Public Health

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.

Juggling GMOs: Balancing Benefits, Risks, & Unknowns

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

by George Kidd, UMN Law Student, MJLST Staff

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

TV Advertising Not the Only Problem in Fight Against Childhood Obesity

October 26, 2012
Food and Agriculture, Public Health

by Bryan Morben, UMN Law Student, MJLST Staff

What happened to the days when kids would get together to play a game of football in the neighborhood? Or what about playing with Barbie dolls, cabbage patch kids, or a slumber party? Children today are just not entertaining themselves like this anymore. I have three younger brothers, and all I ever see them doing is sitting on the computer, playing videogames, or watching TV.

All of my brothers are as skinny as it gets, but probably only because they are also very active in school sports, especially hockey. Many other kids their age and younger also waste hours in front of a monitor or TV screen, but without the physical activity. Childhood obesity is turning into what some would call an “epidemic.” More than twenty-three million children and teens in the U.S. are overweight or obese, a four-fold increase over the past four decades.

A relatively recent study in Canada suggests that banning fast-food advertising to children may lower obesity rates. For the last thirty-two years in Quebec, it has been illegal for fast-food companies to advertise to kids. Researchers have estimated that as a result, children in Quebec consumed 13.4 to 18.4 billion fewer calories per year. Additionally, Quebec has the lowest childhood obesity rate in Canada.

Childhood obesity is generally the result of eating too many calories and not getting enough physical activity. Banning fast-food advertisements to kids may be one solution to help reduce the first part of that equation. Check out the article “Food Advertising and Childhood Obesity: A Call to Action for Proactive Solutions” in Volume 12, Issue 2 of the Minnesota Journal of Law, Science & Technology. It gives a great analysis of the relationship between food advertisements and childhood obesity and proposes solutions that may assist in reducing the impact of advertisements on children’s health.

But I question whether banning fast-food ads is really the answer we should be focusing on. I think the problem runs deeper than that. If kids were forced to put down the controller or remote and burn off some calories outside they wouldn’t be in the position to be watching a fast-food ad in the first place. Let me know what you think the most effective solution might be by commenting below.

Food Trends: Mid-Calorie Foods

October 25, 2012
Food and Agriculture, Public Health

by Johanna Smith, UMN Law Student, MJLSTStaff

Looking at the packaging on a food item can be very overwhelming. Not only does the product contain required nutritional information and an ingredients list, many products also contain health claims or statements on the front of the package to grab the customer’s attention. Common terms to see include organic, low-fat, high fiber, and low-carb. In “How Can Better Food Labels Contribute to True Choice?,” recently published in the Minnesota Journal of Law, Science & Technology, J.C. Horvath discusses the evolution of the regulation of claims made on food packaging. In addition to regulatory pressure, the other major source of pressure that determines what shows up on food packaging is consumer preference.

A decade or so ago, the hot trend was to highlight items as being non-fat or low-fat. However, consumers quickly realized that eliminating all fat and calories eliminated the taste of the food that they liked and the popularity of these items declined. This set the stage for the successful marketing of mid-calorie foods. These foods have less fat and fewer calories than the original version of the food, but more than the typical diet food. The goal is to mimic the taste profile of the regular version of the product, but reduce the calories and fat. Examples of recent marketing successes include Edy’s/Dreyer’s Slow Churned ice creams and Hershey’s Simple Pleasures chocolates. Many different drinks, including soda, sports drinks, and juice are also trying to find success in this balancing act.

While I applaud the effort to provide “healthier” options to consumers, mid-calorie foods should not be thought of as diet foods. The labels used on mid-calorie food packages should not lead consumers to think that it is a low-fat or low-calorie diet food. In many instances, the mid-calorie food still contains relatively high amounts of fat and calories per serving. If incorporated into a person’s diet correctly, mid-calorie foods are an easy way to eliminate unnecessary fat and calories. For example, if someone has already decided to eat some chocolate, choosing Hershey’s Simple Pleasures over a regular Hershey’s chocolate bar is a good choice. But, the better choice may be to not have any chocolate at all. Moderation and variety are still the keys to a healthy diet.

Incidental Findings: It’s My DNA, and I Want to Know if Something Is Wrong With It.

October 15, 2012
Bioethics, Public Health

by Ryan J. Connell, UMN Law Student, Joint Degree Program Fellow, MJLST Staff

As genetic research continues to develop, researchers are more apt to make incidental discoveries in the course of the research on a subjects DNA. Susan Wolf, Founding Chair of the University of Minnesota’s s Consortium on Law and Values in Health, Environment & the Life Sciences, points out in her article “The Role of Law in the Debate over Return of Research Results and Incidental Findings: The Challenge of Developing Law for Translational Science,” that, with this development, there is a serious question that must be asked, but that the law does not really answer: do researchers have to report these incidental findings to the subject?

Is this something that necessarily must be addressed by the law? I think so. Researchers need guidance on this front. Right now if a researcher finds something that may or may not have adverse health consequences for a subject the researcher must balance competing interests. What if they do disclose the risk? Is a pure researcher qualified to evaluate medical risks? The researcher could be very wrong in their analysis; could a subject who was told that they might be at risk for a serious health problem, but was not, hold a researcher liable for emotional stress? On the other hand, if a researcher comes across some potential risks and does not tell the subject, and the subject suffers as a result, should the researcher be liable?

I think the answer to this problem lies in waivers. Before people make themselves subject to research they should sign a waiver to either not hold a researcher liable for any incidental findings reported, or agree to not receive any information about any incidental findings.

This really should be the patient’s decision. Some geneticists think that it is better not to let people know if they have a risk for Huntington’s disease, or Alzheimer’s disease because there are no interventions. Likewise some geneticists feel that they would only report a risk of cancer if it is specifically requested.

From my point of view, if my genes are used for research and the researchers find that I am at risk for something, I want to know. I don’t care if there is nothing that I can do about it; I should know about it. My personal view is not shared however, some feel like they want to contribute to research, and then they don’t want to be bothered again.

This is a complicated issue with no clear solution. How do you feel? Do you want a researcher to tell you if they think you are at risk? Would you hold a researcher liable if they mistakenly told you that you were at risk for a horrible disease? Or would you be more likely to hold a researcher liable for not telling you that you were at risk for a disease? Do you think a waiver, or some other agreement is necessary between a researcher and a subject before any research is conducted?

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