Green light for US stem cell work

[Peltigera]

Green light for US stem cell work

US regulators have cleared the way for the world's first study on human embryonic stem cell therapy.

The US Food and Drug Administration have been considering the 21,000 page application for months.

The decision by the FDA to give the go-ahead comes at a symbolic moment, just days after the inauguration of President Barack Obama.

Since 2001 there have been limits on federal funding for embryonic stem cell research.

The decision of the FDA is independent of White House control, but the new president is widely expected to adopt a more pragmatic and science-oriented approach to stem cell research.


Under President Bush, federal funding had been limited to around 60 stem cell lines created from embryos destroyed prior to August 2001.

Scientists had warned that only 20 eligible cell lines remained useful for research and many of these were problematic.

Researchers had told the BBC that the restrictions had slowed down their work.

Controversy

Geron Corp, the company behind the research, plans to initiate a clinical trial in a handful of patients paralysed due to spinal cord injury.

Interest in use of embryonic stem cells is due to their ability to turn into any of the body's 200 cell types.

Using embryos donated through IVF treatment scientists have coaxed the stem cells inside into many types of tissue. One embryo can provide a limitless supply because the cell lines can be grown indefinitely.

But the use of human embryonic stem cells in research is controversial with some campaigners saying it is unethical.

Geron, a biotech company based in "silicon valley" south of San Francisco, has spent $170m on developing a stem cell treatment for spinal cord injury.

The research will use cells coaxed to become nerve cells which are injected into the spinal cord.

In animal trials of the treatment, paralysed rats regained some movement.

Company chief Dr Tom Okarma said: "What stem cells promise for a heart attack or spinal cord injury or diabetes is that you go to the hospital, you receive these cells and you go home with a repaired organ, that has been repaired by new heart cells or new new nerve cells or new islet cells that have been made from embryonic stem cells."

'Pivotal decision'

Professor Chris Mason, an expert in regenerative medicine at University College London, described the FSA decision as "historic" and a "pivotal milestone in the development of embryonic stem cell therapies.

He said: "The knowledge that will be gained in this first clinical trial deploying embryonic stem cell derived material will accelerate the development of all future stem cell therapies."

Professor Pete Coffey, director of the London Project to cure blindness, said: "It's great news for the field.

"This strengthens our recent call for regulators in the UK to help provide a clear process for researchers to take this forward.

"It's also exciting for me because it brings our own moves towards clinical trials with embryonic stem cells for age-related macular degeneration a step forward."

Professor Robin Lovell-Badge, head the MRC National Institute for Medical Research, said it often took 15 to 20 years to develop a therapy.

"It takes a long time and much work to derive processes that will efficiently and reproducibly give an appropriate cell type for grafting and many animal experiments to test efficacy and safety.

"An appropriate set of patients have to be identified for the first tests and clinicians willing to participate in trials.

"And the regulatory hurdle is, understandably, a huge one - in this case it required 21,000 pages of documents."

He added that for those patients desperate for treatment, and for their families, the news showed the research is moving in the right direction.

But Josephine Quintavalle, director of Comment on Reproductive Ethics (Core), which opposes embryonic stem cell therapies, dismissed the research as "highly speculative".

"The work is at a highly experimental stage and there's still a question mark over the capacity of these cells to form tumours," she said.

"What worries me is that patients will really believe this is going to cure their spinal injury."

She pointed out that other research teams in Australia and Portugal were developing spinal therapies using adult stem cells.

"We've never changed our point of view, which is that embryonic stem cell treatments cannot ever be justified," she said.


Story from BBC NEWS:
news.bbc.co.uk/go/pr/fr/-/1/hi/health/7847450.stm

Published: 2009/01/23 14:10:49 GMT

© BBC MMIX

[Georgina]

It's certainly controversial, but I'm glad to know it's at least back on the table for discussion.

[MacBeth]

I do not really understand the controversy. I have heard the arguments, but the therapeutic possibilities are so great that those arguments seems pretty silly to me.

[Georgina]

I understand the controversy. I'm sure that I've decided in my mind when a human life begins, exactly, but it's not long after conception.

At the same time I understand (or to the best of my limited ability) the enormous potential for relieving human suffering that resides with stem cells and hence the dire need for research.

I find it difficult.

[wheelspinner]

I've never quite understood the conflation of the stem cells issue with right-to-life issues.

I may be wrong, but I understood that the stem cells were grown from non-viable embryos produced in the course of IVF treatments. Having been close to people who have gone through decades of IVF, I can assure you that no IVF candidate is going to donate a viable embryo for stem cell research. It just would not happen.

As harsh as it sounds, these embryos are in fact medical waste. To me, the analogy is not with abortion but with organ donation. If your relative is going to die anyway, would you be prepared to see his or her organs used to benefit research or some other medical recipient? Surely that is the same as the question whether an embryo that is going to die anyway should be used to benefit others. As with organ donation, I believe that's a personal decision. The embryo does not belong to the State, that's for sure.

[Rob]

I understand the fear, and I don't disagree that it's warranted, but I think that under a rational administration, laws can be written to allay it. Unfortunately, some of the stem-cell proponents didn't do themselves any favours with their shrill arguments suggesting that such tissue is somehow less human or less alive than those who might benefit from it. Most of us don't think of our deceased loved ones as medical waste, wheelspinner. There's better language to make the point.

[Pax]

Well... clearly, all stem cells, pretty much by definition, have the capacity to become fully realized human beings.

[wheelspinner]

Jan 25, 2009 20:05:37 GMT -5 Rob said:

I understand the fear, and I don't disagree that it's warranted, but I think that under a rational administration, laws can be written to allay it. Unfortunately, some of the stem-cell proponents didn't do themselves any favours with their shrill arguments suggesting that such tissue is somehow less human or less alive than those who might benefit from it. Most of us don't think of our deceased loved ones as medical waste, wheelspinner. There's better language to make the point.

Rob, I never used the term "medical waste" to refer to a deceased loved one. I do think you are drawing an extremely long bow to call a non-viable embryo that is the result of a failed IVF procedure a "deceased loved one".

To put it another way, how would such an embryo be disposed of were it not to be used for stem cell research?

[Rob]

WS, I'm not sure why you're so determined to cast me on the other side of every issue, but here's the connection: You call embryos "medical waste." Then you say the analogy isn't with abortion but with organ donation, and then you say, "If your relative is going to die anyway..." If it's analogous, it's analogous.

There are moral and ethical issues. In my opinion, they can be dealt with satisfactorily, but poohpoohing them isn't satisfactory.

[wheelspinner]

Jan 25, 2009 22:49:26 GMT -5 Rob said:

WS, I'm not sure why you're so determined to cast me on the other side of every issue

I'm not. Coincidence does not equal causation.

, but here's the connection: You call embryos "medical waste." Then you say the analogy isn't with abortion but with organ donation, and then you say, "If your relative is going to die anyway..." If it's analogous, it's analogous.

Nevertheless I did NOT say that "deceased loved ones" are medical waste. You know I didn't say that. Please stop twisting my words to make out that I have said something abhorrent.

I'd be interested to know your answer to my question. What happens to non-viable embryos that are the by-product of a failed IVF procedure, if they are not used for stem cell treatment? Full ceremonial burial? Or perhaps (dare I say it) disposal under medical waste procedures? Or something else?

I am not pooh-poohing anything. I just don't see the correlation between a non-viable embryo and an adult human being. I also, if you care to read what I actually wrote, expressed the moral position that even if you are to treat such an embryo as life, it remains an individual decision as to how it should be disposed of - just like our "deceased loved ones".

[crazielollie]

I understand the controversy. It's based on a difference in morals and ethics involving life itself. That's silly?

Therapeutic possibilities exist only for those who want life or a certain quality of life and have no morals or ethics that get in the way a treatment using embryos as a base.
There is a controversy. Obviously, private industry is able to accomplish this and find it financially feasible. For those who have no problem with it, this is good. For those who have a problem with it, using tax dollars to finance it make it a personal problem as it's their money fostering something they are morally and ethically against.

Much is being done with adult stem cell research that may make the whole controversy unnecessary.

There is also the further fear that while the embryos used now are considered "medical waste", it opens the door for creation of embryos in the future strictly for medical use. That's ringing alarm bells in many even among those who don't believe life begins at conception.

[wayneinfl]

"Green light for US stem cell work"

That's kind of a misleading title. Adult stem cell research has been allowed for the longest time. Embryonic stem cell research has been legal, too, and we've been regulating it and limiting the amount of taxpayer money we put towards it.

[MacBeth]

Lollie, I cannot help it if the far flung arguments posed by the far right on this topic made the headlines and slogans that shaped the views of so many when the reality was that those involved paid very close attention to the ethics of the course of study.
So, yes, the reaction is silly. And reflective of not taking the time to take a look at those doing the work and their positions, stated quite clearly in their research and in papers widely published, but rather going with the easily remembered, politically inspired slogans about stem cell research.

[Pax]

Problems with stem cell research in the last eight years haven't been due to regulation... the government didn't limit research... they simply refused to fund it, beyond the 20 "existing" cell lines.

All that said, it does occur to me that therapies based on stem cells are so potentially lucrative, and with the research that has been done having been so promising, that I'm surprised that companies haven't privately funded research into it.

[crazielollie]

#12 - Again, it's silly because it doesn't agree with your morals or ethics. For those who human life begins at conception, this is a serious issue. If that is one's belief, using living embryos for experimentation is an ethical issue. It's not to those who are doing it and they consider this ethical by their standards. It's only sillly to you because you don't share the belief.

As to slogans and headlines - both use them to push their cause. In this case there is an ethical issue. Has the Pope backed this research? Probably not but that's because he's just a right wing nut. Any moral or ethical views that don't agree with the view of the that most heavily pushed by science are considered "right wing nuts". Give me a break.

[MacBeth]

You don't need a break, Lollie. You only need to see that there are those what will disagree with you that maintain a pretty strong moral code AND an acceptance of science.
No one says you have to agree, but to stand in the way of the lives that there appears is a pretty good chance to be saved is not right in any way I can see.
Once we start caring about those who are currently alive as much as we do the cell that might be alive if a whole series of actions and reactions take place, then I will probably see the points you are trying to make as less cruel. But there is little evidence that these drawn out moral arguments based on a belief that cannot be factually determined is doing anything more than contributing to the deaths of those who might have been helped by the science that has been limited to the scraps that the Bush administration left available for scientific research.
Sort of reminds me of fiddles and fire.....

[Rob]

I can't be quite that dismissive, Beth. Pharmaceutical and med-tech firms aren't really noted for concerning themselves with ethics. Someone is going to profit hugely from these technologies and products. Handing over human cells or tissue or organs to save lives is one thing; handing them over without control of how they will be used so that a firm can earn a billion dollars is a somewhat different thing.

That's not handicapping science. It's not siding with the Bush administration, which I think made some terrible decisions regarding stem-cell experimentation. It's just skepticism about the altruism of firms that have, in the past, profited greatly through dishonesty.

[MacBeth]

I have no illusion that they are altruistic. And if I implied they were, I am sorry - it was not intentional and really not even part of my reasoning (at least it was not supposed to be)

I only know that there are those who seem to know what they are talking about that say there is promise there to help many ill-but-living people. And to me it is wrong to not embrace those that are already here over those that probably would never have been functionally alive.

[Calluna]

Jan 27, 2009 16:41:28 GMT -5 Rob said:

I can't be quite that dismissive, Beth. Pharmaceutical and med-tech firms aren't really noted for concerning themselves with ethics. Someone is going to profit hugely from these technologies and products. Handing over human cells or tissue or organs to save lives is one thing; handing them over without control of how they will be used so that a firm can earn a billion dollars is a somewhat different thing.

This has actually always been the basis of my argument that stem cell research should remain federally funded. When federal funding was pulled, it put it all into the hands of the pharmaceutical companies, and out of the public sector. Federal research operates under much stricter ethical standards than pharmaceutical companies do, especially when those pharmaceutical companies only need to do their trials in countries that have more lax standards to circumvent federal laws here.

I have no problem with using an embryo that was going to be destroyed anyway to save lives, but I sure would prefer that was done in the public research sector so the results are shared more broadly, and open to scrutiny, both for the greater benefit of using those findings for further research or therapies, and for the benefit of knowing what does not work so efforts are not duplicated that waste such a valuable resource.

In fact, my view is that if such research is allowed to progress in the public sector, where much more is shared about it, then we may more quickly arrive at discoveries that allow us to do away with embryonic stem cells and in essence, reverse engineer adult stem cells to act like embryonic cells...but to do that, we need to know what makes those cells stop being totipotent.

[crazielollie]

#15

In other words, all are to get their conscience in line with whatever the scientific community says it should be. That's danged close to saying that because science can, science should. I didn't even say I disagreed with it only that dismissing the concerns of those who do as "silly" is foolish and very dismissive of a conscience bound belief that many share.

[MacBeth]

No, Lollie. For me it is much simpler than that.

Choose to help one of the following:

1. The already living, fully formed human being in need of medical treatment
2. The cells that would not have been in category #1

Of course there has to be oversight so that the truly nutty do not take things in wrong directions, but the basics are pretty much the same that I have about the far right position on abortions - show you care about the living, and I might then more seriously consider that position on the potentially living.

Call it dismissive, or too simplistic or anything you choose. For me it is not that difficult a call


In other words, all are to get their conscience in line with whatever the scientific community says it should be.

No, but I will go with that before I go with the "I believe/think/feel/am told this is wrong, so no one can do it" no matter who is helped

[chaos393]

Excess embryos from fertility clinics are destroyed/discarded all the time. If they're headed for the dustbin anyway...why not recycle them into something useful?

[MacBeth]

Exactly, chaos

[crazielollie]

...and when more embryos are needed than those that are slated for the"dustbin" anyway, then what? They do we create embryos in order to continue on? That's what's at the heart of the controversy. We've already had cases of purchased eggs from individuals who are more likely to produce a "better baby" for those who can't produce their own.

Beth - those who believe human life begins at conception put the embryos in the same column as a fully developed human being. Of course, they also put in that same column those who are severly impaired and those who live in extreme poverty. I'm sure you do the same but all don't which is why we have things like "purchased" organs for transplants.

The work being done with adult stem cells is also promising.

[MacBeth]

Yes it is. But that does not mean that there are not other avenues of study that have been hindered, not because of science and not even because of possible future abuses (which seems that many in the scientific and government communities elsewhere have dealt with in a pretty reasonable way), but because of the belief of some as to what constitutes life. Not the science of life, the faith of it. And as a person of faith I do not discount that, but I also do not pretend it is science either.

If we as a society showed more interest in those that are already alive, these discussions of protecting the potentially alive would seem more reasonable to me. Right now it far too often looks as an excuse - my felling trumps your life for those who could be bur are not being helped.

We have too long looked down our noses at science, and too long put on high the beliefs of some portions of our society. It it time for balance.

[wayneinfl]

"Excess embryos from fertility clinics are destroyed/discarded all the time. If they're headed for the dustbin anyway...why not recycle them into something useful?"

Dead Jews were discarded from extermination facilities in Nazi Germany, too. Probably made sense to take their possessions and gold dental work and recycle them into something useful. But I don't like the idea that a financial incentive could encourage more of the deaths. It's a conflict of interest.

[Pax]

There's a conundrum in the "it's a child, with the full rights of a human being from the moment of fertilization" argument. It is best illustrated with this actual phone call that was made in to a conservative radio show host that at the time was making a great deal of hay over this very topic.

He was asked: "Okay, let's say there's a fire at the fertility clinic, and you have to make a choice: You can choose to save those fifty embryos over there in the petri dish, or you can save the seven-year-old child in the other room. Which do you choose?"

An honest answer to that question destroys the absolutist argument, and for that matter, shows the flaw in comparing such use of embryos to Nazi concentration camp victims.