Protect What New York Won!

FIGHT TO KEEP WHAT NEW YORK WON!

by Don C. Reed

Paul Richter is a hero to me.

Shot three times in the line of duty, Trooper Paul was temporarily paralyzed. He was lucky, he says, regaining full motion (though he still has a lot of nerve pain.)

But instead of just thinking about himself, Paul managed to persuade every Democrat and Republican in the New York legislature to pass a spinal cord injury research act—and he did it almost without a single tax dollar!

“Uncle Paul’s Law” is funded almost entirely by a traffic ticket add-on. Since car crash is the number one cause of spinal cord injury, it makes sense that those who endanger their own and other people’s lives should help pay. (In California, I was inspired by the New York effort to propose the Roman Reed Spinal Cord Injury Research Act.)

A great law—already helping not only New York, but every paralysis-suffering person in the world.

I believe that one day my paralyzed son Roman Reed will fulfill Christopher Reeve’s prediction to “that Roman and I will stand up from our wheelchairs and walk away from them forever”.  Cure did not come in time for our great champion, but I still believe in his great dream.

When that happens, New York will have been part of that tremendous effort—if we act now, to prevent bureaucratic short-sightedness from killing it. The only expense is a very nominal administration cost—other than that, it costs New York nothing—and it might mean a great deal to people suffering the agonies of paralysis.

Read a note from Dr. Sally Temple, and then send one e-mail to the two government officials below—please?

It need not be long. Even a single sentence: “I support the New York Spinal Cord Injury research law” is helpful. Remember,

ANY HELP IS BETTER THAN NO HELP.

But time is short, so please act right now, and send a short note to these two gentlemen….

Senator Carl Kruger

kruger@senate.state.ny.us

Assemblyman Herman D Farrell, Jr.

farrelh@assembly.state.ny.us

Thanks so much,

Don C. Reed

P.S. Below is more info from Dr. Sally Temple.

 
Governor David Paterson has recently proposed terminating the Spinal Cord Injury Research Program (SCIRP) administered by the NYS Department of Health in his Executive Budget proposal. (Chapter 338, Laws of 1998).
 
Here is the document showing the proposed cut:  Click here: NYS DOB: 2010-11 Executive Budget Briefing Book – Health Care  Third bullet up from bottom of page.
 
We need all people who are impacted by spinal cord injury to write letters to protest this. The letters should go to their local NYS senators (if NYS residents) and to:
 
 
Senator Carl Kruger
Chair, NYS Senate Finance Committee
913 Legislative Office Building
Albany, NY 12247
 
and to
 
Assemblyman Herman D. Farrell, Jr.
Chair, Ways and Means Committee
923 Legislative Office Building
Albany, NY 12248
 
Regular letters are probably best, but email is fine too:  kruger@senate.state.ny.us or farrelh@assembly.state.ny.us
 
 
This medical research program was created thanks to the amazing efforts of Paul A. Richter a NY state trooper who fought valiantly to initiate the program motivated after he was shot three times and left paralyzed by a would-be gun trafficker in Lake Placid on September 30, 1973. The research program was also strongly supported by Christopher Reeve, and by many patients, families, advocates and researchers in NYS.
 
SCIRP is funded using money from surcharges imposed on motorists that are convicted of moving traffic violations not by tax dollars. Hence it only has admin impact on NYS. Most of the devastating spinal cord injuries are from motor vehicle accidents.
 
The NYS SCIRP has successfully grown spinal cord injury research in NYS and beyond. Over the past 10 years it has distributed 54 million dollars, funding basic research, but most importantly translational research to find new therapies that are most likely to help spinal cord injured patients. The program encourages scientists who had not been in the field to enter, and to collaborate with researchers from other disciplines towards creative solutions. Even though our lab had no history in SCI work, we received a grant that has helped us get into the field and produced some highly promising findings that we are moving towards a novel SCI therapy. Many other labs received funding and were highly productive (eg Ravi Kane, Deanna Thompson, Bob Linhardt at RPI; Mark Noble and Steve Goldman, U Rochester; Raj Ratan the Burke Rehab Institute in white plains). The program has led to multiple patents that are being developed, and new hope for SCI treatments.
 
The program was gaining recognition nationwide, and a recent meeting held in NYC at the academy of sciences building, next to ground zero, attracted the premier spinal cord researchers in the country. 
 
Losing this program will have an economic impact: it is a high tech job magnet – local institutes in NYS are now able to attract excellent spinal cord researchers from other states who want to move here to take advantage of the NYS funding opportunity. RPI just interviewed a young researcher in this area, and so did we. Each principle investigator who comes here will typically develop a lab of six people, provide jobs for local technicians and bring other researchers into the state.  This in turn leads to industry partnerships – the SCIRP fits with Gov Paterson’s recent initiative – Diversifying the New York State Economy through Industry-Higher Education Partnerships. http://www.ny.gov/governor/reports/pdf/IHETF_Report_FINAL.pdf
 
 Work in spinal cord research can have additional benefits in finding drugs for other nervous system disorders. Look at the recent success this week of Acorda Therapeutics, headed by Ron Cohen, a company founded to cure spinal cord injury now has FDA approval for Ampyra, estimated to be a billion a year drug for multiple sclerosis treatments – this is a NYS based company, headquartered at 15 Skyline Drive Hawthorne, NY 10532  Phone: 914-347-4300.
News on Ampyra: http://www.reuters.com/article/idUSN2216578120100122?type=marketsNews
 
 
If there is anything you can do to save this valuable research program, the high tech jobs and local industry it can create, and hope for new treatments for spinal cord injured patients, please will you help.
 
All best,
 
Sally
 
 
Sally Temple
Scientific Director
New York Neural Stem Cell Institute
One Discovery Drive
Rensselaer NY 12144
USA
 
phone: 518 694 8188;
fax: 518 694 8187
 
New York Neural Stem Cell Institute, non-profit for CNS research
 
 
 
 

WORLD TURNED UPSIDE DOWN–HELP, HELP?

WHEN THE WORLD TURNS UPSIDE DOWN

Folks, I want to ask your help on something. It won’t cost you any money, and only about thirty seconds of your time.

If you are a Facebook member, (if not, you can easily become one) go to: http://VoteForSMA.com, and click on VOTE FOR CHARITY.  I just did.

Why?

As you know, I have a little friend Pranav, age 4, who has spinal muscular atrophy, a cruel condition not unlike a slowly progressing spinal cord injury.  That is about the terrifying thing that can happen to a family, when your child is endangered—and most children with SMA die before the age of 2. Pranav is paralyzed, but he is still fighting on.

 Enter Bill, Victoria, and Gwendolyn Strong, whose family is fighting to cure SMA.

His group, the Gwendolyn Strong Foundation, (named after his daughter, who has the condition) supports research to find a cure for SMA—and they have already contributed funds to Dr. Hans Keirstead.

Here’s the deal. If enough people go to http://VoteForSMA.com, and click on VOTE FOR CHARITY, and his group wins this advocacy contest, one million dollars will go to advancing the cause of Spinal Muscle Atrophy research for cure.

Look at the picture of Bill, Gwendolyn, and Victoria. A terrible disease turned their family’s world turned upside down.

Help them straighten it around—for everyone.

Please read  the following message from the Strong family carefully, and then click on that http://VoteForSMA.com address; it might (with no cost to you) help him and his group achieve a serious funding breakthrough—and he has given me his personal word that every nickel will go to the research.

If you want to contribute a buck or two, that’s fine as well—but to vote is for free.

Vote To Fund Research To Help Cure SMA, The Leading Genetic Killer Of Babies

Your free vote for the Gwendolyn Strong Foundation (GSF) in the final round of the Chase Community Giving campaign on Facebook will help us win a $1 Million grant for neuromuscular disease research, including extremely promising and groundbreaking stem cell programs, and has the potential to accelerate a cure for our daughter’s disease, Spinal Muscular Atrophy (SMA), and materially benefit many other conditions that impact millions of people.

Final round voting on Facebook runs from Jan. 15-22. Please go to http://VoteForSMA.com to vote for GSF to win $1M to help cure SMA.

SMA is a degenerative and terminal disease with no current treatment or cure. While not a household name, SMA kills more infants and young children than any other inherited condition. One in 40 people unknowingly carries the SMA gene — few have any known family history. Babies with SMA are born perfectly healthy and their mind is never impacted. Yet, within months of an SMA diagnosis, their bodies begin to fail them. They become completely paralyzed and require machines to help them eat, cough, swallow, and breathe. These vibrant, intelligent children will slowly become “locked-in” and over 90% die before their 2nd birthday; many never see their 1st.

My daughter, Gwendolyn, has SMA and my wife and I started GSF to fight for a cure for this cruel disease and to fight alongside our little girl. Gwendolyn was born perfectly healthy in October 2007, but was diagnosed with SMA at 6-months-old. At only 2-years-old, Gwendolyn has now outlived most of her peers and doctors consider her an outlier. It is torture to watch our little girl’s body and physical abilities rapidly deteriorate right in front of our eyes — as her mind continues to grow and mature. Our once babbling baby is now completely paralyzed and, although it kills me to admit this, she has even begun to lose the ability to smile her sweet smile. Gwendolyn continues to fight for every single breath, every single day and, as parents, we refuse to accept “nothing” as our treatment plan — not when SMA research is so very promising. We founded GSF so that we could close the gap on funding for promising research in the pipeline — for Gwendolyn, for all babies battling SMA, and to ensure that no future babies are stolen by this cruel disease.

Although there is currently no treatment and no cure for SMA, there is mountains of hope as research of SMA is extremely mature. The SMA gene has been identified, a backup gene found, and the lacking muscle supporting protein discovered. So much is known of SMA in the research community that SMA is considered a “gateway” disease whose research is already benefiting many other more common conditions that impact millions of people, including: spinal cord injuries, Alzheimer’s, ALS/Lou Gehrig’s, Parkinson’s, the muscular dystrophies, and even some forms of cancer.

The Gwendolyn Strong Foundation, a 501(c)(3) nonprofit, was recently voted as one of the top 100 nonprofits of more than 500,000 organizations in the Chase Community Giving campaign on Facebook. For that honor, we received a $25,000 grant from JP Morgan Chase — which we proudly and immediately directed to a groundbreaking stem cell program at UC Irvine led by Dr. Hans Keirstead that is headed to human clinical trials in 2010 and was named as a project that could “change science forever”.  GSF is now in the final round of the Chase campaign with a chance to win up to $1 Million. We have already pledged 100% of anything we receive from the final round to SMA focused awareness and research programs. This is an extremely material amount of funding for SMA and WILL accelerate that cure. Please take 30 seconds to vote for GSF to win the $1M grant to help cure SMA and benefit many other life-altering conditions.

Final round voting on Facebook runs from Jan. 15-22. Please go to http://VoteForSMA.com to vote for GSF to win $1M to help cure SMA.

For more information on the GSF Chase campaign, please go to http://GwendolynStrongFoundation.org/Chase

Christmas Eve in the Stem Cell World

CHRISTMAS EVE  IN THE STEM CELL WORLD: December 24, 2009

 By Don C. Reed

 An act of personal kindness can mean so much, can’t it? One touched me the other day.

 My printer was jammed—a sheet of paper wedged inextricably– I could only get little pieces out.

 Life without a printer? I knew mine was getting increasingly ancient, and would have to be replaced, sooner rather than later– but times were tight financially.

 What to do, what to do? I had just bought a new re-filled second-hand cartridge and the people who sold it to me seemed nice… so I called them up and told them—and they were nice enough to say bring it over. They spent 45 minutes taking the printer apart—and freed the rollers.

 That’s why I am giving a free Christmas plug to CARTRIDGE WORLD, owned by Dominique Woon, at the Gateway Shopping Center, Fremont CA 94536 

Ph. 510-790-2023, Email fremontcw@yahoo.com  

 Christmas moments.,,

 I was talking to New York scientist friend, Mark Noble the other day, and the conversation was just getting to the point when I would ask him for another favor. (That is the secret of my success by the way—have friends who are smarter than me, and who are also good-natured and talented and willing to consider helping with just one more chore) when suddenly his voice changed. I heard laughter in the background, and Mark said:

 “But this is impossible!”

 His daughters who had flown in for a surprise birthday party to celebrate his sixtieth birthday! And with them were Doctor Sally Temple and other luminaries of the New York stem cell scene.

 Even I was willing to let him off the hook that time, so he could go enjoy that magical moment! (Of course, I called him later…)

 We have so much to be thankful for, in this our stem cell world.

 For one thing, we have a friend in the White House now! Merry Christmas, President Obama! Thank you for supporting science in general, and stem cell research in particular!

 And a special thank you to all the scientists who spoke up during the previous administration, when it was not always wise to do so. Elizabeth Blackburn was removed from the Presidential Biomedical Advisory Commission when she objected to ideology rather than science motivating policy—she later received the Nobel Prize for her work identifying telomeres, which I forget what they are, except they are important for the growth of cells.

 People spoke up, like the 80 Nobel Laureates who spoke up on behalf of embryonic stem cell research, to try and persuade President Bush to all federal funding for new stem cell lines. And the 100 university deans who did the same—you know how difficult it is for the head of a college to take a political stand?

 I am grateful our friends in the House and Senate, who have fought for stem cell research (all forms) since hescr was first isolated in 1998. People like Nancy Pelosi, Tom Harkin, Orrin Hatch, just to name a few of the hundreds who stood up when it mattered..

 Perhaps most of all, on behalf of patient advocates everywhere, from us and our families, I send a holiday hug to the scientists, every stem cell researcher on this planet, whatever your specialty: adult, embryonic, Induced pluripont, SCNT– thank you.

 And thank you to the fighters, the people who will not quit, no matter what, even at the cost of their own health, and by so doing, bring us all closer to cure.

 People like Joe and Nina Brown, the stalwarts of Texas, though they are taking turns going to the hospital! No more of that nonsense, please, your motto for the New Year is to be healthy!

 And the quiet warriors, people like Karen Miner, Susan Rotchy, Fran Lopes and all the folks at Research For Cure, working away, year after year, raising money for research at the University of California at Irvine.

 Naturally Bob Klein, as one appreciates Everest. We all know how difficult it is to raise a dollar or two for research—but to raise billions?

 The staff at the California Institute of Regenerative Medicine, the CIRM, past, present, and future. The world knows about President Alan Trounson and chairman Klein—but only insiders know the great gifts of people like Jennifer Pryne, Melissa King,  Pat Becker, and Jaye Huntington. Without them, our champions would sink in an ocean of hopeless disorganization!

 California legislators like California’s Gloria Romero, Dean Florez, Anna Eshoo, Pete Stark, so many more! Our own Art Torres, former California state Senator,working full time for the CIRM, using the skills of a political lifetime to advance the cause of cure.

 Champions fallen, but who will never be forgotten: Edward Kennedy, whom we lost, but who is with us in spirit, working toward the day when quality health coverage is an expectation for all people. Christopher Reeve, whose bill was finally passed—hidden inside an agricultural bill, shame on the opposition—Christopher’s greatness soars on.

 Of course, I am glad for my family. Like yours, they are priceless. Gloria: for the years of laughter, and love. Roman, for blazing courage. Desiree, for amazing determination, associate athletic director at the University of Tennessee;  Terri and Josh, for putting up with my son and daughter and brightening every day of their lives; Roman junior, my first grandson, for his sweet kind heart; Jason, for a smile which warms the room and great coloring skills, always staying within the lines; Jackson, the only 5 year old who ever asked for an appointment with the principal to discuss a change in color for the school uniforms; our grand-daughter, 7 month Kate, for her new teeth to savage an apple; for my father, Dr. Charles H. Reed, for living his Christian faith in acts of kindness.

 Scientist Activists: Larry Goldstein who set aside his personal calendar to fly to Texas and Nebraska in their hours of greatest need; Wise Young and Patricia Morton, never resting, always working to find cures for paralysis.

 And for greatness given, but seldom credited—people helping pass California’s Prop 71.

 Gloria and I drove down to Los Angeles to visit my sister Barb, who is still defying the odds of cancer and leukemia, she and husband Chris are living strong.

 And while we were there, we attended the Southern California portion of the 5-year anniversary of Prop 71, a thank you to the 7 million voters who made the California Institute for Regenerative Medicine possible.

 There will be a part 2 next month if all goes well, and you bet I will be there cheering.

 But Southern California was where Prop 71 began, and it is fitting that our 5-year anniversary be celebrated here first.

 What a night!  Out the window, the college my daughter went to, UCLA. (The food was terrible, that fancy-schmancy stuff that’s good for you, while I looked around for something with the three food groups, grease, sugar and salt.).  

Bob Klein was master of ceremonies, of course, introducing (just a few of the folks whose efforts made Prop 71 possible.

 Naturally there were talks by scientists, but (mercifully!) these were short- “three minutes”, Bob said, and some of them actually were that short!

 DISEASE TEAM PRESENTATIONS BY TEAM LEADS INCLUDING: (for more, see bottom of page)

Dr. Karen Aboody, City of Hope:

 Dr. Donald Kohn, UCLA:

 Dr. Mark Humayun, USC

 Dr. Eduardo Marban, Cedars-Sinai

 Dr. Dennis Slamon, UCLA

 Dr. John Zaia, City of Hope

 These were leaders of hand-picked groups fighting for a breakthrough soon—not twenty years from now, but four–within the life of their grant, to have a drug or treatment ready for testing. This is really an astonishing timeframe.

 I was in a mood to just smile till my cheeks hurt, and clap my hands now and again, and hope to see some of our greatest friends—is that Janet Zucker over there? Yes, it is, her cheerful determined face beaming as Bob called her and Jerry up for a special award. (Jerry could not make it, unfortunately, but movie directors are busy, I am told…)

 It was their group, CuresNow, which first approached Bob Klein and asked him to develop Proposition 71.

AWARD RECIPIENTS IN ATTENDANCE INCLUDED:

Eli and Edythe Broad, champion givers, people whose behind the scenes generosity has helped so many efforts, not stem cells alone, but whole colleges assisted by their kindness;

 Dr. Keith Black, Founding CIRM Governing Board Member; Cedars-Sinai, featured on the cover of TIME magazine as one of the heroes of medicine;

 Doug Wick & Lucy Fisher—yay, Hollywood! These folks with Red Wagon, a division of Sony Pictures, use their clout to help fight diabetes and other medical maladies and have done so for a good long time—I told Lucy about Connecticut (the state) being in danger of losing funding for its stem cell program, and she immediately went and told Art Torres, who told Nick Andros, who told me—communication, concern, energy.

 Dr. Brian Henderson, Founding CIRM Governing Board Member; USC, Distinguished Professor of Preventive Medicine, Kenneth T. Norris Chair in Cancer Prevention.

 Governor Schwarzenegger was unable to join us, but we raised a holler that surely was heard in Sacramento, thanking the Republican Governor who saw the future of medicine and helped make it happen: Arnold Schwarzenegger deserves the thanks of a nation for his dedication to the cause of cure.

ADDITIONAL AWARDEES (NOT IN ATTENDANCE) INCLUDE:

Sue and Bill Gross (these folks established a foundation at UC Irvine which will surely be one of the cutting edge institutions in the world in neurologic research.

 Stewart and Lynda Resnick: who have donated so much to medical research that UCLA named a hospital after them;

 Michael J. Fox, whose body may shake, but his courage never will.
 

Nancy Reagan: her endorsement and support was enormous to the stem cell movement;

 Brad Pitt: I remembered his intelligent questions to the scientists, and his willingness to do a free ad for Prop 71.

 Henry Samueli: in addition to helping the CIRM be born, Mr. Samueli and wife Susan established the Center for Integrative Medicine at the University of California;

 Gayle Wilson, Former California First Lady, Founding CIRM Governing Board Member: also served as catalyst for the establishment of the California State Summer School for Math and Science (COSMOS) and still serves as chair of that board. 

David Baltimore, Nobel Prize Winner, Founding CIRM Governing Board Member;

 Tina Nova, CEO, Genoptix; Founding CIRM Governing Board Member

I am indebted (again!) to Melissa King for her notes on who was there….

 Also in attendance on 12/15 in LA were:

* Leadership from the CSU system, including:

Susan M. Baxter, Ph.D.
Executive Director
California State University
Program for Education and Research in Biotechnology

Elizabeth L. Ambos, Ph.D.
Assistant Vice Chancellor for Research Initiatives and Partnerships
California State University

* Leadership from Southern California campuses of the CSU and California Community College systems

* Principal Investigators and STUDENTS from CSU and Community College Campuses that are part of the CIRM Bridges to Stem Cell Research Program (about 30 students in all), including students from Pasadena City College, CSU Long Beach, CSU LA, Cal Poly Pomona and others.

* Leadership from USC, UCLA, City of Hope, Cedars-Sinai, Children’s Hospital LA and other institutions

* Stem cell program scientific and administrative leaders from USC, UCLA, UC Irvine, Cedars-Sinai and City of Hope

* Key political leaders including CA Secretary of State Debra Bowen and new Assembly Speaker John Perez.

And that was only a sampling of our friends in the Southern half of the State!

 I would like to close with a paragraph from a letter I wrote to one of our sisters in struggle—Rayilyn Lee, Ray of Arizona! She is tough as nails, and keeps on keeping on, despite advance of Parkinson’s. Ray can no longer speak, nor write with her hands, but she can work the computer, and argue with enemies of the research, and she will not be denied.

 I hope she will not be too embarrassed if I say what I wrote to her in a personal letter:

 Dear Rayilyn Lee:

 Remember, you are making a difference. You help me remember why we fight. Thanks for being there, in the tough times. Generations yet unborn will benefit. They will never know our names, but there will be a path out of their suffering, and we will have made it possible.”

We will prevail.

“And as Tiny Tim, who did not die, observed: “God bless us, every one!”—Charles Dickens, a Christmas Carol.

Merry Christmas, everybody.

Next year will be great.

Approved Disease Team projects: (taken from CIRM webpage)

(See the Disease Team media materials for more information about the funded teams.) 

Grant number	Investigator	Institution	Intl. Collaborator	Total CIRM Funding
DR1-01421	Karen Aboody	City of Hope National Medical Center		$18,015,429
	Co-PIs: Jana Portnow	City of Hope National Medical Center
	Larry Couture	City of Hope National Medical Center
	The group proposes to treat brain tumors using neural stem cells that are genetically modified to carry a tumor-killing drug.
DR1-01423	Emmanuel Baetge	Novocell, Inc		$19,999,937
	Co-PI: Jeffrey Bluestone	University of California, San Francisco
	The group proposes to treat people with type 1 diabetes by implanting insulin-producing cells generated from human embryonic stem cells.
DR1-01426	Mitchel Berger	University of California, San Francisco		$19,162,435
	Co-PIs: Webster Cavenee	Ludwig Institute for Cancer Research
	Evan Snyder	Burnham Institute for Medical Research
	The group proposes to treat brain tumors using neural stem cells that are genetically modified to carry a tumor-killing drug.
DR1-01430	Dennis Carson	University of California, San Diego	Canada	$19,999,826
	Co-PI: Catriona Jamieson	University of California, San Diego
	International Partner: John Dick	University Health Network
	The group intends to develop six drugs – three monoclonal antibodies and three small molecules – to destroy leukemia stem cells.
DR1-01431	Irvin Chen	University of California, Los Angeles		$19,999,580
	Co-PI: Geoff Symonds	Calimmune, Inc
	This group proposes to treat HIV/AIDS using an RNA interference approach to modify the patient’s blood-forming stem celis. When transplanted back, those cells will produce T cells that are resistant to HIV infection.
DR1-01444	Mark Humayun	University of Southern California	MRC	$15,904,916
	Co-PIs: David Hinton	University of Southern California
	Dennis Clegg	University of California, Santa Barbara
	International Partner: Peter Coffey	University College London-Institute of Ophthalmology
	The group intends to treat macular degeneration using transplant retinal cells derived from human embryonic stem cells.
DR1-01452	Donald Kohn	University of California, Los Angeles		$9,212,365
	Co-PIs: Thomas Coates	Children’s Hospital of Los Angeles
	Victor Marder	University of California, Los Angeles
	The group proposes to treat sickle cells disease using a gene therapy approach to modify the patient’s blood-forming stem cell so that they produce normal red blood cells.
DR1-01454	Alfred Lane	Stanford University		$11,709,574
	Co-PIs: Anthony Oro	Stanford University
	Marius Wernig	Stanford University
	The group proposes to treat the skin disease epidermolysis bullosa using genetically modified iPS cells created from the patient’s own skin cells.
DR1-01461	Eduardo Marban	Cedars-Sinai Medical Center		$5,560,232
	The group intends to repair heart tissue damaged by heart attack using stem cells taken from the patient’s own heart.
DR1-01471	Samuel Pfaff	The Salk Institute for Biological Studies		$15,644,881
	Co-PIs: Lawrence Goldstein	University of California, San Diego
	Don Cleveland	Ludwig Institute for Cancer Research
	The group intends to treat people with Amyotrophic lateral sclerosis by implanting precursor astrocyte cells derived from human embryonic stem cells.
DR1-01477	Dennis Slamon	University of California, Los Angeles	Canada	$19,979,660
	Co-PIs: Garry Nolan	Stanford University
	Michael Press	University of Southern California
	International Partner: Tak Wah Mak	University Health Network
	The group proposes to develop drugs that destroy the cancer stem cells in solid tumors.
DR1-01480	Gary Steinberg	Stanford University		$20,000,000
	Co-PI: Stanley Carmichael	University of California, Los Angeles
	The group intends to treat stroke using implanted neural stem cells derived from human embryonic stem cells.
DR1-01485	Irving Weissman	Stanford University	MRC	$19,999,996
	Co-PIs: Ravindra Majeti	Stanford University
	Beverly Mitchell	Stanford University
	International Partner: Paresh Vyas	Weatherall Institute of Molecular Medicine, Oxford University
	The group intends to generate a monoclonal antibody that destroys leukemia stem cells.
DR1-01490	John Zaia	City of Hope National Medical Center		$14,583,187
	Co-PIs: Paula Cannon	University of Southern California
	David DiGiusto	Beckman Research Institute of City of Hope
	This group proposes to treat HIV/AiDS using a gene therapy approach to modify the patient’s blood-forming stem celis. When transplanted back, those cells will produce T cells that are resistant to HIV infection.
Total funding				$229,772,018

What Paralyzed People Want

WHAT PARALYZED PEOPLE WANT

By Don C. Reed

Remember the old English legend about the man who had to find out (on pain of death) what every woman wants?

Hold that thought, please…

A few days ago, Gloria and I drove down to a paralysis support group meeting at  Santa Clara Valley Medical Center. An outstanding medical facility (a Center of Excellence in every sense of the word, though always short of funding) SCVM works with paralyzed people, both during treatment and, importantly, afterward.    

As every good meeting should, this one began with pizza. Everybody had two pieces of pizza (well, maybe somebody had more than his share, but nobody tattled on the former pizza-eating champion of Castro Valley High) and then we talked.

Gloria took notes, for which I am indebted. I always start off writing stuff down, but then I get excited and when I start to talk the pencil stops.   

With the exception of us and one or two attendants, everybody in the room was paralyzed. Gloria always says, “Look past the chair”, which is good advice, because it is the spirit of the person which determines him or her, but at this meeting life in a chair was the common denominator, and we were all linked by that experience.

One man, David, was leaving the medical center.

Soft-voiced Richard Patterson called the meeting to order, and then focused on David: asking him, did he have any concerns, or worries about leaving the center? 

I almost choked on my pizza. What a question!  Four months ago, David’s body had been healthy, normal. Then, the accident, and paralysis… But here at least there were nurses and therapists, doctors and friends in chairs, people who understood, and wanted to help. There were ramps, accessible bathrooms and showers.

Now, to leave an environment designed to meet his needs, trading it for a world which basically does not care—did he have any concerns? 

There was a long pause. 

But Richard waited patiently, giving David the interviewer’s gift of silent attention.

At last, David said, as a matter of fact, he did have some questions about flying—what was involved, for a paralyzed person on a commercial airline?

I thought about Roman, and what it took to get him on a plane. For one thing, he had to be lifted by two or three attendants and/or me, from his wheelchair into the narrow aisle chair. Then, for his own protection, they had to strap his legs together, which I hated. He was always cheerful about it, encouraging them as they took on the unfamiliar task. 

Practical tips came from all corners of the room.

The chair itself: make sure it gets on the plane! Single out an individual, get him/her involved, ask if they personally will make sure your only means of transportation gets safely stowed aboard. If the plane arrives without the chair, you are stuck in the airport. Once you are actually on board, ask another steward to go and double-check, make sure the chair was stowed. It must be securely fastened,  tied into place, a high-performance piece of gear must not bounce around loose.  At the far end of the flight, inspect your chair before you transfer into it; if it is damaged, complain immediately.

Toilet needs: plan ahead.  Wheelchair drivers can’t fit into narrow airplane bathrooms. Restrict fluids several hours before. Catheterize (inserting a rubber tube into the urethral canal) right before the trip. If you get caught short on the flight, ask for a blanket for privacy, put it across your lap, and “cath” yourself right there. For those with no hand use, the caregiver must travel in the seat beside yours.

Tonight’s main event speaker was a scientist, who planned to ask the opinions of paralyzed folks about a project he was working on. A great idea—but at the last minute he had to cancel.

Richard went ahead anyway. I got the impression that he was pretty good in emergencies, that he would go ahead with the meeting in the middle of a flood. Sure enough, he passed around copies of brainstorming tips from the scientist, questions about the project.  

Unfortunately– the brainstorming sheet was written in scientific-ese… for me at least, it was indecipherable.

If the scientist had been there to translate, maybe it could have worked—but it was full of sentences like: “MAP study felt to be unrealistic with sample size”.

I knew if Roman was here, (he was coaching his son’s basketball team) he would be asking one particular question—the same one asked every year at “Meet the Scientists Day”, at the Roman Reed Spinal Cord Injury Research Act, held at UC Irvine. The scientists explained their projects, and that was fine. But also the scientists were there to listen to the people in chairs.

“If you had control over a scientist, what would you want him or her to work on?”

Richard was kind enough to let me ask that question of the group.

As always, the comments were direct, and stimulating.

“They could develop a personal ultrasound monitor, small enough to take along, let me know when the bladder is full”, someone suggested.

As always, bowel and bladder control was the most prominent concern. No one likes to be tied down by the needs of the body, two hours (and an attendant) just to use the toilet.

Which was more important, walking or gripping? Hand use, by far.

They were of course interested in the project closest to human trials: Dr. Hans Keirstead’s work with embryonic stem cells, differentiated into cells to re-insulate those in the damaged spinal cord. They knew this was only for “acutes” (new injuries, only a few days after the accident) and only for low injuries, broken backs instead of necks. (The latter may be changing, due to new data just presented to the FDA).

They wanted scientists to focus on chronic injuries, those who had been paralyzed for a while. This is crucial. 

Nobody stays acute. Every new injury becomes an old one, and that means chronic.

Suddenly, everything stopped. Above us was a thrum-thrum-thrum-thrum noise—a helicopter approaching. Someone said he hated that sound, because it meant the arrival of a paralyzed person: some one else whose life was now so monumentally challenged.

Like the young man I met here years ago, shot in a drive-by attack. Almost completely paralyze, he told me his goal in life was to be able to direct attendants how to take care of him. He could breathe and talk but that was about all. I wondered how he was doing. Was he still alive? Did he have the money to take care of himself?

The voices rose again.

Spasticity was a major concern: when the legs flail about, uncontrollably. When this happens to Roman, I am never sure what to do. Generally, I do as little as possible. If I was to tackle the legs, the violence of the struggle might pitch him off the chair. On the other hand, we did not want his foot lashing against a doorway or something.  So, was this something scientists should work to prevent, or was it valuable as a form of exercise?

Dysreflexia, when nerve messages blocked by the damaged spine cannot get through, and suddenly a wave of unforeseen consequences happen, perhaps including death.

Sexual function, one person said, and a wave of nods went around the room.

And then somebody said—

Politics.

Now, you cannot say stem cell politics in front of me and expect me to be silent. There are certain topics about which I must speak or explode.   

Naturally, I had to brag about the California Institute for Regenerative Medicine. I told the good stuff, like that one billion dollars had already gone out in research, plus the program had already attracted another billion dollars in matching funds.

I pointed them to the website (increasingly powerful) www.cirm.ca.gov, where you could click on the “meetings” tab and find out when the next one was, and join us there.

They would be so welcome. Also necessary, if their views were to advance.

I go to as many of the meetings as I can, which is most of them, and I talk the way I eat pizza, which is to say enthusiastically—but often I am the only public person there.  

This wonderful program, dedicated champions of research working to advance the dream of cure—but the disability community all too often is not there.

“Nothing about us, without us”, a disability advocate once said, and that is a terrific sentiment, words to live by—but it also puts the responsibility on  people in chairs.

Suppose there is a hearing in the State Capitol about stem cell research. Somebody has to speak to the concerns of the enormous disability community.

I will go, of course, and so will Roman and Karen and two or three other stalwarts, when their health and schedule permits—but there should be dozens there, at least.

Roughly one American in five has a disability, either physical or mental—and these folks have families—when you stop and think, that’s pretty much everybody.

If the disability community was ever represented in anything like our true numbers, the government could never ignore us again

This ridiculous fight about health care would have been over before it began—like, duh, public option, that is a middle of the road option, not extreme—of course we will have it!

It took so few people to move a mountain.  If just the people in this room—maybe thirty– worked together, there was no limit to what they could accomplish.

I told them about Texans for the Advancement of Medical Research, (TAMR) and how a group of people no larger than this group had fought back against the anti-research forces—and had done so for years. Texas has a three billion dollar cancer program, and as we get closer to cures, it is only right and proper that some of that money should go to stem cell research. The opposition worked hard to deny that, putting in a clause that no embryonic stem cell research should ever be funded—but TAMR fought back, and left that door open to the future. Texas is still the most conservative state in the nation, probably, but one day they will get tired of denying their community the hope of cure. When they do, it will be because of a few patient advocates, themselves with health problems, but they would not sit home and be left out of the equation.

Everybody here had the paralysis mountain to climb, in addition to all the other problems everyone faces. It is tough—extremely tough—for even the most dedicated wheelchair warrior to travel.

But remember the story of the man who had to find out what every woman wants?

Finally, he met up with an old woman, bent and wrinkled, who said she would tell him the secret—if he promised to marry her. Seeing the alternative was execution, he said yes.

And she whispered the secret in his ear. Every woman wants–

Power. They want the same thing every person wants: control over their own destiny.

It is the same for people in chairs. Nobody wants charity, but everybody wants to control their own life—and that cannot be achieved individually.

Does the opposition fight alone? Never.

And neither should we.

The only way to advance is to organize.

Example: Remember when HIV/AIDS was considered an automatic death sentence?

What if the patients had just accepted what the doctors told them, that there was no hope? Nothing against doctors, of course, but they are mechanics of the body. As with an auto mechanic, there is more for a doctor to know than they can ever learn in a lifetime; they cannot be expected to know what scientists spend their own lives learning as well.

The people with HIV/AIDS got tired of being left alone to die, and so they got vocal. They and friends and family organized, and made noise systematically, until all of a sudden the reaction was: “Oh, no, here they come again—we better do something!”

Today, while there is still as yet no cure for HIV, there are medications available, and our friends have a chance at living– because the HIV/AIDS community got active.

We face huge decisions: like should we put protections of stem cell research into law? If not, what is to prevent an anti-research President (as I believe a President Sarah Palin would be, for instance) from doing damage? When Senator Diane DeGette and Representative Mike Castle come up with their new version of the Stem Cell Research Enhancement Act, (twice vetoed by former President Bush) we must get that passed without delay.

Huge example: the National Institutes for Health  (NIH), is the ultimate source of research funding in our land. If we want the scientists to have the funding to fight for cures, the National Institutes of Health itself must be funded.

President Obama supports the NIH, bigtime. But we need to let him know we back his efforts. If we do not, there is a distinct possibility the NIH funding may be savagely cut. Remember, every leader works on consensus. He/she must balance the competing interests. And who are the competing interests? These are the folks who step up to the table and demand to be heard.  If we do not speak —we will be ignored.

Want something you can do right now? Here is a message from our friends at Research!America, whose sole purpose is to advance the research which will save lives and ease suffering. (They of course have no connection to any of my personal opinions; I just support their work, and so should every American family who wants the best medicine science can provide.)

I clicked on the following, which is set up so you can contact the President: took about 90 seconds to go to the website and send an email they have waiting there for you—so easy!

And vital.

 

Thank President Obama for Reprioritizing Science and Health Urge Him to Fulfill His Commitment to Research During this season of thanks, join advocates nationwide to express your gratitude for the recent revitalization of research. The American Recovery and Reinvestment Act has invigorated the research community after years of diminishing budgets for the National Institutes of Health. Please contact President Obama now to thank him for his recommitment to science and urge him to continue to make research a priority in Fiscal Year 2011. It is critical to strengthen the scientific and economic momentum generated by ARRA by making NIH’s new research capacity permanent. President Obama will decide what funding to recommend for NIH before the end of the year. Patients, scientists and other research advocates across the U.S. must demonstrate our collective support for his innovation strategy by sending a strong call to robustly invest in NIH.  Write to President Obama today!

 

 

 

 

 

 

 

 

 

Nebraska Stands up for Stem Cells– and Scientific Freedom

NEBRASKA STANDS UP FOR SCIENTIFIC FREEDOM!

 By Don C. Reed

 Moments ago, a Nebraskan, University Regent Jim McClurg, struck a blow for scientific freedom. I just had to tell you about it!

 Eight members on the board of regents. Four had authored a resolution to restrict embryonic stem cell research to only those few inadequate cell lines which existed before 2001—in other words to stop the research—at the only place in the state that could do it.

 Consider the pressure. The man’s phone number had been posted publicly by the Religious Right, which urged its membership to call Mr. McClurg, and “politely” (their word) convince him to vote the way the Religious Right demanded.

 But he would not bend. He voted against the resolution. He deserves the respect and appreciation of all who support research for cure.

 He and three other members of the board—thank you, Chuck Hassebrook of Lyons, Bob Whitehouse of Papillion, and Kent Schroeder of Kearney—all voted in favor of research for cure.

 The President of the College J.B. Milliken also spoke out clear and strong, which is extraordinarily difficult politically for a college leader: but he stood up for all of us.   

 Champion scientist Larry Goldstein set aside his crowded schedule, and came to Nebraska to speak with whomever would listen. If you have heard Larry talk, you know you have heard one of our field’s best advocates, and an outstanding human being.

 And fighting every step of the way, were the patient advocates: like my buddy Victoria Kohout—and Sanford M. Goodman, President of the Nebraska Coalition for Lifesaving Cures.

 Mr. Sanford was kind enough to credit this column for spreading the word. He said that when he contacted other states to ask for information, they knew about the struggle, because they read it here. If so, I am very glad. If Nebraska wins, everybody wins.

 But this is Sandy Goodman’s moment, when he fought for Nebraska and the future of stem cell research.

 I want you to hear exactly what he said, when everything was hanging in the balance.

Chairman Schroeder and Regents; thank you for the opportunity to address you today.  I am Sanford M. Goodman, President of the Nebraska Coalition for Lifesaving Cures.

You have heard that research institutions in six other states have prospered under more severe restrictions than in Nebraska and that the work of international scientific leaders suggests that we should focus all our efforts on iPS, a key premise of the proposed resolution.

Notwithstanding the fact that the state analysis is too simplistic to be meaningful, of the states cited, only Louisiana has research restrictions similar to those being proposed here, and the two stem cell biologists there that I spoke to anticipate building pressure to remove those restrictions.

Iowa and Michigan were listed as having had bans of some sort – and they were both lifted due to the negative impact on those states.  Virginia has a cloning ban but no restrictions on embryonic stem cell research.  Minnesota and Pennsylvania were incorrectly listed as having long-standing bans on the use of embryonic stem cell lines.

As for the international scientific leaders cited, make no mistake about it — none would support the proposed resolution.  Indeed, two who contacted us yesterday are appalled that their names were used in this context.

Two of them were interviewed for a current article, along with Shinya Yamanaka and another scientist, in which they unanimously describe the important, ongoing role for new embryonic stem cell lines in highly regulated, ethical research to alleviate suffering and save lives.  George Daley also emphasized this point in his e-mail to us.

Among others, you have received letters from James Thomson and Sir Ian Wilmut, the International Society for Stem Cell Research, representing thousands of stem cell researchers, and, just yesterday, the American Association for the Advancement of Science, the world’s largest multidisciplinary science society, representing the interests of ten million scientists worldwide, and publisher of the prestigious peer-reviewed journal, Science.  Every single one of them expressed their support for President Milliken’s position on this issue.

The evidence is overwhelming that the underlying premise of the proposed resolution is entirely without foundation.  It will hinder, not advance, the University’s biomedical research program.

The resolution will harm the university and I urge you to vote it down.

I will close with substantially the same words with which I closed when I first addressed this issue before the regents on September 7, 2001.

I noted then that some see the derivation and use of embryonic stem cells as a devaluation of life.  But everything about embryonic stem cell research is a celebration and affirmation of life.

Parents yearning for a genetic offspring create the embryos in the first place.  Scientists dedicated to the preservation and improvement of life seek the opportunity to apply their skills and efforts to the search for cures with the otherwise to be discarded remains of these excess embryos.  Parents and loved ones of those who suffer want only to see them restored to the full enjoyment of a long life.

I quoted Senator Orin Hatch then as declaring “that this research is consistent with bedrock pro-life, pro-family values.”  Last March he said, “I strongly believe that being pro-life means helping the living by allowing critically important and ethical medical research to go forward.  This research enhances, not diminishes, human life.”

Life is what this work is all about.

So I urge you to make it clear to the dedicated researchers throughout the University of Nebraska system that you recognize their commitment to life and support them in their efforts; that you will stand with them through controversy; that Nebraska will not shrink from its obligation to contribute its talents to this great and promising new era of medical research.

Thank you.”

And thank you, Nebraska.

NEBRASKA DECISION: Resolution to Ban Embryonic Stem Cell Research?

NEBRASKA DECISION: Resolution to Ban Embryonic Stem Cell Research?

Friday, November 20^th, Religious Right forces will attempt to impose their beliefs on the state of Nebraska. If they win, embryonic stem cell research will be banned at the University of Nebraska, (NU)— the only place large enough to do the research.

As you know, right to life groups had already agreed to a compromise law: LB 606, signed by every legislator in that state, and which was supposed to have settled the issue.

In exchange for major concessions and advantages given away by the pro-research side (no SCNT or therapeutic cloning, also no new stem cell lines made in the state, even a half-million dollar annual grant given to the Religious Right’s research of choice, adult stem cell research) the religious right groups agreed to back off on further anti-research legislation.

It was a harsh law, very restrictive. But at least it was something (we thought) that would let the researchers work without fear of further harassment.

Unfortunately: as soon the anti-research forces got their law, they immediately shifted their attack– to the only place in the state that could actually do the research.

If they can block embryonic stem cell research at NU, they will have succeeded with their original goal of blocking the research in the entire state, and all this talk of “compromise” will be revealed as an empty joke.

 Technically, they did not break their word. Technically.

 But it reminds me of another joke: remember the one about the Russians and the Americans having an athletic contest?

 According to the story, the Russians had a two-way contest with America, some sports event with only two countries entered. Russia lost; America won.

 But the Russian press release said: “Russian athletes perform brilliantly, finish strong second. American athletes do terribly, finish next to last.”

 That press release was technically accurate. But its planned impact was otherwise.

 Similarly, the Nebraska Religious Right did not break its carefully worded official promise—like a nation which signs a peace treaty, promising to end its war of bow and arrows and then shifts to machine guns instead—but there was a point of honor here.

 The bill (LB 606) was supposed to settle the issue for the state. It was a compromise. It was carefully worked out, with the full involvement of the Religious Right groups in the state. It involved major restrictions on the research—but it could have been lived with.

 It was peace.

 And then the peace was violated by this new assault.

 Personally, although an outsider to the state, I supported LB 606. I thought it was a reasonable compromise, though at the very edge of acceptability–and I backed it. Every great step forward is a compromise, and I supported this one. I felt it might be even be a useful example, an olive branch between two sides.

 People in the middle can shake hands; extremists never can.

 And then this happens?

 Personally, if I were a member of the Religious Right, (which obviously I am not) I would be on the phone right now, recommending that the move against the University of Nebraska be stopped: because it poisons the well for chances for future cooperation.

But of course they are not taking my advice. Here is how they will try to block the research.

They essentially claim ownership of the board of Regents of the University of Nebraska. Before the election, the Right to Life groups passed out a form, detailing their positions. If you wanted their support (which may swing 5% of the votes in a close election), you must agree to their demands. Apparently, a majority signed that political agreement.

 Now, the Religious Right issued their commands:  ordering the board to ban the research—shutting down the research they could not defeat in law.

Four Regents, all of whom received the Right to Life endorsement, wrote the resolution.

Four of eight. One more vote, and they can impose their policy. Who is that one man? 

His name is Jim McClurg. Whatever he decides in the end, he deserves credit for courage. When offered a chance to co-author the resolution (and give it the fifth vote, which would have imposed it on the state) he declined, saying:

“There’s a lot of good people on both sides of this issue who have heartfelt opinions on it. I’ll decide once I’ve heard what everybody has to say.”

—World Herald Bureau, Leslie Reed, “Stem Cells to Face Vote”, November 13, 2009

The religious right is putting enormous pressure on Mr. McClurg. They have publicly posted his name, email, and phone number, and encouraged their members to call him.  This is dirty pool, political bullying of the worst sort.

How would you like to have a bunch of religious enthusiasts calling your home, day and night?

As for the resolution itself, it is two pages of rationalization, trying to put as good a face as possible on the theft of research from a state.

Here is the only part that matters.

“…no research with stem cells derived from human embryos may be conducted unless the stem cell lines used in the research were derived prior to 8 p.m. Central Standard Time, on August 9, 2001….”

In other words, defy the Obama NIH guidelines, and go back the Bush era restrictions.

This is an extremist position: out of touch not only with the beliefs of Nebraskans ( NU President J.B. Milliken estimates that between 2/3 and ¾ of all Nebraskans support embryonic stem cell research) but also with the State’s government, the official state policy, America’s current policy and much more.

If the board obeys the right-to-life command, they will be overriding a carefully worked-out policy signed by all 48 Nebraska state legislators (Democrats and Republicans unanimously voted yes on LB 606, the compromise legislation), and the Governor of the State Dave Heineman, who signed that bill into law. 

The policy also ignores the expert opinion of virtually the entire scientific community.

Do I exaggerate? Let me prove my point, two ways: 

First, remember the national law, HR 3, the  bi-partisan Stem Cell Research Enhancement Act (Castle,DeGette), to allow federal funding for stem cell lines made from left-over blastocysts, which would otherwise have been thrown away after In Vitro Fertility (IVF) procedures.

Who was against it? Here is the official list of organizations which opposed this bill.

  GROUPS AGAINST the Stem Cell Research Enhancement Act:

The following list was obtained from the RSC Republican Study Committee, Rep. Jeb Hensnarling, (R-TX), Chairman, 132 Cannon House Office Building, Washington, DC 20515.Legislative Bulletin, January 10, 2007

 “National Right to Life Committee, US Conference of Catholic Bishops, Family Research Council, Christian Coalition , Concerned Women for America, Focus on the Family, Christian Medical Association, Eagle Forum, Traditional Values Coalition, Southern Baptist Convention, Susan B. Anthony List, Republican National Committee for Life, Cornerstone Policy Research, Culture of Life Foundation, Religious Freedom Coalition, Coral Ridge Ministries, Center For Reclaiming America.”

End quote.

How many scientific groups do you see up there? How many patient groups? How many medical groups, disease advocacy groups, research groups–— there aren’t any. The opposition was entirely conservative religious/ideological political organizations.

And this, I strongly suspect, is what you would find if you made a list of those groups that are trying to kill the research at the college.

Point Two: Which groups support embryonic stem cell research?  That group is huge, far too large to fit comfortable in this small column. A part of it is included at the bottom of the page.

But if you want to really see the vast level of support, here is a website to visit.

Alliance for Stem Cell Research is a group I worked with to help pass Proposition 71, which funds stem cell research in California, the largest source of embryonic stem cell research funding in the world.

If you push control/click on it, and go to “coalition”, you will see the really astonishing levels of American support for embryonic stem cell research.  

If the Nebraska University Board of Regents caves in to the religious right, it will have a long term negative effect on the state. Jobwise, Nebraska will be denied opportunities open to the rest of the country. In humanitarian costs, the nation will be denied Nebraska’s contribution to the advancement of medical science.

But right now, think of just one child, growing up in Nebraska today, maybe dreaming of becoming a scientist, to help heal suffering and save lives through medical research.

If this backwards resolution is passed, the only advice I could give to that child would be:

Leave Nebraska.

Folks, there is a lot more I could say, but time is running short. The decision will be made this Friday, in Lincoln, Nebraska. If you have an opinion, voice it now, or forever hold your peace.

Here is how you can be heard.

Below is a short piece I found on the web, from a champion athlete of Nebraska. (Please note that he has no connection with any of my opinions.)  I am running it without the pictures, to save space.

Protect Research in Nebraska

I’m Rik Bonness and these are our sons, Eric and Beau.

Both of our sons have Type 1 diabetes. They have lived with tens of thousands of finger pricks, insulin shots and constant worry over signs of retina or nerve damage or kidney failure. We believe someday there will be a cure for diabetes.

As an All-American center at the University of Nebraska, I was expected to give 100% every minute of every game.

And that’s what we need to do here in Nebraska when it comes to research. Stemcell research – including embryonic stem cell research – offers hope to our sons and thousands of Nebraskans who suffer from diabetes, Parkinson’s and other devastating diseases.

 For years, it has been the policy of the University of Nebraska to follow the strict, ethical guidelines established by the National Institutes of Health, the federal government and state law. But now the Board of Regents is being pressured to change that policy to ban some of the most promising avenues of research.

 Now, I’m asking you to give 100% for Nebraska.

Please go to www.nebraskacures.com and ask your regent to keep the University’s existing research policy.

 8401 West Dodge Road, Suite 100, Omaha, NE 68114  402-390-2461

www.nebraskacures.com

 P.S. Here is a partial list of the supporters of  California’s stem cell research initiative: compare it to the list of  opponents of  H.R. 8.

 

Home Get the Facts Our Coalition Get Involved About Stem Cells Newsroom Stories of Hope Campaign Updates Video & Audio En Español Contact Us			Coalition Members   A partial list of members. Titles and affiliations are included for identification purposes only. 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Cure Autism Now Foundation CuresNow Cure Paralysis Now Cure Pulmonary Fibrosis and COPD Cystic Fibrosis Research, Inc. Diabetes Research Institute Diabetes Research Institute Foundation Elizabeth Glaser Pediatric AIDS Foundation Diabetes Coalition of California Facioscapulohumeral Muscular Dystrophy Fair Foundation: Fair Allocations in Research Friends of Cancer Research Hereditary Disease Foundation An international organization committed to the cure of Huntington’s disease. International Society for Stem Cell Research Juvenile Diabetes Research Foundation Steven and Michele Kirsch Foundation     Late Onset Tay-Sachs Foundation Leeza Gibbons Memory Foundation The Leukemia & Lymphoma Society Lupus Foundation of America, Inc. California Chapter Lupus LA Maximum Life Foundation The Miami Project to Cure Paralysis Michael J. Fox Foundation for Parkinson’s Research Napa Spinal Cord Injury Network National Association of Hepatitis Task Forces National Brain Tumor Foundation National Coalition for Cancer Research (NCCR) National Medical Association National Parkinson Foundation, Orange County Chapter National Prostate Cancer Coalition The Neuropathy Association Paralysis Project of America Parkinson’s Action Network Parkinson’s Alliance Parkinson’s Disease Foundation The Parkinson’s Institute Peninsula Parkinson’s Support Group, Inc. Peninsula Stroke Association PKIDS Project ALS Prostate Cancer Foundation Research! America Research for Cure A non-profit organization raising funds for cures for spinal cord injury, multiple sclerosis, Alzheimer’s disease and other neurological diseases. San Francisco AIDS Foundation Sickle Cell Disease Foundation of California Stem Cell Action Network Stem Cell Research Foundation Student Society for Stem Cell Research Team Parkinson United Spinal Association Women’s Cancer Research Fund   Medical Groups and Hospitals   AIDS Services Foundation Orange County American Academy of Pediatrics, California District IX American Nurses Association of California American College of Obstetricians and Gynecologists, District IX American College of Cardiology, California Chapter American Society of Gene Therapy American Society of Hematology American Society for Reproductive Medicine American Society for Neural Transplantation & Repair Association of Northern California Oncologists Auxiliary to the National Medical Association Promotes the interests of physicians and patients of African descent. Alameda-Contra Costa Medical Association The Buck Institute for Age Research The Burnham Institute California Academy of Family Physicians California Association of Nurse Practitioners California Biomedical Research Association California Society of Anesthesiologists California Medical Association Comprised of over 35,000 physicians. California Society of Pathologists Cedars-Sinai Health System Central Valley Health Network Providing health care to 98 clinical sites in 19 Central Valley counties.   Childrens Hospital Los Angeles Children’s Oncology Group, California Coalition Cord Blood Options Endocrine Metabolic Medical Center Genetics Policy Institute HealthTech: The Health Technology Center Humboldt-Del Norte County Medical Society Institute of Myeloma and Bone Cancer Research Kern County Medical Society LA Care Health Plan Lifepoint Wellness Los Angeles Biomedical Research Institute (LA BioMed) Marin County Healthcare District Monterey County Medical Association Medical Oncology Association of Southern California Pennington Institute for Health and Wellness San Francisco Medical Society A nonprofit organization consisting of over 1200 physicians that advocate in the interest of public health. San Joaquin Medical Society Sierra Sacramento Valley Medical Society UCLA AIDS Institute Venice Family Clinic     Nobel Prize Winners   Sidney Altman, PhD Sterling Professor of Biology & Chemistry, Yale University Nobel Prize in Chemistry (1989) David Baltimore, PhD President, California Institute of Technology Nobel Prize in Physiology or Medicine (1975) Baruj Benacerraf, MD Past President, Sidney Farber Cancer Institute Former Chair of Pathology, Harvard Medical School Nobel Prize in Physiology or Medicine (1980) Paul Berg, PhD Professor of Cancer Research Emeritus, Director Emeritus Beckman Center Stanford University Nobel Prize in Chemistry (1980) J. Michael Bishop, MD University Professor and Director, G.W. Hooper Foundation Chancellor, University California, San Francisco Nobel Prize in Physiology or Medicine (1989) Paul D. Boyer, PhD Professor Emeritus of Biochemistry University of California, Los Angeles Nobel Prize in Chemistry (1997) Sydney Brenner, PhD Distinguished Professor Salk Institute for Biological Sciences Nobel Prize in Physiology or Medicine (2002) Renato Dulbecco, MD Distinguished Professor and President Emeritus Salk Institute for Biological Sciences Nobel Prize Physiology or Medicine (1975) Edmond H. Fischer, PhD Biochemistry Professor Emeritus University of Washington Nobel Prize in Physiology or Medicine (1992) Walter Gilbert, PhD Professor of Cellular and Molecular Biology Harvard Univeristy Nobel Prize in Chemistry (1980) Donald Glaser, PhD Professor of Physics and Neurobiology University California, Berkeley Nobel Prize in Physics (1960) Joseph L. 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Trial of American Stem Cell Research–Dismissed?

THE TRIAL OF AMERICAN STEM CELL RESEARCH—DISMISSED?

 By Don C. Reed

 As you recall, the lawsuit against America’s new stem cell guidelines (Sherley et al vs. Sebelius et al, filed August 19, 2009) was moving forward;  until resolved, all federal funding of embryonic stem cell research was shut down.

 Research delayed is research denied. Every day the opposition can tie us up in court is a victory for them, and another day for people like my son to remain paralyzed, and my sister suffer cancer, and millions more good folks: their cures delayed, their hopes denied.  

 The plaintiffs had made their case, arguing that embryonic stem cell research should not be funded. Our side (the defendants) responded—asking for the case to be thrown out.  

 Everything depended on “standing”: could those making the complaint show some injury they had received (or would receive) from the new stem cell research guidelines?

 Without legal standing, there can be no case.   

 But there were five sets of plaintiffs; if even one had a legitimate grievance, the suit could go forward, the research funding would remain blocked for the length of the trial—and in California, a similar lawsuit had tied up the funding for our beautiful stem cell research program for two years…   

 So here we go. For each plaintiff I will quote the official description, claim of injury, some court comments, my own views– and the judge’s decision.   

1. Nightlight Christian Adoptions, (Nightlight) “… an adoption agency that helps individuals adopt human embryos that are being stored in fertilization clinics.”

 Looking it up on the web, I found Nightlight is a fee-charging nonprofit, which helps childless couples obtain blastocysts from In Vitro Fertility (IVF) clinics. Nightlight appears to be either part of a company called Snowflakes, or closely associated with them. They are not shy about charging fees.

 Here are some of their cost estimates: 

 “Program fees: Snowflakes Program fee: $8,000;

Nightlight home study fee is $2,600;

Fertility clinic frozen embryo transfer fees $3,000-$5,000.  

Total Fees $12,000–$16,000.” (the possibility of additional charges is made clear.)

 Alleged Injury: “Nightlight alleges that the (new) guidelines will cause a decrease in the number of embryos available for adoption.”  

 The court commented: “This alleged injury does not satisfy the “injury in fact” requirement because it is speculative and dependent upon third party conduct. The guidelines do not mandate a decrease in the number of embryos available for adoption.  Rather, the guidelines allow funding for hesc research on embryos that were donated “by individuals who sought reproductive treatment,, and who gave voluntary written consent (their emphasis) for the embryos to be used for research purposes.”

 By my non-lawyer understanding, “third party” means someone not named in the lawsuit. This is important because it is the new guidelines that are being sued– and nothing in the guidelines orders a decrease in the number of embryos. The decision (whether the blastocysts shall be frozen and stored, destroyed, given away or donated to research) remains exactly where it should be: with the un-named third party—the donors.  

And the Judge’s official finding?

 “Accordingly, the Court finds that Nightlight lacks standing (emphasis added) because its alleged injury is “mere unadorned speculation as to the existence of a relationship between the guidelines and the third party conduct.” Indeed, if Nightlight suffers any injury at all, it will be because of the choices of third parties not before this court, and not because of the guidelines.”

 If this were baseball, that would be strike one—but it would take five strikes to put the anti-research team out of the game.

 2. Shayne and Tina Nelson, William and Patricia Flynn: “The Nelsons and Flynns are clients of Nightlight who seek to adopt human embryos in the future.”

 These folks had children through the IVF process, with the help of Nightlight, adopting (and implanting) left-over blastocysts. I am glad for them. Most couples want a child. I have two, and they are treasures to me. That is why I will fight to protect them, and that includes not allowing politics to block research for cure.

 Alleged Injury:  “The Nelsons and Flynns, who each have had a child through the adoption of an embryo from Nightlight, allege they are seeking to adopt additional human embryos. They contend the guidelines injure them by “jeopardizing the likelihood that embryos will become available in a timely manner for adoption and implantation.”

 Apparently, the four clients of Nightlight worry that the new guidelines mean they will have less blastocysts to choose from, if they decide to have another child through IVF, with the help of Nightlight. Presently, there are about 450,000 blastocysts frozen in storage.  How many choices are required?   

 “The Court finds that the Nelsons and Flynns have not alleged a concrete and imminent injury… the guidelines do not regulate embryonic adoption… neither the Nelsons nor the Flynns allege…guidelines have erected any barriers to their efforts to adopt an embryo.”

 FINDING:  “Accordingly, the Nelsons and Flynns do not have standing.” (Strike two…)

 3. Embryos “The Embryos consist of all individual human embryos that were created for reproductive purposes, but are no longer needed for those purposes.”  

 Alleged Injury: “The embryos, through Nightlight, contend that their lives will face a recurring risk of destruction as a result of the guidelines.”

 I hardly know where to start: “The embryos…contend…” Talking blastocysts? This is more than just foolishness. This is a subtle attempt at deception, like the anti-research propagandist who talked about embryonic stem cells, while behind him was a huge picture of a baby in the womb. They know the research is about cells, cells, nothing but cells, but they use words which plant a false picture in the minds of the listeners.

 Even the word “embryo” is to my mind prejudicial, because it implies a baby in a womb, which is false; we are talking about bits of tissue smaller than the point of a pin– and not in the woman’s body. No blastocyst can ever become a child, unless it is implanted in the womb. No mother, no child; this is not rocket science.

 And what amazing arrogance in this claim… How could any organization claim the right to decide what is best for every unused IVF embryo in the world?  

 A great deal is at stake here, as the Court noted:

 “This case…concerns whether an embryo qualifies as a person (emphasis added)… The Supreme Court has stated that “the unborn have never been recognized in the law as persons…”

 This is vital. If a blastocyst (the first linkage of microscopic sperm and egg) can be declared a full human under law, the entire field of embryonic stem cell research becomes illegal, as does every woman’s right to choose to terminate her pregnancy—ever. The In Vitro Fertility process would be illegal, and many forms of birth control.

 This is the Religious Right’s personhood concept: their attempt to get every blastocyst declared a legal person, with standing in a court of law. If they win on “personhood”, our hopes and dreams for embryonic stem cell research are gone.  

 But the judge spoke out clear and plain, no translation required: “The Court finds… that the embryos are not “persons” under the law, and thereby do not have standing.”

 We must remember this. We are fighting to save real people’s lives, not potential ones. A droplet of sperm may contain the beginnings of a million lives, but that does not mean each one should be protected under law.

 The exact time when tissue becomes a person has been argued for centuries. Is it viability, when a child can live on its own, outside the womb? That is the official definition, according to American law. Or, as the Catholic Saint Thomas Aquinas opined, does life begin at the “quickening”, when the mother first feels the baby stirring in her womb? Earlier? Later?

  “Personhood” wants humanity declared at the joining of sperm and egg—even in a Petri dish of salt water, outside the womb, when there is no possibility it could become a child.

 What’s next, are we going to say that new life begins at the twinkle in Dad’s eye?

 But while we can argue forever about that definition, there is no debate about the personhood of my son Roman, who is paralyzed, or my sister Barbara, who has cancer. They are full human beings, protected by the law of this land. Their right to life is guaranteed under the Constitution– and must not be jeopardized by political games, which could block research to heal disease or disabilities which blight their lives.

 FINDING: “Accordingly, the Court concludes that the embryos lack standing because they are not persons under the law.” (Strike 3 of 5…)

 4. Christian Medical Association, (CMA) a non-profit which “strives to improve the ethical standards of health care in the United States and abroad”.

 Note: The CMA appears to be part of a larger group, the 2,400 member Christian Medical and Dental Association (CMDA). If that assumption is correct, (I could not find the CMA listed as a separate organization) I am not sure why the CMA sued, while their parent organization did not. Perhaps they disagree; I do not know. (I do know, however, that even some of the nation’s most conservative Christians no longer worry about this issue. A poll was taken at a recent Values Voters Summit, the ultimate conservative gathering, put on by the Family Research Council. When 5,000 values voters were asked to list their issues of concern, less than 1 (one) per cent listed “early embryo research”.)

 Alleged Injury:  “CMA alleges that it will suffer injury because: the guidelines will frustrate CMA’s purpose and require CMA to devote significant resources to address and counteract the grave ethical problems posed by illegal public funding of embryo research.”

 This is an amazing claim, when you think about it. If a “frustration” argument was allowed, it would open the door for lawsuits against probably every law ever passed.  

 The Court stated: “Frustration of purpose is not a sufficient injury to establish standing….allegations that frustrate an organization’s objectives is “an abstract concern that does not impart standing.”

 Finding: “Accordingly, the Court finds that CMA lacks standing.” (Strike 4…)

 5. Drs. James L. Sherley and Theresa Deisher, adult stem cell researchers.

 “Drs. Sherley and Deisher specialize in adult stem cell research and plan to seek NIH funding for adult stem cell research in the future. In addition, Dr. Sherley has one proposal currently pending.”

 Alleged Injury: Drs. Sherley and Deisher contend that the new guidelines will “result in increased competition for limited federal funding and will thereby injure their ability to successfully compete for… NIH stem cell research funds.”

 To me, this sounds like they want a monopoly on what type of research gets funded. During the Bush Administration, adult stem cell research was heavily favored; seven times more money given to it than embryonic; even under the Obama Administration, adult stem cell research appears likely to receive triple the funding of embryonic. Personally, I favor a level playing field, where the quality of science will decide.

 “ The Court finds that increased competition for funding is an insufficient injury to impart standing… The guidelines neither prevent nor hinder either doctor’s opportunity to compete for funding. Indeed, Drs. Sherley and Deisher’s proposals for adult stem cell research can receive funding, if they survive the review process all applicants undergo…

 “… the guidelines will not “almost surely cause (Drs. Sherley and Deisher) to lose” funding…  The application process to receive NIH funding is extremely competitive. Only about 22% of applications receive NIH funding… Even if the guidelines did not exist, Drs. Sherley and Deisher are not assured of receiving funding…”

 Finding: “Accordingly the court concludes … that Drs. Sherley and Deisher lack standing.” (Strike 5!)

 “Conclusion: For the reasons set forth above, the Court finds that plaintiffs lack standing and will grant defendants Motion 22 to dismiss. A separate order shall issue this date.

 “Signed by Royce C. Lamberth, Chief Judge, on October 27, 2009”

 So did we win?

 Yes.

 Will they appeal? No way of knowing, of course, but probably they will.

 I am sure they believe in their side as thoroughly as we believe in ours.

 We won’t give up; neither will they.

 Until cures come.

 P.S. Below is the Court’s decision on the case. I two-finger-typed the Judge’s decision below, so you can read as much or as little as you like of it.  It is essentially complete, but I left out document references, etc. You can find the original on the web, just Google it.  (For my two previous articles on this subject, go to www.stemcellbattles.com)

 United States District Court for the District of Columbia

 James Sherley et al, Plaintiffs, v. Kathleen Sebelius, et al   Cic. No. 1;009-cv-1575 RCL

Memorandum Opinion

 This matter comes before the court on defendants’ Motion to Dismiss. Plaintiffs brought this suit to enjoin the defendants from taking further actions to implement and apply the guidelines promulgated by the National institute of Health (NIH) that provide for public funding of human embryonic stem cell (hesc) research. Defendants motion states, among other things, that plaintiffs lack standing. This court agrees with defendants and finds that plaintiffs lack standing. Accordingly, the Court will grant Defendants motion to dismiss.

1. Background

Plaintiffs are Drs. James L. Sherley and Theresa Deisher, Nightlight Christian Adoptions (Nightlight), Embryos, Shayne and Tina Nelson, William and Patricia Flynn, and Christian Medical Association (CMA), Drs. Sherley and Deisher specialize in adult stem cell research and plan to seek NIH funding for adult stem cell research in the future. In addition, Dr. Sherley has one proposal currently pending. Nightlight is an adoption agency that helps individuals adopt human embryos that are being stored in fertilization clinics. The Embryos consist of all individual human embryos that were created for reproductive purposes, but are no longer needed for those purposes. The Nelsons and Flynns are clients of Nightlight who seek to adopt human embryos in the future. CMA is a non-profit association of doctors that strives to improve the ethical standards of health care in the United States and abroad. Together, plaintiffs seek to enjoin defendants “from applying the Guidelines (promulgated by NIH) or otherwise funding research involving the destruction of human embryonic stem cells.”

 On March 9, 2009, President Obama issued Exec. Order (which) removed President Bush’s limitations on hesc research. In addition, the Order directed NIH to issue new guidelines to allow hesc research to the extent permitted by law.

 After a notice and comment period, NIH issued the final guidelines on July 7, 2009. Under the guidelines, for an applicant to conduct research on hESC derived from embryos donated on or after the effective date of the guidelines, the applicant must either limit his or her research to cell lines posted on an NIH registry, or submit an assurance of compliance with part A of the Guidelines (which) ensure that the proposed research involves only hesc that are no longer needed for reproductive purposes and were voluntarily donated to be used for research  purposes. For an applicant to conduct research on hesc derived from embryos donated before the effective date of the guidelines, the applicant must either show compliance with part A of the guidelines, or submit materials  to an advisory committee, which will make recommendations concerning the eligibility for NIH funding.

 Plaintiffs allege that the guidelines, by allowing NIH to fund hesc research , will cause them irreparable harm. Specifically, Drs. Sherley and Deisher contend that the new guidelines will “result in increased competition for limited federal funding and will thereby injure their ability to scccessfully compete for… NIH stem cell research funds,.” Nightlight alleges that the guidelines will cause a decrease in the number of embryos available for adoption.  The embryos, through Nightlight, contend that their lives will face a recurring risk of destruction as a result of the guidelines. The Nelsons and Flynns  maintain that the guidelines will “jeopardize the likelihood that embryos will become available” for them to adopt in the future. Finally, CMA alleges that the guidelines will frustrate its purpose and require it to expend significant resources to combat the ethical problems posed by hESC research.

1. Discussion.

Defendants move to dismiss plaintiffs’ complaint on the grounds that this Court lacks subject-matter jurisdiction, or, in the alternative, that plaintiffs have failed to state a claim upon which relief could be granted.  The Court finds that it lacks subject-matter jurisdiction because subjects do not have standing. Therefore, the Court need not address defendants’ additional arguments.

1. Legal Standard

Federal courts are courts of limited jurisdiction. When a defendant files a motion to dismiss for lack of subject-matter jurisdiction pursuant to Rule 12 (b) 1, the plaintiff must demonstrate by a preponderance of evidence that the court has subject-matter jurisdiction. The Court must accept all the factual allegations in the complaint as true and draw all reasonable inferences in the plaintiff’s favor.  Furthermore the court may consider material outside of the pleadings in its effort to determine whether the court has jurisdiction in the case.

 A court lacks subject-matter jurisdiction if the plaintiff fails to establish standing. (“The party invoking federal jurisdiction bears the burden of establishing standing.”) To have constitutional standing the plaintiff must demonstrate  1. an injury in fact; 2. causation: and 3. redressability.  An injury in fact is “an invasion of a legally protected interest which (a) concrete and particularized … and actual or imminent, not conjectural or hypothetical.    (internal citations and quotations omitted)

 “When a plaintiff’s asserted injury arises from the Government’s regulation of a third party that is not before the court, it becomes ‘substantially more difficult ‘ to establish standing ….. The court, however, will not dismiss a complaint  brought by multiple  plaintiffs if one of the plaintiffs has standing.  (the presence of one party with standing is sufficient to satisfy articles  III”s case-or-controversy requirement”

1. Plaintiffs lack standing

 CMA:  CMA alleges that it will suffer injury because: the guidelines will frustrate CMA’s purpose and require CMA to devote significant resources to address and counteract the grave ethical problems posed by illegal public funding of embryo research. Frustration of purpose is not a sufficient injury to establish standing…. allegations that frustrate an organization’s objectives is “an abstract concern that does not impart standing.” Indeed, plaintiffs do not argue in their opposition that this injury is sufficient for standing purposes. Accordingly, the Court finds that CMA lacks standing.

 Nightlight:    Nightlight contends that it will suffer injury  because the guidelines will cause a decrease in the number of embryos available for adoption. This alleged injury does not satisfy the “injury in fact” requirement because it is speculative and dependent upon third party conduct. The guidelines do not mandate a decrease in the number if embryos available for adoption.  Rather, the guidelines allow funding for hesc research on embryos on embryos that were donated “by individuals who sought reproductive treatment,, and who gave voluntary written consent (their emphasis) for the embryos to be used for research purposes.” Thus, for Nightlight to suffer an injury, potential embryo donors have to choose to donate their embryos for research, and not for adoption.

 The choice, however, is not simply whether to donate embryos for research or for adoption. The donors must choose between continuing to store the embryos, discarding them, donating them for research, or giving them to an adoption agency involved in embryonic adoption.

 Accordingly, the Court finds that Nightlight lacks standing because its alleged injury is “mere unadorned speculation as to the existence of a relationship between the guidelines and the third party conduct.” Indeed, if Nightlight suffers any injury at all, it will be because of the choices of third parties not before this court, and not because of the guidelines.

 Embryos.  Nightlight also seeks to proceed in this complaint on behalf of all embryos created for reproductive purposes that are no longer needed for such purposes. The complaint alleges the embryos face the risk of imminent injury, i.e. destruction, as result of the NIH guidelines. The Court finds, however, that the embryos are not “persons” under the law, and there(by) do not have standing. (my emphasis)

 Plaintiffs’ reliance on Hatch v. Riggs Natl. Bank, 361, F.2d 559, 566 (D.C. Cir. 1966) for the proposition that embryos qualify as persons and should have a guardian ad litem appointed to represent their interest is misplaced. “Hatch” concerned the “interests of unborn and/or otherwise unascertainable beneficiaries of a trust.” An unborn’s legal interest in a trust has been recognized for centuries. See Roe v. Wade, 410 U.S. 114, 162, (1973) (noting that historically guardians at litem have been appointed to represent property interests of the unborn that are “contingent upon live birth”). This case, however, does not concern whether an embryo qualifies as a person in order to enforce a trust. Rather, it concerns whether an embryo qualifies as a person in order to assert a liberty interest. The Supreme Court has stated that “the unborn have never been recognized in the law as persons in the whole sense” and that they have no right to life protected under the Fourteenth Amendment…Accordingly, the Court concludes that the embryos lack standing because they are not persons under the law…

 The Nelsons and Flynns, who each have had a child through the adoption of an embryo from Nightlight, allege they are seeking to adopt additional human embryos. They contend the guidelines injure them by “jeopardizing the likelihood that embryos will become available in a timely manner for adoption and implantation.”

 The Court finds that the Nelsons and Flynns have not alleged a concrete and imminent injury.  As discussed with Nightlight, the allegation that fewer embryos will be available for adoption is speculative and dependent upon third parties. Moreover, the guidelines do not regulate embryonic adoption, and neither the Nelsons nor the Flynns allege that the guidelines have erected any barriers to their efforts to adopt an embryo. Accordingly, the Nelsons and Flynns do not have standing.

 Drs. Sherley and Deisher allege that the guidelines “will result in increased competition for limited federal funding and will thereby injure (their) ability to compete successfully for….NIH stem cell research funds. “ The Court finds that increased competition for funding is an insufficient injury to impart standing.

 Drs. Sherley and Deisher contend that they have standing under the “competitor standing” doctrine. Under the competitor standing doctrine, a plaintiff “suffers constitutional injury in fact when agencies lift regulatory restrictions on their competitors or otherwise allow increased competition.”

 The competitor standing doctrine is not applicable to the facts of this case. The Supreme Court has held that the competitor standing doctrine applies only “when the particular statutory provision (or regulation) involved… reflects a legislative purpose to protect a competitive interest.”  Here, Drs. Sherley and Deisher have not demonstrated that they have a protected competitive interest in receiving NIH funding. Their only protected interest is their opportunity to compete with other applicants for limited NIH funding… The guidelines neither prevent nor hinder either doctors opportunity to compete for funding. Indeed, Drs. Sherley and Deisher’s proposals for adult stem cell research can receive funding if they survive the two-tier review process that all applicants undergo.

 In addition, the cases relied upon by Dr. Sherley and Deisher are readily distinguishable. In both cases, the competitor standing doctrine applied where the petitioners were active participants in the strictly regulated economic markets of energy, communication, and banking. … Drs. Sherley and Deisher, however, are not participants in strictly regulated economic markets. They are applicants for research grants… As stated above, Drs. Sherley and Deisher may still receive funding.

 Last, even if the competitive standing doctrine did apply, Drs. Sherley and Deisher would not have standing because the guidelines will not “almost surely cause (Drs. Sherley and Deisher) to lose” funding…The application process to receive NIH funding is extremely competitive. Only about 22% of applications receive NIH funding. Thus, even if the guidelines did not exist, Drs. Sherley and Deisher are not assured of receiving funding for adult stem cell research.

 Accordingly the court concludes that the competitor standing doctrine does not apply and that Drs. Sherley and Deisher lack standing.

1. Conclusion: For the reasons set forth above, the Court finds that plaintiffs lack standing and will grant defendants Motion 22 to dismiss. A separate order shall issue this date.

Signed by Royce C. Lamberth, Chief Judge, on October 27, 2009

 

 

FOUR HORRORS: Stroke, Diabetes, Blindness, ALS– and How Embryonic Stem Cell Research May Defeat Them

 

 

FOUR HORRORS: Stroke, Diabetes, Blindness, ALS—and How Embryonic Stem Cell Research May Defeat Them

By Don C. Reed

 Before I met the monster on the road, I had been on my way South to Los Angeles for the Independent Citizens Oversight Committee (ICOC). This was an especially important meeting at which the big disease team grants would be decided, as much as $20 million each, loans or grants. Some projects would go forward, others would die.

 My cell phone rang. 

 Pulling off the freeway and fumbling through my suitcase (keep ringing, keep ringing!), I found the phone, opened it, recognized the numbers on the screen.

 Dr. Hans Keirstead…. I dreaded what the voice might say.

 He had a project in question: a way to use embryonic stem cells to fight Spinal Muscular Atrophy: important not only to the children who suffer and die from this terrible condition, but to the entire field of research. Some of the problems he was taking on in this project would affect everyone.

 But the funding had been turned down.

 The problem, as I saw it, was procedural:  the official cutoff deadline for new project information was April… Since the cutoff date, Dr. Keirstead had gotten a ton of new information, some 9,000 pages of it, including the results of animal testing, and much correspondence with the FDA: important stuff which I felt sure would change the opinions of the reviewers—but they had not seen it.

 There was a process for appeal, and I had been encouraging him to use that process to try and overturn the denial of funding.  

 As a member of the public I have a First Amendment right to talk to just about anyone, (including state employees like the ICOC, who enjoy the equally valid right to ignore me) and I had spoken with about half of the 29-member board who would be making the final decision. (I emailed first, asking if we could talk. Those who did not object strongly enough got a phone call.) Most of them said the same thing, that it was an uphill battle, (like everything else in this business) but they would listen at the meeting with an open mind. That was all anybody could ask.

 Could the potentially game-changing new information be included?

 I believe the National Institutes of Health (NIH) has ways that late-breaking news can be added to proposals, and we should consider incorporating those procedures into our own bylaws. But in the meantime we had the “extraordinary appeals” process, and if the scientist was willing–

 “I decided not to go forward with the appeals process”, said Hans Keirstead.

 Internally I said something unprintable. I had invested maybe seventy hours in the struggle to understand and defend this one project, and was loaded for bear.  But–

 “I understand their decision,” he said, “If I had been a reviewer, and only got what I was able to give them in April, I would probably have done the same thing…”

 And so, on a technicality of timing, a grant would not be given: what might have been a hugely important embryonic stem cell project would not be funded by us.

 Well. Adjusting to the new reality, the fight that would not happen, I pulled back out onto the empty stretches of Highway I-5, just past Bakersfield, before the L.A. grapevine. Since gas prices skyrocketed, there are far fewer vehicles driving: I was almost alone on the road.

 In the distance was a blur across the road. I paid it no mind, thinking it some object that would soon be gone, went back to my day-dreaming,now my mind was free to wander.

 The ground in that area is desolate, barren. A huge road-side sign blamed it on the government—“this dustbowl brought you by Congress”—apparently the same people who put up the sign, “where water flows, food grows” beside the canal.

 Translation: Southern California wants more of Northern California’s water.

 I thought about the movie, CHINATOWN, based on a true story, the multi-gazillion dollar consequences of a water rights decision, made by a government board…. (You can read about it in “Rivers in the Desert: William Mulholland and the Invention of Los Angeles”, by Margaret Leslie Davis.)

 The real culprit was also at the side of the road—cotton…. raw material for underwear, cotton is a robber of water, thieving moisture more greedily from the soil than any other crop.

 The blur in the distance grew, into something huge and dark across the freeway.

 A vast wall of dirt, suspended in the air.

 Bizarre and ugly tendrils reached out from it, coiling and extending, like a special effects monster, creature of darkness, snatched from the ground…

 There was no way around, no time to think, just step on the brakes as hard as I could without losing control, reducing speed from 70 to 30, entering the wall…

 Whooooshshshsh…. Darkness. I could only hope the road went straight ahead, because I could see nothing…

 Then, the other side, my car emerging filthy, windshield wipers scraping dirt, brown sky ahead, the sun glaring palely.

 It being almost Halloween that day, thoughts of monsters entered my mind, Godzilla coming to stomp some poor city again.  

 But real-life horrors come at us every day, rearing up out of the unexpected, coming to destroy our lives.

 Consider just the financial costs of four horrible—and presently incurable– medical conditions:  Stroke. Diabetes. Blindness. ALS.  

 In one year, stroke costs America $56 billion in medical costs.

 Diabetes–$174 billion. 

 Vision problems (of which macular degeneration is a huge component)– $51.4 billion. 

 ALS—I cannot find an overall figure, but it may cost two hundred thousand dollars–for one patient, per year.   My rough guess (based on 20,000 patients) would be $4 billion.

 Add that up:  $285 billion a year—for just four medical conditions. 

 We spend so little fighting back against these real-life horrors: as if Godzilla attacked New York– and the military got a nickel for a slingshot to fight it.

 Opponents complain about the expense of California’s entire stem cell program– which has a budget of only $295 million a year—roughly  one one/thousandth of the cost of just those four conditions. If we can help alleviate or cure even one of those devastating conditions, it would be the greatest bargain in medical history.

 

 Fast forward to the meeting.

 Two dozen leaders of the ICOC sitting at a square of four tables. Champions all. People like Ed Penhoet, just chosen to be a special biomedicine adviser to the President. (Dr. Alta Charo, one of our advisors, was also recently honored by being selected to advise the FDA!) Bob Klein was recently honored by Research!for America, receiving the Gordon and Llura Gund Award for medical research advocacy. Over there was Television’s Leeza Gibbons, head of her own organization to fight Alzheimer’s, and to her right was Sherry Lansing, former President of Paramount Motion Pictures, battling for cancer research—a book could be written about just the members of this board. Not a political hack among them. 

 Today, they would be deciding the biggest medical research grants in our history.

 Before the meeting began, $210 million had been set aside (with a buffer of an additional $30 million) for the disease team grants.

 To my amazement, the review board (a separate panel made of scientists from different states and nations, none from California) had recommended cautiously—$189 million.

 What? We were not going to spend the money budgeted to fight disease?

Naturally, being of an age when everything reminds me of something else, I had to step up to the microphone and give my two cents worth, telling a true story which seemed applicable.

 A settler in old West times was found dead after an Indian attack. Arrows were stuck all through him—and, clutched uselessly in his hands, a single-shot rifle, its one bullet unfired…

 I would have fired that bullet, I said. After that, I like to think, I would have swung the  rifle as a club until it broke, and then looked around for rocks to throw. 

 We are here to fight terrible diseases and conditions. We have the money, let’s go for it.

 “But only when the science is first-rate,” Bob Klein put in quickly.

 At the end of two days careful consideration, the ICOC approved the expenditure of just shy of $230 million.

 Our money was on the table, the bets were made. Fourteen grants…   

 Here came something ironic.

 Guess which got more money– embryonic or adult stem cell research?

 Prop 71 was designed to be sure the best science was funded, at a time when President George Bush’s ideological convictions were blocking the advance of embryonic and other advanced forms of stem cell research.

 Today, adult stem cell research (often combined with gene therapy) got the bulk of the funding. The opposition of course is playing this up for all they can, trumpeting this as “proof” that they were right all along, and there is no need for hESC research.

 Let’s look a little closer.

 These are grants for team projects which had the best chance to advance—in just four years– to a phase one clinical trial for an “incurable” disease or disability.

 Remember all the advantages adult stem cell research has had: a fifty year head start, massively preferential funding from Washington, zero political harassment—contrast that with the virulent opposition from the religious right and its allies in state and national capitols, not to mention near strangulation of funding– it would be natural to assume that all of these ready-to-go grants would be for some form of adult stem cell research.

 But that is not quite how it worked out.

 Remember the four “monsters” mentioned earlier– stroke, diabetes, ALS, and macular degenerative blindness?

 Naturally, being California, we are going after all four– and the weapon of choice to fight them?

 Embryonic stem cell research.

 With every option available, California chose embryonic stem cell research for these four horrific conditions. Why?

 Because California is going for the best method to find a cure. Adult, embryonic, iPS—we seek to save lives and ease suffering. Unlike our opponents, we do not select medical research by its political acceptability.

 Personally, I believe that embryonic or the embryonic-like reprogramming (or SCNT, which has a lot more potential still to be explored) will be the way to go: that projects based on adult stem cells will eventually need to be re-done with the more powerful hESC or reprogramming approach.

 Even so, one of the projects I spoke up most vigorously in favor of was an adult stem cell project, Dr. Irv Weissman’s attack on leukemia.

 Why? Because not only do I (and the scientific community!) have enormous respect for Dr. Weissman, but also because I know I can be wrong. If an adult stem cell approach turns out to the best way to help people, of course I’m for it.

 That’s what medical research advocacy is about: to find out—and fund—the best.

 Take a quick look at the four embryonic stem cell projects.  This information comes from the website of the California Institute for Regenerative Medicine website:  www.cirm.ca.gov. The reports are also available through the clickable list at the bottom.

 I have shortened them (thirty-some pages down to 3), for ease of reading. Other than that (and parenthetical insertions like this one) these are the actual words.

 STROKE

 Description: stroke occurs when a blood clot blocks a blood vessel in the brain, and cuts off blood flow. Brain cells begin to die…(which) can cause permanent loss of motor control, movement and cognitive abilities… (imagine being paralyzed, losing the ability to speak, perhaps even unable to think properly—dr)

 Quick Fact: Stroke causes more serious long term disabilities than any other disease.

 Disease Team Award: The Stanford University-led team (Primary Investigator Dr. Gary Steinberg) plans to use cells derived from human embryonic stem cells… to improve recovery in the weeks and months following a stroke.

 The team will be…(turning) embryonic stem cells into neural (nerve) stem cells…normally found in the brain. When these…cells are transplanted into the brains of mice or rats one week after a stroke, the animals are able to regain strength in their limbs.

 Based on these findings, the Stanford-led team proposes to further develop these neural stem cells into a clinical development program for stroke in humans…. 

 MACULAR DEGENERATION BLINDNESS

 Description: Macular degeneration (a disease of aging) gradually destroys sharp central vision, making it impossible to see faces, to read, or to drive… deterioration of the retina… 

 Underlying (the retina) is a single layer of cells (retinal epithelial cells, RPEs)… that provide support, protection and nutrition…to the retina.  Degeneration of (these support cells) leads to … vision loss.

 Quick fact: Age-related macular degeneration (AMD) affects more than 1.75 million Americans. There is currently no cure….

 Disease Team Award:  Led by researchers at the University of Southern California, (the team will) …use human embryonic stem cells to replace dysfunctional or destroyed (RPE) cells to slow or reverse the disease. They plan to coax human embryonic stem cells to differentiate into… (RPE) cells that can be transplanted into the eye.

 The replacement cells will function normally to support to and protect the…retina and prevent further degeneration and vision loss.

 

AMYOTROPHIC LATERAL SCLEROSIS (ALS)

 Description: ALS, also known as Lou Gehrig’s disease, is a progressive disease that involves the death of motor neurons (which are) cells in the brain…and spinal cord that connect directly to muscle. As these cells die, signals from the brain to the muscle are cut off and patients lose motor control…(leading to) paralysis…and death. …. People with spontaneous ALS (one of two kinds of the disease) have higher levels of… glutamate in the spinal fluid… Scientists suspect glutamate may be involved in (the cause of) ALS…

 Quick Fact: There is no cure for ALS, but there is a drug, called riluzole, that extends life by a number of months(3-6).  Riluzole decreases… glutamate, and in turn, decreases damage to neurons…

 Disease Team Award: The team at the Salk Institute for Biological Studies plans to protect surviving neurons from further degeneration in people diagnosed with ALS. The strategy involved targeting (astrocyte) cells which…surround and protect neurons. (Astrocytes regulate glutamate.)

 The team intends to grow human embryonic stem cell-derived astrocyte precursors that will be transplanted… into the spinal cord environment to prevent further…degeneration caused by ALS. The work…should be effective in (both varieties of) ALS.

TYPE 1 DIABETES

 Description: People with type 1 diabetes, known as juvenile diabetes, cannot produce insulin… which (normally) helps take up sugar from the blood. … Although it is possible to replace missing insulin with injected insulin, people with diabetes still tend to have higher than average blood sugar levels. This excess sugar damages the retina, nerves, kidney and blood vessels. Because of this damage, people with diabetes often have cardiovascular disease, kidney failure, blindness, and (may) need amputations due to wounds that can’t heal.

 Quick Fact: (approximately) 15,000 youths in the Unites States (are) newly diagnosed with type 1 diabetes annually.

 Disease Team Award: Dr. Jeffery Bluestone and the Novocell, Inc-led team has developed methods to make large-scale batches of replacement beta cells from human embryonic stem cells (hESC).

 … these hESC-derived beta cells cure experimental disease in mice and rats. ..The team now plans to complete the manufacturing, efficacy, safety testing required to generate the necessary data for FDA approval to test in Phase 1 clinical trials.”

End of quoted materials.

 

So. Despite the enormous advantages given to the field of adult stem cell research by the previous administration (which favored it over embryonic more than 7-1 in terms of grant money), and although adult stem cell research has been around since the middle of the last century, compared to embryonic which was isolated just 11 years ago—even so, hESCr was chosen to attack these four horrific incurables.

 I think it was Dr. Kevin Eggan of Harvard who came up with a great line recently. He was asked if there was still a need for human embryonic stem cell research, (hESCr) since there were other options,  like iPS, the skin cell reprogramming, which he helped develop.

 Eggan answered, (if memory serves) that of course we still needed human embryonic stem cell research, because everything else was an imitation—and hESCr was the real thing.

 So what we do we need next?

 How about an RFA (Request For Applications) for a major grant to fund actual clinical trials? Before any cures can reach people, they must be tested, and this can cost a bunch of money—so far, Geron (back on track for human trials next year, btw) has spent about $45 million, and will probably spend that much again—we need a way to support these crucial tests—maybe matching grants?–so good ideas will not stay locked up in the labs.

 And if Dr. Keirstead’s SMA work finds enough funding elsewhere, (which I am confident it will, although slower than if we had been able to fund it through CIRM), maybe his project will be eligible for that one…

 At the two-day meeting, there was far too much to talk about—the international advances alone have far too much substance to be summed up in a short article.

 For me, there was one moment when it all came together, and it happened right before the meeting official begins.

 CIRM person Melissa King led the pledge of allegiance. She began it as she always does: “please stand, if you are able”.

 I never hear those words without getting a little misty-eyed: not only in pride for my state and our nation, which make possible this magnificent effort: but also reminding me why we are here.

 Below is the official write-up from the California Institute for Regenerative Medicine, which I lifted from their website. (They of course have no connection to my opinions.)  Under that is a clickable list of the 14 projects funded, in case you want an up-close look. (I underlined and bold-printed the word “human embryonic stem cells” on the title of the four hESCr projects I talked about.)

 Oh, good news, the lawsuit against America’s embryonic stem cell research program was thrown out!  More to follow soon. It is an important decision, which may (IMHO) affect anti-research legislation across the country…

 Stay tuned!

 best,

 Don C. Reed

CIRM, the UK and Canada Award more than $250 Million to Accelerate the Pace of Bringing Stem Cell Therapies to the Clinic

October 28, 2009

ImageIMCE: 

 

Novel funding mechanism speeds the path of research

Los Angeles, Calif., October 28, 2009 – The California Institute for Regenerative Medicine, the state stem cell agency, and two international partners awarded more than $250 million to 14 multidisciplinary teams of researchers in California, the UK and Canada to develop stem cell-based therapies for 11 diseases. The Disease Team Research Awards include approximately $8 million from the Medical Research Council, UK, and approximately $35 million from the Cancer Stem Cell Consortium, Canada, to fund the international portions of the collaborations.

CIRM’s 29-member Governing Board voted to approve funding for the four-year grants, which mark the first CIRM funding explicitly expected to result in a filing with the FDA to begin a clinical trial. The Disease Team Research Awards fund research teams that include basic scientists and clinicians from both academia and industry. These collaborations speed the process of establishing clinical trials by insuring that clinically relevant issues are considered early and avoiding potential safety issues being discovered late in the process.

CIRM President Alan Trounson said the pace of the Disease Team projects stands in contrast to the decade or more that’s usually required to reach clinical trials. “Scientists have talked for years about the need to find ways to speed the pace of discovery. By encouraging applicants to form teams composed of the best researchers from around the world we think CIRM will set a new standard for how translational research should be funded,” he said.

Each team will be actively managed by CIRM and the agency’s international partners for those teams with cross-border collaborations. Decisions to move forward with the project will be made at key points in the development cycle.

“This unique partnership is another opportunity for the people of California to lead the way in this important research and advance potentially life-saving science,” said Governor Schwarzenegger. “These grants will help unite some of the best scientists throughout the world, including right here in California, to find new therapies and cures for people suffering from chronic and life-debilitating diseases. I am proud California remains at the forefront of this innovative research and I look forward to the results of this international collaboration.”

“This initiative is bringing together the leading minds in cancer and stem cell research from Canada and California,” said Dr. Morag Park, Scientific Director of the Institute of Cancer Research, part of the Canadian Institutes of Health Research (CIHR), the Government of Canada’s health research agency. “CIHR, in conjunction with Genome Canada and through the Cancer Stem Cell Consortium, is proud to fund Canadian Scientists in this cross-border collaboration that will engage scientists from many disciplines, combine resources, technologies and knowledge to find more effective treatments for leukemia and solid cell tumours.”

Sir Leszek Borysiewicz, Chief Executive of the Medical Research Council: “The partnerships that have been established between the UK and CIRM have brought us closer to delivering the promise of stem cell treatments for debilitating conditions. We hope these projects will accelerate treatments to early clinical trials, eventually leading to a direct benefit for people suffering from age-related macular degeneration, which up until now has been regarded as incurable and also acute myeloid leukaemia. The MRC has led the way for UK translational researchers and together with our partners at CIRM we look forward to realising the full potential of stem cell research”

Other diseases being targeted by the teams include HIV/AIDS, type 1 diabetes, damage from heart attack, sickle cell anemia, amyotrophic lateral sclerosis also known as Lou Gehrig’s disease, and epidermolysis bullosa, a hereditary life-threatening condition of the skin’s connective layer. The 14 awards will go to seven not-for-profit institutions and one for-profit institution. The award to the one for-profit grantee will take the form of a loan.

“CIRM’s loan program will recycle money back into future awards and leverage the voter’s commitment to the field,” said Robert Klein, Chair of the CIRM Governing Board. “In providing stem cell funding in the form of loans, CIRM is able to fund more science and make a more significant impact on the speed of bringing new stem cell-based therapies to the people of California and the world.”

Other ICOC Business

The board also voted to approve an update to CIRM’s on-going strategic plan. The current plan, approved in 2006, anticipated a slower pace of research toward potential clinical applications. The revision proposes an increased emphasis on moving safety tested candidate therapeutics to the clinic and encourages closer ties to industry and national and international collaborators to meet those goals.

Approved Disease Team projects:

(See the Disease Team media materials for more information about the funded teams.) 

Grant number	Investigator	Institution	Intl. Collaborator	Total CIRM Funding
DR1-01421	Karen Aboody	City of Hope National Medical Center		$18,015,429
	Co-PIs: Jana Portnow	City of Hope National Medical Center
	Larry Couture	City of Hope National Medical Center
	The group proposes to treat brain tumors using neural stem cells that are genetically modified to carry a tumor-killing drug.
DR1-01423	Emmanuel Baetge	Novocell, Inc		$19,999,937
	Co-PI: Jeffrey Bluestone	University of California, San Francisco
	The group proposes to treat people with type 1 diabetes by implanting insulin-producing cells generated from human embryonic stem cells.
DR1-01426	Mitchel Berger	University of California, San Francisco		$19,162,435
	Co-PIs: Webster Cavenee	Ludwig Institute for Cancer Research
	Evan Snyder	Burnham Institute for Medical Research
	The group proposes to treat brain tumors using neural stem cells that are genetically modified to carry a tumor-killing drug.
DR1-01430	Dennis Carson	University of California, San Diego	Canada	$19,999,826
	Co-PI: Catriona Jamieson	University of California, San Diego
	International Partner: John Dick	University Health Network
	The group intends to develop six drugs – three monoclonal antibodies and three small molecules – to destroy leukemia stem cells.
DR1-01431	Irvin Chen	University of California, Los Angeles		$19,999,580
	Co-PI: Geoff Symonds	Calimmune, Inc
	This group proposes to treat HIV/AIDS using an RNA interference approach to modify the patient’s blood-forming stem celis. When transplanted back, those cells will produce T cells that are resistant to HIV infection.
DR1-01444	Mark Humayun	University of Southern California	MRC	$15,904,916
	Co-PIs: David Hinton	University of Southern California
	Dennis Clegg	University of California, Santa Barbara
	International Partner: Peter Coffey	University College London-Institute of Ophthalmology
	The group intends to treat macular degeneration using transplant retinal cells derived from human embryonic stem cells.
DR1-01452	Donald Kohn	University of California, Los Angeles		$9,212,365
	Co-PIs: Thomas Coates	Children’s Hospital of Los Angeles
	Victor Marder	University of California, Los Angeles
	The group proposes to treat sickle cells disease using a gene therapy approach to modify the patient’s blood-forming stem cell so that they produce normal red blood cells.
DR1-01454	Alfred Lane	Stanford University		$11,709,574
	Co-PIs: Anthony Oro	Stanford University
	Marius Wernig	Stanford University
	The group proposes to treat the skin disease epidermolysis bullosa using genetically modified iPS cells created from the patient’s own skin cells.
DR1-01461	Eduardo Marban	Cedars-Sinai Medical Center		$5,560,232
	The group intends to repair heart tissue damaged by heart attack using stem cells taken from the patient’s own heart.
DR1-01471	Samuel Pfaff	The Salk Institute for Biological Studies		$15,644,881
	Co-PIs: Lawrence Goldstein	University of California, San Diego
	Don Cleveland	Ludwig Institute for Cancer Research
	The group intends to treat people with Amyotrophic lateral sclerosis by implanting precursor astrocyte cells derived from human embryonic stem cells.
DR1-01477	Dennis Slamon	University of California, Los Angeles	Canada	$19,979,660
	Co-PIs: Garry Nolan	Stanford University
	Michael Press	University of Southern California
	International Partner: Tak Wah Mak	University Health Network
	The group proposes to develop drugs that destroy the cancer stem cells in solid tumors.
DR1-01480	Gary Steinberg	Stanford University		$20,000,000
	Co-PI: Stanley Carmichael	University of California, Los Angeles
	The group intends to treat stroke using implanted neural stem cells derived from human embryonic stem cells.
DR1-01485	Irving Weissman	Stanford University	MRC	$19,999,996
	Co-PIs: Ravindra Majeti	Stanford University
	Beverly Mitchell	Stanford University
	International Partner: Paresh Vyas	Weatherall Institute of Molecular Medicine, Oxford University
	The group intends to generate a monoclonal antibody that destroys leukemia stem cells.
DR1-01490	John Zaia	City of Hope National Medical Center		$14,583,187
	Co-PIs: Paula Cannon	University of Southern California
	David DiGiusto	Beckman Research Institute of City of Hope
	This group proposes to treat HIV/AiDS using a gene therapy approach to modify the patient’s blood-forming stem celis. When transplanted back, those cells will produce T cells that are resistant to HIV infection.
Total funding				$229,772,018

 

 

 

 

 

 

 

 

 

 

 

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.

Re-Impose Bush Ban? Research Opponents Hope to Turn Back the Clock

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 23^rd. 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 17^th—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.