Vioxx, the painkiller drug responsible for 30,000 to 100,000 cardiovascular-related
health risks, was approved for children only weeks before it was
pulled from the market.
With the outstanding negative side-effects found in adults using
Vioxx, such as heart attack and stroke, many wonder why the drug
had been approved for children, or at all for that matter.
However, with over 300,000 children in the United States suffering
from some form of rheumatoid disease, very few drug treatments exists.
In fact, this may be the reason why the FDA and other researchers
were initially on board with Vioxx, failing to ask questions concerning
its safety.
The only other approved drug available for children suffering from
juvenile arthritis is Enbrel, which is known to trigger rare complications
such as lymphoma, a cancer of the lymphatic system.
As early as 1999, both Merck and the FDA had strong hints about
the cardiovascular risks associated with the drug. Merck's "wonder
drug" was turning out to be anything but a wonder.
Many Merck critics claim the company had plenty of warning signs,
yet continued advertising for the drug regardless. Despite concerns,
the company proceeded with the pediatric test, which lasted a mere
three months, and sent the drug on its way to thousands of suffering
children.
One spokeswoman for Merck claims that information about heart risks
were printed on the label. According to studies, the label being
referred to is the fine-print package insert, which is rarely read.
One FDA researcher found evidence of cardiovascular disorders associated
with Vioxx use. Before the drug was approved for children, he reported
his findings at a medical conference. However, FDA officials ignored
the study, stating it was not considered the "gold-standard"
by the pharmaceutical industry. Thus, the evidence was not strong
enough to deter approval for pediatric use.
The FDA remains unapologetic for the decision they made concerning
Vioxx, in that the correct decision was made based on the information
they were given. The agency also agrees that pulling the drug from
the market was the right thing to do.
Newsday
October 11, 2004.
Washington
Post October 18, 2004.
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