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BLOODLINES
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Ask the Experts

Our experts:
* Patrick Coyne, J.D., Patent Attorney
* Susan Ring, Gestational Surrogate
* Mark Rothstein, J.D., Law and Ethics Scholar
* Bonnie LeRoy, M.S., C.G.C., Director, Genetic Counseling Program
* Stuart Newman, Ph.D., Developmental Biologist
* Nanette R. Elster, J.D., M.P.H., Law and Ethics Scholar

Many of the following questions refer to stories in the film BLOODLINES: Technology Hits Home. Please see the end of this feature for descriptions of those cases.

The Expert: Patrick Coyne, J.D., Patent Attorney

Q: How much is money driving this technology and what role does the patent process play?
A: Lots and lots. Tremendous amounts of money—billions of dollars—are involved. The patent process is a critical part of our economy, and in particular, the systems for developing new drugs and treatment therapies.

We often take innovation for granted. Developing a new therapy or drug requires the investment of millions of dollars, often hundreds of millions. Candidate compounds must be: screened; characterized; evaluated relative to hundreds or thousands of alternatives; developed into a workable therapy or drug; and tested. This requires carefully controlled, human trials before a new drug is approved by the Food and Drug Administration (FDA).

All of this costs money, lots of money, and takes years of effort. Add to that the fact that many promising candidate compounds end up not working out for various reasons. They may: not be more effective that the existing therapy; raise safety concerns; have undesirable side effects; or the market for the therapy may not be big enough to enable the manufacturer to recover its research and development costs and earn a reasonable profit.

Innovators will not make this magnitude of investment if competitors could free-load off their development effort and simply copy the new product. Copyists could charge a lot less than the innovator because they will not have to charge enough to recover their investment in research and development, and will be able to sell their product at a much lower price. Consequently, innovators want some assurance of being able to make a profit on their investment. Patents give the innovator the ability to exclude others from selling their innovation in competition with them for a limited period of time, currently 20 years. This ability to sell—without copyists undercutting your price—allows the innovator to recover its investment and make a profit.

The public ultimately determines what a patent is worth. Most patented inventions are not commercially successful. Some estimates claim that only about 2% of issued patents even generate enough money for their owner to pay back even the legal expenses of getting the patent, let alone the research and development cost of making the invention in the first place.

A patent does not give the innovator the right to sell anything. It simply gives the patentee a "veto" to keep others from making, using, or selling the invention, without the patentee's permission. Anyone who wants to sell the invention must still comply with all other applicable laws, such as the antitrust laws, food and drug laws, and environmental laws.

The reason we have patents is not to benefit the inventor but to benefit the public. The inventor is required to disclose the invention to the public. Although the Patent Office keeps the application confidential until it issues, once it issues, the invention is published for all the world to see.

This provides two very important benefits. First, the patent covers only what the inventor disclosed and claimed as his invention. Patents do not protect ideas, only the way they are expressed. Everyone is free to read the patent and improve upon the invention. That is one of the goals of the patent system: by disclosing the invention and allowing the inventor to charge more than he or she could if competitors could copy the invention, competitors have an incentive to improve the technology further and make their own inventions. More new ideas are available to the public.

Second, after the patent expires, everyone is free to use the invention without having to pay the innovator anything. The invention becomes part of the public domain of ideas, enriching society as a whole.

Q: What is your opinion on gene patenting and how does it differ from the chimera patent story?
A: There is a substantial issue in gene patenting that is not raised by the chimera application. The chimera is not naturally-occurring; it is man-made. Although genes may also be made by man, a multitude of genes are naturally-occurring. Some patents have been filed for naturally-occurring genes. A few years ago, I identified over two hundred claims that had been allowed by the Patent Office for "isolated and purified" genomic sequences. Some of these sequences occur naturally in the human body. The Patent Office has been reviewing these types of claims much more carefully in recent years and is now requiring that the Applicant demonstrate that the genomic sequence be useful for something other than its natural function.

Many more patents have been filed for genetic sequences that have been modified in some way. Although the starting material may be naturally occurring, the subject matter has been modified—made by man—and is not naturally occurring.

Two older cases held that isolating and purifying a substance is not enough to get a patent. Years ago applications were filed for isolating and purifying elements, such as uranium and tungsten, from their ores. The courts held that, although the process for refining the ore may be patentable, the isolated and purified element was not.

The analogy is very close for gene patents. Although the processes and equipment for gene sequencing may be patentable, the resulting "isolated and purified" "genomic sequence," that is merely "refined' from the naturally occurring gene, is not new.

Q: What about the issue of the technology just going overseas? What do other countries do about patents or experiments like this one?
A: Much of this technology is not only "going overseas," it is already there. Some foreign countries have addressed these issues; most have not.

For example, China has an extremely active biotechnology industry. The Chinese Government is actively supporting the development of biotechnology as a national priority. Although China currently restricts human genetic experimentation, those regulations could be changed. Reports have been published of work being done on these issues in spite of the restrictions.

The European Union (EU) has addressed some of these issues formally, such as the patenting of a human. The EU has restricted patenting of human genetic research more definitively than has the U.S. Nonetheless, Researchers in Italy—as well as researchers in the U.S.—have reportedly combined bovine (cow) and human cells and allowed an embryo to develop, at least partially.

The U.S. allows limited stem cell research and several patents have been issued to various researchers who are active in this area. Congress has not yet addressed these issues directly.

As with any other commercial activity, there is a free market in research and development. This work is, and will continue to, gravitate to nations that are more liberal in allowing research, and providing support for, these technologies.

Q: Aren't there laws related to patents that make such morally suspect cases impossible?
A: Whether a case is "morally suspect" is in the eye of the beholder. One person may be offended by any form of what they consider cruelty to animals, while many people enjoy a good hamburger. One may be offended by the notion of creating a chimeric animal that looks, and may even act, human. Yet, if you were dying of a condition that was untreatable, and the only hope of a cure or at least extending your life, was to grow a replacement organ in a chimera, what would you do? Would it matter whether the organ was one that the chimera could "spare," like a kidney; or one that was critical, like a heart or lungs?

The Patent Office initially took the position, relative to the chimera application, that it had the authority to reject the application on so-called "moral grounds." Shortly after the application was filed, ABC World News Tonight ran a segment on the application. Although applications are confidential and the Commissioner rarely, if ever, speaks out publicly about pending applications, then-Commissioner Lehman took the unusual step of issuing a Press Release commenting on the application. The Press Release claimed that the Patent Office has the authority to reject an application on "moral grounds," prejudging the application before it was even reviewed by an Examiner. Once the Examiner reviewed the application, however, the Patent Office did not reject it on "moral grounds."

The Applicant challenged the Commissioner's authority to reject applications on moral grounds. Although the moral grounds argument was used almost a century ago to reject applications for morally objectionable inventions, such a gaming devices and stills, it has rarely been invoked since. There is nothing in the Patent Laws that gives the Commissioner the right to reject applications on moral grounds. Moreover, a morality rejection would inject an extremely subjective element into an otherwise systematic process of examining applications relative to the statute and regulations.

The Courts have held that the Patent Office is required to allow patents for anything that is new and made by man. Neither the Courts nor Congress have extended to the Patent Office the discretion to exclude those otherwise patentable inventions, because the Commissioner feels they are immoral.

Q: How do your other patent clients feel about this patent?
A: Some were worried, initially, that a Patent Office decision denying a patent would set a precedent that other biotechnology inventions may be rejected. As noted in the program, however, the PTO has allowed a number of similar patents that were filed after this application. Most are no longer concerned that this application will set that type of precedent.

In my experience, what business clients need most is predictability. Even if the rule is not the one they would like to see, a predictable outcome enables business people to plan their investment. The uncertainty of this critical area of the law remaining unsettled is itself a threat.

Q: How do I contact the Patent Office to challenge the patent in question?
A: The Patent Office is located in Arlington, Virginia.

Members of the public are not able to challenge patent applications. You have to have what the Courts call "standing" in order to challenge a patent application. A patent is essentially a contract between the Patent Office and the inventor. Although patents are also important to the public, members of the public do not have standing to challenge a patent simply because they do not like it or are offended by it.

It is unusual that the public could even find out about a patent application. The Patent Office is required to keep all patent applications confidential. The Applicant is free to disclose that they have filed a patent application and the Applicant did so in this case.

Patents can be challenged—after they issue—by anyone who is accused of infringing the patent.

A patent application can also be challenged by someone who thinks they invented the subject matter of the application first. In addition, a patent can be challenged—by any person—after it issues, whether or not they are accused of infringing it. They can institute a so-called "Reexamination Proceeding." A patent can be reexamined, however, only for certain specific issues relating to whether or not the invention was already described in earlier patents or printed publications.

The Commissioner has, on rare occasions, reviewed applications on his own initiative. For example, one was challenged when a foreign government complained that the applicant was trying to patent a folk remedy that was well known in the foreign country.

Q: The issue of privacy of medical and genetic information is one that should be taken up immediately by our legislatures and above all by Congress. The most obvious hazard to all of us is the threat to medical insurance, given that it is still run by for-profit corporations, but the third segment of the show reveals the threat to employment as well. Insurance was designed on the basis of reaching the maximum spread of risk and sharing the costs in the whole community. Congress, where are you?
A: I disagree with the assumption that Government is to be trusted above private commercial motivation, in all circumstances. Congress has a role, as does the private sector. The founding fathers certainly did not share the questioner's distrust of private enterprise. Rather, they feared the abuse of power by the Government. As a consequence, they left us a legal system that reflects an inherent distrust of governmental power. Beginning with our Constitution, our system provides an exquisitely detailed system of checks and balances to prevent Governmental abuse of power.

The last hundred years of economic activity have shown that neither extreme—purely commercial self-interest or regulatory control—produces optimal results. As with most things in life, the truth lies somewhere in between. In spite of popular perceptions, we Americans live in one of the most heavily regulated economies on earth. Doubtless, there will continue to be a fundamental market force behind the use and deployment of these technologies, held in check by regulatory action to prevent the most extreme abuses, as we face this brave new world.

Q: The definition of what is human is obviously an important one because we accord unique privileges and rights to humans. But how exactly do we define 'humans' when the qualities/characteristics that are believed to be uniquely human fall into expansive bell curve distributions? Where is the cutoff at which point a severely disabled person is no longer considered a human and accorded respective human rights? That scenario probably doesn't sit well with most people but given the new genetic technologies by which we can artificially distort what it means to be human shouldn't those kinds of considerations have to be made? By the same logic, is it fair to establish rights based on biological/physiological fact? Normative valuations are not simply the logical inferences of biology, so how will the bridge from 'genetics' to 'rights' be built?
A: Luckily, the principal democratic and republican Governments do not discriminate between members of our species based on where an individual falls on that bell curve. To date, we have adopted a far simpler approach of simply being a member of our species, homo sapiens sapiens. Nonetheless, other governments have discriminated based on such distinctions, depriving the infirm, handicapped, or other "undesirable" persons, rights on such grounds. Germany in the early 1940's comes readily to mind.

There is currently no cut-off, at least in our present legal framework, where someone is no longer human. Rather, we have taken an inclusive view of the issue, at least under more progressive governments.

Yes, the ability to manipulate the human genome pose starkly the question of what is human. That is why the chimera application, for example, is so important. How much non-human component is enough to make the organism, that may otherwise look and even act human, non-human? Our past approaches are not up to the challenge.

Our society has historically established rights based upon biological and physiological facts, namely, distinguishing our human species from all other animal species, in the eyes of the law. These are arbitrary, legal concepts. Ultimately, they are decisions that will have to be made by our society, collectively, including our deliberative legislative bodies, and the courts.

Please note: These comments reflect the views of the author and do not necessarily reflect the views of the author's firm or any past or current client of the author or his firm.

The Expert: Susan Ring, Gestational Surrogate

Q: How did you get into surrogacy? How much money do you make?
A: The first time I became interested in surrogacy was right after the birth of my first child and then when my little boy was a few months old, a couple that I came in contact with as I was strolling my adorable son in the stroller was admiring my son. The woman was in tears because she could not have children, my heart went out to her and I couldn't imagine anything worse in the world than not having a child. Then believe it or not, I followed Oprah on TV for a few years about finding your passion and your meaning in life, and I found mine. Each surrogacy is different in the way of monetary compensation of expenses. A typical surrogacy is $20 - 30 K made on a progressive monthly schedule as the 40 week pregnancy progresses.

Q: Are you in touch with other people who do this? Why do they do it?
A: I am in constant contact with other surrogates on a daily basis. We share information and experiences and support each other along the way. It is a web based program for surrogate mothers. Some of them do it for the same reasons I do: they are passionate about what they do. It's a feeling of the absolute gift of giving. Many do it for their own reasons, but most do it because they love the feeling of creating a family for someone who can't themselves and are happy when they are pregnant. It is a huge commitment, don't forget the endless lab, doctor appointmentss. The shots of hormones with 22 gauge needles, pills and patches as we are getting pregnant. The timing, the patience, the family of your own that has needs, the swelling of your belly, the good days and the not so good days. . . but in the end, you look into that sweet little face and know it was all worth it.

Q: Do you think most surrogates are like you, or are you very exceptional?
A: I think there are many exceptional surrogates, in fact, I know a few. They are educated in surrogacy and in childbirth and have taught me a thing or two. We share our information on a special web site just for surrogates around the U.S. It's great to have that kind of support.

Q: You are the first person who has ever made me think surrogacy could be a good thing, but after your experience how could you do it again?
A: Surrogacy is a good thing! I am passionate about what I do and when you look into the eyes of a little baby that you helped create, let alone helped start a FAMILY, there are no words. I am always in awe of the miracle of birth. The only words I could come up with are "Why wouldn't I do it again?" I am so blessed to be healthy, get pregnant easily and labor easily. There is nothing quite like life nudging and gently kicking inside your womb.

Q: How can you do something that is just selling your ability to make babies? Isn't this just rent a womb?
A: It's all a matter of opinion in whether you believe it is "selling my abilities" or "renting a womb." Although I believe your statements are judgmental, I respect your opinion and what you think and I hope you respect mine. Just because there is money exchanged in a contractual situation in surrogacy, in my humble opinion, it doesn't cheapen it at all. In fact, it provides a win-win situation and helps a childless couple become a family and helps a surrogate provide for her family and plan for her children's futures.

Q: Can you tell me a little about how your boys, who seem so NORMAL!, feel about you carrying other peoples' babies? Do they really take it so well?
A: My boys are the light of my life. I have always been very honest and open with them about surrogacy and I've always answered questions they have that pertain to their ages of understanding. The hardest thing here was that the first time I didn't bring the baby home with me. And I assured them that this was just like before, mom wouldn't bring the babies home this time either. This time I did bring the babies home with me. They didn't quite understand why someone wouldn't want their children, but I told them that their mom believed in what she was doing and couldn't let two beautiful babies not be taken care of by someone who would love them. The boys did get attached and that was a difficult thing to go through. They opened their hearts and their home and shared their mom with the twins and we all have a very special bond, along with very dear friends of mine who helped me along the way, with their families too.

Q: What happened with the twins? Do you see them? Do they know who you are? Are they okay? what about the first child you carried for that couple?
A: The twins (a healthy girl and boy) were adopted by a very special, loving family who had been through 13 failed IVF's and much disappointment in the way of having a family. One day I'll have to tell this story, it really is a miracle type of story and to all of us that were a part of it, know that it happened for a reason. They are doing great, happy and healthy, they are all so very content. The twins will know who I am as they grow up (they are only 1 year old) and their parents will tell them their special story. The first child I gave birth to is sharing joint custody between the intended mother and intended father who abandoned the twins. I pray for his health and happiness everyday.

The Expert: Mark Rothstein, J.D., Law and Ethics Scholar

Q: How can any corporation possibly validate conducting experiments on its workers? Are the workers asked prior to exposure? How is this different from something like the Tuskegee experiments?
A: All research involving human subjects should satisfy ethical standards of informed consent, balancing of benefits and risks, etc. Research conducted by employers on their workers may not be regulated by the federal research regulations, because the research is probably not federally funded. Nevertheless, ethics rules should apply, and there is even a good argument that even greater protections should be afforded workers involved in research because they are "vulnerable" and subject to coercion in their participation. For a further discussion, see Mark A. Rothstein, Ethical Guidelines for Medical Research on Workers, Journal of Occupational and Environmental Medicine 42:1166-1171 (2000).

Q: The issue of privacy of medical and genetic information is one that should be taken up immediately by our legislatures and above all by Congress. Congress, where are you?
A: There are two bills in the Senate (Sen. Daschle and Sen. Snowe) and one bill in the House (Rep. Slaughter) that would prohibit genetic discrimination in employment and health insurance. At the state level, 43 states have enacted laws prohibiting genetic discrimination in health insurance and 31 states have enacted laws prohibiting genetic discrimination in employment. The problem is that all of these laws and bills are too narrow and too weak. For a further discussion, see Mark A. Rothstein & Mary R. Anderlik, What is Genetic Discrimination and When and How Can it Be Prevented?, Genetics in Medicine 3:354-356 (2001).

Q: Would you expect to see more or less legislative guidance on issues relating to genetic and reproductive technology in the future?
A: I expect to see greater regulation on genetic and reproductive technologies, although it is not clear how long it will take to happen. Among the areas in need of regulation are the laboratories performing genetic tests and the clinics engaged in assisted reproduction technologies.

Q: What kinds of discrimination are you referring to in the film ("We know there has been medical discrimination. . .") that you think will continue or get worse with genetics?
A: Health based discrimination has been common for a long time, and it is the reason why the Americans with Disabilities Act was passed in 1990. "Traditional" health-based discrimination involved individuals who were symptomatic with cancer, epilepsy, diabetes, AIDS, mental illness, etc. Genetic testing raises the possibility that discrimination could involve currently healthy individuals who were considered at increased risk of illness in the future. Some employers might not want to hire these at-risk individuals because of increased health care costs or the likelihood of absenteeism, turnover, etc.

Q: Do you know what the role or position of American unions is when it comes to genetic testing and the use of genetic information?
A: Unions oppose genetic discrimination in the workplace as well as employers emphasizing worker genetic risks to occupational hazards instead of cleaning up the workplace. I think it's fair to say, however, that the issue of genetics in the workplace has not been a high priority for unions in the U.S. so far.

Q: People talk about the possibility that people won't participate in research or that valuable therapies will be missed and lives will be lost if we don't fully endorse genetic technology. What is your position on these claims?
A: Various genetic technologies hold great promise in preventing, treating, and curing various diseases. In many cases, the lessons we learn from genetics are applied in "traditional" types of medicine and do not involve exotic manipulation of genes. For example, pharmacogenomics is a new avenue of research into the effects of genetic variation on individual differences in reaction to pharmaceutical products. This research is leading to more individualized (safer and more effective) treatments for cancer and various illnesses. For a further discussion, see Mark A. Rothstein, ed., Pharmacogenomics: Social, Ethical, and Clinical Dimensions (John Wiley & Sons 2003).

The Expert: Bonnie LeRoy, M.S., C.G.C., Director, Genetic Counseling Program

Q: It seems like the ethical issues with genetic technologies only arise in very unusual cases. Do these questions really apply to all of us in everyday life?
A: Ethical challenges arise everyday in all areas of medicine. Genetic medicine has some special challenges because it is a relatively new area of medical practice and also because it is advancing very rapidly; faster than most practitioners can think about and therefore address all possible problems before they arise. These challenges are not confined only to a few dramatic cases but those cases serve to illustrate them well. For example, the practice of assisted reproductive medicine has few guidelines and the outcomes as far as impact on family and society have not been studied well. The case shown in Bloodlines illustrates dramatic examples of this issue.

Q: What kinds of things are you seeing in genetics counseling? Are people coming in for depression gene testing or for designer baby kinds of things?
A: The majority of people come for genetic counseling because they are at risk for having a child with a birth defect or because they already have a child with a birth defect and they want to know what happened, will it happen again, who else in the family could it happen to, what treatments or research is available to help me, and how do we make a new life with these medical problems. People also come in because they have a family history of a condition such as cancer or heart disease or mental illness and they want to understand the risks of developing this disease or of passing this condition onto their children. They are also interested in any testing that can tell them more about their risk.

Q: What are your biggest concerns about how genetic technology will be used based on what you see everyday?
A: Right now, I am concerned that the public, as well as primary care providers, expect way too much from genetic technology. It is a problem when genetic technology is used with the expectation that medicine can fix the disease that is running in the family. Many times genetic tests are used to make a diagnosis of a suspected condition. In these cases, the information can help families better understand the condition, understand the risk to others, and make decisions about reproduction and lifestyle. This is valuable information but most families are hoping for a cure and in most cases, this likely will not happen soon. Other times, genetic tests are used to better predict a risk for a condition such as the case for some cancers. However, those results only provide risk information. This is extremely valuable information but again, we are not close to knowing how to cure most genetic conditions. Heightened expectations can lead to the misuse of genetic testing as was illustrated in the Burlington Northern case in Bloodlines. In this case, the railroad company appeared to believe that there was a genetic test that could accurately predict who would get carpal tunnel syndrome in the general population and in fact, no such test exists. They were supposedly planning on using the test results to say that those with "abnormal" results would have developed carpal tunnel syndrome anyway and therefore working on the railroad did not case this in some people. There is no evidence that would be the case. So in this example, the company was misusing a test to give them results that would not predict the disease of interested in the first place.

Q: I don't really understand what my genes know. Can you give me a basic, simple explanation of what I could learn from them?
A: Very basically, genes are blueprints for the production of proteins that our cells need to function properly. These proteins direct the development of the embryo, telling cells how to grow and become different organ systems. They tell cells how to make the chemicals we need to live such as insulin, blood clotting factors, brain chemicals, and many others. They make the proteins that form new cells when we need them as well as many other functions. Right now, there are tests that can look at the function of some genes but not most. For example, there are tests that can tell us if we have a change in a gene that causes that gene to either not be able to make the protein that it should be able to make or to make a form of the protein that can't work. This is the case for Cystic Fibrosis and Hemophilia and Huntington disease and many others. There are some tests that can tell us if we have inherited a familial form of breast or ovarian or colon cancer. These tests look for a change in a gene that results in a protein that can no longer help cells know when to stop growing. Because of this, there is an increased risk for tumors with this type of gene change. What we cannot do now is use testing to predict our medical future. There is no test that will survey our genes and say, 'you are going to get diabetes when you are 55, cancer when you are 65 but you will not get arthritis.' That may happen someday but it is not possible right now.

Q: What kinds of discrimination or injustices do you see in your practice related to genes?
A: Cases of actual discrimination are relatively rare. I did see an individual who wanted testing for Huntington disease because of a family history of the condition and after the bill was submitted to the insurance company, the company raised the rates to that person by quite a bit. This person was self-employed. The bill was sent following a physical examination and genetic counseling for Huntington disease. Eventually the test results showed that this person did not have the gene and then the rates were restored but this indicates to me the risk for insurance discrimination. The greatest injustices in genetic medicine are the same as those that occur in all areas of medicine. People with limited or no insurance have poor access to care. A disease or a birth defect in a family can decimate a family financially and health care costs for chronic conditions are quite a burden for typical people.

Q: Do you think we're being sold a bill of goods with this testing stuff? Is there anything happening here other than companies wanting to make a fortune?
A: The incentive for a private company to develop a test or a pharmaceutical treatment is, of course, profit. However, the goal of genetic research is to better understand how genes work and with that knowledge, understand what happens when they don't work with the ultimate objective being treatment or cure. Most common conditions have a genetic basis and a better understanding of gene function will hopefully lead to more targeted treatment for each particular individual.

Q: Can you imagine a testing situation where people would not have to worry about how genetic information would be used?
A: That is difficult. Hopefully someday everyone will have access to basic healthcare. If this were the case, the concern over loosing your health insurance because your genetic testing shows you are at a high risk for some condition, would be minimal. However, the eligibility criteria and costs for life and disability insurance are both determined from risk. One of your greatest predictors of risk is family history and therefore, genetics. In addition, social stigmatization is always a concern.

Q: Do you see people feeling better after genetic testing? If I am considering it, what do I have to think about?
A: Many people who decide to have genetic testing do feel better. However, they do so after considering all of the potential risks and benefits and deciding that there is more benefit for them than risk. It is important to think about what actual information that particular test will give you. What will you do with that information and what is going to be the impact on your life? What role does your family play? What support do you have? What options do you have for dealing with the condition in your family that do not include testing? Would those options be enough for you? A genetic counselor can help you think about all of the risks and benefits of each test and help you make a decision about whether or not testing is right for you. You can find a genetic counselor near you by going to the National Society of Genetic Counselors website at www.nsgc.org and click on "find a genetic counselor".

The Expert: Stuart Newman, Ph.D., Developmental Biologist

Q: Would you please tell us more about the patent application for a half chimp/half human? What exactly are they proposing to do to achieve this, and is science getting close enough to accomplish this, if such research would be permitted? What, if any are the positive aspects of this kind of experimentation between humans and animals?
A: As I noted in the "Bloodlines" program, the patent application was a way of publicly raising the issue of potentially disturbing developments in biotechnology, and the need to create a regulatory framework. I have no intention of producing a half chimp/half human, although technically it would be possible. In the 1980s, scientists produced half goat/half sheep ("geeps") using the techniques described in my patent application. Since the application was filed, some scientists have proposed producing half human/half mouse embryos to study embryo stem cells. This would infringe the patent if it were granted, and in principle, that work could be blocked. Other potential uses for part-human part-nonhuman organisms is as sources of transplantable organs. A major point of filing the application was to raise awareness that some things that are feasible and useful would also be unacceptable. Imagine an ape that has 60% human cells being used in laboratory experiments! (Many people object even to regular apes being used in this way). Thus far, the U.S. Patent and Trademark Office has rejected the application, asserting that it is "inappropriate subject matter" for a patent. However, they have issued patents on animals containing human genes.

Q: The definition of what is human is obviously an important one because we accord unique privileges and rights to humans. But how exactly do we define 'humans' when the qualities/characteristics that are believed to be uniquely human fall into expansive bell curve distributions? Where is the cutoff at which point a severely disabled person is no longer considered a human and accorded respective human rights? That scenario probably doesn't sit well with most people but given the new genetic technologies by which we can artificially distort what it means to be human shouldn't those kinds of considerations have to be made? By the same logic, is it fair to establish rights based on biological/physiological fact? Normative valuations are not simply the logical inferences of biology, so how will the bridge from 'genetics' to 'rights' be built?
A: In my view, this is the most profound issue raised by the new reproductive technologies. Even in the absence of genetic manipulation, some of the most deeply felt divisions in society are over who belongs to the human species as an enfranchised member: some say embryos qualify, some say they don't. Some say people in comas, or advanced Alzheimer's sufferers, are full members of the human community; others would deny them life-extending resources.

With the possibility of producing human-related organisms by experimental means—clones, in which fragments of cells are combined to produce embryos, embryos that are genetically manipulated at early stages, chimeras, in which embryo cells of humans and other species are combined—the resulting organisms will have an ambiguous status. To what extent will near-humans, or experiments gone awry, be considered part of the human community?

Opinions will vary on this. Many will say that if the intention is to produce a healthy baby, then even if the manipulation fails, the developmentally-impaired "result" must be considered fully human. But the prospective parents who commission such a manipulation may not agree. After all, their intention may have been to produce a biologically improved child, perhaps one with characteristics they themselves do not have. If they are informed by their physician that the manipulation has let to a "less perfect" rather than a "more perfect" outcome, they may opt for termination or denial of life support.

Some bioethics commentators who advocate the eventual use of these technologies to produce "better" children have suggested that parents who embark on such enterprises will be heroes, like the explorers of the past who opened up new possibilities for humanity. However, the risks these parents will be taking are not primarily to themselves, but to the health and bodily integrity of their future offspring.

Moreover, when the technology under consideration is cloning, where the genetic material derives almost exclusively from a single person, the notion of biological parent is itself ambiguous. Biologically, the clone will be a sibling, not a child, of the genetic donor. In fact, a clone will be a commissioned biological experiment, not anyone's child in any traditional (or legal) sense.

Then there will be cases in which the intention might be not to produce a new person, but to produce a partly-human animal or embryo, to serve as a bone marrow or organ donor for an existing person. This is already being proposed by some scientists and medical researchers, and patents have been granted on animals containing human genes to serve as sources of transplantable organs. But there is no generally accepted consensus for how much human genetic material, or what percentage of human cells, an animal may have before it may be considered human, or human-like, or for how long it would be acceptable to incubate such an entity. Some scientists and bioethics commentators have proposed that human organisms that have had their brain development blocked by genetic manipulation would be suitable organ donors. But such experiments can also fail: brain development may not be completely inactivated and such organisms would then have an ambiguous human status.

Such problems and ambiguities will inevitably arise as soon as genetically manipulated human embryos become objects of scientific and medical research. No matter where any one of us personally chooses to draw the line, there will continue to be compelling scientific and medical arguments to cross that line. This has led some scientists and other commentators, including supporters of a woman's right to abortion, and research with embryo stem cells, to advocate prohibiting genetic manipulation of developing humans.

Q: I find the whole notion of people creating half-human half animal embryos totally frightening. I think the risk of this work being misused by those of evil or selfish intent is so great it defeats any usefulness that might result from it. What do you think?
A: I also think this is disturbing. The initial impulse might be quite benign—trying to understand how cells communicate to form organs or promote tissue repair. But there is no generally accepted stopping point once this is underway. If a half-human half-animal embryo of one week of development is scientifically or medically useful, perhaps one of four weeks or seven months would be even more so. There might even be medical benefits to bringing it to full term—for example as sources of transplantable organs. It's not so much that people promoting this would have evil intentions (although some may). The troubling thing is that through sound scientific and medical motives, spurred on by the inevitable commercial interests, we could wind up a place where no one wants to be.

There are many means apart from producing part-human embryos and animals to gaining the scientific knowledge and developing the medical technologies required to bring about needed treatments. The medical procedure shown on the "Bloodlines" program, in which a patient received a graft of animal cells, does not have the same troubling implications. If tissue grafting or gene insertion is done on a fully-formed person, rather than on an embryo, it does not alter the species identity of the person, or produce an organism of indeterminate biological or social status.

Q: In your opinion, where does the balance between scientific research and public safety lie? Is it a matter of educating the public about the benefits of genetic research, or a matter of public policy to stop "scary" scientific practices altogether?
A: I think both are important—the public needs to be informed about the benefits of genetic research, which are many, but also needs to told when a research activity may be unsafe or crosses into new ethical territory. When gene splicing research was developed in the 1970s, safety regulations were put in place because some scientists had warned about possibilities of accidentally creating new infectious agents. Soon some of these scientists regretted raising this issue because it made their work inconvenient, and began to argue that the safety warnings had been without any merit. Two years ago, however, an Australian research group inadvertently produced a fatal mouse virus by adding a normal gene to an otherwise innocuous virus, exactly the scenario the critics of regulations claimed could not occur.

Similar controversies are now in play concerning gene therapy trials and genetically engineered crops. Positive developments may ultimately emerge from these fields, but the public is not served by investigators or commercial representatives who downplay potential problems. Gene therapy protocols currently in use apparently tend to induce cancer, as some critics of the trials had speculated early on. Genetically engineered crops can transfer their new genes to other crops and weeds in unforeseen ways. If those raising questions about these new technologies had the same clout and resources as those promoting them, the public might feel that its interest was being served. Unfortunately this is not the case and the public has been reduced to a position of passive consumption, hoping for the best.

The Expert: Nanette R. Elster, J.D., M.P.H., Law and Ethics Scholar

Q: Do you recommend legislation around these baby making techniques and if so, what do you recommend? There are so many extenuating circumstances surrounding each case, I wonder if it makes sense to try and legislate a "one size fits all" ruling about reproductive issues or if they should be decided on a case by case basis.
A: While each individual case is different and presents its own unique set of facts and circumstances, I think that courts need some legislative guidance. Legislation can be crafted in a way that still allows for judicial discretion in its application. This will allow courts to take into account the specific factors of each case.

Setting minimal standards—a floor, so to speak—which would allow for refinement and expansion not only with regard to individual cases but also with regard to new developments in the technology would be progress toward protecting the interests of all participants in assisted reproduction (intended parents, donors, children, health care professionals). In view of the rapid changes in ART, involving professional societies such as the American Society for Reproductive Medicine and the American College of Obstetricians and Gynecologists, consumers, and other interested parties in setting these minimum standards will provide flexibility and fluidity while ensuring a basic level of protection for participants. Regulation and oversight of ARTs will help to ensure that these practices continue to develop and flourish in order to help many build their families.

Q: Are people really designing their babies and asking for human cloning to make babies? How big an appetite is there for these things?
A: According to several surveys, most people are not interested in cloning as a way of building their families, however, there are some who have exhausted all other means and strongly desire to have a child genetically connected to him or her and believe that cloning is a way to do this. The legality of cloning for reproductive purposes continues to be debated at the state and federal level, with at least a handful of states, including California, enacting laws prohibiting cloning for reproductive purposes.

Other technologies that may be requested which sometimes raise the issue of "designer babies" include sex selection and preimplantation genetic diagnosis. Requests for these technologies are often made to prevent the birth of a child with a serious health condition. The same technologies that may help a couple have a child free from a serious genetic condition, however, may also be used to enable a couple to select particular traits of a child.

Q: What have the courts said (if anything) about how many parents a child can legally have? What do the infertility clinics say?
A: Courts and laws generally find that no more than two parents can be legally responsible for a child. Several court cases have confronted this very issue. The California case of Johnson v. Calvert in which a woman gestated an embryo created from the egg and sperm of couple and subsequently decided that she wanted to parent the child addressed this issue. In that case, the court noted that under the law, both women had a potential claim to motherhood of the child (one having gestated the child and the other being genetically connected to the child), however, only one woman could be recognized as the legal mother. The court ultimately found that the woman who provided the egg for the child should be recognized as the legal mother because that was the intent of all parties involved in the arrangement and but for the arrangement, no child would have been born.

As for infertility clinics, they really do not have much say in how many parents a child can have. Some clinics do require or recommend, however, that participants enter into legal agreements before proceeding with medical treatments in order to clearly define the roles of all of the participants in a particular reproductive arrangement.

Q: Do we know anything about the effect of these situations (several biological and non-biological parents) on kids?
A: Unfortunately, we do not have very much information about this. In part, the lack of information results from the difficulty in tracking and following up with families especially since reproductive decisions are very private choices and afforded the utmost privacy protections. Also, because these technologies are relatively new-the first in vitro birth occurred less than 30 years ago and egg donation only about 20 years ago.

Additionally, children may not be informed of the circumstances of their conception and therefore, it would not be possible to know how they are impacted. All in all, there is little information about how these technologies impact the psychological growth and development of children. Currently, little longitudinal research has been done in the United States to determine whether children born through ART suffer any long-term psychological harms as a result of their technological conceptions.

Q: What are other countries doing about reproductive technology? Is it a free for all everywhere?
A: Regulation of reproductive technologies has occurred in at least 20 other countries. The regulation in other countries ranges from very restrictive and prohibitive to quite liberal. In the United Kingdom, for example, the Human Fertilisation and Embryology Act of 1990 established the Human Fertilisation and Embryology Authority (HFEA) which has the responsibility for regulating existing and new reproductive technologies. The HFEA web site defines its role as "A statutory body which regulates, licenses and collects data on fertility treatments such as IVF and donor insemination, as well as human embryo research, in the UK." (http://www.hfea.gov.uk/)

Australia is another country which regulates reproductive technologies. In Australia, however, regulation of this field occurs on a state by state basis rather than continent-wide. While some states in the United States do have laws addressing some reproductive technologies, no comprehensive or uniform regulation currently exists in the U.S.

Q: Is this baby selling and aren't there laws about that?
A: There are laws against baby selling. In Illinois, for example, the law reads "No person and no agency, association, corporation, institution, society, or other organization, except a child welfare agency . . . , shall request, receive or accept any compensation or thing of value, directly or indirectly, for placing out of a child." (720 ILCS 525/1 (2003)). Similarly, in South Carolina "No person may sell or buy a minor child, or request, or accept, receive, or pay any fee, compensation, or any other thing of value as consideration for relinquishing the custody of a child for adoption." (S.C. Code Ann. 16-3-1060 (2002)). And, some states do prohibit paid surrogacy which may be an outgrowth of the concerns about baby selling. Other states do, however, recognize that there is a difference and have legislated accordingly. In Alabama, for example, surrogate motherhood is specifically excluded from the prohibition on baby-buying (Code of Ala. Sec. 26-10A-34 (2003)).

The more difficult part of your question is whether surrogacy is baby selling. Debate about this issue continues with some believing that it is tantamount to baby selling and others supporting the view that the surrogate is being paid for her time effort and inconvenience in gestating the child and that the practice does not turn the woman or resulting child(ren) into commodities. So, even under the law, there is not one clear answer to your question.

Chimera Patent Case (Patent on a part human, part chimpanzee) In early 1998, developmental biologist Stuart Newman applied for a patent on a creature that would be part human and part animal. The United States Patent and Trademark Office rejected his application in June of 1999 on the grounds that the invention "embraces" a human. Newman, who applied for the patent to spark public discussion on the patenting of life and has no intention of actually creating the creature, has since appealed the patent office's decision and plans to continue to do so, up to the Supreme Court if necessary.

Susan Ring Surrogacy with Twins Case Susan Ring was a gestational surrogate for a couple who backed out of the surrogacy arrangement when Susan was pregnant with their twins, telling Susan that the twins would go to foster care. Though California law gave her little legal standing, Susan fought to prevent the "intended parents" from carrying out their stated plans. She took the twins home with her for several months before she was legally allowed to find a suitable home for them in an adoptive home.

Burlington Northern Genetic Testing Case In February 2001, the U.S. Equal Employment Opportunity Commission (EEOC) brought suit against the Burlington Northern Santa Fe Railway (BNSF) for doing secret genetic testing on its employees. The employees had filed claims for work-related injuries based on carpal tunnel syndrome, and the company wanted to determine if the injuries were in fact work related. The EEOC claimed that the test was illegal because it did not meet the Americans with Disabilities Act's requirement that tests be work-related and of business necessity, and further, that certain employees were illegally retaliated against for refusing to submit to the test. The case ultimately settled (in 2002), but it brought to center stage some of the ADA's limitations, both in proving discrimination and in protecting against the use of genetic tests in the workplace. (Note: There is no known gene responsible for carpal tunnel syndrome. BNSF used an inappropriate test for their stated goal.)

Consider the following questions:

What kind of resource is the body? Should we, for instance, consider the human genome a public resource?

Who benefits from and who bears the costs—economic, social, psychological—of new biotechnology?

Where should we draw the line on human modification? Should we allow screening out embryos with disabilities? "Enhancing" humans? Changing future generations?

How and by whom should these decisions be made?

Are we obliged to use the tools we have to improve living things, even if that means destroying some life in the process?

How and to what extent should the elements of life (genes, tissues, embryos) be recombined, discarded or relegated to the market?

Do genetic and reproductive technologies introduce new—or newly potent—harms? How do those harms weigh against the benefits?

How should human beings be treated? Are they part of a genetic community, a source of valuable resources and services, or active agents in genetic evolution?

Do new reproductive and genetic technologies allow or even force us to choose what kinds of people there should be?

Do we need to explore new ethical or social models of balancing the individual with the community?



Our Experts
Mark Rothstein, J.D
Mark Rothstein, J.D.
Director, Institute for Bioethics, Health Policy and the Law, University of Louisville
Susan Ring
Susan Ring
Gestational Surrogate
Bonnie LeRoy, MS, CGC
Bonnie LeRoy, M.S., C.G.C.
Director, Graduate Program in Genetic Counseling,
University of Minnesota
Stuart Newman, Ph.D.
Stuart Newman, Ph.D.
Professor of Biology,
New York Medical College
Patrick J. Coyne, J.D.
Patrick J. Coyne, J.D.
Patent Attorney,
Partner at Finnegan,
Henderson, Farabow,
Garrett & Dunner, LLP
Nanette R. Elster, J.D., M.P.H.
Nanette R. Elster, J.D., M.P.H.
Professor, Institute for Bioethics, Health Policy and Law,
University of Louisville