Monthly Archives: March 2016

Bioethical Controversies Surrounding Physician-Assisted Suicide

Physician-assisted suicide, or voluntary euthanasia, has sparked highly controversial opinions surrounding the right to control one’s own death. Physicians incessantly weigh benefits of a procedure against risks of harm and face ethical dilemmas when balancing beneficence and the duty to do no harm, non-maleficence.

Some physicians believe that by assisting in death, they are abandoning their medical and ethical duties. Typically, patients seeking assisted suicide experience inability to engage in pleasurable activities, a loss of dignity, and a loss of autonomy. For terminally ill patients, if all curative medical interventions have been exhausted, some physicians begin the next step of administering relief in depression or other mental illnesses even when it only provides a short period of improved life quality.

However, other physicians believe that they are helping patients by providing them the choice to die on their own terms. The honor in having the right to a dignified death is strongly supported by secular humanism, an officially recognized belief by the Belgian government, which has the most liberal laws surrounding euthanasia.

The Netherlands, Belgium, and Switzerland allow physician-assisted suicide to be administered to not only terminally ill patients, but also patients suffering from mental illnesses. The National Institute of Health looked into physician-assisted suicide records in the Netherlands and found that 37 of 66 assisted deaths were cases that mentally ill patients refused recommended treatment options.

In countries like Belgium where psychiatric care is minimally funded, physicians have been pushed to accept the limits of psychiatry. There, when patients request euthanasia, physicians may classify patients mental illnesses as terminal and comply with requests to die.

When a patient requests euthanasia, Belgian doctors have the right to conscientious objection. However, lawmakers are attempting to change the current law by requiring all doctors to respond to the patient’s request in a very short amount of time and to refer the patient to another doctor that will fulfill their death request.

Not only is this controversy difficult for physicians, but also it is a huge problem for religious institutions that do not support self-inflicted death. The Catholic Health Association believes that suicide and euthanasia will never be morally acceptable opinions and therefore, “Catholic health care institutions may never condone or participate in euthanasia or assisted suicide in any way.”

In the United States, the most fundamentally protected rights are those embodied in the Constitution, including an individual’s right to preserve autonomy and retain bodily integrity by refusing life-sustaining medical treatment. Cruzan. However, in Vacco v Quill, the Supreme Court decided that although a competent individual can refuse unwanted medical treatment, there is not a constitutionally protected right for individuals to choose to die. The right to die is left for the states to determine.

Currently, only four states including Oregon, Washington, Vermont, and most recently, California, have implemented statutes allowing physician-assisted end of life options for terminally ill patients. In Montana, the Supreme Court decriminalized physician-assisted suicide upon the request of a terminally ill and competent patient. The court determined that the right to die with dignity is not contrary to public policy and physicians are not committing a crime by prescribing a lethal dose of medication as long as the terminally ill patient makes the final decision to take the lethal dose on his own, without any assistance.

This year, Canada and Columbia have also decriminalized physician-assisted suicide. The debate continues in England as well as here in the United States, where an additional 23 states anticipate hearing proposals regarding the right to die.

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Federal Investigation on Potential Link Between Artificial Turf and Cancer

By: Nawa Arsala

After years of concern from athletes, their parents and coaches, a federal investigation on the potential link between artificial turfs and cancer has commenced. The Environmental Protection Agency, the Consumer Product Safety Commission and the Centers for Disease Control and Prevention will work together to research “whether crumb rubber, as part of an artificial turf field or as playground fill, is safe for their children to play on.”

Artificial turf, also known as synthetic turf, is a popular alternative to grass fields. It provides a consistent year-round, durable, all-weather playing surface with very low maintenance.  Crumb rubber, which is what is used in artificial turfs, is made from scrap car and truck tires that are ground up and recycled.

In a letter to President Obama, Senators Blumenthal and Nelson, asked for a comprehensive study of the correlation between the crumb rubber in cancer. The Senators cited extensive research from University of Washington soccer coach Amy Griffin. Her research found that 153 reported cancer cases involving athletes spent significant periods of time playing on crumb rubber turf.  Of those cases, 124 were soccer players, 85 of whom were goalies. Moreover, of the types of cancers, blood cancers like lymphoma and leukemia were the most diagnosed.

The investigation, known as the Federal Research Action Plan on Recycled Tire Crumb Used on Playing Fields and Playgrounds, will test different types of tire crumb and work with scientists to evaluate the potential cancer toxicity of various chemicals. The task force will meet with athletes, parents, coaches and industry representatives directly to get fire-hand perspectives on the potential exposures. According to the Synthetic Turf Council, “crumb rubber has been critically examined and studied since the late 1980’s. Science has proven it to be safe for children and people of all ages.”

Further, the task force hopes that by the end of 2016, a draft status report will identify the key constituents of concern, and an initial evaluation of potential cancer and non-cancer toxicity of key chemical constituents.

Although we have to wait until the end of the year for the federal hypothesis, there are many independent reports with plausible theories. One popular theory by chemical engineer Stewart D. Simonson, is that the increased cancers by athletes on artificial turf fields are due to “repeated electrostatic charge  buildup and electrical discharge due to triboelectric effects from the crumb rubber turf and  plastic blades of grass in contact with player’s skin and jerseys.” Further, as goalies have a higher incidence of cancer, it can be attributed to their repeated dives into the turf, which increases their electric charge due to an exchange of electrons between the grass and rubber fill material and the players.

As of late last year, more than 50 counties and cities in 17 states have reassessed their approach to crumb rubber turf. Montgomery County, Maryland, a suburb right outside Washington, banned new artificial turfs this year in a resolution for the “Use of Plant-Derived Materials for Infill in Artificial Turf.” Several surrounding counties, including Fairfax County, VA, have also enacted petitions to follow Montgomery County’s unanimous decision. Until these changes are made, many parents across the nation have chosen to not allow their children to play on artificial fields.

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CDC Issues New Opioid Prescription Guidelines to Primary Care Physicians

On March 15, 2016, the Centers for Disease Control and Prevention (CDC) issued guidelines on prescribing opioid painkillers that were aimed at primary care physicians. These guidelines were a response to the opioid epidemic that has resulted in opioid abuse, overdose, and death. Primary care physicians prescribe nearly half of the opioid painkillers consumed in the United States. These guidelines are not intended for physicians treating cancer patients or for end-of-life care. These guidelines come after several other attempts in recent years to curb the epidemic. In 2014, the Drug Enforcement Agency re-classified some controlled substances from Schedule 3 to the more restrictive Schedule 2. The Obama administration also stepped up general spending on treatment and prevention programs in response.

At the center of the guidelines is the recommendation that non-opioid therapy be the first line of treatment for chronic pain and that opioids only be prescribed when their benefits for pain and function outweigh the risks.

These guidelines have sparked a fierce debate. Some pain specialists and patient advocates have remarked that these guidelines could deny patients pain relief. The line between drug-addicted patients who do not truly need relief and legitimate patients is blurry and difficult to identify.

As the number of deaths from opioids has increased, state and federal agencies have implemented a variety of solutions in attempts to curb these deaths. Some states, like Nebraska, have mandated limits of opioid medications that patients may be prescribed per year. Other states have instituted “pain management contracts,” where patients must agree to random drug testing before receiving an opioid prescription. And many medical associations now offer doctors training in opioids and chronic pain, encouraging them to first try alternative remedies like physical therapy, acupuncture, anti-inflammatories, antidepressants, and counseling. While these other options can work, they don’t always work for some patients who legitimately have an immense amount of pain. These other options can also be much costlier than opioid medications, and not all insurance programs cover all of these remedies.

Critics of the CDC guidelines have argued that the guidelines are not based in strong evidence. However, Dr. Debra Houry, director of the CDC’s National Center for Injury Prevention and Control, counters that evidence for the benefits of opioid medications is also lacking.

While the guidelines are not perfect, they play an important role in the debate around opioid therapy, and finding the line between drug-addicted patients and legitimate ones who need relief.

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New Hope for Eradicating Blood Cancers: Successful T-Cell Trials Provide Possible Alternative to Toxic Treatment Protocols

For years, researchers, survivors, and various interest organizations, have tirelessly sought to develop or fund cutting edge treatment protocols that would help increase survival rates for blood cancers and eventually lead to a much-desired cure.

According to the Leukemia and Lymphoma Society, there are currently 327,520 people in the United States are living with or are in remission from leukemia. Generally, achieving remission has more than quadrupled since the 1960s. The “overall relative survival rate” for all blood cancers was 60.3 percent between 2004 and 2010. More specifically, patients with Chronic Lymphocytic Leukemia (CLL) have a survival rate of 85.3 percent, the highest overall survival rate within the leukemia category; Acute Lymphoblastic Leukemia (ALL) has the highest survival rate for children at about 92 percent, but an overall survival rate of 70 percent. Acute Myeloid Leukemia (AML) has the lowest for adults at 25.4 percent. AML in children under 15 years old has a 66.3 percent survival rate.

In February, researchers from Boston University published a report with promising findings about an innovative treatment for patients with blood cancers. Dr. Hui Feng and her team, Dr. Nicole M. Anderson, Dr. Dun Li, and Dr. Fabrice Laroche, suggest that T-cell leukemia cells can support its growth and survival, leading to more patients achieving remission.

The Boston University team worked with 35 terminally ill leukemia patients, and 94 percent successfully went into remission utilizing genetically modified T-cells. The study suggests that the T-cell therapy has the greatest success with blood cancers, however, oncologists and researches are hopeful that similar results can be achieved with tumors.

Similar trials have been conducted in the United Kingdom, Italy and throughout the United States with great success. How do the oncologists and researchers perform the T-cell process that seems to be drastically changing therapy options for blood cancer patients? In the simplest terms, T-cells are removed from the patient’s body, genetically modified, and the modified T-cells are transfused back into the patient. The study suggests that the CARS (Chimeric Antigen Receptor) molecules “reduce the ability of the cancer to shield itself from the patient’s immune system, allowing the T-cells to attack the cancer.” Given the nature of blood cancers, a treatment that is able to weaken a cancer cell’s ability to fight the immune system is groundbreaking.

Other than the Boston University team, US San Diego announced that it is conducting three T-cell like trials: ZUMA-1, ZUMMA-2 and ZUMMA-3. With several research institutions conducting trials and furthering the research on this groundbreaking protocol, T-cell therapy could provide alternatives to aggressive and toxic therapies that, albeit, stops the cancer cells from rapidly expanding, also kill good cells as well. The Federal government, via the United States Food and Drug Administration (FDA) appears to be supportive of T-cell related trials. In 2014, the FDA granted Breakthrough Therapy status to an Investigation New Drug (IND) application submitted by University of Pennsylvania’s Perelman School of Medicine, focused on T-cell therapy treatments in ALL patients.

While researchers and oncologists posit that T-cell therapy is ground breaking and “extraordinary”, patients and families are also thrilled that a new treatment could potentially become widely available, particularly those patients that have tried traditional treatments and failed to achieve remission.

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Battle in Washington State over Hepatitis C Medications Changes Target from Insurers to Medicaid

In early February, the Seattle Times reported on the case of David Morton, the face of a class-action lawsuit against private insurers Group Health and BridgeSpan Insurance.  In the case, Morton and others allege that the Washington state private insurers failed to pay for a new drug called Harvoni.  This drug not only treated Hepatitis C, but has the ability to cure it.  Group Bridgespan has already updated its policy to allow coverage of all Hepatitis C patients, while Group Health has expanded to coverage of those with lower levels of liver damage.

The insurance companies were limiting use of the drug, which costs more than $1,000 per pill or $95,000 for a 12-week course, to only those with a more “severe” infection.  Therefore, the class alleged that the decision by the insurance company was a cost-based one, not one of medical necessity.  This was further evidenced by the fact that other insurers in the state did cover the drug.

It is not only private insurers who are rationing the drug, but the Washington state Medicaid program (among others) which limits the use of the drug to people with the most severe fibrosis, or liver scarring.  This is despite the fact that the American Association for the Study of Liver Diseases (AASLD) espoused the benefits of the drug for all those with Hepatitis C.  This was a reversal of their previous recommendation which prioritized use of the drug with those of “greatest need” based on level of liver disease, due to the cost and availability of the drug.  The new recommendations from the AASLD have even been accepted by the Washington Insurance Commissioner, who is encouraging insurers to follow the guidelines as it considers what the standard of care should be.

However, not everyone is convinced of the drug’s effectiveness.  A report from the Center for Evidence-based Policy released in May 2014 evaluated the effectiveness of sofosbuvir, which is the active component in both Harvoni and another Hepatitis C drug called Sovaldi.  They noted that despite the claims of curing Hepatitis C, relapse is possible in patients who received a full treatment regimen.  Some figures suggest anywhere from a 5 to 28 percent relapse rate.

Two weeks after the case against the private insurance companies was filed, another case was filed, this time against the Health Care Authority (HCA), Washington State’s Medicaid provider.  Just as in the case against the private insurers, this one is alleging that cost – not medical necessity – is the determining factor in hepatitis drug coverage.  The Washington Medicaid Director, in a September letter to the U.S. Senate, estimated that it would cost $242 million just to cover the high risk patients.  If that coverage expanded to all Hepatitis C patients, it would balloon to $3 billion.

This issue has expanded well beyond Washington State.  All states across the country vary in coverage for the drug.  For example, Michigan has just decided to cover the drugs under its Medicaid programs while New York has decided to investigate the practices of its private insurers, and New Mexico begins to contemplate the financial effects of covering the medicine.  Even as far away as India, there are challenges to the patent itself in hopes of opening up more access to the drug.

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