This 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.
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.
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, JD, 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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2 thoughts on “Designing Children: Patents and the Market are not Sufficient Regulation”
Jennifer, you suggest in this interesting commentary that the use of this technology should be confined to screening embryos for undesirable traits like diseases, rather than desirable, non-disease traits like eye color.
But you don’t say why. Aside from demonstrating how shallow I am, why would it be wrong of me to make sure my child was born with blue eyes rather than green? Or, more seriously, born with high rather than average intelligence? In the first case, my child is no worse off for having blue eyes. And in the second, she’s actually better off than the child who would have otherwise been born.
Do we really need to worry about the homogenization of our humanity, where nearly everyone is blue-eyed and smarter than average (apologies to Garrison Keiller)? It doesn’t seem very likely to me, given the high cost (and medical discomfort and risk) of IVF and PGD. And given the highly non-instrumental way most of us will keep on making babies.
I know I’m drifting into deep waters. Could you throw me a line?
I deliberately left that discussion out of this post so as to not distract from the point that we should still be having the discussion even in the face of technology and patent exclusivity. With that being said, there are a number of reasons, IMO, to be concerned about the widespread use of IVF and PGD with no regulations.
First, the gap in access due to the high cost could give rise to a situation where those who can afford PGD 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 PGD could exacerbate the problem by unevenly allocating not only resources but also abilities to those with money. Medical discomfort and risk are also likely to decrease as the technology is better developed – especially if an artificial womb is perfected.
Overcoming the gap in access, however, raises another issue – the potential loss of genetic diversity. Some disease causing genetic mutations are beneficial in the face of other diseases. For instance, the mutation that leads to sickle cell anemia protects against malaria in people who are heterozygous for the mutation. Mutations in the T cell receptor CCR5 makes a person more susceptible to infection by West Nile Virus but protects against HIV and smallpox infections. We don’t know all the mutations that are beneficial against diseases. It is possible that super-healthy, PGD-designed children would be ill equipped to defend against an emerging disease where some members of a genetically diverse population could have such protection.
Finally, expansion of the usage of PGD raises the questions of how we define disease and what attributes society would want to encourage. For instance, selection for embryos that are carriers of the mutation for malaria resistance/sickle cell anemia would preserve the malaria resistance in case it becomes needed in the future, but selection for embryos free of the mutation would relieve descendants from the worry of sickle cell anemia. Additionally, the definition of disease or disability may vary. Many in the deaf community view deafness not as a disability but as a minority cultural group. Should parents be able to select for deafness as well as against it – even if society must pay for accommodations for non-hearing members?
None of this is to say that there is a moral imperative that we must regulate the technology in a certain way. In fact, the pathway for regulation is so unclear because many of these arguments pit the needs/wants of society against the needs/wants of the individual.
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