The Central Problem
In the Merck, the FDA, and the Vioxx Recall case study, the question as to whether or not Merck conducted itself in a socially responsible and ethical manner with regard to Vioxx is the central problem we will examine in this case. Many argue that the sole problem lies within the pharmaceutical company Merck and Co., Inc., and while that may in fact be the case, other parties such as the Food and Drug Administration (FDA) can be held responsible as well. Merck a “research driven” pharmaceutical company “dedicated to putting patients first,” is one of the largest pharmaceutical companies throughout the world (Presley, 2). The American pharmaceutical giant manufactures, markets, research and develops a variety of health …show more content…
Merck focused solely on financial gains and the impact the drug had on company revenue, neglecting its ethical responsibility to both consumers and its shareholders.
Important facts of the case
If you search the web regarding Merck, the FDA, and the Vioxx Recall you’ll find a number of primary and secondary sources with central facts regarding the Vioxx case. While there are a number of variables to consider, I focused on the factual data that provided integral facts about this case. In the early 90s congress passed the Prescription Drug User Fee Act (PDUFA) that requires pharmaceutical companies to pay the FDA to review proposed medicines. This came as a result of pressure to get drugs into the market quickly as consumers were fearful that they were not receiving medicines quickly. This act allows the FDA to provide reviews that approve or disapprove various drugs—companies seek to enter into the market; yet the process was found that “two thirds of the survey lacked confidence that adequately monitors the safety of prescriptions once they are on the market” (Lawrence, 483). Because there was pressure to get drugs into the market the FDA shortened the approval time which caused the approval percentage to increase from 1.56 percent to 5.35 percent in 2001. While at the same
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The case consists of two major pharmaceutical companies that joint to collaborate their research and pharmaceutical technologies to start a joint venture in India. Both have valuable resources that have benefited both companies during the joint venture. Now both are questioning if there is still any value in maintaining the joint venture in India and will be deciding what will be the best route to take. Ranbaxy Laboratories wants to be bought out, but Eli Lilly is worried of the financial implications of such move.
Sweeping the nation on a mass caliber is the opioid crisis. Stories have been depicted by every news channel across the nation on the crisis that has destroyed countless individuals lives. According Alanna Semuels's article, "Are Pharmaceutical Companies to Blame for the Opioid Epidemic?", she reports the fault of the calamity. Semuels points out that the perpetrator of this utterly horrendous plague is the doctors who have over-prescribed medication, as well as the pharmaceutical industry. This crisis has been slowly evolving over the past decades but is only now making its way into the mainstream media headlines. The pharmaceutical industry has been steadily infiltrated its' way into all arrangements of healthcare in the sole pursuit of gaining
Dr. David Graham is the senior scientist within the FDA’s Office of Drug Safety. Graham became concerned when he started to see an increased number of patients having heart attacks and strokes after taking a large does of the drug Vioxx, back in 2002. He raised his concern to the FDA saying that the warning label needs to be changed due to his new findings. He had trouble getting this any attention from the FDA’s administration and decided it was time to ‘blow the whistle’ and go to the media.
Bell continued to interview a journalist named Greg Critser, who authored the book “Generation RX,” which is about the relationship between America and pharmaceuticals. He exclaims that drug companies advertise their product so much that it internalizes inside individuals that the drugs they’re selling are good and not poison, then he continued where the drug is somewhat of a poison where it kills another thing off to benefit another. Pharmaceutical companies also lobby the political side of their ambitions to cover up the negative side of their
The Pharmaceutical industry has been in the spotlight for decades due to the fact that they have a reputation for being unethical in its marketing strategies. In The Washington Post Shannon Brownlee (2008) states, “We try never to forget that medicine is for the people. It is not for the profits. The profits follow.” This honorable statement is completely lost in today’s world of pharmaceutical marketing tactics. These tactics are often deceptive and biased. Big Pharma consistently forgets their moral purpose and focuses primarily on the almighty dollar. Big Pharma is working on restoring their reputation by reforming their ethical code of conduct.
Last year, in September 2004, Merck withdrawed Vioxx, off the market. Studies of Vioxx showed that it doubled the risk of a heart attack or stroke for patients who have used it more than 18 months. After Merck, withdrawed Vioxx from the market, the FDA, issued a public health advisory for the users of Vioxx. Therefore, Vioxx was on the market for five years without
While some have identified Merck as a visionary company dedicated to a "core values and a sense of purpose beyond just making money" (Collins & Porras, 2002, p. 48), others point out corporate misdeeds perpetrated by Merck (e.g., its role in establishing a dubious medical journal that republished articles favorable to Merck products) as contradictory
Over the past couple of decades, a sudden change has started to take over the way business is done. The time when no rules applied, and anyone could do what they pleased at the cost of others or the environment is rapidly ending. Instead, companies today have become aware that it is essential for them to employ ethics and morality in their actions, if not they will be heavily scrutinized and rejected by the public. This way of thinking also applies to the pharmaceutical industry, which over the past century has been rapidly expanding. Do to the fact that this industry can determine the health and lives of millions of people, it is imperative that this industry follow an ethical and moral path.
Society expects drug companies to improve people’s well-being and to behave like a nonprofit company not overly concerned with making large profits. However, investors
Merck was one of the largest pharmaceutical companies in the world. • Merck was about to lose patent protection of two of its best selling drugs, which had been a significant part of their $2 billion annual sales. • Merck began putting millions of dollars into research (up to $1 billion) and within three years, Merck was able to discover four powerful medications. • Profits weren’t all that Merck cared about; Merck’s founder believed that “medicine is for people. It is not for the profits.” • He also believed that following the “medicine is for people” philosophy would lead to profits and had yet to fail.• River Blindness is caused by parasitic worms, which can be found in
In 2000, Merck began to cooperate with Schering-Plough on several research products and in 2009 acquired their longtime partner in an effort to diversify its products and reach a broader consumer base. With challenges that include rising prices of research and prescription drugs, Merck has managed to forge forward and overcome obstacles. Merck’s survival has been a subject of speculation many times throughout the years; from the 2004 recall of their top selling drug (Vioxx) due to undesirable side effects to the recently curtailed trials of their very promising new anti-clotting drug (Vorapaxar) due to negative trial results. Kenneth Frazier, Merck’ CEO, has also come under heavy criticism due to his unconventional decision not to cut research budgets in order to increase profits. This strategy differs greatly from the usual path and it has cost Merck investor confidence which resulted in lowered stock prices . Although Merck has been subjected to challenges throughout their history they have always managed to stay afloat and maintain their reputation as a leader in healthcare.
The corporate social responsibility states that "corporations can and should act ethically and be accountable to society for their actions." Pharmaceutical companies work to save lives and make a profit. Individuals should make sure that
Costs of the decision included negative public perceptions of the firm and denial of treatment to economically disadvantaged and uninsured consumers. the decision was ethical because the benefits of new life saving drugs outweighed the costs of denial of treatment to the few. So GSK regarding to its primary stakeholders was social responsible.
Merck was established in 1891 to improve human and animal health through the development of innovative products. Merck currently has two reportable segments, the Pharmaceutical Segment and the Vaccines and Infectious Diseases Segment. Merck sells products through several channels including wholesalers, retailers, hospitals, clinics, government and managed health services providers. In the 1980’s the Merck was very successful in producing 10 major new drugs and had a very healthy pipeline. In later years, Merck has entered into joint ventures with many other pharmaceutical companies in order to expand its pipeline. In the last several years Merck has