Presentation By Shelly Brunson Matthew Schratwieser Vernon Tilly Jr.

Transcription

1 Presentation By Shelly Brunson Matthew Schratwieser Vernon Tilly Jr.

2 Merck conducted clinical trials on the Cox 2 inhibitor Vioxx and submitted the data to the FDA. The FDA approved Vioxx for the treatment of osteoarthritis, acute pain in adults and menstrual symptoms and later rheumatoid arthritis. After growing concern for the length of time it took to get drugs on the market the FDA created a fast track system to get drugs on the market much faster. In order to do this, pharmaceutical company s had to pay a much larger price to the FDA to move the approval process along more quickly. Vioxx was advertised to appeal to the consumer. For example, they used Dorothy Hamill, an Olympic figure skating champion in their commercials to relay the message that she would not let arthritis stop her from continuing to skate. After careful monitoring, scientists at Merck discovered that patients who used Vioxx for over 18 months were more than twice as likely to have a heart attack or stroke than those who were taking placebo, Merck decided to recall Vioxx.

3 In the end, Merck acted in a socially and ethically responsible way by recalling Vioxx and legally settling with those effected by Vioxx. On the other hand, Merck could have been more diligent in recognizing that Vioxx had preliminary data that showed possibility of cardiovascular events was of great concern. Merck should have taken this opportunity to conduct more trials to study the risk of cardiovascular events in patients taking Vioxx. Consideration needs to be given to the FDA who also has an ethical responsibility for approving the medication although there was data to prove that the drug did have cardiac risks.

4 Merck should have heeded Dr. Alise Reicin s forewarning of the cardiovascular risks versus downplaying it during the early development of Vioxx. Merck s pressuring of its scientists to bring a blockbuster drug to market before its time could have been stopped through internal controls. Merck should have come clean much earlier about the risks of Vioxx to cardiovascular patients. Their code of ethics and core values should have been reviewed and heeded, people first profits later.

5 Pharmaceutical Companies: Companies must conduct studies to ensure product is safe. Companies must follow ethical guidelines in not covering up negative studies. Companies must fully disclose side effects exhibited during studies.

6 Government and the Court System: Government must create standards designed to ensure purity and consistency of drugs. Government must monitor studies to verify methods and results of new drugs. Government must follow up on reports of unforeseen side effects from approved drugs. The role of the court system is to enforce the laws that the government imposes.

7 Patients and Doctors: Doctors must be aware of drugs effects and possible side effects and proper dosing for each possible patient demographic. Doctors must inform patients of possible side effects and likelihood of each side effect. Patients must be involved in their medical decisions and follow doctors prescribe dosage.

8 Do away with direct-to-consumer advertising of prescription drugs. FDA overhaul to bring about change in the way they approve drugs no rush jobs. Disallow Political Action Committees (PACs) and lobbyists for the pharmaceutical industry. This may never happen but it should for all. The 1992 Prescription Drug User Fee Act (PDUFA) should be repealed, even with its benefits it reeks of corruption. Enact stiffer penalties for manufactures who knowingly cause harm, and at the FDA for negligence on their part for not protecting the harmed.

9 Are there any questions for the presenters at this time?

10 Lawrence, A.T. & Weber, J. (2010). Business and society: Stakeholders, ethics, public policy (13th ed.). New York: McGraw-Hill Irwin.