Merck & Company, Inc: The Recall of Vioxx Essay

IntroductionGeroge W. Merck stated once stated, We try never to forget that medication is for the people. It is non for the profits. The profits follow. Initially, rofecoxib was the blockbuster medicate that Merck needed due to the upcoming Zocor patent lessening in 2006. With an estimated 27,785 bosom attacks and sudden cardiac deaths that could endure been avoided if Celebrex had been single-valued functiond instead of rofecoxib, Merck faces the speculation of non only having to suffer enormous civil and criminal penalties, but also losing the trust of patients. M any parties are partially culpable, but Merck faces the grave uphill battle of regaining a reputation that once served as a market differentiator in the 1980s, Merck was voted the Most Admired Company in the Statesn employment for seven consecutive categorys.A critical go forth in this national is to analyze the events listed in the case and propose an alternate course of action that may avail prevent fut ure deaths from other pharmaceutical medicines while non prohibitively restricting innovative research that could potentially save lives if tested properly. lively Points and IssuesMerck was relying on the success of rofecoxib due to Zocors expiring patent and the direct competition rofecoxib was engaged in with Celebrex, which had a first mover advantage. While Celebrex was also a cyclooxygenase-2 inhibitor, rofecoxib was the only Cox-2 inhibitor proven to be beneficial for ulcers and gastrointestinal bleeding. Once studies came out suggesting that Vioxx contributed to a greater number of cardiovascular problems than naproxen, Merck seemed to opportunistically interpret these results. Furthermore, Merck did non institute any studies that might keep found negative cardiovascular results, and solicitude failed to perform a study that focused specifically on the cardiovascular risks of Vioxx. Instead, Merck spent a record amount on publicise the gastrointestinal clear of the d o drugs in a period of uncertainty. The advertising in the time of uncertainty is really unparalleled, and opens the door to skeptical (Appendix).Stakeholder ImpactsMerckMerck wanted to discover a drug in the Cox-2 inhibitor distinguish that would compete with another class of drugs copen as nonsteroidal anti-inflammatory drugs (NSAIDS). Cox-2 inhibitors were developed to eliminate the most common view set up of other NSAIDs, ulcers and gastrointestinal bleeding, as an estimated 15,000 people die from GI bleeding annually Vioxx was designed to treat those high-risk candidates. Vioxx was the only Cox-2 inhibitor proven to become a upbeat for ulcers and GI bleeding. Thus, the blockbuster status was created a stronger drug with a proven benefit for ulcers and gastrointestinal bleeding. As the events unfold in the case, the crucial errors occur prior to the decision to recall the drug on kinfolk 30, 2004. After Merck versed that patients had double the risk of heart attack or s troke than if they took placebo and two refreshing competing Cox-2 inhibitors were introduced, Merck decided to pull the drug, but it was already far too late.Dr. Eric Topol, a highly regarded cardiologist conducting research at the Cleveland Clinic, was the first researcher to raise questions about Vioxx. While he concluded that Vioxx produces a risk of heart attack five times greater than naproxen sodium, some believed that Mercks scientists interpreted the data opportunistically by saying the difference was due to the protective effect of naproxen, this downplayed the important possibility that Vioxx was contributing to cardiovascular problems. Some scientists say that the protective effect of naproxen argument is implausible, and notable that naproxen would contain to be three times as effective as aspirin to flier for the difference. While the FDA didnt buy this argument and issued a warning on all Vioxx labels, galore(postnominal) began to wonder if this was the first si gn of an unethical deception, cover-up, and manipulation by Merck. Additionally, as the label was added, Merck would later ironically cite the VIGOR study in defense of Vioxx it increased the risk only in those patients believe to be a high risk.However, Dr. Gregory D. Curfman, editor of the prominent New England Journal of Medicine state that it had solid prove that important data on cardiac events was deleted or withheld. Dr. Curfman argued that the three deleted heart attacks occurred in people who were otherwise at low risk for heart problems, which would in conclusion discredit Mercks pick out that is only increased the risk for high-risk patients. The FDAs mild warning hardly curbed the widespread use of the drug, yet Merck continued to advertise its big benefit to consumers more than any other company in 2000 (Appendx) it causes fewer cases of stomach bleeding. However, this is only a problem for a very small percentage of patients. Thus, there was turn up that hundreds of thousands of people were using the drug that didnt really benefit from its one advantage.Merck seemed to engage in deceptive marketing practices highlighting this benefit and not the immense risks to compensate for its declining financial situation, nor the fact that the drug was designed specifically for consumers that were in the high-risk gastrointestinal category. In March 2000, management first learned the results from a study of 8,100 rheumatoid arthritis patients that began to take the medication in January. The results from the Vigor study should throw off alerted management to the potential dangers and risks of using Vioxx. However, since the FDA repeatedly approved the drug, this psychologically this seemed to create the illusion that the drug was safe. While evidence was mounting against the potential risks, in 2000 alone, Merck spent $160 million in direct-to-consumer advertising, the highest that year for all drugs.FDAThe FDA has commonly been criticized for requi ring superfluous test. However, others argue that drugs are rushed through testing due to enormous pressure from the drug companies. Even afterward a drug has been approved, many of the risks are still unknown. The mild warning abandoned by the FDA seemed entirely inappropriate, an action that ultimately prolonged the use of Vioxx for consumers that were not high-risk candidates. In Mercks defense, it was promoting a product that did in fact reduce pain and gastrointestinal problems however, it omitted the crucial dilate that it increased the risk of cardiovascular problems. The FDA responded by giving Merck a warning, but ultimately, the FDA failed in its ultimate art to protect the American consumer.DoctorsThe doctors prescribing the medications failed to sufficiently research the medication and seemed to rely too heavily on the make up ones mind of Merck salespeople and/or the general public. If physicians were cognizant that only a small percentage of the population would actually benefit from the fewer gastrointestinal problems, but would expose themselves to a potentially higher risk of developing heart problems, the doctors should have at least informed the patients that NSAIDS might be a safer alternative. The risk-benefit for many patients simply was not justified. The mild warning given by the FDA did not prompt most doctors to research the warning, as fundamentally all drugs have notable risks.Doctors and patients are also usually light uponed by the psychological bushel of new drugs-these drugs are perceived to be better than existing drugs on the market. Knowing this psychological affect on consumers, the doctors may have felt pressured to prescribe the drug if consumers were asking for it after seeing the advertisements. However, Vioxx was first approved for people with a high risk of GI problems. It is estimated that only about 10% of the prescriptions for Vioxx were most likely for patients that had a high risk of GI problems the drug w as widely overprescribed and was not the optimal treatment for many patients.Patients and AdvertisingAs Merck spent over $500 million advertising Vioxx, many critics try to blame Merck for promoting a product that many believed had a risk that severely outweighed the benefit, particularly for patients without a prior history of gastrointestinal problems. An underlying problem in the case is that medicines in America are overused. some(prenominal) health problems can be avoided by a lifestyle change. Patients need to know that all medications are potentially dangerous and should be used sparingly. However, in the Vioxx case, many consumers were ultimately oblivious about the risk-benefit tradeoff, as it was not mentioned in the advertisements or consultations with physicians.Options and Solution ImplementationConsidering that Merck adheres to the philosophy of its founder, George Merck, medicine is for the people. It is not for the profits, the course of action taken by modern-day Merck executives followed a path seemingly prompt by financial pressures. The executives seemed to believe that the success of the company was heavily reliant upon Vioxx, and wanted to mitigate any negative associations the drug had with cardiovascular problems.When evidence began to come in showing a potential colligate between Vioxx and cardiovascular problems, Merck did not run any studies that attempting to reveal the cause of the negative cardiovascular results. Management should have listened to Dr. Deepak Bhatt, a cardiologist at the Cleveland Clinic, who proposed a study of Vioxx in patients with severe chest pain to Merck management. Dr. Bhatt commented at the time they Merck should have done a trial like this. If they Merck internally thought this drug was safe in patients with heart disease, there was no reason not to do it. Management never ordered a test that would directly explain the results of the clinical trial in 2000. The FDA sent Merck a warning letter for mini mizing the serious cardiovascular findings. However, a better option would have been for the FDA to put a black-box warning on Vioxxs label, or stop the direct-to-consumer advertising until the issue was sorted out.Considering Merck operates under the aforementioned motto, Vioxx was not the optimal treatment for the majority of the patients that took the medication. The patients were not cognisant of this, and Mercks aggressive marketing campaign rein agonistic the belief that this was the proper medication for all patients. Many patients were unnecessarily exposed to a risk due to aggressive marketing tactics when other NSIDS would have been the optimal medication for many patients, not to mention at a lower cost. The government should pay for tests that compare new drugs to older drugs. Many older drugs are simply ignored in promote of newer, heavily advertised drugs. Ultimately, it may take several years following approval for side effects to be exposed-a phenomena that could b e avoided altogether if this analysis is done.In addition, the patent life of drugs should be blanket(a). Obviously after this tragedy, drug makers should be required to conduct more studies, but the patent life should be extended to mitigate the pressure to rush drugs to market. Another year of testing means another lost year in terms of patent coverage, and many companies feel pressured to rush drugs to market due to the declining exclusivity period. Bringing a drug to market takes roughly 14 years at a cost of $1.3 billion. If companies are forced to go through additional testing, patent lives should be extended to ensure the incentive for future innovation. Additionally, this could help save the pressure placed upon the FDA to rush drugs to market if companies have longer exclusivity periods, allowing the FDA to conduct additional testing that could potentially prevent future problems.Communication AnalysisVioxx was a medication that was designed to alleviate the gastrointesti nal problems for high-risk patients. Vioxx was effective for these high-risk patients that did not have weak hearts. The drug should have never been prescribed to 90% of the patients that received the medication. In the end, some people who shouldnt have been winning the medication died, and the people who could actually benefit from the medication couldnt use it because it was pulled from the market. Once preliminary evidence began to mount that there was evidence of this potential link, the aggressive advertising should have stopped immediately.Management should have communicated more clearly to the physicians that this medication was primarily for high-risk patients and articulated the cost/benefit more clearly. In addition, ignoring negative evidence seemed to prove managements confirmation bias. Managements deceptive packaging of the drug to increase sales has marred the reputation of a company that may never sufficiently recover. The rigidity of management, unethical, and cr iminal behavior has tarnished a once respected name.