Vioxx demonstrates the unethical practice perpetuated within the business community. Typically, the pharmaceutical companies often put their financial interests above the health and safety of drug users. The paper also highlighted the unethical drug approval process implemented by FDA. The paper suggests that the government should introduce tougher drug approval process to ensure that FDA approves only the ethical products into the market.
The case provides the overview of a controversy that involves Vioxx, a drug produced by the U.S. based Merck (Merck & Company), a leading global pharmaceutical company in the United States. Vioxx is an anti-inflammatory drug used for the treatment of acute pain and arthritis without irritation. Merck launched Vioxx in 1999 for the treatment of the acute pain and arthritis and ever since the drug was launched, medical experts had written series of reports about the cardiovascular risks associated with the long usage of Vioxx. Years after the company had launched Vioxx, there were several reports published in medial journals linking Vioxx's to heart attacks. However, Merck disagreed with all reports made against Vioxx until the company internal study confirmed that Vioxx could be associated with cardiovascular risks if the drug was used for more than 18 months.
In 2004, Merck was forced to recall Vioxx from the market because of its associated risks of heart attack and strokes to long-term users.
Fundamental objective of this report is to provide a case analysis on Vioxx.
3. Major Issues
The Vioxx case is a typical example of the issue of business ethics in the business community where companies put their financial interests above the interests of the public. In 1999, FDA (Food Drug Association) approved Merck's application to launch Vioxx into the market. Before the drug was launched into the market, Merck had set up a clinical trial to establish that the drug only caused fewer gastrointestinal problems. However, an independent Data Safety and Monitoring Board ordered to monitor the clinical trial warned about a heightened risk of cardiovascular events that a user could develop after a long use of the drug. Despite a clear warning sign, Merck continued to develop an aggressive marketing campaign for the drug. (Presley, 2005). Years after Vioxx was launched, there were series of cardiovascular cases caused with the used of the drug. Typically, it was reported that Vioxx caused 88,000 out of 140,000 heart disease cases in the United States. The issue made the medical community and the public to raise concern about the ethical process of drug development and regulatory process in the United States.
Phua, (2008) argues that there is a need to raise a doubt about the quality of research and development implemented by many pharmaceutical companies. Many pharmaceutical companies covered the side effects of the drugs launched into the markets because of their financial motives. Typically, Vioxx issue was not the only the unique case where pharmaceutical companies were forced to withdraw their drugs from the markets because of the side effects the drugs caused to users. In the United States, Redux and Pondimin, which was an appetite suppressant drug was withdrawn from the market in 1997, when it was discovered that it could cause heart valve damage. Rezulin, which was a drug for the Type 2 diabetes, was withdrawn from the market in the year 2000 after it was discovered that it could increase the risk of liver toxicity. Other drugs forced out of the markets were Baycol and Raplon in 2001, Raxar and Hismanal in 1999, and Duract and Posicor in 1998.
The cases of the increase in the number of drug being withdrawn from the markets have raised the public concern about the integrity of the pharmaceutical drug approval process. In the United States, FAD (Food and Drug Administration) is in charge of approving the newly launched drug. Typically, it is important that the process of approving the drug produced by the pharmaceutical companies should be based on the objective scientific evidence and should be protected from lobbying by the pharmaceutical companies. If there is a conflict of financial interests (for example, owning stock in pharmaceutical companies, or consulting for pharmaceutical companies), the drug approval process could be compromised. It has been claimed that the approval process of the U.S. Food and Drug Administration is not ethical and the whole approval process has been compromised. The FDA is underfunded and it relies significantly on the fees received from the pharmaceutical companies for carrying out the review of the drugs. Thus, the pharmaceutical companies use this advantage to put a strong pressure on the FDA to speed up the approval of new drugs.
Villanueva et al. (2003) also argue that marketing and sales techniques implemented by the pharmaceutical companies are questionable. Pharmaceutical companies often influence the prescribing pattern of physicians in various ways. One of their advertising strategy is to target (KOLs) key opinion leaders in biomedical community to promote their drugs. In the case of Vioxx, Merck used several celebrities including former athletes - Bruce Jenner and Dorothy Hamill to endorse the drugs. Shortly after Merck launched the product, the company used aggressive marketing strategic to promote Vioxx in the U.S. And outside the United States. The aggressive marketing promotion implemented by the company made Vioxx to become one of the best selling drugs. Merck also offered discount rates to hospitals to influence physicians across the United States to speed the prescription of the drugs. The nominal pricing policies employed by the company were to make physicians to have the habits of prescribing the drugs for patients. Thus, the whole strategy that Merck employed to produce and market the drug reveals that the company put its financial interests above the health and safety of the community.
4: Problem Analysis
The negative publicity associated with Vioxx has generated problem within the United Stated. Years after Merck launched the product into the market; over 20 million Americans had used the products. The problem was that the company put Vioxx into the market without adequate warning that the drug could lead to cardiovascular disorder after long use. Although, the company claimed that they did not have the idea that long use of the drug was associated with heart attack. The issue made many Vioxx's users to file over 300 law suits against Merck. One of the suits filed against Merck was the case of Ernst vs. Merck & Co. Carol, who was the wife of Robert Ernst, accused Merck that Vioxx led to the death of her husband. Robert Ernst, Carol's husband developed cardiovascular complexity for continuously taking Vioxx and six months after he took the drug, Robert developed cardiovascular complexity, which eventually led to his death. (Mancinelli, 2006 ). Carol's case against the company made Merck to pay $253.4 million in punitive and compensatory damages. Added to this case, Vioxx was linked to the 88,000 out of 140,000 of heart disease cases and most of the cases were kept out of the public eyes before FDA ordered the company to withdraw the drug from the markets. The issue points out that the Merck was only concerned about the company's financial interest. Despite the obvious ethical issues and health risks surrounding Vioxx, in 2005, the government advisers still concluded that the benefits associated with Vioxx outweighed its danger and it was patients to decide whether or not to keep using the drugs. The government advisers stated that the prescription should have a strong warning advising users on the side effect of its long-term use. However, it was revealed that 10 of the government drug advisers who supported the continuous use of Vioxx were in some way financially tied the drug.
Apart from the problem caused to drug users, the pull out of Vioxx from the market caused financial stress to shareholders. It is revealed that the sudden pull out of Vioxx from the market resulted to the drastic fall of the company share price and Merck's share price fell $45 to $33 wiping out the $28 billion in market capitalization. (Appleby & Krantz, 2004). In 2004, Merck's revenue went down by 20%. The issue made shareholders to file the class action lawsuit against Merck for failing to disclose the material information concerning the safety profile of Vioxx.
Analysis of the problem reveals that the total blame should not be put on the Merck Company. The Merck is for profit organization with sole objective to maximize profits. The FDA should be blamed on this issue by allowing Vioxx to pass the clinical test and approved the drug to go public.
The case of Vioxx is a typically ethical issue within the medical community. The case reveals that FDA and Merck have not put the health and safety of drug users into considerations before allowing the drug to go into the public. The case reveals that there is lack of effective public regulatory control over the entire pharmaceutical drug development and approval process. The government needs reorganize the drug approval process implemented by the FDA.…