When Can Patients Expect Approved Therapies?

The availability of effective therapies for ME/CFS, FMS, and Gulf War Syndrome is still quite a ways off. Pharmaceutical companies have expressed a great interest in screening currently available HIV therapies, and compounds that did not pan out for treating HIV.  Likely it will be four years before the FDA approves any existing drug for treating XAND disorders - By next summer a number of drug candidates that work against XMRV will be selected for Phase II clinical trials (A Phase I trial is not necessary for a new indication), followed by a larger scale Phase III trial, which will likely not be completed well into 2012, with approval in 2013!  For new chemical entities, it will be even longer - at least that long for protease inhibitors (purifying the protein, doing X-ray crystallography studies, and finding small-molecule inhibitor candidates), then starting from scratch with phase I studies - what is going to turn out to be about a 10 year process, and likely the FDA won't grant accelerated review.

It's not to say that when results from ongoing studies begin to surface, that doctors won't begin the label of practicing current HIV drugs off-label to XAND patients.  However, such patients will have to shoulder the cost of treatment themselves, as insurers will be very reluctant to cover a drug which is not indicated for a particular disorder by the FDA.  High drug costs in the United States, which has been decried as criminal by AIDS activitists, will present a formidable barrier to most people.  In some countries with publicly funded health care systems, these drugs will be even harder to obtain: HIV patients have programs where drugs are given free of charge at clinics, and are not available in community pharmacies.  In some jurisdictions like British Columbia, which has a publicly funded drug plan, despite being approved for use by the federal government, the drug plan will do time-consuming studies which last on the order of 2 or more years, further delaying availability of treatment - so much for universal health care!

Scientific Consensus is Building Towards XMRV as Causal Agent of ME/CFS

I had the opportunity to speak with one of the researchers who attended the  Cleveland Clinic conference a short while back.  Since the landmark study appeared in Science last month, several groups have been in a race to replicate the findings of Dr. Judy Mikovits - preliminary results are beginning to come in, while other researchers are waiting for their virus samples to arrive.  There is now reasonable certainty that XMRV is the causal agent of CFS/ME, as opposed to probable grounds at the time of publication.  It is hoped that by the middle of next year XMRV will beyond a reasonable doubt be shown to be the causal agent of ME/CFS.

XMRV seems to follow Koch's postualtes, except for the first one: "The microorganism must be found in abundance in all organisms suffering from the disease, but should not be found in healthy animals."  The third "The cultured microorganism should cause disease when introduced into a healthy organism", and fourth "The microorganism must be reisolated from the inoculated, diseased experimental host and identified as being identical to the original specified causal agent." has yet to be shown.  However, the main criticism of Koch's postulates is that it does not account for asymptomatic infections.

It is worth noting that there was considerable attention paid to possible therapeutic agents for ME/CFS.  This is still very much of a gray area at this time - and it will be several months before it is known which existing HIV drugs will work against XMRV - only a couple Reverse Transcriptase inhibitors, and Raltegravir have shown early promising results.  This in itself has already led to a few doctors prescribing AZT off-label to ME/CFS patients outside of clinical trials, in addition to a handful of individuals purchasing the drug online from internet pharmacies - however AZT IS NOT a drug that should be taken without medical supervision under any circumstance.