Drug Policy

Snortable Chocolate Fails the Smell Test, But What Exactly Is It?

Tommy Tobin, MJLST Guest Blogger

 

Snorting chocolate does not sound like a good idea. In fact, it sounds downright crazy. Enter the aptly named “Coco Loko.”

As reported by the AP, Coco Loko is a cocktail of cacao powder and common energy-drink ingredients, such as guarana and taurine. Marketed by a company called Legal Lean, the product makes several bold claims and promises, including feelings similar to ecstasy and “a steady rush of euphoric energy that is great for party goers to dance the night away without a crash.” Oddly, that promised effect is juxtaposed with promises of “calm focus” and “natural relaxation.”

Legal Lean advises users to “consume responsibly.” Warnings include the all too familiar boilerplate that product statements have not been evaluated by FDA and that the products are not intended to diagnose or treat any disease. A notable product warning also advises potential customers that Coco Loko is “not recommended for children or pregnant women.” Legal Lean also notes that the product “may impair your ability to drive a car or operate machinery, and may cause health problems.” It is certainly helpful that the company recognizes that snorting a chocolate concoction up one’s nose may result in health issues and is warning potential consumers accordingly. Self magazine summarized the situation succinctly: “If it sounds like a bad idea to snort what basically amounts to glorified hot chocolate mix, you’re right.”

As the Huffington Post recently put it, “snortable chocolate exists now, for some reason.” The mere fact that this product exists raises myriad questions, not least of which is what the product actually is and how it will be regulated.

According to ABC News, FDA is currently weighing whether the product falls within its jurisdiction and is currently “not prepared to issue a determination regarding whether and how this product is subject to FDA jurisdiction at this time. In reaching that decision, FDA will need to evaluate the product labeling, marketing information, and/or any other information pertaining to the product’s intended use.”

While the intricacies of regulatory classifications are enough to make one crazy, Coco Loko’s regulatory future remains to be seen. As the administrative law bloodhounds at FDA continue their work sniffing out the proper classification for this product, here are some preliminary thoughts.

 

Is Coco Loko a Food?

Strictly speaking, probably not. The statutory definition of food, 21 U.S.C. § 321 (f), is not tremendously helpful here. The statute’s most applicable definition defines “food” as an article used for food or drink for man or other animals. Snorting something through one’s nose is not generally how most people consume their food or drink, especially as the nose is woefully devoid of taste buds.

Legal Lean may argue that an alternative use of the product is as a hot chocolate mix. Presumably, the Coco Loko powder could be used as a drink when dissolved in hot water. Even so, the company markets the product as “infused raw cacao snuff.”

The product’s marketing as “snuff” is highly suggestive that the company does not consider that the product is meant to be food, given that “snuff” is taken through the nose. Put differently, the company may huff and puff that the product is a “food,” but in the end, the stuff is “snuff” by their own admission.

 

Is it a Drug?

Possibly. Coco Loko is likely not a “drug” under 21 U.S.C. § 321 (g). One applicable definition of “drug” includes items “intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease in man or other animals.” Such an intention is expressly disclaimed by the makers of Coco Loko.

Another definition of “drug” applies to “articles (other than food) intended to affect the structure or any function of the body of man or other animals,” with a carve-out for foods and dietary supplements. Coco Loko does promise a rush of serotonin and endorphins, as well as “increased overall happiness.”

The structure or function claims made by Coco Loko could make it a “drug” if it is found to be neither a food nor dietary supplement. Put another way, the product appears to be an inhaled stimulant, and regulators could plausibly put it in the category of “drug” given the claims the product is making, in the case that the product does not fit in other categories.

 

Is it a Dietary Supplement?

It depends. Regulators could label Coco Loko as a “dietary supplement” under 21 U.S.C. § 321 (ff). Just as the definition of “food” was quite broad, so too is the statutory definition of “dietary supplements,” which helpfully notes that the term:

 

1) means a product (other than tobacco) intended to supplement the diet that bears or contains one or more of the following dietary ingredients:

(A) a vitamin;

(B) a mineral;

(C) an herb or other botanical;

(D) an amino acid;

(E) a dietary substance for use by man to supplement the diet by increasing the total dietary intake; or

(F) a concentrate, metabolite, constituent, extract, or combination of any ingredient described in clause (A), (B), (C), (D), or (E).”

 

Given the inclusion of cacao in the product, a colorable claim could be that Coco Loko contains a dietary substance used by man to supplement the diet. That said, is someone actually supplementing their diet by inhaling through their nose? Not being a doctor myself, I can only surmise that the snorted chocolate may have a circuitous path from the nose to one’s stomach—if it ends up there at all.

More on the nose, US News & World Report notes that the product’s label includes B vitamins, ginkgo biloba, blood flow-improving amino acid L-Arginine, as well as energy drink staples guarana and taurine. So, it would seem that Coco Loko would meet the vitamin and amino acid test.

Other aspects of the “dietary supplement” definition in 21 U.S.C. § 321 (ff) include that the item must not represent itself for use as a conventional food or as a sole item of a meal or the diet. “Dietary supplements” must also be labeled as such. If its labeling does not call it a “dietary supplement,” Coco Loko cannot be a “dietary supplement.” According to Ars Technica, Legal Lean is already marketing Coco Loko as a “dietary supplement.”

Incorporated by reference into the § 321 (ff) definition of “dietary supplements” is the requirement that the product be intended for ingestion under 21 U.S.C. § 350 (c)(1)(B). That section requires products be “intended for ingestion in tablet, capsule, powder, softgel, gelcap, or liquid form.” While Coco Loko is a powder, it is unlikely that it is “ingested” in the typical meaning of that term. The statutory provision also provides an alternative definition for items “not intended for ingestion in such a form” that are otherwise “not represented as conventional food and is not represented for use as a sole item of a meal or of the diet.” Both incorporated definitions are predicated on “ingestion,” and Coco Loko’s method of intake is unlikely to fit the plain meaning of “ingestion.”

By analogy, a suppository also bypasses the mouth when they are taken into the body. Even so, suppositories generally go into one end of the alimentary canal—rather than the sinuses or the lungs. Moreover, neither suppositories nor this inhaled chocolate are “ingested.” No less an authority than the Oxford English Dictionary includes a definition of “ingest” that equates ingestion with the introduction of material into the stomach or mouth.

Coco Loko faces an uphill battle getting a “dietary supplement” label given that is probably not “ingested” or intended for ingestion. According to the FDA Law Blog, “FDA has consistently taken the position that articles not intended for ingestion do not qualify as dietary supplements.” In the end, FDA may find that “ingestion” is distinct from insufflation, or the act of breathing something into the body.

Even if Coco Loko is labeled as a “dietary supplement” and met other aspects of the § 321 (ff) definition, the Secretary of Health and Human Services, pursuant to 21 U.S.C. § 342 (f), could conceivably find that it presents a “significant or unreasonable risk of illness or injury.” While unlikely, the Secretary has the authority to declare a dietary supplement so unsafe that it poses “an imminent hazard to public health or safety.” That said, do not hold your breath for such a declaration—if you do, it’d be harder to inhale the chocolate.

 

Concluding Thoughts

While the safety and propriety of snorting crystalline chocolate powder through one’s nostrils is up for debate, FDA is hard at work sniffing out the proper regulatory classification of Coco Loko.

My preliminary thought is that Coco Loko might be labeled a “dietary supplement,” given its ingredients. On the other hand, its method of delivery—through the nasal passage—is not one typically seen in dietary supplements and is unlikely to fit the “intended for ingestion” prong of the incorporated statutory definition.

Alternatively, FDA may label the product a “drug,” especially with its “structure or function” claims. Either way, if you think I’m going to go snort chocolate anytime soon—you’re loko.


Happy Mother’s Day to all the Moms!: Law, Science, Technology and Beagles

Angela Fralish, MJLST Guest Blogger

Beagles are well-known as a quintessential family dog because they love humans and listen to their owners (most of the time). What is less known, is that those same traits are the primary reasons they are used in 95% of canine medical experimentation. Although, beagles are not biologically comparable to humans, they are compliant people-pleasers, making them ideal subjects for scientific experiments.

This reality is a hard pill to swallow for animal lovers and scientists alike. To scientists, research beagles are a necessary evil decreasing the pain and suffering of humans. To advocates, beagles are victims of unspeakable cruelty.

One law bridges the divide between these opposing views to help the beagles. The Beagle Freedom Bill, created by the Beagle Freedom Project (BFP), forges a compromise between animal rights lawyers, scientists and medical technologists. The Bill asks that ”tax-payer funded laboratories offer up the “experimentally-spent” dogs and cats for public adoption through rescue organizations.” In other words, once the beagle is no longer used for research, the dog is given a home instead of euthanasia. Minnesota was the first state to sign the Bill into law in 2014, and since then, 5 more states have joined. Currently, 5 additional states are considering adopting this law as well.

In addition to legislative measures, the BFP has found other ways to help research beagles. They have created new technology such as the Cruelty-Cutter app which helps shoppers easily scan products for humane animal testing, and sued the USDA demanding restoration of scrubbed animal records. The Beagle Freedom Project is a leader in animal science law and a great example of how lawyers, scientists and technologists can work together for the greater good of both humans and animals.

Scientists are working to replace this “necessary evil” as well. According to Dr. Teresa Arora’s article Substitute of Animals in Drug Research: An Approach Towards Fulfillment of 4Rs, research methods are being developed that are “superior to using animals to learn about human disease or predict the safety of new drugs [and include] stem cells, microdosing, DNA chips, microfluidics chips, human tissue, new imaging technologies, and post-marketing drug surveillance.” There is even a Center for Alternatives to Animal Testing at John Hopkins University and the NC3R in the UK.

For an employee of medical research looking to carve out meaning in their every day workweek, helping research animals through new collaborative measures is one way to answer the call. As a lawyer, scientists or technologist, you can help develop policy, arbitrate between groups, hold violators accountable, assist in medical technology development, vote for the Beagle Freedom Bill or adopt a research beagle. According to Congressman Earl Blumenauer, “members of Congress are realizing that protecting animals is not just the right thing to do, it’s also developing to become potent politically.” Congress will need help understanding the relationship between animal models and science in order to make improvements. That help will come from people who work in these fields on a daily basis.

The Beagle Freedom Bill highlights the plight of animals languishing in labs and promotes cruelty-free lifestyle choices everyone can make. Now that BFP has opened the door, it is time for all of us to show a little gratitude to the beagles for their sacrifice in advancing medical science such as chemotherapy and insulin. We can do this in our own unique ways, and although we can’t change the world for all beagles, for some beagles, we can change the world.

As Mahatma Ghandi stated, “The greatness of a nation and its moral progress can be judged by the way its animals are treated.” I hope ours is one of progress.


Something to Chew On: The FDA, Food, and a Healthy Dose of Definitions

MJLST Guest Blogger, Tommy Tobin

[Editor’s Note: This post is #3 in a series on current FDA issues. You can find the previous post here and here.]

Is food medicine? The answer to this simple question is surprisingly complicated.

The name of the Food and Drug Administration (FDA) seems to distinguish between foods and drugs. So too does the Federal Food, Drug, and Cosmetics Act, which helpfully defines “food” as “(1) articles used for food or drink for man or other animals, (2) chewing gum, and (3) articles used for components of any such article.”

While it is not difficult to swallow the concept of chewing gum being food, the broad legal definition of “food” is somewhat circular and does not provide much guidance by itself.  Indeed, the definition of “drug” under the same law notes that drugs are, in relevant part, “articles (other than food) intended to affect the structure or any function of the body of man or other animals.”

Setting the table for further discussion, it should be noted that foods and drugs face different regulatory burdens. For example, drugs face pre-market approval. As for foods, the FDA does not have sole regulatory oversight over food products, which it shares with approximately 14 other federal agencies. The Government Accountability Office labeled the patchwork of federal food safety oversight as a “high risk issue” noting that it had caused “inconsistent oversight, ineffective coordination, and inefficient use of resources.”

Knowing whether an item is a drug or a food dictates whether it is regulated appropriately and even which laws apply to the item. From the definitions, it would seem that foods are categorically not drugs. Yet, sometimes foods do function as medicine. For example, the Harvard Food Law & Policy Clinic argues that “for critically and chronically ill people, food is medicine.” Part of the Clinic’s work has advocated for expanded medically-tailored food and nutrition interventions to improve health outcomes and reduce overall health care costs for high-risk, high-need populations. Even outside of high-risk populations, it is likely many of us provide self-care through food, such as sipping chicken soup for colds or the flu.

Adding more food for thought, there are several terms that blur the lines between the categories of “food” and “drug.” The FDA notes that “terms like ‘functional foods’ or ‘nutraceuticals’ are widely used in the marketplace” but are not explicitly defined in the Food, Drug, and Cosmetic Act. While one could devote a book to the regulation of nutraceuticals and functional foods (and some have done so), it is sufficient here to note that nutraceuticals and functional foods have their own definitions in the relevant, non-regulatory literature. According to an article in the aptly-titled scholarly journal Nutrients, a nutraceutical is “food (or part of a food) that provides medical or health benefits, including the prevention and/or treatment of a disease” and functional foods are “food products that have an added positive health benefit” (internal citations omitted). Notably, each definition expressly notes that these items are foods, not drugs. Put another way, an apple a day may keep doctors away, but apples enriched with antioxidants may be a functional food that merits a price premium from consumers.

The terms have largely arisen out of marketing practice, and a combination of the words “nutrition” and “pharmaceutical.” Entire publications have devoted themselves to the news and scholarly analysis of these products, including Nutraceuticals World and the Journal of Functional Foods. One recent article examined whether Jelly Belly, the jelly bean purveyor, could support its claims that its Sports Beans were “clinically-proven” to maximize sports performance.

Further blurring the line between foods and drugs, a “medical food” is defined under a statute that has “drug” in the name, but the product is not actually a “drug.” A “medical food” is defined under the Orphan Drug Act, as “a food which is formulated to be consumed or administered enterally under the supervision of a physician and which is intended for the specific dietary management of a disease or condition for which distinctive nutritional requirements, based on recognized scientific principles, are established by medical evaluation.” Pursuant to the above definition, the FDA has declared that medical foods must be taken only under the supervision of a physician. According to a recent FDA Guidance Document, medical foods are explicitly not drugs and are not subject to the requirements that apply to drugs. As an example, one medical food, Deplin, is an orange pill that advertises itself as a “prescription medical food” specifically designed to meet the “clinical dietary management of depression and schizophrenia.”

In the supermarket, consumers may stroll from the pharmacy aisles to the food aisles, seeing pharmaceuticals one moment and nutraceuticals the next. With consumers willing to pay a price premium for healthy foods, including functional foods, foods that make claims to reduce disease and promote good health are likely here to stay.


Evaluating an FDA ban on Use of Human-Used Antibiotics in Animals

Nathan Vanderlaan, MJLST Staffer

Over the past several years, antibiotic resistance in humans has become one of the leading health concerns in the United States. Many heads are turning towards the U.S. farming industry, and the antibiotic consumption by animals as a leading culprit. Today, about 80% of all antibiotic consumption in the United States is attributable to animal consumption. Many argue that unless the government takes stronger regulatory stances on the animal consumption of antibiotics, an inability to effectively fight a number of illnesses due to antibiotic resistance will be on the horizon.

In her article “Slowing Antibiotic Resistance by Decreasing Antibiotic Use in Animals,” Jennifer Nomura argues that the FDA should implement a total ban on the use of antibiotics in animals that are also used therapeutically in humans. Currently, the FDA has taken the position that there is no definitive proof that antibiotic use in animals leads to greater resistance in humans. As such, they intend to allow producers to continue to use antibiotics used to treat humans in farming practices until a scientific correlation between resistance and farm use is established. Nomura advocates that the FDA transition from this “wait-and-see” policy and enter the realm of stiff antibiotic regulation. She argues that the FDA is under such an obligation based on their duty to minimize risks to human health. However, this duty may suggest that the FDA should not rush into a total ban on antibiotics also used in human health.

An all-out ban on such antibiotics may in fact have a more detrimental impact on human health. The potential that a ban would lead to increased incidence of disease cannot be underscored. While Nomura suggest that disease may be kept down due to improved farming practices, the reality of creating the infrastructure to promote such practices may not be feasible for a country with such high meat production. And although several countries have been successful in making the transition from these kinds of antibiotics, their success may not be entirely indicative of the success a large country like the U.S. will have. If the incidence of disease goes up after a ban, consumers will likely suffer medically and financially, and these risks cannot impulsively be set aside.

Nonetheless, the FDA must take notice of the growing problem of antibiotic resistance. Resistance is giving rise to “super-bugs” and leading to more unpreventable deaths every year. While steps must be taken to address these growing concerns, any action taken by the FDA should not be hasty. Instead of an outright ban on all antibiotics used for humans as well, the FDA should do a full risk analysis regarding the impact giving these drugs to animals poses to humans. Then the FDA should conduct an individual analysis of the highest risk antibiotics being used, tackle these antibiotics first, and then slowly transition away from the use of certain antibiotics once it is determined such a transition will not threaten the health of humans or the nations live stock.


Drug Shortages: A Mask for Reprehensible Activity?

Ethan Mobley, MJLST Articles Editor

Access to life-saving prescription medication grabbed headlines after Turing Pharmaceuticals raised the price of its HIV drug, Daraprim, by about 5,000% overnight. While the Daraprim price hike initially appears to be driven by pure greed, it’s at least conceivable that basic economic principles of supply and demand may have played a minor role. Indeed, many other drugs have undergone serious price hikes arising from innocent supply constraints. While the defensibility of Daraprim price hikes remains uncertain, the story does bring to focus an issue affecting accessibility of hundreds of other life-saving prescription medications—drug supply shortages.

Drug shortages naturally restrict many patients’ ability to obtain life-saving medication, which can have disastrous effects. The Minnesota Journal of Law, Science & Technology addressed the issue in 2013 with a note written by Eric Friske. Friske found that drug shortages are often caused by a “combination of perturbed supply, manufacturing capacity, and utilization.” Friske then analyzed the efficacy of proposed (and now failed) legislation meant to reduce these supply shortages by requiring manufacturers to notify the FDA of impending shortages; the legislation would have also allowed the FDA to collaborate with manufacturers in order to streamline production. However, Friske determined these tools were insufficient to properly combat the shortage problem and proposed his own solution. In addition to notification requirements, Friske pushed for affirmatively incentivizing manufacturers to produce certain drugs and streamlining the drug manufacturing approval process.

Since Friske’s proposal, we’ve seen new legislation and regulation that aims to reduce the number of drug shortages. What’s more, the legislation and regulations contain notification requirements, manufacturer incentives, and streamlined approval processes—just like Friske proposed. While it’s obvious the drug shortage problem has not been solved, it is equally clear drug shortages have decreased over the past few years. Hopefully the trend continues so that life-saving drugs remain accessible to everyone, and drug companies will no longer be able to use supply shortages as justification for obscene price hikes.


Compulsory Licensing and Health Law

Nolan Hudalla, MJLST Staffer

In her articleA Public Health Imperative: The Need for Meaningful Change in the Trans-Pacific Partnership’s Intellectual Property Chapter, Roma Patel discusses the benefits that TRIPS “flexibilities” provide to the pharmaceutical markets in developing nations. Specific to this discussion, Ms. Patel notes that malaria is a permissible reason for a country to declare a “national emergency” or “circumstance of extreme urgency” under TRIPS. Such a declaration would allow a nation to utilize the TRIPS compulsory licensing provision. This permits “a government to allow the sale and manufacture of patented medicine without the patent holder’s consent.” With the recent development of aviable malaria vaccine, what can we expect the impact of this provision to be? In particular, will countries invoke compulsory licensing on the basis of a malaria “national emergency,” and, if so, what results can we anticipate?

According to history, we can’t expect much. According to Nicol & Owoeye, “[t]o date, there is little to suggest that the Implementation Decision and the Protocol [for the compulsory licensing provisions] can meaningfully contribute to reversing the failure of the industrialized world to supply essential medicines to the countries that need them the most. Nor does there appear to be widespread enthusiasm for using Implementation Decision and Protocol mechanisms to facilitate the provision of low-cost or no-cost pharmaceuticals to those most in need.” This certainly appears to be true for impoverished African nations. For example, the continent has already been devastated by the HIV/AIDS epidemic, yet compulsory licensing has not provided a sufficient solution. In fact, according to a UNAIDS report, “[o]f the 21.2 million people in Africa eligible for antiretroviral therapy in 2013 under the 2013 WHO guidelines, only 7.6 million people were receiving HIV treatment as of December 2012.”

Brian Owens’ article Questions Raised about Whether Compulsory Licenses get Best Pricesdiscusses one of the reasons for the disappointing results of compulsory licensing. He notes that “[t]he use of so-called ‘compulsory licenses’ by developing countries to obtain cheaper drugs for HIV and AIDS by circumventing patents has not been the best strategy for achieving the lowest prices over the past decade . . . .” Expanding on this, Owens states that, “of the 30 cases of compulsory licensing from 2003 to 2012 for which reliable data was available, the median price achieved through international procurement was lower for 19 of them [than compulsory licensing]—in the majority of cases by more than 25% . . . . The effect was strongest in the poorest countries, where in six out of seven cases the procurement price was more than 25% lower than the compulsory license price.” Amir Attaran, the director of the study discussed in Owens’ article, asserts that “countries should not rush into using compulsory licenses until they have exhausted all other options. “Countries can save money using compulsory licenses, but they can save more by negotiating and using international procurement channels . . . If saving money is paramount, then compulsory licenses may not be the optimal strategy.”

Unfortunately, saving money is paramount for many African nations. Thus the greatest “flexibility” given to these nations is not always a practical solution. Perhaps the arrival of the first malaria vaccine will motivate international leaders to learn from prior experience. Hopefully the international community will reconsider compulsory licensing, as Roma Patel did, to determine how it can better provide access to life-saving medications.


Major Medical Institutions Allegedly Failing to Report Clinical Trials

Jessica Jayasuriya, MJLST Managing Editor

The Food and Drug Administration Amendments Act of 2007 requires that parties responsible for clinical trials submit clinical trial inform to the Director of NIH no later than one year after either the end date or the estimated end date of the trial.

However, several sources are alleging that Stanford University, Memorial Sloan Kettering Cancer Center, the University of Pennsylvania, the University of Pittsburgh, the University of California San Diego, and other major medical research institutions are failing to submit their clinical trial results within the deadline, and sometimes even at all.

The public database created by the legislation was intended to help the public, particularly medical professionals, scientists, and other researchers, to quickly access the latest findings on human testing of drugs, medical devices, and the like.

Institutions’ failure to turn in their results, however, is directly counteracting this legislative purpose. This is particularly concerning because doctors may not be getting critical information including adverse events in drug trials.

Interviews with the offending institutions indicate that the primary reason for these deadline lapses on the institutions’ end is due to being too busy and a lack of funding. Memorial Sloan Kettering, however, specifically stating it submitted some of its reporting in order to finish medical journal articles related to its trials. On top of institution failures to submit, is clear that the NIH is compounding the issue by failing to follow up on clinical trial deadlines.

Experts interviewed by the sources have further expressed concern that pressure from sponsoring drug companies may also be part of the reason why these clinical trials are not coming to light.


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

Allison Kvien, MJLST Managing Editor

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

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

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


Crime and Treatment: A Creative Drug Policy

by Shirshira Kother, MJLST Staff

In our society, it seems as though drug addiction is a commonality for prison inmates. It tends to play some role in every crime scene and horrific headline that we hear about. Drugs have been a driving force for many criminals because it significantly alters their decision-making and ultimately affects their actions. While there is no mistake that those who act under the influence of drugs will be subject to justice system, there perhaps a better way to discourage this behavior by redefining addiction.

An article titled Why Neuroscience Matters for Rational Drug Policy in volume 11 of the Minnesota Journal of Law, Science and Technology, explores the possibility of addiction as a neurological problem that may be solved by specific treatment to rewire an individual’s brain. David M. Eagleman, Mark A. Correro & Jyotpal Singh analyze how consistent use of chemical substances destruct areas of the brain that control voluntary actions.

David M. Eagleman, Mark A. Correro & Jyotpal Singh analyze how consistent use of chemical substances destruct areas of the brain that control voluntary actions. The article continues to explain how policy regarding drug use and addiction should be more geared toward treating those affected by the condition versus punishing them for becoming addicted. They suggest that chronic users may not actually continue their use on their own accord but are driven their brains. Chemical abuse can restructure the functions within the brain and lead many criminals to act out of deprivation of the drug. This concept has come across several arguments, most of which revolve around the policy effect of allowing criminals to “blame their brains” for their actions. The authors however suggest that the mere explanation of chemical abuse and how its effects have led to a crime does not, relieve the individual of their responsibility. It allows the system to better rehabilitate the individual.

The process suggested would mirror the procedure used to treat an aliment in order to restore one’s health. The use of drugs is associated with positive stimulus and once the brain has been repeated exposed to a chemical, it becomes dependent on that stimulus to function and destroys behavior inhibition, which often leads to impulsivity. Depriving it of the substance can cause severe side affects to the individual and drive them to act without thought or reason. The article introduces two new radical methods in rehabilitating these individuals. Most medications used to treat addicts either reduce the positive response the drug elicits or counter acts the reaction by producing a negative one. By using real time neuroimaging, doctors can better understand cues associated with craving and try to override the responses to those cues. A second suggested method is a vaccine to block the receptors related to the positive response addicts experience when using drugs. This vaccine would not allow the addict to get high thus reducing their use.

While still fairly new, these two innovations can change rehabilitation of those incarcerated from chemical use and abuse related crimes. Perhaps, the biggest concern is whether these options will have long-term positive effects and keep the individuals off of drugs. If successful, this method would not only remove potentially dangerous individuals from society but also groom them to rejoin the world: chemical free.


The Art of War on Drugs

by Ke M. Huang, UMN Law Student, MJLST Staff

Ke M. Huang.jpgA recent New York Times article addressed the research of a psychology professor at Columbia University that aimed to discredit misperceptions about drug addicts. The article cited Professor Carl Hart saying: “Eighty to 90 percent of people who use crack and methamphetamine don’t get addicted,” Hart continued, “And the small number of who do become addicted are nothing like the popular caricatures. His research showed that, for example, recruited addicts who were given a choice between a dose of crack and $5.00 sometimes chose the money. Findings such as this led Professor Hart to conclude that addicts can make rational economic decisions.

In the Volume 11, Issue 1 of the Minnesota Journal of Law, Science & Technology, Eagleman et al. also shed light on drug addiction by offering two additions to drug policy. After presenting an overview of the shortcomings of the U.S. drug policy, and a summary of the modern neuroscientific understanding of chemical dependency, Eagleman et al. suggested that the government should try implementing (1) cocaine vaccines, and (2) neuroimaging feedback to treat drug addiction. The first measure creates on the recipient of the vaccine an immune response to cocaine molecules that can weaken, if not eliminate, the high of the cocaine. The second measure, like biofeedback, allows an individual to view a graphical representation of the activity in a certain area of her brain, and let her practice to control it. Thus Eagleman et al. support a more rehabilitative, rather than retributive, policy to addressing issues of chemical dependency.

As someone who was raised in the country with one of the least criminalized drug policies in Europe–Portugal, I stumbled upon literature that also suggested that a country’s war on drugs does not have to be a hot war. Since 2001, Portugal implemented a drug decriminalization reform. A drug user is not arrested, but referred to a squad often times made up of a lawyer, a social worker, and a medical professional. The squad finds whether the user is addicted. If yes, he may be then referred to a treatment or be penalized, such as being banned from a certain neighborhood or losing a driver’s license. If not, he is unlikely to be sanctioned. About 5% users are brought before the squad the second time in the same year. A 2010 study in the British Journal of Criminology concluded that Portugal’s drug policy reform was quite successful. Teen drug use decreased, law enforcement authorities seized more drugs, and, though adult drug use rates climbed, the rates were lower than the neighboring nations that did not adopt drug policies like those in Portugal.

About 2500 years ago, Sun Tzu wrote “the skillful leader subdues the enemy’s troops without any fighting.” Similarly, the literature discussed indicates that the war on drugs could be a peaceful fight after all.