Money You Can Feel

A federal district court in DC ruled yesterday that the Treasury Department's failure to issue paper currency that is readily distinguishable to blind and visually impaired individuals violates section 504 of the Rehabilitation Act. The case is American Council of the Blind v. Paulson.

The judge explained that "like deaf students who can have real access to a lecture only with an interpreter or a real time transcript, blind or visually impaired people cannot make effective use of American money without help." The court stopped short of ordering a remedy, but discussed the possibility of embossing or punching holes in bills, or printing new bills of different sizes. The court is holding a separate conference to determine the appropriate remedy, but the Treasury Department will almost certainly appeal the decision.
- Alicia Ouellette, Director, AMBI Health Law & Bioethics

Fossett on the Mess Over Who Will Own California Stem Cell Cures

David Jensen, whose California Stem Cell Report is the ultimate source for all things California, has been following a largely invisible debate between the California Institute for Regenerative Medicine (CIRM) and the California biomedical industry over the pricing and accessibility of therapies developed from CIRM funded research. While the terms of the debate are complex, briefly CIRM wants to impose requirements for preferential pricing for California purchasers for whatever therapies ultimately emerge from CIRM sponsored investigations. The biomedical industry is resisting these efforts, claiming CIRM’s proposed regulation is redundant with existing federal and state laws on pricing for outpatient prescription drugs and not very well defined for other types of diagnostic tools or therapies. Drug manufacturers are required to give state Medicaid programs discounts or rebates on prescription drugs sold at retail, for example, but drugs administered in a physician’s office or outpatient clinic (such as chemotherapy for the treatment of cancer) are not subject to these requirements. Medicaid can and does decide what it will pay for a particular chemotherapy, but the state gets no rebate.

Discussions over intellectual property are not the usual places where decisions over pricing, coverage, and accessibility get made. These decisions are usually made by public and private payers about particular drugs used to treat particular conditions that have been through clinical trials, received FDA approval for particular uses, and have at least partially known strengths and weaknesses relative to other treatments for the condition. At least as importantly, they take place in the context of particular sets of economic relationships that aren’t the same for all specialties or all drugs. Specialists such as oncologists who administer drugs in their offices, for example, get considerable income from “buy and bill” arrangements under which they buy therapeutic agents and “sell” them to the insurance company paying the bills, usually at a considerable mark-up, while physicians who treat by prescription are less dependent on pharmaceuticals for income. We know none of these things about whatever therapies will emerge from CIRM’s research program and won’t know them for a while, so it’s difficult to say what a “fair” outcome is going to wind up looking like.

Perhaps more importantly, trying to tie product pricing to the award of a research grant really doesn’t address the question of appropriate access because CIRM’s not the one that will be making the decisions about how and whether stem cell therapies will be available under what conditions and to whom, either in California or elsewhere. These decisions will be made by Medicaid programs, Medicare, and private insurance companies; all of whom will be trying to balance access to new treatments with affordability. In typical American fashion, these decisions will likely be made in a decentralized fashion and they won’t be the same everywhere. Jamie Robinson of Berkeley, who’s one of my favorite health economists (that’s a VERY short list), has a great article in the last issue of Health Affairs on how insurance companies are managing the use and cost of the current wave of biopharmaceuticals. There are also several excellent articles in that same issue on Medicare’s attempts to set a reasonable policy for dealing with newly emerging technologies. What’s NOT there, and should be, is any description or assessment of how state Medicaid agencies are making these same determinations. Demands that California get a price break on stem cell therapies are probably unavoidable politically, but advocates who want to insure that lower income groups get appropriate access to these therapies should be looking to Medicaid rather than CIRM to make that happen.
Jim Fossett, AMBI/Rockefeller Institute Federalism and Bioethics Initiative

The American Medical Students Association Statement on Embryonic Stem Cell Research

AMSA's Interim Policy Proposal on Stem Cell Research is out:

The American Medical Student Association
BELIEVES that all types of stem cell research, including embryonic stem cell research, umbilical cord blood stem cell research, and adult stem cell research, should be explored to the fullest potential, while abiding by appropriate ethical guidelines, for the purposes of advancing treatment and preventing disease.

BELIEVES that nuclear transplantation, used for the purpose of creating embryonic stem cells that are an immunologic match for a given patient, and for the purpose of studying genetic defects and congenital anomalies, is an acceptable form of research.

hat tip: Art Caplan

Big Spending Selfish Old People

Dominic Sisti points out that there is another perspective on end of life care costs.

China admits using organs from executed prisoners | Chron.com - Houston Chronicle

Finally. the Chinese admit what has been known for some time now--there has been a flourishing market in China in organs taken from executed prisoners:

"Apart from a small portion of traffic victims, most of the organs from cadavers are from executed prisoners," said Huang, reported the English-language China Daily newspaper Thursday. "The current organ donation shortfall can't meet demand." ... Americans are among the foreigners who have headed to China for transplants as the waiting time for kidneys and livers has grown in the United States. U.S. transplant doctors say the majority seem to be patients of Chinese ancestry who feel comfortable navigating the medical system there.

One was Mabel Wu, 69, of Northridge, Calif., who received a kidney in July at the Hemodialysis and Organ Transplantation Center of the Taiping People's Hospital in Dongguan, a city in Guangdong province...

The family paid about $40,000 for the surgery. They were told only that the donor was a 30-year-old male.

- Art Caplan

Across the Pond, Two Very Different Approaches to Treatment of Ill Newborns

Our man Art Caplan writes in MSNBC

: Can you name the only group in the United States that is required by law to accept medical treatment? It is newborn babies.

In 1985 Congress amended the laws governing support for child abuse and neglect programs to mandate that all infants born in the United States receive medical care. No matter how sick or disabled, all newborns, according to what became known as the Baby Doe law, must be treated. That is what makes the just-issued report by the Nuffield Council on Bioethics in England so startling.

The council, a private organization whose reports are very influential in Britain, argues premature babies born before 22 weeks gestation should not be given treatment to prolong their lives. The council was not arguing for any form of active killing. Its view is that since only 1 percent of infants born between 22 and 23 weeks of age survive long enough to leave the hospital, starting aggressive treatment on babies born at 22 weeks or younger is wrong."

The report is already drawing support from many pediatricians and neonatologists. It also drew the support of religious leaders including the Church of England (Anglican) House of Bishops and the Catholic Bishops’ Conference of England and Wales.

Who is right?
So does the law in the United States requiring treatment of every infant need to be changed? Or are the Brits wrong to try and draw a clear line in the sand for when medical treatment will not be offered in the full knowledge that these preemies will die? The answer is a bit of both.

American law was intended to protect the rights of the disabled. For many years children born with Down syndrome or spina bifida were not given aggressive treatment if their parents did not want it or if doctors deemed it inappropriate. But in the early 1980s, the Reagan administration and the famous Surgeon General C. Everett Koop protested these practices, resulting in the passing of a law that stopped discrimination of the disabled in the neonatal nursery.

But the federal law went too far. In its effort to ensure that children were not allowed to die simply because they had a disability, Congress wrote a law that was overly restrictive.

A 22-week-old premature baby is not in the same medical circumstances as a child born with Down syndrome who simply requires a surgical repair of his digestive tract to survive.

Extremely premature infants are the nightmare of every neonatal hospital and obstetrician. Medicine does not know how to save them and when it tries, if often produces a child whose life is very short and whose suffering is beyond description.

The fact is that when a baby is born at less than 22 weeks gestation, all medicine can do is try experimental and unproven procedures to prolong life. I don’t say they should never be done but the Baby Doe law should be amended to permit some discretion to parents and doctors as to whether they want to try desperate, experimental interventions.

Medicine's limits
The British report goes too far in the other direction. It is true that trying to aggressively treat any baby born at less than 22 weeks results in an overwhelming number of horrible outcomes. But if parents want to try new experimental techniques knowing that the odds are very, very, very long then I don’t think public policy should prohibit that.

There is a limit to what medicine can do. Tiny preemies should not be forced to endure care that does not work and that only prolongs dying, and most major religious traditions understand that. Existing American law is too restrictive — we wind up giving treatment when common sense and basic respect for human dignity say we ought not.

The new British report has the courage to take on this problem. It may go too far in the other direction of prohibiting care. The right answer lies somewhere in between.

patentingpeople.com

patentingpeople.com covers the conference tomorrow at Cardoza law school of issues in the patenting of life. Here's a short excerpt from their introduction to the subject of the conference. I'll be talking about the patenting of stem cells, in case you need a nap.

When, if ever, should we grant patent rights – government-guaranteed exclusivity to technology – to inventions “encompassing” a human organism or – more broadly – aspects of humanity? If patents create an incentive for innovation, do we want to “incentivize” this kind of research? What happens when a chimeric animal – patented and, therefore, owned by someone – turns out to be too human? Or, if these kinds of technological advances are inevitable, is the disclosure system of patent law better than having cloning technology veiled in secrecy?

And While We're Still At It ... the Women's Bioethics Blog!

Women's Bioethics Blog is on fire. Regular postings, never boring, awesome authors and the entire enterprise of the WBP is just getting more and more important and established. I was always a fan, maybe even the first whole-hearted bigtime fan, and Kathryn Hinsch has done something most would say was impossible. But now it's time (while we're praising things) to really point to the great blog they're making and what an impact it has had.

And While We're At It: The Bioethics Blog from Antigua

Our faculty member Linda MacDonald Glenn teaches bioethics regularly in Antigua, because clearly she has good karma, and her group of students has a blog called The BioEthics Cafe -- Essays from the Edge of Paradise. Check that out too.

Biopolitical Times

Add this one to your regular reading/blogroll list: a great new blog from the Center for Genetics and Society, an Oakland, California based think tank on, well, genetics and society. Here's the address: Biopolitical Times.

Applied Ethics, Ranked

The rankings for philosophy Ph.D. programs in applied ethics from the Philosophical Gourmet are up.

Brian Leiter created the only real rankings of philosophy departments moons ago, when I had no grey hair. At first they were Brian's educated guesses - but still they were the only resource online attempting to rank the quality of graduate training. He took and continues to take constant hits for trying. When we tried to do something similar, though not a "ranking" per se in bioethics, at AJOB, there was a near revolt among the editorial board. We dropped it. He didn't.

Today his rankings are produced by the key philosophers in areas of specialization all across the discipline and influence pretty much anyone who is choosing to become a philosopher. The new rankings have been up one day and have already been visited 6,000 times. He ranks applied ethics through a survey of those considered to be key players in applied ethics who are philosophers, specifically Donald Ainslie, Samantha Brennan, Thomas Carson, Julia Driver, Gerald Dworkin, Gerald Gaus, Jeff McMahan, Christopher Morris, Alastair Norcross, Thomas Pogge, Gerald Postema, David Schmidtz, and Wayne Sumner.

Their rankings this year in Applied Ethics - which will not be revisited until 2008 except on his updates service, are now up right here - a full list split into quartiles. These aren't bioethics rankings. It shows. They aren't rankings in fact that anyone who wanted to work in a medical school would be well served by utilizing as the primary resource. But they are important in a number of ways, and if you are thinking about where you want to go and what you want to do in terms of moving into this field, check it out.

NOVA | Family That Walks on All Fours | PBS

This speaks for itself. I think.

Next on NOVA:
FAMILY THAT WALKS ON ALL FOURS
Tuesday, November 14 at 8PM ET/PT on PBS

An intense scientific debate has ignited around a quiet but extraordinary family living in rural Turkey -- a family with five adults who walk on all fours. Since bipedalism has long been considered one of the defining characteristics of modern humans, such a discovery raises fascinating questions about genetics, society, and the evolutionary history of our species. Is this the anthropological find of the new millennium, or simply a unique medical case? NOVA sets out to unravel the controversy and meet the individuals who have captured the imagination of scientists around the world.

On the web:
The Family and Me; Working with the Ulas family deeply affected psychologist.
Defne Aruoba.

There's a teacher's guide as well.

Art Caplan Talks About Smart Mice

MSNBC's Linda Dahlstrom talked with Art about his new book Smart Mice, Not so Smart People for an interview today.

The Bioethics & Embryonic Stem Cell Election Wrap Up

Now that the dust has settled at least a little bit, it’s worth looking to see what precisely happened in the election around embryonic stem cells and other issues of bioethical interest. Bottom line—the landscape in Congress has shifted some, but not enough to get the Feds back into the game in a big way. The action around supporting embryonic stem cell research still remains with the states, some of which are likely to push large scale stem cell initiatives.

Referenda/Constitutional Amendments
South Dakota Abortion Ban (Referred Law 6)—This referenda to overturn a state law which would have outlawed almost all abortions except those necessary to save the life of the mother passed—the ban was overturned—by 55-45 percent, slightly ahead of the last pre-election polls. The lack of exceptions for rape and incest appears to have troubled many voters—a majority of supporters and pre-election undecideds told pollsters they might have supported the ban had it contained clearer exceptions. Ban advocates tried to claim that there were exceptions in the law, but these claims did not appear to have been persuasive.

Missouri Constitutional Amendment (Amendment 2)—This amendment, which unambiguously legalized embryonic stem cell research and somatic nuclear cell transfer (SCNT) but explicitly outlawed so-called “reproductive cloning” , passed by a narrow margin of 51-49 percent. The amendment had been favored by almost two-thirds of poll respondents early this year, had steadily lost support over the summer and fall as opponents labeled it the “clone and kill” amendment. Supporters had outspent detractors by better than 10-1, making the closeness of the final vote something of a surprise Newly elected United State Senator Claire McCaskill, a strong supporter of the amendment, ran ahead of the amendment in most areas of the state.

Congressional Elections

The Democratic take-over of the House and the apparent Democratic control of the Senate are widely being interpreted by the political gurus as a national referendum on the Iraq war, corruption, and the Bush Administration in general.The election results have shifted the balance of Congressional opinion on embryonic stem cell research, but not enough to provide a veto-proof majority in favor of expanded federal support for this research in both Houses.

There may well be a veto-proof pro-stem cell block in the Senate. The Senate vote on HR810, the stem cell bill that President Bush vetoed, was 63-37, meaning that pro-stem cell forces need 4 more votes to get the two-thirds majority necessary to override a Presidential veto. They may well have gotten them—of the six Senate elections that the Democrats won, five anti-stem cell Republicans (Lincoln Chafee of Rhode Island voted for the bill) were replaced by pro-stem cell Democrats, giving pro-stem cell forces one more vote than they need to override a veto.

Things are not so clear in the House. 238 Representatives voted for HR 810, 53 votes short of the 291 needed to overturn a Presidential veto. It appears that pro-stem cell forces came up short of this number. Of the 27 seats that had been called to change party hands as of about noon yesterday, 11 Republican representatives, mostly Northeastern moderates had voted for HR810, while 16 voted against it. Stem cell advocates can pick up at most 16 votes from this set of seats. Of the eight seats that were still listed as being in play, four were held by pro-HR 810 Republicans and one by a pro-HR810 Democrat, meaning that stem cell advocates can pick up at most three votes from this group. Bottom line—stem cell advocates might have picked up 20 or so votes for another HR 810 type measure, leaving them 30+ votes short of the numbers they would need to override another Presidential veto.

It doesn’t seem likely that a new version of HR 810 in the new Democratic Congress would produce a different outcome. Stem cell advocates might be able to get a Presidential veto over-ridden in the Senate, but probably not in the House. Even if a new HR 810 were successful in expanding the stem cell lines that federal funding could be used to investigate, it might be difficult to expand federal funding for an expanded embryonic stem cell research effort—after growing substantially through the late 1990’’s and early 2000’s, NIH budgets have flattened out recently and are barely growing, if at all. Even if approved in principal, expanded financial support for embryonic stem cell research might be a hard sell. Big changes in the next two years, in short, seem unlikely.

State Elections
What seems much more likely after Tuesday’s elections is a significant uptick in the level of state and research support for embryonic stem cell research. States have been committing way more money to this research than the federal government, and Tuesday’s results seem likely to increase state support. The next two states likely to get into sponsoring stem cell research in a big way are New York and Wisconsin. New York Governor-elect Eliot Spitzer, who won election by almost 50 points, is proposing a program to spend $1 billion in state funds to support this research, and re-elected Wisconsin governor Jim Doyle has proposed major state support for stem cell research in that state. Pro-stem cell governors Ron Blagojevich in Illinois and Jody Rell in Connecticut were also re-elected by significant margins, and a number of states have pursued smaller funding initiatives. As noted by Kirk Johnson in the New York Times on November 9th, Democrats also gained over 275 seats and nine legislative chambers in state legislative elections, so the climate for such initiatives may have improved in some state capitals. While it’s important to note that not much money has been spent to date on research—for an assessment of various state programs by the Bureau of National Affairs, look here [PDF]check out their Medical Research Law and Policy Report -- this may begin to change shortly.

Even after a significant change in the balance of power in Congress, in short, embryonic stem cell research seems likely to remain very much a state issue. Look for major new initiatives from Wisconsin and New York in the upcoming legislative sessions, and smaller initiatives elsewhere.

Jim Fossett
AMBI/Rockefeller Institute
Federalism and Bioethics Initiative

The IOM Really Does Get Bioethics

The IOM has announced the election of new IOM members from a number of fields, including ours. Hearty congratulations to:

DAN W. BROCK, Frances Glessner Lee Professor of Medical Ethics, and director, division of medical ethics, department of social medicine, Harvard Medical School

R. ALTA CHARO, J.D., Warren P. Knowles Professor of Law and Bioethics, Law School and School of Medicine and Public Health, University of Wisconsin, Madison, and visiting professor of law, School of Law, University of California, Berkeley

ELLEN WRIGHT CLAYTON, M.D., J.D., Rosalind E. Franklin Professor of Genetics and Health Policy, professor of pediatrics, professor of law, and co-director, Center for Biomedical Ethics and Society, Vanderbilt University, Nashville, Tenn.

Also elected, NICHOLAS A. CHRISTAKIS, M.D., PH.D., professor of medical sociology, department of health care policy, Harvard Medical School, and stem cell pioneer RUDOLF JAENISCH, M.D., professor of biology, Massachusetts Institute of Technology, and founding member, Whitehead Institute for Biomedical Research, Cambridge.

Cloning Eggtroopers

CAMR Gloats Speaks Out on Stem Cell Elections

From the press release from the Coalition for the Advancement of Medical Research, the following:

"We believe that pro-embryonic stem cell positions played a positive and decisive role in the election or re-election of candidates such as pro-stem cell Maryland Senator Ben Cardin and pro-stem cell Missouri Senator Claire McCaskill, to name a few. And, we are pleased that stalwart stem cell champions Rep. Mike Castle (R-DE) and Rep. Diana DeGette (D-CO), as well as Senators Orrin Hatch (R-UT), Ted Kennedy (D-MA), and Dianne Feinstein (D-CA) were re-elected and are coming back to Washington in January.

"Thanks to the advocacy efforts of Michael J. Fox and the millions of Americans affected with debilitating diseases and disorders for which embryonic stem cell research provides hope for better treatments and cures, the issue of stem cell research stayed on the front burner this election cycle. We look forward to working with the U.S. House and Senate in 2007 to bring forth legislation that will provide federal funding for embryonic stem cell research. Americans who themselves or whose families are impacted by cancer, diabetes, Parkinson's, Alzheimer's, spinal cord injuries and other diseases and disorders let their voices be heard, and for that, we are grateful."

The Chronicle Mantra: States? What States?

The Chronicle sort of takes issue with Fossett, but not really, since like most major media [and all of mainstream bioethics] they are obsessed with whether or not the federal government will reach the level of support for ESCR to begin doling out some tiny percentage of what the Stem Cell Republic of California is already providing. Perhaps you'll have a different judgment. Jim will:

Even if Democrats run the table and win every Congressional race up for grabs in Tuesday's elections, Congress would probably lack the majorities necessary to overcome a likely presidential veto and expand federal funds for research on human embryonic stem cells.

That assessment comes from a Chronicle analysis that examined how a Democratic sweep might alter the pattern of voting on a bill, approved by Congress this year, that would expand the financing. President Bush vetoed the measure, HR 810, and the House of Representatives failed to muster the votes to override the veto. Two-thirds majorities are needed in both chambers to overturn a presidential veto.

The issue has since become a major factor in some Congressional races, as Democrats have used it to try to attract swing voters. Republicans cast almost all of the votes against the bill. Some polls indicate that two-thirds of Americans want to expand federal financing of the controversial research.

The House of Representatives approved HR 810 in 2005 by a vote of 238 to 194. (Democrats are a minority of House members, but 50 Republicans were among those voting yes.) To overcome Mr. Bush's veto, supporters of the bill would have needed 291 votes, or two-thirds of the 435 seats in the House over all.

Rep. Michael N. Castle, a Delaware Republican who sponsored HR 810, plans to introduce similar legislation next year, said a spokeswoman, Kaitlin Hoffman, on Friday. She said that Congressman Castle planned to strengthen the language's ethical guidelines in ways that might win over some opponents of the current bill, including President Bush. For example, she said, the new bill could spell out requirements that parents give informed consent to donate embryos for the research.

Many Democrats and a few Republicans running for contested seats have indicated that they would vote for legislation like HR 810. But after the election, Ms. Hoffman said, "we probably will still not be close enough to 291" to override a veto.

The Chronicle analysis focused on 62 House races that have been defined as competitive by the Cook Political Report, a nonpartisan newsletter regarded as having the pulse of Congressional electoral politics. The Chronicle examined how the incumbents in those races had voted on HR 810 and what positions on the issue have been taken by their challengers.

In only a minority of the 62 races do Tuesday's elections appear to have the potential to shift votes on the stem-cell issue in the legislation's favor. That's partly because the 62 include 12 Republican and five Democratic incumbents who voted for HR 810. In at least two other races in which the Republican incumbent voted against the bill, the Democratic challengers say they would have done the same.

The 62 seats also include 15 where Republican candidates are favored to win, and most of them say they oppose expanding the federal financing.

In the 373 House races that are defined as noncompetitive by the Cook Political Report, Tuesday's elections are expected to result in little change in the balance of votes on the stem-cell issue. So the Democrats would need a lot of upset victories by party candidates who favor expanding stem-cell research to pick up the 53 additional seats required to reach a veto-proof majority.

In the Senate, Democrats are expected to pick up several seats, perhaps enough to yield the 67 needed to override a presidential veto. Sixty-three senators, Democrats and Republicans, voted for HR 810 in July. But a Senate override would be moot if the House failed to go along with it.

Complicating Democrats' attempts to draw distinctions with Republicans, some GOP candidates in House races have issued statements proclaiming that the candidates support stem-cell research. The statements go on to say, however, that the candidates endorse federal financing only of the noncontroversial forms of the research, involving stem cells derived from the adult body and umbilical cords.

McGee in The Scientist:Working with Stem Cells? Pay Up.

The masses are fighting about whether to legalize, ban, fund, demonize or exaggerate stem cell research. The Californians can't wait to get rolling on their $3 billion Stem Cell Domination plan. But the whole debate, even this coming week, seems a bit absurd against the backdrop of patents in stem cell research:

In August 2001, I told a US Senate subcommittee that as much as half of stem cell revenue would likely end up going to patent holders because of absurd patents on the human embryo. No one seemed to care. The debate over embryonic stem cells then was whether it was ethical to do research on them. That is mostly still true, but it won't be for much longer. With $3 billion for stem cell research coming down the chute in California, researchers are terrified. They fear that their own innovations will be credited inappropriately or result in unfair profits, because they will have to license the basic stuff of life from the University of Wisconsin Alumni Research Foundation (WARF). Wisconsin is the home of James Thomson, the researcher who successfully identified and cultured human embryonic pluripotent stem cells, roughly simultaneous to a similar experiment by John Gearhart at Johns Hopkins. All of that has led to complaints from two groups - the Foundation for Taxpayer and Consumer Rights and the Public Patent Foundation - that have now forced the US Patent and Trademark Office to reconsider the patents. The taxpayers of California are none too pleased either. The $3 billion, they are beginning to gripe, was to go to stem cell research, and they're furious that someone who filed a patent on looking at the human embryo could collect royalties every time an embryonic stem cell is made, or used in a discovery, regardless of whether that cell came from Wisconsin. So can someone own the cells that make up what is important about a human embryo? And if so, do we have to pay them every time we make our own embryonic cells, every time we make a medicine or other innovation from embryonic cells, and even when we use the cells to teach? At least at the blastocyst stage, the answer is essentially yes. The broadest claim made by Thomson in US Patent No. 6200806 is to "a purified preparation of pluripotent human embryonic stem cells which (i) will proliferate in an in vitro culture for over one year, (ii) maintains a karyotype in which the chromosomes are euploid and not altered through prolonged culture, (iii) maintains the potential to differentiate to derivatives of endoderm, mesoderm, and ectoderm tissues throughout the culture, and (iv) is inhibited from differentiation when cultured on a fibroblast feeder layer." WARF, in this and two other patents, in essence owns virtually all imaginable characteristics of human embryonic stem cells. Wisconsin also controls five cell lines, which the state's former governor, former Secretary of Health and Human Services Tommy Thomson, just happened to authorize under the Bush "ethical cells" policy of 2001 as among those cell lines in which "the evil had already been done," so the cells were doubly blessed. Basically, if it looks like an embryonic cell, you'd better pay up. And if you try to make something out of your own embryo - yes, the one you made with your own body, from your own body - well, hope you have good lawyers...

Access the rest here at The Scientist.

And Now for the Looney Anti-feminist Theory of the Year: Who's to Blame for Pastor Haggard's Fall from Grace? His Fat Lazy Wife

Oddly in the downfall of Pastor Haggard he tried to excuse his time spent with a hired male prostitute by saying he had contacted him in order to by meth. Apparently in some circles meth abuse is more acceptable then homosexual activity. But now his defenders posit a new theory for his weekly dalliance into the world of depravity--his fat lazy wife. She went to seed thereby driving him into the arms of a gay prostitute! Glad that some in the evangelical right are willing to be expansive in their search for the biological basis of homosexuality!!
- Art Caplan

Jim Fossett Election Roundup on States, Bioethics & Stem Cells

So as not to be out of step with other pundits of the season, it seems appropriate to take a closer look at how embryonic stem cell research has fared as an election issue. The flap over Michael J Fox’s pro-stem cell ads has raised the issue’s visibility nationally and in some campaigns, but how it will play out as an electoral force is still very much an open question.

In this election cycle, embryonic stem cell research has been very much a Democratic issue. Democratic voters are typically pro-stem cell by large margins, while both Republican voters and politicians have been very much divided. Significant numbers of Republicans voted for the stem cell bill that President Bush vetoed, and a survey released in August by the Pew Research Center showed a sharp split between moderate Republicans, who support embryonic stem cell research by significant margins, and conservative Republicans, who are strongly opposed. Particularly in the districts we’ve labeled “stem cell suburbs”—traditionally Republican areas where many Republicans are more socially liberal than the Republican party base—Democratic candidates have tried to use embryonic stem cells as a “wedge” issue to attract traditionally Republican voters who are uncomfortable with the national party’s social conservatism. The most common Republican response, though hardly the only one, has been that they’re all for the research, they just don’t want to destroy embryos to do it.

This election is also unusual in that it seems to be much more about national issues than the typical midterm election. Midterms are usually low turnout affairs that are more about local issues than national ones. This time, however, national concerns seem to be more prominent, to the benefit of the Democrats, with stem cell research largely overshadowed by concerns about Iraq, health care, terrorism and the economy. The President is unpopular, the Iraq war is not going well, an unusually large number of Republicans are involved in scandals of one type or another, and people have been much more likely to tell pollsters that they are making voting decisions on the basis of national than local issues. Estimates by the folks at Pollster.com, who have crunched truly awesome amounts of survey data, indicate that these national forces amount to roughly a six point and rising Democratic advantage in the House and slightly less than 5 points and declining in the Senate.

As a result, many Democratic candidates have gone to some lengths to portray their opponents as staunch Bush Administration supporters, while many Republicans have gone to some trouble to distance themselves from the Administration.

With that said, let’s look at the major Congressional races and referenda where embryonic stem cell research has been something of an issue. This list probably isn’t complete---it’s been compiled from several sources and reflects races where a Democrat supporting embryonic stem cell research is running against a Republican who opposes it and the difference has been visible enough to attract the attention of at least one reporter. Summaries of polling data in each race are largely taken from Pollster.com and the election coverage of the Washington Post. Not all races are like this—in a few races, such as the Pennsylvania Senate race, both candidates oppose this research, and in a larger number, both candidates support it. In other races, there may be differences between the candidates, but neither candidate has made embryonic stem cell research an issue.

Constitutional Amendments/Referenda

South Dakota Abortion Ban (Referred Law 6)
This vote isn’t about stem cells, but things seem to have heated up lately. This is a referenda on a state law to ban all abortions except those necessary to prevent the immediate death of the mother. The state legislature explicitly rejected amendments to provide exceptions for rape, incest, and to preserve the health of the mother, but ban supporters are arguing that there are exceptions in the law. The ban has attracted considerable opposition from editorial pages and from the state chapter of the American College of Obstetricians and Gynecologists. The most recent statewide poll in late October, sponsored by the Sioux Falls Argus Leader, showed the ban losing 52 percent to 42 percent.

Missouri Constitutional Amendment (Amendment 2)
This is a vote on an amendment to the Missouri constitution to unambiguously legalize embryonic stem cell research in Missouri. Amendment supporters have outspent detractors better than 10-1. While the amendment has been regularly described in local coverage as “polling well”, the most recent poll I was able to find, sponsored by the St. Louis Post Dispatch, showed the amendment winning 51-35 percent, with an unusually large number of undecideds for this stage of a highly publicized campaign.

Senate Races

The Missouri Senate race between incumbent Republican Jim Talent and State Auditor Claire McCaskill is ground zero for stem cell politics in this election cycle, but this one is too close to call. There’s been a slight movement to McCaskill over the last couple of weeks, but nothing that anybody’s calling decisive. Amendment 2, and the ads Michael J. Fox did for McCaskill, could plausibly help either candidate. Watch this one.

In other contested Senate races, the embryonic stem cell issue has been raised, but seems unlikely to be decisive. Fox made campaign ads for Democrat Benjamin Cardin in Maryland and has made appearance with Democrats Sherrod Brown in Ohio, Jim Webb in Virginia, and Robert Menendez in New Jersey (there may be others), and Democrat Amy Klobucher has been running pro-stem cell ads in Minnesota. There are other issues, however, in these races that seem more likely to be decisive. Klobucher and Brown have been running well ahead for some time, and Menendez seems to be establishing a lead in a solidly Democratic state. Cardin has lost some of his lead recently, as Republican Lieutenant Governor Michael Steele, who’s run a very solid campaign, has scored several endorsements from local black politicians, but Cardin is still running ahead in this Democratic state. Virginia’s a dead heat—Republican incumbent George Allen has made several gaffs, and Webb is consistently running a tiny lead based on strong support from the Northern Virginia suburbs around Washington DC.

House Races

Of the dozen or so House races I looked at where there’s a difference in announced position on embryonic stem cell research (there are almost certainly others), seven are what we’ve labeled “stem cell suburbs”—traditionally Republican suburban districts, mostly in the Northeast or Midwest, that are relatively affluent, well educated, and may be more socially liberal than the Republican base. Kerry won or ran strongly in several of these “stem cell” districts in 2004, but five have Republican incumbents and the one open seat election is to replace a retiring Republican. The other seats are demographic mixed bags, containing mixed urban, suburban and rural areas in Iowa, Minnesota, Colorado, California, and New York. Despite their recent electoral histories, most of these dozen districts are rated as “toss ups’ or “leaning Democrat” by the gurus—in only a couple of districts do Republicans appear to have a solid advantage. The old political adage is that “undecideds” tend to break for the challenger, so several of these seats may change hands on Tuesday. In most of these districts, however, other issues besides embryonic stem cells—scandals and Iraq, among others-- have occupied most of the candidates’ attention and seem likely to be more decisive.

Bottom Line?

My record as a forecaster is no better than anybody else’s, but I’ll hazard a couple of guesses. One is that this election is unlikely to produce a veto-proof majority in Congress for embryonic stem cell research—the Senate is too close to call, but may not even produce a Democratic majority, and a number of pro-stem cell Republicans, particularly in the Northeast, are seen as being in trouble, so that even a sizeable Democratic majority in the House is unlikely to produce enough new stem cell votes to override a Presidential veto of another attempt to expand federal funding for embryonic research. This means that the initiative for embryonic stem cell research, at least for the next couple of years, is likely to remain with the states.

Second, the “Michael J Fox effect” is difficult to define with any degree of certainty. Following the initial set of ads, several Democratic candidates appear to have concluded that it works to their advantage to underline the differences between themselves and their rivals on this issue by running pro-stem cell ads or making appearances with Fox. How much this will help or hurt is hard to tell—the stem cell issue may get some Democratic voters out, but it may also motivate some conservatives to come out and vote Republican.

As to my bottom line for the entire election, I’ll hazard a guess that the Democrats will pick up 25-30 seats and retake the House, but the Senate will wind up 50-50.

Finally, bioethicists (and anybody else who reads this) should be sure to exercise their responsibilities as a citizen and vote. If you haven’t done so already, check out your local races, either on pollster.com or somewhere else, and do something about your findings.
Jim Fossett, AMBI/Rockefeller Institute Federalism and Bioethics Initiative

Udo Thinks About Drugs Again

Just coming down from Pluto [press] is this edited collection that promises to cover - with 30 different authors, all of whom will be hunted down and killed by big pharma assassins, no doubt - the "* current regulation of the industry * ethical issues in developing and distributing drugs * how it prices and markets drugs * recommendations on how to improve pharmaceutical policy * the importance of pharmaceuticals * the structure of the pharmaceutical industry * what drugs are needed on a worldwide scale." Just make sure that if you work at Cleveland Clinic you order this to your home address and don't buy it while you're at work.

The NAS on Election Day

NAS2, our cute name for the continuing effort by NAS to play the leading role in defining and refining rules for ethical stem cell research, rolls on. In anticipation of an update to their rules [see the scary skeleton book on the right], more than a dozen academics, and industry folks will be speaking. Register to watch at the Emerging Issues in Human Embryonic Stem Cell Research Registration Page and prepare for a day of streaming video.

Medical Research on the Edge

The Cleveland Plain Dealer begins a multi-part story today on the use of cord-blood stem cell transplants for Tay Sachs children. Some years ago I pointed out in the context of Penn's work on innovative gene therapy for a different set of childhood genetic disorders that parents with dying children are not in a strong position to offer truly informed consent when a cutting edge innovative intervention is proposed. This story makes that point abundantly clear--fatal disease in a child is a hugely 'coercive' factor in the decisions that parents make.
Arthur Caplan

Britain Needs a Few Good Men

Independent reports:

Couples are to be offered free fertility treatment in return for donating sperm to other women who are desperate for children. The offer, by the Care group of IVF clinics, comes as fertility experts warned that the shortage of sperm stocks in the UK was reaching crisis levels and had plummeted to a record low.
The chronic shortage of sperm stocks in the UK has also prompted approaches to Britain's soldiers to donate sperm, in a move reminiscent of Lord Kitchener's "Your Country Needs You" recruitment campaign in the First World War.

Art Caplan