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!
Read the full article here.
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