57 replies to this topic

[reason]

The FDA seems to be succeeding in the courts with regard to shutting down the few groups in the US trying to offer first generation stem cell therapies, and placing a heavy burden of regulation upon them. This most likely means that for another decade or so the only realistic way to access most of the present variety of stem cell therapies will continue to be medical tourism: "It's official: stem cells are drugs. At least, that's the opinion of the US district court in Washington DC, which has ruled that the Food and Drug Administration (FDA) has the authority to regulate clinics offering controversial stem cell therapies. Treatments in which stem cells are harvested from bone marrow and injected straight back into the same patient are deemed part of routine medical practice - not regulated by the US government. But if the cells are subjected to more than 'minimal manipulation', the FDA maintains that the therapy becomes a 'drug', which must be specifically approved for use. It was on this basis that in 2008 the FDA began moves to shut down Regenerative Sciences, a clinic in Broomfield, Colorado, that treats orthopaedic problems using a stem cell therapy called Regenexx. ... Regenexx consists of mesenchymal stem cells, which give rise to tissues including bone and cartilage, taken from a patient's bone marrow and grown in culture for about two weeks. Centeno has published a series of case reports describing its use to treat joint problems - but no controlled clinical trials. ... Regenerative Sciences challenged the FDA's authority to regulate its activities, setting the stage for a legal fight. In 2010, the FDA sought an injunction to take Regenexx off the market. This has now been granted in the court's ruling. Christopher Centeno, medical director of Regenerative Sciences, vows to appeal. 'This is really round one. Our position remains that a patient's cells are not drugs.'"

Link: http://www.newscient...crack-down.html

<br> <br>View the full article

[mpe]

If the FDA does this to your own cells, how long before they regulate (ban) c60&oo ?

[Turnbuckle]

If stem cells are drugs, so is sperm.

[Logic]

http://www.avaaz.org/en/

This is the most effective way I know of, of fighting this sort of thing.

Edited by Logic, 29 July 2012 - 10:51 AM.

[Florian Xavier]

i hate them so much

[Logic]

So lets start a petition and see what happens!

http://www.avaaz.org...art_a_petition/

Everybody loves to moan about this sort of thing, but when it comes to doing something we all back away!?
This is as easy as some typing and mouse clicking.

Edited by Logic, 30 July 2012 - 08:21 AM.

[Turnbuckle]

So lets start a petition and see what happens!

http://www.avaaz.org...art_a_petition/

Everybody loves to moan about this sort of thing, but when it comes to doing something we all back away!?
This is as easy as some typing and mouse clicking.

A petition does nothing. The federal government is grabbing up more and more power for itself and it isn't going to be stopped by a list of names. If anything, that just saves them the trouble of preparing a list of troublemakers.

[Logic]

Have you looked at the success that Avaaz has had so far Turnbuckle?
http://www.avaaz.org/en/highlights.php

A list of over 15 000 000 troublemakers... Would make me wonder just who it would be that would feel that they were in trouble!?
I think we all underestimate the power of the internet.

[Turnbuckle]

Have you looked at the success that Avaaz has had so far Turnbuckle?
http://www.avaaz.org/en/highlights.php

A list of over 15 000 000 troublemakers... Would make me wonder just who it would be that would feel that they were in trouble!?
I think we all underestimate the power of the internet.

What list of 15 million people?

[Logic]

Check the homepage; top right.
15 358 344 members and counting.

When you start a campaighn here; all those members get emailed.
Check the links posted.

"Avaaz is inspiring… it has already made a significant difference."

–Al Gore


Edit:
15 358 344 went up to 15 358 420 in the time it took to post this............................

Edited by Logic, 30 July 2012 - 12:46 PM.

[Logic]

"In just 3 weeks, over 3 million of us worldwide signed a petition opposing a scandalous bill that would give the US government the right to shut down any website – targeting sites like YouTube, WikiLeaks and even Avaaz!
We worked with other organisations such as DemandProgress, and President Obama’s team responded.
Avaaz organised a 1 hour meeting with top White House officials to deliver the petition.
The White House subsequently condemned the bill and key backers withdrew their support.
As of right now, the Internet censorship bill is dead in the water.
When we started, everyone told us the bill could not be stopped, now it’s been ditched by both parties -- a huge win for internet freedom and for people power!"

http://www.avaaz.org/en/about.php

[Turnbuckle]

I'm going to have to be cynical about this, Logic. Avaaz may have some successes here and there, but the forces of big government just back up a little and try a new approach. The Obama administration would love to kick Wikileaks off the air, but has instead taken a more stealthy approach, drying up its source of funds and going after its leader with secret indictments and false allegations. In the meantime, the WH keeps amassing more power over Americans. With Supreme Court decisions expanding the commerce clause and the taxation clause, the feds have now gained the constitutional power to regulate everything we do and everything we don't do.

[kismet]

A petition does nothing. The federal government is grabbing up more and more power for itself and it isn't going to be stopped by a list of names. If anything, that just saves them the trouble of preparing a list of troublemakers.

That's incorrect -- or a lie. Under Obama there has been an unprecedented drop in government spending; sans money spent on the safety net (or tax cuts to the rich), but that's not an increase in the SIZE of gov.

Also, there are very few stem cell therapies that are proven to do much. It would be unethical NOT to regulate them SOMEHOW, of course, we could and should debate the how, but not the principle.

With Supreme Court decisions expanding the commerce clause and the taxation clause, the feds have now gained the constitutional power to regulate everything we do and everything we don't do.

you mean like in Europe? With "evil" mandatory health care. Come on, people!

Edited by kismet, 30 July 2012 - 03:21 PM.

[Turnbuckle]

A petition does nothing. The federal government is grabbing up more and more power for itself and it isn't going to be stopped by a list of names. If anything, that just saves them the trouble of preparing a list of troublemakers.

That's incorrect -- or a lie. Under Obama there has been an unprecedented drop in government spending; sans money spent on the safety net (or tax cuts to the rich), but that's not an increase in the SIZE of gov.

Also, there are very few stem cell therapies that are proven to do much. It would be unethical NOT to regulate them SOMEHOW, of course, we could and should debate the how, but not the principle.

Spending has increased under Obama, but I didn't say that. I said that federal power has increased, and it increases steadily under both parties. This ability to force us to buy insurance can be applied to many other areas, just as the expansion of the commerce clause in Gonzales v. Raich (2005) gives the government the power to regulate what we do in our own homes. As Justice Thomas noted in his dissent, "If the majority is to be taken seriously, the Federal Government may now regulate quilting bees, clothes drives, and potluck suppers throughout the 50 States. This makes a mockery of Madison's assurance to the people of New York that the 'powers delegated' to the Federal Government are 'few and defined,' while those of the States are 'numerous and indefinite'."

Thomas wasn't being an advocate of individual rights here, just state's rights over federal rights.

As for your idea that it would be unethical not to regulate stem cells, why, exactly? Drugs are regulated yet they still do vast harm and drug companies still have to pay out billions. If they did harm with stem cells, whether they were regulated or not, they'd still have to face class action lawsuits if they screwed up. In any case, government regulators are in bed with the regulated, not with the public. The regulators serve for a time and then move to the companies they regulated. There isn't any ethics or morality involved; it's all quite corrupt.

Edited by Turnbuckle, 30 July 2012 - 03:34 PM.

[kismet]

Yes, but not spending that matters for our discussion re. gov. SIZE. Adjusted for cyclical factors -revenue, safety net, etc. - and inflation, Obama administration has spent very little compared to other presidents. See e.g. http://krugman.blogs...rnment spending

[Logic]

I'm going to have to be cynical about this, Logic. Avaaz may have some successes here and there, but the forces of big government just back up a little and try a new approach. The Obama administration would love to kick Wikileaks off the air, but has instead taken a more stealthy approach, drying up its source of funds and going after its leader with secret indictments and false allegations. In the meantime, the WH keeps amassing more power over Americans. With Supreme Court decisions expanding the commerce clause and the taxation clause, the feds have now gained the constitutional power to regulate everything we do and everything we don't do.

I understand your cynacism Turnbuckle, but feel that there is hope with organisations like this:
Avaaz has, IMO, had more than 'some' success due its size and the fact that every time a new approach is tried they are onto it. The above mentioned internet law is not the 1st one to be squashed by them for example.

Note that the powers that be have also already tried, unsuccessfully, to shut them down.

"All that is necessary for evil to triumph is for good men to do nothing"

[caliban]

If stem cells are drugs, so is sperm.

Also, there are very few stem cell therapies that are proven to do much. It would be unethical NOT to regulate them SOMEHOW, of course, we could and should debate the how, but not the principle.

As for your idea that it would be unethical not to regulate stem cells, why, exactly? Drugs are regulated yet they still do vast harm and drug companies still have to pay out billions. If they did harm with stem cells, whether they were regulated or not, they'd still have to face class action lawsuits if they screwed up. In any case, government regulators are in bed with the regulated, not with the public. The regulators serve for a time and then move to the companies they regulated. There isn't any ethics or morality involved; it's all quite corrupt.

These are the only relevant contributions so far.

stay on topic.

[Logic]

Yes; sorry about that.

However; the topic is
[FightAging] FDA Reaches to Regulate (i.e. Block) Simple Stem Cell Therapies
so ways to stop/reverse this sort of thing are somewhat relavant in the same way that simply winging about it would be acceptable...

[kismet]

Still offtopic, but to confirm what I said with a better reference: http://krugman.blogs...ing-government/

(Yes, the current administration is a conservative one and acts accordingly)

Yes, this can be split from the thread. OTOH, it is somewhat on topic to say that the whole "big government reaches to regulate XYZ" meme is usually plain wrong and based on politics, unfortunately. I never hear that the FDA is regularly overreaching from actual insiders.

Edited by kismet, 11 September 2012 - 09:25 PM.

[Mind]

Still offtopic, but to confirm what I said with a better reference: http://krugman.blogs...ing-government/

(Yes, the current administration is a conservative one and acts accordingly)

Yes, this can be split from the thread. OTOH, it is somewhat on topic to say that the whole "big government reaches to regulate XYZ" meme is usually plain wrong and based on politics, unfortunately. I never hear that the FDA is regularly overreaching from actual insiders.

Now you have heard from an insider claiming the FDA is a burden upon new treatments. There is NO ethical reason to prevent fully-informed rational AND dying people from trying new treatments (while they assume the increased risk of new meds/treatments). The FDA is an executioner for these people. Plain and simple.

Edited by Mind, 03 December 2012 - 12:32 PM.

[maxwatt]

...or the FDA (probably unwittingly) is preventing them from spending their assets on ineffective therapies thus preserving their estates for their heirs.
Cynical, I am.

While I believe this is a drag on developing new and cutting edge treatments, it also prevents some outright dangerous protocols from being foisted on the gullible. Without the FDA, we would have lead acetate in our vinegar, among other things. But it does seem they are overreaching. What I want to do with my own stem cells is my business, not the FDA's.

Remember the genetically identical mice, they transfused the combined blood supplies of an old mouse and a young mouse for a few days: the old mouse was rejuvenated, and the young one was unaffected, suffered no ill effects. I want to use my stem cells to clone my blood and rejuvenate it, if not from a human clone, at least from a blood tissue clone. This one is worth fighting.

[Turnbuckle]

Without the FDA, we would have lead acetate in our vinegar, among other things.

Huh? Whatever companies put into their products they will be responsible for. If they kill or injure people with lead, lawsuits will fly, FDA approval or not.

[maxwatt]

when the FDA was formed, lead acetate in vinegar was a problem. There were no lawsuits. Granted our society was then less litigious.
Thanks to industry pressure, the FDA cannot ban pthalate plasticizers nor BPA in food containers (liners of canned food, e.g.) and these are known endocrine disruptors. Fed to mice in amounts consistent with what we are likely to get in a processed food diet, they cause abnormalities such as premature menses, slight genital deformities, and male-on-male mounting behaviors. But the FDA overruled their scientists, because the ill effects "were only demonstrated in mice", not in humans.

I wonder if the Southern baptists and other fundamentalists realize the FDA is part of a plot to promote homosexuality?

[Turnbuckle]

when the FDA was formed, lead acetate in vinegar was a problem.

Lead acetate in vinegar was used in Roman times to dye gray hair. And still is--the FDA has not banned it.

[maxwatt]

They (FDA) keep it out of your vinegar and other food. Lead acetate has (I am told) a sweet flavor, and 19th century manufacturers would steep vinegar in lead containers to sweeten it. It is toxic in sufficient quantity, like other heavy metals. The Romans were aware it was poison, but it is also hallucinogenic, which was the main use the Roman aristocracy made of it. Few overdid it to the point of general dementia, according to my source. Some historians claim such use of lead was one reason for the decline of Rome,; besides dementia, it will result in sterility; supposedly a reason the upper classes did not reproduce, but I think that theory is discredited. (Source is a book on the archaeology of Pompeii I read years ago.)

Even lead acetate hair dye's fda-mandated package warning cautions not to use it on eyebrows, as blindness can result. This does not stop beauty salons from using it to dye eyebrows.

[Turnbuckle]

They (FDA) keep it out of your vinegar and other food.

The FDA is not needed to keep it out of food. If anyone put lead in food (or toys) they would be subject to criminal penalties and/or enormous lawsuits. The purpose of the FDA these days is not to protect American citizens but to protect the profits of companies.

[niner]

They (FDA) keep it out of your vinegar and other food.

The FDA is not needed to keep it out of food. If anyone put lead in food (or toys) they would be subject to criminal penalties and/or enormous lawsuits. The purpose of the FDA these days is not to protect American citizens but to protect the profits of companies.

Someone needs to monitor and test, and to see to it that food, supplement, and drug production facilities aren't disasters waiting to happen. I don't think penalties alone will do the job. You still need cops to catch the bad guys.

[sthira]

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

No. You're wrong.

[Turnbuckle]

They (FDA) keep it out of your vinegar and other food.

The FDA is not needed to keep it out of food. If anyone put lead in food (or toys) they would be subject to criminal penalties and/or enormous lawsuits. The purpose of the FDA these days is not to protect American citizens but to protect the profits of companies.

Someone needs to monitor and test, and to see to it that food, supplement, and drug production facilities aren't disasters waiting to happen. I don't think penalties alone will do the job. You still need cops to catch the bad guys.

And when the cops and bad guys switch places every few years?

[niner]

If the police force is corrupt, then we should clean it up, not disband it. By cops and bad guys switching places, do you mean that people are moving back and forth between Pharma and the FDA? I don't think that's as malign as it sounds, or particularly common.