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1.: FDA "PUTS HOLD" ON STEM CELL TRIALS—WHY? From: Stephen Meyer

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1.: FDA "PUTS HOLD" ON STEM CELL TRIALS—WHY?

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

Mon May 19, 2008 12:05 pm (PDT)

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

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