Tuesday, November 29th, my paralyzed son Roman Reed and I attended the farewell party of the Geron stem cell research department.
Roman squeezed his wheelchair in beside Chief Scientist Jane Lebkowski, Joe Gold, sixteen years at Geron, and Kate Spink, who had organized the world's first human trials with embryonic stem cells.
It was a roomful of giants: 66 of the world's best stem cell research scientists and technicians. They had succeeded in the initial stage of the world's first human embryonic stem cell trials. These were safety trials for GRNOPC1, a stem cell product which might ease previously-incurable spinal cord injury paralysis -- they should have been lauded as heroes -- instead they were losing their jobs.
It would be different if their experiment had failed. But they had done everything right, played by the rules all the way: and in so far as they had been allowed to go, they had triumphed.
By FDA requirements, the first trial for any new drug or therapy must be safety. Could the cells be injected into a newly-paralyzed person without doing them harm? Opponents of the research had always maintained that the stem cells would cause cancer.
Didn't happen. There was no harm done to any of the patients.
The second step would have been to inject significantly larger quantities of cells into other newly-injured patients, perhaps five times as much, to see if there was a positive effect. The cells injected would be increased from roughly two million cells to as much as ten million -- a couple teaspoonsful, small in quantity but potentially huge in impact.
But this next step, as well as the final one to try a much larger group of patients, will not take place with Geron.
Why were the trials stopped, if they were going well? The immediate answer is financial. To take a new therapy or medicine to market is incredibly costly. The price was just too high for Geron, a small company, though it always fought above its weight class.
But political harassment is part of the picture as well: the hate-filled propaganda the Religious Right and their allies in the Republican party had spewed at supporters of the research, as well as actual political attacks, laws proposed to fine scientists, even jail them for research. There was also favoritism shown the "less controversial" adult stem cell research, funded lavishly compared to the embryonic variety. In 2008, for example, human adult stem cell research received $297 million in federal funds -- embryonic, only $88 million. Even now, under a far more progressive Administration, adult stem cell research receives nearly triple the funding ($341 million compared to $125 million) of embryonic.
The result? A small company had to do much of the work the federal government should have done.
But no matter the political obstacles: the people of Geron (especially including their indomitable CEO Tom Okarma) changed the equation. Never again should a newly paralyzed person be told what my son was told -- that there was no hope.
Katy Spink said to her colleagues: "Time after time over the past eight years, I have seen you deliver on goals that the rest of the world has considered to be impossible...Together, we have pushed back the bounds of medicine forever."
Joe Gold: "The methods we've discovered to grow human embryonic stem cells... are now essential tools being used by researchers all over the world... We forged a path that not only educated the FDA but also provided a route for others to bring future life-changing therapies to people who desperately need them... we have all been part of something that has changed the world."
And Jane Lebkowski: "You faced social, religious, scientific, financial, regulatory, clinical and media challenges, yet you overcame all these hurdles with rigor, integrity, and grace... the technology will continue to be developed because you have shown that it is possible. ..
"We should remember the words of Senator Edward Kennedy:
"The work goes on, the cause endures, the hope still lives -- and the dream shall never die."
Follow Don C. Reed on Twitter: www.twitter.com/diverdonreed
It is one thing to close a trial to further enrollment for scientific reasons, such as a problem with trial design, or for ethical reasons, such as an unanticipated serious risk of harm to participants. It is quite another matter to close a trial for business reasons, such as to improve profit margins.
Read more: http://www.thehastingscenter.org/Bioethicsforum/Post.aspx?id=5640&blogid=140#ixzz1fVbS4zSO
SOme religious heads get their inspriation from studying one book, others get their religious inspiration from studying creation. It would be nice if those that limit their religious inspiration to just one book were able to appreciate and marvel at ALL of creation. then they might appreciate science as a religiously inspired disclipline. scientists have the best data on creation.
I thought that embryonic stem cells had the problem of fighting the immune system and plouripoint stem cells were considered the most promising path forward? It would be nice if private sector fanatics were able to appreciate that bottom up and top down organization control systems compliment each other. they do not cover the same area, and thus a mix of these approaches is more adaptable to solving a wider area of problems. technology and medtech need long term high risk investment. something gov is better at covering than the impatient capitalism practiced today.