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Gene Therapy: Present and Future

If our group has learned anything from these past few months of learning about field of gene therapy is that right now, no one truly has the answers to the ethical, societal and economic implications that this scientific cure could bring.

Taking a step back, we began our research at the start of it all. What is gene therapy? Through thorough research into this, we found that gene therapy is equal parts technology and medicine. Technologically, there are therapies ready to be put on the market to cure diseases such as blindness, Alzheimer’s, Parkinson’s and more but there is more to it than just technology, remember this is medicine. In the tech world, speed is everything. It is all about winning the race against smartphones, smart TV’s, AI, anything. In medicine, there is a time press that comes from the DOH in emergencies but most of the time, speedy remedies to disease put up red flags for those being treated later on. What gene therapy has done is take medicine from a personal relationship, to a big business, one that is on track to be bigger than the pharmaceutical sector. This big business is seen in one of our insights into the cost of gene therapy. The overall controversy of how one can afford to buy a gene therapy is due to the high costs that of the gene therapies that are on the market today such as the first FDA approved gene therapy Kymirah among others.

Such being the case, Dr. Mark McClellan, former FDA commissioner and current leader of the Duke-Margolis Center for Health Policy, concluded that the healthcare system is far behind the medical industry and the advances it has made so, being that patients, doctors and researchers, and insurance companies have mutually exclusive interests, it is impossible for everyone to win. The entire gene therapy field is now looking to monetize on their ability to cure what used to be deemed incurable diseases and this is where the ethics of it all come into play.

Journalist and historian, David Perry wrote, “the pro-information approach demands that everyone involved in genetic counseling have access to the best data and presents it in a value-neutral way.” In giving everyone equal access to gene therapy, this must include attainable price points, no discrimination and equal opportunity for everyone to take advantage of. The FDA is just no longer enough to control the medical and genetic communities. The ethical future of gene therapy is now beyond the typical, “this is wrong” and “this is right” because we have never had to deal with the controversial issues that we are dealing with now as a result of gene therapy. From “designer babies” to biological weapons, these are both things that health professionals and even legislators have yet to encounter scenarios such as these but because of this, getting out ahead of the possible negative implications of these two examples, is more important now than ever.

We are in a place where CRISPR can help farmers combat climate change by genetically altering their crops, incentivize football stadiums to start “DNA Days” and, lead to the insurance and pharmaceutical industries to be left in the hands of tech giants like Amazon, Apple and Google. As such, there needs to be some sort of precedent set so that none of these three scenarios gets any worse than they already have. With genetic testing companies like 23andMe and Ancestry becoming more familiar in the public eye, they are being sold to customers who have no idea that they are basically giving our their privacy rights to their own genetic information for results that are little to completely, inaccurate.

This is why education within this industry is more important now than ever. Without proper understanding, the Frightful Five, the FDA, the federal government could all have influence over every single person residing the in the United States because of those who feel it is important to send a swab of their DNA to a lab in order to see just what percentage English they really are. What people sending in their cheek swabs needs to know is that scientists are still working, to this day, trying to uncover the complex information of the millions of genes that reside in the human body. We simply do not know enough to give sufficient information to people who are just looking to see if they are carrying a genetic mutation. These 23andMe, Ancestry, and Helix tests cannot significantly provide lifesaving information and as a result, should be used with a grain of salt, or even less than that. It seems unlikely for anyone to give up the password to their email but when shipping their DNA to an unknown lab somewhere in the United States, people do not seem to show the same concern for their privacy. Thinking about the millions of people having their data breached across the country, by more companies than one, how can we be sure that this genetic information will not be next? Now even thinking ahead, the potentially 6 million more students studying harder, retaining more information, and ultimately becoming better learners because of gene therapy treatments will be ahead of the present generations. Taking it a step further, if this trend is multiplied across generations, eliminating prohibitive, cognitive disorders in students, it could reshape the entire education system with many subsequent disruptions.

With a Frightful Five company such as Amazon at the brink of breaking into the healthcare industry, it could mean positive things for gene therapy whether it investment in research, funding of drugs, therapies and clinical trials, these tech companies, although you do not want to trust with your health data, can contribute a lot to the gene therapy community. But, there needs to be a point at which the line is crossed and sure, donating genetic information for research is ethical and legal but when it is collected through your Google search history or updates on your Apple health app, there needs to be a call for change. In the end, with the Frightful Five having taken initiative within the healthcare industry to fund gene therapy programs and rebuild the healthcare system of the nation, they can push bounds in the battle for updated health services unlike anyone else can and this gap between the Frightful Five and everyone else is what needs to be addressed.

And to end on a global note, the future of gene therapy is the United States barely has a clear path ahead of it so thinking about how the rest of the world compares is a whole other thing on its own. Isolated countries such as North Korea, Russia and China make it difficult to know how exactly the countries have progressed in their 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.

There are a lot of things to ponder over here, but the best place to start is by educating yourself on the future that could be completely disrupted by this biotechnological innovation and then looking for ways to protect your genetic and health information, so if that means resisting buying genetic testing kits, not updating your Apple health data, or any of the other numerous ways to protect yourself, that at least is a good place to start.

Big Data in Genetics

Privacy is just not something to be expected in this day and age of technology and apart from the voluntary use of social media sites and applications that blatantly infringe on this right, people set themselves up for even more invasion when they request their genetic information. Ancestry and family lineage sites for the last few years has been picking up due to shows like “Who Do You Think You Are” and basically any tear-jerking story about long lost siblings who found one another through searching their lineage that you read on your Facebook page every morning. Lately, however, these sites, and not even getting to genetic testing sites like 23andMe, have been asking for more than just a last name and a few answers to personal questions. They have been asking for their customer’s DNA, their genetic data and the repercussions of allowing for a corporation to have the ultimate template and profile of you are greater than you even know. 

It seems harmless enough, just take a swab of your cheek and ship the sample to a company who within two weeks will mail you back a sheet that has your genetic lineage and maybe even a genetic profile to warn you of some genetic disorder you may have. Speaking on a positive note, what could this company have to gain from helping people learn more about their past and their own selves besides doing it from the perspective of a service to others. Well, in fact they have a lot to gain. Since so many people refrain from actually reading the privacy policy before shipping their genetic data through the mail, they do not even realize that they are signing away their right to sole ownership of the data that is collected. Ancestry.com now has the rights to use the data that has been sent their way for their own purposes and if these purposes are to sell the information to the highest bidder, worst case scenario, they have the broad right to do so. Although legally companies such as ancestry.com and Helix do not have the license to sell away your genetic information to third parties, they do reserve the right, without your deliberate permission, or with it following your purchase of the genetic testing kit, to sell it to pharmaceutical and research companies. Now, this already seems like the only boundary these genetic testing sites are crossing is an ethical one where the whole hurt one for the greater good comes into play but when you find out how one of Ancestry’s partnerships is with Calico Labs, which is founded and operated by Google, Inc., you might sing a different tune. With a technology giant such as Google becoming so interested in the health sector of the nation’s economy, certain eyebrows should, and must be, raised before consenting to shipping off DNA that could potentially wind up in the hands to the very people who endlessly track and monitor its users. It is already a breach of rights when a genetic-information-collection company can claim rights to someone’s genetic information but when it can ultimately be shared with a corporation that is not always looking out for the welfare of its users, there needs to be a stop to it.

Before you decide to get your DNA tested for signs of genetic anomalies, keep one thing in mind, scientists are still working, to this day, trying to uncover the complex information of the millions of genes that reside in the human body. We simply do not know enough to give sufficient information to people who are just looking to see if they are carrying a genetic mutation. These tests cannot significantly provide life saving information and as a result, should be used with a grain of salt, or even less than that. Knowing this, as well as the fact that the genetic industry as a whole lacks substantial privacy laws and regulations, there should be more wariness when it comes to giving up your genetic data so easily. It seems unlikely for anyone to give up the password to their email but when shipping their DNA to an unknown lab somewhere in the United States, people do not seem to show the same concern for their privacy. Is this precaution for not sharing DNA samples a little extreme right now, considering how the healthcare and tech industry still cannot utilize genetic information for anything more than research? Perhaps. But, with millions of people having their data breached across the country, by more companies than one, how can we be sure that this genetic information will not be next? People need to expect more from their legislators when it comes to protecting their privacy so whether it be securing the pass-codes on their smartphones or protecting the use of their genetic data, people should care because even though it is not here yet, it is well on its way and preparation for it is vital.

The Baltimore Ravens: Bringing Biotechnology to the Mainstream

At-home genetic testing has grown more and more relevant in the last few years with companies like 23andme and Orig3n taking genetic tests from the lab to the local pharmacy. Biotechnological companies such as the two linked above have found a way to tap into the driving force of people: curiosity. Curiosity is what keeps shows like “Who Do You Think You Are” and websites like ancestry.com running because people are innately curious about their past, themselves, and how they ought to be living. With this growth in biotechnology, people now have the capability to check their DNA for signs of disease and even their religion. Coming off of the right intentions, having access to the inner threads of one’s DNA could be not all that bad, but from the opposite side, the realization that mailing a swab of your DNA to a lab in who knows where and being tested by who knows who, can definitely be off putting. Realizing privacy within the fourth industrial revolution has become harder and harder, and now, we are at a point where a person’s age, gender and health information can be shipped from a residential house to a lab without much question, and with the naïve intention of trying to figure out just how European their lineage really is.

One company, already mentioned above, that took this naivety of people and used it to their advantage was Orig3n. Being so convinced that Baltimore Ravens fans would be curious as to the makeup of their DNA, they partnered with the Ravens to hold a local “DNA Day” at the home stadium of the NFL team.

This, of course, did not go over too well with the Maryland Department of Health and the Food and Drug Administration who both pulled the plug on this day before it even began. Looking back on this, Orig3n has decided not give up and is looking to reschedule this day as it is something that they, and Ravens fans supposedly, have been looking forward to doing for months. However, when it comes to asking for a cheek swab of a football fan coming into a public stadium, thinking that something like this does not concern governmental approval, is a little too confident by part of Orig3n.

The company has yet to offer a reason for why they believed “DNA Day” was going to be a good idea, why they have decided to pair with a football team to get it started and most importantly, for what they would be using these DNA samples for. Now why Orig3n thought it was going to be okay for hundreds of people to give up their DNA on a cotton swab without being given an explanation for it being done, is definitely sketchy at best. Since Orig3n has not come out with information about their plans for the DNA collection, based on their past tests offered through their website, it can be assumed that within a few months the hundreds of football fans who gave up their DNA will be given information about their skin aging, muscle force, language ability and vitamin D levels. As can be seen by this short list, none of these results would really influence a lifestyle change for anyone that is having these tests conducted and so, comes the question: why bother to do this at all.

The most this particular company can tell is that this person needs more get outside more and since this is not a significant amount of information that can be told through a strand of DNA, how is it that Orig3n has managed to lock a deal with a national football team? We are talking about a vast biotechnological industry full of companies that dominate the market simply because it can warn women that they are carrying the BRCA gene, or warn people for signs of genetic conditions and yet, the Ravens chose Orig3n. Since Orgi3n has yet to unlock the capability of warning someone of a serious disease or genetic condition it seems that they are looking into doing so, but, through Ravens fans that have no idea what they are in for.

Legal Issues of the 3D printing of Organs

The main legal issues that I focused on are over the ownership of the artificially created organs as well as the implications that 3D printing has on the black market sale of organs. The main conclusions that I found were that there is a possibility that the data file of a person’s organ could have split ownership between the subject is came from and the doctors/scientists that transformed it into a data file. The other conclusion that I found pertained to the possible effect that it would have on the black market for organs. The unlimited replication potential will help cause the supply to increase of organs, which will lower the incentive for people to head to the black market in the first place to get an organ. Currently, people wait on donation lists- but some people decided that the black market sale and transplant is more worth their time. The increased supply of organs would alleviate some of demand on the black market because people will be less desperate, but there still remains an issue of getting the organ transplanted by a professional doctor.