The
United States pharmaceutical industry invested $39 billion in research and development of drugs in 2004 alone.
Such a profound and growing market needs oversight into product development. The safety of drugs is something which cannot
be compromised.
Recently, a shadow of doubt has been cast over the United States’ governing Food and Drug Administration. Most notably,
Vioxx, an effective anti-arthritic, has been removed voluntarily by its manufacturer, Merck & Co. Other anti-arthritics
in the same class (cyclooxygenase-2, or COX-2, inhibitors) have been found to carry similar cardiac risks.2
How
were these risks not detected before the drug was approved for the general public? Research conducted during the FDA-required
clinical phases did not appear to alert scientists of its potentially fatal side effects. Were the clinical reports flawed
or incomplete? Is the FDA safety testing process successful in preventing unknown harmful side effects?
Despite efforts by clinical researchers and the FDA’s Center for Drug Evaluation and Research (CDER), often
no drug can be completely evaluated and approved without carrying a risk of harmful side effects. However, it remains the
absolute duty of the FDA to maintain constant watch over pharmaceutical companies to ensure public safety.
2. Aschenbrenner, D. (2005). Cox-2 inhibitors: cardiovascular
risk possibly a 'class effect'. American Journal of Nursing, 105(6), 30-38.