Chapter 21 Questions 1 through 7: On balance, do you believe Merck and Pfizer are ethical and socially responsible companies? Provide reasons for your answer.
In my opinion, both Merck and Pfizer are not ethical and socially responsible companies. This is evident in the case of Merck’s introduction of Vioxx into the pharmaceutical market. Scientists from the University of Pennsylvania discovered potential serious cardiovascular effects of the drug during testing on patients even before FDA approval. However, despite these findings, Merck disregarded the negative effects and continued to develop Vioxx solely to maximize profits.
Both Merck and Pfizer exhibit unethical behavior and a lack of social responsibility. Merck employed the tactic of “Direct-to-consumer advertising” to deceive customers into thinking that Vioxx was superior in safety and effectiveness compared to similar products. This deceitful marketing approach severely damages their ethical standing. Similarly, Pfizer chose not to withdraw Celebrex from the market despite being aware of its problems, mirroring the situation with Vioxx. Rather than prioritizing consumer well-being, Pfizer’s primary objective was to expand their market share by exploiting the circumstances. Regrettably, this decision poses potential health hazards for consumers.
How could the disaster with Vioxx have been prevented initially? In my perspective, Merck should have attentively heeded the advice of scientists from the University of Pennsylvania, warning that Vioxx could result in heart attacks and strokes. During that period, Merck should have recognized the potential health risks for individuals and taken steps to reformulate Vioxx. Additionally, as a local government, they should have regulated and supervised pharmaceutical advertising to prevent consumers from being deceived by false information. 3. What are your thoughts on pharmaceutical advertising?
Firstly, direct-to-customer pharmaceutical advertising has the potential to enhance patient awareness regarding medications. For example, individuals suffering from an illness may be unaware of certain drugs that can effectively alleviate pain. However, through television advertisements, they can discover these drugs. Furthermore, these advertisements not only generate greater profits for pharmaceutical companies but also contribute to the improvement of public health awareness. Nonetheless, there are drawbacks to DTC advertising. A majority of these advertisements fail to disclose the risks associated with the advertised drugs, as only 26% mention the potential side effects or causes of the condition.
In addition, the Journal of Health Communication (2009) asserts that certain advertisements excessively emphasize the advantages of drugs for patients. It is highlighted that direct-to-consumer advertising focuses more on describing the benefits rather than the risks of drugs. Consequently, I hold the belief that DTC is not an optimal approach for promoting drugs. It is necessary for relevant authorities to monitor drug effectiveness through associated advertising and educate consumers about suitable medications and practices to avoid. Additionally, it is important to analyze the concept of relative risk and its significance for drug companies, the FDA, tort lawyers, and consumers.
Despite the fact that drugs usually generate both positive and negative outcomes, like Vioxx – a painkiller that offers advantages to numerous patients despite the increased likelihood of heart attacks – this heightened risk could result in legal consequences and harm the pharmaceutical company’s reputation in the market. Nevertheless, if the company discloses the comparative risk to customers before product usage, it may diminish lawsuits against the firm while simultaneously decreasing sales.
The FDA, also known as the Food and Drug Administration, is under the United States Department of Health and Human Services. It functions as a federal executive department with its primary aim being to safeguard and promote public health. Its main focus is on protecting consumer interests in relation to food and drugs. However, regarding concerns about drug safety, the FDA affirms that it currently has no intentions of seeking additional regulatory authority to suspend such matters. In order for this action to occur, changes would need to be made to existing legislation. Hence, it is crucial for there to exist an appropriate board tasked with evaluating and approving drugs while ensuring that their benefits outweigh any potential harm they may pose to consumers.
Tort lawyers are benefiting from the litigation caused by relative risks, which is negatively affecting the pharmaceutical industry. However, consumers should be cautious of the long-term side effects of drugs and consider their overall health before making decisions, ideally after consulting with a doctor. In relation to this, do you think Merck CEO Gilmartin made a wise decision in recalling Vioxx?
Despite the controversy and potential heart attack connection, Merck CEO Gilmartin’s decision to recall Vioxx was considered unwise. This is because the drug had a significant market share and generated substantial sales for the company. Additionally, it had been on the market for a long time, providing many customers with positive outcomes. Sales data demonstrated that Vioxx effectively met customer needs. However, there was no conclusive evidence establishing a direct relationship between the medication and heart disease.
Multiple studies have demonstrated that the drug poses no risk. However, a recall by Gilmarin would suggest their acknowledgment of a potential association between Vioxx and heart disease. This could raise doubt among customers regarding the safety of other Merck products, potentially harming the company’s reputation and market shares. Conversely, if Vioxx is not recalled, Merck would be required to conduct further research to confirm its absence of direct correlation with heart disease. Nevertheless, it is crucial to acknowledge that all medications carry side effects.
The company should communicate with customers about the initial negative effects of taking the drugs and also allocate resources to research a version of Vioxx that reduces the risk of heart disease. This action has the potential to assist the company in overcoming its present situation. According to a consumer advocate, “Merck’s accumulation of over $10 billion demonstrates the excessive profits these pharmaceutical companies are earning at our expense.” Let’s examine this statement. The pharmaceutical industry is highly lucrative due to substantial risks involved and a steady customer base. When a new product succeeds, it can yield significant profits for drug companies.
Despite the potential negative health effects of drugs, the majority of customers actually experience benefits from them. However, there is a small percentage of unsatisfied customers who may voice complaints about these drugs. Moreover, for customers who are willing to pay any price for effective treatment, drugs can be quite costly. As a result, the credibility of the pharmaceutical industry with its customers is declining. Some comments even suggest that the drug industry influences the FDA in a disgraceful manner.
The role of the FDA is to regulate and ensure consumer safety within the drug industry; however, it often faces challenges in controlling and rectifying issues. The drug industry frequently finds ways to bypass FDA regulations and make profits without technically breaking the law. Although the FDA has authority to remove hazardous drugs from the market, this process can take years. Most products on the market do not pose immediate health hazards but may still have potential risks.
Effectively overseeing every product on the market and ensuring safety becomes a challenging task for the FDA due to limited funds in each department. Therefore, it becomes crucial for government authorities to reconsider drug safety regulations while taking into account these factors.
To address pertinent inquiries, please refer to the Information Boxes on Pages 342 and 346.
In order to maximize societal benefits, it is important for drug companies to behave ethically.
Can the new board effectively address drug safety concerns? Although responsible for postmarket regulatory services, its potential to enhance drug utility safety is limited in preventing significant harm from medications with severe side effects. The board’s main objective is to ensure the safety and effectiveness of drugs after approval and market entry, as clinical trials may not detect all side effects. Some adverse effects only manifest when taken in high doses or over a prolonged duration.
The board’s role is to examine reports of severe and unexpected negative responses to medical products from manufacturers, clinicians, and patients in order to improve public health and product safety. However, it lacks the authority to withdraw drugs from distribution. It is worrying that Celebrex, a medication similar to Vioxx, continues to be sold despite evidence suggesting a 20 percent increase in the risk of heart attack and stroke for patients. The board requires greater power in order to enhance its efficacy.
Ensuring drugs with harmful effects do not enter the market is more crucial than removing them after prolonged usage. The FDA should prioritize guaranteeing the safety of existing drugs available to consumers. Companies have the ability to promote their drugs effectively, potentially leading customers to use them. However, if these medications possess serious side effects, they can endanger a significant population. Consequently, the FDA must establish a more efficient, unbiased, and stringent control over both premarket approval and postmarket surveillance procedures.
In my opinion, all of these practices should be curbed as they can increase the possibility of potential conflicts and compromise the patients’ interests, despite their legality. The financial relationships between doctors and drug companies lead to questions about the influence on prescribing patterns and research results. It is more likely for doctors to prescribe drugs they are familiar with rather than unfamiliar ones. Additionally, when doctors give speeches for drug companies or specific drugs, it can create a perception of safety and effectiveness in patients.
The aim of providing small gifts and free samples is not to manipulate doctors into endorsing drugs, but rather to create a sense of familiarity and comfort with the products. Doctors, because of their profession and authority, can be an effective marketing tool. Although most doctors are capable of accurately assessing research quality, their interaction with pharmaceutical companies could undermine the credibility of their reports and impact clients’ subsequent actions. This may hinder the progress of new drug development.
Complete transparency in marketing practices between pharmaceutical companies and doctors is crucial for effectively resolving the problem of conflict of interest and influence in drug prescription. Additionally, it is vital to disclose financial relationships between doctors and patients to enable well-informed decisions about medications. The text encourages further research on the current status of Merck and Vioxx, a globally recognized company known for commendable social initiatives in 2011. Furthermore, it emphasizes Vioxx’s favorable market position as a high-quality drug.
Merck has made several significant acquisitions. In 2006, it acquired Serono S. A., the largest biotech firm in Switzerland, for $13.2 billion, making it the 7th largest company in the pharmaceutical/biotech sector. Later, in 2009, Merck purchased Schering-Plough, the leading global producer of oral contraceptives, for $41.1 billion. Additionally, in 2010, Merck bought Millipore Corporation for $7.2 billion; a well-known international biosciences company known for its micrometer pore-size filters and tests.
Pfizer’s Celebrex remains on the market without any recalls.
The FDA’s new oversight committee has significantly improved drug safety measures. After a controversial incident occurred, various entities such as mainstream media outlets, medical magazines, customer protection organizations, lawmakers and even FDA staff have shown increased interest in the regulatory actions taken by the authoritative organization FDA to prevent similar incidents from happening again in the future.
In the past, the FDA placed too much trust in the reputation of certain well-known companies. Although the examination process was rigorous before a medical product was released, oversight would diminish or become more lax once the product was available on the market. Following the recall of VIOXX, a new oversight committee was established to strengthen monitoring of drug safety after the launch of any medical product, ensuring that similar incidents would not occur again.
Has the drug industry made any progress in improving its public perception? Yes, the recall of VIOXX has negatively impacted the public perception of the drug industry.
In the first place, these events would decrease customers’ trust in the safety of drugs. Customers would be uncertain when selecting a medical option, and everyone would fear falling ill. Additionally, hospitals and doctors who rely on these medications would face confusion when treating patients. If medical accidents occur, it would be challenging to assign responsibility. 6. Has the drug industry restricted consumer advertising? What about extensive marketing spending on doctors? No, consumer advertising by the drug industry remains unchanged.
Due to the importance of drugs in daily life, customers relied on advertisements and doctors’ recommendations to identify them. In my view, the substantial marketing expenses directed towards doctors may involve interactions between drug company representatives and the provision of gifts. These representatives often attempt to promote the newest and priciest products to doctors, even if they may not be the most superior options. Furthermore, gifts are offered to persuade doctors into accepting their drugs.
