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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] > > ---------------------------------------------------------------------- > To sign-off Parkinsn send a message to: mailto:[log in to unmask] > In the body of the message put: signoff parkinsn > ---------------------------------------------- This mail sent through http://www.ukonline.net ---------------------------------------------------------------------- To sign-off Parkinsn send a message to: mailto:[log in to unmask] In the body of the message put: signoff parkinsn