Drug Policy

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!


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.