Public Health

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.

Reviving GRAS(E): Bringing Reform to the Drug Approval Process

April 3, 2013
Food and Agriculture, Healthcare, Healthcare Reform, Pharmaceuticals, Public Health

by Maya Suresh, UMN Law Student, MJLST Staff

Bringing new drugs to the market has turned into a time consuming and costly process. Resulting in a process that takes roughly 12 years and 1.2 billion dollars to develop a single new drug and move it through the approval process, the current laws administered by the FDA have the potential to stifle potential economic growth. Current laws and FDA regulations require new drugs to go through three phases of clinical trials focusing on safety, optimal dosage, and effectiveness. It is in the prolonged third phase (where effectiveness is tested through extensive clinical trials) that many manufacturers decide to pull the drug from the program as the clinical trials threaten the firm’s financial viability. Ultimately, it is consumers that are hurt by the process, as they are unable to benefit from the drugs.

The negative effect on consumers is what Emily Puchalski hopes to eliminate with the recommendation detailed in her note published in Issue 14.1 of the Minnesota Journal of Law, Science & Technology. In “Bringing Dormant GRAS(E) to Bloom: Reviving The GRASE Concept for Drugs,” Puchalski suggests that a revival of the Food and Drug Administration’s (FDA) “generally recognized as safe and effective” laws and regulations, commonly reffered to as “GRASE”, could minimize the negative effects on consumers. Many drugs, once discovered, have formulations found in earlier drugs that have already been established as safe for consumer use. The GRASE law is grounded in this understanding, and provides a way for these “already established as safe” drugs to get to the market quicker without having to go through extensive clinical trials.

The problem with GRASE however, is that it is very difficult for a drug to achieve GRASE status. Due to this difficulty, GRASE has fallen out of use as manufacturers have stopped trying to achieve the status. Puchalski suggests that if the FDA were to revive GRASE, it could convince manufacturers to apply for GRASE status, allowing already established safe and effective drugs to come to market more quickly, thus benefiting consumers.

It would appear that Puchalski’s recommendation is being heard. In late February Micropharma Limited was able to obtain GRASE status for their new heart health probiotic. Ryan Jones, CEO of Micropharma Limited, echoed Puchalski when he spoke of the benefits the company has been able to reap with the highly coveted status. GRASE status will allow the company to accelerate development of the drug within both the United States and international markets. Further, it provides strong reputational benefits for the company, as it makes clear to the public that Micropharma is committed to investing a significant amount of time and energy into providing safe and effective drugs to the market.

The ability for Micropharma to obtain GRASE status could serve as evidence of a potentially reformed drug approval process. However, the full benefits realized by consumers and the market will only become clear with time.

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

March 12, 2013
Healthcare, Healthcare Reform, Public Health

by Eric Nielson, UMN Law Student, MJLST Staff

This 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.

States Move to Implement Health Insurance Exchanges

February 13, 2013
Healthcare Reform, Public Health

by Brianna Rohne, UMN Law Student, MJLST Articles Editor

Proponents of the Affordable Care Act breathed a collective sigh of relief in June 2012 when the U.S. Supreme Court upheld most of the law in its decision in National Federation of Independent Business v. Sebelius. As Minnesota Lawyer reports, the health care law will have a major impact in 2013 as state and federal agencies rush to implement the ACA’s key features.

Chief among those features are the Health Insurance Exchanges, which are insurance marketplaces designed to help carry out the ACA’s key feature–the individual mandate–by simplifying the process for purchasing health insurance for consumers and small businesses in every state. As Kathleen Sebelius comments, the Exchanges will provide “one stop shopping for health insurance with better information about plan benefits, quality and cost.” The Exchanges, which will be administered at the state level, must be ready for open enrollment in October 2013 and full operation on January 1, 2014.

Department of Health and Human Services rulemaking has stressed flexibility in the creation and operation of the Exchanges, encouraging each state to take the lead in shaping their Exchange in a way that best accommodates local needs and market conditions. For example, states may choose the type of entity to operate the Exchange, limit the insurance plans eligible to participate, and partner with other states to establish regional Exchanges. HHS also offers support in the way of formal partnership, grant funding, technical assistance, and guidance on key topics.

HHS also allows states to opt out of Exchange planning altogether, leaving it up to the federal government to implement Exchanges in those states. As of early January, the New York Times reported that 23 mostly Republican-run states had indicated that they will not set up their own Exchanges. Another 17 states and the District of Columbia are moving to set up their own Exchanges and seven states have asked to collaborate with the federal government.

Ensuring health coverage and subsequently affordable health care for millions of uninsured and under-insured Americans is an ambitious undertaking, fraught with challenges that states and the federal government are just beginning to work through. In a recently published article from the current issue of the Minnesota Journal of Law, Science and Technology titled Developing a Durable Right to Health Care, Erin C. Fuse Brown discusses the momentous shift in policy accomplished by the ACA’s statutory right to health care. She goes on to warn that the ACA’s right to health care is fragile–especially early in its lifespan–and faces significant political and market challenges. Ultimately, the success or failure of the ACA’s most ambitious goals may become apparent as the federal government and states begin its roll-out over the next few years.

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

November 7, 2012
Public Health

by Mike Borchardt, UMN Law Student, MJLST Managing Editor

The 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.

Biobanks Revisted

October 31, 2012
Bioethics, Public Health

by Jeremy So, UMN Law Student, MJLSTManaging Editor

On October 28, Australian researchers published new information about the genetic basis for endometriosis, a condition where the cells lining the uterus flourish in other areas of the body. The researchers, instead of recruiting their own research subjects, analyzed samples stored in biobanks in Australia, Japan, and Europe. Because of their approach, the researchers were able to identify common markers that appeared across the ethnically-diverse study population. The Australian team’s findings highlight the increasing importance of biobanks–repositories for biological research samples–which have become a valuable resource in the fields of genomics and personalized medicine

The increasing importance of biobanks was recently highlighted in a symposia sponsored by MJLST. In the accompanying Spring 2012 issue, researchers and lawyers discussed the one of the primary problem facing researchers who use biobanks: whether to return research results and incidental findings to research participants.

While the Australian researchers have decided to track down the original participants in order to share their findings, other researchers have hesitated to use the same approach. Karen J. Maschke highlighted several such reasons in her recent article “Returning Genetic Research Results: Considerations for Existing No-Return and Future Biobanks.” In the article, Maschke focuses on the approaches of American biobanks researchers, who generally do not share their results with individuals whose DNA was analyzed.

For American researchers, Maschke notes that samples stored for biobank research are regularly deidentified, making it difficult to impossible to contact the original donor. Such a system exists in part because of concerns over whether consent would be granted for samples to be used in certain types of research. Combined with conflicting interpretations of government regulations and other difficulties in actually returning sample results, researchers have hesitated to adopt a disclosure-based system for research results.

Although some may remain hesitant, cooperation between researchers and biobank participants has not necessarily led to negative outcomes.

The importance of resolving this conflict is highlighted by the increasing prevalence and importance of biobanks to scientific research. Several countries are working on expanding their biobank networks. Now, before competing standards come to dominate the field, a uniform system for the return of results should be determined and implemented.

Juggling GMOs: Balancing Benefits, Risks, & Unknowns

October 26, 2012
Environment, Food and Agriculture, Public Health

by George Kidd, UMN Law Student, MJLST Staff

The recent multi-billion dollar loss as a result of the 5th worst drought ever recorded in U.S. history adds fuel to an already raging debate over genetically modified organisms (“GMOs”). Amanda Welters, in “Striking a Balance: Revising USDA Regulations to Promote Competition Without Stifling Innovation,” delivers a fantastic overview of key issues in the GMO debate while also introducing novel legislative ideas garnered from the pharmaceutical industry. Ms. Welters’ article provides important insights into the continuing struggle to provide society with an optimal outcome.

While recent documentaries such as “Food Inc.” and “King Corn” give informative, although one-sided, analyses of the GMO debate, GMO’s may indeed be necessary for the future. The recent drought only emphasizes why utilizing GMO crops may be so necessary. Benefits of using these crops could include increased resistance to severe weather, increased food production from less land, and decreased pesticide use. With so many benefits it is easy to see why these types of crops may have a lasting future.

But the road to societal riches as a result of using GMOs may be a tightrope walk with a long fall. Most of the pushback comes from the fact that the effects of consuming GMO products are largely unknown. Further, when all farmers use GMO seed, biodiversity is reduced, opening up problems if a disease were to effectively eradicate a particular GMO crop. Lastly, while Monsanto has done a good job of creating essentially “self-destructing” seed, reducing the crop yield of further generations of their soybean to encourage farmers to purchase new yearly seed, introduction of modified genetic material may have an irreversible environmental impact.

In light of the World Bank issuing a global hunger warning, perhaps we should accelerate our efforts in moving toward a legislative balancing act in either moving forward with GMO crops or looking elsewhere for innovative ideas. Producers of new GMO technology need to remain adequately incentivized to make GMOs more effective and safer for human consumption. But competition also plays an important role in improving GMO’s future viability. Expiration of Monsanto’s Roundup Ready soybean patents in 2014 will allow generic brand competition to spur price drops and competitive innovation.

In the end, when we do find that optimal balance between innovation and competition, the only winners are us.

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