public health

Is Obesity a Disease?

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.

New Medicine into Old Bottles, Quality and the US Medical System

by Eric Nielson, UMN Law Student, MJLST Staff

Thumbnail-Eric-Nielson.jpgThis entry discusses some of the challenges identified in Grout et al.’s article Mistake-Proofing Medicine: Legal Considerations and Healthcare Quality Implications from Volume 14.1 of the Minnesota Journal of Law, Science, and Technology. If you don’t have any health problems, have family with health problems, or pay taxes then the problem probably doesn’t impact you. The rest of this paragraph is about me establishing my credentials on the subject, if you don’t care, feel free to skip ahead. I have worked as an R&D engineer developing medical devices for more than 15 years. I have a Masters in Medical Engineering from the University of Washington. I am an inventor on several medical device patents. I have worked for a very large company and for several startups. I have conducted market research, physician training, product design, FDA filing preparation, process development, product development, and implementation, etc. I have worked at nearly every stage of medical device development. Devices I have worked on are in literally millions of people in the United States.

The medical delivery system in the United States is fundamentally unchanged in its approach to quality management since the sixties, with the notable exception of anesthesiology (consider how, malpractice pressure forced reform of anesthesiology in the 80s). The public sector of our economy had to make major revisions when foreign competition in the eighties meant that domestic manufacturing could not compete with other countries. American automotive manufacturers took it in the chops because they could not effectively compete with Japanese and Korean companies. Only in the last decade have the automotive manufactures achieved economic efficiencies similar to their competitors (and finally shed some of their legacy costs). Hospitals and private practices never had this wave of foreign competition and so have never had to reinvent themselves to stay in business. Hospitals are heavily subsidized both directly by the taxpayer and through the federal system. The result has been local monopolies with limited real competition, just like the big three automakers before the Japanese entered the picture.

Japan did not invent quality manufacturing. Japanese industry was known for cheap, poor quality goods well into the sixties. What changed is that Japan got serious about producing quality products as a way to compete internationally and move up the value chain. To do this they relied on the work of several notable Americans: Demming, Juran (University of Minnesota graduate), and Crosby. These three together with Taguchi constitute the key founders of the discipline of Quality Management. There are some key concepts that I want to explore in relation to medical providers.

1) “Quality is free.” It is inherently cheaper to do it right the first time than to have to fix it. It is cheaper to spend more on the process to make it so reliable that you don’t have to continue to monitor the output. Your current business is probably externalizing the costs or hiding them and thus minimizes the real cost of defects in the products you make. Time and money are spent to prevent customers from knowing what the actual quality of health care provided by hospitals.

2) Nobody understands the problem better than all of us together. To find the best solution, you need to understand the system from the point of view of everyone who interacts with it. This requires that line personal have the ability to discuss problems and solutions without fear of negative job impact. This does not exist in modern hospitals. Nurses and staff doing the work are not free to identify problems or concerns with physicians. Decisions are not made with consensus but are top down, command and control by people with very limited information. This prevents identification of effective, realistic solutions and instead encourages ineffective window dressing committees.

3) Quality improvement depends on good information and systematic effort. Bluntly Medical providers have systematically hidden outcomes information in an effort to prevent the consuming public from being aware of how bad a job they’ve done. This includes not gathering the information, not publishing information they have, and playing malpractice claims to keep quiet. Take a typical medical procedure and go find the published complication rate. Then take those numbers and talk with specialists in that field about those numbers. What you’ll find is that the published data invariably understates the prevalence of complications at top flight institutions. This is generally a result of selection bias, where only data sets with exceptional outcomes are submitted for publication (so as not to reflect poorly upon the institution). In the absence of good information, these Potemkin village studies underestimate the scope and cost of the problem and encourage administrators and staff to ignore the problem. Nobody ever says Institution X published a study with only a 3% complication rate for procedure Y, we need to get our numbers to that level. They instead say, I wonder what their real rate is or I wonder how they selected their patients for that study.

4) Management needs to lead or it will not happen. This is a system problem. This is not a problem of people not doing their jobs. It is not about people not trying to do their best. The highly complex medical delivery system does not hold anyone responsible for the error rate. It doesn’t not impact salaries, reputation, or stock price the way it does at private companies. Look at the response from hospitals that are killing people every day compared with Toyota’s response to the “sudden acceleration” fiasco. Is the executive team involved? Are resources focused on the problem? Etc. FDA holds management personally, legally responsible for failures of the quality systems at medical device companies. The same standard hasn’t been applied to medical delivery systems. Maybe it’s time to apply this principle outside of Anesthesiology.

Brains on Drugs: The Need for a Drug Policy that Embraces Scientific Understanding of Addiction

by Mike Borchardt, UMN Law Student, MJLST Managing Editor

Thumbnail-Mike-Borchardt.jpgThe strong showing in polls for marijuana legalization efforts in Colorado and Washington illustrate that America’s attitudes toward illegal drugs is starting to shift. Though the attitudes of some voters are starting to shift on pot, there is still a strong disconnect, especially when it comes to harder drugs, between what we know about addiction and the policies we use to curb drug use. In their article in MJLST 11.1, “Why Neuroscience Matters for Rational Drug Policy,” David M. Eagleman, Mark A. Correro, and Jyotpal Singh outline this disconnect between science and policy. As they explain, “Although addiction may involve volitional choices early on, it is best understood as a brain disease.” Despite this being the general consensus of the scientific community, our drug policies do too little to address addiction as a disease.

A good example of this is the use of Suboxone (buprenorphine), a drug used to treat opiate addiction . The US government spent millions of dollars funding Reckitt Benckiser’s development of Suboxone. It is an opiate which is much more difficult to overdose on than other drugs like heroin, and it is used to help manage withdrawal and cravings. Due to fears that it will be abused, Suboxone is difficult for many addicts to get. Doctors must undergo special training to prescribe it, and they are only allowed to write prescriptions for 30-100 patients a year. Additionally, many doctors are wary of prescribing it, as they don’t want to draw addicts to their offices. This makes it more difficult than necessary for addicts to gain access to Suboxone–they turn to drug dealers on the street for a supply of it, and when the dealers don’t have it, they use heroin or other opiates to satisfy their addiction.

Making Suboxone unnecessarily difficult for addicts to get is only one example of the disregard our drug policy shows towards our scientific understanding of addiction. As Eagleman, Correro, and Singh explain (at page 20) , “The United States has a history of combating the drug problem with increased law enforcement rather than customized intervention and rehabilitation.” Despite the fact that treatment has been shown to be far more effective (both cost-effective and effective in reducing drug use) than incarceration, drug treatment programs are underfunded and stigmatized. As the economic recession in the US has led to tighter budgets, drug-treatment programs are often one of the first things on the chopping block. Though US drug policy has generally been, and still is, heavily focused on law enforcement as a solution to the drug problem, there have been some hopeful developments. The Affordable Care Act includes addiction treatment as one of the “Essential Health Benefits” insurers are required to provide. If the law is successful in getting more Americans, especially low-income Americans, health insurance, it could help provide avenues of treatment that were formally unavailable to drug-addicts due to their cost.

Pandemic Flu and You

by Eric Nielson, UMN Law Student, MJLST Staff

Thumbnail-Eric-Nielson.jpgWelcome to flu season. That wonderful time of year where we cross-contaminate millions of bioreactors in our schools and unleash the resulting concoction on humanity.

Flu kills thousands of Americans each year. The good news is that since H1N1 in 2009, we’ve gone without a serious flu pandemic threat. The bad news, according to researchers, is that may be just a matter of luck.

Researchers have recently published multiple methodologies for converting existing animal strains of flu into pandemic capable versions. Flu strains are tested on unimmunized ferrets which are believed to best represent the human disease response to flu (and are kind of cute in a weaselly way). In Korea, researchers created a highly contagious swine flu variant that produces 100% fatalities in brave test ferrets. While it is expected that humanity’s general immunity to flu would provide significant protective effect, it’s still a bit worrisome that a pandemic strain can be produced with equipment little better than a couple of cages and some animals.

Work on bird flu variants that had been mutated to produce contagious versions was also recently described by researchers in the Netherlands . The article states, “The introduction of receptor-binding site mutations Q222L/G224S and the mutations H103Y and T156A in HA, acquired during ferret passage, did not result in increased cross-reactivity with human antisera (table S6), indicating that humans do not have antibodies against the HA of the airborne-transmissible A/H5N1 virus that was selected in our experiments.” Or in plain English, this variation, made with minor mutagenic exposure and some ferrets was indeed a pandemic capable virus.

It is hard to know how bad a flu pandemic would be. The exemplary case of the Spanish Flu in 1918 had a death rate of 3-7% of the population. CDC estimates that a similar disease treated with modern medicine techniques would have a 1.2% death rate. That would mean approximately 3.77 million deaths in the United States. It should be recognized that the Spanish flu pandemic had two waves when the flu mutated and became much more deadly partway through. Anthrax (not a flu) was estimated to have a 75% or higher respiratory kill rate prior to the letter attacks on congress in 2001. The actual death rate from those attacks was 5 of 22 infected or 23%. While modern antivirals, antibiotics, hydration, and ventilators are effective, these resources would be limited in the event of a true pandemic. Especially considering the CDC estimates that 55 million Americans contracted H1N1.

There has not been significant legislation since James Hodge, Jr. stated in his article “Global Legal Triage in Response to the 2009 H1N1 Outbreak” published in 2010 in the Minnesota Journal of Law, Science & Technology that, “If H1N1 was a “test” run of the modern global public health system, then the system has fallen short.” While states have included pandemic preparedness into their planning,the overall level of preparedness is mixed.

The fact of American life is that our politics are reactive to crisis. Even shocks like the bird flu and swine flu have not been enough for our federal and local governments to develop plans to prepare for a pandemic. Instead, the lesson learned has been that there is nothing to worry about. Stay healthy.