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Sunday, 21 December 2014

Benefits of diabetes drugs dubious

In 1997, a group of experts convened by the American Diabetes Association changed the definition of type 2 diabetes, lowering the blood sugar threshold so that as many as 1.9 million more Americans had the condition.
The same pattern played out in 2003, in an even bigger way, when the association changed the definition of a condition known as pre-diabetes and — overnight — 25 million more Americans were affected.
In the decade that followed, the diabetes industry boomed — thanks in part to a 2008 declaration by two endocrinologygroups that pre-diabetes could be treated with drugs if diet and exercise didn't lower blood sugar levels.
Last year, sales of diabetes drugs reached $23 billion, according to data from IMS Health, a drug market research firm. That was more than the combined revenue of the National Football League, Major League Baseball and the National Basketball Association.
But from 2004 to 2013, none of the 30 new diabetes drugs that came on the market were proven to improve key outcomes, such as reducing heart attacks or strokes, blindness or other complications of the disease, an investigation by the Milwaukee Journal Sentinel and MedPage Today found.
Instead, the U.S. Food and Drug Administration approved the drugs based on their ability to lower blood sugar levels, what is termed a surrogate measure. Many of the new drugs have dubious benefit; some can be harmful.
"We have an entire industry — a diabetes economy — that revolves around glycemic control," said David Newman, director of clinical research for emergency medicine at Icahn School of Medicine at Mount Sinai Hospital in New York.
But the disease is not well understood, is difficult to control and can't be cured, said Newman, an emergency room physician who founded, an independent group of physicians who analyze the effectiveness of medical therapies.
"We've called a sign of the disease the disease, but there are no rigorous studies that prove we understand how to treat the illness rather than its symptoms," Newman said.
To be sure, type 2 diabetes — once known as adult-onset diabetes — is a serious problem in America, often requiring drugs. The condition can lead to cardiovascular disease, kidney failure, amputations and more immediate symptoms, especially in those with very high blood sugar levels.
The surging number of cases has closely paralleled increasing rates of obesity, sedentary living and an aging population.
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 Journal Sentinel/MedPage Today investigation found.
The groups that made the changes each receive several million dollars a year from companies that make diabetes drugs.And each of the panels that moved to increase the numbers, or said more patients could be put on the drugs, had majorities of members who received money from such companies.
In one case, 13 of 19 members of a 2013 committee received more than $2 million in speaking and consulting fees since 2009 from companies that make diabetes drugs, according to an analysis of drug company data.
Many of the new drugs approved by the FDA can cause serious side effects, including heart problems, cancers and overdoses leading to an estimate of about 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, an analysis found about 3,300 cases in which diabetes drugs approved since 2004 were the "primary suspect" in a patient's death, according to reports to the U.S. Food and Drug Administration. In another 20,000 cases, the drugs were believed to be responsible for hospitalizations.
"We may be using drugs that are great for lowering glucose but don't do anything for cardiovascular risk," said Clifford Rosen, an endocrinologist and professor of medicine at Tufts University School of Medicine.
It also is unproven whether many of the newer drugs are preventing other diabetes complications such as blindness and amputations, said Rosen, who also is an associate editor of the New England Journal of Medicine and has served on FDA advisory committees.
"Why haven't we done that?" he asked. "There is a lot of pressure from companies to go with the simplest and easiest approach."
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