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Archive for January, 2013

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…”
http://cirm.ca.gov/files/meetings/pdf/2013/012313_item_5.PDF

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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THE GREATEST STEM CELL PROGRAM IN THE WORLD—under attack, again!

By Don C. Reed

Few institutions are more beloved–and more often attacked– than the California stem cell research program, the California Institute for Regenerative Medicine (CIRM).

For patient advocates like my paralyzed son Roman Reed and myself, the $6 billion program is like nothing else on earth: an institute solely designed to bring cure to chronic conditions, often called incurable. Every time I attend a CIRM public meeting, I feel a sense of disbelief, that California was able to make this happen.

Not without opposition! Lawsuits from the Religious Right tried to shut it down; opponents of “big government” wrote countless op-ed pieces opposing our program– well-meaning legislators tried to micromanage it. A small cottage industry of critics emerged: a mixed blessing. The same endlessly-quoted handful of folks offer constant negativity, but also suggestions for improvement, some of which have been adopted.  

The most recent threat comes in the form of a study:  “Committee on a Review of the California Institute for Regenerative Medicine (CIRM): Health Sciences Policy; Institute of Medicine”, available at: http://www.nap.edu/catalog.php?record_id=13523.  

While lacking power in itself, the study could become the basis for a new law  to revise and re-do the California stem cell program, in defiance of the voters’ will.

The study begins politely enough, complimenting CIRM:

 “… enhances California’s position as key international hub of activity… enriching regenerative medicine everywhere… impressive research portfolio…exemplary training program…   translational projects (ready) for industry involvement.”

Unfortunately, the study then recommends radical surgery! The proposed “improvements” would not only overturn the program’s structure, but might even violate state law. CIRM is in our state Constitution.– http://www.cirm.ca.gov/pdf/prop71.pdf)

The study objects to the program’s board of directors, the Independent Citizens Oversight Committee (ICOC), a 29-member panel of experts, appointed by public officials. These board members, the study believes, have an automatic conflict of interest, meaning they could use their votes to benefit the colleges or businesses for which they work.  

“They make proposals to themselves…regarding what should be funded. They cannot exert independent oversight.”—Harold Shapiro, Chair of the study.

This is provably false.

Members of the ICOC may NEVER “make proposals to themselves”. They are prevented by law from so doing: board members may neither discuss nor vote on projects which could benefit their parent organizations.

Here is what actually happens. 

First, California scientists offer their proposals. These are evaluated by the Grants Working Group, (GWG), a panel with a majority of out-of-state stem cell experts.

Each project is scored, from 1-100. The grant proposals fall into three categories: essentially YES, MAYBE, and NO. 

At a public hearing, the projects are listed in order of scoring, on a big screen in the auditorium.  The various grant proposals are also divided by color, so it is easy to tell which is recommended for funding.

The board has read the proposals, posted  on the public CIRM website (www.cirm.ca.gov). They have been reminded which projects they may not discuss.

The chairperson asks: does anyone want to move a proposal up or down?    

In most of the cases, probably 90%, the ICOC agrees with the recommendations. 

But if a board member challenges the placement of a grant, then the CIRM’s scientific staff will give its opinions, pro or con. The scientist applying for the grant may also speak. The board makes comments, as do we in the public—our only chance to do so.

Example:  a recent disease team proposal was offered, a new way to fight Alzheimer’s disease with its terrible memory loss.

http://www.researchstore.com/technologynetworks/News/stemcells_wins_20_million_from_cirm_for_alzheimers_disease_program?productid=EF6D220C-8225-4A37-A21F-126572F21FD3

It was a major grant, a $20 million dollar project by Stem Cells, Inc., led by Dr. Frank LaFerla of UC Irvine. It had been rejected by the Grants Working Group. But I had studied the proposal and it seemed groundbreaking– the scientists had achieved unprecedented memory return in the laboratory mice.  So, in the three minutes allowed me (as for any member of the public) I argued in support.

The debate lasted an intense 45 minutes. When all sides had been heard, the chair called for a vote by the board. One by one they declared themselves: those who were eligible.     

When the votes were counted, the Alzheimer’s project had won. It is going forward today. Will it work? I don’t know. But we are going to find out.

To me, this is America at our best:  everybody having their say: the board, the scientists, the patients, the public: transparent government, out in the open, no secrecy.

Unfortunately, this is what the study would destroy.

“The board…should not be involved in day-to-day management. (It) should delegate day-to-day management responsibilities to the President…” — Section 3, page 11

What do they mean by “Day-to-day management”? Nothing less than who gets the money.  Giving grants for stem cell research is not trivial housekeeping; it is our whole program. Take that away from the board, and they might as well go home.  

And who does the study suggest should now make these crucial decisions, instead of our 29-member board, interacting with scientists, staff, patient advocates and the public?

Two people would be in charge, one of whom works for the other.

“The Senior Vice President and the President…decide on a final slate of proposals to submit to the ICOC for a “yes” or “no” vote on the entire slate.

…the ICOC (Board)… should NOT (emphasis added) be empowered to evaluate individual applications…..”)– Section 4, page 18

“A “yes” or “no” vote on the entire slate?   

If the Board can only make a blanket decision on several dozen projects at once, all the research projects going forward or none of them—what kind of choice is that? Are they going to say NO, and block all the research?    

Instead of our open process, funding decisions would be made in private; the public would be denied meaningful participation: and our Board reduced to a rubber stamp.

Wednesday,  January 23rd, is an all-day workshop (10:30 AM to 6 PM) to consider the IOM study.   To attend, come to the Claremont Hotel, 41 Tunnel Road, Berkeley, CA 94705.  Or listen to the audiocast at (800) 700-7784.  Participant Access Code: 279280

Information at: http://www.cirm.ca.gov/Agenda_2013-01-23/icocgoverning-board

Opinions may be sent to the Board Chairman Jonathan Thomas, jthomas@cirm.ca.gov

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