Failed TB Vaccines Raise Questions and Mistrust

Oxford University researchers have been creating and testing the MVA85A vaccine, meant to serve as a booster to the Tuberculosis (“TB”) vaccine. In the course of the research, it was discovered that the researchers falsely portrayed pre-clinical results of the booster in order to gain funding for clinical trials. The researchers misrepresented information in both applications for funding and in information given to parents whose children would receive the booster. They claimed that the booster was both safe and more effective at protecting against TB than the regular vaccine alone. The researchers also falsely claimed that the booster had been safely tested in multiple animal studies, which had never occurred. In fact, researchers at Stellenbosch University in South Africa later performed an animal study and the results did not support use of the booster as a way of increasing the effectiveness of the TB vaccine.

The misrepresentations made by the Oxford University researchers have raised questions about the safeguards in place for pre-clinical research. Unlike the extensive requirements for clinical trials, pre-clinical trials do not have to be registered with appropriate authorities, which increases the likelihood that errors and omissions go unnoticed.  Many believe that a registry should be established for pre-clinical trials to provide proper oversight and ensure that unsafe drugs do not reach the marketplace.

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Former First Lady Barbara Bush Announces Plans to Seek Comfort Care

After battling congestive heart failure and chronic obstructive pulmonary disease, former First Lady, Barbara Bush, has announced that she will no longer seek medical treatment and instead will focus on “comfort care.” Barbara Bush is 92 years old. Her announcement has sparked a debate about end-of-life care and decision-making.

Palliative care experts want to correct any misconceptions that people may have about Mrs. Bush’s decision and specifically want to disprove the “common myth about palliative care [that patients] are being denied medical help.” They explain that palliative care is a patient-centered approach that focuses on reducing a patient’s symptoms and making them as comfortable as possible as they near the end of their lives.

Many praise Barbara Bush for providing an honest perspective on her end-of-life care decision and encourage others to explore their health care options and discuss their wishes regarding palliative care with their health care providers, families and loved ones.

 

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End of Life Care for Individuals with Intellectual Disabilities: Who Decides?

Health care providers must often ask their patients difficult questions about their preferences regarding end of life care. Patients or their legal representatives must ultimately decide how to answer these questions. In some states, however, the answers for patients with intellectual disabilities may be governed by state law rather than patients’ wishes.

Depending on the severity of a patient’s condition, a patient with intellectual disabilities is often deemed to lack capacity to make autonomous health care decisions. Generally, a legal representative is authorized to make health care decisions for such patients. Yet, in some states, the law imposes limitations on the type of decisions a legal representative can make when the patient has an intellectual disability. For example, in New Hampshire, a legal representative of a person with an intellectual disability cannot decline life-sustaining treatment, despite the fact that the patient may have indicated a wish not to receive such treatment. If a legal representative believes that a patient does not wish to receive life-sustaining treatment, the only option to ensure that the patient’s wishes are met is to petition a court to decline treatment, which can be an onerous legal process.

Many advocates for improving patient care believe that such approach can reduce the quality of palliative and end of life care that a patient with intellectual disabilities receives. They argue that states should amend their laws and follow a more patient-centered approach as followed in New York, which recently passed a law that allows legal representatives to withdraw life-sustaining treatment for a patient with intellectual disabilities if there is sufficient evidence to prove that such decision is consistent with the patient’s wishes.

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Will Mississippi’s 15-Week Abortion Law Survive Constitutional Muster?

 

On March 19, 2018, Mississippi Governor Phil Bryant signed an abortion bill into law that some say will likely be overturned. The new law places a ban on abortions after only 15 weeks of pregnancy, making it the shortest gestational age limitation on abortions in the U.S.  The Governor has stated that the law will help make Mississippi the “safest place in America for an unborn child.”  Opponents, however, are arguing that this unprecedented ban is unconstitutional and endangers the health care of women in Mississippi. The Center for Reproductive Rights, among the opponents, is characterizing the law as a “flagrant assault on reproductive rights” and is fighting to have it overturned. Similar laws that have attempted to be passed in other states were all overturned by the court system, which has consistently found that such short gestational age limitations create an undue burden for women seeking to have an abortion and, therefore, violate women’s constitutional right to an abortion.

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“That, With Profound Sadness, Is My Judgment”: High Court in England Rules to Turn Off Infant’s Life Support

Isaiah Haastrup suffered “catastrophic brain damage” at birth due to oxygen deprivation. At 11 months old, the infant was unable to move or breathe on his own, had a low level of consciousness, and did not respond to stimuli. He was placed on a ventilator to help him stay alive. Although Isaiah’s parents wanted to keep him on the ventilator as necessary for his condition to improve, the Hospital where he was being treated believed that his prognosis was weak and improvement was very unlikely. Thus, the Hospital sought legal action to discontinue Isaiah’s life support, despite his parents’ objections.

Justice MacDonald of the High Court in London passed his ruling on the matter with “profound sadness” and held that it was not in Isaiah’s best interest to continue his life-sustaining medical treatment. After the decision, the Hospital stated that it would transfer Isaiah to palliative care and work with and support his parents in ensuring that he obtains appropriate care.

The case echoes that of Charlie Gard who, in July 2017, was also 11 months old, and was terminally ill. His parents wanted to bring Charlie to the United States for an experimental treatment, but the High Courts in London were convinced that his condition would not improve and ordered that Charlie be taken off his ventilator.

 

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Arizona Legislation Raises Constitutional Concerns Regarding Frozen Embryos

After Arizona cancer survivor Ruby Torres divorced her husband, her ability to have children on her own depended on seven frozen embryos she had created with her ex-husband.  Unwilling to financially support a child resulting from one of the embryos, Ruby’s ex-husband opposed her decision to conceive and a family court judge ordered that the embryos be donated to another couple based on a medical agreement that had been signed when Ruby first underwent in vitro fertilization.

New Arizona legislation, SB 1393, could present a solution to the type of challenges that were faced by Ruby and her ex-husband. The bill would remove all financial and parental responsibility from a spouse that does not want a frozen embryo, and would require clinics to store such frozen embryos for 99 years.  While this bill may help women like Ruby use their frozen embryos to have a child, it also raises a number of ethical concerns. Mostly, it could create personal crises-of-conscience for those spouses who do not want a child bearing their DNA to be born with an ex-spouse.  Critics of the bill are calling it a “back-door attempt” to create constitutional rights of personhood for “fertilized eggs, zygotes, embryos, and fetuses.”

 

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Stem Cell Therapies: U.S. Changing Lanes

The U.S. Food and Drug Administration (“FDA”) has been vocal about their efforts to curtail stem cell programs. Yet, in a surprising turn of events, the FDA commissioner, Dr. Scott Gottlieb, and the director of FDA’s Center for Biologics Evaluation and Research, Dr. Peter Marks, have recently co-authored a paper that promotes more accurate research regarding the use of stem cell therapy in medicine. The paper sets forth a detailed plan for assessing the effectiveness of stem cell therapy.

Stem cells have the abilities to mimic other cells in the human body, cells that may not be working properly or at all in patients with various diseases and, therefore, can have significant impacts on the outcome of health. Most promising about Drs. Gottlieb and Marks’ paper is that it opens the door for expanded use of stem cell therapy in the U.S. which was long thought to be closed. In short, it appears that stem cell programs will no longer be given a cold hard “no,” in both the medical and regulatory context.

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Tags: Science, Stem cells, Health, Law, FDA

Federal District Court Issues Injunction Against Trump Administration Exceptions to Contraceptive Coverage Mandate

In October, the Trump administration enacted two rules that expanded an employer’s right to deny women insurance coverage for contraceptive services. The rules offer exemptions to the contraception coverage mandate to any employer that objects to covering contraceptive services due to their religious or moral beliefs. The administration contends that Congress has a “consistent history of supporting conscience protections for moral convictions alongside protections for religious beliefs,” and argues that the contraceptive coverage mandate imposed a “substantial burden” on an employer’s exercise of freedom of religion. However, Judge Wendy Beetlestone of the Federal District Court in Philadelphia disagreed and issued a preliminary injunction on December 15th against the enforcement of these rules.

Judge Beetlestone ruled that the Affordable Care Act contained no statutory provisions that permitted the Trump administration to enact such expansive objections, stating that it is hard to imagine a rule that “intrudes more into the lives of women.” She found legal flaws with the enactment of these rules, including procedural errors under the Administrative Procedure Act. She also explained that these rules would lead to harmful consequences to tens of thousands of women who are at risk of losing coverage.

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Controversial U.K. Policy Withholding Surgery from Smokers and Obese Patients

The United Kingdom’s county of Hertfordshire has expanded a controversial health care policy that withholds surgery from patients who are obese or who smoke. The policy was originally implemented in 2011 and, at the time, only applied to hip and knee operations. In 2012, it was expanded to include other non-urgent routine surgeries. Under the policy, patients were banned from having surgery for a specific period of time as an effort to urge them to improve their health by losing weight or quitting smoking in order to become eligible for surgery. However, the most recent expansion of the policy is labeled as an “indefinite” ban on all routine surgeries until the patient’s health is improved.

Proponents assert that the expanded policy will help patients improve their health while also alleviating the county’s health care budget and reducing length of hospital stays. Opponents, however, argue that the policy is unethical.  One professor of psychology, Robert West, has expressed that “[r]ationing treatment on the basis of unhealthy behaviors betrays an extraordinary naivety about what drives those behaviors.” Although reducing obesity and smoking prior to any surgery is beneficial to a patient’s recovery, it remains unclear whether withholding surgery altogether is actually successful in improving overall health.

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Ethical Dilemmas Presented by the Legal Euthanization of the Mentally Ill

Cornelia Geerts, a fifty-nine year old woman who struggled with mental illness in Belgium, asked her psychiatrist to help her end her own life. In 2014, about one year after her initial request, a physician administered a lethal dose of drugs that killed her. Euthanasia is currently legal in only five countries: Canada, Colombia, Luxembourg, the Netherlands, and Belgium, where Ms. Geerts’ death occurred. Euthanasia is not legal anywhere in the U.S., but six states and Washington D.C. have legalized physician assisted suicide, which allows physicians to prescribe lethal drugs to terminally ill patients for patients to administer themselves. Belgium and Luxembourg permit euthanasia of people suffering from terminal illnesses as well as people suffering from mental illnesses, who may not be at the end of life.

The number of patients euthanized because of psychological suffering makes up a small percentage of euthanization cases in Belgium—of the approximate 2,000 euthanasia deaths that occur per year, only about 40 involve those who were suffering from mental illness. Though these cases are few, they highlight the bioethical dilemmas that physicians and lawmakers face in dealing with mental health issues and an individual’s right to make his or her own healthcare decisions. Advocates argue that individuals suffering from mental illness should be afforded the same rights as those who suffer from a physical illness. Yet, others believe that it is nearly impossible to know when a mentally ill individual decides to end his or her own life with sound mental capacity and not as a result of their underlying mental health disorder. Opponents believe that society has a responsibility to help those suffering from mental illness and to find help through means other than euthanasia.

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