America needs the ISLET Act
Woman injects insulin, used to control diabetes. (Getty Images)
There was a time during our lifetimes when a childhood diagnosis of diabetes was considered a death sentence. Though this is no longer the case, a diagnosis of Type 1 diabetes remains a life-altering event. Nearly 1.5 million Americans suffer from Type 1 diabetes, and one in 10 Americans are affected by Type 2 diabetes. Diabetes attacks a person’s heart, kidneys, vision and nervous system, and it is the eighth-leading cause of death in the United States.
Diabetes affects your body’s ability to produce insulin, which helps to control sugar levels. Islets are groups of cells made in your pancreas that help make insulin which in turn helps manage your blood sugar levels. If you have diabetes, your body can’t make enough insulin or can’t use it properly.
Television is flooded with ads for diabetes-related drugs. These drugs help manage the disease, but they do not cure it. Fortunately, a cure for diabetes is on the horizon. Research at the Diabetes Research Institute, the Mayo Clinic and Northwestern University, among many others, has shown that islets from the pancreases of cadavers have been successful in reversing the devastating effects of diabetes.
In clinical studies across the world, diabetic patients have been receiving transplants of islet cells, and research outcomes have shown reduced dependency or even elimination of the need for patient insulin injections. Across the world, but not in the United States.
One of the reasons for this is that the Food and Drug Administration has chosen to classify islets as drugs, rather than as an organic part of the human anatomy. Worse yet, the FDA has awarded total control of islets to a single drug company. Aside from the obvious fact that islets are a part of a human organ (heart, liver, kidney transplants are not treated as drugs), awarding control to a single, for-profit corporation awards influence over who will receive islets, and at what cost. This level of control is an obstacle to islet research and ultimately compromises efforts to find a diabetes cure.
The ISLET (Increase Support for Life-saving Endocrine Transplantation) Act would correct this outdated regulation. It would reclassify islets, and all human cells, as organs. It would totally negate the FDA’s misclassification of islets as drugs and open the use of those cells to all medical companies. The ISLET Act has bipartisan support, and companion bills introduced in the House and Senate are identical. This means that if the bills are passed, little effort would be needed to reconcile the proposed legislation.
There is much work remaining on this promising therapy, and there remain technical challenges, such as the limitations of available supplies and patient rejection. Research accomplished to date has led scientists to believe that the use of a person’s own stem cells to form islets that can be returned to the patient could “teach” the body to create its own insulin and thus stop the disease. For a child with diabetes, this research is a much-needed ray of hope.
Passage of the ISLET Act would promote innovation, improve patient access to islet transplantation and potentially enhance outcomes and quality of life for individuals living with Type 1 diabetes. U.S. Rep. Don Bacon, R-Neb., is a co-sponsor of the House bill. It would prolong life for millions of individuals today, and for the lives of millions of children in generations yet-to-come.
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