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FDA Could Delay Adult Stem Cell Breakthroughs
destinyland writes "A Colorado medical advocate says, 'The FDA contends that if one cultures stem cells at all...then it's a prescription drug,' in arguing that revolutionary new treatments could be delayed by 20 years — even using cells extracted from your own body. According to the FDA, even therapies that simply re-inject your body's adult stem cells could be prohibited without five years of clinical trials and millions of dollars of research. How useful are cultured stem cells? 'In animal models, they routinely cure diabetes.'"
This is not the government saying this, it's a "Colorado medical advocate". It's one guy's opinion on what might happen. And, gosh, guess what industry he's in...
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Considering it took over a decade to go from the hypothesis of "bacteria cause peptic ulcers so lets use antibiotics" to it being standard practice why would anybody expect stem cells to appear with any speed at all. (I mean that example we're talking about giving people an already existing drug with already known properties in humans and it still took years. Stem cells will be MUCH slower to go from any discovery to actual treatment.)
Did you know 80 to 90% of the moderators on slashdot wouldn't recognize a troll even if one dragged them under a bridge.
When a drug is found to cause significant problems after it's release, we're outraged, and when the FDA says we actually need to test radical new treatments before giving them to people, we're outraged.
Either we're stupid, or we just enjoy being outraged by stupid stuff, I can't tell which...
Blessed are the pessimists, for they have made backups.
Take one of your own well-behaved, tightly regulated stem cell out of its milieu, subject it to various biochemical stresses, and then re-introduce it to your body. You may just have transformed it into an unregulated, tumour-producing cell. Or accelerated it along a transformational path that could take a long time to become apparent.
I'd say that precaution is warranted dealing with something like this. Especially when you have a very long-lived animal like a human, with decades of time during which manipulated stem cells could transform malignantly, versus the limited lifespan of most animal models.
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The risks, while no doubt ultimately manageable, of playing with pluripotent cells are neither trivial nor theoretical. They have this nasty habit of turning into good old tumors.
Now, if you don't like the FDA, or think that the FDA approval process needs to be modified, great. That is a perfectly legitimate position, and might even be true(the situation is complex enough that it probably varies a bit from case to case). However, if that is so, just say so. A strategy of attempting piecemeal exemptions for various powerful biological interventions is just bullshit.
It's like the difference between being a libertarian and having an accountant in the cayman islands.
Shh! They're both run by the Illuminati.
Some doctors and all pharmaceutical companies and hospitals do not want to cure you with a blue pill. Their whole existence in life is to maximize their profits, to do otherwise is not in the interest of their share holders.
Stem cell results are dangerous. Should we just ignore the risks?
Until we get a good handle on it it certainly should be treated like it is potentially hazardous, because it is.
This is even worse -- much worse -- than the time the FDA tried to regulate the newly-invented pepper spray for defense against bears as a "pesticide".
They want their own fingers in the pie. It is as simple as that. And we should not let them do it.
But if they aren't available, then you don't get them.
If they aren't well tested, and you have problems with the drug, the doctor is much more open to malpractice suits or investigations by the friendly Board of Medical Examiners.
Insurance companies routinely won't pay for 'experimental' therapies.
Besides, this whole article is a bunch of whining from the people invested in the new tech. The writer waxes breathlessly enthusiastic about something that has barely been attempted. It is really unclear that dumping pluripotent cells back into the body is either safe or effective or even particularly sane given the fact that MOST of a multicellular organism's time and energy is spent controlling cell division and PREVENTING things from growing.
Whatcouldpossiblygowrong?
Faster! Faster! Faster would be better!
Anyone who needs treatments that the FDA doesn't want to allow will have to incur the added expense of going somewhere with a free market for medicine. Sucks for the people who can't afford it.
-jcr
The only title of honor that a tyrant can grant is "Enemy of the State."
I realise this is totally offtopic, but it did catch my eye that the vogue phrase is "animal models" instead of "animal experiments". I don't want to even start a battle about the ethics of animal experimentation, but I just found it interesting that they seem to try to sidestep the issue altogether by cushioning their words. Sounds like politics as usual.. so hey, maybe it's not all that off-topic after all.
Now, back to your regularly scheduled Slashdot mayhem.
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Definitely fully tested. I remember one episode...
I know of lots of "end of the earth stories". Science doesn't back it up completely, unless you're talking about real threats (like grey goo or a mutant airborne and massively contagious e-bola virus).
Just because there's media hype about "what if" doesn't make it true. Yes, "fully tested" has to involve human trials at some point; but with the success we've had in curing rat diabetes and growing spare organs, I believe it has proved itself (definitely at least as an experimental therapy).
Dealing with mutations is always a risky business. --- there are safety procedures in place for a reason.
There are already therapies available that are much more dangerous. Mutations are a problem though? Wow, there's been too many horror movies on that subject; and that's all they continue being. Mutations mean cancer at worst, not the next fictional zombie threat.
Take for example: bone marrow cancer. Treatment is difficult, and even -if- it is successful, it can still rear problems that will kill. This is a treatment, because people choose to try an experimental (albeit common) treatment rather than none at all.
What I see in this is the drug companies saying "no" to alternative treatment. They like the profits they make! (after all, who wouldn't?). They are also effective lobbyists (because they have moolah to throw around) and have the most to lose from independence of various drugs.
Is it so surprising that we're simply dealing with an antiquated business model that is stifling innovation?
There are no perfect answers, only the right questions. More questions at http://foresightandhindsight.blogspot.com/
I understand the FDA's desire for caution if caution truly represents its motives but there are also other considerations. Encouraging widespread use of a substance with possible long term effects is not a good idea. However, for many of the people adult stem-cell therapy could help, getting cancer twenty years down the road, or even five, isn't an issue if they die waiting for approval of the treatment. Unfortunately, many people including my Mom, are inflicted with diseases stem-cell therapy has been proven to cure, or effectively treat. Many of these ailments such as ALS or Multiple Sclerosis progress quickly and kill or deteriorate people's quality of life at an aggressive rate. Within a period of six months a twenty-two year old male can go from perfect health to a hospital bed in which he cannot move, talk, breathe or eat on his own. Within six months his only form of communication becomes blinking. Many of the people with these illnesses cannot work or live their life and as their conditions endure they suffer waiting for the final blow. Would it not be more in people's interest to give them the choice. If they don't want to risk getting cancer from a treatment they do not have to get it and can use alternative methods until more research is available. But for those who could benefit and cancer is a less dangerous risk than their original illness or for people who are willing to take the risk for reasons of their own shouldn't they be able to? I just wonder what happened to the allowance for personal responsibility.
Also, kdawson != editor.
But I suppose we already knew that.
I'd suggest that a more appropriate example would be laetrile, if we're talking about people exporting their health care. People went to Mexico for that one, despite that it is apparently ineffective for treating cancer. Those people paid plenty of money and put their health at (further) risk for something unlikely to provide any benefit. Even undergoing currently accepted chemotherapy regimens is placing one's health at risk--but there is generally expected to be a benefit that outweighs that risk, since we have confidence that our chemotherapy regimens can actually provide that benefit.
Laypeople are not and really can't be expected to be health care experts, in general, and so it's somewhat unreasonable to expect that the average person is sufficiently knowledgeable to solely determine what kind of treatment will be effective for his major illnesses. That is one of the reasons we have medical doctors and researchers, after all. Health and health care have a connection that is so nebulous that it's very difficult to make informed choices without well-organized bodies, ones which do, compile, and disseminate the kind of intensive research necessary to provide the information that enables people to make sound medical choices.
Simply because there is a market for fake cancer cures, for instance, does it then become ethical to let people exploit that market and make money off of the completely natural ignorance of the lay public? However, it'd be hard to stop people from going to Mexico to get these "cures," so I guess perhaps we have to ask ourselves--assuming that we can't dissuade people from wanting these fake cures--if we would rather have them getting them in the States or in Mexico. Honestly, that's a dimension of the problem I hadn't really thought of until I was writing this comment today.
It's going to take longer than a month for *any* putative stem cell treatment to show results. Human cells simply cannot divide that quickly. So the "ticking time bomb" argument is a little fanciful. Further, the cardinal example given here, diabetes, will not kill you quickly as long as you manage it with meds. Properly controlled, diabetes (either Type 1, Type 2, or gestational/MODY) is a serious disease, but an eminently treatable disease.
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