Fredda Branyon pleads guilty to charges of selling unapproved stem cells

[barbara]

In 2009, her forum sponsorship was terminated when I couldn't get any straight answers from her. I also exposed the fact that she was calling herself Dr. Fredda Branyon and was not a licensed doctor. The wheels of justice move slowly. Stem cell treatment is not like taking an aspirin. It can be dangerous and patients need to wise up to this. Who knows where the stem cells even came from? Scary at best. I do hope that New Hope as she used to call her operation is out of business for good.



http://www.massdevice.com/news/global-labs-former-owner-pleads-guilty-selling-unapproved-stem-cells-massdevicecom-call

Global Labs former owner pleads guilty to selling unapproved stem cells | MassDevice.com On Call
August 19, 2011 by MassDevice staff

Former Global Laboratories owner Fredda Branyon pleads guilty to 12 counts in connection with selling illegal stem cells.


MASSDEVICE ON CALL — Former Global Laboratories Inc. owner Fredda Branyon pleaded guilty to 12 counts in connection with selling unapproved stem cells for nonresearch purposes.

Branyon, who also owned New Hope Medical Center in Scottsdale, Ariz., send cells derived from umbilical cord and cord blood tissue, making more than $311,000 in sales from April 2009 through February 2010, court records show.

The shipments, which were later used to treat patients with immune disorders, went to the same address in Brownsville, Texas, though the identify of the buyer was not disclosed, the Brownsville Herald reported.

Branyon, 57, faces up to three years in prison and a fine of up to $10,000.

 

[barbara]

Stem cell case could land woman in prison
By CINDY GEORGE, HOUSTON CHRONICLE
August 23, 2011

Umbilical cords, once considered medical waste, turned into a $300,000 stem cell gold mine for one Arizona businesswoman whose black market dealings in Texas border towns landed her in Houston federal court.

According to filings by prosecutors, the laboratory owner bought umbilical cords from a Del Rio midwife who told new parents that their babies' tissue would be donated. She then hired a researcher to extract stem cells from the cord blood and later sold the stem cells to a Brownsville man who used them to treat patients with chronic illnesses.

In actuality, neither the woman nor her company had approval from the U.S. Food and Drug Administration to manufacture, sell or distribute stem cells.

The law and a dozen federal charges caught up with Fredda Branyon this summer. And last week, the 58-year-old cut a deal admitting to details of the scheme, pleading guilty to one count of introducing an unapproved drug through interstate commerce, and agreeing to cooperate with the ongoing investigation.

According to court documents, Branyon was the director and operator of the Scottsdale, Ariz.-based New Hope Medical Center, which advertised stem cell therapies for cancer and chronic illnesses. The company later became Branyon Integrative Medicine, and its website routinely discussed the use of stem cells to treat diseases.

Umbilical cord blood is rich with stem cells that, if used to treat or prevent human disease, would be considered a drug under federal law.

In 2008, Branyon acquired a company called Caledonia Consulting, and renamed it Global Laboratories LLC.

Often referred to as "Dr. Branyon," according to the plea agreement, she did not have a medical license but did receive a degree in naturopathic medicine from the Southwest College of Naturopathic Medicine and Health Sciences in Arizona, according to court records.

To replenish Global's supply of stem cells, Branyon bought umbilical cord tissue from a midwife operating a Del Rio birthing center, and hired a South Carolina medical school professor as a consultant to provide "viable stems" that "were not created in any FDA-approved laboratory or under FDA guidelines," the plea agreement said.

Forms falsified

In early 2009, Branyon was contacted by a man who had purchased stem cells from Caledonia's previous owners. He also claimed to be a physician at a Brownsville clinic, as well as the stem cell research director at a Mexico City medical school, the plea deal said. Branyon admitted shipping stem cells to that buyer with a form indicating that the products were for research only, while knowing they would be used for treatments.

The Brownsville man, the Del Rio midwife and the South Carolina consulting researcher are not named in court papers.

'Very, very specific rules'

Experimental stem cell therapies are being explored through FDA-approved clinical trials, such as several run by Dr. Charles Cox, a Houston researcher. He said he had not heard of a black market for umbilical cords to produce stem cells.

"There are very, very specific rules regarding your ability to do things in terms of clinical use of a cell therapy," said Cox, a professor of pediatric surgery at UTHealth and director of pediatric trauma at Children's Memorial Hermann Hospital. After hearing about the Branyon case, he said: "It's illegal, unsafe and probably biologically invalid."

Branyon, who is free on $50,000 bail, is scheduled for sentencing on Nov. 18. She could receive up to three years in prison. Under her plea agreement, prosecutors could ask the judge for a lighter sentence if Branyon provides "substantial assistance" in the continuing probe.

cindy.george@chron.com

 

[danny]

Another good one to add to the pile! I am glad I didn't ever go here!


Stem-cell inquiry includes professor at MUSC
Arizona doctor pleaded guilty in case

By Renee Dudley
<a href="mailto:rdudley@postandcourier.com">rdudley@postandcourier.com</a>
Saturday, August 27, 2011
An Arizona doctor facing federal criminal charges in connection with selling human stem cells for unapproved medical treatments paid a Medical University of South Carolina professor to help her, according to court documents filed last week.

An MUSC spokeswoman refused to identify the professor and said in a statement, "The university defers all inquiries regarding specifics of the investigation to the appropriate federal authority."

Spokeswoman Angela Dodge of the U.S. attorney's office in Houston, the agency handling the case, declined comment on whether the Charleston professor, a paid consultant for the Arizona business, will face charges.

Fredda Branyon, 57, of Scottsdale, Ariz., pleaded guilty to selling stem cells made from umbilical cord and cord blood tissue for "non-research purposes" and without U.S. Food and Drug Administration approval, according to the plea agreement filed Aug. 18 in U.S. District Court in Houston.

Branyon allegedly sold the stem cells for $300,000 to a Texas health care worker who used them to perform medical procedures on patients with Lou Gehrig's disease, multiple sclerosis and other autoimmune diseases.

Branyon, who had "no formal training" making stem cells, hired the MUSC professor to help her, according to the plea agreement.

The professor occasionally traveled to Arizona, but "would also examine and review stem cells created from cord blood while conducting research at the medical school," according to the agreement, which identifies the professor only by initials.

Read more
Plea agreement

FBI press release

MUSC response

The professor "did create viable stems which (were) provided to the defendant," according to the agreement.

In a statement, MUSC spokeswoman Heather Woolwine said the school "was contacted by federal investigators in August 2010 in regard to an ongoing federal investigation into activities that may have involved one of our faculty members. ... The university provided all of the requested information and will continue to cooperate fully with federal authorities."

MUSC also conducted an "internal review audit" involving the professor, Woolwine said in the statement. She declined to provide the audit's findings.

Between April 2009 and February 2010, Global Laboratories, Branyon's company, sold more than 180 vials of stems cells to the unidentified Brownsville, Texas, health care worker, according to the plea agreement.

During that time, Branyon bought umbilical cords from a Del Rio, Texas, birthing facility.

What's a stem cell?
Stem cells are found in umbilical cord blood, bone marrow and in blood after administration of growth factors. Stem cells can be used in the treatment of cancer and other life-threatening illnesses, along with high doses of chemotherapy and radiation. The immune cells from the stem-cell transplant act to prevent the cancer from spreading.

Mothers who had just given birth at that facility were asked whether they wanted to donate their umbilical cords and cord blood tissue for research, even though the material actually was being sold to create stem cells for medical procedures, the agreement said.

"The public has a right to expect that the drugs, or in this case stem cells, introduced into the marketplace are safe for public consumption and meet strict FDA guidelines," U.S. Attorney Jose Angel Moreno said in a statement.

Cory Nelson, special agent in charge of the FBI's San Antonio field office, said in a statement that operations such as Branyon's "intentionally risk the public's health for profit."

Branyon was released on a $50,000 personal recognizance bond pending sentencing Nov. 18. She faces up to three years in prison and a fine of up to $10,000, according to the U.S. attorney's office.

Attempts to reach Branyon by phone and through her website were unsuccessful. Her secretary in Arizona said Branyon would not discuss the case.

The investigation, led by the FBI office in Brownsville and the Food and Drug Administration's Office of Criminal Investigations, is ongoing.

 

[barbara]

I think it's time to out the professor too and the Texas health care worker.
Risking patient's lives is not a humanitarian gesture, it's plain and simple greed.

 

[sandralee]

Glad to see that stemcellpioneers stays on top of issues like this - very scary, exactly the sort of thing the 60 minutes segment "21st Century Snake Oil" warned against. The ICMS recently published minimum standards for patient recruitment - 11 guidelines that give patients a great list to apply to every provider of commercialized stem cell treatment that they consider.