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 an alert about the potential dangers of this "unproven treatment for multiple sclerosis."
Italian Dr. Paolo Zamboni first 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 anxious to participate in a Buffalo study looking for narrowed veins. Asked about skepticism over 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: About 55 per cent of patients with multiple sclerosis and up to a quarter of healthy people studied show narrowing of 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 know what 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 sclerosis demand access to a new procedure that MS specialists warn is at best experimental and at worst dangerous, CBC News follows a Calgary blogger into the operating suite in Poland as she has the procedure. Ginger MacQueen says her experience is all the proof she needs.
April 14, 2010: Zamboni publicly distances himself from initial media claims of a cure, advising "people under treatment to wait for new evidence" rather than follow "blogger patients." Some neurologists, vascular surgeons and MS patients agree that following proper procedure is essential in determining if the MS treatment is safe and effective.
May 5, 2010: CBC News reports a handful of Canadians with MS had angioplasty to open their neck veins under the radar in 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 support seven new research projects investigating the relationship between multiple sclerosis and impaired blood drainage from the brain and spinal cord, known as chronic cerebrospinal venous insufficiency or CCSVI.
June 15, 2010: The vein-opening procedure should be offered in 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 surgeon says a blinded trial of the treatment should be done in Canada.
August 23, 2010: Newfoundland and Labrador's health minister says his province is willing to fund trials to test Zamboni's therapy following a meeting of provincial health ministers.
Sept. 13, 2010: Five months after the procedure, MacQueen said she has had no numbness, tingling or spasticity in her muscles. Her heat intolerance and bladder spasms are also gone. Scientists acknowledge her personal experience is compelling but caution there are no objective measurements showing real, long-lasting improvements.
Oct. 26, 2010: Some Canadians who've travelled out of the country to treat their narrowed or blocked neck veins tell CBC News they'll submit a claim for medical costs on their income tax returns — another idea discussed on blogs and Facebook.
Nov. 18, 2010: CBC News reports the death of 35-year-old Mahir Mostic of St. Catharines. Mostic died on Oct. 19, one day after doctors in Costa Rica tried 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 a second trip to a foreign clinic to have his veins reopened. Vascular surgeon Dr. Marcial Fallas of Clinica Biblica in San Jose announces he won't try a stent again unless it is proven to work specifically in neck veins.
Dec. 29, 2010: Mostic's girlfriend, Bedrana Jelin, grants permission to broadcast a home video of his attempts to walk in the hopes it will spur officials to help other Canadians caught 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 also promises to support the federal government if a national MS registry developed.
April 5, 2011: Manitoba announces that it will $5 million for clinical trials of the CCSVI procedure.
June 29, 2011:The federal government reverses its stand and agrees to fund clinical trials of CCSVI.
July 8, 2011: CBC News reports the death of Maralyn 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 government announces a web-based study to be conducted 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 a study documenting serious health complications in multiple sclerosis patients who travelled outside of Canada for liberation therapy. The study followed just five patients, who were treated in Calgary hospitals in the Fall of 2011 after complications from their surgeries.
Dec. 8, 2011: B.C. launches a new, voluntary patient registry to record the positive and negative impact of liberation therapy for people with multiple sclerosis. Participants will be followed for three years through four telephone interview surveys.
Feb. 24, 2012: In Saskatchewan, the deadline closes for applications to participate in a two-year, double-blind trial of liberation therapy. Names will be drawn to fill 86 spots from among nearly 700 applicants. The study will take place in New York state.
April 18, 2012: Federal Health Minister Leona Aglukkaq announces a research proposal for a clinical trial for CCSVI in persons with MS. The trial is to determine the safety of liberation therapy and 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.