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.'"

FTC != FDA

[Anonymous Coward]

Heh.

Re:FTC != FDA

[evanbd (210358)]

Also, kdawson != editor.

But I suppose we already knew that.

Non-Story

[afabbro (33948)]

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...

Re:Non-Story

[Kell Bengal (711123)]

It might be the point of view of one man, but it's not a crazy position to take. I for one would want any medical treatment fully tested and certified, irrespective of if it's made out of 'modified' bits of me. Cancers, if you recall, are actually a part of you gone wrong. If I'm dying of cancer, sure, I'll try damn near /anything/ in my last days. However, if it's something that will be offered as a routine treatment to non-critical patients then it needs to run the full gamut of testing, like every other contender.

Re:

[oldhack (1037484)]

Interestingly enough, some researchers see connection between tumor and stem cells.

Re:Non-Story

[rts008 (812749)]

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:Non-Story

[smegmatic (1145201)]

more specifically, the hypothesis is that cancer is caused by stem cells. http://www.economist.com/science/displayStory.cfm?story_id=12202589 [economist.com] is a decent popular science article.

Re:Non-Story

[interkin3tic (1469267)]

To clarify THAT, one hypothesis is that there are stem cells in tumors. This makes it tough to treat tumors, as the cells you really need to get are the stem cells seeding the tumor, but they tend to be missed by a lot of chemotherapy drugs as they may be slower-dividing, as stem cells may be in other contexts.

There are some cancers that may arise from normal populations of stem cells as well, but no one is saying all cancerous cells came from a population of stem cells. No one is saying all cancers have stem cells keeping them going either.

Note that's all theory, some of it may be outdated, some or all of it may have been disproven. I'm not too up to date, and stem cell biology moves really fast compared to most other fields in bio.

Re:Non-Story

[.orvp (208389)]

Definitely fully tested. I remember one episode of 7 Days involved a cure for cancer having been found, but what they didn't know was that there was a long term side effect to the cure that reared an ugly head 15 years later when it wiped out 80% of the population or something. The cure had looked so promising that they mass produced and distributed the drug to as many people as they could, even if the cancer could have been treated in other means. They did this without the full clinical trial period because it was seen as vital.

Dealing with mutations is always a risky business. While it would be nice personally to not have to die from cancer, or have a relative die, there are safety procedures in place for a reason.

Re:Non-Story

[mellon (7048)]

Yeah, that's almost like that episode of Sliders with the vampires. Or zombies. I forget which. Anyway, yeah, that's a really good reason why we shouldn't ever release any new medicine. It's just too dangerous to humanity as a whole! :')

Looking at the comparisons

[Celeste R (1002377)]

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:

[Thaelon (250687)]

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

Re:Non-Story

[Smallpond (221300)]

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

Re:Non-Story

[fuzzyfuzzyfungus (1223518)]

But we just might want them telling drug companies that, yes, they do actually have to test for safety and efficacy before they start selling the stuff...

The private sector has the virtue of (mostly) being extremely responsive to competitive incentives. This is good when those incentives drive development. This is bad when those incentives drive obfuscation, misdirection, and the burial of inconvenient data. Consider the twisted tale of the "Australasian Journal of Bone and Joint Medicine" [ft.com] an entire sham scientific journal printed to order by Elsevier, for Merck.

Re:

[QuantumG (50515)]

Meh, if you sign a waiver you can pay a doctor to do anything to you.. short of deliberately killing you.. the legality of that varies from state to state.

Re:

[darkmeridian (119044)]

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.

Delayed

[dmomo (256005)]

My stem cells couldn't be any more delayed than they already are. Ohh. Pickles.

Considering how long

[NotSoHeavyD3 (1400425)]

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 (56603)]

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...

Re:OUtrage for everyone!

[Anonymous Coward]

Don't underestimate the ability of average citizens to be both stupid and angry.

Re:

[jmorris42 (1458)]

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

Oh it gets worse. Ok, you are a drug company and you have a promising drug. After jumping through hoops for as long as a decade you finally get FDA approval. You have tested your new drug in various animals, several stages of human trials and the whole bit. The government has finally certified your drug to be safe and effective. So you go on the market. We will ignore the untold human misery that could have

Re:OUtrage for everyone!

[AlexMax2742 (602517)]

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?

due diligence

[nten (709128)]

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.

Re:OUtrage for everyone!

[Brett Buck (811747)]

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

Re:OUtrage for everyone!

[xouumalperxe (815707)]

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?

Precautionary Principle

[meehawl (73285)]

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 (1223518)]

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:

[fuzzyfuzzyfungus (1223518)]

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 b

Animal models...

[Austerity Empowers (669817)]

'In animal models, they routinely cure diabetes.'

That's great for models, but what about ugly people? Don't we get a cure?

Re:

[oldhack (1037484)]

Give me a break. Who cares about ugly people?

Re:Animal models...

[bluefoxlucid (723572)]

Amy Winehouse has a "Love Ugly People" movement going on, on alternate Tuesdays from her "Love Jack Daniels" and "Love Crack-Addicted Cock Whores" forums.

Re:Animal models...

[lena_10326 (1100441)]

That's great for models, but what about ugly people? Don't we get a cure?

You have several cures. Money, beer, and plastic surgery.

When one realizes

[WillRobinson (159226)]

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:When one realizes

[rts008 (812749)]

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:When one realizes

[the_humeister (922869)]

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.

As a physician, let me ask: What are you talking about? What are these diseases that you speak of that can be easily cured with a pill that the pharmaceutical companies don't want to make?

Heart disease is the most common cause of death in this country. Why? Usually, it's because of lifestyle issues: no exercise, eating poorly, smoking, etc.

The most common cancer that kills people? Lung cancer. Want to decrease the risk of lung cancer? Stop smoking.

Stem cell treatments have resulted in cancer

[topham (32406)]

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 (1010737)]

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.

See you in Thailand, Mexico, or India.

[jcr (53032)]

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

Re:

[ultramk (470198)]

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.

Laetrile and health care choices

[Wilson_6500 (896824)]

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.

Totally offtopic

[rantingkitten (938138)]

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:Totally offtopic

[Anonymous Coward]

Those are trade terms...

An animal model is a well characterized and well understood animal, often a very specific line of a given species, used as a model for a disease. You can't know that the results you're seeing are mappable to what would happen in a human if you haven't characterized your model yet. For example, to model a respiratory virus you need an animal that can be infected by it and exhibits similar pathology to humans. Chimps are not a good model for HIV as they don't develop AIDS, as another example.

Animal experimentation would apply to all sorts of things that might not be considered animal models.

Story at 11 ...

[gordguide (307383)]

"FTC could delay Adult Stem Cell Breakthroughs"

In related news, the FDA has decided to intervene in the Janet Jackson Superbowl "Wardrobe Malfunction" litigation.

Cancer isn't the worst fate.

[esinclair (1532509)]

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.

It's all about power.

[jcr (53032)]

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

Re:drats

[nizo (81281)]

Never underestimate zombie Superman.

Re:

[fuzzyfuzzyfungus (1223518)]

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.

Re:Why is this a gov decision?

[jcr (53032)]

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

Re:Why is this a gov decision?

[Anpheus (908711)]

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.

Re:So?

[ColdWetDog (752185)]

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?