The Victoria Advocate
Sunday, March 27th, 2005

Speaking last July, Ron Reagan outlined the most promising type of embryonic stem cell research.

“Let’s say that 10 or so years from now, you are diagnosed with Parkinson’s disease. There is currently no cure, and drug therapy, with its attendant side effects, can only temporarily relieve the symptoms,” the son of President Ronald Reagan said.

“Now, imagine going to a doctor who, instead of prescribing drugs, takes a few skin cells from your arm. The nucleus of one of your cells is placed into a donor egg whose own nucleus has been removed. A bit of chemical or electrical stimulation will encourage your cell’s nucleus to begin dividing, creating new cells which will then be placed into a tissue culture.

“Those cells will generate embryonic stem cells containing only your DNA, thereby eliminating the risk of tissue rejection. These stem cells are then driven to become the very neural cells that are defective in Parkinson’s patients. And finally, those cells – with your DNA – are injected into your brain where they will replace the faulty cells whose failure to produce adequate dopamine led to the Parkinson’s disease in the first place.”

What Reagan described is called somatic cell nuclear transfer (SCNT). It holds the promise of effective treatments and cures for many diseases and disabilities.

“SCNT is the only field of stem cell research that could eliminate immune system rejection because the cells contain the patient’s DNA,” according to Texans for Advancement of Medical Research (TAMR), a coalition of scientific and medical research groups and health advocacy organizations.

“SCNT cells can potentially grow into any cell type of the body, are capable of seemingly unlimited growth (i.e., production of more of the same cells), have the potential to replace cells damaged by disease or injury, and can provide insight into the causes of diseases,” TAMR continues.

Scientists believe this type of stem cell research ultimately could treat or cure Parkinson’s disease, as Reagan noted above, as well as diabetes, cancer, heart disease, spinal cord injury, traumatic brain injury, amyotrophic lateral sclerosis (Lou Gehrig’s disease), blindness, multiple sclerosis, sickle cell anemia, strokes, muscular dystrophy and probably others.

Opponents of embryonic stem cell research contend that it involves the taking of human life. While that is arguable when applied to other types of embryonic stem cell research, it is not true of the SCNT process.

SCNT begins with an unfertilized human egg, also called an ovum or oocyte. Not even those who maintain that life begins at conception – the union of ovum and sperm – can logically claim that an unfertilized egg is a life.

Sperm activates repressed genes in a human ovum that may allow it ultimately to develop into a viable human being. Without that sperm, these repressed genes cannot be activated. So the egg – even if something else, other than sperm, is put into it – cannot develop into a viable human being, according to William Brinkley, the dean of the Graduate School of Biomedical Sciences at Baylor College of Medicine in Houston and one of the top cellular-molecular biologists in the nation.

According to TAMR, “30 percent to 50 percent of the genes necessary for fetal development are not properly expressed in SCNT cells. SCNT cells are intended to cure diseases, not to create babies.”

If a blastocyst – “a microscopic collection of 100-200 undifferentiated cells that divide in a Petri dish for about five days,” TAMR explains – created by SCNT were to be implanted in a human uterus, it would not develop into a viable human being, Brinkley notes.

The Victoria Advocate
Sunday, March 29th, 2005

Election-year politics, particularly a heated race for a congressional seat, in 2002 unexpectedly put stem cell research on the Iowa General Assembly’s agenda. That is rarely the best time or context for lawmakers to take a thoughtful look at such a complex issue.

Iowa legislators initially considered a draconian bill that would have outlawed all cloning and embryonic stem cell research. But the General Assembly ultimately opted for a less drastic measure, Senate File 2118, that prohibits reproductive and therapeutic cloning but allows some embryonic stem cell research. Gov. Tom Vilsack, a liberal Democrat, signed the bill into law.

Unfortunately, the Iowa cloning ban prohibits research into the most promising type of embryonic stem cell research, somatic cell nuclear transfer (SCNT), according to a briefing paper compiled by the University of Iowa Carver College of Medicine.

Once it is fully developed, SCNT would replace the nucleus of an unfertilized egg with the nucleus from a cell provided by the patient seeking treatment. As explained in detail in Sunday’s editorial, “Truly pro-life,” the cells this process then would produce would be used to treat, perhaps to cure, the patient.

The Iowa cloning ban, however, considers that to be therapeutic cloning – despite the fact that the cells SCNT produces cannot become a viable human being, according to William Brinkley, the dean of the Graduate School of Biomedical Sciences at Baylor College of Medicine in Houston and one of the top cellular-molecular biologists in the nation.

“Many people who might benefit from the therapy would be too sick to leave the state (or even the hospital) to donate their stem cells, so these people would be prohibited from receiving the therapy,” the University of Iowa briefing paper notes.

Beyond that very practical human aspect, on a larger scale, the SCNT ban in the long term will mean that Iowa will not be able to compete with states where SCNT is legal and public dollars help fund embryonic stem cell research. The Des Moines Register, Iowa’s largest newspaper, last week urged the General Assembly to revisit and revise the cloning ban.

This is a good example of what the 79th Texas Legislature should not do as lawmakers consider the baker’s dozen bills on stem cell research before them this session.

Texas legislators should reject out of hand House Bill 864, by state Rep. Phil King, R-Weatherford, and Senate Bill 943, by state Sen. Ken Armbrister, D-Victoria.

Like the Iowa law, both measures go beyond banning human reproductive cloning – a procedure this newspaper strongly opposes – and effectively prohibit SCNT research and therapy in Texas. Unlike Iowa, which has only one, Texas has multiple world-class medical schools – in Houston-Galveston, San Antonio and Dallas – so such a ban would devastate this state’s long-term competitiveness in biomedical research. This prohibition also would dearly cost Texans seeking treatment with SCNT therapy if they have to travel out of state for it, once it is developed.

To outlaw human reproductive cloning – a ban this newspaper strongly supports – but not prohibit embryonic stem cell research and therapy, the Texas Legislature should enact either House Bill 1929, by state Rep. Beverly Woolley, R-Houston, or Senate Bill 1733, by state Sen. Eliot Shapleigh, D-El Paso. The two bills are based on legislation sponsored by a much-respected conservative, U.S. Sen. Orrin Hatch, R-Utah, in Congress.

The Woolley and Shapleigh measures would prohibit human reproductive cloning in Texas. They also would keep embryonic stem cell research, including SCNT, legal. And both would establish an advisory committee on research to develop regenerative or reparative medical therapies or treatments. In other words, an ethics oversight committee. Its members would include biomedical researchers, medical ethicists, legal experts and religious representatives.

As local anti-abortion activist Wm. Paul Tasin wrote in an e-mail to this page last week, “To ignore the spiritual and moral implications of this debate is not a debate at all.” While we differ with Tasin in many regards, we agree that ethical oversight, as the Woolley and Shapleigh bills would provide, is necessary to ensure that research and the therapies it ultimately yields are ethical and to prevent abuses of sound science.

State Rep. David Swinford, R-Amarillo, and state Sen. Judith Zaffirini, D-Laredo, have introduced more narrowly focused bills to ban human reproductive cloning and keep SCNT research and therapy legal in Texas. Either of these would be a better alternative than the King and Armbrister bills.

“SCNT doesn’t destroy or create life,” says Baylor College of Medicine’s Brinkley.

That is the sound science upon which Texas law should be based. It should prohibit human reproductive cloning but not research that ultimately may yield therapies to prolong life and improve the quality of life for countless people in the Lone Star State and, indeed, worldwide.

The Victoria Advocate
Wednesday, March 30th, 2005

The Maryland House of Delegates on Monday approved, by an 81-53 vote, a bill to spend $23 million a year in public funds on stem cell research. The money would come from the state’s tobacco settlement income.

The Maryland Senate Health Committee earlier approved spending $25 million a year to fund embryonic and other stem cell research, and the bill may go to the full Senate soon.

The legislation’s backers contend that state funding is needed to maintain Maryland’s position as a leading biomedical research state.

Without state money to support embryonic stem cell research, they say, Maryland will lose both its competitiveness and many top researchers working there to other states that publicly fund this promising effort.

Last November, California voters approved Proposition 71, authorizing the state to raise $3 billion in bond money over the next decade to fund embryonic and other types of stem cell research.

Gov. Arnold Schwarzenegger and former first lady Nancy Reagan were among the prominent Republicans supporting the initiative.

“The University of California at Los Angeles will spend $20 million over five years to establish a stem cell research institute and compete for new state funds to fight cancer and other diseases,” Reuters news service reported earlier this month.

UCLA is only one of the Golden State’s many biomedical research centers competing for state money – and top researchers from other states that do not fund stem cell research.

Two weeks after the California vote, “Wisconsin Gov. Jim Doyle proposed to invest $750 million in biotechnology, including $375 million for an Institute of Discovery at the University of Wisconsin-Madison that would serve as a center for the more than 50 Madison scientists working with stem cells,” according to The Milwaukee Journal Sentinel.

In January, New Jersey “Acting Gov. Richard J. Codey entered what he called ‘the race for the cure’ by proposing to spend $380 million on research. New Jersey’s planned spending gives the state a lock on second place in the stem cell research race, behind California,” The New York Times reported.

Also in January, “Connecticut legislators introduced a bill that endorses research on embryonic and adult stem cells, and Gov. Jodi Rell has said she would take between $10 million and $20 million from the current budget surplus to promote stem cell research in the state,” according to The Scientist magazine.

Worried that New York will fall behind nearby New Jersey and Connecticut, legislators from both major parties are backing a proposal to invest at least $100 million of public money to fund embryonic and other types of stem cell research in the Empire State.

Earlier this month, the Illinois Senate Health and Human Services Committee approved a bill to put a proposition on the November 2006 ballot authorizing the state to sell $1 billion in bonds to create the Illinois Regenerative Medicine Institute and fund embryonic and other stem cell research.

With its world-class medical schools and research facilities in Houston-Galveston, San Antonio and Dallas and a thriving biomedical industry, can Texas afford to be left behind as other states provide public funding for stem cell research?

Five bills have been introduced in the 79th Texas Legislature to authorize public funding for various types of stem cell research.

State lawmakers should consider them in light of maintaining Texas’ biomedical competitiveness and retaining top researchers.

Legislators also should consider the overall economic development this promising research field offers for states that position themselves now to take advantage of it as it continues to develop.

This newspaper has endorsed Gov. Rick Perry’s Texas Enterprise Fund, which the 78th Legislature created and funded two years ago, and his proposed Texas Emerging Technology Fund, which the 79th Legislature is considering now.

The Enterprise Fund has brought new businesses and new jobs to Texas, contributing to the state’s economic development and the growth of its tax base. The Emerging Technology Fund, which would invest public money in high-tech research and technological developments, would do the same.

Texas lawmakers should consider making the same kind of investment in stem cell research. The biomedical field is already a key segment of the state’s economy, and stem cell research increases its potential for economic growth. Other states are making this investment.

July 7, 2004

Beckie McCleery (512) 585-3329

Judy Haley (713) 464-8707

Texas Medical Association Endorses All Forms of Stem Cell Research 
TAMR Praises Respected Physician Organization

The Texas Medical Association (TMA), the state’s most respected physician organization and the country’s largest with more than 39,000 members, has formally announced its support for embryonic stem cell research (see attached article reprinted from the July 2004 issue of TexasMedicine). In making this endorsement, the TMA adds prestige and an important voice to the groundswell of public and private citizens, professional and health advocacy organizations, and elected officials who support research on all types of stem cell research -embryonic, adult, and cord blood cells.

“We are grateful to the TMA Council on Scientific Affairs, which authored the resolution of support, and to the organization as a whole for this acknowledgment of the importance of stem cell research,” said Beckie McCleery, President of Texans for Advancement of Medical Research (TAMR). “We will work together in the next legislative session to advance research and treatment opportunities in Texas.”

“Stem cells have the potential to provide cures or treatment for many devastating diseases. Ethical considerations, which often arise when a field of research is new, should be evaluated as research proceeds,” Dr. Leo Cigarroa, chairman of the TMA Council on Scientific Affairs was quoted as saying in a recent Associated Press news release.

Cigarroa, a family practitioner from Laredo, hopes the endorsement will help to convince President Bush to expand federal funding for stem-cell research. In the same press release, Cigarroa said that he does not, “think the good Lord intended people to spend the last 20 years of their life in debilitating conditions.”

TAMR is composed of leading scientists, physicians, ethicists, health groups, and individuals who support biomedical research for the purpose of curing diseases and alleviating suffering. TAMR was created last legislative session in response to the threat to stem cell research in Texas. TAMR is helping to build a bi-partisan coalition within the Texas legislature that supports all types of stem cell research.

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Texas Medicine

A Publication of the Texas Medical Association

Texas Medicine Public Health Feature — July 2004

Hope or Horror? Texas Physicians Choose Hope in Backing Therapeutic Cloning

By Ken Ortolon

Senior Editor

Will stem cell research give physicians new ways to treat disease? Or threaten society with the horror of humans created solely for their stem cells and the prospect of designer babies? That was the debate reignited in February when So uth Korean researchers revealed that they had successfully harvested stem cells from a cloned human embryo.

Some in Congress want all embryonic stem cell research banned. USA Today reports that 33 state legislatures are considering laws supporting, funding, or condemning embryonic stem cell research.

But supporters say stem cell research and so-called “therapeutic cloning” should be embraced because of their great potential for creating new cures for disease. They urge lifting a ban on federal funding of embryonic stem cell researc h before the United States falls behind other nations.

Meanwhile, several private institutions, including Harvard University, are moving forward with stem cell research without federal money.

In May, Texas physicians joined the fray. The Texas Medical Association House of Delegates voted to support research on both embryonic and adult stem cells and to support therapeutic cloning in biomedical research. However, the house a lso decided to oppose cloning for producing a human child.

Corpus Christi clinical geneticist Raymond C. Lewandowski Jr., MD, says abandoning or limiting research on any type of stem cells would be “premature and ill-advised since we haven’t seen what the potential of any of them really is yet .”

Measuring the Potential

The new policy the house approved was recommended by the TMA Council on Scientific Affairs in consultation with the Board of Councilors. The policy, based largely on an American Medical Association Council on Scientific Affairs report, supports biomedical research on multipotent stem cells, including embryonic, adult, and umbilical cord blood stem cells. It also supports somatic cell nuclear transfer (SCNT) technology, or therapeutic cloning, for biomedical research ; opposes cloning specifically for producing a child; and encourages public support for federal funding for research involving pluripotent stem cells.

Dr. Lewandowski, a member of the council and primary author of the report, says the research community does not support reproductive cloning.

“No one within the organization or within the legitimate scientific community believes that human cloning should ever occur.”

Therapeutic cloning is another matter, however.

In its report, the council concluded that all types of stem cells show great potential for therapeutic application, but embryonic stem cells have the maximum potential.

“In most cases, to be useful in research and eventually medical therapies, these cells must be able to be grown in tissue culture, maintain genetic stability for at least eight months, and have the ability to differentiate into any org an type,” the report states. “Under some circumstances, freshly collected stem cells may be useful without cultures. Stem cells from embryonic tissue clearly possess all of these potentials. It is not currently known if stem cells deri ved from adult tissues have these potentials.”

There are four potential sources for embryonic stems cells. They are embryos created for reproduction that went unused and are stored by fertility clinics, SCNT, parthenogenesis, and more than 70 embryonic stem cell lines that existed before President Bush’s August 2001 ban on federal funding. While the 70 stem cell lines can be used in government-funded research, only 13 are available to U.S. researchers. Parthenogenesis involves selecting eggs at a point in their maturation cycle when they still have their full complement of genes and artificially stimulating them to induce cell division. It has been successful in rodent embryos, but not in humans.

Building a Better Cell

SCNT involves removing the nucleus from an egg and replacing it with a nucleus from an adult cell. This “new cell” then forms a blastocyst from which stem cells can be harvested.

The council concluded that embryonic stem cells created through SCNT are better for therapeutic purposes because they can be administered to the nucleus donor without eliciting an immune response.

O. Edwin McClusky, MD, former chair of the Council on Scientific Affairs, and Albert Sanders, MD, former chair of the Board of Councilors, say those panels backed embryonic stem cell research, including SCNT, because of its tremendous promise in treating a wide range of diseases.

While acknowledging concerns that “some rogue” scientist might attempt to use SCNT to produce a human child, Dr. Sanders says the Board of Councilors feels the risk versus the reward is worthwhile.

“If you’ve got appropriate safeguards on it and complete agreement that cloning leading to production of a child is wrong, then I think you can keep a lid on it so that it’s only used for valid research.”

The Council on Scientific Affairs began examining the issue of therapeutic cloning last summer, and its report was vetted with several other TMA councils and committees, TMA physician leaders, and some physicians known to hold pro-life positions prior to approval by the full council at TMA’s Winter Conference in February. The council received little negative feedback, and the House of Delegates approved the policy without debate.

Where’s the Therapy?

However, not all physicians support the policy. New Braunfels family physician Beverly B. Nuckols, MD, spoke against it before a House of Delegates reference committee. She said therapeutic cloning is a misnomer because it provides no therapy for the organism that is the subject of the research.

She believes embryonic stem cell research violates a physician’s first duty to “do no harm,” and destroying a human embryo, even one created artificially through SCNT, amounts to taking a human life.

“I don’t believe any human has a right to kill another human and, by species definition, these embryos are human beings, Homo sapiens. I believe we need to draw the line now as to whether humans are to be killed by other humans for the benefit of a third or fourth person, or whether we’re going to say no, humans will not be killed by other humans unless that person is a direct danger to another.”

AMA policy says cloning for biomedical research is “consistent with medical ethics.”

A Ken Ortolon can be reached at (800) 880-1300, ext. 1392, or (512) 370-1392; or by e-mail at ken.ortolon@texmed.org.

July 2004 Texas Medicine Contents

“Reprinted with permission of Texas Medicine and the Texas Medical Association.”

June 7, 2004

Beckie McCleery (512) 585-3329

Judy Haley (713) 464-8707

First International Stem Cell Conference Honors Nancy Reagan, Tackles Tough Issues 
TAMR Recognizes Courage in Action

As flags fly at half-staff to honor a hero lost to degenerative disease, TAMR (Texans for Advancement of Medical Research), along with preeminent scientists and health advocacy representatives attending the First International Stem Cell Conference in California, praised the courage of the “other hero” of the Reagan family, Nancy Reagan, for her strong public support of stem cell research. In a recent speech, Mrs. Reagan spoke of the pain of watching disease slowly destroy the President’s body, and of her conviction that too much time has already been lost in this fight to save lives. “Her courage, as a Republican and a conservative, provides leadership for the ‘silent majority’ to break that silence,” said Beckie McCleery, President of TAMR and a speaker at the Conference. “We have already seen a number of Senators and Representatives, including Texas’ own Kay Bailey Hutchison, taking a public stand in support of stem cell research.”

With the U.S. National Institutes of Health now saying that expanding the policy will speed research, Congressional support for stem cell research is growing. In April, 206 Representatives sent a letter to President Bush encouraging him to expand the current stem cell policy, and many others sent separate letters of support for the research. The similar Senate letter is still being circulated and signed. TAMR Secretary Melinda Rose said, “We suggest President Bush honor President Reagan by expanding the current embryonic stem cell policy to include the 400,000 parent designated frozen embryos that would otherwise be discarded, to be used for research to find a cure for Alzheimer’s and a myriad of other diseases. What a legacy that would be for a true American hero!”

The International Stem Cell conference, held June 5-6 on the UC-Berkeley University Campus, was the first grassroots advocacy event of its kind. Over 300 attendees-health advocates from across the nation-heard all sides of the ethical debate about embryonic stem cells, and listened as scientists described the potential power of stem cells to repair and regenerate lost tissue. “Stem cell research, a completely new field of medicine, is the next ‘giant step for mankind,’” said TAMR President McCleery.

TAMR is composed of leading scientists, physicians, ethicists, health groups, and individuals who support biomedical research for the purpose of curing diseases and alleviating suffering. TAMR was created last legislative session in response to the threat to stem cell research in Texas. TAMR is helping to build a bi-partisan coalition within the Texas legislature that supports all types of stem cell research.

U.S. Senator Kay Bailey Hutchison Signs Stem Cell Support Letter to President Bush

May 14, 2004

Beckie McCleery (512) 585-3329

Judy Haley (713) 464-8707

U.S. Senator Kay Bailey Hutchison Signs Stem Cell Support Letter to President Bush TAMR Applauds this Bold Step to Cure Degenerative Diseases

Once again, U.S. Senator Kay Bailey Hutchison has taken a bold position of leadership for the state of Texas. Last week, 206 members of the U.S. House of Representatives, including conservative pro-life Republican leaders, sent President Bush a bi-partisan letter asking him to expand his policy on stem cell research. This week, the Senate began to weigh in with a similar bi- partisan letter, and one of the first Republicans to sign on was Senator Kay Bailey Hutchison of Texas.

Long known for her support of biomedical research, Senator Hutchison recently formed the Texas Academy for Science, Engineering, and Medicine, bringing together preeminent leaders to push Texas further to the forefront in these fields. Now she has taken her support a step further by signing the Specter-Harkin letter, which will be sent from the Senate to President Bush. Senator Hutchison’s signature sends a signal to the science and medical community across Texas that the time has come to advance stem cell research, a new frontier of medicine. To our elected officials, at both federal and state levels, her signature also clarifies that stem cell research is supported by conservative, pro-life Republicans.

“Growing numbers of citizens and elected officials are recognizing that the stem cell lines made available under the President’s current policy are far fewer than expected. And, because the cells were grown on mouse feeder lines, they are contaminated with mouse viruses and proteins, making them unsuitable for human therapy. These problems will have a direct impact on how quickly cure therapies can be developed for diabetes, Parkinson’s, MS, and other degenerative diseases,” said Judith Haley, Vice President of Texans for Advancement of Medical Research (TAMR).

“Stem cell research is not a Republican or Democrat, conservative or liberal, pro-life or pro-choice issue,” said Beckie McCleery, TAMR President. “It crosses all lines of thought and belief. With their public support, members of Congress are clearly articulating a desire to advance stem cell research to cure the most devastating diseases of our time. We are very grateful to Senator Hutchison for stepping out and taking a lead on this issue.”

TAMR is composed of leading scientists, physicians, ethicists, health groups, and individuals who support biomedical research for the purpose of curing diseases and alleviating suffering. TAMR was created last legislative session in response to the threat to stem cell research in Texas. TAMR is helping to build a bi-partisan coalition within the Texas legislature that supports all types of stem cell research for regenerative medicine.