Multiple sclerosis vein opening: a timeline

In Canada's multiple sclerosis community, 2010 began with enthusiasm for a new Italian treatment to relieve the sympoms of MS through surgery, an enthusiasm that fairly exploded in the media and through social networks.

A handful of Canadian provinces and the federal government promised to oversee controlled studies to explore the controversial treatment.

But only some of these are underway, and now, in May 2012,the U.S. Food and Drug Administration (FDA) issued analert about the potential dangers of this "unproven treatment for multiple sclerosis."

Italian Dr. Paolo Zambonifirst proposed the simple plumbing concept of blocked veins from the brain that could be cleared to relieve MS symptoms. The idea captured people's imaginations and took off before researchers and politicians could catch up.

The cold, hard look of science eventually dampened expectations somewhat. Speaking in Toronto in April, Zamboni himself reflected on the sobering and ambiguous results of a study that showed half of MS patients had blocked veins, as did a quarter of healthy people.

"I recommend people under treatment to wait for new evidence," Zamboni cautioned.

MS patients facing worsening symptoms including blurred vision, losing the ability to stand or walk, and short-term and long-term memory problems felt they couldn't wait for the slow pace of large-scale, randomized, controlled trials especially if vein opening could actually change the long-term course of a disease that naturally waxes and wanes.

By May 2012 , at least seven studies were underway in North America, sponsored by the MS Society of Canada and its U.S. counterpart,to determine whether vein abnormalities and MS are linked, as Zamboni proposed.

Here is a timeline of recent notable events surrounding the Zamboni treatment:

Feb. 8, 2010: MS patients were anxiousto participate ina Buffalo studylooking for narrowed veins. Asked about skepticismover his unorthodox treatment approach from the medical community,Zamboni tells reporters:"My suggestion is to investigate patients as soon as we can, not to simply criticize. Look and confirm the data."

Feb. 10, 2010: About55 per cent of patientswith multiple sclerosis and up to a quarter of healthy people studied show narrowingof their neck veins that may be a risk factor in the neurological disorder, a preliminary study shows.

April 7, 2010: A"desperate bunch"attend a forum hosted by the Multiple Sclerosis Society of Canada,wanting to knowwhat kind of testing and experimental treatment approaches work best to open neck veins.One U.S. clinic that started doing Zamboni's procedure stopped after a stent put into a patient's vein went into his heart. Another patient died of a cerebral hemorrhage after a similar surgery.

April 13, 2010: As hundreds of Canadians who with multiple sclerosisdemand accessto a new procedure that MS specialists warn isat best experimental and at worst dangerous, CBC News follows aCalgary bloggerinto theoperating suite inPoland as she has the procedure.Ginger MacQueensays her experienceisall the proofshe needs.

April 14, 2010:Zamboni publicly distanceshimself from initial media claims of a cure, advising"peopleunder treatment to wait for new evidence" rather than follow "blogger patients." Some neurologists,vascular surgeons and MS patientsagreethat following proper procedure is essential in determining if the MS treatment is safe and effective.

May 5, 2010: CBC News reportsa handful of Canadians with MShad angioplasty to open their neck veinsunder the radarin this country, paid for by provincial health plans, before surgeons voluntarily stop performing it here.

June 11, 2010: Multiple Sclerosis Society of Canada announces $700,000 in funding to supportseven new research projectsinvestigating the relationship between multiple sclerosis and impaired blood drainage from the brain and spinal cord, known aschronic cerebrospinal venous insufficiencyor CCSVI.

June 15, 2010: The vein-opening procedureshould be offeredin a randomized clinical trial under the supervision of an ethical committee, Zamboni tells the House of Commons health committee by videoconference. He maintains the procedure has resulted in better cognitive and motor function, and fewer symptoms of chronic fatigue, among people with MS who were treated with balloons. A Toronto vascular surgeonsaysa blinded trial of the treatmentshould be done in Canada.

July 28, 2010: SaskatchewanPremier Brad Wallsays his province is willing to fund trialsof the promising but unproven treatment.

August 23, 2010:Newfoundland and Labrador'shealth minister says his province is willing to fund trials to test Zamboni's therapy following a meetingof provincial health ministers.

Sept. 13, 2010: Five months after the procedure, MacQueen saidshe has had no numbness, tingling or spasticity in her muscles. Herheat intolerance and bladder spasms are also gone. Scientists acknowledgeherpersonal experience is compellingbut caution thereare no objective measurements showing real, long-lasting improvements.

Oct. 26, 2010: Some Canadians who've travelled out of the country to treat theirnarrowed or blocked neck veinstell CBC Newsthey'll submit aclaim for medical costson their income tax returns another idea discussed on blogs and Facebook.

Nov. 18, 2010: CBC Newsreports the deathof 35-year-old Mahir Mosticof St. Catharines. Mostic died on Oct. 19, one day after doctors in Costa Ricatried to dissolve a blood-clot complication that formed around a metal stent used to prop open his a vein in his neck. Like some other patients, Mostic spent thousands of dollars for asecond trip to a foreign clinic to have his veins reopened. Vascular surgeon Dr. Marcial Fallas of Clinica Biblica in San Jose announces hewon't try a stent againunless it is proven to work specifically in neck veins.

Dec. 29, 2010: Mostic's girlfriend, Bedrana Jelin,grantspermissionto broadcast a home video of his attempts to walkin the hopes it will spurofficials to help other Canadianscaught in the same situation.

Mar. 1, 2011: The Ontario government creates an expert panel to define best practices in follow-up care for people who have gone abroad for CCSVI treatment. It alsopromises to support the federal government if a national MS registry developed.

April 5, 2011: Manitobaannounces that it will$5 million for clinical trials of the CCSVI procedure.

June 29, 2011:The federal governmentreverses its standand agrees to fund clinical trials of CCSVI.

July 8, 2011: CBC News reports the death ofMaralyn Clarke, 56, of Calgary. Clarke had her neck veins opened at a clinic in California on April 13, and was taken off life support five days later. Her official medical record said she had an "irreversible brain injury."

July 27, 2011: The Alberta governmentannounces a web-based studyto beconducted by researchers at the University of Calgary and the University of Alberta, as well as experts in the MS community.

August 24, 2011: Researchers at the University of Calgary release astudy documenting serious health complicationsin multiple sclerosis patients who travelled outside of Canada for liberation therapy. Thestudy followed justfive patients, who were treated in Calgary hospitals inthe Fall of2011 after complications from their surgeries.

Dec. 8, 2011:B.C. launches a new, voluntary patient registryto record the positive and negative impact ofliberation therapy for people with multiple sclerosis. Participantswill be followed for three years through four telephone interview surveys.

Feb. 24, 2012: In Saskatchewan, thedeadline closes for applicationsto participate in a two-year, double-blind trialof liberation therapy. Names will be drawn to fill 86 spots from among nearly 700 applicants. The study will take place inNew York state.

April 18, 2012: Federal Health Minister LeonaAglukkaq announcesa research proposal for a clinical trial for CCSVI in persons with MS. The trial is to determine the safety ofliberation therapyand obtain better evidence on patient outcomes.

May 10, 2012:The U.S.FDA alerts"health care professionals and patients about injuries and death associated with the use" of liberation therapy. The "FDA encourages rigorously conducted, properly targeted research to evaluate the relationship between CCSVI and MS," says Dr. William Maisel, chief scientist and deputy director for science in the FDA's Centre for Devices and Radiological Health.