What is the state of the union for stem cells in America today?
Overall I think it’s extremely encouraging and the field has great momentum in 2014. Of course there are challenges too and big risks.
On the positive side, there have never been more stem cell clinical trials underway than there are now at 4,303 in clinicaltrials.gov. While the most intense proponents of adult stem cells and the biggest fans of pluripotent stem cells often do not see eye to eye, I believe that both areas are advancing in important ways. Not all stem cell clinical trials are good ones or in the best interests of patients, but I think the trend of an overall increasing number is good news.
We need as many stem cell ‘weapons’ in our arsenal against disease and injury as possible. Both adult stem cells and pluripotent stem cells via embryonic and induced pluripotent stem cells are going to reduce human suffering in the future. Only supporting one main type of stem cell is shortsighted and harmful.
The fact that there still is an “us vs. them” divide in the stem cell world based on types of stem cells is a major challenge that we face. One of my goals with this blog and my book is to address this antagonism through education and fostering communication, especially amongst parties who do not agree and who do not usually talk. For example, what is good news for pluripotent stem cells is not necessarily bad news for adult stem cells. Vice versa isn’t true either. This false axiom of an inverse relationship does only harm.
Another big challenge is that as legitimate stem cell research builds and we see ever more evidence-based innovative medicines being developed, there are in parallel an increasing number of people who seek to take advantage of the excitement over stem cells to make money from patients. For example, the number of dubious stem cell clinics has never been higher in the US alone. This kind of health-related exploitation is not specific to stem cells. I’d imagine that over the course of human history, whenever something new came along that got people excited, there inevitably was some huckster who tapped into the buzz to try to make money at the expense of vulnerable people. Same as it ever was, the best approach to this challenge again remains education and perseverance.
I’m an academic, but I believe that commercialization of stem cell technology is essential. However, if you are selling stem cells, to do it ethically and legally, you need to do your homework and get truly educated, hire experts, consult bioethicists, put patients first, and follow the laws and regulations of the day even if you disagree with them. If you don’t agree with the laws and regulations, work to change them without violating them at the same time. On the positive side, I’m very hopeful that in 2014 the state of the stem cell field will continue to strengthen as we see more legit for-profit stem cell entities that have good intentions start and proceed with clinical trials. We need to continue to break down the wall between academia and industry. I’m encouraged as I see more and more signs of that happening.
Another challenge and opportunity is within the area of regulatory oversight. At the federal level, I have proposed in my new book 5 key reforms for the FDA to make the FDA of the future even better for the stem cell field. The FDA needs to become a faster, more proactive, and better communicating agency. It needs to promote innovation, while holding onto accountability. In addition, the FDA would better serve the American people by being more consistent in its regulatory approach to stem cells. For example, being a very slow, stickler with for-profits with good intentions and proven track records, while at the same time taking no action whatsoever (or only slowly taking action over a period of years) about highly dubious for-profit operations that make wild claims & race ahead of the science to sell interventions to hundreds or thousands of patients certainly sends an ambiguous confusing message from the FDA. At the same time, I also believe the FDA needs a mechanism to allow for compassionate use of stem cells specifically for fatal illnesses, but with extreme care and very specific guidelines.
I’m not holding my breath for rapid change at the FDA, but we in the stem cell community can continue to try to carefully nudge the FDA in positive directions. Even what seem to be incremental changes may add up to big positive outcomes for patients and the field. Again, there is an opportunity here. We also need to educate state medical boards of stem cells.
Another key area is physician education. There are hundreds of physicians in the US alone who are either doing stem cell-based medicine or want to, but remarkably there remains not a single active, academic US training program for them in cellular and regenerative medicine. That has to change. I have set forth some ideas on how to make this happen and proposed a curriculum.
A final major challenge today for stem cells is lack of funding. At the basic and pre-clinical levels, funding is extremely low and shaky relative to the monetary support required to realize the great potential of stem cells. Here in California, for example, the future is very uncertain as we do not know what the status of CIRM will be past 2017. At the same time, NIH funding has never been more difficult to get and maintain, which not only hurts stem cell research at all levels, but also biomedical research more generally. In the for-profit sector, where there is also great excitement, funding remains a huge obstacle to advancing stem cells to help patients too. Clinical trials are just too expensive and the failure rate for potential new drugs–whether chemical or biological like stem cells–is very high. We have to persevere and find creative new ways to fund clinical trials research.
Overall, I remain very confident in the state of the stem cell field, both in the US and globally, despite the challenges in front of us. Keeping open minds, doing our homework, sticking to accountability, requiring evidence-based medicine, and more generally not backing down from challenges, will lead us to positive outcomes for the field.