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[FightAging] FDA Reaches to Regulate (i.e. Block) Simple Stem Cell Therapies


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#31 sthira

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Posted 06 December 2012 - 03:32 AM

The purpose of the FDA these days is not to protect American citizens but to protect the profits of companies.


"FDA is concerned that the hope that patients have for cures not yet available may leave them vulnerable to unscrupulous providers of stem cell treatments that are illegal and potentially harmful.

"FDA cautions consumers to make sure that any stem cell treatment they are considering has been approved by FDA or is being studied under a clinical investigation that has been submitted to and allowed to proceed by FDA.

"FDA has approved only one stem cell product, Hemacord, a cord blood-derived product manufactured by the New York Blood Center and used for specified indications in patients with disorders affecting the body’s blood-forming system.

"FDA regulates stem cells in the U.S. to ensure that they are safe and effective for their intended use."

http://www.fda.gov/f...s/ucm286155.htm




#32 Turnbuckle

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Posted 07 December 2012 - 04:26 PM

Here is a letter sent by FDA staff to the President complaining about corruption in the agency.


The purpose of this letter is to draw your attention to the frustration and outrage that FDA physicians
and scientists, public advocacy groups, the press, and the American people, have repeatedly
expressed over the misdeeds of FDA officials. Recent press reports revealed extensive evidence of
serious wrongdoing by Dr. Andrew von Eschenbach, Dr. Frank M. Torti, top FDA attorneys, Center
and Office Directors, and many others in prominent positions of authority at FDA. As a result, Dr.
Frank M. Torti, Acting Commissioner and the FDA’s first Chief Scientist, abruptly left the Agency.
But, the many other FDA managers who have failed to protect the American public, who have
violated laws, rules, and regulations, who have suppressed or altered scientific or technological
findings and conclusions, who have abused their power and authority, and who have engaged in
illegal retaliation against those who speak out, have not been held accountable and remain in place.



It goes on for 4 pages.

#33 sthira

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Posted 07 December 2012 - 06:11 PM

Here is a letter-to-the-president...


Meanwhile, good people at FDA go on and on trying to protect you from yourself. Regarding the current thread topic, stem cell therapy, for example, FDA advises consumers:

"While stem cell therapies theoretically have potential promise, their use also raises a number of safety concerns including: the ability of the cells to migrate from the site of administration and differentiate (or change) into inappropriate cell types; excessive cell growth; and the development of tumors. These safety concerns must be addressed as part of the risk/benefit evaluation of these products."

http://www.fda.gov/N...s/ucm286218.htm




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#34 Turnbuckle

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Posted 07 December 2012 - 06:24 PM

Meanwhile, good people at FDA go on and on trying to protect you from yourself.


Thanks but no thanks. I don't need big brother to police my cells.

#35 sthira

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Posted 07 December 2012 - 06:47 PM

Thanks but no thanks. I don't need big brother to police my cells.


Yes you do, and so do the rest of us innocent consumers.
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#36 niner

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Posted 08 December 2012 - 02:12 PM

The problem with allowing people to injure themselves is that the costs of that injury are rarely borne entirely by that person. The costs are often borne by all of us, which is the general problem with the Libertarian version of "Freedom". I'd love for smart guys like Turnbuckle to be able to experiment on themselves even more than is already the case, but I don't want to pick up the tab because some corrupt or (more likely) incompetent supplement maker tries to make a quick buck and injures a bunch of people.

#37 Turnbuckle

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Posted 08 December 2012 - 03:23 PM

The problem with allowing people to injure themselves is that the costs of that injury are rarely borne entirely by that person. The costs are often borne by all of us, which is the general problem with the Libertarian version of "Freedom". I'd love for smart guys like Turnbuckle to be able to experiment on themselves even more than is already the case, but I don't want to pick up the tab because some corrupt or (more likely) incompetent supplement maker tries to make a quick buck and injures a bunch of people.


This is an argument for a totalitarian state, but it misses the point being argued, that the watchdog itself is corrupt and is passing through dangerous drugs to make a buck.
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#38 niner

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Posted 10 December 2012 - 04:10 AM

The problem with allowing people to injure themselves is that the costs of that injury are rarely borne entirely by that person. The costs are often borne by all of us, which is the general problem with the Libertarian version of "Freedom". I'd love for smart guys like Turnbuckle to be able to experiment on themselves even more than is already the case, but I don't want to pick up the tab because some corrupt or (more likely) incompetent supplement maker tries to make a quick buck and injures a bunch of people.


This is an argument for a totalitarian state, but it misses the point being argued, that the watchdog itself is corrupt and is passing through dangerous drugs to make a buck.


No it's not. It's an argument for a Free Market world where everyone is responsible for their own actions. That means they don't get to offload the cost of their bad decisions on the rest of us. Which means that unless we are willing to let them die when they get sick, then we have to prevent them from harming themselves. I'd be fine with letting them die, as long as doing so didn't harm a bunch of other people, but it usually doesn't work that way. Basically, it comes down to where you want to be on a continuum between letting one person do anything they want, to the other extreme of preventing that person from causing any harm whatsoever to others. Most people put a pretty high premium on not being harmed by others. We've tried to craft a world where there's a low likelihood of being harmed by others, while still having reasonable personal freedoms, because that seems to be what the majority of people want. It isn't simple, and involves shades of grey rather than foundational documents that fit on bumper stickers. I pointed out above that if the watchdog is corrupt, then we should fix that, not throw away the watchdog. Here, I'm addressing a different aspect of the problem.

#39 Turnbuckle

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Posted 10 December 2012 - 11:49 AM

The problem with allowing people to injure themselves is that the costs of that injury are rarely borne entirely by that person. The costs are often borne by all of us, which is the general problem with the Libertarian version of "Freedom". I'd love for smart guys like Turnbuckle to be able to experiment on themselves even more than is already the case, but I don't want to pick up the tab because some corrupt or (more likely) incompetent supplement maker tries to make a quick buck and injures a bunch of people.


This is an argument for a totalitarian state, but it misses the point being argued, that the watchdog itself is corrupt and is passing through dangerous drugs to make a buck.


No it's not. It's an argument for a Free Market world where everyone is responsible for their own actions. That means they don't get to offload the cost of their bad decisions on the rest of us. Which means that unless we are willing to let them die when they get sick, then we have to prevent them from harming themselves. I'd be fine with letting them die, as long as doing so didn't harm a bunch of other people, but it usually doesn't work that way. Basically, it comes down to where you want to be on a continuum between letting one person do anything they want, to the other extreme of preventing that person from causing any harm whatsoever to others. Most people put a pretty high premium on not being harmed by others. We've tried to craft a world where there's a low likelihood of being harmed by others, while still having reasonable personal freedoms, because that seems to be what the majority of people want. It isn't simple, and involves shades of grey rather than foundational documents that fit on bumper stickers. I pointed out above that if the watchdog is corrupt, then we should fix that, not throw away the watchdog. Here, I'm addressing a different aspect of the problem.


You're mixing things up. It isn't a free market world when other people have to pay for your actions. What you're saying seems to be that if you have insurance, either governmental or private, or even charitable (and thus your costs are spread to other people) then you no longer have freedom of action because your choices could cost other people. You shouldn't be allowed to smoke or drink or eat anything that might cause disease or experiment with C60 because the effects of untested chemicals might be bad. Your thinking is a rationalization for big brother and totalitarianism, not freedom.
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#40 sthira

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Posted 10 December 2012 - 01:34 PM

We're trying to live in a sane society; we're interdependent; our actions affect others whether we like it or not. You may think taking c60-olive oil mixtures is smart and maybe this unstudied chemistry will help cure your ailments. But what happens if the unforeseen strikes you down, and suddenly that experiment goes wrong and you're gasping for life? You'll dial 911, and then a load of government and private assistance will try its best to help you -- whether you want that safety or not. We're trying to live in a sane society. Glibly tossing around emotive words like "totalitarian" and "dictatorship" is unhelpful.
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#41 Turnbuckle

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Posted 10 December 2012 - 03:31 PM

We're trying to live in a sane society; we're interdependent; our actions affect others whether we like it or not. You may think taking c60-olive oil mixtures is smart and maybe this unstudied chemistry will help cure your ailments. But what happens if the unforeseen strikes you down, and suddenly that experiment goes wrong and you're gasping for life? You'll dial 911, and then a load of government and private assistance will try its best to help you -- whether you want that safety or not. We're trying to live in a sane society. Glibly tossing around emotive words like "totalitarian" and "dictatorship" is unhelpful.


I'm not being glib, this is how freedoms are lost. But anyway, ask yourself, in a world where everyone dies and most of health care goes to keeping people alive during their last few weeks, what economic difference does it make if I die of lung cancer at 60 or natural causes at 100? In fact, the cost to our social systems may be less by my dying at 60 since there will be no social security payout. So the "sane society" argument is flawed at its core. (And the phrase "sane society" is just as emotive as totalitarian.)

Edited by Turnbuckle, 10 December 2012 - 03:32 PM.

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#42 Mind

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Posted 14 January 2013 - 10:15 PM

Good to see someone else ragging on the establishment and the FDA.

James Watson, co-discoverer of the double helix structure of DNA, lit into targets large and small. On government officials who oversee cancer research, he wrote in a paper published on Tuesday in the journal Open Biology, "We now have no general of influence, much less power ... leading our country's War on Cancer."
On the $100 million U.S. project to determine the DNA changes that drive nine forms of cancer: It is "not likely to produce the truly breakthrough drugs that we now so desperately need," Watson argued. On the idea that antioxidants such as those in colorful berries fight cancer: "The time has come to seriously ask whether antioxidant use much more likely causes than prevents cancer."



#43 niner

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Posted 14 January 2013 - 10:37 PM

And the phrase "sane society" is just as emotive as totalitarian.


Seriously? As in "I'll fight to the death so my children won't have to live in a sane society!" ??

#44 Turnbuckle

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Posted 14 January 2013 - 11:31 PM

And the phrase "sane society" is just as emotive as totalitarian.


Seriously? As in "I'll fight to the death so my children won't have to live in a sane society!" ??

Your example is so far off that I can't believe you seriously posted it. But if it isn't a joke, sthira was implying that if you don't agree with his claim that you shouldn't take care of yourself but wait for the government to declare whatever you want to take as safe, then you are not interested in living in a "sane society." This is of course ludicrous and borderline hysterical, and you could extend his argument with no trouble at all to give government total control over everything we do--totalitarianism. In any case, the word sthira used--emotive--doesn't have anything to do with the meaning of the words, only the tendency of the words to evoke emotions.

Edited by Turnbuckle, 14 January 2013 - 11:50 PM.


#45 niner

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Posted 15 January 2013 - 01:33 AM

And the phrase "sane society" is just as emotive as totalitarian.


Seriously? As in "I'll fight to the death so my children won't have to live in a sane society!" ??

Your example is so far off that I can't believe you seriously posted it. But if it isn't a joke, sthira was implying that if you don't agree with his claim that you shouldn't take care of yourself but wait for the government to declare whatever you want to take as safe, then you are not interested in living in a "sane society." This is of course ludicrous and borderline hysterical, and you could extend his argument with no trouble at all to give government total control over everything we do--totalitarianism. In any case, the word sthira used--emotive--doesn't have anything to do with the meaning of the words, only the tendency of the words to evoke emotions.


He didn't say we shouldn't take care of ourselves. He was trying to point out that you live in a society; there's a safety net there, and you benefit from it (in terms of risk reduction) whether or not you think it's a good idea for it to exist. I see no claim (maybe I missed it) that we should not take care of ourselves and wait around for the government to help us. I think maybe the implication of the term "sane society" was that it would be insane to live in some sort of every man for himself libertarian free-for-all. I don't think that's exactly what you're arguing for though. Isn't all of this getting pretty far afield of whether or not the FDA should exist, or whatever the heck this thread is about?

Edited by niner, 15 January 2013 - 01:34 AM.


#46 Turnbuckle

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Posted 15 January 2013 - 01:51 AM

And the phrase "sane society" is just as emotive as totalitarian.


Seriously? As in "I'll fight to the death so my children won't have to live in a sane society!" ??

Your example is so far off that I can't believe you seriously posted it. But if it isn't a joke, sthira was implying that if you don't agree with his claim that you shouldn't take care of yourself but wait for the government to declare whatever you want to take as safe, then you are not interested in living in a "sane society." This is of course ludicrous and borderline hysterical, and you could extend his argument with no trouble at all to give government total control over everything we do--totalitarianism. In any case, the word sthira used--emotive--doesn't have anything to do with the meaning of the words, only the tendency of the words to evoke emotions.


He didn't say we shouldn't take care of ourselves. He was trying to point out that you live in a society; there's a safety net there, and you benefit from it (in terms of risk reduction) whether or not you think it's a good idea for it to exist. I see no claim (maybe I missed it) that we should not take care of ourselves and wait around for the government to help us. I think maybe the implication of the term "sane society" was that it would be insane to live in some sort of every man for himself libertarian free-for-all. I don't think that's exactly what you're arguing for though. Isn't all of this getting pretty far afield of whether or not the FDA should exist, or whatever the heck this thread is about?

He implied that we shouldn't take C60 until the government approved, because it could cost society as a whole. You can easily make the same argument about sports--since society has to support those who are injured--about smoking, drinking, staying up all night, or living in any way that is statistically more dangerous than the norm. This does not make for sanity or a sane society. It makes for an insane society, a soulless society, an unfree, insect society. It is completely un-American, but unfortunately, it is where we are headed. In 2005, the Supreme Court gave the federal government total dominion over American citizens under the commerce clause. The FDA will benefit from that ruling and will one day come down hard on the supplement industry. We are living in a unique time when we can get a surprising number of things over the internet, especially compared with other Western nations. I don't see how that can continue. Governments don't leave power on the table for very long. It is possible that the momentum for pot legalization will blunt a resurgence of FDA authority for some years. But it won't last forever.

#47 Mind

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Posted 15 January 2013 - 07:08 PM

It's an argument for a Free Market world where everyone is responsible for their own actions. That means they don't get to offload the cost of their bad decisions on the rest of us.


Believe it or not Niner, there are people who value freedom so much that they will accept the consequences of their actions. They will not go beyond the help of family, friends or private charity. Totalitarians among us are so scared of this concept, of this possibility, that they won't even allow people too live free and accept the consequences. Some people just want to be left alone, but sadly, in the U.S. that is no longer allowed. It is all about fear, power, and envy. The "rulers" cannot allow even one person to live free, because it would undermine their power.
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#48 sthira

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Posted 15 January 2013 - 08:19 PM

He implied that we shouldn't take C60 until the government approved, because it could cost society as a whole.


Take all the experimental chemicals you want and call yourself free. But to remain consistent with your position do not call 911 if you get into trouble. Extend that, too, and don't use public roads to reach your government supported private hospital, either. Stay free, and stop using the 9,000 other benefits of the federal, state, and local governments you take for granted.

#49 Turnbuckle

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Posted 15 January 2013 - 08:34 PM

He implied that we shouldn't take C60 until the government approved, because it could cost society as a whole.


Take all the experimental chemicals you want and call yourself free. But to remain consistent with your position do not call 911 if you get into trouble. Extend that, too, and don't use public roads to reach your government supported private hospital, either. Stay free, and stop using the 9,000 other benefits of the federal, state, and local governments you take for granted.

I'm not to use public roads or emergency services that I paid for unless I agree to give up all my rights and become a slave of the sate, eh? Great. First I'm forced to pay for things and then I find out that I've lost my freedom along with my money.

#50 sthira

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Posted 15 January 2013 - 08:41 PM

I'm not to use public roads or emergency services that I paid for unless I agree to give up all my rights and become a slave of the sate, eh? Great. First I'm forced to pay for things and then I find out that I've lost my freedom along with my money.


No one is asking you to give up your rights and become a slave of the state.
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#51 Turnbuckle

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Posted 15 January 2013 - 08:41 PM

I'm not to use public roads or emergency services that I paid for unless I agree to give up all my rights and become a slave of the sate, eh? Great. First I'm forced to pay for things and then I find out that I've lost my freedom along with my money.


No one is asking you to give up your rights and become a slave of the state.

What is your political stance. Are you a communist?
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#52 sthira

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Posted 15 January 2013 - 09:13 PM

What is your political stance. Are you a communist?


Thanks for asking. I tend to vote for democrats, but not always. I've also supported republicans, independents, libertarians, and green party candidates. How is my political stance relevant in this thread?

#53 Turnbuckle

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Posted 15 January 2013 - 09:16 PM

What is your political stance. Are you a communist?


Thanks for asking. I tend to vote for democrats, but not always. I've also supported republicans, independents, libertarians, and green party candidates. How is my political stance relevant in this thread?

Because your collectivist thinking could be right out of Pyongyang.
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#54 Turnbuckle

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Posted 16 January 2013 - 01:08 PM

Getting back to the issue raised in the OP, at least our pets can benifit, even if the FDA has restricted stem cell therapy for us mere citizens--

Mikey, a full-blood German shepherd, is up and running again, taking the stairs and trying to sprint along side his companion Gunnar, a narcotics-sniffing work dog of the same breed.

Before late November, Mikey was hobbling along with “the most progressive hip dysplasia I’ve seen in 13 years,” said Dr. Michael Herman, a veterinarian who owns South Charlotte Animal Hospital in Pineville. “His X-rays were just horrific, showing bone against bone.”...

“I normally take about two tablespoons of fat from either the shoulder area of the animal or the abdomen and within that fat is five to 50 times the amount of stem cells than what we can get from bone marrow,” he said.

Herman ...has offered the costly FDA-approved procedure for animals for more than a year. A typical stem cell treatment costs about $2,000. It is only offered by his office for pets with osteoarthritis, fractures and ligament and tendon injuries.

http://www.charlotte...-stem-cell.html


What is costly and approved for animals ($2,000!) is a dirt cheap but federally prohibited treatment for humans.

Edited by Turnbuckle, 16 January 2013 - 01:10 PM.


#55 david ellis

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Posted 19 January 2013 - 08:43 PM

Something is really wrong when concentrating my own stem cells is in the way of simply getting a little more fat under my metatarsals. My future includes a wheelchair if this doesn't change soon.

#56 niner

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Posted 19 January 2013 - 09:07 PM

It's an argument for a Free Market world where everyone is responsible for their own actions. That means they don't get to offload the cost of their bad decisions on the rest of us.


Believe it or not Niner, there are people who value freedom so much that they will accept the consequences of their actions. They will not go beyond the help of family, friends or private charity. Totalitarians among us are so scared of this concept, of this possibility, that they won't even allow people too live free and accept the consequences. Some people just want to be left alone, but sadly, in the U.S. that is no longer allowed. It is all about fear, power, and envy. The "rulers" cannot allow even one person to live free, because it would undermine their power.


I would love it if people would take complete responsibility for their decisions. The fact is, only a handful do, and the vast majority don't. I don't think there's anything "totalitarian" about my not wanting to pay for other people's stupidity. You're making it sound like we already live in North Korea. Meanwhile, I break laws left and right, but I don't (as far as I know) harm others. Oddly enough, the jackbooted thugs haven't knocked my door down as of yet. I pretty much get left alone, aside from the occasional automobile-related interaction with the local gendarmerie. I can usually talk my way out of those.

I do obey the laws of physics...

#57 Link

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Posted 21 January 2013 - 06:26 PM

As a taxpayer, i have a problem with people who wilfully or negligently allow themselves to come to harm and then expect the government to pick up the tab.

However, as a motorcyclist, i would say you can't just go around banning every activity that carries an element of risk to a person's health.

From what i've read on adult stem cells, and considering the fact that the person is already suffering from some disease that likely costs tax payers in some form anyway, current adult stem cell procedures don't carry a particularly significant risk of causing additional harm to the patient. From what i can see, at worst they are merely ineffective

Of course, I'm not an expert in such matters. It would be interesting to see statistics of complications from existing adult stem cell procedures and their cost to society when compared to other personal choice activities like extreme sports or plastic surgery.

My personal feelings are that, as long as an adult stem cell procedure does not make any unverified claim about what it can do for the patient, and the procedure has shown to be safe enough as to at least not cause the person serious harm, then the patient who has all the information and is paying out of their own pocket should be able to make that choice.
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#58 Mind

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Posted 07 April 2013 - 04:37 PM

A similar situation in Italy? http://www.newscient...ll-therapy.html

If the families and patients are aware of the risks, why not let the trial continue?




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