The explosion in diabetes diagnoses and diabetes drugs seems to be never-ending, but there are some serious questions raised about the “health” of the diabetes treatment market.
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The market for diabetes drugs is now $23 billion, however questions are being asked again about the definitions that commence treatment of the diseases, as well as the ties between the big pharmaceutical companies making diabetes treatments and the groups who actually define the treatment of the disease.
Litigation and other issues have been swirling around diabetes drugs for many years already and the use of surrogate markers by the FDA to approve the medicines instead of actual outcomes showing a benefit is another matter raising serious concerns, according to the WSJ.
For instance, in 1997, an American Diabetes Association panel changed the definition of type 2 diabetes by lowering the blood sugar threshold so up to 1.9 million more Americans had the condition, according to The Milwaukee Journal-Sentinel and MedPage Today.
In 2003, the ADA changed the definition of pre-diabetes and 25 million more Americans were affected. And in 2008, two endocrinology groups declared that pre-diabetes could be treated with drugs if diet and exercise failed to lower blood sugar levels, the papers wrote.
Meanwhile, none of the 30 new diabetes drugs that became available between 2004 and 2013 demonstrated an improvement in key outcomes, such as reducing heart attacks, strokes or blindness. Instead, the FDA approved drugs based on the ability to lower blood sugar level.
Doctors say the convergence of new drugs and the expanded definitions for diabetes and pre-diabetes has led to an over-medicalization, the papers write.
Read more at the Wall Street Journal