Print an organ, save a life

By Andrew Peterson

U.S. organ donation systems have a supply and demand problem. The number of individuals in need of life-saving organs outstrips supply. The National Kidney Foundation reports that, as of November 2016, over 120,000 individuals are waiting for a life-saving organ transplant in the U.S.. Of these individuals, 100,791 require kidney transplants with a median wait time of 3.6 years. Many die before receiving a transplant. It is estimated that 13 individuals die every day waiting for a kidney.

There are several proposed solutions to this problem. Some have argued that the U.S. should adopt a mandatory deceased donation policy. This would resolve supply shortages and curb the illegal practice of organ trafficking. Another option is a regulated organ market. This approach would incentivize the exchange of human body parts between parties who are not be motivated by altruism.

These solutions are ethically messy, and policy makers might be reluctant to attach their names to these ideas. But what if we could avoid the ethical mess by leveraging technology?

What if we could print an organ?

We are in the midst of a 3-D printing revolution, and the prospect of printing organs is not mere science fiction. Reports in Nature and the Economist highlight that 3-D printing is already used for artificial joints, bone grafts, and cartilage structures. The U.S. market for printed body parts is greater than $500 million, and annual growth is increasing exponentially. Printing organs is favorable as compared to other methods, such as xenotransplantation: printed organs can be customized, can be printed on demand, have no viability window, and are not susceptible to zoonotic disease.

Despite this potential benefit, printing whole organs still faces technical obstacles. This is where policy makers have an opportunity to act. Below we highlight two recommendations that could position the U.S. as a medical technology leader in the 3-D printing revolution, and could ultimately save lives.

Recommendation 1: Incentivize collaborations between scientists and industry

The growth of the 3-D printing industry has already outpaced market forecasts. Economist project the industry will be worth $20 Billion by 2020. This pace of growth can be leveraged toward increased medical technology research by incentivizing relationships between science and industry. Federal research dollars could be used for match making in research project grants, or broad investment in University infrastructures that promote collaboration. The U.S. is already leading 3-D printing innovation. This model could put the U.S. in a position to make one of the most profound medical technology breakthroughs of the 21st century.

Recommendation 2: Promote discussion of ethical issues associated with printed body parts

New technologies bring new ethical questions. Printed body parts are no exception. Should we maximize equitable access of printed organs—or 3-D printing units? Should insurance companies pay for printed organs as they do for prosthetic technologies? And should printed organs be enhanced beyond normal function? These questions require discussion between industry leaders, scientists, and science and technology policy experts. Federal dollars can promote these discussions by integrating ethical analyses into research projects. The U.S. Human Genome Project and BRAIN Initiative use this incentive model. Federal dollars that support the 3-D printing revolution can do the same.     

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“Do no harm” is NOT Enough

computer-1149148_1280By Beth Russell

“If it ain’t broke, don’t fix it, right,” my granddad used to say, right before he would wink at me, chuckle, and say “let’s see if we can figure out how to make it better.” This type of ingenuity is at the root of American innovation, invention, and process evolution. Observation, experimentation, and a national drive for optimization are part of our culture. As we have moved from the 20th century into the 21st, there has been a fundamental shift from “one size fits all” solutions, towards more personalized solutions.

The Precision Medicine Initiative is one of the great goals of our time. However, most of our medical treatment is still geared toward the treatment that will usually work, rather than the treatment that is the best for the individual patient. What would the world look like if we could change that in years rather than decades? What if we could do it cheaply, and easily, with information that already exists?

We can. To start the process, we need only to do one thing – to share. Buried within our medical records, our genetics, and our health data, is the information that we need to make our medical treatments better. Our diversity in population, hospital, and practitioner policies, and personal health decisions compose an enormous health data set. If we are willing to share our data with researchers and to insist that the insurers, hospitals, and practitioners make sure that the data is interoperable, we will be well on our way.

We often have widely held medical practices that are not actually supported by scientific data. This is illustrated by a recent decision by the Department of Agriculture and the Department of Health and Human Services to remove daily flossing from their guidelines. Apparently, there was no actual scientific data behind it. Such practices are often low-risk procedures or treatments that do not warrant the expense of a clinical trial. Many of these will probably turn out to be accurate for most people, but not necessarily for everyone. I for one don’t plan to stop flossing anytime soon.

These sorts of medical practices are typically adopted based upon observation and consensus. This approach is cheap but relies on practitioners detecting a pattern of good or bad results, is highly subject to human bias, and is much more geared towards safety than efficacy. There will always be room for common sense and human observation in the medical process but they will miss both small, and rare effects.

For over a century the arrow has been shifting away from simple observation towards data-based decision making. Large observational studies like the Framingham Heart Study and the Nurse’s Health Study have had outsize impacts on medical practices but they are still too small. Only with many observations from numerous patients can we detect the variations in efficacy and safety that are needed for precision medicine.

Today, clinical trials are the gold standard for medical treatments. These experiments are expensive, time consuming, and often suffer from low subject numbers and a lack of diversity. They also can run into ethical issues, especially with vulnerable populations. Even when the results of clinical trials are excellent, their results aren’t always adopted initially by practitioners. Medicine tends to be slow to adopt change. Data sharing will allow scientific analysis to extend beyond the length of time and number of subjects that are used in any “trial” and will allow us to better evaluate drugs and treatment after they go to market, not just before they are approved.

Data sharing is also important for areas of medicine for which traditional clinical trials are difficult or impossible to run. One of these areas is surgery. Most surgeries are not subjected to clinical trials and there is great variation in the methods for even relatively common surgeries from hospital to hospital. How does a patient decide where to get a life-saving surgery? Recommendations from friends and family are the number one method for choosing a doctor. There is no place to look to find out whose favorite method is the best one overall, nor the best for the individual patient. This needs to change. Sharing our medical data will make this possible.

Medical practice is poised for a revolution. We are beginning to move from treating the symptoms to treating the person. This can only happen if enough of us are willing to share. So let’s practice our earliest kindergarten lesson already.