The only inaccuracies I could see were that I did not correspond with Fredda Branyon in 2007. I first started talking to Fredda Branyon in 2008. The other point of contention is that I did not state that federal regulation was the only way to ensure patient safety. I believe that the ICMS guidelines can do that just as well as federal regulations. I was disappointed that she did not mention the ICMS as I did discuss it with her. Otherwise this reporter did a better job of quoting me than those from major sources such as CNN. I also found it interesting that Branyon stated she was going to conduct a study and yet this reporter was not able to find any evidence of it apparently. I guess when the money is good, who needs a study?
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Stem Cell Smuggler Pleads Guilty
09/27/2011 Michelle Bialeck
An Arizona lab owner pleads guilty to selling illegal stem cell treatments.
A former Arizona laboratory owner has pleaded guilty to selling unapproved stem cells across state lines.
Fredda Branyon, the former owner of Global Laboratories in Scottsdale, AZ, faces up to three years in jail and up to $10,000 in fines. Appearing before a US district judge on August 18, Branyon admitted that in 2009 her company sold stem cells for non-research purposes without FDA approval.
Specifically, she admitted to selling 183 vials of stem cells to an individual in Brownsville, TX on 27 separate occasions between April 2009 and February 2010 for approximately $300,000. This individual then treated patients suffering from autoimmune diseases with these stems cells.
The stem cells were not created under FDA guidelines or in an FDA-approved facility. Instead, Branyon created the stem cells from the umbilical cord tissue purchased from a Del Rio, Texas midwife. Because Branyon did not have an experience creating stem cells, she hired a Charleston, SC medical school professor to assist her.
“It’s a real disservice to people who are really trying hard to follow rules, and perhaps overly strict rules because of the misinterpretations of what stem cells are. To do something like that just makes it harder and harder for those therapies to become actualized,” said Broad Institute stem cell researcher John Rinn.
In 2009, Branyon announced that her Branyon Integrative Medical Group (BIMG) would perform a study on the treatment of HIV-related illness using umbilical cord-derived stem cells. The study was designed as a six-month program to be overseen by Mexican physician Edgar Payan Arechiga. It is not known if this study was actually conducted. The BIMG, formerly known as the New Hope Medical Center, was founded by Branyon to offer alternative treatments for patients suffering from cancer and other chronic illnesses.
“It’s just too easy to make money off of sick people, and some of these [stem cell] clinics are taking real advantage,” says stem cell clinic watchdog Barbara Hanson. After a bad experience in a Tijuana stem cell clinic that promised to cure Hanson and her friend’s chronic obstructive pulmonary disease (COPD), the two women co-founded the online forum Stem Cell Pioneers in 2007. The forum gives patients interested in stem cell therapies a place to share information related to stem cell treatments, doctors, clinics, and results.
In 2007, Hanson posted information on the forum about Branyon’s background, pointing out that Branyon was not an accredited doctor in the US. At that time, Branyon wrote in an e-mail to Hanson, “Because of pulling in many many types of treatments from around the world (some not FDA approved) for other MDs and DOs I decided not to become licensed. I never lost a license because I never had one to loose [sic]. With the type of research that I have donated my life to, I could in no way have done it with a license.”
But despite this information, many chronically ill patients desperate for a cure continue to risk their lives in clinics that promise stem cell cures without government approval or oversight. While Hanson and patients like her continue to believe in the promise of stem cells therapies, they understand the importance of federal regulation to ensure patient safety.
“There’s many questions out there, but there are also people, millions of us sick and many, many people dying every single day, and all they’re getting is a lot of endless research, and very few clinical trial opportunities. That needs to change. We need to get it going,” said Hanson.
Branyon will be sentenced on November 18.
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Stem Cell Smuggler Pleads Guilty
09/27/2011 Michelle Bialeck
An Arizona lab owner pleads guilty to selling illegal stem cell treatments.
A former Arizona laboratory owner has pleaded guilty to selling unapproved stem cells across state lines.
Fredda Branyon, the former owner of Global Laboratories in Scottsdale, AZ, faces up to three years in jail and up to $10,000 in fines. Appearing before a US district judge on August 18, Branyon admitted that in 2009 her company sold stem cells for non-research purposes without FDA approval.
Specifically, she admitted to selling 183 vials of stem cells to an individual in Brownsville, TX on 27 separate occasions between April 2009 and February 2010 for approximately $300,000. This individual then treated patients suffering from autoimmune diseases with these stems cells.
The stem cells were not created under FDA guidelines or in an FDA-approved facility. Instead, Branyon created the stem cells from the umbilical cord tissue purchased from a Del Rio, Texas midwife. Because Branyon did not have an experience creating stem cells, she hired a Charleston, SC medical school professor to assist her.
“It’s a real disservice to people who are really trying hard to follow rules, and perhaps overly strict rules because of the misinterpretations of what stem cells are. To do something like that just makes it harder and harder for those therapies to become actualized,” said Broad Institute stem cell researcher John Rinn.
In 2009, Branyon announced that her Branyon Integrative Medical Group (BIMG) would perform a study on the treatment of HIV-related illness using umbilical cord-derived stem cells. The study was designed as a six-month program to be overseen by Mexican physician Edgar Payan Arechiga. It is not known if this study was actually conducted. The BIMG, formerly known as the New Hope Medical Center, was founded by Branyon to offer alternative treatments for patients suffering from cancer and other chronic illnesses.
“It’s just too easy to make money off of sick people, and some of these [stem cell] clinics are taking real advantage,” says stem cell clinic watchdog Barbara Hanson. After a bad experience in a Tijuana stem cell clinic that promised to cure Hanson and her friend’s chronic obstructive pulmonary disease (COPD), the two women co-founded the online forum Stem Cell Pioneers in 2007. The forum gives patients interested in stem cell therapies a place to share information related to stem cell treatments, doctors, clinics, and results.
In 2007, Hanson posted information on the forum about Branyon’s background, pointing out that Branyon was not an accredited doctor in the US. At that time, Branyon wrote in an e-mail to Hanson, “Because of pulling in many many types of treatments from around the world (some not FDA approved) for other MDs and DOs I decided not to become licensed. I never lost a license because I never had one to loose [sic]. With the type of research that I have donated my life to, I could in no way have done it with a license.”
But despite this information, many chronically ill patients desperate for a cure continue to risk their lives in clinics that promise stem cell cures without government approval or oversight. While Hanson and patients like her continue to believe in the promise of stem cells therapies, they understand the importance of federal regulation to ensure patient safety.
“There’s many questions out there, but there are also people, millions of us sick and many, many people dying every single day, and all they’re getting is a lot of endless research, and very few clinical trial opportunities. That needs to change. We need to get it going,” said Hanson.
Branyon will be sentenced on November 18.