Friday, December 4, 2009

Vioxx and Ethics

In May of 1999, Merck was granted approval by the Food and Drug Administration ( FDA) to market rofecoxib ( Vioxx). Ted Frank writes in his working paper titled” The Vioxx Litigation about 2 individuals that took Vioxx and suffered from its effects…”Robert Ernst was fifty-nine, with two partially blocked arteries, when he suddenly died in his sleep from an arrhythmia. He had been taking the painkiller Vioxx for eight months. On August 19, 2005, a Brazoria County jury in Angleton, Texas, held Merck, the pharmaceutical company that sold Vioxx, liable for his death. The jury assessed damages at a staggering $253 million: $24 million “compensatory” damages and $229 million in punitive damages.

Frederick Humeston suffered a heart attack after taking Vioxx for two months. On November 3, 2005, a New Jersey jury, presented with the same evidence that led the Ernst jury to assess punitive damages for outrageous conduct, found that Merck had done nothing wrong in its marketing or sale of Vioxx, and exonerated Merck, without even having to evaluate Mr. Humeston’s shaky evidence of causation or questionable claims of substantial injury. Still, Merck spent millions of dollars defending itself in the seven trial.

In the next preceding months , more than 80 million patients had taken the drug and sales for Vioxx reached into the billions. With profits soaring, Merck kept Vioxx on the market, ignoring several studies that were stating that Vioxx was linked to excessive risk of myocardial problems and strokes. After thousands and thousands of people reported having cardivascualr issues related to taking vioxx, Merck pulled the plug on Vioxx. The withdraw of Vioxx was the largest prescription drug withdrawal in history. Had Merck and the FDA not ignored all the signs along the way that this drug was not safe for the public, this whole situation could have been avoided.

February 8, 2001 , the FDA Arhtritis Advisory Committee met to discuss their concern over the cardviovascualr risks associated with Vioxx, according to the New England Journal. But the FDA waited 2 years after the fact to convene a study to determine the effects that Vioxx could have instead of following the advise of many studies that were running concurrently with Vioxx reported billion dollar surge in sales. They were not concerned with the health and safety of arthritis patients and other that were taking this drug, they were more concerned with making a profit. I consider this to be very unethical because it shows that companies will stop at nothing to make an easy dollar. The FDA had the opportunity to conduct more studies to assess the dangers that Vioxx presented but they never initiated such research. Merck continued to reassure the public that this drug was safe to take and send out many publications and pamphlets, giving the public the opinion that they had to need to discontinue usage.

This type of behavior is not accepted. Allowing people to be misled in order to achieve financial gain in thievery and should be considered murder in this case. Merck spent over $100 million per year in direct to consumer advertising, a type of activity that the FDA strictly regulates, but in this case they drew a blind eye and let them continue on their marketing campaigns. Society should hold these 2 accountable for destroyed the quality of life that patients taken Vioxx. Given the amount of people that took Vioxx, the FDA and Merck are responsible for the lives of those patients. Had they been honest and open with the public, they could have saved people from suffering.

I personally take some prescription drugs, a few of which are said to have adverse effects on the heart if taken out of dosage. When I take my medicine I assume that the FDA has done their part fo assure that this product is safe. We are the general public have no way to really test these types of things out. They allow millions of drugs to be put on the market and they need to take the time to properly study and research them before they hit the market. Doing so after the fact is very careless and selfish .

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