The Controversy Over Gene Therapy and Its Effect on Cancer

Nikki Maddux

Copyright 1996

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The era of scientific advancement in the twentieth century has encouraged several scientific fields to merge into a new, futuristic science called Biotechnology. One idea behind Biotechnical science is taking advantage of molecular biology. At the forefront of this advancement is gene therapy which " attempts to treat disease at its origin on the molecular level"(Kreeger,1996). "Essentially, this therapy deliberately introduces genes into the human cells to compensate for aberrant genes that cause genetic disease" (Beese, 1996). This therapy can be administered in two ways. One is germ-line therapy which not only treats the cells of that individual but these treated cells could be passed onto the individual's offspring. This type is the focus of much of the opposition of gene therapy itself because trials take many years and few results have proved conclusively safe for those treated and their children. The other type of therapy less opposed is the somatic cell approach that only affects the cells of the individual being treated. Cancer has recently been the target for several different types of somatic cell therapy and along with them come a set of controversial aspects that question its role in society.

Cancer is an ever- increasing disease that affects all ages, sex and race. It has no preference for where it resides as it can be found in several organs and on several different tissues. However, one special similarity appears whether the cancer is found on the breast or in the colon; it is an over growth of cells in the area infected. The cancer seem to arise from abnormalities in genes involved in growth and differentiation of cells. Certainly, environmental factors can indeed contribute to cancer, but learning the actual number of genes in the body that are involved in cell growth can help in deciphering whether environment, genetics or the combination of the two is/are the culprit. Either way, genes do play a role in cancer and viable ways to effect the problem genes and stop cellular growth are needed.

Effective approaches to treat cancer include surgery, radiation and chemotherapy. Surgery is very effective in the early stages of the disease but there is a risk that all of the infected cells weren't removed or the cancer may come back. Radiation can also be very effective but the side affects can be very harsh for the patient. Along with this, normal cells of the body have the potential to be altered by the treatment process and cause an entirely new set of difficulties. Though chemotherapy has been successful in many cases, there is a fear that like bacteria, the cancer cells can become resistant to these drugs (National Medical Center,1996). It seems clear that somatic cell gene therapy could be a viable treatment for those people who have had little success from the other treatments or possibly prevent the cancer from returning.

One type of somatic cell therapy is taking advantage of a cell already found in the body called TIL or tumor infiltrating lymphocytes that come from other parts of the body to combat bacterial infections and have the ability to attack and destroy cancer tissue in the same manner. These lymphocytes are taken from the body and inserted with a lab synthesized gene that produces TNF. TNF or tumor necrosis factor, produces an antitumor toxin that cuts off the new developing blood supply in the tumor region. The altered TIL are reintroduced into the body, go to the cancer site and alter DNA of the other cells by introducing the new gene. The blood supply is cut off so that no new cells can survive while the TIL destroy the already present cells. This approach maximizes the genes benefit and minimizes the potential for toxicity in other parts of the body (National Cancer Inst., 1991).

TNF is also proposed in a different type of therapy where it is used to immunize individuals against their own cancer. Small pieces of cancer tissue are taken from the person and inserted with genes for TNF that have antitumor activity. These modified tissues are then reintroduced into the person and go to the cancer site where the cells should regress, disappear and immunize the individual from that cancer. This trial has been successful in rats but further investigation by several committees are needed before human trials can be approved (National Cancer Inst.,1991).

Another type of therapy being analyzed in reoccurring brain tumors is called the suicidal gene approach. This Herpes Simplex thymidine kinase gene has no cancer related attributes like TIL in the body, but causes death of cancer cells just the same. The gene is inserted into the human cancer cells where it changes the DNA of the cells. In return, these cells become susceptible to antiviral drugs like Ganciclovir which then kills the cancerous cells.

All three types of therapy described above take advantage of somatic cells and though not as controversial as germ-line therapy, conflict still arises. One conflict is found in the scientific community's difference in ideas for research in this area. Another site for conflict is the public's lack of information on the difference between somatic cell and germ-line therapy which leads to their fear of both types. There is also the controversy over government policy and the economic potential of a gene market.

Several fields are intermeshed within biotechnical experimentation and applications which lead to several controversial ideas of gene therapy. Some scientists believe that gene therapy is the new age fighting soldier against disease and push clinical studies with more integrated therapies. While other field scientists argue that only large, well controlled trials can conceivably show the effectiveness of genetic therapy. Humans are not easily put into a trial this way so no major trials have been conducted. Those trials previously reporting conclusive results have no incontrovertible evidence that this therapy has actually cured people within a small trial(The Scientist,1996). Yet, others will retort to the fact that the use of genetic therapy is so new that no concrete evidence either way can be determined so soon. Many more experiments and further analysis is required before that type of conclusion can be made.

Public health and safety is another concern in the scientific community, especially those that work with this type of genetic material. Much of the concern has been alleviated since the early beginnings of this research. The rapid advances in this area have provided the information needed to show that most of the genes worked with only effect the tissues they are targeting. Yet, the newness of this biotechnology allows new, potentially hazardous genes to still be found giving rise to new types of health problems. Today, however, precautions are taken to prevent accidents with those materials known to be hazardous. Another fear of scientists is the recent "Pandora's clock" rave found in the movie theaters and television movies that are so popular. Fear of such outbreaks can cause more problems with the public who have no information to alleviate their concern or enable them to distinguish the difference between fact and fiction.

The newness of gene therapy not only spawns controversy within the scientific community, but it migrates to the public. Society is very important in the broadening of gene therapy use. "Ultimately, their opinion will effect what sort of applications will be used and what researchers can implement"(Macer, 1992). A rumor starts small and moves from person to person only to end twisted and misinterpreted. This also occurs as the topic of gene manipulations move from scientific realms into media circles and out to the public. The outcome is confusion and overexageration. This is more evident in this century of increasing moral obligations as seen in the abortion and human rights rallies of today. Recombinant DNA topics are so new in terms of information that is available and dispersed to the public. This causes society to get only bits and pieces of facts which they then fill the gaps with fiction given to them by the media or made up by other people. The biggest fear of gene manipulation is genetic engineering or the making of superior individuals. Many people believe that this type of therapy is simply the first step in creating the perfect being and many people already fearful of science are now completely against the manipulation of DNA.

A prime example of this type of fear happened at the first Asilomar Conference where many questions not only came from the public but more importantly, came from the scientific group itself. Though this conference represented a breakthrough in genetic information it also became an example of misinterpreted facts or facts were not in evidence.. There was a tendency for reporters, with the aid of scientists, to overstate the findings or the immediacy of applications to human problems(Berg, 1995). This also brought about the concern of religious leaders who even today feel that science is manipulating God's creation.

Certainly, religion is a large fire in the gene therapy pan even more these days. Many believe that gene manipulation is beyond the human's territory and should not be attempted. God puts people of different shapes, sizes and faults on earth for a reason and it should be left that way. Still others say that god gave human's the brains and tools to help others less fortunate to live a better life. The beliefs religion brings to the surface will always have a impact on any gene manipulation application.

The ultimate problem with public perception is their fear brought about by misconceptions by media and television. However, not all of society is oblivious to scientific advancement and many more people these days are educated in technological concepts of some type. As more information becomes available, scientists make an effort to get the facts out as quickly as possible and it appears in recent surveys that more people are familiar with what gene therapy does. More time will be needed for the majority of society to truly understand the implications gene therapy has on life as we know it. One Public opinion survey reported by Fowler in 1995, of those surveyed in 1993 in the US:(Beese,1996) Another public survey was given in ten different countries by mail in response to 150 questions of which 35 were open ended. The international groups who tallied the surveys were concerned that there was little or no distinction between germ-line and somatic cell therapy by the public. The great fear of gene therapy seems to be that the public does not understand the differences between the two types of therapy. Possibly somatic cell therapy could be more readily accepted if more information was available. Even though the survey concludes that most people have an understanding of gene therapy, it may be impossible to eliminate all the fears of genetic manipulation. This is because the fears are shared by people with a high awareness of technology as well as those who are unfamiliar with it(Macer,1992). All of these aspects of public opinion can have an impact on how the government regulates the research that is done by scientists. These same scientists are also the ones putting out the exact information society uses to make decisions on genetic manipulation . It is a circular argument that ultimately depends on the governmental guidelines on gene therapy.

Government policies on genetic therapy have been very reasonable for the scientists doing this research. A basic set of guidelines have been adopted, but little regulation has been put into law. This positive working relationship between the biotechnical community and the government is primarily because of the formation of the RAC and NCI committees that oversee the types of research done and make sure all guidelines are constantly followed. The formation of such groups have shown the scientific community's concern for human well being by acting upon the issues most discerning to the public. In return, the government on an act of good faith have limited their part in implementing laws into legislature on this subject. However, one main concern is the international versus national regulation differences. Some believe a consistent guideline should be established internationally in order to secure safety for all nations. One of these ideas is that some countries could take advantage of less limiting rules and create harmful genes that could be used as a type of weapon for war. Though this seems far fetched, germ warfare is very real and devastating as could future gene manipulating weapons. Again, a strict set of guidelines for all nations could also prevent genetic engineering from occurring anywhere in the world. Other nations argue that each culture is different in their religions and should have the right to decide their own standards based upon those ideals. Still others comment on the fact that some nations are more technologically advanced and should be able to further their research without limiting guidelines that are less advanced. It is however very clear that the government is a deciding factor in the advancement of gene therapy.

Scientists and the public help to decide government regulations and all three groups (public, scientifc and governmental) effect the economic aspects of gene therapy as a marketable industry. The simplistic idea understood by these groups is that this therapy could be used as a tool to save individuals with deadly diseases that cannot be cured by other means. The discussion exists in how the procedure is done, who it is done by, and how it is bought. Some say that the medical and research fields should be in complete charge in order to secure health and safety. Because relevant research is needed and has to be funded, many medical companies find that funding such experiments will be beneficial to them in the long run. Possible economic persuasion is a problem when the public sees researchers as "money takers" rather than "cure makers". Still there are those who believe that researchers are basically the right hand of big corporate companies who only report what needs to benefit the companies and not the public. No scientist likes to hear this type of accusation but in other cases like tobacco testing, such points have been substantiated.

On the other hand, without the help of pharmaceutical and biotechnical companies to establish certain agents for gene transfer, gene therapy could not be utilized and available to all of society. Questions that arise are: would some large companies create their own gene therapy groups and would the safety guidelines be adhered to as closely as in a medical or research environment? There are no answers to these questions which gives people cause for alarm. Yet, some in the scientific realm agree that if companies do not sell gene therapy but sell the gene reagents for gene transfer methods then all groups could benefit in one way or another. One important aspect of economics is if companies can economically benefit from gene therapy on a large scale. So the question is if scientific information can be applicable to the public and economically feasible to companies supplying the product. The feasibility of such therapy has yet to be determined because many trials are still in progress and no great long term successes have been reported to date.

Certainly scientists, the government and the companies have a vested interest in the success of gene therapy for one reason or another. Ultimately, the individuals who might be effected by this therapy are the important people who should have the greatest interest in its failure or success. Recently, a television show sponsoring breast cancer awareness quoted that 1 out of every 4 women will be diagnosed with this cancer. If I were sitting at a table with the women of my family, 4 of us would have breast cancer. The reality is that no one is resistant to cancer and the seriousness is that it can occur anytime and anywhere. Certainly, there have been cures for many with the more accepted treatments. However, there are just as many people with cancer that haven't been cured. As a woman, an aspiring scientist and a future mother I support genetic therapy for cancer. My concern lies with the future uses of gene therapy beyond deadly illnesses. Certainly, in an idealistic world I would hope that this fantastic tool is only used for positive aspects of medical and research work. As a realist, I know that sometimes the anticipation of "what will happen if?" becomes a great source of danger.

The danger lies in the concept that DNA can be manipulated and synthesized in so many ways that have not all been accounted for. One major concern I have is the survey already presented shows that 42% of those people who have some understanding of gene therapy would approve of using it to improve children's IQ's. This type of gene therapy is unacceptable because it is being used not for a medical tool but an human enhancer to an already healthy child. This is a step towards creating a perfect race. Another concern is that if gene therapy proves to be a valuable tool and a marketable industry then it could be taken for granted and used more as a money maker than an apparatus of immense medical importance. Not only could this produce many medical complications but more importantly a major disaster could bring all gene research to a halt. Then despite all of our knowledge and ability to help those medically challenged no new positive therapies could ever occur.

In conclusion, I believe that somatic gene therapy should be utilized to its fullest potential for diseases in humans with the strictest consideration of all guidelines that have been developed. Children should have the upmost consideration for somatic and germ-line therapy that disposes of family diseases, embryonic abnormalities and any chronic diseases like muscular dystrophy, etc which hinder a child's survival. In no way should germ-line therapy be used to improve an already healthy adult or child by increasing intelligence, strength or physical attributes. This can only occur if the scientific community, public groups and government participate in deciding the limitations on gene therapy. The government needs to work closely with the scientists to develop basic laws which prohibit the application of these therapies for use other than those that are deemed medically necessary. They should make sure that these guidelines pertain to large companies as well as the biotechnical science and medical groups. Along with this there should be a close relationship between the government, RAC and NCI committees in working to update the guidelines every year. Furthermore, there should be an international group that establishes basic but strict guidelines for all nations. The need to maintain consistent regulations in all nations would be one way to stop the use of genes as a military weapon. Already germ warfare is a valid weapon of today and it is possible for gene warfare to be the weapon of tomorrow. Therefore, a group from the United Nations should be formed to preside over the implementation of the regulations to prevent further use of germs or genes as weapons. Though the international committee would enforce the guidelines, laws concerning gene therapy should be left to each nation. This would allow scientists the freedom to conduct complex research and allow its application in various areas in the genetic field. It would also give the public peace of mind to know that therapy would only be used for medical reasons and not genetic manipulation for human perfection. The governments of many nations might consider gene therapy a valuable tool for their people knowing that there are international regulations put on its use. Ultimately, as a ordinary person, I want to know that my children have a more than average chance to live a good life with the help of disease fighting tools like gene therapy. On the other hand, I want to know that my children will survive without the threat of gene warfare by either accidental or deliberate means. I believe there are some times when you can have your cake and eat it too.
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