By Jaydee Hanson

Jaydee Hanson is CTA's Program Director for Human Genetics.

Spanning over a decade of legal initiatives, research, and coalition building, the International Center for Technology Assessment (CTA) has been at the forefront of human genetics issues.  Currently, CTA is working to halt or limit eugenic practices through legal paths including regulatory work and litigation. CTA is working to (1) ban eugenic practices including human cloning and germline intervention, such as human-animal hybrids; (2) create a restrictive regulatory regime to prevent eugenics practices such as pre-implantation genetic screening and genetic screening in employment or insurance; (3) work to bar the patenting of humans and other higher life forms, including the patenting of elements of those life forms (genes, organs, cell lines and embryos); and (4) spread the anti-eugenics message and significantly expand the coalition working on these critical issues.  Realizing the need for bipartisan coalition building among a variety of constituencies and stakeholders, CTA has been educating legislators from all parties on these issues.  CTA utilizes grassroots organizing and media outreach to create a significant public movement in opposition to the new eugenics revolution. CTA uses a variety of materials, including reports, articles, editorials, list serves and advertisements to increase public awareness of the issue.

The New Eugenics

The advent of genetic manipulation techniques gives humans tremendous power to control the DNA of everything from food to animals, including human beings.  Genetic manipulation of human beings may potentially combat genetic diseases, but it would also alter the genetic make-up of future generations.  As this technology evolves, will prospective parents be able to control the traits of their children?  A recent study by the Genetics and Public Policy Center found that nearly three-quarters of U.S. IVF clinics now offer pre-implantation genetic diagnosis and forty-two percent of clinics provide non-medical sex selection services.  As researchers claim new "links" between certain genes and non-medical traits, an increasing number of prospective parents will likely test embryos for traits that may or may not actually be genetically linked. The next step towards direct human genetic engineering may take place in the IVF labs. A 2004 poll by the Genetics and Public Policy Center found that 20% of those surveyed approved of genetic engineering to create desirable traits (76% disapproved). Another survey found that over a third of people surveyed would choose genetic modifications of their children to ensure that the children had an "appropriate" sexual orientation.

The IVF industry is virtually unregulated due to the stand-off in this country between "pro-choice" and "pro-life" constituencies.  The last federal attempt to regulate the IVF industry was tabled in 1981 by President Reagan who thought the regulations drafted during the Carter Administration too readily approved of the manipulation of embryos.  As a result, IVF labs are only barely regulated by the various states, and at the federal level they essentially only have to report on their success rates.

The passage of stem cell legislation in the House and Senate and its expected signing into law by the next President will result in regulations for federal funding of research on embryos, likely including additional regulation of IVF clinics where the embryos designed for stem cell research are stored.  We have been meeting with members of the feminist and pro-choice community to identify how we can make a difference in federal regulations and legislation and draw more attention to the eugenic aspects of the industry without threatening couples' privacy rights.

We will continue to work with the feminist and pro-choice community to develop legislation that can pass in the next Congress, and we will work with our broad coalition to develop regulations aimed at stopping the implantation of cloned embryos.

Gene Therapy

We are in the final stage of completing a report examining the serious problems with gene therapy.  Fifteen years ago, gene therapy was approved as a panacea for all illnesses.   Like embryonic stem cell therapy today, gene therapy promised to cure diabetes, Parkinson's, and many other diseases.  Our review of the FDA and NIH files obtained through a freedom of information request makes clear that this research has not yet resulted in any cures, but has caused many patients and their families much additional suffering and has even caused additional deaths that are linked to the therapy itself.  In short, the scientific understanding of what a gene is was seriously misrepresented.  Very few diseases are caused by a single gene.  For example, in the case of Severe Chronic Immune Deficiency, the gene therapy itself resulted in the first genetically engineered leukemias in a third of the patients who survived the therapy.

We will release the report along with a documentary that our executive director, Andrew Kimbrell, is working on related to the "gene" myth.  At this time, CTA is investigating new avenues to have more extensive federal review of the gene therapy experiments funded by the US Congress.

Stopping Genetic Discrimination in Insurance and Employment

Genetic discrimination occurs when an entity or individual treats a person, family, or group differently based on that person, family, or group's real or perceived genetic status, particularly with regard to future health, life span, or tendency toward a certain behavior. The root of genetic discrimination is the theory that particular human characteristics and abilities are determined by genes, coupled with society's accumulated myths, fears and stereotypes about people with a wide range of disabilities and chronic health conditions. The major achievement of the present Congress was the passage of the Genetic Identity Non-Discrimination Act (GINA). The US Senate had twice passed legislation that would ban genetic discrimination in employment and in health insurance, but when the House finally passed its bill, a conservative Senator held up the legislation. Our staff helped negotiate an agreement between pro-choice and pro-life groups that led to final passage of the bill without weakening it.  In the next Congress, we need to work to see that the provisions of this bill are extended to members of the U.S. military, a group that was excluded from GINA.

Challenging Gene Patents

Thousands of patent applications have been filed with the United States Patent and Trademark Office for human genetic material.  Patents covering human genetic material are a recent and controversial development, but already more than 20% of human genes have been patented.  Gene patents claim exclusive control over naturally occurring human genes and limit the use of genes in research and diagnosis. In November 2005, the National Academies of Science recommended modifying the patenting system so that patents do not impede research on diseases or techniques to diagnosis and treat them.

Because many gene patents either directly claim or include genes and/or the corresponding proteins that are essential to genetic diagnosis, a grant of exclusivity may hinder both health care and the advancement of scientific technology.  Patents can obstruct future innovations by preventing researchers from looking for alternative uses for a patented gene.  Gene patents are also attracting opposition worldwide because they grant their holders certain exclusive rights over specific sequences of human genes for 20 years from the date of filing the application.

Gene patent holders often use their exclusive control over genetic material to charge excessive fees for diagnostic testing and to prevent other researchers from utilizing the specific genetic sequence for further research.  Patents held by a company on one or two genes may prevent another company from offering a test that covers all known genetic mutations.  As a result, a patient may be told that he or she does not have a gene that causes a certain kind of cancer only to learn later that he or she has another gene that also causes the cancer.  This already happens with breast cancer gene testing.  A study published in 2006 found that 12% of those from high-risk families with breast cancer and with negative (wild-type) commercial genetic test results for BRCA1 and BRCA2 nonetheless carry other mutations that could lead to cancer.

Amazingly, even human embryos have been patented (in Europe, but not yet in the U.S.).  We have successfully blocked the U.S. Patent and Trade Office from patenting human embryos by attaching riders to the Commerce Department appropriations bill, but with a new Congress, we plan to push for legislation permanently banning human embryo patents.

In the next two years, we will:

1) Challenge gene, plant, animal and human embryo patents at international meetings of the World Intellectual Property Organization and in U.S. courts, and pursue opportunities to change U.S. law to severely curtail and prohibit these kinds of patents.

2) File legal challenges to key patents as another way to dispute what we believe is the unconstitutional granting of patents of genes and life forms.

3) File a legal petition requesting a review of all human gene patents pursuant to recent research showing that even correctly "spelled" codons (DNA sequences) in genes do not act as predicted in the gene patents.

4) Work to pass legislation to ban or limit the granting of gene patents.

Preventing Human Cloning

Since the cloning of Dolly the Sheep was announced to a startled world in February of 1997, the specter of human cloning has hung over all debates on human genetics.

From the start, the debate was focused not on cloning animals but on cloning people.  In 2004, a South Korean team of researchers led by Dr. Hwang Woo-Suk claimed to have successfully used the process by which Dolly was cloned to create 11 human stem cell lines - something that was feared by many and hoped for by others. However, in late 2005, a scandal erupted over the falsification of these claims and numerous other violations of scientific ethics surrounding this research. Now, Dr. Hwang is partnering with a California promoter to earn money from dog cloning.

While cloning of human embryos has not yet been demonstrated to succeed beyond a few cells, the debates over human cloning have gripped many nations, drawn in multilateral organizations like the United Nations and the Council of Europe, brought corporate biotech lobbyists into action, and had the unexpected effect of sparking co-operation between such seemingly strange bedfellows as pro-life activists, environmentalists, and liberal feminists. The International Center for Technology Assessment has worked at the United Nations, in the U.S. Congress, and in various state legislatures to stop all human cloning experiments.  Thus far we have been successful at keeping funding for human cloning off proposals in the U.S. Congress to fund stem cell research.

The challenge facing public policy has been how to prevent human cloning and at the same time how to resolve the question of the research use of cloned human embryos. So-called "therapeutic cloning," intended to produce one-on-one medical treatments through the cloning of an individual patient to obtain stem cells from the embryo, would require the clonal manufacture of hundreds of millions of embryos using the eggs of hundreds of thousands of women - if it works.   Meanwhile, the use of "adult" stem cells - from cord blood or various parts of the adult body - has begun to yield rich clinical results. The recent development of pluriopotent stem cells from genetically engineered adult cells has only slightly slowed the call for cloning of human embryos. The difficulty in obtaining eggs from women for research, however, has prompted a renewed interest in human-animal hybrids as research tools.

Both the House and the Senate have nonetheless passed an embryonic stem cell measure that does not include human cloning. Individual states have taken various positions. Many foreign countries have enacted comprehensive cloning bans, including Canada, Italy, and Germany, and the United Nations General Assembly passed a resolution recommending that member states ban all forms of human cloning.

Three challenges face our efforts in the next two years:

1) While Congress is likely to pass a bill approving embryonic stem cell research on embryos left over from IVF embryos, researchers in states that have approved cloning embryos for stem cell research will continue to press for federal funding of the work.

2) Some "Right to Life" groups advocate genetically engineering and cloning defective embryos that cannot develop into fetuses.  This has provoked a fierce debate within the "Right to Life" community, but has champions in both the Bush White House and Congress.  We still need to work to block this kind of cloning as it will provide funding for other human cloning efforts.

3) The U.S. FDA approval of foods deriving from animal clones for human consumption presents a new challenge to our efforts to enact legal prohibitions on human cloning.  If animal cloning becomes more widely accepted, it may become a funding source for the scientists that will attempt human cloning.  CTA plans to conduct policy briefings for Members of Congress and their staff and for representatives of the US administration on the various issues related to the dangers of human cloning, including genetic changes caused by the cloning process (including the use of cloning for genetic engineering), the large number of eggs required from women for cloning experiments, and the high failure rate of cloning experiments in animals. We have developed background papers on human and animal cloning for these briefings. We will also work with those parts of the pro-choice and pro-life community that oppose all kinds of cloning to assure that federal funding for all kinds of cloning is prevented.

Challenging DNA databases

Across the U.S., state after state is approving DNA databases, ostensibly to better solve criminal cases; but the expansion of these databases to include anyone even stopped for a minor crime and to include the family members of suspected criminals represents a major challenge to genetic privacy.  Recently, the National Institutes of Health announced that its databases may be used for research that the samples were not originally intended for.

DNA has tremendous identification potential.  The genetic information it provides describes our individual lineage, pre-disposition to disease, physical characteristics, and likely much more that we haven't yet discovered.  As such, people have a strong interest in the privacy of their DNA.

Governments need to recognize importance of individual privacy and balance privacy interests with research and criminal justice needs when determining policies of DNA collection, profiling, and retention.

Finally, while certain Congressional members have worked with us in the past to keep human cloning at bay, we need to double our efforts to educate the new Members of Congress and the new Administration as to why no one should see human cloning or genetic engineering of humans as the way to achieve healthier people.


Jaydee Hanson became CTA's Program Director for Human Genetics in 2004.  From 1981 to 2004, he was staff director of genetics and bioethics issues for The United Methodist Church, and he was the church's legislative director from 1991 to 2004. Email:

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