US experts urge limits for some drug safety trials

* IOM warns on randomized trials for drugs on market

* IOM says so-called real world trials can be sound

* FDA sought IOM’s advice ahead of Avandia meeting

WASHINGTON, July 9 (BestGrowthStock) – Clinical trials aimed at
pinpointing emerging safety problems with drugs already on the
market should only be conducted when other, less invasive
research is not an option, a government advisory group said on

The Institute of Medicine’s report, requested by U.S. Food
and Drug Administration officials, comes ahead of a
highly-anticipated meeting next week on GlaxoSmithKline Plc’s
(GSK.L: ) (GSK.N: ) diabetes drug Avandia, that has come under fire
for potential heart risks.

Glaxo is conducting a randomized, controlled trial called
TIDE to compare Avandia to Takeda Pharmaceutical Co’s (4502.T: )
rival drug, Actos, after safety concerns emerged with Avandia
that the FDA and its advisers concluded were unclear.

While the IOM did not target the Avandia trial in
particular, FDA Commissioner Margaret Hamburg asked the
independent, nonprofit medical group to weigh in with at least
an initial finding on general ethical issues involving the
safety of studying the risks of drugs already in use.

The FDA called for the Avandia/Actos study in 2007. But
some analyses of other data since then have convinced some
researchers that Avandia’s risks are greater than those of
Actos and have repeatedly called for the trial to be halted.

Glaxo has defended its drug, saying data overall shows it
does not increase the risk of heart attack, stroke or death.

On Tuesday and Wednesday, FDA’s panel of outside experts
will weigh numerous studies and analyses before recommending
whether Avandia should remain on the market, be pulled from the
market, or various options in between.

The panel also will be asked to weigh in on the TIDE

In its report, the IOM said randomized controlled trials
should only be done when “a responsible policy decision cannot
be made based either on the existing evidence or on evidence
from new observational studies.”

It also said studies of real world use of a drug — known
as observational studies and often done by reviewing insurance
claims and other databases — can yield strong enough evidence
to make a decision on a drug already being sold.

Public Citizen, a consumer advocacy group, along with a
prominent scientist and ethicist have called on Hamburg to
immediately halt the trial, saying Avandia has already been
shown to be worse than its rival.
(Reporting by Susan Heavey; Editing by Tim Dobbyn)

US experts urge limits for some drug safety trials