Implications of Regenerative Medicine
Designer babies, 3D printed organs, growing tissue in a lab - all possible future medical advances which seem almost beyond belief right now. But they aren’t as far out in the future as many think.
Regenerative medicine is a field on the forefront of biomedical research right now. CRISPR, a gene editing system, and stem cells are especially hot topics of research when it comes to clinical research and disease modeling. The possibility of treating untreatable conditions like Alzheimers or cystic fibrosis, or even repairing damaged organs, is motivation enough to continue research. But as these options become more of a practical possibility, we have to start considering the societal, ethical, and legal implications of regenerative medicine.
What is Regenerative Medicine?
Let’s use an example situation. Most believe a heart attack is just an acute life-threatening situation. While it is, of course, life threatening in the moment, heart attack survivors still have a lower average life expectancy and a poor prognosis for the rest of their lives. This is because the heart never fully heals itself after a heart attack. Important parts are forever damaged so the heart can no longer function efficiently. Here’s where regenerative medicine comes in. What if we could repair the heart so it could be perfectly healthy and work like normal? There are a few techniques that are being researched on this.
CRISPR and Stem Cells
The first major technique is Clustered Regularly Interspaced Short Palindromic Repeats (CRISPR). CRISPR is actually a natural viral defense system found in most bacteria which has recently been harnessed for use in humans. At the very basic level, it is able to target a specific gene and cut the DNA to make that gene inactive. It can also add to the genome or make other slight modifications. It is, of course, much more complicated than this, but it’s the general idea.
Another technique is through the use of stem cells. We all have stem cells in our body, they are the basic cells which change into their specialized cell types throughout their lifetime. A stem cell could change into a blood cell, or a neuron, or any other type of cell in the body.
The cells in our heart are notorious for their inability to regenerate, unlike other cells in our body. For example, if you get a papercut, it only takes a few hours for the cells to divide and regenerate and eventually heal the cut. Other parts of our body can regenerate too, like our liver, but they take longer. The cells in our heart can't do this, so when it is damaged, it is damaged for life.
Implanting stem cells into the heart through certain methods can allow them to differentiate into those cardiac cells and eventually repair the heart.
Sickle Cell Anemia is another example of a condition that has the potential to be treated with regenerative medicine. Individuals with sickle cell have a mutation that affects the shape of their red blood cells, which makes the cells unable to function properly. This condition is extremely painful, inconvenient, and can be life threatening. A few years ago, Victoria Gray became the first patient to be treated for sickle cell anemia with gene editing, and it was relatively successful.
Regenerative medicine techniques can be a miracle for all future patients who can be saved or treated. But, like most good things, it’s never that simple. There are numerous safety concerns and limitations that are being researched and have to be dealt with before widespread clinical use of these techniques.
But on an even broader scale, there are the implications of what these treatments mean for the world if they do become practical treatments.
Ethical Implications of Regenerative Medicine
Should gene editing and stem cells even be options for treatment?
A major debate within the scientific community is regarding the source of stem cells. Stem cells are most often taken from embryos that were leftover and unused from in-vitro fertilization (IVF) treatments. If a patient has success early in her IVF treatments, or no longer has need of the embryos, she has the option to donate them to science, which is where most stem cells are gathered from. Still, using embryonic stem cells is a very controversial topic.
Then there is the safety concern. Like I mentioned before, these techniques are not 100% accurate. In fact, as of current models, they are pretty inefficient. How do we weigh the risks versus the benefits of these technologies? Do they become a last chance hail mary? Or should they be the first option even for relatively healthy patients? And who decides when it is safe or if the treatments are “safe enough”? What does “safe enough” even mean?
Clearly, there are an infinite number of questions that must be answered about the appropriate use of regenerative medical technologies before use - and since they are so new, there are no clear standards or guidelines.
This brings me to the legal issue.
Legal Implications of Regenerative Medicine
As these techniques become more widespread, important conversations about legality have started to take place, yet it is nearly impossible to standardize these laws across the world, or even across the country, especially with the extent of controversy and debate.
When is a physician allowed or encouraged to bring up these treatment options? How do we obtain informed consent for the procedures knowing the extent of risk involved? Is there an age limit or health threshold for the treated patients?
Then there are the issues of patents and intellectual property. Which therapies are FDA approved and will certain companies have a monopoly on these life saving treatments? At this point they become more like pharmaceuticals than procedures, which exacerbates societal issues already in place.
Societal Implications of Regenerative Technologies
The first, and arguably biggest, societal concern is who gets access to these potentially expensive and hard to access treatments. Like many cutting edge therapies, regenerative technologies will likely be extremely expensive, especially when they are first integrated into the system. This has the potential to create issues of financial need versus life saving treatments. If only the wealthy have access, it will create a potential disparity for future generations, where the wealthy live longer and better because they have access, and those below a certain income will have an unfair disadvantage, widening socioeconomic inequality.
Only the rich can create designer babies and edit their genetics - which brings up even deeper rooted problems of classism, racism, and eugenics.
There’s also the concern of how gene editing affects future generations. If we edit the genome of a person now, will their kids and grandkids and all their descendants inherit these different edited traits? At that point, we’ve changed the course of humanity, if you think about it. What happens to natural selection and evolution if we simply get rid of all our inconvenient traits?
So obviously, there’s a lot to consider before widespread use of these regenerative techniques. It is not enough to address the biomedical limitations, but the ethical, legal, and societal ones as well. Hopefully, in the near future, more conversation about this topic will be sparked and we can eventually move towards safe and equitable use of regenerative medicine.
References
https://news.harvard.edu/gazette/story/2019/01/perspectives-on-gene-editing/
https://www.theguardian.com/science/2017/jan/08/designer-babies-ethical-horror-waiting-to-happen
https://www.inventuslaw.com/legal-issues-in-stem-cell-therapy-in-the-u-s/