Endocrine Ethics Blog

The biggest bioethics story of the year, topping off the 200^thanniversary of the publication of Frankenstein (see: https://frankenstein2018.com) was the announcement by Dr. He Jiankui on November 25^ththat he had just created the world’s first genetically modified babies using the gene editing tool known as CRISPR cas9.  He announced this at the 2^ndinternational gene summit (see: http://www.nationalacademies.org/gene-editing/2nd_summit/index.htm); the story officially broke in MIT Technology Review (see: https://www.technologyreview.com/s/612458/exclusive-chinese-scientists-are-creating-crispr-babies/).

I also discussed this case earlier this month on a University of Kentucky podcast (http://uknow.uky.edu/research/ethics-crispr-twins-week-behind-blue)

What did He do?

Dr. He claims to have eliminated the gene that makes us susceptible to HIV in an effort to create HIV-resistant babies since the father is HIV-positive. (The gene is called CCR5). He also claims to have created another pregnancy which is still in the early stages.

This was a staggering announcement because it means Dr. He reportedly edited human embryos that were implanted back into the mother. This is called human germline editing – also known as human germline engineering. Human germline editing involves changing the DNA of sperm, eggs or embryos – which is passed down through generations, and which have unknown consequences to the human genome overall. Essentially, Dr. He may have changed the human DNA sequence for generations to come by creating a heritable mutation and genetically modified descendants. The babies in question are called Lulu and Nana (pseudonyms); when they grow up and have children of their own, they will pass on this changed DNA sequence to their children, who will pass it on their grandchildren. This could affect untold thousands of people in the future. Nobody knows the consequences of the mutation Dr. He has introduced – it could have altered the genome in significant and negative ways.

Scientific concerns

 Several scientific peers have raised serious questions:

• He has not published his data for scientific scrutiny. Nobody can verify what, exactly, he did, or if he is telling the truth.
• This was conducted without IRB approval, ethical oversight or informed consent. Dr. He’s institution –Southern University of Science and Technology, in Shenzhenhad no knowledge of his work; the hospital where the embryos were implanted and eventually born states it had no knowledge of what he was doing (see: http://asia.blob.euroland.com/press-releases-attachments/1108747/HKEX-EPS_20181127_003332422-0.PDF)
• It will be difficult to get this research published in a peer reviewed journal because it doesn’t meet the publication standard of IRB-approval. There are also several conflicts of interest in his research.
• There appears to be no scientific or clinical rationale for this particular gene edit because there are many ways to reduce HIV transmission in newborns, and HIV experts stated that these babies were at very low risk of contracting HIV in the first place. This trial did not even meet the standard of “unmet medical need”. So even if these girls remain HIV negative life long, we’ll never know if this apparent gene edit was responsible. Dr. He actually introduced new mutations into the babies’ genomes that could alter how CCR5 works. We just don’t know.

Ethical concerns

Ultimately, every bioethicist around the world has called this research completely unethical, including over 100 Chinese scientists who have stepped forward. Dr. He also violated an international moratorium on creating live births with human germline editing. In December 2015, the first international summit on gene editing took place in which the scientific community agreed that while research on human germline editing could be done on discarded embryos– so we could study and learn more about this — it could not be used to create live births because it was years away from practical application. In fact, I discussed this moratorium in December 2015 (see: http://endocrineethicsblog.org/editing-ourselves-2015-and-crispr/).

Creating live births using germline editing is illegal in several countries, including the UK and Canada. China has now declared this illegal, too. In the U.S., federal funds cannot be used for intentionally creating a human embryo that is edited or modified.

The bioethics consensus is that until sufficient public debate surrounding the ELSI consequences  – the ethical, legal and social implications  — of human germline editing takes place, this research is not only premature, but may not even be an acceptable scientific pursuit.

In a year where ethics violations in government without “checks and balances” have dominated the news, it seems the science news was no exception. The CRISPR twin research violated the Nuremberg Code, the Declaration of Helsinki and the Belmont Report.

Although some bioethicists question if we should respond to what “He Says” in the absence of any data, if someone is even claiming to have altered the human genome, science must provide a strong and swift rebuke. Because the last thing we want is (ahem) a copycat.

If you’re an endocrinologist with patients in their reproductive years, then here is a prescription for mandatory viewing: Hulu’s The Handmaid’s Tale, which is to reproductive justice what the 1997 film, Gattaca was to genetic sequencing. Part cautionary tale, and part “we’re practically there.” And soon, “Um…that actually happened last week.”

The premise of the series is that in the wake of decades of unregulated environmental toxins, most American women are now sterile; a small minority are able to conceive. Meanwhile, the political structure of the U.S. deteriorates into an authoritarian state ruled by Christian fundamentalists who assign roles to the females in the population: some are the “wives” of the ruling class in traditional marriages where women are subservient to males; some are forced “domestics” (the cooks and housekeepers); some are forced into reproductive service as “handmaids” to the infertile couples. Handmaids must submit to unconsensual intercourse with the male heads of households to which they’re assigned, with the goal of serving as surrogate birth mothers for the infertile ruling class. What about the lesbians? They are “gender traitors” who have forced clitoridectomies. (For more analysis of the series, see: https://www.newyorker.com/magazine/2017/05/22/a-cunning-adaptation-of-the-handmaids-tale).

Based on the 1985 novel by Margaret Atwood, The Handmaid’s Tale asks a central question in the Trump era: Do women have autonomy or not? And, by extension, do women’s voices mean anything?

In 1985, Atwood was initially writing the novel in the context of the Reagan era, and the “moral majority” which was a movement that inspired her fictional and futuristic version of the United States in which the Constitution is dissolved by a far right, Christian militia, renaming the U.S. “Gilead”. Here is a 1981 New Yorker piece on the burgeoning “moral majority” entitled “A Disciplined Charging Army”: https://www.newyorker.com/magazine/1981/05/18/a-disciplined-charging-army

The 1980s “moral majority” was a feminist backlash movement that wanted to stop women’s social and reproductive progress, which it saw as a threat to the traditional family. But The Handmaid’s Tale was also written during the burgeoning era of artificial reproductive technologies (ART), such as IVF and surrogate motherhood. The “moral majority” eventually became the base of the Republican Party, which now operates all three branches of government. In 2017, to satisfy its base, we watched the Republican Party disband its Constitutional duties of oversight to cede control to the Executive Branch. We watched, too, as our democratic norms once “guaranteed” under the U.S. Constitution eroded. Now, we are living in a time in which the U.S. Congress is actively enabling an authoritarian, illiberal President of questionable decision-making capacity. Ultimately, the Trump era is one where anti-feminist, anti-civil rights, anti-science, and anti-evidence-based policies are fast becoming normalized. Legislators who are proponents of the Trump agenda pride themselves on restricting women’s reproductive rights and the civil rights of the LBGT community; the President is actively trying to ban transgender persons from military service (See: http://endocrineethicsblog.org/the-presidents-gender-bender/)

Of course, erosion of women’s reproductive rights did not happen overnight; state legislatures have been in Republican control for several years due to low voter turnouts in local and mid-term elections during the Obama era. A myriad of abortion restrictions and TRAP laws were introduced between 2011-2016 (See: http://endocrineethicsblog.org/2016/06/), but over 400 more abortion restrictions were introduced in 2017, with some states requiring completely unethical statements be made to the patients seeking the procedures, including (in Utah) a requirement that doctors attempt to medically rescue aborted fetuses when they are removed from the womb. (See: http://www.motherjones.com/politics/2017/04/guttmacher-report-abortion-restrictions-proactive-legislation-first-quarter-2017/#). In April, President Trump signed a new law to withhold public funds used for family planning (see: https://www.npr.org/sections/thetwo-way/2017/04/13/523795052/trump-signs-law-giving-states-option-to-deny-funding-for-planned-parenthood)

Earlier this month we learned that the Trump Administration has now banned the CDC and the Department of Health and Human Services from using certain words, such as “evidence-based”, “fetus” and “transgender”. (See: https://www.washingtonpost.com/national/health-science/cdc-gets-list-of-forbidden-words-fetus-transgender-diversity/2017/12/15/f503837a-e1cf-11e7-89e8-edec16379010_story.html?utm_term=.d1971c7307a8).

Ultimately, despite so many political distractions, 2017 was a very productive year for the erosion of women’s reproductive and civil rights.

On January 21, 2017, the year began with the Women’s Marches across the U.S., and in many other countries the day after the 45^th President of the United States was elected despite his statements on video that he could “grab women by their pussies” whenever he wanted. The iconic symbol of the Women’s Marches became the pink “pussy hat”. But as the year progressed, policies targeting women have been a key part of the Trump agenda. Here is a summary of legislation on the menu in the first 100 days: https://www.americanprogress.org/issues/women/reports/2017/04/25/430969/100-days-100-ways-trump-administration-harming-women-families/).

Additionally, there were multiple attempts to repeal the Affordable Care Act and remove basic access to women’s health. (See: http://endocrineethicsblog.org/kill-bill-volume-1/)

But the most significant achievement in eroding women’s rights was the appointment of Neil Gorsuch to the “stolen” Supreme Court Seat. Gorsuch, a conservative judge, remains a threat to Roe v. Wade. The Trump Administration has also been very busy installing conservative judges on the federal courts (https://www.nytimes.com/2017/11/11/us/politics/trump-judiciary-appeals-courts-conservatives.html), who will surely help to rule in favor of laws that erode women’s reproductive rights and justice in the future. For now, the federal courts have held that women still have reproductive rights. But that could change quickly, particularly with the current Attorney General at the helm, who would feel right at home in “Gilead”. Alas, even if Trump gets impeached, the current Vice President is a character right out of “Gilead”, too. Under a potential Pence Administration, a Gileadian future is even more possible. We have already seen some foreboding signs this year. Undocumented pregnant women have been held against their will by the Justice Department, and prevented from accessing constitutionally protected abortions. In one case, even when the ACLU attorneys ultimately won the case for an undocumented teen to get an abortion, the Justice Department started suing the ACLU’s attorneys. See: https://www.washingtonpost.com/politics/courts_law/undocumented-immigrant-teen-has-abortion-ending-weeks-long-court-battle/2017/10/25/9805249a-b90b-11e7-9e58-e6288544af98_story.html?utm_term=.6930202c44b6

and

https://www.huffingtonpost.com/entry/doj-aclu-jane-doe-undocumented-teen-abortion_us_59fb213be4b0b0c7fa387271

As for Atwood’s dystopian premise of environmental toxins interfering with fertility, that story has been ongoing since the discovery of endocrine disruptors (see: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3845732/) in the wake of weak regulations on organochlorines. Although the Obama Administration began to implement stricter regulations on environmental threats, in 2017 the EPA was effectively dismantled, and its scientists silenced, by the new anti-EPA director, Scott Pruitt. (See: https://www.pbs.org/wgbh/frontline/film/war-on-the-epa/). Between the destruction of the EPA, and the President’s exit from the Paris Climate Accord, it’s “deregulation gone wild” as polluters are granted the freedom to let loose. There is no telling how environmental deregulation will affect reproductive health; children’s health, and public health in general.

We are closer to The Handmaid’s Tale than you think, but there are signs that women are beginning to use their rage to prevent a future that is so tangible, we can taste it. The #MeToo Movement, which erupted in the Fall, closed the year, as women started to call out by name their sexual predators, sexual harassers and uninvited gropers, putting an end to several prominent males’ careers. It remains to be seen if there will be a male backlash. But we need to remember that right now, women’s civil and reproductive rights hang by a thread.

Atwood stated that The Handmaid’s Tale was an “antiprediction” because “if this future can be described in detail, maybe it won’t happen.” Indeed 2017 paved the way for women’s reproductive rage to translate into real legislative power. In Virginia, women were responsible for nearly flipping the state legislature by running for local office and voting out white males. In Alabama, African American women, in particular, were responsible for staving off a white male predator who meets the legal definition of a pedophile, and even stated he was pro-slavery.

The Handmaid’s Tale is too close for comfort; but 2018 may become the year women literally run for their lives (and reclaim their reproductive autonomy). One thing is certain: women will no longer accept “Lock Her Up” when they ask for power.