FDA halts adult stem cell procedure
November 29, 2003 11:34 AM Subscribe
The FDA has put the brakes on clinical trials of a promising form of stem cell therapy which uses the body's own stem cells to heal dammage. The procedure was used earlier this year to heal the heart of a teenager who was shot in the heart by a nail gun. Other research is being done with the body's own stem cells on the heart and the spinal cord, and new ways to produce large numbers of adult stem cells have been discovered by MIT and the British company TriStem. With the controversy over embryonic stem cells, I'm glad that adult stem cell therapy is showing promise. [Some links via FuturePundit, who is rather annoyed with the FDA.]
Mh as far as I understand the issue is that (quoting)
Clinical trials can be conducted using living cells without FDA's permission if the trial meets certain conditions. One condition is that the cells being given to a patient perform the same function in the patient as in the donor. This is known ashomologous use.
If these conditions are not met, clinicians must apply for permission by submitting an Investigational New Drug (IND) application. In the case of the Michigan proposal, FDA considers the use of stem cells derived from the bone marrow for use in repairing heart tissue to be “non-homologous” even though the cells came from the patient himself
That's because, apparently, FDA or scientific community still doesn't have enough data on the nature of the cells that are "repaired" by stem cells. Are they brand new cells, or repaired cells ? How do they work and how long do they work ?
As far I as I can see (and that's not so far I'm not cell technician) FDA concern seems to be legitimate. I'd rather put more pressure on legalizing stem cell experimentation regardless of the source of the cell (embryo,bone marrow) so that scientific community can do paralellel-experimentation (which speeds up analysis while maintaining the rigor of scientific sperimentation).
For the problem of terminal illness - right to choose an experimental cure : I think that if there is consolidated scientif proof that a patient is terminal and his/her only chances are that of an experimental cure, then he/she should do whatever gives an additional chance , but the doctors should be responsible not only of informing the patient of the experimental nature of the treatement (no-brainer) but also for the decision of proposing an experimental treatement (which would require doctor at least to show on what scientific data/grounds is their suggestion of using experimental approach founded on).
Great post Homunculus, thanks a lot.
posted by elpapacito at 12:31 PM on November 29, 2003
Clinical trials can be conducted using living cells without FDA's permission if the trial meets certain conditions. One condition is that the cells being given to a patient perform the same function in the patient as in the donor. This is known ashomologous use.
If these conditions are not met, clinicians must apply for permission by submitting an Investigational New Drug (IND) application. In the case of the Michigan proposal, FDA considers the use of stem cells derived from the bone marrow for use in repairing heart tissue to be “non-homologous” even though the cells came from the patient himself
That's because, apparently, FDA or scientific community still doesn't have enough data on the nature of the cells that are "repaired" by stem cells. Are they brand new cells, or repaired cells ? How do they work and how long do they work ?
As far I as I can see (and that's not so far I'm not cell technician) FDA concern seems to be legitimate. I'd rather put more pressure on legalizing stem cell experimentation regardless of the source of the cell (embryo,bone marrow) so that scientific community can do paralellel-experimentation (which speeds up analysis while maintaining the rigor of scientific sperimentation).
For the problem of terminal illness - right to choose an experimental cure : I think that if there is consolidated scientif proof that a patient is terminal and his/her only chances are that of an experimental cure, then he/she should do whatever gives an additional chance , but the doctors should be responsible not only of informing the patient of the experimental nature of the treatement (no-brainer) but also for the decision of proposing an experimental treatement (which would require doctor at least to show on what scientific data/grounds is their suggestion of using experimental approach founded on).
Great post Homunculus, thanks a lot.
posted by elpapacito at 12:31 PM on November 29, 2003
The FDA has put a stop to stem cell therapy, because it threatens to cure diseases which for now are only treatable by a lifelong dependence to pharmaceutical companies' medications, which have been overly inflated in price due to patent laws and 'the free market'.
When questioned about this development, every congressman averted their eyes, mumbling something about capaign donations, and how they were late for a flight to Barbados for a meeting with some friends in the pharmaceutical and tobacco industries.
The president, who we will still assume is George W Bush, was quoted as saying, "We can't bear the risk of taking money out of the hands of wealthy legal drug CEOs with these kinds of therapies that threaten their livelihood. If we continue like this, they could lose their cars, their Yachts, or even their summer homes. And I know what its like to have a summer home, I have one in Texas. But I use mine every week, and its more of a place to avoid work than anything, but really, the rich don't deserve this kind of treatment." He continued by muttering in incomprehensible language for 10 minutes before realizing Air Force One was waiting to take him to Barbados.
posted by benjh at 12:32 PM on November 29, 2003
When questioned about this development, every congressman averted their eyes, mumbling something about capaign donations, and how they were late for a flight to Barbados for a meeting with some friends in the pharmaceutical and tobacco industries.
The president, who we will still assume is George W Bush, was quoted as saying, "We can't bear the risk of taking money out of the hands of wealthy legal drug CEOs with these kinds of therapies that threaten their livelihood. If we continue like this, they could lose their cars, their Yachts, or even their summer homes. And I know what its like to have a summer home, I have one in Texas. But I use mine every week, and its more of a place to avoid work than anything, but really, the rich don't deserve this kind of treatment." He continued by muttering in incomprehensible language for 10 minutes before realizing Air Force One was waiting to take him to Barbados.
posted by benjh at 12:32 PM on November 29, 2003
Anyone opposed to this research should be made to sign an acknowledgement to that effect and then be denied any treatments that result from it for the rest of their lives.
posted by rushmc at 3:47 PM on November 29, 2003
posted by rushmc at 3:47 PM on November 29, 2003
What is really ominous is that the doctors are considering moving their research overseas. How much more will we lose due to this administration and its policies?
posted by Beansidhe at 4:50 AM on November 30, 2003
posted by Beansidhe at 4:50 AM on November 30, 2003
Nice post.
The financial motivation is a big one, to be sure, but so are the values of W's core constituency -- the religious right. Stem cell research of any kind will forever be linked in their minds with abortion. Nevermind that this has exactly zero to do with abortion.
posted by LittleMissCranky at 9:33 AM on November 30, 2003
The financial motivation is a big one, to be sure, but so are the values of W's core constituency -- the religious right. Stem cell research of any kind will forever be linked in their minds with abortion. Nevermind that this has exactly zero to do with abortion.
posted by LittleMissCranky at 9:33 AM on November 30, 2003
The most interesting link in this post is the one about TriStem. I have a feeling it will make the rounds again.
posted by yonderboy at 9:56 AM on November 30, 2003
posted by yonderboy at 9:56 AM on November 30, 2003
Yergh, not that argument again.
While Bush is a crazed Christian with a stupid mission(s), not all people against abortion are religious. There's many secular arguments against abortion.
That being said, having read a little more, I can see Stem Cells and Abortion are linked like chalk and cheese.
posted by shepd at 1:37 PM on November 30, 2003
While Bush is a crazed Christian with a stupid mission(s), not all people against abortion are religious. There's many secular arguments against abortion.
That being said, having read a little more, I can see Stem Cells and Abortion are linked like chalk and cheese.
posted by shepd at 1:37 PM on November 30, 2003
Since these procedures deal only with adult stem cells, abortion has nothing to do with this, and as far as I know Bush and most pro-lifers enthusiastically support adult stem cell research. What's going on with the FDA seems to be more a function of bureaucracy than philosophy. I agree with elpapacito that they do have legitimate concerns, but ultimately I agree with FuturePundit that they shouldn't stand in the way of clinical trials. This is promising stuff, as Bonnville's recovery shows.
posted by homunculus at 1:47 PM on November 30, 2003
posted by homunculus at 1:47 PM on November 30, 2003
(vaguely OT) Actually, abortion has next to nothing to do with fetal stem cell research. The majority of researchers are content to do research using discarded embryos. When a couple decides to have a child via artificial insemination, there are often many unused embryos. They stay on file for a few years, and are then discarded instead of used for research. This would be a viable source of stem cells, according to what I've read.
Is everybody getting their "facts" on stem cells from that South Park episode where Christopher Reeve sucks them out of aborted fetuses, or what? Somehow the words "stem cell" got equated with "baby murder" and now increasing numbers of researchers are leaving the US so that they may continue research.
posted by mikeh at 7:01 AM on December 1, 2003
Is everybody getting their "facts" on stem cells from that South Park episode where Christopher Reeve sucks them out of aborted fetuses, or what? Somehow the words "stem cell" got equated with "baby murder" and now increasing numbers of researchers are leaving the US so that they may continue research.
posted by mikeh at 7:01 AM on December 1, 2003
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posted by the fire you left me at 11:38 AM on November 29, 2003