Saturday, January 7, 2012

FBI crackdown on unproven stem cell therapies

They are the modern equivalent of snake oil merchants: clinics that charge desperately ill people thousands for unproven stem cell "cures". Now the US federal government is cracking down on one of the most notorious ? and the defendants include a scientist at a leading research university.

Vincent Dammai, of the Medical University of South Carolina in Charleston, is named in a federal indictment as part of a team that allegedly received more than $1.5 million from people with cancer and neurodegenerative diseases.

The charges follow an investigation by CBS News into Lawrence Stowe of Fort Worth, Texas.

Stowe was filmed claiming that infusions of stem cells, given by his associate Francisco Morales at a clinic in Mexico, could reverse symptoms of amyotrophic lateral sclerosis ? a fatal and incurable form of motor neuron disease.

Dammai's role, according to the indictment, was to extract stem cells from umbilical cord blood collected by Jesus Alberto Ramon, a midwife in Del Rio, Texas. Dammai and Ramon allegedly worked with Global Laboratories of Scottsdale, Arizona, which supplied the cells to Morales. Fredda Branyon, who ran Global Laboratories, pleaded guilty to supplying an unapproved treatment in August.

Morales, Dammai and Ramon, all named in the indictment, were arrested in December. Stowe, named in a second indictment, is still at large and "considered a fugitive", according to the FBI.

Warning signal

The case underlines concerns that some mainstream researchers could be abetting clinics offering unproven stem cell therapies. "I'm personally very happy that the FBI and the Food and Drug Administration has stepped in," says Larry Goldstein, a stem cell biologist at the University of California, San Diego. "I hope that it serves as a warning signal."

While Dammai is alleged to have been a knowing participant, other scientists may have been duped into supplying cells that are later used by rogue clinics. To avoid this, biologists should ask for credentials when responding to requests for stem cell samples, argued bioethicists Zubin Master of the University of Alberta in Edmonton, Canada, and David Resnik of the National Institute of Environmental Health Sciences in Research Triangle Park, North Carolina, in the journal EMBO Reports last July (vol 12, p 992). They should also make recipients sign contracts detailing how the cells will be used, the pair added.

Internet searches reveal several hundred clinics offering unproven stem cell treatments, says Douglas Sipp of the RIKEN Center for Developmental Biology in Kobe, Japan. How many, if any, have obtained cells from mainstream biologists remains a mystery. "By nature these clinics are opaque and secretive," says Sipp. "We really don't know what's in the vials."

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