Bioprinting, Part 2 - The Ethical Conundrum
"I worry about how well patients understand the risks associated with these new technologies," said the Baker Institute's Kirstin Matthews. Most patients in clinical trials believe that the intervention has a chance to help them, even though that typically is not the case. For 3D-printed technologies, "there will most likely be a lot of failure" before scientists get it right.
03/27/14 6:30 AM PT
Nearly 120,000 people in the United States are on the waiting list for an organ transplant that may save their lives, according to the American Transplant Foundation.
"In the short term, we need many more people to register to be a potential organ donor," Jordan Miller, assistant professor of bioengineering at Rice University, told TechNewsWorld.
However, donor organs require immunosuppressive therapies, which can limit the recipient's quality of life, so over the long term, the medical community is "extremely excited about focused research funding to help progress 3D-printed organoids and organs for treating human patients."
The present thinking is that it will take decades to clear up the many technical problems that still have to be resolved before 3D-printed organs can be used for transplants. However, given that improvements in technology tend to follow a logarithmic rather than a linear pattern, the wait might be shorter.
What's the Right Thing to Do?
Research into using 3D printers to create human organs has given rise to a variety of moral and ethical questions.
The issue will trigger a major debate on ethics and regulation, Gartner has predicted, possibly sparking calls to ban the use of 3D printing for human and nonhuman use by 2016.
The Haves and the Have-Nots
Money, or the lack of it, will give rise to what might perhaps be the most pressing ethical concern.
Some of the new products could become cheaper and more accessible alternatives to current technology, but other products, such as functioning organs, which will be extremely complex to build or print, "will likely be only accessible to those willing to pay for personalized treatments," Kirstin Matthews, Fellow in Science and Technology Policy at Rice University's Baker Institute, told TechNewsWorld.
Patients who don't have the money "will be left on the organ transplant waiting lists," Matthews suggested, although that will depend on how much coverage the Affordable Care Act will provide.
If the new technology is more expensive [than existing treatments], it likely will not be added to healthcare coverage and therefore will be available only to the elite, Matthews said. "This will continue to expand the access divide between the haves and the have nots."
Biology vs. Technology
The cost of healthcare will lead to "a race between biology and technology," predicted Charlie Whelan, healthcare and life science director of consulting at Frost & Sullivan.
"Just because something works in the lab doesn't mean it will work in the marketplace, especially with the cost of healthcare," Whelan told TechNewsWorld.
An associated problem will be related to triage -- deciding, in essence, who deserves to receive the new technological treatments.
"We'll be in a situation where we'll have to decide whether, for example, we'll give an artificial kidney to an 80-year-old, who only has a few years to live and also needs an artificial heart," Whelan mused. "We have these thorny questions that I don't think we've had the need to deal with just yet because the technology isn't there."
However, this "hard economic calculus" already is being practiced when it comes to organ replacement therapy now, Whelan pointed out, so perhaps current best practices can be extended when the new technology finally is ready to use.
Being First Is Not Always Best
Another issue of concern is that the first patients to undergo transplants with 3D-printed organs will of necessity be desperate -- and because their doctors are breaking new ground, they will serve as guinea pigs.
"I worry about how well patients understand the risks associated with these new technologies," Rice University's Matthews said.
Most patients in clinical trials believe that the intervention has a chance to help them, even though that typically is not the case, Matthews remarked. For 3D-printed technologies, "there will most likely be a lot of failure before scientists discover the right methods, cells, techniques. Patients will have unreasonable expectations and might in fact be worse off after trying a new technology."
Rules and Regulations
There already are guidelines to handle patients being exposed to new medical technologies.
Hospital oversight boards would regulate donor issues, cells and tissue for informed consent, Kevin E. Healy, who chairs the department of bioengineering at UC Berkeley, told TechNewsWorld.
A magazine covering ethics in biology, engineering and medicine already exists.
The Biomedical Engineering Society approved a code of ethics back in 2004.
"Medical consent laws and medical ethics have come a long way since the days of Henrietta Lacks," Rice University's Miller said. "The FDA has strict safety and efficacy standards for implants made from a patient's own cells."
Beauties and Beasts
There might exist areas in which regulations and ethics may be ignored: illicit clinics catering to athletes and people seeking body modification for personal satisfaction or to gain an edge for themselves.
"It does not seem unreasonable to presume that individuals will try to find ways to enhance themselves with 3D printing if they can get an advantage," fretted Rice University's Matthews.
"Some athletes already assume significant risks to increase their performance on the field using illegal substances with serious side effects," she continued. "Others might seek enhancements to help achieve their ideal of beauty."
The federal government might not get involved in regulating cosmetic efforts, Matthews suggested. For athletes, organizing bodies such as the NCAA and NFL likely would be involved.