Q+A-Should Avandia be pulled? Questions remain

WASHINGTON, July 9 (BestGrowthStock) – Regulators in Europe and the
United States will meet separately this month to debate if
GlaxoSmithKline’s (GSK.L: ) diabetes drug Avandia should be
restricted or even banned, but documents released on Friday
show the experts strongly disagree about the drug’s safety.
[ID:nLDE66817F]

Here are some questions and answers about Avandia:

WHAT IS THE PROBLEM WITH THIS DRUG?

Diabetes is a serious chronic illness and is a direct cause
of heart disease, but several studies have shown that Avandia,
known generically as rosiglitazone, may itself damage the
heart. Both Avandia and rival drug Actos, made by Takeda
Pharmaceutical Co (4502.T: ) and known generically as
pioglitazone, raise the risk of heart failure.

Two studies published last month showed that Avandia raises
the risk of heart attack and stroke compared to Actos, but a
third study showed that diabetics who took Avandia had a lower
risk of heart attack, stroke or death than patients taking
drugs of a different type. [ID:nN28257505]

Avandia is a member of a drug class called
thiazolidinediones or glitazones. They affect a gene called
PPAR-gamma and help the body use insulin more effectively. The
first drug in the class, Rezulin or troglitazone, was pulled
from the market in March 2000 after 63 people who took it died
from acute liver failure and nearly 40 others needed liver
transplants.

WHO DID THE STUDIES?

One of the studies was a “meta-analysis” of 56 trials
involving people taking Avandia or other diabetes drugs. Done
by longtime Avandia critic Dr. Steven Nissen at the Cleveland
Clinic it found those taking Avandia were 28 percent to 39
percent more likely to have a heart attack.

The second study by David Graham and colleagues at the U.S.
Food and Drug Administration and the U.S. Centers for Medicare
and Medicaid Services found people taking Avandia had 1.25
times the risk of heart failure compared with those taking
Actos, 1.27 times the risk of a stroke and 1.14 times the risk
of dying.

The third study, paid for by the U.S. National Institutes
of Health, found that adding Avandia to the mix of diabetes
drugs lowered the risk of heart attack, stroke or death by 28
percent.

WHY IS THIS DRUG STILL ON THE MARKET?

That is just what consumer groups such as Public Citizen
and Consumers Union are asking.

But it can be difficult to show that a drug is dangerous,
especially in a disease like diabetes, which is already usually
complicated with heart disease and other symptoms as well.

More than 700 pages of internal documents released on
Friday showed FDA staffers disagree about how to interpret the
studies.

Members of the U.S, Congress, including Republican Senator
Charles Grassley, Democratic Representative Rosa DeLauro and
Senate Finance Committee Chairman Max Baucus, have questioned
the FDA’s regulation of Avandia.

A current trial called Tide is designed to directly compare
Avandia and Actos.

The FDA has scheduled an advisory panel meeting on the
heart safety of Avandia on July 13-14. The European Medicines
Agency’s Committee for Medicinal Products for Human Use will
discuss the issue in London on July 19-22.

HAVE PEOPLE SUED OVER THIS?

Yes. In May, a lawyer involved in some of the suits said
Glaxo had settled with nearly 700 people who said they suffered
harm because they took Avandia. [ID:nN11123771]

Joseph Zonies, one the lead plaintiffs’ lawyers in the
federal case pending in a U.S. District Court, estimated that
3,000 cases have been filed in the federal litigation and says
another 4,000 to 6,000 could be filed later.

WHY IS THIS DRUG NECESSARY?

The World Health Organization estimates that 171 million
people globally had diabetes in 2000 and projected that number
will nearly double by 2030 to 366 million.

Diabetes raises the risk of heart disease, stroke, kidney
failure and other illnesses. Uncontrolled blood sugar levels
can damage the blood vessels, and patients can lose toes, feet
and legs to diabetes, while kidneys can fail and damage in the
eyes can cause blindness.

While diet and exercise can control diabetes, many people
also take prescription drugs.

WHAT OTHER DRUGS ARE THERE?

Diabetics have 12 classes of drugs to choose from.

New drugs include Merck’s (MRK.N: ) Januvia and AstraZeneca
(AZN.L: ) and Bristol-Myers Squibb’s (BMY.N: ) Onglyza. Many other
drugs are in clinical trials, attacking diabetes with a variety
of approaches.

Older drugs such as metformin and a class known as
sulfonylureas are available generically and can also help lower
blood sugar.
(Writing by Maggie Fox; Editing by Lisa Richwine and Tim
Dobbyn)

Q+A-Should Avandia be pulled? Questions remain