phr Penn
Healthcare Review
The Transparency Issue
Dear Readers, Editors-in-Chief
HELEN WU CLAUDIA HEJAZI-GARCIA
Editorial
LEEYU ADDISU JOJO MILAN-HOWELLS ERIN LEE EESHA BALAR DHIVYA ARASAPPAN
Writers
KYNE WANG SHAHANA BANERJEE OM GANDHI SARASWATI SRIDHAR EMILY HUYNH
Transparency is a word that was taught to us all the way back in elementary school. It meant being honest about your actions, like telling your teachers that your dog didn’t actually eat your homework—you just forgot to do it. In today’s world, the pandemic has highlighted the need for this term in healthcare, especially with the companies such as Theranos coming to light. The healthcare system must focus on making medical information understable and efficient for everyone to understand; not harder. Healthcare company executives, physicians, and medical authorities have a moral imperative to share all necessary medical information with the patient, as is demanded by the bioethical principles. However, this is not always the case. When putting together this issue, we wanted to focus on a lasting legacy of the pandemic that will be paramount for our healthcare systems moving forward. In the Transparency Issue brought to you by editors of PHR and contributing writers, we have highlighted aspects of the healthcare system that have propelled transparency and others that need a lot of improvement. We hope that this issue makes you more away as a healthcare aficionado, patient, and consumer.
Design Lead
FARHAANAH MOHIDEEN
Thank you so much for taking the time out of your day to read our first print publication in almost 2 years. We can’t wait to enjoy it with you in-person for the first time.
Designers
Best, Helen and Claudia
SHAAN PATEL ALYSSIA LIU CAROLINE PAIK
Please note: These articles were prepared by members of the Wharton Undergraduate Healthcare Club. The opinions do not represent the school or club’s official positions on the issues. The Wharton Undergraduate Healthcare Club is an independent, student-led organization of the Wharton School of the University of Pennsylvania. All content is the responsibility of the club.
Contents COVID in China
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Healthcare Innovation - Vain Attempt or Vital Priority?
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Written by Kyne Wang, Designed by Shaan Patel
Written by Shahana Banerjee, Designed by Farhaanah Mohideen
Transparency in Biometric Data Storage Written by Leeyu Addisu, Designed by Alyssia Liu
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The Ethics of Informed Consent: Should physicians strive for informed consent despite its challenges?
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Origins of the Opioid Crisis: Hidden Motives of Business and Government
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Written by Emily Huynh, Designed by Farhaanah Mohideen
Written by Om Gandhi, Designed by Caroline Paik
The Cultural Reset
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The Deeper Implications of Public Health on our Lives Written by Erin Lee, Designed by Farhaanah Mohideen
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Covid-19 and Transparency in Healthcare: Learning from the Theranos Trial
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Patient Reported Outcomes: The New Future of Diagnosis
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Written by Jojo Milan-Howells, Designed by Alyssia Liu & Caroline Paik
Written by Saraswati Sridhar, Designed by Farhaanah Mohideen
Written by Eesha Balar, Designed by Caroline Paik
Designed by Shaan Patel
Stores shut. Streets cleared to an eerie silence. Hospitals prepared to lay siege. A new coronavirus was wreaking havoc in several countries, catching the healthcare system off guard and startling all. It was like SARS all over again. 5
THE INFODEMIC The impact of the 2003 SARS epidemic was most notable in its influence on mask-wearing.1 Following the epidemic, mask-wearing became embedded in everyday practice.² When COVID-19 came to prominence, the SARS-affected countries armed their people. Masks become ubiquitous as both a measure of personal protection and social responsibility.³ Healthcare communication was unified. Masks were already the social norm in these countries.4 In others, masks became a symbol and catalyst of the politicization of science in the media. Misinformation during COVID-19 perpetuates poor responses to the pandemic. The COVID-19 pandemic has been paired with the term “infodemic”—a global spread of health misinformation.5 The pandemic is revealing not only disparities in national crises communication but also cultural differences, with countries responding differently to the pandemic.6 Misinformation scales with popularity, as masks have been a primary source of discussion around its efficacy as personal protection from the virus.5 According to the Pew Research Center, 52% of Americans rely on social media for news, and nearly half the public said they have been exposed to some misinformation about the virus.7 In countries with a large several news outlets, highly polarized environments are contributing to a pleth-
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ora of misinformation regarding COVID-19 in an increasingly politicized media ecosystem.8 Is striving for complete transparency undermining the U.S. response to the pandemic? As outlets for sharing information have grown exponentially in the last decade, many wonder how that affects the quality of the information itself. In many instances, the plethora of information outlets have made it significantly easier to amplify concerns, but when pushed beyond its boundaries, this amplification leads to hysteria.
OPPOSITE APPROACHES ON OPPOSITE SIDES OF THE WORLD The most common contrasts in approaches to the pandemic are drawn between China and the United States. In China, the tight control on information has raised eyebrows internationally. Misinformation was strictly dismissed and disciplined, usually leading to a complete eradication of the information source. In the beginning of the pandemic, Li Wenliang, a Wuhan doctor, tried to warn fellow professionals of a disease that was reminiscent of the 2003 SARS coronavirus; he was briskly silenced by police, being told to “stop making false comments” and immediately investigated for spreading rumors.9,10 From one side of the aisle, this may be another representation of the ramifications of authoritarianism. As the 2003 SARS outbreak also originated in China, some argue that the cover-up was a strategy to avoid tarnishing international reputation. On the other side, this initial censorship can be viewed as a precaution—simply waiting for more information. Whatever the true motives were, China’s censorship succeeded in shifting the nation away from accusations of cover-ups to a call for strength and condemnation of misinformation.10 This was similar to China’s 2003 approach to SARS, a devastating
outbreak not too long ago.1 A study published in the Journal of Tropical Medicine and International Health deduced that for a new, rapidly spreading disease that did not respond to traditional/pre-existing medicine, traditional public health measures took precedent.1 In 2003, China declared a “People’s War,” mobilizing the masses in a collective effort to stem the spread of the disease.1 Collectivism manifested itself through mask-wearing and local monitoring. A people’s surveillance system was initiated, where family and neighbors monitored each other to ensure the containment of SARS cases.1 Fast forward to COVID-19, an appeal to unity was evident in the compliance of the public with public health recommendations. The lack of transparency in the Chinese media ecosystem served as a filter, allowing only for the scientific information that was deemed reliable and relevant to enter society. Although this lack of transparency challenges the accuracy of their COVID-19 case/death counts, the country has undoubtedly returned to normal life. Regardless of the data on mask-efficacy or case/death counts f ro m China deemed accurate, it is evident that the control of information has led to calmness for most Chinese citizens.
On the other side of the world, the United States has been a highlight in the global response to COVID-19.14 With the leading number of cases and deaths, the United States is experiencing a back-andforth rally between science and politics. Over time, as stated by President Barack Obama, “we have watched as scientific integrity is undermined and politicized to advance political agendas.” Science has always been intertwined in U.S. politics, however: The culturally accepted neutrality of science as an industry is unequivocally leveraged to build consensus within polarized environments.15 In COVID-19, public health information was delivered through the White House, a symbol of partisan divide—especially during a turbulent 2020 election season.16 Although this may have been an attempt at uniformity, the free-media environment overrides the credibility of the appeal to unity. The free-media landscape in the United States has perpetuated mass hysteria during COVID-19. As stated in an International Journal of Environmental Research and Public Health article, the resulting hysteria may have contributed to policy errors by governments not in line with health recommendations: potentially to reduce panic and downplay aspects of the pandemic to maintain control and unity.17 Information is transparent in the United States in comparison to China, but has this played a role in diluting Source: Getty Images12
For Mimi Zainal, a mother of two children, "I prefer the kids to wear masks... it gives me a peace of mind to know they are more protected," she says.11 China’s brisk response to mandating public health measures in a manner deemed authoritarian by the West has led to lowcase counts for more than a year.
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the significance of the pandemic? It is an unchallenged notion that science constantly moves forward to shed truth and debunk falsehoods of the path; this was evident in the onset of the pandemic in the United States—especially with mask-policy. Mask-efficacy has been a primary source of debate in the early months of the pandemic. Initially, the Surgeon General of the United States implored the public to “STOP BUYING MASKS!”14 The CDC initially deemed it unnecessary to wear a mask until reversing its position in July of 2020.14 As politicians called for action, portraying their voices as a symbol of reliability to their constituents, a partisan divide began to form: A Pew Research Center study found that 39% of Republicans in comparison to 11% of Democrats found that news coverage is “largely inaccurate,” exacerbating the polarization of information.18 Transparency in the industry has been traditionally regarded as a symbol of pursuing the truth, advancing society one step at a time. But when science mixes with society, it is important that uniformity is approached with more emphasis.
ment is in hopes to arrive at a more informed.21 Government policies, like those governing hate speech, should regulate that social media platforms allow multiple entities to evaluate the credibility and truth of a claim and then flag it if deemed misinformation. These entities must be clearly visible on each flag and have appropriate markers indicating political bias. Not so different from journal peer-reviewing, adversarial fact-checking will assist in neutralizing the social media landscape and differentiate fact from falsehood by accommodating fact-checking input from both sides of the aisle.
We have seen two contrasting approaches to communicating information during COVID-19 emerge: centralized control in China and mostly unregulated dissemination as seen in the United States. Both have key benefits and drawbacks that are crucial to take into consideration for actions forward:
Benefits Centralized Unified front with uniformity in communication and perception Free Unrestricted sharing of information, drawing from multiple perspectives and resources
A distinction should be made between transparency in science and healthcare. Transparency in science promotes innovation and development, whereas transparency in healthcare enters a grey area of how to shape the public’s interpretation of certain information. During a public health crisis, it may be more important to ensure unity of inforDrawbacks mation over transparency. TransReduction of free speech parency helps shed truth, but it also and lack of transparency yields a great opportunity for misinProne to misinformation formation.
and polarization
First introduced by Cornell Professor of Psychology Dr. Stephen J. Ceci, Ceci proposes a multi-entity review process from various sources from, usually opposing, ends of the political spectrum.19 As “adversaries,” agreements on the factuality of a matter bears much more merit than the social media platform itself.21 With claims being aggressively fact-checked by teams of individuals with diverse political positions, anything other than agreement can prompt readers to critically analyze how persuasive each side’s argu-
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Healthcare Innovation: Vain Attempt or Vital Priority? By Shahana Banerjee
Designed by Farhaanah Mohideen
It’s the no secret how pandemic has impacted
the healthcare industry. There have been dramatic changes in many healthcare sectors, new business models, and unexpected collaborations. Overall health spending was disrupted, hospital spending fell while prices accelerated, nursing home healthcare was often substituted with home health care, and the loss of employment often led to loss of health insurance.1 However, will this massive shift still retain effects in a post-pandemic era? Chances are, yes. According to a survey administered by McKinsey that was given to leaders in the healthcare industry, 90% agreed that the future of business models, products, services, and processes will be fundamentally changed.2 Now more than ever, the emphasis on healthcare organizations improving and extending their innovation efforts has been emphasized. While the pandemic had placed unexpected demands on the contemporary healthcare system, the industry’s response underlines its ability to quickly bring innovations to market along with its resilience. With the pandemic still partially in motion, and the rollout of new variants and vaccines, the movement of innovation is essential to continue with a successful response to COVID-19.
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One of the most impactful changes that has been brought on by the pandemic lies in the digital sector. With people trapped in their homes with no way of communicating directly with their physicians, the healthcare system has seen a rise of telehealth and digital engagement with patients. Providers paved a way for patients to participate with these new tools and technologies, letting them be treated remotely while limiting the risks of COVID transmission. On the basis of remote care and virtual monitoring, new models have also been planned where employees have better flexibility and work conditions, along with accelerated collaborations between pharmaceutical/medtech companies and stakeholders.2 These shifts are not only enabling healthcare to transform its operations, but also change perspectives on how our system can be made more efficient and accessible. Healthcare leaders have had to collaborate with their stakeholders and choose initiative priorities to allocate their resources to. This rise in transparency that we have seen with stakeholders and healthcare companies has been vital in not only battling the pandemic but in moving forward with innovative efforts. Even though we are freshly in a post-pandemic time, this relationship between stakeholders and innovation has ameliorated quality, accountability, safety,
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and informed decision-making, and the effects of these benefits are paving the way for the future of healthcare. In order to keep up with the healthcare industry’s ever changing nature, innovation has had to scale up to its necessary limits. Though it may seem bold, some healthcare players have cascaded their innovation goals to all relevant stakeholders, and this has been considered one of the most critical reasons for driving innovation both during and after the pandemic. One key action has been finding a vaccine quickly, by moving from gene sequence to clinical testing in 16 weeks, according to the CEO of the Coalition for Epidemic Preparedness Innovations (CEPI).3 Luckily enough, the public saw the first vaccine candidate enter a Phase I clinical trial within ten weeks of the genetic sequences being released. This pandemic was a testament to our healthcare system’s resilience, and in a post-COVID reality, healthcare leaders must assess which parts of their business models are durable and which are potentially points of weakness. The Centers for Medicare & Medicaid Services have granted 80 new telemedicine services, while similar reimbursement models have emerged in other countries.4 If such trends persist, this country’s healthcare could shift to digital pathways that would only
create more opportunities for evolved business models. This further emphasizes how partnerships and collaborations with stakeholders in the system need to be further supported. The coronavirus outbreak unexpectedly destabilized health systems around the world. In order to prepare for future pandemics, coordination and transparency amongst healthcare companies and their stakeholders is essential, especially in terms of avoiding healthcare marketplace failures and promoting better outcomes and more trust. By expanding on existing knowledge on viruses and investing in innovative programs that stress prevention, the healthcare industry will effectively be able to work against future health crises, while also supporting well-funded initiatives and health efforts. The NIH had already implemented task forces and strategies that promote preventive medication services appropriate for patients, such as the U.S. Preventive Services Task Force.5 Similarly, further community-based prevention actions can be implemented which focus on population health and valuing outcomes based on features like environment, while assessing risk factors, health outcomes, and other wellness indicators. After the crisis that throttled the whole world, the implementation of open, interdisciplinary decision-making processes is not only necessary, but likely. The COVID-19 pandemic acts not only as a reminder, but also as an incentive of why cross-sectoral collaboration is imperative at all levels of society in order to build durability when dealing with the long-term effects of Covid. The pandemic should be perceived as a way to bolster the current efforts that already exist to promote healthcare transparency. Furthermore, transparency amongst healthcare innovation can be used as a long-term strategy for promoting value and competition within the industry. Covid has highlighted how nontraditional collaborations and clarity between health industries, sectors and stakeholders are essential in finding effective decisions for urgent issues. We are currently facing a reality where companies, such as large healthcare providers, are adopting decision-making processes that include key stakeholders from across their systems, which allows rapid development of initiatives and deployment of innovations in a post pandemic world. Prioritizing innovation after such a crisis can be key to growth in recovery and now more than ever, the importance of coordination and openness is critical for future pandemic preparedness and achieving new bars of achievement.
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TRANSPARENCY IN BIOMETRIC DATA STORAGE By Leeyu Addisu Designed by Alyssia Liu
We are now more connected to our electronic devices than ever before. Our favorite devices are familiar with the most private details of our lives, like the route that we travel each day or what app we open first in the morning. In addition to that, technology hardware companies like Apple, Microsoft, and FitBit now have access to an abundance of biometric data such as fingerprint scans, facial scans, and vocal recognition. Unlike other types of confidential data such as a password, we are unable to make changes to our biological 12
characteristics. It’s impossible for someone to edit their fingerprint or the patterns of blood vessels of their retina. While this makes biometric data an excellent identification tool, it also makes it incredibly dangerous if taken into the wrong hands. Hospital databases are regulated under stringent security protocols, but technology companies are not required to meet the same requirements. As the use of biometric technology becomes more prevalent, a greater degree of transparency is necessary.
individual Apple watches are compiled for comprehensive analysis. Conducted in partnership with organizations like the American Heart Association and Harvard School of Public Health, these studies are highly transparent, and participants are able to withdraw at any time -- once filing the necessary paperwork.
Unlike tech companies, hospitals face strict governmental regulations under the Health Insurance Portability and Accountability Act (HIPAA) of 1996.1 Under HIPAA, patient’s names, images, and biometric data are protected. Over the course of a year, just a single patient can generate 80 terabytes worth of data in the form of electronic medical records. This is a massive amount of data to keep track of and hospitals are liable for the safeguarding of this information. Most importantly, under HIPAA, patients have the right to obtain a copy of their own confidential records. Tech companies do not face such a responsibility, and the uses of our personal data are shrouded in mystery. A massive set of biometric data, far larger than that held by hospitals, is in the hands of tech companies, especially those that produce watches and health monitors such as Apple and Fitbit.2 Imagine the amount of data generated by someone who wears an Apple watch all day. Information about their movements, sleeping habits, and even more are being continuously monitored. It is unclear how this data is being stored and how it is used by tech companies.3
Unfortunately, most studies being done using biometric data are so secretive, that the participants may not even know that they are a part of them. Last February, Facebook had to pay a $650 million settlement in a privacy lawsuit after using biometric data without permission from users.5 An Illinois judge found that Facebook violated privacy laws by storing and re-creating faces of users using facial recognition technology.6 The lack of uniformity in privacy laws between states makes this action technically legal in several other states. Standardization of federal privacy laws is necessary to pressure technology companies into being more transparent. The European parliament has recently taken the step of outlawing remote collection of biometric data. Similar action will be required in the United States to make the practice illegal.7
We must consider the ethics of biometric data collection within the near future, as the digital identity solutions market will grow to $30.5 billion by 2024.8 The fear of surveillance, or “being watched” without our knowledge, preys upon our primal instincts, as seen with the myth that the COVID-19 vaccine is being used to implant a tracking chip within our bodies. The subconscious fear of unwarranted surveillance is still present in society today, and we need transparency to However, this does have its benefits. For example, new illuminate the precise uses of biometric data. Increasing transparency will be essential to our future as an generation Apple watches can monitor the environment and warn of dangers such as loud noises or detect advanced society, as technological innovations create falls and call for help.4 Apple is also putting some of the new privacy concerns. Transparency will be the key to the most optimal and safe implementation of such biometric data collected to good use with their Apple Research app. This app allows consenting Apple watch technologies. owners to join health studies in which data from their 13
The Ethics of Informed Consent: Should physicians strive for informed consent despite its challenges? Written by Emily Huynh
Designed by Farhaanah Mohideen Introduction Informed consent is the process by which a clinician strives to ensure the patient understands the possible ramifications of medical treatment.1 A patient-voluntary action based on moral and legal premises of patient autonomy implies that once a patient obtains full disclosure they can then exercise their patient autonomy and accept or decline care. However, researchers have posited numerous challenges to obtaining informed consent, including the quality of consent, limitations of the law, and problems of broad consent.2 For example, issues arise in how clear a patient’s understanding of medical interventions are after the exchange of information. Although a doctor may tell the patient all of the possible ramifications of care, the patient may not comprehend the information in full. Lastly, several case studies have presented conflict with broad consent and medical research, as patients in the past have unknowingly participated in research they would not have agreed to, thus violating their informed consent.3 Given conflicts concerning informed consent, is it a practical ideal that doctors should strive for even though it is often unattainable in practice? This article will use deontological and utilitarian perspectives to explore whether doctors should make efforts for informed consent despite its challenges, and acceptable breaches to it. Through a deontological framework, actions are 14
deemed “right” or “wrong” based on its adherence to rules. A utilitarian position judges actions on the premise of it benefitting the majority. Deontological and utilitarian aspects of medicine necessitate the notion of informed consent due to the existence of informed consent laws and the need to foster trust with the patient for better health outcomes. However, avoiding the Nocebo Effect presents an instance in the utilitarian framework that may justify the breaching of informed consent. Although it may be deemed “unattainable” in many aspects, physicians should continue to strive for it. Deontology: US Laws and Informed Consent Doctors should implement informed consent since legally, many states have embraced informed consent in the form of statutory laws. Therefore, through a deontologist perspective, it is a doctor’s duty to follow laws that concern them, regardless of the consequences of the action of informed consent. Further, informed consent policies are built on the systemic ethical approach of respecting patient autonomy.4 That is, the doctor has a duty to respect patient autonomy, and informed consent is a vehicle for it. Due to its many posited failures, a countering position may state that informed consent cannot actually be enforced, therefore informed consent laws are useless. Concordantly, while anti-discrimination laws in the US exist, total anti-discrimination in itself is arguably unattainable due to inherent implicit biases and systemic
racism. Nevertheless, this does not negate the fact that US residents should strive for it. Likewise, simply because perfect informed consent is difficult to achieve, this does not mean it should be completely thrown out the window. If medical malpractice arises, patients can rely on legal statutes as a means of persecution to hold the physician accountable. Overall, rules concerning informed consent are valid, and rules that prioritize the notion necessitate doctors to strive for it. A Utilitarian Lens: Facilitating Trust The notion of informed consent is necessary in building physician-patient trust. In order for a patient to autonomously comply with medical advice, they must trust the physician. Patient compliance to beneficial medical advice is necessary for a doctor to achieve their primary goal of healing. Thus, a clinician should not jeopardize trust with the patient. Infringing on informed consent puts a patient’s trust at risk, therefore, requirements for informed consent are justified and physicians should strive for it.5 Through this consequentialist, utilitarian lens, informed consent is strongly favorable given the conducive outcome of heightened medical confidence. There is substantial evidence that informed consent enables trust, and a lack thereof diminishes it. In a
2006 study, researchers found that representatives of a Washington, DC community “emphasized the need for full and honest disclosure of information before a study begins,” and that a “key reason for informed consent” is “to help build a relationship of trust between researcher and participant.”6 Further, in a 2012 study, researchers posited that “a robust informed consent process” can strengthen parents’ confidence in a newborn screening program, which would promote maternal health through early detection of disease.7 On the other hand, failing to disclose the risks of care can foster lasting medical skepticism. Several authors posit that a series of harmful medical experiments on Black patients conducted without informed consent have warranted a strong sense of distrust among Black Americans.8-10 Multiple papers cite the Tuskegee Medical Experiment, the unconsenting acquisition of cells from Henrietta Lacks, and other egregious research endeavors, as vehicles for a lack of confidence in the medical field from Black Americans.9-11 Authors argue that such distrust has led to low vaccine rates in Black communities,10-13 which has negatively impacted health outcomes in the Black population, as well as overall COVID-19 mitigation progress. Consequently, doctors should venture for informed consent, since the lack thereof can lead to less medical trust, and thus, poorer
health outcomes. Alternatively, one may argue that informed consent may actually damage trust. One author posits that, “when trust starts out very low, the standard consent process may diminish it further. In interviews with African-Americans about medical research, one participant stated, ‘If you give consent, then you don't have any legal rights. When you sign that paper, you sign all of your rights away.’”14 However, distrust likely would be less of a problem if historical instances provided informed consent in the first place. Much of the medical distrust in the Black community rests on the fact that there have been a series of medical malpractices that neglected to inform participants of ramifications of treatment or research. If doctors nonetheless provide informed consent, the net positive outcomes greatly outweigh the negative - coinciding with utilitarian principles. A Utilitarian Lens: The Nocebo Effect While a need for patient trust and duty to follow physician laws necessitate informed consent, a utilitarian framework can also be used to undermine it, as exemplified by the Nocebo Effect. Author Shlomo Cohen posits that, in medical contexts, “the expectation of a negative outcome precipitates the corresponding symptom or leads to its exacerbation.”15 This phenomenon states that if a doctor informs an at-risk patient of the possible adverse ramifications of treatment, the patient may be more likely to experience such undesirable side effects.15 For example, Self-Assessment Method of Statin Side Effects or Nocebo reports that “90% of adverse effects” from statin therapy were largely explained by the Nocebo Effect,16 and there have been instances in which if patients are told an analgesic will make their pain worse, it actually does so.16 Through a utilitarian framework then, a doctor should not provide informed consent to patients vulnerable to the Nocebo Effect in order to ensure a lack of adverse outcomes in treatment. The physician thus deprioritizes the principle of patient autonomy and brings greater focus to non-maleficence. However, one may argue that withholding informed consent on behalf of the patient fosters a sense of medical paternalism, making explicit decisions without the input of the patient. This then raises the question of whether the act of non-maleficence outweighs the doctrine of patient autonomy. Nonetheless, a utilitarian view may enable the breachment of informed consent when a 16
patient is unable to make their own medical decisions and the physician is confident that disclosing adverse side effects will exacerbate them. However, a multitude of authors have noted that the phenomenon of medical mistrust has affected large minority populations, where the Nocebo Effect has documented relatively few cases. Therefore, applying utilitarian theory, the need for higher trust in the medical institution from minority communities greatly outweighs breaching informed consent to avoid the Nocebo Effect. Conclusion This paper discusses how the need for and breach of informed consent can be viewed through deontological and utilitarian frameworks. Deonotologically, informed consent is necessary since due to the law and a doctor’s duty to respect patient autonomy. Through a utilitarian lens, informed consent facilitates a more trusting relationship between the physician and patient, leading to better health outcomes. One may argue that foregoing patient autonomy and prioritizing nonmaleficence may justify a violation of informed consent, as depicted through the Nocebo Effect. However, medical mistrust causes more harm in a greater number of people, thus adhering to informed consent to foster trust instead of foregoing it to avoid the Nocebo Effect benefits the greater good. All in all, despite its challenges, informed consent is a notion most, if not all, patient facing physicians should undertake.
Origins of the Opioid Crisis: Hidden Motives of Business and Government Written By Om Gandhi Designed by Caroline Paik
Introduction: A Paradigm Shift Narcotics have a long and storied past in the United States— from the opium poppy that alleviated the excruciating pain of Revolutionary War era soldiers to synthetic opioids that take the lives of around 50,000 people annually.1 Although there have been waves of opioid epidemics throughout history, the modern epidemic can be traced back to the late 1990s, when the paradigm for physicians prescribing painkillers shifted from a period of underprescription of opioids to a period of overprescription. This was followed by 20 years (and counting) of increased opioid access, addiction, and overdose among the American population.2 To truly understand the origins of the modern opioid epidemic, it is crucial to unravel the ‘perfect storm’ of factors that caused this paradigm shift in the first place. The Pharmaceutical Industry Evidence shows that pharmaceutical juggernauts
played a driving role in the overprescription of opioids. In the 1980s, pharmaceutical companies introduced synthetic opiates to the market that had a similar chemical structure to natural opiates like heroin and morphine. The claimed advantage of these new opioids was an alleged solution to the age-old problem of opiate prescription: addiction. Initially, the perception around opioids was fearful— regardless of manufacturer claims, it was assumed that they were just as addicting as their opiate counterparts.3 Attitudes began to shift when a non peer-reviewed letter to the editor in the New England Journal of Medicine introduced the possibility of opioids not being addictive at all. This infamous “Porter and Jick” note was cited favorably by over 600 scholarly articles and then became a major piece of propaganda for pharmaceutical companies. With the apparent backing of the scientific community, perceptions of opioid 17
safety began to change sharply.4 Advertisements citing Porter and Jick, and the scholarship derived from their claims, called instances of drug addiction “pseudoaddiction”-- a condition that presents as addiction, but has few of addiction’s long-term adverse effects.5 Thus, pharma giants like Purdue Pharma, Cephalon, and Insys Therapeutics aggressively marketed their products as safe. For example, Purdue spent $200 million in 2001 alone to promote OxyContin’s benefits and downplay any dangers.6 Johnson and Johnson also recently settled claims that they concealed the addictive properties of fentanyl and their other opioid products to both doctors and patients.7 This aggressive marketing in bad faith pushed doctors to prescribe opioids to patients with pain needs that could have been met by less addictive pharmacological options. The wave of opioid demand that followed resulted in tremendous oversupply from drug manufacturers. Therefore, questionable scholarship and corporate bad-faith allowed for the vast overproduction of opioids, which planted the seeds of the current crisis. Drug Distributors Drug distributors are responsible for delivering the supply of prescription medications from manufacturers to pharmacies, hospitals, and clinics-- simply put, they act as the middleman.8 The current regulatory regime in the United States for drug distributors is codified in the Controlled Substances Act (CSA), which imposes certain reporting and compliance requirements on drug distributors. Core among these requirements is the duty to report and stop so-called 18
“suspicious orders,” defined as requests for controlled substances (like opioids) that occur unusually frequently or ask for unusually large numbers of pills. The CSA effectively requires drug distributors to self-police because wrongdoing can only be seen by government regulators long after medications have been distributed.9 Since drug distributors lose potential profit every time they report an order as suspicious (and thus can no longer fill it), they have little incentive to fulfill their legal obligations. It should be no surprise that throughout the opioid crisis, the three largest drug distributors— CardinalHealth, McKesson, and AmeriSourceBergen— were found not abiding by their legal obligations to stop suspiciously large orders from going to pharmacies.10
tor license was suspended in 2007.12 In fact, one McKesson distribution facility “processed more than 1.6 million orders for controlled substances..., but reported just 16 orders as suspicious.” In 2021, the three big drug distributors reached a $26 billion settlement with attorney generals from dozens of states to release them from civil liabilities associated with their role in the opioid epidemic.13
For example, according to Washington state’s attorney general, the failure of drug distributors to monitor, report, and halt suspicious drug orders is responsible for 10,800 opioid overdose deaths from 2006 to 2018. Within that time period, drug distributors shipped 3.8 billion opioid doses into Washington, far more than could possibly be required. Estimates based on shipping data suggest these companies may have shipped between 250,000 to a million suspicious orders into Washington between 2006 and 2014.11
Governmental Agencies The two government agencies that have the most profound connections with the opioid epidemic are the Food and Drug Administration (FDA) and the Drug Enforcement Administration (DEA).
McKesson, Cardinal Health and AmerisourceBergen have faced reprimands by the Drug Enforcement Administration (DEA) for failing to monitor and stop suspicious orders. McKesson has paid more than $160 million in fines, Cardinal has been fined multiple times since 2008, and AmerisourceBergen’s distribu-
Drug distributors clearly contributed to the epidemic in putting their profits above legal obligations and allowing a tidal wave of suspicious orders, but they weren’t alone in having the ability to halt much of the crisis in its tracks. Government agencies also had many opportunities to mitigate the opioid crisis, but ultimately failed to do so.
FDA Multiple parties have found fault in the FDA’s failure to regulate the opioid industry. A former FDA commissioner argued that it was wrong for the FDA to allow pharmaceutical companies to promote opioid use for pain. Both a Presidential Commission in 2017 and the National Academy of Sciences (NAS) also publicly called on the FDA to change its opioid policies.14 One key example of non-rigorous FDA oversight concerns the 1995 approval of Purdue Pharma’s extended-release (ER) oxycodone drug, an extremely potent and
highly addictive opioid. Normal FDA procedure requires drugmakers to present at least 2 randomized controlled trials which clearly demonstrate a drug’s efficacy for a proposed use-case. In ER oxycodone’s case, Purdue presented only one short study, a 2-week clinical trial in osteoarthritis patients. Furthermore, Purdue’s application proposed a range of use-cases that was extremely broad for a drug as potent as ER oxycodone. Nevertheless, the FDA approved the drug for all proposed uses, despite having a substandard quantity of evidence demonstrating its effectiveness in comparison to its side effects. Later appraisals would castigate the FDA for not restricting Purdue to marketing the drug for conditions as dire as severe pain caused by lifespan-limiting illness. ER oxycodone would go on to be marketed for uses as low-grade as lower back pain.15 Lax regulatory oversight at the FDA was not limited to approval of new drugs. In 2002, the FDA convened an advisory committee of 10 external experts to determine if the use-cases of common opioids should be narrowed. The committee found that the opioid use standards at the time were acceptable. It later emerged that eight of the experts had financial ties to pharmaceutical companies, including Purdue and other opioid manufacturers. The obvious conflict of interest present on the committee was not evaluated by the FDA, and the panel’s recommendation eliminated an opportunity to reign in the crisis near its onset.15,16 DEA Other governmental organizations like the DEA also failed to act.
As part of its regular duties, the DEA is tasked with publishing and enforcing annual quotas for the production of many classes of drugs, including opioids. Despite increasingly clear indications of a runaway opioid crisis, the DEA failed to moderate its quotas and issue guidance for the reduction of opioid production. Until 2016, the opioid quota was raised every year for several decades. Between 2006 and 2012, DEA quotas permitted the manufacture and distribution of approximately 1 trillion milligrams of the opioids oxycodone and hydrocodone. Given that a standard dose of either drug is 7.5 milligrams, the DEA allowed the production of 130 billion opioid pills. During the same six years, the actual quantity of opioids produced was 57% of the DEA established quota— in other words, the contemporary extremely high level of opioid production was merely 57% of the DEA’s incredibly permissive quota.17 Politicians are also seeking to ascertain the reasoning behind the DEA’s peculiar quota policy. Senators Kennedy (R-La.) and Durbin (D-IL.) issued a public letter in July 2020, urging the DEA to utilize the increased authority granted to it by the Opioid Quota Reform Act of 2018 to adjust opioid quotas to reflect current realities. The letter also scolded the agency’s previous quota increases, noting that DEA allowed aggregate production quotas for many common opioids to increase at incredibly fast rates: in the period between 1993 and 2015, four of the most common opioids had their quotas increase by sizes between 1200% and 3900%.18
Thus, both the FDA and DEA abdicated their responsibilities in regulating the opioid market at critical junctures. While the FDA relied on shoddy methodologies to approve new opioids and failed to address conflicts of interest, the DEA allowed manufacturers to produce a far larger number of opioids than necessary. Both agencies are, at least in part, complicit in the crisis. Conclusion: A Perfect Storm The devastating impacts of the opioid crisis didn’t come about by pure chance: they arrived due to a perfect storm of factors that allowed for the oversupply of drugs, amplification of opioid demand, and lack of oversight. Pharmaceutical giants used crooked marketing and false science to flood the markets with opioids. Drug distributors and governmental agencies didn’t intervene to stop the crisis in its tracks. In short, blame for the opioid crisis can’t be placed on just one group, as many organizations had a hand in the making of the crisis. Learning from their mistakes will be crucial for preventing future calamities.
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T he
t l u u ral C
By Jojo Milan-Howells
Designed by Alyssia Liu and Caroline Paik
Fever. Cough. Shortness of breath. Sore throat. A loss of taste or smell.
We are all aware of the symptoms of SARS-CoV-2 and the effects that it has on our body. How could we not? Our screens were constantly bombarded with the warning signs of SARS-CoV-2 and the typical “bless you” you received when you sneezed was replaced by a judgemental stare. For some people, the months of March 2020 to June 2021, marked a time of panic and detrimental effects to all aspects of life, especially to mental health. 20
Suicide, depression, anxiety levels rose in 2020, especially amongst younger generations. According to a series of surveys released by the U.S. department of health and human services, the prevalence of symptoms of anxiety disorder in June 2020 was approximately three times those reported in the second quarter of 2019 (25.5% versus 8.1%), and the levels of depression was approximately four times that reported in the second quarter of 2019 (24.3% versus 6.5%).1 Suicidal thoughts also increased during this time; approximately twice as many respondents reported serious consideration of suicide in the previous 30 days than did adults in the United States in 2018, referring to the previous 12 months (10.7% versus 4.3%).2 This rampant decline in mental health was not necessarily caused directly by SARS-CoV-2 itself, for example the depression brought by the loss of a family member to the disease, but from our social response to SARS-CoV-2.3 The fact that we were constantly reminded that interacting with our friends and family’s could potentially lead to infection, brought about harm to our social lives and hence our mental health. Most people agree that because of both the physical and mental damage caused by SARS-CoV-2 , that it was a dark time for our world, but there may have been a silver lining in all this chaos; a cultural “reset '' for Gen Z. Any time a group of individuals meet with a giant shock, whether that be a natural disaster or outbreak of violence, there is an inadvertent reset as a result.4 Dr. Kent D.W. Bream, associate professor of Clinical Family Medicine and Community Health at the University of Pennsylvania, noted that he’s already seen a shift in mindset between his current students and his students pre-COVID. Dr. Bream noticed that the pandemic disrupted a cycle of dysfunctional competition at UPenn, by physically removing the need for students to outdo the previous year.5 “If you look at any student group before COVID, everybody was a vice president in charge of something. You join a group and you are only there for a week and suddenly you are the vice president for external affairs. It's a group for like 12 students. I dont know what you are talking about external affairs but there was this need to always outdo the person before you by title, media coverage, attention, or award.”6 Dr. Bream observed that his students lived in a mindset of “You are better than the person who came before you” and needed to prove it in every
facet of their lives.7 Furthermore, this mindset led to an “interminable escalation” in which students always have “to have more money, have a bigger job, have a better grad school, have more papers” than the person who came before them and this “constant need to compare and exceed” one’s predecessors “was particularly toxic before the pandemic.”8 This is where the Covid silver lining comes in. Dr. Bream notes that what caused this cultural reset was the fact that students no longer had anyone else to compare themselves to.9 As a result, they focused more on themselves physically and mentally as they tried to discover their own goals and aspirations instead of basing them on others.10 Furthermore, this independence led people to start questioning the hegemony of group thought and expectations, which ultimately led to a healthier mindset and outlook on life.11 Having seen the positive impact from this dark time, one can only ask if this is going to be a permanent change for Gen Z or are we once again going to find our lives dictated by the generations that came before us?
21
The Deeper Implications of Public Health on our Lives By Erin Lee
Designed by Farhaanah Mohideen The concept of public health has become increasingly more that - public. It’s difficult to remember a time where no one would bat an eye if someone coughed or sneezed on the train, or in a classroom. Fast forwarding to today, that one-second cough can generate a wave of assumptions, skepticism, and even fear in others. The entire world knows far too well how COVID has affected our everyday lives, and how it has affected our health system. But another drastic effect has been the popularization of public health, and how it has been integrated in our day-to-day actions, conversations, and thoughts. With such visible cues of public health compliance, like masking and social distancing policies, it has become common practice to assume we know other’s beliefs regarding the severity of the pandemic. Subtle signs like a mask hanging below the nose, or no mask at all can decide our first impressions of someone before they even speak.1 Because of public health measures - some of our privacy has been lost, namely due to health reporting, tracking, and limits on our physical movement due to social distancing and quarantine protocols.2 But access to the lives of others have been gained; we have become increasingly aware of the activities of others in their personal life and how those activities have affected us. Personal beliefs and health decisions that wouldn’t normally be shared with anyone but close friends and family have now been brought to light, such as feelings towards vaccines and relationships with doctors and medicine in general. Our health is now so closely woven with our social relationships, and our actions more visible to others. This increasing awareness and transparency between us has both benefits and ill effects as we navigate this new space of public health in the years to come. The contrast between the somewhat “private” health of the past and the much more public health we 22
experience now presents an interesting conflict with American ideals. As a whole, Americans value independence, privacy, and individual freedom to make our own choices. These are the very principles that our nation was founded upon. The pandemic, to some, has infringed on these values, with countless mandates and restrictions that have called for total compliance and uniformity in an effort to stop the spread of the virus. With political and economic systems that are often rooted in individualism and privatization, the use and enforcement of public health mandates served as a culture shock for many.3 Amidst a deeply polarized political landscape, the pandemic completely severed America’s biggest political parties, creating arguably the largest division yet, further exacerbated by polarization in media coverage.4 Public health became a political weapon, with logic being thrown to the side and some using non-compliance as a way to channel their feelings towards changes in political power, and express their frustration with their freedoms being taken away. In particular, in the summer of 2020 when lockdown mandates were in full effect, many grouped together in protest of mask and lockdown protocols. Some refused to acknowledge the evidence proving the benefits of wearing masks, while others went as far to claim that COVID is just a conspiracy theory or a hoax.5 While there is too much scientific evidence to disprove the false statements or bewildering excuses that anti-maskers/vaxxers may use, there is no argument that the polarization of our country due to differing views on COVID has held us back from collectively moving forward to continue fighting against the virus, and progressing in other social and political issues. The new found transparency in our social relationships has also caused polarization in our personal relationships. Social situations and gatherings became
an incredibly tricky space to navigate, as otherwise close friends and family members may have come to hold different beliefs on what was acceptable to them in each phase of this changing pandemic. In a sense, we’ve lost the privacy to compartmentalize different parts of our life and the people we spend time with. We have to be transparent about where and with whom we spend our time to be responsible about meeting up with others without potentially exposing them. This isn’t to say that we shouldn’t have to be transparent - in fact, we should all be cognisant of the situations we are putting ourselves and others in, as well as the boundaries that each individual is comfortable with. This is the only way we can limit the spread and the loss of life due to this virus, and any other that we may encounter in the future. While not everyone exactly adopted these practices, the people who adhered to COVID guidelines and continue to be aware of the risks, as the virus still exists, have experienced the subtle but impactful shift in the way that public health is integrated into our lives. Although we have suffered many losses because of the pandemic - having a greater awareness of public health can help us moving forward. With all of the information available to us about the virus, many people have become better at doing their own research and finding out what is or isn’t factual. Additionally, we have become more educated and engaged in our own health. We have experienced ourselves how our own decision-making affects the health of others.
We have been able to expose the health disparities that exist and what needs must be met in the healthcare system, particularly in terms of social determinants of health for minority and low-income communities.6 We have become greater health advocates for ourselves, for our loved ones, and for those that are at higher risk. Yes, we should look forward to the day where the virus is completely eradicated, and masks no longer need to be worn. However, we should not try to bury the pandemic deep in our memory and forget all the lessons we learned with it. We should ask ourselves - how can we continue to be aware of our actions and the implications they have on others? How can we take advantage of this new dynamic between health and social spaces to protect others? At the end of the day, we are all humans with our own lives and loved ones that we care deeply for. Positioning our mindset to be more public health oriented may be a change, but by now, we are experts on change. Our empathy for others should triumph over the minor discomfort of having to be more transparent about our lifestyle. We must learn to protect each other, because above all else, empathy is what we must hold on to - with or without a pandemic.
23
Covid-19 an d Transparency in H ealthcare: Learning from the Theranos Trial
The past two years have been cataclysmic for the healthcare industry, as a global pandemic has disrupted major market dynamics, exacerbated inequities, and overwhelmed infrastructure, workforces, and supply chains. The AHA estimates that recent financial challenges include an average of $50.7 billion per month, including drug shortage costs, wage and labor costs, capital costs, and equipment costs.2 A significant percentage of hospitals in the United States reported negative margins of operation, which tend to significantly impact those who are at a socioeconomic disadvantage as these losses, caused mainly by supply costs, overwhelmed by Covid-19 patients, lack of resources, and cancelled procedures, continue to pile on.5 Among the many pre-existing issues that existed in the American healthcare system that were exacerbated by the onset of the pandemic, one of them is a major lack of transparency between healthcare behemoths and its internal and external stakeholders, as well as its customers and patients.
Written by Saraswati Sridhar 24
Designed by Farhaanah Mohideen
Healthcare markets in the United This issue was demonstrated when federal relief funds and pandemic States have struggled with transpar- 41-45% of entities conducting clin- aid. Congress distributed more ency on a variety of issues for a sig- ical trials for a wide variety of vacthan $100 billion worth in aid as nificant amount of time. For exam- cines and therapeutics being tested part of the Coronavirus Aid, Relief, ple, the pricing of certain services disclosed only their top results and and Economic Security (CARES) involves a complex maze of stakeonly 12% of clinical trial results Act, but major concerns were raised holders, third-parties, and contrac- were made publicly available, while by the American Hospital Associtors. This results in an extremely only 7% of contracts and deals ination (AHA) about the manner in complicated scenario, where it is volved in vaccine distribution were which these funds were distributed: difficult to guarantee efficiency and made publicly available.2 Governfor example, only 44% of federal transparency for all parties, includ- ment agencies, like the FDA, play a funds were truly made available to ing price transparency for users.4 role in this phenomenon, because hospitals and health systems during This issue, as of recently, translated while they choose to explain key the pandemic.3 to a lack of transparency in the decisions and authorizations to the The frenzy and desperation sales of vaccines during interacpublic, they often fail to provide for quick solutions in the realms tions between governments and comprehensive access to the conof COVID-19 management and major pharmaceutical companies crete data and trends they used to treatment also causes widespread to mitigate the pandemic. vulnerability to powerful These dynamics are highly agents acting in bad faith beneficial to specific and participating in exexecutive stakeholders, tremely unethical activities “...Official price rates as it provides a competisuch as price-gouging and are often negotiated behind tive advantage by making fraud, similar to the case closed doors, and the vast highly vital information in Brazil mentioned above. majority of price variability inaccessible from the genA prominent case of wideis shielded from patients...” eral public, and instead spread scamming and fraud choosing to partake in surfacing throughout the elaborate rebate schemes pandemic is that of Elizaand co-pay accumulator beth Holmes’s Theranos, a programs that usually work against make these decisions. This results well-known biotechnology startcustomers and patients. Official in major hindrances in our abiliup aiming to devise technology price rates are often negotiated bety to monitor the true safety and that could employ tiny amounts hind closed doors, and the vast ma- efficacy of the Covid-19 vaccines, of blood to detect a wide variety jority of price variability is shielded as well as safeguard against political of illnesses using portable, inexfrom patients.1 One consequence corruption and manipulation and pensive, and accessible machines. of this lack of transparency is that fraud. One prominent example of Although the crimes this company stakeholders benefiting from this a major shortcoming in vaccine has been charged with are unrelatarrangement is an augmentation in transparency can be illustrated ed to the pandemic, the transparout-of-pocket costs, which in turn, by a serious allegation of potenency problems that led to Holmes’s leads to poorer patient compliance tial corruption in a deal between racket are very similar to those and worse outcomes, further inthe Brazilian government and an experienced by many stakeholders creasing major health disparities. Indian biotechnology giant known throughout the pandemic. Activity The issue of transparency in as Bharat Biotech for their Covexin referred to collectively as “stealth healthcare costs has become even vaccine8; these deals subjected the research” routinely employed by a more important after the advent of Brazilian government to investivariety of up-and-coming medical a global pandemic. A major risk to gation of possible fraud and finanbreakthrough and biotechnology the response to the pandemic on a cial and contractual irregularities. startups, characterized by a broad global scale is an extension of the Moreover, major vulnerable stakelack of peer-reviewed evidence.9 previously described lack of data holders were also privy to a lack of As a result, the valuation of these transparency to government deals. transparency in the distribution of companies are often significantly 25
disconnected from concrete and externally-sourced data. As seen with this particular case, a lack of transparency about a company’s prog-
and therapeutics, so the issue of audit hospitals for compliance data transparency, especially with with existing transparency requireregard to clinical trials, is highly ments, and requiring all hospitals prescient and applicable. to present services in a comprehen A lack of sive and user-friendly shoppable transparency format. During a historic price in healthcare transparency initiative during this dealings contime period, most private health“A lack of transparency in tributed to an care plans were required to disclose healthcare dealings contribexacerbation price and cost-sharing information uted to an exacerbation of of healthcare to the public. This information is healthcare inequities that inequities that presented to the public in the form have a disproportionate imhave a disof an online, personalized tool conproportionate taining information about all of a pact on the most vulnerable impact on the patient’s out-of-pocket costs, negomembers of our populace inmost vulnerable tiated rates between providers and cluding low-income families members of our third parties, and historical inforand communities of color.” populace inmation on all charges and prices.7 cluding low-in- Similar laws (both pre-existing and come families new laws) could be implemented to and communimake all dealings between governress and numerically quantified ties of color. Factors that aggravate ments and companies completely technological outcomes among the inequity include loss of health inaccessible to the public. Another internal stakeholders and investors surance, lack of price transparency, step towards increased healthcare in the company led to fraudulent and the spread of misinformation transparency could also involve behavior and serious legal conseand distrust. Often, the vulnerabili- eliminating large quantities of red quences. Unfortunately, such major ty of these populations places them tape, third-party dynamics and issues presented in the Theranos at higher risk for being exploited by sometimes the parties themselves, dealings are not unique solely to the many faults in our healthcare as well as exploitative rebate and larger healthcare markets; studies system. There are many possible copay-accumulation schemes. In have shown that more than half of solutions to the meagre healthcare conjunction, these solutions emall biotechnology startups are worth transparency at the industrial and ployed in a concerted and compremore than $1 billion and 40% of governmental companies in the general context. levels. For exam“...laws could be implemented Overvaluation of certain companies ple, large compato make all dealings between can lead to unrealistically high exnies and startups governments and companies pectations from both stakeholders should be reand consumers that contribute to a quired to particcompletely accessible to the wider-scale hindrance of important ipate in scientific public.” predictions and action regarding peer-review of outbreak response, management, their data beand treatment. It also contributes to yond a clandesreduced trust in large pharmaceutine circle of investors and execuhensive manner, can be instrumentical agencies and governments as tives, in order to produce a greater tal to reducing costs and improving well as the promulgation of conlevel of accuracy in predictions of outcomes and healthcare security spiracy theories and misinformadisease management and company both nationally and globally. tion.6 During the pandemic, there valuation. At the level of hospitals was an uptake in a wide variety of and medical care, legislation was new startup companies dedicated to introduced during 2019 and 2020 the development of novel vaccines by the Trump administration to 26
Patient Reported Outcomes: The New Future of Diagnosis By Eesha Balar Designed by Caroline Paik In a world where we are constantly seeking to improve, how can we optimize the efficiency of our healthcare system and make sure patients receive the care they need? Surprisingly, the solution may stem from a concept as simple as the patient-provider relationship. Traditionally, within this relationship, voices are heard unequally, with the physician holding the upper hand and making decisions based on what he or she sees clinically, often without much input on how patients truly feel. With shifting times and increasing awareness of the patient’s role in making health-related decisions, enter the patient-reported outcome (PRO) measurement system—patients are starting to have their voice heard as well, allowing for better communication regarding their needs, and a more reciprocal, transparent relationship. How are patient-reported outcome measurement systems formatted and integrated in routine practice? The idea behind recording patient-reported outcomes is relatively simple—physicians can use a system to send patients a comprehensive list of questions, ranging from quality of life to specific symptoms they feel in relation to their disease to adherence to their current treatment plan, and use their answers to gain a well-rounded depiction of the patient for a more targeted treatment plan. While thoroughly developed for clinical trials, this measurement is relatively new to the medical practice world. The questionnaires, typi-
cally around 9-12 questions, are formed using well-established professional “rubrics,” such as the Common Terminology Criteria for Adverse Events (CTCAE), and are conducted electronically through email, telephone systems, or in-clinic kiosks. Depending on the practice, patients are sent reminders through their system of choice to complete the survey before, during, and/or after the visit. The systems used to measure these PROs vary in their features; for example, the eRAPID, or the Electronic patient self-Reporting of Adverse events: Patient Information and aDvice, system used commonly in oncology requires patients to report their symptoms from home, and the resulting data is transferred directly to the patient’s electronic health record in advance of the consultation. Another system used at Memorial Sloan Kettering Cancer Center sent automatic alerts to clinicians if a patient reported an answer indicating a serious symptom, or severely worsening conditions compared to the last time the survey was completed.1 What are the benefits and downfalls in utilizing PRO measurements? The benefits to PROs are believed to outweigh its harms, for both the patient and physician. Generally, PROs can be taken across different disciplines, including oncology, primary care, surgical procedures, and beyond. Another important aspect is the system’s facilitation of critical care, as immediate action can be taken in response to completing a survey on PROs to prevent the patient’s health from deteriorating. Ad-
27
ditionally, for the information that it provides to the physician, minimal time is needed for patients to complete their part. On the other hand, the data provided by patients will prevent any asymmetrical information exchange and cover any gaps in the physician’s “outsider” assessment—only the patient knows how they are truly feeling. On the scientific end, PROs will contribute toward a better understanding of the effects of the disease, assisting with future cases. More personally, in developing a specific course of treatment, the physician can be made more aware of the patient’s preferences. At the same time, there are many limitations when it comes to PROs. For example, the questionnaires are not always written perfectly and they do not include question or answer choices that are relevant to the patients’ condition. In a study on Parkinson’s patients at a Swedish university hospital, many patients felt that important areas regarding their health state were missing, or that questions did not provide any accurate options of how they were feeling. Additionally, the way the questionnaire was used in the study was inadvertently less relevant for certain populations, such as the elderly and those with worse health.2 In thinking about disparities, many PRO surveys are implemented on technology that not everyone may have access to. There are even deeper disparities of race, ethnicity, and education level— an investigation on backgrounds of patients who are willing to provide PROs displayed a significant difference between white and nonwhite groups, the youth and elderly, and those at higher education levels versus less-educated people, with the latter of each comparison not being fully represented by patient data.3 Another such barrier of usage pertains to errors that have not yet been addressed with wording, as PROs have only recently been introduced into the hospital setting. For example, patients may misinterpret an ambiguous question and select the incorrect choice. Additionally, questionnaires with only multiple choice-style formats and numerical scale answers, rather than open-ended style prompts, may not reflect accurately how patients really feel. In a mere 9 questions, how well can patients’ symptoms truly be assessed? There is still more research to be conducted on the reliability of PRO systems in displaying and therefore improving patients’ well-being, but the bene28
fits seen thus far are promising. What does the future look like for PROs? PROs are increasingly being integrated with more advanced technology, especially applications on mobile devices. For instance, one recent app from Minnesota, called the PROMIS Reporting Insight System from Minnesota, is designed to be user-friendly and utilized in a variety of ambulatory settings in addition to for research. It addresses the issue of PRO data being transferred to health information technology systems, which makes it difficult for medical personnel to use and share information for research, by rendering it directly accessible for clinicians during a visit. The app is also unique in how it utilizes an algorithm to generate recommendations for the patient based on answers given and provides a live comparison to others with similar ailments, adding to physicians’ knowledge of symptom trends and providing patients with an idea of how others may be treated.4 In the future, such apps will therefore be useful in improving reliability in data and patients represented. Arguably, the most impactful application of patient data from PRO-measuring technology like PRISM is towards policy. A retrospective study discusses how data could be used in guiding pharmaceutical labelling of side effects, setting health policies on improving quality of life, and creating more effective clinical guidelines for professionals to refer to.5 With increasing usage of PRO-based tools, we may see many actions within our healthcare system not only shaped by administration, but also by the very agents the institution was set up to aid: patients. Overall, the PRO measurement system shows promise in providing patients a better ability to communicate with their physician. However, implementing this in all hospital systems and medical practices will require us to take a deeper look into possible barriers on both the patient and physician end. With current trends and new methods of implementing PROs, we can only hope that it will contribute towards greater transparency between patients and providers, and improve clinical decision-making within the wider healthcare community.
“There are even
deeper disparities of race, ethnicity, and education level”
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WHARTON UNDERGRADUATE HEALTHCARE CLUB
