1. Diabetes drugs improve lab tests, but not much more, particularly in pre-diabetics.
None of the 30 diabetes drugs approved by the FDA in the last decade have rigorous proof of reducing clinical outcomes such as heart attack, stroke, blindness, or amputations.
2. Physicians and drug makers have reported diabetes drugs as the "primary suspect" in thousands of deaths and hospitalizations.
At least 3,300 deaths and 20,000 hospitalizations have been linked to new diabetes drugs in adverse event reports submitted by clinicians and pharmaceutical companies to the FDA since 2004.
FDA's Adverse Events Reporting System (FAERS) collects case reports from healthcare providers, pharmaceutical companies and the general public. These are the reports that were used for the MedPage Today and the Milwaukee Journal Sentinel analysis.
Although the FAERS database is known to be incomplete, it is one of the few tools to monitor risks for drugs already approved. (For full discussion of methodology, see howMedPage Today/Journal Sentinel conducted the analysis.)
Reporters reached out to the drug makers. All who responded cited the limitations of the FDA's reporting system and said they monitor reported problems.
3. Diabetes drug makers paid physicians on influential panels millions of dollars.
The physicians in the American Association of Clinical Endocrinologists and American Diabetes Association panels that have presided over changes in defining pre-diabetes and diabetes or patient treatment guidelines received more than $2 million for consulting and speaking activities for diabetes drug manufacturers: