Saturday, June 09, 2007

Letter from Senator Diane Feinstein re: Stem Cell Research Enhancement Act of 2007

Dear Mr. Austin:

Thank you for contacting me to express your support for embryonic stem cell research. I appreciate the time you took to write and welcome the opportunity to respond.

At the dawn of this new era in medicine, I believe it is important to support medical research that offers hope for those living with serious diseases, such as Alzheimer's, Parkinson's, diabetes, cancer and multiple sclerosis. While I oppose human reproductive cloning, I strongly support stem cell research, which has the potential to spur medical innovation and new medical treatments.

On April 11, 2007, the "Stem Cell Research Enhancement Act of 2007" (S. 5), passed the Senate by a vote of 63-34. I was proud to be an original cosponsor and strong supporter of this bill. It would also allow Federal funding for research conducted on stem cell lines left over from invitro fertilization clinics, which I believe is an important step in advancing biomedical research. This legislation must now be reconciled with the House of Representatives "Stem Cell Research Enhancement Act of 2007," (H.R. 3), which passed by a vote of 253-174 on January 11, 2007. I will keep your support for this legislation in mind as I continue to advocate for passage of a final version of this legislation.

Again, thank you for writing. I have included my floor statement on Stem Cell research for your review. If you have any further questions or comments, please do not hesitate to contact my Washington, D.C. office at (202) 224-3841. Best regards.

Statement of Senator Dianne Feinstein
In Support of S. 5
March 23, 2007

"Mr. President, I rise in support of the Stem Cell Research Enhancement Act of 2007 that is known as S. 5. It is really the only bill of the two that will allow scientists to fully pursue the promise of stem cell research.

I want to particularly thank Senators Harkin and Specter, Kennedy and Hatch, who have been in the leadership of this issue for the past several Congresses. I also want to point out, in the case of the distinguished Senator from Utah, he is very pro-life. I have listened to him over these many years. I have listened to the real wisdom he has espoused on this issue. I hope more people will pay attention to him because I think he is right with respect to this issue.

On August 9, 2001 -- that is 6 years ago -- President Bush limited Federal research funding to 78 stem cell lines already in existence. Nearly 6 years have passed, and in that time two things have happened. First, most of these 78 stem cell lines are no longer available for scientific work. Many lines developed abnormalities and mutations as they aged. Only 21 lines are available today. These lines are all contaminated with mouse feeder cells and therefore are useless for research in humans. They do not have the diverse genetic makeup that is necessary to find cures that benefit all Americans, and researchers cannot use them to examine rare and deadly genetic diseases.

This was, in fact, the President's policy. It is now clearly established that policy does not work, that policy is moribund. Yet the President will not relent and Federal research on stem cells cannot go forward. Secondly, public support for stem cell research -- full-blown stem cell research -- has grown. Sixty-one percent of Americans responding to a poll in January of this year support embryonic stem cell research. This is also a bipartisan issue. Fifty-four percent of Republicans in an ABC News poll also support embryonic stem cell research. The majority of the American public support this bill. We know the current policy is handcuffing our scientists and is not allowing this research to move forward. So the solution is obvious. We should pass this bill.

I think the time has come for the President to come to this realization, and it is my hope he will see he has been mistaken.

The bill we are debating today offers a compromise. This bill will not destroy any embryo that would not otherwise be destroyed or discarded. It will allow promising research to move forward. It would end the impasse. It would take off the handcuffs.

President Bush had the opportunity to take a step forward 9 months ago when the House and Senate sent him the Castle-DeGette bill, on which this bill is based. He made it the first and, so far, only veto of his Presidency. My colleagues and I made a commitment that we would raise this issue again and again -- as long as it takes. Today we are fulfilling that promise. We know this bill will one day become law -- if not this year, then next year; if not next year, then the following year.

The majority of the American people, the majority of the scientific community, other nations, many of our States have embraced the promise of stem cell research. The President can stand in the way of such an overwhelming consensus for only so long.

With every passing week, the inevitability of this legislation grows clearer. Just since the President's veto, officials from his own administration have acknowledged the shortcomings of the current policy. More research has demonstrated the unique promise of pluripotent, multipurpose stem cells. States and private institutions are forging ahead without Federal support.

Finally, and importantly, more Americans are waiting for cures and treatments for catastrophic diseases. This is a very large lobby indeed.

So today we have another opportunity to move hope forward. The two bills before us today present a very stark choice. Only one bill, S. 5, the Stem Cell Research Enhancement Act, embraces all forms of stem cell research. This legislation provides a simple and straightforward way to provide American scientists and researchers with immediate access to the most promising stem cell lines.

It states that embryos to be discarded from in vitro fertilization clinics may be used in federally funded stem cell research, no matter when they were created.

While opponents have suggested this bill will lead us down a slippery slope, the parameters created by the bill are numerous and, in fact, strict. Let me give you some examples.

The embryos must be left over following fertility treatment. The people donating the embryos must provide written consent. The donors may not be compensated for their donation. Finally, it must be clear that the embryos would otherwise be discarded.

This legislation will not allow Federal funding to be used to destroy embryos. With restrictions in place, over 400,000 embryos could become available while ensuring that researchers meet the highest of ethical standards.

Let's be clear. We are talking about embryos that will be destroyed whether or not this bill becomes law. It is an indisputable fact, and everyone would agree these embryos have no future. When President Bush adopted his ill-fated policy in 2001, he allowed lines already in existence to be used for federally funded research because "the life-or-death decision" had already been made.
The same is true here. In terms of the basic ideology of the President's earlier policy, this bill is no different than the earlier policy because the life-or-death decision has already been made with respect to these particular embryos. These will never be implanted. They will never be adopted. They will never be used.
This bill has not been held up because it is flawed. There is nothing wrong with this bill. The bill has been held up because of ideology, not policy.
There is a clear scientific consensus on this issue. Embryonic stem cell research has been endorsed by 525 organizations and 80 Nobel prize laureates. These groups and these experts represent the entire panoply of American health care, the young and the old: the American Association of Retired Persons, which we know as AARP; the Society of Pediatric Research; the American Geriatrics Society.
They represent a wide range of medical experts. The American Medical Association supports this bill. The American Academy of Nursing supports this bill.
They are from varying regions in the country: the University of California system, the University of Kansas, the University of Arizona, the University of Chicago, and the Wisconsin Alumni Research Foundation.
They represent patients struggling with a wide variety of afflictions: the Christopher Reeve Foundation, the Lung Cancer Alliance, the Arthritis Association, the ALS Association, the Juvenile Diabetes Research Foundation.
They represent a variety of religious faiths, including the Episcopal Church and the National Council of Jewish Women.
These groups represent a variety of patients, medical disciplines, and religious faiths. They are from all over this country, and they all support expanding stem cell research. This consensus now even includes Bush administration officials. Last month, NIH Director Dr. Elias Zerhouni testified this:

From my standpoint as NIH director, it is in the best interest of our scientists, our science, and our country that we find ways and the Nation finds a way to go full-speed across adult and embryonic stem cells equally.
That is a pretty unambiguous statement from the man who heads the Institutes of Health.
The Senate and the President should listen to the scientists who best understand this issue and give them access to the stem cell lines that successful research demands.
Jennifer McCormick of Stanford University's Center for Biomedical Ethics has said:

The United States is falling behind in the international race to make fundamental discoveries in related fields.
It is time to address and reverse that sentiment.
In a letter to President Bush, Nobel laureates called the discoveries made thus far by stem cell researchers a significant milestone in medical research.

They go on to say that:

Federal support for the enormous creativity of the United States biomedical community is essential to translate this discovery into novel therapies for a range of serious and currently intractable diseases.
They are not alone. Paul Berg of Stanford, George Daley of Harvard, and Laurence S.B. Goldstein of the University of California at San Diego recognize the promise and the need for embryonic stem cell research. These esteemed researchers have said:

We want to be very clear. The most successful demonstrated method for creating the most versatile type of stem cells capable of becoming many types of mature human cells is to derive them from human embryos.
This is the science.
You can quote a scientist here or a scientist there who will differ with that, but the bulk of people in this field worldwide believe as this statement reflects.
As Lucian V. Del Priore of Columbia University said:

This is important and exciting work.
It is time we use the wisdom of these respected scientists and embrace the promise of biomedical research using embryonic stem cells.
Scientists have learned more about stem cells -- how they work, how they may one day be used for cures -- since we last considered this issue, I guess some 10 months ago. This past August, scientists from the University of Edinburgh used embryonic stem cells from an African clawed frog to identify a protein that is critical to the development of liver cells and insulin-producing beta cells. This could lead to a better understanding of diabetes and liver disease as well as new treatments.
Then during the next month or two, in October, scientists at Novocell, a San Diego biotech company, announced the development of a process to turn human embryonic stem cells into pancreatic cells that produce insulin. This could be another significant step toward using stem cells to treat diabetes.
In September last, researchers used human embryonic stem cells to slow vision loss in rats suffering from a genetic eye disease that is similar to macular degeneration in humans. Macular degeneration is the leading cause of blindness in people aged 55 and over in the world. It affects more than 15 million Americans. This research means stem cells could one day be used to restore vision in many of these patients. Just think of that: fifteen million people who are surely going to go blind, and that blindness might be stopped.
In March, a team at the Burnham Institute in La Jolla, CA used embryonic stem cells in mice to a treat rare degenerative disorder called Sandhoff's disease. This condition, which is similar to Tay-Sachs disease, destroys brain cells. The mice treated with stem cells enjoyed a 70-percent longer lifespan, and the onset of their symptoms was delayed. The stem cells migrated throughout the brains of the mice and they replaced damaged nerve cells. No one ever thought that could be done before. This suggests that embryonic stem cells may effectively treat this disease as well as other genetic neurological conditions, including Tay-Sachs.
So all of this work is just beginning. Scientists will now work to translate these promising advances into cures for humans, and such a feat will almost certainly require access to viable lines of human stem cells. Unless the President's policy is overturned, these lines will not be available, and without access to additional stem cell lines, the cures and treatments will never move from mice to humans.
Many States, frustrated with Federal gridlock and the loss of their best scientific minds, are moving forward. I am particularly proud of my State of California. In 2004, California voters, by a whopping margin, approved Proposition 71 and created the California Institute of Regenerative Medicine. That institute is spending $3 billion over 10 years supporting promising research conducted in California. This work will be done with careful ethical oversight. It also bans human reproductive cloning, something we can all agree is immoral and unethical. Over $158 million in research grants has now been approved, making California the largest source of funding for embryonic stem cell research in America.
Promising projects include creating liver cells for transplantation at the University of California at Davis, developing cellular models for Parkinson's disease and Lou Gehrig's disease, ALS, at the Salk Institute. This will give a better understanding of how these diseases work and yield possible treatments, as will work at Stanford to more effectively isolate heart and blood cells from embryonic stem cells. These are only some of the more than 100 labs in California now working.
One might say: All right, why not let the private sector and the State address this problem? Why do we need Federal research? I want to concentrate a few moments on that. The actions of California and the actions of other private and public institutions do not substitute for Federal funding and a standardized national policy. Much of this debate focuses on stem cell lines themselves, but scientists need much more to succeed. They need expensive equipment and lab space in which to work and collaborate, and there is the rub. For scientists working on embryonic stem cells, this means taking great care not to intermingle their work on approved stem cell lines with those that are not approved. If Federal funds, for example, built a lab or bought a freezer, a petri dish, or a test tube, these resources cannot be used on research involving lines not included in the President's policy. As I said, there are no lines left in the President's policy. Therefore, they can't be used. This has created a logistical nightmare.
The duplication and careful recordkeeping required is an enormous disadvantage faced by the U.S. stem cell scientists. Many have gone to extreme lengths to ensure they follow these regulations. The stakes are high: Any mistake could result in the loss of Federal grants for a researcher's lab.
Let me give a few examples. University of Minnesota researcher Meri Firpo buys one brand of pens for her lab that receives Government money and another brand of pens for use in her privately funded lab. This helps her ensure that a ballpoint pen purchased with Federal grant money is not used to record results in her lab that works with stem cell lines not covered by the President's policy.
UCLA is using a complex accounting system to allocate Federal and private dollars in careful proportion to the amount of time a researcher spends working on either approved or unapproved stem cell lines. A stem cell researcher, Jeanne Loring at the Burnham Institute in La Jolla, CA, designed labels for all her equipment: Stem cells in a green circle denote equipment that can be used with all stem cell lines, while equipment bought with Federal funds is marked with a red circle with a slash through it.
At the University of California in San Francisco, biologist Susan Fisher worked for 2 years to cultivate stem cell lines in a privately funded makeshift lab. Unfortunately, the power -- the electricity -- in her lab failed. She couldn't move her lines into the industrial-strength freezers in the other lab because they were federally funded. The stem cell lines on which she had worked for 2 years melted and were gone. So 2 years of work was out the window because of this ridiculous situation.
Money that could otherwise be devoted to research is instead used to build labs and purchase duplicate equipment, and the cost is significant. Scientists at the Whitehead Institute for Biomedical Research in Cambridge, MA, didn't want to fall behind international stem cell leaders, so they established a second lab. They had to buy a $52,000 microscope, two incubators which cost $7,500, and a $6,500 centrifuge. They already owned this equipment. They had the equipment, but they couldn't use it because that equipment was published with Federal dollars. To me, this makes no sense. I don't think we can afford this kind of wasteful duplication with what are very precious research dollars. Our scientists should be focused on investigating disease, not worrying about who pays for their pens or their test tubes. So bottom line: We need a reasonable Federal policy that includes funding for viable stem cell lines.
I don't need to tell my colleagues about the famous faces and the average people who are behind this legislation. It is nearly 70 percent of the population. I don't have to tell my colleagues about Michael J. Fox, who showed the Nation the true face of Parkinson's disease. I don't have to tell my colleagues about First Lady Nancy Reagan, who has spoken out in support of this and other legislation, or Christopher Reeve, who lived his life refusing to accept that his spinal cord injury would never be healed, or Dana Reeve, who stood by her husband and then tragically lost her own battle with cancer. Just as important are the millions of Americans who may not have a famous face, but put everything they have in us in the hope that we will do the right thing. The right thing is pretty simple. It is to give them a chance to live -- to live.
That is what we are talking about. I don't think there is any other piece of legislation that more involves the right to life than this piece of legislation.
These are people who are going to die. They live with catastrophic, often terminal diseases; they suffer immeasurably. Suddenly, there might well one day be a cure, or their disease might be put in remission. The kind of research might be done that can mend a broken spinal cord. How can we not support this? How can we look at the facts? Life or death is not involved for the embryo that is used. That is exactly what this legislation is. These are embryos that have no chance at life. All we ask is that they be put to work to protect human life. It seems to me that is not too much.
I hope this bill not only will pass here by a substantial margin but that some way, somehow, the 67 votes we need in this body to overturn a Presidential veto will be present. I think the American people demand no less.
I yield the floor."

Sincerely yours,
Dianne Feinstein United States Senator

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