Public Health

Would Monetary Compensation Incentivize You to Register as an Organ Donor?

Na An, MJLST Article Editor

In the United States, the number of patients on the waitlist for receiving organ donations is much greater than the limited number of supplies.  One person is added to the list every 10 minutes, while only 3 in 1,000 people die in a way that allows for organ donation.  As deceased individuals constitute about two thirds of organ donors, 22 patients die waiting for a transplant every day.  The organ shortage also devastates the qualify of life for more than 100,000 people, and costs national economy tens of billions of dollars every year.  It incentivizes international organized black markets and human trafficking.  The organ shortage has multiple reasons, chief among which is people’s unwillingness to register as donors.  Study has shown that 95% of U.S. adults support organ donation; yet, only 48% of them actually signed up as donors.  Additionally, hospital procedures and customs often allow a family’s objection to undermine the wish of an intended donor.

Currently, the organ donation system is regulated by state law, federal law, government agencies, and hospital procedures.  Each state maintains its own donor registry, mostly linked to the driver’s licensing process, and state laws vary in their donation education program.  The National Organ Transplant Act (Act) instituted the Organ Procurement and Transplantation Network (OPTN) to match donated organs with recipients on the waitlist.  The Act also prohibits the sale of organs.  While the legislatures and courts remain silent, hospital procedures dictate.  For example, hospitals will almost never retrieve organs without the family consent even when doing so would be against the wish of the deceased.  Complicating the issue further is the inherent human rights of the donor, his/her family, and the recipient.

Confronting these issues, Stephanie Zwerner, in her article “A Small Price to Pay: Incentivizing Cadaveric Organ Donation with Posthumous Payments,” proposed a national donor registry and incentivization system.  First, a national donor registry will replace state registries, and eliminate the interstate discrepancies and inefficiencies.  The national registry can be consolidated with OPTN for effective administration.  To improve the validity of donor intent documentation, the article proposed donor registration through health insurance application, registration to vote, or income tax reporting.  Unlike “check-the-box” in driver licensing, everyone will be given a chance to fully consider their decisions.  Families and hospitals would be more willing to respect the wishes of intended donors.

To further incentivize registration, the article proposed a single lump sum payment to the donor’s estate financed by the recipient’s health insurance provider upon the event of an executed cadaveric organ donation.  Monetary compensation for organ donation has been a controversial topic.  Not only it is illegal under federal statute, it has also been considered as the “commodification of human body parts” and an intrinsic evil.  It decreases respect for life and human body, and can lead to exploitation of people in dire economic circumstances.  Acknowledging these negative consequences, the author presented several benefits: increasing donations while decreasing familial objections, saving lives, relieving people on the waitlist for many years of suffering, reducing black markets and the economic burden on national economy.  Considering that one donor could potential save eight lives, the article argues that the benefits outweigh the negative implications.


Recent Ninth Circuit Ruling an Important One for State and Local Governments Seeking to Regulate Genetically Modified Plants

Jody Ferris, Note & Comment Editor

Genetically modified plants (GMOs) are and have always been a hot topic in agriculture and food policy.  Since they were first developed, groups have been lobbying at various levels of government to impose regulations on how they are grown or to have them banned outright. A noteworthy decision has come down for those following legal challenges to GMO regulation. In Alika Atay et al. v. County of Maui et al., the Ninth Circuit court in Hawaii has ruled that state and local governments may regulate the production of GMOs in their jurisdictions.

The original suit was filed by GMO proponents after the County of Maui enacted a ban on genetically modified crops.  The court held that federal regulation of GMOs does not preempt state and local regulation after the variety is commercialized. This means that the United States Department of Agriculture holds jurisdiction over all GMO varieties prior to commercialization, which is the period during development and testing before the variety is sold on the market. According to the Ninth Circuit, after the variety is commercialized, however, state and local governments are free to enact regulations, including outright bans of GMO production, without the need to worry about federal preemption.

Interestingly, the county regulations in Hawaii that were at issue in the suit were nonetheless stricken down by the court because the State of Hawaii already has a comprehensive regulatory scheme which the court held to preempt county GMO regulations.  This outcome disappointed local environmental and anti-GMO groups due to their support of the new county level GMO restrictions.  However, the decision will help clarify the respective regulatory responsibilities between individual counties and the State of Hawaii. Despite the disappointment of these groups, the decision that there is no federal preemption on regulation of commercialized GMO varieties is an important one for many of the states in the Ninth Circuit, as there are counties in Washington and California, for example, which have also enacted bans on GMO production.

This decision will likely be an encouraging one for states wishing to enact their own regulations for how GMO varieties are grown and handled.  It is also encouraging for individual counties who wish to enact GMO bans or county level regulations, should state level regulations not be preemptive.  It will certainly be interesting to follow how state and local governments structure any future regulatory activities in light of this ruling.


Drinking the Kool-Aid? Why We Might Want to Talk About Our Road Salt

Nick Redmond, MJLST Staffer

Winter is coming. Or—at least according to the 2017 Farmer’s Almanac“winter is back” after an exceptionally mild 2015–2016 season, and with it comes all of the shoveling, the snow-blowing, and the white walkers de-icing of slippery roads that we missed last year. So what does the most overused Game of Thrones quote and everyone’s least favorite season have to do with Kool-Aid (actually, Flavor-Aid)? Just like the origins of the phrase “drinking the Kool-Aid,” this post has to do with cyanide. More specifically, the ferrocyanide compounds that we use to coat our road salt and that are potentially contaminating our groundwater.

De-icing chemicals are commonly regarded as the most efficient and effective means of keeping our roads safe and free from ice in the winter. De-icing compounds come in many forms, from solids to slurries to sticky beet juice- or cheese brine-based liquids. The most common de-icing chemical is salt, with cities like Minneapolis spending millions of dollars to purchase upwards of 15,000 tons of treated and untreated salt to spray on their roads. In order to keep the solid salt from clumping or “caking” and becoming unusable as it sits around it’s usually treated with chemicals to ensure that it can be spread evenly on roads. Ferrocyanide (a/k/a hexacyanoferrate(II)) and the compounds sodium ferrocyanide and potassium ferrocyanide are yellow chemicals commonly used as anti-caking additives for road salt in Minnesota and other parts of the country, and they can be found in varying concentrations depending on the product, from 0.0003 ppm to 0.33 ppm. To put those numbers in perspective, the CDC warns that cyanide starts to produce harmful effects on humans at 0.05 mg/dL, or 0.5 ppm.

But why are chemicals on our road salt troubling? Road salt keeps ice from forming a bond with the pavement by lowering the freezing point of snow as it falls on the ground. As the salt gets wet it dissolves; it and the chemicals that may be attached to it have to go somewhere, which may be our surface and ground waters or the air if the liquids evaporate. The introduction of these chemicals into groundwater is of particular concern for the 75% of Minnesotans and people like them who rely on groundwater sources for drinking water. The potential for harm arises when ferrocyanide compounds are exposed to light and rapidly decompose, yielding free cyanide (CN and HCN). Further, as waters contaminated with cyanide are chlorinated and introduced to acids they may produce the harmful compound cyanogen chloride, a highly toxic gas that was once considered for use in chemical warfare. Taking into account the enormous amount of salt used and stored each year, even small concentrations may add up over time. And although the EPA has placed cyanide on the Clean Water Act’s list of toxic substances, the fact that road salt is a non-point source means that it’s entirely up to states and municipalities to decide how they want to regulate it.

The good news is that ferrocyanides are among the least toxic cyanide salts, and tend not to release toxic free cyanide. What’s more, the concentrations of ferrocyanide on road salt are generally quite low, are spread out over large areas, and are even further diluted by precipitation, evaporation, and existing ground and surface water. In order to really affect drinking water the ferrocyanide has to (1) not evaporate into the air, (2) make its way through soil and into aquifers, and (3) in large enough concentrations to actually harm humans, something that can be difficult for a large molecule. Despite all of this, however, the fact that Minneapolis alone is dumping more than 15,000 tons of road salt each year, some of it laced with ferrocyanide, should give us pause. That’s the same weight as 15,000 polar bears being released in the city streets every year! Most importantly, these compounds seep into our garden soil, stick to our car tires and our boots, and soak the fur of our pets and wild animals. While cyanide on road salt certainly isn’t a significant public health risk right now, being a part of local conversations to explore and encourage alternatives (and there are a number of alternatives) to prevent future harm might be something to consider.

At the very least think twice about eating snow off the ground (if you weren’t already). Especially the yellow stuff.


Digital Health and Legal Aid: The Lawyer Will Skype You Now

Angela Fralish, MJLST Invited Blogger

According to Dr. Shirley Musich’s research article: Homebound Older Adults: Prevalence, Characteristics, Health Care Utilization and Quality of Care, homebound patients are among the top 5% of medical service users with persistently high expenses. As it stands, about 3.6 million homebound Americans are in need of continuous medical care, but with the cost of healthcare rising, the number of elderly people retiring, hospitals closing in increasing numbers and physician shortages anticipated, caring for the homebound is becoming expensive and impractical. In an article titled Care of the Chronically Ill at Home: An Unresolved Dilemma in Health Policy for the United States, author Karen Buhler-Wilkerson notes that even after two centuries of various experiments to deliver and finance home health care, there are still too many unresolved issues.

One potential solution could be at the crossroads of technology, medicine and law. Telemedicine is a well-known medical technology providing cost effective medical care for the homebound. Becker’s reports that telemedicine visits are often more affordable, and access is a very important component, both in the sense of enabling patients to communicate through a smartphone, and the ability for clinicians to reach patients at a distance, particularly those for whom travel to a hospital on a weekly basis for necessary follow-ups or check-ins would be costly and is not feasible. Telemedicine is a form of affordable technology reaching homebound patients.

Legal aid organizations are also beginning to integrate virtual services for the homebound. For example, at Illinois Legal Aid Online, clients are able to have a live consultation with a legal professional, and in Maryland, a virtual courthouse is used for alternative dispute resolution proceedings. Some states, such as Alaska and New York, have advocated for virtual consults and hearings as part of a best practices model. On September 22nd of this year, the ABA launched a free virtual legal advice clinic to operate as an online version of a walk in clinic. However, despite these responsive measures, virtual technology for legal aid is expensive and burdensome.

But what about the cancer patient who can’t get out of bed to come in for a legal aid appointment, but needs help with a disability claim to pay their medical bills? Could diversifying telehealth user interfaces help cure the accessibility gap for both medicine and law?

Some organizations have already begun collaborations to address these issues. Medical Legal Partnerships work together to provide comprehensive care through cost effective resource pooling of business funds and federal and corporate grant money. Partnerships resolve the sociolegal determinants impacting the health of a patient. One classic case example is the homebound patient with aggravated asthma living in a house with mold spores.  A lawyer works to get the housing up to code, which reduces the asthma, and consequently future medical costs. Lawyers resolve the economic factors perpetuating a health condition while physicians treat it biologically. These partnerships are being implemented nationwide because of their proven results in decreasing the cost of care. In the case of telehealth, the homebound asthmatic patient, could log on to their computer, or work through an app on their phone, to show the attorney the living conditions in high resolution, in addition to receiving medical treatment.

The government seems to be favorable to these resolutions. The Health Resources and Services Administration allocated $18 million to health center collaborations seeking to improve quality care through health information technology. Further, the FDA has created the Digital Health program to encourage and foster collaborations in technologies to promote public health. Last year alone, Congress awarded $4 million to the Legal Services Corporation, who then disbursed that money among 15 legal aid organizations, many of which “will use technology to connect low-income populations to resources and services.” Telehealth innovation is a cornerstone for medical and legal professions committed to improvements in low cost quality patient care, especially for the homebound.

Medical facilities could even extend this same technology profitably by offering patients an in-house “attorney consult” service to improve quality of care. Much like the invention of the convenient cordless phone, a telehealth phone could be used in house or outpatient to give a health organization a leading market edge in addition to decreasing costs. Technology has yet to fully develop the number of ways that telehealth can be used to deliver legal services to improve healthcare.

So if there is a multidisciplinary call for digital aid, why aren’t we seeing more of it on a daily basis? For one, the regulatory law landscape may cause confusion. The FDA governs medical devices, the FTC regulates PHI data breaches and the FCC governs devices using broadcast services or electromagnetic spectrum. Telehealth touches on all of these and results in jurisdictional overlap amongst regulatory agencies. Other reasons may involve resistance to new technology and ever-evolving legislation and policies. In Teladoc, Inc., v. Texas Medical Board, a standard of care issue was raised when the medical board issued an injunction for physicians who prescribed medicine, but had not yet seen the patient in person. One physician in the case stated that without telehealth, his homebound patient would receive no treatment. Transitioning from traditional in person consultations to virtual assistance can greatly improve the health of patient, but has brought an entourage of notable concerns.

Allegedly, the use of telehealth was first executed by Alexander Graham Bell in 1876 when he made a phone call to his doctor. Over 140 years later, this technology is used by NASA for outer space health consults. While the technology is still relatively new, especially for collaborative patient treatment by doctors and lawyers, used wisely, it can be an interdisciplinary collaborative renaissance in using technology to improve healthcare systems and patient lives.

From all perspectives, virtual aid is well funded future component of both the medical and legal fields. It can be used in the legal sense to help people in need, in the business sense as an ancillary convenience service generating profits, or in the medical sense to provide care for the homebound. The trick will be to find engineers who can secure multiuse interfaces while meeting federal regulations and public demand. Only time will tell if such a tool can be efficiently developed.


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

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.


The Large Effect of Food Advertising on Children

Zach Berger, MJLST Staffer

The goal of advertising is to persuade consumers to purchase the advertised product. Advertising, as a form of commercial speech, is given considerable legal protection. Despite these protections, and with the rise of obesity in the you of America, advertising has become a topic of debate in the past several decades. As discussed in the Minnesota Journal of Law, Science & Technology article Food Advertising and Childhood Obesity: A Call to Action for Proactive Solutions by Roseann B. Termini, Thomas A. Roberto, and Shelby G. Hostetter, many theorists believe food advertising targets children “who are too young an immature to distinguish advertising puffery from truth.” Children have limited cognitive abilities, and assume the advertised food products are healthy. Without government regulation or parental intervention, these children can maintain these misconceptions and carry the unhealthy habits they developed at a young age into adulthood.

Unfortunately, the percentage of obese children has only gone up since the aforementioned article was written. According to a recent study, 20.5% of twelve to nineteen year olds are considered obese in the U.S., as well as 17.7% of children age six to eleven. As mentioned by Termini et al., food advertising can contribute to childhood obesity in several different ways: Time spent watching TV detracts from time that could be engaged in exercise, food advertisements encourage unhealthy choices, food products partnering with TV/movie characters encourages children to buy unhealthy products, and children snack excessively while watching TV. Although some companies have attempted to self-regulate, these attempts are not always successful.

Termini et al. suggested several solutions to limited the damage done to children by unhealthy food advertisements. These included: banning fast-food advertising on child-targeted TV, regulating food advertisements directed at children as well as the companies that produce them, eliminating tax breaks for food advertising, and increasing parental intervention. One such solution was recently reintroduced with the announcement of the Stop Subsidizing Childhood Obesity Act. This law would amend the tax code by eliminating tax deductions for advertising that is directed at children and which promotes unhealthy food and drink. The revenue this law would bring will go towards funding the U.S. Department of Agriculture’s “Fresh Fruit and Vegetable Program.” As the name states, this program provides fresh fruit and vegetables to all students at participating schools.

Overwhelming evidence suggests that the programs children watch on TV influences their eating habits. Although some of the onus is on the parents to supervise what their children eat, more consistent regulation of food advertising can help reduce childhood obesity. There is still a long way to go, but we need to be proactive if we want to have any chance of halting childhood obesity in its tracks.


Disruptive Manufacturing is Disrupting the Law: Minnesota Journal of Law, Science & Technology Presents a Symposium on the Rapid Emergence of 3-D Printing and Its Legal Implications

Nia Chung, MJLST Symposium Editor

Imagine your six-week old newborn suddenly stops breathing. You rush him to the hospital, where he is diagnosed with tracheobronchomalacia, which means that his windpipe has collapsed. Your doctor tells you that she can provide the conventional treatment of conducting a tracheostomy and putting your newborn on a ventilator which might lead to further breathing problems and possible heart stoppage. She goes on to tell you that she can 3-D print a device that will instantly help your newborn breathe, and she does. This is a true story. Kaiba Gionfriddo, who was treated at C.S. Mott Children’s Hospital through a groundbreaking cross-disciplinary effort between the University of Michigan’s Medical and Engineering schools, doctors, faculty, and researchers in 2011, was the first patient ever to experience a surgery of its kind. Kaiba’s story was just the beginning of medical and surgical breakthroughs using 3-D printing.

But what exactly is 3-D printing? 3-D printing, also called additive manufacturing, is the process of making solid three-dimensional objects from a CAD (Computer Aided Design) digital file. Based on this digital file, 3-D modeling software “slices” the three dimensional model “into hundreds or thousands of horizontal layers. The sliced file is then uploaded to a 3-D printer, which creates the 3-D object. There are several technologies 3-D printer manufacturers can utilize to generate 3-D objects—some use melting or softening material in a technology called “selective laser sintering” or “fused deposition modeling” and others cure a photo-reactive resin with a UV laser. A small, low-quality object can be printed in less than 10 minutes, while larger, high-quality objects may take up to several hours to print. By and large, 3-D printers are cost-effective, efficient, and can provide insurmountable benefits to the healthcare industry.

Baby Kaiba and his biodegradable splint showed the world how 3-D printing can be used in healthcare. Researchers have taken it further by bioprinting trachea, grown using a patient’s own stem cell cultures. This would essentially be the “first artificial bioprinted organ,” and doctors are hoping for Food and Drug Administration (FDA) approval. What the FDA has approved recently, however, is the first ever 3-D printed drug product. In August 2015, the FDA approved Aprecia Pharmaceutical’s Spritam (levetiracetam). A drug product used orally to treat “partial onset seizures, myoclonic seizures and primary generalized tonic-clonic seizures in adults and children with epilepsy.” Other examples of how 3-D printing is transforming healthcare include 3-D printed blood vessels, heart valves, low-cost prosthetics designed specifically to a patient’s anatomy, and electronic sensors that monitor heart strain, oxygenation, and temperature that can be perfectly attached to a patient’s heart.

Although additive manufacturing is cost effective, waste-reducing, and efficient, it presents legal challenges in areas ranging from intellectual property to product liability. A white paper published by Reed Smith outlines the impact 3-D printing will have on areas including regulatory issues, patent and copyright law, tort liability, and insurance. For example, what is a “product”? Is it the CAD digital file, the 3-D printed product, or both? Who is the manufacturer? Is it CAD or is it the 3-D printer? If I am in need of a replacement hip, and agree to have a 3-D printed hip implanted into my body, if that product is defective, who is liable—the hospital that performed the hip replacement surgery, the 3-D printer manufacturer, or the 3-D imaging software? From an intellectual property law standpoint, 3-D printing can provide easier access to counterfeit products, and can blur the line on what constitutes patent infringement. If a hospital 3-D prints repairs a medical device by 3-D printing a nonpatented replacement component, this would likely be lawful. On the other hand, “replicating replicating a patented device by using a 3D printer to create all of its components may well constitute patent infringement.” Because 3-D printing brings, along with its benefits, many unanswered questions in the law, the Minnesota Journal of Law, Science & Technology (MJLST) will be hosting a symposium on these very issues. It will feature experts on intellectual property, regulatory, and tort liability issues surrounding 3-D printing in an all day event. The symposium will consist of several panels and a keynote speech by Candice Ciresi, General Counsel of Stratasys, a leading 3-D printer manufacturer, along with breakfast and lunch. MJLST Volume 17.2, its symposium issue, will publish articles on issues covered at the live symposium.

Today, medical devices, body parts, pharmaceutical drugs, guns, and food can be 3-D printed in a matter of hours to be utilized by private citizens. Please join us at the symposium to hear from some of the nation’s experts on how we must regulate this technology moving forward and what we can expect from 3-D printing in the near future.

Minnesota Journal of Law, Science & Technology presents “A Symposium on Disruptive Manufacturing: The Rapid Emergence of 3-D Printing and Arising Legal Concerns.” The symposium will be held on March 4, 2016 at Walter F. Mondale Hall, The University of Minnesota Law School, 229 19th Ave. South, Room 25, Minneapolis, MN 55455, from 8:00 A.M. to 3:00 P.M. To attend the symposium or for more information, please e-mail chung439@umn.edu or visit the symposium’s website at https://sites.google.com/a/umn.edu/mjlst-symposium-2016-3-d-printing/home. Please visit and RSVP on our Facebook page: https://www.facebook.com/events/1651569518452959/


Let’s Talk: The Cold & Flu Season & Personalized Medicine

Allison Kvien, MJLST Managing Editor

As we approach cold and flu season, it is time we all start thinking about properly taking care of ourselves. Many individual factors have been linked to your heath. A Newsweek article reported that people who get less than 5 hours of sleep a night are 4.5 times as likely to become ill. According to The L.A. Times, an elevated heart rate could mean that a cold is on the way. Finally, an article from Harvard found a link between your popularity and how early in the season you become ill (yes, really—and I guess this explains why I haven’t gotten the flu since I was a kid). While this is all helpful information, it represents only a few factors that contribute to a person’s overall health. Over the years, the practice of medicine has become more accepting of the concept that “one size does not fit all” and that patients may need more personalized medicine.

One interesting development in personalized medicine was ten years ago, in 2005, when FDA approved the first race-specific drug, BiDil. As Dorothy E. Roberts explained in her MJLST article, BiDil, is “a combination drug that relaxes the blood vessels, [and] was authorized to treat heart failure in self-identified black patients.” Many scholars and citizens alike have found the approval of BiDil controversial, for a variety of reasons, legal, political, ethical, and otherwise. It may be, however, simply one more step on the path to personalization of medicine for patients. As Roberts reported, “BiDil increased survival by an astonishing 43 percent. Hospitalizations were reduced by 39 percent.” Roberts’s opinion, however, was that BiDil should have been approved for all heart failure patients, regardless of race because there was no underlying genetic difference in African Americans that the drug relied on for its positive results. The economic results of the BiDil drug may prevent others from going developing race-specific drugs for a while, though; BiDil has been described as a “flop.”

Cold season medicine is normally pretty generic. Think: Airborne, Sudafed, Advil, and cough drops, my favorite of which are the less-than-pleasant tasting Fisherman’s Friends that completely numb your throat—seriously, try them. I think the concept of personalized cold and flu medicine is particularly interesting because our current cold season medicine is normally over-the-counter and generalized. Can you imagine a future where you pick up a cold medicine tailored specifically to your genetic background? Well, it may already be happening. Just two years ago, FDA approved personalized flu vaccines for three groups: the elderly, children, and those with allergies. These personalized vaccines may allow some groups of our population to receive them when they wouldn’t otherwise be able to, or to at least receive them more safely. Specifically for flu vaccines, anyway, this step in personalization may not also reflect increased overall effectiveness in preventing illness. But let’s not give you an excuse to not get your flu vaccine. Go get that flu shot that was made just for you!


Scientific Responsibility: Why Lawyers are Imperative in Scientifically Informed Neuro-ethics

Thomas Hale-Kupiec, MJLST Staff Member

In Volume 11, Issue 1 of the Minnesota Journal of Law, Science, & Technology, Eagleman, et al. conclude that “the neuroscientific community should continue to develop rehabilitative strategies so that the legal community can take advantage of those strategies for a rational, customized approach” in Why Neuroscience Matters for Rational Drug Policy. Though perhaps this assertion is valid in the context of Drug Addiction, I believe it is necessary to limit this assertion to solely rehabilitative drug addiction studies; to allow a further extension of this conclusion would be sociologically detrimental. I postulate that beyond ideas of who we define as a “Neuroscientist,” legal experts need to be at the forefront of this debate in order to better define and formulate ideas of “rehabilitation.”

In a related reflection entitled ‘Smart Drugs’: Do they work? Are they ethical? Will they be legal?, researcher Stephen Rose poses a number of ethical and neurological impacts of mind enhancing substances. The author posits an interesting question: what is “normal” for a brain? If someone undergoes pharmacological manipulation, what should the standard be for “abnormal?” For instance, Rose poses that some substances could be used for patients with Down Syndrome to allow for cognitive enhancement. Is this a valid designation as “abnormal?” Inexorably linked to this issue would be Autism Spectrum Disorder — where on the spectrum does a cognitive “abnormality” manifest? Further, how do we define potentially less visible disorders such as “anxiety?” With this spectrum of diseases and mental health conditions, variety of measured “abnormalities,” and varying pharmacological treatment effectiveness, I think we need to be mindful that neuroscientific constructions are often blurry, but always need to be conceptualized within the paradigm of ethics.

More than ever, the question of “what is abnormal” and “what mandates treatment” needs to be addressed in pharmaceutical policy. For instance, federally designated controlled substances like marijuana may be effective at treating anxiety and other medical conditions. Should the legal community allow for Eagleman’s assertion to snowball? Imagine an increasing number of states embrace evidence that the active ingredients in marijuana could treat certain medical conditions? Should the scientific community solely argue the validity of these findings? Legal professionals, bioethicists, and regulators need to be included in these questions. It is not that the data driven outcomes need to be pursued; rather, that a level of ethics and sociological morals need to be layered above these decisions.


America’s First Flu Season Under the ACA

Allison Kvien, MJLST Staff Member

Have you seen the “flu shots today” signs outside your local grocery stores yet? Looked at any maps tracking where in the United States flu outbreaks are occurring? Gotten a flu shot? This year’s flu season is quickly approaching, and with it may come many implications for the future of health care in this country. This year marks the first year with the Patient Protection and Affordable Care Act (ACA) in full effect, so thousands of people in the country will get their first taste of the ACA’s health care benefits in the upcoming months. The L.A. Times reported that nearly 10 million previously uninsured people now have coverage under the ACA. Though there might still be debate between opponents and proponents of the ACA, the ACA has already survived a Supreme Court challenge and is well on its way to becoming a durable feature of the American healthcare system. Will the upcoming flu season prove to be any more of a challenge?

In a recent article entitled, “Developing a Durable Right to Health Care” in Volume 14, Issue 1 of the Minnesota Journal of Law, Science, and Technology, Erin Brown examined the durability of the ACA going forward. Brown explained, “[a]mong its many provisions, the ACA’s most significant is one that creates a right to health care in this country for the uninsured.” Another provision of the ACA is an “essential benefits package,” in which Congress included “preventative and wellness services,” presumably including flu shots. For those that will be relying on the healthcare provided by the ACA in the upcoming flu season, it may also be important to understand where the ACA’s vulnerabilities lie. Brown posited that the vulnerabilities are concentrated mostly in the early years of the statute, and the federal right to health care may strengthen as the benefits take hold. How will the end of the ACA’s first year go? This is a very important question for many Americans, and Brown’s article examines several other questions that might be on the minds of millions in the upcoming months.