FDA "PUTS HOLD" ON STEM CELL TRIALS-WHY?
 The Food and Drug Administration has telephoned Geron (just a phone call!) 
to tell them they may not proceed with their stem cell trials: that the 
paralysis treatment that was to have been tried on people-the world's first 
human trials with embryonic stem cells!--has once more been delayed.
 Let's back up a little.
 First, as you know, the FDA is a government agency, with the power to say 
yes or no to human trials of new medicines, products, and therapies.
 If they said yes to Geron, the corporation would offer special stem cells 
(oligodendrocytes, made from human embryonic stem cells, from the 
Presidentially-approved stem cell lines) to about forty newly-paralyzed 
people. The cells would hopefully re-insulate (remyelinate) damaged nerves 
in the patient's injured spine, and possibly alleviate the horrific 
condition.
 The potential treatment was pioneered by Dr. Hans Keirstead, originally 
funded by the Roman Reed Spinal Cord Injury Research Act. It became real for 
me on March 1, 2002, at the University of California at Irvine. On that day, 
I held in my hand a laboratory rat which had been paralyzed, but which now 
walked again-and this while my paralyzed son sat in his wheelchair, a few 
feet away.
 This first Geron treatment would only affect newly paralyzed people, whose 
injury was in the "acute" stage, just hours after the accident. It would not 
help my son, or any other person with a "chronic", or older injury.
 But what a tremendous step forward it would be, to ease a condition long 
considered incurable.
 Geron would be paying for the human trials, putting nearly the entire net 
worth of their company behind embryonic stem cell therapies.  They and Dr. 
Keirstead worked closely with the FDA, following its instructions, 
determined nothing should be overlooked.
 Then came the first official hearings: April 10th, 2008.
 The hearings, it seemed to me, were politicized: in my view, the people in 
charge did not seem to want the trials to go forward, and were looking for 
excuses to stop it. (I wrote two previous columns on which can be found in 
the archive sections of Karen Miner's and my website, 
www.stemcellbattles.com/archives:
 #436 Friday, April 25, 2008
FDA STEM CELL HEARINGS POLITICIZED?
 #439 Tuesday, May 6, 2008
THE DREAM, OR THE NIGHTMARE: Stem Cell Crisis Approaching?
 I also spoke at the Independent Citizens Oversight Committee, voicing those 
concerns.
ICOC Chair Bob Klein expressed concern: that the FDA might put in a 
condition that embryonic stem cell trials might only be allowed for dying 
patients. This would be a disaster, meaning that human trials for embryonic 
stem cells to heal blindness as well as paralysis could not go forward, for 
example.  He asked for volunteers on the board to be on a special FDA 
committee. Board members Jeff Sheehy and Leesa Gibbons volunteered for the 
chore!
But the overall response from almost everyone (and these are supporters of 
the research, good people, whose opinions I respect) was that the situation 
would be handled on the basis of scientific merit, and the safety of the 
patients, nothing more. Again and again people said, no, no, everything is 
fine, don't worry.
But I do worry. It seemed to me that the people on the FDA committee were 
adult stem cell research supporters, and that we were up against a stacked 
deck.
What if the committee had already decided not to let the human trials to go 
forward, because of political considerations?
As I see it, the Bush Administration is firmly opposed to embryonic stem 
cell research, and would gladly block it.
Whether the FDA was independent of politics, I had no way of knowing.
And then, the other shoe dropped.
The FDA telephoned Geron and told them the trials were "on hold": blocked. 
Why? For how long? We are not told.
Here is part of Geron's official press release.
 ".the company received verbal notice today from the FDA that the company's.cell 
therapy for spinal cord injury.has been placed on clinical hold. an order 
that the FDA issues to a sponsor to delay a proposed trial or to suspend an 
ongoing investigation.
"We have not yet received a letter from the FDA explaining the decision to 
place the submission on hold, so we are unable to comment specifically," 
said Thomas Okarma, Ph.D, M.D., Geron's president and chief executive 
officer. "Once we have the letter and have had a discussion with the agency, 
we will communicate our findings.We are disappointed with this action given 
the interactions we had with the FDA over four years leading to the filing, 
and the breadth and depth of the submission, some 21,000 pages, predicated 
on those discussions with the agency.".  (for more information, visit 
www.geron.com)
What does this mean?
The delay could be completely innocent: a need for more clarification, a 
misunderstanding, the simple lack of time (the FDA is chronically underpaid 
and understaffed). It could be a legitimate concern for safety.
Or it could be politics.
I called up Dr. Okarma, and asked him what he thought. He repeated what had 
been said above, but added that we should know in two to three weeks.
That is how long it should take for the FDA's letter to be transmitted to 
Geron.
Then we will know the reasons for the delay.
Maybe there will be sensible reasons.
And if not? If the bar for approval is set inappropriately high, if unfair 
conditions are attached, so the chance for progress is delayed or denied?
Then, folks, it is the advocates' hour.
If the FDA letter shows signs of being a political attack: our duty is 
clear.
In every state across the land, advocates must lead.
We will need every group to respond, and not just their boards, but their 
membership: every advocate will need to write letters and make phone calls 
to the media, and to our elected officials.
Politics must not deny good health to our families, and that means the best 
research must be allowed to go forward, untrammeled by political 
restrictions.
I was on a phone conference with CAMR (the Coalition for the Advancement of 
Medical Research) yesterday, and I raised the issue, and one member said:
"CAMR will probably not take part in a decision affecting a private 
company-unless there seem to be political attacks on embryonic stem cell 
research."
Which is precisely my point.
Political attacks on embryonic stem cell research cannot be allowed in the 
Food and Drug Administration; these folks must be above political 
maneuverings.
If the process has been interfered with by ideology, we must act.
So what do we do now?
We get ready.
May I suggest you consider contacting your friends, telling them to prepare 
for a major policy offensive?
When that letter from the FDA is released, its contents must be studied, 
carefully, by every patient advocate (leadership or not) in the country.
And if it is bad news, unfair conditions imposed to block progress, then we 
do everything in our power to rouse the country.
We will need to make this the biggest news story around.
Every media outlet can and should be contacted.
Editorial boards of newspapers should be approached, both in person, and by 
letter writing.
People in wheelchairs must speak and be seen on every television channel.
Voices never heard before must emanate from every radio station.
Because this is not just about paralysis.
This is for everyone-- and the fight must come from everyone as well.
Neither age nor condition must disqualify our involvement. So many times I 
have been told by champion advocates: "I am too old for cure to come for me; 
this is for my grandchildren, so they will not have to go through what I 
have endured."
Whether an advocate fights from a wheelchair or hospital bed, from a student's 
desk or a homemaker's kitchen, they-we-are striking a blow, not just for 
ourselves, but for our families, and our loved ones, healthy or not.
One hundred million Americans suffer disease or disability which stem cell 
research may one day alleviate, or cure.
If we speak as one, we can never be ignored again.
Don Reed
www.stemcellbattles.com

Rayilyn Brown
Board Member AZNPF
Arizona Chapter National Parkinson Foundation
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