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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New Genetic Testing Bill: Potential for Progress or Potential for Discrimination?

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.”

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When Defenders Bring Disease: The U.N. Cannot Cure Cholera Crisis After Causing the Epidemic

For more than six years, Haiti has been fighting a Cholera epidemic caused when Nepalese U.N. peacekeepers leaked waste into the water supply. In December, the former U.N. secretary general, Ban Ki-moon, apologized to the country and promised $400 million to help fight the epidemic. However, only a small portion of the goal ($2 million) was raised, with only six of the 193 U.N. members contributing funds. Several countries donated outside of the fund, but the money raised was far from the announced goal.

Experts speculate that the lack of funding may have been caused by competing concerns about other highly publicized emergency situations that required funding and U.N. resources. For instance, the Ebola outbreak in Africa seemed to be of higher interest to donors than the Cholera outbreak in Haiti. The damage from Cholera cannot be ignored, though, with 800,000 people in Haiti affected.

From The New York Times, “After Bringing Cholera to Haiti, U.N. Can’t Raise Money to Fight It”

Excerpt from article:

He finally acted after the organization’s independent investigator on extreme poverty and human rights, Philip Alston, said in a scathing report that the United Nations’ failure to take responsibility for the cholera crisis was “morally unconscionable, legally indefensible and politically self-defeating.”

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Must Doctors Comply with Unconventional Requests of Patients?

A growing interest in “transhumanism” has presented an ethical dilemma for doctors. Individuals, like the bioartist Stelarc, are seeking surgeons who will perform unconventional procedures such as surgically implanting an ear on a forearm. For various reasons, most doctors are unwilling to perform these procedures. However, bioethicist, Francesca Minerva, argues that doctors should comply with these requests as long as they are legal.  According to Minerva, it is not the responsibility of individual physicians, but the responsibility of the government to determine whether or not such procedures are beneficial to society.  She further explains that, until the government makes such determination by promulgating new laws and regulations, denying individuals the opportunity to “enhance” their bodies violates patient autonomy.

From Bioedge, “Is it ethical to refuse a patient surgery for body art?”

Excerpt from article:

‘According to the basic principle of respect for autonomy, patients are entitled to decide if undergoing a certain treatment is in their best interest. And what constitutes one’s best interest is, at least in large part, based on one’s own assessment.’ If a request is legal, an ethical doctor must comply.

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Researchers Restore Hearing in Deaf Mice by Inserting a Normal Copy of the Mutated Gene

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?’”

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Bioprinting Technology May Ease Donor Organ Deficit

Each year, about 120,000 Americans need organ transplants, yet the demand for donor organs far outweighs the supply. The solution: Bioprinting. A 3-D printer is used to dispense different cells, creating layers of cells that form tissue. So far, artificial organs are successfully functioning in animals. Mice, for instance, were able to conceive and give birth by means of prosthetic ovaries.

However, as this new industry emerges, so does the opportunity to capitalize on it. A company in China estimates that the market in America for artificial livers is approximately $3 billion annually. With that sort of potential for profits, larger companies have taken an interest in the future of bioprinting. Well-known companies are making significant progress printing skin for burns and ulcers. A company in Pennsylvania has developed a method to print skin directly onto the patient by spraying stem cells onto the area in need of new skin. Such interest by major companies is advancing this new technology.

From The Economist, “Printed human body parts could soon be available for transplant”

Excerpt from article:

But a lack of suitable donors, particularly as cars get safer and first-aid becomes more effective, means the supply of such organs is limited. Many people therefore die waiting for a transplant. That has led researchers to study the question of how to build organs from scratch.

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