Category: Blog

In 1994, the state of Ohio convicted Warren Keith Henness for aggravated murder.  The Ohio Supreme Court later set an execution date for Henness for January, 2015.  However, the Ohio Department of Rehabilitation and Corrections has pushed Henness’ execution date and the dates of many others, because they have been unable to obtain the necessary drugs to carry out the executions.  This problem is not limited to Ohio. More than 20 states will face great difficulty obtaining the specific drugs in the future.  As of January 1, 2016, there were 2,943 death row inmates in the United States.  The number of executions completed in 2015 was the lowest in 25 years, and half of the stays of execution were due to states’ inability to obtain the necessary drugs.

On May 13, 2016, Pfizer, an American global pharmaceutical corporation, announced that it will now enforce a distribution restriction on the specific drugs which are included as part of the lethal injection protocols.  Lethal injection procedures vary by state, but several use a one, two, or three-drug protocol, which requires an anesthetic or sedative, typically followed by pancuronium bromide to paralyze the inmate and potassium chloride to stop the inmate’s heart.  There are seven specific drugs that will now only be distributed to certain wholesalers, distributors and direct buyers, and all are required to agree to not resell the drugs to prisons.  The seven drugs: propofol, pancuronium bromide, midazolam, hydromorphone, rocuronium bromide, vecuronium bromide, and potassium chloride, are FDA-approved drugs used every day in efforts to treat illnesses and save lives.  Companies like Pfizer believe that these products should no longer be used for capital punishment.

Pfizer’s move is the last step in closing off the remaining FDA-approved manufacturers of drugs used in executions as all of the major pharmaceutical companies in the United States now stand together on this issue.  While the announcement is probably partly a public relations move and partly a business decision, Pfizer, along with other drug makers, say that their products are supposed to be used to save lives, not take them.  The companies believe that drugs have a certain value, but if associated with death due to the use in capital punishment, those drugs will lose that value.

Pfizer’s decision poses many questions for states that use lethal injection.  States may continue to search for the drugs needed to administer executions.  However, the 31 states that still impose lethal injection as capital punishment will possibly end their search by violating the law.  Some states have already looked to state-regulated compounding pharmacies that mix individual ingredients in the strength and dosage required to perform the procedure.  Though these compounding pharmacies distribute drugs for lethal injection, they often do not want their identities known to avoid lawsuits for contractual liability.  Few states allow methods such as electrocution, and even fewer states allow the gas chamber, hanging, and firing squad, but with the position taken by pharmaceutical companies, more states could resort to such procedures.  For example, Tennessee said in 2014 that if the drugs for lethal injection are unavailable, the state can use the electric chair.  A year later, Utah reintroduced firing squads.  Though it is difficult now to say how much of an impact Pfizer’s decision will have, states that use lethal injection will have to start looking for alternatives.

On March 31, the Health Law and Justice Society hosted its spring symposium “Drug Promotion in the 21^st Century: Off-Label Marketing and First Amendment Concerns.”

Although the Food and Drug Administration (FDA) approves drugs for specific medical purposes, many treatments approved for one use are also effective for other diseases and conditions. The FDA has traditionally prohibited the promotion of medical products for uses other than those approved by the agency and reflected in the labeling. This restriction, however, has recently been weakened by successful legal challenges based on the First Amendment guarantee of freedom of speech. The symposium provided an overview of these issues and assessed recent legal developments, including several important cases decided in the past year. The panelists also discussed the implications of expanding the right to off-label promotion for the FDA, the drug industry, and medical practice. Professor Lewis Grossman, Professor of Law at American University Washington College of Law and food and drug law scholar, introduced and moderated the panel.

 

The speakers for the symposium were 1) Allison Zieve, J.D., Director, Public Citizen Litigation Group; 2) Richard Samp, J.D., Chief Counsel, Washington Legal Foundation; 3) Adriane Fugh-Berman, M.D., Associate Professor and Director of PharmedOut, Georgetown University Medical Center; and 4) Anne K. Walsh, J.D., Director, Hyman, Phelps & McNamara, P.C.

 

Ms. Zieve offered an illustrative history of how FDA’s authority over drugs has evolved. Her comments focused on the FDA’s requirements of safety and efficacy for new drugs before approval for sale on the market and balancing that with what is considered “truthful” speech. She emphasized that laypeople may not be able to properly evaluate truthful scientific statements in terms of safety and efficacy for human use. Furthermore, she stated that allowing industry to successfully use the First Amendment to discuss truthful statements about off-label uses of drugs could potentially have severe consequences for the public.

Mr. Samp’s comments focused on truthful speech, and regulations of commercial speech. He emphasized that the current trend in courts is to apply closer First Amendment scrutiny to restrictions on non-misleading commercial speech.

Ms. Fugh-Berman brought a physician’s and academic perspective on this issue. Among many things, she discussed the fact that while off-label uses of drugs can sometimes be rational and inevitable, most of the time, it is not. She focused on scientific support for off-label uses of drugs. She said that industry controls what information and studies the public sees and that companies usually have a great deal of information regarding off-label uses of their drugs.

Finally, Ms. Walsh’s comments discussed the interplay between the Federal Food, Drug, and Cosmetic Act, and the False Claims Act.

The symposium was an incredible event with truly esteemed speakers. The AUWCL community was incredibly lucky to have such knowledgeable speakers come and offer their expertise. To watch the event and hear further details, please visit: http://media.wcl.american.edu/Mediasite/Play/5a8de06dc577415b84aee30771df3e111d.

On March 30^th, the Blue Cross and Blue Shield Association released a report on their study of those who were newly insured in the private market thanks to ACA reforms – and found that they were sicker, and costlier, than previous enrollees. The report was used by Blue Cross and Blue Shield to explain the premium increases they have asked for, and which many insurance commissioners have approved.  Those offering Blue Cross plans are also asking for certain other aspects of the ACA, such as special atypical enrollment periods, to disappear so that insurance companies can better control when and who signs up for coverage.  It should be no surprise that Blue Cross and Blue Shield companies should want increased premiums and more predictable enrollment periods – 23 of those companies reported a collective $1.9 billion decline in earnings in the first three quarters of 2015 as a result of their inclusion in the ACA national exchanges.

The report analyzed health insurance for 4.7 million Americans across all 50 states that were newly enrolled in 2014 and 2015.  One aim of the study was to find out if the ACA provisions not allowing insurance companies to disqualify people for pre-existing conditions in fact resulted in a sicker group of insureds.  The study found, in fact, newly enrolled insureds had higher rates of high blood pressure, diabetes, depression, coronary artery disease, H.I.V. and hepatitis C.  Diabetes and hepatitis C, in particular, were found to be twice as common among new enrollees, and H.I.V. was more than three times as common.  However, even Blue Cross and Blue Shield recognized that the prevalence of these diseases will shrink in new enrollees as those diseases are treated or even prevented through the insureds’ new healthcare options.  Programs to prevent and treat diseases more effectively are already paying dividends as such programs see fewer hospital admissions, readmissions, and hospital infection rates.  Blue Cross and Blue Shield is using the report not only to justify its premium increases, but to espouse the need for better care management such as making sure those with chronic diseases continue to take their medicine, or that people take advantage of preventative care, like flu shots,  to prevent illnesses that require more expensive treatments.

Another aim of the report was focused on costs and medical service usage.  Among new enrollees, visits to doctors and other medical professionals was 26 percent higher and hospital admissions rates were 84 percent higher.  The increased medical service usage the study observed may also be a result of the policies being more comprehensive, another requirement for private marketplace policies under the ACA.  It could also be the result of new enrollees having put off medical care and making up for it upon being enrolled, which could mean the service usage could flatten out over time.  On the whole, medical costs for new enrollees were 19% higher than employer-based group members in 2014 and 22 percent higher in 2015.

However, increased cost, usage, and pre-existing condition prevalence may be a sign that the ACA is working.  Administration officials, for example, have stated that these figures are signs that healthcare is now reaching vulnerable populations that it had not before, which was the intent of the ACA.  Although costly, the ACA reforms have decreased the number of uninsured citizens and helped close the health insurance gap between lower and higher income Americans.

On March 29, 2015, SB 234 was signed into law making Utah the first and only state in the nation to require that doctors administer anesthesia or analgesic for women who are undergoing abortions at 20 weeks and later in order to prevent fetal pain. In 2015, Montana Governor, Steve Bullock, vetoed a very similar measure.

Those in favor of the law say that the regulation prevents fetuses from suffering during abortions. However, at the center of the debate in the legislature was the scientifically disputed notion that a fetus can feel pain during the procedure. Doctors in Utah and across the United States say there is no proof that fetuses are able to feel anything at that point in the pregnancy. Literature reviews from the Journal of the American Medical Association and the American Congress of Obstetricians and Gynecologists state that fetal pain is unlikely before the third trimester which begins at 28 weeks. Doctors opposing the law further say that sedating a woman during an abortion procedure puts the woman at risk for complications, and that it will interfere with the relationship between a physician and patient.

Senator Curt Bramble, the bill’s sponsor and a CPA with no known medical background, says the purpose of the bill is to protect those who have no voice. Bramble, who originally wanted to ban abortions after 20 weeks, further says that if abortions are going to be at all legal, then doctors must take steps to alleviate pain to the unborn child. However, an OB-GYN and abortion provider in Utah, Dr. Leah Torres, has since emailed the governor because she does not understand what the law is requiring her to do. As ‘fetal anesthesia’ does not exist in standard medical practice, the law does not specify how doctors are supposed to administer anesthesia or analgesic in these situations. When the Montana Legislature proposed a similar law, which was later vetoed, physicians asked similar questions as those doctors were also unsure what exactly was being asked of them.

How safe is anesthesia for the mother? There are three main types of anesthesia: local, regional, and general, though the Utah legislature did not specify which type or how it should be administered. Doctors tend to avoid general anesthesia except in cases where they find it to be absolutely necessary. Dr. Esplin, a Utah doctor who testified at the committee hearing for this law, said, “women having abortions will either be placed under general anesthesia – meaning they’re unconscious and hooked up to a breathing tube – or sedated with a heavy dose of narcotics.” Those opposing the law say that not only is there no benefit for the woman in administering an anesthetic, but it adds an additional risk to the woman’s health.

Based on inconclusive evidence, women in Utah are now mandated to undergo anesthesia to have an abortion at 20 weeks and later, where previously, women were given a choice whether or not they wanted to be anesthetized. Fetal pain is a complicated and controversial topic in science, but the ability to feel pain at that specific point in gestation is, for now, unproven. In absence of scientific evidence proving fetal pain, perhaps such a bill is simply another way to limit abortion access for women.

On March 30^th, doctors at Johns Hopkins announced that they have successfully completed the first liver and kidney transplant from an HIV positive donor. The surgeries were completed a couple of weeks ago and both patients are doing well, one has already gone home and the other is expected to go home soon. The liver and kidney came from the same HIV positive donor and each organ went to two separate HIV positive recipients. The transplant marks the first successful HIV-to-HIV transplant in the United States; similar transplants, however, have been performed in South Africa.

Johns Hopkins is the first U.S. hospital to gain approval from the United Network for Organ Sharing, a non-profit organization that manages the federal government’s organ transplant system. The approval is a big victory for the surgeons, infectious disease specialists, and the HIV advocates who spent years lobbying the federal government to allow the transplants. Since 1988, when Congress amended the National Organ Transplant Act, HIV positive individuals have been banned from becoming organ donors.  The amendment was a response to the AIDS crisis in the 1980s when HIV almost certainly led to AIDS and then death. However, HIV is now a manageable chronic disease and not the fatal public health crisis that it was in 1980s. It was not until the HIV Organ Policy Equality Act (HOPE Act) was passed in 2013 that medical professionals were allowed to begin researching the possibility of a HIV-to-HIV organ transplant.

The HOPE Act and the recent success at Johns Hopkins will give those who are HIV positive a better chance at getting an organ transplant. Prior to the HOPE Act, HIV positive individuals could be organ recipients, but viable organs were being wasted because they came from individuals who were HIV positive. A study conducted before the passage of the HOPE Act estimated that 500-600 individuals infected with HIV could donate organs annually, possibly saving 1,000 lives every year.

There is approximately 122,000 people on the transplant list at any given time and there is a consistent shortage of donors. Although many people who need organs die on the transplant list, individuals with HIV are particularly vulnerable and die even faster than their HIV negative counterparts. HIV-to-HIV organ transplants will benefit both people who are HIV negative and HIV positive. Allowing the transplants will enable HIV positive individuals to get much needed organs faster by utilizing good organs that had previously wasted. It will also benefit people who are HIV negative by shortening the transplant waiting list.

This has all been made possible by the passage of the HOPE Act and the work done at Johns Hopkins. Medical professionals at Johns Hopkins hope to share the protocols they developed with other transplant centers around the country, so that the procedure will benefit many more nationwide.

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.