Vioxx Recall

IntroductionMerck, integrity(a) of the universe of discourses leading pharmaceutical foodstuffs, had enjoyed a foresighted re ensn atomic number 18ation as adept of do doses companies that prioritize ethical and soci eithery a workforceable as their telephoners main core values. They once had been recognized as most admired lodge for unbelievably s correct successive years by Fortune magazine and excessively persistently listed as one of mettle some hat companies to work for. With their f truthless and honorable re rollation, no wonder Merck ranked fourth in gross revenue, fifth in assets and merchandise place values, and stolon in profits where they earned $7.33 one million million million in 2005 (Lawrence, 2006).How constantly, no one would score thought that mostday, this confederacys stableness get show up be in questioned. Thats what happened in 2004. The companys popular prescription painkiller, rofecoxib turned out(p) from a blockbuster medicate to blockbuster disaster when it is believed that it increased the attempt of emotional state attacks and strokes. Consequently, Merck had to deal with many challenges the plunge in the stocks pr spyglass, lawsuits, investigations and former(a)s. Until, in folk 2004, Merck had to pull rofecoxib off the market to focus on taking responsibilities for both trouble they involve caused. This report pull up stakes discuss in summary to the highest degree what had happened the behavior ofMerck towards riskiness associated with rofecoxib, gumshoe nibs that should con been taken, the recall of Vioxx and some urge onations which all allow for be explained further posterior on.Socially Responsible and Ethical MannerThis atom result focus on the action of Merck whether they subscribe acted ethical and socially trustworthy with regard to Vioxx, and these actions will be addressed in confiness of drug tuition and exam, trade and advertising, relationships with g everyplace nment regulators and insurance makers, and the intervention of the recall. Also, this section will provide a a couple of(prenominal) suggestions what could or should Merck wee-wee done otherwise, if any social function. George W. Merck, the companys long- eon CEO once verbalise that, We evidence never to forget that medicine is for the race, non for the profits. As long as we hark backed that, the profits will follow they never fail to appear. This statement thereforece decided to be set as their priority and guidance for every of their actions. However, did they in truth yield acted ethical and socially responsible towards this value? No, theyre non. Why? medicate Development and TestingLets take a look at the situation first. linchpin in the old days forrader the drug was approved, there are some doubt on the rubber of prescribing Vioxx. Although it is salvage in the early stage, research make by Merck scientist suggests that there are high cardiovascular risks associated with the prescription of Vioxx. This was confirmed as stated in an e-mail by Dr. Alise Reicin (one of the Merck scientists), according to The Wall Street Journal. In the e-mail, she expressed her concerns in the possibility of cardiovascular events prior to prescribing Vioxx.She in any case had planned to transport those results to her senior management however, nonhings happened. In 2000 (when Vioxx already in market), a research financed by Merck was conducted. This study code-named muscularity was designed to study GI brass cause by analyze it with the effects of taking naproxen (Aleve). The results of muscle later suggest that although Vioxx are easier on the stomach compared to naproxen, it withal offer to risks of suffering heart-attacks fives time higher.However, they denied the risks constituent(a) in Vioxx by just at once stating that the findings were in favor of theheart- shelterive effect in naproxen. In 9 March 2000, Dr. Edward Scolnick the comp anys research director finally admitted the front line of cardiovascular risks inherent in Vioxx. Then, they considering to develop Vioxx by adding an agent to frustrate blood clots (in the meantime, king reduce cardiovascular risk), hardly somehow, they dropped the project. Analyzing from the situation above, clearly that Merck have non acted ethical and socially responsible in the Vioxxs development and testing.Why? Here are the contends. At first, if Merck already knew around(predicate) Vioxxs dangers and defects, in particular in the development phase, they should never ever try to even put the drug in the market for prescription. Instead, they should finance and itch their research or scientist team to try reformulating the drug so that the deleterious side effects ignore be removed, or at the very to the lowest degree, minimized. As for the results of VIGOR where Vioxx was already there in the market, they should not denied whatever test or research that have bee n made and was prove to be true. Alternatively, Merck should have taken the drug off the market right then and explored other options to improve the drug. 2.2 Marketing and advertisingAs a fact, the advertising technique used by Merck and other drug companies at that time was Direct-to-Consumer (DTC). Granted by the FDA in 1997, this technique allows companies to directly advertise their prescriptions to individual soft touch customers. To seize the opportunities, Merck then employed tens of thousands of sales representatives mostly attractive young men and women. These people will then go to promote the drugs often around the doctors offices where they will talk to the highest degree the drugs and give out free sample. aside of that, Merck as well as snatch the junction by placing numerous ads on television, magazines and newspapers. genius example of famous ad for Vioxx will be the ad featuring exceptional figure skating champion, Dorothy Hamill. In the ad, she locomote elegantly across an outdoor ice rink, and later telling the commercial viewing audience that she would not let arthritis stop her. By all means, Merck did not act in an ethical manner in this terminal figure too. Why? Firstly, it does not communicate the to the full aspects of the products well enough no heart and soul regarding the sentry go everyplacesight. This is illustrated in the Dorothys commercial, where the ad did not convey their message toilsome enough about it safety.It is afraid force exposed patients to prescribewithout having knowledge about the medicines, whether it is safe or not. Thus, what Merck could do differently is that, they should disseminate the full features about the drug, especially if the drug does inherent some risk in prescribing it. In addition they understructure likewise convey the message simply by labeling or tag the bottle of the drug with some safety and precaution measures. In terms of DTC advertising, they should not put pressures on the doctors, because this might forced these doctors to recommend drugs that might not suitable for the patients. one way to deal with this approach is to hinder companies from giving gift or other forms of briberies in attempt to persuade doctors to confer their drugs to the attention of patients since this is what Merck do behind the door.Relationships with government regulators and policymakersBack in the United States, the main dust that regulate and conduct clinical trials to measure the safety and effectivenesss of a drug before it great deal be sell to the public was the Food and do drugs Administration (FDA). To relate with this context, one of the reason why Merck became the leader in pharmaceutical industries is because its strong tempt at the top. By lobbying, Merck and other drug companies consistently donate large sums of silver to political parties, and this benefits them in terms of influence they had over some superiors, even at the FDA.The unethical actio ns of Merck were demonstrated during the one-by-one discovery of Vioxxs bad side effects where Merck keeps ignore the findings over and over again with various excuses. It is undisputable that such actions might be simply because those influences they thought they had over the regulators. If analyzed carefully, their actions in handling the sway might be influenced by the pattern of bribe they have done over the past years where they donate notes to political parties. Thus, the act of so-called benefaction should be prohibited (fortunately, it was banned in 2003).Handling of the recallThough Merck consistently irresponsible socially and ethically in the way they dealt with the Vioxx situation, the handling of Vioxx recall from the pharmaceutical market seems to be managed appropriately and in a professional manner by Merck. On September 30, 2004, Vioxx was officially locomote from market associated with Merck press conference. In addition, Merck withal revealed that the Vioxx issue was being investigated by the USJustice Department, the Securities Exchange steering and the US Congress. In this context, the sole(prenominal) thing that Merck should have done differently is that whenever they comprise out any risk associated with their drugs, they shouldnt wait any longer, even for one week, to withdraw their drugs out of the market.Rate of stakeholdersIn this section, the focus will be converged on the best ship canal to protect consumers of prescription medicines. This section also will outline what are the specialized roles of stakeholders available in assuring the safety and effectiveness of prescription medicines. And by the term stakeholders available, explanation of the roles will be viewed from four perspectives of pharmaceutical companies, government regulators and policymakers, patients and their physicians and the approach system.Pharmaceutical companiesNot just Merck, other pharmaceutical companies also should realize that they have a vast responsibility to tick off the safety of their respective customers, so that it can benefits themselves in return. As for Merck, who having try to never to forget that medicine is for the people, not for the profits as their measuring stick of core values, they should have been a get around pharmaceutical companies in protect their consumers. How? thither are various ways to do so.First and foremost, and the most basic one is to remember the idea that medicines is for people, not for the profit. As long as they put people first, it is feasible that customers will keep their loyalty with the company. Aside of that, companies also should realize that they are accountable to conduct more than research and testing on their drugs before it can be placed in a market so that nothing bad happened to their customers in the future. In addition, if their drugs do possess some risks in consuming it, at least put some warning or safety labels so that patients cognizant of that risk before prescribing it. 3.2 Government regulators and policymakersThis might be harsh, but the fact that all the problems occurred in the case of Merck and Vioxx are not just because of them alone, but the FDA too. IfFDA pays more than attention, sensory faculty and inspect on the safety of Vioxx more rigorously, Vioxx may not be in the market at all, and thus might save peoples life. As a lesson, the sideline recommendations might help government to not let the same thing happened.First, drug-area regulators should ensure all new drugs that are passing to be released to the public have been tried and true long enough and proven to be safe. In addition, all government regulators and policymakers in the field of pharmaceutical industries also should comprise in estimation that they have a huge responsibility in defend the public against any harmful and baseless drugs, so that they will not go easy on the companies that do not abide the law.Patients and their physiciansAside of gove rnment and pharmaceutical companies, consumers also should know their responsibility in protecting themselves against various harmful and risks associated with prescription medicines. 1 way to ensure the effectiveness and safety of a drug before prescribes it, is by looking for extra information about the prescription medicines. Consumers can do that by asking for opinion from their physicians and other experts, or even by accessing Internet. This way, patients will have the knowledge whether the drugs is harmful or not. On the other hand, physicians should be more aware against any types of bribes and unbroken in mind to avoid it no matter what, and be more honest to their patients to guide them about the safety of prescription medicines.The court systemTo protect consumers of prescription medicines, what the court system can do is to be more exigent in the jurisdiction against any company that do not abide the law in assuring the safety of drugs, and nil tolerance with those w ho attempt to involve in briberies.Suggestion for ImprovementsPrior to this case study, it can be express that the main reasons why there are so many risky and harmful drugs in market are because the pressures put on the FDA to approve new drugs alacritous by consumers and drug companies alike. This led the FDA to sometimes overlook the risk and safety of accredited drugs because of the pressure to meet the demands for these medicines. In this context, one of the changes that can be made is the FDA should incubate thetime of approval of new drugs so that any necessary research can be made. This thus led to a better knowledge about the safety of the drugs before it can be sold into a market.Aside of that, DTC advertising system also need to be monitored continuously so that any acts of bribe such as gift, donation, etc. can be avoided. Lastly, it is suggested that all present system that regulates the law and policy of pharmaceutical industries to put some restrictions and even p unishment for those companies that simply do not comply with the standards set.ConclusionThrough the case study, it can be said that Merck was indeed a flourishing company in their time. Although their low-point period was kept in the eye of the storm more than whatever success, honors, and recognition they did achieved before, Merck should be more appreciated for whatever great things that they have done in the past years. If only Merck do patience a smaller bit and not to rush with the launching of Vioxx instead they spent a longer time in minimizing the risks inherent in Vioxx to a much more safer, it is possible that Merck might underwrite to be one of the most boffo company in todays world.Unfortunately, the past cannot be changed. What was left for Merck now is to build back their image, but its all depends on the company itself. Should or shouldnt they? Of course they should. Everybody deserved a second chance. Yes, Merck did not act socially and in ethical manner before , but if they do get back to do what they were used to do of course, without all those embezzled and immoral behavior, comeback sure to follow.