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

Since the discovery that stem cells have the ability to become any tissue, and the isolation of the cells from days-old human embryos by researchers at the University of Wisconsin in 1998, possibilities suddenly seemed endless -- doctors could grow nerve fibres to patch a severed spine, make new organs to replace damaged ones or create brain cells to help patients with Alzheimer's disease. In short, some currently incurable diseases could be cured.

A 2001 attack on President Bush -- after he allotted federal funds for research but not for study that involved cells from human embryos to appease religious conservatives -- by high-profile figures like former first lady Nancy Reagan and the late actor Christopher Reeve made the general public aware of what was once considered exotic science.

Stem cell treatments in the United States are illegal until they have undergone complex clinical trials and been approved by the Food and Drug Administration. Trials are currently under way, primarily in Europe, where the political climate surrounding stem cell research is more favorable than in the United States. But while these trials look promising, scientists agree that the complex biochemistry of humans means successful stem-cell therapies are years, if not decades, away.

Brown and van Rooyen -- neither of whom have a background in science -- relocated to Miami Beach and formed their own company, BioMark International, in 2002. They don't believe they've done anything wrong. According to the couple, science has proven the therapeutic power of stem cells -- they're simply making them available now.

A Legal Loophole

For people with life-threatening or degenerative illnesses for which there is currently no cure, a decade -- or even a few years -- is too long to wait. It's easy for companies who offer hope in the form of untested stem-cell therapies to capitalize.

To get around the problem of FDA approval, Ghen relied on the Access to Medical Treatment Act. The act, applicable only in certain states, makes it lawful for doctors to try untested therapies on people with incurable diseases.

Relying on the same legal loophole, van Rooyen and Brown worked hard to build relationships with doctors who would refer patients and administer the treatment -- a subcutaneous injection of 1.5 million umbilical-cord stem cells for $26,000.

"Over a short period of time, we had miraculous results and more and more physicians started referring patients, especially in the area of multiple sclerosis," said van Rooyen (who sometimes used the alias Mark Dehavillan). "Neurologists were opposed to what we were doing, but there is a lot of arrogance in the medical profession. These stem cells were only discovered in the late 1980s and most doctors didn't know about them."

Along with multiple sclerosis, the conditions Brown and van Rooyen treated were those with the poorest prognosis: spinal-cord injuries, Parkinson's disease, muscular dystrophy and amyotrophic lateral sclerosis (ALS, also known as Lou Gehrig's disease, which gradually paralyzes the muscles and usually kills within two to five years).

"We had 22 doctors in five states," said Brown in January, "and 80 percent of the patients treated in over 80 disease types had significant clinical benefit."

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