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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 =(
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.
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.
'In animal models, they routinely cure diabetes.'
That's great for models, but what about ugly people? Don't we get a cure?
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.
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.
TFA doesn't actually say either way; but I'd overwhelmingly assume the former. Consider donor blood use and organ donations. Those were once experimental, are now routine, and they clearly don't run "Will the late Mr. X's liver work in Mr. Y, a randomized, controlled, 5 year study" every time somebody takes a flying leap off their donorcycle.
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."
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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"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.
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.
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.
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.
http://en.wikipedia.org/wiki/Gunboat_diplomacy
The idea that in the age of intellectual property, if your not inline with the US gov policy, you will be given a demonstration of US might.
Fined into bankruptcy.
The DIA and CIA where hints at the long deep connections with Big Pharma.
No upstart is going to win the race to the next generation of medical treatments.
If the USA cannot or will not invest in basic science, move to a part of the world where 'biology' is not a dirty word.
Domestic spying is now "Benign Information Gathering"
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.
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
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