Saturday 1 February 2014

Property Ownership Rights as Applied to Medical Research

Carl Stuart.
Stuart Medical Series: Book Review
Property Ownership Rights as Applied to Medical Research.
In the book, The Immortal Life of Henrietta Lacks, the author, Rebecca Skloot, states the life story of Henrietta Lacks, a modest woman whose cells were used for medical research without her consent. She was employed in a tobacco farm. Her cells were used to develop the first immortal human cell lines, commonly known as the HeLa cells. Research done on HeLa cells led to the inception of a multibillion dollar industry which specialized in the trade of biological specimens. The HeLa cells have been traded in large amounts all over the world, and massive profits have been made during such trading. Lacks’ family has not benefitted from these business ventures. In fact, the family learnt that Lacks’ cells were still alive twenty years after her death. In her book, Skloot has raised the issue of whether people own the tissues in their body in the same way as they have property ownership rights to a car, a piece of land or even a house (Skloot 23). This paper analyzes the concept of property rights as it has been explored in the book, and what needs to be done about it and rationale behind such an action(s).
In the book, Skloot points out the importance of property rights over human tissues. There are questions whether Lack owns her cells (the HeLa cells), which were used in medical research, and are still being used today (about 60 years after her demise). The author explains, using examples, how body tissues have not been patented. In fact, it was the first lawsuit in 1980s, which raised the issue of patenting body cells. This lawsuit involved a person named Moore, who was involved in another scientific experiment which led to the development of the strains of cells known as Mo (Skloot 140).
Moore had a malignant form of cancer, and the attendant doctor recommended that it could only the treated by excising and replacing the spleen tissue. The doctor performing the operation on Moore collected sample tissues from the semen, spleen and bone marrow. Moore had signed a consent form, thereby giving the hospital the right to use his cells for research (Skloot 146). However, Moore had queried if his cells had any commercial value, but his doctor answered that they had no commercial value at all. But Moore suspected that the doctors were not disclosing the full information to him. He later found out that his cells were being used to develop a cell line which was called Mo, and he thereafter sued the doctor for theft. His doctor, Dr. Golde, had patented his cells, and had already profited from them. Moore’s cells were said to have been vital in the acquisition of the patent. The reason for this is that not all cell strains are worth patenting (Landecker 179). However, Moore’s cells produced a unique form of protein which could be utilized to manufacture medicines that could be used in the treatment of cancer (and other infections), and in the research for a HIV vaccine. If Dr. Golde had not patented these cells, Moore could not have profited the sale of his cells. This lawsuit against Dr. Golde was opposed by scientists all over the world, since they perceived that such a litigation would encourage every person(whom they extracted research specimens from) to sue them for cell lines that they had used in research. The scientists argued that the only people with legitimate rights to these cells were the scientists who had extracted them, and the financiers who had provided finance that enabled these strains to be developed. They asserted that without the valuable contributions of these people, the cultures could not have existed in the first place (Lenk et al 41). Personally, ethical morality avers that the scientists (and their financiers) and the patients (from whom the specimen were extracted from) should proportionally share the profits derived from the sale of the patented human cells and tissues. Undoubtedly, the scientists (and their financiers) would take a significantly bigger proportion of the proceeds from such sales, while the patient would receive a specific percentage from such sales.
Likewise, the lawsuit against Dr. Golde caused numerous debates among policy makers, scientists and lawyers who unanimously stated that giving the individual patient the rights to the patent would result in many logistical problems that would be hard to solve, and it would also impede the development of medical sciences. Fortunately, the lawsuit against Dr. Golde was dismissed by the court, and the judge even cited the case of the HeLa cells, where the owners of the cells had not come forward to claim the rights to ownership. Later, Moore appealed against this verdict in 1988 in a California court, and he won the appeal (Lenk et al 45). The judge comments were that the patient has the right to manage what is done to their body, and therefore he has the right to what becomes of their cells. Fortunately, Dr. Golde appealed against this verdict and emerged victorious. Moore was never given any portion of the profit, but the judges agreed that Golde had erred by not taking informed consent, and was thus guilty of breaching the principle of fiduciary of duty when he used his power as a doctor to violate the trust that the patient had placed on the doctor-patient relationship (Skloot 148). The court ruled that the doctors should disclose to the patients their financial interests, although this was already a legal obligation (Lenk et al 46). Personally, it is evidently clearly that the rights of the patients to their sample tissues are overruled by the need to advance medical knowledge and therapeutics. Moreover, these patients must understand that they are promoting the common good of the society, and that their lawsuits against doctors are based on retrogressive assessments of the prevailing circumstances.
Till today, matters pertaining to tissue ownership rights are still unclear. In the U.S.A, a person has a right to privacy. This right gives them complete control of their body, and they are therefore solely responsible for making decisions regarding their bodies, such as procreation and refusal of medical care. However, the protection of privacy of the human body does not apply to the tissues of the body. Hence, once a tissue has been detached from the body, it stops being the property of the owner (Landecker 175). Personally, this prudential aspect of the constitution ensures that scientific research and the advancement of medical sciences are not curtailed and restricted by human subjects who make the wrong assessments(of the existing circumstances) and thereafter arrive at improvident decisions.
There are several questions that have been raised in an attempt to comprehend the logic behind the reasons for the legal distinctions between right to privacy and right to ownership of tissues. Landecker states “Does it mean that when the cells or tissues are detached from the body, they cease being part of the person’s body? Or is it that these tissues have an endless potential value to science and research?” (176). However, it is clear that if the HeLa cells availability was limited, the various advances in medicine such as discovery of the polio vaccines and other scientific advancement would not have been made (Landecker 176). Personally, the logical basis for such distinction is that the tissue biopsies (and excisions) cease to be part of the patient’s body upon the completion of the biopsy or excision procedure. The reason for this is that the tissues are not going to be grafted back into the body of the patient, and that the patient also understands that these tissues have been lost from his body forever.
Other cases concerning tissue ownership rights have also been taken to courts. However, the courts have based their verdicts of the ownership rights on the basis of the existing medical circumstances. Apparently, medical advancement is only possible if the researchers are not frustrated by private agenda. Hence, it is imperative that medical research should be regulated. If the development and utilization of cell lines are not regulated, the whole process would be turned into a business venture with the cell strains ending up in the hands of the highest bidder, who may not have the best interest with regards to the promotion of public health and safety. Hence, non-regulation of cell lines debases the principles of medical research. Moreover, the integrity of bio-repositories would be compromised. Also, accountability in research would be unattainable, because it would be compromised, since it would be focused on making money. Furthermore, medical research would also be influenced by prejudicial interests. For instance, with legal rights on body tissues, the donors would decide on how their tissues are stored and used (Lenk et al 659). Personally, this means that it would be possible for some people to come up with a queer conditionality, such as the right to determine which ethnic group is to benefit from the knowledge accrued from the research on his tissues. This would contravene the precept of equality in the provision of health care. Hence, it is clearly evident as per the information provided above, that a patient must never be given the rights to tissue specimens that have been removed from his body, since the provision of such rights would impede the advancement of health sciences, and it would also undermine moral and ethical practices in the professions of health sciences.
Nonetheless, despite the fact that the laws so far don not recognize the rights to ownership of tissues, it has however given the individual the right to withdraw their tissues from research at will. However, they do not have any right over how these tissues are used (Lenk et al 659). Personally, this directive is imprudent since it gives the individual the right to interfere with medical research.
Since the cases of Lacks and Moore, there have been other cases which have shown that there is a need to address the issue of property rights over biological material, while at the same time ensuring that the scientific research is not curtailed. Although scientists have clearly stated that the contribution of the financiers and the scientist led to the development of a culture, and thus it is only their opinions that count; it is important to bear in mind that the culture could also not be developed without the original material given by the donor. This therefore means that the contribution of the donor and other stakeholders are important. As such, they should have a stake in whatever profits that may be obtained from the material extracted from the body. For instance, the HeLa cells which have been sold in millions of sets have created billions of dollars in profit, but not even a single penny (from these profits) has benefitted the surviving members of Lack’s family as they still live in poverty (Solbakk et al 390). According to Skloot, Lacks’ daughter queries as follows: “If her mother’s cells have made such a huge contribution to medical advancement, how come her family does not even have medical insurance?”(123). this paper does not call for the commercialization of human tissues, but it just asserts that the donors of such specimens need to at least benefit from the commercialization of their specimens.
Scientists have clearly stated that not all cell strains are important for medical research. In order to avoid a situation whereby people sell their specimens (thus hindering medical advancement), there should be regulations that recognize the ownership of these unique tissues and cells, and thereby require the doctors to disclose this information to their respective patients. Slavin’s case epitomize this idea. The doctor recognized that Slavin (a patient who had hemophilia) had developed cells which had potential financial value (Solbakk et al 389). The reason for this unique observation was that the patient had received blood from many donors. Blood at his time did not go through the rigorous process of testing before being transfused into a patient. As a result, Slavin had received blood with different strains of hepatitis B virus, and his body developed a unique type of anti-hepatitis B antibodies. When his doctor discovered this, he informed him. His blood was then used to develop a vaccine for hepatitis B, and he profited from this venture (Skloot147). Personally, this clearly illustrate that the development and commercialization of human cells can be mutually beneficial to all the stakeholders. Hence, mutual benefit can be accrued in all other similar circumstances.
The field of biotechnology is rapidly developing. This creates many ethical concerns that must be fully resolved. Tissue ownership rights are one of the major unresolved issues in the field of biotechnology. Although it is not possible to draw a line of distinction between protecting the right to medical and scientific research, and the individual property rights; it is evident that a lot need to be done to promote a consensus between these two distinct rights. This should however not be done at the expense of medical and scientific research. Having regulation that allows for extremely limited patent rights in special cases, such as that of the HeLa cells and Moore case will ensure that the donors of biological specimens also get to benefit from their contribution. The public also need to be actively involved in finding the balance between these two conflicting issues.
                                                                    Work Cited         
Landecker, Hannah. Culturing Life: How Cells Became Technologies. Cambridge, Mass: Harvard University Press, 2009. Print.
Lenk, Christian, Judit Sándor, and Bert Gordijn. Biobanks and Tissue Research: The Public, the Patient, and the Regulation. Dordrecht: Springer, 2011. Print.
Skloot, Rebecca. The immortal life of Henrietta Lacks. Sydney: Pan Macmillan, 2010.Print.
Solbakk, Jan H, Søren Holm, and Bjørn Hofmann. The Ethics of Research Biobanking. Dordrecht: Springer, 2009. Print.



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