Stem Cell Scams in the United States: FDA Warning

U.S. authorities arrested in December 2011 a midwife, an assistant professor, and a “fake” doctor. The three men were jailed for the manufacture, sale and use of stem cells without FDA sanction or approval.

The contentious stem cells traveled across states into Mexico where they were used in unauthorized stem cell treatment performed on gullible patients suffering deadly incurable diseases.

In the elaborate criminal scheme, the midwife, who operated a maternity care clinic in Texas, obtained umbilical cord blood from birth mothers by telling them it was for “research” purposes.

In the next step of the interstate crime, the midwife then sold the cord blood to a laboratory in Arizona.

The lab sent the cord blood to a paid an assistant professor at a university in South Carolina, who was one of its paid consultants. Stem cells can be derived from the cord blood comes taken from human placentas, and the professor then used university facilities to manufacture stem cell products, which he sent back to the lab.

The lab then sold these to a man representing himself as a U.S.-licensed physician, who, in the final step of lawbreaking, then traveled to Mexico to perform unapproved stem cell procedures on people suffering from cancer, multiple sclerosis and other autoimmune diseases.

All in all, the three defendants allegedly received more than $1.5 million from patients seeking treatment for incurable diseases.

The owner of the laboratory in Arizona was convicted of unlawfully introducing stem cells into interstate commerce. She faces up to three years in prison and a fine of up to $10,000. Criminal cases were filed against the midwife, the professor and the quack doctor who performed the ‘treatments’.

Stem cell promise, criminal opportunity
Because stem cells are the precursor cells or “building blocks” of the body that develop into blood, brain, bones and all body organs, they offer the hope of being a renewable source of replacement cells and tissues to treat many diseases or conditions for which there is no treatment, or few treatments exist.

“Stem cells can come from many different sources and under the right conditions can give rise to many different cell types,” says Stephanie Simek, Ph.D., deputy director of FDA’s Office of Cellular, Tissue and Gene Therapies.

Some of these diseases—Parkinson’s disease, amyotrophic lateral sclerosis, spinal cord injury, burns, heart disease, diabetes and arthritis—are severely debilitating and disabling, the hope that patients have for a cure leaves them vulnerable to unscrupulous providers of stem cell treatments that are illegal and potentially harmful.

Concerned over this, the United States Food and Drug Administration issued an advisory warning consumers to make sure that any stem cell treatment they are considering has been approved by FDA or is being studied under a clinical investigation that has been submitted to and authorized by the agency. The warning is posted on its website.

“Scammers like these offer false hope to people with incurable diseases in order to line their own pockets with money,” said Special Agent in Charge Patrick J. Holland whose office worked the case with the Federal Bureau of Investigations and the Internal Revenue Service’s Criminal Investigations Division.

Holland, who is posted at the FDA’s Kansas City Field Office and works with the FDA’s Office of Criminal Investigations (OCI), vowed that the agency would aggressively pursue perpetrators who expose the public to the dangers of unapproved stem cells.

In its warning, the FDA said it wanted consumers to be aware that the agency has approved only one stem cell product: Hemacord. This is a cord blood-derived product made by the New York Blood Center and used in patients with disorders affecting the body’s blood-forming system.