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FDA OKs First Human Trial of Neural Stem Cell Therapy
An anonymous reader sends word that the FDA has approved a phase 1 trial for Neuralstem, a company with a patented stem cell procedure targeting ALS (Lou Gehrig's disease) and other spinal conditions. The company's CEO said in a press release, "While this trial aims to primarily establish safety and feasibility data in treating ALS patients, we also hope to be able to measure a slowing down of the ALS degenerative process." Results are expected in 2 years. The trial will involve 12 ALS patients who will receive stem cell injections in the lumbar area of the spinal cord. An information site for the disabled community adds hopefully: "If it makes it through all stages of testing, we will see if doctors are willing to [use] it on subjects that have injuries coming from physical injuries like diving accidents."
Probably not, to be honest. If they're just starting Phase I right now, figure on at best 6-8 years or more before a possible approval by regulatory agencies, which naturally assumes that this treatment would be demonstrated as both safe and efficacious. Phase I doesn't take much time, but Phases II and III can easily take years- particularly for a disorder like ALS, where patients would need to be monitored for months to determine the treatment's effects. In Stephen Hawking's particular and remarkable case, it is not merely the progression of his ALS that would be an issue; the man is 67 years old right now.
"FDA staff reviewers expressed concern about the number of patients who were left out of the study because they died."
Why does it matter?
One reason it matters is that we are forever being told how embryonic stem cell research is going to find the cure for every disease under the sun, and anyone who thinks the money should be diverted to research into stem cells from alternative sources is a religious nut who should shut up, yet of nearly 100 current treatments using stem cells, there is not a single one that uses embryonic stem cells. If this were better known, then all the resources being wasted on this dead-end research could perhaps be used more profitably.
Far fewer people have dies waiting on something then would ahve if they just rushed or ignored testing.
So, do you believe that you're entitled to make that decision for someone else? If you don't have the right to do it, then neither does a government.
-jcr
The only title of honor that a tyrant can grant is "Enemy of the State."
Can someone who understands statistics and FDA trial phases explain something to me. . . Is a sample size of 12 really big enough to be a reasonable 'safety' trial? Or do they start with a small trial, just to find out if there's any problems so severe that they would affect almost *anyone*, then in future phases, increase the sample sizes to more and more test subjects, looking for those problems that only affect 1/1000 or 1/100000 patients?
You think it's the FDA that's been holding up stem cell research, and not the religious yahoos?
The only thing "held up" was federal funding for stem cells that resulted in destruction of the embryo/fetus. The research was not banned in any way. It did not affect any stem cell research from cells taken from your own body (which have the added benefit of being much less likely to be rejected). Nor did it affect Amniotic cells.
There are more legal hurdles right now to test on animals (which Neuralstem admits to doing), than stem cells. And if the animal rights crowd gets their way, this research area is toast because no one is going to experiment on humans without animal trials first. But keep blaming "religious yahoos" for all the problems.
The whole "evil religious people are against stem cells" is a typical wedge issue cooked up by politicians to get you away from looking at the arguments and issues and vote in a knee-jerk "Good vs Evil" mentality that makes you so darn easy to control. Animal testing is a complex argument around what does it mean to "feel" pain, etc. Well, guess what, there is a complex moral discussion surrounding whether it is a good idea to chop up embryos/fetuses and use them for spare parts. You know, kinda like what does it really mean to be human, what is morality, etc. In a way, it sounds vampirish -- to consume the cells of another entity with human DNA to improve your own health. Potentially, create a child and abort it so you can live longer. How close do you want to go to people as "spare parts"? You should at least understand and sympathize a little bit that a large number of people in a representative government may not want their tax money to go to something like that.
To reduce it down to calling people "yahoos" is inane.
If it proves to be effective early in the trials, he can afford to meet his doc in "some hospitals in the far east"(better yet in Cabo) for the treatments. It happens every day, at great expense to the sick and great risk to the providers. The FDA may not approve, but the people who can't afford to wait for the bureaucratic trials to inch along do.
Imagination drew in bold strokes, instantly serving hopes and fears, while knowledge advanced by slow increments...
And none of you guys seem to realize that ESC research is done on embryos that were headed for the incincerator anyway.
If ESC treatments become viable, IVF leftovers do not provide a sufficient supply for more than a tiny fraction of the people who would request treatment
Besides, many people will still have ethical problems with forcibly "harvesting" parts / cells from people, even if they are headed for the incinerator. Didn't we just have this same debate a few years ago with harvesting condemned criminals for organs? "And none of you guys seem to realize that these organs are being taken from people who were headed for the electric chair anyway."
All I mean is that the ethics of ESC are severe -- and even amplified when humans are in play. If your argument for "research only -- no treatments expected" holds, then would using animal ESCs sidestep any of this for you, while still gaining many of the research benefits?
On the funding issue too, I'm wary of the uninformed public making choices as to what needs to be spent where when they rarely have the context or understanding of what the research is supposed to accomplish.
I suppose I think that when I give the government money, I am hiring them to provide a service for me. If I don't want my car mechanic adding a spoiler onto my car, I don't intend to pay him for it. I may not understand the implications of the performance and whatnot, but if I would rather it be spent on something like better roads or schools, why shouldn't I have a say in where my money goes? Yes, I'm sure that these research dollars will have paid off in the future for our children and their children, but if my child is flunking basic math right now because their school can't afford good teachers, I think it's a bit unfair to call them an ignorant hick just because they don't place quite the priority on stem cell research as you do, and would rather see the government shuttle that money elsewhere.
In a word, if you want it, spend your own money on it, and don't just get upset and call people ignorant when they don't share your priorities. Other people have legitimate needs for this cash, and there's only so much of it to go around.
It shouldn't be a democratic process because then we'd end up spending half our money on "Does prayer heal?" and we'd all be smoking like chimneys wondering why we were dropping dead.
Well it's good that we're not a democracy here -- we're a republic. Sadly, it seems that we're trending ever and ever closer to a democracy though, which has never been a stable (or productive) form of government.
I don't mean to sound elitist, I think most people are -capable- of learning enough to make good decisions on funding of stem cells, but they clearly haven't.
Then if people aren't willing to give you their money, then in the meantime, spend your own. Again, you seem upset that people aren't willing to just give you their limited funds for your priorities. Noone's stopping you from spending your own -- they're just not happy when you try to reach into their pockets for your interests. Plenty of disease research groups (such as March of Dimes, etc) evangelize and raise awareness and gather donations for a cause or for research. It's a bit awkward when such evangelism is skipped and the conclusion is mandated through legislation on the federal level. Yes, fundraising is work -- but at least you're respecting people and their basic liberties. I know it's tempting to want Big Brother to handle all of this for us, but when the government looks like a hammer, all of our little problems start looking like nails.