What Happens with Stem Cells After 2008? More of the Same.

David Jensen, whose California Stem Cell Report remains the authoritative source for anything going on around stem cells in California, has been reporting on the proceedings of a stem cell conference being put on by Stanford and Burrell and Company. Several speakers have been apparently saying something we’ve been arguing for a while now--- regardless of who wins, the presidential election of 2008 is not likely to produce any major changes in what one speaker called the “bizarre patchwork” of state funding and regulation of embryonic stem cell research. While many stem cell advocates would like to see a set of uniform federal standards and a big uptick in NIH funding, the likelihood of either of those things happening anytime soon after 2008 seems increasingly remote. While a new president, especially a Democratic one, might well sign the bill President Bush has vetoed once and is threatening to veto again to expand the number of stem cell lines eligible for federal research support, that’s likely to be all that happens. A major increase in NIH funding for ESC seems unlikely—one speaker at the conference even raised the possibility that NIH might even try to steer money away from ESC research because of all the state and private money already in play. Even if there’s a sizeable increase in stem cell funding, it would only make NIH one funder among many, and not likely the biggest one at that. NIH would have to increase its ESC funding roughly by a factor of eight to be competitive with California’s budget, and that doesn’t even include the funding in play from other states and private donors. While Congress could independently pass a law preempting individual state laws and establishing a uniform set of ESC research standards, the odds of that happening are less than slim. There’s no clear national consensus around a whole host of issues that would have to be addressed in such a bill, and the possibility that Congress could unify itself around one approach seems too remote to contemplate. What seems likely to happen instead is more of what we’ve got now—more states weighing in with ESC funding programs of widely varying sizes (look particularly at what New York and Wisconsin wind up doing) and ESC research being heavily supported in some states and illegal in some others. There will be increasingly vocal debates over royalties and product pricing that will be resolved in a wide range of ways, and conflicts between the rules that apply to collaborating researchers located in different states. This “bizarre patchwork” is markedly less efficient and more administratively difficult than a single funding source and set of rules would be, but it’s an accurate reflection of conflicting and diverse public views about ESC that don’t show any sign of going away anytime soon.
- Jim Fossett, Director, States and Bioethics Program of AMBI & The Rockefeller Institute

Ten Years Since Dolly...

Art Caplan writes in MSNBC:

Ten years ago today, the birth of the first cloned mammal - a sweet-faced sheep named Dolly - was announced to the world. Her creators, a team of veterinary scientists at Scotland's Roslin Institute, approached their landmark scientific achievement with a sense of humor: They named the lamb after Dolly Parton. (The DNA they used to clone her came from a breast cell.) Much of the rest of the world, however, was not amused.

Dolly's creation set off a storm of fear, confusion, misunderstanding, pandering and double-talk that culminated in the greatest fraud ever perpetrated in the history of biomedicine - the false claim that a South Korean scientist had cloned human embryos and made stem cells from them.

Dolly's creators were so giddy because they had demonstrated it was possible to reactivate all the genes in a cell taken from an adult mammal. They made a grown-up cell act like a kid again.

At the time, almost no scientist thought cloning was possible from the DNA of adult animals. Cloning had already been accomplished in tadpoles and by using embryonic cells, but science dogma held that once a cell had grown up and become specialized - by turning into a skin cell, a hair follicle or a breast cell, for instance - its DNA was through. There was no way to get that DNA to switch on again and act like an embryo.

What intrigued scientists about Dolly had little to do with what captivated the rest of humanity. The main preoccupation of religious, philosophical and social commentators 10 years ago was how rapidly Dolly would be followed by the creation of a human clone who would destroy the world.

So, where are these clone armies?
In the weeks following Dolly's announcement, mainstream media reports were full of irresponsible speculations by all sorts of experts and "authorities" on what Dolly's birth meant for you and me.

Some worried that cloning would lead fiendish dictators to create armies of clones bred for war. Others fussed that the rich and egomaniacal would seek to create clones of themselves so they could live forever. Still others warned that clones would serve as mobile spare-parts farms. Need a liver or a kidney? Just carve out your clone's and off you go, good as new. And what about cloners resurrecting the dead from bits of DNA found at museums, graveyards and churches?

All this nutty speculation led to a worldwide panic about biological engineering as seen before only in Hollywood films from the 1950s such as "Invasion of the Body Snatchers" and "Attack of the 50 Foot Woman." Presidents, popes and potentates across the globe went bonkers warning us against human cloning. Laws forbidding human cloning - which were premature at best, since the chances of producing a human clone hard on the heels of Dolly's birth were, as I tried to point out at the time, next to nothing - were proposed left and right.

Then it got truly scary. Because that's when the cavalcade of cloning kooks came out.

Bring in the clowns
The parade was led by the felicitously named Richard Seed, a physicist who announced in December 1997 that he intended to clone the first human being. Anchors and talking heads everywhere granted Seed a worldwide platform to babble on about his plan to use cloning to bring humans closer to God. Seed was soon followed in his "I will clone and you cannot stop me" mania by Kentucky fertility expert Panayiotis Zavos and maverick Italian fertility doctor Severino Antinori, best known for helping a 62-year-old woman become pregnant. For a time these two teamed up and proposed setting up a cloning operation on a boat in international waters.

These characters did their best to convince the world that they held the bottle in which the genie of cloning resided. The media and politicians lapped it up. But this gaggle of kooks paled in comparison to the arrival of the group forever linked in the minds of the world with human cloning: the Raelians.

The Raelians, a religious cult that believes extraterrestrials used genetic engineering to create life on Earth, secured a worldwide audience with their cloning threats.

In 2002, Dr. Brigitte Boisselier, a college chemistry professor, Raelian bishop and CEO of the sci-fi start-up Clonaid, along with Rael, the founder of the Raelians and a former French pop singer and race-car aficianado, announced to an aghast world press that Clonaid had successfully cloned a human being. Boisselier said that the mother delivered by Caesarean section somewhere outside the United States, and declared that both the mother and the little girl, Eve, were healthy.

Despite loads of fanfare and claims of a slew of additional clones, no DNA proof was ever offered up.

Why anyone would think that a chemist with a bad hair-dye job and a cult leader parading around in a Starfleet uniform had the scientific know-how and skills required for human cloning was not apparent. However, these two took over the airwaves for weeks. They also appeared as witnesses testifying about cloning in the U.S. Congress and before the National Academy of Sciences!

A perfect storm of nutty professors, kooky cultists and shameless self-promoters used the media to get their screwball message out: Human cloning was not only possible, it had been done and the frightening power of cloning resided perilously in the craziest hands on the planet.

Mainstream madness
Things were not going all that much better in mainstream science. The scientists who created Dolly got into a nasty dispute over who deserved credit for her creation.

Dolly herself got sick, was euthanized and wound up stuffed for a display at a museum in Scotland in 2003. Scientists worldwide managed to clone other species including mice, goats, pigs, cattle and rabbits but at a terrible price in terms of stillborn, sick and deformed animals.

But the biggest blow - to scientific integrity - was still to come. Scientists quickly recognized that cloning might be a useful way to take advantage of the embryonic stem cell discovered shortly after Dolly's birth, but with much less fanfare. Cloned embryos made from adult human cells might hold the key to technology capable of replacing worn-out or damaged human cells.

The drive to be the first to show that cloning human embryos was possible led to dubious announcements by a few scientists that they had made cloned embryos. The cloning race culminated in the whopping lie told to the world by South Korea's Hwang Woo-suk. In a fabricated paper published in May 2005 in the prestigious journal Science, he claimed to have cloned many human embryos and extracted stem cells from them.

Those who hated the prospect of any form of cloning - animal or human - and those who were morally horrified by the prospect of human embryonic stem cell research, including President Bush, Sen. Sam Brownback, R-Kan., Rep. Dave Weldon, R-Fla., and Rep. Ron Paul, R-Texas, among others, proposed bills that would stop the strategy of "clone and kill." The tactics, incredibly, worked.

Public funding for embryonic stem cell research foundered on the legacy of fear built by nuts, the media, scientists bickering amongst themselves, fabricators and politicians who played the cloning card again and again.

So where does this dismal history leave cloning today?

Animal cloning has proven incredibly difficult. There are noises being made about introducing meat or milk from cloned animals into the food supply, but the economic practicality of that happening given how hard and expensive it is to clone animals makes this all talk. The huge risk of creating a dead or deformed baby has put all talk of human cloning firmly on the back burner. The fact that there still has been no successful cloning of a primate using Dolly-style techniques shows just how hard - or maybe, impossible - human cloning is.

Cloning for research is still of interest to scientists around the world, but no one has been able to make it work reliably.

The place where cloning continues to thrive is in Hollywood, TV and science fiction. There, clones are still mined for body parts, mad scientists can still gin up a possessed clone kid and evil dictators still create their clone armies to conquer the galaxy.

Ten years after the announcement of Dolly's creation, cloning is a subject that still scares most of us when all it really is is a new, very difficult, very inefficient and very tricky way to make a lamb.

The ASRM - cough - I Mean HFEA Set to Enact Payment-for-Eggs Plan in Britain

The Observer in London points to a shocking move by the HFEA to increase the supply of eggs for embryonic stem cell research, following on the suggestions of the initial report by the new stem cell research association ISSCR:

Women who go through the medical procedure to harvest the eggs from their ovaries, which doctors describe as 'invasive' and possibly dangerous, will be paid 250 Pounds plus travel expenses, the existing maximum compensation for any egg or sperm donor. Anyone agreeing to donate will have to show that they are acting for altruistic reasons, for example because they have a close relative suffering with one of the conditions scientists are trying to develop new treatments for with the aid of human eggs.

What a fabulous decision, in light of the fact that HFEA was the last governmental organization to hold out for conservative policies with regard to this matter, against such outliers as the South Korean Hwang group, where payment for egg donation worked out so well that it resulted in the obvious oppression of women, including the most obvious donors - those who work in labs that need eggs.

Thankfully there were ethicists in the Hwang lab. Not so thankfully, they published a report claiming beyond a shadow of a doubt, on the basis of their very close observation of the egg donation process, that the Hwang group was doing a fabulous job, and that no coercion occurred, only to later back up a little bit, then retract their claim. Even less thankfully, the loudest claim to date by an ethicist to the effect that payment for eggs is a great idea is the same author of that article, whose observations led him to conclude that he was - quoting here - 100% certain of the ethical propriety of the Hwang group's procurement group. The group - remember them - that coerced at least one team member to donate eggs because she knocked a petri dish containing eggs onto the lab floor. Obviously it was a popular view among the ISCRR crowd who lack funding for stem cell research or a good supply of eggs - but a shortsighted view to say the least, and informed by zero research - except for that lovely article retracted from AJOB.

There are those who have suggested that perhaps there might be problems with payment:

There were also warnings last night that poor women could be tempted or coerced into taking part for the money. 'The HFEA could be unwittingly opening the door to barter or sale of eggs, including women in Britain as well as abroad, even though it is saying that women doing this would do so for purely altruistic reasons,' said Donna Dickenson, emeritus professor of medical ethics and humanities at the University of London and one of Britain's leading experts on the issue.

'The sum of £250 would still be enough of an inducement for women from eastern Europe, for example, to come to Britain to sell their eggs. That's clearly turning eggs into an object of trade and that's disturbing. Once the principle of egg donation for research is established, it will become harder to prohibit paid egg donation.'

But at the end of the day, HFEA will ignore the several leading stem cell researchers who begged it to reconsider on moral grounds despite the scientists support for embryonic stem cell research:

The HFEA, chaired by Shirley Harrison, is set to approve the policy despite a host of leading scientists voicing a range of concerns during the consultation process.

Some argued that the putative benefits of stem cell research had been exaggerated, while others highlighted the medical dangers to women who undergo the painful and invasive three-stage process to remove the eggs.

So a stunning move by Britain into the wild wild west of egg donation, and without data or careful regulations or a provision to re-examine the policy in short order on the basis of the experiences of women and clinics. At least it is stunning to me based on the work of our research group concerning the disposition of the Brits toward this sort of issue. To say nothing of the outstanding work by AAAS commissions chaired by among others Jonathan Moreno and Alta Charo, which counseled quite clearly of the issues here.

Scaring Off Science: Missouri Anti-Stem Cell Research Crowd Takes a Page from the New Jersey Playbook and Tries to Kill Construction

Although they don't mention it, Jonathan Moreno and Sam Berger are ripping on New Jersey pro-life tactics as well as those in the Show Me State. This in their new web piece about Missouri on the CAP site, a nice review of the problems in that state, and a clear indication that people are taking seriously the importance of moving from federal to state examination of bioethics problems.
hat tip: Art Caplan

Berger & Moreno Go to Town Over the Alternative Stem Cell Report

At the Center for American Progress, Sam Berger and Jon Moreno picked a fight with whomever would listen concerning the idiotic White House report on alternative sources of stem cells. Well, listening was New Republic National Review Senior Analyst Ramesh Ponnuru, and you can watch what Berger and Moreno do to his analysis of their piece on the CAP site linked above. No point quoting it, I'm just not capable of typing even one more time either the work by or the critique of the New Republic/Weekly Standard on stem cells.

I'd say that someone should kick these guys and let them know that the voters already decided, and continue to decide, state by state by state ... and that nobody wants to destroy embryos, whether they are little people or not, and that the activity of doing so will likely fade away if only the basic science can get accomplished, and preferably through a decent funding mechanism so that the entire embryo isn't owned by companies as a result of the rush of venture capital into the funding and regulatory vacuum.

But I won't say that, because inside-the-beltway fights about stem cell funding are about as invisible out here in the fields as the annual Wonkette debate over which congressional aides are most attractive, and certainly just as futile. Only in Washington can so much debate ensue over a bill that can't survive a veto and that wouldn't really compete with California's budget even if it did.

White House Plays Politics, Again, with Science;Just One Lie After Another...

The White House is playing politics with science in a highly deceptive way. No one knows if adult stem cells or fetal cells will perform in the same way as embryonic stem cells. No one knows much of anything about any of the science because it is all new. It is true that, contrary to the report, Dr. Atala has said that federal funding for embryonic stem cell research ought proceed for the same reasons I have just given. The notion that there are viable alternatives to embryonic stem cell research has about as much substance as earlier Presidential statements that all embryos now frozen in U.S. IVF clinics could find couples willing to adopt them.
-Art Caplan

[The Ridiculous Report]

Islamic Code of Ethics Includes Therapeutic Cloning

SciDev.Net reports on the new Islamic code of medical ethics up for a vote:

Muslim states are being asked to allow the cloning of human embryos for research into possible medical treatments — so-called therapeutic cloning — while maintaining a ban on the reproductive cloning of human beings. Both provisions are included in the draft text of what is being proposed as the first international Islamic code of medical and health ethics, approved during the eighth conference of the Islamic Organization for Medical Sciences (IOMS), held in Cairo last month. The proposed code addresses the relationships between physicians, their patients, and wider society from the perspectives of both Islam and medical ethics. It takes into account Islamic views on new medical techniques such as in vitro fertilisation and gene therapy.

New England Journal Editorial: Good Luck Dodging Stem Cell Science with the Hurlbut Trick

I've already been awfully critical of William Hurlbut's idea that the stem cell debate can be obviated by an artful dodge in embryo creation. I noted too that just a few days after Hurlbut's idea was celebrated by the superconservative religious scholars whom he had bless his idea, they turned on him. Today the circle is truly complete, as scientists put to rest the idea that Hurlbut has figured out what counts as an embryo: New England Journal of Medicine has today published an editorial entitled "Altered Nuclear Transfer in Stem-Cell Research * A Flawed Proposal" by Melton, Daley and Jennings, that reads in part:

Hurlbut's argument for the ethical superiority of altered nuclear transfer rests on a flawed scientific assumption. He argues, on the basis of supposed insights from systems biology, that it is acceptable to destroy a CDX2 mutant embryo but not a normal embryo, because the former has "no inherent principle of unity, no coherent drive in the direction of the mature human form." But these are ill-defined concepts with no clear biologic meaning, and an alternative interpretation would be that embryos lacking CDX2 develop normally until CDX2 function is required, at which point they die. Philosophers may debate these and other interpretations. We see no basis for concluding that the action of CDX2 (or indeed any other gene) represents a transition point at which a human embryo acquires moral status.

-GM

Swiss Voters Support Embryonic Stem Cell Research

In the first vote ever by a populace on the legality of embryonic stem cell research, Swiss affirmed a government plan to use (only) leftover embryos of a particular age, and only when those embryos would not be used otherwise. Opponents included both the influential Swiss Catholic Church and the Green Party.

Choice? What Choice?

Arlen Specter is up for Chair of the Senate Judiciary Committee, which is one place many in Washington (and lots of other places) expect W to spend some of his "political capital" on limiting or even reversing Roe v. Wade. Specter is on record as being pro-choice. So, already the key Republican in favor of embryonic stem cell research, he decided he'd be clear with the media about his view of Roe. You can just guess what the conservative protestants thought about that idea - they decided maybe the Senator would not be the best guy to run the nomination process for new judges. National Review suddenly called him 'our own worst enemy', and LifeSite said he 'Borked himself'. Conservative Voice said he would be a disaster in the role. And these are just stories from the past three days. But remember, Specter is a prosecutor by training and long experienced. So he adroitly responded to Karl Rove's phone calls by talking to Judy Woodruff on Monday and let Bush and us know that:

I led the fight to confirm Justice Thomas and I almost lost my seat as a result of it in the United States Senate. And every one of President Bush's nominees I have supported in the committee and on the floor.

The fate of Roe is at maybe its most delicate point since the Casey decision that came out of Specter's home state. Here's hoping the Senator fights for choice half as hard as he will have to fight to get this job.

Embryonic Stem Cell Research Legal Now in Spain

Incredibly, even Spain is allowing some forms of ESR. This shows just how hollow and illogical the ban that the President has imposed on federal funding and the anti-ESR arguments of the President's Council truly are. - Art Caplan

UPDATED: ES Cells Save Embryos

onwisconsin.com and Washington Post are running pieces on Memorial Sloan-Kettering's work aimed at saving mouse embryos who were destined to die, using mouse embryonic stem cells. Robert Schatz of Scripps in La Jolla describes the procedure as "the birth of a new science." The knockout mice had extraordinary cardiac defects, and the stem cells did not change the DNA that had caused those defects. "Instead, [the stem cells] influenced the young mice's ability to express certain genes." Benezra: "stem cells act like nurses, restoring 'sick' [embryonic] cells to health." The human implications are already in trials using adult stem cells. This is huge news, and it will be interesting to see how quickly it makes its way into the mainstream media. The ethical issues are going to be no fun at all for those who oppose hES research. AND UPDATE: Here's the first piece on the ethics of the matter: Medical News of Today.