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Monday, February 13, 2012

Texas Medical Board gives early OK to adult stem cell rules


There is no substantial data to indicate that adult stem cells are beneficial for patients other than those undergoing bone marrow transplants.

Photo, taken 2012-02-13 13:57:02

Photo by Todd Wiseman

After months of deliberation — and input from Gov. Rick Perry, among others — the Texas Medical Board on Friday gave preliminary approval to a set of rules on adult stem cells in Texas that are less stringent than those originally proposed.

With no opposition, the vote on a topic that has received much scrutiny and skepticism since last spring took only about five minutes.

“It’s been a delicate balance between our absolute goal to protect the public and at the same time [our] desire not to stifle what we feel will be a huge boon to medicine,” said Dr. George Willeford, a member of the board. “Perhaps we’ve been criticized by the media for taking a middle road, but [the middle road] was absolutely necessary.”

In the weeks leading up this meeting, members of many Texas academic institutions had written to the Board to express concern that the rules — "Standards for Use of Investigational Agents" — were too restrictive and created what they felt might be onerous regulations on any treatment that could be undergoing clinical trials.

Discussion of changing the Texas Administrative Code to include regulating these trials began last summer after Perry used adult stem cells to treat a recurring back injury. Perry learned of and advocated for the treatment after Dr. Stanley Jones — a Houston orthopedist, donor and personal friend of the governor — flew to Japan to receive the same treatment for his arthritis.

At the moment, extracting, growing and using adult stem cells is considered largely experimental and can cost anywhere from $10,000 to $50,000. However, those at the meeting expressed hope that this new treatment could eventually become affordable and accessible to more Texans.

Under the rules OK'd on Friday, patients will be informed that using adult stem cells, or any investigational agent, has not been approved by the FDA and that any clinical trials will be approved and overseen by an Institutional Review Board, or IRB.

The board and industry leaders hope this new rule will give them more data on the potential benefits of using adult stem cells. Currently, there is no substantial data to indicate that adult stem cells are beneficial for patients other than those undergoing bone marrow transplants — used for decades to treat leukemia and sickle cell anemia.

In late August, the board's initial rule had included language requiring consent forms detailing the risks and benefits, and stating that any treatment offered needed to have a favorable risk/benefit ratio.

Now that the proposed change has been approved by the board, the rule will be printed in the Texas Register, where the public can view them and comment on them. Further drafts of the rule may be drawn up, with the final version put to vote for adoption during the April board meeting.

"Some language was removed and some was added," said Mario Salinas, director of Texans for Stem Cell Research. "Patients are going to be informed as to [the] pros and cons that will ensue from being in a clinical trial. Whatever language was deleted was made better with the new language that was added."

Glenn McGee, president of strategic initiatives for Houston-based Celltex Therapeutics — which was founded by Jones and Perry donor David Eller, and is the only Texas adult stem cell bank thus far — was also in attendance Friday and happy with the proceedings.

“Texas decided, unlike anyone else in the country or anyone in the world, to take a position on how to think about stem cells and the practice of medicine,” McGee said. “I think Texas will become the source for articles about adult stem cell use in peer reviewed articles.”

The Texas Tribune
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donmargolis, anonymous:

Typical comment from writer who is either ignorant or writes for a paper which is bribed by Pharma to mislead. "There is no substantial data to indicate that adult stem cells are beneficial for patients undergoing other than bone marrow transplants" is the "Big Lie" of the 21st century, where the Nazi Party of 80 years ago is replaced by Pharma and its thousands of fully-controlled corrupt doctors.

In order to protect Pharma's DAILY profits of a quarter BILLION dollars, they spend tens of millions to convince a kept-ignorant USA public of the above lie. They, (and you?) know that as of today there are 25,000 human patients walking around, their lives massively improved by stem cells given to them in clinical trials or commercially by the very few competent stem cell doctors in the world.

Of course, in Pharma-controlled medicine, 25,000 huge successes do not count, so all YOU may read about in your fully-controlled press is that TWO people have had their vision improved by embryonic stem cells, the hoax created by Pharma. 25,000 to 2. You should be proud of your talent! to deceive with a headline, since no one quoted in the article says anything like your headline.

Don Margolis, Chairman Repair Stem Cell Institute

3 months, 1 week ago
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(This comment was removed by the site staff.)

3 months, 1 week ago

Riddlemethis, anonymous:

As for Texas - Ya'll might want to take a look at this. http://sctmonitor.blogspot.com/2012/0...

3 months, 1 week ago
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intheknowstemcells, anonymous:

Don Margolis - Speaking of misleading writer who are in it to make a buck and not fully benefit their patients, why don't you stop plagiarizing the work of others by altering their stories to suit your profit motive.

A case in point is a story you recently published in your online newsletter (Feb) and on your web site about Pro/Am dancer Janet Vaughan after she began dancing again after successful stem cell therapy in Panama.

You altered the title and removed all references to the clinic that performed the treatments and the country in which it was located in a deliberate strategy to mislead your readership. Why? So when they contact you about getting the same treatment, you can send them to a place from which you receive kickbacks instead of the place that actually performed the treatment in which the patient is interested.

Here is a link to the original story:

http://www.prweb.com/releases/stemcel...

And here is one to the Don Margolis sanitized version: http://www.repairstemcells.org/Resour...

Tell us Don, how does it benefit your readers to NOT know where this treatment was done and who did it? There are many more examples on Don's sight.

So Don calling any writer biased and/or profit motivated is just the pot calling the kettle black.

3 months, 1 week ago
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intheknowstemcells, anonymous:

Don Margolis - Speaking of misleading writer who are in it to make a buck and not fully benefit their patients, why don't you stop plagiarizing the work of others by altering their stories to suit your profit motive?

A case in point is a story you recently published in your online newsletter (Feb) and on your web site about Pro/Am dancer Janet Vaughan after she began dancing again after successful stem cell therapy in Panama.

You altered the title and removed all references to the clinic that performed the treatments and the country in which it was located in a deliberate strategy to mislead your readership. Why? So when they contact you about getting the same treatment, you can send them to a place from which you receive kickbacks instead of the place that actually performed the treatment in which the patient is interested.

Here is a link to the original story:

http://www.prweb.com/releases/stemcel...

And here is one to the Don Margolis sanitized version: http://www.repairstemcells.org/Resour...

Tell us Don, how does it benefit your readers to NOT know where this treatment was done and who did it? There are many more examples on Don's sight.

So Don calling any writer biased and/or profit motivated is just the pot calling the kettle black.

3 months, 1 week ago
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intheknowstemcells, anonymous:

Oops... Don's "site" not "sight"

3 months, 1 week ago
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(This comment was removed by the site staff.)

3 months, 1 week ago

Shannon Sutlief, staff:

Several comments were removed from this story. We refer you to our Terms of Use Agreement, specifically under the "Content Posted on the Site" section.

We encourage dialogue, but please keep it within our terms of use.

3 months, 1 week ago
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Riddlemethis, anonymous:

Here's an idea Shannon - Investigate what was removed as well. It's all true. Might save you from writing fluff pieces the rest of your career.

3 months, 1 week ago
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Riddlemethis, anonymous:

Given the fact that Bush was listening to the likes of Don Margolis, and David Prentice (the failed pathologist turned lobbyist for the American Catholic Bishops), it’s little wonder he was completely void of the facts when I had to talk to him about it.

Fortunately, our current President had no problem processing information and separating fact from fiction when I briefed him on the issue.

For Action to Advance Stem Cell Research please visit this link. http://www.stemcellactionnetwork.org/ For a concise PowerPoint explanation – Webcast of Labor-HHS Hearing on Stem Cell Research http://appropriations.senate.gov/webc...

3 months, 1 week ago
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Riddlemethis, anonymous:

And by the way, David Prentice (Margolis' buddy) answers to Tony Perkins of the FRC. The same Tony Perkins that handed over 82.5K to Grand Wizard David Duke of the KKK during his election campaign in Louisiana. Got google?

3 months, 1 week ago
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Riddlemethis, anonymous:

One other thing, To the other comments from "intheknowstemcells" -Don't tail gate here sir. You are now in Panama because you were kicked out of Costa Rica. You and Margolis are no different from each other - you are both just here fighting over the same piece of cheese.

3 months, 1 week ago
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intheknowstemcells, anonymous:

@Riddlemethis - Actually, I was just pointing out the fact that he does exactly what he accuses "writers in the pockets of the Big Pharma profit machine" of doing. I just happened to use a current post from his newsletter. If you bothered to look at my posts elsewhere on the net, you'd notice I've been "tailgating" 'Ol Don for a lot longer than you have. One other thing you might be interested to know is that 'Ol Don doesn't even have an "Institute". Read his newsletter. I subscribe to it and that is where I read the recent story about Panama by the way. At the bottom, you'll see this address:3010 LBJ Freeway Suite 1200 Dallas, Texas 75234, adnd if you google it, you'll see that it's nothing more than a virtual office in Dallas: http://www.davincivirtual.com/loc/us/.... So now that I got all that out of the way, let me make it simple so even you can understand my point. a) Margolis plagiarizes the work of others to send people to his clinics that pay him commissions b) He reprints articles written by others and alters them to suit his own commercial interests (the Panama story just happens to be the most recent one and like I said before, take a look at his web site and you will see MANY other examples, not just Panama) c) and this is the most important fact - if you read (a) and bother to check (b) you will see that nothing he publishes can be trusted because one cannot tell when he's altering the facts. THAT was my point from the beginning. Do you get it now?

3 months, 1 week ago
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intheknowstemcells, anonymous:

and personally, for anyone who is considering any kind of stem cell treatment abroad, I would recommend reading the International Society for Stem Cell Research (ISSCR) patient site before making any decisions: http://www.closerlookatstemcells.org/...

3 months, 1 week ago
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mezzetin_subaquatic, anonymous:

cheese?

3 months, 1 week ago
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intheknowstemcells, anonymous:

Lastly, after looking at the "Stem Cell Action Coalition" web site recommended by 'riddleme', which seems to be from the embryonic stem cell lobby, it seems to me that "riddlemethis" is nothing but a "Left Wing Don". Seems that you two are the ones fighting over the 'same piece of cheese' not me. And it also appears like you've been cutting and pasting the same post to 'Ol Don for at least the past year: http://www.forbes.com/sites/matthewhe...

And just to be fair and complete, I suppose that I should mention that anyone seeking stem cell therapy abroad should also look at the International Cellular Medicine Society (ICMS) web site too: http://www.cellmedicinesociety.org/ They present an alternative view to the ISSCR.

3 months, 1 week ago
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knoepfler, anonymous:

Take it easy folks!

I think "intheknow" and "riddleme" are not on opposite sides really.

FYI, I also have a patient's guide to stem cells on my website that I think patients and scientists as well as others will find useful:

http://www.ipscell.com/patients-guide...

Intheknow, I have some questions for you--drop me a line. knoepfler@ucdavis.edu

Paul

3 months, 1 week ago
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Kimler1, anonymous:

Paul, thank you for the excellent post.  I encourage everyone to read it. 

As for responding to the story above. Great reminder from the moderator..  I encourage everyone to read the proposed rules in the Texas Register when they appear. Provide constructive feedback.  Until we see what this medical board has put together, we really cannot put much stock into any of these comments. 

3 months, 1 week ago
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