Outside the U.S., Businesses Run With Unproved Stem Cell Therapies

Stem cell clinics offering unproven therapies for a range of diseases have become a multimillion-dollar industry, operating in Mexico, Ukraine, Barbados, China and elsewhere.

Charging tens of thousands of dollars, the clinics typically draw patients who have exhausted conventional therapies.

The backgrounds of the people behind the clinics vary — many see themselves as crusaders for the disabled and dying.

Tom Hill had been diagnosed with amyotrophic lateral sclerosis, also known as ALS or Lou Gehrig's disease, an incurable deterioration of the nervous system that spares the cognitive parts of the brain, leaving its victims sharply aware as they slowly die. The doctors told him there was no way to reverse the disease. Tom refused to listen. In the spring of 2003, he found http://www.biomark-intl.com. BioMark International offered a stem cell injection for a variety of illnesses, including Parkinson's disease, muscular dystrophy, depression and ALS. Tom threw himself into setting up a BioMark injection.

"They normally charge $21,000 but they want to be listed on my website," he wrote on a notepad.

He got the fee down to $10,000.

The stem cells could be injected into a vein, which BioMark said would bring the biggest results in three months, or into the fat of the abdomen for improvements that would come later but last longer. Tom decided he would split the cells and do it both ways. From the week he was diagnosed, he had told everybody that he would survive. He had fought so hard. This was a cure whose power nobody could deny. Alone with the doctor, Tom felt the sting of two needles. In a few minutes, it was over. Restoration had begun, he thought.

In October, the family of Craig Lauver, an ALS patient in Mifflintown, Pa., who was convinced that a BioMark injection could cure him, called the FDA with concerns about the company.

The FDA began a fraud investigation, persuading the Lauver family to help set up an undercover operation. Craig Lauver's brother, Nelson, said he asked BioMark to send somebody to inject the cells.

When a BioMark representative arrived from Arizona on Nov. 14, an FDA agent was there posing as Nelson's business colleague. The representative talked about the therapy, while two FDA agents in a bedroom controlled a video camera hidden in a lamp. After about 20 minutes, they entered the living room and pulled out their badges.

The FDA questioned and released the BioMark representative.

The same day, the FDA raided BioMark's office in Miami Beach, according to an e-mail the company sent to a patient.

The FDA froze BioMark's Bank of America accounts, which held $264,554.12, court documents show.

The company was shut down, but on the Internet it still looked like a thriving business. The website was dense with links to news articles about stem cells and diseases. The words "BioTech Advances" were bannered across the top, alongside the image of somebody peering into a microscope. A DNA double-helix spiraled down the left. There were links for "Research and Development," "Scientific Support" and "Testimonials."

On the Internet, satisfied BioMark customers described improvements, such as smoother skin, better sleep and more energy — sometimes within hours of their injections. Scientists leave open the possibility that the patients are experiencing more than the placebo effect, but without controlled clinical trials it is difficult to know what is happening.

In early November, Tom received an e-mail from BioMark stating that the board of directors wanted to offer him a second treatment. He would only be required to pay about $1,000. Perhaps the first stem cell injection just needed a boost. He was ready to wire the money as soon as BioMark scheduled an appointment. Then the news arrived. BioMark was under investigation for fraud. [...] On March 23, 2004, Tom Hill died at Haven House Hospice in Atlanta. He was 56. The FDA recently sent Valerie, Tom's wife, a check for $6,896, part of the money the government seized from BioMark. The company remains under investigation.

One afternoon in December, Valerie returned home to find a message on her answering machine from BioMark.

It was for Tom.

Valerie didn't know it, but the company had set up an office in London and found doctors in Tijuana and Rotterdam, the Netherlands, to start administering their injections again. It set up a Swiss bank account to receive payments from patients.

The caller said she would phone back but never did.

A NEW SEARCH FOR HOPE

The patients arrive every few weeks at the Corporativo Oncologico in Tijuana — Americans slumped in wheelchairs, hobbling on crutches or carried by loved ones toward the stem cells inside.

The clinic's main business is providing low-cost radiation treatments. But recently Dr. Armando Garcia, the head of the clinic, began administering stem cells for BioMark.

The field of stem cells is so new that almost anybody can claim its potential. Without subjecting their therapies to clinical trials — the standard of Western medicine — it is difficult to know if the treatments work.

At least three clinics trace their roots to the Institute for Problems of Cryobiology and Cryomedicine in Kharkov, Ukraine. Founded in 1972, the institute researched techniques for freezing biological samples for use in medicine and agriculture.

For nearly two decades, scientists at the institute experimented with solutions made from aborted fetuses, injecting people for ailments including diabetes, multiple sclerosis and depression.

In the early 1990s, Ukrainian researchers familiar with the institute's work started a Kiev company called EmCell, charging $25,000 per treatment.

Rader, who had heard about EmCell through a business contact, later formed his own company, offering treatments in the Bahamas.

The Bahamian government asked him to leave in 2000 after a New York television station aired a critical report.

Rader, who said his cells come from the former Soviet republic of Georgia, now meets patients one weekend a month in the beachfront city of La Romana in the Dominican Republic. His company, Medra Inc., is based in Malibu.

One of the busiest overseas clinics is run by Dr. Hongyun Huang, a 49-year-old Beijing neurosurgeon who says he has a waiting list of more than 1,000 foreign patients.

Huang returned to China in 2000 eager to try them in humans. He treated people with spinal cord injuries before taking on patients with amyotrophic lateral sclerosis, or ALS, injecting the cells into holes drilled into their skulls.

Most of his patients are from the United States and Europe. They pay $20,000 each for the surgery.


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