Bernie:
We have brought the world together for three days.
I am personally moved by the support from the entire state from the governor on down.
I declare this meeting adjourned.
Tuesday, September 23, 2008
Laurie Zoloth, Northwestern University
Stem cell debates have their own weather . . .they created their own storm and always took place on a certain landscape.
The rest of the world had its own debate . . . but ours was predicated on this notion of "moral authority". The Bush doctrine.
The debate in stem cell science was driven by the same arguments that drove so many debates --notably the one about the economy that has brought us to a crisis.
The American taxpayer dollar is less and less available to scientists . . . several arguments have made their way into our consciousness--all wrong.
1. A free market is inherently just. No regulation is the best regulation.
2. When the wealthy are happy, the poor are happy. Policies that get some people rich will also help those at the bottom
3. You can just bank on an infinitely expandable future in every area.
4. Sheer individual determination can get you what you desire.
5. We need to be accommodating.
All wrong. The American economic catastrophe happened because liberals have been too accommodating . . . we need to stand up for what we believe: the enlightenment, the scientific method, the power of reason. The community has its own place alongside individual determination. The future is not infinitely expandable. There are many policies that benefit the wealthy that also harm the poor, and de-regulation of the mortgage industry is one of them. A free market has built-in inequities that will eventually harm it as a whole as well as cause damage to many of its members.
We have not defended and fought effectively for these ideas.
You, the advocates, made the research possible by forcing the issue. When the election is over and the science goes forward, it will be time to take on the real moral issues, and the advocates will need to be ready to take on those issues. Who gets cured? Who pays for those cures? Who makes those decisions?
It's almost the end.
The rest of the world had its own debate . . . but ours was predicated on this notion of "moral authority". The Bush doctrine.
The debate in stem cell science was driven by the same arguments that drove so many debates --notably the one about the economy that has brought us to a crisis.
The American taxpayer dollar is less and less available to scientists . . . several arguments have made their way into our consciousness--all wrong.
1. A free market is inherently just. No regulation is the best regulation.
2. When the wealthy are happy, the poor are happy. Policies that get some people rich will also help those at the bottom
3. You can just bank on an infinitely expandable future in every area.
4. Sheer individual determination can get you what you desire.
5. We need to be accommodating.
All wrong. The American economic catastrophe happened because liberals have been too accommodating . . . we need to stand up for what we believe: the enlightenment, the scientific method, the power of reason. The community has its own place alongside individual determination. The future is not infinitely expandable. There are many policies that benefit the wealthy that also harm the poor, and de-regulation of the mortgage industry is one of them. A free market has built-in inequities that will eventually harm it as a whole as well as cause damage to many of its members.
We have not defended and fought effectively for these ideas.
You, the advocates, made the research possible by forcing the issue. When the election is over and the science goes forward, it will be time to take on the real moral issues, and the advocates will need to be ready to take on those issues. Who gets cured? Who pays for those cures? Who makes those decisions?
It's almost the end.
Owen Hughes, Pfizer
Law and regulation are what happen to us when we lose trust.
So, there's been a loss of trust from stakeholders on so many sides of this issue. Academics, business people,
He's talking about patents and the strange mess we're probably about to find ourselves in. The bush policy which limited NIH support defined an area where funding cannot go; the burden it imposed on everybody trying to do both kinds of work was pure overhead.
And how does it work when the government marches in and takes control of what you created partially using their money (this is called a reach through) -- a catastrophe . . . but only avoidable with fully understood and clear regulations, like at the NIH.
So now if a state tries to protect its investment, the law is not well understood. The CIRM is operating as a part of the CA government, and its policies have the force of law. Nobody quite knows yet how it will play out . . . and it will get more complicated if the NIH decides to enter the funding arena. The trigger points for the reach through events will be different for feds and states, and we don't clearly know what they are.
You'll have a federal agency, a state agency, private investors, and maybe foreign nationals all with a financial stake in how it plays out.
Time now to overcome the vacuum in which we've been operating during the Bush administration. Won't be simple.
So, there's been a loss of trust from stakeholders on so many sides of this issue. Academics, business people,
He's talking about patents and the strange mess we're probably about to find ourselves in. The bush policy which limited NIH support defined an area where funding cannot go; the burden it imposed on everybody trying to do both kinds of work was pure overhead.
And how does it work when the government marches in and takes control of what you created partially using their money (this is called a reach through) -- a catastrophe . . . but only avoidable with fully understood and clear regulations, like at the NIH.
So now if a state tries to protect its investment, the law is not well understood. The CIRM is operating as a part of the CA government, and its policies have the force of law. Nobody quite knows yet how it will play out . . . and it will get more complicated if the NIH decides to enter the funding arena. The trigger points for the reach through events will be different for feds and states, and we don't clearly know what they are.
You'll have a federal agency, a state agency, private investors, and maybe foreign nationals all with a financial stake in how it plays out.
Time now to overcome the vacuum in which we've been operating during the Bush administration. Won't be simple.
Alta Charo, UMadison, Wisconsin
A look backward in time . . . the politics go all the way back to Roe V Wade in 1973, which led to special legislative rules involving fetuses, which led to same for embryos.
1980 - 1992 were years in which all science was suspended because there was no regulatory board to review proposals. The Reagan and Bush I administrations simply didn't have a review board. Simple solution.
During Clinton, we got a review board . . . and an advisory panel which took 9 months to come out with ethical guidelines, which were basically a plagiarized version of what already existed in the UK.
Then the Democrats were routed from the congress in 1994, and Clinton got very timid about this area. Embryo research was specifically mentioned in the Contract With America. The Dickey amendment was passed in 1995 and is still the law.
In 1998 when we first got stem cells to work on, we had to focus on lines because of that amendment.
In 2001 we had only funding for existing lines so that the gov't couldn't be somehow accused of enticing people to kill embryos.
The result is that we have no rules -- no funding from the feds means that there are no federal rules.
Instead we got state rules along with state funds. When states give you money they have to give you rules as well to say how you can spend it. So now we have a patchwork of funds and rules across the nation that was abandoned by its own federal government. There are also players from around the rest of the globe at work in our country.
So now we have to figure out what the rules are in which people will figure out how to collaborate. We can assume that whoever wins in Nov, we will have federal funds and that also means federal rules . . . but . . . federal law does not eliminate or necessarily override state rules . . . and it doesn't do anything at all to privately funded efforts.
How the hell are we going to come up with a coordinated set of rules . . .it will all be a legislative and bureaucratic slog. It will take a very long time. And the Dickey amendment will still be in force under the congress manages to do its thing.
We may see a dismal parade of scientists traipsing from agency to agency, trying to figure out under what rules they have to operate . . .
So, let's say the scientists somehow navigate that arena and then approach the FDA for permission to carry out their trials. In the 60's and 70's we loved the slowness of the FDA because it kept American women from taking thalidomide as they did in Canada and the UK. During the 80's and 90's there was pressure to hurry up and get things done a lot faster. Then about 5 or 6 years ago there was a slew of drugs subjected to intense intention from the public and the policy community . . . and the slowdown became the right way to go again.
So here we are with translational research in stem cell therapy. The FDA is in Mode Caution, not Mode Aggression. They want to know how confident we are that we're making safe decisions. How pure must your lines be? How many undifferentiated cells are in your transplants? Do we need medical records from the original donors of embryos from 9 years ago? Do we need to maintain immuno-suppressed animals for months and months and months to be sure that tumors are not forming? Will we be forced repeatedly to start over because our animals die of infections before our data is collected?
Okay, let's say that all that gets dealt with. Woo hoo, clinical trials. Uh oh. We now have a HUGE demand, lots of it from people who believe that their condition is going to kill them before they can get the drug. Think about thousands of people demanding to take part in clinical trials . . .ACT UP is the model.
There will somehow have to be access to treatments that have not been tested yet. They did that with the Aids patients -- but this is a biologic and not a drug. And biologics are much more complex and detaile--not to mention expensive- to manufacture than drugs . . . but we're going to have to figure out how to do it. The reason is that Americans are always ready to believe that the newest thing is the best.
But, let's say that all that gets dealt with. Woo hoo, new therapies. Uh oh. We now have the greatest new thing since sunlight in every headline, and that will mean a ton of people ready to buy it who HAVE NO healthcare. Big new struggle.
For 35 years the conversation about stem cell research has focused on the moral status of the embryo . . . let's get over it already.
For my money, the ethical issues are just beginning.
Great talk.
1980 - 1992 were years in which all science was suspended because there was no regulatory board to review proposals. The Reagan and Bush I administrations simply didn't have a review board. Simple solution.
During Clinton, we got a review board . . . and an advisory panel which took 9 months to come out with ethical guidelines, which were basically a plagiarized version of what already existed in the UK.
Then the Democrats were routed from the congress in 1994, and Clinton got very timid about this area. Embryo research was specifically mentioned in the Contract With America. The Dickey amendment was passed in 1995 and is still the law.
In 1998 when we first got stem cells to work on, we had to focus on lines because of that amendment.
In 2001 we had only funding for existing lines so that the gov't couldn't be somehow accused of enticing people to kill embryos.
The result is that we have no rules -- no funding from the feds means that there are no federal rules.
Instead we got state rules along with state funds. When states give you money they have to give you rules as well to say how you can spend it. So now we have a patchwork of funds and rules across the nation that was abandoned by its own federal government. There are also players from around the rest of the globe at work in our country.
So now we have to figure out what the rules are in which people will figure out how to collaborate. We can assume that whoever wins in Nov, we will have federal funds and that also means federal rules . . . but . . . federal law does not eliminate or necessarily override state rules . . . and it doesn't do anything at all to privately funded efforts.
How the hell are we going to come up with a coordinated set of rules . . .it will all be a legislative and bureaucratic slog. It will take a very long time. And the Dickey amendment will still be in force under the congress manages to do its thing.
We may see a dismal parade of scientists traipsing from agency to agency, trying to figure out under what rules they have to operate . . .
So, let's say the scientists somehow navigate that arena and then approach the FDA for permission to carry out their trials. In the 60's and 70's we loved the slowness of the FDA because it kept American women from taking thalidomide as they did in Canada and the UK. During the 80's and 90's there was pressure to hurry up and get things done a lot faster. Then about 5 or 6 years ago there was a slew of drugs subjected to intense intention from the public and the policy community . . . and the slowdown became the right way to go again.
So here we are with translational research in stem cell therapy. The FDA is in Mode Caution, not Mode Aggression. They want to know how confident we are that we're making safe decisions. How pure must your lines be? How many undifferentiated cells are in your transplants? Do we need medical records from the original donors of embryos from 9 years ago? Do we need to maintain immuno-suppressed animals for months and months and months to be sure that tumors are not forming? Will we be forced repeatedly to start over because our animals die of infections before our data is collected?
Okay, let's say that all that gets dealt with. Woo hoo, clinical trials. Uh oh. We now have a HUGE demand, lots of it from people who believe that their condition is going to kill them before they can get the drug. Think about thousands of people demanding to take part in clinical trials . . .ACT UP is the model.
There will somehow have to be access to treatments that have not been tested yet. They did that with the Aids patients -- but this is a biologic and not a drug. And biologics are much more complex and detaile--not to mention expensive- to manufacture than drugs . . . but we're going to have to figure out how to do it. The reason is that Americans are always ready to believe that the newest thing is the best.
But, let's say that all that gets dealt with. Woo hoo, new therapies. Uh oh. We now have the greatest new thing since sunlight in every headline, and that will mean a ton of people ready to buy it who HAVE NO healthcare. Big new struggle.
For 35 years the conversation about stem cell research has focused on the moral status of the embryo . . . let's get over it already.
For my money, the ethical issues are just beginning.
Great talk.
John McNeish, Pfizer
John is the executive director of regenerative medicine for Pfizer.
I really believe stem cell technology is at the tipping point -- and whenever you approach this kind of event it's very important to bring all the parties together.
We've been using stem cells as tools for drug discovery for 15 years now -- and my little sound bite is: better cells mean better drugs.
We've tried to take the lead in recognizing regenerative therapies, as well as cancer. We think that not so far in the distant future cells will actually be therapies, and that stem cells can be used to deliver therapies, to get drugs to where we need them to go.
Then there are combination therapies, in which your cell does both jobs -- delivers a molecule and acts as a healant itself.
iPS is all about making time go backwards . . . we have a lot of work to do with iPS cells and their derivatives.
Somewhere between 10 and 15% of all drugs brought into safety trials fail because of arrhythmia . . . so if we can make cardiomyocytes (heart cells) we could use them to prevent all those failures
They've done testing to show that cells in vitro behave exactly as they do in vivo under the influence of hundreds of drugs. This means that what happens to a living cell in the lab is exactly the same, functionally and chemically, as what happens to it inside a living body.
Small molecules modify stem cell fate . . .this gives us hope that you can identify drug-like molecules that will get stem cells to do what you want them to do in vivo.
He's talking about directed differentiation and tons and tons of testing in the lab followed by more of the same in animal models . . .
Reuters quote: "Pfizer quietly launches stem cell unit" He laughs at this. We are not hiding this, whatever they think. Couldn't they just have said "Pfizer launches stem cell unit?"
His speech rate is double what would be considered normal; probably he's going faster than usual because they got started a bit late and are trying to stay on schedule so people can make their planes.
I really believe stem cell technology is at the tipping point -- and whenever you approach this kind of event it's very important to bring all the parties together.
We've been using stem cells as tools for drug discovery for 15 years now -- and my little sound bite is: better cells mean better drugs.
We've tried to take the lead in recognizing regenerative therapies, as well as cancer. We think that not so far in the distant future cells will actually be therapies, and that stem cells can be used to deliver therapies, to get drugs to where we need them to go.
Then there are combination therapies, in which your cell does both jobs -- delivers a molecule and acts as a healant itself.
iPS is all about making time go backwards . . . we have a lot of work to do with iPS cells and their derivatives.
Somewhere between 10 and 15% of all drugs brought into safety trials fail because of arrhythmia . . . so if we can make cardiomyocytes (heart cells) we could use them to prevent all those failures
They've done testing to show that cells in vitro behave exactly as they do in vivo under the influence of hundreds of drugs. This means that what happens to a living cell in the lab is exactly the same, functionally and chemically, as what happens to it inside a living body.
Small molecules modify stem cell fate . . .this gives us hope that you can identify drug-like molecules that will get stem cells to do what you want them to do in vivo.
He's talking about directed differentiation and tons and tons of testing in the lab followed by more of the same in animal models . . .
Reuters quote: "Pfizer quietly launches stem cell unit" He laughs at this. We are not hiding this, whatever they think. Couldn't they just have said "Pfizer launches stem cell unit?"
His speech rate is double what would be considered normal; probably he's going faster than usual because they got started a bit late and are trying to stay on schedule so people can make their planes.
Don Reed
The best part of being an advocate is the incredible people you get to hang out with!
Governor Arnold Schwarzenegger's FAX number
916 558 3160
The BEST advocacy tool is a one-sentence political letter. Here's one you could send to the governor.
Please veto SB 1565 because it threatens California's Stem Cell program.
This bill is on the CA floor right now. If the gov. signs it and it becomes law, the gains of Prop 71 will be lost. The people on the ICOC are the best -- all of them there because they are fearless and dedicated. The guy you just heard is one. We have champions, leaders, and people who have given their hearts and souls to this cause.
The bill would add bureaucrats to the ICOC to overtake the decision-making process, and they're pretending the reason for this change would be to make sure the uninsured would have access to future cures.
When my son was paralyzed and I wanted to get a law passed, I imitated a NY police officer who was shot. His name was Paul Richter, and Governor Pataki told him that if he could get every congressmember in NY to sign on, he would get $15 added to every traffic ticket. (Pataki later reneged on this promise and put the money into the general fund.)
We did a letter campaign that consisted of one and two-sentence letters and fought our heads off to get $1.5 million/year. One of our scientists was funded and invented a petrie dish, the first new design in a century. We funded Hans Keirstead's research that goes on to this day. We had to add this sentence into CA law:
Research involving human embryonic stem cells from any source . . . shall be legal.
Bob Klein put $3.1million--his life savings--into the campaign for Prop 71. We learned not to ever, ever debate. Use the same words . . . over and over, never waste your time arguing. Example:
Do you support stem cell research? (If yes, sign here. If no, move on.)
George Lakoff gave us this sentence. American families deserve access to the best medical care science can provide.
Catholics support stem cell research by a 72% majority embryonic stem cell research.
When you see an article in the paper that you like, call that person and thank them. Offer to be a resource, and you've made a friend.
Don speaks in a crotchety-old-man voice: If God had decreed that a certain person should die of chicken pox it would be a sin to subvert that by a vaccination. Rev. Timothy Wright, Yale, 250 years ago.
Don lives on words form Chris Reeve: One day Roman and I will stand up from our chairs and walk away from them forever.
Mark Noble gets up to ask: What do you want us to do? (Mark is collaborating with Stephen Davies on his terrific work with astrocytes)
Don says do your work; I don't presume to know what you should do. Danny says, lock arms with us. Come with us to where we have to go and be ready to explain this research in layman's terms.
Jackie from the national association of biology teachers: Students turn into advocates when they learn what's at stake . . . what can we teachers do to help eliminate the controversy so they stop debating and lose their fear of it? Danny says, right now we're going to the high schools to help them learn about this research. I think that there needs to be more of an effort . . . we're a little late in the game, to be honest, but we'll be in touch with you as we gear up. Don says go to CAMR Advocacy and Americans for Cures, both of which have clear and lucid explanations -- like this one:
embryonic stem cells are like cash, they can be spent anywhere and buy anything. Adult stem cells are like gift certificates--you can only use them in certain stores.
Question: (Actually a suggestion for the biology teachers) follow the stories and make sure everything you read can be found in multiple publications and is well-sourced.
Governor Arnold Schwarzenegger's FAX number
916 558 3160
The BEST advocacy tool is a one-sentence political letter. Here's one you could send to the governor.
Please veto SB 1565 because it threatens California's Stem Cell program.
This bill is on the CA floor right now. If the gov. signs it and it becomes law, the gains of Prop 71 will be lost. The people on the ICOC are the best -- all of them there because they are fearless and dedicated. The guy you just heard is one. We have champions, leaders, and people who have given their hearts and souls to this cause.
The bill would add bureaucrats to the ICOC to overtake the decision-making process, and they're pretending the reason for this change would be to make sure the uninsured would have access to future cures.
When my son was paralyzed and I wanted to get a law passed, I imitated a NY police officer who was shot. His name was Paul Richter, and Governor Pataki told him that if he could get every congressmember in NY to sign on, he would get $15 added to every traffic ticket. (Pataki later reneged on this promise and put the money into the general fund.)
We did a letter campaign that consisted of one and two-sentence letters and fought our heads off to get $1.5 million/year. One of our scientists was funded and invented a petrie dish, the first new design in a century. We funded Hans Keirstead's research that goes on to this day. We had to add this sentence into CA law:
Research involving human embryonic stem cells from any source . . . shall be legal.
Bob Klein put $3.1million--his life savings--into the campaign for Prop 71. We learned not to ever, ever debate. Use the same words . . . over and over, never waste your time arguing. Example:
Do you support stem cell research? (If yes, sign here. If no, move on.)
George Lakoff gave us this sentence. American families deserve access to the best medical care science can provide.
Catholics support stem cell research by a 72% majority embryonic stem cell research.
When you see an article in the paper that you like, call that person and thank them. Offer to be a resource, and you've made a friend.
Don speaks in a crotchety-old-man voice: If God had decreed that a certain person should die of chicken pox it would be a sin to subvert that by a vaccination. Rev. Timothy Wright, Yale, 250 years ago.
Don lives on words form Chris Reeve: One day Roman and I will stand up from our chairs and walk away from them forever.
Mark Noble gets up to ask: What do you want us to do? (Mark is collaborating with Stephen Davies on his terrific work with astrocytes)
Don says do your work; I don't presume to know what you should do. Danny says, lock arms with us. Come with us to where we have to go and be ready to explain this research in layman's terms.
Jackie from the national association of biology teachers: Students turn into advocates when they learn what's at stake . . . what can we teachers do to help eliminate the controversy so they stop debating and lose their fear of it? Danny says, right now we're going to the high schools to help them learn about this research. I think that there needs to be more of an effort . . . we're a little late in the game, to be honest, but we'll be in touch with you as we gear up. Don says go to CAMR Advocacy and Americans for Cures, both of which have clear and lucid explanations -- like this one:
embryonic stem cells are like cash, they can be spent anywhere and buy anything. Adult stem cells are like gift certificates--you can only use them in certain stores.
Question: (Actually a suggestion for the biology teachers) follow the stories and make sure everything you read can be found in multiple publications and is well-sourced.
Jeff Sheehy, AIDS Research Institute
I need to remark on something . . . HIV/AIDS has not really focussed on stem cells. i want to say that what Bernie Siegel and Bob Klein are doing here is getting us out of our individual silos of specific diseases and into the playing field.
I've become friends with all these people who represent a whole collection of conditions and diseases . . . I've always been focused on AIDS and AIDS and AIDS. This is the best.
For Danny . . . we in CA won, but that's not the end. We do feel that we own the stem cell space. 12 of our 29 board members have relationships with patient advocacy groups. Patient advocates are co-chairs of the standing committees. We're funding stem cell research, but are we really moving the science forward in a significant way? Are we getting results.
At a recent meeting, a member who had been following Geron's application for FDA permission gave an eloquent presentation about where the data was missing.
For me it was one of those moments where the scientists seemed to be talking down to us as advocates . . . what we all need to understand is that working as partners with advocates is the most effective way for research to go forward.
We ought to be stopping everything right now in CA and going after those FDA issues. We need to break some NiH patterns here.
Here's a question . . . who is going to get to be in a trial, and who is going to decide?
There's going to be a question of whether placebo trials are needed.
When I think of clinical trials, I think about my friend Jeff Getty, who got a baboon bone marrow transplant that he didn't expect to survive.
I know that if I don't risk my life its over
He felt that participating in risky science is necessary; what he learned through direct experience was that suppressing the immune system drained tthe sea in which hiv swims . . . and his act made it normal for aids patients to get organ transplants. a lot of people are alive because jeff decided to risk his life.
How is it okay for someone else to make a decision for patients?
science is not always linear; the results of Jeff's again were not what anybody expected
i've heard endlessly about the death of Jesse Gelsinger from a gene therapy trial that went wrong
Trials go wrong all the time, but the response is not then to fold up and go home--it's heartbreak.
We can't not do trials because we might fail. we need trials sooner rather than later, and we must be ready for inevitable failures.
I go back to 1996 after Jeff got his transplant . . . within that year, cocktail drugs were introduced and dying aids patients were literally rising from their beds.
I've become friends with all these people who represent a whole collection of conditions and diseases . . . I've always been focused on AIDS and AIDS and AIDS. This is the best.
For Danny . . . we in CA won, but that's not the end. We do feel that we own the stem cell space. 12 of our 29 board members have relationships with patient advocacy groups. Patient advocates are co-chairs of the standing committees. We're funding stem cell research, but are we really moving the science forward in a significant way? Are we getting results.
At a recent meeting, a member who had been following Geron's application for FDA permission gave an eloquent presentation about where the data was missing.
For me it was one of those moments where the scientists seemed to be talking down to us as advocates . . . what we all need to understand is that working as partners with advocates is the most effective way for research to go forward.
We ought to be stopping everything right now in CA and going after those FDA issues. We need to break some NiH patterns here.
Here's a question . . . who is going to get to be in a trial, and who is going to decide?
There's going to be a question of whether placebo trials are needed.
When I think of clinical trials, I think about my friend Jeff Getty, who got a baboon bone marrow transplant that he didn't expect to survive.
I know that if I don't risk my life its over
He felt that participating in risky science is necessary; what he learned through direct experience was that suppressing the immune system drained tthe sea in which hiv swims . . . and his act made it normal for aids patients to get organ transplants. a lot of people are alive because jeff decided to risk his life.
How is it okay for someone else to make a decision for patients?
science is not always linear; the results of Jeff's again were not what anybody expected
i've heard endlessly about the death of Jesse Gelsinger from a gene therapy trial that went wrong
Trials go wrong all the time, but the response is not then to fold up and go home--it's heartbreak.
We can't not do trials because we might fail. we need trials sooner rather than later, and we must be ready for inevitable failures.
I go back to 1996 after Jeff got his transplant . . . within that year, cocktail drugs were introduced and dying aids patients were literally rising from their beds.
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