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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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THE GREAT INTERNATIONAL… STEM CELL DAY POETRY CONTEST!

By Don C. Reed, http://www.stemcellbattles.com

Dear Stem Cell Research Supporter:

First, consider sending this notice to everyone on your e-list. You’ll see why in a minute.

How are you going to celebrate the second annual Stem Cell Awareness Day, September 23rd.? (Hint: even if it is just that you wished your loved one a “Happy Stem Cell Awareness Day!”, be sure to send a note saying that to: stemcellday@cirm.ca.gov).

Folks, Stem Cell Awareness Day is our holiday; it is brand-new, only our second year. Last year, we celebrated only in two nations, America and Australia. This year we need to grow it, across the country, across the world.

Where? Everywhere. In every state or nation with people who might benefit from the healing powers of regenerative medicine—there is where we should raise attention to our cause.

In a moment, fifteen ways to celebrate: but first…

The Great International Stem Cell Day Poetry Contest!

This is something we are organizing here at the California Institute for Regenerative Medicine (CIRM). Don Gibbons and Ellen Rose are heading up the effort at CIRM; I am the enthusiastic volunteer.

What does that have to do with you? First, you support stem cell research. Second,
anyone who scribbles can throw a rhyme together—why not make one up to celebrate Stem Cell Awareness Day?

The THEME is: “What stem cell research means to me”. That is pretty broad: covers just about anything. Your poem could be fun, or serious. It could be about the agony of illness, the heroism of those who struggle on no matter what, and it definitely could be on the shining hope of cure.

LENGTH: It could be short as a couplet (two rhyming phrases) or as long as a page: (no longer, 250 words max, and only one poem per person, please.) Also, it should rhyme.

ATTITUDE: It must not be malicious, salacious or litigious — but a poem can let you say things you may have kept bottled up for a while, like:

“A pox on the enemies of research on stem cells,
May they get massive headaches, and have both their ankles swell!”

Um, well, moving right along…

Who can enter? Everybody. Patient advocates, family members, people who never thought about writing a poem, anyone who wants to try. Shakespeare is safe, we are not trying for literary masterpieces here.

And everybody will win. How so?

First, Don Gibbons, the indefatigable press agent for CIRM, says: “If we get a fair number of submissions from both scientists and patient advocates, there could be winners in multiple categories”.

AND—there will be prizes…nothing expensive, of course, just something small you will enjoy, and the very best poems will be printed in a CIRM official document, maybe posted on the web.

AND—you are guaranteed a place in our official stem cell endless poem!

Here’s how the “endless poem” works.

Everyone who sends in any poem will have something in our official endless poem. Maybe it will be a line from his/her poem, a phrase, a word, and/or their name, depending on the number of responses.

As official volunteer, I get to cobble representative phrases and/or author names into one loooooooong poem. (As a former English teacher, I have done this before, and it is perhaps not a literary achievement—okay, sometimes it is awful– but it is fun, and it can say something.

So, crank up your literary engines, and send your poem to: stemcellday@cirm.ca.gov.

Now. How else can we mark our holiday?

We want things easy, and doable. Think of the 4th of July. People have picnics, politicians make speeches. We can certainly do that!

Nothing spectacular: nobody has any money. (If you want spectacle, of course, go to the World Stem Cell Summit, September 21-23; Bernie Siegel has been working all year to make that event a standout; and it is still not too late to sign up; just google World Stem Cell Summit and you will find it at once.) Yet we must mark this day, in ways large and small, to rally awareness to the cause of cure—almost anything is better than silence.

Here are fifteen suggestions.

1. What about a Stem Cell Awareness Day backyard barbeque for friends? Everybody brings some food, sit around, gossip about whoever is not present. If you want to get fancy, hand out some one-page easy-reading fliers about the good news of stem cell research? (If everybody chips in a dollar, you just had a fund-raiser—and you could send the $10 or whatever it is to the group of your choice—they will be glad for donations of any size.)

2. What about a Stem Cell Awareness Block Party? Same as suggestion one, but with a couple home-made posters. (WANT MORE INFO ON STEM CELLS? Go to http://www.cirm.ca.gov, lot of good stuff there, plus if you go to Youtube and look up CIRM stem cells you will find plenty of visuals. Try: http://www.youtube.com/cirmtv

3. If you are a SCIENTIST, how about visiting your local high school, give a brief talk in a science class: nothing elaborate, just what you do, and your hopes for the future? Contact the principal of the school, ask him or her. Chances are, they will be delighted to have you speak!

4. Contact your local paper. Ask if they know that September 23rd is Stem Cell Awareness Day. They will say no. Then, ask if you could send them some materials– see below for your handy-dandy home-made press newsrelease!* They will almost certainly say yes. They might do an article on it—at very least, they can list the celebration of Stem Cell Awareness Day in their Announcements calendar.

5. Call your State Representative, or Senator, or Governor, ask him or her to issue a statement supporting Stem Cell Awareness Day, celebrating September 23rd official SCAD for your state. (They do this all the time, by the way, for industries important to their constituencies: there is Spinach appreciation day, etc. And it can vary year by year, so don’t worry about all the good days being taken).

6. Call your local college, ask if they have a stem cell science program, and if not, why not? Plant a seed!

7. Google “biomedicine” in your state, see how many companies there are in the Life Sciences in your area. Find a biomedical company (many of them are small right now, Mom and Pop companies, just starting off), ask if they give tours, or literature, find out a little about what they are doing. Stem cells are not only good, but good business too!

8. Join a patient advocacy group, one related to a condition whose cure you support. If you already belong to a group, ask the leadership to send an E-blast to everyone, reminding them that September 23rd is Stem Cell Awareness Day.

9. Help your newspaper write a story about your family member’s (or your) medical condition and your hopes for regenerative medicine. That is easily done. Make up the news release (see below), call the news desk, ask who does feature stories, talk a little bit, ask if you can send them a newsrelease—they are almost guaranteed to say yes (remember 70% of all newspaper stories are planted by someone outside, who calls up and requests the article.)

10. Write a one-page (250 words) family letter to the local newspaper, about your hopes for stem cell research—and reminding everyone that September 23rd is Stem Cell Awareness Day. And– SEND THAT MESSAGE (and this one, too, please) TO YOUR E-LIST.

11. Call your local radio talk show host, and make a comment on stem cell awareness. Ask them to do a show on stem cell research.

12. Contact the White House comment call number: (Comments: 202-456-1111) and remind President Obama that September 23 is Stem Cell Awareness Day—and thank him for keeping his campaign promise to reverse the Bush stem cell restrictions.

13. Paint a Stem Cells for Hope picture and send an electronic copy to CIRM.

14. Purchase a book about stem cells—nothing sends a message to publishers faster than a bought book—we need to encourage the sharing of stem cell information in every way.

15. Participate in the Great International Stem Cell Poetry Contest!

P.S. Here is a special message from the California Institute for Regenerative Medicine.

Stem Cell Awareness day is about outreach and education. The purpose of Stem Cell Awareness Day is to:

• Deliver information to the public about the science of stem cell research
• Raise awareness of the current state of research across all types of stem cell science
• Convey the future promise that stem cell science holds for a wide variety of therapies and diagnostic applications

Events being planned include:

In California: For Students:
On Stem Cell Awareness Day, CIRM will facilitate approximately 50 high school classroom presentations throughout the state by CIRM-funded stem cell researchers.

For the Public:
CIRM is working with stem cell researchers who have received Early Translational grants and patient advocacy groups to organize several public education events. These events will focus on specific applications of stem cells in treating disease.

Internationally: CIRM is working with the countries and organizations it collaborates with to organize additional activities for Stem Cell Awareness Day. This can include a range of activities such as: Public proclamations, symposia and workshops, outreach events, patient advocacy events.

CIRM is developing and hosting a Web site for Stem Cell Awareness Day –
http://www.stemcellday.com Please contact us at stemcellday@cirm.ca.gov to have activities added to the site.

*SAMPLE NEWSRELEASE

Headline: STEM CELL AWARENESS DAY CELEBRATED BY LOCAL FAMILY

Contact info: Your name, phone number, email

Event: The ________family has a special reason for celebrating the second annual STEM CELL AWARENESS DAY on September 23rd. That reason is hope.

Background: (briefly state your personal reason for supporting stem cell research, in my case, I am the father of a paralyzed young man.)

Reason the article is important: Last year America spent $2.3 trillion on health care costs; 75% of that mountain of medical expense was due to chronic (incurable) illness. Nothing lowers medical costs like curing a disease.

Last year, for the first time, Stem Cell Awareness Day was celebrated in Australia and America. The ________ family hopes everyone who believes in the possibilities of regenerative medicine will consider celebrating Stem Cell Awareness Day.

The __________ hopes the special day will revitalize all families whose loved ones suffer, and who deserve access to the best medical treatment American science can provide.

For more information on Stem Cell Awareness Day, email stemcellday@cirm.ca.gov.

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UNCONSTITUTIONAL? Changes to California Stem Cell Program May Require State Vote

By Don C. Reed

It was just a small office conference room in the city of San Francisco, with clean white tables and simple chairs.

But on every table was a microphone.

And what was decided between the hours of 10:00 and 11:30 AM, on July 16th, 2009, could affect the lives of millions of suffering human beings.

Seated at the front table were Bob Klein, Art Torres, and Jeff Sheehy. Attending by phone were Duane Roth, John Reed, Joan Samuelson, Claire Pommeroy, Susan Bryant, and Francisco Prieto, and maybe one or two others I did not type fast enough to catch.

This was the legislative subcommittee of California’s stem cell program.

Today they would decide how to respond to an 84 page report from the Little Hoover Commission (LHC), a catalog of criticisms and suggestions for changes in the law. The report was titled: “Stem Cell Research: Strengthening Government to Further the Voters’ Mandate”. (Please note that word “Further”– it will be important later on.)

The meeting began with a shock. Bob Klein relinquished the chairmanship of this important committee, passing the baton to vice-chair Art Torres.

Former California Senator Torres is of course no stranger to the politics of hope. He has fought for people’s rights for decades, including work with Cesar Chavez and the United Farm Workers.

But nobody knows the stem cell program like Bob Klein. True, he would retain the chairmanship of the larger governance board, the Independent Citizens Oversight Committee (ICOC), but why give up this small but crucial responsibility?

Four words: “my wife’s health challenges” was all he said, but the room went still. Danielle Guttman-Klein works on her environmental programs with the same enthusiasm and dedication her husband brings to stem cell research. When you meet her, vibrant, athletic, a smile like the young Doris Day– it is hard to believe she is battling cancer.

New chairman Torres said he had not yet voiced his opinions on the report, and would hold his comments till after everyone else had their say.

Bob continued. Some of the Little Hoover Commission suggestions were intriguing, he said, worthy of careful consideration. Others “should not be on the table at all, or they might sweep everything away”.

CIRM Attorney James Harrison spoke. This is the man who helped Bob Klein write Proposition 71, so he knows it backwards and forwards. He works with Remcho, Johansen & Purcell, one of two law firms associated with Proposition 71 since it began. The other is Nielsen, Merksamer, Parrinello, Mueller & Naylor. Both firms provided documents.

There were three sets of changes suggested. In the 90-minute meeting, we could only discuss one, the most serious. Enacted into law, these changes would:

1. Cut our board of directors in half, from 29 members to 15.

2. Reduce board members’ terms to 4 years, instead of the current 6 or 8.

3. Let the Governor choose most of the board: 11 of 15 members.

4. Eliminate the Chair and vice-Chair’s statutory powers.

5. Allow the new board to elect the chair and vice chair only from its members.

How serious are these changes?

According to a public letter from California State Senator Dean Florez, Senate Majority Leader, these changes would “essentially re-write Proposition 71.”

They may also be unconstitutional.

Article II, section 10 (c) of the California Constitution sets guidelines for changing an initiative like Prop 71, the California stem cell program.

“The Legislature may amend or appeal…an initiative statute by another statute… only when approved by the electors unless the initiative statute permits amendment or repeal….” –emphasis added.

So they have two options:
1. set up another initiative to change the first, including a new vote of the people;
2. use whatever guidelines for change exist in the original law.

Option 1 is difficult. To “re-do” an initiative, the legislature has make up another initiative with the changes they want, get it approved by Assembly and Senate, (possibly the Governor? I am not sure) and finally present it to the voters—who may not appreciate this flouting of their will.

Option 2 is to use guidelines for amendment already in the initiative.

Does Proposition 71 have provisions to allow such changes? Yes, but with conditions.

“…Proposition 71 can only be amended by the Legislature “to enhance the ability to further the purposes of the grant and loan programs created by the measure”…(Section 8.) Amendments that do not further the purposes of the grant and loan programs created by Proposition 71 can only be adopted by another vote of the people.”—Nielsen, Merksamer, et al.

Remember that word “Further” in the title of the Report? That is a politically loaded term, since any new laws affecting Prop 71 must “further the purpose” of the initiative.

Would the first group of changes meet that standard, and “further the purpose” of the initiative?

In a word, no.

Proposition 71’s purpose was to make grants and loans to advance stem cell research, in a non-political way. That is clear from any reading of the Proposition 71 language, ballot materials, campaign literature, and the non-partisan legislative analysis provided by the state.

California voted for our program to be set up in a very specific way: so politics would not interfere with research for cure. Our families deserve the best medical treatments science can provide—not what is ideologically acceptable.

In Proposition 71 the power of selecting the governing board was spread widely, to prevent any individual from imposing political domination over the research.

Some of the LHC suggestions would politicize our program.

For example: on their suggested new and smaller board of directors, 11 of 15 members (73%) would be chosen by the next Governor.

What happens if that Governor was against embryonic stem cell research?

California has been fortunate in Governor Schwarzenegger’s steadfast support of the research. He has stood by our stem cell program again and again, even when that was not politically easy. In the history of medicine, he has earned a place of honor.

But another Governor might oppose the research. Last year’s national Republican platform called for the criminalization of embryonic stem cell research. A governor who supported that extreme position could easily “stack the deck”: choosing board members who would push the research into a direction not intended by the voters. Or, the new Governor might decide our state “can’t afford it”. With the power of the board, they could deliberately slow down the program–or reduce our funding, as was suggested during the LHC hearings.

The conversation began. (My comments, as always, are taken from memory and notes; if I mischaracterize anyone’s position, I hope they will straighten me out on the matter.)

To fight, or not to fight; that was the question, it seemed to me. Should the legislative subcommittee accept or reject these five most serious LHC suggestions?

Board member Jeff Sheehy appeared to regard the Little Hoover Commission as an opening position, details to be worked out later. He credited the California program as something wonderful, which should be continued on a long-term basis, and that meant having the flexibility to adjust along the way. He seemed willing to consider some of the LHC recommendations.

He also saw a need for change right now. For instance: patient advocates on the board cannot have substitutes, which wreaks a hardship. Joan Samuelson, for example, has Parkinson’s disease. It is sometimes difficult for her to deal with the condition as well as the work; she and other patient advocates should be allowed a substitute for board meetings when the need arises.

That is perfectly reasonable. But do we need to revamp the entire program to accomplish it? We could do what our governing board usually does, “agenda-ize” the problem, put it on the official calendar for discussion, and then work out an answer. That is what the ICOC is all about.

Jeff Sheehy questioned the large size of the present board, pointing out that it can be difficult to get the “quorum”: enough eligible folks to make an official vote.

Some meetings do have a little frantic scurrying around to get enough folks in the room. These are top executives, all with crammed schedules, and it is not always easy to get them together. But they cooperate, and it works out. I doubt there have been more than three or four votes that had to be rescheduled; this inconvenience seems a small price to pay, compared to the benefit of having some of the best minds in the nation working together. (To see the caliber of our board, go to http://www.cirm.ca.gov, and look up their short bios; I guarantee you will be impressed.)

Bob Klein spoke on the positive aspects of a large board of directors. Our 29-member board was patterned after the similarly-sized (26 members) University of California board of Regents. Our board setup allows a broad diversity of opinions, virtually guaranteeing better outcomes. Also there is a lot of work to be done; a smaller committee might not accomplish all the chores. As it is, the board’s ten patient advocates are spread thin. They must be represented on several committees, and are overworked; to cut their number in half would aggravate the situation.

Dr. John Reed noted that any changes should be considered carefully, because sometimes what seemed like even a common sense alteration could have devastating consequences.

That made sense to me. For our program, the ICOC board is like the hull of a ship, on which everything else depends; weakening that would be like drilling holes in the hull.

Major changes also meant possible lawsuits. Joan Samuelson, an attorney herself, reminded us how lawsuits delayed our program before, draining our resources, slowing us down almost two years. The opposition’s lawyers were sure to go over any change “with a magnifying glass”, as she put it. They would search for the smallest detail which could work to their advantage, any foot-hold that could allow them to challenge us in court, to delay or deny our research.

We had a telephone call from Spain, where CIRM President Dr. Allen Trounson had been speaking at the International Stem Cell Research convention. He spoke with delight of the reception the California effort was receiving from the world. “Unprecedented level of support,” he said, and the smile in his voice came through, even over the static crackle of the phone.

Finally, Chairman Art Torres spoke. He said he had worked with the Little Hoover Commission before; they had the luxury of proposing all manner of changes, after which they could “wash their hands of the matter.” But we could not do that. Whatever changes were made, we would be stuck with. In regards to allowing the next Governor to appoint 11 of the 15 board members, Art was not in favor of giving such power to one person. As for the size of the board, Senator Torres had served on many boards, all different sizes, from as small as 3 members to as large as 75—more than double the size of ours. His thoughts on the ICOC? A highly successful board, he said; it had vigorous discussions, made solid, well-grounded decisions—“and at the end of the day, you guys still manage to genuinely like each other!”

And now a motion was needed, to be followed by public comment, and the vote.

Bob Klein made the motion: that the legislative subcommittee should reject this group of changes on grounds they might be unconstitutional, or require another ballot measure. A suggestion was offered by board member Dr. Claire Pommeroy, that the words “on the basis of information received from counsel” be inserted into the motion. This was accepted by the maker of the motion as a friendly amendment.

Then it was public comment time.

David Jensen of the California Stem Cell Report noted that the position of the law firms cited (that the LHC proposals could be unconstitutional without a state-wide vote) was only a legal opinion; other law firms might study the same information and come to a different conclusion.

Fair enough: anyone who listened in on the Sotomayor hearings can vouch for the difference of opinions possible in any interpretation of law.

On the other hand, both of these law firms have been connected to the stem cell program since its inception. It is their business to keep track of every detail of any argument which might affect our stem cell program. Their arguments are backed up by solid legal precedent.

When it was my turn, I quoted Winston Churchill, who said:

“Democracy is the worst form of government, except for all the others”.

There is room for improvement in everything, from democracy itself to our stem cell program.

But it must be admitted the California Institute for Regenerative Medicine is doing a terrific job.

Even the Little Hoover Commission report begins by acknowledging the California program as the “envy of the world… The institute…has directed more than $700 million toward scientific exploration, in the process leveraging an additional $900 million in private and institutional money that has built new facilities, lured scientists to California and spurred growth in the state’s life sciences industry.”

In other words, Prop 71 has done exactly what it promised to do—only better. Not only did it advance stem cell science and the biomedical industry, but it even brought in an unexpected bonus of $900 million dollars!

Why should major changes be imposed on such an outstanding program?

Does the doctor say to a healthy patient, “Okay, you are in great shape—let’s do major surgery?”

As the old saying goes, “If it ain’t broke, don’t fix it!”

At last, everyone had had their say. A roll call vote was taken.

The first group of changes was rejected: 8-0, with one member abstaining.

What happens next?

August 6th is the next legislative subcommittee meeting, to discuss more aspects of the Little Hoover Commission’s report. As always, you are invited; see http://www.cirm.ca.gov for information.

On August 19th and 20th, there will be a meeting of the full ICOC, where the recommendations of the subcommittee will be discussed, and our governance board will take a position.

I will have to miss that meeting. Gloria and I are celebrating our 40th wedding anniversary by going to Paris. It is financially foolish, we can’t afford it, but we are going anyway. So while you folks are working, I will be in the city of lights, eating French pastry, and trying to work up my nerve to ride that rickety elevator up the most beautiful building in the world, the Eiffel Tower.

But in my suitcase will be the LHC report. I will study it every day. And, to steal a line from America’s favorite stemcell-supporting body-builder/moviestar/Governor: “I’ll be back.”

I would not want to miss the coming battle over the Little Hoover Commission’s proposed changes; it will be a long fight, perhaps our most difficult. The LHC report has gathered many (if not most) of the criticisms that have been thrown at us since 2004, seemingly accepting them all as gospel, and turned them into recommendations for change—to be imposed by law. This next stem cell battle will be like facing all the previously defeated challenges, again.

It is a trifle irritating. After more than a year’s hard work, Proposition 71 won the election. After almost two years in court after that, we beat the lawsuit challenges, including appeals all the way to the California Supreme Court. Since then, our program has survived who knows how many audits, investigations and oversight procedures—not to mention the seven bills previously offered to “improve” us– and now, another one, potentially combining elements from all the others?

Unfortunately, that would appear to be the situation. The LHC-begun law may not happen right away, but it seems to be well into the planning stages.

At a recent committee hearing for another bill (the excellent stem cell education bill, SB 471, from Senators Gloria Romero and Darrel Steinberg) Senator Elaine Alquist spoke about using one of her bills (probably the half-completed SB 343, which is presently about stem cells and intellectual property) to carry some or all of the Little Hoover Commission changes.

What does that mean for us, the patient advocacy community?

We will do as we have always done: study the bill when it comes, discuss it with friends, decide if it is a threat to the California research program– and then take part in the democratic process.

A Little Hoover Commission member told me that one of our options was simply to ignore them; I told him we would never be so rude—nor can we afford to be.

For this is no philosophical debate. This is binding law, intended to permanently alter our shining stem cell program.

The California Institute for Regenerative Medicine offers hope to all who suffer chronic disease and disability.

This is about people we love: like Danielle Guttman-Klein and my sister Barbara, both of whom have cancer, and my son Roman, who is paralyzed, and our little friend Pranav, four years old, who has spinal muscular atrophy—and millions of other folks, your relatives and mine, our friends, our neighbors, ourselves—this is for everyone.

The California program is worth every effort to defend.

P.S. Available at the meeting was an open letter from California Senator Dean Florez, Senate Majority Leader, and a member of the Little Hoover Commission. Portions of it follow below.

Senator Florez states:

“… I would like to note, for the record, my concerns regarding the (Little Hoover) Commission’s report on the California Institute for Regenerative Medicine (CIRM)…

“…the report recommends reducing the size of CIRM’s governing board from 29 members to 15 members and concentrating the power of appointment to the Governor, who would be responsible for appointing 11 of 15 members. The report also recommends stripping the power of the Lieutenant Governor, the Controller, and the Treasurer to make appointments eliminating the statutory duties of the chair and the vice chair….

“…the recommendations, if adopted by the Legislature, would essentially rewrite Proposition 71. (emphasis added, DR) In adopting Proposition 71, the voters specified the governance structure they desired and limited the Legislature’s ability to amend the law. Under Proposition 71, the Legislature may only amend the law to enhance CIRM’s ability to further the purposes of its grant and loan program. The Commission’s recommendations appear to be inconsistent with the voters’ intent and therefore could only be accomplished by proposing another ballot measure…

“…the Commission’s recommendations appear to lack a firm foundation. For example, when I asked (at an earlier meeting—DR) why a 15 member board was inherently better than a 29 member board, Commission members responded that an academic expert on non-profit governance had testified that the ideal board size was seven to nine members, but the expert himself stated that he did not have sufficient knowledge of CIRM’s operations to opine about the ideal board size for CIRM…

“…I am also concerned about the Commission’s attempt to shift power over the agency to the Governor. … CIRM was designed to be an independent agency. Proposition 71 therefore dispersed appointment authority to the Governor, Lieutenant Governor, the Controller, the Treasurer, the Legislature, and UC Chancellors. By concentrating appointment authority in the Governor, the Commission would undermine the careful and deliberate balance struck by Proposition 71. In a controversial area like stem cell research, such a change would threaten the independence that CIRM needs to ensure the success of its mission.

“Finally, I am concerned about the Commission’s apparent rush to conclude its report. As one member said at the meeting, five minutes and a sandwich is not adequate time for Commission members to absorb the information that was presented. While I appreciate the substantial effort that Commission members and staff put into drafting the report, I am concerned that due to its rush to approve the report, the Commission gave disproportionate weight to CIRM’s critics and did not consider a broader range of views on the complex issues that are the subject of the report…”

Dean Florez, Senate Majority Leader, State Capitol, Sacramento, California

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A GLOBAL SHOUT: How Will You Celebrate Stem Cell Awareness Day?

By Don C. Reed

September 23 is the world’s second annual Stem Cell Awareness Day (SCAD).

This year, we have a lot of reasons to celebrate. Just to name three:

1. President Barrack Obama authorized a relaxation of America’s restrictions on federal funding of embryonic stem cell research. The revised NIH guidelines have just been released; they are sensible, and can be worked with. I was worried, because the opposition had mounted a major national campaign to try and derail the research; but they did not succeed. Hope won; fear lost. This will help every state that has a program or wants to start one.

2. Despite relentless opposition, the California Institute for Regenerative Medicine (CIRM) continues to “go forward”, as Christopher Reeve always said. The CIRM has already awarded $761 million in research and facilities grants—and has brought in roughly one billion dollars more additional funding in matching grants and donations. An incredible 300 (three hundred!) published scientific papers resulting from CIRM-funded work brings us incrementally closer to cures for chronic disease and disability.

3. Assuming no last minute glitches, the world’s first human trials with embryonic stem cells will take place in a matter of days: Geron’s and Dr. Hans Keirstead’s long-awaited spinal cord injury effort, to try and ease the cruel grip of paralysis. (Readers of this column may remember this work was originally funded by California’s Roman Reed Spinal Cord Injury Research Act, named after the author’s son.) Although this first set of trials is primarily a safety test, the excitement is palpable; around the world people suffer every day, without the hope of cure, and now, for the first time, there will be actual official, verifiable tests of a way to repair the damaged nerves inside newly injured people…

So– how should we celebrate Stem Cell Awareness Day?

Last year, the main event of the first Stem Cell Awareness day was an Australian/Californian joint video conference, with scientists on two continent’s bringing the research to world attention.

And this year?

The California Institute for Regenerative Medicine (CIRM) is once more playing a coordinating role for Stem Cell Awareness Day activities — here is a note from Ellen Rose, who is helping to coordinate those events.

“Stem Cell Awareness Day will be celebrated on Wednesday, September 23, 2009. Events are being planned in California and around the world to engage the public in a variety of activities that raise awareness of stem cell research.

“CIRM is helping to coordinate a series of public events in California as well as offering an exciting classroom opportunity on that day for high school students and science teachers.

“Helping to educate and inform the next generation of scientists is an important part of CIRM’s outreach mission. Science educators are on the front lines of that broader effort and CIRM hopes to support these efforts by making stem cell researchers available to visit high school science classes to present a module on stem cell science and/or take questions during class on September 23rd.

“If you are interested in participating in this state-wide activity, and would like us to match a stem cell scientist with one or more of your classes, please email Ellen Rose at CIRM: erose@cirm.ca.gov. We will be matching local researchers with classrooms in the fall.”

There will be more from Ms. Rose and the California Institute for Regenerative Medicine as the day approaches.

Where will you be on September 23?

I personally plan to celebrate the day at the Genetics Policy Institute’s World Stem Cell Summit, in Bethesda, Maryland. I have no idea what GPI Founder Bernie Siegel has in mind by way of noting the day, but, knowing him, it will be special. For the silver-haired promoter of regenerative medicine, every day is Stem Cell Awareness Day!

If there is any way you can make it for the World Stem Cell Summit, folks, September 21-23, I absolutely recommend it. GPI stem cell events are not to be missed. I have been to them all, and every year I think, there is no way he can top this one—and then the next one comes along! Last year’s Summit was at the birthplace of stem cell research itself, Madison, Wisconsin– this one will be at in the hometown of the FDA, Bethesda, Maryland: at Johns Hopkins University, hosted by Maryland’s State University system.

A fact sheet on the event follows at the bottom of the page: for more information, click on http://www.worldstemcellsummit.com .

Now– what else can we do on September 23—Stem Cell Awareness Day—how can we make it memorable?

If you belong to a group, is there something you can do to mark the day? Maybe a little party, or that low-key fundraiser you have been meaning to do?

As you know, Proposition 71 was supported by more than 70 groups, large and small— medical, scientific, research or disease awareness groups– do you belong to one of those?

Could you contact the leadership, ask if they could announce Stem Cell Awareness Day, send an e-blast to the membership, reminding them about September 23rd?

Celebrating Stem Cell Awareness Day on September 23 is important. We need to remember how far we have come, and the attacks we have weathered. The hard work is paying off.

We are the patients and families, the scientists, doctors and therapists, the government leaders and taxpayers, everyone who believes that cure may come.

Think what we have accomplished.

Can you name any other medical advancement in the history of the world that has been so driven by patient activism?

It has been an uphill battle all the way: countering the forces of inertia, fear, and ignorance.

If you are an advocate, you know. Thousands of people labored long years to get us where we are today. Some are no longer with us. We should remember their sacrifice, honor their memory: appreciate the good that has been accomplished, the hope for what is to be, the future we can only imagine—as we fight to make it possible.

Think of Michigan, Texas, New Jersey, Connecticut, Maryland, Georgia, South Dakota and more—tremendous fights, some we won– and some we lost.

But we are going forward all the time. Even some of the battles we lost brought light as well as heat. True, we have not won in every state: not yet. Some states are disaster areas in terms of research freedoms, with actual jail sentences threatening stem cell scientists.

But it will not always be that way. The people of every state love their families exactly as we do—when cures start to come, leaders everywhere to face reality.

A movement has been born, which will one day touch the lives of everyone on Earth.

You are a part of that effort.

What will you do on September 23rd?

And the ultimate? If I can dream for a moment…

Do you remember the old great movie, NETWORK? In it, the announcer (Peter Finch, in an Academy Award-winning performance) asked everyone to lean out the window of their house, and yell:

“I’m mad as Hell– and I’m not going to take it anymore!”

My dream is quieter than that, but bigger, much bigger.

What if everyone who could be affected by stem cell research (everybody on earth!) would stop what they are doing, just for a moment, and just go outside, in front of their homes or places of work.

That’s all. Just go outside. Every street on Earth would be full. For a moment, all would be silent, as we realized the power of our numbers.

Visualize all of us, how ever many hundreds of billions of people that is, all stepping out of our houses, coming right out in front, families, friends, neighbors, all of us.

The smallest whisper would echo around the world, uniting us all. Think of that.

If we all just said the words of Christopher Reeve, very softly:

“Go Forward.”

If it came from all of us, those two words would add up, becoming a roar that would build and build until it could be heard on Mars—a global shout.

Even the most stubbornly obtuse politician could never ignore us again.

September 23rd. Celebrate Stem Cell Awareness Day. And make a little noise.

Contact your local paper, let them know what you have in mind. Remember, 70% of everything in a newspaper is “planted”: put there by the subjects of the article. Just make a one-page letter about your event, large or small. Call them first, tell them about it, ask if you can send them a news-release. They will always say yes, because they will at least want to consider it. Then you e-mail the news-release, and chances are, they will either send a reporter to cover your event, or at very least run your announcement.

In either case, you won; you advanced awareness of stem cell research.

And that is the purpose of Stem Cell Awareness Day: this coming September 23rd.

How could we celebrate this day? Drop a line to Karen Miner and me at stemcellbattles@aol.com, and share your thoughts.

Now, here is that Fact Sheet I mentioned, on the World Stem Cell Summit.

2009 WORLD STEM CELL SUMMIT: FACT SHEET

Conference Overview:
Presented by the Genetics Policy Institute (GPI), the Summit is hosted by Johns Hopkins University, the University System of Maryland, Maryland Department of Business and Economic Development, Maryland Technology Development Corporation and Maryland Stem Cell Research Fund.

With more than 150 sponsors, supporting organizations and media partners, the World Stem Cell Summit is the flagship, networking event, bringing together the founding visionary researchers, clinicians, business pathfinders, key policy-makers, regulators, advocates, experts in law and ethics to present compelling presentations, share information, and together chart the future of regenerative medicine.
The comprehensive, multi-track program covers all areas of stem cell science (hESC, adult and iPS), disease models, drug discovery, tissue engineering, scaffolds, bioreactors and nanotechnology. Five panels covering progress reports for cancer, diabetes, spinal cord injury and multiple sclerosis, Parkinson’s/ALS/Neurological Disorders and cardiovascular disease. Numerous panels cover commercialization, funding, economic development, Federal agencies’ perspectives, law and ethics.
Conference Co-Chairs
Curt Civin, University of Maryland; Chi Dang, Johns Hopkins University; Linda Powers, Toucan Capital Corp.; Karen Rothenberg, Maryland Stem Cell Research Commission; Bernard Siegel, Genetics Policy Institute
Sample Conference Speakers
Leading scientists: Irving Weissman (Stanford), Anthony Atala (Wake Forest), Ronald MacKay (NINDS), Sally Temple (NY Neural Stem Cell Foundation), Stephen Minger (Kings College), Jeanne Loring (Scripps Research Institute), Doris Taylor (Minnesota)

Key Policy Leaders: Gov. Martin O’Malley (Maryland), Gov. Jim Doyle
(Wisconsin), Bob Klein (California Institute for Regenerative Medicine), James Greenwood (Biotechnology Industry Organization)

Business Leaders: Mahendra Rao (Invitrogen), Alain Vertes (Roche), David Amrani (Baxter), Martin McGlynn (StemCells, Inc.), Michael West (BioTime), Jane Lebkowski (Geron), Ian Ratcliffe (Stemgent), Paul Grayson (Fate Therapeutics).

Medical Philanthropy: Alan Lewis (JDRF)

Conference History:
The 2009 World Stem Cell Summit marks the fifth annual summit presented by GPI. Past event partners include: University of Wisconsin-Madison Stem Cell & Regenerative Medicine Center, WiCell Research Institute, Harvard Stem Cell Institute, Stanford University, Baylor College of Medicine and the United Nations.
Conference Attendees:
The Summit will attract more than 1,200 of the most influential stem cell stakeholders from 25 countries representing the fields of science, business, policy, law, ethics and advocacy. 100 plus internationally renowned speakers will be present—producing a unique international network designed to foster collaborations, economic development, technology transfer, commercialization, private investment and philanthropy.

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How Not to Kill a Stem Cell Program in Three Easy Steps

By Don C. Reed

Check out Alex Philippidis’s scoop article:

“The chair of California’s state Senate Health Committee, Elaine Alquist (D-San Jose) said through a spokesman… she will wait until 2010 to introduce legislation to restructure the governance and some operations of CIRM.”— “Chair of California’s Health Committee Will Wait Until 2010 to Introduce CIRM-Altering Bill”. (http://www.genomeweb.com/print/919873?page=show) BioRegion News, July 6, 2009

This is so important. Remember the Little Hoover Commission’s laundry list of changes the critics want made to the California stem cell program?

California Senator Elaine Alquist, (D-San Jose) has been considering adding some of those changes to one of her bills already in progress, probably Senate Bill 343.

However, the budget crisis currently needs her full attention. Sensibly, she is putting off her decisions on the bill to change the stem cell program.

The Senator will have time to decide which changes are worth including in her bill.

Also, we in the patient advocacy community now have time to get ready.

There is a whole laundry list of changes offered in the Little Hoover Commission Report, 84 pages of them: some are worth considering, others serve no useful purpose, a few could do actual harm–

–and one, the plan to politicize the Independent Citizens Oversight Committee (ICOC), is a poisoned apple in the lunchbox.

It would be a disaster to split the ICOC and give control over its membership to the Governor of California.

Why? Consider the Governor’s power.

We have seen the good that a champion of stem cell politics can do in that office. Time and again, Governor Schwarzenegger stood up for stem cell research in the Golden State. He supported Proposition 71 before California voted it into law; he was there for us in the grinding early years of lawsuits, even authorizing a loan of $150 million to the program, so it could begin. Governor Arnold Schwarzenegger has earned the thanks of a grateful nation for his steadfast support of the potentially life-saving research.

But what about an opponent?

If suggestions by the Little Hoover Commission become law, another Governor could easily undermine the world’s largest source of embryonic stem cell research funding.

Here is how it could be done.

First, remember the governing board of the California stem cell program, the Independent Citizens’ Oversight Committee? Twenty-nine members, appointed by a variety of leaders, so no single individual can run the show. At present, the Governor appoints 5 of 29 members, so that he influences the makeup of the Committee, but cannot dominate it.

But what if the Governor got to pick three-fourths of the committee?

All he or she would have to do is put opponents of research on the board of directors.

A committee with a majority of research opponents could decide to not spend the money; or, use their majority to vote to spend it on research supported by the Religious Right—or they could just say, sorry folks, California can’t afford it—and let the program die.

For this nightmare to occur, three changes would be required.

1. Make the Committee small.
2. Shorten their terms in office, so they could not become independent.
3. Allow a super-majority of the now-small committee to be chosen by the Governor.

This is exactly what the Little Hoover Commission recommends.

The following quotations are taken directly from the Little Hoover Commission Report.
They recommend the following:

1. “…Decrease the size of the board to 15 members…
2. Reduce terms to four years for all new members….
3. Allow the governor to appoint 11 (of 15—DR) members…”

Could I be worried for nothing? Quite possibly.

I love the California stem cell program.

When the meetings begin and Melissa King announces the Pledge of Allegiance, saying, “Please stand if you are able”, and we put our hands on our hearts, I feel so proud to be an American, like looking up at the statue of Liberty. And remember what is written at the base of that immortal statue, in Emma Lazarus’s immortal words?

It does not say, “Give me your strong, your wealthy, your well-established…” No. It says in words we dare not forget:

“Give me your tired, your poor, your huddled masses yearning to breathe free, the wretched refuse of your teeming shore. Send these, the homeless, tempest-tossed to me, I lift my lamp beside the golden door!”

Like a living extension of the statue’s promise, the California Institute of Regenerative Medicine, or CIRM, reveals democracy’s strength: people working together to day find a cure for suffering, assisting those who have been told, there is no hope: people like my paralyzed son Roman, and my sister Barbara, who has cancer.

Until the day comes when I cease to care about my family, I will always be proud of the CIRM, an institution dedicated to the search for cure.

Also, if I sometimes seem defensive, that might be because the California stem cell program has endured non-stop attack since its inception. The critics have come at us from every angle, hitting us in big ways and small: lawsuits tried to crush us out of existence altogether; others were semi-harassments, endless new laws tried to tie our hands, multiple audits and repetitive investigations worked diligently to find something—anything—wrong. We emerged from the numerous trials by fire just fine, but sometimes it felt like that ancient Chinese torture, the death of a thousand cuts.

And our most relentless opponent? Senator George Runner (R-CA, district 17) is a religious conservative (his website describes him and his wife Sharon Runner as founders of “Desert Christian Schools”) bitterly opposed to early stem cell research. He has been called the “virulently anti-embryonic stem cell Republican George Runner” by the Los Angeles City Beat, (March 24, 2005). Mr. Runner opposed Prop 71 since before it was voted into law, and ever since. He has authored or co-authored numerous bills (7, if memory serves) attempting to revise and re-write our stem cell program.

His most recent bill (SB 1565, vetoed by Governor Schwarzenegger) contained a provision removing California’s preference for embryonic stem cell research, and requested the Little Hoover Commission (LHC) to “study” the California stem cell program, offering ways to fix its alleged problems—including “conflict of interest, real or perceived”– by making up a new state law or laws.

His newest bill lost (as had the other six) but the LHC decided to go ahead anyway.

And who was serving on the Little Hoover Commission, when it made its decision to go ahead with its plans to change California stem cell program?

Senator George Runner’s wife, former Assemblywoman Sharon Runner.

Is that a conflict of interest, that Senator Runner’s wife helped make a decision her husband wanted? It certainly could be “perceived” as one.

What if Senator Runner, Assemblywoman Runner, and/or their ideological colleagues were in charge of the California stem cell program? Can anyone believe they would not use their power to alter what they so clearly despise?

In about six months, Senator Alquist will decide which of the Runner-inspired
Little Hoover Commission recommendations to put into her possible new law.

Some of the proposed changes may be unconstitutional.

According to California law, even if lawmakers do not like a voter initiative, they do not have the legal right to overthrow it: they may only make minor adjustments, improvements which “further the purpose” of the initiative.

The people’s voice must be respected, and the initiative process is the purest form of democracy. Prop 71 was begun by the people, not the legislators; it was debated, fought for (and against), and then we had the vote.

Only another initiative can now legally alter its purpose. Major changes—like removing the independence of the ICOC—may only be done by another initiative. Two CIRM-connected law firms stated that at least some of the LHC changes may violate California law. The LHC acknowledges that possibility.

The Little Hoover Report raises a long list of objections, many worth discussing. Certainly we can find ways to improve anything, not only the California stem cell program, but also the Little Hoover Commission, or either political party, even democracy itself. (Remember Winston Churchill’s great comment that “Democracy was the worst system of government, except for all the others–”?)

Change is a part of life. But some changes are deal-breakers, so extreme they destroy the whole purpose—like subtracting the power of the vote. Without the right to vote, and the power to uphold a vote once taken, there is no democracy.

Politicizing the ICOC is a deal-breaker: a line which must never be crossed.

If the ICOC can be made a political tool, to be used at the whim of the next governor, we lose the independence of science which was the reason for Prop 71’s existence.

Senate Majority Leader Dean Florez (D-16th district) said it best:

“…I am concerned about the Commission’s attempt to shift power over the agency to the Governor. Like the Little Hoover Commission itself, CIRM was designed to be an independent agency. Proposition 71 therefore dispersed appointment authority to the Governor, the Lieutenant Governor, the Controller, the Treasurer, the Legislature, and UC Chancellors. By concentrating appointment authority in the Governor, the Commission would undermine the careful and deliberate balance struck by Proposition 71. (emphasis added—DR) In a controversial area like stem cell research, such a change would threaten the independence that CIRM needs to ensure the success of its mission.”—Senator Dean Florez, Majority Leader, July 6, 2009

Is the CIRM against all changes, as some critics have implied?

Not at all. Every bill that has been offered to change the program has been considered by the ICOC board, and many of their better elements have been adopted. This strategy of cooperating with the legislature and implementing needful change is healthy, and should continue.

The next meeting of the ICOC legislative subcommittee, in fact, Thursday, July 16th, will be to consider the suggestions of the Little Hoover Commission. Judging by past history, it is an easy prediction that their recommendations will receive serious consideration, and some will become part of the program.

Change must be done carefully; it is seldom as simple as it looks. For instance, the LHC suggests hiring more employees by removing the 50 employee cap. However, it offers no ideas on how the new employees will be paid. The LHC must surely be aware there is a 6% limit on the amount of CIRM money that can be spent on staff, that limit having been imposed so that the maximum amount of funding can go to research. I am all in favor of hiring more folks to help with the chores, but where is the money to pay them?

The stem cell program is a triumph. Despite relentless opposition, it has done more than survive: it has thrived. It brought in more money from outside sources ($900 million in contributions) than it spent in tax dollars ($732 million); provided new jobs at a time when much of the economy is stagnant or worse: made California the stem cell research center of the world, and brought us closer to cure for chronic disease and disability.

In short, the California Institute for Regenerative Medicine is doing exactly what Proposition 71 promised—and what we voters hired it to do.

We do ourselves no favors by messing with success.

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THE “DO-OVER” COMMISSION: California Stem Cell Program to be Re-written?

In the very near future, perhaps today, the Little Hoover Commission is going to release a catalog of “improvements” to the California stem cell program, of which they appear to know very little. Unfortunately, those recommendations have a chance of becoming law.

The hard work of years may be unraveled in this “Do-over” of our stem cell program.

But first, let me pose a seemingly unrelated question.

I know nothing about real estate, except I think houses cost too much. So, based on the fact that I have a complaint, (justified or not) should I be put in charge of making a new law on how to run the housing market?

Why not? The Little Hoover Commission (LHC) gets to do exactly that to the California stem cell program. The LHC has recently been “studying” the California Institute for Regenerative Medicine. I put the word “studying” in quotes because to the best of my knowledge two board members and one staff member attended one and perhaps two meetings of the Committee they wish to utterly change. This tiny subcommittee did appear to have read the complaints of the program’s critics; those they know well. But the positive side, the tremendous achievements of the California program, brought about by the combined intelligence of the board and chairperson, in addition to the dedicated staff? That seems to have escaped the LHC’s notice.

Wednesday and Thursday, June 24th and 25th, I drove to Sacramento, enduring four hours of traffic jam each day, to find out the plans for this panel of non-experts and our beautiful stem cell research funding program.

Interestingly, for a group dedicated to good government and transparency, the Little Hoover Commission has kept its draft report determinedly secret.

The report has gone through two drafts, and the public has not been shown either one.

What a difference from the Institution they are studying! Our stem cell program does virtually everything out in the open. At meetings, the public can give comments before the meeting, during the meeting, after the meeting—and almost all of its documents are public. When you attend, there are always stacks of documents waiting for you. Those same documents (first draft, second draft, whatever) are also available on line, at http://www.cirm.ca.gov.

At Little Hoover? Just the opposite. We the public were not allowed to see the document in question until it is too late to do anything about it, after they are through with it.

So, first we are denied information, the foundation of democracy.

Citizen input? That is only allowed—before the meeting is underway.

How is a person supposed to know what to respond to, at the beginning of the meeting, especially if the most important information is kept secret?

But I spoke anyway! From listening to their public conversations, I knew enough to recognize a serious threat to our program.

I made the point that California’s stem cell program was important to the nation, and that the patient advocacy community would of course defend it. I mentioned my paralyzed son, of course, and the Roman Reed law, which provided initial funding for the spinal cord treatment which goes to human trials this year.

And I even talked about football. I don’t like football much anymore, after what it did to my son. But he loves it still, and our team was the 49’ers.

So I asked the committee to remember when the San Francisco 49’ers ruled, winning four Super Bowls, led by Joe Montana, and Steve Young.

Would the LHC suggest we take away the world’s best football team and replace them with a farm team from somewhere?

That is what the LHC intends to do to the California stem cell program—take out the winning’est team there is.

They want to remove all 29 members of our board, and replace them with 15 political appointees—11 from the Governor, 2 from business and 2 from “independent scientists”.

This would be a completely politicized board.

What if a Governor did not approve of stem cell research? He could appoint 11 enemies of the research, and they could do whatever they wanted, even transferring our funds somewhere else.

How much discussion did they give such huge questions? Almost none.

Only one point was raised: of their proposed half-committee, how many members would it take to make a quorum, the minimum number of board members needed to pass a vote.? They argued about this for ten minutes—and then one of them said, “Well, how do they do it now?” Not a single commissioner could answer.

They did not know. They wanted to change the entire governing board (the ICOC or Independent Citizens Oversight Committee) and they did not even know how it worked. (The answer is 2/3 of eligible participants.) But they did not know.

The only bright spot in the proceedings came when Senator Dean Flores, (to my knowledge the only active legislator on the panel) spoke up.

He said: “If we don’t know how the governing board works, why are we in such a hurry to change it?”

“Well, because it is too big,” a board member said.

“And are you saying that big is bad?”

“Well, generally a big board is more for fundraising than decision-making,,,”

“And what do you base that on? Is there some study you can site, or is that just a value judgment on your part?”

“Well, it is just general knowledge….”

“Oh, like the Board of Regents for the UC college system, that’s 26 members? Are they too big?”

“Well, we’re not talking about them!”

Unfortunately,Senator Flores, due to the budget crisis, could only stay a few minutes.

When he left, the Commission seemed to recover from being flustered, and went on to endorse the report.

When I get the report, I will write about it.

If it becomes legislation I will naturally oppose it with every fiber of my being.

The CIRM is one of the great accomplishments of our time, and of course we will not let it sink. We will organize, local, state, and national organizations, and we will stand up for America’s greatest stem cell program. (Do I exaggerate? Last year, the CIRM provided seven times as much money for early stem cell research as the National Institutes of Health. No other program even comes close. Of course we will defend it.)

But there was one priceless moment which for me summed up the day.

The committee was served lunch. Nothing luxurious: a good sandwich, a pack of what looked like potato chips, an apple, a cookie—but as they ate, the meeting continued, because the room had to be vacated shortly.

And one board member raised her hand and said:

“Not a criticism, but I wish next time we could have more time to study the information. Five minutes and a sandwich just is not enough time, not for something so important.”

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ANOTHER ATTACK ON CALIFORNIA STEM CELL PROGRAM?
By Don C. Reed

Action Requested: share this information with friends. Consider sending polite letter of support for the California stem cell program to: littlehoover@lhc.ca.gov, attention Stuart Drown. Watch this space for a potential new law attacking the California Institute for Regenerative Medicine.

Dear Stem Cell Research Supporter:

On May 27th, an open meeting of the Little Hoover Commission was held to discuss ways to drastically overhaul the California stem cell program.

It was a disaster.

First, a little background. The Little Hoover Commission* (LHC) is a California “efficiency organization” with the power to suggest new laws to “improve” the function of California programs. That sounds okay, doesn’t it?

But the California stem cell program has already been “improved” half to death; much more such “improvement” and the patient may not survive!

As you know, the CIRM (California Institute of Regenerative Medicine) has endured three lawsuits, (which nearly shut it down for two years); been audited five times (came up squeaky clean, thank you very much), and has had seven (7) laws thrown at it; can anyone name a government program which has been more systematically investigated, almost to the point of harassment?

And yet it has prevailed. All seven laws were defeated, the audits found the CIRM open and honest, the lawsuits were defeated on every point.

But now comes the Little Hoover Commission anyway, to take its turn.

Friends of this column might remember I have been worried about this group.

As you know, stem cell research’s greatest enemy in California is probably Senator George Runner. Mr. Runner, described by one newspaper (the Los Angeles City Beat, 3/24/05) as “virulently anti-embryonic stem cell Republican George Runner” is against our research in general and Proposition 71 in particular. He is, I believe, co-author to every anti-CIRM law that has been proposed. One of his bills was the source of the original request for the Little Hoover Commission to study the California program, and his wife, Assemblywoman Sharon Runner, was until very recently a member of the Little Hoover Commission.

However, at the first meeting of the LHC discussing the stem cell program, several board members complimented it. One said Bob Klein deserved “an A plus” for leveraging $272 million in California dollars into $1.15 billion in purchasing power; another said the program should be studied as an example of government at its best: successful public/private partnership.

So was I worried for nothing?

Unfortunately, no. My worst fears were just realized.

Here are three of the LHC’s proposed changes. (They said a lot more, but they were talking very fast, and I am only a two-finger typist—not to mention they provided zero written documents as to their recommendations, which made things rough on people trying to provide accurate coverage of the public meeting.)

1. The Little Hoover Committee would gut the leadership board of the California stem cell program, the Independent Citizens Oversight Committee (ICOC): weakening it, and putting it under political control. They would reduce the ICOC by half, from 29 to 15 members. And, in place of the non-political structure of the board, the LHC would impose a new way to select the membership, politicizing it.

The ICOC is a non-political governing board, designed to be above ideology and partisan politics. It is deliberately large, 29 members, so as to provide a diverse cross-section of opinion: science, education, business, patient advocates.

The LHC was quite open about their intention: they wanted to impose a “more traditional board where the Governor and Legislation have control”. This not only opens up the possibility of removing our funding, but flouts the voters’ will; California voted for a program where science would be judged on its own merits, not subject to the changing winds of political ideology.

2. The Little Hoover Commission would take away the ICOC board Chairman’s salary, as well as the vice-Chair’s. They would deliberately weaken the Chair’s authority by transferring most of his responsibilities to the President. Also, they would shorten his term in office from 6 years to two; there was even talk of eliminating his position altogether, or passing it around the ICOC membership, taking turns, making the position a “non-executive executive”!

This is ludicrous.

To understand what a mistake this would be, consider what skills the chairperson must provide, both by need, and by California law.

First, how is our program funded? Our only source of money is the sale of California bonds. No bond sales, no funding. Fortunately, our current Chairperson, Robert N. Klein II is an acknowledged expert on these bonds, having worked with them since 1975. (Klein set up and helped run the highly successful California Housing Finance Agency, also financed by bonds.)

Second, the success of our program depends on deep knowledge of and experience in interaction with state and federal law.

The chair is Bob Klein, the man who designed the California stem cell program, and who has steered it through innumerable crises. He served unpaid for the first five years, before financial conditions forced him to take a salary, $150,000 a year, small compared to most executives.

Could he be replaced by a board member or even the President of CIRM?

Under the law, “Mandatory Chairperson Criteria” Proposition 71 requires:

“…(ii) Experience with state and federal legislative processes that must include some experience with medical legislative approvals of standards and/or funding.”

It also suggests: “(B) Additional criteria for Consideration:…

(iv) Direct knowledge of and experience in bond financing.”

Do we know anybody like that? Hmm, let’s see. The President, esteemed scientist Dr. Alan Trounson, (being Australian) would not be eligible under the law, because he has no such experience; also according to his testimony, he has no understanding of bond sales, which are the lifeblood of our program.

Who does know about bond sales, and whose idea was it to use them to fund the stem cell program? Bob Klein.

Whose idea was it to develop and sell “bridge anticipation notes”—BANs, another form of bond—which got us through the first two years when law suits blocked our funding? Bob Klein.

And who is trying right now to negotiate federal guarantees for our loans to biomed companies—as much as a billion dollars backup funding? Bob Klein.

One false step, and we could lose millions of dollars of new money for California.

We must have a chair who understands not only the twists and turns of stem cell politics, but also the complications of bond finance.

To the best of my knowledge, there is exactly one person in the world with a skill set like that—the man the Little Hoover Commission would “term out” of office.

3. The LHC proposes hiring more staff to help with the work at CIRM. That sounds pretty good, at first—except they would not authorize any more money for this. Prop 71, by law, can only spend 6% of total funding on employees. The LHC noted that, but suggests no provision to change it. Apparently they expect current employees to take a pay cut to hire the new workers.

So, if we cut everyone’s salary in half, we could hire twice as many people! An interesting concept. I wonder which of the LHC members would like to go first, and reduce his or her income, by way of example?

Throughout the hearing, LHC board members displayed a staggering lack of knowledge about the program they would so radically change.

Example: as a reason to change the ICOC governing board, one LHC member stated that biotech was “locked out of representation on the (ICOC) board”…apparently not realizing four biotech representatives are in fact installed on that board.

Example: Objections were raised to the alleged “throwing out” of the CIRM’s strategic plan. CIRM spokesperson Don Gibbons pointed out that this was incorrect: the “new” strategic plan was an addition to and extension of the previous one, not a replacement: and this fact was plainly labeled as such, from the front page onward. These additions included the new loan program, and also reflected some major changes in science.

Example: One member came close to slandering the men and women of the ICOC, accusing them of “giving themselves grants… anyone would want to play cards, if they could be guaranteed a stacked deck.” This is not only insulting, but factually inaccurate; board members are not even allowed to speak about grants affecting their institutions, let alone vote on “giving themselves grants”.

The public was not allowed to view the LHC draft document.

True. The board members and staff were allowed to have copies of the proposed changes, but not the public. This would seem contradictory to the LHC’s mission of increasing transparency of government. Apparently, the only time the public will see the actual document– will be after it is too late to offer comments on it!

Important: LHC members stated several times that they were against any legislative changes which would require “going to the people”, i.e. needing a public vote. They much preferred a legislature-only approach. The people, one individual noted, are “not interested in change”. Others agreed, calling it (popular vote on change) “arduous” and “futile”. At an earlier meeting of the LHC, a member stated his opinion that at least some of the changes sought by critics could not be achieved without a Constitutional amendment, which means a public vote.

Prop 71 was passed by initiative, and approved by the voters of California; much of the law was placed in the Constitution, meaning a vote of the public would almost certainly be required to amend it.

So would the LHC changes be Constitutionally legal?

“That’s for the courts to decide,” one member said, shrugging off the possibility of a few more years in court.

As the father of a paralyzed young man, I cannot be so casual about anything which may delay cure research. This struggle is personal to me, not some sort of intellectual exercise. The scientific challenges are difficult enough, without needless political delay.

When the meeting was over, a member of the LHC came up to me and said, “We want the CIRM to thrive and flourish!”

To which I responded, “Then why gut it? Why remove the heart and soul of a highly successful program?”

By any objective measure, the California stem cell program is an enormous success. Just one example: remember the $272 million budgeted for construction—which was leveraged into $1.15 billion in buying power. How did the ICOC and its Chairman accomplish this? They insisted that matching funds be required from institutions seeking facilities grants. In this manner the purchasing power of California dollars was multiplied three times over. How many programs, public or private, can bring in more funds than they put out? I know of none. And this is the Committee the LHC would weaken; this is the chairman whose salary the LHC would take away.

The ICOC board is a convergence of expertise, not a conflict of interest. Their diversity is a strength, and their chair makes sure every viewpoint is heard, which is probably why most decisions are close, often unanimous; they wrestle out their decisions, arguing, struggling, working it out, finding what is right—in the full light of public view– and California benefits.

The old expression applies: “if it ain’t broke, don’t fix it.”

Does that mean the program is perfect? Of course not. No institution on earth should be beyond correction. If a speed-reader was to wade through the endless pages of the public record of the ICOC meetings, he or she would find countless arguments about policy and performance, as problems are identified, dealt with, and policies set up to prevent their recurrence. That is healthy.

Positive interaction with our governmental leadership in Sacramento and Washington is actively sought; witness our new Vice-President, cancer-survivor Art Torres, whose sole job that is. Mr. Torres is a veteran of many years public service, including working with Cesar Chavez and the farm workers union, and he came out of retirement just to work with the California Institute for Regenerative Medicine.

Well, there it is.

The final draft of the Little Hoover Commission report will be released soon.

If you want to offer your thoughts and recommendations, or just voice your support for the California program, send an email to littlehoover@lhc.ca.gov, attention Stuart Drown. (On a personal note, I have met Mr. Drown several times, and corresponded with him, and he has always been polite and professional.)

So what do we do now? Consider writing the letter.

Above all, get ready.

Update your email lists. If you live in California, consider the idea of visiting Sacramento in the near future. If Senator Runner or someone else puts up a law based on LHC, which he almost certainly will, there will be hearings to attend.

If you don’t live in California, we will still need your help. This will be an interactive effort. If an attack law develops, we who support the CIRM will be going through our phonebooks and e-lists, organizing our defense.

Across America, wherever you live, the success or failure of the California stem cell program affects you and your loved ones: all who hope and work for cure.

Let there be no doubt in anybody’s mind. We in the patient advocacy community appreciate, support, and will defend the CIRM and the ICOC. It is the concrete realization of our hopes for cure, an institution dedicated solely to finding cures for illness and injury which afflict our families– we will not sit idly by when it is attacked.

Any law calling for a weakening or political “do-over” of California’s stem cell program must and will be vigorously opposed.

Don C. Reed, co-chair, Californians for Cures
Californians for Cures sponsored the Roman Reed Spinal Cord Injury Research Act, source of the first state-funded embryonic stem cell research in America.

*Important: Not all the LHC board members were present that day, (this is budget crisis time at the California capitol) and I know of at least one member who strongly opposes the direction the committee is taking. It may be that the committee will reconsider their current position– a good reason to send them your thoughts: littlehoover@lhc.ca.gov.

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