Nick's Policy

C & C: Bioethics Nick Wilcox
February 10, 2008

Policy Paper

The field of biotechnology is an expanding one thanks to the continued improvement of technology. Biotechnology is “the use of living organisms or their products to modify human health and the human environment.”(P. Peters 1993) As the technology improves doctors are able to run more tests and perform more experiments. These samples can go on to make the doctors a considerable amount of money. But what about the patients from whom these samples were taken? Even though, the samples come from the patients bodies they are being left out to dry, because they will never see any of this money. And sometimes the samples they use in these tests and experiments have been taken illegally. This is almost exactly what happened in the cases of John Moore and Henrietta Lacks. This is why my case is needed.
The first case depicted will be that of John Moore v. The Regents of the University of California. In 1976 John Moore was suffering from Hairy-Celled Leukemia when he first went to the University of California’s doctor seeking help. Because Hairy-Celled Leukemia affects the spleen, the doctors concluded that to treat the problem the spleen would have to be removed. The two doctors after examining the spleen decided it would be beneficial to take samples from the spleen so that further examination could be performed of them. So the doctors had the surgeons deliver the spleen to their offices, without the consent of Moore.(Paul 1990) The doctors asked him to continue coming back as part of the follow up to the procedures, but they were really try to get more samples from Mr. Moore. After some research had been done the doctors working on the samples patented them. After that they then sold their finding to Genetic Institute and Sandoz Pharmaceuticals for an undisclosed amount of money. Finding this out John Moore took the institution to court. The jury, however, felt that Mr. Moore did not need to be awarded money. The only thing to come out the case was a reform to consent forms.(Ema) This is the least bad of the two cases for the exploitation of the samples.
Henrietta Lacks was an African-American woman who was killed by an aggressive form of cervical cancer. Her suffering ended on October 4, 1951 when she died.(Portier) Before she died her resident took some samples from her. The samples that were taken were some of the aggressive cancer cells. These samples eventually found their way into the hands of Dr. Gey who had been searching for a means by which to study cancer. These cancer cells had an extraordinary reproduction time; they were able to make a whole new generation of cells every twenty-four hours. Because of the this amazing ability the cells were and still are being bought and sold for continued research of various viruses.(Skloot 2000) Dr. Gey said, while holding a test tube of Henrietta’s cells, “A new age of medical research has begun- one that, someday, could produce a cure for cancer.”(Smith 2002) He made this statement on the same day she ended up dying. Since these cells are so widely used one might assume that the Lack’s family might have received some sort of compensation. In fact, to this day the family has yet to see any money for it. This is a prime example of what can happen when unconsented samples are used.
An issue that needs to be addressed in order for this policy to work is that of informed consent. Informed consent is “the process by which a fully informed patient can participate in choices about their health care.” (K. Edwards) Elements of informed consent include telling the patient of alternative options, what the patient’s option consists of, both pros and cons, and making sure the patient understands what will happen. (K. Edwards 1998) Informed consent was designed to help protect the patients and make sure the patients know their rights. (National Cancer Institute 2001) Informed consent is important for determining whether or not a sample was derived legally.
The main point of this policy is to avoid the exploitation of tissues and other samples that have been taken from a patient and any point in time. A main role in stopping the exploitation is that of the informed which has addressed earlier. The courts currently side with the doctors.(J Kaiser 2006) The policy that I am proposing is if a person has not consented for a doctor to use said patients donation, but do anyway the patient will receive a large portion of the earnings from the hospitals or companies. That amount will be 60% of the total amount earned by the samples. This money would be purely profit so money would not have to be taken out of any other programs. Using the samples without consent should fall under malpractice. Currently the cost of malpractice insurance premiums is going up so it would be assumed that the doctor would have enough to cover any costs.(III 2008) If the patient sees fit the doctor can also be sued. Plus if the company or hospital continues to make a profit off of the sample they will receive a 40% royalty that should be compounded monthly. A royalty is essentially a payment that allows the doctor to continue to use that person’s sample. The last item I want to cover with this policy is that of consent tissue samples. Even though the samples may be consented the donor should still receive a 40% royalty for the samples; that is if the samples become money producing. All of this deals with money that has already been made so no federal funding would be required for this policy. Since it would be easy for doctors to go and practice in other states this policy would have to take place as a federal law. It would be hard to mandate something on a state on the state level. The penalties are very steep so one would think that this would discourage doctors from doing these things illegally. The policy maybe very narrow, but it would do what it is supposed to well.
Some may think that enforcement of this policy would be very difficult. This policy would not require any agency or outside organization to help run searches. It will come down to two things. The first is that of the ethical beliefs of the doctor and their ability to know right from wrong and choose right. This means they would notify the patient if they were to use a sample from that person. Secondly, the responsibility to come forward and call out the doctors would fall squarely on the shoulders of the patient. No other person would be able to initiate the law suit, unless the named patient was deceased. The policy makes it very easy not to worry about enforcement, because it takes care of itself.
Doctors and others may have problems with my policy. They may have a couple of different comments like “the doctors are the ones who know how to use the product, why should they split the money,” or “if they didn’t take the samples John Moore’s spleen would just be in the trash.” To both of these statements I say the origin of sample will never change. The patient is always the one who should final say over what happens to their bodies or for that matter what is taken out of their body. These reasons are not important enough to override the fact patients should have the final say.
This policy if enacted will be able to do one thing and one thing well. It will be put in place to help stop the exploitation of patient samples. The cases of John Moore and Henrietta Lacks are just two cases. There are many more cases like this out there I chose to focus on these two. So many professions have lost some of their credibility due to accusations. The medical field is one that needs to be completely trustworthy, because people are constantly putting their lives in doctor’s hands. This policy if followed will give credibility back to the doctors as well. This policy is needed to help patients become compensated for the samples they let the doctors take.
Edwards, K (1998) Ethics in Medicine: Informed Consent, Retrieved on February 16, 2008 from
http://depts.washington.edu/bioethx/topics/consent.html

Ema. (1990). Moore v. The Regents of the University of California.
http://www.4lawschool.com/torts/moore2.shtml. accessed on January 23, 2008.

Insurance Information Institute (2008) Medical Malpractice.
http://www.iii.org/media/hottopics/insurance/medicalmal/. accessed on March 10, 2008.

Kaiser, J. (2006). Court Decides Tissue Samples Belong to University, Not Patient.
http://www.sciencemag.org/cgi/content/full/312/5772/346. accessed on March 11, 2008.

National Cancer Institute. (2001). A Guide to Understanding Informed Consent.
http://www.cancer.gov/clinicaltrials/AGuidetoUnderstandingInformedConsent/Page2.
accessed on March 11, 2008.

Paul, E. (1990). Natural Rights and Property Rights. Harvard Journal of Law & Public Policy,
13, 10-16.

Peter, P. (1993). What is Biotechnology?.
http://www.accessexcellence.org/RC/AB/BC/what_is_biotechnology.html. accessed on
March 11, 2008.

Portier, B. (2001) Filmmaker Immortalizes ‘Immortal’ Cells. Harvard Gazette Online. July 21,
2001.

Skloot, R. (2000). Henrietta’s Dance, http://www.jhu.edu/~jhumag/0400web/01.html
Accessed on January 23, 2008.

Smith, V. (2002). Wonder Woman. The City Paper. Circulated on April 17, 2002.

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