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Medical Forum / Diseases and Disorders / AIDS / December 20052004 HIV Standard of Care: early intervention = NO benefit
After years of promoting "early ARV" treatment as "life-saving", the pharma shills on this newsgroup are STILL biting their tongues over the July 2004 revision of the HIV Standard of Care as published in JAMA: "For less severely compromised individuals (ie, asymptomatic individuals with CD4 cell counts > 200/microL), there are no definitive data from prospective, randomized controlled studies to determine when antiretroviral therapy is associated with a survival benefit." My favorite parts are the disclosures about the outrageous conflicts of interest by the doctors who have been misleading about HIV treatment since the first AZT studies. Enjoy! susie ____ In the 7/14/04 JAMA article titled "Treatment for Adult HIV Infection: 2004 Recommendations of the International AIDS Society-USA Panel," Yeni et al. state: "Randomized clinical trials have demonstrated a survival benefit with the use of antiretroviral therapy by patients with severe immunodeficiency. For less severely compromised individuals (ie, asymptomatic individuals with CD4 cell counts > 200/microL), there are no definitive data from prospective, randomized controlled studies to determine when antiretroviral therapy is associated with a survival benefit. In the absence of such data, the decision to initiate therapy should be made based on survival and disease progression information obtained from observational studies, the consequences of moderate degrees of immune deficiency, and the long-term safety of antiretroviral drugs." --------------------------------- JAMA.2004 Jul 14;292:251-265. Treatment for Adult HIV Infection 2004 Recommendations of the International AIDS Society-USA Panel Patrick G. Yeni, MD; Scott M. Hammer, MD; Martin S. Hirsch, MD; Michael S. Saag, MD; Mauro Schechter, MD, PhD; Charles C. J. Carpenter, MD; Margaret A. Fischl, MD; Jose M. Gatell, MD, PhD; Brian G. Gazzard, MA, MD; Donna M. Jacobsen, BS; David A. Katzenstein, MD; Julio S. G. Montaner, MD; Douglas D. Richman, MD; Robert T. Schooley, MD; Melanie A. Thompson, MD; Stefano Vella, MD; Paul A. Volberding, MD Abstract: Context Substantial changes in the field of human immunodeficiency virus (HIV) treatment have occurred in the last 2 years, prompting revision of the guidelines for antiretroviral management of adults with established HIV infection. Objective To update recommendations for physicians who provide HIV care regarding when to start antiretroviral therapy, what drugs to start with, when to change drug regimens, and what drug regimens to switch to after therapy fails. Data Sources Evidence was identified and reviewed by a 16-member noncompensated panel of physicians with expertise in HIV-related basic science and clinical research, antiretroviral therapy, and HIV patient care. The panel was designed to have broad US and international representation for areas with adequate access to antiretroviral management. Study Selection Evidence considered included published basic science, clinical research, and epidemiological data (identified by experts in the field or extracted through MEDLINE searches using terms relevant to antiretroviral therapy) and abstracts from HIV-oriented scientific conferences between July 2002 and May 2004. Data Extraction Data were reviewed to identify any information that might change previous guidelines. Based on panel discussion, guidelines were drafted by a writing committee and discussed by the panel until consensus was reached. Data Synthesis Four antiretroviral drugs recently have been made available and have broadened the options for initial and subsequent regimens. New data allow more definitive recommendations for specific drugs or regimens to include or avoid, particularly with regard to initial therapy. Recommendations are rated according to 7 evidence categories, ranging from I (data from prospective randomized clinical trials) to VII (expert opinion of the panel). Conclusion Further insights into the roles of drug toxic effects, drug resistance, and pharmacological interactions have resulted in additional guidance for strategic approaches to antiretroviral management. Author Affiliations: Department of Infectious Diseases, Hospital Bichat-Claude Bernard, X. Bichat Medical School, Paris, France (Dr Yeni); Department of Medicine, Columbia University College of Physicians and Surgeons, New York, NY (Dr Hammer); Department of Immunology and Infectious Diseases, Harvard Medical School, Boston, Mass (Dr Hirsch); Department of Medicine, University of Alabama, Birmingham (Dr Saag); Department of Preventive Medicine, Universidade Federal do Rio de Janeiro, Rio de Janeiro, Brasil (Dr Schechter); Department of Biomedicine, Brown University School of Medicine, Providence, RI (Dr Carpenter); Department of Medicine, University of Miami School of Medicine, Miami, Fla (Dr Fischl); Department of Medicine, University of Barcelona, Barcelona, Spain (Dr Gatell); Department of HIV Medicine, Chelsea and Westminster Hospital, London, England (Dr Gazzard); International AIDS Society-USA, San Francisco, Calif (Ms Jacobsen); Department of Medicine, Stanford University Medical Center, Stanford, Calif (Dr Katzenstein); Department of Medicine, University of British Columbia, Vancouver (Dr Montaner); Departments of Pathology and Medicine, University of California and San Diego VA Healthcare System, San Diego (Dr Richman); Department of Medicine, University of Colorado School of Medicine, Denver (Dr Schooley); AIDS Research Consortium of Atlanta, Ga (Dr Thompson); Istituto Superiore di Sanità, Rome, Italy (Dr Vella); Department of Medicine, University of California and San Francisco Veterans Affairs Medical Center, San Francisco (Dr Volberding). =================================================== Financial disclosures of AIDS researchers - 7/14/04 JAMA JAMA, July 14, 2004 Vol 292, No. 2 251-265 Treatment for Adult 2004 Recommendations International AIDS Society- USA Panel Patrick G. Yeni, MD Scott M. Hammer, MD Martin S. Hirsch, MD Michael S. Saag, MD Mauro Schechter, MD, PhD Charles C. J. Carpenter, MD Margaret A. Fischl, MD Jose M. Gatell, MD, PhD Brian G. Gazzard, MA, MD Donna M. Jacobsen, BS David A. Katzenstein, MD Julio S. G. Montaner, MD Douglas D. Richman, MD Robert T. Schooley, MD Melanie A. Thompson, MD Stefano Vella, MD Paul A. Volberding, MD Patrick G. Yeni, MD Dr Yeni has received research grants for site investigator from GlaxoSmithKline, Bristol- Myers Squibb, Boehringer Ingelheim, Roche, Tibotec/Virco, and Gilead. Dr Yeni has received honoraria for advisory positions and lecture sponsorships from Abbott Laboratories, Bristol-Myers Squibb, Boehringer Ingelheim, Roche, Tibotec/Virco, and Merck Sharp and Dohme. Scott M. Hammer, MD Dr Hammer has received research grants for site investigator from Roche, GlaxoSmithKline, and Merck. Dr Hammer has been a consultant for Bristol-Myers Squibb, GlaxoSmithKline, Merck, Shionogi, Pfizer, Boehringer Ingelheim, Shire, Gilead, and Tibotec/ Virco. Martin S. Hirsch, MD Dr Hirsch has received research support from Takeda. Dr Hirsch has been a consultant for Schering Plough, GlaxoSmithKline, and Bristol-Myers Squibb. Michael S. Saag, MD Dr Saag has received research support from Abbott Laboratories, Bristol-Myers Squibb, Gilead Sciences, GlaxoSmithKline, Ortho Biotech/Johnson&Johnson, Pfizer/Agouron, and Hoffmann- LaRoche. Dr Saag has been a consultant for Abbott Laboratories, Boeringer Ingelheim, Bristol-Myers Squibb, Gilead Sciences, GlaxoSmithKline, OrthoBiotech/Johnson & Johnson, Pfizer/Agouron, Roche, Schering-Plough, Shire Pharmaceutical, TherapyEdge, Tibotec/ Virco, Trimeria, Vertex, and ViroLogic. Dr Saag has received honoraria for positions on the speakers bureau for Abbott Laboratories, Boeringer Ingelheim, Bristol-Myers Squibb, Gilead Sciences, GlaxoSmithKline, OrthoBiotech, Johnson & Johnson, Pfizer, Agouron, Roche, Schering-Plough, Shire Pharmaceutical, TherapyEdge, Tibotec/Virco, Trimeria, Vertex, and ViroLogic. Margaret A. Fischl, MD Dr Fischl has received research grants from Abbott Laboratories, Bristol-Myers Squibb, Gilead Sciences, GlaxoSmithKline, and Ortho Biotech. Dr Fischl has received honoraria for continuing medical education programs from GlaxoSmithKline. Dr Fischl has served as an advisor for Agouron Pharmaceuticals and GlaxoSmithKline. Brian G. Gazzard, MA, MD Dr Gazzard has received research grants from Abbott Laboratories, Boehringer Ingelheim, Pfizer, GlaxoSmithKline, Bristol-Myers Squibb, and Johnson &Johnson. Julio S. G. Montaner, MD Dr Montaner has received grants from Abbott Laboratories, Agouron Pharmaceuticals, Shire Biochemical, Boehringer Ingelheim, Bristol-Myers Squibb, DuPont Pharma, Gilead Sciences, GlaxoSmithKline, Roche, Kucera Pharmaceutical, Merck Frosst Laboratories, Pharmacia & Upjohn, and Trimeris. Dr Montaner has received honoraria for speaking from Abbott Laboratories, Agouron Pharmaceuticals, Shire Biochemical, Boehringer Ingelheim, Bristol-Myers Squibb, DuPont Pharma, Gilead Sciences, GlaxoSmithKline, Hoffmann-La Roche, Kucera Pharmaceutical, Merck Frosst Laboratories, Pharmacia & Upjohn, and Trimeris Inc. Dr Montaner holds 2 US patents, one regarding use of nevirapine and another regarding pharmacological applications of mitochondrial DNA assays. Dr Montaner has 2 patent applications that are pending, one regarding pharmacological applications of mitochondrial DNA assays and another regarding sepsis. Robert T. Schooley, MD Dr Schooley has received grants from GlaxoSmithKline, Bristol-Myers Squibb, Merck, and Tibotec/Virco. Dr Schooley has been a consultant for Abbott Laboratories, Pfizer, Hoffmann-LaRoche, GlaxoSmithKline, BristolMyers Squibb, Merck, Vertex, ViroLogic, and Tibotec/Virco. Melanie A. Thompson, MD Dr Thompson has received grants from Abbott Laboratories, Agouron/ Pfizer Pharmaceuticals, Boeringer Ingelheim, Bristol-Myers Squibb, Chiron Corporation, GlaxoSmithKline, Gilead Sciences, Merck Research Laboratories, Oxo-Chemie, Roche, Serono, Theratechnologies, Triangle Pharmaceuticals, Trimeris, and VaxGen. Dr Thompson has been a consultant for Abbott Laboratories, Agouron/Pfizer Pharmaceuticals, GlaxoSmithKline, Gilead Sciences, Serono, and Triangle Pharmaceuticals. Dr Thompson has received honoraria for lecture sponsorships and continuing medical education from Abbott Laboratories, Agouron/ Pfizer Pharmaceuticals, Boeringer Ingleheim, Bristol-Myers Squibb, GlaxoSmithKline, Gilead Sciences, Roche, Serono, Triangle Pharmaceuticals, and Trimeris. Mauro Schechter, MD, PhD Dr Schechter has received honoraria from Abbott Laboratories, Bristol-Myers Squibb, GlaxoSmithKline, Merck, and Roche. Dr Schechter has been a consultant for Abbott Laboratories, BristolMyers Squibb, GlaxoSmithKline, Merck, and Roche. Jose M. Gatell, MD, PhD Dr Gatell has served in advisory positions for Roche, Bristol-Myers Squibb, Merck Sharp and Dohme, GlaxoSmithKline, Gilead, Boehringer Ingelheim, Abbott Laboratories, Tibotec/ Virco. Brian G. Gazzard, MA, MD Dr Gazzard has received lectureship fees from Abbott Laboratories, Boehringer Ingelheim, Pfizer, GlaxoSmithKline, Bristol-Myers Squibb, and Johnson & Johnson. David A. Katzenstein, MD Dr Katzenstein has held advisory positions at Boehringer Ingelheim, Bristol-Myers Squibb, Gilead Sciences, GlaxoSmithKline, Merck, ViroLogic, Visible Genetics, and the Doris Duke Charitable Trust. Dr Katzenstein holds a US patent for polymerase chain reaction assays monitoring antiviral therapy and making therapeutic decisions in the treatment of AIDS. Stefano Vella, MD Dr Vella has received lecture sponsorship for satellite symposia and continuing medical education programs from Merck, Agouron, Gilead, Boehringer Ingelheim, and Roche. Paul A. Volberding, MD Dr Volberding has received honoraria from Gilead, Bristol-Myers Squibb, GlaxoSmithKline, and Boehringer Ingelheim. Dr Volberding has been a consultant for Pfizer, Bristol-Myers Squibb, and Shire. Douglas D. Richman, MD Dr Richman has been a consultant for Abbott Laboratories, Bristol-Myers Squibb, Chiron, Gilead, GlaxoSmithKline, Merck, Novirio, Pfizer, Roche, Takeda, Triangle, and ViroLogic. Corresponding Author: Patrick G. Yeni, MD, Hospital Bichat-Claude Bernard, 46 Rue Henri-Huchard, 75877 Paris Cedex 18, France (Patrick.Yeni@Bch .Ap-Hop-Paris.Fr). At some point, the whole ludicrous edifcace will come tumbling down like a tenament built for the poor in a corrupt, "third world" nation. The only interesting thing will be how it is communicated to the public. My gues is something like the following: "HIV probably plays a role in the multi-factorial pathogenesis, but many of the symptoms that do the most harm are due to other agents. We need to be more attentitive to those agents, for the purposes of mortality and morbidity." In other words, they will try to "BS" their way out of the worm-infested box they nailed themselves into, hoping that nobody pays too much attention to how they do it. "HIV" will be mentioned less and less often. They might say that so many "mutations" of the "virus" have occurred that it is impossible to know what any one person who is "positive" will face several years down the "AIDS" road. Perhaps they will present us with a new phrase, such as "AIDS-like complexes" or "ICDM" (immuno-compromised disorder manifestation). Perhaps they should hire me to help them with this task, though considering how pathetically non-journalistic the "media" has become, it should be fairly easy to accomplish. > They might say that so many "mutations" of the "virus" > have occurred that it is impossible to know what any one person who is > "positive" will face several years down the "AIDS" road. This seems to have already happened, given the doublespeak one finds on the CDC's pharma-edited website. > Perhaps they will present us with a new phrase, such as "AIDS-like > complexes" My all-time favorite is: Immune Restoration Syndrome Which the CDC defines as the flareup of opportunistic infections that appear when previously healthy HIV+ people begin using the "life-saving" drugs. Orwell would appreciate this as "health through illness". At no time in the history of human medicine has the concept of "health through illness" been embraced. The only thing that came close would be bloodletting. > or "ICDM" (immuno-compromised disorder manifestation). Perhaps they > should hire me to help them with this task, though considering how > pathetically non-journalistic the "media" has become, it should be > fairly easy to accomplish. I would LOVE to work the spin circuit for Pharma - too bad they tend to hire in their own image. They can do so much better than the likes of Gary Stein or George Carter or Brian Mailman or any of the other Public Relations contractors who infest these newsgroups. susie > At some point, the whole ludicrous edifcace will come tumbling down > like a tenament built for the poor in a corrupt, "third world" nation. [quoted text clipped - 4 lines] > need to be more attentitive to those agents, for the purposes of > mortality and morbidity." Can you name any of those so called "other agents"? Gary Stein >> At some point, the whole ludicrous edifcace will come tumbling down >> like a tenament built for the poor in a corrupt, "third world" nation. [quoted text clipped - 6 lines] > > Can you name any of those so called "other agents"? Tregs fill the request, and rather nicely I might say. susie >>> At some point, the whole ludicrous edifcace will come tumbling down >>> like a tenament built for the poor in a corrupt, "third world" nation. [quoted text clipped - 10 lines] > > susie Please describe in detail your so called Tregs theory of AIDS. So far all I've seen you post here is the word Tregs and nothing to either explain what you mean by the term or how it applies to AIDS. Gary Stein Gary: As I've proposed, let us get a group of experimental animals and pump them up with corn oil, poppers, semen with PGE in it, antibiotics, cortisone, EBV, several herpes, CMV, etc. If you think they won't get "AIDS" from this exposure, I'll be willing to make an offer to you: We will do this experiment, and the loser pays for all expenses, and signs a notarized statement that he thinks he is incorrect. The animals would have to die at an age that is at least 25 percent of the "normal" group, on average. I would feed the "normal" group what I want, to show the difference diet can make here. The point is that if the animals die from this "lifestyle," then you can't claim that a virus that has not been properly isolated is to blame. At best, you could say that "AIDS" will occur due to what people do to themselves, and that there is a remote possibility that a yet to be identified retrovirus could cause all these problems. It would make no sense to make this claim, but one can't "prove" a negative, so to "cover your butt," I guess you might feel obliged to say something silly like this. > Gary: > [quoted text clipped - 17 lines] > negative, so to "cover your butt," I guess you might feel obliged to > say something silly like this. Don't forget to include the unsterile polio vaccine made from monkey kidneys as well as the CDC's 1980 unsterile HepB vaccine that was administered to the gay boy tops in the gay sex clubs in the large US cities from coast to coast. susie >> Tregs fill the request, and rather nicely I might say. >> [quoted text clipped - 3 lines] >I've seen you post here is the word Tregs and nothing to either explain what >you mean by the term or how it applies to AIDS. It's doubtful he can, of course. "Tregs theory of AIDS:" This appears to be a variant of the anergy phenomenon. Read Jamie Cunliffe's morphostasis hypothesis of the "immune system," for example. After a certain amount of antigenic exposure, the body "shuts off" Th1 activity so that there is not wholesale tissue damage. As Cunliffe notes: "When Th1 activation of phagocytes becomes excessive, anergy is switched on. This inhibits wholesale self-destruction. The aggression of phagocytes is downregulated. However, this leads to the accumulation of tissue debris that must be cleared. Hence Th2 cells, B-cells and the free antibody system evolve to tag this debris in a way that promotes its clearance (C-micron)." http://www.morphostasis.org.uk/Papers/Evolving.htm This explains what one might call "classic AIDS." KS results from the excess cellular debris, in conjunction with the oxidative stress of poppers, and possibly a viral co-factor (not "HIV"). In the absence of poppers, virus, etc., one would likely be studded with boils/skin tags. Due to the CDC's refined definition, "AIDS" is just about meaningless. "Clean" people who have lupus or one of many conditions and who test "positive for HIV" are told not to worry. "Dirty" people are told to take drugs that are extremely toxic, and guess what happens a few years down the road? But this is why I titled a post, "What, exactly, is the HIV/AIDS hypothesis?" That is, with the evidence that exists, and the CDC's definition, and the sociological way people are determined to have "HIV/AIDS," we are no longer in the realm of anything remotely resembling science. In the context of the Cunliffe hypothesis, "immune systems" have a life expectancy. Excess antigenic exposure "burns it out." Toxins (such as the "cocktail" drugs) can act as a surrogate immune system, but the body eventually deteriorates to the point of "no return" due to the damage that such toxins do. This is why "dissidents" who avoid the drugs often die young. And this is why I offer to take a version of the "Duesberg Challange." The only problem is that no virus resembling what "HIV" is described to be has ever been isolated, so there really is no way to take this challange even if it could be arranged (see the Perth Group's writings for a detailed account of what actually has been done, and termed "isolation"). >>> Tregs fill the request, and rather nicely I might say. >>> [quoted text clipped - 6 lines] > > It's doubtful he can, of course. YOU can, if you try. While George Mary DOES NOT have HIV, Gary Stein purports to being salvaged from his "AIDS deathbed" by the antiviral cocktails nearly 10 years ago. Gary has an education ... why can't he use it? Is there ANY excuse for people with this disease to sit at home and do nothing more than review the drug company talking points? susie There was a good report on sciencdaily.com, on Nov. 13, 2005, which lends support to the observation that "immune systems" have a "life expectancy." Cunliffe might say that the outermost "shell" consists of WBCs, and primate species, at least, have evolved so that the amount of "promiscuity" is consisent with this shell. In this case, if you "use it" too much, you "lose it" at a much younger age than is "normal," hence an "AIDS" will occur. Here's the report: Promiscuity May Be Key Factor In Immune System Evolution, Study Suggests A new study indicates that evolution of the immune system may be directly linked to the sexual activity of a species. A comparative analysis of 41 primate species demonstrates that the most promiscuous species have naturally higher white blood cell (WBC) counts -- the first line of defense against infectious disease -- than more monogamous species. The findings will be reported in the Nov. 10 issue of the journal Science. "Our findings strongly suggest that the most sexually-active species of primates may have evolved elevated immune systems as a defense mechanism against disease," says principal investigator Charles L. Nunn, a research associate in the Department of Biology at the University of Virginia. "We looked at animal species with a range of mating behaviors and found a strong relationship between high WBC counts and high promiscuity in healthy animals. The more monogamous species have lower WBC counts." The researchers compared 20 years of data on average white blood cell counts for 41 primate species. The 41 species represent the major primate evolutionary groups and the full range of mating behaviors. Some of the species are highly promiscuous, such as the Barbary macaque, whose females may mate with up to ten males per day while in heat. Other species have varying levels of monogamy, including some that mate with one partner for life. The researchers found a direct correlation between WBC levels and mating behavior. Data for each species come from zoos and are composed of veterinary reports of basal, or normal, WBC counts for healthy females. "The implication of our finding is that the risk of sexually transmitted disease is likely to be a major factor leading to systematic differences in the primate immune system," Nunn says. "This puts the evolution of sexual behavior in close relation to the evolution of the immune system." The researchers also compared other behavioral and social factors that might affect the animals' immune systems, including high population density, which increases the risk of exposure to disease, as well as exposure levels to soil-borne pathogens, namely fecal contamination. They found that mating promiscuity affected WBC counts far more than other disease risk factors. "We expected to see a correlation between WBC counts and various behavioral and ecological factors, but were surprised to find that sexual activity appears to be the key factor in how the immune system develops," says co-author John L. Gittleman, U.Va. associate professor of biology. "This opens up many new questions about behavior and the immune system." The researchers also compared mean WBC counts of humans to the various primate WBC counts, and found that humans are on par with the more monogamous primate species. "Based on this comparison, humans are more similar to the more monogamous primate species," Nunn says. The research is funded by the National Science Foundation and the National Institute of General Medical Sciences, and was conducted by three U.Va. scientists in the Department of Biology: Nunn, who specializes in primates; Gittleman, who uses computational methods to study evolution; and Janis Antonovics, who studies sexually transmitted diseases. Correction: www.sciencedaily.com >>>> At some point, the whole ludicrous edifcace will come tumbling down >>>> like a tenament built for the poor in a corrupt, "third world" nation. [quoted text clipped - 12 lines] > I've seen you post here is the word Tregs and nothing to either explain > what you mean by the term or how it applies to AIDS. Child's play, Mr. Stein. Since you purport to have an education, why don't you put it to use? You have many fine medical libraries in your area, so put down your pharma Talking Points Strategy Guide and use one. Meantime, while I will CONTINUE to post information pertinent to Tregs, but that doesn't excuse you from doing your homework. After all, YOU are the one with AIDS, not I. susie |
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