Best writers. Best papers. Let professionals take care of your academic papers

Order a similar paper and get 15% discount on your first order with us
Use the following coupon "FIRST15"
ORDER NOW

BS1

/in /by

Discovered in a Merck lab in 1994 the drug was one of a new class of painkillers called COX-2 inhibitors which reduce pain and inflammation without the sideeffectsulcersand gastrointestinalbleedingthatpainkillers such as ibuprofen can cause.Vioxxworked beautifully in clinical trials with arthritis patients and was approved by the FDA in 1999. EdwardScolnick president of Merck Research Labs even let it be known that he was takingVioxxhimself for back pain.
But in September 2004 Merck removedVioxxfrom the market after a study found a higher rate of heart attacks and strokes in patients taking the drug.Vioxx on the market for five years had been marketed in 80 countries with worldwide sales totaling $2.5 billion in 2003. When it was pulled from the market 2 million Americans were takingVioxx.
The pharmaceutical industry was astonished that the well-respected company had marketed a drug known to cause higher rates of cardiac events. Almost 20 years earlier Merck established a reputation for social responsibility by donating a treatment for river blindness to patients in developing countries.
Stillmore shocking was the admission that as far back as 1998 Merck knew the drug had problems. Even before FDA approval researchers outside Merck had found evidence that it might increase the risk of a heart attack. In 1998 a group at the University of Pennsylvania discovered that COX-2 inhibitors interfere with enzymes thought to ward off cardiovascular disease. A 2001 study testing the drug against nonprescriptionnaproxenshowed thatVioxxwas safer thannaproxen but it also found thatVioxxdoubled the risk of cardiovascular problems. Merck put a positive spin on the data highlighting the lower risk of side effects not the cardiac complications.
By April 2002 the FDA mandated that Mercknotea possible link to heart attacks and strokes onVioxxslabel. At the time Merck was spending more than $100 million a year on direct-to-consumer advertising building the blockbuster status of the drug.
Merck continued to minimize the problems up until a month before withdrawing the drug. The deathblow to the drug was the results ofAPPROVe a database analysis of 1.4 million patients. Ironically this study was designed to test whetherVioxxreduced the risk of colon polyps. Instead it showed that patients who took the drug for at least 18 months had double the risk of heart attacks and strokes as those who took the placebo. For a few weeks Merck focused on the fact that it took 18 months forVioxxto cause problems. However Merck researchers continued crunching the data and concluded that the safety window might be as little as three months.
The researchers who told Merck CEO RayGilmartinabout theAPPROVeresults pointed out that the company was under no obligation to recall the drug. Merck could take the data to the FDA and have the labeling changed. In fact the majority of outside clinicians whom Merck consulted in the first few days suggested it do justthatsince there were millions of people who were benefiting fromVioxxand not getting heart attacks. ButGilmartindecided that withdrawing the drug was the responsible thing to do.
Since the drug was withdrawn investigators have linkedVioxxto more than 27000 heart attacks or sudden cardiac deaths nationwide from the time it came on the market in 1999 through 2003. Over 11000 lawsuits have been filed against Merck.[i]
Questions
1) If Merck can donate $50 million in free doses ofivermectin what does that say about the amount of revenue the company generates in the drug research and distribution industry?
2) In the case ofVioxx known serious side effects were being reported and yet the company was slow to suspend or remove the drug from the market. What does this say about the approval process of drugs to the market and why companies would be reluctant to give up the revenue stream for a commonly used drug likeVioxx?
3) Merck finally pullsVioxxfrom the market and has 11000 lawsuits to handle. How would you feel if you were the company president and you were a known name and face of a company that was responsible for the stroke or heart attack of a past user of the drug?
AWARE:Make sure to cite at least one outside source to support your answers.At least three sentences per question.

 
Looking for a Similar Assignment? Order now and Get 10% Discount! Use Coupon Code "Newclient"