Medical Utopias

Medical Utopias: Christian Ethical Reflections about Emerging Medical Technologies

I presented this paper at the conference Christian Responses to Global Health Issues in Jakarta, Indonesia. The paper is published in the Proccedings.

Medical utopias are often about good health, absence of suffering, and even delaying of aging process. The last two decades have seen a tremendous increase in emerging medical technologies to achieve these utopias[1]. The completion of the sequencing of the human genome sets the stage for the next step in genetic and molecular editing or modification. The increase in computing power, storage capacity, connectivity, and the upgrading of the Internet have opened avenues of new diagnostic and therapeutic modalities. The perfecting of sustaining cell growth in vitro and cell nucleus transfer has opened the way to cloning, stem cell harvesting, and a new field of regenerative medicine. However, these emerging technologies bring with them a large number of bioethical concerns that need to be addressed. These concerns involving tissue engineering, bioelectronics, new genetics, cloning, gene therapy, germ-line genome modifications are only the tip of the iceberg. In this paper I will reflect on three areas of concern. Firstly, the emergence of the digital patient will be considered. This digital patient will be deeply formed and informed by health information technology (IT), data interoperability and issues involving privacy, confidentiality and data security. Secondly, the direct to customers (DTC) genetic screening tests will be discussed. The ethical issue of saliva taken at home and be tested for genetic diseases and prediction of other illnesses which is marketed directly to the consumers will be examined. Finally, the development of new pharmaco-therapeutics will be explored. There have been changes in the way new drugs are tested and these changes do raise some ethical concerns. The examination of these ethical issues will be done within a biblical and theological framework.

A Christian ethics framework should be biblically and theologically based, immersed in Church traditions and critiqued by rational thinking. The major moral ethics theories are consequentialism[2], deontologism[3], virtue ethics theory and recently principlism[4]. While each of these moral ethics theories has their own merits, a Christian ethics framework seem to align with that of virtue ethics. Virtue ethics focus on the character of the person who performs the act more than the act itself. It has its roots in the Aristotelian or Classical ethical system with its cardinal virtues of justice, prudence, courage, and temperance. Augustine in the 1st Century CE modified this by incorporating the work of the Holy Spirit into his framework of the virtues of faith, hope and love. Thomas Aquinas in the 13th Century, built on both the work of Aristotle and Augustine to develop his Natural Theology and a Christian virtue ethics framework. Of special relevance to this framework are his explanation of natural law, principle of totality and principle of double effect. The natural law dictates that good be pursued and evil avoided. The principle of totality means that the human body may be changed only to ensure its proper functioning. The principle of double effect allows for an act that is good but unfortunately has a bad effect. In modern terms, operating on a young mother with ectopic pregnancy to save her life is a good act. The unfortunate bad effect is that this cause the death of the fetus developing in the fallopian tube. Recently philosopher Alasdair MacIntyre reviewed many of the moral ethics theories and concludes that the Aristotelian-Thomistic tradition is “the best theory so far” (MacIntyre, 2007). He refines the theory by highlighting the role of language and narratives in his linguistic virtue ethics. With this as background, I propose that the Christian ethics framework should include these four overlapping components: the sovereignty of God, the sanctity of human life, the stewardship of humankind, and the way of love. God created this creation for our use and we have to take care of it and each other in love.[5] Most Christian anthropologies start with Adam but I propose that the Christian framework begins with Christ. Ted Peters and Gaymon Bennett note, “God’s love identifies us with the future truth of who we are becoming, not with the merits of our genetic inheritance” (Peters & Bennett, 2012,666-674) . This distinction will become useful as the challenges of emerging technologies are viewed through the lens of a Christian ethics framework.

Modern computers have revolutionized the way we live since it was invented almost three decades ago. The evolution of the computer, doubling of processing power every 18 months, the incredible increase in storage capacity and medium, and expanding functionality of software coding is phenomenal. It has contributed significantly to all aspects of our lives. In healthcare, healthcare information technology (IT) is used in hospital management and increasingly in patient care. Enter the digital patient. The digital patient is a human patient whose every measurable parameters (heart rate, weight, blood pressure, and others), medical records, compliance and financial data are stored in his or her electronic health record (EHR), accessible to whoever who has clearance. There are some who believe that the more data or information there is available, the better will be the healthcare.

The first concern is whether health IT actually improves patient care as promised? It may be argued that healthcare IT must be beneficial because the number of healthcare providers using basic EHR in USA has increased from 2009. It must be noted that EHR uptake was slow from 2001 to 2009. The increased uptake is because of two Government-based initiatives: HITECH[6] in 2009 and Medicare and Medicaid EHR Incentive Programs in 2011 which give financial incentives to healthcare providers who implement EHR. A major source of resistance to EHR comes from physicians who find that EHR takes time away from their patients. Part of the allocated patient’s time is used by their physicians to input data to EHR. Another negative effect of EHR from the patients’ perspective is that they find that their physicians are looking more at their screen than at them. In a Medscape survey on physicians using EHR in 2014, 70% of respondents said EHR decreases their face-to-face time with patients, 57% said it decreases their ability to see patients, 27% said it makes it difficult to respond to patients’ issues, and 26% reported that it decrease their ability to formulate patient treatment plans (Kane & Chesanow, 2014). According to the authors, the physicians’ frustration with EHR seems to be increasing as compared to the responses in the previous year.

A study was published in Annals of Internal Medicine of adverse drug events (ADEs) recorded in a highly computerized hospital over a 20 week period. One quarter of the 937 admissions had at least one ADEs. 9% resulted in serious harm. Of the errors associated with the ADEs: 61% involve ordering, 25% monitoring, 13% administration, and 1% dispensing (Nebeker, Hoffman, Weir, Bennett, & Hurdle, 2005). Health IT may not actually improve healthcare. It brings with it a new set of ADEs. Health IT is expensive to implement. An unbiased review is needed to show whether health IT do significantly improve patient care. There is significant marketing pressure to use health IT. Implementing and maintaining health IT may cost health providers millions of dollars which in turn raises the healthcare cost. Treating the digital patient takes away time that is rightly due to the real world patient as real world patients have limited time with their physicians.

The second concern for the digital patient is data interoperability. What it means is whether computers can communicate with each other. The foundation of healthcare IT is in accounting, keeping stock and billing. It is excellent in generating data. It may even be programmed to offer solutions based on these data. There are a few assumptions here; that the data collected is correct, that the information is being communicated, and that humans who carry out the treatment understands what needs to be done. The computer will collect data that it is programmed to do. This depends on the programmers who depend on feedback from medical professionals on what data is needed. Data needs context to be useful and interpreted correctly. To share information, computers need to communicate with each other. For example data created for the patient in the Emergency Department need to be communicated to the inpatient system which forms part of the patient’s EHR. Similarly blood tests and x-rays from the diagnostic departments needs to be incorporated into the patient’s EHR. In principle this is easy but in practice it is difficult as those who try to develop health EHR in healthcare IT have discovered. Computers communicate by software code. Each healthcare IT providers will have their own set of propriety codes. Without the same propriety codes, computers cannot communicate with each other. These propriety codes are often updated as modifications are continually being made to improve the system. Major modifications will result in a new version. Each new version may have many changes. Eventually, the latest version may not be backward compatible to the older versions. This is an issue of data interoperability.

Unless it is a brand new hospital designed with healthcare IT in mind, most hospitals have developed their health IT piecemeal. Initially the set up may be on administrative and billing. Later the laboratories and other diagnostic features. Finally the EHR is stared with outpatient prescriptions. Often the case, these steps may be implemented at different time with different healthcare IT providers. The problem arises when attempts are made to link these different systems together. These are called the legacy systems. The only solution is to buy a brand new hospital-wide health IT system and start afresh. Even then it may only work within one hospital. If the patient is transferred to another hospital, his or her EHR may not follow or captured unless it is by the same health IT provider and of a compatible version. Universal EHR will not work unless computers are able to communicate but incompatibility is a major issue that healthcare IT providers are still unable to solve.

The third concern are issues involving privacy, confidentiality and data security of the digital patients. Security may not be the highest priority in healthcare IT designs. There are so many other obstacles that need to be overcome. Insurance companies and future employers will benefit from having access to confidential health information of potential clients or employees. Data Protection Act is being enforced in many countries because of the risk of such knowledge falling into the wrong hands. Symantec in its Internet Security Threat Report (ISTR) 2015 noted for the fourth year in a row, healthcare industry continues to be the sector with the largest numbers of security breaches – 37% with about 7 million identities exposed. In comparison, the next sector with securities breaches is retail with 11% in the same year. The same report also highlighted that breaches done with intension to obtain confidential patient records has increased to 82%. The report notes, “Unfortunately, for the most part, the healthcare industry is not prepared to face today’s cybersecurity risks, no matter if they are hospitals, pharmaceutical or biotech companies, medical device manufacturers, health insurers, national health agencies, or employers”(Symantec, 2015, 85-86). This is of serious concern as patients’ EHR should be protected by encryption and multiple layers of securities as these are sensitive information and may be abused if it end up in the wrong hands.[7]

There are immense marketing forces to make healthcare IT an integer part of patient care. The digital patient is created by health IT. Whether it is the panacea to improved healthcare, reduce cost, and ADEs remains to be seen. In the meantime it is vulnerable to online attackers who seek the confidential information stored in the EHR.

Companies are offering direct to customers (DTC) genetic screening for people who wants to know about their risk to diseases and are willing to pay. What is needed is some saliva or a blood sample which is couriered to the company and the customers will receive a detailed analysis of their genes and their relative risk to certain diseases. The types of tests include single gene tests, multiple gene tests and personal genome scanning or genome-wide-testing in which thousands to millions of genetic markers are tested throughout the genome. The purpose is to determine the relative risk of the person tested of developing certain diseases. According to a list compiled by the Genetics and Public Policy Centre (USA), there were at least 29 companies, most of which have their headquarters in the USA, selling DTC test in May 2010. Over the last few years, many more may have been incorporated.

This is of ethical concern because of the unproven scientific validity and reliability of these tests. The companies seem to analyze everything – from real disease causing gene mutations to gene variations which may or may not have any risk for any disease. Physicians used to be the gatekeepers of ordering medical tests. The reason is that the raw data results from these tests needed to be interpreted in the context of the patient’s health (individualized medical supervision). In DTC, these companies are deliberately bypassing the gatekeepers to offer their tests direct to customers. The companies also take on the role of interpreting the results. Within the DTC genetic testing market there is the great deal of variation regarding the purpose of the tests on offer; for example, different tests can provide information regarding ancestry, carrier status, disease risk (presymptomatic, prenatal, susceptibility), nutrigenomics or pharmacogenomics which will need someone with medical training to interpret (Howard & Pascal, 2012) , 105

Due to these concerns, the U.S. Food and Administration Agency (FDA) halted DTC companies from offering these tests in 2013. However, in a news release dated 15 February 2015, the FDA reversed their decisions and allow the companies to continue. Furthermore, it directs that these tests do not need any further FDA approval. “The FDA believes that in many circumstances it is not necessary for consumers to go through a licensed practitioner to have direct access to their personal genetic information,” Alberto Gutierrez, Ph.D., director of the Office of In Vitro Diagnostics and Radiological Health in the FDA’s Center for Devices and Radiological Health noted, “These tests have the potential to provide people with information about possible mutations in their genes that could be passed on to their children”("FDA permits marketing of first direct-to-consumer genetic carrier test for Bloom syndrome," 2015). It appears as if medical supervision and genetic counseling are not considered relevant in DTC matters.

Developing and testing of new drugs are very expensive. It also takes a long time for drug testing to go through the processes of laboratory, animals and finally human trials. For example, every new drug must be tested for carcinogenicity. The initial short term in vitro mutagenicity test may be done in the laboratories. The drugs are added to mammalian cells or microorganism in glass dishes to see if it damage or alters the DNA leading to mutation causing mutagenicity. These drugs are called mutagenic carcinogens. There is also another category or non-mutagenic carcinogens are those which do not act on DNA which needs to be tested.

The next phase is lifespan in vivo tests in rodents. Non-mutagenic carcinogens are those which are metabolized in animals to produce a carcinogenic substances. This means feeding rodents the drugs over the span of their lifetime which may be 18-24 months. Because of the difficulty in extrapolating across species, WHO recommends testing two species- rat and mice. Overall, non-clinical carcinogenic studies in rats over 3 years cost about USD 1 million per compound. After these come the human trials.

Can the animal aspect of the drug trials be reduced without compromising the validity of the results? Herein lies an ethical concern. There is a movement to reduce testing to one species using genetic engineered rats. This movement was initiated by the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH). ICH comprises three pharmaceutical associations and regulatory bodies of the EU, USA, and Japan.

In July 1997, ICH approved the guidelines for ‘Testing for Carcinogenicity of Pharmaceuticals’ which propose a short term rodent lifespan study instead of the long term lifespan studies. This involves three types of genetically engineered rodents (created 1970s). These are rodents where oncogenes are introduced or where the tumour suppression genes are removed (‘knocked out’).

In the tgAC study, carcinogens were introduced to the mouse skin. This raised questions as most pharmaceuticals are ingested orally. Only 23 chemicals were used. The approval were given even before the validation studies were done. In these trials, the results were obtained in 8 weeks.

The validation was done in the 2000s by International Life Sciences Institute (ILSI). John Abraham and Rachel Ballinger note that the validation studies were “driven by senior scientists from American pharmaceutical firms such as Schering-Plough, Sanofi Sterling Winthrop, Novartis, Johnson & Johnson. Merck, and Pfizer” (Abraham & Ballinger, 2012), 99). While respect is given to the integrity of the various scientists involved, there is always a suspicion of multinational Pharmaceutical companies stacking the decks in their favor.

Pharmacogenomics is the new science of how genetic factors affect the response of some people to certain drugs. For example, warfarin is tolerated in some patients but not in others. Warfarin is for long term use in patient to prevent thromboembolic events. Findings from a recent trial shows that pharmacogenomics information is helpful in determining the use of warfarin and its dosage for different patients. It has been shown that people with CYP2C9 in their genes are better at metabolizing warfarin. Also VKORC1 gene is related to the dosage need. Hence knowledge of genetic information is useful in the patient’s use of warfarin (Kitzmiller, Groen, Phelps, & Sadee, 2011).

Pharmacogenomics may also be used in human drug trials. If the genetic information is available on a group of persons who can tolerate the drugs with minimal side effects, a new drugs may be tested only on these people. The subsequent favorable phase three (human) trial reports will be submitted to FDA for approval. FDA is only interested in the initial trials results. Once approved, other side effects are reported as adverse reactions. Like the genetic engineered rats, pharmacogenomics may be used to fast track the approval of new drugs.

The ethical concerns here involve drug testing, the current close partnership and funding of research institutions by pharmaceutical companies, and the market driven need to fast track new and relatively untested drugs unto the general population.

There is no doubt that emerging technologies are revolutionizing our lives and are here to stay. While there are many positive aspects, the market driven forces behind emerging technologies are causing some concerns. This paper only highlights a few of them. Examining emerging technologies through the lens of Christian ethics framework is useful in keeping perspectives. The sovereignty of God acknowledges that God is in control and we are allowed to create new things using his created materials. Stewardship ensures we make good use of these technologies while the way of love and sanctity of human lives ensure that we do no harm but seek the good of others.

Health IT is useful in making order out of the information mess that is in a healthcare center but not at the expense of quality patient care and patients’ right to their privacy and confidentiality of their records being compromised. DTC is market driven and does not take into consideration misinterpretation of results without adequate medical supervision. This will lead to unnecessary fear leading to harm. Market driven fast track drug trials in the long term may cause more harm than the good the drug may do. To summarize, this paper identifies some concerns how emerging technologies, instead of being a blessing may become a bane when it is driven by the marketing of a consumer driven society.

Abraham, J., & Ballinger, R. (2012). Power, expertise and the limits of representative democracy: genetics as scientific progress or political legitimation in carcinogenic risk assessment of pharmaceuticals? Journal of Community Genetics(3), 91-103. doi:10.1007/s12687-011-0060-2

Beauchamp, T. L., & Childress, J. F. (2009). Principles of Biomedical Ethics (6th ed.). Oxford: Oxford University Press.

FDA permits marketing of first direct-to-consumer genetic carrier test for Bloom syndrome. (2015). FDA News Release. Retrieved from http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm435003.htm (Accessed 12 May 2015)

Gordijn, B. (2006). Medical Utopias: Ethical Reflections about Emerging Medical Technologies (S. L. Kirkby, Trans.). Leuven: Peeters.

Howard, H. C., & Pascal, B. (2012). Is there a doctor in the house? The presence of physicians in the direct-to-consumer genetic testing context. Journal of Community Genetics(3), 105-112. doi: 10.1007/s12687-011-0062-0

Kitzmiller, J. P., Groen, D. K., Phelps, M. A., & Sadee, W. (2011). Pharmacogenomic testing: Relevance in medical practice: Why drugs work in some patients but not in others. Cleveland Clinic Journal of Medicine, 78(4), 243-257. doi:10.3949/ccjm.78a.10145

MacIntyre, A. (2007). After Virtue (3rd ed.). Nortre Dame, IN: University of Notre Dame Press.

Nebeker, J. R., Hoffman, J. M., Weir, C. R., Bennett, C. L., & Hurdle, J. F. (2005). High rates of adverse drug events in a highly computerized hospital. Archives of Internal Medicine, 165(10), 1111-1116. doi:10.1001/archinte.165.10.1111

Peters, T., & Bennett, G. (2012). A Plea for Beneficence: Reframing the Embryo Debate On Moral Medicine (2nd ed., pp. 666-674 ).

[1] Ethicist Bert Gordijn in his critique of a medical utopia brought about by technology suggest these technologies must fulfil three criteria: (1) the objectives for medical research must be worth striving from an ethical point of view, (2) further research must actually contribute to a realization of these objectives, and (3) any ethical problems concomitant with the further development and application of medical research field must be justifiable or surmountable (Gordijn, 2006, 39-55). However, he did not take into consideration, the misuse of these technologies by unscrupulous people for their own profits as a fourth criterion.

[2] Consequentialism of which Unitarianism is a subset is a moral theory that defines an act is good if it produces the greatest number of happiness for the greatest number of people. Its foremost proponents are Jeremy Bentham (1748-1832) and John Stuart Mills (1806-1873).

[3] Deontologism uses a rights-based or duty-based system of analysis. Foremost proponents include Immanuel Kant (1724-1804)

[4] Principlism, based on the works of Tom Beauchamp and James Childress, includes (1) respect for autonomy, (2) beneficence, (3) non-maleficence, and (4) justice. (Beauchamp & Childress, 2009)

[5] Forthcoming book, Tang, Alex, Christian Biomedical Ethics in a Changing World, Armour Publisher (2016)

[6] The goal of this legislation is to promote the use of digital technology to curb healthcare costs and improve care. It is titled Health Information Technology for Economic and Clinical Health Act (HITECH).

[7] Patient’s EHR are much worth much more to hackers or thieves as they contain more complete information (name, age, address, social security card and credit card numbers, and passwords) than information obtained from other sectors. (Symantec, 2015, 85)