Is FDA A Deadend for Medical Devices and Diabetic Kids??

  • by: |
  • 07/27/2011
Another depressing example of how the path for approval of  medical devices has become constipated at the FDA in response to the so-called consumer advocates such as Public Citizen, Consumers Union, Merrill Goozner, Diana Zuckerman.    To quote British philosopher Isaiah Berlin, "disregard for the preferences and interests of individuals alive today in order to pursue some distant social goal that their rulers claimed is their duty to promote has been a common cause of misery of people throughout the ages."   The groups above have been a constant source of misery in our time.


www.sfgate.com/cgi-bin/article.cgi

Lives wasted as FDA stalls on diabetes care

Wednesday, July 27, 2011

For more than 20 years, my daughter Piper has lived with the constant, frightening, deceptive and malicious disease called type 1 diabetes. Piper has always been prone to the kind of hypoglycemic - low blood sugar - life-threatening attacks that come on hard, fast and without warning. She almost drowned as a youngster after becoming unconscious from low blood sugar. In college, she went into hypoglycemia while she slept and didn't wake up in the morning. Fortunately, she was discovered and emergency care saved her life.

Unfortunately, the Food and Drug Administration has been dragging its feet on technologies that could revolutionize diabetes care and make these kinds of episodes a thing of the past. Key trials are on hold and it looks to be years more before these proven, life-saving technologies are available for patients in the United States. Meanwhile, kids are dying.

Every hour of every day, individuals with type 1 diabetes have to balance insulin, food and activity to try to prevent low and high blood sugars, and the devastating and costly complications: seizures, comas, kidney failure, heart disease, blindness and amputations. The human cost is incalculable; the economic cost isn't: Diabetes costs our nation more than $174 billion a year and $1 in $3 of Medicare spending goes to care for people with diabetes.

Perhaps the most gut-wrenching story of diabetes is the specter of "dead in bed" - kids found dead in the morning after a completely normal evening. Dead in bed occurs because blood sugar levels can suddenly change. When this happens while sleeping you are unable to adjust insulin to right the body's blood sugar, which can be life threatening.

We know how to prevent these attacks, but we don't - at least not here in the United States. Breakthrough technologies that protect against dangerous diabetes episodes are already available elsewhere, but not at home. Low-glucose suspend systems have been approved for nearly three years and used safely in more than 40 countries worldwide, but they are not available in the United States because of the FDA's unnecessarily slow process.

These pumps stop delivering insulin automatically when a monitor indicates that the body's glucose levels are low. The low-glucose suspend technology is the first phase of an artificial pancreas, a combination of a continuous glucose monitor and an insulin pump with software that would communicate between the two to automatically monitor glucose levels and administer insulin doses. The artificial pancreas would address both high and low blood sugar levels. In 2006, the FDA recognized the importance of this technology and placed the artificial pancreas on its Critical Path Initiative. But now key trials are on hold until the FDA provides a roadmap for outpatient studies. A draft is promised in December.

It should not have taken this long, and must not take any longer. When I testified before Congress, my message was simple: this technology could revolutionize diabetes care and it is imperative that the FDA provide reasonable guidance immediately. Waiting is not an option. My daughter's life, and those of millions of people with diabetes, depends on it.

Pam Sagan of Los Altos is a former board member of the Juvenile Diabetes Research Foundation International.




CMPI

Center for Medicine in the Public Interest is a nonprofit, non-partisan organization promoting innovative solutions that advance medical progress, reduce health disparities, extend life and make health care more affordable, preventive and patient-centered. CMPI also provides the public, policymakers and the media a reliable source of independent scientific analysis on issues ranging from personalized medicine, food and drug safety, health care reform and comparative effectiveness.

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