Medical procedures, especially ones as cutting-edge as lab grown organs and artificial skin, are not inexpensive, and thus far there are only a few individuals and institutions with the knowledge to implement them. As first-world countries find cures for more and more formerly fatal ailments and diseases, there will be a wider gap between the rich and poor nations. Until training and supplies are provided to third-world countries to save their patients just as we save ours, tissue engineering's spread will not truly be global.
Categories of Scrutiny
- The FDA regulates tissue engineered products as tissues, biological products, medical devices, "combination products," and xenogenic products (from a non-human source) where applicable.
- There are over 30 FDA standards with "potential relevance" to TE/Regenerative Medicine.
Supporting Stem Cell Research: "An Embryo is a Cell Cluster"
Arguments:
- An blastocyst at this stage is not a human being until it develops the first signs of a nervous system
- The number of people that this could save outweighs the concerns
- Abortion is already legal and once it is performed, the cells will go to waste if not used for scientific research
- Only with federal funding and support would the correct restrictions be able to be placed on this emerging science to make sure it does not go too far.
Issues of Tissue Engineering: "At what cost?"
Embryonic Stem Cells: The Age-Old Question
Any time a branch of science calls for the use of these stem cells, certain groups become upset. When an embryo is harvested in the blastocyst stage (around 150 cells), it is destroyed, causing some debate as to whether this is murder or simply removing cells; in essence, when does life begin?
Ethical Issues
Against Stem Cell Research: "This Is Murder"
Arguments:
- Life starts at conception and this unborn person has the same rights as any other human being.
- Some ethicists and scientists oppose it because they see it as unethical and unneccessary (adult stem cells may be more versatile than previously thought)
- Some people oppose harvesting of embryos while supporting research on already-aborted fetuses, because the fetuses are already dead while the embryos still had a chance.
Legal Issues
FDA and Quality Control: Ensuring Honesty
The FDA must ensure that the quality of these medical solutions is high enough so as to not cause unnecessary danger or harm to the patient. Due to Tissue Engineering's multidisciplinary nature, often multiple branches of the GDA become involved before a product can become widespread.
Nothing Comes for Free
It has been thouroughly addressed here that tissue engineering will bring good to patients desperate for medical attention. But will all those who need it have access when it matters?
Social Issues
Long Live the Rich
- When reading sweeping appraisals of tissue engineering, so many times does the reader's mind to expect to hear a phrase somewhat along the lines of "this will help people all over the world." In reality, this kind of statement seldom appears, for good reason: the benefits will not be global.
