Wednesday, November 15, 2017 8:44:15 AM
Three men were arrested in the United States and charged with 15 counts of criminal activity related to manufacturing, selling and using stem cells without FDA sanction or approval.
According to the criminal indictment, one of the accused, a licensed midwife who operated a maternity care clinic in Texas, obtained umbilical cord blood from birth mothers, telling them it was for “research” purposes. Instead, the midwife sold the cord blood to a laboratory in Arizona which, in turn, sent the blood to a paid consultant at a university in South Carolina. The owner of the laboratory in Arizona was convicted in August 2011 of unlawfully introducing stem cells into interstate commerce. She faces up to 3 years in prison and a fine of up to $10,000.
The consultant, an assistant professor, used university facilities to manufacture stem cell products. He then sent the products back to the lab, which sold them to a man representing himself as a physician licensed in the U.S. The man then traveled to Mexico to perform unapproved stem cell procedures on people suffering from cancer, multiple sclerosis and other autoimmune diseases.
The three defendants allegedly received more than $1.5 million from patients seeking treatment for incurable diseases.
“Scammers like these offer false hope to people with incurable diseases in order to line their own pockets with money,” says Special Agent in Charge Patrick J. Holland of FDA’s Office of Criminal Investigations (OCI), Kansas City Field Office. “FDA will continue to aggressively pursue perpetrators who expose the American public to the dangers of unapproved stem cells and ensure that they are punished to the full extent of the law.”
FDA’s OCI worked the case with the Federal Bureau of Investigations and the Internal Revenue Service’s Criminal Investigations Division.
http://www.fda.gov/ForConsumers/ConsumerUpdates/ucm286155.htm
PMCB next?
Disclosure: I am involved in and support the SEC whistleblower program, I may be rewarded cash for information that leads to the successful enforcement by the SEC of a federal court or administrative action of 1m+.
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