FDA Takes the Advocates’ Advice: Approves Drug from Muscular Dystrophy

In an article dated September 19, 2016, Muscular Dystrophy patients and advocates, with the help of select members of Congress, celebrated the FDA’s approval of Eteplirsen, a drug manufactured by Sarepta Therapeutics for treatment of a type of muscular dystrophy that predominantly affects boys in their childhood. Advocates fought heavily for the approval even though there are limited clinical trials to confirm the drug’s effectiveness. While the drug may help up to 12,000 Americans affected by the disease, critics worry that the FDA has set a “dangerous precedent” by its decision.

From NYTimes.com, “F.D.A. Approves Muscular Dystrophy Drug That Patients Lobbied For”

Excerpt from article:

[I]t was taken as a deeply troubling sign among drug policy experts who believe the F.D.A. has been far too influenced by patient advocates and drug companies, and has allowed the delicate balance in drug approvals to tilt toward speedy decisions based on preliminary data and away from more conclusive evidence of effectiveness and safety. . .

To read full article:   F.D.A. Approves Muscular Dystrophy Drug That Patients Lobbied For




Are Legal Limits for Marijuana Level Impairment Reliable?

The number of fatal car crashes involving marijuana use doubled in the state of Washington after the use of recreational marijuana was legalized.  One of the difficulties the state has encountered in preventing such crashes is determining per se limits for the amount of marijuana drivers can have in their systems.  Unlike alcohol impairment, which is defined by a blood alcohol content (BAC) level of .08 or higher, marijuana impairment is difficult to quantify. There is no reliable data showing that drivers become impaired at a specific level of marijuana content. Frequent users of marijuana, for example, may maintain higher levels of the drug for a longer period of time then occasional users. Thus, depending on the individual, drivers with relatively high levels of marijuana in their system might not be impaired, while others with low levels may be unsafe behind the wheel.  While there is no clear indication that a certain level of THC definitively increases the risk of car crashes, some states have implemented per se limits ranging from 1 ng/mL of THC to 5 ng/mL.

The AAA Foundation for Traffic Safety, however, is urging states to implement more comprehensive enforcement measures to improve road safety.  It suggests that, rather than relying on arbitrary legal limits, states should use a two-component system that requires (1) a positive test for recent marijuana use and, more importantly, (2) behavioral and physiological evidence of driving impairment. Marshall Doney, AAA’s President and CEO explained: “States need consistent, strong and fair enforcement measures to ensure that the increased use of marijuana does not impact road safety.”  But to maximize road safety, all motorists are advised to avoid driving while impaired regardless of whether the use of marijuana is legal in their state.

Source: https://www.sciencedaily.com/releases/2016/05/160510103131.htm

“Extreme Overvalued Belief” or Mental Illness?

Society and courts of law often find themselves struggling to understand what causes someone to commit a violent act. Mental illness is often cited as the motive for such crimes.  However, Dr. Tahir Rahman, an Assistant Professor of Psychiatry at the University of Missouri’s School of Medicine, has concluded that in some cases, violent crimes are not the result of mental illness but rather an “extreme overvalued belief,” a term Dr. Rahman uses to classify the cause of criminally violent behavior when psychosis can be ruled out.

Dr. Rahman conducted a case study on Andres Breivik, a Norwegian terrorist who claimed to be a “savior of Christianity” after detonating a car bomb that killed 77 people in 2011. A psychiatric team concluded that Breivik was not psychotic and instead diagnosed him with personality disorder. Dr. Rahman suggests, however, that Breivik’s criminal acts were a result of his extreme overvalued belief.  An extreme overvalued belief is “a belief that is shared by others and often relished, amplified and defended by the accused.”  This intense emotional commitment to a particular belief is what causes the accused to commit a violent act.  Dr. Rahman hopes that his study can help forensic psychiatrists properly identify the motive for a crime in courts of law when a defendant’s sanity is in question. Although more research must be done to fully understand the concept of extreme overvalued beliefs, Dr. Rahman also hopes that future research will enable mental health professionals to identify early signs of such extreme beliefs and intervene before violent behavior occurs.


Source: https://www.sciencedaily.com/releases/2016/05/160523130806.htm

Should Children Make Their Own Medical Decisions?

Julianna Snow, a 5 year old girl who suffered from an incurable neuromuscular disease, died on June 14, 2016 after a long, hard fight that sparked a great deal of debate among bioethicists. Julianna was diagnosed at 2 years old with Charcot-Marie-Tooth disease, and by 4 years old she could not use her arms or legs and had to use a feeding tube. However, the effects of her illness were only physical and not mental. After being in and out of the hospital, Julianna’s parents were informed they would need to make extremely difficult medical decisions the next time Julianna got an infection that would make it hard for her to breathe.  Even though Julianna was only 4 years old, her parents decided to include her in such medical decisions. To honor her wishes to “go to heaven” and not go back to the hospital, her parents decided to care for Julianna in the comfort of her own home.

This decision was highly criticized by some who believed Julianna’s parents “painted a coercive picture” to influence their daughter’s decision to “go to heaven.” Bioethicist Arthur Caplan, for example, argues that a 5 year old child is incapable of making this kind of decision especially in light of the case of Cassandra C., a 17 year old girl who refused chemotherapy but was mandated to receive treatment when a court concluded she lacked capacity to make such decision. Yet, the doctors who were most involved in Julianna’s care supported her parents’ decision. Even Bioethicist Arthur Caplan admitted after meeting Julianna that “she taught [him] and others that even a child can become very knowledgeable about a challenging illness and can convey thoughtful and remarkable feelings about her illness and her ideas.”

Julianna received hospice care for the last 18 months of her life and in that time she celebrated her fifth birthday as a princess. She died in her mother’s arms at home in her princess room.


Sources: http://www.cnn.com/2016/06/14/health/julianna-snow-heaven-over-hospital-death/


Study Concludes that Variability in Transplant Centers’ Decisions to Accept Organ Donations is as Much to Blame for Inequality in Transplant Care as Geographic Borders

A patient’s eligibility to receive an organ transplant is determined by, among other things, the patient’s location and consequently, geographic borders have been routinely blamed as the predominate cause of inequality among transplant care. However, the Perelman School of Medicine at the University of Pennsylvania recently found that transplant center variability in deciding whether to accept an organ may also play a role in such inequality and waitlist mortality.

As explained by the study, a Model for End-Stage Liver Disease (MELD) score is used to prioritize patients on the liver transplant list. Despite this uniform system, there remain disparities among the 11 Organ Procurement and Transplantation Network (OPTN) regions across the United States. When an organ becomes available, the United Network for Organ Sharing (UNOS) ranks all patients eligible to receive the organ based on blood-type match, the recipient’s geographic location, MELD score and the recipient’s willingness to accept organs with certain unfavorable characteristics. The organ is then offered at a transplant center at which the highest-ranked patient is waitlisted. The center may in turn decline the organ based on donor age, donor-recipient size mismatch, or a decision that a patient with lower priority has a greater risk of death and is therefore a better recipient for that particular organ. Perelman’s study found significant variability in the organ acceptance rate among transplant centers, with some accepting organs for their first-ranked patients as low as 16% of the time to as high as 58% of the time, even after adjusting for donor, recipient, and transplant center characteristics.

A center’s decision to accept an organ is a matter of life and death. In order to reduce the variability in such decision-making among transplant centers, and maximize access to lifesaving transplant care, the study suggests that organ acceptance rates of all transplant centers should be made public so that patients and referring providers can make informed decisions when selecting a center for their care.

 Source: https://www.sciencedaily.com/releases/2016/01/160127154825.htm

New Study Suggests that Medical Errors are the Third Leading Cause of Death in the U.S.

A new study published by BMJ (formerly the British Medical Journal) in May 2016 suggests that medical errors may cause more deaths than lower respiratory diseases.  This would make medical errors the third leading cause of death (following heart disease and cancer) in the United States.  The study indicates that at least 251,454 deaths each year are due to medical error.  This number is much higher than that reported by previous studies. One reason for such discrepancy may be the lack of accurate data regarding deaths caused by medical error.  Causes of death listed on death certificates are based on insurance billing codes, which “are designed to maximize billing rather than capture medical errors.” As a result, death certificates fail to address human errors or other system failures.

The doctors who completed the study hope that their analysis will “lead to real reform in a health care system [that] is letting patients down.” They suggest that better reporting mechanisms must be put in place to address medical errors that lead to death. Some proponents believe that a space should be added on death certificates to indicate whether death was related to a medical error. However, to avoid legal implications when a doctor indicates such a cause of death, legislation would need to attach some protection or privilege to this information (for example, by prohibiting the information to be used in a lawsuit). Such legal protections would encourage accurate reporting by doctors and, in turn, would help establish a course of action for minimizing the most common medical errors that lead to patient death.

Source: http://www.cnn.com/2016/05/03/health/medical-error-a-leading-cause-of-death/

Young, Mentally Ill Patients Placed in Nursing Homes Meant for Elderly

The trend of “population mixing” in nursing homes is on the rise as more young people with brain injuries and mental illnesses are being placed in facilities intended to serve an elderly population. Unfortunately, for young patients in need of long-term skilled nursing care who rely on Medicaid and other government funding for health care, placement in a nursing home is often the only available option. This is because there are few remaining facilities specifically designed for patients with mental illnesses or brain injuries.


Although “population mixing” in nursing homes has been occurring for some time, the recent increase is linked to a spike in resident-to-resident altercations (“RRAs”). RRAs are most common in nursing homes with shared rooms and pose a significant risk to elderly patients who are involved in an altercation with younger, more physically able patients. In order to decrease the incidence of RRAs between young, able-bodied patients and physically vulnerable elderly patients, experts opine that it is necessary to increase government funding for mental health facilities so as to provide better treatment options for young patients.  Nursing home could then be dedicated to care for the elderly populations they were designed to serve.


Source: http://www.bloomberglaw.com/exp/eyJpZCI6ImEwajR3N3E3YzE/anM9MCZzdWJzY3JpcHRpb250eXBlPWJuYWhsciZpc3N1ZT0yMDE2MDUyNiZjYW1wYWlnbj1ibmFlbWFpbGxpbmsmc2l0ZW5hbWU9Ym5hIiwiY3R4dCI6IkJCTkEiLCJ1dWlkIjoicHo5dVZVTENaOW12QXhKRDJkOHVlZz09a25WNVYxKzNzOG4vZUpvMGplYW4wQT09IiwidGltZSI6IjE0NjQxMTY1NjU1MzMiLCJzaWciOiIxYlE0cXhNQUZYZUczS1ZvVjlXNmFrVURoZU09IiwidiI6IjEifQ==?emc=bnahlr:blaw:1003

Massachusetts Challenges Gilead’s Hepatitis C and H.I.V. Drugs

Maura Healey, the Massachusetts Attorney General, has begun an investigation into the pricing of Gilead Sciences’ Hepatitis C drugs due to possible violations of Massachusetts’ consumer protection laws. Gilead’s Hepatitis C drugs, Sovaldi and Harvoni, have been applauded as “breakthrough” treatments for the disease, curing most patients in 12 weeks with minor side effects. However, the drugs come at a lofty price — anywhere between $84,000 and $94,000 for a course of treatment – which has led Ms. Healy to the conclusion that Gilead’s pricing of the drugs may be resulting in “massive public harm” by making the drugs unavailable to vulnerable populations.  In particular, the demand for the drugs, and with Gilead’s pricing structure, has placed a costly burden on state Medicaid and prison health care programs, causing many such programs to strictly limit access to the drugs.  As a result, Ms. Healy argues, Gilead effectively created a cure for Hepatitis C, but then made that cure unavailable through its pricing structure.

Although Gilead contends that its high prices are offset because Sovaldi and Harvoni may help patients avoid costly liver diseases, and that substantial discounts may be available to certain consumers and insurance companies, this is not the first time Gilead has faced scrutiny of its practices.  The AIDS Healthcare Foundation recently filed a lawsuit against Gilead regarding its HIV drug, Tenofovir, and a lawsuit filed by the Southeastern Pennsylvania Transportation Authority regarding Gilead’s exorbitant prices was recently dismissed.  It remains to be seen whether Gilead has violated any laws, but perhaps the ongoing scrutiny of Gilead’s practices will lead to a mutually beneficial resolution, which Ms. Healy hopes will be a reduction in price.

Source: http://www.nytimes.com/2016/01/28/business/gilead-faces-fights-over-hepatitis-c-and-hiv-drugs.html?ref=health

STD? No Marriage License for You!

Oklahoma State Senator Anthony Sikes recently authored a bill that would not only require screening for sexually transmitted diseases (“STD”) as a prerequisite to obtaining a marriage license, it would deny the license altogether if one partner has been diagnosed with having an STD. If enacted, Senate Bill 733, the state Department of Health will be directed to require blood tests “for the discovery of syphilis and other communicable or infectious diseases” before a marriage license can issue. Furthermore, the law will require that, in order for a marriage license to issue, both partners must provide documentation from a physician stating that they are either not “infected” or, if they are “infected,” that the disease is not “communicable” to the other partner.

Although Fox23 News reports that Senator Anthony Sikes was “not available to comment,” the executive director of Tulsa Cares, a local nonprofit organization, has already pointed out that the proposed law will only increase fears about HIV without impacting the spread of the disease.  What’s more, the law will almost certainly face challenges under patient privacy laws and the American Disabilities Act.  While it remains to be seen whether the Bill will move forward in the Oklahoma State Legislature, it raises concerns about the politicization of serious public health issues.





Seattle Man Who Infected at 8 People with HIV Ordered to Stop or Face Jail

A Washington court recently issued a cease-and-desist order against a man, known as “AO,” who is accused of spreading HIV to his sexual partners.   Since his diagnosis in 2008, “AO” has infected at least 8 sexual partners. Although the King County Department of Health previously issued two cease-and-desist orders against the man, those orders were ignored and the agency “felt legal enforcement was the best way to assure the health of the patient and public.” Now, “AO” is under court order to attend HIV counseling centered on adopting safe behaviors to prevent infection of future sexual partners. If “AO” disobeys this order, he could face jail time and escalating fines. This is only the second time in the history of the Seattle public health department that officials used a 1988 state law to restrain a contagious person infected with a sexually transmitted disease.

Read more here.