Empirical vs anecdotal evidence of XMRV results - the sliding scale
The need for transparency - and practicality
CTOT, I completely agree that we have yet to see empirical validation of XMRV/ME/CFS causality - much less similar scientific evidence of treatment efficacy. And when I hear about a successful therapeutic intervention for ME/CFS,
I first of all want transparency, so that I understand where on the sliding scale of evidence this intervention falls. So when I hear of spectacular single or multiple-case successes, I can intelligently assess whether it is scientifically reasonable to call this a cure or not.
Why entertain alternatives?
That said, beggars can't be choosers, and our patient community definitely falls within the former distinction. As Mike infers, if we limit ourselves only to treatments endorsed by clinical trials that have made it all the way to Phase III - IV, we might wait a long, long time. Which isn't always an option, and Mike's dire pre-treatment status is a vivid example of that.
Scientific perfection vs Breakthrough Innovations
I believe one of the single biggest impediments to effective treatment for ME/CFS has been the medical profession's terminal case of "groupthink", and aversion to out-of-the-box thinking. Look at Dr Zamboni and his radical way of looking at MS - iron accumulation in the brain resulting from blocked veins. Why the SAM HILL did it take so long for the medical community to see this? (and yes, like XMRV, the theory of Chronic Cerebrospinal Venous Insufficiency and its treatment still need to be scientifically validated). My observation is that medical guidelines can entrench best practices so rigidly that they fossilize and create the kind of intellectual rigidity that paralyzes the medical profession when they see a complex, multi-system case. No wonder it took an innovative outsider to shake things up with XMRV.
The Rare Disorders Precedent: Orphan Drugs
Also, in the arena of Rare Disorders (and one might argue that some of the subsets of ME/CFS might qualify), where patient sample size is extremely limited, one will NEVER have the numbers to be able to say, "Treatment A cures all cases". One might never get the 300-3000 patients needed, for example, for a Phase III clinical trial. Rare disorder organizations and clinicians recognize this, and weigh the treatment urgency and the patient's clinical status, with the risks of a given "orphan" therapy. And prescient governments enact Orphan Drug legislation (eg. the EU and the US have such legislation - Canada still does not), so that vital medications that have not passed full scientific muster, can be made available to desperately ill patients with no other therapeutic options. (Hence Ampligen received Orphan Drug status in the EU, and was available through a non-legislated Compassionate Program in Canada, even though the product hadn't passed full clinical trials.)
So where are you on the evidence spectrum. How much do you need?
I'm a nerd, and I like science. But I'm also a pragmatist, and for that reason, while I'm whispering incantations for XMRV to be "it", so that we have some understanding of why I haven't been able to fight off a common parvovirus infection. I'm also carefully reviewing as much of the alternative literature as possible to better understand my options to address this possible retrovirus XMRV, move out of the chronic illness shadows, and return to living life in great honking bites again. And yes, I'm on the VipDx XMRV diagnostics list. After all, this is year 11 for me, and counting.
Eg. Low-dose Naltrexone as an Alternative Therapy - efficacy may never be "proven"
Which is why I'm also on Low-dose Naltrexone (LDN) now. Yes, LDN has research studies, but not right through to Phase IV. That said, there appears to be a chorus of rheumatology, neurodegenerative patients - and HIV patients - who are benefiting from it. It's discussed on most association websites for organizations from Crohn's to ImmuneSupport to Arthritis to MS to AIDS. Abundant anecdotal evidence, partial scientific evidence. An added benefit is that high-dose naltrexone HAS had rigorous safety studies, and I've made the (probably reasonable) leap of faith that if it's not toxic over long-term use at a high dose, then it's probably OK at an ultra-low dose. But I do bristle a tad when some of the LDN websites pass LDN off as "proven" when it just isn't.
And I remain mindful that LDN will likely NEVER get the full-blown clinical trials needed to definitively prove its efficacy. It's off patent, and there's not much business incentive now for a pharma to pay the $200 million or so it takes for a full series of clinical trials. In other words, I'd consider LDN "alternative" - and it may well always be in that realm. But for now, I'm "in".
Balancing urgency vs risk
Alternative therapeutics are often the only door for patients in dire circumstances. When you hear of a spectacular turnaround such as Mike's, I immediately think: Publish it, publish it, publish it! This may very well be one of those "out of the box" breakthrough innovations that could bring us back to health. And it might be the very first link in a chain from single-case study to multiple case study to... clinical trials. Or it might be a treatment that isn't patentable - so like LDN, in the absence of an angel investor, it may never achieve full scientific blessing - even if it merits it.
A modicum of "Informed Consent"
What I look for with alternative meds is some feeling of "informed consent". Is the patient fully informed of all the known risks - and also apprised of the uncertainty in the treatment? Or is it passed off as a scientifically-proven treatment, when it is not? I want to know the risks or uncertainty around alternative therapies, and successes defined as scientific or anecdotal. And I am concerned that many patients might not be able to discern the difference when anecdotal evidence is presented as proof. It's all in the presentation - and in my view, with transparency comes credibility. There is no shame in being an innovator.
Risk associated with Alternative Medicine - a personal choice
As for risk, I've already crossed the barrier of travelling to another country for a potentially risky procedure (in my case a heart biopsy in Germany to confirm a chronic viral infection related to my ME/CFS) that was considered "alternative" in North America, but is abundantly documented in European peer-reviewed research, and is standard in Germany for patients with "atypical angina" and viral heart disease. (And yes, I'll be posting more when I'm up to it). But I knew the risks going in, and frankly, didn't have a choice to ignore my virally-induced heart failure, as my Canadian docs did.
Transparency and practicality: those are my two criteria for feeling comfortable on the spectrum from anecdotal to empirical evidence.
As for what I look for in a forum on ME/CFS, it's a combination of: the quality and timeliness of information; openness to both ends of the alternative/empirical rigor spectrum; user-friendly organization; and a healthy tone, which for the most part this website truly embodies. An admin issue, and in the interests of clarity - might I suggest we split this thread into: 1) Alternative therapies for ME/CFS and XMRV; and 2) Discussion of XMRV Test Results?
Let's keep it real.
