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Cancer is prevalent in my family. My mother died young (58) of breast 
cancer; my older sister died of leukemia, a form of blood cancer (age 23); 
my younger sister is battling both cancer and leukemia right now.

So when I hear that the field of stem cell research may be held up because 
of the possibility of cancer, how shall I feel? Cautious, definitely. Cancer 
is a serious risk.  But the only way any of us can keep safe from cancer 
altogether is to live on a different planet.  The air we breathe, the water 
we drink-polluted. The food we take into our bodies-chemicals, pesticides, 
preservatives, all known carcinogens.

Should we stop the research because of that fear?  Should we say, no human 
trials with embryonic stem cells until we can guarantee there are no risks 
at all?
 In other words, never?

As you know (if you have suffered through this column for any length of 
time) the FDA is considering allowing human trials for embryonic stem cell 
therapies.
 April 10th was a hearing, and the transcript is available online, at the 
FDA page. (http://www.fda.gov) The search box is at the upper right corner 
of the page, type in embryonic, then choose the April 10th hearing 
transcripts if you want to read the complete word-by-word testimony. Some 
parts of the hearing were closed, I understand, but you can definitely get 
the message.

The number one topic-voiced on almost every page of the transcript-is the 
fear of cancer.
 Over and over and over, statements are made about cancer and teratomas and 
tumors, as if our field was as dangerous as tobacco, which of course is 
allowed.
Numerous statements are made about not allowing the trials to go forward 
until all possible threats of cancer are removed.

Is there a risk of cancer?
 Here are the facts, as plain as I understand them, and always with the 
proviso that I am neither scientist, nor doctor.
 If a scientist were to put pure embryonic stem cells into my body, there 
would almost certainly be a teratoma. A teratoma is a lump, a growth, a 
tumor-not cancer. A teratoma is harmless of itself, unless it grows in a 
place where any lump would be dangerous-like the spine. We don't want it, 
but a teratoma is not cancerous.

Also-and this is important- a teratoma comes (if it does) only when 
undifferentiated embryonic stem cells are put in. To the best of my 
knowledge, no scientist wants to do this-nobody wants to put 
undifferentiated cells in. They want to differentiate (change) the cells 
first.  Think of a carpenter's nails, screws, nuts and bolts. These all 
begin as hot liquid metal, very dangerous to work with-but we do not use 
them in that formless shape-at the nail factory, the molten iron is poured 
into molds, and shaped, and cooled. We only use them when the metal is 
completely set.

Same with stem cells. The embryonic stem cells are 
differentiated-shaped-into whatever kind of cell is needed. We use them only 
after differentiation.
 In the Keirstead/Geron experiments, that means oligodendrocytes, cells to 
create myelin, cells to insulate damaged nerves in the spine.
 These are already differentiated.

For the past few days I have been struggling with the nearly 300 page FDA 
report, the transcript of the April 10th hearing on embryonic stem cells and 
"safety". I put that in quotes because that is not all that is being 
debated; there is also the unsaid agenda which everybody carries.

All of us have a plan. With me, it is to advance the research.
 With some of the folks in the hearings, it seems to be the opposite-what 
kind of logical-sounding excuse can they come up with that will delay human 
trials?
 It is never easy, guessing the intent of people's minds. Honorable folks 
can disagree. Very intelligent folks, doctors and scientists, and as always, 
part of me wants to say, well, these folks are smarter than me, let them 
alone, don't make a fuss.

But everybody on earth is smarter than me in one thing or another-that does 
not mean I am going to keep silent. Not to mention I am a parent, and this 
affects my paralyzed son, and millions like him, all around the world, 
somebody's loved one, afflicted with one incurable condition or another.  I 
don't intend to be on my deathbed (many years from now!) and there is my son 
in his wheelchair beside me-still in his wheelchair? I am sure he would be 
polite and not actually say, gee Dad, if only you had stepped up to the 
plate.

No, before I head into the great beyond, I intend to see my son on his feet: 
walking around, kicking a soccer ball, or kicking an anti-science 
politician-sorry.
 So I will always voice my opinion, no matter how much more qualified the 
opposition may be.
 And I will also have a backup plan.  So here it is, my secret backup plan.

Roman and I will probably go to China.
 Not now, of course. The research is not ready.  But when it is, I think the 
Chinese will bring it together first. That's why I'm studying Mandarin every 
day, one hour, without fail: tapes in the car, books by my bedside, little 
cards in my wallet.
 When the time is right, I will borrow on my house again, like I did when 
Rome was injured, and we will go.

I will work with a Chinese spinal cord injury surgeon (some of whom already 
do 300 traditional spinal cord operations in a year), and a scientist or 
two, make sure everyone knows exactly what has to be done (always assuming 
Roman agrees, of course) telling them in two languages exactly the mix of 
stem cells and neurotrophic agents or whatever has to be administered.

After the operation, I figure it will take six months of rehabilitation, 
which we will do in China also, because we could not afford it here, even 
borrowing on the house.

Why China? Why not stay in my own land, especially since I honestly believe 
the research breakthroughs will happen here?
 There is an American option, of course. I will write about that in the near 
future.  But to go from idea to implantation, the way it looks now, there 
are too many road blocks in the way.  Naturally, I will be working to remove 
those obstacles, but. in a few minutes I will pick up my Chinese/English 
dictionary and start the morning practice. Maybe I am wrong.  I hope I am.

But when I see cancer fear being systematically spread-even hyped!-- in the 
FDA report, it feels like they are just going through the motions, after 
which they fully intend to deny the trials. Right now, as you know, the FDA 
orally notified Geron that the trials were "on hold", for unspecified 
reasons.  Geron is waiting for a letter from the FDA explaining those 
reasons.

It is my guess the FDA will deny the trials. The letter will say something 
like there are too many risks for the trials to go forward at this time, and 
here are a list of impossible conditions that must be met first, before 
embryonic stem cell research is allowed a chance.  If I am wrong, fine. 
Some good people tell me, don't worry, be patient, just wait-- the next 
President will fix things.

But what if the FDA establishes guidelines that are impossible to meet, and 
those guidelines have to be overturned before human trials can take place?
 It will be very hard for new FDA scientists to overturn safety standards, 
even misguided ones.  If the stem cell trials are blocked by unfair tactics, 
like setting the safety bar impossibly high, you and I will need to speak 
up.

Start thinking about this. Discuss it with your friends. Think about groups 
you belong to, media folks you may know.Get ready.

Don Reed
www.stemcellbattles.com






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Rayilyn Brown
Board Member AZNPF
Arizona Chapter National Parkinson's Foundation
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