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Archive for October, 2009

 

TO SAVE A CHILD:  Why the ICOC Should Reconsider Grant Proposal DR1-01449

 

from Don C. Reed

 The most eagerly anticipated grants of the California Institute for Regenerative Medicine are the disease team grants: major funding, as much as $20,000,000 each.

 The posted results of the new grants offers an opportunity for public involvement.

 I disagree with one of the projects’ placements, and am speaking up about it.

 First, a little background.

 The California Institute for Regenerative Medicine (CIRM) has a board of directors, the Independent Citizens Oversight Committee (ICOC). They decide what research projects get funded. A board of reviewers, all from outside the state, studies the proposals and offers opinions, but that is all they are: opinions. By law, the ICOC makes the final decision.  This is a vital part of the program, only the California board may decide.

One grant I was positive would get funded was a project to use embryonic stem cells (after differentiating them, of course!) to fight Spinal Muscular Atrophy (SMA) type one. This condition is almost unbelievably cruel:  SMA kills infants, often before they reach one year of age.

 To my knowledge, there has to date been no funding of research for this terrible problem; that alone was in its favor, a reason to strongly consider any reasonable proposal.

 There was also the approach itself to be considered—and, perhaps most important, who was doing it. Was the scientist in charge someone worthy of the public trust?

 Now, the application process is a mix of public and private. The scientists apply privately, and then the results are posted (without their names) on the CIRM website.

 But after you hang around the field for a while, you get to know who the players are, and there are not that many at the very top.

 Certainly, anyone who follows stem cell research closely would recognize the work of Dr. Hans  Keirstead,  who is to embryonic stem cell therapeutics roughly what Edison was to lightbulbs. It was public knowledge he had been working several years on a SMA project, and would be applying for a CIRM grant to advance the effort.  I figured, well, this was one grant proposal that was practically guaranteed. 

 But when I read the results, to my dismay, the Keirstead SMA project was not recommended for funding—it was listed dead last!

I read the reviewers’ objections on the public page, and was staggered. What was going on here?

 “Insufficient preliminary data”… was the key objection, though there were others, some general, some very specific: even one on the way the stem cells would be injected, with reviewers saying it should not be done with a hand-held syringe.

 Then I remembered: this is how it has been for Keirstead, all throughout his career. He is a pioneer, taking giant leaps into the unknown; often he is the key source of preliminary data—precisely because he goes first…

 Naturally, I wanted to help– hopefully without making things worse!

 First, I called up a friend at the California Institute for Regenerative Medicine, to ask if it was legal for me to contact the scientist, and also the ICOC.

 I was informed I had a First Amendment right to do so– and they had an equally valid right to ignore me—but the ICOC were state officials, so being contacted by the public was not without precedent.

 I tried to reach Dr. Keirstead, to ask him if he would want to use the system developed by the CIRM, to make what is called an “extraordinary petition”, where he objected to the rejection of his project: would he be willing to fight for the grant.

 Getting in touch with Keirstead is not easy. Basically, you (or I, anyway) have to be willing to make about a dozen calls, day after day. Also, he has an assistant, Michelle, who is politely savage about guarding access to the scientist’s time. Naturally, I approve of such protection—except when it comes to me, of course!

 But at last we connected, and I asked him if he wanted to speak up about the decision on his funding.

 He said yes.

 I took the reviewers’ objections from the public document, broke them into ten pieces, gave them to him as questions. His answers (hopefully I understood them correctly) are in caps.

 OBJECTIONS FROM REVIEWERS:

1.     Reviewers cited lack of preliminary data demonstrating
disease-modifying activity of hMNPs.

KEIRSTEAD NOW HAS A GREAT DEAL OF SUCH DATA. THERE SHOULD BE A MECHANISM TO SUBMIT NEW DATA IN THESE DISEASE TEAM APPLICATIONS, AS THE PACE  OF PROGRESS IS FAR FASTER THAN CONVENTIONAL RESEARCH.

2.     They felt an IND filing in 18 months would be premature.

IN A FORMAL PRE-IND MEETING, THE FDA RULED OTHERWISE. THEY AGREED TO ACCEPT KEIRSTEAD’S IND WITHIN MONTHS.

3.     Transplanted cells must replace dying motor neurons, also extend
axons that exit the spinal cord, find target, innervate muscles. Distance is
great.

THIS IS INCORRECT. THE PRIMARY MECHANISM OF ACTION IS NURSING, AND KEIRSTEAD HAS MUCH DATA TO SUPPORT A NURSING ROLE. A FETAL STEM CELL BASED CLINIAL TRIAL WAS JUST APPROVED FOR ALS ON THE BASIS OF NURSING, PROVIDING PRECEDENT FOR THIS APPROACH.

4.     No evidence provided of efficacy of therapy in animal model?

KEIRSTEAD NOW HAS A GREAT DEAL OF SUCH DATA; THAT DATA WAS REVIEWED BY THE FDA IN KEIRSTEAD’S RECENT PRE-IND MEETING

5.     transplanted hMNPs may not rescue when disease damage done before
birth.

THIS IS INCORRECT. THE RATIONALE FOR TRANSPLANTING 2-6 MONTHS AFTER  BIRTH IS TO TREAT THE ENDOGENOUS MOTOR NEURONS BEFORE THEY DIE.

6.     full spinal cord motor neuron replacement may not be feasible;
incomplete rescue of motor neuron function may not give positive outcome.

KEIRSTEAD’S DATA CLEARLY INDICATES FUNCTIONAL RECOVERY IN PRE-CLINICAL ANIMALS MODELS WITH THIS APPROACH. THIS DATA AND THIS APPROACH WERE REVIEWED BY THE FDA IN KEIRSTEAD’S RECENT PRE-IND MEETING

7.     concern that much data was in vitro, may not apply to in vivo.

KEIRSTEAD NOW HAS A GREAT DEAL OF ANIMAL DATA, AND THIS DATA WAS REVIEWED BY THE FDA IN KEIRSTEAD’S RECENT PRE-IND MEETING

8.     safety data described, but not presented, making difficult to
evaluate.

SAFETY DATA IS NOW COMPLETE, AND THIS DATA WAS REVIEWED BY THE FDA IN KEIRSTEAD’S RECENT PRE-IND MEETING

9.     data needed on lot variability of  hMNPs, and safety with dead cells,
which may result in infection.

LOT VARIABILITY DATA IS NOW COMPLETE, AS IS ALL SAFETY DATA REQUIRED BY THE FDA. THIS DATA WAS REVIEWED BY THE FDA IN KEIRSTEAD’S RECENT PRE-IND MEETING

10. objections raised to hand-held syringe

SUCH OBJECTIONS ARE UNFOUNDED. THIS APPROACH WAS REVIEWED BY THE FDA IN KEIRSTEAD’S RECENT PRE-IND MEETING, AND DEEMED SUFFICIENT

11. suggests need for ethics member to address infant participation

AGREED. ETHICS REVIEW HAS BEEN ADDED.

12.  recommend pediatrician inclusion on  research team.

AGREED. PEDIATRICIAN HAS BEEN ADDED.

 Next,  I contacted friends in the SMA community, (I didn’t have any, so I had to reach out) and fortunately they were patient with this stranger calling them up–  hopefully at least one will be able to come to the meeting and speak,  and another will provide written testimony.

 I also plan to speak, and (if allowed) here is roughly what I will say:

 “Honored members of the Independent Citizens Oversight Committee:

 As you know, I am not a scientist. But in the past fifteen years, since my son Roman Reed became paralyzed in a college football accident, I have been on a personal quest to find a cure. The only way that will happen, is for the entire field of regenerative medicine to move forward.

 Grant proposal DR1-01449 is just such a pivotal project.

 Here are ten reasons why it deserves funding. 

  1. The project has an unparalleled urgency. The condition to be fought is Spinal Muscular Atrophy (SMA), a terrible condition which literally strangles children, weakening and destroying the motor neurons which control all movement, including breathing and swallowing.

 2. The goal of the project is to heal the ravages of SMA with an infusion of new and healthy motor neurons: replacing damaged cells with new. This approach is a cornerstone of embryonic stem cell therapy: to replace cells that do not function, or which have died, with cells that are healthy, vibrant, alive.  Also, those new cells bring with them neurotrophins and other nourishments to strengthen and save the cells remaining, and help new ones develop.

 3. A successful outcome to this battle would not only offer hope to agonized parents of children with SMA, but could benefit our entire field of regenerative medicine.  Among the benefits of this project could be: the means to produce large volumes of high purity cells; the restoration of motor nerves; the successful outcome of large animal studies, requested by so many critics; and answer the question of whether transplanted cells can not only survive, but go where they are supposed to go, and link up correctly, and function.  

 4. Numerous other neurological conditions would benefit from a success, including spinal cord injury, ALS (Lou Gehrig’s Disease), polio, and other forms of SMA.

 5. While the investigator’s name was carefully redacted from the proposal, anyone who follows the field can recognize the work of Dr. Hans Keirstead. This is the man whose work gave Proposition 71 its one and only success to build around; this was the experiment highlighted on 60 MINUTES TV and featured in our campaign ads. He a recognized leader in the field.

 6. The criticism is made that he lacks sufficient preliminary data to justify the risk of funds. Similar reviewer objections of insufficient preliminary data have been made against researcher’s work throughout his career, because of the pioneering nature of the efforts: however, when he has been funded, he has succeeded. One of his projects, as you know, is now close to human trials: the world’s first.

 7. The ICOC has established a policy allowing “extraordinary petitions” so that researchers can have the opportunity to as for a special review of their case when unique situations arise; this is a crystal-clear validation of that policy. 

 8. Due to positive response from FDA, applicant now has multiples of increased documentation, previously unavailable for reviewers.  Documentation has flooded in; exceeds 9,000 pages.  

 9. Financial bargain: because team has been preparing for 3 years, will not require 4 years of support, but only 18 months.

 10. The scientist has already has completed steps toward FDA approval, including: production of motor neuron manufacturing facility to make cells required; small animal proof of concept studies; FDA-reviewed safety studies, showing no adverse effects.

 So that part was ready.

 Next I emailed several members of the ICOC board, (after all these years I do know some as individuals, and have their emails) asking if we could talk. Several said they would be willing to talk to me, though it was a long shot. Two individuals I specifically did not reach out to were Dr. Susan Bryant and Dr. Os Steward of UC Irvine, both of whom work closely with Hans. I felt it would be unfair of me to ask their help. But I was able to make contact with about eight of the board’s 29 members. Some I have talked to already, the rest I will hopefully speak with today, Monday.

 Responses so far include:

 1. Success this year not likely;

  1. Scientist should try again next year for the next disease team grant cycle;
  2. Keirstead should try for a different kind of grant, a translational grant;
  3. Keep fighting: this is a public process, and we have every right to be part of it;
  4. Sounds promising, we will keep an open mind at Wednesday’s meeting!

 So that is where we are right now. I will keep working on this issue, advancing it every way I can think of.

 Will we succeed Wednesday? I don’t know.  In the past decade and a half I have been shot down too many times to not recognize the possibility of defeat.

 But I read the testimony from a parent, who buried two children due to SMA.

 There really is no fallback position, when faced with a threat like that.

We must prevail.

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RE-IMPOSE BUSH BAN? Research Opponents Hope to Turn Back the Clock

 

By Don C. Reed

 

Using a variety of approaches, anti-research forces are attempting to turn back the clock: either to the days of the Bush Presidency, or perhaps even all the way back to those happy times known as the Dark Ages, when the Church dictated science policy. 

 

Do I exaggerate? Here are three examples: one national, two from the states.

 

First: remember the lawsuit (Sherley et al v. Sebelius et al) filed by the Christian Medical Association and others against the Federal Government in an attempt to stop federal funding for embryonic stem cell research? (Go to www.stemcellbattles.com, click on September, scroll down for two articles: one, a summary of the case, and the second, the Government’s response.)

 

Here is a shocking update..

 

“… a hearing was held Wednesday, October 14 in U.S. District Court in Washington, D.C., on a preliminary injunction to block implementation and federal funding under the NIH guidelines. Chief Judge Royce C. Lamberth listened to oral arguments, and will likely issue a decision by November 1 (in the meantime, NIH has indicated that it will not permit the expenditure of any funds for human embryonic stem cell research before that date.)” (emphasis added, DR)

 

–David Prentice, Family Research Council Blog, October 15, 2009 (Yes, that is the same Dr. David Prentice and Family Research Council that always opposes our research.)

 

 

Another article put it more bluntly, but with the same result:

“Case seeks to reinstate Bush administration ban on using taxpayer dollars for research on human embryos. (and)… overturn Obama’s decision to fund embryonic stem cell research. 

 

“…A hearing was held Wednesday to reinstate a ban on taxpayer funds being used for embryonic stem cell research. The case, Sherley et al. v. Sebelius et al., was filed in federal court, Aug. 19, and seeks to overturn guidelines established by the National Institutes of Health, which allows for federal funds to be used for embryonic stem cell research.

 

“(The) hearing resulted in a temporary suspension of the ability to allocate federal taxpayer dollars to embryonic stem cell research…” (emphasis added, DR)

–Holly Smith, Kansas Liberty: 16 October 2009

Assuming these reports are accurate, (I have a call in to the Health and Human Service Department to verify) consider what is really happening here: 

The Religious Right’s goal is to block the research. Since funding is the lifeblood of all research, if the funding is suspended, even for an hour, for that amount of time, they have won. By shutting it off, they have stopped the research.

Maybe the suspension will be for a few days—or maybe it will drag on for years, as the case is appealed through all the various levels of court, up to and  including the U.S. Supreme Court, the Roberts Court, one of the most conservative in American history.  

Should the research funding be stopped– on the basis that it is being challenged in court?

That was done in California, denying us our stem cell program’s rightful funding for two years.  I felt that suspension of funding was wrong then, and this newest suspension is wrong as well.

This is like being found guilty—and penalized—by reason of being sued.

 

That’s from the national front: now let’s take a look at two state assaults, Nebraska and Michigan.

 Nebraska hinges on something as simple as a broken promise.

Remember the Cornhusker state’s nine-month struggle to find a compromise between their scientists and the Religious Right?

A law was passed (LB 606) which everyone seemed able to live with. It imposed stringent restrictions on embryonic stem cell research funding in the state—no new lines to be created by state dollars– and banned public funding of Somatic Cell Nuclear Transfer altogether. It even provided funding for adult stem cell research, $500,000 a year, (zero for embryonic) giving the conservatively-approved methods a head start.

What did the pro-research side gain, in exchange for giving up so much? Only one thing. The state law would allow the scientists to do their work without fear of political harassment. They could do embryonic stem cell research, within careful guidelines.

There was even a sidebar agreement that neither side would advance legislation, either in support of, or opposition to, stem cell research.   This was signed by every major right to life group in the state.

I thought, well,  the scientists have to work with one hand tied behind their backs, but at least they will be allowed to work without further harassment.

Unfortunately…

Having achieved everything they could get through law, the Religious Right put political pressure against the only place in Nebraska big enough to actually do the research.  (The only similarly-sized facility large enough is Creighton University– a Catholic school.)

The University of Nebraska (NU) is a top-notch research center— but it has a board of directors, called Regents—and they, like everyone, are susceptible to political pressure.

The board is being pressured to limit embryonic stem cell research to only lines made before 2001—reverting to the old Bush policy, which banned government funding to all new stem cell lines. This is like limiting the aircraft industry to planes existing before the Wright Brothers flew at Kitty Hawk.

Because those lines are so old as to be virtually useless, this attempt to turn back the clock amounts to a banning of the research.

The next meeting of the Board of Regents is this Friday, the 23rd. We already know the anti-research folks are advertising a picket effort outside the Regents board meeting. They will also be inside the meeting (as is their right) and will be actively participating.

This is not small. Everybody knew what was at stake. The scientists would agree to accept a series of restrictions on their work, in exchange for which they would be allowed to work in peace.

That promise was utterly broken, and it is a shame. Here was a chance for bitter opponents to work together, and it seemed like it was happening.

But the “pro-life” groups took as much as they could from this one area, seemingly making whatever promises it took to get what they wanted– and then turned around and tried to shut down the research again.

 

Finally, Michigan faces a series of 6 connected laws to squelch embryonic stem cell research in that state.

These laws are brought to us by Senator Tom George, (R-Kalamazoo), co-chair of MiCAUSE (Michigan Citizens Against Unrestricted Science and Experimentation), the official opposition to loosening stem cell restrictions in the Wolverine State.

Now, this is interesting.

Remember that a citizen’s initative, Proposal 2, was offered: it would allow stem cell research that was permissible nationally to be allowed in the Wolverine State as well.

During that campaign, the opposition, MiCAUSE, backed primarily by the Catholic Church, repeatedly claimed that if Proposal 2 passed, it would be impossible—even illegal– to regulate the research at all. It would be, they implied, just mad scientists running around doing whatever they wanted. They even paid for a commercial showing an actor in a cow costume, raising its hoof in objection to animal-human hybrids!

Here is their key argument, taken from the Michigan Catholic Conference publication, Focus, Volume 36, Number 3, October, 2008.

In giant letters splashed across the page.

Proposal 2: Unregulated Embryo Destruction

“…If Proposal 2 were to pass, how would embryo research be regulated?

 “It wouldn’t. In fact, it would be illegal to place any regulations or restrictions (emphasis added) on human embryo research in Michigan. If Proposal 2 were to pass, human embryo destruction and research would become the first industry to be completely immune from any local or state laws.”—October, 2008. 

Hmm.

If Senator George’s group honestly believed it would be “illegal to place any regulations or restrictions” on the research, why is he trying to do exactly that right now?

Representative George is not breaking the law. (I disagree with the six laws he proposes—Senate Bills 647, 648, 649, 650, 651, and 652 are apparently designed to kill the research by massive over-regulation– but they are not illegal.)

I suspect his side was just making propaganda again, part of their endless series of unfounded assertions, which it is our job as advocates to point out.

AND—October 17th—House Joint Resolution II (HJR II) was introduced in the Michigan Congress.

This is one of those poisonous “personhood” bills. 

Some of it is written in dark ink and ALL CAPITAL LETTERS, like shouting:

Article 1, Sec. 28. (1)  EVERY HUMAN PERSON HAS A RIGHT TO LIFE, WHICH IS THE PARAMOUNT AND MOST FUNDAMENTAL RIGHT GURANTEED UNDER THE CONSTITUTION AND LAWS OF THIS STATE…THE WORD “PERSON” APPLIES TO ALL HUMAN BEINGS…FROM THE BEGINNING OF THEIR BIOLOGICAL DEVELOPMENT, INCLUDING FERTILIZATION…”

It sounds okay at first, until you think about it. 

Why do they want to redefine a “human person” from its present definition (a viable baby that can live on his or her own after having been born) way back to a microscopic union of sperm and egg, including frozen blastocysts , or a dot in a dish of salt water?

Because this new definition of personhood may let them overturn Roe v. Wade, and criminalize all abortions. This is part of a multi-decade effort, the central goal of the right-to-life establishment.

And they have a point.

Who really is in favor of abortions? Are they not an act of desperation?

If there was a way to eliminate the need for abortions– to make every baby planned, and wanted, and safe, and provided for—who could be against that?

But a personhood law? Disaster.

By giving sperm and egg unions legal standing in a court of law, personhood bills like HJR II will not only strip away every woman’s right to choose, making reproductive freedoms a thing of the past, but would also end forever all embryonic stem cell research, (criminalizing it as an act of murder), ban the entire In Vitro Fertility method of helping childless couples have a baby—and also make most forms of birth control illegal.

A personhood bill is like cleaning your home with a nuclear bomb: when the blast is done, and the mushroom cloud blows away, everything is clean beyond clean, absolutely sterile; the bugs are gone, the germs are gone—but so is the house, and the neighborhood.

 

Someday, (and may that day come soon) you and I will not have to be involved in the struggle to protect and advance medical research.

The cures will be many: the results evident and undeniable. The opposition (already a narrow minority, though powerful) will look around, realize they have marginalized themselves. They will declare victory, and look for something else to attack.

Regenerative medicine will be taken for granted.

But that time is not now. Right now, we are needed. Too much is at stake. If we are strong, and help each other, the world will benefit in ways we only dimly glimpse for now, like international cooperation: already Germany and Israel, formerly bitter enemies, are working together on embryonic stem cell research. And just a couple days ago, China and the California stem cell program announced they will be working together—and think about jobs.  Instead of the frustration of too many shoes pounding the pavement in search of fewer and fewer jobs, by attacking chronic illness we find the source of endless work and a new economy.

Things are going to change, and for the better, if we just hang on.

Not long ago, I met a lawyer friend in the halls of our state capitol. We were talking about the next big legislative attack on the California stem cell program, which will probably come in about ten months.

In a burst of optimism, I said maybe this one would be the last. I had a momentary flash of happy fantasy where I imagined hanging up my advocate’s hat, and settling back to watching kung fu movies on TV, and writing books about the sea.

But my lawyer friend smiled, and said probably not: most likely we would see each other in the halls next year too, because there would be another legislative battle to be fought, sure as the coming of Spring.

And baseball.

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2009 WORLD STEM CELL SUMMIT EXCEEDS ALL EXPECTATIONS 

By Don C. Reed

“Breathes there a man with soul so dead, that never to himself hath said, “this is my own, my native land…?”—Sir Walter Scott.

High on the side of the Hilton Hotel is a glass-walled bridge connecting to the Baltimore Convention Center: crossing it was like walking on plush carpets through the sky.

The 2009 World Stem Cell Summit was housed in three ballrooms, each big enough to host its own convention. High ceilings? You could buzz a plane around in there! 

Surrounding  the ballrooms was a collection of stem cell displays: biomed companies, exhibits from colleges, states, nations—and a changing set of science posters, each one deserving of a conversation with the scientist standing beside it.

Martin O’Malley, Governor of Maryland, greeted us on opening day. Movie-star handsome and a superb speaker, Governor O’Malley announced that Maryland and California would be cooperating on stem cell research: because “healing people is our American pride!”. He reminded us that stem cells are “weapons of mass salvation”; that “Maryland has spent $56 million on stem cell research in the last three years”; that with only 2% of the nation’s population, Maryland controls 8% of America’s biotech; “Maryland has always fought above our weight class!” 

Bernie Siegel of the Genetics Policy Institute (primary sponsor of the event) had a special advocacy award to honor the Governor—who then returned the favor by giving Bernie one as well! 

This is the fifth such Summit, and the best. The only problem was an embarrassment of riches: literally too much to choose from: a three-ring circus jammed with activity. 

For example: how could I, as a medical research advocate, choose between the following three panels?

  1. Business models for successful stem cell companies– and Innovative Funding Mechanisms;
  2. Stem Cells in Clinical Treatments and medical tourism;
  3. Stem cell research progress report: Parkinson’s/ ALS /Neurological disorders. 

I really needed to attend all three.   

 “Hey, Jeannie Fontana is speaking!” said Melissa King, stalwart staff leader at the California Institute for Regenerative Medicine. That settled it. Dr. Fontana is not only a dedicated scientist, but also a down-to-earth friend.    

So, come with us into that room, and see what happens next.

Four people with only microphones between them and a crowded auditorium–  

And controversy! By far the most heated (Bernie would say “lively”) discussion came on this issue: “stem cell tourism.” 

Think what that means. 

Stem cell tourism is going to another country and trying a stem cell treatment not available—or not allowed– in your own nation.

Would you do it? Imagine if doctors told you there was nothing they could do to alleviate your condition, or your loved one’s? Would you go abroad, try a perhaps untested medical treatment?  Would you spend your life savings on it?  

When my son Roman was first injured, paralyzed from the shoulders down, after a college football accident, I would have done anything (still would) to ease his suffering. But back then, if someone in a lab coat had told me eating dirt was a treatment, I might have leaped for a shovel. Today, I would ask for the mud to be analyzed.

I have had fifteen years of education in a subject no one would want to know. I have learned to respect the enormity of the challenge, and been forced to accept the long patience, because that is the only chance we have to win.

But the emotion of needing cure– like air when you are choking—that never goes away.

When customers are desperate, snake oil salesmen can get away with a lot.

On the other hand, what if there was a genuine cure, and another country found it first, and only politics was in the way? 

And how are we supposed to know what is going on anyway, when scientists are so hard to understand?   

Those are the questions: here are the panelists.

Grant Albrecht has a golden voice and an actor’s face and presence—but it hurt to watch him stagger from chair to podium. He spoke of the grim reality of Transverse Meyelitis, a debilitating neurological disease. (Dr. Fontana describes it as “a progressive spinal cord injury, without the injury itself”.)  Grant had to give up a starring role in a Broadway play, when his legs would no longer support him. He began a search around the world, hunting for a cure. $50,000 went to one company, $25,000 to another. He would have considered almost any method, feeling that he was on his “last legs”. One comment from Grant seemed particularly important: 

“We have a problem like a five-alarm fire, and the government is giving a drip-drip-drip response.” 

And now, the central figure: Alex Moffett, CEO, Beike Holdings. Beike, headquartered in Thailand and China, is one of the world’s largest stem cell tourism destinations.

Mr. Moffett said his company has 400 employees, 8 Ph.D’s, 100 MDs.   His voice was soft, almost hypnotic:  a charming unflusterable personality. He stated that his company, has treated 6,100 patients with adult stem cells. (Only adult or cordblood cells, no embryonic or iPS.) Mr. Moffett acknowledges “mistakes were made” in early years, but now he wants to go ahead and do things right. 

He tried to make a distinction between good and bad stem cell tourism: calling it bad when cures are promised, and physicians not properly trained; but good when there was oversight, top quality labs, and transparency.

Some of his company’s centers were in China, he said, and that nation has just passed stringent new guidelines. The clear implication was that if Beike was not legitimate, they would not be allowed to practice in China. 

The next speaker. Doug Sipp, immediately stated that China is “handsomely paid” by Beike, implying at least the possibility of conflict of interest. He reminded us that even though China is an unquestioned superpower, it also faces great money problems.

(I hasten to add that I have enormous respect for China’s scientific efforts. I spend an hour a day struggling to learn Mandarin, so I can at least show respect when talking to Chinese scientists, who are making an enormous contribution to regenerative medicine.)

Mr. Sipp worked four years (2005-2009) for the International Society for Stem Cell Research (ISSCR), and is also Secretary-Treasurer of the Asia-Pacific  Developmental Biotechnology Society and other international groups.

He  asked: if what Beike does is legitimate, than why not share their data, if that data does exist? He cited the need for “appropriately-designed experiments with proper peer review”.  He also noted that Beike’s website had originally claimed treatments for 26 diseases, but now only claimed 12. 

He suggested anyone in the audience considering stem cell tourism should first visit the ISSCR website for a free “PATIENTS HANDBOOK”, with points to consider before allowing yourself to become a research subject.

Someone (from the audience?) mentioned a website: www.Quackwatch.com.  

The third member of the panel was the aforementioned Jeanne Fontana, M.D., Ph.D, who serves on the California stem cell board as a substitute for Dr. John Reed, of Burnham Institute. Dr. Fontana has a sunny disposition, a personality that engenders good feelings. 

But she was not smiling today.

Dr. Fontana lost her mother to Amyotrophic Lateral Sclerosis, (ALS), Lou Gehrig’s disease. This is a deadly serious matter to her. When her mom was diagnosed in the late nineties, Dr. Fontana did a world-wide literature search, and found no cure.  Now, there might be as many as 170 offshore clinics offering “stem cell treatments”—were they for real?

She spoke about the need for independent testing for treatments, not just in America but everywhere—and that testing should be done by someone without a financial connection. 

She had two main questions for Beike: 1. Do patients improve after the treatments offered?  2. Is there data, and if so, why not share it?   

This need for accurate data was echoed by what seemed most of the audience: if Beike is for real, it should gather and share its results. 

Some audience speakers expressed polite skepticism; others seemed angry.

I tried to listen dispassionately, to hear both sides. 

However, I felt my teeth grinding together when I heard that Beike treats patients with spinal cord injury paralysis.

It has been a decade and a half since my son was paralyzed, and I have been alert for a cure ever since. “Roman’s Law”, the Roman Reed Spinal Cord Injury (SCI) Research Act, has funded (directly and with matching grants from the NIH, etc.) more than $62 million in research toward that goal.

 If there was a substantive treatment, I am reasonably certain I would know about it.

I know people who have gone overseas to have the Olfactory Epithelial Glia (OEG) treatment, where a surgeon reaches a scalpel up through the patients’s nose, scrapes off part of his or her brain (this sometimes removes the ability to smell) the only part of the central nervous system that regenerates itself—and spreads it like jelly on the injured spine—for maybe $40,000– and, in my opinion,  it does not work.

One audience member rose to say a positive word on behalf of Beike. She stated that her loved one had gone there, been given an undescribed treatment, and did recover some function. (This was a blindness issue, and the excitement was that the patient reportedly could see, at least somewhat, afterwards.) However, she added, there was no follow-up.

“Why was follow-up so important?” I asked Dr. Fontana later.

“Because the treatments themselves may have negative consequences.”

For example, her mother was given “glutathion, an anti-oxidant, a very mainstream alternative medication”. As a side effect, it gave her mom diarrhea. For most folks, that would be only a minor inconvenience. But for ALS sufferers (who may lose their ability to swallow) the inability to retain fluids is life-threatening.  Dr. Fontana was able to get her mother the attention she needed, a nasogastric tube for feeding, and an IV insertion, but even so “there was a drop in function after that, from which she never recovered.”

Even something as seemingly innocuous as cord blood (used by some of the clinics which offer “stem cell treatments”) has the possibility of negative consequences. There must be follow-up, so we can know exactly what happened, good or bad. 

Remember Celebrex, the pain-reliever? One of its side effects was apparently heart attack—we need to know these things.

Someone commented that the anecdotal stories from patients and their families are not always reliable, their judgments clouded, because they (we) want so badly to have hope. 

Linda Powers of Toucan Industries stood up, and made an impassioned plea for respect for Beike’s representative, saying she was “staggered by the savagery of the criticism”, and the “sweeping generalities” of the comments from audience and panelists. 

I did not feel anyone was being rude, but there was definitely tension, and her point was important; courtesy is an essential ingredient for reasoned discourse.

Dr. Jeanne Loring stepped to the mike. This top-notch scientist is always on the alert for anything which might help or hurt our endeavor. 

She stated that she has analyzed hundreds of stem cell samples and had a standing offer to analyze cells for any patient who is considering an overseas procedure: she asked Dr. Moffett if Beike would provide her with samples of the  stem cells they use in  patients.

And Alex Moffett, CEO of Beike, gave a one-word response. He said: “Yes”.

It will be interesting to see what happens next….

In a private conversation several days later, Dr. Loring told me: “I am always suspicious of any kind of clinical use of stem cells that does not have oversight—an independent agency’s verification of the results.” 

She also stated that her analysis of the stem cells should in no way be construed as an endorsement, but merely a service for the patients. “I offer this as a free service on behalf of patients and I will not endorse any company’s approach. This is the principle of caveat emptor—the buyer deserves to know what he or she is buying.”

I also emailed a representative of Beike, told him I was writing an article, and asked him what were the spinal cord injury treatments given there.

He replied: “For spinal cord injury we provide cord mesenchymal stem cells and sometimes we provide mesenchymal stem cells from the patient’s own bone marrow. This is delivered by injections into the spinal cord fluid and at least one IV.”

—Steven Marshank, personal communication.

So—would I take my paralyzed son to Beike?

No.

First, while I am neither scientist nor doctor, I do not believe that adult or cord blood stem cells have the power of embryonic, SCNT, or iPScells. Among the latter three is where I believe the main answers will be found.  

Second, I cannot recommend any treatment that has not been systematically documented, tested, and proven.

I have faith in the carefully documented grueling years of hard work put in by scientists like Drs. Hans Keirstead and Thomas Okarma of Geron, battling their way toward human trials with embryonic stem cells. Their struggle is long, slow, arduous and frustrating, (more than seven years work, and 22,500 pages of documentation,  enough for 50 books!) but it will be worth it in the long run, because we will know exactly where we stand. If it succeeds, we know what was done right, and will be able to do it again, reliably. If not, we can find the mistakes in the documentation.

Will I still listen to what companies like Beike have to say?

Of course.

As moderator Bernie Siegel put it, while the Summit does not endorse any stem cell treatment companies or organizations, the conversation itself is vital. 

The lines of communication must remain open. 

And that is where we must leave it for now.

Three days, jammed with memorable moments.

If you blinked, you missed something.

For example, Mike West, founder of Geron and now Biotime. This great scientist and businessman pretty much began the biomedical field, bringing together  ace scientists Jamie Thomson and John Gearhart to form Geron.  I looked forward so much to hearing whatever he wanted to say.

But I had to miss his speech!

I was invited to appear on a National Public Radio Show—side by side with Dr. John McDonald– Christopher Reeve’s neurologist.

It was great to hear Dr. McDonald talk—I was there as a father of a paralyzed young man and an advocate for research; he was a champion of focused rehabilitation. He cited the crucial importance of “in-home exercise”, therapy that can be done without needing to travel to an exercise center.

They introduced us with a joke, saying “The doctors are in the house!”—I appreciated the promotion, but had to make clear there was only one physician present: the Director of the International Center for Spinal Cord Injury at Kennedy Krieger, he is also Associate Professor of Neurology at Johns Hopkins.

You can hear the interview, if you like: Google it: look up Maryland public radio: Midday with Dan Rodricks, Tuesday September 22, noon to 1.

I was able to use my favorite statistic, that chronic disease and disability costs America $2.3 trillion a year, more than all federal income taxes ($1.8 trillion) combined—and of that mountain of money, 75% goes to treat chronic (incurable) ailments– which is why no medical health program can succeed without an element of cure.

And I tried to express the emotion that united us…

The future of stem cell science is like the first sight of land in the middle of the ocean—you see the tops of trees on the horizon, a patch of green that is a new land, waiting…

And then we hurried back to the Summit!

So many amazing individuals to meet, old friends, and new, everybody special!

Like Dr. Fanyi Zeng, the Secretary-General of the Chinese Society for Stem Cell Research. This tiny vigorous exclamation point of a person reminded me so much of the famous actress Zhang Ziyi, star of Crouching Dragon, Hidden Tiger. A graduate of the University of Pennsylvania , Dr. Zeng’s English is perfect, but she went through a lot of science, very fast: my pen and brain had trouble keeping up.

Her subject was the comparison between the new kind of stem cells taken from skin, (Induced Pluripotentiary Stem Cells, iPS) and the embryonic standard.

She spoke about mouse induced Pluripotent  stem cells, which resemble mouse embryonic stem cells. She wanted to ask, how alike are they?  She used a rigorous test, (the scientists in the room were nodding vigorously) and found them indistinguishable.

This is of course hugely important. If we can get the same results from iPS cells that we achieve with hESCs, then we can move forward faster on the research– without the endless opposition of the religious right.

Dr. Jeanne Loring spoke. Director of the Center for Regenerative Medicine at the Scripps Research Institute in La Jolla, California, she was looking at human cells with a molecular analysis, studying the machinery that makes one cell type function differently from another. She also found that the two types of stem cell were essentially indistinguishable. She cautioned, however, that we have ten years of experience with embryonic stem cells, and only two years with the new iPS cells.

As she said later, “We need to test them in many different ways, compare them to hESCs, find out if they have the same credentials. Only then can we feel comfortable about developing therapies using iPSCs.” 

Always dapper and elegant, looking like he just stepped off the cover of GQ magazine, Dr. Jose Cibelli spoke on the same subject, with what appeared to me to be very similar conclusions: that iPSCs look much like hESCs. That means a lot, coming from an SCNT expert. (Personally, I feel we have not even begun to fully understand the possibilities of Somatic Cell Nuclear Transfer, SCNT, of which Dr. Cibelli was one of the earliest proponents.) That is a lot of letters, but they matter.

And as one of Michigan’s champion scientists spoke, I worried about his state.

Michigan fought a terrific battle to overturn some of the nation’s most  cruelly restrictive research laws—an effort supported by many volunteer organizations across the country– and we won.

But, the opponents of research are trying to bring the restrictions back, one way or another. This year, not one but six connected laws will be thrown at the Michigan scientists, trying to give the research (in my opinion) the death of a thousand cuts, making it incredibly complicated and frightening—and scare off any research in that state.

Internationally renowned, Dr. Cibelli is also the Associate Scientific Director of the Program for Cell Therapy and Regenerative Medicine of Andalusia, Spain.

A native of Andalusia, Dr. Natividad Cuenda spoke. She discussed agency’s work on cellular reprogramming. Her goals are to translate into useful forms the results obtained in three research programs: cell therapy and regenerative medicine, clinical genetics and genomic medicine, and nanomedicine. Andalusia has multiple tissue banks available to their scientists: spinal fluid bank, stem cell bank, tumor bank, and a DNA bank. As Executive Director, she directs the agency to plan governmental resources, to incorporate the stakeholders, as well as working on how to share knowledge, facilitate cooperative research, and help to sponsor non-commercial clinical trials with advanced therapies…

I am glad Dr. Cuenda is on our side—but I am not entirely certain she sleeps!

And speaking of internationalism, Canada has spent $80 million on a Stem Cell Network, to develop standardized methods for stem cell researchers. 

“Investment in research is an answer to our moral obligations: an act of faith as well as reason”, Canadian spokesperson Drew Ryall said.

Canada also initiated an exciting symbolic step forward, a linking of arms for research.

They want people to visit their website, and put their name in support of stem cell research. It is easy. I did it myself, and I am computer-challenged. Just click on the link, go there, and see if you like it as much as I do.

I got so excited about this idea, I emailed the Canadians after the event, asking for a paragraph of explanation—and here it is, including the link:

“The World Stem Cell Summit marked the release of the Stem Cell Charter, a major global outreach initiative. Released by the Canadian Stem Cell Foundation, and backed by several international organizations, such as the Genetics Policy Institute (GPI), Juvenile Diabetes Research Foundation (JDRF) and the Stem Cell Network (SCN), the Charter is a one-page, interactive, web-based document that outlines a framework to move stem cell science forward responsibly. The Foundation aims to create an international grassroots community of scientists, business people, policy makers, patient advocates and members of the public who believe in the importance of stem cell science and will lend their time, voice and other resources to moving the field forward. We’re asking everyone to visit stemcellcharter.org (hyperlink: http://stemcellcharter.org), read and sign the Charter and send it to friends, family and colleagues. While you’re on the site, check out “Rock Star Scientists” and mini videos about different areas of stem cell science.”

Michael Werner spoke about the newest effort to bring the stem cell world together, through the new Alliance for Regenerative Medicine. This is going to be big, folks.

I want to do a separate article about it, after I have a chance to talk to Mr. Werner. I have put in a couple of calls, but we have not connected yet, and I did not want to discuss it without checking with him first.

Former Congressman Jim Greenwood spoke. He is now the leader of BIO, the Biotech Industrial Organization. Representing more than 900 companies, BIO works to give the emerging industry a voice. This is a crucially important organization, although understaffed and overworked. I know the primary folks involved, stellar advocates Tricia Brooks and Patrick Kelly. Tricia, long-term fighter for the cause, famously interrupted her honeymoon to visit the government of Costa Rica– to ask them to reconsider their stance on stem cell research. Patrick Kelly is the state efforts man, great person to talk to if you have a question on a state stem cell effort.

“We need public policy environment conducive to growth” said Mr. Greenwood. Even now, when the Bush limitations have been largely repealed, there is reason to fear “mischievous amendments”. 

“Proactive leadership must drive the research, not merely permit it”, the former Congressman said.

Dean Tozer, representing Advanced Biohealing, spoke about something called a Dermagraft, a healing “skin” for diabetic skin lesion, which costs $1,425 each. Expensive—but then I thought about pressure sores paralyzed people get, like ulcers on heels or hips, which can rot flesh to the bone, and keep a person bedridden for months. It was complications from a pressure sore which, I believe, led to the death of the great champion Christopher Reeve.

Biospherix offered a new kind of “clean room”, the Xvivo Workstation, to allow perfectly sterile environments—and it appears to be separable, for ease of different projects. I have no idea if it is any good or not, having no expertise in that field, but it looked like it was something valuable, less cumbersome and space-consuming. 

Alain Vertes of Roche, the gigantic pharmaceutical company, spoke about his company’s recent purchase of Genentech, the biomed company. Roche has “prudent optimism” about regenerative medicine, he said. I had a chance to speak with Dr. Vertes later, and found out he has a son whose name, Romain, is very like my son’s, Roman. I told him our sons shared a name– and we shared a dream. 

It was interesting to me that Roche worries not so much about losing money by making a wrong investment, but the bigger fear is the loss of momentum, going in a wrong direction.

Devyn Smith of Pfizer spoke. He wrote a fascinating article in the book of the Summit, called “Creating Partnerships with Large Pharma?” which I read three times.

Dr. Smith stated that Large Pharma (and you don’t get much larger than Pfizer) needs to cooperate with the regenerative medicine movement for a very simple reason: it is in its best interests. This was important; people have suggested that the drug manufacturers might not want us to succeed, because they make tons of money selling medicines, whereas regenerative medicine is to fix people, not just maintain them in their misery. 

However… for the first time in decades, large Pharma is losing money….. a loss of 1-3% this year, if I understand correctly– why? Their time of patent exclusivity is expiring.

They need to find new ways to heal people… I recommend the article strongly. 

Representative Michael Castle (R-DE) was there! This dedicated man has been irreplaceable in the struggle to advance stem cell research. With Diana DeGette, Congressman Castle co-authored the Stem Cell Research Enhancement Act, twice passed by Congress and the Senate– and twice vetoed by President Bush.

I was delighted to have the chance to say thank you to him publicly: when my son rises from his wheelchair and walks again, I will feel that Congressman Castle (R-DE) personally gave him a helping hand.  

Bob Klein, the Chairman of the Independent Citizens Oversight Committee, (ICOC) was up next. Due to the nature of California’s stem cell program, (many public meetings!) I can often hear Bob speak, sometimes a couple times a week, but I never miss the chance; he always has something new to say.

Bob mentioned a recent press article claiming that a small number (perhaps 5%) of research buildings funded by CIRM might not be able to meet their construction schedules.  The article, said Bob, had it backward:

“In today’s economic climate, a 95% success rate is phenomenal!”

Did you know that in the past 2 years CIRM scientists have published 330 scientific articles in reputable journals? These are additions to stem cell knowledge, the scientific dialogue that must occur if we are to win.

Now some things about our stem cell program I have to hear several times before I can understand–over and over, until suddenly there is a sort of click when things fit together—like, oh, that’s what that means.

Recently, Bob has been talked a lot about the importance of stability of funding.

Usually, when he talks about bonds or money, it makes my eyes glaze over…

But this was different.

Remember when the CIRM provided $272 million for buildings, and donors contributed an additional $880 million

“Why did those big donations happen now?”, Bob asked.

“That money was out there, waiting to be donated, perhaps sitting there for decades—why was it donated right now?” Bob asked.

Because, he said, for the first time, our stem cell program provided reliable funding:  a long-term commitment. Donors contributed so hugely because they wanted to be part of something lasting, that could make a difference.

Our research program will provide reliable funding for at least ten or twelve more years; it may even become a permanent institution. That was why the big-buck donors stepped up, because California’s program was not something that would vanish in the next budget battle. We have proved our staying power, and our funding source is reliable.

Maybe something similar should be done for the national government, making a reliable funding stream for regenerative medicine, not subject to the whims of politics…

New York’s stem cell program is also cause for pride.

The Empire State’s investment in stem cells is already paying off. New York scientists have developed what may be the world’s first patient-specific ALS cell line, a huge breakthrough in Lou Gehrig’s disease, so the progress of the disease can be followed in a Petri dish instead of a terminally ill person.

I thought of Jeannie Fontana’s mom, and my friend Jon Ames, who lost his son David to the terrible disease. Jon had taken his son all around the world, trying everything that looked even reasonably feasible: to no avail. Now, New York has brought us closer to the day when ALS will no longer be a death sentence.

New York also created a similar stem cell model of type 1 diabetes—and there are 26 million diabetics in America.

Think what this means, in money terms alone, if we found a cure! A person with type one diabetes faces annual medical costs of roughly $13,243. Without diabetes, that same person only pays about $2,540—by finding a cure, we save eleven thousand dollars per person—every year!  Nothing cuts costs like cures.

Susan Solomon of the New York Stem Cell program spoke on their decision to pay women who donate eggs.

Bravo, New York!

This is truly wonderful. When a woman donates eggs to help another couple have a child, she can be paid a significant amount of money, as much as $50,000. But if she wants to donate eggs to help save lives and ease suffering, she cannot be paid? That does not make sense to me. 

Rumor has it that Brooke Ellison (the paralyzed young woman Christopher Reeve made a movie about) worked hard on that issue, supporting New York’s courageous and principled stand. (Bernie, by the way, mentioned Brooke’s speech to the convention two years ago as the most moving advocate testimony he had ever heard.) I kept looking around for Brooke, but she could not make it this year.

Cure is for everyone, but no one deserves it more than those whose bodies have been crippled in service to the country: our soldiers.

An important panel discussion was held on Regenerative Medicine for Wounded Soldiers and Civilians—what happens to our brave young men and women when they are carried home wounded from the battlefield? What if there was a way to make them whole again, to re-grow their arms or legs? It is my understanding that the Defense Department has a $250 million dollar grant to try to regenerate limbs—but they are only allowed to use adult stem cells! This was begun under the Bush Administration, and I hope will be adjusted.

How is the rest of the world doing?

Linda Powers of Toucan Enterprises took us on a whirlwind tour of World Biomed.  When the website (www.worldstemcellsummit.com) has everything together, it would be valuable to look up her presentation, which shows you the other countries’ progress.  But in person her material was too interesting, and went by too quickly for me to capture it.

One speaker pointed out that Germany gets stem cell assistance from Israel. Is that not wonderful, that former enemies are now working together for the good of their people?

Germany also announced an official cooperation with the California stem cell program.  

Cancer researcher Dr. Curt Civin of Maryland was a pleasant surprise to me: plain-spoken and brilliant: he provided well-thought-out material, completely understandable.  Best known for his 1984 discovery of a way to isolate stem cells from blood, (for which he won the 1999 National Inventor of the Year Award) he reminded us of a crucial fact: the NIH funds 90% of all  biomedical research in the United States .

He pointed out the vital necessity of also keeping track of state efforts: quoting Supreme Court Justice Louis Brandeis: “The states are laboratories of democracy”. He noted that 20 states have new stem cell laws under consideration, either positive or negative… 

JDRF received a richly deserved award. Every American owes a debt of gratitude to this hardworking organization; their advocacy underlines that we can only win as a field; that research funding and academic freedom benefits all, not just those with one condition. 

For grassroots advocacy, Danny Heumann accepted an award on behalf of Cure Michigan and Michigan Citizens for Stem Cell Research & Cures.  Michigan has worked so hard for its freedoms, and cheerful Danny was just the right person to share the joy.

Stanford’s Dr. Irv Weissman, bearded and burly, gave off a friendly warmth, like a woodstove stove in Winter. Often called the father of adult stem cell research, he is a tremendous advocate for scientific freedom.

Wise Young pointed out serious shortcomings in the Obama stem cell research funding policy—like that SCNT and parthenogenesis were not eligible for funding.

 “We must raise our voices, tell Congress and the President.  There is no law which prevents our funding…parthenogenesis, but the NIH is restricting itself…”

If a method of deriving stem cells is not effective, science will figure that out. But why should the NIH block something from funding—a political decision, not a scientific one? 

So much: so many good people, everywhere you looked, champions across the hall:  like Amy Comstock-Rick, President of CAMR, the Coalition for the Advancement of Medical Research—and a dedicated advocate for Parkinson’s Action Network.

Dr. Jane Lebkowski of Geron had the unenviable task of speaking on a day when we were all dying to know what was going to happen with her company and the FDA and the spinal cord injury human trials of embryonic stem cells. She could not, of course, tell us what was going on; nothing must be allowed to jeopardize this great leap forward. But her excitement was clear, and her detailed knowledge of the subject and the field was exactly what was needed. My personal reading of the situation is that everything is moving forward exactly as it should: carefully, but expeditiously.

Peter Kiernan (of Christopher and Dana Reeve Foundation) gave us the inside story of how the Christopher Reeve Act finally passed–hidden inside a land use bill! How sad, that something so wonderful had to be essentially tricked into being.

Kiernan also spoke on the CDRF’s important survey, revealing a staggering undercount of spinal cord injury—not two hundred fifty thousand people paralyzed with an SCI — but one million two hundred fifty thousand! That’s right. The previous estimate was literally short by a million people…

He spoke about the opposition, which he dubbed the “armies of the night”, better organized than we, and that advocates should learn to speak with a united voice.

He cited scientific progress—nerves have now been connected to muscle, which was once thought impossible, but now we are doing it—as embryonic stem cell research allows us to study spinal cord injury in a dish of saltwater, instead of a patient.   

Josh Basile is a soft-spoken new power in the advocate arena. Josh said a ocean accident paralyzed him, and took his voice– but he got it back through advocacy.

Sabrina Cohen brought a spark of glamour to the plain grinding hard work of raising funds for research. Her outfit recently raised $25,000 for Dr. Hans Keirstead, for example, targeted and effective funding. For more info, check out her organization at www.sabrinacohenfoundation.org

Maryland Patient Advocate John Kellerman, Maryland Stem Cell Research Commission, was fighting both Parkinson’s and cancer. His beautiful daughter stood beside him as he expressed a simple dream, that he might one day be able to dance at her wedding.

Lunch conversations with experts let the conversation continue on an up-close and personal basis—making friends and swapping business cards. (Hint: if you don’t have a card, get one made; you can do it cheaply on the internet, and you really need some.)

How about a World Premiere? The Summit was indeed the global premier of BioBusiness.TV, a ten-part series, “Stem Cell Review” starring top names in our field.

Passing in the hall was Dr. Steven Bauer, Chief of the Cellular and Tissue Therapy Branch of the FDA.  This is the man who oversaw the committee which decided if embryonic research was ready to go ahead.  As I had been concerned about what seemed to me unreasonable holdups on the stem cell human trials, I called up his office, and he was kind enough to spend time on the phone, patiently answering questions. We did not always agree, of course, (and he could not discuss the Geron project at all, which was appropriate)– but he is a genuine scientist, and a caring and dedicated public servant.

NIH’s Ann Hardy was present as an expert on health surveying and epidemiology, so we can know more precisely the nature of the diseases we are up against.

I had the privilege of speaking on an advocates’ panel—talk about great co-workers!

Ellen Arnold is one of the amazing Texans for the Advancement of Medical Research: working with TAMR, she volunteers so much time, people sometimes forget she is an actual lobbyist, supposed to be making a living at this. But if you spend a little time with her, you understand the depth of her commitment. Ms. Arnold spoke about the avalanche of anti-research legislation Texans have had to contend with for years.

Mary Wooley, President of Research!America, said much that resonated with the room; you could feel that tingle when speaker and audience connect.

We need to raise the overall awareness of science in America, she said. If you ask a citizen to name a scientist, they will usually think of Einstein, but after that…usually no one. How many movie stars, athletes, politicians can we name? Dozens. But folks whose work saves lives and eases suffering? We need to bring scientists into the public eye, as the fascinating people they are.

She spoke about the “Starbucks Test”. If you were to meet your Congressional Representative in Starbucks, drinking coffee–would he or she recognize you? Would they know what your issues are? As advocates, we need to be in such close contact with those who represent us, that they recognize us instantly

The third member of our panel was Howard Zucker, who served as an Assistant Director-General of the World Health Organization. An astonishing individual, as a college student he designed neurological experiments which were performed during astronaut trips to outer space. Several years ago, Dr. Zucker wrote a paper for the  Federal Working Group on Regenerative Medicine: Bernie Siegel regards  it as a blueprint for the emerging biomed industry. Now at last, it seems to be gathering the attention it deserves

When it was my turn to speak, I had fun, and hope the audience did not suffer too much.

I told how a line in the 1931 movie classic “Dracula” helped me sway some religiously fundamentalist relatives: “The blood is the life” is the line from the movie, but it originally comes from the Bible, Leviticus, Chapter 17, verses 11 and 14. We were at a big family reunion, and there came a deep hush when the subject of stem cell research came up. So, I did for them my Bela Lugosi Dracula imitation, ending with “the blood is the life…”—and then got serious, pointing out that there is no blood at all in stem cell research—no implantation in the womb, nor any child at all—and one interpretation of the Good Book verses is that, life begins when the blood flows in the veins. Since that does not happen until about the third week inside the mother, stem cell research would not be against Biblical teachings, because it does not take place in the womb. That argument worked with that audience. They looked it up in the nearest available Bible, verifying according to different translations—and that was it. 

I spoke about the need to support biomed, to encourage the new industry with governmental support and tax shelters, exactly as we did with the computer industry, which now employs millions

Biomed must think of itself as a new Defense Department, for it saves lives just as soldiers do—and it is the foundation of a new and permanent economy.

At Bernie’s request, I spoke on both “zero-budget” campaigns for stem cell legislation, (Roman’s law, which funded Dr. Hans Keirstead’s  work, now brought to human trials by Geron)  and a professionally-funded campaign (Proposition 71, California’s six billion dollar effort), which is of course far better– providing you can find the funding. There is, unfortunately, only one Bob Klein, to give his life savings to fund a campaign, and then work almost five years free as the new program’s chair.

Of course I spoke about Christopher Reeve, our movement’s champion. Not a day goes by, that I do not take strength from his courage and his wisdom. I read the line from his letter to our family: that one day he and Roman would “rise up from their wheelchairs, and walk away from them forever”.

Change did not come in time for Christopher. Our champion has fallen but the flame of his faith still lights our way; America—and the world– has taken up the torch.

In the question and answer period, Dr. Mark Noble stood up from the audience. White-haired and muscular, he looks more like a retired football player than the pioneer of stem cell research which he is. In 1983, he co-discovered the first precursor cell isolated from the Central Nervous System. In 26 years since, he has not only lived in the lab more than the average two scientists, but has often taken a stand politically, defending our research.

When he said he had a “difficult question”, I got a little nervous. After fifteen years listening to scientists, I can keep up if they talk slow—but a difficult question? I was wishing Dr. John McDonald was sitting up there beside me, so I could pass it off to him!

Then came the question: what can scientists do better, to assist advocates?

“Keep doing what you are doing”, I said: “As advocates, we support scientists, so you can do what we cannot.” Scientists are doing the impossible with the invisible, using microscopes to find ways to fight incurable disease.

But– there are also chores no scientist wants, but which must be done nonetheless.

First:  be involved politically; otherwise, those who know nothing will be making the decisions– like whether or not to allow research funding– or if it can be done at all.  For example, it bothers me to so often be the only member of the public to attend our California stem cell program meetings. Where are the scientists, at meetings which may decide the destination of literally hundreds of millions of dollars?

Second: talk small. People process new information at about an 8th grade level: Junior High School level. If you are talking at the Doctoral level—maybe the equivalent of a 20th grade education—we will not understand you. The finest idea in the world cannot be supported, if it is not clear. Grab your local teenager, and explain your project to him or her. If they run out of the room, that is a clue; your presentation might need work.

Three, we must help each other. Ellen Arnold was kind enough to mention a small favor I was able to help with: on a crucial Texas stem cell vote, she asked me to locate ten scientists who could “talk people” and who would make phone calls to Lone Star lawmakers. I was able to hook her up with scientists, and one of them—the great Dr. Larry Goldstein of San Diego—was so amazingly kind that he actually flew to Texas, and spent time with a key legislator. That legislator’s vote meant the difference; a cruel and short-sighted law was defeated.

Texas is still free. The research we support is still not funded—not yet—but because of the work of Texans for the Advancement of Medical Research, the opposition has not been able to criminalize it. People like Joe and Nina Brown, literally breaking their own health, fighting for research which will benefit others. They will prevail.

One day, Texas will be a center of world biomedicine, and it will be, in large part, because of TAMR.

I want to close with a story about Bernie Siegel’s wife. Lovely Sheryl is a dear person, always with a smile to share. I thanked her once for sharing Bernie with the world, because it has to be difficult sometimes, Bernie being so involved with all the endless chores he does. She just smiled and said, “You’re welcome!”

But this particular incident happened at the awards ceremony dinner, when we were all leaning back, our bellies full of good food, our minds jammed with more information than we could process at the moment. I was just looking around to see I could wangle an extra dessert… (no, I didn’t get it; they were wise to me).

Sheryl walked up to the microphone, tapped it to make sure it was working.  She said that several months ago (March, I think) she had wanted to have a birthday party for Bernie– who had declined.  

“How can I have a party?,” he said, “My friends live all over the world, who could I not invite?” 

Which is of course perfectly true. International Bernie lives on a plane more and more these days, speaking, networking, making friends for the cause wherever he goes.

So Bernie put his foot down, and said no. As any good wife would do, Sheryl ignored him—and brought a little cake with candles to the stage.

 “This is Bernie’s birthday party,” she said, holding up the cake; “You are his friends.”  

The ruckus we raised let her know she had that right.

The World Stem Cell Summit was indeed a party—and a wonderful way to celebrate Stem Cell Awareness Day.

And,  there is a present waiting for you—the  entire conference will soon be available online, free, at:  www.worldstemcellsummit.com

P.S. A special advocate shout-out to Dr. Elizabeth Blackburn, who was just named a Nobel Prize winner for her work with telomeres, the basis of embryonic stem cell research. Readers of this column will remember her as the member of the Bush Presidential Bioethics Commission, who was removed from that body, apparently for her continuing strong support of research not favored by that President.

Thank you so much, Dr. Blackburn, and congratulations from the millions of people who will benefit from your work.

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