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


Dental Inequality: When Medicaid Isn’t Cutting It

The U.S. Medicaid system has a major gap in coverage for dental care. Although states are required to provide dental benefits for children of low-income families that qualify for state Medicaid benefits, the same requirement is not imposed for adult coverage. Even in states where adult dental coverage is included in the state’s Medicaid program, it is often very limited.

Dental care is an essential part of health care that is often overlooked and undervalued. Poor dental hygiene can worsen other pre-existing conditions. Oral infections, for example, can contribute to heart disease and stroke. Advocates are pushing for better dental care coverage as an effort to improve overall public health and wellbeing. Studies have found that when Medicaid covers dental care, the number of dental visits can increase by 22%.

Advocates also worry, however, that as the Trump Administration proposes additional cuts to state Medicaid programs, any possibility of increased dental coverage will be the first to go.

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Tags: Health, News, Dental, Medicaid

The 21st Century Family Tree – Rising Concerns of Ancestral DNA

In recent years, ancestral DNA kits have become increasingly popular, and with decreasing costs these products have become readily accessible. Although the idea of uncovering genetic makeup is tempting to many, bioethicists have concerns about these products.

The potential risks of obtaining and sharing genetic information are not fully disclosed to consumers.  In a study published in the European Journal of Human Genetics, it was noted that the privacy policies of genetic testing companies are “murky” and fail to sufficiently inform consumers that they could receive “unexpected information.” For example, when an unexpected step-brother was identified through “George Doe’s” genetic testing results, the bombshell to the family resulted in the divorce of his parents. As these tests are accessed by more people, bioethicists foresee more “George Doe” stories.

An even greater concern is privacy. Although the companies generally allow consumers to choose whether or not to share their genetic and personal information in information-sharing databases, there is no guarantee that the information of one individual will not be indirectly identified through a relative’s genetic submission. Without appropriate privacy safeguards in place, there are real concerns that “humanity is on the verge of learning a lot of life-altering information that it can’t unlearn.”

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The Costs of Protecting Religious and Conscience Rights in Health Care

President Trump’s new push to have a government-wide enforcement of conscience protections in healthcare may cost the healthcare system over $300 million to implement and an estimated $125 per year to maintain in following years.  The cost to the government is estimated at $900,000 per year.  The “right of conscience” refers to the rights of healthcare professionals to refuse care to patients based on the clinicians’ personal and religious beliefs.

Prior to Trump’s election there was, on average, one complaint filed per year that alleged a violation of conscience and religious rights. Since his election, this number has increased to over 40 complaints each year.  Traditionally, issues of conscience and religious objections have been reserved for healthcare facilities to handle internally. However, some workers claimed that such internal resolutions were often ineffective, and they were forced to participate in certain procedures despite their objections.  The government’s new enforcement efforts raise concerns not only about costs, but about whether they will provide an avenue for doctors to discriminate against patients and deny necessary care on the alleged grounds of conscience and religious objections.

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What Will Your Genome Sequence Say About You?

Scientists have created a handheld device no bigger than a smartphone that is capable of sequencing the human genome in a matter of minutes. The device will allow users, including physicians, hospitals, and individual patients, to quickly decode genomes and apply the results in patient care.

In the short term, the device can promote patient-centered care that is tailored to a patient’s individual needs and genetic composition. However, researchers also hope to use the decoded genomes obtained from the device to better understand how genetic sequencing affects overall public health. Even though the human genome has been successfully decoded, much remains to be learned about various aspects of the genome sequence.

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Freedom in Gender Identity in the State of Washington

The New Year in the State of Washington brings a positive change for the LGBTQ community. Effective January 27, 2018, Washington residents who do not identify with the male or female gender will now have the option to change their birth certificate and have an “X” displayed as their gender. For adults, this change can be made without the approval of a physician. Minors will need to provide consent from a parent or legal guardian as well as additional documentation from a physician.

Advocates believe giving non-binary individuals this freedom to choose gender “X” will reduce discrimination and harassment associated with a physical appearance that does not match the gender displayed on identifying documents. Oregon and California have similar policies on their agenda to take effect in 2018, and it is the hopes of advocacy groups that other states will follow suit.

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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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DNR Tattoo Raises Questions on How Patients Can Effectively Convey Their Health Care Wishes

A Florida man was brought to the emergency room of Jackson Memorial Hospital in an unconscious state.  He had a “Do Not Resuscitate” tattoo on his body, which contained his signature.  The Hospital’s ethics committee decided that the tattoo was an accurate representation of the man’s wishes and decided to honor them (i.e., by not preforming resuscitative measures).  Later, the hospital located a copy of a formal DNR-order consistent with the man’s tattoo.  Although in this case the DNR-order was consistent with the tattoo, and actions already taken by the Hospital with respect to the man’s end-of-life wishes, the case raises ethical questions as to how patients can convey their end-of-life wishes effectively. Hospitals and physicians also question how they can mitigate the risk that a tattoo, or similar conveyance of end-of-life wishes that falls short of legal requirements for such advanced directives, is in fact inconsistent with what the patient would want. Many advocates suggest implementing a statewide online database for all advanced directives to be located in one easily-accessible location. Using such database would allow physicians to quickly identify whether a patient has an existing advanced directive in place. Oregon is currently one of the few states that have such database in place.

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To Donate or Destroy: Embryo Donation Practices in Australia Shed Light on Ethical Dilemmas

Embryo donation raises a series of challenges. In Australia, the market for embryo donation is comprised of high demand and low supply. In addition, embryos cryopreserved for future reproduction are only kept frozen for a maximum of ten years; then the family must decide whether to destroy or donate the embryos. However, there is no legislation in Australia to direct this decision or to protect the interests of families who choose to donate.

While the thought of destroying an embryo feels unethical to many individuals, the decision to donate may not seem acceptable either. Australian law prohibits anonymous donations and presumes that, at the age of 18, a person is entitled to know the identity of those who donated gametes from which he or she was conceived. Yet, Australia has no legislation that requires people who conceive using donated embryos to inform their children of the embryos’ origins or to inform the donors about the children their embryos helped conceive.

Although the law does not clearly protect the interests of donors, some Australians have found positive experiences when deciding to donate rather than destroy their embryos. Koby and David Argall, for example, explain that the possibility of an embryo staying “frozen in time” was not an option for them and believe that the decision to donate is one of the most important and positive decisions an individual can make.

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New York Approves Use of Medical Marijuana for PTSD Treatment

New York has become the latest state to legalize medical marijuana for treatment of post-traumatic stress disorder (“PTSD”). New York will join 28 states and the District of Columbia which have already approved such use of medical marijuana. The news was widely celebrated by many veterans groups who have found their current treatments too severe or ineffective.

Veterans groups also hope this trend in state law will motivate change in federal law, which currently prohibits physicians engaged by the U.S. Department of Veteran Affairs from prescribing medical marijuana to veterans for PTSD. Some commentators contend that evidence on the efficacy of medical marijuana has been inconclusive and therefore, the legalization of such treatment is premature, but clinical trials assessing the effectiveness of medical marijuana in treating PTSD are ongoing.

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