The gene therapies that are currently within clinical and observational studies today in the United States encompass treatments for various diseases and genetic disorders. However, the FDA had only announced at the end of last month that it approved Kymriah as the nation’s first gene therapy to be placed on the market as a treatment for acute lymphoblastic leukemia. This should come as a surprise considering how long scientists and researchers have been working within the genetic field of medicine but have only just been given the green light to put these treatments. It is the restraint of the FDA to approve genetic therapies that begs the questions: what are they afraid of and, is their fear going to put us behind the rest of the world?
The FDA has been known to be strict when it comes to their federal guidelines of accepting clinical trials of gene therapies before releasing them to the drug markets but it is significant that they be so tedious in their accepting of therapies that are the first of their kind. The United States is a country where litigation is man’s best friend and as a result, even corporations who fund gene therapies take steps to ensure that there are no serious repercussions can occur because of their negligence. One of the biggest fears facing the genetics community is the effects of creating or modifying human embryos, done to prevent future generations from getting genetic diseases or disorders from previous generations. An army of perfectly born humans can definitely been seen as something as a threat to the world but there are still a few countries who do not see perfecting humans and their genetics as something to be feared, but something to be researched, tested and even implemented. As can be seen, scientists have already been able to edit dangerous mutations in DNA and genes and in doing so, open up a can of worms that can never be closed again.
Currently, the United States is in its own boat when it comes to its stance on genetically modifying CRISPR embryos and this boat is one where the government does not completely ban the practice as other countries such as those in Europe and South America have. However, the regulation of the research being done and tested in monitored by private, independently based organizations. It is significant in noting that the most lenient countries of the world that do not ban the testing of CRISPR embryos are China, India, Japan and Russia. These four countries have already been known to conduct clinical trials in using CRISPR to genetically modify embryos and other types of cells within the human body, without much publicity. Since there are countries that are in the world right now who do not have to go through the FDA policies and guidelines before being accepted to conduct clinical trials or have the luxury of being monitored by private entities, there is no doubt a fear that these countries can endanger the lives of those around the world.
Especially with isolated countries such as North Korea, it is difficult to know how exactly the country has progressed in its biotechnological warfare, including gene therapy, and what the affects can be on the rest of the world when a country, although small compared to the US, can utilize science to become a super-powered population. It is to avoid scenarios such as the one posed by North Korea that the FDA was put in place. In order to ensure that the medicinal and agricultural sectors of the nation were being regulated and monitored, there needs to be an organization that oversees research that secure public health and safety. But, just having one country, out of hundreds with the capability to genetically alter genes and embryos with this agency in place, is not enough to guarantee that gene therapy will only be used for good.
To know that there are four major countries in the world right now who have little to no oversight can be unsettling to say the least and begins the debate on whether there should be global law or committee to oversee genetic manipulation so that it does not get out of hand. Being that it would be difficult to oversee global research into gene therapy, having at least a discussion about the global point of view, repercussions and growing opinions about this new generation of gene therapy and healthcare is best step forward in protecting the future generations that will be the ones to deal with the aftermath of gene therapy.