Alleged U.S. Stem Cell Fraudsters Shielded by South African Legal Logjam

There has been anecdotal evidence on both sides. A damning article in the Los Angeles Times in 2005 told of an ALS sufferer who received treatment from BioMark with no results and died seven months later. But South African Bridget Hall, whose son Matthew suffered a spinal-cord injury at 18 that left him a quadriplegic, told Marie Claire South Africa that after the first injection sensation returned to Matthew's body; after a follow-up injection 18 months later movement returned to his hands and he could walk between parallel bars.

Brown and van Rooyen claim that there hasn't been a single negative side effect, but one former employee who spoke to Marie Claire on condition of her anonymity said that "people would call in all the time saying, 'I can't use my hands, I have a high fever, my doctor doesn't know what it's from.'" She believes that all of these could have been side effects from the injections.

Raised Suspicions; an Undercover Operation

In October 2003, when the family of an ALS sufferer contacted the FDA to raise concerns about what BioMark was doing, an undercover operation was arranged. The FDA brought in the FBI and BioMark's Miami Beach office was raided, its bank accounts were frozen (court records show that they held $264,554.12) and the company shut down. Within 24 hours the doctors the company worked with had severed ties with BioMark.

Van Rooyen claims that they weren't misrepresenting themselves to anyone -- neither patients nor doctors. "Obviously the FBI threatened to revoke their [doctors'] medical licenses," he said. "We were set up in the most horrible, vindictive manner."

According to van Rooyen, BioMark was also under political attack: "The Bush administration supports the pharmaceutical industry, which wants smaller would-be contenders in the multibillion dollar stem cell arena to be put out of business."

Not Fit for Use on Humans

While they were being investigated by the FBI, van Rooyen decided to concentrate on the European market. (Legislation governing stem cell research is more liberal in the EU, though treatments still require complex medical trials and government approval.)

The couple left the United States for van Rooyen's native Cape Town, changed the business's name from BioMark International to Advanced Cell Therapeutics (ACT) and their own names to Sebastian Carlyle and Sean Castle, and hired 20 employees. Cape Town became their administrative center (although patients were told the company's offices were in Switzerland) and treatments allegedly took place in clinics around the world from Holland to Pakistan -- and even on a ferry in international waters off the coast of Ireland.

Following a three year probe by the FBI and the FDA where the couple appeared on the FBI's Most Wanted List, Van Rooyen and Brown were indicted and charged with fraud and the distribution of unapproved and misbranded drugs.

Shortly after the indictment, the BBC program, "Newsnight," reported that the stem cells being used by ACT were meant for laboratory research purposes only, not for use on humans. Purchased from a Californian manufacturer called AllCells, they contained an animal protein called fetal bovine serum. Van Rooyen told Marie Claire magazine in South Africa that he is taking legal action against the BBC, but on what charges exactly remains unclear.

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