Jonathan Leichty
Biology Senior Seminar
11/6/00
The controversies surrounding genetic testing, patenting and the modification
of genes both as used in disease treatment and genetic enhancement are
on the verge of becoming larger realities.
A. Discussion on genetic testing.
1. The use of genetic testing in employment process.
2. The use of genetic testing in the screening of insurance candidates
by insurance companies.
3. Use of genetic testing to tailor specific treatments to the patent
B. Discussion on genetic modification
1. Discussion on using genetic procedures to repair defective DNA/cure genetic disease.
2. Discussion on genetic modification for the purpose of enhancement
of traits.
C. The controversy over gene patenting
1. Arguments of the biotech industry.
2. Arguments of the Conference of European Churches.
3. Compare and contrast in an example the opposing viewpoints on gene patenting.
The initial draft of the Human Genome project is now completed, giving access to the DNA sequences of a human. But it is not the genetic information that is shared that has come under the greatest degree of interest. Rather, the estimated .001% of variance in the genetic code is the subject of recent and expanding controversy; it is our difference not similarities that are most subject to controversy. One such controversy involves the genetic screening of potential employees, to spot potential problematic areas in their genetic make up. Similarly insurance companies may screen clients before deciding what category of clientele to put them in based on genetic risk factors. But the greatest controversies come with the fact that our genetic make up is alterable. There is substantial research being done on how human diseases can be treated using genetic procedures to replace faulty genes, but who stands to profit from this and what are the potential risks? Furthermore, can a treatment based on human genetic information (which is shared by all) be subject to the same patent laws as are other commonly used medicinal tools and methods? And perhaps the most controversial is the prospect of enhancing humans using genetically fostered techniques to produce desired traits. What are the risks and who will have access to the benefits of genetic enhancement? What remains certain is that the controversies surrounding genetic testing, patenting and the modification of genes both as used in disease treatment and genetic enhancement are on the verge of becoming larger realities. But will the systems be in place to deal with the consequences of the genetic age?
A. Discussion on Genetic testing.
Amongst the most pervasive of current issues involving human genetics is the use of genetic screening as applied by employers and insurance policy companies. People are alerted to the current and potently expanding use of genetic screening as it applies to employment opportunities. As Francis S. Collins put it in his July twenty of 2000 testimony to the U.S. congress, “already in genetics research studies, we are seeing individuals who opt not to participate in research because of their fear that this information could fall into the wrong hands and deny them of a job or promotion”. Collins goes on to give the example of a man who was rejected in a job application process because he reveled information that he was a carrier of Goucher’s disease. Collins further explained that the individual’s condition as a carrier, has no impact on whether or not he could fulfill his job requirements. In fact, the defective gene in question is recessive and the individual mentioned had the functional version of the gene in question, preventing the possibility that he would be afflicted with Goucher’s decease.
As an example against using genetics to discriminate; President Clinton has signed an executive order that grants protection to federal employees of the executive department from reveling genetic information about themselves. This recent occurrences has further prompted legislation, which is now under consideration, that would prevent discrimination in the employment process that is based on genetic information in the public sector job market, just as it is now illegal in the United States to discriminate based on disabilities (Collins 7/20/2000). So obviously the use of genetic testing as a basis for job discrimination is regarded as having enough relevance to have garnered the attention of U.S. legislators.
Just as genetic testing could be used by employers to spot genetic deficiencies
in potential employees, it can also be used by insurance companies to screen clients
to see if they are genetically prone to specific diseases. The use of such
tests is already a reality for life insurance companies in Britain, which have
been given access to genetic test results that indicate whether or not the policy
recipient has the genes for Huntington’s disease. Huntington’s disease is
of particular interest to life insurance companies because it causes the premature
death of those who develop this genetic disease. It is likely that access
to more tests will follow (Economist 10/21/2000).
Furthermore, the implementation of the greater use of generic testing could have
a significant impact on how insurance operates as a whole. The author for
The Economist points out one possible scenario in his article “Insurance in the
Genetic Age.”
Premiums would continue to rise in what market experts call a “death spiral”, as healthy people dropped their insurance. In the end, only the least healthy individuals would remain in the pool; they would pay astronomical premiums, but insurance companies’ profits would disappear. If genetic information is shared, insurers will also face eventual problems. As the human genome is gradually unlocked, they will garner fewer policy-holders and lower profits. Most people will still need insurance: they will still face enough uncertainty to reap some benefits, as a group, from risk-pooling—and besides, genetics alone do not determine most destinies. But the healthiest people, with a firm knowledge of their sturdy genes, will not find insurance as attractive as they would previously have done; meanwhile, those facing the greatest potential problems will become uninsurable.
The author goes on to warn of the potentials of “creating a genetic underclass”
of individuals based on genetic information. In any case, it can be argued
that the problem is within the hands of government intervention to solve the issue,
due to the regulatory nature of the situation (Economist).
Genetic testing can not only be used as a diagnostic tool, but it also has potential in the area of curative medicine. In fact the use of genetic testing medicinally may become, “as routine as blood pressure and temperature checks” (Haseltine Sep/Oct2000). Currently it is impossible to know for certain if a person will respond positively to a certain drug therapy, because many illnesses can be caused by a variety of different genetic factors, while showing the same symptoms externally. So how can doctors be certain which drugs will be effective if there is uncertainty as to the cause? With the use of genetic testing and additional research on which specific genes are instrumental in the illness, it is possible to spot the specific genetic factors, which are causing the illness in an individual. With this information, informed treatments could be given to each patient; taking much of the guesswork out of prescribing prescription drugs, sense it would be known which specific areas to target for a particular individual (Haseltine Sep/Oct2000).
B. Discussion on genetic modification.
But the medicinal potential of further understanding of the human genome douse not stop with a better understanding of which treatments to prescribe. In his article The Dawn of the Genetic Age, Mark Nichols makes some predictions regarding the use of genetics in the medical industry. He explains that one outcome of further research into the human genome may include, “…prescription drugs tailored to each patient’s genetic makeup and gene therapies”(7/10/2000). Nichols furthers his predictions that by “2020 doctors will pick the best drug for a patient by taking into account individual genetic profiles, and by 2040 gene-therapy techniques and drugs designed to treat disease by targeting specific genes will be in widespread use”(7/10/2000).
Nichols makes some strong predictions, but still other medicinal uses of genetics are being investigated. These include the use of genetic knowledge in treatments designed to repair the defective genes themselves or, gene therapy. Trisha Gara in her article “Repairing the Genomes Spelling Mistakes” explains the advances in a form of gene therapy known chimeraplasty with which, ”…researchers have shown that they can remedy defects caused by a single DNA spelling mistake in both cultured cells and experimental animals”(7/16/99). But despite advances, limitations are still widely acknowledged. For instance it is estimated that using the process of chimarplasty five to ten percent of the treated cells end up with the corrected gene. This leaves at least 90% that do not respond (Gara 7/16/99). So clearly there is still a gap that needs to be breached in order to get convincing results. Add to this the fact that we can not predict all of the outcomes of using genetic cures for diseases. It is possible that perhaps the treatment “will start fixing other parts of the genome that aren’t broken, ”causing potentially harmful mutations in the process. But despite the warning signs researchers are looking to the approval of the FDA to start tests in human subjects, given the outcome of further studies of the risks of the procedures in animals (Gara 7/16/99).
Similar to the treatment of genetic diseases is the genetic enhancement of individuals. Both processes are similar in that they involve the direct manipulation of genes. But the case of genetic enhancements is even more difficult to sort through. While genetic enhancement could represent the correction of medical problems, it can also include the manipulation of the genetic code to favor desired traits. The results of such enhancement would also be heritable, since the sequences that have been introduced could be passed onto gametes (Gordon 3/26/99). In several instances the use of genetic enhancement techniques have been tried in animals; but so far they have “failed to yield even one unequivocal success”(Gordon 3/26/99). Gordon further explains that the reasons for the difficulty of successful outcomes lies in the complex factors which control traits. Multiple genes can be associated with the various traits that are expressed; it is difficult to tie down what characteristics are related to which combinations of genes. Also, if multiple genes control a characteristic, then modifying just one of the associated genes may not produce the desired effect. Still another concern is that genetic tampering for the prospect of enhancement could produce negative side effects or unpredictable results as given by examples involving experiments done in animals. Consider an example of swine that were given genes to produce enhanced growth hormones. The swine did not show enhanced growth, but rather a tendency to carry less body fat. Given these results Gordan warns us that, “before a human embryo is treated with recombinant DNA, we must know exactly what we are doing”(3/26/99).
C. The controversy over gene patenting
Clearly there are a lot of potential commercial uses involving human
genetics, so with those uses comes the controversy over who owns the rights
to use that information for financial gain, and indeed should anyone have
the right to patient a gene. A viewpoint on what it means to patent
a gene from the biotech research industry may go as follows:
The “genes” being patented are not the genes in people’s bodies, much less the aggregation of all genes. Rather, “genes,” as we in genomics understand them, are isolated DNA sequences and proteins expressed by those DNA sequences—individual genes removed from the natural context of the human body and rendered useful by crafting them in specific ways for medicinal use (Haseline Sep/Oct2000).
John Benditt explains still another argument used by biotic corporations to allow
the patenting for genetic patenting. “Biotechnology corporations argue that
without the ability to profit from their work, bestowed by the rights to specific
genes, they will have no incentive to invest in R&D”(Benditt
Sep/Oct2000).
But those are not the only arguments. The Conference of European Churches
(CEC) has stated that it is against, “any attempt to establish ownership of what
must be regarded as a common good of all humanity”(ENI 9/13/2000).
The CEC is also concerned that the power to decide what to do with genetic advances
and information stays in the hand of the people, not biotech companies.
One crucial example that shows how the two sides take strongly differing viewpoints is to compare their reaction to the recent statements by United States President Bill Clinton and British Prime Minister Tony Blair have called for “free sharing of information on the human genome”(Haseltine Sep/Oct2000). Donald Bruce (who is a representative of CEC) is concerned that their statements are flat, “’if they really mean what they say, they’ve got to do something about the way legislation is working’”(ENI 9/13/2000). However, in his article The Case for Gene Patents, Haseltine views the same statement in a very different light, ”their statement specifically underscored the necessity to protect the intellectual rights to genomics-derived products and treatments”(Sep/Oct2000). The arguments have been given, but this is the dilemma; should power to control what is done with out genetics be placed in the hands of Biotech companies or with the general populace. Both sides of the issue have stated their viewpoint on the benefits of supporting their desired outcome and opposing the alternative.
After surveying the issues regarding Human Genetics it becomes
certain that there will be controversy. Just how much of an effect
the various outcomes will have is difficult to measure, just as it is difficult
to predict what will become of the genetic research and techniques that
are being pioneered today. However all people are bound to genetics, because
of this each of person is subject to what comes out of the controversies
surrounding genetic testing, the patenting of genes, as well as alteration
to the genome in the form of enhancements to produce desired characteristics
and the treatment of disease.
Benditt, John. (Sep/Oct2000). Gene Genie. Technology
Review, Vol. 103 Issue 5, p10,
Collins, S. Francis. (7/20/2000). Genetic Information In
TheWorkplace. FDCH Congressional Testimony. Washington, DC: eMedia
Works, Inc.
ENI. (09/13/2000). Church Says No To Gene Patenting.
Christian Century, Vol. 117 Issue 25, p899, 2p, 1bw.
Gara, Trisha. (07/16/99). Repairing The Genome’s Spelling
Mistakes. Science, Vol. 285 Issue 5426, p316, 3p,
Gorden, W. Jon. (03/26/99). Genetic Enhancement In Humans.
Science, Vol. 283 Issue 5410, p2023, 2p.
Haseltine, A. William. (Sep/Oct2000). The Case For Gene
Patents. Technology Review, Vol. 103 Issue 5, p59, 1p.
Nichols, Mark. (07/10/2000). The Dawn Of The Genetic Age.
Maclean's, Vol. 113 Issue 28, p46, 2p, 3c.
The Economist. (10/21/2000). Insurance In The Genetic Age.
Economist, Vol. 357 Issue 8193, p23, 2/3p, 1c.