10 Questions - Audley

10 Questions

David Audley, Executive Director and CEO of the ICMS

Q: How has the ICMS changed in the last three years?

A: It has been a remarkable three years. We honestly started with about a handful of docs nervous about the direction of the FDA. We had a very US-centric focus. I think our decision to move towards providing standards for the practice of medicine and education for the docs and internationalization membership was critical for our growth and expansion. We now have active chapters of the ICMS in Asia and South America, and non-US physicians and scientists make up about 40 % of our membership.

I also think one of the biggest, and maybe most positive changes was embracing patient safety as a basic tenet of the Society. It really guides everything from our IRB to our Standards and Treatment Registry. That drove our initial guidelines project as well as the off shore clinic report.  We took a lot of heat for that report, quite unfairly I think. It was really easy for people who were skeptical of the therapies and critical of the field to say that the ICMS was just trying to promote clinics. We were basically discredited as apologists for unproven therapies.  Our vision was, and remains today, that patients will seek these therapies out, and they deserve to have some unbiased information to help them make an informed healthcare decision.

Q: One of the biggest criticisms about the ICMS has been what some see as a too cozy relationship between the Society and clinics. How does ICMS balance the need of engaging clinics and its need to be an impartial standards organization and professional medical society?

A: We really try hard to maintain a very strong dividing line. At the leadership level, we have some pretty simple policies: our board of directors is a strategic board, which means it sets the mission of the ICMS. People involved in providing treatments can serve at this level.  And they should. No one would question bankers serving on a board for a professional banking association. Where we make a real line of demarcation is the main oversight board, our Medical Advisory Board.  We have made a commitment that this board, because of their unique position to evaluate accreditation processes and protocols, needs to be completely independent. That is why the MAB is composed of academic clinicians and researchers.

The question, however, is deeper than how we manage the Society. The question is really about why we engage clinics at all. The basic answer is that patients are being treated and we, as a patient safety and standards organization, need to be informed about what is being done in these clinics. We need to see data about outcomes, we need to understand how the cells are being processed and injected. We need to understand how the patients are being treated. We also have to balance this with our commitment to standards and to the highest professional and medical ethics and with good patient care. We can’t get the data about patients if we don’t have a relationship with clinics.

And one of the biggest issues right now is the lack of data. Without data there is no basis to show that these therapies are or aren’t effective. People on both ends of the spectrum take this as a way to either condemn the whole field as snake oil and dangerous or claim miracle cures. Both of which are inaccurate, and unproven. The only way to deliver on the promise of these cells is through data, and the only way to do that is to work collaboratively with clinics.

Q: What is the stance of the ICMS on off-shore clinics and medical tourism?

A: Medical tourism has existed for years, long before the advent of stem cell therapies. I don’t think we can stop medical tourism. What we can do is make sure that patients are informed about the treatments that they are seeking. They need to know where the cells are coming from, how they are being processed and be fully informed about the any risks. Patients also need to be told that there are no guarantees: Stem cells are not magic pixie dust and they can’t cure everything.

My main concern is not that there are foreign clinics. I have visited clinics in half a dozen countries, and some of them are providing care that exceeds what people can find in the US. No, what concerns me is that because of the restrictions on providing these therapies in the US, just about the only place that patients can get these therapies is at clinics that are off-shore. And while there is a handful that is good, there are scores that are a complete mystery. There is a complete lack of transparency. How is this serving the public interest? We care enough about patient safety to not allow them to access these therapies in the US, where there are strong licensing and medical boards, but not abroad where there is almost no oversight and patients really have no idea what they are getting.

Q: Who is responsible for the proliferation of off shore clinics?

A: There would not be clinics if there were no patient demand. But that is too simple and answer. I think that the US is responsible for the proliferation. Patients will always seek out treatments. By insisting on FDA approval, or three-phase clinical trials, we halted this innovation within the US. Doctors in Panama, Mexico, China, etc, saw this as an opportunity to provide these therapies. So, the result is that now the US exports patients to other countries to get innovative medical care because they can’t get it here. And, ultimately, the issue is that we don’t know about what kinds of oversight is provided, and we don’t know the standard of care in these clinics.

Q: Do you see this as one of the defining values of the ICMS?

A: Yes. We say that the ICMS is here to advance and define cell-based medicine. Providing peer-oversight is integral to this mission. That is why we have an Institutional Review Board. This is why we have built a Treatment Registry. The only way to advance this field, and ultimately deliver on the promise of these therapies, is by providing real, actual outcomes from transparency and peer oversight.

Q: Where do you see the field moving?

A: I see the steady professionalization of the field. I see a three-phase progression. Right now, we are firmly entrenched in a phase 1 model. That phase is defined by the inventor: a physician that has developed, as part of his or her practice, a novel application of these cells. The physician treats the patients, and she is really limited by time and resources as to the number of patients that she can treat. She is also very protective of her therapy, and doesn’t want to share details about it for fear that someone will replicate it. Phase 2 happens when these doctors figure out that the way to scale the treatments is not to hire more staff, which only adds overhead, but to license her protocols to other docs. This will steadily increase the total number of patients that can access the therapy, but it is also limited because it requires building an entire organization to manage the licensed relationships and recruit new docs. Phase 3 happens when someone comes into the field with the determination to buy the best protocols for specific disease and conditions, orthopedic, cardiac, neuro, etc. Phase 3 is when cell medicine becomes standard of care. This is what we all need to move towards. This is when we will have identified those protocols that are not only safe but also show positive outcomes for patients.

Q: What is it going to take to get there?

A: The only way to get there is through data. Independent collection, evaluation and reporting of data is the key. We need to move past testimonials and small case studies from a single clinic. As long as it is a single physician presenting his own data, collected by his own staff, the data is going to be suspect. That is the foundation of the Treatment Registry: an independent data collection and analysis system. Without this we will never be able to show the safety or outcomes data necessary to advance this field. And the only way we can get this data is for clinics to be willing to be transparent and participate with the ICMS.

Q: What do you think the biggest hurdle for the ICMS is moving forward?

A: I think there is still some residual belief that the ICMS is an anti-FDA crusader, and an exclusive club for a few select clinics.  As the field has professionalized, so has the ICMS. We moved in August to a paid membership, and we are in the process of appointing new people to serve on the board of directors.

There is also this amorphous sense that if people get involved with the ICMS that it will put a target on their back. But the only way to advance this field, to really help make this a standard of care, is to stop trying to hide.  Whether they are genuinely afraid of FDA, or of the ISSCR, the reality is we are the only professional medical association dedicated to cell-based medicine. If they are engaged in this field, then they need to step up, join and help set the standards. At the end of the day, either a professional medical association, like the ICMS sets the standards, or the politicians or regulators do. If physicians want medical professionals to set the standards, then the choice is clear: join the ICMS.

Q: You mentioned the ISSCR, what is the relationship between the two groups?

A: Personally, I really respect the work of the ISSCR. We have worked hard to incorporate their guidelines and their work in bio-ethics into our standards. They do a wonderful job providing a voice to the research community. They represent the bench, and we represent the bedside. I think that it makes sense to work collaboratively, and I hope to be as effective an advocate for my members as they are for theirs.

Q: What accomplishments are you most proud of?

A: I am immensely proud of the growth of the Society, and of our success in bringing together a truly international society. With physicians and researchers from 35 countries, like Peru, Jordan, Kenya, Costa Rica, Spain, I think we are a representation of the global cell medicine community.

But what I am most proud of is what is next: With the announcement with AABB to explore a joint accreditation program, we will be bringing a new chapter to this field. Combining the 50+ years of experience of the AABB with the domain expertise of the ICMS, will provide an amazing program. Additionally, the announcement in the coming weeks about providing a line of medical malpractice insurance to ICMS members will be a game changer. The field is steadily becoming more professional, more transparent, and the ICMS is providing the leadership to advance cell-based therapies.