US allows use of embryonic stem cells

[Judi Lynn]

Source: Financial Times

US allows use of embryonic stem cells
By Andrew Jack in London

Published: January 23 2009 08:13 | Last updated: January 23 2009 08:13

US regulators have approved the first use of embryonic stem cells in humans.

The move raises the prospect of a groundbreaking approach to medical treatment that had been blocked since 2001 by George W. Bush as president. Just two days after the inauguration of President Barack Obama, who opposed his predecessor’s ban on federal funding for embryonic stem-cell research, the Food & Drug Administration authorised Geron, a US biotech company, to begin clinical trials for patients with severe spinal cord injuries.

~snip~
Thomas Okarma, president and chief executive of Geron said: “This is the dawn of a new era. This goes beyond pills and scalpels to achieve a new level of healing.” He said there could be setbacks. Geron would need to recruit at least eight patients, and follow their progress for at least a year but “if we can turn a quadriplegic into someone who can walk with a cane, this will go fast-track like lightning”.

Mr Okarma said there were considerable challenges for regulators in ensuring safety in the fledgling field of embryonic stem-cell treatment. The chief executive was not aware of any political interference in the decision of the FDA, which had respected a series of deadlines since the company first sought approval in March.

But he criticised the “crazy” period following President Bush’s ban on federal funding, which he said left Geron isolated in supporting embryonic stem-cell research while many other researchers had followed financial support to study less promising uses of adult stems. “This is a triumph of private innovation over public inertia,” he said, stressing that Geron had invested $200m since 1995 in the field, and that the new administration needed to draw up more ambitious plans than simply permitting federal funding.




Read more: http://www.ft.com/cms/s/0/8c9243f6-e924-11dd-9535-0000779fd2ac.html?nclick_check=1

[Historic NY]

1. Good news....the President gives hope to those needing a cure..

and progress in research. For 8 long years we have stagnated.

[av8rdave]

2. My diabetic daughter and I are excited

After 8 years of pandering to the lunatic fringe, there is a ray of hope!

[Dulcinea]

14. This is what I've been waiting for.

My sister is a type 1 diabetic. My MIL died of complications from Alzheimer's. Stem cell research could greatly help so many people like them! Hooray! :bounce:

[salguine]

24. Yeah, for two minutes before your HMO refuses to pay for it. A new healthcare

system needs to be put in place right alongside it. Preferably a national single-payer universal one.

[varelse]

27. Good point

until that is done, this is "good news" for some, not all of us.

[av8rdave]

40. I think the benefit here will be down the road, unfortunately

Anything accomplished with stem cell research will for some time be considered experimental, in which case nobody will cover it until it becomes mainstream.

Along with a viable health care system, we need the funding and the process to bring major medical advances to the public faster.

[berni_mccoy]

28. As are my two sons with type-1 (check my sig)

[av8rdave]

39. Great link!

My daughter is Type 1 also. In the first few months of the * administration, I wrote the boy genius a letter trying to explain what life with diabetes is like. At the time, there was actually legislation pending that would have allowed health insurance companies to drop coverage for diabetic supplies in some states. I used the letter to try to explain just how devastating this would be - for countless families.

I wish I saved the reply I got, but I was so angry I shredded it. The letter basically said aren't you aware diabetes is largely preventable, and if we worked on living healthier lives, this wouldn't be so much of an issue now, would it?

I honestly think that moron prided himself on his ignorance.

[berni_mccoy]

65. OMG, are you serious? He said diabetes is preventable? Tell that to my sons' immune systems

I wish people would separate the disease from the condition. Diabetes is too overloaded of a term.

I get tired of explaining to people that Type-1 is primarily an auto-immune disorder and type-2 is a metabolic disorder (*sometimes* brought about poor diet/exercise).

You can't prevent type-1 (yet).

Anyone who watches our video will realize our boys are very athletic (one is a competitive gymnast)

[av8rdave]

83. He was just throwing in some incomplete data about type 2

I guess as far as he knows, type 1 doesn't even exist. Of course, he doesn't know much, and I don't believe he ever wanted to.

It was probably the most infuriating letter I've ever received!

[whistle]

32. I'm sure thousands if not millions of people will benefit as medical breakthroughs

...now begin to occur on some of our most devastating diseases

[lifesgreat]

82. A real solution?

Everyone should go to www.stemcellresearch.org and check out the facts.

Adult stem cells have shown repeated success at forming true insulin-producing islets, and have successfully reversed diabetes in animals. Embryonic stem cells have shown no success.

The latest research findings regarding embryonic stem cells are that they do not actually produce insulin in response to glucose changes in their environment and are NOT the pancreatic beta cells needed to treat diabetes. When placed in animals, the cells did not reverse diabetes; instead, they formed tumors.

By contrast, adult islet cell transplants have already allowed hundreds of juvenile diabetes patients to throw away their insulin needles, and even newer approaches, which do NOT use embryonic stem cells may be in human trials soon. For an overview see: www.stemcellresearch.org/facts/factsheet-04-03-02.htm.

Good luck to you and all those with diabetes.

[av8rdave]

84. Interesting site

More propaganda

[laissezfairesucks1]

60. HealthInsurance Mandates VS. Public Healthcare

Has anyone ever considered that publicly funding stem cell research in a healthcare system which privatizes the profits and discoveries is not progressive? I support publicly funded stem cell research as I support publicly funding research and teaching universities. BUT the way the system works now, those discoveries are granted intellectual property rights to PRIVATE companies who then sell those novel medicines back to the public which already PAID for the discovery. Obama has tapped Tom Daschle for "healthcare reform" not Hillary Clinton, whose early, past efforts included expanding Medicare Medicaid, truly progressive socialized publicly funded healthcare. (The current media meme is that her efforts failed because she was "heavy handed"! A joke considering what Dick Cheney's Energy task force accomplished!) Daschle's book pushes health insurance mandates, more HMOs and privatized health insurance, NOT healthcare. I fear our tax dollars will go into the pockets of Big Pharma, and as the government runs out of money, our publicly funded Medicare Medicaid will be cut. If the public funds stem cell research, the benefits should be distributed fairly, PUBLICLY.

[midnight]

3. I don't understand all the science, but also didn't understand why

embyonic stem cell research was haulted?

[cosmicone]

4. The fundies are against it because they think every embryo and

every sperm is god created "life" -- so the fundie W banned it. Since embryonic stem cells only come from embryos, fundies won't let them be used.

[No Elephants]

6. Yet, they let the embryos be thrown in the garbage, literally. Just not used to try to help others.

[bulloney]

8. That's the inconsistency of the fundies' position.

I don't hear any Right-to-Lifers in my area object to artificial means of impregnating a woman, where they implant several embryos in the woman, knowing that most or all of them will not become a baby. There are other means in which embryos are discarded and I don't hear any objections from that group, either. But, god forbid if you use stem cells from a fetus.

I think these people are just rabid Republicans and this is an issue where few, if any Democrats support. So, they try to pigeonhole every election (even county commissioner and other local races)into a referendum on abortion and/or stem cell use from fetuses.

[AlbertCat]

50. Nor do so called "Right -to lifers" adopt unwanted babies.

You're on your own after birth, kid.

Every anti-abortion advocate should be required to adopt at least 1 to 5 unwanted children. Can you hear the excuses? "I can't afford it!" "We don't have time to raise all those kids" "We don't have room" "How can I give those kids a quality life at this point in my life?"

Hmmmmm....

[Tangerine LaBamba]

75. Bet you didn't know this,

but it was common knowledge in Austin and in Washington - that the Bush "twins" were products of in vitro. Laura and George tried it the regular way - oh, man, what a BAD, BAD visual that is - and got nowhere.

So they went the in vitro route and got the "twins."

[Ilsa]

85. How do people know this? Did the family talk about it alot? Why would

residents of Austin know when * and the twins didn't live there until he was governor?

Just curious. I don't want to repeat it without some degree of substantiation. I'm in Texas, but further south of Austin.

[Tangerine LaBamba]

86. It was a common topic of discussion,

and the people I heard it from - god, this goes back a long way - were connected in Republican circles in Washington. One is a good friend of mine in spite of her being a high-powered lobbyist. It didn't seem to be any kind of secret. It was discussed in a Kitty Kelley book, which surprised me, because a lot of people here don't particularly like Kelley any more.

But, check with your politically connected friends who go back more than twenty, twenty-five years. As I said, it's been around for a long, long time.

And, my sympathies to you on your state receiving its latest returning residents, but we're awfully glad to get Pickles and Dim Son out of our air space.

[Ilsa]

89. Oh yeah, they can do far less damage here in Texas vs Washington.

Fortunately, I'm quite a few miles from them. Wish they'd just get the hell out and move to Paraguay (if we aren't going to bother prosecuting them).

I hadn't heard about the Kittie Kelley source for this. I'll ask a friend whose political background goes way back (he met HHH at the Dem Convention in Dallas in '68).

[4lbs]

9. Ssssh! That fact doesn't compute with GOP'ers.

n/t

[Jawja]

And this is where their hypocrisy is so

hideous. Every sperm or zygote is sacred human life; but the citizens of Iraq who died as a result of a needless invasion do not matter.

[Tyler Generation]

25. Women don't have your period

Men, don't masturbate it's all wasting life! :sarcasm:

[Posteritatis]

71. Hell, a few times they tried to claim *each stem cell* was a human (nt)

[whistle]

33. Ignorance and superstition primarily plus the greed of the pharmaceutical industry

[RantinRavin]

42. Embryonic stem cell reasearch was NEVER haulted

Only the use of federal dollars to pay for the research. It seems this company did the research utilizing private monies.

[NickB79]

80. I wonder how many years earlier we may have had this if fed. funds were allowed

Bush didn't outright ban embryonic stem cell research, but he threw every speedbump he had in it's path.

[underpants]

5. That is great. Long overdue. A bad and "triangulated" decision by Bush reversed

yes!

[Scratchee]

16. This WAS Bush policy

These trials are in accordance with long-standing Bush policy.

From CNN: "The Food and Drug Administration has approved the trials, which will use human stem cells authorized for research by then-President George W. Bush in 2001."

From the article excerpted here at DU: "The chief executive was not aware of any political interference in the decision of the FDA, which had respected a series of deadlines since the company first sought approval in March."

[No Elephants]

21. As I recall, Bush limited scientists to using contaminated embryonic stem cell lines.

[Scratchee]

23. Please read again

My quote from the CNN story addresses this. The approval that is the subject of this thread is a product of the Bush policy.

[LynnTheDem]

30. groundbreaking approach to medical treatment

that had been blocked since 2001 by George W. Bush

[Scratchee]

36. "Raises the prospect of..."

...a groundbreaking approach.

In other words, Obama may, in the future, allow new types of federally funded research. But there is no doubt that this particular approval is the product of the standing Bush policy. The request for trials was made last March, and has been on track for approval since then.

[LynnTheDem]

54. You just go on praising George W. bUsh.

Don't let anyone stop ya!


:rofl:

[winter999]

56. Oooo - good retort.

Are the blinders tight enough?

[Scratchee]

74. I'm not the one praising this decision.

No doubt the official policy on federal funding for stem cell research will change soon...BUT IT HASN'T HAPPENED YET. I mean, seriously, is there anything in the reporting of this story to suggest that Obama lifted a finger to make it happen? This approval has been in progress since March. The trials will use stem cell lines approved for federal funding by Bush (and it's not clear to me that any federal funding is involved anyway.)

I'm with Obama on this one. But I'll save my praise until he actually enacts some new policy.

[TxRider]

79. You recall wrong

Bush only limited federal funding to those stem cell lines..

He didn't, and couldn't, limit research to those lines.

Research on -all- stem cell lines went on just fine using -private- funding.

A big misconception on many people's part. Bush just banned the government funding of research, not the research itself, which has hardly been slowed at all by lack of government grants for it.

The big pharma companies, research institutions etc. can research all they want with their own funds.

[NickB79]

73. This treatment is coming to market IN SPITE OF Bush policies

Yes, Bush allowed a *limited* number of stem cell lines to be used for research. For a field like this to reach it's full potential, THOUSANDS of lines should be in circulation amongst labs. Bush limited it to a few dozen. It was better than nothing, but just barely. He also prevented much-needed federal funding from reaching most of the labs working with those few lines. Many biotech companies were forced to fund their stem-cell research exclusively out of their own pockets or the pockets of donors. Without these substantial setbacks, we may have seen this treatment being used on humans several years ago.

[DS1]

43. It was his "big challenge" while he was on vacation for a MONTH

at his Crawford shithole.


Stem cells or not stem cells, it took him an entire month to decide. The media made a huge deal of his 'intense reflective internal deliberations', and thus, The Decider was born.

[jeff30997]

7. "turn a quadriplegic into someone who can walk with a cane"

That's fantastic news.Science rules !

[Pastiche423]

87. Unfortunately, it probablt will only work w/new injuries

But I believe it will help older injuries in getting back more body functions.

ESCs working w/Methylprednisolone soon after injury is believe to prevent new crips.

This is fabulous news!

[FloridaJudy]

10. Once again, thank you President Obama!

It feels as if the Dark Ages are finally ending.

[laissezfairesucks1]

61. But Will the Benefits be PUBLIC?

You thank Obama, and I agree with his decision. But the public dollars to fund stem cell research will likely end up PRIVATIZED by Big Pharma and along with social service cuts (which Obama alluded to in his inaugural speech ("programs will be cut")this means only the wealthy and those who can afford the health insurance mandates that are coming will get the benefits (and likely impoverish them in the process). Obama needs go a step further and re-introduce PROGRESSIVE taxation and fund expanded Medicare Medicaid, two proven progressive cost effective quality programs.

[Optical.Catalyst]

11. President Obama does not let religion cloud his ability to make the correct decision

[TZ]

12. now technically the ban on FEDERAL funding

hasn't been lifted yet, but President Obama has promised to do that. This is one of the private companies that defied Bushco and did the research on their own.

[DUlover2909]

13. Thank you Obama. Thank you, thank you, thank you.

I am so freaking relieved that he acted on this swiftly. I'm in no need of stem cells myself, but Shrub's veto is one that I will not ever forget. Go forward science. Do what you do.

[tclambert]

15. Off to a good start.

If you want to choose sides on science, you gotta be pro science. If Republicans insist on being the anti-science party, they make themselves into loonies. Good job Obama, good job Democrats.

[blondeatlast]

17. People first and foremost--thatnk you, Mr. President!

Insulin dependent for 40 years, long before personal glucose monitoring was available. I'm crying--the possibility is there that even at my age, I can be a recipient (similar treatments have been going on at the University of Minnesota to remarkable success).

:patriot:

[Best_man23]

18. The White House, now with Science

Waiting for President Obama to sign executive order authorizing federal funding for stem cell research.

The announcement of the first use of stem cells in humans brings hope to those with diabetes, Alzheimers diesease and Parkinson's.

When I think of funding stem cell research, my mind goes back to this powerful video from Sen Claire McCaskill's campaign.

http://www.youtube.com/watch?v=QMliHkTDHaE

[No Elephants]

19. A picture is worth

everything sometimes.

[greymattermom]

22. Reeve foundation

I wrote a grant to send to the Reeve foundation, but their endowment is so low that they did not accept any proposals for one of their two deadlines this year. Very sad.

[4_TN_TITANS]

20. Damn....

I wish I could accomplish in a month what this president has done in a few days. Anyone still not impressed?

[lunatica]

26. Finally we're in the 21st Century!

Science has pretty much ended it's stage of discovery and started it's stage of development. We have the science, as Al Gore says. We just need to use it now.

[LynnTheDem]

29. EXCELLENT!!! Welcome back to the future, America!!!

:) :) :)

[road2000]

51. Applause to you, Lynn!

Great reference you slipped in there.

[Hawkeye-X]

31. My dad was a beneficary of his own stem cell transplant..

Just to beat lymphoma. He's been cancer free for the last 6 months or so. I'm even wondering when our son is born in about 6 weeks or so, we should save some of his cord blood in case one of us has cancer.. but $7,000 a year to maintain the cord blood is pretty pricey.

Hawkeye-X

[WePurrsevere]

34. Thank goodness! This means so much to me...

This effects my DH and I on a a very personal level. Hopefully we'll be around to benefit from what this type of research comes up with but even if not it gives us some hope that others will someday.

[ThatsMyBarack]

35. Maybe it can help my Parkinson's dad....

[juajen]

38. There has been ongoing research in California on stem cells.

My brother also suffers from Parkinson's Disease, and is in a nursing home in San Francisco. I am very hopeful that this will not go forward full steam; but there are people who are undertaking treatment for this right now. I'm not sure of the companies involved, but I bet you could google it. My brother has not been tagged, and research is limited.

[Jefferson23]

37. More good news from President Obama, fantastic. When you

think about how completely absurd for a nation such as ours to have neglected research like this and the reasons for those decisions is still a shock to me. The Bush years were truly INSANE!

[DS1]

41. I hope the first person who can walk again knocks on Bush's door and slaps that motherfucker

[bdamomma]

44. thank goodness.

and believe or not I think of Specter on this one cause he was for it.

[Politicalboi]

78. Probably because

It would benefit him down the road. If not he would be right there with Bush. I hate Specter.

[aquart]

45. I read it and started to cry. Have we gone sane?

[Deep13]

59. Looks the the country has gotten all rational on us.

Damn! That's all this country needs if for people to be all reasonable.

[Bette Noir]

46. Wow. It's almost like we live in a free country

That's not run by religious loons.

Note-- I'm not equating religion with lunacy. I'm just pointing out that there is some overlap.

[Cairycat]

47. Losing my vision in my early 50's

to an inherited form of macular degeneration. Expensive injections into my eye are slowing the loss, but it is stem cell research that holds the promise of a cure. The more lines open the better - hopefully before I'm legally blind. Thank you, President Obama!

[Kajsa]

55. ------

:hug:

My vision is going also, at age 57.

This sounds very promising.

:)

[recoveringrepublican]

72. Losing my hearing in my early 20's here, I think it's too late for me

my brain would go nuts with all the sound, but maybe if my kids have to face it they won't have to go through all that I have.

[montanto]

48. More good news. Thank you.

[man4allcats]

49. This is the dawning of the Age of Aquarius

and Thank God and President Obama!

[road2000]

52. It's also the assault on 'unreason'! n/t

[sofa king]

53. It's a shame that it came too late to save Saint Ronnie

Or maybe it's the silver lining.

[superconnected]

57. Look, the future can move forward now. All progress stopped under dumbya,.

[Deep13]

58. No! Save the snowflake babies!

:evilgrin:

:bounce: :toast: :party: :kick: :applause:

[Lucky 13]

77. !

:rofl:

[Dukkha]

62. very happy to see our science moving into the 21st century

the fundies can stay in the medieval age if they wish, but we can now join the rest of the modern world in advancing the human race

[laissezfairesucks1]

63. But Healthcare System is Moving Backwards

Publicly funded research is a good theing. Privatized patent rights on that research is a BAD thing. Our system is moving backwards towards privatized health insurance which means more HMOs. Tom Daschle is poised to push through HEALTH INSURANCE MANDATES. If the public funds the discovery of stem cell medicines, they should have public access to those discoveries through expanded Medicare Medicaid, or simply a single payer universal healthcare system like the rest of the First World has enjoyed for decades.

[Stellabella]

64. Thank God.

The nightmare of Bush is slowly being unraveled.

[WhiteTara]

66. Green light for US stem cell work

Source: bbc

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.

Read more: http://news.bbc.co.uk/1/hi/health/7847450.stm

---

also a video

:woohoo: the life affirmers are in charge!

[Hope And Change]

67. K & R!

[Gregorian]

68. I forgot! Yet another great thing about ridding our country of Bush!

Now sick people can be well!

Thank you world for giving us a humane president!

[newtothegame]

69. I soundly support stem cell research...but why do we want to do embryonic...

when you can get stem cells from cord blood and other non-"living" sources?

[NickB79]

81. Because there is still debate about how effective adult stem cells are in treatment

Numerous studies have come out showing that adult stem cells can potentially give rise to a wide variety of tissue types. Numerous OTHER studies have questioned the results of those studies, and in some cases discredited them altogether. Cord-blood stem cells, for example, have so far only been developed into other forms of blood cells and marrow. Adult stem cells have required extensive treatments and techniques to initiate pluripotency. Embryonic stem cells, on the other hand, have been shown to easily diversify into every tissue type in the human body by labs around the world.

Given time and money, scientists could probably get adult stem cells to be as easily manipulated as embryonic stem cells. However, since the US alone discards tens of thousands of embryos a year into the trash, it doesn't make sense to ignore their potential and slow future medical advancements.

[Igel]

70. Perhaps only the timing is Obama related.

The funding was private, so the research wasn't a problem. The ban only applied to federal funding for research, and not to clinic trials. It's almost a certain thing that the trial got the go ahead last week or before.

So the "life affirmers" weren't involved, except to the extent that they were appointed or hired or kept on under the previous administration.

In other words, those of awesome and great importance, apparently, weren't important at all in this decision. Then again, a naive reading the article would tell you that. But don't let that stop you from misattributing the significance of the trial. After all, those of awesome and great importance must be given all glory, even if it's not earned, in order to prove to us that they are of awesome and great importance.

Otherwise their true inner humility won't be evident, and the science can't be seein as serving the proper political ends, thus making science truly depoliticized (tm). (/snark, mostly)

It's a step forward that it's made it to clinic trials, but that's not reason to misappropriate the credit or get all worked up over a new age biomedical technology; stem-cell trials have been going on for a while, just not with the hESCs of holiness. Most procedures that get to this stage stop with it; either there aren't advantages over the placebo (moderately unlikely in this case, IMHO) or there are risks that didn't show up in previous testing.

In other words, it's an opportunity not to show only humility, but also patience and common sense.

[Lucky 13]

76. Thank you.

Thank you. Thank you. Thank you.

Let the science begin.

[Career Prole]

88. Thank you, President Obama.

From my big sis who suffers from MS.

[Raster]

90. Time for American science to come out of the dark ages of fear and superstition...

and into the light of knowledge and reason!

We Can Do Better!:kick: