And I feel at least partly culpable for this fear ridden mindset by having spent a good part of the 1990s writing about the brutal laws of drug resistance. (In my defense, much of the fear seemed justified at the time: de jure and de facto serial monotherapy were more or less the law of the land back then--not only because we didn't know any better but also because new drugs were mostly approved one at a time, and we all felt rather desperate to add on each new one as it became available.)
Let's get right to the meat of it: EVERYONE I KNOW who is on an Atripla or Atripla-esque (that would include Truvada+Viramune and quite possibly Gilead's new "quad" FDC Stribild) regimen has successfully ELIMINATED their Saturday and Sunday doses (and a smaller number, the midweek dose, as in Wednesday, as well) and maintained an "undetectable" plasma viral load--for many, many years.
Forget for a moment the break this reduced lifetime pill burden imparts on your liver, kidneys, bones (lower risk of osteomalcia and osteopenia) and other body systems--I think the psychological impact of being freed from the daily and lifelong bondage to pill taking is nearly unquantifiable! And these two considerations don't even begin to touch on what is perhaps, given the world in which we live, the ultimate calculation for all of this: money.
Think of the savings to national health programs in South Africa, Uganda, Malawi and the like.
By taking two (or three--although admittedly there is only anecdotal data for the midweek-skipping protocol) fewer days of a $20,000 a year drug regimen, someone will be saving (or losing)--what's 2/7 of $20,000?--$5,714 (or $8,571 if you include the Wednesday skipped dose) a year. That's $476 (or $714) a month. Multiply that by the hundreds of thousands of people on these tenofovir-emtricitabine regimens and you have nothing short of a Counter Revolution.
Apply the same math (2011 sales figures) to annual Atripla sales of $2B and annual Truvada sales of $1.4B and the numbers take your breath away. The FOTO protocol alone would knock off $571M a year from Atripla sales and another $400M from those of Truvada. Looming patent expirations, for Bristol's efavirenz and Gilead's tenofovir and emtricitabine, will obviously lessen the cost savings component of this argument.
Twelve years ago next month, the Stop the Medness! cover of Poz hit the newsstands, and after a month or two of scrambling the prospect of skipping dose was pretty much put to rest, as QD, FDC and better tolerated regimens appeared on the scene and big pharma marketing machines rolled out their own version of Operation Dessert Storm via MD talking heads with supper club cash to pitch the limit-the-losses damage control messages. Similarly, cash hungry ASO's gobbled up the easy money, launching START projects and even DOT adherence programs to help the drug kings make sure folks get hooked up with their products ASAAP and to make certain they are faithfully refilling their prescriptions.
My fear is that it is now too late for the thousands or ten of thousands of people this information could have helped--much in the way that the too little, too late discussions of Is This My Beautiful Life? have arrived ten years tardy for the people that campaign could have helped. I can only hope I am wrong again.
Mike is due to complete his five-year licensing program in East Asian medicine in the spring of 2014 and is eager to return to the working world. He looks forward to applying the fruits of his study and life experience to helping people minimize the use of life-long drug taking and to discover more effective management of conditions for which suboptimal or no effective treatment currently exists.
In 2013 he presented his insomnia research at the biannual meeting of the Society for Acupuncture Research at the University of Michigan (Ann Arbor, MI) and to the Center for Integrative Medicine at the University of Maryland School of Medicine in Baltimore, MD. He currently serves as a peer reviewer for The American Acupuncturist, a quarterly research journal of the American Association of Acupuncture and Oriental Medicine. He can be reached in New York City at mbarr (AT) pacificcollege.edu
From 1990 until shortly before it closed its doors, he was part of the clinical research team at St. Vincent's Hospital in Greenwich Village, NY. His research and that of his colleagues has been presented at medical conferences world-wide and published within the pages of The New England Journal of Medicine, Lancet, Annals of Internal Medicine, Clinical Infectious Diseases and others. With Dr. Ramon A. Torres, he co-authored chapters for two medical textbooks. From 1992 to 1994 he served on the Immunology and Primary Infection committees of the AACTG of the National Institutes of Health/National Institute of Allergy and Infectious Diseases.