Category: Blog

By: Karina Velez

Zika virus is a mosquito-borne disease currently spreading throughout Central and South America. Since March 2014, 14 countries and territories of the Americas reported cases of Zika infection. People with Zika infection usually suffer from fever, skin rash, muscle and joint pain, malaise, headache, and conjunctivitis. These symptoms usually last less than one week and are mild. Four out of five people with Zika virus have no symptoms, according to the World Health Organization (WHO). Most cases of Zika infection require no specific treatment, but a growing concern is the effect of Zika virus on pregnant women and their newborn babies. In November 2015, the Ministry of Health of Brazil noted a marked increase in microcephaly (in which the head circumference of newborns is smaller than expected) that coincided with Zika virus circulation in the country. Zika virus is affecting multiple counties in Latin America. The number of Zika cases among travelers visiting or returning to the United States will likely increase and the virus is expected to spread to North America. Currently, affected regions are advising women to avoid getting pregnant due to the link to birth defects. Additionally, pregnant women are being advised not to travel to affected areas. Experts say that Zika may rise to the level of a global threat because there is no vaccine or treatment available.

Preventative measures that people in affected areas can take include avoiding mosquito bites by using Environmental Protection Agency (EPA)-registered insect repellant (which are all evaluated for effectiveness); wearing long-sleeved shirts and long pants; staying in places with air conditioning or that use window and door screens to keep mosquitoes outside; and sleeping under a mosquito bed net. In the upcoming weeks, WHO and other organizations will monitor the development of the virus. WHO is concerned that this year’s El Nino could cause the virus to spread further through an increase in mosquito populations. El Nino typically brings warmer temperatures and shifting precipitation patterns, creating ideal breeding conditions for mosquito populations to thrive in. Reduction of standing water is necessary to interrupt the mosquito breeding patterns.

WHO could declare a global emergency when it meets on Monday, Feb 1st 2016. If WHO makes such a declaration, it will essentially be issuing a “a global Amber Alert for public health,” as stated by Susan Kim, a deputy director of Georgetown University’s O’Neill Institute for National and Global Health Law in Washington. This declaration will shine a light on the virus and generate a worldwide response. This is a sensitive matter for WHO because it has only issued global emergencies during three other health endemics: the H1N1 swine flu in 2009, the Ebola outbreak in 2014, and the reappearance of polio in Syria and other countries in 2014. WHO officials want to make sure that nations don’t take inappropriate steps to limit travel or trade because of the virus, said Bruce Aylward, assistant director-general of the WHO. Nonetheless, a strong response erring on the side of precaution is necessary because this virus is an inchoate infection and we have very little knowledge about it. Individuals are being exposed to it and they have no immunity to the infection and therefore more unknown affects and symptoms may arise and cause a serious pandemic.

By: Alexandra McLeod

Recently, an influential government appointed panel solicited by Human and Health Services (HHS) gave screening for postpartum depression during and after pregnancy a “B” rating in the Journal of the American Medical Association.  This new rating, if accepted, means that the Affordable Care Act would have to cover the screening of mothers during and after pregnancy for depression. As research has developed about this issue it has been found that postpartum depression can occur during pregnancy and if left untreated the mood disorder can negatively impact the child. Some individuals are curious as to why depression may occur in expectant mothers and the answer to that question is still unclear. The postpartum depression may stem from a mother not being able to bond with her child during or after birth or it is sometimes found to be genetic. In more recent years, research demonstrated more mothers suffer from postpartum depression after giving birth to their children. It is said that one of every seven mothers experiences the feeling of depression and only more recently have these mothers felt comfortable to talk to their doctors about these concerns.

Several healthcare providers (ex: obstetricians) have said that women have fears of hurting their children or themselves or concerns about the child’s welfare that is out of the mother’s control. This leads to mothers sometimes not being proactive with their prenatal health and if continued to go untreated a mother’s mental illness could affect the child’s well being. Previously, doctors were concerned with the risks of treating depression during pregnancy through a low dose or medication or screening because of the impact the protocols may have on the baby. However, as a result of growth within the medical field there is greater access to mental health facilities, safer ways to screen mothers for depression, and lower dosage anti-depressant medication that mothers can take that do not negatively impact the baby. It is important that women take advantage of these services to allow every mother the opportunity to play an active and positive role in her child’s life. Mayor Bill de Blasio of New York announced a goal to include universal screenings in women’s routine care.

While there is a large push to enact legislation for depression screenings during and after pregnancy the panel did not request a certain number of screenings for the expectant mothers during pregnancy and after birth to ensure that all mothers are receiving the proper care. The number of screenings can be determined upon future research and doctors’ opinions on the subject matter to protect their patients. This type of legislation is important because of the increasing number of expectant mothers that seem to be experiencing racing or suicidal thoughts. There is not better way to protect these women than being proactive and making sure the care that expectant mothers need is provided for these women through the new Affordable Care Act. A strong and loving motherly influence is important in a child’s life and the new depression screening guidelines will help make this possible.

In April 2015, the Kansas State Legislature passed the Kansas Unborn Child Protection from Dismemberment Abortion Act. This law, with few exceptions, would ban “dilation and evacuation” abortions, or “D&E” abortions. These abortions are the primary method for second-trimester abortions in the United States. These abortions are common and considered the safest option for a second-trimester abortion. Kansas became the first state to ban this procedure.

Weeks before the law was to take effect last summer, three doctors filed a lawsuit over the bill. The key issue was whether the Kansas Constitution provides a right to abortion. In January 2016, an evenly divided Court of Appeals blocked this law, stating that the rights of due process and equal protection protect the procedure. The court, citing Roe v. Wade, further stated that the United States Constitution has protected the right to an abortion for over 40 years. The court affirmed the lower court’s injunction. The case is now going to be reviewed by the Kansas Supreme Court.

The appellate court’s opinion offers both sides of the issue. It states that the “rights of Kansas women are not limited to those specifically intended by the men who drafter our state’s constitution in 1859.” The other side states, “there is nothing within the text or history…the Kansas Constitution Bill of Rights to lead this court to conclude that these provisions were intended to guarantee a right to abortion.”

Opponents of the bill point to the fact that medical science supports this procedure as the safest option, and that to override science is “astonishing.” Furthermore, if this law were to move forward, there would be no alternative for women who seek this procedure.

Supporters of the bill focus on the graphic nature of its title. They argue that proponents of the procedure purposely use terminology that the public can’t understand. In explaining this, they analogize it to a doctor who wouldn’t say, “we’re going to disarticulate your limb. He’s going to say, we’re going to have to break this bone and reset it.”

This case will be widely watched for the effect that it will have on women throughout Kansas, and potentially in other states. This law would place an undue burden on women seeking to exercise their right to this procedure, which the United States Supreme Court also stated was unconstitutional in Stenberg v. Carhart. The Kansas Court of Appeals appropriately protected cited the rights to due process and equal protection for the women in Kansas.

Currently, the Department of Veterans Affairs does not allow doctors to even discuss the use of medical marijuana to veterans irrespective of state law legalizing medicinal marijuana use. Lawmakers in Illinois and New York that have legalized medical marijuana are urging changes to current policy in order for VA doctors to use modern medicine treatment options for veterans suffering from PTSD.

Nearly half of the states across the United States have passed laws allowing marijuana to be used for medicinal purposes. Despite state action, marijuana still continues to be prohibited under federal law.

Since 1970, the federal government has categorized marijuana as the most dangerous type of drug: a Schedule I controlled substance. Schedule I is defined as drugs with no currently accepted medical use, high potential for abuse, and high risk of dependence. However, commonly known medicinal marijuana benefits include reduced pain and anxiety, treatment of conditions including seizures, PTSD, chemotherapy-induced nausea, glaucoma, AIDS wasting syndrome, neuropathic pain, multiple sclerosis, and insomnia.

Regardless of doctors recommending marijuana to combat negative health effects, the federal government continues to categorize it as a Schedule I controlled substance along with heroin, ecstasy, and LSD.

In 2011, the Drug Enforcement Administration (DEA) denied categorizing marijuana as a Schedule II drug because there has not been enough research on the drug. Recently, in December 2015, the Food and Drug Administration (FDA) recommended that marijuana’s classification be changed.

Currently, marijuana requires an excessively strict process for approved research. The FDA requires researchers to be approved as an Investigational New Drug (IND), which renders the drug safe and effective for their intended use. Additionally, the DEA must review the application and issue special licensure and registration because of its classification as a Schedule I controlled substance. Lastly, the National Institute on Drug Abuse (NIDA) is responsible for supplying the research grade marijuana to the approved researchers.

The FDA’s lack of approved research rests on their claim that the purity and potency of the drug may vary considerably. Although NIDA requires strict testing and compliance for any FDA approved marijuana research, states are lacking in uniformity of testing procedures.

The FDA wants the potency levels for using marijuana well defined so that patients and doctors may control the exact dose. Recently, new mechanisms for testing potency have been developed, but certain states only require some of the cannabinoids to be tested. For example, in Connecticut every production facility is required to test only THC and CBD levels, but the other cannabinoids are not being tested.

The FDA also wants the purity of marijuana to be ensured. Medicinal marijuana is prescribed to people who suffer from some adverse health condition; the patients are not typical healthy individuals with strong immune systems. Thus, there is a need for marijuana to be free of E Coli, pesticides, and mold. Despite this, states continue to lack uniformity in testing purity.            In California, for example, the grower or the dispensary facility may test the marijuana. This may result in growers selling unclean marijuana to distributers. Conversely, in Connecticut, every production facility must have every strain and every product tested to ensure the marijuana is clean.

Although medicinal marijuana dispensaries provide information and individualized consultations, uniform testing, research, and amended laws governing such practices are necessary to fully understand the effects of marijuana.

By: Nawa Arsala

A volunteer participating in a clinical trial in France died last week, while five more remain hospitalized in critical condition. On January 17^th, the Portuguese company Bial conducting the trial issued a press release confirming the death of the volunteer at the University Hospital of Rennes, while the remaining five could be permanently disabled due to neurological damage.

The drug being tested, which has been referred to as BIA 10-2474, is a painkiller meant to treat anxiety and motor disorders. A major public health issuing plaguing the United States today is addiction to pain relief drugs, therefore, there is a great need for non-addictive drugs in this therapeutic area. Study-provided documents explained that the drug in development was for “the treatment of different medical conditions from anxiety to Parkinson’s disease, but also for the treatment of chronic pain of sclerosis, cancer, hypertension or the treatment of obesity.”

The drug was intended to work on the body’s endogenous cannabinoid system, which deals with pain. Simply put, the drug should have stimulated the same receptors as the active components of marijuana. Bial believes that the drug has the potential to reduce pain and anxiety, among other neurological conditions. Earlier reports said the drug was related to cannabis, but Bial maintains that it does not contain cannabis or cannabis extracts.

The trial was run by the clinical research organization, Biotrial. Clinical research or contract research organizations, provide support and various services for pharmaceutical companies through various stages of drug development. In this case, the French company Biotrial ran the Phase I trial. In the European Union, this stage is the first time the drug is tested in humans. Generally during this stage, trials are conducted on healthy volunteers and are intended to see how the body responds to various dosages of the drug. As this trial began in July, it is likely this accident could have been a result of an increased dosage. This phase is not intended to test the effectiveness of the drug, but rather to see if there are any side effects. Phase II is intended to test for effectiveness, and Phase III increases the volunteer pool and compares the effectiveness to a placebo. In this case, 90 volunteers were given the drug. All of the volunteers were men, ranging from 28 to 49 years old. Further, there were an additional 38 volunteers who received placebo, which is considered highly unusual in a Phase 1 trial, since the purpose is to test safety, not effectiveness.

The trial has been suspended and the Paris prosecutor’s office has opened an investigation. The health minister of France Marisol Touraine said she has “no knowledge of a comparable event.” Bioethicists around the world have called into questions the consent of the volunteers.  The most vital aspect of human research is the ability for the volunteer to give informed consent. As many volunteers in clinical trials are compensated, many Phase I volunteers could be poor and easily exploited, as ascertained by bioethicist Carl Elliott.

The tragedy in Paris was truly unprecedented. With countless diseases vying for medications, the clinical trial process is vital for innovation. Although lives were lost in this instance, volunteers in clinical trials have saved innumerable of lives throughout history.

On November 19, the Health Law and Policy Brief hosted its fall symposium “Telemedicine: Regulatory Framework & Barriers to Expansion.” Telemedicine emerged over 40 years ago and is a rapidly expanding area of healthcare in the United States. The panelists at the symposium discussed the current state of Telemedicine, its regulatory framework, and the barriers to its expansion. Mr. Gary Capistrant, the Chief Policy Advisor to the Telemedicine Association, moderated the panels.

The first panel focused on barriers to the expansion of telemedicine. The speakers on the panel were 1) Ms. Alexis Gilroy, Partner at Jones Day; 2) Ms. Amy F. Lerman, Senior Counsel at Epstein Becker Green; and 3) Mr. Jeffrey Mitchell, Of Counsel at Lukas Nace Gutierrez & Sachs LLP.

These three speakers brought up and discussed several important barriers that need to be addressed for telemedicine to reach its full potential. Ms. Alexis Gilroy emphasized that regulation of telemedicine is state by state. Regulators are dealing with a huge number of rules that vary, and there is yet another layer of regulation once telemedicine moves outside of the United States. In some ways, regulators can supervise telemedicine more directly, but varying rules complicate that. A potential solution is to create a federal system of regulation, but that would take away power from states, which raises another host of issues. Ms. Amy Lerman focused on barriers regarding payment. The question from all telemedicine clients is how they are going to get paid. The various state regulatory regimes also have varying reimbursement schemes, which seriously hinder telemedicine, which cannot move forward if they are not paid. Finally, Mr. Jeffrey Mitchell questioned the idea of “universal service.” While technology has made magnificent advances in the last two decades, there is still the problem of affordable access to phones and the Internet in rural areas, which are usually in greater need of telemedicine. Even if rural areas do have access to phones and the Internet, connectivity is constantly an issue. A solution is to subsidize rural phones by overcharging urban businesses, however that comes with its own problems that have yet to be adequately addressed.

The second panel focused on how the federal government regulates mHealth devices. The speakers on this panel were 1) Mr. Daniel Gottlieb, Associate at Epstein Becker Green; and 2) Mr. Robert Jarrin, Senior Director of Government Affairs at Qualcomm.

Both of these speakers built upon the comments of the speakers on the first panel and further elucidated how involved the government is in regulating telemedicine. Mr. Daniel Gottlieb described the various ways that the federal government regulates mHealth devices. Mr. Gottlieb began by applauding telemedicine saying that clinical data obtained through its programs has immense potential to spur medical advances. He explained that clinical and IT personnel collaborate in telemedicine programs. The Department of Health and Human Services (HHS), the Food and Drug Administration (FDA), and the Federal Communications Commission (FCC) then regulate their efforts. If certain programs work with patients in the European Union (EU), they then also must comply with the EU Data Privacy Directive. His points echoed those of Ms. Gilroy. While careful regulation is necessary for safety purposes, Mr. Gottlieb emphasized a need to streamline the regulation of telemedicine. Mr. Jarrin’s points reiterated the fact that there are several regulatory bodies involved in telemedicine. As the Senior Director of Government Affairs for Qualcomm, Mr. Jarrin emphasized that he is responsible for 1) state and federal laws pertaining to telemedicine; 2) FDA regulatory oversight over mHealth devices; 3) congressional committees’ perspectives; 4) Medicare and Medicaid telehealth reimbursement; and 5) FCC broadband healthcare efforts. Compounding these responsibilities is how much of a risk a device is. The FDA classifies devices in different groups based on risk; however determining risk is a complicated process. Mr. Jarrin called for more guidance and transparency from government agencies, particularly the FDA.

The symposium was a wonderful event, and the AUWCL community was incredibly lucky to have such knowledgeable speakers come and offer their expertise.