Tag Archives: CRISPR/Cas9

Regulating CRISPR: How the US and the Rest of the World Compare

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.

How Does the Law Combat Genetic Modification?

How does the law adjust for genetic modification. If we look at how it combats it now we might be terrified for how the future might look. Monsanto is the world’s largest GMO seed company and uses its wealth to harass and bully farmers into using their product indefintely. However, farmers aren’t the only ones tricked into succeeding into Monsanto’s plans. Congress has just passed a bill alleviating Monsanto of any liability if people get sick from their modified seeds.
What does this mean for human gene editing? Right now the big issue is patent infringement. The CRISPR/Cas9 is the only type of tool like it out there. But, as history has shown, a successful invention is a copied invention. But if a couple have a child who has received modified genes from one parent, does one company own those genes? The video above shows my thoughts and feelings on the subject. Up next on the blog is how does this tool affect how our society will interact, react, and live in the future…

Sources:
http://www.forbes.com/sites/jonentine/2013/04/02/exposing-the-anti-gmo-legal-machine-the-real-story-behind-the-so-called-monsanto-protection-act/
http://www.nature.com/nbt/journal/v33/n3/full/nbt.3160.html
http://www.usatoday.com/story/money/business/2013/06/04/farmer-monsanto-genetically-engineered-wheat/2388957/

A Better Understanding of CRISPR/Cas9

Who created the tool of genetic editing? Meet Jennifer Doudna, one of the co creates of the tool CRISPR/Cas9 the genome editing tool that is already in full effect. Before we begin on the details of this amazing breakthrough lets recap our last discussion. In the previous video, we went over the basic element of genetic modification and I laid out the foundational use of CRISPR/Cas9 which we have explained allows certain genes to be cut and other genes to be inserted into that spot. The basics for this use to to combat different diseases and issues that we would want to combat. However, Dr. Doudna explains how this is not the end of the possibility of this device. We could make a person taller, bones stronger, change their hair or skin color, by adjusting the genes when the child is still an embryo.

This sounds pretty neat right? But when will this technology be able to make those adjustments to humans? Well the problem as Dr. Doudna explains in the video above that we have the tool but do not necessarily know the instructions or the full range of the tool. The scenario we are currently at is like putting together a pieces of a puzzle with a blindfold on. While the task may seem impossible at first the more we become familiar with the pieces (genes) then we start to understand how each piece interacts with one another.

Dr. Doudna explains that we have been able to learn alot from CRISPR/Cas9 but we have a long way to go. But her final point is what we will be covering in the next post. What are some of the social and ethical implication? What unintended consequences are coming from the use of this device? What can we do now to ensure society can be safe from itself?

Sources:
http://www.hhmi.org/scientists/jennifer-doudna
http://www.nature.com/nbt/journal/v32/n4/full/nbt.2842.html
http://www.actionbioscience.org/biotechnology/glenn.html