Introduction
The opioid crisis in the US is now recognized as a national problem. In 2016, the total number of deaths from opioid overdose exceeded those from road accidents and gunshot wounds (Vivolo-Kantor et al., 2018). Long-taking prescription painkillers can lead to severe drug addiction. One of these most popular drugs is Oxycontin, which is manufactured by Purdue Pharma (Narconon, 2022). The main ethical dilemma lies in the marketing strategy of the company, which, through aggressive advertising, hooked a huge number of people on the ‘legal drug’. This study aims to explore the Purdue Pharma crisis, its causes, and ways to avoid a recurrence. The thesis of the work is the assertion that Purdue Pharma faced a crisis due to the neglect of ethical standards in the pursuit of profit.
Causes of the Crisis
The Background of Purdue Pharma
Purdue Pharma was initially organized as a small family business. Sackler’s family bought out Purdue Frederic in 1952, which researched, developed and licensed medicines and health products (Posner, 2021). Arthur Sackler was the first publicist to convince The Journal of the American Medical Association to include a color brochure in one of its editions (Pellerin, 2019). After Arthur’s death in 1987, his brothers renamed the company Purdue Pharma (Posner, 2021). In the 1970s, opioids were not used in medicine in the United States; however, despite the stigmatization of opioids, painkillers based on them were widely used in hospice services to help dying patients (Bisaga et al., 2018). In 1987, the innovative painkiller MS-Contin appeared on the market, which became a popular option in the treatment of cancer patients (Press et al., 2019). In parallel, there has been a discussion among the medical profession that the use of opioids in the treatment of non-cancer diseases, which can be equally debilitating for the patient, should be considered.
Despite its popularity, MC-Contin could not become the most popular painkiller: in large part due to the fact that there was prejudice towards morphine. Soon Perdue Pharma released pure Oxycodone with a controlled-release formula similar to MC-Contin. The company produced tablets in dosages of 10, 80, and 160 milligrams, which were stronger than any prescription opioid (Nury et al., 2022). In 1995, the FDA approved the use of Oxycontin for moderate to severe pain (Kibaly et al., 2021). At that point in time, the company was successful despite the ongoing stigmatization of opioid drugs.
Advertising Campaign
Purdue Pharma launched one of the largest advertising campaigns in pharmaceutical history. The company’s goal was to convince physicians that Oxycontin could be prescribed for a variety of pain conditions, not just cancer and surgery. Purdue Pharma has trained employees to deal with doctors’ objections and convince them that the drug is virtually non-addictive (Hughes, 2022). Purdue Pharma approached the promotion from all directions: wholesalers received discounts, pharmacists who ordered the drug for the first time were reimbursed, and patients received coupons for starter packs (Hughes, 2022). The organization paid thousands of medical practitioners to attend seminars and talk about the benefits of Oxycontin.
Using as a Drug
With the popularization of the medicine, it became known that Oxycontin could be used as a drug. The packaging of the product carried a warning about a possible narcotic effect: if the powder from the crushed drug was injected, this would lead to the absorption of a potentially toxic dose (Bavli & Steel, 2020). Some patients with prescriptions for Oxycontin began to sell the drug on the black market. From 1996 to 2001, the number of Oxycontin prescriptions in the US rose from 300,000 to nearly six million (Siddiqui, 2022). Due to the popularization of the use of opioid-containing drugs, the United States was on the verge of a medical crisis.
Opioid Crisis
The opioid crisis is becoming a major public health threat. The Opioid Crisis Commission, established by Donald Trump, has announced a figure of 64,000 people who have died from the abuse of opioids (Gong & Liu, 2018). Before the crisis entered its dangerous phase, the total economic burden on the state from opioid addicts was about $80 billion, including health care and criminal justice costs (Hagemeier, 2018). According to the Table 1, 130 people die every day because of opioid abuse (Appendix 1). The opioid crisis has already been designated a public health emergency.
Summing Up the Causes of the Purdue Pharma Crisis
Purdue Pharma has long managed to avoid direct responsibility for its contribution to the US opioid crisis. In 2007, the company admitted in a criminal proceeding that it had used doctors’ misconceptions about the power of oxycodone to its advantage (Kaplan, 2022). The filings state that the company was well aware that the doctors’ belief that Oxycodone was weaker than morphine was wrong (Kaplan, 2022). In accordance with the agreement reached Purdue Pharma paid $600 million in fines, and three top managers of the company pleaded guilty and were sentenced to multimillion-dollar fines and community service (Coffee Jr, 2020). However, Purdue Pharma has not abandoned its strategies and is promoting Oxycontin in other countries using panel discussions and paid speakers.
First of all, the crisis situation arose due to improper management, carried out contrary to moral and ethical considerations. The advertising campaign to promote treatment with opioid-containing drugs was deliberately based on false information. During the campaign, the leaders used manipulation through the substitution of concepts. Opioids were said to be the only way to deal with daily pain, and the risks of getting addicted were greatly underestimated. By such manipulation, the organization caused terrible undulating consequences that turned into an opium crisis.
Purdue Pharma Reaction
By 2007, it became clear that Purdue Pharma should be held accountable for the US opioid crisis. The Sackler family agreed to pay an additional $1 billion and put the company under the control of a community board (Marks, 2020). Members of the billionaire Sackler family and their company Purdue Pharma have reached an agreement with a group of states that have long resisted the company’s bankruptcy plan. If the next deal is reached, the Sackler family will pay up to an additional $6 billion to help communities undo the damage from the opioid crisis (Office of the Attorney General for the District of Columbia, 2022). The agreement marks a major moment in the national opioid litigation, an effort by state, local and tribal governments to hold companies in the vast pharmaceutical industry accountable for the opioid addiction crisis.
Ethics
Although many pharmaceutical companies were drawn into the production of opioid drugs, the main focus was on Purdue Pharma, as Oxycontin dominated the market initially. “We are pleased with the mediated settlement, under which all additional settlement funds will be used for opioid, overdose medication, and casualty programs,” Purdue said in a written statement (Mail Online, 2022). Members of the Sackler family have not admitted wrongdoing or any personal responsibility for the public health crisis. The Sackler family said, “We sincerely regret that Oxycontin, a prescription drug that continues to help people suffering from chronic pain, suddenly became part of the opioid crisis” (Mail Online, 2022). As such, Purdue accepts no responsibility for causing the opioid crisis. The company cannot be ethically justified as it deliberately misled doctors and patients that Oxycontin was not addictive.
Business Benefit
From a business strategy standpoint, Purdue’s advertising campaign was undeniably successful. The company became one of the leading manufacturers of opioid drugs, which were very popular with patients with chronic pain. Neglect of moral and ethical standards led to a strong increase in profits. However, at this point, the company will obviously need to seriously change direction. Activities under restrictions, and huge financial losses should soon lead the company to bankruptcy. Public outcry and rising disapproval will seriously hamper Purdue Pharma’s operations.
General Perception of the Reaction
Purdue is predictably in denial, shifting the blame to consumers, despite the fact that the company’s disruptive contribution has already been proven. Such a reaction and non-recognition of their mistakes, most likely, will no longer allow the company to function normally. The main mistake is to play down one’s own guilt in the global crisis and defend the position that no one knew about the ability of Oxycontin to cause addiction. The best strategy for Purdue Pharma in this situation would be to fully admit its guilt, pay compensation to all victims and make a serious contribution to the fight against the opium epidemic.
Ways to Avoid a Similar Crisis
Medical Crisis
The opioid crisis and its deadly consequences are attracting the attention of the public and medical organizations. After defeating the crisis, it is necessary to learn from it, and focus on the cause-and-effect relationship in order to prevent the situation from recurring. The main method of dealing with such a crisis is effective clinical interaction with people who use psychoactive substances like opioids. Timely and competent access to medical treatment is the most effective strategy in the fight against the epidemic. Existing models of care allow physicians and nurses to prescribe medications to treat opioid use disorders. At the same time, medical professionals should offer alternative forms of help as many affected individuals require psychological assistance.
Public funding is also essential to resolve global crises. It is necessary to create reserve funds that will protect lives at risk. Medical efforts to treat substance use disorders, and in particular opioid use disorders, should be expanded within primary health care and integrated with specialist drug dependence treatment. Affordable and effective medical care, which usually includes medication, should become the standard in clinical practice. In addition, state control over the activities of pharmaceutical companies should be strengthened in order to prevent discrepancies with moral and ethical standards and legal requirements.
Acting on the Ethical Basis
Most likely, for Purdue Pharma, successful operations after the payment of fines and increased control will become almost impossible. However, it is necessary to consider the paths that brought the company to its predicament so that other pharmaceutical organizations can learn from this case. According to Table 2, Purdue Pharma should perform organizational, ethical and operational changes to prevent another crisis (Appendix 2). The fundamental problem that led the company to bankruptcy is the inconsistency of the advertising campaign with moral and ethical considerations.
Advertising Compliance with Ethical Standards
Compliance with ethical standards in communication with potential customers is the basis for the functioning of any pharmaceutical company. Particular attention should be paid to the promotion of prescription-only or addictive drugs (Selgelid & Jamrozik, 2020). The medicines that research companies produce and the scientific information they provide to physicians are essential components of quality patient care (Selgelid & Jamrozik, 2020). Quality service should be based on providing clients with complete information about a particular type of treatment.
Giving patients information about medications can encourage healthcare providers to explore different treatment options to best meet the needs of patients. To further support these important goals, the global pharmaceutical industry has made significant changes in recent years to the global control of companies’ interactions with healthcare professionals (Selgelid & Jamrozik, 2020). From the point of view of the Purdue Pharma case, they violated the first rule of ethical operation by providing false information to users during an advertising campaign. To avoid a repeat of the situation, pharmaceutical companies should rely only on proven clinical efficacy and safety.
Advertising information includes commercial materials that are related to specific products and are distributed to patients or healthcare professionals. The main need for advertising materials of pharmaceutical companies is that it must be proven and reliable (Sawad, 2021). To avoid a crisis situation, the pharmaceutical industry must remain a reliable partner in the medical field. It is hard to say whether Purdue Pharma really wanted to mislead customers and raise profits by increasing the number of opioid-addicted citizens. Most likely, there was no specific malicious intent, but only an unwillingness to believe that their methods of earning money are not ethical and pose a threat to public health.
Consideration of the Public Opinion
Since the main clients of pharmaceutical campaigns are medical institutions and patients, it is necessary to take into account public opinion when introducing new medicines. Purdue Pharma’s mistake was ignoring the public’s stigmatization of the use of opioid drugs. The main prejudice was related to the fear of use, due to the fact that previously drugs like morphine were used only in the treatment of particularly difficult cases. Changing public opinion on an issue like this is a fundamental shift, and it takes a significant amount of time. Purdue Pharma, in an attempt to expedite this process, has resorted to unethical techniques. To prevent this situation from happening again, pharmaceutical companies, when advertising their drugs, must be aware of public attitudes and not influence it artificially.
Avoiding Manipulative Techniques
The main divergence of Purdue Pharma’s activities, which led to the crisis, concerns the company’s use of manipulative, unethical tactics during advertising, sales, and attempts to change public opinion. The main argument that the pharmaceutical company used during the large campaigns was that they had finally found a revolutionary remedy that could allow people to live without daily chronic pain (Cutler & Glaeser, 2021). If people were critical of these statements, it would become clear that getting rid of pain is given in exchange for dependence, not only physiological, but moral. Nevertheless, one cannot accuse them of being gullible, it was on the hope of people to get rid of suffering that Purdue Pharma made a bet, which is certainly unethical and unacceptable for a pharmaceutical company. It is necessary to avoid such manipulations so that the situation does not repeat itself in the future, and thousands of people are not left deceived.
Organizational Changes
If the company manages to cope with the crisis and can adapt to the new conditions, organizational changes will be required to continue working. Layoffs and liability measures have already affected top managers of Purdue Pharma, but more structural changes are needed. Compliance with a specific form of accountability will require a dedicated department working alongside oversight to ensure full compliance with the law. It is also possible to form a department that will monitor the compliance of advertising materials with ethical standards. To organize this process, a strong leader is needed who is interested in restoring the company’s reputation. There needs to be a clear message from Purdue Pharma that their mission can be providing help to people with chronic pain, based on ethical and legal principles.
Conclusion
Purdue Pharma is rightly accused of causing the opioid crisis. These consequences were caused by the unwillingness of the business to reckon with the ethical principles of the organization of pharmaceutical production. Lying during the advertising campaign, manipulating the audience, avoiding negative consequences led the company to near bankruptcy. To avoid such crises, if the company continues its activities, structural changes are needed. First of all, Purdue Pharma should ensure abandoning aggressive marketing that does not have an evidence base. In addition, public attitudes to a critical health issue should not be manipulated. To ensure compliance, Purdue Pharma must establish a department that will address issues related to ethical business conduct.
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Appendix 1
Table 1. Opioid Statistics
* According to US Department of Health and Human Services (2021).
Appendix 2
Table 2. Changes to Prevent Crisis