The article’s tone mimics the roller-coaster nature of these debates: stories of miraculous recoveries, "groundbreaking" research by mavericks, yet also caution by skeptical experts, conflicting evidence, and calls for more trials. It could’ve navigated this debate with a bit less emotion and fewer poignant adjectives, but in truth it’s tough to summarize in a flat way the suffering of patients, their hope for a better life, and their anger at the hesitancy to disseminate what they see as an answer to their prayers.
So yes, the article could’ve been less emotionally charged, and no doubt some readers will focus on the hopeful anecdotes, such as those at the beginning and end. But all and all, we think it does a solid job of hanging counterweights on that positive emotion, adding many cautionary statements — sometimes from the practitioners of liberation themselves.
Our favorite line, and maybe the heart of the issue, is when it shows Dr. Bonn citing the need for rigorous studies, while understanding patients’ frustration, their suffering, and the roller coaster ride they’ve been on. It expresses empathy without false hope.
We read that Paulette O’Leary (of Toronto) paid $13,000 for the procedure at a US medical center. However, as it seems the procedure was performed as part of a clinical trial, we’re unsure how generalizable her costs were to other situations — to what other patients or insurance companies might pay.
Since the article implies that liberation is not commonly available outside of clinical trials, we’ll take this mention of costs as sufficient for an experimental procedure.
There’s a mixed bag here. First, the most salient statement that liberation "offers quality-of-life improvements that are impossible with any of the seven approved MS drugs" (See criterion for Compare the new approach with existing alternatives? – below.). Maybe we’ve misunderstood the author’s intent; maybe "offers improvements" was intended to mean "offers the hope for improvement," commenting on patient point-of-view of the potential instead of evidence for the reality. The author seems clear elsewhere that the benefits are uNPRoven. However, the sentence as written is so broad, it has to earn a strikeout on this criterion.
Now to the rest of the article. Although formal clinical evidence on benefits isn’t covered, we’re given a sense of the outcomes from certain studies and, anecdotally, from certain physicians. The article mentions that Dr. Bonn treated only three MS patients, "but the results were good." That statement is way too vague, and whether it was the journalist or Bonn’s take, it shouldn’t be reported without clarification. What exactly does "good" mean — miraculous benefits? Temporary? Encouraging?
Then we hear that Dr. Scalfani has given the procedure to about 20 patients, "a few with ‘miraculous’ results," the first developing a clot. That’s not data but it shows the limits to the anecdotal benefits mentioned earlier, ie, most of his patients did not have miraculous results. Earlier we read, generally, that "not all MS patients get better after angioplasty." Such qualitative statements fit with the earlier report of Zamboni’s study of the not universal prevalence of CCSVI in MS, and its appearance in two comparator groups of people.
While it’s early to quantify outcomes, since the article isn’t covering any particular late-stage study, there is enough focus on harms to counterbalance the anecdotal benefits available at this time. We’re told that up to 47% of Zamboni’s cases (in a study? in practice?) had re-narrowing of veins after angioplasty. We hear about the complications at the Stanford study using stents, one open-heart surgery and another death.
The author states that patients with MS feel they are being discriminated against because "in their view, they have little to lose." It’s important then that we’re told the serious potential complications of balloon angioplasty in general (and the associated medications if stents are implanted), ie, "rare" vein ruptures and clots. It would’ve been better to quantify these more knowable harms. We’re also told of the experience of angioplasty, threading a tube deep through a vein while under sedation.
We also hear the potential perils of having an experimental procedure done by physicians who are new at it. Of note was the story of the blood clot that developed the first time Dr. Sclafani’s did the procedure.
The article qualifies the preliminary level of evidence in several explicit ways, observing that many experts are unconvinced, citing some of the conflicting evidence regarding the contribution of CCSVI and the outcomes for liberation, and stating that the clinical hero of the story, Dr. Bonn, himself "sees the need for rigorous studies." A particularly important passage in the article comes when we’re told that MS societies are spending their money on studies of diagnosis and epidemiology, not treatment. It highlights that we’re not even sure of the role of these veins, which needs to be established before addressing whether the treatment is appropriate or effective.
We give props to the reporter for devoting space for Ms. O’Looney, of the MS society, to address patients’ urgency for the procedure. The rationale for their approach sets a cautious, fair-minded tone for the rest of the article.
It seems that many readers would walk away thinking that there is no clinical evidence yet to support the use of the procedure, but that trials are ongoing and desired. The article may have benefited from a little more weight on the lack of clinical trials on liberation and the difference between that type of evidence and pathophysiological evidence (eg, Zamboni’s studies of the underlying vein disorders).
It’s also good, for evaluating the quality of evidence, to know the number of patients involved when outcomes are described, and the article mentions the rough numbers of patients in the Zamboni study and Scalfani’s anecdotal series.
An exception to the fairly balanced discussion of the evidence comes near the end when the author states that liberation "offers quality-of-life improvements that are impossible with any of the seven approved MS drugs." There is nothing that substantiates this claim from the information provided. (See criterion for Compare the new approach with existing alternatives? – below.)
We were torn about how to judge this criterion. The story seems to imply – although it’s not crystal clear – that angioplasty is only for MS patients found to have the CCSVI condition. And the story does raise doubts – "poor vein drainage doesn’t bother everyone who has it." But the story could have done a better job in explaining that multiple sclerosis is a disease that has a variety of presentations. Some patients have very indolent disease over a long period of time without serious progression. The story could have been clearer that this may not be appropriate for all patients with MS. For example, some patients have MS that is quiescent. Should they have their blood vessels fixed?
Nonetheless, we’ll give the story the benefit of the doubt on this criterion.
The article includes optimistic interviews with patients and physicians, but also cautionary interviews with Ms O’Looney and admissions of treatment failures and selective success from Dr. Scalfani. Dr. Bonn himself, the story’s hero and smiling face in the photo, states that there’s a need for rigorous studies.
Conflicts of interest from the physicians quoted and MS Society interviewee are given. We would have liked to hear more about, or specific examples of, those "skeptical experts" mentioned generically, so we can judge their potential interests ourselves.
The article claims that liberation offers quality-of-life improvements that are impossible with any of the approved drugs, which modify the immune system. The claim is not substantiated, and we think it goes too far considering that, without evidence of efficacy, we don’t know how many MS patients receive such improvements with liberations, or if trials will prove any statistically significant benefit. Presumably the FDA-approved drugs have a body of clinical evidence, so anecdotes do not put liberation on equal footing with these drugs for comparison.
The statement could’ve been softened to refer more to the procedure’s potential, which is essentially hypothetical without evidence.
The article implies that the procedure is experimental, not reimbursed, and that some doctors who had been performing it outside a clinical trial have been told to stop for legal reasons. We’re also told of patients going to Bulgaria and Poland to have the procedure. We think these pieces of information sum up to a picture that liberation is not commonly available in the US, pending clinical trials.
It would’ve been better if the availability was explicitly stated.
We’re told that liberation is a novel application of angioplasty, which is commonly used for vessel conditions like coronary heart disease. The article also traces some therapeutic mechanisms and speculated mechanism for the pathology underlying this treatment.
It’s clear that this story didn’t rely on a news release.