Arizonan Guilty In Stem Cell Smuggling
A stem cell under a microscope..
By John Guzzon
Modern Times Magazine
Aug. 24, 2011 — The Scottsdale-based operator of a laboratory and clinic was convicted last week of manufacturing, selling and transporting across state lines, adult derived human stem-cells.
Fredda Branyon, 57, of Scottsdale, Ariz., pleaded guilty pursuant to a plea agreement to introducing an unapproved new drug into interstate commerce, specifically, stem cells derived from umbilical cord and cord blood tissue for non-research purposes without FDA approval. The criminal information alleges that in January 2009, Branyon was the owner of Global Laboratories LLC, of Scottsdale, and that she, through her company, manufactured, sold and delivered stem cells to an individual in Brownsville, Texas.
The charges were the result of a joint investigation conducted by special agents of the FDA-OCI and the FBI Brownsville office, which is continuing.
“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,” said Moreno. “The public has an equal right to expect that those who fail to meet those standards will be investigated and prosecuted.”
At a hearing last week before United States District Judge Melinda Harmon, Branyon admitted she knew that FDA approval was required to distribute and sell stem cells for non-research related purposes but nonetheless sold stem cells to an individual in Brownsville, Texas, who later performed medical procedures using the stems cells on patients suffering from autoimmune diseases. The stem cells were not created under FDA guidelines nor in an FDA approved facility.
According the factual basis filed of record with the plea agreement, Branyon sold approximately 183 vials containing stems cells to the individual in Brownsville on 27 separate occasions between April 2009 and February 2010 and received approximately $300,000 for the sale of the stem cells. Branyon also admitted that beginning in August 2009, she began purchasing umbilical cords from a Del Rio, Texas birthing facility. Later, Braynon, who had no formal training regarding the creation of stem cells, employed a Charleston, S.C., medical school professor as a consultant to aid her in the creation of stem cells from the umbilical cord tissue.
“As evidenced by this investigation, protection of the public takes many forms, not the least of which is the aggressive pursuit of individuals or corporations who intentionally risk the public’s health for profit,” said Nelson.
“This criminal information demonstrates the commitment of the Food and Drug Administration to protect the American public from the harms inherent in being exposed to unapproved new drugs,” said Holland. “The FDA will continue to aggressively pursue perpetrators of such acts and ensure that they are punished to the full extent of the law.”
Branyon faces up to three years in prison and a fine of up to $10,000 for the conviction. Judge Harmon has set sentencing for Nov. 18, 2011. Branyon has been ordered released on a $50,000 personal recognizance bond pending sentencing.
Branyon also has ties to New Hope Medical Center in Scottsdale. The facility is still operating although they did not agree to talk with Modern Times Magazine.
In an October 2009 press release, Branyon touted a merger between New Hope Medical Center and Bio Stem Genetics, thereby creating a new company, Branyon Integrative Medical Group.
New Hope Medical Center provides alternative cancer treatments. They have partnered with Centro Medico Del Noroeste, located in Sonora, Mexico where they provide treatment.
“This merger with BioStem Genetics will offer our patients a more intensive treatment option,” Branyon said in 2009. “Patients will be given the opportunity to participate in clinical trials and be given greater access to offshore treatments that, until now, have been extremely difficult to find.”
Many of the therapies provided by New Hope Medical Center are considered “experimental” in the U.S. Stem cell therapy is not approved for treatment in the United States — although some clinical trials are underway — and is therefore not FDA approved.
A thriving industry has sprung up — especially in Latin America — where many claim stem cell treatments have cured their ailments.
New York Yankees pitcher Bartolo Colon received a stem cell treatment on his ailing right arm in the Dominican Republic last year and is attributing his resurgence in 2011 to the procedure.
John Guzzon is editor of Modern Times Magazine.
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