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!
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At least some of the older HIV-drugs has dropped in price dramatically and are now affordable without subsidies. However newer drugs are often easyer to administrate and could have less side effects. /Patrick
ReplyDeleteThis is a nice and thoughtful blog. Thank you. It is good to be reminded that the process for drug approval is a long and costly one. On the other hand the situation in the United States at the current time is a dynamic one - and not enough is known yet about the causality and activity of XMRV. Knowing more will take time. The delving into this unknown could lead to the above scenario (new drugs or off-label existing drug), but on the other hand it could lead to something completely unexpected.
ReplyDeleteChris
Can Dr. Luckett (yet?) comment on imprlications for treatment in the alternative health world? For example,I believe I've read that coconut oil has strong antiviral, antibacterial, and antifungal properties that have been clinically, significantly useful in the treatment of HIV. I wonder if the alternative health world is looking into implications for treatment (tx) based on xmrv findings. Would it make sense to look at alternative treatments for HIV as a guideline?
ReplyDeletePaula
Paula,
ReplyDeleteThe issue with many natural compounds is despite being shown to have potent anti-viral activity in vitro, they have poor in-vivo activity. The reason is that whatever you ingest gets brought to the liver, and metabolized through "First Pass" metabolism - a lot of compounds get inactivated by the Cytochrome P450 enzyme system, and through glucoronidation - where they are then excreted in bile. In pharmaceutical development, the practice is often to isolate some of these converted compounds, find out how they were acted on by the liver, and modify them by say replacing a hydrogen with a fluorine, so that it will slip by the liver into general circulation unaffected. One compound that has relatively good bioavailability is chicoric acid. It is found in echinacea, and salad extract, one source - http://www.scalime.com/anglais/chirolineanglais.pdf
I am taking a medication for fibromyalgia (guaifenesin) but I seem to run into more problems than most with how fast it works. This appears very possibly linked to P450 cytochrome problem. Are there natural ways to inhibit P450 that might be useful and therefore useful with other possible alternative treatments? I know grapefruit inhibits P450 but then I read a study indicating grapefruit may increase risk of breast cancer, so dont' want to mess with that! I recently read about chlorophyllin for help with carcinogenic toxins in meat and other enviromental toxins as cancer preventive supplement (see life extension organization) and in that article, I read chlorophyllin inhibits P450--this appears to be part of its M.O.? I wonder if one took this with meds or supplements, if that would help with the P450 problem (but maybe it's not healthy to inhibit them too much; they also serve an important detoxing function, yes?). I read your post on chicoric acid. with this med I'm taking for fms, guaifenesin per Dr. ST. Amand's protocol, I cannot take any plant or fruit ingredients in supplements because they have salicylates that would block the guaifenesin (due to molecular structural similarity, they occupy same receptor site) Maybe chicoric acid, if just an acid, is extracted enuf where it no longer contains the plant ingredients. I will try to look into that. Thank you so much for your feedback to my post.
ReplyDeletePaula
Dr. Luckett:
ReplyDeleteYour blog is terrific. I would like to send you an essay I published on living wtih CFS which is the basis for a forthcoming book. If you are interested. Is there an address I could send it to? I think your sister might appreciate it as well. I have had severe CFS for 17 years and have a brother and Dad with Asperger's. Best wishes, ES
This is an excellent blog, thank you Dr Luckett. AS you allude to, although it will be many years until an FDA-approved treatment for XAND/CFIDS becomes available, it is entirely possible that an effective treatment will emerge as early as this year (2010). Because of the possibility that XMRV is causal, clinicians and researchers are currently testing dozens of existing agents, and if one of them proves to be effective, then physicians and patients who are willing to go off-label (and who can afford to do so) will finally have an available treatment.
ReplyDeleteCheers,
Drew