The Slippery Slope: A Bittersweet Diabetes Economy

But the number of people with diabetes or pre-diabetes and who are candidates for drugs has been magnified by organizations and doctors with financial ties to drug companies, the MedPage Today/Milwaukee Journal Sentinel investigation found…

Many of the new drugs approved by the FDA can cause serious side effects, including heart problems, cancers, and overdoses leading to an estimated 100,000 emergency room visits each year by people with dangerously low blood sugar, according to published research, interviews, and other data reviewed for this story…

In recent years, the FDA has increasingly relied on “surrogate” measures when approving new drugs. In heart disease, that can mean relying on better numbers on a cholesterol test rather than reductions in actual heart attacks. In cancer, it can mean relying on the shrinkage of tumors, rather than the drug actually increasing survival.

An earlier MedPage Today/Milwaukee Journal Sentinel investigation found that 74% of 54 new cancer drugs allowed on the market between 2004 and 2013 were approved based on surrogate measures.

Surrogate endpoints are attractive to both industry and regulators because they provide a faster, less expensive pathway to marketing approval than clinical trials that ask if a drug decreases the number of heart attacks, kidney failure, or death. The reason is simple: clinical trials that rely on those hard endpoints take years longer and require many thousands of patients…

For years, a mantra in the diabetes community has been a concept known as tight or intensive glycemic control. It means using drugs to drive blood sugar levels down to more acceptable levels.

But recent research has shown that attempting to tightly control glucose can increase the risk of hypoglycemia and its complications — seizure, unconsciousness, or death.

Often, it is older people who are the most susceptible to hypoglycemia.

A 2014 study in JAMA Internal Medicine of people with an average age of 77 showed that 404,000 patients were admitted to the hospital because of hypoglycemia between 1999 and 2011, compared with 280,000 for hyperglycemia. Five percent, or 20,000 people, died within 30 days of their hypoglycemia admission. The study was based on Medicare data…

Doctors say the convergence of new drugs and the expanded definitions for diabetes and pre-diabetes has led to an over-medicalization of blood sugar disorders.

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