The twenty-first century has seen pharmaceutical companies grow in unprecedented size and strength. Due to the unprecedented growth the larger pharmaceutical companies have gained leverage and power in the prescription drug industry, but they lack innovation to market and they seek ways to help the business continue to increase its profits. The pharmaceutical industry was once ethically sound and was a valuable player in the development of human health. However, overtime with the lack of innovation pharmaceutical companies are becoming an unethical market that exploits patients, doctors and anyone else it can to increase its profitability.
With eyes only on profitability this can create a hazard for patients because there is deficient testing of the drugs prior to the drugs hitting the American market. In this research paper we will cover the many facets of PharmaCare, Coleria, and Wellco and the drug AD23 side effects, and its manufacturing in an impoverished nation with the low wages and unsafe working conditions. All of which will be covered throughout this document. Marketing and Advertising The Food and Drug Administration relaxed the regulations regarding the need to advertise the side-effects of prescription drugs in 1997. (FDA)
The relaxed regulation allows for direct-to-consumer advertising and this change the marketing strategies. There is now an influx of pharmaceutical advertising using infomercials. Gary Humphreys informs us in his article, “Direct-to-Consumer Advertising Under Fire”, that pharmaceutical companies “spent just under $5 billion last year alone” (576) on this type of advertising. The infomercials somehow make consumers believe that there is a need for them to have the drug and therefore create an increase in its sales.
Because consumers have a desire to take control of their health they are now going in the doctor’s office and telling the doctor’s about the infomercial and the drug that they would like to try. However, consumers are not aware that they prescription drug companies are not required to share all of the side-effects of the drugs and it may cause serious health problems when consumers can ask for drugs by name. According to the Centers for Disease Control and Prevention prescription drug abuse is not an epidemic. The high use of prescription drugs has led to a decrease use in illegal drugs.
In the United States it is common for Medical Doctors to receive a sales pitch from a drug company regarding their prescription drugs and highlight the many benefits of it as well. This is target marketing in which drug companies are targeting those in the medical field and those that are most likely to offer the product to a consumer and in turn this will lead to an increase in drug sales. This practice leads to questions related to medical ethics in the industry. Intellectual Property Protection The laws and regulations have strengthened the intellectual property protection of branded drugs.
One of the primary reasons for the Intellectual Property Protection was to get the pharmaceutical world thinking and give incentives for those who are being innovative. Products can be fixed for a specified time frame if they have a patent; what this means is it eliminates any direct competition which in turn allows the inventor to set the price of the drug and many times they are charging top dollar. The inventor is trying to recoup all money spent on the creation of the drug while also making a hefty profit.
The Intellectual Property Protection have increased patent life of approximately 50 percent of all drugs from 1980 to present which contributes to prescription drug spending. A 1998 Congressional Budget Office (CBO) study showed that manufactures tend to introduce new branded drugs at premium prices, and then raise these prices. The study found that even after similar branded products enter the market, drug companies often continue to increase the price. The ethical issue is because when the patent is lengthened it delays the entrance of less expensive generic drugs.
And as a result the branded drugs dominate the market and the cost is passed down to the consumer. Regulations and Product Safety The Federal Food, Drug Administration is responsible for establishing the Code of Federal Regulations which outlines the rules and regulations governing pharmaceuticals. The rules are divided into sections and include guidance based on drug categories. Due to each person having varying reactions to pharmaceutical products not all side-effects are detected during clinical testing.
The Federal Food, Drug Administration is responsible for sharing the information with consumers. However, it seems a bit unethical because the large pharmaceutical companies do not have to share all of side-effect information that may assist consumers in making its choice on whether to try a product or to not try a product. Through various survey’s it was discovered that consumers are under the opinion that pharmaceutical companies need to have improved internal controls to ensure their compliance with regulations.
Due to physicians and pharmaceutical companies working together and are dependent on one another there needs to be controls in place that would have an unbiased view of the regulations. The government will need to continue introducing new regulations that will aide in monitoring the relationships. Direct-To –Consumer Marketing Direct to consumer is a form of advertising that markets directly to consumers bypassing the distributor. In the mid 1980’s pharmaceutical companies provided information about prescription drugs to doctors and pharmacists.
The Federal Drug Administration (FDA) allowed print ads to run and the pharmaceutical companies had great success and were then permitted to begin running advertisement on television. Currently over $5 billion is spent annually to present this advertisement to the American public via direct marketing print ads, television broadcast, and online. There is an issue with this is that the FDA does not voluntarily monitor these ads and the advertisement may actually be misleading and the American public may not be aware that the ad did not pass the FDA check.
The Office of Prescription Drug Promotion (OPDP) is required to take action against ads that violate the law and are required to take action along with communicating information to consumers and employees in the health care industry. Prescription-drug ads prompt nearly one-third of Americans to ask their doctors about an advertised medicine, and 82% of those who ask say their physicians recommended a prescription. The findings in a national survey by USA TODAY, the Kaiser Family Foundation and the Harvard School of Public Health come as drug advertising hit a record $4. 8 billion in 2006, up from $2.6 billion in 2002.
“Our survey shows why the drug companies all these ads: They work,” says Drew Altman, president of the Kaiser Foundation. “Many people get drugs they otherwise wouldn’t. While there’s a debate about whether that’s a good thing for patients, it does cost the country more. ” Among people who requested a drug, 44% said physicians gave the one they asked about, while slightly more than half said doctors prescribed a different drug. Sometimes, doctors did both. When duplicate answers were removed, the poll found 82% of patients got some type of prescription. (USA Today)
I would make the argument against Direct-to-Consumer marketing although it seems to be is working and putting the choices back into the consumers’ hands. My argument against the direct-to-consumer advertisement is simply because consumers are not being provided all the necessary details about a product. Drug makers are ignoring the guidelines that apply to consumer education and are highlighting only a few on the many side-effects. Consumers often will not take into consideration doctor’s recommendations also because they visit their doctor with hopes of gaining the same results as what was shown in the marketing ad.
The many infomercials seem to favor male enhancements drugs such as Cialis and Viagra which can confuse children if they, see the infomercial. It should be the responsibility of physicians to determine the proper medications for their patients. Compounding Pharmacy Regulators Generally, state boards of pharmacy will continue to have primary responsibility for the day-to-day oversight of state-licensed pharmacies that compound drugs in accordance with the conditions of section 503A of the FDCA, although FDA retains some authority over their operations.
For example, the adulteration or misbranding of drugs compounded under section 503A, or false or misleading statements in the labeling or advertising of such drugs, may result in violations of Federal law. Firms that register with FDA as “outsourcing facilities” under section 503B will be regulated by FDA and inspected by FDA according to a risk-based schedule. (FDA) In the PharmaCare scenario should have enacted the Prescription Drug User Fee Act (PDUFA) of 1992 earlier. According to Forbes magazine, to solve this problem, Congress enacted the Prescription Drug User Fee Act (PDUFA) of 1992.
PDUFA provided a mechanism whereby charges were levied on pharmaceutical companies for each new drug application (NDA) filed. The revenues from these “user fees” were used to hire 600 new drug reviewers and support staff. These new medical officers, chemists, pharmacologists, and other experts were tasked with clearing the backlog of NDAs awaiting approval. Consequently, the FDA was able to reduce review times of NDAs to 12 months for standard NDAs and to 6 months for priority applications that involved significant advances over existing treatment.
As a result of PDUFA, the timing of U. S. drug approvals began to mirror that of the rest of the world. (Forbes) If the Act was in place the pharmaceuticals would have been reviewed sooner and it could have possible saved lives. Utilitarianism: The ethical theory of Utilitarianism would state that any decision concerning business conduct should be proper and the decision that is made should be best for the greatest number of people. When looking at the PharmaCare scenario did not allow all stakeholders the option to take into consideration the drug that they were providing to them.
It would seem as though the management team and Coleria focused only on the thought and idea that the pharmaceuticals would produce more good than harm or bad consequences and in this case if they had gambled they would have lost. They continued to sell that drug with a thought process that the drug was helping more people than hurt with only a small number of people affected by side effects therefore it justified the need to continue producing and distributing. Deontology: The deontological ethics places morality and moral laws as a standard in which people should make their decisions.
The process used by PharmaCare and Coleria did not follow deontology because although the company and its management staff was aware of the side effects of the drugs being made and the numerous deaths that were caused they did nothing to stop its production. They were more concerned about the profits they were gaining and did not take into consideration the moral outcome. PharmaCare or Coleria did not treat consumers as they would like to be treated therefore we know that PharmaCare and Coleria did not operate under the ethical values of deontology.
Virtue ethics: Virtue ethics suggests that helping people is a good charitable and kind thing to do. The virtue ethics although seem as though they would be the same as deontology it differs because it focuses in the motives a moral character and emotions in our moral life. The management team at PharamaCare or Coleria did not seem to consider the virtue ethics at least not to those that worked with them. The virtue of honesty was absent in its transactions and the way that business was done.
Something that is important to a person that is operating under virtue ethics they consider the actions of what they are doing and honest people would not do dishonest acts intentionally because they would have believed that honesty is the best practice. Ethics of care: Pharmaceutical companies have a duty to provide medicines to both the physicians and the consumers that will address the health needs of its patients in a safe manner with little to no side effects. PharmaCare and Coleria again did not accomplish this simple duty of care. The company provided a medicine that caused great harm and even death to some in order to earn a few extra dollars.
There was a huge conflict of interest between the PharmaCare, Coleria and the consumers who needed the medications because there was a duty to share the side effects, there was a duty to provide additional testing on the medicine and there was a duty to discontinue the manufacturing of the drug when the drug failed to do what consumers needed. The health of the consumer or patient should be presented to them completely free of bias or potential for bias and consumers should not be misled. Your own moral/ethical compass:
PharmaCare and Coleria had a moral and ethical duty to do what was right and in my opinion that did not adhere to any moral ethical standards in their business transactions. Their lies and misleading strategies hurt those that needed them and those that were in a vulnerable condition. There were many people that requested, believed in, and should have benefited from a medicine that would help them lead a more fulfilling life and in some instances it ended their lived prematurely. PharmaCare and Coleria were obligated to share with consumers the main risks that were associated with taking the drug.
When considering the moral and ethical questions in some instances when thinking of the case it swayed even in mid-thought on occasion. The thoughts went from what would I do if I were in need of the medication would I want to take it and risk the side effects because of a promise of improved health. Or would I pass on taking the drug and continue suffering with my illness. I was under the thought that although many died that had it not been for the large profits that the pharmaceutical companies received, that it would have been simply said that they were improving humanity and the quality of life.
There is no agreement with the steps that were taken and it seems a bit unfair for many, it was not the proper thing for PharmaCare and they should have discontinued the use and production of the drug until testing and improvement was done. PharmaCare/Coberia – Intellectual Property law The generous laws in the United States regarding Intellectual Property laws aided in protecting PharmaCare and its manufacturer Colberia. However, these protection laws failed to protect the workers at Colberia or the many consumers that were hurt or killed due to a bad drug.
It has been said that intellectual property is a pharmaceutical company’s most valuable resource because it can protect the company and help with the success of the company. Colberia a developing nation aided PharmaCare in manufacturing an affordable drug and along the way PharmaCare exploited the intellectual property laws. In the 1990’s there was an urgent need for medications and PharmaCare acted on greed without taking into consideration the harm it could do the reputation of its business due to its interpretation of intellectual rights.
Because Colberia was a less developed country PharmaCare was able to find intellectual property protection. The drug AD23 was manufactured in Colberia at much lower cost which was seen as a great opportunity for PharmaCare. Unfortunately, PharmaCare was not able to manage the facilities or the business adequately. Intellectual property laws have faced scrutiny over the years and increasing pressure to ensure that intellectual property laws and standards are not compromised.
PharmaCare did not create economic growth in Colberia the wages it paid to the workers was unfair and unjust given the huge profits and bonuses received by PharmaCare and its management staff. PharmaCare repays Colberia PharmaCare has a moral obligation to pay Colberia and its citizens by investing in the area. There are many things that the giant pharmaceutical company can do, however it would be best if life-long improvement were made to have a positive impact on generations.
The Global Poverty Info Bank says it best; “Improve the infrastructure, fighting widespread disease, and combatting poverty. Infrastructure- the physical resources like roads, telecommunication networks, schools and drains – is necessary for a society to function: people can’t access healthcare if there are no hospitals; trade can’t take place if there are no roads on which to transport goods to markets. Infrastructure facilitates the basic functions of a society that are necessary to transport resources and people, produce and trade goods provide essential services and ultimately reduce poverty.
Suggest at least three (3) ways the company could compensate the people and nation of Colberia for the use of its intellectual property and the damage to its environment. ” I agree with the assessment of repaying Colberia with putting money and resources into the country to build new infrastructure, provide medical resources and medications to fight widespread disease and then assist with fighting hunger by providing resources to teach and provide items for growing and cultivating plant foods. PharmaCare could make amends to the entire country by aiding the citizens in developmental growth.
PharmaCare vs. Nike – Ethics Both PharmaCare and Nike hired laborers to perform work that would have cost substantially more in the United States. Both PharmaCare and Nike received a wave of consumer criticism and other negative feedback because of the unfair labor practices. Both have been accused of human rights violations and when you think of the countries in which they place the manufacturing businesses along with the working conditions, although completely different lines of business and different types of manufacturing; they both faced similar consumer backlash and economic concern.
Both will need to ensure that working conditions are up to acceptable standards and that workers are fairly compensated. A Code of Conduct should be drawn up and all management and workers should sign. The Code of Conduct would consist of hours, compensation, reporting, training and employee or employer expectations. PharmaCARE and WellCo lawsuit
The lawsuits against PharmCare and Wellco are possible and would be very successful. Many of those that had taken the drug along with those that are left behind should have the right to sue and be successful at gaining compensation. Due to many of the side effects that were not disclosed it lead to the hospitalization and death of the patient should ensure compensation to those affected due to their loss. Often times companies with a lot of financial resources prefer to settle the case quickly and have little public exposure and many have all parties involved to sign a confidentiality clause. The various types of restitution are:
•Death of a loved one
•Loss of quality of life
•Pain and suffering’
•Lost wages die to poor health
Any person negatively impacted whether they are a patient or employer will have the opportunity to recoup some of its losses or acquire punitive damages. The faulty drugs had a devastating effect on many people and the pharmaceutical companies made a huge profit, and most are covered by insurance policies that would assist in paying the many forthcoming lawsuits.
The PharmaCare brand
At the current time PharmaCare continues to build its brand and is trying to regain consumer confidence. The mission and commitment statement of Pharmacare is stated below and as PharmaCare is rebuilding it remains cautious about its interactions so as not to cause harm to consumers and its shareholders as it has done in the past. The Mission of PharmaCare is: “is to develop an organization of regional pharmacies that is palpably different from our competition.
The vision is to realize this distinction by concentrating on different patient populations, that is, those who need specialized, personal service; create partnerships with referring physicians; build loyalty among our employees; give back to the community; resurrect the time-honored practice of door-to-door delivery, and rely on word-of-mouth to create demand. PharmaCare continued with a commitment statement that reads as follows, “To our patients: Treat our patients with the same compassion, care and individual attention that we give to our family members.
To our physicians: Understand that physicians are able to serve their better when we serve the physicians better; therefore we are available, flexible, convenient, responsive. To our Case Managers and Care Givers: Streamline the process between prescription and the medication. Streamline the process between the refill request and the medication. Provide medication-related, logistical, and financial information and assistance when requested and proactively.
PharmaCare will need to continue conducting business in the same manner as stated in both the mission and commitment statement in an effort to remain a valuable resource to the pharmaceutical world. Ethical changes of PharmaCare The ethical conduct of PharmaCare is vital to the success and profitability of the company. The integrity PharmaCare will be reviewed for years to come and as such PharmaCare management team and stakeholders will need to react proactively to any negative feedback and communication that it may receive.
PharmaCare will need to ensure that all employees are receiving a fair wage and that if using developed countries that they are being fairly compensated for the land, space and its residents. PharmaCare will need to ensure that all drugs are approved by the FDA and are safe to be on the market. PharmaCare will need to disclose any relevant information that is known regarding the side effects to enable them to make informed decisions on their choice of medication. PharmaCare will need to ensure that it is operating within all regulations and laws that have been set by the FDA and its affiliates.