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¶ … Harris, Gardener (17 Feb 2005) "Medical Panel Poses Pointed Questions to Drug Makers Over Risks of Painkillers." The New York Times. Sunday Edition. Retrieved 19 Feb 2005 at http://www.nytimes.com/2005/02/17/health/17fda.html?pagewanted=
Perhaps the some of the most infamous research studies conducted in recent years were the ones currently undergoing FDA scrutiny, regarding the safety of the once-popular COZ-2 inhibitor drugs such as Vioxx and Bextra and Celebrex. An early Vioxx study found that patients taking the medication had more than four times the risk of undergoing a heart attack as those individuals in the control group. Those patients in the control group were taking Naproxen, another common pain pill but not a COX-2 inhibitor. The Merck Company has since stated it believed that the difference might have resulted because Naproxen protected against heart problems in a manner similar to aspirin.
This raises an important...
The control group was given another painkiller that chemically different than the drug being tested, to validate the hypothesis that COX-2 inhibitors were more effective in treating pain and giving patients with chronic pain a more normal life. However, because no drugs are without side effects, the improved cardiovascular health of the control group relative to the test group was inaccurately attributed to the drug being used by the control group, according to Merck.
Also, because the studies consisted of elderly or ailing patients with many health concerns, it was often different to isolate the variables of the hypothesis being tested, namely if the COX-2 inhibitor drugs were effective (which they were) in controlling pain and…
Merck Novartis Merck and Novartis Financial Statements 2012 Balance Sheet • What components of stockholders' equity do each of the companies disclose? Merck & Co. provides a consolidated statement of stockholders equity on their balance sheet. They disclose the number of shares, share types, retained earnings, and some historical data (Merck & Co., 2013). Novartis provides a much more thorough and detailed report of their shareholders equity in their annual report. Not only do they
Corporations have many stakeholders, of which the shareholders are just one group. There are also, for example, creditors, employees, suppliers and customers. In the case of pharmaceutical giants, society at large is also a stakeholder of a sort. The products a company like Merck develops improve the health and well-being of the population at large. Government can be said to be the stakeholder that represents this interest. In the case of
Merck's Medco The acquisition of Medco (by Merck) is a sign of shifts that are taking place in the health care industry. What is happening is there has been an emphasis on providing total health care solutions to consumers. As they are demanding that they have access to: the best services and want to have their different needs combined into one plan. This has lead to changes in the way health
It is different than a criminal action, which involves a breach of duty owed to society at large. It is possible that actions are both tors and crimes; but only the state may prosecute a crime, but any injured party may bring a lawsuit against another as a tort ruling. There are a number of different torts; ranging from assault to negligence, all with foundations in the common law
More than anything else, this case exemplifies a keen sense of legal risk management. The company made enormous profits from the drug while it was selling it; it was highly effective for its on-label purpose and had no known dangerous side effects. After finding that they could be responsible for causing heart problems in patients taking the drug, the company pulled it for ethical reasons and as a means of
Merck and Vioxx -- Research Data How did Merck misuse research data to support their decision for marketing the COX-2 Drug Vioxx? In November of 1998 the pharmaceutical company Merck submitted Vioxx's application to the Food and Drug Administration seeking approval for the COX-2 inhibitor drug, as a treatment for osteoarthritis, on the basis of clinical trials involving 5,400 patients. Merck said the rates of cardiovascular risk were "similar" among patients taking