Controversial Down's syndrome testing gets Swiss go-ahead

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Controversial Down's syndrome testing gets Swiss go-ahead

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US journal prints controversial bird flu research

"Flu tests strips can be seen in a laboratory in the central German city of Hanover in 2009. The US journal Science published research Thursday on how a mutant bird flu may spread among mammals and possibly humans, following months of controversy over the risks of bioterrorism. (AFP Photo/Nigel Treblin)" title

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Group Takes Aim at Controversial 'Disorder'

PJ James' Extreme Weight LossMore Health HeadlinesBaby Saved by Smallest Artificial Heart'Idol' Winner to Get Kidney Surgery'Ridiculously Photogenic Surgery Girl' Goes...Hospitalized Man Learns He's IntersexIn The NewsArthritisAllergiesDr. Richard BesserCold & Flu Home> Health'Sensory Integration Therapies' Lack Evidence, AAP SaysBy DAN CHILDS (

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Tennessee governor signs controversial "gateway sexual activity" bill

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FDA Issues Warning on Controversial MS Treatment

HealthDay – 1 hr 34 mins ago THURSDAY, May 10 (HealthDay News) -- Doctors and patients need to be aware of the potential risk of injuries and death associated with an experimental treatment for multiple sclerosis called liberation therapy, the U.S. Food and Drug Administration said in an alert issued Thursday.

Liberation therapy is used to treat chronic cerebrospinal venous insufficiency (CCSVI) -- a narrowing of veins in the neck and chest -- believed by some to cause multiple sclerosis (MS) or worsen the disease. They think it does so by impairing blood drainage from the brain and upper spinal cord.

The controversial procedure uses balloon angioplasty devices or stents to widen narrowed veins in the chest and neck. But the FDA has not approved this treatment for chronic cerebrospinal venous insufficiency, and the agency said it has learned of deaths, strokes, damage to the treated vein, blood clots, cranial nerve damage, abdominal bleeding, and migration of stents in the body as a result of the treatment.

Also, studies examining a possible link between the two conditions are inconclusive, and the criteria used to diagnose chronic cerebrospinal venous insufficiency have not been adequately established, the FDA said.

"Because there is no reliable evidence from controlled clinical trials that this procedure is effective in treating MS, FDA encourages rigorously conducted, properly targeted research to evaluate the relationship between CCSVI and MS," Dr. William Maisel, chief scientist and deputy director for science in the FDA's Center for Devices and Radiological Health, said in an agency news release.

"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," he added.

MS is a progressive autoimmune disease that affects the nervous system. Its underlying cause is unknown.

The FDA also is notifying doctors and clinical investigators who are planning or conducting clinical trials using medical devices to treat chronic cerebrospinal venous insufficiency that they must comply with FDA regulations for investigational devices.

Dr. Fred Lublin, director of the Corinne Goldsmith Dickinson Center for Multiple Sclerosis at Mount Sinai School of Medicine in New York City, welcomed the alert. "The FDA's action is well-founded and provides an important safeguard for individuals with MS," he said.

"There are safety issues with the procedures associated with CCSVI, as detailed in the FDA alert," Lublin said. He also said the very existence of chronic cerebrospinal venous insufficiency is unclear. And, "whether there is any relationship between CCSVI and MS, as either a cause or consequence, is unproven," he added.

Without scientific studies supporting the treatment of chronic cerebrospinal venous insufficiency in patients with MS, the procedure cannot be recommended, Lublin said.

More information

The American Academy of Family Physicians has more about multiple sclerosis.

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