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Vidic 2:00 L19 VIROTHERAPY: THE ETHICS AND FUTURE Bradley Gobin ([email protected]) INTRODUCTION: ETHICS AND TREATMENT Naming someone who has been impacted by cancer is far too easy a task for any person to do. Cancer is possibly the most dangerous and deadly medical condition that faces the world today. With 12.7 million people diagnosed with cancer every year and 7.6 million deaths it is safe to say that it is very large medical and engineering problem [1]. In the United States alone the National Cancer Institute spends over $4.9 billion every year on just research for a cure, or improvements in the treatment of cancer [2]. Even with this huge amount of money spent on cancer treatment, the treatments have not been making large and greatly effective advancements. This is why I believe that oncolytic viruses and the use of virotherapy is one of the keys to unlocking a future cancer treatment that is much more effective that the methods used currently. This type of treatment is important to me because this is what I plan to research later in life and I greatly support this method. I think that it is not very well known and needs to be focused on more as a legitimate cure for cancer. Virotherapy has to be done in an ethical way according to the set engineering standards so that it can be both effective and safe. The ethics of research is almost as important as the research itself. With any medical or engineering research there are very strict guidelines to follow to keep the procedure ethical. These guidelines or canons for this particular topic are set by the National Society of Professional Engineers (NSPE) and the Biomedical Engineering Society (BMES). These canons are set to uphold the integrity and morality of all professional engineers. If these canons were not in place, then the engineers would not be held to any standard of ethics. This scenario would then allow them to cut corners in order to maximize profit even if it was at the expense of the welfare of someone or something else. An example that will be discussed in greater detail would be a case where a company is trying to get a new virotherapy treatment out onto the market quickly to cut cost of production and maximize its profits. This might be done by cutting corners and not analyzing information completely. This may also cause the company to modify its data and make it appear that this treatment is better and more complete than it actually is. The canons that tie to this specific example of research from the NSPE are “Engineers shall hold paramount the safety, health, and welfare of the public. If engineers' judgment is overruled under circumstances that endanger life or property, they shall notify their employer or client and such other authority as may be appropriate.” And “Engineers shall University of Pittsburgh, Swanson School of Engineering 2013-10-29 be objective and truthful in professional reports, statements, or testimony. They shall include all relevant and pertinent information in such reports, statements, or testimony, which should bear the date indicating when it was current. [3]” The first canon requires that all engineers keep the safety and health of the public as the main guideline of what they are trying to accomplish, and to use their own judgment as to when something is not safe or the best option for the welfare of the public. The second canon indicates with that the information that is reported should be kept truthful and not altered in an attempt to better the image of the research. The BMES canon that applies to this specific case is very similar to the NSPE canons stated previously. The BMES canon is “Biomedical engineers involved in research shall comply fully with legal, ethical, institutional, governmental, and other applicable research guidelines, respecting the rights of and exercising the responsibilities to colleagues, human and animal subjects, and the scientific and general public. [4]” This canon deals with the engineer being held responsible for his actions dealing with his research and subjects, and to be certain that choices are ethical and right and ensure the highest quality of care. As said by the world health organization “The critical role of ethical practices in health care and research is not only well recognized to ensure equity in health care and research, but also is important to protect individuals and communities from unnecessary risks and harm. [5]” These are just a few of the canons of ethical engineering that are applicable to the case mentioned earlier with a business trying to get a new virotherapy treatment out on the market as fast as possible by trying to cut corners. Engineers and we who plan to become engineers need to be aware of these canons and how they apply to what we do. WHY IS VIROTHERAPY EVEN IMPORTANT Now before we go into any more of the ethical issues of oncolytic viruses and virotherapy we need to point out why it is important to be worrying about being ethical to begin with. HOW VIROTHERAPY WORKS First off what is virotherapy and oncolytic viruses? Virotherapy is the use of engineered oncolytic viruses to treat cancer. This is done by taking normal viruses that occur naturally and changing them to do what the engineer wants them to do. A normal virus infects the body and goes throughout the body finding cells that have a specific genetic make-up that matches that on the virus. Once a virus finds the Bradley Gobin cell with this make-up, it injects a new genetic code that causes the cell basically to turn into a virus factory. This in turn destroys the cell, but the process makes large amounts of viruses that can then go out and find a new cell to infect, and start the cycle over again. The engineered oncolytic viruses do this exact same thing, but they only target and replicate in the cancerous tumor cells [6]. This destroys only the cancerous cells, while leaving all the normal body cells completely unharmed. Since these oncolytic viruses do not cause any harm to the healthy cells, the body then does not filter the oncolytic viruses as it would for normal viruses. This and because the tumors have no immune system allows the viruses to function with little interruption [7]. Since no oncolytic viruses are being removed, they are able to grow exponentially, and destroy more cancer cells as time goes on [8]. When there is a high concentration of the oncolytic viruses in one spot, they then spread out through the person and search for any cancerous cells that may have metastasized to other parts of the body. Once enough of the cancerous cells die off the body is then able to combat the tumor itself. The body can detect the remains of the cancer cells, and then is able to produce cells in the immune system that are better able to combat the current cancer and cancer that may form later on in the person’s life [9]. radiation. The healthy body cells do not develop this resistance, and are killed at a faster and faster rate. BACK TO THE ETHICS Now that there is a basic understanding of what virotherapy is, how does this tie into the ethics mentioned earlier? Say that a company is researching a new way to produce these oncolytic viruses and wants to get it onto the market as fast as possible. In order to do this they speed up the process which may causes them to skip or maybe not go as deep into a part of the research. This could be putting the safety of the people using this treatment in jeopardy due to unforeseen flaws or complications. This violates all of the ethical canons mentioned earlier. The first canon from the NSPE are “Engineers shall hold paramount the safety, health, and welfare of the public. If engineers' judgment is overruled under circumstances that endanger life or property, they shall notify their employer or client and such other authority as may be appropriate. [3]” An example of using professional judgment of ethics comes from the recent NSA information leak and Edward Snowden, a computer engineer working for the NSA. In this case Snowden used his judgment that what he was doing was morally wrong, so he let the world know what was going on in order to hold the government responsible. [10] That point is more difficult than it sounds when it comes to medical fields, since nearly all medical treatments are weighing potential risks and benefits. The people that are given the treatment may view the potential benefits to outweigh the risks so they will want to go forward with the treatment. What can a doctor do when they think a treatment is a bad idea, but the person receiving the treatment wants it? [11] This means that the engineer’s main responsibility is to make sure that whatever they are making is, to the best of their knowledge, safe to the public. If the engineer feels that it is not safe, he or she should then notify whomever the product or in this case treatment, is intended for that research may not be completed and continued research is needed. The next canon that would be violated in this situation is the NSPE canon of “Engineers shall be objective and truthful in professional reports, statements, or testimony. They shall include all relevant and pertinent information in such reports, statements, or testimony, which should bear the date indicating when it was current. [3]” This applies because all too often medical reports are biased to make it seem that a new type of treatment is a perfect solution and does not have many negatives. This would happen in the situation of a company trying to get the new virotherapy treatment out on the market because they may not understand all of the possible negatives, and may hide some of the known negatives so that it appears to be much better than it is so more people will use it over other options. Most people would see the side effects VIROTHERAPY COMPARED TO OTHER TREATMENTS Why should a person even bother with this treatment when there are many other treatments out there that are much more popular? Most people that are diagnosed with cancer are put on regimens of chemotherapy and radiation therapy. Ask anyone that has been put through these treatments and they will tell you that it one of the worst things that a person can imagine. They sometimes even end up in worse condition after the treatment than before the treatment. These treatments use the same things that cause cancer to try to cure it. Chemotherapy uses highly toxic chemicals to try to kill the cancer cells and it has been proven that cancer is caused by unnatural and harmful chemicals. Radiation therapy uses focused radiation to try to kill the cancer cells, and radiation has been shown to cause all types of cancer. Using the same things to cure cancer that can cause cancer has been shown to possibly cause new cancer to form in the person. Neither chemo nor radiation therapy can distinguish between healthy body cells and cancerous cells, which results in losing just as many healthy cells as the cancerous cells. This leaves the person very weak and unable to fight the cancer or any other diseases that they encounter. The cancerous cells have also been shown to develop a resistance to the treatments, which means that each new tumor growth requires stronger and stronger regimens of chemo or 2 Bradley Gobin that are published by the company and expect that those were all of the side effects and none were being covered up. It seems like medical companies would have learned by now not do this in modern times, but it actually happens all too often. A recent case was in 2010 when a mumps vaccine that was used for a short period of time had a 97% infection rate [12]. This means that 97% of the people that were given the vaccine then developed full strength mumps. The company that made the vaccine later admitted to not fully following guidelines and simply trying to fill the demand. They also admitted to hiding possible side effects and problems with the vaccine. There was little thought about the safety of the people that the vaccine was intended for. The canon that deals with this situation the best is the one that is set by the Biomedical Engineering Society, which states “Biomedical engineers involved in research shall: Comply fully with legal, ethical, institutional, governmental, and other applicable research guidelines, respecting the rights of and exercising the responsibilities to colleagues, human and animal subjects, and the scientific and general public. [4]” This ethical canon is very similar to the first one stated by the NSPE but it adds the part of respecting the rights of the human subjects. It would be a violation of human rights to give patients a treatment about which not everything is known, and essentially having the person be the unwilling test subject for the treatment. It would be hard to say what could be done in the situation above. One thing would be simply to slow things down and try to go more in-depth to fully understand the situation of the research. The person running the research may not want to, but it is what is needed. Yes, this would mean that the company may not get the virotherapy treatment out as quickly as they want to and they may lose out on some money in the short term. These are the things that need to be done in order to keep the patients safe and make sure that the engineers follow the standard of ethics that all engineers have to follow. REFERENCES [1] (2013). “World Cancer Day” Center for Disease Control and Prevention. (Online Article). http://www.cdc.gov/cancer/dcpc/resources/features/WorldCa ncerDay/ [2] (2013). “Cancer Research Funding”. National Cancer Institute. (Online Article). http://www.cancer.gov/cancertopics/factsheet/NCI/researchfunding [3] (1993) “NSPE Code of Ethics for Engineers” National Society for Professional Engineers. (Online Article). http://www.nspe.org/Ethics/CodeofEthics/index.html [4] (2004). “Biomedical Engineering Society Code of Ethics” Biomedical Engineering Society. (online article). http://bmes.org/files/2004%20Approved%20%20Code%20o f%20Ethics(2).pdf [5] (2011). “Bioethics” Eastern Mediterranean Health Journal. (Online Article). http://go.galegroup.com/ps/i.do?action=interpret&id=GALE %7CA271883780&v=2.1&u=upitt_main&it=r&p=AONE& sw=w&authCount=1 [6] M. Zeyaulla. (2012) “Oncolytic Viruses in the Treatment of Cancer: A Review of Current Strategies” Pathology and Oncology Research. (Online Article). http://link.springer.com/article/10.1007%2Fs12253-0129548-2 [7] A. Katsnelson. (2011) “Engineered Viruses Selectively Kill Cancer Cells” MIT Technology Review. (Online Article). http://www.technologyreview.com/news/425293/engineered -viruses-selectively-kill-cancer-cells/ [8] R. Auer. (2012) “Oncolytic Viruses: Smart Therapeutic for Smart Cancers”. Future Oncology. (Online Report). http://go.galegroup.com/ps/i.do?id=GALE%7CA284022433 &v=2.1&u=upitt_main&it=r&p=AONE&sw=w [9] N. Seppa. (2013). “Virus Used as Cancer Killer: Treatment Triggers Immune System to Kill Malignancies” Science News. (Online Article). http://go.galegroup.com/ps/i.do?id=GALE%7CA323973723 &v=2.1&u=upitt_main&it=r&p=AONE&sw=w [10] G. Greenwald. (2013). “Edward Snowden: The Whistleblower behind the NSA Surveillance Revelations” The Guardian. (Online Article). http://www.theguardian.com/world/2013/jun/09/edwardsnowden-nsa-whistleblower-surveillance [11] P. Heift. (2012) “Am I Obligated to Give Therapy Against my Better Judgment” UBM Medica. (Online Article) http://rt4rf9qn2y.search.serialssolutions.com/?ctx_ver=Z39. 88-2004&ctx_enc=info%3Aofi%2Fenc%3AUTF8&rfr_id=info:sid/summon.serialssolutions.com&rft_val_fm t=info:ofi/fmt:kev:mtx:journal&rft.genre=article&rft.atitle= Consultations+IN+Ethics&rft.jtitle=Oncology&rft.au=Paul+ R+Helft&rft.date=2012-1001&rft.pub=United+Business+Media+LLC&rft.issn=0890- WHY ETHICAL STANDARDS ARE NEEDED Just say there were no set standard of ethics to follow for engineers. What would happen? Well one thing is that there would be no way to keep the engineers that are making things in check. This means that whatever they make, may not be as safe or as good as it could be. Purchasing a product or having a treatment done would just be on the faith that the one engineer had an ethical approach to his or her work. ETHICS FOR THE FUTURE Ethics need to be taught to all engineers and future engineers. The world needs engineers and people to invent new things, but only if the things that they are making and the process by which they are made, are held to high ethical standards. All of us who plan to be engineers need to understand that the approach for our research needs to be done keeping the welfare of others as the number one goal. 3 Bradley Gobin 9091&rft.volume=26&rft.issue=10&rft.spage=995&rft.exter nalDocID=2793990541¶mdict=en-US [12] J. Auferheide. (2013) “17 Examples of Admitted Vaccine Failures” VacTruth. (Online Article). http://vactruth.com/2013/02/23/17-examples-ofvaccine-failure/ ADDITIONAL SOURCES D. Tolmach. (2013) “Chemotherapy” The Journal of the American Medical Association. (Online Article). http://rt4rf9qn2y.search.serialssolutions.com/?ctx_ver=Z39. 88-2004&ctx_enc=info%3Aofi%2Fenc%3AUTF8&rfr_id=info:sid/summon.serialssolutions.com&rft_val_fm t=info:ofi/fmt:kev:mtx:journal&rft.genre=article&rft.atitle= Chemotherapy&rft.jtitle=JAMA&rft.au=Deborah+Tolmach +Sugerman&rft.date=2013-0710&rft.pub=American+Medical+Association&rft.issn=0098 -7484&rft.eissn=15383598&rft.volume=310&rft.issue=2&rft.spage=218&rft.exter nalDocID=3025220201¶mdict=en-US ACKNOWLEDGEMENTS I would like to thank the other members of my engineering group, Eric Rizzo and Ami Hirata for helping with this essay and keeping me motivated. 4