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.


IVF Side Effects: Birth Defects and Childhood Leukemia

Two studies published in Pediatrics have found that women using assisted reproductive technology (“ART”), including IVF, give birth to children with a higher risk of developmental disorders and cancer. The first study was a cancer study that combed through all birth records in Norway from 1984 to 2011. The birth records were compared to the cancer registry data. The researchers concluded that ART-conceived children had a 67% higher risk of leukemia. However, the overall risk of cancer was not significantly greater for ART children. The second study focused on developmental disabilities in children. Researchers analyzed the birth records of more than 330,000 children and found that ART children had a 27% higher chance of being referred to Early Intervention, a program designed to help disabled infants and toddlers. Since ART babies are more likely to be premature, the researchers took into consideration the link between preterm babies and developmental disabilities and concluded that premature births were not the primary cause of ART children being referred to Early Intervention.

Because the studies are preliminary, the authors are not suggesting that women avoid IVF and other reproductive technology procedures. There can be other contributable factors that need to be considered, such as advanced maternal age, hereditary genetic diseases and reproductive health of women seeking reproductive treatments. The lead author on the developmental disability study, Dr. Hafsatou Diop, acknowledges that there are risk factors undergoing IVF, but states that, no matter how children are conceived, women can take certain measures in reducing the risk of pregnancy complications by avoiding smoking and drinking, maintaining good health and eliminating stress. Dr. Diop further explained: “While there is an increased risk, we don’t necessarily think that it is enough to influence one’s decision about whether or not to proceed with ART.”


Heroine Addicts: Assist Them or Save Costs?

American heart surgeons are facing a difficult decision with respect to heart valve transplants for heroin addicts: whether to continually replace addicts’ heart valves or refuse to operate. The cost of a heart valve transplant, including six to eight weeks in the hospital, can be over $500,000.  Although recipients of heart valve transplants are asked to abstain from drug use after the procedure, most heroin addicts fail to comply, meaning that the procedure will have to be repeated in the future. As a result, surgeons must decide whether performing a heart valve transplant for a heroin addict is a reasonable use of health care resources, especially considering that most heroin addicts do not carry health insurance.

Clinical ethicists opine that surgeons are not obligated to perform repeat operations on heroine addicts who fail to comply with treatment restrictions.  Such ethicists argue that heroine addicts have a responsibility to change their behavior and when they fail to do so, surgeons have no duty to perform repeat procedures that would otherwise be unnecessary. However, according to substance abuse counselors, abstaining from heroine once addicted can be extremely difficult and many addicts continue their drug use to avoid withdrawal symptoms and maintain a sense of equilibrium, not to simply “get high.” Unfortunately, heroine use is on the rise and, at least for the foreseeable future, cardiac surgeons will continue to face this ethical dilemma.


Frozen Embryos: People, Property, or Something In-Between?

While debates over the personhood of fetuses have been raging for years, a new issue has been arising with increasing frequency: what is personhood status of frozen embryos? There have been many recent disputes about how to deal with frozen embryos when the progenitors of such embryos disagree about their use. For example, a divorced Missouri couple is currently involved in a custody battle over their frozen embryos, which were created when the couple were married and went through the process of in vitro fertilization. While the former wife would like to keep the embryos to have more children, the former husband would like the embryos to be destroyed. Similar issues arose for actress Sofia Vergara, whose ex-fiancé wants to use frozen embryos they made when they were engaged.

Cases of this nature beg several important questions. How should embryos in vitro be classified? Does the embryo have rights? What are the rights of each progenitor? Anti-abortion activists have argued that embryos should be treated like other children, while pro-choice advocates contend that people should not be forced to procreate. In the Missouri case referenced above, the Court has tried to avoid these difficult issues with a compromise, calling the embryos “a unique form of marital property” and awarding joint custody to the disputing parties.  Under the Court’s holding, the embryos may only be used if both progenitors agree. While this decision provides a temporary solution, it still leaves many issues unresolved and significant questions unanswered.


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.



Teen Texting Can Lead to Better Health Care

Parents try, and often fail, to control cell phone use at dinner tables around the country.  What parents might not realize is that those bright screens with ringing and beeping noises represent a way in which teenagers might be able to improve their own health.  As telemedicine becomes a bigger part of the health care delivery system, researchers have been investigating the relationship between medical services and technology.  Further, start-up companies and application developers are looking for ways to “incorporate medical care into our relationship with our [beloved cellular] devices.”  For example, several studies have indicated that teenagers with chronic medical issues, such as those who undergo liver transplants or those who suffer from Type 1 diabetes, may better follow their treatment plans by receiving text message reminders.

Dr. Cindy Osman, a clinical associate professor of pediatrics at New York University, believes cell phones improve health care for teenagers, who tend to document certain ailments on their phones before visiting a doctor’s office.  Heath care providers are able to diagnose and recommend sound medical advice from either listening to an ill teenager speak on the phone or seeing a picture of an injury or ailment.

There are obvious risks, specifically misinformation and privacy concerns, with incorporating cell phone technology into health care, but Dr. Marcin, a pediatric critical care specialist at the University of California, Davis, acknowledges that adolescents are already living on these devices and utilizing them for self-diagnosis with varying degrees of success.  Dr. Marcin believes that application developers and teenagers need to come together with the health care field to try to find a way that best utilizes cell phones for all parties involved.


HIPAA: The “Toothless Tiger”

When Congress passed the Health Insurance Portability and Accountability Act (“HIPAA”) in 1996, the Office for Civil Rights (“OCR”) of the Department of Health and Human Services (“HHS”) was charged with enforcing regulations intended to protect the privacy of health information.  Although the premise of HIPAA was to allow a patient to safely assume that what was said in an examination room stayed in the examination room, a recent article in The Washington Post has revealed that the enforcement of HIPPA regulations is falling short.  For example, in 2014 alone, OCR received approximately 18,000 HIPPA complaints, but only brought 6 formal actions.  Moreover, the law does not allow patients a private right of action to sue an offending health care provider and OCR has admitted that repeat offenders are not tracked.

Solutions to protecting patient and consumer health care information, in large part, do not require legislative action.  For example, OCR could use the tools already at its disposal to levy punitive damages on repeat offenders, which would incentivize businesses to protect patient data.  Furthermore, in the long run, a “whistleblower” mechanism, such as a qui tam action under the False Claims Act, could incentivize HIPPA compliance, although such an action would involve Congressional approval.


The Impact of Obesity on Nursing Homes

Nursing homes in the United States are finding themselves both overwhelmed and unprepared to accommodate the recent influx in moderate to severely obese patients, whose numbers increased over 10% between the years 2000 and 2010. The inability of nursing homes to accommodate these patients has been attributed, at least in part, to the lack of specialized equipment necessary to care for severely obese patients, such as motorized lifts and larger wheelchairs. Although the Medicaid program covers over 60% of all nursing home residents nationwide, Medicaid does not generally cover the specialized equipment required by obese patients, placing the economic burden of purchasing such equipment on nursing homes without providing reimbursement.

Unfortunately, due to the economic burden of caring for obese patients, some of the nation’s largest nursing home chains, such as Genesis HealthCare, have begun to close bariatric care programs. As a result, hospitals must find alternatives to nursing home care for obese patients who cannot be safely discharged back to the community. Although some experts argue that obese patients may be able to challenge denials of nursing home admission, the issue is “far from settled” and finding new methods of transitioning obese patients from hospital care to community care is poised to become a pressing issue of public concern.


What to Expect as a Medical Resident: A Higher Risk of Depression

A recent study published in the Journal of the American Medical Association (JAMA) found that 29% of medical residents suffer from depression, which is a significantly high number when compared to the 8% of the general public that suffers from depression. The meta-analysis study, conducted by Dr. Douglas Mata, reviewed a total of 54 studies from 1963 to 2015. The analysis consisted of over 17,000 residents and relied mostly on self-reports. Additionally, Dr. Mata found that depression among residents had not only increased since 1963, but also increases throughout a physician’s residency. By tracing the mental health before and during the doctors’ residencies, the study found that the symptoms of depression in the residents being tracked increased by 15%. Dr. Mata, who is a resident himself, believes that the demanding hours play a significant role on residents’ mental health. He explained that many residents do not even have time to go grocery shopping.

However, there is no conclusive finding that determines the source of the residents’ high depression rates. The JAMA article includes an editorial by Dr. Thomas L. Schwenk, who speculates on the probable causes for the depression. Dr. Schwenk states that the main causes of depression among residents include the need to reconcile old-school training methods with modern technology, the lack of mental health care for residents, and the long hours and sleep deprivation. The cap on resident work hours, as is established by the Accreditation Council for Graduate Medical Education, is currently set at 80 hours per week. Due to these long hours, many residents are also socially isolated. In the United States, 400 doctors die of suicide every year. To combat this problem, Dr. Schwenk proposes a change to the work environment, such as providing ways for medical residents to de-stress from the traumatic life or death events they often endure.


29% of Young Doctors Are Depressed: Study

Innovative or Experimental? Brain Surgeon Tests Rumored Treatment on Three Patients

Under what circumstances is it acceptable for doctors to treat a patient, particularly one with a very poor prognosis, with an untested or experimental treatment? Dr. Paul Muizelaar confronted this problem firsthand a few years ago, when he performed three surgeries based on a long-lasting hospital rumor.  The rumor was that for a certain type of brain tumor, called glioblatoma multiforme, an infection of the wound site during surgery could actually extend a patient’s life significantly. A few studies on the method led to divergent results.  At present, there is no scientific consensus on the procedure’s effectiveness.

Despite this lack of data and previous failure to secure funding for animal research on the topic, Dr. Muizelaar first tested this treatment on a friend of his who was diagnosed with the deadly tumor and had exhausted all standard treatments. The treatment would include surgery on the tumor, during which Muizelaar would intentionally infect the brain with a type of bacteria found in fecal matter. Muizelaar had been given limited approval to conduct the surgery from the hospital’s review board, as it could probably be classified as “innovative treatment” rather than human research. The outcome was just enough to give some hope, and so Muizelaar quickly wanted to try it on another patient. This led to a second surgery, on another patient who had already exhausted the usual treatment options.  The hospital’s administration was much more hesitant about this second surgery. Muizelaar was told that if he planned to do any more of these surgeries he should submit a formal application to the FDA and hospital. However, Muizelaar performed one more surgery. He said that at the time it didn’t even occur to him that he wasn’t following those instructions, and he was just trying to treat the patient. This last patient was newly diagnosed, hadn’t had any standard treatments yet, and ended up passing away within a few weeks of the surgery.

Muizelaar was widely scrutinized for these surgeries and was eventually forced to retire from his high-ranking position at the hospital. Did Dr. Muizelaar go too far? He claims that his goal was only to help patients and that these patients had almost no other hope for survival. Any formal research progress in this area would have taken many years after these patients’ deaths. Should doctors be able to test ideas on patients without following the usual protocols for human research? Is this type of regulation stifling innovation or protecting patients from dangerous experimentation?