Public Health

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

November 13, 2015
Drug Policy, FDA, Pharmaceuticals, Public Health

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!

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

November 13, 2015
Drug Policy, FDA, Pharmaceuticals, Public Health

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

November 5, 2014
Pharmaceuticals, Public Health

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

October 18, 2014
Healthcare, Healthcare Reform, Public Health

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.

The High Cost of Medical Errors

March 1, 2014
Healthcare, Public Health

Mayura Iyer, MJLST Staff

When we feel unwell, or have an injury, or are battling a serious condition, we turn to doctors and hospitals to take care of us and return us to health. But what if these professionals are actually adding to the harm? A recent study in the Journal of Patient Safety stated that between 210,000 and 440,000 patients each year suffer some type of preventable harm that contributes to their death. These numbers are staggering and make medical errors the third leading cause of death in America. With statistics like that, you would expect the problem to be the topic of every major headline, however, these facts are not well documented or disseminated.

John Grout, John Hill, and Arlen Langvardt discussed the prevalence and causes of medical errors and how to mistake-proof the healthcare industry in their article in Volume 14, Issue 1 of the Minnesota Journal of Law, Science & Technology. Their article stated that medical errors stem from the multi-factorial, complex nature of medical procedures and from the subjective component of providing medical care. However, the article goes on to suggest several ways in which medical errors can be minimized through “mistake-proofing” measures that have had great success in other industries. The article gives examples of a variety of mistake-proofing methods, from using devices to monitor staff hygiene to using computers to aid the process of prescribing medication.

So why, when there are ways to tackle the issue, are the rates of medical errors not improving? Part of the problem is the institutionalized culture of healthcare. There has historically been a pass of sorts for the errors of doctors, granting them a pardon for reasonable human error. Furthermore, there is a culture of overlooking the mistakes of colleagues – partly because of a fear of retaliation and partly because there is an unspoken rule of maintaining and protecting professional reputations. However, when the cost of error is equal to the value of human life, it is necessary to break down harmful practices and implement policies that will adequately address the problem of fatal medical errors.

Academics, administrators, and doctors themselves have recognized this issue and even suggested easily to implement methods of error reduction. Dr. Marty Makary, a surgeon at Johns Hopkins Hospital, has suggested simple ideas like using cameras to record medical procedures and electronically-published reviews and ratings to make healthcare providers more accountable and thus minimize errors. With the problem only increasing, it will soon be impossible for healthcare providers to ignore. But recognizing the problem is only the first step; the more complicated task will be implementing policies that address the issue and ensuring adequate compliance. However, with the insight offered by practitioners and academics alike, the solution to this problem seems within reach.

A Farm Bill for Hansel and Gretel

February 18, 2014
Food and Agriculture, Healthcare, Public Health

Ke M. Huang, MJLST Staff

Once upon a time, a farmer and his new wife, who had no means to support the farmer’s first wife’s children, decided to abandon the children in the woods. These children–Hansel and Gretel–found in the woods a charming little house made of sweets. A wicked witch lived in that house.

Earlier this month, President Obama signed into law the Farm Bill of 2014. According to a New York Times article, the President called the Farm Bill a “jobs bill,” and “innovation bill,” a “research bill,” and a “conservation bill.” Yet, amid the provisions of the Farm Bill that addressed topics such as crop insurance, conservation, and trade, there were also provisions that touched on the issue of healthy nutrition of families.

Senator Stabenow (D-MI), chairwoman of the Senate Agriculture Committee and the author of the Farm Bill, emphasized that part of the Bill’s purpose was to improve nutrition choices in families. Changes such as doubling SNAP benefits (formerly called food stamps) for buying healthier foods and financing new grocery stores in underserved areas reflect that purpose.

A question remains whether the Farm Bill of 2014 will be effective in achieving that purpose. Especially for nutrition among the children, the article by Termini et al. in the Volume 12, Issue 2 of the Minnesota Journal of Law, Science & Technology offers some answers. In other words, the article addresses the predicament of modern day Hansel and Gretel who are lured by sugared snacks, french fries, and company.

In Food Advertising and Childhood Obesity (2011), Termini et al. (1) provide some alarming data about nutrition-related health complications among American children, (2) discuss the relationship between the health complications and food advertising, and (3) propose several solutions to address these health complications. While Termini et al. mention advocates of consumer choice, the authors primarily propose measures for the food industry, the government, and parents. For example, akin to the SNAP benefits for buying healthier foods, Termini et al. propose tax incentives for buying healthy food.

In final analysis, even if the often-regarded villain in the story of Hansel and Gretel is the witch, at least the government was partly responsible for the predicament of the children. Had the government funded a SNAP benefit program for the children’s family, or even subsidized the family farm through a crop insurance program, the parents would not have to leave the children alone in the woods. Just some food for thought.

Guest Commentary – Climate Change: Is Anyone Ever Going to Do Anything About It?

February 3, 2014
Environment, Public Health

by Myanna Dellinger, JD, MA – Associate Professor at Western State College of Law and Director of the Institute for Global Law and Policy

Extremely cold weather conditions still haunt the American North and Northeast. Meanwhile, California is suffering through July temperatures in January and the worst drought since 1895. No doubt about it, we are witnessing ever more frequent extreme weather events. Since nations still can’t agree on what to do about this urgent problem, it may be up to local actors such as cities, states, companies, and NGOs to take the required action now.

Nations have agreed to “try” to limit global warming to 2° C and to agree on a new climate treaty by 2015 to take effect by 2020, but in reality, we are headed towards a 5.3° C increase. Even if the 2° degree target were to be met, vast ecological and economic damage would still occur in the form of, for instance, severe economic disruptions to our food and water supply.

Disregarding climate change is technologically risky too: to meet the target of keeping concentrations of CO2 below the most recently agreed-upon threshold of 500 ppm, future generations would have to literally pull CO2 out of the air with either machinery that does not yet exist and may never become technically or economically feasible, or with bioenergy crops that absorb CO2, which would compete with food production.

My article “Localizing Climate Change” argues that effective and urgent action is likely to come from the local and not the national or international levels.

In fact, the parties to the climate treaty framework UNFCCC similarly recently agreed that cities, other subnational authorities, and the private sector must play a role in future treaty-making contexts. This makes sense. Local actors may be the ones best situated to find out what can be done technically and politically in each location. Meanwhile, nations are almost unbelievably playing two fiddles at the same time, subsidizing fossil fuel development much more than cleaner energies. That’s right: although renewable energy policies are becoming more prevalent, they are financially and politically outcompeted by the rapid growth of fossil fuels in the USA and elsewhere. Perhaps indicative of the true state of affairs is the fact that climate adaptation talks are intensifying as mitigation agreements seem to be stalling. It doesn’t help that a secretive network of conservative billionaires is pouring billions of dollars into a vast political effort attempting to deny climate change and that–perhaps as a consequence–the coverage of climate change by American media is down significantly from 2009, when media was happy to report a climate change “scandal” that eventually proved to be incorrectly reported. Little wonder that the most recent IPCC report concluded that it is “extremely likely” (i.e. with 95-100% certainty) that human activity is the principal cause of climate change.

If you think all this is driving you crazy, you may be right. Shifts in climate have been strongly linked to human violence around the world, such as spikes in domestic violence in Australia, increased assaults and murders in the United States, land invasions in Brazil, police violence in Holland, and civil conflicts throughout the tropics.

What are we, as a nation, doing about this? In the summer of 2013, President Obama announced the first-ever United States Climate Action Plan. This relies on a number of Executive Orders, as the Senate is still unlikely to ratify a climate treaty. As with other recent Congressional gridlock, this highlights the importance of local action. If the United States was willing to ratify a new climate change treaty, this could spur much-needed action by the relatively low number of nations needed to make a big impact on the problem. After all, the world’s top ten emitters account for 70% of global greenhouse gas emissions.

This leads to my questions: Where is the most likely and substantively effective action going to come from: local or national/supranational entities? If you think climate change must be countered at the national and international levels, who is then responsible? For instance, should it be the historically largest emitters (among them, the USA and China), the most capable (the industrialized world), the most progressive (arguably the EU), or . . . ? Is anything even going to happen at all, or are we as human beings simply incapable of worrying about the future as a recent study indicated?

Is Obesity a Disease?

October 4, 2013
Healthcare, Public Health

by Katelyn DeRuyter, UMN Law Student, MJLST Note and Comment Editor

The fact that many Americans are obese is hardly news. Obesity in America has been a source of news reports, social commentaries and literature for well over a decade. In her book review of “The Omnivore’s Dilemma: A Natural History of Four Meals” by Michael Pollan, published in Issue 8.1 of the Minnesota Journal of Law, Science & Technology, Morgan Holcomb discusses how obesity rates in America were part of Pollan’s motivation to write “The Omnivore’s Dilemma.” More recently, American obesity has been described as an epidemic, and the health risks associated with obesity are gradually becoming common knowledge. Obesity is even compared, by some, to smoking and alcoholism. A recent LawSci blog post, “Is Food the New Tobacco: Science, Advertising, and the War against Obesity?” looks at Roseann Termini’s article, “Food Advertising and Childhood Obesity: A Call for Action for Proactive Solutions,” and draws parallels between the role of advertising in the rise of cigarette addiction and the current obesity epidemic.

A question that is overlooked in this dialogue is whether obesity is, in fact, a disease. Whether obesity is considered a disease has real consequences including altering social stigmas, increasing funds allocated for research and expanding treatment accessibility. The debate over whether obesity should be considered a disease is not new. However, new life has been breathed into the debate following the American Medical Association’s (AMA) official recognition of obesity as a disease. The New York Times quoted Dr. Harris, a member of the AMA’s board, as stating that “[r]ecognizing obesity as a disease will help change the way the medical community tackles this complex issue that affects approximately one in three Americans.” A recent Forbes article, “Declaring Obesity a Disease: the Good, the Bad, the Ugly,” provides a closer look at how the AMA reached its decision.

In reaching the conclusion that obesity is a disease, the AMA overruled its own council’s recommendation. The AMA’s Council on Science and Public Health (Counsel on Science) had been tasked with studying this issue over the past year. The Council on Science’s recommendation against categorizing obesity as a disease rested, in part, on the concern that body mass index (BMI) is a simplistic and inaccurate tool; BMI is the tool generally used to define obesity. The Council on Science was also concerned that recognizing obesity as a disease might increase reliance on drugs and procedures and decrease the emphasis on lifestyle changes.

From a legal perspective, this classification raises interesting questions regarding future interpretation of Congressional intent when “disease” is used without a specific definition. While only time will be able to tell the actual effects of this classification, this is certainly a “must watch” area for health law attorneys.

Country of Origin Labeling for Food and Pharmaceutical Products

September 26, 2013
Food and Agriculture, Pharmaceuticals, Public Health

by Daniel Schueppert, UMN Law Student, MJLST Staff

The USDA has recently lifted restrictions on the practice of shipping US Chicken to China for processing, for an eventual return to the US. Under the present regulations, chicken originating from US farms can be shipped to China for processing, then shipped back to the US for sale. This chicken need not include Country of Origin Labeling (COOL) to indicate that it has been processed in China. This change comes in the wake of a years of food safety scares relating to China’s food supply. Although the Food Safety Inspection Service (FSIS) has completed audits of the China’s “poultry processing inspection system” and certified some of the Chinese processing plants and procedures, American consumers have retained some reservations about the safety of chicken processed in China. As it stands, this system leaves consumers in the position of not knowing which country their chicken products have been processed because the Chinese operations are considered a comparable food component to what results from US processing.

This recent action by the USDA clearly raises questions concerning the United States’ food safety, and perhaps security. A sophisticated consumer may nevertheless be able avoid chicken products known to be processed in China, but absent COOL disclosures this may be a difficult task and arguably involve some guess work. This is not necessarily the case with generic pharmaceuticals, an area in which there are substantial parallels to the chicken debate. Some of the concerns raised relating to the quality and safety of chicken processed in China also bring to light the COOL requirements for other consumables like pharmaceuticals. Import screening and labeling for pharmaceuticals, and particularly off patent generics, is a convoluted area of regulatory law where Federal agencies to not always agree. Currently many of the various components of just one pharmaceutical drug are manufactured all over the world and come from a variety of sources. Manufacturing in India, China, and Eastern Europe account for a large part of the market.

The FDA’s main measure on determining the quality of components in generic drugs is a fuzzy spectrum concerning the “bioavailability” of certain chemicals but this measure does not necessarily take account of inert components or varying quality or quantities of active ingredients. Much like chicken, a consumer or regulatory agency would be hard pressed to find a problem with these products until a quality control issue develops and American consumers are put at risk. COOL labeling regarding Chicken and Drugs are developing issues without a clear regulatory action in sight. Stay tuned to the Minnesota Journal of Law, Science & Technology for further updates.

Is Food the New Tobacco: Science, Advertising, and the War against Obesity?

April 18, 2013
FDA, Food and Agriculture, Public Health

by George David Kidd, UMN Law Student, MJLST Staff

Globally, obesity and its underlying ailments have overtaken tobacco as the top preventable cause of death. But, while eating right and exercising might go a long way towards solving the problem, the solution might not be that simple. What drives consumer buying behavior, through more modern forms of how we interact with the world, might substantiate food science and advertising as powerful mechanisms to attack the obesity epidemic.

In Food Advertising and Childhood Obesity: A Call for Action for Proactive Solutions, published in Issue 12.2 of the Minnesota Journal of Law, Science & Technology, life and health sciences author Roseann Termini and others add advertising to the already-large list of “other” factors affecting childhood obesity rates. Indeed, children are not as informed as adults about health and may be more likely influenced by certain channels of advertising, such as television. To address this concern, one of her proposed solutions is to ban, regulate, or even shift tax structure in order to control advertising that specifically targets children. While this might be an effective mechanism to reduce demand, it may only be a partial solution. For one, because children are not, generally, the direct purchaser of food, but rather depend upon parents, to what extent does advertising actually affect the buying decisions of parents?

An article recently mentioned in The New York Times, The Extraordinary Science of Addictive Junk Food, might help answer this question. Mr. Moss similarly explores the “obesity epidemic,” but from a corporate standpoint, positing that consumers are primarily driven to buy what “tastes good.” While Mr. Moss’s article also agrees that advertising is part of the problem, he paints a more complete picture of what might be the underlying cause of parental acquiescence in a child’s poor dietary choices. The perfect combination of salt, fat, and sugar might be, in part, to blame as addicting foods that influence buying behavior. In this way, food is likened to tobacco, except, unfortunately, while people can choose whether to begin smoking, all people must eat.
While the analogy between food and tobacco may be imperfect, the point is there. If the majority of the food available to the everyday consumer is manufactured as addicting, to what degree is there a choice to eat healthy? If, in order to survive in the marketplace, a corporation has to manufacture “addicting” foods to compete, how can we make these addicting foods into disease-preventing rather than disease-aiding choices? Food science and advertising may contain the answer.

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