19 minute read
Written by Leeyu Addisu, Designed by Alyssia Liu
TRANSPARENCY IN BIOMETRIC DATA STORAGE
By Leeyu Addisu Designed by Alyssia Liu
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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 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.
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
However, this does have its benefits. For example, new generation Apple watches can monitor the environment and warn of dangers such as loud noises or detect falls and call for help.4 Apple is also putting some of the biometric data collected to good use with their Apple Research app. This app allows consenting Apple watch owners to join health studies in which data from their 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.
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 illuminate the precise uses of biometric data. Increasing transparency will be essential to our future as an advanced society, as technological innovations create new privacy concerns. Transparency will be the key to the most optimal and safe implementation of such technologies.
The Ethics of Informed Consent:
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. 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
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 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 “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
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
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 distributor 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
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.
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).
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.
