov 7, Azadeh Jamali, Iran, Islamic Republic Of
# 4,383:
7:14 pm PST, Nov 7, Michael W Evans, California
# 4,382:
2:49 pm PST, Nov 7, Stephanie Lehr, Kansas
# 4,381:
11:44 am PST, Nov 7, Carol Tessier, Massachusetts
# 4,380:
12:08 am PST, Nov 7, April Calicdan, Canada
# 4,379:
11:44 am PST, Nov 6, Mark Paul, California
# 4,378:
10:29 am PST, Nov 6, Name not displayed, California
My husband is recently diagnosed with diabetes, plus my paternal grandmother, and aunts on both sides of the family live with it. Please realize those with diabetics need attention and resources. Thank you.
# 4,377:
10:21 am PST, Nov 6, Name not displayed, Ohio
# 4,376:
9:03 am PST, Nov 6, Lorene Rowland, Montana
# 4,375:
8:38 am PST, Nov 6, Debra Covill, Texas
I have been a diabetic for almost 17 years and am also a R.N. for 25 years so I am very familar with the effects of this disease upon myself and also upon the people that I care for on a daily basis. With the expanding incidence of this disease we need to do all we can to educate and change causes and make dietary changes to turn this around. It is not going to be easy and education is the key.
# 4,374:
7:46 am PST, Nov 6, John Viacrucis, Minnesota
My mom has diabetes, her side of the family had diabetes. So, this is really personal to me.
# 4,373:
7:19 am PST, Nov 6, Deborah Otto Sunderman, South Carolina
# 4,372:
5:18 am PST, Nov 6, DORIS LEHR, New York
My son has diabetes,so this disease really hits home.
# 4,371:
10:13 am PDT, Oct 27, Matthew Murphy, Delaware
The FDA Mission Statement claims responsibility "for advancing the public health by helping to speed innovations..." I am saddened that this agency has become the single biggest barrier to a better quality of life for people with diabetes in this country.
# 4,370:
9:35 pm PDT, Oct 14, Matthew Silvers, Idaho
As a registered nurse and Certified Case Manager who works with acute and critical inpatients in a community-based hospital, I encounter numerous patients who do not have the exposure to appropriate diabetes education. They have primarily been exposed through advertising, which does not educate to the proper levels. 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. It IS time for a change. Thank you for your time and consideration. Sincerely, Matthew Silvers RN CCM (Idaho)
# 4,369:
3:39 pm PDT, Oct 12, McCarthy Hanger, California
Please focus more resources on the treatment of diabetes and make it a priority for the health of the nation.
# 4,368:
3:09 pm PDT, Oct 10, Ada Torres, Texas
Insurance companies have refused to accept my application because I have diabetes. I was applying for life insurance and I was denied because of my diabetes. Then about 4 years later I was offered by this same company a life insurance because I wasn't on insulin yet. Insulin or not a person with diabetes should not be discriminated against with the opportunites to prepare for our death just like anyone else.
# 4,367:
6:26 am PDT, Oct 9, Valerieanne Durgin, Tennessee
We need to do whatever it takes to continue the help for those of us who have Diabeties. It can be a frustrating disease but manageable.
# 4,366:
5:30 am PDT, Oct 9, Ioakim Sismanidis, Greece
# 4,365:
12:30 pm PDT, Oct 8, Melissa Grisham, Tennessee
I was diagnosed 6 months ago with Type 2, my father and his aunt both died young due to complications. If the rate of Diabetes is increasing as rapidly as they report, shouldn't the research and investment be towards the largest growing disease in the nation. It's effects on other organ systems increases the heart and kidney failure rates.
# 4,364:
8:18 am PDT, Oct 8, Martha Neider, California
As a diabetic patient (Type 2) I know how important new technology and drugs are that bring hope of a better life, and ease of treatment.
# 4,363:
9:47 am PDT, Oct 5, Marcia Ferrell, Ohio
My sister had Type I Diabetes for thirty years. She had her leg amputated and had a horrible life with this horrible disease. Please do something to help find an easier way to help control this disease. She ended up dying at the somewhat young age of only 49.
# 4,362:
8:15 am PDT, Oct 2, Fran Eriksen, Oregon
My husband has been diabetic for 34 years and has had a kidney transplant and in May of this year had a below the knee amputation. Our youngest son was diagnosed when he was 15 1/2 and his oldest daughter was diagnosed two years ago at age 6. Yes, you might say that diabetes has ruled my life without being diabetic.
# 4,361:
6:46 pm PDT, Sep 27, Name not displayed, New Mexico
I have had Type I diabetes since 1965 - 44 uears! I have been an insulin pump user for the last 8 years. Because of the FDA roadblocks and the incredible time it takes to approve new medical devices, insulin pump features, and CGM. this has driven up the price of insulin pumps, insulin, and insulin pens. Diabetics in the US need the FDA's help, not beauracratic delays and excuses.
# 4,360:
3:25 pm PDT, Sep 25, William Oatman, Iowa
I was diagnosed with type 1 diabetes in 1993 at the age of five. Since then it has been a constant struggle between being able to afford doctor visits and medicine, and being able to afford any other necessities. More recently, my father's insurance dropped me from coverage for no longer being a full time student, and it has been an even greater struggle being able to afford all of the supplies and the necessary doctor visits for maintaining my health.
# 4,358:
12:29 pm PDT, Sep 19, Name not displayed, Massachusetts
# 4,357:
3:08 pm PDT, Sep 17, Jason Valletta, Iowa
# 4,356:
5:28 pm PDT, Sep 16, Gloria Sennert, Missouri
Since people with type 1 diabetes rely on insulin daily to remain alive, it's essential that they be protected from faulty insulins, meters, pumps, etc. Please make sure they receive full protection.
# 4,355:
3:34 pm PDT, Sep 16, Judith Conoyer, Missouri
Please address this important issue as soon as possible. I have a great niece with juvenile diabetes. Thank you.
# 4,354:
2:28 pm PDT, Sep 16, Beverly West R.N., Massachusetts
When a social worker tells a 67 year old diabetic that he can't get his SNAP food credit increased ( even though dietic food costs 35% more on average), you know something is terribly wrong: My niece and her husband just got turned down for a SNAP Food credit increase ( He's diabetic and they both live on SSI). Which would you prefer: An extra $100 for dietic food, or $180,000 a month for Hospital costs if or when John has a Diabetic blackout or slips into a Coma? Taxpayers already pay for his SSI and VA, so its your decision. If Obama wants to prevent complications associated with diabeties, obesity, and other ailments, wouldn't it make sense to issue specified food vouchers/ Dietic foods/Care boxes to VA clinics,Food pantries and other institutions that address the needs of Low income Americans? Why is it that Government Commodities ( often delivered to Non Profit Organizations) are extremely high in Sodium and Carbs? Worst of all, not ONE version of the Healthcare proposals include incentives to encourage responsible, healthy lifestyles: Therefore, Costs will skyrocket.
# 4,353:
7:56 pm PDT, Sep 15, Connie Towns, Virginia
# 4,352:
11:49 am PDT, Sep 15, Kristina Starr, Missouri
I know too many people suffering from this disease and who also have large out of pocket expenses in order to treat it. Please help them.
# 4,351:
7:27 am PDT, Sep 15, Ronald Mutimba, Ohio
Access to the latest in diabetes medication and drugs is crucial to a diabetics survival, we have already been struck by a chronic lifelong condition please do not saddle us with another
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