The latest in a series of troubling
developments for the manufacturers of the diabetes drug Avandia comes
in the form of a new report suggesting that pharmaceutical company
GlaxoSmithKline (GSK) knew of the cardiac risks associated with the
drug even before the public became aware.
Intended to help diabetes sufferers
through better blood sugar regulation, the drug has unfortunately
been at the heart of a number of reports of life-threatening
complications including heart disease and pulmonary edema. The drug
already contains a "black box" warning, a labeling
requirement prescribed by the FDA only in cases of the most severe
potential side effects, the strongest warning that can be placed on a
legal drug.
Most recently, senators Max Baucus and
Charles Grassley released a 2008 memo from the Food and Drug
Administration (FDA) that stated that there was "strong
evidence" that Avandia confers an increased risk of heart
failure when compared to a competitor. At the time, FDA reviewer Dr.
David Graham argued to an advisory panel that Avandia should be
pulled from the market and sales stopped.
The senators' report speculates
that GSK may have known "several years prior" of these
possible cardiac risks and may even have "attempted to
intimidate independent physicians ... to downplay findings." GSK
has denounced the findings, saying that the report mischaracterizes
their research efforts.
Though the FDA has stated that patients
already on the drug should not stop taking it without
consulting a doctor, they are convening a new advisory panel of
outside experts to reconsider the safety issues associated with
Avandia. Unfortunately, this closer scrutiny may come too late for
patients who have already suffered harmful side effects. Many of
these victims have already been seeking out assistance from a number
of different Avandia law firms helping those harmed by the
diabetic drug .