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.'"

Non-Story

[afabbro]

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...

Considering how long

[NotSoHeavyD3]

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.)

OUtrage for everyone!

[spinkham]

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...

Precautionary Principle

[meehawl]

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.

Urm?

[fuzzyfuzzyfungus]

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 [scientificamerican.com].

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.

Re:FTC

[Henry V .009]

Shh! They're both run by the Illuminati.

Re:Non-Story

[Smallpond]

After all, we don't want to have doctors developing new treatments. That's what government bureaucrats are best at.

When one realizes

[WillRobinson]

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.

Re:OUtrage for everyone!

[Brett Buck]

Either we're stupid, or we just enjoy being outraged by stupid stuff, I can't tell which...

      Can't it be both?

      It's just another example of not wanting to accept EITHER the risk, or the delay, because no one can make a fucking decision and stick with it anymore.

        Brett

Stem cell treatments have resulted in cancer

[topham]

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.

Frigging Bureaucracies!

[Jane Q. Public]

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.

Re:So?

[ColdWetDog]

Doctors can write prescriptions for experimental drugs.

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?

Comment removed

[account_deleted]

Comment removed based on user account deletion

Totally offtopic

[rantingkitten]

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.

Re:Non-Story

[rts008]

Yes, and interestingly enough, some researchers see a connection between video games and violence, running Windows and a botnet, and watching violent movies will cause you to go 'postal', and...
Do I have to go on?

Re:When one realizes

[Anonymous Coward]

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.

QFT.

When Big Pharma can begin profiting from curing diseases, then your ailments will be cured. Until then, continue shelling out your money for their allowing you to live for the next 30, 60, or 90 days.
Take solace in knowing that you help to employ thousands of people to research, develop, test, manufacture, advertise, distribute, diagnose, prescribe, prepare, bill and sell the medicine that you could be doing without, had they actually tried to cure rather than treat problems.

Re:Urm?

[fuzzyfuzzyfungus]

Then you would fall under: "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".(which is the "libertarian" half of the analogy)

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.

My point was simply that stem cells, even the patient's own, are subject to legitimate questions of safety and efficacy to at least the same extent as other drugs, and to a greater extent than many. Either no drugs should be under the FDA's purview, or stem cells deserve to be. Either option is a fine position. I just don't like "FDA in general is fine; but stem cells are special for some poorly defined and irrelevant reason".

Looking at the comparisons

[Celeste R]

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?

...Oh wait, this is /. That should go without saying.

Re:When one realizes

[Burdell]

They don't want to cure you, they want to treat you. A cure is a treatment that ends (because duh, you're cured). If you aren't cured, you have to keep going back to the doctor, getting nice expensive prescriptions, month after month, year after year.

Cancer isn't the worst fate.

[esinclair]

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.

Re:FTC != FDA

[evanbd]

Also, kdawson != editor.

But I suppose we already knew that.

Re:Non-Story

[darkmeridian]

And I guess doctors should be allowed to sell whatever treatments they want without any government interference. The Dalkon Shield, thalidomide, etc. should have all been allowed without any government regulation. Yay! Doctor knows best. Government is ineffective and useless, etc.

Re:Non-Story

[Thaelon]

But when you're dying of cancer, what are you going to do if it doesn't work, die?

Re:See you in Thailand, Mexico, or India.

[ultramk]

So, I don't quite get it: Are you not old enough to remember thalidomide, or are you so old that you've forgotten it? Thalidomide was the logical result of the kind of free market you're promoting.

If you think that we as a society are now, or will ever be inclined to accept a certain percentage of flipper-babies as the natural result of the implementation of your anarcho-capitalist ideals, well, you're even more naive than you seem.

Re:OUtrage for everyone!

[AlexMax2742]

The FDA, being the State, is of course blameless.

I know you love shoe-horning in "capitalism good government bad" bullshit in every single one of your posts, but I'm curious as to what exactly the FDA did in your hypothetical situation that you imply was worthy of blame?

Laetrile and health care choices

[Wilson_6500]

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.

Re:Non-Story

[mal3]

I'm particularly not crazy about stem cells being cultivated, and possibly embryos destroyed, for frivolous treatments.

I'm not particularly crazy about you not realizing that this has nothing to do with embryos even though the article summary(not even the article itself), mentions twice that the stem cells don't come from embryos.

Re:Looking at the comparisons

[interkin3tic]

Mutations mean cancer at worst, not the next fictional zombie threat.

Er... I think zombies actually are worse than cancer. Less likely yes, but still worse.

Re:When one realizes

[rts008]

Okay, I've seen this 'mindlessness' echoed down this thread, so I 'went for the head of the serpent', so to speak.
Speaking as someone that has worked in the medical profession, and has close ties to those that still do, I will categorically deny the delusional accusations of your post.

What you accuse all of us for may be true on the 'C*O', PHB level, but I can assure you from the 'Doctor' level and down, that the prevailing attitude is 'take care of the patient to the best of our abilities'. Period.
Yes, there will be exceptions/outliers, but that is true with any profession.

Your blanket assertions and overly broad generalizations do an insulting disservice to the medical community.

I await your apology.

Re:OUtrage for everyone!

[xouumalperxe]

TFA, in all its incredibly biased glory (Dr Centeno this, Dr Centeno that, FDA is in Big Pharma's pocket, stem cells are a panacea, end of article) only implied that the protocol itself would be treated like a drug (requiring their standard for clinical trials), and disingenuously compares stem cell treatments to fertility treatments. 'cause implanting an embryo in an uterus, essentially mimicking a natural process and with a "safe" mechanism for rejection, is exactly the same as using stem cells to produce stuff that has no clear parallel -- or maybe not.

Besides, we're talking about implanting engineered tissues based on highly plastic and division-propensic cells. Really, it barely requires long-term testing. I mean, what could possibly go wrong?

Re:Non-Story

[Anonymous Coward]

"After all, we don't want to have doctors developing new treatments."

I don't. Most doctors are not scientists. Hell, some scientists aren't really ethical scientists, but the medical practice is hardly straight up researchers and followers of the scientific method, probably not even a majority. I find it strange people don't know this or don't want to believe it.

Esp. those doctors in the past, before oversight, were the ones who routinely performed therapies and treatments that maimed and killed patients. I forget the exact quote, but one rather well known story was a surgeon lecturing about how his surgery cured the patients, stating if he hadn't done them on the other half in the test group, they would have suffered.

A student in lecture hall chimed in, "Which half?"

Even today, with heavy oversight, there are still problems. SciAm mentions them in their briefs of scientific research. Last year, during a immunotherapy trial, a patient died and several suffered badly. This is not unusual; you just often don't hear about them because you don't look for them, or you don't look into things when you see hear a clinical trial has failed.

"That's what government bureaucrats are best at."

That government bureaucracy known as the FDA has saved more lives than harmed. The reason the medical field today has safety and efficacy is because of the FDA, NOT because the body of doctors stood up and said they would regulate themselves. Additionally, many of the FDA researchers and those that become bureaucrats are scientists that are careful and understand the implications.

You and others may make fun of the 7 days fictional story all you want, but that is simply the moderators and commentators showing your hate and ignorance of actual history and science, going after an issue because you disagree with it, not because the evidence and concern has been shown one way or the other. After all, there is precedence. Look up diethylstilbestrol DES, a drug given to the mother which caused cancer in their daughters 20 years later.

Diabetes

[meehawl]

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.