Bioethics - Lecture 8 PDF

Biosecurity and Research Bioethics [APBI304]  Lecture 8 Ownership and Control of Human Tissue and Genetic Data By Dr. Mariam Gamaleldin Assistant Professor of Molecular Biology  The Immortal...

Biosecurity and Research Bioethics [APBI304]  Lecture 8 Ownership and Control of Human Tissue and Genetic Data By Dr. Mariam Gamaleldin Assistant Professor of Molecular Biology  The Immortal Life of Henrietta Lacks APBI304 Video from: https://www.youtube.com/watch?v=22lGbAVWhro  The Immortal Life of Henrietta Lacks ▪ Henrietta Lacks was a patient who died from cervical cancer. ▪ In 1951, months before she died, her tumor was harvested and sent to Dr. George Gey, who found that the tumor kept growing uncontrollably even after it was harvested from Henrietta’s body. ▪ The cells’ resilience enabled scientists to culture the cells from the tumor and perform experiments on them. They came to be known as HeLa cells, in reference to Henrietta’s name. Was it ethical to use Henrietta Lacks’ cells in this way? APBI304  The Immortal Life of Henrietta Lacks “I’ve [Skloot] tried to imagine how she’d feel knowing that her cells went up in the first space missions...or that they helped with some of the most important advances in medicine: the polio vaccine, chemotherapy, cloning, gene mapping, in vitro fertilization.” “If you pretty up how people spoke and change the things they said, that’s dishonest. It’s taking away their lives, their experiences, and their selves.” Does the same hold true of our tissues? “...She’s the most important person in the world and her family living in poverty. If our mother so important to science, why can’t we get health insurance?” APBI304 Photo from: https://afro.com/lawrence-lacks-side-story/  Key concerns with Henrietta’s story Was it okay that Henrietta’s cells were kept and used without her consent? (RECALL Informed Consent in Lecture 2) Was it okay that scientific research was (and continues to be) done without the consent of Henrietta or her family? Was it okay that her cells were used and are still being used to generate profit not only without her consent, but also without any benefit for the family she left behind? Is it okay that everyone knows the identity of the donor woman? APBI304  Publishing HeLa’s genome sequence ▪ In 2013, a group of researchers published HeLa’s genome sequence, which was available to the public. ▪ This generated a public outcry demanding that Henrietta’s genome sequence become protected from unlimited access. ▪ Because of this outcry, the National Institute of Health (NIH) agreed with the Lacks family to move the genome to a database that has controlled access and to form a committee including the Lacks family to review research that is being done on the data. APBI304  Is the HeLa case generalizable to all biospecimens? The HeLa case was exceptional in several regards: 1. It is rare for a biospecimen to be as valuable as the HeLa cells proved to be. Usually, research takes many samples from many people in order to produce valuable data. 2. It is rare for a specimen donor to be as famous as Henrietta Lacks. Therefore, the donor identity is not typically threatened by the online availability of genomic data. Harming an anonymous donor through the availability of online data requires special motives, technical prowess, and the means to use the data to harm the donor. APBI304  Biospecimens in the modern world Biobanks Definition: ▪ A biobank is a collection of human biological samples (biospecimens) and associated information that is organized in a systematic manner for research purposes. Biobanking can be public (non-profit) or private (commercial). APBI304 Photo from: https://www.biobanking.com/biobanks-a-platform-for-modern-biomedical-research/  Biobanking APBI304 https://www.youtube.com/watch?v=66moI1ZHMYs  Biobanking procedure APBI304  The ethics of owning the body or body parts The English philosopher, John Locke, said that “every man has a property in his own person.” Stephen Munzer had a different opinion on this subject in that people do not necessarily own their bodies completely but they have “limited property rights in them.” The Declaration of Human Rights prohibits any person from owning another person (slavery). What about a dead person’s body? APBI304  Ownership of a dead body ▪ “There can be no property in a corpse” has been part of the customary law since 1614 until 1908. ▪ In 1908, an exception was made to the statement, because of the following case: Case of Doodeward v Spence Doodeward bought a dead preserved fetus with two heads in order to display it in an exhibition. However, the police seized it. Doodeward sued the police in court claiming ownership over the corpse. The court ruled that since the corpse was skillfully modified/preserved, this means that it acquires a special property (the skill) that allows it to be owned or bought, or sold. The act of preserving the corpse in a bottle was enough to justify possessing and owning it. Ever since 1908, ownership of corpses under special conditions has been allowed. APBI304  The 1998 Case of the Royal College of Surgeons ▪ An artist by the name of Anthony- Noel Kelly stole some preserved body parts from the Royal College of Surgeons in order to create some sculptures, which would later be exhibited in an art gallery in London. ▪ Kelly was accused of theft on the premise established in the Doodeward v Spence case in 1908, which is that corpses could be owned if they had undergone “skillful” treatments or modifications. ▪ Kelly was imprisoned for 9 months. APBI304  Human tissue ownership ▪ Based on the aforementioned cases, it so became that when: 1. The recipient acquires the right to possess a body part once it is removed from the donor. 2. The recipient earns additional rights, such as the right to ownership, if he modifies or processes the body part. APBI304  Ethics of human tissue commercialization Generating profit from buying and selling human tissues has been explicitly prohibited by the Council of Europe’s Convention for the Protection of Human Rights and Dignity of the Human Being with Regard to the Application of Biology and Medicine: Convention on Human Rights and Biomedicine. “The human body and its parts shall not, as such, give rise to financial gain.” -Article 21, Prohibition of Financial Gain “When in the course of an intervention any part of a human body is removed, it may be stored and used for a purpose other than that for which it was removed, only if this is done in conformity with appropriate information and consent procedures.” -Article 22, Disposal of a removed part of the human body N.B. The body parts excluded from these rules are hair and nails as they are normally discarded. APBI304  Consent models for biospecimens 1. General notification: Donors are informed passively of the possible use of biospecimens for research and they are given the option to either opt- in or out depending on the default position. ▪ If the default position is for the individual biospecimens to be used, the individual is given an option to opt-out. If the default position is for the sample NOT to be used, the individual is given the option to opt-in. 2. Study-specific consent: Donors are contacted to acquire their consent before each study. 3. Blanket consent: Donors are requested to give consent to all possible future research done on the biospecimen. APBI304  Consent models for biospecimens (cont.) 4. Broad consent: Donors are required to consent to future research on the biospecimens under certain conditions, such as maintaining the right to withdraw or overseeing the future study done on the donated biospecimen. 5. Categorical consent: Donors check the options that they would like their donated biospecimens to be used for in the future. 6. Dynamic consent: donors are digitally enabled to change their consent options according to the latest scientific developments and the donor’s own circumstances. APBI304  Patenting biological samples To define “patent”, one first has to define “intellectual property”: ▪ Intellectual property: is a property that is produced by the human intellect and is intangible (e.g., an idea, an invention). ▪ Patent: is a legal form of the monopoly of intellectual property that gives exclusive rights to the holder. If the invention/idea produced is original, novel, and non- obvious, it is patentable. The rights a patent confers are geographically and temporally limited in nature as well as in scope. APBI304  What kind of biological samples can be patented? 1. Biological material which has undergone a technical procedure in isolating or making it. The fact that it exists in nature as it is does not prevent it from getting patented. 2. A process that is used to make, modify or utilize the biological material. 3. A novel application of the biological material or the process (even if the material or process is patented). 4. Inventions pertaining to material taken from the human body. However, the use of this invention has to be stated in the application for the patent. APBI304  What kind of rights do patents give their holder? 1. A patent typically prevents other people from importing, utilizing, or selling an invention. For example: if a scientist applies for a patent for a heart-rate- measuring device, others would not be allowed to make the same device to measure heart rate. The scientist would also be allowed to sell that device for profit but other people would not be allowed to sell the same device. 2. However, the patent does not per-se give the holder the right to measure heart rate. If it does, then the scientist has to go through certain extra steps to acquire the right to measure heart rate (e.g., safety regulations). APBI304  What about patenting human tissues? Moore v. Regents of the University of California Case (1990) APBI304 Video from: https://www.youtube.com/watch?v=E1yInC8vQcY  Moore v. Regents of the University of California Case (1990) ▪ The Supreme Court of California ruled in favor of the Regents of the University of California, citing the following reasons: 1. Moore’s cells had undergone genetic engineering to be used as a cell line in the lab (the Mo Cell line). This meant that the cells were modified with a high level of skill enabling them to be owned as property (RECALL the Doodeward v Spence case). Therefore, Moore had no property rights over his modified cells. 2. Once Moore’s organs left his body, they could be claimed as property by someone else (similar to abandoned property) (RECALL slide 15). ▪ However, the judges ruled that the physicians should have given Moore informed consent regarding the economic interests in his own cells and tissues. APBI304  Washington University (WU) v. Catalona Case ▪ William Catalona, a physician, routinely removed tissues from patients and asked them if he can use the tissues for research purposes. The patients would sign a consent form giving up all their rights to these tissues for the sake of research. ▪ The tissues of Catalona’s patients were deposited in the WU biobank along with tissues from other patients. ▪ WU objected when Catalona transferred 100,000 USD worth of tissue samples from the biobank to a privately owned lab. ▪ Because of this, Catalona moved to Northwestern University and informed the patients of his decision asking them if he can take their tissue samples with him. ▪ Many patients gave Catalona consent to transfer the samples. However, WU objected and sued Catalona, claiming they had ownership of the tissue samples, not Catalona. APBI304  Washington University (WU) v. Catalona Case ▪ Many of the patients took Catalona’s side in the lawsuit saying that they support the transfer of their samples to Northwestern University so that Catalona can resume doing his research, which would help him find a treatment for prostate cancer. ▪ They also stated that they did not consult with Catalona to help WU make a profit. They supported Catalona’s research endeavors rather than WU. ▪ The court ruled that the patients had no right to authorize the transfer of the tissue samples as they had signed away their rights when they donated their samples. ▪ The court also stated that the patients had donated their tissue samples not to Catalona per se but to WU, which has intellectual property rights over what Catalona produces when he is hired at WU. APBI304  Take-home message from Moore v. Regents of the University of California Case & WU v. Catalona Case ▪ Tissue donors have the right to be informed of what their donated tissues would be used for and if their tissues would be used for commercial purposes. ▪ The donor loses ownership of the donated material once he has donated it. ▪ The donor no longer has a say in what happens to his donated tissue once he has donated it. ▪ If the donated tissue/material is sufficiently processed, it can be commercially used. ▪ Currently, the patients do not have any rights to any financial returns generated from the processing of the donated tissue. APBI304  What about commercial use of the human genome? ▪ In October 1994, the former NIH scientist and CEO of Human Genome Sciences, Craig Venter, announced that the only researchers that would have access to the sequencing data of the human genome are those that gave Venter rights to commercial exploitation of the data. ▪ This led to an outcry from the scientific community showcasing that Venter’s action was deeply ethically problematic. ▪ In 1997, the Universal Declaration on the Human Genome and Human Rights declared that: “The human genome in its natural state shall not give rise to financial gains.” Q: Why is the commercialization of body parts and the genome prohibited? A: Because commercialization compromises human dignity and integrity. APBI304  What about commercial use of the human genome? ▪ With the advent of genome sequencing technology, companies (e.g., 23andMe and AncestryDNA) appeared on the market that performed direct-to- consumer (DTC) genetic health testing of the entire genome. ▪ 23andMe was founded in 2006 with Google acting as a primary investor. ▪ The activity of 23andMe remained unregulated until 2013, during which 23andMe collected large amounts of genomic data from clients. This raises many questions: 1. Who owns the genomic data? 2. How is the data being used? APBI304  What about commercial use of the human genome? (cont.) ▪ In 2018, 23andMe sold the clients’ genetic data to GlaxoSmithKline (GSK), a major multinational pharmaceutical company, for 300 million US dollars. This data would be used for developing new drugs. ▪ This deal was perfectly legal because when 23andMe clients used the genetic testing service, they consented to their data being used for “research purposes”. However, did the patients really know that the data would be sold for millions of dollars to major pharmaceutical companies? (No) Also, do the patients have any rights to the money generated from the deal? (No) APBI304 https://time.com/5349896/23andme-glaxo-smith-kline/  What about commercial use of the human genome? (cont.) ▪ Studies have shown that most of us just check the box without actually reading the terms and conditions. ▪ One study found that 98% of users of a fictional social network consented to give up their firstborn child (they did not read the terms and conditions). ▪ It is these terms and conditions that let us know whether our data will be sold to other people. ▪ It also covers issues regarding privacy issues and the protection of the data. APBI304  What about patenting human genes/human genome? ▪ In 2013, the famous actress Angelina Jolie underwent a double mastectomy surgery when she found out she had a breast cancer-causing mutation in the BRCA1 and BRCA2 genes. ▪ At the time, the genetic testing for the BRCA1 mutation was patented by Myriad Genetics, a company that specializes in genetic testing. ▪ Because of the patent, the test was extremely costly and did not allow the majority of women who have the BRCA mutation to get tested. This raised the question of whether it is ethical APBI304 for genes to be patented. Association for Molecular Pathology v. Myriad Genetics, Inc. Case APBI304 Video from: https://www.youtube.com/watch?v=O3jzxlMHPzg Association for Molecular Pathology v. Myriad Genetics, Inc. Case ▪ In 2013, the Supreme Court ruled that genes are NOT patentable, because they are products of nature not inventions. ▪ This resulted in the invalidation of Myriad’s patents on BRCA1 and BRCA2. ▪ The Supreme Court ruled, however, that complementary DNA (cDNA) is patentable because it has undergone skilled processing/modification. ▪ The ruling on genes NOT being patentable meant that more people can have access to genetic testing. APBI304 Photo from: https://www.aclu.org/cases/association-molecular-pathology-v-myriad-genetics  What about patenting human genes/human genome? APBI304 Video from: https://www.youtube.com/watch?v=kUpgfARGmXs THANK YOU