Promising assisted reproductive technologies come with ethical, legal and social challenges – a developmental biologist and a bioethicist discuss IVF, abortion and the mice with two dads
Promising assisted reproductive technologies come with ethical, legal and social challenges – a developmental biologist and a bioethicist discuss IVF, abortion and the mice with two dads
Assisted reproductive technologies are medical procedures that help people experiencing difficulty having or an inability to have biological children of their own. From in vitro fertilization to genetic screening to creation of viable eggs from the skin cells of two male mice, each new development speaks to the potential of reproductive technologies to expand access to the experience of pregnancy.
Translating advances from the lab to the clinic, however, comes with challenges that go far beyond the purely technical.
Conversations around the ethics and implications of cutting-edge research often happen after the fact, when the science and technology have advanced beyond the point at which open dialogue could best protect affected groups. In the spirit of starting such cross-discipline conversations earlier, we invited developmental biologist Keith Latham of Michigan State University and bioethicist Mary Faith Marshall of the University of Virginia to discuss the ethical and technological potential of in vitro gametogenesis and assisted reproductive technology post-Roe.
How new are the ethical considerations raised by assisted reproductive technologies?
Keith
Every new technology raises many of the same questions, and likely new ones. On the safety and risk-benefit side of the ethical conversation, there’s nothing here that we haven’t dealt with since the 1970s with other reproductive technologies. But it’s important to keep asking questions, because the benefits are hugely dependent on the success rate. There are potential biological costs, but also possible social costs, financial costs, societal costs and many others.
Mary Faith
It’s probably been that way even longer. One of my mentors, Joseph Francis Fletcher, a pioneering bioethicist and Episcopal priest, wrote a book called “Morals and Medicine” in 1954. It was the first non-Roman Catholic treatment of bioethics. And he raised a lot of these issues there, including the technological imperative – the idea that because we can develop the technology to do something, we therefore should develop it.
Fletcher also said that the use of artifice, or human-made creations, is supremely human. That’s what we do: We figure out how things work and we develop new technologies like vaccines and heart-lung machines based on evolving scientific knowledge.
I think that in most cases, scientists should be involved in thinking about the implications of their work. But often, researchers focus more on the direct applications of their work than the potential indirect consequences.
Given the evolution of assisted reproductive technology, and the fact that its evolution is going to continue, I think one of the central questions to consider is, what are the goals of developing it? For assisted reproduction, it’s to help infertile people and people in nontraditional relationships have children.
What are some recent developments in the field of assisted reproductive technology?
Keith
One recent advance in assisted reproductive technology is the expansion of pre-implantation genetic testing methods, particularly DNA sequencing. Many genes come in different variants, or alleles, that can be inherited from each parent. Providers can determine whether an embryo bears a “bad” allele that may increase the risk of certain diseases and select embryos with “healthy” alleles.
Genetic screening raises several ethical concerns. For example, the parents’ genetic profiles could be unwillingly inferred from that of the embryo. This possibility may deter prospective parents from having children, and such knowledge may also have potential effects on any future child. The cost of screening and potential need for additional cycles of IVF may also increase disparities.
There are also considerations about the accuracy of screening predictions without accounting for environmental effects, and what level of genetic risk is “serious” enough for an embryo to be excluded. More extensive screening also raises concerns about possible misuse for purposes other than disease prevention, such as production of “designer babies.”
In vitro gametogenesis involves making egg or sperm cells from other adult cells in the body.
At a genome-editing conference in March 2023, researchers announced that they were able to delete and duplicate whole chromosomes from the skin cells of male mice to make eggs. This method is one potential way to make eggs that do not carry genetic abnormalities.
They were very upfront that this was done at 1% efficiency in mice, which could be lower in humans. That means something bad happened to 99% of the embryos. The biological world is not typically binary, so a portion of that surviving 1% could still be abnormal. Just because the mice survived doesn’t mean they’re OK. I would say at this point, it would be unethical to try this on people.
As with some forms of genetic screening, using this technique to reduce the risk of one disease could inadvertently increase the risk of another. Determining that it is absolutely safe to duplicate a chromosome would require knowing every allele of every gene on that chromosome, and what each allele could do to the health of a person. That’s a pretty tall order, as that could involve identifying hundreds to thousands of genes, and the effects of all their variants may not be known.
Mary Faith
That raises the issue of efficacy and costs to yet another order of magnitude.
Keith
Genome editing with CRISPR technology in people carries similar concerns. Because of potential limitations in how precise the technology can be, it may be difficult for researchers to say they are absolutely 100% certain there won’t be off-target changes in the genome. Proceeding without that full knowledge could be risky.
But that’s where bioethicists need to come into play. Researchers don’t know what the full risk is, so how do you make that risk-benefit calculation?
Mary Faith
There’s the option of a voluntary global moratorium on using these technologies on human embryos. But somebody somewhere is still going to do it, because the technology is just sitting there, waiting to be moved forward.
How will the legal landscape affect the development and implementation of assisted reproductive technologies?
Mary Faith
Any research that involves human embryos is in some ways politicized. Not only because the government provides funding to the basic science labs that conduct this research, but because of the wide array of beliefs that members of the public at large have about when life begins or what personhood means.
The Dobbs decision, which overturned the constitutional right to an abortion, has implications for assisted reproduction and beyond. Most people who are pregnant don’t even know they’re pregnant at the earliest stages, and somewhere around 60% of those pregnancies end naturally because of genetic aberrations. Between 1973 and 2005, over 400 women were arrested for miscarriage in the U.S., and I think that number is going to grow. The implications for reproductive health care, and for assisted reproduction in the future, are challenging and frightening.
What will abortion restrictions mean for people who have multiple-gestation pregnancies, in which they carry more than one embryo at the same time? In order to have one healthy child born from that process, the other embryos often need to be removed so they don’t all die. In the past 40 years, the number of twin births doubled and triplet and higher-order births quadrupled, primarily because of fertility treatments.
IVF may transfer one, two, or sometimes three embryos at a time. The cost of care for preterm birth, which is one possible outcome of multiple-gestation pregnancies, can be high. That’s in addition to the cost of delivery. IVF clinics are increasingly transferring just one embryo to mitigate such concerns.
The life-at-conception bills that have been put forth in some U.S. state legislatures and Congress may contain language claiming they are not meant to prevent IVF. But the language of the bills could be extended to affect procedures such as IVF with pre-implantation genetic testing to detect chromosomal abnormalities, particularly when single-embryo transfer is the goal. Pre-implantation genetic testing has been increasing, with one study estimating that over 40% of all IVF cycles in the U.S. in 2018 involved genetic screening.
Could life-at-conception bills criminalize clinics that don’t transfer embryos known to be genetically abnormal? Freezing genetically abnormal embryos could avoid destroying them, but that raises questions of, to what end? Who would pay for the storage, and who would be responsible for those embryos?
How can we determine whether the risks outweigh the benefits when so much is unknown?
Keith
Conducting studies in animal models is an important first step. In some cases, it either hasn’t been done or hasn’t been done extensively. Even with animal studies, you have to recognize that mice, rabbits and monkeys are not human. Animal models may reduce some risks before a technology is used in people, but they won’t eliminate all risks, because of biological differences between species.
The death of Jesse Gelsinger, who was a participant in a gene therapy clinical trial in 1999, led to a halt in all gene therapy clinical trials in the U.S. for a time. When the Food and Drug Administration investigated what went wrong, they found huge numbers of adverse events in both humans and animals that should have been reported to the advisory committee but weren’t. Notably, the principal investigator of the trial was also the primary shareholder of the biotech company that made the drug being tested. That raises questions about the reality of oversight.
I think something like that earlier NIH advisory committee but for reproductive technologies would still be advisable. But researchers, policymakers and regulators need to learn from the lessons of the past to try to ensure that – especially in early-phase research – we’re very thoughtful about the potential risks and that research participants really understand what the implications are for participation in research. That would be one model for translating research from the animal into the human.
The FDA approved a gene therapy for a form of congenital vision loss in 2017. The child in this photo, then 8, first received gene therapy at age 4. Bill West/AP Photo
Keith
A process to make sure that the people conducting studies don’t have a conflict of interest, like having the potential to commercially profit from the technology, would be useful.
Caution, consensus and cooperation should not take second place to profit motives. Altering the human genome in a way that allows human-made genetic changes to be propagated throughout the population has a potential to alter the genetics of the human species as a whole.
Mary Faith
That raises the question of how long it will take for long-term effects to show. It’s one thing for an implanted egg not to survive. But how long will it take to know whether there are effects that aren’t obvious at birth?
Keith
We’re still collecting long-term outcome data for people born using different reproductive technologies. So far there have been no obviously horrible consequences. But some abnormalities could take decades to manifest, and there are many variables to contend with.
One can arguably say that there’s substantial good in helping couples have babies. There can be a benefit to their emotional well-being, and reproduction is a natural part of human health and biology. And a lot of really smart, dedicated people are putting a lot of energy into making sure that the risks are minimized. We can also look to some of the practices and approaches to oversight that have been used over the past several decades.
Mary Faith
And thinking about international guidelines, such as from the Council for International Medical Science and other groups, could provide guidance on protecting human research subjects.
Keith
You hate to advocate for a world where the automatic response to anything new is “no, don’t do that.” My response is, “Show me it’s safe before you do it.” I don’t think that’s unreasonable.
Some people have a view that scientists don’t think about the ethics of research and what’s right and wrong, advisable or inadvisable. But we do think about it. I co-direct a research training program that includes teaching scientists how to responsibly and ethically conduct research, including speakers who specifically address the ethics of reproductive technologies. It is valuable to have a dialogue between scientists and ethicists, because ethicists will often think about things from a different perspective.
As people go through their scientific careers and see new technologies unfold over time, these discussions can help them develop a deeper appreciation and understanding of the broader impact of their research. It becomes our job to make sure that each generation of scientists is motivated to think about these things.
Mary Faith
It’s also really important to include stakeholders – people who are nonscientists, people who experience barriers to reproduction and people who are opposed to the idea – so they have a voice at the table as well. That’s how you get good policies, right? You have everyone who should be at the table, at the table.
If you have visited an island like one of the Hawaiian Islands, Tahiti or Easter Island, also known as Rapa Nui, you may have noticed how small these land masses appear against the vast Pacific Ocean. If you’re on Hawaii, the nearest island to you is more than 1,000 miles (1,600 kilometers) away, and the coast of the continental United States is more than 2,000 miles (3,200 kilometers) away. To say these islands are secluded is an understatement.
For me, watching the movie “Moana” in 2016 was eye-opening. I knew that Polynesian people traveled between a number of Pacific islands, but seeing Moana set sail on a canoe made me realize exactly how small those boats are compared with what must have seemed like an endless ocean. Yet our fictional hero went on this journey anyway, like the countless real-life Polynesian voyagers upon which she is based.
Islands in Polynesia can be thousands of miles apart. NASA
As an astronomer, I have been teaching college students and visitors to our planetarium how to find stars in our sky for more than 20 years. As part of teaching appreciation for the beauty of the sky and the stars, I want to help people understand that if you know the stars well, you can never get lost.
U.S. Navy veterans learned the stars in their navigation courses, and European cultures used the stars to navigate, but the techniques of Polynesian wayfinding shown in Moana brought these ideas to a very wide audience.
The movie Moana gave me a new hook – pun not intended – for my planetarium shows and lessons on how to locate objects in the night sky. With “Moana 2” out now, I am excited to see even more astronomy on the big screen and to figure out how I can build new lessons using the ideas in the movie.
The North Star
Have you ever found the North Star, Polaris, in your sky? I try to spot it every time I am out observing, and I teach visitors at my shows to use the “pointer stars” in the bowl of the Big Dipper to find it. These two stars in the Big Dipper point you directly to Polaris.
If you are facing Polaris, then you know you are facing north. Polaris is special because it is almost directly above Earth’s North Pole, and so everyone north of the equator can see it year-round in exactly the same spot in their sky.
It’s a key star for navigation because if you measure its height above your horizon, that tells you how far you are north of Earth’s equator. For the large number of people who live near 40 degrees north of the equator, you will see Polaris about 40 degrees above your horizon.
If you live in northern Canada, Polaris will appear higher in your sky, and if you live closer to the equator, Polaris will appear closer to the horizon. The other stars and constellations come and go with the seasons, though, so what you see opposite Polaris in the sky will change every month.
Look for the Big Dipper to find the North Star, Polaris.
You can use all of the stars to navigate, but to do that you need to know where to find them on every night of the year and at every hour of the night. So, navigating with stars other than Polaris is more complicated to learn.
Maui’s fishhook
At the end of June, around 11 p.m., a bright red star might catch your eye if you look directly opposite from Polaris. This is the star Antares, and it is the brightest star in the constellation Scorpius, the Scorpion.
If you are a “Moana” fan like me and the others in my family, though, you may know this group of stars by a different name – Maui’s fishhook.
If you are in the Northern Hemisphere, Scorpius may not fully appear above your horizon, but if you are on a Polynesian island, you should see all of the constellation rising in the southeast, hitting its highest point in the sky when it is due south, and setting in the southwest.
Astronomers and navigators can measure latitude using the height of the stars, which Maui and Moana did in the movie using their hands as measuring tools.
The easiest way to do this is to figure out how high Polaris is above your horizon. If you can’t see it at all, you must be south of the equator, but if you see Polaris 5 degrees (the width of three fingers at arm’s length) or 10 degrees above your horizon (the width of your full fist held at arm’s length), then you are 5 degrees or 10 degrees north of the equator.
The other stars, like those in Maui’s fishhook, will appear to rise, set and hit their highest point at different locations in the sky depending on where you are on the Earth.
Polynesian navigators memorized where these stars would appear in the sky from the different islands they sailed between, and so by looking for those stars in the sky at night, they could determine which direction to sail and for how long to travel across the ocean.
Today, most people just pull out their phones and use the built-in GPS as a guide. Ever since “Moana” was in theaters, I see a completely different reaction to my planetarium talks about using the stars for navigation. By accurately showing how Polynesian navigators used the stars to sail across the ocean, Moana helps even those of us who have never sailed at night to understand the methods of celestial navigation.
The first “Moana” movie came out when my son was 3 years old, and he took an instant liking to the songs, the story and the scenery. There are many jokes about parents who dread having to watch a child’s favorite over and over again, but in my case, I fell in love with the movie too.
Since then, I have wanted to thank the storytellers who made this movie for being so careful to show the astronomy of navigation correctly. I also appreciated that they showed how Polynesian voyagers used the stars and other clues, such as ocean currents, to sail across the huge Pacific Ocean and land safely on a very small island thousands of miles from their home.
theconversation.com – Iain Boyd, Director of the Center for National Security Initiatives and Professor of Aerospace Engineering Sciences, University of Colorado Boulder – 2024-12-17 17:28:00
The recent spate of unidentified drone sightings in the U.S., including some near sensitive locations such as airports and military installations, has caused significant public concern.
Some of this recent increase in activity may be related to a September 2023 change in U.S. Federal Aviation Administration regulations that now allow drone operators to fly at night. But most of the sightings are likely airplanes or helicopters rather than drones.
The inability of the U.S. government to definitively identify the aircraft in the recent incidents, however, has some people wondering, why can’t they?
I am an engineer who studies defense systems. I see radio frequency sensors as a promising approach to detecting, tracking and identifying drones, not least because drone detectors based on the technology are already available. But I also see challenges to using the detectors to comprehensively spot drones flying over American communities.
How drones are controlled
Operators communicate with drones from a distance using radio frequency signals. Radio frequency signals are widely used in everyday life such as in garage door openers, car key fobs and, of course, radios. Because the radio spectrum is used for so many different purposes, it is carefully regulated by the Federal Communications Commission.
Drone communications are only allowed in narrow bands around specific frequencies such as at 5 gigahertz. Each make and model of a drone uses unique communication protocols coded within the radio frequency signals to interpret instructions from an operator and to send data back to them. In this way, a drone pilot can instruct the drone to execute a flight maneuver, and the drone can inform the pilot where it is and how fast it is flying.
Identifying drones by radio signals
Radio frequency sensors can listen in to the well-known drone frequencies to detect communication protocols that are specific to each particular drone model. In a sense, these radio frequency signals represent a unique fingerprint of each type of drone.
In the best-case scenario, authorities can use the radio frequency signals to determine the drone’s location, range, speed and flight direction. These radio frequency devices are called passive sensors because they simply listen out for and receive signals without taking any active steps. The typical range limit for detecting signals is about 3 miles (4.8 kilometers) from the source.
These sensors do not represent advanced technology, and they are readily available. So, why haven’t authorities made wider use of them?
Drones were all the buzz in the Northeast at the end of 2024.
Challenges to using radio frequency sensors
While the monitoring of radio frequency signals is a promising approach to detecting and identifying drones, there are several challenges to doing so.
First, it’s only possible for a sensor to obtain detailed information on drones that the sensor knows the communication protocols for. Getting sensors that can detect a wide range of drones will require coordination between all drone manufacturers and some central registration entity.
In the absence of information that makes it possible to decode the radio frequency signals, all that can be inferred about a drone is a rough idea of its location and direction. This situation can be improved by deploying multiple sensors and coordinating their information.
Second, the detection approach works best in “quiet” radio frequency environments where there are no buildings, machinery or people. It’s not easy to confidently attribute the unique source of a radio frequency signal in urban settings and other cluttered environments. Radio frequency signals bounce off all solid surfaces, making it difficult to be sure where the original signal came from. Again, the use of multiple sensors around a particular location, and careful placement of those sensors, can help to alleviate this issue.
Third, a major part of the concern over the inability to detect and identify drones is that they may be operated by criminals or terrorists. If drone operators with malicious intent know that an area targeted for a drone operation is being monitored by radio frequency sensors, they may develop effective countermeasures. For example, they may use signal frequencies that lie outside the FCC-regulated parameters, and communication protocols that have not been registered. An even more effective countermeasure is to preprogram the flight path of a drone to completely avoid the use of any radio frequency communications between the operator and the drone.
Finally, widespread deployment of radio frequency sensors for tracking drones would be logistically complicated and financially expensive. There are likely thousands of locations in the U.S. alone that might require protection from hostile drone attacks. The cost of deploying a fully effective drone detection system would be significant.
There are other means of detecting drones, including radar systems and networks of acoustic sensors, which listen for the unique sounds drones generate. But radar systems are relatively expensive, and acoustic drone detection is a new technology.
The way forward
It was almost guaranteed that at some point the problem of unidentified drones would arise. People are operating drones more and more in regions of the airspace that have previously been very sparsely populated.
Perhaps the recent concerns over drone sightings are a wake-up call. The airspace is only going to become much more congested in the coming years as more consumers buy drones, drones are used for more commercial purposes, and air-taxis come into use. There’s only so much that drone detection technologies can do, and it might become necessary for the FAA to tighten regulation of the nation’s airspace by, for example, requiring drone operators to submit detailed flight plans.
Vaccinations provide significant protection for the public against infectious diseases and substantially reduce health care costs. Therefore, it is noteworthy that President-elect Donald Trump wants Robert F. Kennedy Jr., a leading critic of childhood vaccination, to be secretary of Health and Human Services.
Doctors, scientists and public health researchers have expressed concerns that Kennedy would turn his views into policies that could undermine public health. As a case in point, news reports have highlighted how Kennedy’s lawyer, Aaron Siri, has in recent years petitioned the Food and Drug Administration to withdraw orsuspend approval of numerous vaccines over alleged safety concerns.
I am a biochemist and molecular biologist studying the roles microbes play in health and disease. I also teach medical students and am interested in how the public understands science.
Here are some facts about vaccines that Kennedy and Siri get wrong:
Nevertheless, the false claim that vaccines cause autism persists despite studyafter study of large populations throughout the world showing no causal link between them.
Claims about the dangers of vaccines often come from misrepresenting scientific research papers. In an interview with podcaster Joe Rogan, Kennedy incorrectly cited studies allegedly showing vaccines cause massive brain inflammation in laboratory monkeys, and that the hepatitis B vaccine increases autism rates in children by over 1,000-fold compared with unvaccinated kids. Those studies make no such claims.
In the same interview, Kennedy also made the unusual claim that a 2002 vaccine study included a control group of children 6 months of age and younger who were fed mercury-contaminated tuna sandwiches. No sandwiches are mentioned in that study.
Similarly, Siri filed a petition in 2022 to withdraw approval of a polio vaccine based on alleged safety concerns. The vaccine in question is made from an inactivated form of the polio virus, which is safer than the previously used live attenuated vaccine. The inactivated vaccine is made from polio virus cultured in the Vero cell line, a type of cell that researchers have been safely using for various medical applications since 1962. While the petition uses provocative language comparing this cell line to cancer cells, it does not claim that it causes cancer.
Vaccines undergo the same approval process as other drugs
Clinical trials for vaccines and other drugs are blinded, randomized and placebo-controlled studies. For a vaccine trial, this means that participants are randomly divided into one group that receives the vaccine and a second group that receives a placebo saline solution. The researchers carrying out the study, and sometimes the participants themselves, do not know who has received the vaccine or the placebo until the study has finished. This eliminates bias.
Kennedy is co-counsel with a law firm that is suing the pharmaceutical company Merck based in part on the unfounded assertion that the aluminum in one of its vaccines causes neurological disease. Aluminum is added to many vaccines as an adjuvant to strengthen the body’s immune response to the vaccine, thereby enhancing the body’s defense against the targeted microbe.
The law firm’s claim is based on a 2020 report showing that brain tissue from some patients with Alzheimer’s disease, autism and multiple sclerosis have elevated levels of aluminum. The authors of that study do not assert that vaccines are the source of the aluminum, and vaccines are unlikely to be the culprit.
Notably, the brain samples analyzed in that study were from 47- to 105-year-old patients. Most people are exposed to aluminum primarily through their diets, and aluminum is eliminated from the body within days. Therefore, aluminum exposure from childhood vaccines is not expected to persist in those patients.
Ironically, Kennedy’s lawyer, Siri, wants the FDA to withdraw some vaccines for containing less aluminum than stated by the manufacturer.
Vaccine manufacturers are liable for injury or death
Kennedy’s lawsuit against Merck contradicts his insistence that vaccine manufacturers are fully immune from litigation.
His claim is based on an incorrect interpretation of the National Vaccine Injury Compensation Program, or VICP. The VICP is a no-fault federal program created to reduce frivolous lawsuits against vaccine manufacturers, which threaten to cause vaccine shortages and a resurgence of vaccine-preventable disease.
A person claiming injury from a vaccine can petition the U.S. Court of Federal Claims through the VICP for monetary compensation. If the VICP petition is denied, the claimant can then sue the vaccine manufacturer.
The majority of cases resolved under the VICP end in a negotiated settlement between parties without establishing that a vaccine was the cause of the claimed injury. Kennedy and his law firm have incorrectly used the payouts under the VICP to assert that vaccines are unsafe.
The VICP gets the vaccine manufacturer off the hook only if it has complied with all requirements of the Federal Food, Drug and Cosmetic Act and exercised due care. It does not protect the vaccine maker from claims of fraud or withholding information regarding the safety or efficacy of the vaccine during its development or after approval.
Good nutrition and sanitation are not substitutes for vaccination
Kennedy asserts that populations with adequate nutrition do not need vaccines to avoid infectious diseases. While it is clear that improvements in nutrition, sanitation, water treatment, food safety and public health measures have played important roles in reducing deaths and severe complications from infectious diseases, these factors do not eliminate the need for vaccines.
After World War II, the U.S. was a wealthy nation with substantial health-related infrastructure. Yet, Americans reported an average of 1 million cases per year of now-preventable infectious diseases.
Vaccines introduced or expanded in the 1950s and 1960s against diseases like diphtheria, pertussis, tetanus, measles, polio, mumps, rubella and Haemophilus influenza B have resulted in the near or complete eradication of those diseases.
It’s easy to forget why many infectious diseases are rarely encountered today: The success of vaccines does not always tell its own story. RFK Jr.’s potential ascent to the role of secretary of Health and Human Services will offer up ample opportunities to retell this story and counter misinformation.
