In September
2001, the FDA fired off a warning
letter to Merck & Co. concerning the manner in which
it was promoting Vioxx. The letter contended that Merck &
Co. had engaged in false and misleading advertising.
The FDA was concerned with statements by Merck officials that
minimized the findings of the VIGOR study. The letter said
in part:
[Y]our promotional campaign discounts the fact that in the
VIGOR study, patients on Vioxx were observed to have a four
to five fold increase in myocardial infarctions (MIs) compared
to patients on the comparator non-steroidal antiinflarnmatory
drug (NSAID), Naprosyn (naproxen).
We have reprinted the full text of that warning
letter to Merck. It should be noted that this letter
was written seven months before the FDA finally warned the
public of the risk by requiring a warning label on the medication.
The FDA finally required Merck & Co. to add a warning to
Vioxx in April 2002. This warning clearly was inadequate to
protect consumers and inform physicians of the problems with
the drug. Even after the warning was placed on the label,
Merck & Co. continued spending $100 million per year promoting
the drug. It has been estimated that more than 2 million people
were on the drug at the time of the withdrawal.
In the face of criticism over its handling of the Vioxx withdrawal,
the FDA has announced it will re-evaluate the manner in which
it regulates
the drug industry. Some states, including North Carolina,
Alaska, Arkansas, Idaho, Kansas, Minnesota, Missouri, Montana,
Oregon, Washington Wisconsin, and Wyoming have implemented
their own drug
safety program to protect residents against dangerous
drugs like Vioxx. This warning system can alert pharmacists
within seconds of possible drug dangers.
On March 1, 2005, a top FDA official admitted to a Senate
panel that the agency made significant mistakes in handling
the Vioxx withdrawal. Dr. Sandra Kweder noted that the agency
should have been more forceful in requiring stringent label
changes when evidence began to accumulate that Vioxx may lead
to significant health problems.
For more information about the Vioxx withdrawal,
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