Last week an FDA
Advisory Committee recommended that restrictions on the diabetes drug, Avandia,
be lessened. The restrictions were originally placed in 2010 because of
concerns that the drug caused an increased risk of heart failure. The
increased risk of heart failure was originally suggested by a researcher at the
University of Cincinnati, he performed a study compiling data from several old
Avandia trials. His work suggested a 43% increased risk of heart attack
in diabetic patients taking Avandia. GlaxoSmithKline,
the developer of Avandia, insisted that they had a study being performed that
showed no increased risk of heart failure and had a superior design to the data
analysis study.
At the time of the
2010 decision, Avandia was the most popular diabetes drug on the market, its
popularity instantly dropped and the pharmaceutical company was accosted with
lawsuits. Settling these lawsuits and dealing with other issues from the
FDA's decision cost the company a small fortune.
The re-review we saw
at the FDA last week is extremely rare. The committee was called because
of an analysis performed by Duke University. Duke re-analyzed the data
from the original study by GlaxoSmithKline. This is a study that was
specifically designed to show cardiac risk and that the company had stated
showed no increased risk of cardiac event in patient's taking the medication.
Duke's analysis
matched that of GlaxoSmithKline and because of this the board reversed their
initial decision and recommended that restrictions be lessened. They have also
asked that additional studies be performed to confirm this result. It is important to note that the advisory
board decision is only a recommendation to the FDA, so no formal lessening of
restrictions has been made at this point.
If this reversal is
formally made by the FDA it won’t erase the damage done. Millions of
Americans were using Avandia and were forced to change drugs because of these restrictions;
they were told that the drug was dangerous to their health, which may not have
been true. Avandia's stock plummeted, the company lost millions on
penalties and legal cases, and the drug's reputation is forever tarnished.
GlaxoSmithKline is
certainly not a hapless victim; they had a history of data integrity issues
with other drugs that led to a mistrust of the Avandia data. However,
when making decisions like this it’s a fine line between being cautious for
reasons of patient safety and jumping to unfair conclusions about the risks of
an experimental drug or treatment.
Pharmaceutical
companies are often placed in a bad light by our society. We view them as
power hungry, money grabbing machines that have little or no regard for the
people they claim to help. This is a gross misinterpretation. Certainly,
they are companies and therefore concerned with profit margins, but our
American market system is based on a big risk/big reward theory.
These companies risk
billions of dollars on drugs that have a limited chance of ever getting to
market. Clinical trials are hugely expensive and placed under heavy scrutiny
along the way. This is not to say that data cannot be manipulated. However, even the most cynical among us
should admit that a pharmaceutical company would be concerned about the safety
of their drug, if for no other reason than that being repeatedly sued is an
expensive endeavor.
It is important in a
situation like this, with so much at stake, to have all of the facts before
making a decision. It’s nice that the
advisory committee has corrected their mistake, but it would have been nicer to
have avoided the error in the first place.
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