Removing Vioxx from the Market

 

 

 

 

For year, the drug Vioxx, developed and marketed by Merck, was one of the blockbuster drugs on the market. One of a number of so-called Cox-2 anti-inflammatory drugs, Vioxx was considered by many people a miracle drug for alleviating the pain from arthritis and other painful afflictions. Vioxx was marketed heavily on television, prescribed by most physicians, and used by an estimated two million Americans.
All of that changed in October 2004, when the results of a large study were released. The study which followed approximately 2,600 subjects over a period of about 18 months, concluded that Vioxx used over a long period of time caused a significant increase in the risk of developing serious heart problems. Merck almost immediately pulled Vioxx from the American market and doctors stopped prescribing it. On the basis of the study, Merck faced not only public embarrassment, but the prospect of huge financial losses.
More specifically, the study had 1,287 patients use Vioxx for an 18-month period and it had another 1,299 patients use a placebo over the same period. After 18 months, 45 of the Vioxx patients had developed serious heart problems, whereas only 25 patients on the placebo developed such problems.
Given these results, would you agree with the conclusion that Vioxx caused a significant increase in the risk of developing serious heart problems? First, answer this from a purely statistical point of view, where significant means statistically significant. What hypothesis should you test, and how should you run the test? When you run the test, what is the corresponding p-value? Next, look at it from the point of view of patients. If you were a Vioxx user, would these results cause you significant worry?
After all, some of the subject who took placebos also developed heart problems, and 45 might not be considered that much larger than 25. Finally, look at it from Merck’s point of view. Are the results practically significant to the company? What does it stand to lose? Develop an estimate, no matter how wild it might be, of the financial losses Merck might incur. Just think of all those American Vioxx users and what they might do.

 

Sample Solution

Merck & Co. announced a voluntary worldwide removal of rofecoxib (Vioxx) on Sept. 30 after a research found that people taking the drug for a long time have twice the risk of heart attack as those taking a placebo. The APPROVe (Adenomatous Polyp Prevention of Vioxx) 3-year clinical trial was assessing the efficacy of rofecoxib in preventing the recurrence of colorectal polyps in individuals with a history of colorectal adenomas. It was discontinued in late September (2 months before it was planned to end). It found that after 18 months of treatment, people using rofecoxib had a relative risk of major cardiovascular events, such as heart attacks and strokes, that was roughly double that of patients taking placebo.

who suffer from hereditary diseases cannot live a normal life. The use of CRISPR/ CAS9 for medical treatment, however, be used to genetically rectify these issues before the baby is even born. The embryo of the child formed from the parents can be biologically altered to remove the genetic mutation that causes the disease (Gene Therapy- Mayo Clinic, n.d). In medicine research, researchers’ best interests are to do with treatments for illnesses, so the power that is gene editing will be used to benefit all of humanity, even if it is kept behind laboratory walls. Furthermore, using it for medical research has a lot less problems associated with it, and less societal consequences. There is, although, an important factor to consider here; medical research is not always morally or ethically justifiable. There are many historical examples of immoral medical research. In 1951, a young woman called Henrietta Lacks was taken to Johns Hopkins Hospital where she was given treatment for her cervical cancer. Dr George Gey, a cancer and virus researcher in the hospital would often keep cells from patients for medical research. He found Lacks’ cells to be quite unique and even today, HeLa cells help us study the effect of viruses and toxins. While this was beneficial, the doctors at the hospital passed on her cell samples without her consent or knowledge (Nature, Nature, (DTU) and (UNIL), 2020). This demonstrates how medical research can also often be ethically questionable.

My essay not only argues for gene editing only being used for medical research and treatment, but also for it to be kept exclusively in the laboratory. If gene editing were used in medicine, but outside of the lab, large healthcare business may patent gene- editing technology and proceed to charge exorbitant amounts for people to use this technology, rendering it far out of reach for those who cannot afford it. This already exists with general privatised healthcare in many countries (Collyer and White, 2011), and gene editing should not be restricted, as something with so much potential. We have seen the value that society places on appearance and beauty standards that exist, so those less fortunate who do not have access to it may not feel that they conform with said societal beauty standards as is the case with the latest fashion, for example- in a study conducted on college students by Lauren A. McDermott and Terry F. Pettijohn II of Coastal Carolina and Walden University (Pettijohn II and McDermott, 2012), students rated models and not only were African- American Models rated lower, but so were models wearing clothes with no branding or less expensive clothes.

One ethical theory that may be important and useful to consider is utilitarianism. A utilitarian standpoint may provide counterarguments to my thesis. Utilitarianism is about what will give the most people the most happiness. In other words, what will increase the total ‘amount’ of happiness in the universe (Driver, 2009). Restrictions put into place on the use of gene editing (i.e. only using it in labs) will mean that less people will have access to it. If we allow gene editing to be used outside of the lab, more people are likely to get valuable life- saving treatment. This means that there should be no restrictions an

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