Showing posts with label patient advocates. Show all posts
Showing posts with label patient advocates. Show all posts

Thursday, April 19, 2007

CIRM Facilities Rancor: Delay and Dollars

Contentious, personal, confrontational, sarcastic – all could accurately describe last Friday's session of a key group of the California stem cell agency.

But, based on the transcript, the descriptions miss what was fundamentally important about the meeting and also what was hardly said. And that is: The agency is not required to spend $300 million on bricks and mortar – the major labs so desired by California research institutions. It is merely authorized to do so. And delaying them could mean more money for other endeavors.

The meeting of the Facilities Working Group was cited by CIRM President Zach Hall in his letter announcing that he was stepping down early. (See "Edifice" below.) The nominal topic of the meeting involved the laying more of the groundwork for $222 million in grants for major research facilities at California universities and nonprofit institutions.

But by the end of the acrimonious session, the Facilities Group, dominated by patient advocates, had set the stage for a major debate within the CIRM Oversight Committee. Three days prior to the Facilities meeting, patient advocates had lost a straw vote within the 29-member Oversight Committee for a more modest proposal for a written survey instead of the public hearings approved by the Facilities group. A seeming routine matter that was freighted with major baggage, including who is in charge – the Oversight Committee or its advisory groups?

Other issues emerged as well. The Facilities meeting highlighted the difficulties that any organization faces when it tries to operate without a "permanent" CEO. Hall was already a lame duck at the time of the meeting, having announced his departure last December. The session also demonstrated persistent divergence about the role of the CIRM president. Oversight Committee Chairman Robert Klein insisted that Hall execute the wishes of the Facilities Group even though Hall believed they conflicted with the Oversight Committee.

Finally, there were questions of the balance between making grants with great speed and exercizing due diligence.

Prop. 71
, which altered the California Constitution and created CIRM, provided for spending as much as $300 million on laboratory facilities. If the agency does not spend all of the sum, the remainder could go for more direct development of cures and therapies, a high priority for patient advocates who sit on the board. At the same time, top executives from California universities sit on the Oversight Committee. Their view is that they do not have enough room for existing researchers, much less the ones that are being recruited to come to the Golden State to perform embryonic stem cell research financed by CIRM. Construction costs are spiraling upward, and any grants will buy less in 12 months than they do today.

Prolonging the grant process could, however, mean that more funds would be ultimately available for patient advocate-backed research. Unwilling to wait, institutions will find other funding sources. Needs will change. Grant criteria could become more strict, ruling out some institution's plan. Some projects may become prohibitively expensive because of rising construction and equipment costs.

No one on the Oversight Committee is talking publicly about such a delaying strategy but it is clearly viable. And it is one that is not likely to be regarded kindly by institutions represented on the panel.

At last Friday's meeting, Hall said that the Oversight Committee had indicated a need for speed in moving grants forward and that he was receiving the opposite instructions from the Facilities Group. He said his first responsibility was to the full Oversight Committee. Hall said,
"I feel it is very important that it be worked out at the highest governance level for this whole organization, which is the board. I think that is the key. This is a really important issue here, and there's a, I would even say, a cultural difference between those involved in the scientific culture who see the need, who understand the urgency, and who are trying to move this forward in order to get the whole project going, and those here whose point of view I have heard(at this meeting)."
Oversight Committee member Marcy Feit, CEO of Valley Healthcare Systems, said she did not detect the same urgency as Hall. She said,
"This is a public agency with taxpayer dollars. And we are foolhardy if we don't pay attention to our responsibility. But nowhere on that (April 10) board meeting did I hear any board member not encourage us to do our job. So I would beg to differ with you that there is a cultural difference. There is not a cultural difference. I think if there were the rest of the board members here today, they would agree with us."
James Harrison, CIRM's private counsel, said,
"Zach is correct, that the ICOC expressed its intent that gathering information through a survey or through some prenoticed letter was not necessary or desirable in light of the sense of urgency that was expressed."
Oversight Committee member David Serrano-Sewell, vice chair of the Facilities Group and author of the public hearings motion, said it would not mean a delay in approving grants. In response to a query, he said in an email,
"Will undertaking a deliberative approach cause a delay? No, it will not. The Facilities Working Group can do its thing and meet the deadline, but it will need the support of the president to make it happen. That's where things got a little tense (see item below)."
To resolve the $222 million worth of edifice issues plus the question of who will be in charge of CIRM beginning in May, the institute is attempting to set up a special meeting of the Oversight Committee as soon as possible. The meeting is likely to be in the form of a conference call.

The committee will be operating in an atmosphere damaged by the rancor of last Friday's Facilities meeting. For a closer look at the acrimony, see the item below.

A Friday Filled with Acrimony

"Time out. Time out," said Rusty Doms, chairman of CIRM's Facilities Working Group, at one point as the discussion threatened to wheel out of control.

It was a conference call meeting last Friday that CIRM President Zach Hall later cited as one reason for his early departure as head of the $3 billion institute. Dom also resigned, submitting a terse letter with no explanation.

On the agenda was the topic of how to give away $222 million for embryonic stem research facilities.

The contentious discussion went on for some length. Questions of responsibility, due diligence, consideration of the public interest, loss of purchasing power, conflicts of interest and more surfaced.

At one point, Oversight Committee member David Serrano-Sewell, vice chair of the Facilities Group, repeatedly demanded that Hall answer a question with a yes or no. It related to a motion, authored by Serrano-Sewell, for public hearings on research lab needs. The motion had just been unanimously approved by the group.

Hall said that the vote contradicted the position of the Oversight Committee three days earlier. This exchange followed, according to the transcript of the meeting:
Hall: "Now, given the unanimous vote of this working group, there is no – I think there's no point in us doing that(preparing an outline for a major facilities RFA for the June Oversight Committee meeting). It's very clear, but it's also very clear to me that there are two different points of view represented on the ICOC(Oversight Committee)."

Serrano-Sewell: "Zach, it's a simple question. yes or no? Before the June meeting, will you aid this working group in a hearing?"

Hall: "I will."

Serrano-Sewell: "Yes or no? Will you assist this working group?"

Hall: "I want direction from the ICOC about how we should proceed on this."

Serrano-Sewell: "I'll take that as a no. If you're not helping us before the June meeting by committing resources, saying, yes, working group, I will commit resources, I will commit time in aiding you setting up these hearings which you unanimously passed."

Hall: "I'm sorry."

Serrano-Sewell: "It's either a yes or a no."
At this point, Hall said it was a matter that needed to be worked out by the full Oversight Committee and reflected a cultural difference within that group.

More sharp exchanges can be found in the transcript. But care should be taken in the reading. It was a conference call situation. Tone of voice, facial expressions (where the participants were together) are all missing. And there may transcribing errors, which can occur because of the difficulty in hearing all participants.

One such error seems to involve a quote for Serrano-Sewell. In the transript, he is quoted as saying, "I wanted to create a constitutional crisis." We queried him about the remark. He said he recalled saying that he did NOT want to create a crisis.

Saturday, February 17, 2007

Patient Advocate Don Reed on the CIRM Grants

Hi, Folks!

David Jensen was kind enough to allow me a small guest spot in his excellent column.

As you will see, it is not the balanced calm objectivity he always tries for.

I am a supporter of the California Institute for Regenerative Medicine. To me, it is the noblest institution which ever advanced the hopes and dreams of suffering humanity—because its sole function is work for cure, to ease suffering, end pain, and save lives.

Thank you for this opportunity to address you.

Don C. Reed

Oh, and if you would like to see Governor Schwarzenegger, Bob Klein, the Independent Citizens Oversight Committee, Karen Miner, Roman Reed and yours truly in action, go to



http://cbs5.com/video/?id=20865@kpix.dayport.com


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The California Institute for Regenerative Medicine, the CIRM, is the pride of our nation, the standard for science, and the envy of the world. It did not happen by itself.

Bob Klein dared to dream that California could become the center of the stem cell research universe. He worked tirelessly toward that end, and the Golden State said yes, voting to approve—and fund--the groundbreaking new research.

But lawsuits blocked us, delaying our hopes of cure. Research delayed is research denied. Right now, one hundred million Americans suffer disease and disabilities described as “incurable”, but which might be alleviated or healed with stem cell research. We needed help.

Arnold Schwarzenegger came through. His decision to authorize the $150 million loan was bold, forward-looking, compassionate.

I wish so much that another great champion, Christopher Reeve, could have been with us today. He would have been so proud. The man who, as my son said, was more like Superman in real life than in the movies, gave us a letter saying, “One day, Roman and I will stand up from our wheelchairs, and walk away from them forever.”

I believe in that great dream. And when it happens, when Roman Reed stands up from his wheelchair, we will remember this day.

Thank you, Governor Schwarzenegger. Thank you, Bob Klein. And thank you, California.

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