Major Changes Accepted at California Stem Cell Program

By Don C. Reed

As a long-term patient advocate, I have attended probably more public meetings of the California stem cell program than anybody, staff included; and I have never ceased to be amazed at the dedication of all concerned.

The most recent meeting was a response to what I consider a grossly misguided study of our program by the Institute of Medicine. Google it for the full 166 page.

The study maintained the California Institute of Regenerative Medicine (CIRM) was rife with potential conflicts of interest, including, according to their view, patient advocates: people with a medical condition, or their family.

“…The committee believes that personal conflicts of interest arising from one’s own or a family member’s affliction with a particular disease…can create bias for board members..” ibid–section 3, page 14

Patient advocates are the people who organized, led, fought for, and supported Proposition 71, the citizens’ initiative which led to the California Institute of Regenerative Medicine. Bob Klein who inspired the program has a son with type one diabetes. My son Roman Reed is paralyzed from the shoulders down. Patient advocates stood on street corners for nearly a year gathering signatures to get the measure on the ballot. Without us, there would be no three billion dollar stem cell program.

Yet now, having done the work, we were not to be part of the decision-making?

Pioneering stem cell scientist Dr. Jeanne Loring said it best, in a letter she asked me to read into the public record:

“Patient advocates are extremely valuable to us researchers.

“With my first CIRM grant, I started meeting patient advocates, and now I can’t imagine pursuing a disease-related research project without them…They are wonderful sources of knowledge: Jeff Sheehy taught me about HIV/AIDS and patient activism, I learned about Parkinson’s disease from Joan Samuelson, autism from John Shestack, David Serrano-Sewell and Diane Winokur have educated me about MS and ALS.

“Advocacy makes CIRM-funded research breathtakingly relevant and uniquely powerful to change the course of medicine.”— Jeanne Loring, Ph.D. ,Professor and Director of the Center for Regenerative Medicine at the Scripps Research Institute in La Jolla, CA.

Even so, those three words, “conflict of interest”, are huge, whether applied to patient advocates, or to the board of directors: the Independent Citizens Oversight Committee (ICOC).

Virtually every critic of the program alleges conflicts of interest, noting (correctly) that many of the institutions which get research money are also on the ICOC. For example, the University of California system has many researchers; it is natural for it to be represented on the board—where else should the money go, if not to where the researchers are? And the members are not allowed to vote on anything which might benefit themselves.

Yet, like Caesar’s wife, CIRM must be above suspicion: held to the highest standards.

The Board listened to the IOM: and offered changes to address the criticism.

From the official CIRM statement:

“One of the big issues raised by the IOM report was that our current governing structure created a perception of conflicts of interest in how we fund research,” says Chairman Jonathan Thomas. “While no one has found any actual conflicts, these changes directly address the broad public perception.”

Translation: no actual conflicts of interest were found, only the possibility that some might develop.

This fit with earlier studies. Both the California legislature and the State Controller’s office had found no conflicts of interest in the program.

In fact, the CIRM’s: “conflict of interest rules are modeled on, but exceed, the standards established by the National Institutes of Health…”

But perceptions, accurate or not, can be damaging. Chairman Thomas believed the board must answer the issue, or lose credit with the public. He offered a draconian solution:

“By having board members who belong to institutions that can get CIRM money abstain from all votes on funding we take even the perception of conflict of interest out of the picture….”

Thirteen members of the board of directors just had their right to vote taken away.

From now on, institutions which could receive funding from the program will no longer be able to vote–at all.

How significant were the changes? In a published e-mail to Chairman Thomas, the study’s leader, Harold Shapiro, former President of Princeton, commended the stem cell agency for its response, calling it:

“…very thoughtful and significant…will serve the long term interests of the citizens of California and the field of regenerative medicine. … dealing with financial conflicts of interest, enhancing the credibility and integrity of the scientific review process…”

With an essentially unanimous vote, (one abstention) the board voted to approve the changes (subject to a month’s public comment) for a trial period of one year. When that testing phase is done, the changes will either become permanent, or be altered.

And the patient advocates? Their vote was taken away on the Grants Working Group, which recommends research projects to the board—but patients on the board will still vote—and our right to participate in public comment has not been infringed.

“These are big potential changes, and important ones,” said Jonathan Thomas, JD, PhD, Chair of the Board. “We are proposing them to address the concerns of the IOM, and to demonstrate how seriously we take the recommendations detailed in their report….”

All change is painful, more so when its necessity is questionable.

But there can be no debate that the board took the high road. Even those who would be losing their right to vote still approved the changes; their belief in the program and the importance of its public perception was more important than their personal authority.

For the California stem cell program, the conflict of interest issue should officially be declared null and void.

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