Tag: biotechnology

Human Microchip Implantation: A Bridge Too Far?

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This post is a part of our Bioethics in the News series

By Sabrina Ford, PhD

Technology. It invades every corner of our lives and for the most part improves the quality of life. From typing on a flat panel with a little TV screen attached, to a smartphone enabling users to share with others collected data that lives in the cloud. A CT/X-ray image of a C2 spinal fracture (aka Hangman’s Fracture) taken in the middle of the night at a small Midwestern rural hospital is sent to a West Coast spine surgeon, and within minutes, an expert opinion is returned to that rural hospital. Technology is convenient, pervasive, and unavoidable.

In the past 15 years, discussion and related controversy has taken place about a Radio Frequency Identification Device (RFID) or microchip that can be implanted in human bodies. That chip would contain, store, and update data about us. Might such an implant be a benefit or a risk? Some investors are betting on its appeal. The compound annual growth rate (CAGR) from 2020-2027 of the healthcare microchip is expected to grow by 22% and be valued over $6.4 million by 2027. RFID microchips (herein referred to as microchips) are already used for many things from your credit/debit card, to those efficient logistics used to move your Amazon package.

Illustrated cyborg eye with electronic circuits
Image description: An illustrated cyborg eye with electronic circuits. Image source: jemastock/Vecteezy.

Getting to the bridge

Implanted microchips are a terrifying idea to some of us—sufficiently frightening to harken images of robots and androids—the stuff of science fiction. For some of us, implanting something foreign in our bodies for the management of big data and convenience is disturbing. Another concern might be the potential breach of privacy and the surveillance of our daily life. If the chip contains medical, personal, social information, and GPS data, could we lose all autonomy? Do we maintain our autonomy if, with sufficient information, we consent to the decision? What will all the information be used or misused for? What if our employer, insurer, or a government entity decides to check on us?

These questions raise other concerns about autonomy. Enough employers considered compulsory microchips for their employees that in 2020, Michigan and several other states introduced and passed bills designed to prevent employers from forcing employees to accept microchip implants. This pre-emptive strike was against a growing technology, utilized perhaps to track safety, productivity and movement. As with many things in the United States, some vulnerable employees with microchips might be targeted, either unintentionally or intentionally, thereby putting them at further economic and social disadvantage.

Some have already crossed the bridge

It is estimated that currently approximately 10,000 people in the world have implanted microchips. Perhaps that doesn’t sound like many, but if investors are hedging their bets correctly, the technology is on its way to widespread adoption. A large number of those “cyborgs” reside in Sweden and employ the technology not for health care reasons, but instead use microchip implants to unlock their car doors, buy a coffee, or swipe into the gym. That rate of chip adoption makes sense in a society like Sweden, which is the second most cashless society (after Canada) in the world.

Photo of microchip being held between two fingers
Image description: A photo of an RFID implant held between two fingers. Image source: Dan Lane/Flickr Creative Commons.

Many argue that an RFID tag and implanted microchips can increase cybersecurity. Not being able to log into your computer without first swiping into the building and into your office door might offer a level of comforting protection against physical hacking in the workplace. In addition, many in healthcare delivery believe medical mistakes would be greatly reduced and quality of care increased if our medical charts were loaded on microchips, monitoring disease states like heart disease and diabetes, improving management of medications, and reducing surgical mistakes. If, with microchips, first responders or doctors had real-time access to accurate medical information there is potential to save lives in medical emergencies. The HITECH Act—or Health Information Technology for Economic and Clinical Health Act—calls for the interoperability of electronic health information for privacy and safety of the patient. As it is now, it doesn’t make sense for an individual to have different electronic health records in a number of physician offices. If our world were to be efficiently hyperconnected, one can argue that everyday life could be improved and streamlined.

A bridge too far

But would it be? We are covered, watched, followed, and violated through our digital footprint on a daily basis. Perhaps not necessarily with microchips, but pause to consider your actions today. You took your morning walk as public cameras captured your movement down the block, into the convenience store for a cup of coffee, where you used your debit card or smartphone to pay for the transaction, and that transaction was caught on the store camera. You then check your fitness wearable for heart rate, steps, route, and all that other good stuff. Later, you swipe in and out of the building as you stop into your office for a few hours, in and out of several doors, and log on to your computer—accessing various applications in the cloud—all the while answering your email and checking your calendar. Later in the day, you visit your doctor, either in person or via telemedicine, and she enters your ailments, diagnostic tests ordered, and electronic prescriptions into the electronic health record. As you wind down for the evening you make your market list in your favorite grocery store app, use your smart television to access your favorite shows, and access your books on a reading app. All of this is accomplished in the cloud, and on the “grid” in huge databases. Is this trek through the digital world so much different than a microchip that holds your digital footprint? You’ve left a day’s breadcrumb trail on almost every aspect of your life, and not even as consciously as Hansel and Gretel. As for implants in general, clearly Americans accept them, as witnessed by artificial joints, IUDs, cochlear implants – and don’t forget about those implants for hair and breasts.

Over the bridge

The described dilemma is that implanting a chip has the potential to be a violation of rights, yet the chip might equally offer safety and convenience. The implantable microchip is not fully developed and has a long way to go, but the technology is on its way. Microchips today are not sufficiently powerful to collect and communicate big data or to follow us all over the world the way our smartphones do. As with most technologies, the tipping point for implantable chips will come when they become so very useful that they’re simply hard to refuse.

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Sabrina Ford, PhD, is an Associate Professor in the Department of Obstetrics, Gynecology and Reproductive Biology and the Institute for Health Policy in the Michigan State University College of Human Medicine. Dr. Ford is also adjunct faculty with the Center for Ethics and Humanities in the Life Sciences.

Join the discussion! Your comments and responses to this commentary are welcomed. The author will respond to all comments made by Tuesday, March 16, 2021. With your participation, we hope to create discussions rich with insights from diverse perspectives.

You must provide your name and email address to leave a comment. Your email address will not be made public.

More Bioethics in the News from Dr. Ford: COVID-19 Vaccine: “Not throwing away my shot”; Contemplating Fentanyl’s Double Duty

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CRISPR Dangers Highlight the Need for Continued Research on Human Gene Editing

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This post is a part of our Bioethics in the News series

By Jennifer Carter-Johnson, PhD, JD

The excitement and potential of CRISPR to treat severe genetic conditions by editing disease-causing DNA has taken an unexpected hit. A recent Wall Street Journal article highlighted the unexpected results from a CRISPR study in which attempts to edit a human gene responsible for blindness resulted in the loss of the entire chromosome from the cells in the embryos. These results echo another study conducted in human cell lines published earlier in 2019.

CRISPR is a targeted gene editing process that allows scientists to direct genetic modifications with far more precision than prior procedures. CRISPR has been touted as a gigantic leap in the ability to modify DNA by creating or repairing pinpoint DNA mutations without affecting other areas of the chromosome on which the gene resides. The recent study indicates that the technique might not be as straightforward in humans – and thus neither will be its use to fight disease.

Blue DNA double helix puzzle with missing pieces
Image description: A partially assembled puzzle that is an image of blue double helix DNA molecule structures. Image source: Arek Socha/Pixabay

CRISPR Technology – Promise and Problems

The value in CRISPR mediated genetic modification can be seen in a wide variety of biotechnology products, such as genetically modified crops and new biologics. But perhaps the most exciting and most controversial potential for CRISPR can be found in the desire to modify embryonic genomes to remove genetic abnormalities for which we currently have no cure.

This promise of embryonic gene editing is appealing not only because it would remove the condition from the child born from the gene-edited embryo, but also because the offspring of that child would also be free of the condition. CRISPR gene editing – because it is done at the embryonic stage – creates germline mutations that are passed to future generations. In a therapeutic use of CRISPR, those mutations would be cures for often untreatable diseases.

However, it is this very promise that raises many of the problems with CRISPR embryonic gene editing. Much debate has surrounded embryonic gene editing. Until this recent news, there were fears that CRISPR may make gene editing too easy. The technological development of CRISPR in embryonic gene editing is moving at a breakneck pace as scientists around the world are working on procedures. Biohackers work in their garages and livestream the use of CRISPR to edit their own genomes.

Many are debating which genes should be targeted and how fast the research into actual trials should proceed. Most agree that severe diseases would be the best place to start, but should the technology be deployed for cosmetic benefits such as eye color, or diseases for which a treatment exists? The dangers of CRISPR editing are unclear, and there has been an informal moratorium on the use of the technology to create children. Despite that, there has been at least one rogue scientist who has created genetically modified embryos and brought them to full term birth.

International Policy on Human Gene Editing

The scientific research is not occurring in a vacuum. Each country decides how CRISPR can be used in its medical system – both when the technique is safe enough and on which diseases it should be used.

An international commission recently pronounced that the technology is not ready for clinic implementation because scientists don’t understand the full safety issues surrounding its use in human embryos. The commission described some of the potential clinical uses in the future and outlined a basic safety protocol for approval.

One of the creators of CRISPR, Jennifer Doudna, has also spoken out against applying CRISPR too hastily to embryonic gene editing. 

Based on the recent studies showing loss of chromosomes, the international commission and other scientists are correct to call for a moratorium on clinical embryonic gene editing.

Blue and green DNA double helixes and binary code
Image description: An abstract image of blue and green double helix structures and binary code (zeros and ones) against a black background. Image source: Gerd Altmann/Pixabay

CRISPR – The Path Forward

The setback in CRISPR gene editing does not mean that the technology and research should be discarded. The potential to change lives is too great; however, the dangers of use with our current understanding are even greater. So how do we move forward with CRISPR in embryonic gene editing? The answer must include balance – in research strategies and in voices.

While the technology is not ready for clinical use, and we have not yet determined which uses would be appropriate if it were available, the science should not stand still. The research surrounding CRISPR gene editing will yield insights into human biology that we cannot predict. For example, the loss of chromosome length in human embryonic cells undergoing CRISPR treatment seems to be different than the response of other species of embryonic cells. And debates about the appropriate use of the technology will allow us to discover more about ourselves as humans. 

As we debate the best way to develop and deploy CRISPR technology, we should look to a variety of stakeholders. Scientists have a solid track record in understanding when recombinant DNA technology has potentially hazardous implications. In the 1970s, the Asilomar Conference allowed scientists to put together research guidelines that allowed the technology to be developed without harming public health. In fact, the international scientific consensus not to use the technology such as described above indicates that scientists are beginning that work. Such a moratorium on clinical uses gives us time to understand how to deploy the technology in the safest manner.

Additionally, there is a role for the voices of the patients whose lives could be changed by the technology. Patients may not be in the best place to judge when the technology should be deemed safe enough to deploy, but they certainly will have input about which mutations cause hardships that merit the risk of germline editing. Many of these patients already work with scientists on potential treatments for their diseases. CRISPR discussions may open another avenue for many.

Finally, there is a role for legal regulation of the use of CRISPR. Governments should listen to the voices of scientists and potential patients in drafting these regulations. But as shown by the example of at least one rogue scientist, there needs to be teeth to the moratorium on CRISPR clinical use at this time. CRISPR and its use in human gene editing raise complicated issues and hold great promise as a powerful tool to defeat genetic diseases. The development of those technologies will not be straightforward or without risk and will require more basic science research to achieve clinical efficacy. But with proper planning, we may learn more about ourselves as humans on the path to a cure.

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Jennifer Carter-Johnson, PhD, JD, is Associate Dean for Academic Affairs and Associate Professor of Law in the Michigan State University College of Law. Dr. Carter-Johnson is a member of the Michigan State Bar. She is registered to practice before the U.S. Patent and Trademark Office.

Join the discussion! Your comments and responses to this commentary are welcomed. The author will respond to all comments made by Tuesday, December 15, 2020. With your participation, we hope to create discussions rich with insights from diverse perspectives.

You must provide your name and email address to leave a comment. Your email address will not be made public.

More Bioethics in the News from Dr. Carter-Johnson: Biohacking: How a DIY Approach to Biology Can Shape Our Future; Web of Interests Surrounding Medicines Makes Patient Access Increasingly Difficult; Humanity in the Age of Genetic Modification; Defining The Spectrum of “Normal”: What is a Disease?; Dawn of False Hope: Spread of “Right To Try” Laws across the U.S.

Continue reading “CRISPR Dangers Highlight the Need for Continued Research on Human Gene Editing” →

Gene Editing: God’s Will or God’s Won’t

Bioethics in the News logoThis post is a part of our Bioethics in the News series

By Leonard M. Fleck, PhD

Give God a rest; do your own gene editing (and thinking). On August 2, 2017 the New York Times headline read, “In Breakthrough, Scientists Edit a Dangerous Mutation from Genes in a Human Embryo.” The mutation was of a gene called MYBPC3, and the result of that mutation is a disease called hypertrophic cardiomyopathy. This disease affects 1 in 500 people. Its victims are typically young athletes. CRISPR-cas9 is the technology used to accomplish the gene editing. More precisely, a synthetic healthy DNA sequence was injected into an egg cell fertilized by a sperm cell with the mutated gene. This healthy DNA sequence was supposed to be copied into the newly created embryo. In fact, however, the maternal DNA was copied, thereby correcting the paternal mutation in 72% of the resulting embryos. A total of 54 embryos were created, later destroyed, after genetic analysis had been done. The remaining embryos were genetically mosaic. This research received worldwide attention.

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Image description: a black and white image of an 8-cell human embryo, day 3. Image source: Wikimedia Commons.

I want to raise two questions. How should we assess this research and its future possible uses from an ethical perspective? How should we assess public policies designed to regulate this research now and in the future? I am going to give more attention to this latter question in the context of a liberal, pluralistic, democratic political culture because many people would demand that the research itself be outlawed, not just regulated. The relevant question to ask is this: What sort of justification must be given for regulating or banning gene-editing technologies used to create or modify human embryos? The short answer I will defend in response to that question is that regulations must satisfy public reason and public interest requirements (as explained below).

From an ethical perspective, gene-editing technology represents considerable potential benefit, as the example of hypertrophic cardiomyopathy above suggests. At least 200 single-gene disorders could be corrected at the embryonic or pre-embryonic level, thereby preventing premature death or substantial diminishment of quality of life in these future possible children (as well as potential descendants of those children). To be clear, no gene-editing technology is ready for clinical application. Off-target effects remain a problem. From an ethical perspective, the risk-benefit ratio of such interventions today weighs too heavily on the risk side. Researchers, however, are confident that these risks can be overcome.

Assuming that the safety issues can be effectively managed, another ethical objection is that these future possible children (maybe for several generations) would not have consented to such fundamental interventions. I do not see this as a compelling objection. Parents today must consent to very risky surgery or other medical interventions in a two-year old child that could result in the death of that child or substantial lifelong impairment. We have to trust the judgment of parents and physicians in such circumstances. We have to believe they are all acting in the best interests of that child (absent compelling evidence to the contrary). This seems perfectly analogous to what would be occurring with gene-editing of an embryo. (For a broad overview of relevant ethical principles, see Wolpe et al., 2017.)

I now want to switch to concerns in the context of public policy. What sort of political justification would be needed to legitimize the complete banning of gene-editing research on human embryos? Here are two answers that are entirely “out of bounds” in a liberal, pluralistic society: (1) doing gene-editing of embryos is “playing God,” and (2) destroying embryos should never be regarded as an acceptable part of medical research.

The phrase “playing God” invokes amorphous religious associations, deliberately and arrogantly engaging in some life-or-death activity that is the exclusive prerogative of God. However, if this is supposed to be a compelling argument for public policy purposes, then large areas of medical practice would have to be outlawed as well. It might well be the will of God that I die from my heart attack, but I still want my surgeon to be agnostic and do the bypass surgery needed to save my life. God is typically described as being omnipotent, though millions of embryos are created annually with thousands of serious genetic disorders. Allowing those future possible children to suffer the awful consequences of those disorders by forbidding the development of the technology that could correct those disorders looks like willful social negligence, not impiety.

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Image description: a bone cancer cell (nucleus in light blue) at the microscopic level. Image source: ZEISS Microscopy/Flickr Creative Commons.

Critics of gene-editing rail against the possible, speculative harms this technology could unleash on future generations of children, all the while ignoring the very real harms current actual children are having to suffer as a consequence of these genetic disorders. This is not just shortsighted; it is ethically and politically perverse. Virtually everyone agrees that it would be premature today to do embryonic gene-editing with the intent of bringing that future possible child to birth. However, nothing would justify laws that would forbid going forward with the research until such time as it would be safe to introduce into the clinic.

Some religious critics will object to the destruction of embryos that will be integral to the development of this technology. We noted above that 54 embryos were created and destroyed in connection with the hypertrophic cardiomyopathy research. Some religious critics will see those embryos as having the moral status of persons with the same rights as you and I. However, this is where public reason must be invoked as the appropriate basis for formulating policy in a liberal, pluralistic society.

Public reason (Rawls, 1996) must be neutral or agnostic with respect to all religious belief systems or other comprehensive worldviews. From an objective, scientific perspective embryos have no capacity to feel pain, no consciousness, no interests, and no personal identity. Embryos are not mini-persons. Some religious adherents may believe otherwise. They are free to affirm that belief in the private social space of their religious community. However, they may not seek to create laws that would effectively impose that belief on citizens who did not share that belief. This would be an illegitimate, illiberal use of the coercive powers of government unless they were able to justify such laws through an appeal to public reasons and related public interests.

Public reasons are reasons that all free and equal reasonable citizens as citizens can accept as reasonable, as consistent with the best science and fair terms of cooperation in a just society. Public reasons are the currency of rational democratic deliberation. Public interests are interests that all citizens have, and that could not be adequately protected or enhanced without the use of the coercive powers of government to control those who would threaten those interests. Protecting air and water quality would be a clear example of a public interest.

A liberal, pluralistic society recognizes and respects many reasonable ways of living a good life. Individuals are free to order their lives in accord with many different reasonable values that do not represent a threat to the rights of others or to various public interests. Consequently, such a society will accept that some people will refuse to use gene-editing technology in the future to alter the genetic endowment of their future possible children. This is political respect for procreative liberty.

It would be illiberal and illegitimate for some political group to use the coercive powers of the state to force religious individuals to use gene-editing technology, contrary to their religious beliefs. Likewise, these religious individuals must be mutually respectful of the procreative liberty rights of others to use gene-editing technology to alter the genetic endowments of their future possible children. This would include paying taxes to support the medical and scientific research needed to develop safe and effective versions of embryonic gene-editing, keeping in mind the taxes needed to pay for the health care needs of children born with cystic fibrosis or muscular dystrophy or any number of other medical problems that could have been avoided with judicious gene-editing.

In conclusion, there can be reasonable disagreement regarding various uses of embryonic gene-editing technology. However, that disagreement will have to invoke public reasons and public interests. God’s will and God’s won’t are not public interests.

Fleck smallLeonard M. Fleck, PhD, is a Professor in the Center for Ethics and Humanities in the Life Sciences and the Department of Philosophy at Michigan State University.

Join the discussion! Your comments and responses to this commentary are welcomed. The author will respond to all comments made by Thursday, December 14, 2017. With your participation, we hope to create discussions rich with insights from diverse perspectives.

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Defining The Spectrum of “Normal”: What is a Disease?

Bioethics-in-the-News-logoThis post is a part of our Bioethics in the News series

By Jennifer Carter-Johnson, JD, PhD

The world of Gattaca once seemed a faraway place where some babies had genetic defects corrected before birth resulting in two classes within society. However, a recent report that a Swedish scientist, Fredrik Lanner, has begun to edit the genome of healthy embryos has made the movie seem ever more probable. This report follows on the heels of reports from China that two teams have edited non-viable embryos to correct for a blood disease and to make the embryos more resistant to HIV infection. Embryo gene editing experiments have also been approved in the UK, and while the U.S. National Institutes of Health refuse to fund such experiments, some state funding agencies are beginning to consider it. The eventual goal of these experiments is to correct genetic diseases at conception, saving people from living lives with Huntington’s disease or with genetic predispositions for heart disease or breast cancer.

Part of the DNA sequences from the human genome
Image description: a page of a book displays part of the DNA sequences from the human genome. Image source: Flickr Creative Commons.

There are a myriad of concerns connected with the editing of human embryos as discussed in the reports mentioned above. Usage of embryos for any research is controversial since some believe that embryos should have rights equal to a born person. Beyond the basic question surrounding all embryonic research, scientists have questioned whether we should be creating designer babies, citing concerns that the use of embryo editing might inadvertently create new diseases. Additionally, access to the technology might be limited due to the high cost, giving rise to a situation where those who can afford to edit their child’s genome will have the advantages of selecting for children who are highly intelligent, highly athletic and low health risks. In a society where class inequalities are becoming ever more pronounced, use of embryo editing could exacerbate the problem by unevenly allocating not only resources but also abilities to those with money.

Perhaps one of the most difficult questions to be answered relates to which genes should be modified. As an abstract concept, using embryonic gene editing to cure a disease is more palatable to many than choosing eye color and height, but identifying a “disease” may be more complicated than it looks. As researchers identify the genetic basis for conditions that impact a person’s health, it forces us to ask if those conditions are diseases or merely a variation on the normal of human existence.

Some mutations that increase susceptibility to disease are actually beneficial mutations in the response to other diseases. The mutation that leads to sickle cell anemia protects against malaria in people who only have one copy of the mutation. Mutations in the T cell receptor CCR5 make a person more susceptible to psoriasis and infection by West Nile Virus but protect against HIV and smallpox infections. Obviously, we don’t know all the mutations that are beneficial against diseases, merely that some people get more or less sick when confronted with certain pathogens. It is possible that super-healthy, specifically-designed children would be ill-equipped to defend against an emerging disease where some members of a genetically diverse population would have protection.

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Image description: a bright blue frame surrounds an artist’s embroidered rendering of the human chromosome map. Image source: Flickr Creative Commons.

Other disease-causing genetic mutations may also shape traits that society views as a positive. For instance, some research links the genetic predisposition for bipolar disorder with high IQ and enhanced creativity. Would the individual or society benefit from ameliorating the former at the cost of decreasing intelligence and creativity? Conversely, if the intelligence and/or creativity are genetically linked to bipolar disorder, well-meaning parents, seeking to increase the potential of their child, may exacerbate a genetically related mental illness.

Finally, one person’s disease is another person’s normal, community and heritage. Deaf parents often resist cochlear implants in their deaf children. These parents don’t view deafness as a disability but rather a community with its own language and customs. This view stands in contrast to the views of many in the hearing community who view deafness as a defect to be cured. Indeed, most deaf people function well in both deaf and hearing areas of society. If embryonic gene editing became a norm, deafness might be “fixed” – a process that some in the deaf community would liken to genocide. Similarly, many in the autistic community refuse to define themselves as having a disease. Not too long ago, homosexuals were considered mentally ill, a view that has become anathema as research into and acceptance of alternate views of sexuality have grown. Understanding the genetic underpinnings of autism and homosexuality would open them to a similar debate about embryo editing.

Some variations from normal are not diseases, they are merely differences. Some diseases or predispositions to diseases mask a greater benefit to the person or to society as a whole under certain conditions. Still others are life threatening diseases that carry little to no benefit as compared to the harm. We don’t always recognize these alterations for what they are, which makes determining which genes to modify a very difficult task as embryo editing becomes more feasible.

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Jennifer Carter-Johnson, JD, PhD, is an Associate Professor of Law in the College of Law at Michigan State University. Dr. Carter-Johnson is a member of the Michigan State Bar and the Washington State Bar. She is registered to practice before the U.S. Patent and Trademark Office.

Join the discussion! Your comments and responses to this commentary are welcomed. The author will respond to all comments made by Thursday, November 3, 2016. With your participation, we hope to create discussions rich with insights from diverse perspectives.

You must provide your name and email address to leave a comment. Your email address will not be made public.

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Designing Children: Patents and the Market are not Sufficient Regulation

Bioethics-in-the-News-logoThis post is a part of our Bioethics in the News series. For more information, click here.

By Jennifer Carter-Johnson, PhD, JD

In an October report entitled “Breeding Out Disease,” 60 MINUTES correspondent Nora O’Donnell reported on the use of pre-implantation genetic diagnosis (PGD) to screen embryos produced during in vitro fertilization (IVF) procedures.i PGD allows doctors to determine if an embryo contains a gene that will lead to disease or increased risk of disease after birth. PGD currently can be used to screen for diseases caused by a single defective gene. Examples of such diseases include cystic fibrosis, Tay-Sachs, muscular dystrophy, sickle-cell anemia, hemophilia, and Huntington’s disease as well as certain types of cancer and some types of early onset Alzheimer’s. For parents who know that they carry a family risk of these diseases, PGD can relieve fear about some of the diseases that their child will face.

DNA-vials
Source: Flickr Creative Commons

The report also described a relatively newly developed patented process that can be used in concert with PGD. The process, and the company that sells the service, is called GenePeeks. GenePeeks uses DNA profiles from a potential set of parents to determine the likely genetic profiles of children from that couple. Couples can then use that information to determine the diseases towards which to direct any PGD screening. However, the patent for the GenePeeks process is written quite broadly and contemplates screening for not only diseases but also over 500 other traits such as eye shape and color, sex, the ability to roll one’s tongue, social intelligence and cognitive abilities.ii While prospective parents don’t quite have the technology to specifically pick and choose the traits, à la the movie Gattaca,iii they would be able to predict and select either for, or against, genetic traits that the child might possibly naturally inherit.

In spite of the peace of mind many prospective parents receive from using these two technologies, a host of ethical and regulatory issues surround them. For instance, the extent to which parents should have the ability to tailor the genetic traits of their children is completely unregulated. Additionally, the disposition of unused embryos is controversial; embryos with disease-causing mutations are usually discarded, and excess embryos are often frozen indefinitely. Other uses for excess embryos, such as stem cell research, are equally fraught with controversy. Beyond such embryonic issues, a cycle of IVF and PGD will cost around 20,000 dollars, making access to this aspect of reproductive technology and disease-screened offspring a luxury. Also, once the DNA of a parent or child is sequenced, the potential exists for insurance companies and employers to discriminate based on genetic profile, and databases of DNA profiles could additionally be matched against forensic data from crime scenes.

In light of these potential problems, Nora O’Donnell interviewed two of the developers and patent owners related to the technology. She independently asked each one what regulations should be in place to keep PGD and GenePeeks limited to disease testing. The responses of the two men interviewed were essentially the same – and essentially wrong. Each explained that due to patent exclusivity few can practice the technology. Both doctors promised to act as gatekeepers for the technology and use it exclusively for screening for disease in embryos and conducting related disease research, rather than crafting designer children – even though such designer activities were explicitly described in the GenePeeks patent. “Trust us,” seemed to be the echoing cry.

However, the number of people who can sell a technology at a given moment has little bearing on whether a technology will need to be regulated. The number of patients GenePeeks and the PGD firm see each year number in thousands. Moreover, patents can be licensed broadly fairly quickly, increasing the reach of the technology even further. Once the patents expire, twenty years after filing, everyone will be free to offer the service for sale. More importantly, and problematically, the issuance of a patent does not indicate that a technology is being used ethically.

Patent law is technologically neutral. In 1980, in the case of Diamond v. Chakrabarty, the Supreme Court determined that “anything under the sun that is made by man” can be patented so long as the new technology is useful, novel and non-obvious. The Chakrabarty case dealt with the patentability of genetically modified bacteria and is credited with ushering in the biotechnology industry.

Furthermore, the same Chakrabarty Court recognized that patents may incentivize technology that needs regulation. In the discussion of the technology underlying genetically modified bacteria, the Chakrabarty Court contemplated a “parade of horribles” that could result if this underlying genetic technology were patented and encouraged. Among the potential problems discussed were the spread of pollution and disease, loss of genetic diversity and a devaluation of human life. The Chakrabarty Court then invited legislatures to pass any laws to regulate this new biotechnology by a “balancing of competing values and interests.”

Congress and various administrative agencies have answered that invitation in a myriad of circumstances and in as many distinct ways. Concerns over cloning and human ownership led Congress to forbid any patents directed toward a human organism.v The development of genetically modified crops and animals resulted in a multi-agency co-operative regulatory regime encompassing the Food and Drug Administration (FDA), the US Department of Agriculture and the Environmental Protection Agency.vi The Genetic Information Nondiscrimination Act (GINA) of 2008 prohibited discrimination in health coverage and employment based on genetic information.vii The FDA has promulgated rules for DNA research and the safety and efficacy of the resulting new biologics as well as the informed consent of volunteers for related clinical trials.  This oversight has not been limited to Federal laws and regulations as state legislatures have dealt with family law issues such as surrogacy agreementsviii and ownership of frozen embryos.ix

As the PGD and GenePeeks technologies develop, so too must the laws and regulations surrounding their use. Recently, the FDA announced new guidelines for proving the safety and accuracy of genetic tests. However, testing accuracy does not address whether the tests should be used in a capacity beyond disease diagnosis. As these technologies demonstrate, inventors and patent owners may be smart, and ethical, but they do not necessarily speak for all segments of society and they are at least in part generally profit-driven. Society needs to consider precisely potential problems beyond technical ability and rather than waiting to react, judiciously guide a growing industry.

References:

i Breeding Out Disease, 60 MINUTES. Last accessed at http://www.cbsnews.com/news/breeding-out-disease-with-reproductive-genetics/.

ii  Method and system for generating a virtual progeny genome, Patent #8620594 (filed Aug 22, 2012).

iii Gattaca, Sony Pictures Entertainment (1997).

iv  Diamond v. Chakrabarty, 447 U.S. 303 (1980).

v America Invents Act of 2011 (Pub. L. 112–29, § 33,Sept. 16, 2011, 125 Stat. 340(enacted September 22, 2011).

vi Emily Marden, Risk and Regulation: U.S. Regulatory Policy on Genetically Modified Food and Agriculture, 44 B.C.L. Rev. 733 (2003).

vii Genetic Information Nondiscrimination Act of 2008 Pub.L. 110–233, 122 Stat. 881 (enacted May 21, 2008).

viii Guide to State Surrogacy Laws. Last accessed at https://www.americanprogress.org/issues/women/news/2007/12/17/3758/guide-to-state-surrogacy-laws/.

ix  See, e.g., Szafranski v. Dunston, 993 N.E.2d 502 (2013).

Jennifer Carter-Johnson, PhD, Jj-carter-johnsonD, is an Associate Professor of Law in the College of Law at Michigan State University. Dr. Carter-Johnson is a member of the Michigan State Bar and the Washington State Bar. She is registered to practice before the U.S. Patent and Trademark Office.

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