Catholic Health Services Provider Faces Lawsuit for Denying Transgender Surgery

Seventeen year old Paxton Enstad, a transgender male, sought chest-reconstruction surgery as part of his gender dysphoria treatment.  When his parents, Cheryl and Mark Enstad, sought to obtain pre-authorization for the surgery, PeaceHealth St. Joseph Medical Center, a Catholic organization, denied the services without offering a rationale as to why it was denied.

The Enstads filed suit in U.S. District Court, claiming that PeaceHealth’s refusal to cover the services violates the Affordable Care Act (“ACA”) and the State of Washington’s anti-discrimination laws.  Specifically, they claim that the refusal to authorize the surgery enforces gender stereotypes and amounts to gender discrimination.

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Read Complaint Here.

 

 

 

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Healthcare Advocates Push for Improvements in Advance Care Planning

Advanced directives, such as a health care proxies, promote quality health care by allowing individuals to leave specific instructions on how others should make medical decisions on their behalf in the event they lose capacity to do so themselves. Yet, nearly two-thirds of Americans do not have an advanced directive in place, and even those that do are at risk that their advanced directives will not be easily located when needed, as most are not recorded electronically.

Currently, the Centers for Medicare and Medicaid Services (“CMS”) reimburses health care providers for discussing advance care planning with their patients, but advocates are pushing for additional measures that would encourage a greater dialogue about end-of-life care, promote the execution of advanced directives, and ensure that advanced directives are readily accessible to providers and health care proxies. Most recently, a bipartisan bill was introduced in legislature that would require CMS to pay Medicare beneficiaries a nominal amount in exchange for writing and electronically recording advanced directives. Advocates hope that the payment would encourage more individuals to execute advance directives. In addition, CMS would maintain all such documentation online and would ensure that it can be accessed by providers and health care proxies as necessary.

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The National Institute of Health’s Path to “Precision Medicine” and the Barriers Associated with the “All of Us” Study

In connection with a data-gathering experiment known as “All of Us,” the National Institute of Health (NIH) is seeking a pool of over 1 million participants. NIH hopes that at least half of the participants will be made up of individuals who have historically been underrepresented in research studies, including certain minority communities. NIH believes this study can pave the way for “precision medicine,” a more personalized type of medicine with treatments based on a person’s genes. However, due to historical mistrust of researchers by minority communities, NIH knows that it has a challenge ahead to encourage underrepresented individuals to participate in the study.

From Stat News, “To advance medicine’s future, the NIH tries to win the trust of communities mistreated in the past”

Excerpt from article:

“People are afraid of being experimented on . . . Researchers know it won’t be easy to find hundreds of thousands of people who have little reason to let the government sequence their DNA but who might be willing to take a chance for a healthier future for their children.”

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Tags: National Institute of Health, NIH, All of Us, Tuskegee, Henrietta Lacks, mistrust, minorities, minority communities, revolution in healthcare, health research, biomedical research, healthy futures, precision medicine

The Risks of Antidepressants: Suicide and a Lawsuit for Inadequate Labeling on Pharmaceutical Drugs

Stewart Dolin began to take an antidepressant called Paxil five days before he committed suicide. His wife, Wendy Dolin, who had noticed a change in his behavior when he started taking the drug, remembers her husband being abnormally agitated in the days prior to his death. Ms. Dolin alleged that a side effect of Paxil, called akathisia, played a role in his decision to commit suicide. Akathisia brings on a state of acute physical and psychological agitation. Ms. Dolin sued the manufacturer of Paxil, GlaxoSmithKline, claiming that the company had not sufficiently warned of the dangerous side effects.

Evidence that surfaced during the trial brought to light results of early clinical trials conducted on Paxil in 2006. According to the studies, “the frequency of suicidal behavior was higher in patients treated with paroxetine compared with placebo” among adults of all ages with major depressive disorder. Though the label on Paxil had once reflected the risk to adults of all ages, the newer label only stated that the increased risk was seen among people under 25 years old. Both labels failed to capture, however, was the true magnitude of the heightened risk. The frequency of suicidal behavior in patients being treated with Paxil was found to be 6.7 times higher than the frequency for those being treated with the placebo. There have also been studies that have found a correlation between akathisia and suicidal behavior.

Ms. Dolin was successful in her lawsuit against GlaxoSmithKline, and a jury awarded her $3 million dollars in damages. This verdict is particularly unusual, as many lawsuits involving suicides are either dismissed or settled outside of court; it serves as a stark reminder to pharmaceutical companies that labels on antidepressants must adequately reflect the risks associated with them.

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Ms. Dolin started an organization called The Medication-Induced Suicide Prevention and Education Foundation (Missd) in memory of her husband and to raise awareness of akathisia. You can learn more about Missd at:  http://missd.co/

 

 

Opinion: House Approves Bill that Defies Basic Standards of Medical Ethics

by Michael S. Dauber

On May 4th, 2017, the Republicans in the U.S. House of Representatives voted to pass the American Health Care Act, an Act that, if enacted into law, would repeal and replace many central elements of the Affordable Care Act, commonly known as Obamacare. The measure has received widespread criticism from many Democrats and from professional medical associations such as the American Medical Association and the American Cancer Society. Many people have questioned various parameters of the bill. This article questions it from an ethical perspective, and in particular, the potential consequences of abandoning health care protections designed under Obamacare to ensure that the most vulnerable people in society receive the care that they need.

The American Health Care Act would strip away protections that have facilitated access to care for pregnant women, patients with disabilities, patients that cannot otherwise afford health care, and patients with pre-existing conditions. While any attempt to discriminate against the sick and needy is unjustifiably wrong, the Act appears to directly target members of groups that are defined as most vulnerable and in most need of protection under most formulations of ethical practice.

For example, the Act would allow states to opt out of Obamacare requirements that prohibit insurers from charging patients with pre-existing conditions higher premiums for health insurance. It further classifies pregnant women, women who have had C-sections, and victims of domestic violence and sexual assault as patients with pre-existing conditions. It also targets elderly patients by allowing insurers to charge elderly patients up to five times as much as members of younger age brackets. Currently, under Obamacare, insurers cannot charge the elderly more than three times the amount they charge younger patients. The Act also includes plans to gradually eliminate $880 billion in Medicaid funding over the next ten years, funds that could have otherwise been utilized to extend coverage to low-income families.

In short, the Act specifically targets some of the most vulnerable members of society who might suffer immensely without health care and who may not be able to afford to pay the costs that many insurers may demand, or may be unable to pay for other essential expenses after paying their insurance premiums. Ahead of the vote in the House of Representatives, Senator Bernie Sanders called the Act “an abomination” and, in a CNN interview with Anderson Cooper, Sanders said, “thousands of Americans would die because they would no longer have access to health care.” Proponents of the Act argue that it is engineered to reduce the burdens of health care cost on the government and on insurers. Yet, the overall effect will be a higher cost for patients. Many patients will suffer and will lose their access to care because of circumstances beyond their control.

In this regard, the Act conflicts with basic principles of contemporary bioethics.  For instance, the Belmont Report (1979), as a blueprint for ethics in human subject research, stresses the importance of respect for the “dignity of persons” while ensuring protections in accordance with justice. The Belmont Report, though focused on ethics in human subject research, has become a defining document in the history of medical ethics, establishing a system in which patients must be respected and special protections must be given to members of vulnerable populations. If a patient falls into a protected class, health care providers have an ethical obligation to ensure that the patient receives the care he or she needs and that the patient is not denied care solely on the basis of disability, economic status, or prejudice against specific medical conditions.

There is an apparent conceptual link between commitment to protecting vulnerable populations in the clinical and research context and commitment to ensuring that vulnerable populations have access to care. The American Health Care Act has not yet become law. It must first obtain approval in the Senate and be signed by the President. Most recently, the Senate decided to modify the bill before voting on it and, as a result, the bill must be sent back to the House for a second vote. As the Senate prepares its own version of the bill, government officials should recognize that a policy that effectively precludes access to health care for members of vulnerable populations is unethical by virtually every principle of medical ethics.

Heterologous Embryo Transfer Poses Novel Legal Questions

Heterologous Embryo Transfer (“HET”) occurs when a woman, unable to conceive a child, has a genetically unrelated embryo implanted. This form of surrogacy, which has been used for over 30 years, is now being complicated by the trend of embryo adoption.

There are often surplus embryos left over when a couple uses assisted reproductive technology, such as in vitro fertilization. In certain situations, the couple will allow the surplus embryos to be adopted by another couple. However, this raises novel legal questions if an issue of custody arises. There is neither legislation nor court precedent addressing what would happen if the biological parents sought custody from the second couple. As embryo adoption continues to increase, there will surely be legal battles over this.

From huffingtonpost.com, “Heterologous Embryo Transfer: A New Frontier in Parenting”

Excerpt from article:

Bringing a child into the world by traditional means is a process fraught with moral, ethical and emotional complications. Bringing a child into the world by non-traditional means, such as heterologous embryo transfer (HET) increases the complications exponentially, begging questions such as what defines a parent (genes, love, pregnancy and delivery, etc…) and who does the child belong to?

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Tags: Bioethics, pregnancy, parenting

Opioid Epidemic: Lawmakers Seek Answers from Manufacturers

In a response to the growing opioid epidemic, the Senate will question five of the biggest opioid drug manufactures.  The Senate is looking for reports regarding marketing practices that may have underplayed the seriousness of opioid addiction.  Some of the allegations include misrepresentation about addictiveness of certain drugs.

From CNBC, “Opioid epidemic: Senate committee opens probe of five big painkiller makers:

Excerpt from the Article: “The investigation will explore whether pharmaceutical manufacturers — at the head of the opioids pipeline — have contributed to opioid over-utilization and over-prescription as overdose deaths in the last 15 years have approached nearly 200,000,” said a press release announcing the probe.

 

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An Increasing Demand For The Right-To-Try

In recent years, thirty-three U.S. states have passed “right-to-try” laws aimed at increasing access to experimental treatments for terminally ill patients. Many such patients feel it is their right to try experimental medications, which have not been fully approved by the Food and Drug Administration (“FDA”) and are otherwise unavailable. On the other hand, some doctors and medical ethicists stand firm in their belief that FDA procedures and clinical trial processes should be adhered to as they were put in place for good reason – to ensure that drug manufacturers are producing a safe product. Furthermore, some argue that “right-to-try” laws do not expand patients’ access to effective drugs since pharmaceutical companies are not obligated to distribute experimental medications.

Excerpt from Article:

Right-to-try laws offer patients an alternative to the compassionate-use, or expanded-access, program the FDA has had in place for more than two decades. As many as 1,821 applications are filed each year, and about 99 percent of them are approved, according to the [FDA].

 

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Use of Social Media to Recruit Participants in Clinical Trials Raises Ethical Concerns

Difficulties faced by researchers in recruiting participants to clinical trials has resulted in the increased use of social media as a research tool. Although recruitment through social media is akin to traditional methods in many aspects, online recruiting raises several additional ethical and regulatory issues, such as privacy concerns and online security risks. However, little guidance has been provided to investigators and Institutional Review Boards to facilitate the review and use of social media as a recruitment mechanism. In light of the many benefits this form of recruitment has to offer to increasing participation in clinical trials, Harvard scholars published an article in the American Journal of Bioethics, offering practical recommendations to assist investigators and Intuitional Review Boards with the implementation of explicit policies for social media recruitment.

Excerpt from Article:

One issue that is specific to the online platform in regards to transparency is whether investigators are required to let people know that they are collecting data. Depending on the nature of the research study, investigators could reasonably obtain information just by “lurking” on the group page. 

 

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Making Health Insurance More Portable: GOP’s Plans for Insurance

In an article dated February 28, 2017, the author discussed a GOP plan to make health insurance more portable by allowing consumers to take their plans with them if they move, retire, or change jobs.  Although a popular idea for many, it does present some structural concerns due to the  setup of insurance markets and networks.

From NPR, “What If You Could Take It With You? Health Insurance, That Is”

Except from the article:

“To be truly portable, consumers must be offered plans regardless of their health status, age or other considerations. Before the health law was enacted, insurers could reject people with medical conditions. But the ACA prohibits insurers from redlining sick people or charging them higher premiums. Although popular in opinion polls, those Obamacare provisions may face some changes under the GOP plans.”

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