Time for stem cell research

[Wise Young]

I am attaching this editorial in the San Francisco Chronicle because I am concerned by both the attitude and the misleading representation of the issues. It was written by Dana Welch who is Executive Director of the Berkeley Center for Law, Business, and Economy. The Center will be holding a meeting on the subject on March 2-4, 2006 (Source).

At the conclusion of the editorial, Welch wrote: "Something as promising for the future of health, science and the economy is important enough to get it right. Let's take the time to do exactly that." I am puzzled by this view because time is exactly what we don't have when it comes to stem cell research. Every year that the investment is delayed, the United States is falling further behind the rest of the world in embryonic stem cell research. More important, the people who may benefit from stem cell therapies don't have the luxury of time.

The editorial points out that nearly 60% of the voters of California voted for this initiative. California and the United States is after all a democracy. The will of the people should be respected. To use lawsuits to thwart the will of the people is anti-democratic. All the issues of debt, intellectual property, and other concerns expressed the Welch were discussed extensively by opponents of the bill before the ballot vote. Despite all these issues, the voters of California overwhelmingly voted for the ballot. Please note that I do not oppose lawsuits, particularly if they address constitutional issues. However, the lawsuits do not appear to challenge Proposition 71 on a constitutional basis. Rather, they seem to be revisiting issues that were decided on by the voters of California.

First, the voters of California have a right to choose a course that puts their state into greater debt. The rationale for Proposition 71 was that it would bring back more to the state in terms of economic benefit.

Second, the Institute for Regenerative Medicine has been moving very fast to place policies into place that would observe the highest ethical standards relating to egg procurement. More important, not all the research will be related to creating new stem cell lines. Why are they holding back research, for example, on existing stem cell lines that is not being funded by NIH? That has nothing to do with egg procurement.

Third, the problems that Korea has with Woo-Suk Hwang's fraudulent fabrication of data has nothing to do with California. The Institute of Regenerative Medicine has both an ethical board and a scientific advisory board that is vigilant and will work hard to ensure vigilant peer review. What happened in South Korea is very unlikely (in fact, some might say is impossible) to happen in California. It is crazy to hold up stem cell research in California because a rogue scientist faked data, coerced women members of his laboratory to donate eggs, and lied about his role.

Fourth, the concern with intellectual property has no merit. After all, the NIH has a clear policy that scientists and institutions being funded by the government to do research has the right to the intellectual property. The government is not in business to make money from intellectual property. They should be in the business of funding research that benefits the people. For example, nobody is seriously challenging the Dole-Bayh Act of 1980, when Congress decided to give intellectual property rights to the inventors of the technology, i.e. the scientists and the research institutions.

None of the above are sufficient reason to hold off the funding of Proposition 71 and thwarting the will of the people of California.

Wise.




http://sfgate.com/cgi-bin/article.cg...NGMQH9UPA1.DTL

Time for stem cell research
Protect our investment by resolving all issues

Dana Welch

Sunday, February 19, 2006

The stem cell research program created by Proposition 71 may at times resemble Dr. Victor Frankenstein's creature: a new life form conceived in bold ambition, of untested parts stitched together with untried methods. But it is worth reminding ourselves why nearly 60 percent of voters approved $3 billion in state-supported bonds to fund it -- and what we must do to protect our investment.

Most biomedical research is funded by the federal government, but in 2001 President Bush cut off federal funding for nearly all human embryonic stem cell research. This edict has meant that other countries, such as Singapore, Britain and Israel, are moving ahead of the US in this extraordinarily promising area of medical and scientific research.

Embryonic stem cells hold significant medical and scientific promise because of their ability to form virtually any other human cell, opening the door to treating a range of cell-based diseases, to developing significant research tools to study disease and to growing medically important tissues useful for transplantation purposes.

For example, diseases like juvenile onset diabetes and Parkinson's disease occur because of defects in one of just a few cell types. Similarly, failing hearts and other organs, in theory, could be shored up by injecting healthy cells to replace damaged cells. Embryonic stem cells can be used to study in the laboratory the progress of debilitating diseases.

But ever since California voters overwhelmingly passed Prop 71 in November 2004, stem cell research has been plagued by one delay after another.

First there was the lawsuit over the authority granted by Prop 71, brought to you by the same folks who brought you the Terry Schiavo litigation. The trial begins February 27, and until it gets resolved, there will be no public money for stem cell research in California.

Then there was the unraveling of the South Korean research amid revelations of coerced egg donations and falsified data. This scandal signals the need to devise rigorous peer review guidelines and scientific oversight to avoid similar setbacks here. It also highlights how dramatically wrong things can go without the proper policies, laws and oversight in place.

To date, not one penny has gone to the stem cell research authorized by Proposition 71 -- and that's probably a good thing. We have the time to answer numerous policy and legal questions that were left unresolved by Prop 71 -- and which will not be addressed by the lawsuit to be heard in Alameda Superior Court.

Among the critical issues left unresolved by Prop 71: How (or indeed, whether) do we pay back the investment? The State of California, already suffering from a massive budget deficit, is issuing $3 billion in general obligation bonds to pay for this research. How can the state recoup its investment? Through royalties, an increased tax base, lower cost health care, -- or should we be satisfied that the benefit will be the advancement of science and mankind? And because the money is coming from the public, which diseases should be addressed first?

The failure to adequately protect egg donors was at the core of the South Korea scandal. How do we ensure truly informed, noncoerced consent, and at the same time obtain eggs from diverse donors so as to address those diseases mainly afflicting minorities?

How about intellectual property ownership rights? Is there a way to structure these potentially lucrative ownership rights so as to encourage investment and the commercialization of promising therapeutics -- and to protect the public interest at the same time?

Prop 71 left these questions and more wide open. Answer any one wrong, or leave them to chance, and we risk a South-Korean-like train wreck, potentially setting back by years the development of potential cures. Answer these questions right, and California becomes a model for other states and countries conducting stem cell research.

This month, the state governing body of stem cell research, the California Institute of Regenerative Medicine, took a giant step toward answering these questions by adopting standards governing the protection of egg donors and guidelines for non-profit intellectual property rights. These guidelines, open for comment for 270 days, address some, but not all, of the unresolved legal and policy questions.

Something as promising for the future of health, science and the economy is important enough to get it right. Let's take the time to do exactly that.

[Faye]

It's interesting to note the tactics used to hold back funding for ESCR in California: Lawsuits

On the federal level another desperate attempt to stop ESCR funding is being used: decoy bills

We should oppose these lawsuits under the guise of protecting consumers AND we should oppose the research decoy bills under the guise of "more scientific research is good", knowing full well that they are merely aimed at stopping ESCR funding.

Personal Statement of Dr. Gazzaniga

I do not support publishing this report with the implied endorsement that special efforts be made in the scientific areas described. While some of the suggestions could be explored in a scientific setting, most are high-risk options that only have an outside chance of success and raise their own complex set of ethical questions. Of primary concern: this effort is a diversion from the simple task at hand which is to move forward with the established laboratory techniques, that are already grounded on a clear ethical basis, for studying embryonic stem cell research and biomedical cloning.

http://www.bioethics.gov/reports/white_paper/personal_statements.html

[Steven Edwards]

It's important to note that one of the "established" techniques Dr. Gazzaniga refers to is human SCNT, which as we now know, has yet to be established.

Wise, thanks for posting this.

[john smith]

Wise and Faye;

It is interesting that this editorial was printed today and I am slightly offended. I have been shopping an OPED for months entitled, Outsourcing Hope. It currently sits with the editors of the SF Chronicle and would have made a good opporsition piece to the editorial of Dana Welch even though it deals with SCREA and not the CIRM.

LOL, I realize my writing credentials are thin by comparison to Professor Welch. However, it is agonizing to keep getting reminded that advocates for the patient population, who represent the issue from the inside looking out, must climb a mountain of prejudice to get access.

Blogging is the radical alternative of contemporary culture, but The Chronicle will reach the masses on both sides of this issue. It seems a letter to the editor would be bad behavior on the part of a sore loser.

LOL, ok I'm done whining. My cat thinks I am a brilliant writer even if The Chronicle does not.

John

[Jaycee]

Originally Posted by john smith

Wise and Faye;

It is interesting that this editorial was printed today and I am slightly offended. I have been shopping an OPED for months entitled, Outsourcing Hope. It currently sits with the editors of the SF Chronicle and would have made a good opporsition piece to the editorial of Dana Welch even though it deals with SCREA and not the CIRM.

LOL, I realize my writing credentials are thin by comparison to Professor Welch. However, it is agonizing to keep getting reminded that advocates for the patient population, who represent the issue from the inside looking out, must climb a mountain of prejudice to get access.

That's exactly the point, I'm sick and tired of having religious and other "professionals" telling us to wait.

Let science do it's job, without the incessant interference of those who oppose the science.

[Faye]

Originally Posted by john smith

Wise and Faye;

I have been shopping an OPED for months entitled, Outsourcing Hope. It currently sits with the editors of the SF Chronicle and would have made a good opporsition piece to the editorial of Dana Welch even though it deals with SCREA and not the CIRM.

LOL, I realize my writing credentials are thin by comparison to Professor Welch. However, it is agonizing to keep getting reminded that advocates for the patient population, who represent the issue from the inside looking out, must climb a mountain of prejudice to get access.

John

John, this is so true. The opinion of prominent people holds far more weight. That is why I am so concerned seeing that Dr. Young is defending CIRM from the opposition's lawsuits at the state level, but goes along with and even supports a Decoy Bill.

It's important to be consistent and not allow the opposition's deceptions using the guise of consumer protection and/or further ( unnecessary)scientific inquiry, to delay researchers from moving forward with the established ESCR laboratory techniques.

The opposition is like a virus which keeps mutating. Very sneaky........

[john smith]

John, this is so true. The opinion of prominent people holds far more weight. That is why I am so concerned seeing that Dr. Young is defending CIRM from the opposition's lawsuits at the state level, but goes along with and even supports a Decoy Bill.

Faye;

I'm sorry, but I disagree with the suggestion that Dr. Young is inconsistent when it comes to the cure or restorative therapies. He has always advocated strongly and unquestionably on our behalf.

SCREA, the decoy bills, the bills that are not decoys, and those that are outright regressive such as the Brownback/Weldon mess, create a situation that beg for nuanced positions. I do not know exactly what Dr. Young or Steven believe is the best course of action. It may be different from mine and yours. No doubt you and I hold positions that are not compatible either. However, I do know that they are fighting for what is best for the patient population. I also believe you are doing the same. Obviously though, we have different ideas.

I also think the ideas and strategies may change as we get closer to a vote on SCREA. It is likely to be presented with revisions that may qualify it for decoy status. Frist holds the deck of cards we are all playing from and it would not surprise me if there is some dealing from the bottom yet to come.

John

[Faye]

Originally Posted by john smith

Faye;
.........I do know that they ( Dr. Young and Steven) are fighting for what is best for the patient population. I also believe you are doing the same.....
John

John, no doubt on the above. However I feel reassured that my position is in line with all other advocacy groups and the vast majority of researchers.

Faye

[Wise Young]

Faye,

I support funding of *all* stem cell research, embryonic as well as umbilical and adult stem cells, as I believe you do. I strongly support SCREA (HR810). I am concerned that HR810 is an unfunded mandate and believe that we should be pushing for not only allowing NIH to fund embryonic stem cell research but we should be asking Congress to appropriate funds for embryonic stem cell research.

The so-called "alternative bills" are essentially earmarking bills that add funds to the NIH budget to fund non-embryonic stem cell research. As I pointed out, any additional funding for NIH this may actually help NIH fund more embryonic stem cell research because competition for funds at NIH is very rough right now. A much more important version of the embryonic versus adult stem cell research is occurring at NIH.

In my opinion, we have been "decoyed" if we spend so much of our time and energy attacking "ESC alternatives" bills rather than supporting HR810 and fighting for funding for embryonic stem cell research. I am concerned to see you criticizing me and others for our positions when we strongly support embryonic stem cell research and other types of stem cell research.

Until I see evidence that the so-called "ESC alternatives" bills are sapping support from HR810 and that they are interfering with embryonic stem cell research, I think that we should focus our time and attention on getting HR810 passed and making sure that it is not an unfunded mandate. That is why I advised BigBob to focus his attention on supporting and finding funding for SCREA.

Finally, in my opinion, it is always best to take the high road and the positive stance than the low road and negative stance in politics. You need the support of everybody when the vote comes. You don't want to attack people unnecessarily and you do not want to antagonize potential supporters. In my experience, winning in politics means supporting the position of others when it does not interfere with your own.

Wise.

Originally Posted by Faye

John, this is so true. The opinion of prominent people holds far more weight. That is why I am so concerned seeing that Dr. Young is defending CIRM from the opposition's lawsuits at the state level, but goes along with and even supports a Decoy Bill.

It's important to be consistent and not allow the opposition's deceptions using the guise of consumer protection and/or further ( unnecessary)scientific inquiry, to delay researchers from moving forward with the established ESCR laboratory techniques.

The opposition is like a virus which keeps mutating. Very sneaky........

[Faye]

Originally Posted by Wise Young

Faye,

Until I see evidence that the so-called "ESC alternatives" bills are sapping support from HR810 and that they are interfering with embryonic stem cell research, I think that we should focus our time and attention on getting HR810 passed and making sure that it is not an unfunded mandate.

Wise.

Dr. Young,

The point is that the decoy bills are designed to sap support from HR810. Legislators who are on the fence about HR810 can easily be misled to believe they are supporting ESC alternatives and that HR810 is unnecessary, when the reality is the other way around: the ESC alternatives are VERY unnecessary and sidetrack us from proven laboratory techiques.

I am expressing my opinion, concern and displeasure at seeing you and Steven have the idea that siding with the opposition is expedient, when all advocacy groups and the majority of scientists feel differently. I question why you would isolate yourselves from all those Pro-ESCR groups.

Disclaimer: I am sure you strongly support Embryonic Stem Cell Research in general