Popular demand for an unproved surgical treatment for multiple sclerosis shows the growing power of social media to shape medical practice—for good and illBy
Katie Moisse | Tuesday, February 8, 2011
When vascular surgeon Paolo Zamboni reported in December 2009 that inflating a tiny balloon inside twisted veins in the neck provided relief from multiple sclerosis, he created quite a stir. The idea that surgically straightening crooked veins could somehow benefit a degenerative nerve problem was astounding. Physicians were skeptical. Zamboni himself concluded that his findings should be subjected to more rigorous testing. Regardless, many people with MS, which affects at least 250,000 people in the U.S., immediately began clamoring for the unproved treatment. Their demands, amplified through a wide range of social-networking platforms, soon proved impossible to resist. In the past year, for instance, hospitals in California, New York, Italy and Poland have offered the Zamboni treatment—at a cost of $10,000 or more because it is not covered by insurance.
Doctors found themselves playing catch-up every step of the way. Even before Zamboni published his results in the Journal of Vascular Surgery, a post on Patients¬LikeMe.com (an online patient community) boasted news of his research, useful links and a dedicated Facebook URL. Community networks traded contact information detailing who would offer the procedure and where. Before-and-after videos were posted on YouTube. Like AIDS activists of 30 years ago but armed with much more powerful communications tools, patients challenged researchers and medical centers to explain why it was taking so long to offer Zamboni’s approach. Yet most MS experts believe that undergoing the procedure at the moment is a very risky proposition.
This episode highlights a growing challenge for patients: how to temper enthusiasm for experimental therapies, now widely and effectively marketed through personal testimonials posted online, until evidence shows that the treatments are likely to do more good than harm. “You can never blame people for being excited about something that sounds like good news, especially when they have a serious disease,” says Aaron Miller, a professor of neurology at Mount Sinai School of Medicine and chief medical officer for the National MS Society. “I think these social-media sites can have a positive function in that they allow patients to discuss research and share their experiences.” But, he adds, “they have a very major risk in leading patients to embark on therapeutic courses that are not necessarily appropriate for them or haven’t been established as being scientifically valid.”
A Dangerous Game
In the case of Zamboni’s work, it is easy to see how patients might be tempted to jump the gun and seek a treatment that initially sounds exciting. After all, the study findings came from a reputable surgeon (though not an MS researcher) publishing in a respected journal. As Daniel Simon, an interventional radiologist in Edison, N.J., says of the work: “It wasn’t Bob’s Journal of MS and Autobody Repair; it was the premier journal of vascular surgery.”
It is also easy to see why racing to get treatment can be a dangerous game to play. In the first place, one study, even a well-done one, does not show that a therapy is ready for prime time. Often in medicine, early positive findings wash away later. And Zamboni himself pointed out that the study had limitations. The small trial was not randomized, double-blinded or placebo-controlled—the combination of which is considered the gold standard in clinical research. Participants also continued to take immune system–modulating therapies known to reduce symptoms.
In the case of MS, as with some other disorders, the difficulty of knowing whether a treatment that seemed to work really did have an effect in a study is compounded by the erratic nature of the disease. The most common form—relapse-remitting MS—has a variable course marked by flare-ups amid symptom-free periods. So it is difficult to know if a certain treatment actually works or was simply taken during a naturally occurring remission. Patients taking placebo have often reported substantial improvements, according to Mount Sinai’s Miller.
Furthermore, the ultimate cause of the disease remains obscure, which makes it hard to gauge the appropriateness of an intervention. Everyone agrees that MS destroys the fatty myelin sheath that enwraps many nerve fibers. Stripped of their insulation, the wires of the nervous system lose their ability to transmit the electrical signals needed for movement, sensation and vision. Most researchers assume some kind of autoimmune response, in which a person’s own defense system attacks rather than ignores the body’s own tissues, is at work.
Given that current MS treatments are a far cry from a cure and do not work for everyone, some people with MS feel there is no harm in trying something that might improve their quality of life. The answer, of course, is that it could also make their quality of life much, much worse. Any surgery carries the risk of infection, and the procedure itself can actually damage the blood vessels, making them more vulnerable to clots and aneurysms.
Without more rigorous clinical trials, it is almost impossible to weigh accurately the potential costs and benefits. The operation to straighten out and puff up crooked and collapsed veins, called venoplasty, is almost identical to cardiac angioplasty—a common treatment for diseased coronary arteries. (Side effects for both include blood clots, infections and severe internal bleeding.) After piercing through a vein in the pelvis, a spaghetti-size catheter is threaded up through a vein near the spine and into the neck, where a balloon on the catheter’s tip is inflated to pop the neck vein back to its normal shape—just like squatting in jeans that have shrunk in the wash stretches them, Simon explains.
But veins, which are more pliable than arteries, often regain their tortuous shape within months after venoplasty, requiring multiple procedures. One MS patient in the U.S. reportedly died from a brain hemorrhage while recovering, and another needed emergency surgery after a stent implanted to permanently straighten a vein dislodged and migrated to the heart.
Ready for Testing
One thing in favor of Zamboni’s approach is it has a reasonable scientific rationale, which not all potential therapies touted on the Internet have. A close look at the characteristic plaques of scar tissue that lend the disease its name shows that they typically cluster around blood vessels. And that, Zamboni says, is key. Veins are flexible and can get twisted, slowing the rate of blood flow and potentially leaving waste and compounds such as iron to accumulate in the brain. Isn’t it possible, he wonders, the buildup triggers an inflammatory response? And if the inflammation lasted long enough, it could eventually end up targeting the myelin wrapping of the nerves. A similar mechanism had been linked to myelopathies, degenerative conditions of the spinal cord, which bear a pathological semblance to MS.
That is a lot of “if’s.” But some physicians consider Zamboni’s hypothesis and treatment plausible enough to test. And the National MS Society and the Multiple Sclerosis Society of Canada have pledged $2.4 million over the next two years to examine the role that problems with venous circulation might play in multiple sclerosis. “There is little doubt that the intense interest in [venoplasty for MS] played a role in the decisions by the National MS Society and the Canadian MS Society to fund further research,” Miller says. Still, it is just too soon, he believes, to offer the procedure unless it is a part of a clinical trial.
A lesson from this episode, Miller says, is that it is important for neurologists and other physicians to be aware of what patients are seeing and reading online. “We can’t bury ourselves in an ivory tower and function as though [social-media sites] don’t exist,” he notes. “What our patients are thinking, we need to address. We have to be aware of it and be prepared to discuss it with them logically.” Miller says his patients almost invariably have been able to engage with him. After he explains the lack of certainty about venoplasty for MS, he observes, they usually agree with his advice to wait. Just how long they will continue to do so, however, may depend a lot on what social media push next.
