Merck & Company, Inc: The Recall of Vioxx Essay

IntroductionGeroge W. Merck stated at one time stated, We look for never to forget that medicinal do drugs is for the lot. It is non for the profits. The profits follow. Initi ally, rofecoxib was the blockbuster medicine that Merck engageed collect to the upcoming Zocor obvious driblet in 2006. With an estimated 27,785 heart attacks and sudden cardiac deaths that could replication over been avoided if Celebrex had been employ instead of Vioxx, Merck faces the possibility of non plainly having to hand enormous accomplished and criminal penalties, but as well losing the trust of patients. galore(postnominal) parties argon partially culpable, but Merck faces the severe uphill battle of regaining a record that once served as a market differentiator in the 1980s, Merck was voted the approximately Admired Company in American Business for seven succeeding(prenominal) years.A critical issue in this case is to analyze the events listed in the case and propose an alter nate course of action that may uphold prevent future deaths from other pharmaceutical medicines while not prohibitively restricting innovative seek that could potentially save lives if tested properly. exact Points and IssuesMerck was cussing on the achievement of Vioxx due to Zocors expiring patent and the direct competition Vioxx was engaged in with Celebrex, which had a prototypic mover advantage. While Celebrex was also a Cox-2 inhibitor, Vioxx was the only Cox-2 inhibitor proven to be beneficial for ulcers and GI shed blood. in one case studies came out suggesting that Vioxx contributed to a greater number of cardiovascular problems than naproxen, Merck seemed to opportunistically envision these results. Further much, Merck did not institute any studies that might name found ban cardiovascular results, and guidance failed to perform a strike that foc utilise specifically on the cardiovascular risk of exposure of exposures of Vioxx. Instead, Merck spent a record amount on advertising the gastrointestinal eudaimonia of the drug in a hitch of uncertainty. The advertising in the time of uncertainty is really unparalleled, and opens the door to inquiring (Appendix).Stakeholder ImpactsMerckMerck wanted to discover a drug in the Cox-2 inhibitor sept that would compete with another class of drugs known as nonsteroidal anti-inflammatory drug drugs (NSAIDS). Cox-2 inhibitors were developed to eliminate the most common side do of other NSAIDs, ulcers and gastrointestinal bleeding, as an estimated 15,000 people die from GI bleeding annually Vioxx was designed to treat those hazardous candidates. Vioxx was the only Cox-2 inhibitor proven to adopt a benefit for ulcers and GI bleeding. Thus, the blockbuster status was fashiond 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 finis to recall the drug on September 30, 2004. After Merck learned th at patients had triple the risk of heart attack or stroke than if they in like mannerk placebo and two novel 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 research worker to raise questions about Vioxx. While he concluded that Vioxx produces a risk of heart attack five times greater than naproxen sodium, some turn overd that Mercks scientists interpreted the data opportunistically by saying the oddment was due to the protective effect of naproxen, this downplayed the important possibility that Vioxx was change to cardiovascular problems. Some scientists say that the protective effect of naproxen furrow is implausible, and noted that naproxen would rich person to be three times as effective as aspirin to account for the difference. While the FDA didnt misdirect this argument and issued a warning on all Vioxx labels, some(prenominal) began to wonder if this was the first sign 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 noted that it had solid proof that important data on cardiac events was deleted or withheld. Dr. Curfman argued that the three deleted heart attacks occurred in people who were differently at low risk for heart problems, which would eventual(prenominal)ly discredit Mercks claim that is only increased the risk for high-risk patients. The FDAs modest warning hardly curbed the widespread use of the drug, yet Merck continued to upgrade 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 evidence that hundreds of thousands of people were using the drug that didnt really benefit from its one advantage.Merck seemed to engage in jerry-built marketing practices highlighting this benefit and not the immense risks to compensate for its declining pecuniary 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 medicinal drug in January. The results from the Vigor study should have 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 guard. While evidence was mounting against the potential risks, in 2000 alone, Merck spent $160 million in direct-to-consumer advertising, the h ighest that year for all drugs.FDAThe FDA has usually been criticized for requiring superfluous testing. However, others argue that drugs are provokeed through testing due to enormous jam from the drug companies. Even after a drug has been approved, umpteen of the risks are still unknown. The sonant warning given 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 detail that it increased the risk of cardiovascular problems. The FDA responded by giving Merck a warning, but ultimately, the FDA failed in its ultimate duty to protect the American consumer.DoctorsThe doctors prescribing the medications failed to sufficiently research the medication and seemed to rely too heavily on the influence of Merck salespeople and/or the general public. If physicians were sensible that only a small percentage of the population would actually benefit from the fewer gastrointestinal problems, but would expose themselves to a potentially higher(prenominal) risk of developing heart problems, the doctors should have at least intercommunicate the patients that NSAIDS might be a safer alternative. The risk-benefit for many patients evidently was not justified. The mild warning given by the FDA did not prompt most doctors to research the warning, as essentially all drugs have notable risks.Doctors and patients are also usually affected by the psychological affect 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 was widely over dictate and was not the optimal treatment for many patients.Patients and advertAs 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, especially for patients without a prior history of gastrointestinal problems. An vestigial problem in the case is that medicines in America are overused. Many 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 i s not for the profits, the course of action taken by modern-day Merck executives followed a path seemingly motivated by financial pressures. The executives seemed to believe that the success of the company was heavily reliant upon Vioxx, and wanted to mitigate any minus associations the drug had with cardiovascular problems.When evidence began to come in showing a potential link between Vioxx and cardiovascular problems, Merck did not impart 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 do 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 apologise the results of the clin ical trial in 2000. The FDA sent Merck a warning earn for minimizing the serious cardiovascular findings. However, a better option would have been for the FDA to tack together a black-box warning on Vioxxs label, or foreswear 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 aware of this, and Mercks vulturous marketing campaign rein hale the belief that this was the proper medication for all patients. Many patients were unnecessarily exposed to a risk due to vulturine marketing tactics when other NSIDS would have been the optimal medication for many patients, not to mention at a lower comprise. The government should pay for tests that compare new drugs to older drugs. Many older drugs are simply ignored in favor of newer, heavily advertised drugs. Ultimately, it may take several years fo llowing approval for side effects to be exposed-a phenomena that could be avoided altogether if this analysis is done.In addition, the patent life of drugs should be extended. 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 armorial bearing drugs to market. Another year of testing means another woolly-headed 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 nigh 14 years at a cost of $1.3 billion. If companies are forced to go through additional testing, patent lives should be extended to moderate the incentive for future innovation. Additionally, this could help alleviate 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 probl ems.Communication AnalysisVioxx was a medication that was designed to alleviate the gastrointestinal 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 taking 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 promotion of the drug to increase sales has marred the reputation o f a company that may never sufficiently recover. The rigidity of management, unethical, and criminal behavior has tarnished a once respected name.