The Institute of Medicine has concluded that it ethically permissible to create “three-parent babies” in clinical experiments as long as certain guidelines are followed and limited to boys only. The FDA must now decide whether to allow the experiments to move forward.
These babies result from a procedure known as mitochondrial replacement therapy, mitochondrial transfer or three-person IVF. The technique aims to prevent rare genetic diseases that cripple energy-producing mitochondria from being passed from a mother to her child.
Mitochondrial transfer is already legal in the United Kingdom. But the U.S. Food and Drug Administration requested that a panel convened by the Institute of Medicine investigate whether ethical considerations should prevent clinical studies in the United States.
For the procedure, researchers extract and discard the nucleus of a donor egg containing healthy mitochondria and then insert the nucleus from a mother’s egg. Sperm from the father fertilizes the egg, creating an embryo in which the bulk of the genetic information come from the mother and father, but a small amount of DNA comes from the donor’s mitochondria.
In a report issued February 3, and summarized in the journal Science, the IOM panel concludes that it is ethical to conduct the experiments, but recommends limiting the technique to making baby boys. That would prevent “germline modification” of future generations because mitochondria are usually inherited from the mother. The committee also recommends the technique be limited to women with serious mitochondrial diseases, and that regulators should take the mother’s health and the expertise of the scientists into account before approving studies.
The British Fertility Society is now recommending that anyone who has traveled to areas impacted by the Zika Virus should avoid trying to conceive naturally, donate sperm or eggs or undergo fertility treatments for 28 days.
In addition, the Centers for Disease Control has recommended that pregnant women postpone travel to places affected by Zika and to abstain from sex or use condoms if their “male sexual partner has traveled to or lives in an area with active Zika virus transmission.”
There are also now reports that active Zika virus has been detected in saliva and urine according to Brazilian scientists. It is important to note that this does not mean the virus can be readily transmitted through these bodily fluids.
The CDC has updated their guidelines to include:
Pregnant women without symptoms of Zika infection can be offered testing two to 12 weeks after coming home from Zika-affected areas.
Pregnant women who have symptoms consistent with Zika should be tested when they’re ill.
Pregnant women who are not experiencing symptoms consistent with Zika virus can be tested when they begin prenatal care. The agency also says follow-up testing can be considered in the middle of the second trimester, because exposure to the virus may pose an ongoing risk.
Pregnant women should receive routine prenatal care, including an ultrasound during the second trimester. The woman’s health care provider may choose to perform an additional ultrasound to check the fetus for microcephaly.
Doctors should talk to women of childbearing age about strategies to prevent unintended pregnancy when Zika is a risk, including approaches to family planning and the correct and consistent use of effective contraceptive methods.
Local public health officials should develop their own guidelines, based on the local risk of Zika transmission and other factors.
For attorneys practicing in the field of assisted reproduction, I strongly encourage you to advise your clients of these risks. As part of our practice, we are now requiring that all clients (whether preparing to undergo an ART procedure or currently pregnant) execute a Zika Virus Acknowledgment that full describes the risks posed by this virus, and to immediately consult with their Reproductive Endocrinologist and/or Obstetrician. Further, this Acknowledgement should obligate all parties to a surrogacy, egg donor, sperm donor or embryo donation agreement to adhere to medical recommendations so as to avoid exposure this virus, including but not limited to restricting travel, using condoms and practicing safe sex.
Rumors of a settlement of the class action lawsuit initiated by an egg donor asserting claims of price fixing and unfair competitive business practices against the American Society of Reproductive Medicine and industry professionals appear to be accurate according to the Wall Street Journal. Worth noting that these guidelines have been largely ignored over the past several years:
The nation’s leading professional association of fertility specialists has reached a settlement with a group of women who claimed the medical group’s guidelines on human egg donor prices violated federal antitrust laws.
Two women who provided eggs to couples struggling with infertility sued the American Society for Reproductive Medicine in federal court in San Francisco in 2011, claiming that the group artificially suppressed the amount they can get for their eggs. Two other women later joined the case.
The medical group agreed to delete provisions in its guidelines concerning egg donor compensation, according to the proposed settlement filed in court last week. It also agreed to pay plaintiffs’ lawyers $1.5 million in fees and costs. The four named plaintiffs would also receive $5,000 each. The settlement needs court approval.
As WSJ’s Ashby Jones earlier reported, the lawsuit challenged egg fee guidelines established by the organization more than a decade ago. The group, which represents fertility specialists, suggested that payments for donated human eggs should not go above $5,000 without justification, and said that payments greater than $10,000 went “beyond what is appropriate.”
The price guidelines aren’t mandates. But more than 90% of the nation’s clinics belong to the society, so they’re widely followed.
Industry groups behind the price guidance say caps are needed to prevent coercion and exploitation in the egg-donation process. But the plaintiffs claimed the guidance amount to an illegal conspiracy to set prices.
Under the terms of the settlement, which still needs final court approval, ASRM agreed to delete some language from the guidelines. According to the proposed settlement:
ASRM will amend the challenged report concerning donor compensation by removing numbered paragraph 3 (which reads “[t]otal payments to donors in excess of $5,000 require justification and sums above $10,000 are not appropriate.”) and by removing the following language from page 4: “Although there is no consensus on the precise payment that oocyte donors should receive, at this time sums of $5,000 or more require justification and sums above $10,000 are not appropriate” and “A recent survey indicates that these sums are in line with the practice of most SART member clinics.”
Law Blog has sought comment from lawyers representing the medical group and the plaintiffs.
“We are pleased that we have been able to reach an agreement with the defendants that, in our view, will benefit the class by removing a compensation guideline that plaintiffs alleged violated the antitrust laws,” Ellen Meriwether, an attorney at Cafferty Clobes Meriwether & Sprengel LLP who represented the plaintiffs, told Law360, which reported on the settlement.
Fascinating look at how restrictions on abortions may be contributing to the spread of the Zika Virus:
The El Salvadorian government have a questionable solution to preventing the spread of the mosquito carried virus. Unpicked in its most simplistic form, the message seems to be: “While we try to kill all mosquitos, or come up with a way to genetically modify them, we suggest you do not have sex for two years”.
A combination of anti-abortion laws and inadequate access to contraception means this ‘solution’ is simply not feasible. While people inevitably continue to have sex, and anti-abortion laws persist, the Zika virus will ultimately continue to spread.
Anti-abortion laws are, unsurprisingly, ineffective. With the availability of illegal backstreet abortion clinics, we have to question whether the Zika epidemic will force more vulnerable women to risk their lives as it spreads throughout the Americas. The virus seems to cause severe birth defects, such as microcephaly, that can dramatically alter its victim’s quality of life. So given the circumstance, it is unsurprising that those women whose foetuses are affected may consider a termination.
The lack of knowledge surrounding a diagnosis like microcephaly will only makes matters worse for parents left in the dark, questioning whether their newborn child will ever be able to walk or talk.
Anti-abortion laws tend to have loopholes. The United Kingdom, as one example, offers NHS abortion services for international patients living in regions where terminations are illegal. So essentially, providing you can afford a plane ticket, medical bills and some form of shelter for a few nights, the procedure is not as inaccessible as governments tend to make out.
Nevertheless, there is an underlying bleakness to this opportunity. In the classic nature of capitalism, the less well-off are once again penalised by financial restrictions not enabling them to jet off across the Atlantic. As Human Rights Watch advocates, “safe abortion services are first and foremost a human right”.
An unwanted pregnancy can pose difficult emotional obstacles for women facing the prospect of a life, far from how they imagined it. Studies have shown, for example, a positive correlation between unwanted pregnancies and an increased risk of postpartum depression. A rise in infanticide – by deliberate neglect – is a possible imminent threat facing regions where abortion is prohibited and Zika fever is on the increase.
In the face of a health epidemic, it is more important than ever for the Americas to reanalyse their laws on abortion. While the virus is uncontained, it is inevitable that newborns affected by Zika will continue to be born with severe health defects. And attempting to avoid this by advising that couples simply stop having sex until some unknowable time in the future when a vaccine or similar medical interventions can be developed is simply nonsensical. With the timescale this unsure, it could end in politicians asking an entire generation not to procreate because of the risk.
Troubling news from the Centers for Diseases Control and Prevention (CDC) which has reported the first case of the Zika virus being transmitted not by mosquito bite, but through sexual contact:
The first case of a sexually-transmitted Zika virus, the infectious disease spreading quickly across the Americas, has been confirmed by the Centers for Diseases Control and Prevention (CDC) in Dallas County, Texas.
Previously believed to only be transmitted through mosquito bites, Zika has already been labeled a “global emergency” by the World Health Organization (WHO) and has inspired governments to act quickly to direct funds toward eradicating the virus.
The virus, which first entered the Americas in 2014 through Brazil, has been linked to underdeveloped brains in newborn babies, which prompted some Latin American countries to recommend women hold off getting pregnant for at least two years. However, all of these countries offer little access to birth control and have strict laws about obtaining an abortion. With the new knowledge that Zika can be transmitted through sex, there may be additional pressure on governments of all sizes to ramp up access to contraceptives and reproductive health information.
Dallas County health officials said that a patient was infected after having sexual contact with a person who had recently traveled to a country where the virus is present.
“Now that we know Zika virus can be transmitted through sex, this increases our awareness campaign in educating the public about protecting themselves and others,” said Zachary Thompson, Dallas County health director. “Next to abstinence, condoms are the best prevention method against any sexually-transmitted infections.”
There is currently no vaccine to avoid contracting the virus, which is undetectable in 80 percent of the people who are infected. Currently, the CDC recommends people “avoid mosquitoes” and steer clear of the countries currently battling the infection on a larger scale.
In addition to the obvious health risks, anyone proceeding with a 3rd party reproductive arrangement ought to consult with their Reproductive Endocrinologist, Obstetrician and attorney regarding what additional precautions that can and should be taken to minimize transmittal of the virus. Among other things, we strongly recommend amendments to any reproductive contract identifying this new risk and the safeguards that must be taken.
Given weather related issues, California, Maryland Rhode Island and Washington, D.C. have extended their open enrollment windows to purchase an Affordable Care Act (ACA) policy:
During the first two open enrollment periods, Healthcare.gov and most of the state-run exchanges extended the final deadline for enrollment. This time around, Healthcare.gov did not extend enrollment, other than to help people complete enrollments that were begun by midnight on January 31.
Just four state-run exchanges announced open enrollment extensions, and at least two of them only apply to people who began their enrollments by January 31:
Maryland: The exchange tweeted that anyone who begins the process by January 31 but is unable to finish on time due to the recent snowstorm, will have until February 5 to complete the enrollment. Enrollments had to be started by January 31, and enrollees must attest that the January blizzard interrupted their ability to finish enrolling by the end of January.
California: The exchange issued a press release stating that anyone who begins the process by January 31 but is unable to finish on time will have until February 6 to complete the enrollment.
Washington DC: Due to the blizzard on the east coast in late January, the DC exchange is giving all residents an additional two days to enroll. The new deadline is February 2 at 11:59pm. Enrollments completed by February 2 in DC will have coverage effective March 1.
Rhode Island: The exchange has a notice on their home page, indicating that people who weren’t able to get through to the call center have until February 8 to enroll. It’s unclear whether this applies to everyone, or just to people who began the enrollment process by January 31. We’ll update this page as more information becomes available.
Major kudos to President Obama for this new Department of Defense policy, which is certain to outrage many on the right who only care about our troops when it serves their political interests:
When Defense Secretary Ash Carter addressed changes to maternity and paternity leave Thursday, he also announced that the Pentagon will start covering sperm and egg freezing for troops who want to preserve their gametes for future use. The action, a part of the Force of the Future initiative, also improved child care services.
Carter said the Defense Department will launch the pilot preservation program and promised to explore widening the department’s coverage of fertility services. “We can help our men and women preserve their ability to start a family, even if they suffer certain combat injuries,” said Carter. “That’s why we will cover the cost of freezing sperm or eggs through a pilot program for active-duty service members.”
According to Carter, the benefit will be offered to any service member who requests it as well as troops anticipating a deployment. He added that the egg- and sperm-freezing program not only will give troops who deploy “peace of mind,” it also will provide “greater flexibility” for service members to decide when they want to start a family. “We can help our men and women preserve their ability to start a family, even if they suffer certain combat injuries.”
“For women who are midgrade officers and enlisted personnel, this benefit will demonstrate that we understand the demands upon them and want to help them balance commitments to force and family. We want to retain them in the military,” Carter said.
The majority of military personnel are in the prime of their child-bearing or fathering years: Nearly half of all enlisted personnel are under age 26, with the next largest group, 22%, being ages 26 to 30. More than 42% of officers are between the ages of 26 and 35, according to Defense Department data.
Women made up 15% of the active-duty force of 1.3 million in 2014.
More than 1,300 veterans of Iraq and Afghanistan suffered injuries to their groin regions and genitalia that would require advanced reproductive surgeries.
While I echo this call, it will likely fall on deaf ears as politicians will do what politicians do and this committee is agenda driven. Also, the ramifications of this investigation could lead us down a very slippery slope and potentially even bring an end to embryo donation as we know it:
In the wake of a Texas grand jury’s indictment of two anti-abortion activists instead of Planned Parenthood after a months-long investigation, reproductive-rights advocates are calling for a redirection of a Congressional panel convened last year to examine U.S. practices around abortion and fetal-tissue donation.
The panel was established by House Republicans in October 2015 as the Select Investigative Panel on Infant Lives. (Democrats, too, have little taste for sublety, calling the panel a “Select Committee to Attack Women’s Health.”) After several Congressional committees failed to find reason to defund Planned Parenthood in several hearings prompted by the Center for Medical Progress’s undercover videos, the select panel was formed to probe further. The panel was backed by $300,000 from a reserve fund to pay for the panel’s activities through Jan. 2, 2016, but its work continues.
The great thing about a grand jury investigation is that its members get to hear from both sides. The Congressional hearings never called on David Daleiden, Sandra Merritt, or other CMP members to testify about the making of the videos that inspired the investigation in the first place; by contrast, the Texas grand jury was able to consider actual evidence about their tactics. Though it was tasked with investigating Planned Parenthood, the jury found reason to charge Daleiden and Merritt with tampering with a governmental record; Daleiden, the jury decided, deserved an additional charge of violating a ban on the purchase and sale of human organs. Congress now has more concrete reason to believe that anti-abortion activists are trying to buy and sell fetal body parts than it does Planned Parenthood.
Last week, the Feminist Majority Foundation joined with Rep. Donna F. Edwards (D-MD), the National Organization for Women, and Planned Parenthood of Metropolitan D.C. to recommend that the House panel either disband or change its focus to the anti-choice extremists behind the rising harassment of and violence against abortion providers. FMF president Eleanor Smeal says Monday’s indictment of Daleiden and Merritt is even more reason for Congress to listen. “[CMP’s] vilification and harassment and false representation works people up and crates a climate in which violence ensues,” she said in a phone conversation. “They’re emboldened to say anything they want, whether its true or not.” Smeal sees a direct link between CMP’s anti-abortion rhetoric and fatal attacks like the November 2015 murders at a Planned Parenthood in Colorado Springs, where the shooter justified his attack with language cribbed from the CMP videos: “No more baby parts.” If the videos warrant a federally funded investigation into Planned Parenthood and other abortion providers, the video’s makers and its effects deserve a similarly rigorous investigation.
But Texas Governor Greg Abbott and Attorney General Ken Paxton performed the public-relations equivalent of sticking their fingers in their ears and humming when they heard the grand jury’s decision earlier this week, insisting that the state’s other ongoing investigations into Planned Parenthood will continue. “The fact remains that the videos exposed the horrific nature of abortion and the shameful disregard for human life of the abortion industry,” Paxton said.
Meanwhile, the district attorney who launched the Texas grand jury probe said she respected the jury for following “where the evidence [led] us.” The Congressional panel could and should do the same. “What we think Congress should do is follow the evidence,” Smeal said. “I’m hoping this is a break for people to say, ‘Wait a minute, we should be suspicious when so many people are telling us these are false accusations.’”
I am ashamed to confess that a long time ago, I was a Republican. I still remember Ronald Reagan’s reference to America being a shining city upon a hill whose beacon light guides freedom-loving people everywhere. Now we have the leading GOP candidate for President retweeting a notorious Neo-Nazi’s racist propaganda. This is the same White Supremacist who has an animated picture of Donald Trump dressed as a Nazi, about to gas Sen. Bernie Sanders, who is Jewish.
We are certainly not fulfilling our duty to leave a better world for our children. Beyond shameful and I hope the GOP condemns Trump for this. But I am not holding my breath.
Not my thesis but the argument of two prominent bioethicists in addressing the issue of organ donation: Is it morally wrong to kill people? Not really, argue two eminent American bioethicists in an early online article in the Journal of Medical Ethics. Walter Sinnott-Armstrong, of Duke University, and Franklin G. Miller, of the National Institutes […]
Blogging about the legal, social and political issues of the day with an emphasis on reproductive rights and bioethics.