Editorial Article

Ethics of Personalized Medicine Revisited

Jack Kushner
Division of Genomic Medicine, George Washington Medical Center, Washington, USA
*Corresponding author:

Jack Kushner, George Washington Medical Center, Division of Genomic Medicine, Washington, USA, Email: jkaoportal@comcast.net


Ethics, Genetic editing, Personalized medicine

Since the original article “The Ethics of Personalized Medicine” was published in 2014, more ethical issues have come to the forefront and are being discussed in various forums. This article revisits the issue and updates the conversation concerning ethical issues that still need to be resolved and debated [1].

Considerable progress has been made in the field of Personalized Medicine over the past years, but more ethical issues have evolved and have not been rectified. One issue stands out above all other matters and that has to do with the cost of medications and healthcare. These issues were hotly debated in the 2016 presidential election in the USA, but as of yet, they still need solving. One of the rising costs of healthcare is tied to the increase in the number of genetic tests being done. The new gene tests increase the expenses for insurance companies. The Food and Drug Administration has approved the gene testing company 23andMe to offer more genetic tests to evaluate patient risks for Parkinson’s and celiac disease [2]. The press has widely reported that some medications for treating cancer and rare genetic disorders can cost as much as $475,000 per treatment. An example would be Kymriah which is made by Novartis to treat a rare form of leukemia [3]. This medication and similar drugs treat diseases by modifying cellular DNA. Another drug which may be used to prevent blindness in a rare genetic disease may cost $900,000 per patient. UniQure is developing hemophilia treatment medication which may cost $5 million over 10 years. Obviously, very few people can afford to pay such a steep price for medications even if they were to overcome the emotional issues and impoverished their families with such an expensive treatment. The pharmaceutical companies and their apologists claim that research and development of medications are tremendously expensive and many times these attempted medications never materialize and never make it to market. Furthermore, the number of patients who will benefit from these medications is very small and cannot support the work that goes into drug development. The pharmaceutical companies state that the value of the medication should reflect the value of the treatment. The fact is that in the final analysis, the drug companies want to make enough money to pay for their expenses and their work and investment, and they need to make a profit to fund future research.

A few experts argue that the expenses by the pharmaceutical companies are exaggerated. They state that once a delivery system is developed so that a modified virus can introduce a gene into a cell, that system can be used again and again at no additional cost to the company [4]. Accurate figures on drug development are difficult to establish. In addition, later research may indicate that the medication is not as effective in treatment and the pharmaceutical company bears the expenses. They argue that they are working on devising models for payment for these medications. One such model might be to not charge for the medication if there is no improvement within a month of the first administration of a new medication. Another idea is to charge for a new expensive medication like one pays for a house; i.e. long term mortgage. And finally, there is the liability issue which can result if a balance is not identified and drug toxicity injures or kills patients by knocking out the neutrophils and the patient’s immune system. Hospitals are also trying to reduce the cost of pharmaceuticals and the cost of health care overall. By using electronic health care records, doctors can be warned about the health care they are providing and the drugs they are prescribing for their patients [5]. The electronic alerts go directly to the patient’s electronic medical record when the doctor writes the orders if research has demonstrated that the medication and treatment may be outdated, toxic with other medications, and very expensive.

An important ethical issue is how a patient’s privacy is protected. DNA biobanks have been established and this concept of linking phenotypic data to the electronic medical record has been spreading. The public wants to be assured that this DNA data will be protected especially from insurance companies, government agencies, and potential employers. But we have recently seen that Equifax has been hacked and the financial and identity data on 140 million Americans may now be compromised. This data could be injurious to family members who have relatives with various genetic diseases and mutations. How safe is this data? As discussed in a previous communication, there still has to be more concern about informed consent, privacy, data ownership, sharing and technological regulation. Furthermore, there should be more regulation of genomic testing in the clinical settings and protection against genetic discrimination and misuse of genetic data [6]. Ethicists and some religious groups are very concerned that the Human Fertilization and Embryology Authority has granted regulatory approval for mitochondrial DNA transfer and has approved genetic modification for research purposes in healthy human embryos. This increases the chance of babies having three parents, two mothers and one father. But recently the Food and Drug Administration has issued a letter to Dr. John Zhang who helped a mother with a genetic disorder give birth by using a combination of DNA from the mother, her husband, and an egg donor [7]. In addition, this paves the way for such techniques as CRISPR/CAS 9 to be used. CRISPR is an acronym for Clustered Regularly Interspaced Short Palindromic Repeats. This pertains to that part of the immune system of bacteria which helps ward off attacks by viruses. Drs. Jennifer Doudna and Emmanuelle Charpentier have demonstrated a tool which includes Cas9-,which targets and edits DNA in a test tube [8]. Some skeptics are concerned about using nontherapeutic genetic enhancement and designer babies [9]. This should be subjected to vigorous ethical debate [10]. The Broad Institute of MIT, Harvard, and Rockefeller University have indicated that they are willing to join a patent pool for the Crispr gene-editing technology. This technology can edit genes in animals and people. The patent pool would allow researchers or companies to obtain a license more efficiently for Crispr utilization [11].

1. Kushner J (2014) The Ethics of Personalized Medicine, Personalized Medicine Universe, 3:42-45.
2. Kolata G (2017) New Gene Tests Could Send Insurers Into a Death Spiral, NY Times B1.
3. Kolata G (2017) Gene Therapies Offer hope, at 6-Figure Prices, NY Times ppA1 and A20.
4. Kolata G (2017) Cost of Creating Cancer Drug is Much Lower Than Thought, Study Finds, NY Times, pp20.
5. Evans M (2017) Hospitals Use Alerts to Curb Unnecessary Care, Wall Street Journal PgR2.
6. Kushner J, Kinter C (2017) The Influence of Chemistry on Personalized Medicine, Curr Trends Biomedical Eng & Biosci 6: DOI: 10.19080/CTBEB.2017.06.555689.
7. Cha AE (2017) FDA Warns doctor on 3-parent embryos. Wash Post A3.
8. Doudna JA, Sternberg SH (2017) A Crack in Creation. Houghton Mifflin Harcourt pp281.
9. Marcus AD (2017) In U.S. First Scientists Edit Out Gene Defect. WSJ, 28:1-4.
10. Genome editing in clinical genetics: points to consider-a-statement of the American College of Medical Genetics and Genomics. Genetics in Medicine 2017
11. Dockser A, Palazzolo J, Rockoff JD (2017) Patent Holders for Gene-Editing Tool Weigh Global Pool, Wall Street Journal, B4.

Citation: Kushner JH (2017) Ethics of Personalized Medicine Revisited. J Precision Med Public Health 1:e007.

Published: 29 September 2017


© 2017 Kushner. This is an open-access article distributed under the terms of the Creative Commons Attribution License (CC BY). The use, distribution or reproduction in other forums is permitted, provided the original author(s) or licensor are credited and that the original publication in this journal is cited, in accordance with accepted academic practice. No use, distribution or reproduction is permitted which does not comply with these terms.