(Adds impact, panel member quote, paragraphs 2-3; also adds
analyst comments, detail, background)
By Lisa Richwine
SILVER SPRING, Md., July 2 U.S. regulators
should require drugmakers to study the potential heart risks of
all new diabetes medicines, an advisory panel said on
The recommendation could force companies to run longer and
more expensive studies and delay new entrants in a $6 billion
U.S. market that was hit last year by concerns surrounding
GlaxoSmithKline PLC's (GSK.L) diabetes pill Avandia.
"Although it might be a little more burdensome ... we need
more studies," said Dr. Clifford Rosen, a panel member and
endocrinologist at the Maine Center for Osteoporosis.
Now, companies generally need to show only that their
medicines lower blood sugar levels. That approach is inadequate
for patients, panel members said.
The group of outside experts that advises the Food and Drug
Administration voted 14-2 to recommend companies do a long-term
study of cardiovascular effects or provide equivalent evidence
to rule out an "unacceptable" risk of heart problems.
Studies need to last as long as five years to detect heart
attacks, strokes and other problems, several panel members
said. Many endorsed the idea of starting the study before
approval and completing it after a drug reaches the market.
The requirement should apply to all experimental drugs even
if they show no signs of concern in early testing, the
"That's a shift in expectations of what we are asking for.
It's a higher level ... of assurance that you've excluded
cardiovascular risks," said Dr. John Jenkins, director of the
FDA's Office of New Drugs.
Some drugs already on the market also may need more study
of cardiovascular safety, panel members said.
The FDA will decide what rules to impose on companies but
usually follows panel recommendations.
Diabetes medicines are among the biggest selling drugs.
U.S. sales of the leading medicines exceeded $6 billion in
2007, according to healthcare information company IMS Health.
Several drugmakers, including Glaxo, Bristol-Myers Squibb
Co (BMY.N), AstraZeneca Plc (AZN.L), Eli Lilly and Co (LLY.N)
and Amylin Pharmaceutical Co AMLN.O, are working to bring new
diabetes drugs to the market.
If the FDA sets strict requirements, "you're going to see
increased research and development budgets, and you're probably
also going to see less development in diabetes," said
Morningstar analyst Damien Conover.
Higher standards could help Merck & Co Inc (MRK.N) by
delaying rivals to its fast-selling drug Januvia, Conover
Nearly 24 million Americans have diabetes, the U.S.
government estimates. Most cases are type 2 diabetes, which
experts link with obesity, poor diet and lack of exercise.
Diabetics produce less insulin, or their bodies use it less
effectively, which makes blood sugar rise. That can damage
blood vessels and organs, leading to blindness, kidney disease,
limb loss and heart disease.
Experts agree blood-sugar control helps prevent
complications such as damage to the eyes and kidneys. But no
conclusive evidence exists that any diabetes drug reduces heart
disease, the top killer of diabetics, FDA officials said.
Concern that diabetes medicines may damage the heart arose
last year when a study by Cleveland Clinic researchers found
Glaxo's Avandia increased the chances of a heart attack.
Glaxo has said Avandia's safety is comparable to similar
pills. But the company agreed to add a strong warning that the
drug might increase heart attack risk with a note that the data
was inconclusive. Studies of cardiac effects are continuing.
(Reporting by Lisa Richwine and Susan Heavey; editing by Tim