Chapter 21 Questions 1 through 7 1. On balance, do you think Merck is an ethical and socially responsible company? Why or why not? How about Pfizer? In my opinion, Merck is not an ethical and socially responsible company with introducing Vioxx into pharmaceutical market. Before the Vioxx approval by FDA, scientists from University of Pennsylvania found that the drug could bring some serious results such as cardiovascular, and there were many serious cardiovascular problems during testing on patients. However, Merck ignored these negative effects, kept developing Vioxx was order to get ample profits.
At the same time , through “Direct-to-consumer advertising”, Merck made customers believe Vioxx that was safer and more effective than other same products. So, I do not think Merck is an ethical and socially responsible company. Pfizer is not an ethical and socially responsible company. Pfizer refused to take Celebrex off the market when Vioxx had been recalled, even Celebrex had same problems with Vioxx. Prizer wanted to take this chance from big trouble in Vioxx to occupy more market share despite Celebrex can be result in health-attack risks.
How could the disaster with Vioxx have been avoided in the first place? First of all, in my opinion, Merck should listen carefully to suggestions from scientists who are from university of Pennsylvania, which is that Vioxx would lead to heart attacks and strokes. At that time, Merck should be aware of risk of health for people, and redevelop Vioxx. Moreover, as local government, they should control and monitor pharmaceutical advertising, avoid customers being tricked through fake data from this kind of pharmaceutical advertising. 3. What is your opinion of pharmaceutical advertising?
Firstly, this kind of pharmaceutical advertising in terms of direct-to-customer can improve patient awareness to drugs. For instance, a person with disease does not know that there are some drugs that can cover and reduce pain, however, they could watch TV advertisement to know these drugs. This kinds of Ad not only bring more profits for pharmaceutical companies, but also make people increase health awareness. However, there are some disadvantages about DTC. Most of DTC advertising hide risks from drugs, only 26% of the ads mentioned risks or causes of the condition.
Besides, some ads overemphasize drug benefits to patient. According to Journal of Health Communication (2009), the average DTC spend too much time on descripting benefits than risks. Therefore, in my opinion, DTC is not the best way to propagate drugs. Relative departments need to monitor the effectiveness of drugs based on relative advertising, and tell customers what are the right drugs and what is the wrong things. 4. Discuss the idea of relative risk. What is the significance of it for the drug firm itself, for the FDA, for tort lawyers, and for the consumer?
Drugs always have side effects which are positive and negative. Product Vioxx is painkiller. Many patients are taking benefits from this product; even though it raises the risk of heart attacks. For drug firm, the relative risk might cause them in lawsuits. It would destroy their reputation in the market. On the other hand, if the drug firm takes the relative risk reasonably, they mention the risk for their customers before they take the product. It might reduce the lawsuits for the firm itself, but it would also cut many sales from the market.
For the FDA, it is an agency of the United States Department of Health and Human Services, one of the United States federal executive departments. The FDA is responsible for protecting and promoting public health. This department’s job is to protect the customers’ benefits from food and drugs. However, in this case, FDA says it wasn’t currently planning to seek new regulatory authority for the ability to suspend the drug safety issues. And it would require changes in the law. Therefore, they should set an appropriate board for approved drugs so that the total benefits should be absolutely higher than harm for the customers.
For tort lawyers, these relative risks are enriching lawyers and destroying the pharmaceutical industry through an excess of litigation and reactionary over regulation. Thus, tort lawyers are taking a lot of benefits from cases happened because of these relative risks. For the consumers, customers should always be aware with the side effects from taking drugs in a long term. They should balance the benefits and harm for their health; and make decision after doctor’s suggestion. 5. Do you think Merck CEO Gilmartin acted wisely in recalling Vioxx?
Why or Why not? We don’t think Merck CEO Gilmartin acted wisely in recalling Vioxx. First of all, Vioxx was taking a large share in the market. It increased huge sales for the company. Product Vioxx was in the market for a while; many customers were taking benefits from the product. Since the huge of sales, we could easily tell this product meets the customers’ needs. Since the controversy happened, Vioxx would raise the risk of heart attacks. However, it was not absolutely proved that the drug is the direct factor to cause the heart disease.
In case, it says “the drug shows no risk by several other studies. ” Therefore, if Gilmarin recalled the product, it means the company admitted the factor of risk in heart disease for Vioxx. Customers would start to question other Merck’s products, so it would hurt other products for Merck. Merck lost market shares and reputation in the future. Oppositely, if they did not recall Vioxx, the company should put more studies to prove it is not the direct factor for heart disease. However, drugs always have side effects.
So the company should let customers notice the negative effects for taking the drugs first, and keep researching an edition of Vioxx to reduce the risk of heart disease. It might save the company from that mess. 6. “The more than $10 billion Merck has hoarded attests to the obscene profits these drug companies are making at our expense,” a consumer advocate speaks up. Evaluate this statement. Drug industry is very profitable because of the high risks and a certain amount of customers. A successful new product would make a lot of profits for drug companies.
However, drugs have side effects, it might potentially cause negative health problem for human beings. Even though there are 95% of customers are having benefits from the drugs, those 5% of customers who are not happy with these drugs would complain. On the other hand, drugs are relatively expensive for customers. Health concerning is always the important demand in people. Therefore, customers would love to pay any price, if these drugs could take care of their health problems. This statement basically shows the pharmaceutical industry is strongly losing credits from their customers. 7. The FDA is in the pocket of the drug industry. What a travesty this is. ” Comment. FDA is supposed to control the drug industry and support the drug safety for consumers. However, in the real world, there are many issues happened every day; and FDA can’t really control it and fix it. Drug industry could always find a way to pass FDA without against the law to make huge obscene profits from their customers. “FDA has the authority to force the removal of a drug from the market, but only if the product is an imminent health hazard, which might take years to go through the legal process. Mostly products will not have health hazard in the market. They might have different factor of risk for people’s health potentially. Therefore, it would be a hard job for FDA to control every product in the market for a clear board; and also it would be a huge expense for FDA to do that since every department has its limited budget. Thus, the government should reset the regulation for drug safety issues. On the other hand, drug companies should act more ethically so that the total benefits would increase for the whole society. Questions in Information Boxes on Pages 342 and 346 P342.
Does this sound like the new board will be the answer for drug safety? Why or why not? The new board involves in the postmarket regulatory services. It would provide more safety of drug utility if it runs efficiently, but it is far away from preventing the massive harm caused by the medicine with serious side effects. Obviously, the board’s role is to continue making sure that the drug is safe and effective after the drug is approved and sold on the market. Because not all side effects can be discovered in the trials process. Some of the ill effects only appear after taken in large doses and over long term.
To observe the market effective to improve product safety and the public health, the board inspects the report of all serious and unexpected adverse reactions from the manufacturers, clinicians and patients. But it lacks of the authority to pull drugs. In the case, it is fairly wired to see that the Celebrix, a comparable drug to Vioxx can still be sold in the market, even though there are some evidence indicated that Celebrex increased patients’ risk of heart attack and stroke about 20 percent. The board needs more authority to perform better.
On the other hand, it is more important to prevent the drugs with ill effects to appear in the market than withdrawn them after a considerable amount of usage. The FDA should devote more effect to make sure that the safety of the drugs in the market. It is easy for the company to stimulate the customers to become the users of the drugs by performing more promotion. If these drugs have serious side effects, they would impose risk to tremendous amount of people. So the FDA needs to be more effective, neutral, and strict to control both the Premarket approval and postmarket surveillance. P346.
Do you think these practices need to be curbed? If so, what would you recommend? In my opinion, all these practices should be curbed. The financial relationships increase the possibility of potential conflicts and compromising of the patients’ interests though it is legal. Their interaction causes questions about the influence of drug companies on prescribing patterns and research results. It is more possible for doctors to prescribe the drugs they are familiar with than those they have never heard of. When the doctors give speeches for the companies or the drugs, it would make the patient believe that the drugs are safe and effective.
The little gifts and free samples are not for buying their souls but for creating the familiarity and comfort with the drugs. The doctors become a perfect marketing tool because of their profession and authority. Most of the doctors are able to assess the quality of the research accurately, but it is still possible that the interaction between doctors and drug companies would diminish the credibility of their report to the drugs and the clients’ action, which would hinder the process of creating new drugs.
To appropriately manage the conflict of interest and influence what drugs doctors give their patients, the marketing practices between drug companies and doctors should be 100% transparent. It also needs to enclose the financial relationship to the patients to help them better evaluate the medicines. Invitation to Research 1. What is the situation with Merck and Vioxx today? Merck, currently, is still big company in the world. During 2011, Merck deserved some awards through their social activities. Vioxx is a good drug in the market. 2.
Has Merck made any large acquisitions? Yes. In 2006, Merck took over Serono S. A. , a Switzerland’s largest biotech firm, for $13. 2 billion, and make it 7th among pharmaceutical/biotech companies. In 2009, Merck acquired Schering-Plough, the world’s largest producer of oral contraceptives, for $41. 1 Billion. In 2010, Merck acquired Millipore Corporation, an international biosciences company known widely for its micrometer pore-size filters and tests, for $ 7. 2 billion. 3. Is Pfizer’s Celebrex still on the market, or has it been recalled? Yes, it is still on the market. . Has the FDA’s new oversight committee been effective in improving drug safety? Yes, the FDA’s new oversight committee been effective in improving drug safety. After this controversial event, more and more people paid attention on the drug safety. The mainstream Medias, medical magazines, some organizations that protect the right of customers, even lawmakers and the staffs inside FDA were all focused on the authoritative organization FDA, and waiting for how it respond such an event and how to prevent similar events happening again in the future.
In the past, FDA over trusted the reputation of some famous and renowned companies. Even though the examine process was strict before the medical launched, the oversight would disappear or being relaxed once the medical appeared in the market. After the recall of VIOXX, the new oversight committee began to strength the monitoring on drug safety after the launch of any medical in order to make sure that no more similar event happens. 5. Has the drug industry made any inroads in improving its public image? Yes, the recall of VIOXX has inroad the public image of drug industry.
First of all, for customers, such kinds of events would reduce the trust about drug safety. Customers would be hesitating when they choose which kind of medical to use and everybody would be afraid of getting sick. Furthermore, for the users such as hospitals and doctors, they would be confused when they take care of some patients. If some medical accidents happen, the responsibility could be hardly to identify. 6. Has consumer advertising by the drug industry been curtailed? How about massive marketing expenditures to doctors? No. The consumers were still being advertised by the drug industry.
Because the drugs were the necessities in people’s daily lives, and the only ways for customers to recognize the drugs were advertisement and the recommendation of doctors. In my opinion, the massive marketing expenditures to doctors could be the interaction between the representatives of drug companies and the gifts for doctors. The representatives of drug companies always try to recommend the latest and most expensive products for doctors even though the products are not the best ones. In addition, the gifts for doctors are used to persuade the doctors accept their drugs.
Cite this Pharmaceutical Industry and Drug
Pharmaceutical Industry and Drug. (2016, Nov 07). Retrieved from https://graduateway.com/pharmaceutical-industry-and-drug/