so - "misunderstand" the phone call - didn't hear the word "not" :)

Quoting rayilynlee <[log in to unmask]>:

>     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
> [log in to unmask]
> 
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