Stem Cell Research Information + Impact

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1.: #446 Friday, May 30, 2008 - FDA, THE CANCER SCARE, AND MY SECRET PLA From: Stephen Meyer

2.: Australian Quadriplegic Thanks Maverick Indian Stem Cell Doctor From: Stephen Meyer

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1.: #446 Friday, May 30, 2008 - FDA, THE CANCER SCARE, AND MY SECRET PLA

Posted by: "Stephen Meyer" Stephen276@comcast.net stephen_meyer_stemcells

Fri May 30, 2008 1:04 pm (PDT)

#446 Friday, May 30, 2008 - FDA, THE CANCER SCARE, AND MY SECRET PLAN

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 <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 <http://www.stemcellbattles.com/>

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2.: Australian Quadriplegic Thanks Maverick Indian Stem Cell Doctor

Posted by: "Stephen Meyer" Stephen276@comcast.net stephen_meyer_stemcells

Fri May 30, 2008 1:10 pm (PDT)

Australian Quadriplegic Thanks Maverick Indian Stem Cell Doctor for
Ability to Breathe
Tuesday, May 27, 2008
[http://www.foxnews.com/images/service_skynews_36.gif]
[http://www.foxnews.com/images/373219/1_61_052708_quadriplegic.jpg]
<http://www.foxnews.com/story/0,2933,358801,00.html#>

SkyNews

Perry Cross

* <http://www.foxnews.com/story/0,2933,358801,00.html#>
* <http://www.foxnews.com/story/0,2933,358801,00.html#>

A man who is paralyzed from the neck down says he can now breathe on his
own after having controversial embryonic stem cell treatment in India.

Perry Cross is the most high-profile patient to have traveled to India
to be injected with the cells - which are banned in his own country
Australia and most of the West.

He was left a quadriplegic after being injured playing rugby when just
19 years old and has no movement below his neck.

He has to be connected to a ventilator to breathe and has spent the past
14 years searching for treatment which might help him regain any
movement.

During this time, Mr. Cross met Superman actor Christopher Reeve and
became the actor's ambassador for stem cell research in Australia.

He has since spoken at the United Nations and is a regular contributor
to television <http://www.foxnews.com/story/0,2933,358801,00.html#> and
radio debates on the virtues of the research.

He also set up a Foundation to raise money to help find new ways to
fight paralysis, which is supported by star Australian cricketer Adam
Gilchrist.

"After 14 years of no change at all since my accident, I can now breathe
on my own," he told Sky News.
"You know, you put your lottery numbers in every week and I feel by
coming here, my lottery numbers have finally come up."
It took a huge leap of faith to travel to India.

The doctor who is administering the stem cells is a controversial figure
in her own country and abroad.

Dr. Geeta Shroff is viewed as a bit of a maverick within the medical
world because of her fierce determination to do her work under her own
terms and in her own way.

She researched her treatment without any grants or financial help and
virtually single-handedly developed it over two years, beginning the
work in a small lab she set up in her garage.
She now has two hospitals in the capital New Delhi where she treats her
own countrymen and women who have terminal conditions or incurable
afflictions.

But she also has an increasing number of international patients - mainly
from countries like Australia, America and Britain where there are much
tighter controls on the use of embryonic stem cell treatment.
Consequently she has fallen out with much of the conventional medical
establishment for steadfastly refusing to publish papers outlining her
methods, research and technique.
Instead she has applied for a patent on her treatment to stop others
from copying and marketing her work.

Dr. Shroff's critics point out that without knowing exactly what she is
injecting and without proper clinical trials
<http://www.foxnews.com/story/0,2933,358801,00.html#> , it is impossible
to say whether there are any long term side-effects and whether the
treatment is safe.

She insists that over the five years she has been administering her
treatment no patient has shown any adverse reactions.

Under Indian law, she is allowed to treat terminally ill and incurable
conditions such as Parkinson's Disease, spinal injury and
Alzheimer's.

But this has led her detractors to claim she is offering false hope to
desperate people and is essentially using them as guinea pigs.

Perry Cross - along with many of the 500 other patients Dr. Shroff is
treating - is unconcerned by the controversy.

"I cannot tell you how restricting my life is in so many ways," he says.

"I can't breathe on my own, I can't bathe on my own. I can't swim or get
wet, the list of things I can't do are a mile long. Why wouldn't I try
everything?"

His team of carers who look after him 24/7 are astonished at his
progress in the last two months since he traveled to India and started
receiving injections every day.

Most of them have been with him for many years.

"This is massive," said one, "We have tried so many times over the years
to get him off the ventilator but never could. It's amazing."

It has given him hope that with more stem cell treatment he may even be
able to develop movement elsewhere in his body.

"Even if I managed to move a finger or one hand, it would be worth it,"
he says.

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