Wednesday, September 17, 2008

English 1010 portfolio 2 FIRST RESOURCE

Broken Bridge cartoon:
http://sks.sirs.com/cgi-bin/hst-graphic-single?id=SUT0568-0-6407&keyno=0000083081&artno=0000194121&auth_checked=Y

Discovery Could Transform Debate Over Stem Cells
COURIER-JOURNAL
(Louisville, KY)
Dec. 12, 2005, n.p.Copyright © 2005 Courier-Journal. Distributed by Knight-Ridder/Tribune Information Services. December 12, 2005. All rights reserved. Reprinted by permission.

Discovery Could Transform Debate over Stem Cells
By Laura Ungar
The (Louisville, Ky.) Courier-Journal

University of Louisville researchers have coaxed stem cells from adult mice to change into brain, nerve, heart and pancreatic cells--a discovery that could lead to treatments for a host of human diseases and possibly end the national debate over the use of embryonic stem cells.
"We have found a counterpart for embryonic stem cells in adult bone marrow. This could negate the ethical concerns," said Dr. Mariusz Ratajczak, leader of the research team and director of the stem-cell biology program at the university's James Graham Brown Cancer Center. The next step is to replicate the experiment with similar cells identified in adult humans.
"It's huge," said Ryan Reca, one of the researchers. "It's an amazing discovery."
Others agreed, although they, like Ratajczak, cautioned that it's early in the research process and that more study is needed.
If the cells from adult humans are found to act like those in mice, and other scientists can duplicate the process on a larger scale, the discovery goes from "very important" to "incredibly important," said Dr. Stephen Emerson, chief of hematology/oncology at the University of Pennsylvania, where Ratajczak used to work.
It could lead to expanded research and "be transforming," he said.
"This is a very important first step," said Scott Whittemore, scientific director of U of L's Kentucky Spinal Cord Injury Research Center.
However, Whittemore said that "there are some major issues that need to be resolved before you can think about" translating Ratajczak's research into medical treatments.
Ratajczak announced some of his findings Monday at the annual meeting of the American Society of Hematology in Atlanta. His team also plans to present a paper Tuesday showing that the type of cells it has identified--called "very small embryonic-like," or VSEL--mobilize into the bloodstream to help repair damaged tissue after a stroke in mice.
Although treatments based on the team's discovery are most likely many years off, the research could hold promise for such conditions as heart disease, stroke, diabetes and Parkinson's disease. Using a patient's own VSELs could eliminate the danger of rejection that could exist with donor stem cells.
Some local residents with diseases that could be treated based on the discovery are optimistic.
More immediately, the discovery could boost disease research, said Gayle Zoeller, a 61-year-old Louisville resident with Parkinson's disease.
"I guess we would get a lot more funding," said Zoeller, who has worked with the nonprofit fundraising group Parkinson Alliance. "You wouldn't have to fight Congress."
And the possibility of more research gives her hope.
"The more study that's going on," she said, "eventually something's going to work."

Controversy over Cells
Doctors and researchers have been extremely interested in stem cells because they have the potential to develop into many cell types in the body.
Embryonic stem cells are able to give rise to any type of cell except those needed to develop a fetus, according to the National Institutes of Health.
Although the potential for adult stem cells has been thought to be more limited, the use of embryonic stem cells has been controversial because it involves the destruction of embryos, which opponents say amounts to destroying human life.
In 2001, President Bush restricted federal funding of research to existing lines of cells developed from embryos. He cited ethical concerns about the destruction of embryos.
But many researchers and groups have persisted in urging such funding, saying embryonic stem cells hold the best potential for medical research.
They also say some of the older stem-cell lines funded under Bush's policy have been contaminated and are not as useful as producing new ones would be.
Ratajczak's recent discoveries show that the newly identified adult cells appear to act like embryonic stem cells. He first described a strategy for identifying and isolating them in a 2004 issue of the journal Leukemia.
But that earlier research also showed that VSELs are very rare and difficult to grow in a laboratory.
The research announced Monday appears to show that VSELs can be grown in the laboratory, multiply into clusters of cells and then be coerced to change into other types of cells, such as brain or heart-muscle cells.
In experiments, the team extracted bone marrow cells from adult mice, put them into a cell sorter to extract the VSELs, put those cells into a Petri dish, and then activated them, using a confidential process that is part of a patent application by U of L.
The cells then were exposed to chemicals generated by the mouse's body called "factors" and changed into cardiac muscle cells, pancreatic cells, nerve cells and brain cells.
"We've established how to isolate and how to unleash the power of this cell," said Ratajczak, who has worked at U of L since 2001.

Wide Implications
A spokeswoman for the National Institutes of Health said the chairman of the agency's stem-cell task force would not comment on Ratajczak's research because he has not had a chance to study it.
But others agreed the discovery could have wide-ranging implications--especially if VSELs in humans can do what VSELs in mice have been made to do.
"It would certainly be very exciting to be able to transform them, convert them into other cells. It might diminish the demand for embryonic stem cells," said Arthur Caplan, a University of Pennsylvania bioethicist.
But he added: "Place your bets on all forms of research right now. It's too soon to say that adult stem cells can do what embryonic cells do."
Staff writer Peter Smith contributed to this story.
Research highlights:

• University of Louisville researchers have caused cells from adult mice to change into brain, heart-muscle, pancreatic and nerve cells. The adult cells seem to mimic embryonic stem cells.
• The research could lead to therapies for stroke and Parkinson's disease, among other things. If other scientists repeat the process on a larger scale, it could reduce the need for embryonic stem cells. It could also eliminate rejection problems that can exist when using stem cells from a donor.
• Although research is in the early stages, it eventually could end the national controversy over the use of embryonic stem cells.

English 1010 portfolio 2 SECOND RESOURCE

Exploring The Promise Of Stem Cells
Exploring the Promise of Stem Cells

by Brenda Patoine
Stem cells have captured the world’s attention for their potential use as therapies for devastating conditions such as Parkinson’s disease, diabetes, and even heart disease. With their capacity to generate every cell type in the body, stem cells have been hailed as virtually unlimited sources for tissue and organ replacements, potentially eliminating the need for organ donors. Yet, for all the hype and hope surrounding these versatile cells, any clinical application is, by all accounts, years or even decades away. Scientists are still struggling to understand how embryonic stem (ES) cells generate daughter cells that can differentiate into multiple cell types. And researchers have not yet perfected the conditions for producing large quantities of these cells in an undifferentiated state. All of these hurdles must be overcome before the true promise of ES cells can be realized. “To make good judgments about how embryonic stem cells function and differentiate, we first need to know how to expand their production and select the best quality control criteria,” says Dr. Anthony Hayward, director of NCRR’s Division of Clinical Research. Toward that end NCRR, along with five other NIH institutes, announced in April 2002 the first grants in its Infrastructure Enhancement Awards in human ES cell research. The two-year grants are designed to enable the laboratories that originally derived human ES cells to expand, test, and distribute their cells to qualified investigators. As of September 2002, five laboratories that have cell lines on the NIH Registry had received awards totaling more than $2.1 million: the University of California, San Francisco (UCSF); the Wisconsin Alumni Research Foundation in Madison; the Karolinska Institute in Sweden; BresaGen, Ltd. in Athens, Georgia; and ES Cell International Pte. Ltd., of Singapore and Melbourne, Australia. Dr Thomson

Photo: Dr. James Thomson and his colleagues were the first to isolate embryonic stem cell lines from nonhuman primates and from humans.

(Photo by Jeff Miller, University of Wisconsin-Madison)

NCRR has long supported ES cell research in animals, most notably the pioneering studies conducted by Dr. James Thomson, Dr. John Hearn, and their colleagues at the Wisconsin National Primate Research Center (NPRC). In 1995 the researchers reported the first isolation and culturing of ES cells from a nonhuman primate—the rhesus macaque. The researchers empirically determined that ES cells could be plucked from a sphere of embryonic cells, known as the blastocyst, and grown on a blanket of mouse connective tissue cells called fibroblasts. These “feeder cells,” which secrete factors that support the growth of the ES cells and prevent them from differentiating, proved to be the critical element in producing rhesus ES cell cultures. Importantly, cultured rhesus ES cells appeared to be capable of differentiating into the various cell types of the body. When treated with certain chemicals in culture or injected into immunodeficient mice to avoid problems with immune rejection, the ES cells differentiated into cells found in bone, muscle, nervous system, and other tissues. (For more information, see the NCRR Reporter, September/October 1995, pp. 4-7.) Using knowledge gained from their nonhuman primate studies, Dr. Thomson and his colleagues took a significant step forward in 1998, when they isolated and propagated ES cells from humans. “The monkey studies were certainly a useful prelude to the human work,” comments Dr. John D. Harding, a health scientist administrator in NCRR’s Division of Comparative Medicine, which supports the network of National Primate Research Centers across the country. “The Wisconsin studies demonstrated early on the feasibility of deriving embryonic stem cells from primates.” As in their nonhuman primate work, Dr. Thomson and his colleagues derived their human ES cell lines from cells formed only days after the egg was fertilized and started dividing. Shortly after the Wisconsin researchers announced their accomplishment, researchers at Johns Hopkins University reported that they had also cultured human ES cell lines, although theirs were derived from primordial germ cells—precursors of human sperm and eggs—taken from medically aborted 5- to 8-week-old embryos.

Although these initial studies of human ES cells were privately funded, in August 2001 the U.S. government began to allow the use of federal funds to support research with approved, pre-existing human ES cell lines, including several derived by Dr. Thomson’s laboratory. These cell lines are listed in the NIH Human Embryonic Stem Cell Registry (http://escr.nih.gov).

Scientists say federal support of stem cell infrastructure is critical because it allows NIH, rather than a commercial entity, to “set the bar” for quality assurance of distributed cells, says Dr. Keith Yamamoto, vice dean for research at UCSF School of Medicine. “When we know that everyone is starting with the same material, we will be better able to compare experiments from different laboratories,” he says.

Although some of the institutions listed in the stem cell registry had begun shipping human ES cells prior to the infrastructure grants, federal funding is expected to dramatically enhance distribution. The infrastructure grants are designed to meet the individual needs of each institution, whether those needs are to rent space, purchase incubators, or add staff, says Dr. Hayward. “We’re simply trying to give these laboratories enough money to enable them to switch from exclusively producing cells for their own research to also producing cells for other laboratories,” he says.

The infrastructure grants also require that laboratories ship at least 200,000 cells to researchers who request them. This will provide scientists with enough cells to have a “master stock” of their own to propagate while using some of the cells for experiments, says Dr. Hayward. Before shipping the cells, scientists analyze them for certain cell-surface markers that identify the cells as both undifferentiated and capable of differentiating, while other markers detect chromosomal abnormalities. These various quality assurances are critical because the cells are expected one day to be used in the treatment of degenerative diseases.

A major barrier to using ES cells clinically has been the requisite use of mouse feeder cells in their production. Typically, human ES cells are grown on a layer of mouse fibroblasts, which provide still-unidentified growth factors that maintain the cells in an undifferentiated state. Unfortunately, reliance on mouse cells opens the door to potential transmission of pathogens, particularly animal viruses, from the feeder cells to the human ES cells. But now, in the September 2002 issue of Nature Biotechnology, scientists from ES Cell International describe a new technique that uses human, rather than mouse, fibroblasts as feeder cells, an advance that is important for developing cells that can be used therapeutically. The researchers first cultured human fibroblasts from adult fallopian tubes or from fetal muscle and skin. A layer of these feeder cells, or the solution in which they were grown, was then used to nurture cultures of human ES cells. With either the feeder cells or the solution, the human ES cells grew at least as well as they did with mouse feeder cells, and they retained all the expected characteristics of stem cells. Cultivation of embryonic stem cells

Photo: Embryonic stem cells can be isolated after a fertilized egg (1) develops into a ball of cells called a blastocyst (2). From inside a blastocyst, the inner cell mass is extracted (3) and deposited (4) on a thin blanket of feeder cells, which allow the undifferentiated stem cells to proliferate. (Courtesy of the University of Wisconsin-Madison)

Aggressive research programs are already underway to test the usefulness of stem cell transplant strategies in animal models of Parkinson’s disease. Other neurological disorders that might prove treatable with stem cells include stroke, spinal cord injury, amyotrophic lateral sclerosis (Lou Gehrig’s disease), and Alzheimer’s disease. In one recent study, Dr. Thomson and his colleagues succeeded in transforming human ES cells into transplantable neuronal precursor cells in vitro, an early step toward potential repair of brain tissue.

While disease treatments based on human ES cells are still many years off, Andrew Cohn, spokesman of the Wisconsin Alumni Research Foundation (WARF), believes that one of the first commercial applications of these cells will be to test drug candidates. “As soon as we can get purified heart tissue, I am confident that drug companies are going to want to use it to screen compounds,” he says. Besides heart tissue, the University of Wisconsin-Madison has programs to develop blood, pancreatic, and neural cells. If potential drugs can be tested in vitro on normally functioning organ tissue, scientists might be better able to evaluate their effects.

Once the therapeutic potential of ES cells is determined, any treatments will likely be evaluated in the NCRR-supported General Clinical Research Centers (GCRCs), says Dr. Hayward. “The national network of GCRCs offers the research infrastructure needed to test new therapies,” he says. “The GCRCs provide investigators with access to sophisticated laboratories and the specialized support staff needed to do the highest quality research.”

For now, the field of human ES cell research is wide open. “If people are interested in going into this area of research, there are no longer many roadblocks,” says Mr. Cohn. “NIH has made research money available, and cells can now be obtained from WARF/WiCell Research Institute and other sites. The more people working in this field, the faster discoveries will be made, and that will be good for us all.”
The stem cell research infrastructure enhancement awards are funded by the Division of Clinical Research of the National Center for Research Resources; the National Heart, Lung, and Blood Institute; the National Institute on Aging; the National Institute of Child Health and Human Development; the National Institute of Diabetes and Digestive and Kidney Diseases; and the National Institute of Mental Health.

For more information about the NCRR Division of Clinical Research, visit www.ncrr.nih.gov/clinical_rsrch.asp. Additional Reading

1. Richards, M., Fong, C.-Y., Chan, W.-K., et al., Human feeders support prolonged undifferentiated growth of human inner cell masses and embryonic stem cells. Nature Biotechnology 20:933-936, 2002.

2. Odorico, J. S., Kaufman, D. S., and Thomson, J. A., Multilineage differentiation from human embryonic stem cell lines. Stem Cells 19:193-204, 2001.

3. Thomson, J. A., Kalishman, J., Golos, T. G., et al., Proceedings of the National Academy of Sciences USA 92:7844-7848, 1995.

English 1010 portfolio 3 FIRST RESOURCE

Bioethics and the Stem Cell Research Debate
SOCIAL EDUCATION
May/June 2006, Vol. 70, No. 4, pp. 203-208 © National Council for the Social Studies. Reprinted by permission.
Bioethics and the Stem Cell Research Debate
By Robyn S. Shapiro

Since its birth in the 1970s, bioethics--the study of ethical issues in science and medicine--has grown to become a significant academic and service-oriented discipline with its own research centers, conferences, journals, and degree programs. As these issues have moved to the center of public debate, the law has assumed an increasingly important place in the discipline of bioethics. The growing importance of the law as a forum for the debate and mediation of bioethical issues is apparent on several fronts. In the United States Supreme Court, bioethical issues have been central to key reproductive privacy cases, from the Court's 1973 decision in Roe v. Wade, 410 U.S. 113, to its 2000 decision in Stenberg v. Carhart, 530 U.S. 914, which struck down a controversial Nebraska partial-birth abortion law. In state courts, bioethical considerations inform judges' balancing of patient health care confidentiality with a "duty to warn" of potentially dangerous patient behavior (see, for example, the California Supreme Court's landmark 1976 decision, Tarasoff v. Regents of the University of California, 17 Cal.3d 425). At both the state and federal levels, bioethical debates help shape end-of-life statutes and court cases, including Cruzan v. Missouri Dept. of Health, 497 U.S. 261 (1990), in which the U.S. Supreme Court upheld the State of Missouri's requirement for clear and convincing evidence that a person in a persistent vegetative state had expressed a wish not to be kept alive by life-sustaining equipment.

Today, embryonic stem cell research stands out as a critically important issue about which we have neither ethical consensus nor clear, comprehensive regulation. The ethical debate centers on the fact that stem cell research involves the destruction of very early human embryos. On the federal level, funding for stem cell research has been limited to research using stem cells derived from a limited number of stem cell "lines." On the state level, approaches range from legislative restrictions on stem cell research to the State of California's plan to provide $3 billion in stem cell research funding through the voter-approved California Institute for Regenerative Medicine. In order for potentially revolutionary stem cell research to progress, scientists' long-term needs must be effectively coordinated with appropriate and effective ethical and legal guidance. This article provides brief scientific background and then discussion of key ethical and legal/regulatory issues that surround embryonic stem cell research.

Background

Embryonic stem cells are precursor cells that have the capacity to divide for indefinite periods of time in culture and to give rise to virtually any type of specialized cells in the body. They are derived from the inner cell mass of a 100-cell blastocyst--a very early embryo, usually only 3-4 days old--long before the cells have started to specialize to create a nervous system, spine and other features that, with further development, would transform the embryo into a fetus. Typically, these cells are derived from embryos that originally were created for infertility treatment purposes through in vitro fertilization, but that are no longer desired or needed by the infertile couple for treatment. The extraction of the stem cells from the blastocyst necessarily requires the destruction of that blastocyst. Because embryonic stem cells are capable of self-renewal and can differentiate into a wide variety of cell types, potential applications of embryonic stem cell research are far-reaching.

For example, embryonic stem cell research holds out great promise to those suffering from Type I diabetes. Type I diabetes is an autoimmune disease characterized by destruction of insulin-producing cells in the pancreas. Some of the current efforts to treat these patients use donated human pancreases for transplantation of islets--clusters of cells on the pancreas that produce insulin--in an effort to restore the insulin-secreting function. Islet transplantation efforts are limited by the small numbers of available donated pancreases, as well as the toxicity of immunosuppressive drug treatments that are required to prevent graft rejection. Use of embryonic stem cells that are instructed to differentiate into pancreatic islet cells has the potential to overcome the shortage of effective material to transplant.

Similarly, embryonic stem cell research offers tremendous potential to those suffering from nervous system diseases that result from loss of nerve cells. Since mature cells cannot divide to replace cells that are lost, therapeutic possibilities do not exist in the absence of a new source of functioning nerve tissue. Conceivably, however, with embryonic stem cell research, nerve cells that make the chemical dopamine could be created for individuals with Parkinson's disease, cells responsible for the production of certain neuro-transmitters could be reconstituted for individuals with Alzheimer's, the motor cells that activate muscles could be replaced for ALS patients, and glia (cells that perform numerous functions within the human nervous system) could be formed for individuals with multiple sclerosis. In addition to these promising therapeutic applications of embryonic stem cell research, such research also could provide new insights into how human beings, organs and tissues develop.

It also has the potential to substantially change the development and testing of pharmaceutical products. New medications could be tested initially on cells or tissues developed from embryonic stem cells, and only those drugs initially found to be safe and effective would be tested further on animals and humans.

Ethical Issues

Notwithstanding the promise of embryonic stem cells, several ethical issues have made stem cell research controversial. The most vexing ethical issues surrounding embryonic stem cell research, which focus on the moral status of the very early embryo, arise from the fact that isolating embryonic stem cells requires destruction of the embryo. Some who condemn embryonic stem cell research believe that the embryo is a full person or human subject, with full rights and interests from the moment of conception.

Others take a developmental view of personhood, believing that the embryo only gradually becomes a full human being and that the very early embryo is not entitled to the same moral protections to which it would be entitled at a later developmental stage. Still others hold that while the embryo represents human life, such life is not a "person" at any time prior to birth. The role of science in deciding the difficult ethical question of the moral status of the very early embryo is unresolved.

Key issues in deciding this question include the following:

• How significant is it that at less than 14 days a blastocyst has no neural tissue? Some contend that this fact makes derivation of stem cells from a blastocyst prior to this developmental stage no different than allowing organ donation at the point of brain death.

• Is it ethically significant that until formation of the primitive streak at 14 days, a blastocyst can undergo complete fission to form an identical twin? One commentator contends that since "individuality is a sine qua non for personhood, it seems safe to consider 14 days of normal embryonic development to be the minimum requirement for a human being to emerge."

• Is the argument for the protection of the "potential" for human life affected by scientific assertions that an embryo does not have such potential unless it is implanted in a uterus?

• Is it ethically significant that a blastocyst created by somatic cell nuclear transfer (see Stem Cell Research and Cloning), if implanted, would be extremely unlikely to develop into a human being? As one commentator notes, "cytoplasmic factors would have to act on an adult nucleus to produce the same patterns of gene activation that are critical for early embryonic development."

Legal Issues

Federal and state legislatures have begun to grapple with the ethical questions involved in stem cell research, but to date, there is no comprehensive or consistent regulation of stem cell research in the United States. Since 1996, riders to federal appropriations language (known as the "Dickey Amendment") have prohibited use of federal funds for "the creation of a human embryo or embryos for research purposes," as well as "research in which a human embryo or embryos are destroyed, disabled or knowingly subjected to a risk of injury or death greater than allowed for research on fetuses in utero..."

In January 1999, however, the General Counsel of the Department of Health and Human Services (HHS) determined that federal law does not prohibit public funding of embryonic stem cell research as long as the research to be funded does not include derivation of the stem cells from the embryo (and, therefore, destruction of the embryo). In other words, cells could be derived from embryos destroyed in private labs with private money, and then shipped to federally funded scientists for study.

Following this legal clearance from HHS, the director of the National Institutes of Health (NIH) convened a 13-member working group to draw up guidelines for research using embryonic stem cells. This group's guidelines, which became effective August 2000, state that research involving embryonic stem cells is acceptable as long as

• the stem cells come from spare embryos that were originally created through in vitro fertilization for infertility treatment purposes,

• the embryos have not reached the developmental state at which the mesoderm is formed,

• the researcher is not involved in the infertility treatment for which the embryos were created and has not played any role in the donors' decision to donate the embryos for research,

• there is no directed donation of embryos for the derivation of stem cells for eventual use in transplantation, and

• the stem cells are not added to human or animal eggs or embryos via somatic cell nuclear transfer.

On August 9, 2001, however, President Bush effectively suspended the NIH 2000 guidelines. He announced that federal funding for embryonic stem cell research would be available only under the following conditions:

• the stem cells are derived from stem cell lines existing as of August 9, 2001,

• the lines were derived with proper informed consent of the embryo donors,

• the embryos used were originally created through in vitro fertilization for infertility treatment purposes, and

• there were no financial inducements made to the embryo donors.

No federal funds may be used for derivation or use of stem cells derived from newly destroyed embryos, creation of human embryos for research purposes, or cloning of human embryos for any purpose. Many contend that the president's restrictions on federal funding of embryonic stem cell research are inhibiting the ability to unlock the potential of embryonic stem cells.

One concern relates to recently discovered chromosomal rearrangements in embryonic stem cells over time, which suggest that the federally approved lines may have limited therapeutic potential. Additional concerns relate to the limited number and the narrow racial diversity of the federally approved stem cell lines. Moreover, in addition to the federal funding restrictions, embryonic stem cell research is also subject to some restrictive state laws. While California is providing government funding for stem cell research through the California Institute for Regenerative Medicine, and New Jersey, Massachusetts, Illinois, Wisconsin, and Texas are considering funding measures, other states--including Iowa, Louisiana, Michigan, Arkansas, Nebraska, North Dakota, South Dakota, and Virginia--have laws that limit embryonic stem cell research.

On the other hand, stem cells, as well as their derivation and their users, are eligible for federal patent protections. In fact, a number of patents relating to human embryonic stem cells have been filed--the most fundamental of which are the "Thomson" patents, named after the University of Wisconsin researcher who led a group that developed the technique for isolating and growing human embryonic stem cells. Thomson patents relate to the methods of deriving and maintaining human embryonic stem cells in vitro, and the products of those methods. These patents were assigned by the inventors to the Wisconsin Alumni Research Foundation, which exclusively licensed their commercial applications within certain fields of use to Geron Corporation, and made licenses to practice under the patent rights for research purposes available through a non-profit corporation. Some have questioned the ethical acceptability of patenting embryonic stem cells.

For example, one commentator has questioned whether the federal government's opposition to direct federal funding of post-August 2001 stem cell lines is consistent with its sanction of exclusive property rights in such lines, since these patent-protected rights can create "indirect research funding" through rewarding market investments. However, such qualms collide with the United States Supreme Court's declaration that "everything under the sun" isolated or manipulated by humanity may be patented and that patent law is not intended to displace the police powers of the states with respect to safety, health and morality. Ironically, then, the current federal position is to allow sensitive ethical questions on stem cell research to be decided by the marketplace, with private money developing products that receive patent protection without the regulatory oversight that would apply to federally funded research.

Conclusion

Stem cell research has emerged as a potential political issue that could play a role in the 2006 mid-term elections and beyond. In his 2006 State of the Union speech, President Bush called upon Congress "to pass legislation to prohibit the most egregious abuses of medical research," including "human cloning in all its forms." Some commentators have criticized this statement for failing to distinguish between human reproductive cloning, which most experts oppose, and therapeutic cloning, in which cloning techniques are used to produce blastocysts for stem cell extraction, not embryos for implantation.

In Congress, there are signs of division in the Republican majority on the question of stem cell research. A bill easing current federal restrictions on stem cell research passed the Republican-controlled House of Representatives in 2005 but stalled in the Senate, which is scheduled to take up the bill sometime in 2006. Several key senators, including Senate Majority Leader Bill Frist (R-Tenn.), have spoken in support of the bill. In the meantime, there is no consensus concerning ethical questions surrounding embryonic stem cell research. Continued careful attention to ethical review of the issues that surround this promising research, and consistent incorporation of such analysis into evolving laws and regulations, will assure the appropriate and effective use of this emerging knowledge.

Stem Cell Research and Cloning

Somatic cell nuclear transfer is also known as therapeutic cloning. The procedure involves removing the nucleus of an unfertilized human egg cell and replacing it with the nucleus of a "somatic cell" (all body cells except reproductive cells such as sperm and egg cells). The egg cell is then allowed to divide for a few days until it reaches the blastocyst stage, upon which stem cells can be extracted.

Therapeutic cloning has the potential to overcome rejection risks associated with organ or tissue transplantations. If the individual undergoing stem cell therapy contributed the somatic cell nucleus implanted in the egg, the resulting stem cells would share that individual's genetic information and would be less likely to be rejected.

Therapeutic cloning is controversial because somatic cell nuclear transfer is also the technique used in reproductive cloning (the effort to create a genetically identical copy of an entire organism such as a human being). Cells produced in therapeutic cloning, however, are not developed past the blastocyst stage, when the stem cells are extracted.

Resources

The Genetic Science Learning Center of the University of Utah, gslc.genetics.utah.edu/units/stemcells, offers an interactive "Stem Cells in the Spotlight" website designed especially for high school students and educators. The site includes an animated graphic--featuring "Stem Cell Guy"--that introduces students to key features of stem cells. Also included on the site are teacher resources and lesson plans.

The National Institutes of Health, stemcells.nih.gov/index.asp, maintains a Stem Cell Information website with good information on stem cell basics and federal policy regarding embryonic stem cell research. The site also provides information on additional resources for researching stem cell issues.

The Center for Bioethics at the University of Pennsylvania, www.bioethics.upenn.edu/highschool, sponsors an online High School Bioethics Project. Included on the site are short briefs on topics ranging from the history of bioethics, to the human genome project, to stem cell research. Many of the briefs outline teacher objectives for the topic and review questions for students. Additional resources are provided in the Teacher's Corner (which requires free registration for access).

The website for the President's Council on Bioethics, www.bioethics.gov, provides PDFs of the Council's white papers and reports on a variety of bioethical issues, including several reports on stem cell research and human cloning. Also included are excerpts from the Council's publication, Being Human: Readings from the President's Council on Bioethics, described as "an anthology of works of literature that speak to bioethical dilemmas."

Robyn Shapiro is Ursula von Der Ruhr Professor of Bioethics and Director of the Center for the Study of Bioethics at the Medical College of Wisconsin, and Health Law Partner at Gardner Carton & Douglas LLP in Milwaukee, Wisc.

The views expressed in this article are those of the author and have not been approved by the House of Delegates of the Board of Governors of the American Bar Association and, accordingly, should not be construed as representing the policy of the American Bar Association.

English 1010 portfolio 3 SECOND RESOURCE

Fetus Farming Prohibition Act of 2006
Fetus Farming Prohibition Act of 2006 (Enrolled as Agreed to or Passed by Both House and Senate) --S.3504--

One Hundred Ninth Congress of the United States of America

AT THE SECOND SESSION

Begun and held at the City of Washington on Tuesday, the third day of January, two thousand and six

An Act

To amend the Public Health Service Act to prohibit the solicitation or acceptance of tissue from fetuses gestated for research purposes, and for other purposes. Be it enacted by the Senate and House of Representatives of the United States of America in Congress assembled,
SECTION 1. SHORT TITLE.
This Act may be cited as the `Fetus Farming Prohibition Act of 2006'.
SEC. 2. PROHIBITION OF THE SOLICITATION OR ACCEPTANCE OF TISSUE FROM FETUSES GESTATED FOR RESEARCH PURPOSES.
Section 498B of the Public Health Service Act (42 U.S.C. 289g-2) is amended--

(1) by redesignating subsections (c) and (d) as subsections (d) and (e), respectively;

(2) by inserting after subsection (b) the following:

`(c) Solicitation or Acceptance of Tissue From
Fetuses Gestated for Research Purposes- It
shall be unlawful for any person or entity
involved or engaged in interstate commerce to-

`(1) solicit or knowingly acquire, receive, or
accept a donation of human fetal tissue
knowing that a human pregnancy was
deliberately initiated to provide such tissue;
or
`(2) knowingly acquire, receive, or accept
tissue or cells obtained from a human
embryo or fetus that was gestated in the
uterus of a nonhuman animal.';

(3) in paragraph (1) of subsection (d), as so redesignated, by striking `(a) or (b)' and inserting `(a), (b), or (c)'; and

(4) in paragraph (1) of subsection (e), as so redesignated, by striking `section 498A(f)' and inserting `section 498A(g)'.

Speaker of the House of Representatives.

Vice President of the United States and

President of the Senate.

English 1010 portfolio 3 THIRD RESOURCE

President Discusses Stem Cell Research Policy
President Discusses Stem Cell Research Policy
July 19, 2006
Page(s) : n.p.
Executive Office of the President
Executive Office of the President
President Discusses Stem Cell Research Policy
By President George W. Bush
The East Room THE PRESIDENT: Good afternoon. Congress has just passed and sent to my desk two bills concerning the use of stem cells in biomedical research. These bills illustrate both the promise and perils we face in the age of biotechnology. In this new era, our challenge is to harness the power of science to ease human suffering without sanctioning the practices that violate the dignity of human life. (Applause.) In 2001, I spoke to the American people and set forth a new policy on stem cell research that struck a balance between the needs of science and the demands of conscience. When I took office, there was no federal funding for human embryonic stem cell research. Under the policy I announced five years ago, my administration became the first to make federal funds available for this research, yet only on embryonic stem cell lines derived from embryos that had already been destroyed. My administration has made available more than $90 million for research on these lines. This policy has allowed important research to go forward without using taxpayer funds to encourage the further deliberate destruction of human embryos. One of the bills Congress has passed builds on the progress we have made over the last five years. So I signed it into law. (Applause.) Congress has also passed a second bill that attempts to overturn the balanced policy I set. This bill would support the taking of innocent human life in the hope of finding medical benefits for others. It crosses a moral boundary that our decent society needs to respect, so I vetoed it. (Applause.) Like all Americans, I believe our nation must vigorously pursue the tremendous possibility that science offers to cure disease and improve the lives of millions. We have opportunities to discover cures and treatments that were unthinkable generations ago. Some scientists believe that one source of these cures might be embryonic stem cell research. Embryonic stem cells have the ability to grow into specialized adult tissues, and this may give them the potential to replace damaged or defective cells or body parts and treat a variety of diseases. Yet we must also remember that embryonic stem cells come from human embryos that are destroyed for their cells. Each of these human embryos is a unique human life with inherent dignity and matchless value. We see that value in the children who are with us today. Each of these children began his or her life as a frozen embryo that was created for in vitro fertilization, but remained unused after the fertility treatments were complete. Each of these children was adopted while still an embryo, and has been blessed with the chance to grow up in a loving family. These boys and girls are not spare parts. (Applause.) They remind us of that is lost when embryos are destroyed in the name of research. They remind us that we all begin our lives as a small collection of cells. And they remind us that in our zeal for new treatments and cures, America must never abandon our fundamental morals. Some people argue that finding new cures for disease requires the destruction of human embryos like the ones that these families adopted. I disagree. I believe that with the right techniques and the right policies, we can achieve scientific progress while living up to our ethical responsibilities. That's what I sought in 2001, when I set forth my administration's policy allowing federal funding for research on embryonic stem cell lines where the life and death decision had already been made. This balanced approach has worked. Under this policy, 21 human embryonic stem cell lines are currently in use in research that is eligible for federal funding. Each of these lines can be replicated many times. And as a result, the National Institutes of Health have helped make more than 700 shipments to researchers since 2001. There is no ban on embryonic stem cell research. To the contrary, even critics of my policy concede that these federally funded lines are being used in research every day by scientists around the world. My policy has allowed us to explore the potential of embryonic stem cells, and it has allowed America to continue to lead the world in this area. Since I announced my policy in 2001, advances in scientific research have also shown the great potential of stem cells that are derived without harming human embryos. My administration has expanded the funding of research into stem cells that can be drawn from children, adults, and the blood in umbilical cords, with no harm to the donor. And these stem cells are already being used in medical treatments. With us today are patients who have benefited from treatments with adult and umbilical-cord-blood stem cells. And I want to thank you all for coming. (Applause.) They are living proof that effective medical science can also be ethical. Researchers are now also investigating new techniques that could allow doctors and scientists to produce stem cells just as versatile as those derived from human embryos. One technique scientists are exploring would involve reprogramming an adult cell. For example, a skin cell to function like an embryonic stem cell. Science offers the hope that we may one day enjoy the potential benefits of embryonic stem cells without destroying human life. We must continue to explore these hopeful alternatives and advance the cause of scientific research while staying true to the ideals of a decent and humane society. The bill I sign today upholds these humane ideals and draws an important ethical line to guide our research. The Fetus Farming Prohibition Act was sponsored by Senators Santorum and Brownback--both who are here. (Applause.) And by Congressman Dave Weldon, along with Nathan Deal. Thank you, Congressmen. (Applause.) This good law prohibits one of the most egregious abuses in biomedical research, the trafficking in human fetuses that are created with the sole intent of aborting them to harvest their parts. Human beings are not a raw material to be exploited, or a commodity to be bought or sold, and this bill will help ensure that we respect the fundamental ethical line. I'm disappointed that Congress failed to pass another bill that would have promoted good research. This bill was sponsored by Senator Santorum and Senator Arlen Specter and Congressman Roscoe Bartlett. Thanks for coming, Roscoe. (Applause.) It would have authorized additional federal funding for promising new research that could produce cells with the abilities of embryonic cells, but without the destruction of human embryos. This is an important piece of legislation. This bill was unanimously approved by the Senate; it received 273 votes in the House of Representatives, but was blocked by a minority in the House using procedural maneuvers. I'm disappointed that the House failed to authorize funding for this vital and ethical research. It makes no sense to say that you're in favor of finding cures for terrible diseases as quickly as possible, and then block a bill that would authorize funding for promising and ethical stem cell research. At a moment when ethical alternatives are becoming available, we cannot lose the opportunity to conduct research that would give hope to those suffering from terrible diseases, and help move our nation beyond the current controversies over embryonic stem cell research. We must pursue this research. And so I direct the Secretary of Health and Human Services, Secretary Leavitt, and the Director of the National Institutes of Health to use all the tools at their disposal to aid the search for stem cell techniques that advance promising medical science in an ethical and morally responsible way. (Applause.) Unfortunately, Congress has sent me a bill that fails to meet this ethical test. This legislation would overturn the balanced policy on embryonic stem cell research that my administration has followed for the past five years. This bill would also undermine the principle that Congress, itself, has followed for more than a decade, when it has prohibited federal funding for research that destroys human embryos. If this bill would have become law, American taxpayers would, for the first time in our history, be compelled to fund the deliberate destruction of human embryos. And I'm not going to allow it. (Applause.) I made it clear to the Congress that I will not allow our nation to cross this moral line. I felt like crossing this line would be a mistake, and once crossed, we would find it almost impossible to turn back. Crossing the line would needlessly encourage a conflict between science and ethics that can only do damage to both, and to our nation as a whole. If we're to find the right ways to advance ethical medical research, we must also be willing, when necessary, to reject the wrong ways. So today, I'm keeping the promise I made to the American people by returning this bill to Congress with my veto. As science brings us ever closer to unlocking the secrets of human biology, it also offers temptations to manipulate human life and violate human dignity. Our conscience and history as a nation demand that we resist this temptation. America was founded on the principle that we are all created equal, and endowed by our Creator with the right to life. We can advance the cause of science while upholding this founding promise. We can harness the promise of technology without becoming slaves to technology. And we can ensure that science serves the cause of humanity instead of the other way around. America pursues medical advances in the name of life, and we will achieve the great breakthroughs we all seek with reverence for the gift of life. I believe America's scientists have the ingenuity and skill to meet this challenge. And I look forward to working with Congress and the scientific community to achieve these great and noble goals in the years ahead. Thank you all for coming and may God bless. (Applause.)

Related Articles
Executive Office of the President Source
SIRS Publishing, Inc. 2006; Lexile Score: 300; 1K, SIRS Government Reporter

English 1010 portfolio 3 FOURTH RESOURCE

Stem Cell Advance Could Change Ethical Debate
SAN JOSE MERCURY NEWS
(San Jose, CA)
Aug. 24, 2006, n.p. © 2006, McClatchy-Tribune Information Services.
Stem-Cell Advance Could Change Ethical Debate
By Steve Johnson
San Jose Mercury News (MCT) SAN JOSE, Calif.--A U.S. company's ground-breaking technique for growing human stem cells without destroying an embryo has triggered hope the procedure may resolve the ethical and legal dilemmas that have severely limited stem-cell research in this country. Advanced Cell Technology, an Alameda, Calif., biotech company, disclosed Wednesday in the journal Nature that it has developed a way to grow stem cell lines from a single cell extracted from a human embryo. "This is an important breakthrough," if other scientists confirm the method works without harming embryos, said Arnold Kriegstein, who directs the Institute for Stem Cell and Tissue Biology at the University of California in San Francisco. Still, some skeptics think the new technique won't end the debate on the ethics of using embryo cells for research. Many scientists believe embryonic stem cells one day may yield treatments for a wide range of human ailments, from Parkinson's disease to cancer to diabetes. Because the cells can grow into any type of tissue in the body, researcher hope to use them to generate new brain cells, veins, bones, even entire organs. They also foresee using the cells to create genetically uniform tissues that could be used in controlled studies to develop better drugs. Researchers typically obtain human embryonic stem cells from embryos that are due to be discarded by fertility clinics. But many people abhor harvesting such cells for laboratory studies. As a result, President Bush has limited federal financing of such research to a few government approved stem-cell lines, which are self-replicating stem-cell colonies. While some stem-cell research advocates have attempted to change the White House policy, others have been trying to develop new ways to grow human embryonic stem cells without running afoul of the federal restrictions. And some experts say the technique developed by Advanced Cell Technology, which borrows heavily from a routine genetic screening technique already used by fertility clinics, seems promising. Under the procedure, human egg and sperm are combined in a laboratory dish and grown for two to three days, producing a cluster called a blastomere of about eight to ten cells. One of the cells is removed and allowed to divide overnight. Then, while one of the divided cells is used for the genetic test, the other is grown into stem-cell lines for research. The remaining cluster of 7 to 9 cells is grown for a few more days and placed in the woman's uterus to become a fetus. Since the cell used to make the stem cells would have been removed from the embryonic cluster anyway for the genetic tests, "this should satisfy the objections" to doing human embryonic stem-cell studies, said Robert Lanza, the Nature article's primary author. After all, he added, "it's not rational at that point to deny people cures when there is no harm going to the embryo." But others offered a more reserved assessment. A panel of bio-ethicists appointed by Bush to consider alternative ways to make stem cells raised another concern in a report last year when it examined the concept used by Advanced Cell Technology. Although the technique hadn't produced human embryonic stem cells when the report was written, the panel noted that it seemed safe in theory because at least 1,000 babies had been born without noticeable harm after having had a cell removed for genetic testing. Nonetheless, the panel expressed serious reservations about the method. "Subjecting otherwise healthy embryos to biopsy procedures in order to derive stem cells seems ethically troubling," it concluded. That echoed the objections from some critics who said even if Advanced Cell Technology's approach seems safe for embryos, it shouldn't be tried. "It's a matter of principle," said Edward Furton, of the National Catholic Bioethics Center in Philadelphia. "You don't take an innocent human being and subject it to risk if there is no advantage to the human being." Christopher Thomas Scott, who directs Stanford University's Center for Biomedical Ethics Program in Stem Cells and Society, said more studies are needed to prove, among other things, that the procedure makes stem cells comparable to those produced in current methods. Others noted that even if the procedure proves a safe and effective way to make stem cells, it still might not pass muster with the Bush administration. That's because Bush's policy bars federal financing for any stem cell lines derived from a human embryo after Aug. 9, 2001, regardless of the method. Given the politics surrounding stem cells, however, it's hard to predict how the federal government will react to Advanced Cell Technology procedure, said Larry Goldstein, a stem-cell expert at the University of California-San Diego School of Medicine. "If you ask, does this have any chance of solving the federal government quagmire about this issue, who the heck knows?" Goldstein said. "It depends on how some lawyer decides to determine all this."

Related Articles
No Stem-Cell Triumph: Embryos Were Destroyed Source Summary Descriptors
Philadelphia Inquirer (Philadelphia, PA) Aug. 31, 2006; Lexile Score: 1370; 6K, SIRS Researcher

English 1010 portfolio 3 FIFTH RESOURCE

Stem Cells Gotten From Unfertilized Eggs
Stem cells gotten from unfertilized eggs
By RANDOLPH E. SCHMID, AP Science Writer
WASHINGTON - A procedure that encourages an egg to begin embryo development without being fertilized could
suggest a new way to produce stem cells, at least for certain patients.

See original article

Researchers were able to get stem cells using unfertilized mouse eggs, they report in Thursday's online issue of the
journal Science. They are now turning their attention to eggs from people, but several problems remain to be worked
out.
Stem cells can develop into many different types of tissue, making them basic building blocks of the developing
body. Finding ways to produce them has become a major research focus, as these cells hold the promise to one day
help repair damage from nerve-destroying illnesses such as Lou Gehrig's disease, or from spinal cord injuries or
other illnesses.
But the work also poses an ethical dilemma, since current methods of producing stem cells require a fertilized
embryo, which is killed by removal of the cells. President Bush has imposed strict limits on federal funding for such
research. The new study, led by Dr. George Q. Daley of the Children's Hospital of Boston, uses a procedure known
as parthenogenesis in which a series of chemical treatments are used to encourage an unfertilized egg to begin
embryonic development.
The report was welcomed by Dr. Ann Kiessling, director of the Bedford Research Foundation that also studies stem
cells.
The idea of starting embryonic development without fertilization isn't new, she said, but these researchers have
taken it a step further by generating stem cells. Kiessling, who was not part of the research team, said this report
should generate interest in trying to do the same with human cells.
The stem cells produced in the process are a genetic match for the egg donor, and thus won't be rejected by the
immune system. But using eggs also means the cells are limited to use in females.
There are different procedures to produce stem cells from male sperm, but the researchers said that is technically
challenging and inefficient.
Stem cells developed by parthenogenesis have what is called altered expression of certain genes. Imprinted genes
act differently depending on whether they are passed along via the egg or sperm. These new stem cells have two
copies of the imprinted genes from the egg instead of one from each, a situation that has been associated with
cancer and poor growth.
Also, such stem cells may have duplicate copies of some mutant genes that have been linked to cancer and
abnormal tissue growth.
"We'll have to demonstrate the safety and durability of cells derived from parthenogenetic embryonic stem cells
before we could imagine any clinical use," Daley said.
Daley said his group is also continuing research on cloning, which should produce higher-quality stem cells than the
egg-only process, but it's a very inefficient method.