Category: Blog

Talking About the Trauma

In the United States District Court of Los Angeles a case is being brought against the Compton Unified School District for failure to not adequately provide appropriate education and assistance for those students who have suffered from a “complex trauma.” The Plaintiffs assert that too often the school district turns to punishment for students who are attempting to cope with the struggles they face in their lives.

To better understand the type of trauma these students are experiencing it is important to understand the environment these children have grown up in throughout their lives. Compton is a city located south of Los Angeles and has an extremely violent reputation; last year alone the murder rate in Compton was five times the national average. These students face problems of addicted parents, homelessness, and a constant fear of violence in their everyday lives. One of the Plaintiffs said that he witnessed his first murder at the young age of eight, took a bullet to the knee, and in 2014 alone witnessed twenty shootings; another Plaintiff was mistakenly arrested at gunpoint by police at school. One plaintiff was sexually assaulted on the bus, on her way home from school. Gangs are a normal part of life and fear is something that students have to accept as a part of their lives. According to Susan Ko of the National Center for Child Traumatic Stress, exposure to violence can have a profound impact on one’s ability to learn.

The suit being brought argues that “complex trauma” should be considered a disability under the Rehabilitation Act and Americans with Disability Act. The complaint states that individuals who experience chronic or repeat trauma demonstrate physiological impairment in performing normal daily activities such as thinking, learning, reading, and concentrating. Something as simple as social interaction can cause bodily distress due to former trauma. Memories of fear can be created on multiple levels in the brain’s system because trauma triggers multiple functions of the brain. Research by Victor Carrion and Shane S. Wong of Stanford University shows that the hippocampus plays an important role in learning new information. Those who have experienced “complex trauma” have a smaller hippocampus, which makes learning more difficult. By classifying “complex trauma” as a disability the complaint asserts that these children will be able to receive the help they need to process their trauma and move forward.

A recent article said that a program implemented in the Los Angeles School District of 10 counseling sessions was effective in helping the students recover and improve their performance in school. By providing programs such as this one in low income areas teachers will receive the training necessary to: recognize trauma and seek mental health support to assist the students in coping with their trauma. These programs will allow school’s from a punishment structured system of handling student outbursts as a result of their trauma to promoting reconciliation and mediation before jumping to a suspension or expulsion.

The school district is extremely sympathetic to these children, but has to acknowledge the large costs that would have to be allocated to these programs and that there are other school districts with these same issues that do not have lawsuits pending.

While the cost may be high,is it possible that now is the time to spend more in cities and neighborhoods such as Compton to promote students getting the help they need for the trauma they have experienced throughout their lives? As a nation we should prioritize investing in children’s futures. It is important to recognize that every child deserves a chance to have a positive learning experience and feel safe in the school environment. While this occurs in places outside of Compton, maybe it is time for all states to take a look at their lower-income neighborhoods to see what they can do to help kids who are suffering from “complex trauma.” These kids deserve a chance to learn and create better lives for themselves and future generations. This transition may not be an overnight transformation, but by classifying “complex trauma” as a disability more students will be able to get the help they need.

 

Health Law & Policy Brief 2015-2016 Applications

Health Law & Policy Brief 2015-2016 Applications

The Health Law & Policy Brief (HLPB) is accepting applications for new members! We encourage 1Ls, 2Ls, 3Ls, and LLMs to apply.

The Health Law & Policy Brief covers a broad range of topics including: health care, food & drug, disability law, administrative law, and business law; both domestic and internationally. HLPB is entirely online. We publish long academic articles by students, professors, and practitioners. We plan to have two issues in the coming year – a Fall 2015 issue and a Spring 2016 issue. HLPB also has a blog component, which features short pieces on new and developing topics. The blog​ ​is located at​ ​https://www.healthlawpolicy.org/ ​and​ ​is updated every month.

We are primarily seeking multiple staff members to “spade” (edit) our academic articles. If selected as a staff member, you will receive training and advance notice before getting a spading assignment. You will be supervised by a more experienced Articles Editor. You will not receive more than one spading assignment per semester.​ ​We are also seeking one Marketing Director​.​

To apply, please email the HLPB Editor-in-Chief, Mohammad Mesbahi, at mohammadh.mesbahi@gmail.com with the​ ​​​subject line “LAST NAME – HLPB Application.”​ ​​Please briefly explain your interest in joining the HLPB, and if applicable, any interest or prior experience in health law, food and drug law, or disability law. Please also attach a current resume (GPA not required).
​​
Application deadline: Friday, October 2, 2015 at 11:59am (noon). ​​ We look forward to receiving your application!

​​Applicants who are selected ​to become members of HLPB ​should try to attend the HLPB Spading and Blogging Training on Saturday, October 3, 2015 from 1:00 PM – 4:00 PM in WCL Room 526.​ ​Those who cannot attend would be expected to notify the HLPB Editor-in-Chief and will be allowed to meet at a later time with the HLPB Editor-in-Chief.​ ​ Those attending this meeting should bring a laptop and their Bluebook.

FDA Proposes Rule Setting Out Proper Consumption Levels for Added Sugar

In July 2015, the FDA proposed a rule that would update the Nutrition facts label on most food packages to include more information about how much added sugar is in a food product and what the appropriate consumption levels are. Added sugars are sugars and syrups that are added to food or beverages when they are processed or prepared.  Major sources of added sugar include soft drinks, sugars, candy, cakes, cookies, pies and fruit drinks; dairy desserts and milk products (ice cream, sweetened yogurt and sweetened milk); and other grains.

The proposed rule will require declaration of the “percent daily value” for added sugars. Presently, it is recommended that daily calories from added sugars not exceed 10 percent of a 2000-calorie diet. In a 2000-calorie-a-day diet, that works out to a daily maximum of about 200 calories a day or 12 teaspoons of added sugar. Currently, added sugar is presented in grams on nutrition fact labels. One gram of sugar contains about 4 calories. http://www.npr.org/sections/thesalt/2015/07/24/425908798/no-more-hidden-sugar-fda-proposes-new-label-rule

Food companies throughout the United States add sweeteners to their products, which increases calories but provides no nutritional value. Also, consuming too much added sugar leads to weight gain, obesity, Type 2 diabetes, and reduced heart health, and heart disease. Most Americans consume way more sugar than they realize. Sugar is one of the few major food components that doesn’t have a recommended consumption level on U.S. food labels, primarily because FDA hasn’t issued recommended consumption levels. This action by FDA will promote consumer awareness and allow Americans to make informed decisions relating to their sugar intake.

“For the past decade, consumers have been advised to reduce their intake of added sugars, and the proposed percent daily value for added sugars on the Nutrition Facts label is intended to help consumers follow that advice,” wrote Susan Mayne, director of the FDA’s Center for Food Safety and Applied Nutrition, in an agency news release.

Currently, the FDA is taking comment on the new proposal for 75 days. Many health activists and consumer advocate groups have applauded the FDA’s efforts to inform consumers about how much added sugar they are actually consuming when they consumer processed foods and beverages. The agency will probably also hear from food companies. The Sugar Association has already weighed in, probing whether the move to constrain added sugars to no more than 10 percent of daily calories is backed by sufficient scientific evidence and studies. Moreover, food companies argue that nutrition fact labels do not influence most consumers and it will be expensive for companies to implement into their products.

This proposed rule is a part of a major overhaul by the Obama administration to modernize nutrition fact labels and inform consumers so they may lead healthier lives.

 

Written by Karina Velez–Fellow Health Law and Policy Brief Junior Blogger

Modernizing Medicine

There is a new wave of medicine that has been sweeping across the healthcare world. Telemedicine (also known as “remote healthcare”) is the new modern wave of healthcare. Telemedicine is the use of medical information exchanged from a single site to another via electronic communications to improve a patient’s clinical health status. The original purpose of telemedicine was to extend healthcare’s reach to rural areas to allow patients from these areas to be provided access to healthcare benefits. The technology that has become available after forty years of development now extends to services using two-way video calling, smart phones, and other wireless tools to provide services to the rural population in the United States. Since telemedicine creation the original purpose has expanded to include a variety of resources to both rural and urban patients in addition to the medical community. First, telemedicine provides primary care for those individuals in rural areas that may otherwise not have access to healthcare. Second there is the ability for doctor’s to monitor those patients who live remotely and need to have blood pressure or glucose levels checked on a regular basis. Third, the telemedicine field allows consumers to obtain specialized medical information, have access to discussion groups on health diagnoses, and provides peer support groups in times of need. Finally, telehealth is giving the medical field a makeover in how it shares information because doctors are now able to access more techniques and services through these devices to grow his or her technique in a particular field of study.

There are significant benefits from the expansion of telemedicine; healthcare can now be provided to a wider range of individuals, telemedicine is more cost efficient, improved the quality that as a nation we provide, and lastly there is more patient’s want to use telemedicine because it reduces the stress and time a person has to dedicate to ensuring his or her body is in good health.

As a result of the increase in patients and doctors alike wanting to use telemedicine, Congress would like to restructure how Medicare pays for telehealth. The representatives in support of this idea have proposed the Medicare Telehealth Parity Act of 2015. The act consists of three phases that are to be implemented over a four year period expanding the coverage of telemedicine not only to the members of the rural community but also to urban areas. Phase 1 consists of expanding the rural health centers and adding centers to metropolitan areas with a population less than a 50,000; this phase also includes the expansion of specialists such as diabetes educators and speech therapists. Phase 2 encompasses expanding telehealth sites to include metropolitan areas with populations of 50,000 to 100,000 people. The third and final phase of Congress’ plan is to then extend the telemedicine services to all geographic locations regardless of population size.

Bipartisan members of Congress that support the expansion of telecommunication have tried to introduce legislation that reimburses those companies that support telehealth endeavors. Unfortunately, in both 2013 and 2014 the bills did not leave the House Energy and Commerce Subcommittee on health despite the support the bill received from the Telecommunications Industry Association and American Telemedicine Association. The representatives are now hoping that the bill will get the chance to leave the Committee and that members of the healthcare community will sponsor this bill in order to have healthcare be available to every individual that needs it. This bill is legislation that would allow medicine to be provided to a larger demographic and ultimately benefit society by having healthcare be provided a little closer to home.

Is Blood Discrimination Against the LGBT Community Really Over?

While June has undoubtedly been a groundbreaking month for the LGBT community with the Obergefell v. Hodges marriage equality decision, May was an important month as well. In May, the FDA followed through on its promise to reevaluate its current stance on blood donation from men who have sex with other men (MSM) by issuing a draft guidance proposing a 12 month deferral period. The draft guidance bars male donors who have “a history in the past 12 months of sex with another man.” The public will have 60 days to comment on the draft guidance and the FDA will ultimately issue a final guidance after reviewing the comments.

Currently, the FDA imposes a lifetime blood donation ban on “men who have had sex with other men (MSM), at any time since 1977.” he MSM rule was implemented in 1983 at the beginning of the AIDS crisis when the spread of the disease through transfusion was first recognized. The ban was initially created to be an outright ban on gay and bisexual men; however, in 1992 the FDA changed to its current policy to shift the focus from excluding whole populations it believes to be risky to excluding individuals engaging in risky behavior.

While it is FDA policy to limit donors based on risky behavior, the end result of the policy is an essential ban on gay and bisexual men.  If the risky behavior the MSM rule is trying to prevent is unprotected anal sex, then the guidance should not be directed exclusively at men who have sex with men. Women have anal sex, unprotected sex, and unprotected anal sex.

Both the current rule and the proposed guidance, perpetuate the stereotype that “gay sex, particularly anal sex, is deviant, disgusting, and diseased.” The rule also highlights the stereotype that if women engage in anal sex, it is an isolated, discreet, and accidental incident and also enforces the stereotype that heterosexual couples having unprotected sex are in a committed and monogamous relationship. But unprotected sex is seen as routine practice for those who identify as gay or bisexual because it is not possible for them to engage in a healthy, committed, and monogamous relationship since their sexual orientation by nature means they are sexually deviant.

Although a change from a lifetime ban to a 12 month deferral is progress, does it really go far enough? The new guidance will allow for a possibility of gay and bisexual men to donate, but the rule still stigmatizes them as a group. Many human rights and advocacy groups criticize the 12 month deferral for being too long because current tests can detect HIV as early as nine to eleven days after exposure.

The draft guidance also attempts to clarify the FDA’s policy on transgender donors. The note reads, “In the context of the donor history questionnaire, male or female gender is taken to be self-identified and self-reported. In instances where a donor has asserted a change in gender identification, medical directors may exercise discretion with regard to donor eligibility.” The FDA has been silent regarding transgender donors, as no official rule or draft guidance has been issued. As a result, blood donation and plasma centers have been left to create their own policy that has ultimately become a complete ban on transgender donors because blood banks and plasma centers view it as the simplest policy. Currently, there are multiple lawsuits around the country against blood and plasma donation centers for discrimination against transgender individuals. A transgender woman in Minnesota, Lisa Scott, is suing a CSL plasma center after being turned away. In Kent, Washington, Jasmine Kaiser is also pursuing legal action against CSL plasma center for being turned away because she was born biologically male.

Although the proposed guidance is a step in the right direction that will allow some gay and bisexual men to donate, the guidance is extremely lacking in its response to transgender donors.  The guidance is also only one step among many steps that should be taken to ensure equality in the way we screen blood donors. Until the FDA abolishes the MSM rule completely and creates proper policies to address transgender donors, discrimination against the LGBT community will continue.

Pharmaceutical Company Preemptively Files Free Speech Suit Against The FDA

By: Nawa Arsala

Free speech is fundamental to the fabric of the United States. Americans fight for it zealously, regardless of the context, from political contributions to cartoon drawing contests. This battle has extended to the pharmaceutical industry. In an unconventional move, a small, Dublin-based pharmaceutical company, Amarin, filed suit against the Food & Drug Administration arguing that it has a constitutional right to share certain information about its product with doctors for unapproved uses.

The FDA approved Amarin’s drug Vascepa in 2012. It is a prescription form of fish oil that is used along with a low-fat and low-cholesterol diet, to lower high levels of triglycerides (fats) in adults, which is linked to heart disease. After the drug’s approval, Amarin requested permission to give doctors information regarding a study that showed Vascepa can reduce the triglyceride levels in less-severely affected patients, not just high-risk patients. The FDA ultimately rejected their request. Amarin’s issue is that many doctors already prescribe Vascepa to patients who do not have abnormally high triglyceride levels. The discretion of the physician to prescribe for an off-label use is perfectly legal and has been deemed the practice of medicine, which the FDA does not have jurisdiction to regulate. Manufacturers on the other hand, cannot promote for off-label uses.

Amarin wants to send doctors clinical trial data they described as “supportive but not conclusive research” that their drug could reduce the risk of heart disease in patients with less severe conditions than were initially approved for. The FDA denied Amarin’s request to share this information with doctors, and Amarin filed their suit. The FDA found that the “hypothesis that a triglyceride-lowering drug significantly reduces the risk for cardiovascular events among” individuals with less severe symptoms, failed to be proven in clinical trials. Nonetheless, Amarin feels its First Amendment right is being infringed upon by not being able to share this use with doctors. Amarin has not been accused of wrong-doing by the FDA yet, but they are possibly the first pharmaceutical company to sue the FDA preemptively. This could be because dietary supplement forms of fish oil are legally permitted to make the same statement without such rigorous regulation by the FDA. However, there seems to be increased regulation of dietary supplements as well after several injuries have been reported using weight loss supplements.

In a private letter to physicians who are paid to speak on behalf of its company, Amarin writes, “if we receive a judgement in our favor, we will move rapidly to deliver to you additional Company-approved training and updated promotional speaker materials related to the court’s interpretation of free speech related to the ANCHOR results.” In reality, free speech is not as romantic as the founding fathers would have hoped, especially in closely regulated markets such as the pharmaceutical industry. Courts consider several factors in determine if the government is infringing on First Amendment rights including, whether a substantial governmental interest being asserted, whether the regulation directly advances that interest and whether it is not more extensive than necessary.

Amarin may look to a fairly recent case in which a pharmaceutical sales representative’s conviction was overturned because the information he shared was not false or misleading. As a matter of fact, Amarin’s attorney ascertains precisely that, that the clinical trial data is truthful and not misleading. The U.S. Department of Justice and State attorney generals have increasingly used the Federal False Claims Act as an enforcement mechanism against health care fraud. The government believes that by promoting off-label uses, the manufacturers caused pharmacies to falsely claim Medicaid payment for drugs in ways unapproved by the FDA. Amarin is at risk for violating the FCA if they proceed in sharing the data directly to the doctors.

Drugs have and continue to save countless lives. The FDA has the duty, through a rigorous preapproval process, to ensure drugs are safe and effective before they are on the market. However, it is the stance of Amarin, that since off-label usage is already so commonplace by physicians and legal, providing more information, rather than less, is safest for the patient to promote overall health and more informed decision-making by physicians.