Ox Fall Down

"Health and Human Services Secretary Tommy Thompson argued that before the current policy is relaxed to permit broader use of stem cells, "we must first exhaust the potential" of the lines approved in 2001. In view of the new lines that have already been derived and that are now available for research funded by nonfederal sources, as well as the findings that are sure to emerge from such research, Thompson's stance will increasingly be analogous to requiring the exhaustive use of slide rules for all computations before allowing computers to be powered up."

"I hope that stem cells yield cures and therapies for a myriad of illnesses, but I know that stem cell research does not offer a cure right now, and it's irresponsible to suggest that it does."

Right. This is a consistent theme from the White House. It's irresponsible to suggest that stem cell research offers a cure right now. Yet, nobody in the science community is suggesting that. That's the reason it's called research. They're trying to figure out if it will have an application. That is the entire purpose of research.

Why is the White House so distracting? (I call the First Lady the White House because the president isn't talking about it.)

That stem cell research does not offer a cure right now is no reason to limit funding to it.

I've included the First Lady's remarks because President Bush has been quiet on the subject. Her full speech is linked here: http://www.whitehouse.gov/news/releases/2004/10/20041021-17.html

Two quick thoughts:

1. The President may be the first to provide federal funding only because he's the first president to have the opportunity. Mrs. Bush implies that previous presidents have ignored something which actually did not exist during their terms. Disingenuous. By her logic we should also applaud President Bush for being the first president to fund the second war in Iraq.

2. "But we know that the promise of research lies in the advancement of scientific knowledge and in a greater understanding of how stem cells can be used to treat illnesses. The President's policy makes it possible for researchers to explore the potential of stem cells while respecting the ethical and the moral implications associated with this research." The first sentence is a throw away line, meaning nothing. Is she getting paid by the word? The second sentence leads me to believe that the administration is forcing individual religious beliefs on science and the country.

I'm particulary harsh on the first sentence because I think she's guilty of distracting. I'm upset with the second sentence because she assumes we share an understanding of the ethics. I assume we do not. It's important for the administration to be absolutely clear on their motivations here. I fully respect disagreement with this research but I want a discussion. The administration needs to push this out in the open. Secrecy and silence makes me think there is a cabal in control. Prove me wrong.

My growing understanding is that the administration is not doing nearly enough, then bragging about the very little that it is doing. All the while religion creeps in on the state and the hospital.

"And one of the most promising ways government can help us improve our lives is by supporting medical research. The President looks forward to medical breakthroughs that may arrive through stem cell research. You might not realize that, because people try to distort his record. But the truth is, George Bush is the first President to authorize federal funding for stem cell research.
Last year, the federal government invested nearly $25 million in embryonic stem cell research and over $191 million in adult and other stem cell research. Many millions more are spent by researchers in the private sector.
My father died of Alzheimer's disease and I share the President's eagerness to find a cure for this devastating illness. We're hopeful that stem cells will yield cures and therapies for a myriad of illnesses. But we know that the promise of research lies in the advancement of scientific knowledge and in a greater understanding of how stem cells can be used to treat illnesses. The President's policy makes it possible for researchers to explore the potential of stem cells while respecting the ethical and the moral implications associated with this research." (Applause.)

This link includes a basic discussion of ethical questions. It also provides links to articles for and against stem cell research.

http://www.isscr.org/public/ethics.htm

In Adobe Acroboat,

http://www.isscr.org/public/ISSCRstemCellPrimer.pdf

"Specific emphasis is placed on the support of promising studies that have been excluded from federal funding since August 9, 2001, when President George W. Bush restricted federal support to studies using a particular set of human embryonic stem-cell lines that were already in existence at that time. The NIH Stem Cell Registry, a list that initially included 64 cell lines and later grew to include 78, has been reduced in practice over the ensuing three years to a mere 19 lines that are characterized and available to researchers."

Bankrolling Stem-Cell Research with California Dollars
Keith R. Yamamoto, Ph.D.

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PubMed Citation

"The only possible source for adequate support of our medical schools and medical research is the taxing power of the Federal Government. Such a program must assure complete freedom for the institutions and the individual scientists in developing and conducting their research work." These powerful assertions of responsibility — public funding of research at the national level and scientific prioritization by independent investigators — from U.S. Surgeon General Thomas Parran in 1945 presaged the peer-review, extramural grant-in-aid program that was established the following year within the National Institutes of Health (NIH). Of the 59 Nobel Prizes in Physiology or Medicine that have been awarded since then, 42 have included at least one scientist working with NIH funds, and today, scarcely a day goes by without news of a medical advance resulting from NIH-supported research.
(Figure)

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Human Embryonic Stem Cells.

Some believe that the Bush administration has retreated from this broad and spectacularly successful mandate, installing on political grounds chilling policies and crippling restraints on federal support in particular areas of biomedical research. Concerned about this perceived lapse, a coalition of citizens, scientists, and businesspeople will put before the California voters on November 2 a $3 billion bond measure to provide state funds for human embryonic stem-cell research at California's public and private academic research institutions.
Proposition 71, the California Stem Cell Research and Cures Initiative, would create the California Institute for Regenerative Medicine, which would allocate, over a 10-year period, at least 90 percent of its funds as grants to academic researchers in California through a competitive, peer-reviewed process that mimics the approach of the NIH. Up to 10 percent of the funds would be awarded rapidly — again in a competitive, merit-based process — for the construction or development of scientific and medical research facilities where the research could be conducted. A working group on scientific and medical accountability standards, composed of ethicists and scientific and clinical experts, would establish rigorous research and ethical standards that would also ensure patients' safety, rights, and privacy.
Any endeavor of this magnitude is sure to arouse some substantial concerns. Some consider the scheme to be simply too expensive and argue that the fragile California economy cannot support such a program in the face of so many other pressing priorities. Although the initiative outlines an intellectual-property guideline designed to generate financial return to the state, the language is vague and may not align well with established academic policies. At a practical level, some worry that even the large cohort of California scientists would not expend such a large bolus of funds thoughtfully and wisely, especially at the outset. Others point out that creating in isolation a state priority that focuses on a single problem, no matter how important, is not the road to sound science policy. Although the backers of the initiative have ready responses to each of these points, they are clearly issues that merit careful consideration.
The institute itself would be dedicated to stem-cell research, from fundamental investigations to clinical trials of potential therapies and cures of a broad range of human diseases; studies using somatic-cell nuclear transfer, also called therapeutic cloning, are included, whereas research into reproductive cloning is explicitly forbidden. Specific emphasis is placed on the support of promising studies that have been excluded from federal funding since August 9, 2001, when President George W. Bush restricted federal support to studies using a particular set of human embryonic stem-cell lines that were already in existence at that time. The NIH Stem Cell Registry, a list that initially included 64 cell lines and later grew to include 78, has been reduced in practice over the ensuing three years to a mere 19 lines that are characterized and available to researchers.
What is at issue here is that the derivation of an embryonic stem-cell line requires the dissection and culturing of about 30 cells from the core of a blastocyst, a microscopic early-stage embryo comprising fewer than 200 cells. The derivation process kills the embryo, even as the stem cells persist and propagate. The embryos themselves are obtained from in vitro fertilization (IVF) clinics, where excess embryos are typically produced in the course of assisted-fertility procedures. An estimated 400,000 IVF embryos are currently in frozen storage and will eventually be discarded, except for those that are donated, with informed consent, for use in research. Some religious conservatives and opponents of abortion have taken a firm stance on what seems to be tenuous, ultimately unsustainable moral, ethical, or logical ground: acquiescence to the discarding of excess IVF embryos, coupled with rigid opposition to the use of embryos for biomedical research. Nevertheless, I believe, the Bush administration has been responsive to this ideology.
Opponents of the California initiative argue that it promises too much, that "Cures" in the measure's title suggests wrongly that the end of disease is just around the corner, and that the current technology is primitive and may simply fail. Indeed, what is needed is extensive research that will determine whether embryonic stem cells, which have the potential to differentiate into every type of cell in the body, could someday be used to replenish the tissues of patients with diabetes, Parkinson's disease, cardiovascular disease, spinal cord injury, and a host of other ailments. Many uncertainties remain, and it is important not to elevate the hope for this technology into a promise of immediate cures. What is certain, however, is that along the way, the work will reveal a wealth of new fundamental information about normal — and abnormal — human development, the "rules and recipes" that promote either proliferation or directed differentiation of stem cells, and the logic and mechanisms of some of the more remarkable aspects of cell function. So an enormous appeal of stem-cell research is its powerful confluence of potential for both basic and medical investigation and application.
The California initiative seeks to redress, at least within one state, the current federal constraints. Research on human embryonic stem cells that relies on federal funding is proceeding at a trickle, and the few lines available in the NIH registry (two of which were derived at my own institution by an esteemed researcher who has since departed for the stem-cell-friendly United Kingdom) are rapidly becoming anachronisms as advances are made by researchers outside the United States or by the few U.S.-based investigators who can muster nonfederal support for their work.
Aside from the obvious negative effect on the rate of research, the federal constraints create two deeper problems. First, apparent advances in our understanding of the conditions or factors that govern stem-cell proliferation or directed differentiation can be tested and verified only by deriving new lines and assessing whether they behave as predicted. Thus, the constraints will not merely slow embryonic stem-cell research — they will actually stop it. Second, federal officials have noted with dismay the paucity of researchers entering the stem-cell field and applying for the $25 million of available NIH funds. Given the remarkable potential for exciting advances, and the intense competition for NIH dollars in every other research arena, this lack of interest must reflect the reluctance of scientists to work in a field that is fenced off by politics. Thus, the constraints are not merely inhibiting current progress — they are choking the pipeline of future investigators.
Into this stifling environment the California initiative would inject an immediate and dramatic increase in annual funding, augmenting the available government resources by more than a factor of 10, and would promote the derivation of new stem-cell lines and studies of somatic-cell nuclear transfer that would span the spectrum from basic research to work toward cures for diseases. The passage of Proposition 71 would redraw the U.S. landscape for human embryonic stem-cell research and thus could help to replenish the intellectual pipeline and curtail the emigration of our researchers, while ensuring the existence of peer-reviewed, investigator-initiated research carried out under stringent safety and ethical guidelines.
Passage of the initiative is important because opposition within the Bush administration remains stalwart. Faced with appeals to relax the restrictions on stem-cell research signed by 264 members of the House and Senate, ranging from Senator Hillary Clinton (D-N.Y.) and Representative Nancy Pelosi (D-Calif.) to Senators Orrin Hatch (R-Utah) and Trent Lott (R-Miss.), a Bush spokesperson asserted that the president "continues to believe strongly that we should not cross a fundamental moral line" by condoning new derivations of stem-cell lines. Health and Human Services Secretary Tommy Thompson argued that before the current policy is relaxed to permit broader use of stem cells, "we must first exhaust the potential" of the lines approved in 2001. In view of the new lines that have already been derived and that are now available for research funded by nonfederal sources, as well as the findings that are sure to emerge from such research, Thompson's stance will increasingly be analogous to requiring the exhaustive use of slide rules for all computations before allowing computers to be powered up.
Would passage of Proposition 71 signal a new era for biomedical research funding in which individual states take on the responsibility for supporting investigations deemed by voters to be particularly relevant or interesting? Might a second-term Bush administration see the California initiative as another outsourcing opportunity? In fact, Surgeon General Parran was resoundingly correct in 1945: the federal government is the only source of adequate support for biomedical research and for ensuring independence for scientists in developing and conducting that research.
In this sense, it is regrettable that Proposition 71 exists at all. It exists because of the perception that, for stem-cell research, the federal government has reneged on the twin promises behind the NIH system: it has abdicated its funding responsibility and usurped scientists' freedom to map out pathways of investigation. In this view, Proposition 71 exists because it has to. The California Stem Cell Research and Cures Initiative should be enacted not as a model for the support of biomedical research, but rather as a stopgap measure whereby our largest state steps in to allow important work to move forward and, in so doing, perhaps reawakens the federal government to one of its most crucial mandates.

Dr. Yamamoto serves as a science advisor for the California Stem Cell Research and Cures Initiative, but the opinions expressed here are his own, and do not necessarily reflect the views of the Initiative organizers.

Source Information
From the School of Medicine and the Department of Cellular and Molecular Pharmacology, University of California, San Francisco.

the current policy will drive research out of the country. Unwise.

by Jeffrey M. Drazen, M.D. (emphasis is mine, not the author's)
In the debate between those who support federal funding for embryonic stem-cell research and those who do not, a critical point has been overlooked. Research using this technology is strongly supported in a number of countries, including Australia, Israel, the Czech Republic, Singapore, Korea, and the United Kingdom. Others in the world appreciate the potential of this technology. If we continue to prevent federal funds from being used to support this research in the United States, the ability of our biomedical scientists to compete with other research teams throughout the world will be undermined. No matter how hard we try, we cannot legislate an end to a process of discovery that many in this country and elsewhere in the world consider ethically justifiable. The work will go on — but outside the United States.
The example of a single disease, diabetes, suggests the range of possibilities. Suppose that next week a group announced that it had successfully performed experiments showing that genetically identical pancreatic beta cells could be grown in tissue culture with use of a donor nucleus from a patient and human embryonic stem cells. If our working community of biomedical scientists had experience with this technology, it would probably take three to six months for the findings to be replicated; without the needed laboratory know-how, as a result of our current federal policy of permitting research with only a limited number of preexisting embryonic stem-cell lines, these experiments could take years to complete, and replication would be likely to happen outside the United States.
The next critical step would be to show that the pancreatic beta cells could be expanded ex vivo to achieve adequate numbers for transplantation and injection into patients with diabetes, where they would "cure" the patients' diabetes. For the data to be convincing, small trials would need to show that the cells functioned as desired for 6 to 12 months in a small number of patients. Again, for this research to be successful, the physicians and scientists who could create and expand the cell lines would need to be trained and ready to participate. Without an experienced workforce, years could be added to the time required. More than likely, such experiments would have to be conducted outside the United States.
Next, a major clinical trial would need to be mounted. The technology to create the cells for transplantation would have to be expanded to many centers, quality-control measures would need to be put in place, patients recruited, beta-cell lines created, cells injected, and patients followed for at least 30 months. Early research would probably use surrogate end points, such as glycosylated hemoglobin levels; studies with adequate power to detect differences in clinical end points, such as the development of renal failure or vascular events, would take much longer. As a conservative estimate, if the fundamental breakthrough at the laboratory level occurred next week, it would be more than five years before there was a stem-cell–based cure for diabetes. Without federal funding for stem-cell research, a prerequisite to the availability of a well-prepared research workforce, these experiments would probably be conducted outside the United States.
Although five years may seem like a long time, on the scale of therapeutic development it is relatively short. If we fail to bring the necessary research technology into the mainstream now, our children and grandchildren may need to leave the United States to benefit from treatments other nations are currently developing. Our research scientists must be able to adopt and use embryonic stem-cell technology as they pursue its use in the treatment of many degenerative diseases. Such research has promise, but it must be nurtured to flourish.
We hope that the advances resulting from stem-cell technology will bring new tools to medical care. In the hypothetical example described above, progress in research would be reported at each step. As journal editors, we undertake to review dispassionately any work on stem cells that is submitted to us. We pledge to report true advances. But for us to do so, the journey must be started. As each significant step brings us closer to the goal, we will be there to report the progress; it would be nice if some of this progress could be made within the United States.

is Ortiz the new Vrabel?

I'm not asking you to change your vote in the presidential election along this issue. I am asking you to call and write the eventual winner and your senators and ask them to keep science moving at full pace.

I also don't yet have a clear idea of their positions.

I have listened to Bush explain he "supports faith-based initiatives" (his wording) and doesn't want to get patients' hopes up.

To respond in reverse order, I'll take care of my hopes, thank you very much. I can handle dashed expectations. Shouldn't be a reason for slowing research. Also, I greatly prefer "research-based initiatives" when it comes to finding cures. I'm faith-based when I go to church or read Matthew. I like to be "science-based," "research-based," and "medically-based" when going through treatments and making decisions about what's the best course.

A simple plug for the separation of church and state and the separation of church and hospital.

Again, I'll get back on my soap box once I've studied this more. Thanks for reading. Next scan a few days after the election.