August 14, 2020

The Niche

Knoepfler lab stem cell blog

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.

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