Puzzling Institute of Medicine stem cell workshop

On November 18 in Washington, D.C. the Institute of Medicine (IOM) of the National Academy of Sciences will hold a workshop on stem cell therapies. The meeting  (agenda here) is also co-sponsored by ISSCR.

I have some major concerns about this meeting.

In principle and in a general sense, I believe this is the kind of meeting and discussion that we need to have in the stem cell field, but unfortunately the way this meeting has been organized is very problematic.

The meeting gets into potential quicksand immediately with its title:

Stem Cell Therapies: Opportunities for Assuring the Quality and Safety of Unregulated Clinical Offerings – A Workshop

Institute of Medicine stem cell meeting
Institute of Medicine stem cell meeting.

What the heck? Did I read that right?

How in the world can we “assure” the quality and safety of unregulated offerings?

It is impossible.

Appropriate regulation is the key to evidenced-based medicine that is safe and effective, whether it is based on stem cells, chemical “pill” drugs, or surgical procedures.

However, the IOM meeting title implicitly suggests, perhaps by accident, the extreme notion there is a legitimate pathway to making unregulated therapies safe and effective.

There isn’t.

If that were the case, why do we even need any regulation at all?

A majority of for-profit, point of care stem cell clinics have demonstrated consistently that absent regulatory oversight (heck, even with regulatory oversight that they try to hide from) that they frankly cannot be trusted to put patients’ best interests first. It’s pretty simple really. The average stem cell clinic’s focus is profit not the patient’s benefit. Of course that is not always the case, but it is true often enough that the field and patients need to be extremely wary. This workshop title does not reflect that caution and grasp of reality that is needed here.

I’m not arguing that the current regulatory framework is ideal. It’s not and I myself have argued for 5 specific FDA reforms in my book. However, we cannot mainstream the idea that stem cell clinics that intentionally evade regulation are to be worked with and accepted. They are in fact dangerous to both individual patients and to the stem cell field as a whole.

Is this title just a big misunderstanding?

If it were just the title of the meeting, one could say it’s not such a big deal, but the agenda also is cause for concern.

I find it notable that the ICMS, an organization in my opinion associated at times with promotion of deregulation of stem cell therapies, and a representative of the assisted reproduction technology (ART) field are speaking, but apparently no one on the regulatory side is present to balance things out. Perhaps we cannot have expected the FDA realistically to have a representative present, but the organizers could easily have found a speaker to articulate the point of view that regulation is essential. Further, the only patient given a speaking slot is one who is a strong advocate for stem cell deregulation. I see no inherent problem having him present a talk, but how about presenting both sides of patient perspectives? There are certainly many patients who’ve had bad experiences at unregulated clinics.

Given the self-imposed hurdles for the meeting itself based on its title, premise and structure, I’m going to be very curious to listen in as the meeting is held next week. To be sure there are some stellar speakers. I hope the meeting turns into a net positive for the field.

7 thoughts on “Puzzling Institute of Medicine stem cell workshop”

  1. Paul – would love to hear your recap of the workshop. I only found out about the meeting as a result of your blog. It’s unfortunate that other professional organizations, like FACT, experienced in peer developed standards for the cell therapy field were not invited to participate. Look forward to hearing more about the discussions.

  2. Well, Dr. Knoepfler everybody appreciates your knowledge and Expertise, but we have to remember that medicine made some of its biggest advancements at (former) times when there was no FDA, no regulatory bodies anywhere…. we are doctors subject to our conscience. MEdicine has existed guided by the ethical conscience of doctors who devoted their life to the Hippocratic oath… not to regulatory bodies influenced by big pharma and stock Exchange indices….. I know there is no way back, but we should not completely Forget that we as doctors are subject to ethical principles stronger and more rigid than regulatory bodies…. our conscience, our medical ethics

    NOt regulated by authorities does not automatically mean it’s subject to evil

  3. Pingback: Knoepfler Lab Stem Cell Blog – Puzzling Institute of Medicine stem cell workshop | Stu's Stem Cell Blog

  4. I have been working with stem cells for 15 years and somatic cell reprogramming since 2007. Since iPS, I have never seen nor read about, a biotechnological advance which has been so rapidly commercialised. My question to you is how can we even “assure” the quality and safety of regulated offerings from a technology which is largely based on an artifactual cultivation method? Standard cell culture is grossly non-physiological and far from biological relevance.

    1. Technological advances for cultivation of penicillin were commercialized on a time scale of 1 year.

  5. Hmm, it depends upon what you mean by “regulation”. Science does not have some bureaucratic big-brother FDA-type regulator standing over us all. (If there was, I’d quit.) Instead, we use a scientific method that is based upon openess and wide participation in order to sort out that which is valuable from that which is drivel. If regulators have any value then it flows from them following the science.

    I looked at the meeting objectives and they seemed reasonable to me.

    As for someone on the regulatotry side, I see Timothy Caulfield (a lawyer) is speaking — and the last publication of his that I read was definitely siding with strong regulation. Pity they didn’t think to invite Richard A. Epstein for balance.

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