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.
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.
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.
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/
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.
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].
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.
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.”
According to a recent article published in The Atlantic, the House Committee on Education and the Workforce recently approved H.R. 1313, a bill that would allow employers to pressure their employees to undergo genetic testing and share the results as part of an employer’s “workplace wellness program.” If an employee opts not to share the results, he or she could be forced to pay significantly more for health insurance.
Proponents of the bill note that it simply builds on programs already in place from the Affordable Care Act; however, critics are worried that the bill will take away many of the privacy, discrimination and insurance protections of the Genetic Information Non-Discrimination Act (“GINA”).
From The Atlantic, “The GOP’s New Bill Would Seriously Disrupt Genetics Research”
Excerpt from article:
“‘People are already being discriminated genetically without mandatory genetic testing—that’s what sexism and racism is . . . . This [bill] would result in a higher resolution of discrimination and more individualized ways of targeting people.’ The dark mirror of personalized medicine is personalized discrimination.”
Two recent publications in the Nature Biotechnology journal show that researchers were able to help deaf mice hear again after inserting a gene, Ush1c, into their ears. Initially, the mice were given Usher Syndrome type IC, which also causes deafness in humans. To combat the deafness this caused in the mice, the mice were then given a normal copy of the mutated gene. The mice, who were profoundly deaf, began to hear. This research has important implications for humans with hearing loss, in that approximately half of the cases of hearing loss in humans has a genetic component.
From wired.co.uk, “Biologists help deaf mice hear again by inserting healthy genes into their ears”
Excerpt from article:
“[T]he work – and the field in general – is trying to answer one big question: ‘Can you manipulate the system to cure things that are wrong?’”
Heroin deaths have quadrupled since 1999, making it a bigger killer than guns in the United States. While addiction is a disease that health professionals are familiar with, the average American still believes addiction is a character flaw rather than a chronic disease. Over 20 million Americans have addiction issues and over 12 million abuse prescription opioids. With the number of Americans suffering from drug addiction rising, politicians are paying more attention to this crisis, with Congress recently allocating $1 billion to address the opioid epidemic.
From huffingtonpost.com, “Heroin Deaths Topped Gun Homicides Last Year, Depressing CDC Data Shows”
Excerpt from article:
“It doesn’t take long for prescription use to evolve into misuse. According to a new Washington Post-Kaiser Family Foundation survey, a third of Americans who took a prescription opioid for two months or longer became addicted to or physically dependent on painkillers.”