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Archive for December, 2012

REMOVE PATIENT ADVOCATE VOICES FROM THE CALIFORNIA STEM CELL PROGRAM?

By Don C. Reed

What group of people was Proposition 71, the California stem cell program, designed to help?

Patients with incurable disease or disability.

Who speaks for them? They do, and we do—the patients themselves and those who advocate on their behalf.  Patient advocates are people like my son Roman, who in his wheelchair, helped gather 1.2 million signatures to get the Initiative on the ballot.

Patient advocate Bob Klein inspired, led, and helped raise the $30 million to pay for the campaign; patient advocates defended the program at every step, including fighting for decent salaries for staff and leadership, so they would be paid well instead of adequately.

So why should anyone want to silence patient advocate voices now—especially when their support will be crucial if there is to be a continuation of the program?

January 23rd, 9-5, an all-day meeting on the future of the California stem cell program will be held at the Claremont Hotel in Berkeley, California. Check with www.cirm.ca.gov for official announcements.

The meeting will focus on a recently completed “study” of the California stem cell program.

The entire 166 page report, “Committee on a Review of the California Institute for Regenerative Medicine (CIRM): Board on Health Sciences Policy; Institute of Medicine” is available at http://www.nap.edu/catalog.php?record_id=13523.

I consider both the study and its recommendations staggeringly misguided.

If its recommendations were enacted, they would silence stem cell patient advocate involvement, eliminate public debate on funding proposals, and delegate the real decisions to secret proceedings by an out-of-state-controlled board.

It would no longer be the program California voted into law.

Presently, patient advocates are both members of the board of directors, and welcome members of the public. Our voices are respected and routinely heard; we are welcome at the table when decisions are made.

This is something wonderful, which would be destroyed if the study’s recommendations were adopted wholesale.

The study was authored by a 13-member panel which had just one stem cell scientist, zero patient advocates, no biotech representatives, and precious little understanding of Proposition 71’s place in California law. http://voterguide.sos.ca.gov/past/2004/general/propositions/prop71text.pdf

It feels so one-sided: with opponents of the program featured prominently, and their opinions given credence.

Where are the 200-plus major organizations representing literally millions of Californians and Americans who support our program? Where are the viewpoints of the California Medical Association, the Coalition for the Advancement of Medical Research, the California Children’s Hospital, the Chambers of Commerce, Bay Bio, the International Society for Stem Cell Research, just to name a few?

The IOM’s objections to California’s program may be summed up in two sentences:

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

This is demonstrably false.

Members of the governing board NEVER “make proposals to themselves”. They are prohibited by law from so doing. In fact, they may not even voice an opinion on any project which might benefit their parent organizations.

Here is how it actually works: scientists offer proposals, which are evaluated by the grants working group, (GWG), with  a majority of out-of-state stem cell experts.

After being scored, the projects are brought before the 29-member Independent Citizens Oversight Committee (ICOC) for a public hearing.

Typically the grant proposals fall into three categories:  recommended, maybe, and not.

The project names and scores are put up on a screen so everyone can see. Then the chair will ask: does anyone believe a particular grant proposal is in the wrong category?

In the overwhelming majority of cases, as high of 90% of the time,  the ICOC agrees with the recommendations.

But when a board member disagrees with a score, he or she may ask that it be publicly discussed.   Also, the grant applicants themselves can submit a petition pointing out errors in the scientific critique.  They are allowed three minutes to state their case.

The CIRM scientific staff gives its opinion, in support or opposition.

The board gives its comments– and we in the public are allowed to offer support or objections—our only opportunity to do so.

Underline that in your mind: this is the patient advocates’ only chance to influence a decision on what shall be funded. Take it away, and we might as well just go home—after doing the work to make the program possible, we would have been shut out.

After this, the board votes.

Instead, the IOM recommendations would silence both the governing board AND  patient advocates.

The board would only be allowed to vote yes-or-no on the entire slate of grants. What are they going to say? No, don’t let anything go forward? They would be reduced to a rubber stamp.

No public discussion would be allowed on individual grants.

Not only would this remove patient advocates, educators, biomedical authorities and ethicists from significant input, it would also violate California law: resulting in the real decisions being made in secret, by the out-of-state controlled Grants Working Group.

This is unacceptable.

The patient advocacy community provide real-life insights on current therapies and policies. No one knows better what patients need to sustain both life and the quality of life—and who better to be heard on the risk/benefit decisions when a new drug or therapy might be tried?

A few days ago, a grant to fight thalassemia and sickle-cell anemia was approved for funding: these diseases disproportionately affect African-American and Asian-American communities. What if that grant had been turned down? Should the public have no avenue to voice our concerns?

Yet the IOM proposal would deny our voice. Why?

The study labels the patient advocates as biased because we want cures for ourselves or our loved ones. Because we are affected, we are ineligible as part of the solution?

“No taxation without representation” would seem to apply here. Those who want our help must accept our intelligent  involvement.

There was a time when patients passively accepted doctoral decisions as from on high.

California today takes a different approach. Here, patients and advocates are active partners in the stem cell program we built.

Do others consider patient advocates useful? Listen to the U.S. Food and Drug Administration.

The “FDA includes Patient Representatives (with voting rights—dr) on advisory committee panels that review products and therapies related to serious and life-threatening diseases…” –http://www.fda.gov/ForConsumers/byAudience/ForPatientAdvocates/default.htm

The IOM report considers the governing board itself to be biased because its members were chosen from leaders of colleges, research institutions, the biomed industry, and other organizations, including ten patient advocates from various disease areas.

This is a convergence of expertise, not a conflict of interest.  Our Initiative was always intended to be led by experts from the scientific and medical fields. When we were sued by the Religious Right, this very issue was part of their attack—and it was defeated. Having experts on a board is nothing shocking. Scientists from prestigious research institutions serve on National Institutes of Health (NIH)  peer review panels. Are they biased too?  The IOM seems to want board members to have no connection with either science or chronic illness—should ignorance be considered an advantage?

The IOM study goes so far as to recommend “Elimination of the current process in which applicants rejected by reviewers appeal publicly to the governing board. …. Instead appeals would be heard only by staff BEHIND CLOSED DOORS.” (emphasis added)

More secrecy, instead of open argument?

The IOM would actually deny board membership to anyone with a “personal conflict”  meaning someone in their  family had an incurable illness, because that might influence their vote. What nonsense is that?

First, it is hard nowadays to find a person who does not a family member suffering a chronic disease or disability. My son is paralyzed, my sister has cancer, my brother has a permanently crippling leg injury—so I would be disqualified—three times!

We need people on the board who care passionately about fighting disease and disability, people who know what it means to have a loved one at risk—that is why we are fighting!

The report does admit the California program made tremendous achievements, saying:

“bold social innovation… enhances  California’s position as one of the key international hubs of activity in regenerative medicine…impressive research portfolio…enriches regenerative medicine everywhere…sets in motion a significant scientific enterprise… an impressive grant management structure… exemplary training program… a pipeline of intellectual property… translational projects primed for industry involvement.”

There we agree. The California stem cell program is indeed something fantastic; it works. So why mess with it, in such a brutal and insulting manner?

If you have an opinion on this subject, join us at the public workshop at the Claremont Hotel, Berkeley, January 23rd, 9-5. If you want to be heard, be there.

At this all-day meeting, the proposals of the IOM will be considered, both in regards to California law (to this non-lawyer some of the changes appear illegal), and the voter-approved structure of Proposition 71, as written in the California Constitution.

As it does with all serious criticisms, the Independent Citizens Oversight Committee will study the IOM opinions carefully. Where improvements can be implemented without compromising the integrity of our program, they will be made.

But the open and interactive structure of this magnificent program must not be destroyed.

 

 

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A Visit to the World Stem Cell Summit

LIKE TOUCHING TOMORROW… 8th Annual World Stem Cell Summit

By Don C. Reed

The just-concluded World Stem Cell Summit, December 3-5, left advocates excited, revitalized, updated—and cheerful!

It might seem odd that the battle against chronic disease, the most terrifying enemy in the history of the world, could sometimes be fun. Chronic disease touches every household. With an estimated 100 million Americans (one in three) suffering an incurable disease or disability—at a financial cost exceeding the annual instalment of the national debt—everyone is affected.

But those who take on this incredible challenge can be some of some of the warmest personalities you could imagine.

Like Bernie Siegel. Organizer of the World Stem Cell Summit, Bernie reminds me of the story of the argument between the Sun and Winter as to who was stronger? Old Man Winter pointed to a man and said, “I will make him take off his jacket”, and blasted him with icy winds. But the man clutched his jacket tighter. The Sun merely smiled, and the man grinned back, and took off his jacket.

That’s Bernie Siegel’s approach to life in general, and the Summit in particular. Inclusion is key to the efforts of the Executive Director of Genetics Policy Institute; he makes everyone welcome at the World Stem Cell Summit. It looks easy when he does it, but he works all year to make these three days welcoming and successful.

This is the premier event of our field, of the movement to empower patients, patient-advocates, scientists, scholars, lawyers and lawmakers—working together for cure.

More than “just” our bodies’ health; biomed is the economy’s well-being, and the two intertwine —as one panel showed—“Stem Cells and Regenerative Medicine as an Engine for Economic Growth”—in Ballroom B.

In that one panel were: Jonathan Thomas, chairman of the Board of the California stem cell program, Frank Stonebanks, of the Ontario Institute for Cancer Research, Glyn Stacey of the UK Stem Cell Bank; and Elona Baum, of the California Institute for Regenerative Medicine– you could build a convention around just those four!

As Gloria Reed, my wife of 43 years said to me: “We really needed another day to see it all!” (not to mention a separate suitcase to pack all the free stuff).

Walking up and down the aisles of the new industry was a burst of adrenaline—here were people staking their business lives on the success of the battle against cronic disease. When scientists succeed in a lab, the next step may be a new business to bring that success to patients in need. Little surprises everywhere—free totebags, quality publications, even a jar of gray and green candies labeled with an alleged joke: “We just hired a molecular biologist. Man, is he small!” Next door to the candy source, biotech’s AKRONBIO, was Liebert Publications, medical reporting, probably the most widely read such publications in the world.

Half an auditorium was devoted to new posters of research from all around the planet.

Everywhere was synergy, everyone benefiting from everybody else.

For me the highlight was Bob Klein’s speech on new ways to fund regenerative medicine. Bob is the inspirational leader of Prop 71, which became the $6 billion California stem cell program, and his keynote address was so jam-packed I will do a separate article on it.

Issues, arguments, and controversies were aired.

For instance, which is more promising, human embryonic stem cells (HESC) or Induced Pluripotent Stem Cells (IPSC)? One is made from throwaway blastocysts left over from the In Vitro Fertilization procedure; the other is made by reprogramming some of the patients’ own cells. The Religious Right tries to shoot down one by advancing the other—but is that the best way to find cures?

Anyone who attended stem cell pioneer Jeanne Loring’s panel saw presentations on the strengths of both approaches, each with value, neither excluding the other. And where did the panelists come from? Loring– Scripps Research Institute; Gary Smith, the University of Michigan; Outi Hovatta, Karolinska Institute, and Timothy J. Kamp of the University of Wisconsin Medical School—internationally esteemed institutions.

(My non-scientist’s opinion is that embryonic will be more powerful—and faster and cheaper—for the purpose of transplanting body tissues and organs; but the reprogrammed cells will be invaluable for drug-testing and disease models.)

A controversial panel inveighed on “Unproven Stem Cell Therapies and Deceptive Claims: hidden dangers to Patients”: stem cell tourism. A desperate patient might consider going to a small country where there are few if any medical regulations. There the owners might open your body and put in something, maybe not even stem cells. One “stem cell clinic” did spinal cord surgery with the patients lying on none-too-clean-looking beds, like a third-rate hotel!

Ann Tsukamoto of Stem Cells Inc., moderated that panel, ably assisted by Doug Sipp, Riken Center for Developmental Biology, James Guest, illustrious spinal cord expert from U of M—and Allan Wu of the Morrow Institute.

Wu brought the house down with a gross-out story: a would-be stem cell tourist kept saying a potential transplant was guaranteed harmless because it was autologous— taken from the patient’s own body—“It’s autologous, it’s autologous!”, he said.

Finally Dr. Wu said, “I could put a STOOL SAMPLE into your brain, and that would be autologous too—but would that make it safe?”

Experts were everywhere, on the platform and in the audience: 175 speakers and attendees from 41 nations.

The dangerous lawsuit, Sherley v. Sebelius, was updated by Attorney Beth E. Roxland. Ms. Roxland performed the seemingly impossible task of making the case interesting. Sherlev v. Sebelius is for me the very essence of a frivolous lawsuit. Two religious-minded researchers are suing America, trying to shut down government support of embryonic stem cell research, because they claim it is economic competition for them and their preferred method of adult stem cell research.

Attorney Roxland concluded by saying the court case will either go forward to the United States Supreme Court—or not—before January 4th. The articulate Roxland has a deep interest in the legal/ethical aspects of the biomedical field, AND she can describe it in exciting, understandable terms—can somebody please hurry up and offer her a job in California? (I’m serious! Contact her at http://www.linkedin.com/in/bethroxland for more info.)

The National Institutes of Health, the crown jewels of American medical research, sent Joshua Hunsberger to describe the NIH’s new Center for Regenerative Medicine.

The University of Miami Miller School of Medicine was ably represented by Dr. Dalton Dietrich of the Miami Project to Cure Paralysis, who made an impassioned defense of Schwann cells, as a way to alleviate spinal cord injury paralysis. Dr. Dietrich announced they had commenced a Stage One (safety) clinical trial.

And for those of us who view government as a necessary part of the solution, Bernie Siegel chaired the panel “Stem Cell Politics: the Post-Election Advocacy Agenda”.

(CIRM’s own Kevin McCormack did an excellent piece on the panel, seeable at: http://cirmresearch.blogspot.com/2012/12/if-they-feel-heat-they-see-light-role.html

As Bernie put it, “stem cells are not a Democrat or Republican issue, they are a human issue, and we need to put aside political partisan issues and work together on this.”

Amy Comstock Rick, chair of the Coalition for the Advancement of Medical Research, discussed why Congress is not immediately going forward with another Stem Cell Research Enhancement Act, like those which passed Congress in 2005 and 2007 before being vetoed by then-President George Bush. In her view, the Senate and House won’t push legislation until they see how Sherley v. Sebelius pans out. Ms. Rick is a fighter par excellence both for CAMR and Parkinson’s Action Network.

Paul Knoepfler, America’s only blogging stem cell scientist took the audience on a leaping tour through vital national science issues: because National Institutes of Health (NIH) funding is level (static) or down, some 90% of grants are not getting funded—and embryonic stem cell research funding is still decreasing, for political reasons, not scientific. Paul has a white paper on stem cells that has been translated into 22 languages….

Then it was my turn, to speak on state issues– a thousand things I wanted to say, and ten minutes to say them in.

Scientists need three things: freedom, funding, and friends.

Freedom: people in this audience had been part of the epic struggles for research freedom in Michigan (Proposal 2) and Missouri (Amendment 2); there we battled for the rights of research, and won. In California, we passed the first stem cell freedom bill in the country, AB 253 (Ortiz) to officially legalize embryonic stem cell research—but the freedom to research came with no money.

Funding: only a handful of states have stem cell research funding programs now—New Jersey, California, Maryland, New York, Connecticut and Illinois—pathetically few, compared to the need. Every state in the country should have a biomed funding program—do we not all struggle with chronic disease and disability?

And friends? I wish I could report that stem cell research was equally backed by both our major political parties. But sadly that is not the case right now.

If you want to really understand the difference between the two parties on this issue, look up the votes on HR 3, the Stem Cell Research Enhancement Act of 2005 and 2007. One statistic tells it all. In the House of Representatives there were 16 Democratic opponents–and 158 Republicans who voted against the research—almost ten times the opposition.

One of our Summit attendees was new Representative Patrick Murphy (D), who had run against incumbent Allen West (R). The Democrat supported advanced stem cell research; the Republican did not. But when the votes were counted (and re-counted) the supporter of stem cell research prevailed.

So much! At a special awards dinner, Florida’s own Sabrina Cohen received the GPI’s Stem Cell Action “Inspiration” Award. A very creative advocate, Sabrina sometimes has audiences remain motionless for sixty seconds, for a hint what it is like to be paralyzed.

Susan Solomon CEO of the New York Stem Cell Foundation received the Leadership Award for helping to “catapult NYSCF into a research juggernaut, raising approximately $100 million in the quest for cures”.

SIXTY MINUTES won the “Media Integrity” Award for their important TV series on stem cell rip-offs.

The hard-working Alliance for Regenerative Medicine (ARM) received the National Advocacy Award.

And the Nebraska Coalition for Lifesaving Cures won the Public Outreach and Education Award for “supporting the efforts…of Nebraska-based medical researchers, science educators, and young collegiate scientists.”—“GPI Stem Cell Action Award Honorees include CBS “60 Minutes and NYSCF’s Susan Solomon”, PR Newswire, 12/7/2012

As I walked backward out of the Grand Ballroom of the West Palm Beach Convention Center, dragged away by the remorseless schedule of the airplane ticket, the last thing I saw was an onscreen video of Christopher “Superman” Reeve talking about another wheelchair warrior, Danny Heumann, a motivational speaker. Patient advocates like Danny are the emotional muscle behind the biomedical revolution. The scientists are often reluctant to speak for themselves, and are sometimes hard to understand. Biomed businessfolk might be discounted because they are (as they should be!) selling something. But patient advocates embody the struggle for cure– and people listen.

Want to hear more? Check out the website, which includes keynote speeches (free!) from men and women who are changing the world through science for the public good.

http://www.worldstemcellsummit.com/

Above all, mark your calendar for next year.

In 2013, December 4-6, the World Stem Cell Summit will be held in San Diego, California, the heart of the biomed and stem cell research community. It will be an epic event, and you do not want to miss it.

It will be like touching tomorrow.

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Disability Rights Treaty Blocked

http://www.huffingtonpost.com/don-c-reed/republicans-block-disability-rights_b_2246201.html

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