Gene therapy presents a number of concerns that are not typical of other medical treatments. In addition to the raw economic cost of their development, gene therapies prompt ethical questions about their use.
From the perspective of the drug companies, gene therapies present two kinds of financial risks that delay their advancement. Most important is the cost of research and development. Gene therapy technologies are relatively new and lack the extensive body of knowledge present...
Gene therapy presents a number of concerns that are not typical of other medical treatments. In addition to the raw economic cost of their development, gene therapies prompt ethical questions about their use.
From the perspective of the drug companies, gene therapies present two kinds of financial risks that delay their advancement. Most important is the cost of research and development. Gene therapy technologies are relatively new and lack the extensive body of knowledge present in other classes of clinical trials. Hence they are considered risky, causing regulatory agencies to set the bar of safety very high, every complication and death carefully scrutinized. There have been exactly three deaths in gene therapy trials since 1999 out of about 2000 studies. Each one made international headlines. However, there is another economic concern for any company pioneering gene therapy. Once they have developed a successful gene therapy treatment at great cost, the pathology they are treating is cured in a given patient. There is no potential market for continuing therapy, as you might have for a chronic condition. Every successful commercialized gene therapy treatment will eventually obviate itself. Compared to conventional drug development, this makes gene therapy very intimidating for medical device companies.
From the societal perspective, perhaps the most dangerous aspect of gene therapy is that the underlying conditions are treated permanently, not just for a given patient, but, provided the therapy affects the patients' germ cells, for all of that patient's descendants. For a condition like hemophilia, which actually endangers an individual, this perpetuity might seem advantageous. However, there is a dangerous slippery slope in this notion of reshaping an entire line of people. Consider conditions where there is a cultural aspect. For instance, the deaf community has a significant social cohesiveness, and numerous deaf parents have already refused cochlear implants to treat deafness in their children. Where does one draw the line at treating pathologies? Could short stature be considered a pathology? Very quickly, the applications of gene therapy may drift from treating congenital illness to making selections based on subjective parental preference or, even more dangerously, the optimization of performance or aesthetics. It would be a narrow line between treating a genetic predisposition for asthma and conveying superlative cardiopulmonary health to promote athleticism.
Once we have expensive gene therapy treatments that can permanently cure congenital pathologies or possibly even improve performance for entire family lines, it becomes an ethical consideration of who receives such treatment. Even in countries with state-sponsored medical care, would such therapies be administered universally, or would they be considered expensive elective treatments? What started off as an egalitarian effort to treat a universal pathology like hemophilia could become a mechanism for magnifying class divisions.
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