Bioethics

Xenotransplantation: Ethics and Public Policy Need To Catch up to the Science

March 5, 2022
Bioethics, Biotechnology, Discrimination, Ethics, FDA, Health, Medical Devices, New Technology, Personalized Medicine

Claire Colby, MJLST Staffer

In early January, surgeons at the University of Maryland Medical Center made history by successfully transplanting a genetically altered pig heart to a human recipient, David Bennett. The achievement represents a major milestone in transplantation. The demand for transplantable organs far outpaces the supply, and xenotransplantation–the implantation of non-human tissue into human recipients–could help bridge this gap. In the U.S. alone, more than 106,000 people are on the waiting list for transplants. Legal and ethical questions remain open about the appropriateness of implementing xenotransplants on a large scale.

The FDA approved the January transplant through an emergency authorization compassionate use pathway because Bennett likely would have died without this intervention. Larger clinical trials will be needed to generate enough data to show that xenotransplants are safe and effective. The FDA will require these trials to show xenotransplantations are non-inferior to human organ transplants. IRB requirements bar interventions where risk outweighs benefits for patients, but accurately predicting and measuring risk is difficult.

If xenotransplantation becomes standard clinical practice, animal rights proponents may balk at the idea of raising pigs for organs. Far before that point, pre-clinical trials will make heavy use of animal models. Institutional Animal Care and Use Committees (IACUCs) which oversee animal research in universities and medical entities apply a “much lower ethical standard” for animals than human research subjects. Bioethicists apply a “3R” framework for animal subjects research that stresses replacing animal models, reducing animal testing, and refining their use. Because of the inherent nature of xenotransplantation, applying this framework may be near impossible. Ongoing discussions are needed with relevant stakeholders.

If both human and animal organs are approved for widespread transplant, but human organs prove superior, new allocation policies are needed to determine who gets what. Organ allocation policy is currently dictated by the Organ Procurement and Transplantation Network (OPTN). As it stands, organ transplantation shows inequality across racial groups and financial status. New allocation policies for organs must not reinforce or worsen these disparities.

Like all medical interventions, patients must be able to provide informed consent for xenotransplantation. The recipient of the altered pig heart had previously been deemed ineligible for a human heart transplant because his heart failure was poorly managed. Reserving experimental interventions, like xenotransplantations, for the sickest patients raises serious ethical concerns. Are these desperate patients truly able to give meaningful consent? If xenotransplantation becomes a common practice, the traditional model of institutional review boards may need updating. Currently, individual institutions maintain their own IRBs. Xenotransplantation of altered animal organs may involve several sites: procurement of the organ, genetic editing, and transplantation may all take place in different locations. A central IRB for xenotransplantation could standardize and streamline this process.

In all, xenotransplantation represents an exciting new frontier in transplant medicine. Responsibly implementing this innovation will require foresight and parallel innovation in ethics and public policy.

The Mysterious Disappearance of Deference: What Is the Supreme Court’s Current Relationship to Federal Agencies?

February 7, 2022
Administrative Law, Bioethics, Copyrights, Regulatory, Uncategorized

Carly Michaud, MJLST Staffer

The Supreme Court has had no shortage of administrative law cases in the (possibly) final sessions of one of the Court’s administrative law scholars, Justice Stephen Breyer. Yet, Breyer has found himself and his ideological compatriots in the opposition on the topic in which he situates his expertise. In the recent case regarding OSHA’s ability to require COVID-19 vaccines, Breyer’s dissent repeated discusses the proper deference an agency’s determination should be given by the Supreme Court.

Notably absent from the case is any mention of the previous key to the relationship between the courts and federal agencies: Chevron deference. In fact, Chevron U.S.A., Inc. v. National Resources Defense Council, was, (as of a 2014 analysis in the Yale Journal on Regulation) the “Most Cited Supreme Court Administrative Law decision”. While previously considered a niche area, administrative law is now so ubiquitous in practice that as of July 2021, 55 law schools require students take a course in administrative law or one of its mainstays: legislation or statutory interpretation.

In spite of this, Chevron appears nowhere in the discussion of OSHA’s vaccine mandate, nor in the court’s earlier revocation of the CDC’s eviction moratorium. This absence suggests that perhaps this Court has become a body of health experts, relying on their own understanding of COVID-19 to determine whether these agency-created regulations are effective in their mission. Both cases center on whether an agency action to prevent the spread of COVID-19 is within the purview of their empowering statute, and, despite the broad statutory authorities of these agencies to protect the health of Americans, both actions were deemed beyond that authority.

But back to Chevron, has it been abandoned as a standard? Not yet, although there was some discussion of this proposition during the oral argument of American Hospital Association v. Becerra last November. The Court has not released an opinion yet on this case, however the Court of Appeals had previously upheld HHS’s ability to set reembursement rates, per its statutory authority.

In a final thrust of irony, the death knell for Chevron deference may come from a case challenging the very statute and the very agency whose decision-making was at issue in Chevron: the EPA and the Clean Air Act. This is particularly ironic as the EPA administrator whose decision-making was being challenged in Chevron was Anne Gorsuch, the mother of Supreme Court justice and noted antagonist of agency authority: Neil Gorsuch. Yes, in a tale mirroring Hamlet, Neil Gorsuch seems determined to destroy the administrative state that had entangled his mother in various administrative scandals. The latest edition of this showdown between the Gorsuchs and EPA is scheduled for Monday February 28, which will see the Supreme Court hearing arguments in West Virginia v. EPA and its consolidated cases.

This behavior by the Court belies a grave concern both about the continued disempowerment of federal agencies—which have been empowered directly by Congress—at the hands of the unelected judiciary. Further, the most cynical of us may see this as a direct assault on the authority of agencies that some justices may politically disagree with, further disregarding the knowledge of learned experts to push their own political agendas.

You Wouldn’t 3D Print Tylenol, Would You?

October 12, 2021
3-D Printing, Administrative Law, Bioethics, Biotechnology, FDA, Food and Drug Law, Health, Healthcare, Healthcare Reform, Medical Devices, Personalized Medicine, Pharmaceuticals, Uncategorized

By Mason Medeiros, MJLST Staffer

3D printing has the potential to change the medical field. As improvements are made to 3D printing systems and new uses are allocated, medical device manufacturers are using them to improve products and better provide for consumers. This is commonly seen through consumer use of 3D-printed prosthetic limbs and orthopedic implants. Many researchers are also using 3D printing technology to generate organs for transplant surgeries. By utilizing the technology, manufacturers can lower costs while making products tailored to the needs of the consumer. This concept can also be applied to the creation of drugs. By utilizing 3D printing, drug manufacturers and hospitals can generate medication that is tailored to the individual metabolic needs of the consumer, making the medicine safer and more effective. This potential, however, is limited by FDA regulations.

3D-printed drugs have the potential to make pill and tablet-based drugs safer and more effective for consumers. Currently, when a person picks up their prescription the drug comes in a set dose (for example, Tylenol tablets commonly come in doses of 325 or 500 mg per tablet). Because the pills come in these doses, it limits the amount that can be taken to multiples of these numbers. While this will create a safe and effective response in most people, what if your drug metabolism requires a different dose to create maximum effectiveness?

Drug metabolism is the process where drugs are chemically transformed into a substance that is easier to excrete from the body. This process primarily happens in the kidney and is influenced by various factors such as genetics, age, concurrent medications, and certain health conditions. The rate of drug metabolism can have a major impact on the safety and efficacy of drugs. If drugs are metabolized too slowly it can increase the risk of side effects, but if they are metabolized too quickly the drug will not be as effective. 3D printing the drugs can help minimize these problems by printing drugs with doses that match an individual’s metabolic needs, or by printing drugs in structures that affect the speed that the tablet dissolves. These individualized tablets could be printed at the pharmacy and provided straight to the consumer. However, doing so will force pharmacies and drug companies to deal with additional regulatory hurdles.

Pharmacies that 3D print drugs will be forced to comply with Current Good Manufacturing Procedures (CGMPs) as determined by the FDA. See 21 C.F.R. § 211 (2020). CGMPs are designed to ensure that drugs are manufactured safely to protect the health of consumers. Each pharmacy will need to ensure that the printers’ design conforms to the CGMPs, periodically test samples of the drugs for safety and efficacy, and conform to various other regulations. 21 C.F.R. § 211.65, 211.110 (2020). These additional safety precautions will place a larger strain on pharmacies and potentially harm the other services that they provide.

Additionally, the original drug developers will be financially burdened. When pharmacies 3D print the medication, they will become a new manufacturing location. Additionally, utilizing 3D printing technology will lead to a change in the manufacturing process. These changes will require the original drug developer to update their New Drug Application (NDA) that declared the product as safe and effective for use. Updating the NDA will be a costly process that will further be complicated by the vast number of new manufacturing locations that will be present. Because each pharmacy that decides to 3D print the medicine on-site will be a manufacturer, and because it is unlikely that all pharmacies will adopt 3D printing at the same time, drug developers will constantly need to update their NDA to ensure compliance with FDA regulations. Although these regulatory hurdles seem daunting, the FDA can take steps to mitigate the work needed by the pharmacies and manufacturers.

The FDA should implement a regulatory exception for pharmacies that 3D print drugs. The exemption should allow pharmacies to avoid some CGMPs for manufacturing and allow pharmacies to proceed without being registered as a manufacturer for each drug they are printing. One possibility is to categorize 3D-printed drugs as a type of compounded drug. This will allow pharmacies that 3D print drugs to act under section 503A of the Food Drug & Cosmetic Act. Under this section, the pharmacies would not need to comply with CGMPs or premarket approval requirements. The pharmacies, however, will need to comply with the section 503A requirements such as having the printing be performed by a licensed pharmacist in a state-licensed pharmacy or by a licensed physician, limiting the interstate distribution of the drugs to 5%, only printing from bulk drugs manufactured by FDA licensed establishments and only printing drugs “based on the receipt of a valid prescription for an individualized patient”. Although this solution limits the situations where 3D prints drugs can be made, it will allow the pharmacies to avoid the additional time and cost that would otherwise be required while helping ensure the safety of the drugs.

This solution would be beneficial for the pharmacies wishing to 3D print drugs, but it comes with some drawbacks. One of the main drawbacks is that there is no adverse event reporting requirement under section 503A. This will likely make it harder to hold pharmacies accountable for dangerous mistakes. Another issue is that pharmacies registered as an outsourcing facility under section 503B of the FD&C Act will not be able to avoid conforming to CGMPs unless they withdraw their registration. This issue, however, could be solved by an additional exemption from CGMPs for 3D-printed drugs. Even with these drawbacks, including 3D-printed drugs under the definition of compounded drugs proposes a relatively simple way to ease the burden on pharmacies that wish to utilize this new technology.

3D printing drugs has the opportunity to change the medical drug industry. The 3D-printed drugs can be specialized for the individual needs of the patient, making them safer and more effective for each person. For this to occur, however, the FDA needs to create an exemption for these pharmacies by including 3D-printed drugs under the definition of compounded drugs.

Intellectual Property in Crisis: Does SARS-CoV-2 Warrant Waiving TRIPS?

February 21, 2021
Bioethics, Biotechnology, COVID-19, Food and Drug Law, Health, Healthcare, Intellectual Property, Patents, Regulatory

Daniel Walsh, MJLST Staffer

The SARS-CoV-2 virus (which causes the disease COVID-19) has been a massive challenge to public health causing untold human suffering. Multiple vaccines and biotechnologies have been developed to combat the virus at a record pace, enabled by innovations in biotechnology. These technologies, vaccines in particular, represent the clearest path towards ending the pandemic. Governments have invested heavily in vaccine development. In May 2020 the United States made commitments to purchase, at the time, untested vaccines. These commitments were intended to indemnify the manufacture of vaccines allowing manufacturing to begin before regulatory approval was received from the Food and Drug Administration. The United States was not alone. China and Germany, just to name two, contributed heavily to funding the development of biotechnology in response to the pandemic. It is clear that both private and public institutions contributed heavily to the speed with which biotechnology has been developed in the context of the SARS-CoV-2 pandemic. However, there are criticisms that the public-private partnerships underlying vaccine manufacturing and distribution have been opaque. The contracts between governments and manufacturers are highly secretive, and contain clauses that disadvantage the developing world, for example forbidding the donation of extra vaccine doses.

Advanced biotechnology necessarily implicates intellectual property (IP) protections. Patents are the clearest example of this. Patents protect what is colloquially thought of as inventions or technological innovations. However, other forms of IP also have their place. Computer code, for example, can be subject to copyright protection. A therapy’s brand name might be subject to a trademark. Trade secrets can be used to protect things like clinical trial data needed for regulatory approval. IP involved in the pandemic is not limited to technologies developed directly in response to the emergence of SARS-CoV-2. Moderna, for example, has a variety of patents filed prior to the pandemic that protect its SARS-CoV-2 vaccine. IP necessarily restricts access, however, and in the context of the pandemic this has garnered significant criticism. Critics have argued that IP protections should be suspended or relaxed to expand access to lifesaving biotechnology. The current iteration of this debate is not unique; there is a perennial debate about whether it should be possible to obtain IP which could restrict access to medical therapies. Many nations have exceptions that limit IP rights for things like medical procedures. See, e.g., 35 U.S.C. 287(c).

In response to these concerns the waiver of a variety of IP protections has been proposed at the World Trade Organization (WTO). In October 2020 India and South Africa filed a communication proposing “a waiver from the implementation, application and enforcement of Sections 1, 4, 5, and 7 of Part II of the TRIPS Agreement in relation to prevention, containment or treatment of COVID-19.” The Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS Agreement) sets minimum standards for IP standards, acquisition, and enforcement and creates an intergovernmental dispute resolution process for member states. Charles R. McManis, Intellectual Property and International Mergers and Acquisitions, 66 U. Cin. L. Rev. 1283, 1288 (1998). It is necessary to accede to TRIPS in order to join the WTO, but membership in the WTO has significant benefits, especially for developing nations. “Sections 1, 4, 5, and 7 . . .” relate to the protection of copyrights, industrial designs, patents, and trade secrets respectively. Waiver would permit nation states to provide intellectual property protections “in relation to prevention, containment or treatment of COVID-19” that fall below the minimum standard set by the TRIPs Agreement. At time of writing, 10 nations have cosponsored this proposal.

This proposal has been criticized as unnecessary. There is an argument that patents will not enter effect until after the current crisis is resolved, implying they will have no preclusive effect. However, as previously mentioned, it is a matter of fact that preexisting patents apply to therapies that are being used to treat SARS-CoV-2. Repurposing is common in the field of biotechnology where existing therapies are often repurposed or used as platforms, as is the case with mRNA vaccines. However, it is true that therapies directly developed in response to the pandemic are unlikely to be under patent protection in the near future given lag between filing for and receiving a patent. Others argue that if investors perceive biotech as an area where IP rights are likely to be undermined in the event of an emergency, it will reduce marginal investment in vaccine and biotech therapies. Finally, critics argue that the proposal ignores the existing mechanisms in the TRIPS Agreement that would allow compulsory licensing of therapies that nations feel are unavailable. Supporters of the status quo argue that voluntary licensing agreements can serve the needs of developing nations while preserving the investments in innovation made by larger economies.

The waiver sponsors respond that a wholesale waiver would permit greater flexibility in the face of the crisis, and be a more proportionate response to the scale of the emergency. They also assert that the preexisting compulsory licensing provisions are undermined by lobbying against compulsory licensing by opponents of the waiver, though it is unlikely that this lobbying would cease even if a waiver were passed. The sponsors also argue that the public investment implies that any research products are a public good and should therefore be free to the public.

It is unclear how the current debate on TRIPS will be resolved. The voluntary licensing agreements might end up abrogating the need for a wholesale waiver of IP protections in practice rendering the debate moot. However, the WTO should consider taking up the issue of IP protections in a crisis after the current emergency is over. The current debate is a reflection of a larger underlying disagreement about the terms of the TRIPS Agreement. Further, uncertainty about the status of IP rights in emergencies can dissuade investment in the same way as erosion of IP rights, implying that society may pay the costs of decreased investment without reaping any of the benefits.

A Cold-Blooded Cure: How COVID-19 Could Decimate Already Fragile Shark Populations

October 10, 2020
Animal Law, Bioethics, COVID-19, Environment, Environmental Law, Healthcare, Maritime Law, Pharmaceuticals, Public Health

Emily Kennedy, MJLST Staffer

Movies like Jaws, Deep Blue Sea, and The Meg demonstrate that fear of sharks is commonplace. In reality, shark attacks are rare, and such incidents have even decreased during the COVID-19 pandemic with fewer people enjoying the surf and sand. Despite their bad, Hollywood-driven reputation sharks play a vital role in the ocean ecosystem. Sharks are apex predators and regulate the ocean ecosystem by balancing the numbers and species of fish lower in the food chain. There are over 500 species of sharks in the world’s oceans and 143 of those species are threatened, meaning that they are listed as critically endangered, endangered, or vulnerable. Sharks are particularly vulnerable because they grow slowly, mature later than other species, and have relatively few offspring. Shark populations are already threatened by ocean fishing practices, climate change, ocean pollution, and the harvesting of sharks for their fins. Sharks now face a new human-imposed threat: COVID-19.

While sharks cannot contract the COVID-19 virus, the oil in their livers, known as squalene, is used in the manufacture of vaccines, including COVID-19 vaccines currently being developed. Shark squalene is harvested via a process known as “livering,” in which sharks are killed for their livers and thrown back into the ocean to die after having their livers removed. The shark squalene is used in adjuvants, ingredients in vaccines that prompt a stronger immune response, and has been used in U.S. flu vaccines since 2016. Approximately 3 million sharks are killed every year to supply squalene for vaccines and cosmetic products, and this number will only increase if a COVID-19 vaccine that uses shark squalene gains widespread use. One non-profit estimates that the demand for COVID-19 vaccines could result in the harvest of over half a million sharks.

Sharks, like many other marine species, are uniquely unprotected by the law. It is easier to protect stationary land animals using the laws of the countries in which their habitats are located. However, ocean habitats largely ungoverned by the laws of any one country. Further, migratory marine species such as sharks may travel through the waters of multiple countries. This makes it difficult to enact and enforce laws that adequately protect sharks. In the United States, the Lacey Act, the Endangered Species Act, and the Magnuson-Stevens Fishery Conservation and Management Act govern shark importation and harvesting practices. One area of shark conservation that has gotten attention in recent years is the removal of shark fins for foods that are considered delicacies in some countries. The Shark Conservation Act was passed in the United States in response to the crisis caused by shark finning practices, in addition to the laws that several states had in place banning the practice. The harvest of shark squalene has not garnered as much attention as of yet, and there are no United States laws enacted to specifically address livering.

Internationally, the Convention on the Conservation of Migratory Species of Wild Animals (CMS) and the International Plan of Action for the Conservation and Management of Sharks (IPOA) are voluntary, nonbinding programs. Many of the primary shark harvesting nations have not signed onto CMS. The Convention on International Trade in Endangered Species of Wild Flora and Fauna (CITES) is binding, but there are loopholes and only 13 shark species are listed. In addition to these international programs, some countries have voluntarily created shark sanctuaries.

Nations that have refused to agree to voluntary conservation efforts, that circumvent existing international regulations, and lack sanctuaries leave fragile shark species unprotected and under threat. The squalene harvesting industry in particular lacks transparency and adequate regulations, and reports indicate that protected and endangered shark species end up as collateral damage in the harvesting process. A wide array of regional and international interventions may be necessary to provide sharks with the conservation protections they so desperately need.

Research and development of medical cures and treatments for humans often comes with animal casualties, but research to development of the COVID-19 vaccine can be conducted in a way that minimizes those casualties. There is already some financial support for non-animal research approaches and squalene can also be derived and synthesized from non-animal sources. Shark Allies, the conservation group that created a Change.org petition that now has over 70,000 signatures, suggests that non-shark sources of squalene be used in the vaccine instead, such as yeast, bacteria, sugarcane, and olive oil. These non-animal adjuvant sources are more expensive and take longer to produce, but the future of our oceans may depend on such alternative methods that do not rely on “the overexploitation of a key component of the marine environment.”

Pacemakers, ICDs, and ICMs – oh my! Implantable heart detection devices

November 16, 2019
Bioethics, Data, Healthcare, Privacy

Janae Aune, MJLST Staffer

Heart attacks and heart disease kill hundreds of thousands of people in the United States every year. Heart disease affects every person differently based on their genetic and ethnic background, lifestyle, and family history. While some people are aware of their risk of heart problems, over 45 percent of sudden heart cardiac deaths occur outside of the hospital. With a condition as spontaneous as heart attacks, accurate information tracking and reporting is vital to effective treatment and prevention. As in any market, the market for heart monitoring devices is diverse, with new equipment arriving every year. The newest device in a long line of technology is the LINQ monitoring device. LINQ builds on and works with already established devices that have been used by the medical community.

Pacemakers were first used effectively in 1969 when lithium batteries were invented. These devices are surgically implanted under the skin of a patient’s chest and are meant to help control the heartbeat. These devices can be implanted for temporary or permanent use and are usually targeted at patients who experience bradycardia, a slow heart rate. These devices require consistent check-ins by a doctor, usually every three to six months. Pacemakers must also be replaced every 5 to 15 years depending on how long the battery life lasts. These devices revolutionized heart monitoring but involve significant risks with the surgery and potential device malfunctioning.

Implantable cardioverter defibrillators (ICD) are also surgically implanted devices but differ from pacemakers in that they deliver one shock when needed rather than continuous electrode shocks. ICDs are similar to the heart paddles doctors use when trying to stimulate a heart in the hospital – think yelling “charge” and the paddles they use. These devices are used mostly in patients with tachycardia, a heartbeat that is too fast. Implantation of an ICD requires feeding wires through the blood vessels of the heart. A subcutaneous ICD (S-ICD) has been newly developed and gives patients who have structural defects in their heart blood vessels another option of ICDs. Similar to pacemakers, an ICD monitors activity constantly, but will be read only at follow-up appointments with the doctor. ICDs last an average of seven years before the battery will need to be replaced.

The Reveal LINQ system is a newly developed heart monitoring device that records and transmits continuous information to a patient’s doctor at all times. The system requires surgical implantation of a small device known as the insertable cardiac monitor (ICM). The ICM works with another component called the patient monitor, which is a bedside monitor that transmits the continuous information collected by the ICM to a doctor instantly. A patient assistant control is also available which allows the patient to manually mark and record particular heart activities and transmit those in more detail. The LINQ system allows a doctor to track a patient’s heart activity remotely rather than requiring the patient to come in for the history to be examined. Continuous tracking and transmitting allow a patient’s doctor to more accurately examine heart activity and therefore create a more effective treatment approach.

With the development of wearable technology meant to track health information and transmit it to the wearer, the development of devices such as the LINQ system provide new opportunities for technologies to work together to promote better health practices. The Apple Watch series 4 included electrocardiogram monitoring that records heart activity and checks the reading for atrial fibrillation (AFB). This is the same heart activity pacemakers, ICDs, and the LINQ system are meant to monitor. The future capability of heart attack and disease detection and treatment could be massively impacted by the ability to monitor heart behavior in multiple different ways. Between the ability to shock your heart, continuously monitor and transmit information about it, and report to you when your heart rate may be experiencing abnormalities from a watch it seems as if a future of decreased heart problems could be a reality.

With all of these newly developed methods of continuous tracking, it begs the question of how all of that information is protected? Health and heart behavior, which is internal and out of your control, is as personal as information gets. Electronic monitoring and transmission of this data opens it up to cybersecurity targeting. Cybersecurity and data privacy issues with these devices have started to be addressed more fully, however the concerns differ depends on which implantable device a patient has. Vulnerabilities have been identified with ICD devices which would allow an unauthorized individual to access and potentially manipulate the device. Scholars have argued that efforts to decrease vulnerabilities should be focused on protecting the confidentiality, integrity, and availability of information transmitted by implantable devices. The FDA has indicated that the use of a home monitor system could decrease the potential vulnerabilities. As the benefits from heart monitors and heart data continue to grow, we need to be sure that our privacy protections grow with it.

Supervised Injection Facilities: A Step in the Right Direction to Mitigate the Opioid Crisis or a Violation of Federal Law?

February 19, 2019
Bioethics, Drug Policy, Pharmaceuticals

Jessica Swanson, MJLST Staffer

Plans for the nation’s first supervised injection facility hit a snag earlier this month when Philadelphia’s top prosecutor filed a federal complaint to keep it from opening its doors. Supervised injection facilities (SIFs) are legally sanctioned facilities that allow people to consume pre-obtained drugs under the supervision of trained staff and are designed to reduce the number of lives that would otherwise be lost to overdoses and provide a bridge to treatment. SIF staff members do not directly assist in consumption or handle any drugs brought in by clients, but are employed to provide sterile injection supplies, free testing, free distribution of the opioid overdose reversal medication, monitoring services for overdoses, and answers to questions about safe injection practices. SIF staff also offer general medical advice and referrals to drug treatment and other social support programs. There are approximately 120 SIFs currently operating in twelve countries around the world, but none in the U.S. However, a handful of U.S. cities, including New York, Seattle, Denver, San Francisco, and Delaware, have inched toward making SIFs a reality as each struggles to combat the increasing amount of drug-related deaths due to the opioid crisis. Philadelphia is by far the closest to becoming home to the nation’s first SIF, incorporated as “Safehouse.” However, on February 5th, the U.S. Attorney for the Eastern District of Pennsylvania, William McSwain, filed a lawsuit aimed at blocking Safehouse from opening its doors.

The civil lawsuit, which is jointly being pursued by Pennsylvania Attorney General Josh Shapiro and the Department of Justice in Washington asks a judge to declare such a facility illegal under federal law. Instead of waiting for Safehouse to open and then conducting arrests and a prosecution, McSwain is asking U.S. District Court Judge, Gerald McHugh, to rule on the legality of SIF plans in general. According to the complaint, a supervised injection site would violate a section of the 1986 Controlled Substances Act (CSA). The relevant section, also known as the “crack house statute,” was enacted during the height of the crack epidemic and was primarily used to shut down crack houses. The CSA makes it a felony punishable by up to 20 years in prison to knowingly open or maintain any place, regardless of compensation, for the purpose of using controlled substances. McSwain argues that Safehouse seeks to disregard the law and override Congress’ regulatory scheme by establishing, managing, and controlling sites in Philadelphia that will allow individuals to engage in the illicit use of controlled substances. Ronda Goldfein, vice president and attorney for Safehouse, argues CSA was not intended to apply to a medical facility focused on saving lives and moving people who are addicted to opioids into treatment. She argues the provision of the CSA in question is widely known to prosecute situations that involve crimes such as drug sales out of a car dealership or music festivals that allowed illegal drugs to flow freely. Safehouse, on the other hand, is a facility with good-faith efforts to improve public health.

Although other states like Pennsylvania are well-intentioned in opening SIFs, it is likely that the Controlled Substances Act is broad enough to encompass SIFs and thus bar them from operating. If Philadelphia or others want to open this type of site, they might want to steer their efforts towards changing the law. Overall, other cities that have expressed their intention of opening a SIF will be watching this case closely as it serves as an important test to determine the legality of SIFs.

Act Fast! Get Access To Your Genetic Past, Present, and Future For One Low, Low Price

October 23, 2017
Bioethics, Health

Hannah Mosby, MJLST Staffer

It’s Saturday morning, and you’re flipping through channels on your TV when you hear the familiar vocal inflections of an infomercial. For three monthly installments of $19.99, you can get access to your complete genetic ancestry, and any genetic predispositions that might impact your health—both now and in the future. From the comfort of your couch, you can order a kit, provide a DNA sample, and poof. . . a month or two later, you know everything you could ever want to know about your own genetic makeup. Sounds a little far-fetched, right?

Wrong. It’s 2017, and genetic testing kits are not only readily accessible to the public—they’re relatively inexpensive. Curious about whether you’re really German and Irish? Wondering if you—like your mother and her grandmother—might develop Alzheimer’s disease? Companies like 23andMe have you covered. The company advertises kits that cover both ancestry and certain health risks, and has recorded the sale of over 2 million testing kits. Maybe you’ve heard your friend, your coworker, or your sister talking about these genetic tests—or maybe they’ve already ordered their own kit.

What they’re probably not talking about, however, is the host of bioethical implications this sort of at-home genetic testing has. To some, ancestry may be cocktail party conversation, but to others, heritage is an enormous component of their personal identity. Purchasing a genetic testing kit may mean suddenly finding out that your ancestry isn’t what you thought it was, and consumers may or may not understand the emotional and psychological implications of these kinds of results. Genetic health risks present an even bigger ethical challenge—it’s all too easy to mistake the word “predisposition” for a diagnosis. Unless consumers are thoroughly educated about the implications of specific gene variants, companies like 23andMe aren’t providing useful health data—they’re providing enormously impactful information that the average consumer may not be equipped to understand or cope with.

It’s also easy to forget about the data privacy concerns. According to 23andMe’s commercial website, “23andMe gives you control over your genetic information. We want you to decide how your information is used and with whom it is shared.” That sounds nice—but is that “meaningful choice” masked in legal-ese? Existing federal regulation bars discriminatory use of genetic information by insurance companies and employers, but how does that affect other entities, if it does at all? Third-party access to this highly personal information is under-regulated, and it can’t be adequately safeguarded by “consent” without thoroughly explaining to consumers the potential implications of third-party disclosure.

It’s easy to get wrapped up in new and exciting biotechnology—especially when it’s publicly accessible. And we should be excited. . . accessibility and transparency in a field as intimidating as genetics can be is worth celebrating. Further, genetic testing brings with it a host of preventative health and personal benefits. However, it also raises some ethical and regulatory concerns, and it’s important to make sure our enthusiasm—as consumers, but also as entrepreneurs—for genetic technology doesn’t outpace the regulatory systems available to govern it.

A New Year! A New You!: Update Your Look on Regenerative Healing Law

January 2, 2017
Bioethics, FDA, Health, Patents

Angela Fralish, MJLST Invited Blogger

Stephen Breyer, Associate Justice for the Supreme Court remarked that in this age of science, we must build legal foundations that are sound in science as well as in law, because a judge is not a scientist and a courtroom is not a scientific laboratory. Further, our decisions should reflect a proper scientific and technical understanding so that the law can respond to the needs of the public.

Human regenerative healing from embryonic stem cell research has sparked many debates on the public’s needs. On one hand, this research has the ability to relieve great suffering and even death, but on the other hand, it is accompanied by the using and destroying of human life. Moral controversy is a dark cloud looming over any courthouse looking to rule on the science of regenerative healing.

Legislative measures have ebbed and flowed with presidencies. Presidents Clinton, Bush and Obama have used executive orders to either expand or reduce federal funding of regenerative healing. President-Elect Trump’s policy is unknown. According to an NPR article issued in November 2016, “his campaign said little about research and development in general, or health research in particular.” This will be an important point in the near future as a Swedish scientist broke taboo in September of this year by altering healthy human embryos. Further, the NIH plans to lift the ban on regeneration in chimeras in early 2017. As it stands, the federal perspective towards future regenerative healing technology remains unclear.

The most recent executive response has been the Cures Act signed on December 13th of last year by President Obama. Sections 3033-3036 support an expedited FDA review of regenerative therapies and demand an update to regulatory law. Practically speaking, this means that clinical trials will be shortened to get the product on the market faster. While some worry this change will compromise ethics, others worry about the United States ability to keep up with a global market. Dr. Brenda Canine quotes, “If concerted long-term investments in research are not made, America will lose an entire generation of young scientists.”

One established principle in regenerative healing is ownership rights under intellectual property law. Challenges have been made on the grounds that researchers are attempting to patent “life,” but courts have allowed ownership rights to certain cell lines. Dr. Nicholas Zachariades wrote in his article titled Stem Cells: Intellectual Property Issues in Regenerative Medicine that “with respect to the stem cells and their use in the field of regenerative medicine, the U.S. Patent and Trademark Office has recognized inventions involving stem cells as patent-eligible subject matter.” He cites to Consumer Watchdog v. Wisconsin Alumni Research Foundation (WARF) where the plaintiff sued WARF for the patent being too broad, but lost because they lacked standing. WARF maintains a valid patent for “in vitro cell culture.”

Keeping up with science will continue to be a challenge. While it is against norms to destroy healthy embryos, there is a pressing need for the U.S. to compete in a global market. Hopefully, researchers, lawyers and politicians will eventually find a way to merge ethical, legal and federal funding policies related to stem cell research and regenerative healing into a solid legal foundation.

The Comment on the Note “Best Practices for Establishing Georgia’s Alzheimer’s Disease Registry” of Volume 17, Issue 1

April 27, 2016
Bioethics, Data, Healthcare, Privacy, Public Health

Jing Han, MJLST Staffer

Alzheimer’s disease (AD), also known just Alzheimer’s, accounts for 60% to 70% of cases of dementia. It is a chronic neurodegenerative disease that usually starts slowly and gets worse over time. The cause of Alzheimer’s disease is poorly understood. No treatments could stop or reverse its progression, though some may temporarily improve symptoms. Affected people increasingly rely on others for assistance, often placing a burden on the caregiver; the pressures can include social, psychological, physical, and economic elements. It was first described by, and later named after, German psychiatrist and pathologist Alois Alzheimer in 1906. In 2015, there were approximately 48 million people worldwide with AD. In developed countries, AD is one of the most financially costly diseases. Before many states, including Georgia, South Carolina, passed legislation establishing the Registry, many private institutions across the country already had made tremendous efforts to establish their own Alzheimer’s disease registries. The country has experienced an exponential increase of people who are diagnosed with Alzheimer’s disease. More and more states have begun to have their own Alzheimer’s disease registry.

From this Note, the Registry in Georgia has emphasized from the outset, the importance of protecting the confidentiality of patent date from secondary uses. This Note explores many legal and ethical issues raised by the Registry. An Alzheimer’s disease patient’s diagnosis history, medication history, and personal lifestyle are generally confidential information, known only to the physician and patient himself. Reporting such information to the Registry, however, may lead to wider disclosure of what was previously private information and consequently may arouse constitutional concerns. It is generally known that the vast majority of public health registries in the past have focused on collection of infectious disease data, registries for non-infectious diseases, such as Alzheimer’s disease, diabetes, and cancer have been recently created. It is a delicate balance between the public interest and personal privacy. It is not a mandatory requirement to register because Alzheimer is not infectious. After all, people suffering from Alzheimer’s often face violations of their human rights, abuse and neglect, as well as widespread discrimination from the other people. When a patient is diagnosed as AD, the healthcare provider, the doctor should encourage, rather than compel patients to receive registry. Keeping all the patients’ information confidential, enacting the procedural rules to use the information and providing some incentives are good approaches to encourage more patients to join the registry.

Based on the attention to the privacy concerns under federal and state law, the Note recommend slightly broader data sharing with the Georgia Registry, such as a physician or other health care provider for the purpose of a medical evaluation or treatment of the individual; any individual or entity which provides the Registry with an order from a court of competent jurisdiction ordering the disclosure of confidential information. What’s more, the Note mentions there has the procedural rules designated to administer the registry in Georgia. The procedural rules involve clauses: who are the end-users of the registry; what type of information should be collected in the registry; how and from whom should the information be collected; and how should the information be shared or disclosed for policy planning for research purpose; how the legal representatives get authority from patient.

From this Note, we have a deep understanding of Alzheimer’s disease registry in the country through one state’s experience. The registry process has invoked many legal and moral issues. The Note compares the registry in Georgia with other states and points out the importance of protecting the confidentiality of patient data. Emphasizing the importance of protection of personal privacy could encourage more people and more states to get involved in this plan.

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