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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.'"
Heh.
now christopher reeve will never walk =(
So how long has the FDA been operatin
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...
Advice: on VPS providers
My stem cells couldn't be any more delayed than they already are. Ohh. Pickles.
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.
What does the Federal Trade Commission have to do with this?
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.
Da Blog
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.
Of course I refuse to RTFA, but the summary isn't clear. Right now, if I want to undergo treatment that involves adult stem cells harvested from me, to be re-injected from me, I might have to wait 5 years. However, what is not clear is whether it will take 5 years to approve the process such that in 6 years, it might take 2 weeks, or will it take 5 years in 10 years when(if) this process is well understood and old hat?
Is it sad that I am more likely to recognize you and your posts by your sig than your name or UID?
'In animal models, they routinely cure diabetes.'
That's great for models, but what about ugly people? Don't we get a cure?
As much as I care about safety, those issues can be resolved by requiring the techniques to extract, grow, and alter cells be approved not that every instance of such a act be considered the creation of a new drug. The doctor in this case is talking about the danger of a bio company trying to create regime like Monsanto with its BT line. In this case specialized stem cell lines would be created and owned by companies who would sell them like drugs for enormous profits. If it is legal to take a person's own stems cells and modify them as needed to treat disease, it means no money for the big drug companies. That is the real danger.
Doctors can write prescriptions for experimental drugs.
Bruce Perens.
Why should the FDA object to this? Its silly I say, 'Reefer madness' all over again! I've been shooting, snorting, and smoking my own DNA for years, and other than compulsively posting on /., I am the very picture of normality.
HA! I just wasted some of your bandwidth with a frivolous sig!
Bad move FTC.
I love it when there's a mistake in the headline. You can tell who didn't even read the summary.
I might actually live long enough to see, and maybe even benefit from this!
The musings of just another geek and his junk.
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.
Larry King (CNN) got a stem cell treatment years ago. Dr Chris barnard (first heart transplanter), got it decades ago and died in his late eighties.
Excuse me, but please get off my Pennisetum Clandestinum, eh!
The FDA wields an unconstitutional power, and they'll grab any excuse at all to interfere with the practice of medicine while people die waiting for new treatments.
-jcr
The only title of honor that a tyrant can grant is "Enemy of the State."
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.
If I piss into a bottle, it comes out of my body sterile and is safe to drink, but left to sit for a few days, it is full of bacteria and not safe. Just because it came from my body doesn't mean it's safe to put back in later or after things have been done to it.
Indefinitely, you surely mean. I wouldn't mind some of my cells splitting a few extra generations.
If there's a legitimate role for an agency like the FDA, it's indicated by its original name, which was the "Pure Food and Drug Administration". Having inspectors who will check up on whether the bottle of pills you've bought is in fact the drug it's sold as and not just gel caps full of chalk, and punish anyone committing fraud, might be worthwhile. How we got from that to the government deciding whether you're allowed to ingest something and whether your doctor is allowed to prescribe it is a tragic story of gradual usurpation by an overfunded bureaucracy.
-jcr
The only title of honor that a tyrant can grant is "Enemy of the State."
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."
Government stands in the way of growth! Interview at 8.
Send your spendthrift head of state this
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.
mirrorshades radio -- darkwave, industrial, futurepop, ebm.
excuse me ? how the fuck would you know what drug causes cancer 1 year down the road with no trials ? how the hell are you supposed to assess vioxx's risk with no data ?
are you stupid ?
how the fuck is an MD or individual supposed to assess risk in any form when the FDA has problems with it ? the only reason the "advisory" crap in EU works is because of the FDA which is literally the guardian of the world drug industry. like the FAA. no FDA=deep doodoo for all customers like the "nutritional supplement" loophole which has resulted in actual deaths.
If it made you more sick or created serious side-effects that would allow for additional medical treatment ($$$) the FDA would approve it immediately without any trials.
"FTC could delay Adult Stem Cell Breakthroughs"
In related news, the FDA has decided to intervene in the Janet Jackson Superbowl "Wardrobe Malfunction" litigation.
The FDA simultaneously enforces standards of ethics and cleanliness that help prevent outbreaks of disease, which affect all of us, and outbreaks of rampant idiocy and ill-advised release of powerful and untested medications.
Without them, we wouldn't ever see salmonella coming. We wouldn't know if any cattle stock had been infected with salmonella, we wouldn't know if the drugs we're buying do what they say they're doing.
They still do what they were originally deigned to do: ensure that we get what we pay for, without the unwelcome side effects that cutting costs brings.
Why do we need a regulatory body to take care of this? European countries have FDA-equivalents which have only advisory powers, they get along fine.
Google "Frances Oldham Kelsey"
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.
"shit" is present tense. The past tense, which I think you want, is "shat".
Wouldn't injecting/implanting stem cells just be some new kind of transplant? Why would it be considered a prescription drug? Is a new kidney or liver a prescription medication?
If they were stem cells from Howard Stern, then we can be sure the FTC would be involved.
The answer to that question lies partly in the sordid little tale of elixer sulfanilamide. To make a long story short, Massengill wanted to produce a liquid version of a one of its drugs and one of their chemists discovered that it would dissolve nicely in diethylene glycol. Aside from being a handy solvent, diethylene glycol is sweet tasting, so it made a perfect base for a liquid medicine. The only downside was the fact that it's poison. The FDA tracked the stuff down and managed to prevent most of it from being distributed, but not before over a hundred people were killed by it. Hundreds, maybe thousands of lives were saved by the actions of the FDA. It's not clear whether the Massengill chemist knew did not know about the toxic effects, or if he was aware of some toxicity, but didn't realize quite how bad it could be. In any case, he ended up committing suicide. As for Massengill, they naturally asserted that the results were unforseeable and denied any responsibility. Massengill paid a small fine for labeling the product an 'elixir' even though it contained no alcohol (diethylene glycol is technically an alcohol as I understand it, but I believe it has to be ethyl alcohol to qualify). In fact, that mis-labeling was the only thing that gave the FDA any authority to seize the drug and prevent it's distribution. If it hadn't been for that, the FDA would have been legally been powerless to do anything.
After that, congress passed the 1938 Food, Drug, and Cosmetic Act, which set the FDA upon its current course. Without that act, and subsequent ones in the same vein, the FDA would be what you prefer. In that case, if someone sold Sulfanilamide in liquid form without any mis-labeling, the FDA would come along and check it and say, yep, it contains Sulfanilamide, just like the label says, sure it's dissolved in FREAKING POISON, but there's nothing we can do about that. Wouldn't that be great? Not that I'm saying that the FDA is perfect. It's a massive bureaucracy and I'm sure there are plenty of cases where it does more harm than good. Without it in its current form, however, drug companies would be killing us off like crazy. I mean, have you seen some of the crap they try to (and sometimes do) pull even with the FDA? The magical era you imagine, back when the FDA didn't interfere and the worst you had to worry about in your medicine was that it contained inert ingredients like chalk is a fantasy. The reality is that even big, respected drug companies did wildly irresponsible things with peoples health.
Interestingly enough, something similar happened recently with cough medicine made with Chinese Diethlyene Glycol. Lots of people died, etc. Now the Chinese do have their own version of the FDA, although it obviously isn't as hands on as the US FDA, plus, it apparently doesn't involve itself in products meant for export. One of the interesting things is that even the pre-1938 duties of the FDA would apply, since the reason it happened is because of mis-labeling. Specifically, diethylene glycol from China keeps getting labeled as glycerine and sold for export. There was another major incident where this happened a decade ago, and lots of minor incidents in other products like toothpaste. It happens because of greed and laziness. It's cheaper and easier to buy inexplicably inexpensive barrels of "glycerin", not test them in any way (not that it should be difficult, the difference in viscosity and the fact that glycerin is odorless and diethylene glycol has a fairly intensely sweet odor should be a dead giveaway to anyone who's actually worked with glycerin), and throw it into childrens medicine. Frankly, the simplest explanation is that the sellers and buyers know what's going on, but just hope that no-one will die, but if they do, hopefully no-one will tie it to the tainted product, but if they do, it was the other guys fault, it was a mis-labeling problem, it was a translation error, well you see, what happened, it's a funny story... It's crap. It should be stamped on, and the people responsible should be chewed to pieces. For that to happen, there has to be someone with teeth to do the chewing, for better or for worse, in the US, that's the FDA.
WTF?!?!?
I don't 'get it'.
What is your point?
Really, I just don't 'get it'.
Be more succinct, or state your arguments in an more understandable format, please.
Really, I don't understand your point.(call me stupid, or dense, but I really don't 'get it')
P.S. Not meant to be 'flame' or 'troll', but I truly don't get where you are coming from in lieu of the original discussion.
Down With Slashdot BETA!!! I've been around the corner and seen the oliphant; you can only abuse me from your perspecti
The FDA doesn't hold sway everywhere.
. . . first look at regulating tobacco (FDA) as a drug? Or go after Smilin' Bob again (FTC)? Or deal with creationism (SCOTUS)? Or real campaign finance reform (Congress)? Or find out WTF Konstantin F. was thinking?
Just sayin' . . .
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.
Perhaps scientists are also trying to avoid the negative connotations of the words "animal experimentation" out of fear for having their labs destroyed, houses firebombed, or so on. I don't know if that alone would stop the sort of people who commit those kinds of crimes, but it might just garner public sympathy (or at least stop propagating the negative images of researchers who use animals).
...Americans that can afford it just go to Brazil or India or Israel or ??? for a "medical vacation" and come back with dollars spent in other countries. Everything that is regulated out of ignorance and/or greed is still available - the drug companies are multi-nationals that are just getting paid in a different currency. Or, maybe I am just too cynical.
http://nwbagpipes.com/
After all, we don't want to have doctors developing new treatments. That's what goveernment bureaucrats are best at.
[my emphasis]
Mod's: Give +1 for 'tongue-in-cheek-funny' responses...and hope the 'parent' was trying for +1'funny', if not, then 'Epic Fail!'
Get off of the fence, and say what you mean to say. Why be obtuse?
Down With Slashdot BETA!!! I've been around the corner and seen the oliphant; you can only abuse me from your perspecti
"aving inspectors who will check up on whether the bottle of pills you've bought is in fact the drug it's sold as and not just gel caps full of chalk, and punish anyone committing fraud, might be worthwhile"
add truth in advertising requirements to that and truth in risk evaluations and requirements that risk / benefit publications are available and truthful
(then prohibit lawsuits from folks who signed a release that was truthful in this regard) oh wait that would make sense
For the most part you are correct.. but it is flawed, otherwise you wouldn't have all these class action lawsuits from people damaged or dying from drugs that went through the testing process... and then there are things like the aspertain controversy... Things are also failing in the system, when food is imported.. What is your trust level of buying food imported from China and sold at the Dollar store ? .. people actually buy this stuff, even after poisoned pets, and hearing about poisoned milk.
waiting for ad.doubleclick.net
The FDA started out with a good mandate: make sure that what sellers are selling is actually what they claim to be selling.
If the seller says it's 100% disease-free milk, then that's what it should be - not watered down milk or from a diseased cow. And so on.
I know a man who had inherited a severe form of heart disease. All the males in his family died in their 40s, and he was getting close - he could barely stand the exertion of standing up. Then he was one of a handful of people who got some experimental gene therapy - and his health was pretty much restored.
That was about ten years ago.
His son is in his thirties now.
The question is, will the gene therapy that saved his father be legal in time to save him?
How many needless deaths will there be before it is legal?
If the FDA wanted to restrict such therapies only to patients who are deemed extremely likely to die within the next five years, that would be reasonable enough while they tested these drugs. If the FDA let doctors and patients make choices about what risks they were willing to take, but made sure that patients and doctors were fully informed as best as possible as to the potential risks of untested medicines - that would be reasonable too.
But, no, the FDA wants to cover their collective ass, and they know that no one pays attention to people who die for lack of access to new drugs, while they do pay attention to "failures" of the regulatory system - so the FDA outlaws new medicines that might save hundreds of thousands of terminal patients each year, on the grounds that these medicines might harm these dying patients.
It's not insane. It's politics.
There have been many times I have been tempted to mark you as 'foe' on /.
I have refrained strictly because of a few 'similar posts' of yours[similar as to this one].
I realise that it probably does not matter to you in the least whether I mark you as friend or foe.
The only reason/s I even bring this up is this/these:
My objection is not to that position; but to the special pleading with which TFS and TFA are laced. "I think that the FDA is wrong/illegal/unethical" is a perfectly coherent and respectable position. "I think that my area of interest should be excluded from FDA oversight because OMG even your own stem cells!!!" is just specious.
I agree 100% with that, but I feel you are 'cherry-picking' and 'twisting/spinning' to suit your point of view.
Okay, trash all of that above! I have reviewed, revised, and have rewritten my opinion and reply....
I mis-understood, and 'knee-jerked' the above reply. The reason I left it 'as is' was to allow you to see my faulty thought-progression/deductive reasoning failure. I consider it a learning experience, and I post this as 'F/OSS'.
I am pretty sure this paragraph is what sparked my 'knee-jerk'. I have read it, and re-read it, and I am still wanting to :
1. "Proclaim: Amen, Brother!"
2. "Down with the Man! Up with Freedom!" (note: please tone down the 'hippie' quotient here, as I am not one)
3. WTF?
4. I don't get it, but I don't think I agree
5. You are nuts!
I am feeling a 'complete disconnect' here, so I will respectfully ask for some clarity.
I do not have a problem with:
cloning,
genetics,
research with DNA,
stem cell research(adult, or embryo)
cyberpunk[with a 'grain of salt']
Just stated to give you some parameters to define my query. (note:I have been drinking, so I may be verbose!)
Vindication, Verification, Validation, or hit with a 'clue bat', I'm not sure what I'm heading for here. :-)
Down With Slashdot BETA!!! I've been around the corner and seen the oliphant; you can only abuse me from your perspecti
Dude!...Get a 'Second Life(tm)!
Won't someone think of the 'furries'?!?
*note: if this did not allow me to be mod'ed +***, and be a 'karma whore', I would not even be aware of 'Second Life'!*
Down With Slashdot BETA!!! I've been around the corner and seen the oliphant; you can only abuse me from your perspecti
I'll take the English Language for $200, Alex ...
"What do you do when you have constipation from watching too much politics on TV ?"
No shit?
Fuck systemd. Fuck Redhat. Fuck Soylent, too. Wait, scratch the last one.
In animal models, they routinely cure diabetes.
I have a question that I would like as many to answer as possible. If the world was infected by a virus and slowly dying while I was the only one in the world with the vaccine that prevents this. Would you say that I'm a murderer if I don't provide people with this vaccine?
I'm asking because religion, but mostly christianity in this case, has prevented millions and millions of people from surviving such diseases. Everyday there's a breakthrough with stem cell research, which is not so difficult to understand as they're the founding bricks of our bodies and thus you can rebuild anything, and everyday christians make us believe that it's actually justified to not use medication because it's not the way "God" wanted. My guess is you answered yes on my first question. So how is this different? How can we tolerate that people "believe" and because of their "belief" others must die. Mothers, fathers, children die in vain because people "believe". Now you might argue that not all christians think this way and that I'm flamebaiting. Fair enough, but remember that the justification for this lies within christianity (remember, "God" didn't want this), so I don't see how it wouldn't be fair to blame christianity. I don't see how it's fair that my children, or your parents or our friends should die because diluted people are believed to be sane.
I am the lawn!
How useful are cultured stem cells? In animal models, they routinely cure diabetes.
Don't get taken in by this sort of statement - there is a lot of things that are routinely done in animal models, which can't just be transferred to humans. One thing about mice with diabetes, that get cured, is that they don't live a normal life for 60 years after that; they are euthanised so you can study their tissues etc. Another thing is that an animal model is only a model - ie. something that is sufficiently similar to conduct your tests on. There is no guarantee that the form of diabetes or Alzheimers or whatever they have is actually very like what humans get.
Finally, diabetes - at least type 1, which is what they cure with stemcells, is the result of an autoimmune disorder. It is all very well to be able to reintroduce insulin producing cells, but if the autoimmune disorder is still there, those new cells will get killed in a matter of weeks or months; and it is not yet understood if that process in itself is damaging to the body, quite apart from the damage to the insulin producing cells. In a mouse model you don't have that problem, because you can selectively kill off its insulin producing cells, causing diabetes, which you then cure by reintroducing the cells.
Back when the FDA was founded, you bought a bottle of aspirin, and you knew exactly what it would do to you, so long as aspirin was in there. Truth be told, though, you weren't shopping "for aspirin", you were shopping for "fix my headache and/or fever", and aspirin happens to do that very well, as everybody and their dog knows. If you go out and shop for "fix my headache and/or fever" these days, you've got a wide world of pharma to choose from. Does oxypoxyboogywoogy do it? Does ibbyfibbywibblywobbly do it? You don't have a fucking clue. Even if they're 100% pure and correctly dosed, for all you know, they'll just make you shit yourself. Mandatory testing means that there's a chance in hell the drug will actually do what it says on the box, which is much more important to the consumer than what molecules are actually in there.
No kidding!!! What do you say at this point?
Par for the course.
You young whippersnappers have no generational achievements to claim, so you started renaming and re-categorising everything to make your mark.
That's why 'we' spell words with 'z' in place of the traditional 's', Web 2.0, "Cloud Computing", 'leveraging the synergy of value-added and feature rich applications of *pukes* blah blah blah(more 'marketdroidspeak'...LOL!)
So you are surprised that 'lab rat' was changed to the more 'politically correct' label of 'animal models'? Hah! That's pretty funny!
Oops, excuse me, I meant: LOL!!!ROFLCOPTER!!111!!!
*sigh*
n00bs!...Now get off my lawn!
Down With Slashdot BETA!!! I've been around the corner and seen the oliphant; you can only abuse me from your perspecti
Hah!HahHahHeeHeeHooHooHaaHowwwoww!!!
Down With Slashdot BETA!!! I've been around the corner and seen the oliphant; you can only abuse me from your perspecti
I think the notion was that at some point there is a level of effort in testing that should count as due diligence. That any side effects found in the future after that amount of testing should be treated as unfortunate accidents and not cause for litigation. If the FDA isn't implying that this sufficient level of testing has been done by signing off, what is it implying? If it is implying that, it should be solely culpable for the subsequent side effects as the company believed in good faith it had done due diligence. Unless of course it bribed the FDA directly or indirectly, which wouldn't surprise me either. Or falsified test results, which wouldn't raise my eyebrows even a little.
That said, if I want to do something stupid to myself, I should be able to buy "dietary supplements" made from my own stem cells and inject them wherever I please.
refactor the law, its bloated, confusing and unmaintainable.
Morality vs. business -- which isn't that unusual a juxtaposition.
The FDA can't even tell the cosmetic industry to stop including toxic ingredients in their products (like lead, formaldehyde, 1,4-dioxane, etc)
How this intelligent gentlemen gets to this conclusion gets me a bit confused...
Every new therapy requires clinical trials, there is no reason why stem cells should be dealt with differently. FDA approval is the result of a benefit/risk assessment process based on clinical data.
So the FDA will regulate stem cells naturally occurring within a human body? Does this mean that the gestational period will be regulated to 20 years from the natural 9 months that it is today?
Can we get beyond some of the nonsense and move toward making things better for mankind? Please?
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.
Da Blog
+1 writer makes sense
i don't see a plan to thwart anything here, just a good old fashioned fiefdom territory grab. Stem cells are an attractive avenue, therefore gov managers want to be associated with the success. its good for the career.
"If still these truths be held to be
Self evident."
-Edna St. Vincent Millay
It is hypothesized that many cancers start in tissues with lots of stem cells and perhaps from the stem cells themselves, e.g. colon lining, skin, bone marrow. So one wants to be very careful using therapies based on re-programmed stem cells. Do the research and clinical testing carefully beforehand.
developing new treatments that actually work is extremely hard, and costs a lot, and the incentives to cheat, either concsiously or unconsciouly, are huge. /., to agree that lack of regulation was part of the problem;
Take the case of the mortgage debacle: I would bet that you could get a majority of people , even people on
The same thing is true about medicine: we have the FDA because of the bad activities of for profit companies; someone has to referee them - they can't be trusted to do it themselves would you really trust some large, for profit company saying that this new pill had no side effects ? Thalidomide, anyone ?
The problem is finding the right balance
Beyond that, as a PhD,it is my opinion that this whole stem cell thing is WAY overhyped - what we should be doing, at this stage of our knowledge, is looking at a lot of different options, rather then focusing on stem cells.
The technical barriers to successfull use of stem cells - many of which have been mentioned - are huge.
For instance, if you inject someone with a few thousand cells that have been grown in the lab, how do you know that one (1) of those cells has not mutated, so that it is an aggressive tumor that will kill you in 5 years ?
In theory, theory and practice are the same; in practice they ain't
the only way you will know in the real world is to inject 1,000 people and see what happens in 5 years.
You could say, I'm dying of cancer today, do what you will. The trouble with that is it opens the doors to charlatans who take advantage of desperate people - all sorts of "companies" with "doctors" and "scientists" will appear, if thereis no FDA regulation, and many of these companies will offer products taht are worse then useless.
FDA regulation may not be good, but it is better then any of the alternatives
In animal models - "miracle cure"
There's lots of cures for lots of diseases that worked well in animal models but failed in people. There was actually a rather bleak failure of a round of hopeful treatments / vaccines for HIV that did well in animal models but flamed out on human subjects. That is why the FDA goes slow.
This is my sig.
Sure, but that's just like saying "I should be able to get a option-alt-a loan from my mortgage broker friend and buy whatever overpriced piece of junk house wherever I please including a mississippi river flood zone".
Sure, I would agree if you sign a waver for any taxpayer subsidized medical treatment and to reimburse collateral damage the lawsuit causes to medical insurance rates (or to waive any medical coverage for any conditions that arise from injecting said stem cells)...
Not saying we need a full-up nanny state, but some stupid actions have the potential to cause enough harm to the commons that as a society, it benefits us to restrict them in some way for the greater good. Forcing everyone else to take a protective/defensive step can sometimes be more expensive than prohibiting/punishing stupid actions. Of course it's possible to overreact and prohibit/punish some stupid actions that don't really cause great harm to the commons, but that's a question of values and judgement.
Fetal stem cells, on the other hand, are as close to pristine genetic condition as is possible.
That's true, but foetal cells are still subjected to a lot of in utero imprinting and differential methylation. And of course, the original egg cell still receives a random assortment of differentially functional maternal mitochondrial organelles.
You probably know that a great deal of in vivo processing is expended to sequester and effectively immobilise and constrain the expression of stem cells and germ cells within the developing foetus. To repeat my earlier argument, removing those cells from that milieu and subjecting them to stresses very far removed from any environmental inputs previously determined for which genetic and epigenetic responses have been encoded by natural selection creates a situation in which any developmental predictions or risk/benefit calculations are problematic. I think that is why a lot more science and research and planning is anticipated before going ahead with large-scale human therapeutic interventions using these cells.
Up until the closing decades of the 20th century medicine basically just went for it, and while this produced a lot of good results, there were also a few very bad outcomes. Modern medicine is more evidence-based. For many large-scale interventions, this can be slower to deploy but over the past couple of decades we have already seen this approach overturn some decades-old beliefs and accepted practices. Some therapies that seemed to make perfect sense upon first glance and analysis have been proven to be either a wash or even to increase mortality. Had these therapies been subjected to longer experimental and analyses stages, their drawbacks might have been caught sooner.
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Fetal stem cells, on the other hand, are as close to pristine genetic condition as is possible.
I guess I forgot to add to my earlier comment that many people assume that embryonic and youthful cells are "pristine" and so devoid of problems. The relative prevalence of blastocytic tumours and leukemias within embryos, newborns, and children argues otherwise.
Da Blog
The problem with the FDA comes from the legal definition of what a drug is. To quote an FDA website on the definition of a drug: The FD&C Act defines drugs, in part, by their intended use, as "articles intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease" and "articles (other than food) intended to affect the structure or any function of the body of man or other animals" [FD&C Act, sec. 201(g)(1)]. This has some rather unfortunately consequences (besides the potential regulation of stem cells). It is why you will never see "nutritional supplements" marketed as having any specific effect on your health. And yet most of us know that vitamin C cures scurvy. I have seen a copy of a notice from the FDA warning a juice company to remove health claims because they would classify the juice as a drug. Compounding this problem is the usual ones of human nature -- the desires of members of the FDA to expand the size and power of their organization. While TFA may imply a conspiracy with big-pharma, you have to admit, the definition of a drug is rather convenient to the pharmaceutical industry and discourages the development of alternative approaches to 'popping a pill'.
Given the brain damaged laws, regulations, etc. being passed in the US recently, that appear to simply stifle innovation, business, energy independance, the dollar, one has to wonder if the government(s) are secretly under the control of forces inimical to the United States. Pod people couldn't do more harm. The US appears to be circling the wagons, and then shooting inwards.
Ya know, for the last 15 years I've been preaching that the FDA may be the far biggest killer last century. By delaying medical tech by "only" 10%, they have caused, because of lower quality of tech, more continued death and misery than they have prevented. Throw in price control via socialized medicine, and the situation could be even worse. Only 30% behind where you'd otherwise be? If you're lucky.
Skip the likelihood of such changes for the moment, but just consider the math. Would you like "free" 1979 medical care today, or "expensive" 2009 medical care? If you think the former, guess again. You just took the head of the line as the greatest mass murderer last century, surpassing Hitler and Stalin.
I fully expect to be downmodded as flamebait since this crushes cherished beliefs, the way an atheist crushes a religious person's groove by pointing out that God loves to let babies be raped to death for some reason.
(-1: Post disagrees with my already-settled worldview) is not a valid mod option.
... we should actually do the research to find out whether they're true, and not just reject these hypotheses out of hand because we'd prefer not to believe them.
That's right let's make those crazy atheist scientists work hard to modify our DNA. That way we can avoid the mistakes of the past and stave off the zombie hoards. Instead human race can die at the tread heels of our cyborg masters.