ACE

Author: Ezinne Okonkwo

  • Understanding the Accountability for Overprescription Debate

    Understanding the Accountability for Overprescription Debate

    Background: The Opioid Epidemic

    Over the past two decades, the opioid epidemic has emerged as a key public health issue in the United States. The first wave of the epidemic was characterized by an increase in opioid prescriptions in the late 1990s paired with marketing from pharmaceutical companies that ensured that opioids were safe for pain management. In the early 2010s, a second wave arose when individuals who had become dependent on opioids sought out heroin as a cheaper and more accessible alternative for pain management. The third wave, starting in the mid-2010s, saw a rise of synthetic opioids such as fentanyl in illegal drug markets, leading to unprecedented levels of overdoses. 

    Prescription opioids are chemicals, both natural and synthetic, that are prescribed for pain management and include commonly-prescribed drugs such as Hydrocodone (Vicodin),  Oxycodone (Oxycontin, Percocet), and Morphine (Kadian). While prescription drugs are used to treat acute to chronic pain related to surgery, injury, or illness, prescription can come with risks. Side effects of commonly-prescribed opioids include increased sensitivity to pain, increased drug tolerance, and withdrawal post-medication. These side effects can lead the way to opioid misuse and addiction. In 2023, 125 million opioid prescriptions were filled in America, and 8.6 million Americans misused prescription opioids.

    Calls for Accountability

    In recent years, blame for the opioid epidemic has shifted towards pharmaceutical companies that produce the drugs and initially advertised their safety. Specifically, many consumers seek to hold pharmaceutical companies legally accountable using the argument that their deceptive marketing tactics have created a public health crisis and therefore constitute a public nuisance. Between 2014 and 2021, more than 3,000 lawsuits were raised against pharmaceutical corporations based on the public nuisance argument. However, 2021 decisions from California and Oklahoma State Supreme Courts held that false advertising was not enough to constitute a public nuisance, weakening the prospects of accountability arguments in other pending cases. 

    Most recently, the U.S. Supreme Court struck down a bankruptcy plan for Purdue Pharma – a major pharmaceutical company – that would have facilitated an $8 billion settlement to the individuals, states, and local governments that had sued the company over opioid-related deaths. While some praised the Court for its refusal to grant Purdue Pharma the bankruptcy relief it desired, others say the Court failed to hold the company accountable by jeopardizing the $8 billion settlement to victims. Today, avenues for holding major pharmaceutical corporations – collectively referred to as Big Pharma –  accountable are highly debated. 

    The Case for Holding Big Pharma Legally Accountable

    Supporters of holding pharmaceutical companies legally accountable for the opioid epidemic cite the companies’ use of deceptive marketing techniques to sell opioids. For example, Purdue Pharma’s Evolve 2 Excellence initiative aimed to increase the sale of OxyContin by instructing their marketing team to promote higher dosages and target high volume opioid prescribers. In 2003, Purdue Pharma launched a misleading marketing campaign about the effectiveness of their prescription drugs despite a lack of proven efficacy in treating pain. In 2014, the city of Chicago sued Janssen Pharmaceuticals, Cephalon, Purdue Pharma, Endo Health Solutions, and Actavis for “knowingly and aggressively marketing [opioids] as rarely addictive” and contributing to several Chicagoan overdose deaths. 

    Proponents of legal accountability for Big Pharma believe that successful lawsuits against major pharmaceutical companies could set important precedents and ensure that other corporations are held accountable for their public health impacts on the US population. When polled, 57% of Americans believed that pharmaceutical companies should be held legally and financially accountable for the worsening opioid crisis. This belief existed across party and ideological lines. An even larger segment of the U.S. population supports compelling Big Pharma to remedy their contributions to the epidemic in other ways, with 73% stating that they want drug companies to fund opioid addiction treatment and 72% arguing that they should distribute naloxone kits for free. 

    Arguments Against Legal Accountability for Big Pharma

    Critics of legal accountability for pharmaceutical corporations argue that lawsuits are temporary solutions that will not deter pharmaceutical companies from producing and marketing harmful drugs in the long term. They hold that given the massive annual profits of the top five pharmaceutical companies, civil suits act as no more than a slap on the. Critics also emphasize the increasing difficulty of using the public nuisance argument against Big Pharma due to the complexities of state and federal oversight.

    Additionally, some opponents of legal accountability for Big Pharma argue that highly-publicized lawsuits only provide a false sense of closure and ignore other factors that underlie the opioid crisis. Critics believe there are multiple causes of the opioid epidemic such as housing and food insecurity, and thus argue that the social determinants of health framework must be adopted in order to best tackle the crisis. Mimi Walters, former United States Representative, discussed how prioritizing settlements with pharmaceutical companies is illogical if people are not simultaneously addressing unfair federal housing programs that create barriers to housing for those who have substance use disorders. Citing lack of economic opportunity, limited drug treatment, and need for pain management as causes of opioid overuse, some believe taking a holistic approach is the only way to manage the opioid crisis from the grassroots. They contend that legal settlements are simply a bandaid solution.

    Moreover, some argue that overprescribing doctors hold just as much responsibility for the opioid epidemic as the corporations that market the drugs. Patient satisfaction and expectations for pain-free experiences have become central to the healthcare industry, leading some doctors to prescribe strong opioids for slight injury rather than saving them for persistent, chronic pain. Critics believe that this push for patient satisfaction, along with a focus on the monetary value of patients, creates a cycle in which physicians prescribe to make money. Opponents also cite the Food and Drug Administration’s (FDA) lack of regulation as a contributing factor. In 2017, the Presidential Commission on Combating Drug Addiction and the Opioid Crisis found that the epidemic was partially caused by gaps in FDA oversight. In 2002, 8 out of 10 members of an FDA advisory committee on opioid prescription had ties to Big Pharma. The committee advised the FDA against regulating overprescription, causing many to argue that accountability efforts should include government agencies and not just corporations.

    Conclusion

    Efforts to hold pharmaceutical companies legally accountable have gained traction in recent years. In 2023, Michigan became the last state in the nation to repeal its legal immunity for pharmaceutical companies. In October 2024, the U.S. Department of Justice brought charges against several pharmaceutical companies and brokers for their role in the unlawful distribution of nearly 70 million opioid pills. While many applaud these efforts, some see them as short-term solutions and argue they must be part of a larger comprehensive approach to address the far-reaching consequences of the opioid epidemic in the years to come.

  • Pros and Cons of the SUPPORT Act of 2018

    Pros and Cons of the SUPPORT Act of 2018

    Background

    The opioid epidemic has emerged as a major public health issue in the United States. Beginning with a surge in opioid prescription in the 1990s and followed by waves of addiction to synthetic opioids such as fentanyl, the crisis has grown and morphed since its inception. Since 1999, there have been more than 600,000 opioid-related deaths in the U.S. and Canada. Over the years, U.S. lawmakers have responded to the opioid epidemic with several policies including the Comprehensive Addiction and Recovery Act (CARA) and the 21st Century Cures Act, which both laid a promising groundwork for prevention and treatment but had limited outreach and funding. In 2018, Congressed passed the SUPPORT Act with the goal to tackle the crisis in a new way.

    What is the SUPPORT Act of 2018?

    The Substance Use-Disorder Prevention that Promotes Opioid Recovery and Treatment (SUPPORT) for Patients and Communities Act of 2018 was signed into law by former President Trump on October 24th, 2018. The bill aimed to address the opioid epidemic through prevention, treatment, and recovery, with emphasis on law enforcement and provisions to Medicare & Medicaid. Its core provisions are as follows:

    • Prevention: The Act includes a set of policies that aim to reduce the incidence of cases related to opioid use and addiction. The bill expands public health education, implements opioid stewardship in hospitals and clinical settings, and promotes the use of alternative pain management theories.
    • Treatment and Recovery: The Act expands access to medication-assisted treatment (MAT), building on top of the work of the TREAT Act and the Addiction Treatment Access Improvement Act. Expansion of MAT will allow administrators of MAT — doctors, nurse practitioners, physician assistants — to combine medications with therapy to address the biopsychosocial aspects of opioid addiction. 
    • Emphasis on Law Enforcement: The Act emphasizes the importance of law enforcement in limiting the distribution of synthetic opioids. The Act also connects law enforcement to healthcare systems in hopes of monitoring the trafficking of opioids. 
    • Provisions to Medicare & Medicaid: The Act expands Medicare and Medicaid to cover a wider range of treatments related to substance use disorders including MAT, therapy, and counseling.

    Arguments in Favor of the SUPPORT Act

    Supporters of the Act emphasize its role in expanding Medicare and Medicaid coverage. They highlight the expansion of coverage including new medications, outpatient services, and health home programs under both Medicare and Medicaid. Proponents believe that the growth of access to treatment allows patients in both residential facilities and outpatient programs to have greater access to treatment. In the past, Medicare has been criticized for its limitations on coverage for substance abuse treatment, so proponents believe that the SUPPORT Act was a crucial intervention to reimburse older patients for medicated treatments, behavioral therapies, and counseling.

    Proponents of the SUPPORT Act also applaud the Act for expanding and developing the healthcare workforce; they hold that it eliminated some systemic barriers to care like long waitlists that previous bills did not address. According to the Department of Labour, the SUPPORT Act piloted several grant programs to “deliver training and employment opportunities to encourage more individuals to enter professions that could address the crisis”. Proponents believe one pilot grant program through the Employment and Training Administration  allowed more people from under-resourced communities join the healthcare workforce and tackle the epidemic in their own communities. Proponents highlight that in addition to providing grants to expand the opioid response workforce, the bill also established funds to respond to economic harm in towns whose workforces are impacted by opioid addiction. 

    Finally, proponents applaud the SUPPORT Act for increasing the authority of healthcare workers and hospital systems in administering substance abuse treatments. Proponents believe medication-assisted treatment, or MAT, is especially important in the fight against the opioid epidemic as it combines the use of medications like buprenorphine and counseling, addressing the physical and mental aspects of opioid addiction simultaneously. The Act gained support from several healthcare advocacy groups for giving registered nurses, nurse practitioners, and physician assistants the ability to prescribe buprenorphine once they obtain certification. They argue that this provision increased access to MAT nationwide. Proponents also praise the Act for its funding of health education programs that educated patients on the dangers of opioid misuse, preventing health consequences early-on. 

    Arguments Against the SUPPORT Act

    Opponents of the bill cite concerns over sustained funding and support from the federal government. The American Hospital Organization raises the issue that Medicaid and Medicare rarely cover the full cost of hospital expenses, leaving a $75.8 billion annual gap that falls on hospitals and other patients to close. With the Act’s expansion of Medicaid and Medicare coverage for substance use treatments like MAT, they argue that hospitals became even more overburdened with costs. The SUPPORT Act provided $6 million for health centers and $2 million for rural health centers for buprenorphine treatment, which critics argued was not enough to sustain the number of patients that need to be served. Similarly, critics contend that the Act did not account for the long-term sustainability of its workforce expansion goals, since the end date for most of its grants was set to January 2023. 

    Critics also emphasize how the SUPPORT Act failed to fully address the housing crisis, one of the socioeconomic factors underlying the opioid epidemic. Mimi Walters, former United States Representative, flags a provision of the SUPPORT Act that provided grants for temporary housing but only extended this funding to 50% of states. She warns that inconsistent funding like this only worsens the ongoing challenge of ensuring that people with substance use disorders secure housing. 

    Opponents of the bill worry about the impact the SUPPORT Act has on sober homes and residential substance use treatment facilities, locations that help people in recovery transition back into their communities and avoid homelessness. The Eliminating Kickbacks in Recovery Act, a part of the SUPPORT Act, made it punishable by either a $200,000 fine or 10 years in prison for sober homes to receive monetary kickbacks. This worried critics who believe that the lack of access to housing and the overcriminalization of residents who utilize sober homes could create a cycle in which people in recovery struggle to find housing and start using substances again.

    ConclusionThe SUPPORT Act of 2018 embodies the struggles the federal government faces in responding to a healthcare epidemic as large and multi-sector as the opioid crisis. Proponents cite the role the SUPPORT Act played in expanding Medicare and Medicaid, developing the workforce, and increasing the abilities of various healthcare workers to provide treatment. Conversely, critics of the SUPPORT Act highlight the bill’s failure to provide enough funding to sustainably support its goals. Congress failed to reauthorize the Act in 2023, signaling a desire for a new approach to the opioid epidemic. Future measures to combat the crisis must learn from the SUPPORT Act’s successes and drawbacks in order to deliver long-term solutions.

  • Ezinne Okonkwo, University of California, Los Angeles

    Ezinne Okonkwo, University of California, Los Angeles

    Ezinne Okonkwo is a third-year Human Biology and Society major at the University of California, Los Angeles (UCLA). Currently at UCLA, Ezinne is involved in activities that showcase her passion for public health policy, advocacy, and improving community health, especially among disadvantaged communities. She is an undergraduate research assistant with the REACH Lab where she enrolls female-identifying patients who have experienced homelessness & PTSD in clinical trials and experiments to help better understand how to alleviate responses to traumatic events. She is also involved in Melanin and Medicine as leadership on the Serve Team, supporting access to healthcare in Black communities around Los Angeles and volunteers with Drug Checking LA which supports harm reduction causes in LA. Through her experiences, she has learned the importance of working in the community and ensuring that the communitys needs are met within the realms of public health. Ezinne wants to able to learn more about public policy in order to best understand and address the problems that affect the communities she wants to serve. After graduation, Ezinne hopes to pursue a dual MPH/MD and become a physician with a robust background in public health, allowing her to better advocate for the well-being of her patients, families, and communities. Outside of school, she enjoys sports, listening to the music of the world, and indulging in her Nigerian culture. 

    LinkedIn