From: Don Reed 
Sent: Sunday, January 06, 2013 2:25 PM
To: undisclosed-recipients:
Subject: Should Patient Advocate Voices be Shut Out of the California Stem Cell Program?



  Should Patient Advocate Voices be Shut Out of the California Stem Cell Program?

By Don C. Reed

Until now, the California stem cell program has been a shining star in its inclusion of patients and patient advocates in the decision-making process.

Proposition 71, which became the California Institute of Regenerative Medicine (CIRM), was begun by a patient advocate, Bob Klein, father of a son with type one diabetes. It was developed and fought for by patient advocates, as individuals and in groups, all the way..  

Of twenty-nine members of the program’s board of directors, ten are patient advocates, roughly equivalent to the number of Americans (one in three) with a chronic disease or disability. –  https://www.milkeninstitute.org/pdf/ES_ResearchFindings.pdf

These patient advocates have voting rights on individual stem cell research projects. In addition, members of the public like my paralyzed son Roman Reed, (or you or I or anyone) can offer our thoughts in a public forum, before important decisions are made.  

The whole program seems designed on the patient advocate motto, “nothing about us, without us.” We are a welcomed part of the process.

But all this may change.  If recommendations from an extremely one-sided report* are taken seriously, patient advocates may be denied meaningful participation.  

Quotations from the report: “Committee on a Review of the California Institute for Regenerative Medicine: Health Sciences Policy; Institute of Medicine” is cited by page number below. Full text available at: http://www.nap.edu/catalog.php?record_id=13523. 

The 166-page paper recommends gutting the power of the board of directors (the Independent Citizens Oversight Committee, or ICOC), which is the voice of the public, and on which the patient advocates serve.  

Listen to this deceptively gentle language:

“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 

Sounds harmless enough, at first. But what is meant by “day-to-day management”?

Deciding who gets the money.      

“…funding recommendations… should be the responsibility of the CIRM scientific staff, reporting to the President”. Summary, page 10, recommendation 4-2.

Giving grants for stem cell research… that is the entire purpose of the program. If that power was removed from the board of directors, they might as well go home.

How would the proposed changes work?

“The Senior Vice President and the President…decide on a final slate of proposals (of research projects) to submit to the ICOC for a “yes” or “no” vote on the entire slate.
…the ICOC… should NOT (emphasis added) be empowered to evaluate individual applications…..”)— Section 4, page 18

This means the Board could not vote (or even give an opinion) on individual stem cell research projects.  It would only have an up or down vote on groups of projects, perhaps 50 at a time. If the only choice was between all the research or none—the board would have no real choice except to approve it—reducing it to a rubber stamp.

Instead, the staff would make the real decisions in secret—approving or rejecting projects-- with no public involvement whatsoever. 

“this process would also eliminate the use of extraordinary petitions (by scientists with complaints-dr)…”—ibid.

Until now, scientists who felt their funding requests had been rejected unfairly could make a public appeal to the board, and patient advocates could speak in support or opposition. 

Instead, if a scientist had a grievance, he or she could only appeal to the same people who rejected them before—and only behind closed doors, in secret.  

Until now, if there was a research project the patients thought was particularly important, we could speak in support of it, when it mattered, before the vote was made.  This important opportunity would be taken away. 

Why? 

The changes are supposed to prevent alleged conflicts of interest on the board.  

Because board members may have ties to colleges eligible for grants, the theory goes, they might use their votes to benefit their parent organizations—although they are legally forbidden to do so. Anyone who attends the meetings regularly has seen the members frequently reminded which items they are not allowed to vote on, to prevent this possible conflict of interest.

In addition, a new definition of conflict of interest called the “personal conflict of interest” would be applied. Anyone who had a chronic illness, (or whose family had one) would apparently not be eligible to serve on the board. 

“…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…”—Section 3-page 14

Do we not want people on the board who are totally committed to cure?  That often means they are fighting for someone they love.  For instance, suppose I was under consideration for board membership.  My mother died of breast cancer, my younger sister has leukemia, my son is paralyzed—would I be disqualified three times? 

The study itself is weakened by its near-total lack of patient advocate involvement. In the entire 166-page report, only one patient advocate is identified, ICOC board member Jeff Sheehy. Long-term critics of Prop 71 are prominently featured-- but where are the voices of those who love the program?  

Anyone who doubts the value of patient advocates need only consult the U.S. Food and Drug Administration. The “FDA includes Patient Representatives on 26 advisory committee panels that review products and therapies related to serious and life-threatening diseases...” http://www.fda.gov/ForConsumers/byAudience/ForPatientAdvocates/default.htm

And what about the dozens of patient advocate groups which enthusiastically endorsed our program? Where are the viewpoints of the California Medical Association, the Coalition for the Advancement of Medical Research, the California Children’s Hospital, the International Society for Stem Cell Research, the Juvenile Diabetes Research Foundation and so many more?  

Evaluating the California stem cell program without input from patient advocates? That is like studying women’s issues while only allowing men to speak.

To this non-lawyer, many of the proposed changes may even be illegal, as they appear to violate the terms of Prop 71, which California voted for, and which is now an official part of our state’s Constitution.  

There will soon be a PUBLIC WORKSHOP to discuss the report. 

Tentatively scheduled for January 23rd, (final date will be posted at www.cirm.ca.gov, under “public meetings”) the meeting will be held at the Claremont Hotel, Berkeley, California, starting at 9:00 AM, and lasting till the early evening.  

The public is urged to attend. 










    




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