May 10, 2012
The Food and Drug Administration on Thursdayissued a safety alert about an experimental treatment for multiple sclerosis a year after a Canadian woman died from the procedure in Orange County.
The warning says the FDA has learned of death, stroke, blood clots and other complications as a result of the angioplasty procedure that uses a balloon to open veins draining from the brain and spinal cord.
Maralyn Clarke of Calgary, Alberta, Canada, traveled to Costa Mesa for vein-opening surgery aftermultiple sclerosis left her unable to work. Her husband, Frank Lamb, said she would have mortgaged their house if necessary to fund the $8,000 procedure. She died five days afterward of a subdural hematoma, or bleeding in the brain. On Thursday the FDA issued a warning about the risks of the unproven procedure.
Maralyn Clarke, 56, died last April at Hoag Hospital, five days after undergoing the procedure at Synergy Health Concepts' outpatient surgery center in Costa Mesa. She is believed to be the world's third documented fatality.
In October, The Register published an investigation of the controversy surrounding the treatmentand detailed the circumstances surrounding Clarke's death. Clarke had traveled from Calgary, Alberta and paid $8,000 in cash for the procedure.
Dr. Michael Arata, the interventional radiologist who performed Clarke's angioplasty, said more research is needed but the patients he spoke with Thursday were not concerned. He said the procedure has a comparable safety record to common elective surgeries such as liposuction.
"I don't think this means anything for our practice," Arata said. "There is the potential for these things to happen, which all our patients understand. It's merely conveying the obvious: If you're going to do something, know there are risks, even life-threatening risks."
In 2009, an Italian vascular surgeon whose wife has MS published a study that found narrowing, twisting and blockage in the veins leading from the brain in MS patients. He said when he dilated their veins, their MS symptoms improved. He named the narrowed veins "chronic cerebro-spinal venous insufficiency," or CCSVI.
Since then, a number of studies have been underway. Canada has banned the procedure outside of clinical trials. Arata and his partners have travelled throughout Canada marketing the procedure, and a large number of Canadians, including Clarke, have traveled to Orange County for treatment.
The FDA said studies have not shown a conclusive link between CCSVI and MS.
"Because there is no reliable evidence from controlled clinical trials that this procedure is effective in treatingMS?, FDA encourages rigorously-conducted, properly-targeted research to evaluate the relationship between CCSVI and MS," said Dr. William Maisel, chief scientist and deputy director for science in the FDA's Center for Devices and Radiological Health, in a statement. "Patients are encouraged to discuss the potential risks and benefits of this procedure with a neurologist or other physician who is familiar with MS and CCSVI, including the CCSVI procedures and their outcomes."
But some critics argue that there's no scientific evidence that CCSVI is an actual medical condition as opposed to anatomic variation. Others say the $8,000 cash procedure preys on the desperation of patients afflicted by MS.
"I think the FDA acted appropriately, given the lack of evidence that this procedure is effective and now the mounting evidence that this has potential for significant harm," said Dr. Michael Brant-Zawadzki, director of neurosciences at Hoag. "I would hope that the patients who are thinking about this procedure or their physicians read the FDA's statement and act accordingly."
Arata disputed the FDA's link to MS because he says CCSVI is a separate vein obstruction condition. He says angioplasty can improve the symptoms of a number of neurological conditions.
Ian Hubbert, 40, of Long Beach was treated by Arata in 2010. He said the vein widening helped with numbness and his ability to walk.
"That wouldn't deter me at all," he said of the FDA alert. "I've gained many things. I still have MS. I slightly feel some of the symptoms. I'm doing pretty good."
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