January 13, 2015

What Is Wrong with Our Diabetes Economy?

The money being paid to certain so-called experts is our problem. In 1997, the American Diabetes Association convened a group of these “experts” and they changed the definition of type 2 diabetes from what it was by lowering the level to 126 mg/dl. Up to 1.9 million more Americans now had diabetes.

In 2003, 25 million Americans were added to the roll when another group of experts defined pre-diabetes as being from 100 to 125 mg/dl. Now I don't think either of these was that bad, but what followed does raise my hackles. This caused the diabetes pharmacological industry to have a decade of booming business. Never mind that the U.S. Food and Drug Administration has not approved any drugs for the treatment of pre-diabetes. In addition, the medical insurance industry has not been willing to pay for any drugs used “off-label” for the treatment of pre-diabetes.

In 2013, IMS Health, a drug market research firm, declared that diabetes drug sales reached $23 billion. This exceeds the combined revenue of the National Football League, Major League Baseball, and the National Basketball Association.

The money trail gets even dirtier. The “experts” were rewarded for their changes in definitions, in that 13 of 19 members of a committee received more than $2 million in speaking and consulting fees since 2009 from big pharmaceutical companies. Prior to that the committee members making the changes in definition each received several million dollars a year from the companies making the drugs.

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.”

Separately, a MedPage Today/Milwaukee Journal Sentinel analysis found about 3,300 cases in which diabetes drugs approved since 2004 were the "primary suspect" in a patient's death, according to adverse event reports to the U.S. Food and Drug Administration. In another 20,000 cases, the drugs were believed to be responsible for hospitalizations.”

Clifford Rosen, MD, an endocrinologist and professor of medicine at Tufts University School of Medicine, said that doctors are using drugs that are great for lowering glucose, but do nothing for cardiovascular risk. Dr. Rosen said it is also unproven whether many of the newer drugs are preventing other diabetes complications.

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.

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.”

The study of the drug saxagliptin (Onglyza), approved in 2009, was designed to show saxagliptin was better at reducing heart attacks, strokes, and cardiovascular deaths than a placebo, but it failed to do so. A 2013 paper in the New England Journal of Medicine showed the drug actually increased the rate of hospitalization for heart failure by 27%. The drug remains on the market, though the FDA says it is investigating the matter.

The money trail will not end, and doctors, researchers, and members of the FDA will continue to build their retirement coffers. And no one will stop this!

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