HIV/AIDS Skepticism

Pointing to evidence that HIV is not the necessary and sufficient cause of AIDS

Black and gay: Doubly at risk — not from HIV, from HIV/AIDS theory

Posted by Henry Bauer on 2009/03/01

Black gay men seek community space in SF
February 7th, 2009
From: Bay Area Reporter – by Matthew S. Bajko –
Isolated not only from the larger LGBT community, but also from each other, the city’s black gay male population is seeking a place to call home. . . .
Creating such a space is seen as key in not only addressing the spiritual and health needs of African American men who have sex with men, but also as a way to combat the disproportionately high prevalence of HIV infection within this subset of the city’s gay male population. Health officials estimate that 1,500 gay and bisexual black men in the city are HIV-positive. While preliminary data has shown a significant drop off of HIV infections among gay black men under the age of 30, infections among older gay black men have been rising” [emphases added]

[Estimates” & “preliminary data” are warning signs that should be taken seriously. Unless these data are indisputable, the question arises: Were the estimators aware of the fact that the proclivity to test “HIV-positive” increases with age from the early teens into middle age? Did they confuse a higher rate among men older than 30 with an “increase” among them?]

“But data local HIV researchers have found point to a continuing HIV epidemic among black men due to their higher chance of having black partners. Studies done by the health department’s HIV epidemiology section have found that among gay men as a whole, black men are seen as the least desirable partners and are perceived as being the most risky for contracting HIV.”

[Official statements have fueled those sentiments for years, by describing HIV/AIDS as increasingly a disease of black communities and by reiterating that black men and women are more likely to test “HIV-positive” than white men and women are, by factors of about 8 and about 20 or more, respectively]

“The result is a closed sexual network, where HIV is more easily transmitted among gay black men, despite the fact they do not engage in riskier sexual practices than other gay men.”

[Once more a ridiculous assertion is passed on by uncritical media. How is “HIV” envisaged to be more easily transmitted among black gay men than among others, if their behavior is no more risky?!]

“’HIV is sophisticated now. We need to be sophisticated about it,’ said Tony Bradford, a member of the working group who is the interim program director of the Black Brothers Esteem program.”

[Balderdash. What’s needed is common sense and looking at facts, there’s been far too much “sophistication” about “HIV/AIDS” — or should I say sophistry?]

“’Because of the small number of black men in San Francisco there is not a visible community,’ said Broome, who is also a member of the working group. ‘There isn’t a space in the Castro black men can call their own.’”

[and this small number is an excellent reason for doubting the reliability of those “estimates” and “preliminary data”, see above]

The fact is — and it’s been clear for many years — that African ancestry brings a probability of testing “HIV-positive” that’s an order of magnitude greater than with non-African ancestry. Black people test “positive” at rates anywhere from 5 times to 100 times more frequently than Caucasians (and Caucasians test “positive” 50% more often than Asians).
Those racial disparities are seen among blood donors, gay men, pregnant women, babies, drug abusers, military personnel — in every social group and in every country and culture. They are OBVIOUSLY not the result of differences in “risky behavior” — even apart from the fact that many actual studies of sexual behavior have found that white Americans are more likely to practice “risky behavior” than are African Americans.

TESTING “HIV-POSITIVE” DOES NOT SIGNIFY INFECTION BY A PATHOGEN.

19 Responses to “Black and gay: Doubly at risk — not from HIV, from HIV/AIDS theory”

  1. Dave said

    Wow a two-fer! You’re gay AND black — so now, you’re really, really, really, really at risk for a deadly retrovirus that, theoretically, will infect us all, but magically seems to avoid, whites, Europeans, women, suburban housewives, the Middle East, old people, straight people, Lesbians, Republicans, Asians, etc, etc, etc.

    This would be a comic farce, if the consequences were not so tragic over the past 28 years.

    Let me repeat and re-enforce my mantra:

    1. The tests are unreliable. They do not detect virus. They do not mean you are sick. They do not mean you will get sick. They do not mean you are infected with “HIV.” They COULD mean something is not well with your body, ie, hypergammaglobulinemia (an excess production of antibodies due to some form of illness,) or it could mean nothing at all; that your immune response has successfully cleared a virus. You don’t know. More importantly, your AIDS doctors don’t know. Don’t make life-altering decisions based on these bogus tests.

    2. The drugs are toxic. The original drug, AZT, is not even medicine, it’s a chemical, specifically, a DNA-chain terminator. If you want to terminate the DNA in your cells, take AZT. It will kill (if it can find) viruses, it will kill your cells — it will kill mitochondria in your cells, because all use DNA (or RNA, which AZT is designed to terminate.

    3. Have a nice day. If you’re gay or black, or even gay and black, feel free to post here. We love you. We don’t care if you’re gay or black. We do care about your health, though. You have been terribly mislead by some serious quack scientists in the AIDS establishment. They mean well, but are quite ignorant. They haven’t a tenth of the work and analysis that Dr. Bauer has done. Beware the tests, beware the drugs.

    And, Have a nice day.

  2. Theatre Guy Z said

    There needs to be a strong voice from the African-American community…someone who wakes up and speaks out on this blatant racism. I am floored by how the black community reinforces these archaic notions of “primitive/savage/over-sexed ‘black’ behavior” through their own campaigns. They are so blinded by people telling them to get tested — they buy into the fact that black men tend to be “on the down-low” — (And PLEASE, there are PLENTY of white married men sleeping with men on the side; anyone in the gay community knows this.) They simply don’t question the statistics and instead, blame themselves. It’s a terrible cycle. It is abusive.

    Sorry for the unfocused rant — but it truly upsets me.

    I often guest-teach at inner-city schools and deal with many black students — and they will all tell you that one of the biggest health threats to them is HIV. “It hits our community hardest,” they say. In fact, the school has posters up right now — targeting HIV in the black community and promoting “National Testing Day” in June.

    What’s amazing is that in America it is explained as a result of conservative church values blocking true sexual identity — thus the “on the down-low” claims — and bisexual men spreading it to women…again, as if this is only a ‘black’ issue. But in Africa, it’s suddenly a heterosexual problem resulting from rampant and frenzied sex with multiple partners and the so-called tradition of “dry sex” and “vaginal drying agents.”

    Could that BE more racist and disgusting — if not downright moronic? I know we are in the age of Obama, but racism is still a giant problem in this country — and the world — and those of African ancestry need to think about who is feeding them this garbage. It looks like a bunch of old, privileged white guys to me. And I know that may seem like a cheap and easy card to play — but is it not somewhat true?

    Someone MUST speak out.

    • Henry Bauer said

      Theatre Guy Z:

      I share fully your feelings about this. Maybe even more strongly, because I’ve been rebuffed when trying to raise the issue with influential people in the black community. I sent a MS about it — how the orthodox view rests inescapably on racist views about sexual behavior — to the DuBois Review of Social Science, and received the same sort of biased reviewing, and editorial complicity in it, as we dissidents regularly receive from mainstream HIV/AIDS journals. The most charitable interpretation I’ve reached is that people are simply scared to question the recognized authorities; which is perhaps a little ahistorical for people whose story has been one of continued denigration and oppression by the recognized authorities.

  3. Dave said

    Within the black community:

    1. Tony Brown, tv journalist, was real good in the 1990’s. Not sure where he stands today.

    “Dr. Peter Duesberg’s courage and his book Inventing the AIDS Virus will save millions of lives. He is not only one of the few people in the world qualified enough to see through the scientific ‘AIDS scam,’ but he is the only one who has sacrificed his career to save the world from it.” –Tony Brown, host of PBS’ Tony Brown’s Journal

    2. Famous Olympian track star, Lee Evans, is still great on the issue (but doesn’t have a large microphone).

    http://www.youtube.com/user/theaidstrial

    3. Of course, there is Magic Johnson, who has made a fortune as the face of healthy AIDS for the past 20 years. The funny thing, though, is that he’s never been sick.

  4. David Jones, M.S.P.H. said

    I think many leaders in the Black community feel overwhelmed by the “epidemic” of AIDS and HIV in their communities, as well as by many of the other problems that seem of greater magnitude in their communities. It is embarassing for them, and I think they genuinely believe that their communities are at serious risk. Some, as Obama’s former minister alleged, believe that AIDS is government-sponsored genocide. There is a strange mix of official CDC-Government propaganda and conspiracy theories motivating many members of the Black community.

    Also, AIDS among minorities and in Africa is a white liberal (not that liberalism is inherently bad) wet dream. Recently, I visited Emory School of Public Health, as I am considering a PhD in Public Health, and everywhere I looked, there was an annoucement of a talk on AIDS in Africa, or in American Minority communities, or a summary of research about HIV in the Black community or in Africa. One would think that AIDS kills more than Cancer or Heart Disease. But those diseases are passe, and don’t elicit the same passion among academic elites, especially in the dreadfully boring public-health elites.

    David Jones, M.S.P.H.

    • Henry Bauer said

      David Jones:

      I agree fully, “overwhelmed” and “embarrassed”; and also not knowing what to believe or how to arrive at a belief.

      Perhaps one reason for the emphasis on HIV/AIDS at Emory is that the Dean of the School of Public Health is former CDC HIV/AIDS chief James Curran, who has remained infamous with me for claiming a correlation exists that the data and figures he gives shows NOT to be a correlation (p. 110 ff. in my book), and for citing as a proof of cause what is only a correlation (p. 194 of my book).

  5. David Jones, M.S.P.H. said

    One more thing — Now we have President Obama, who volunteered (along with Michelle) to be tested for HIV while he was in Kenya prior to running for the Presidency. Can we imagine anyone being able to get him to even entertain the dissident message? I don’t know how it is possible to get the dissident message to the Black community with Obama making it such a huge priority. He is not one to change his mind unless it suits his political purposes. Anyone have ideas? Any African-American dissidents care to comment?

    David

    • Henry Bauer said

      David Jones, re one more thing:

      Obama has to rely on advisers and assistant-colleagues. He naturally — even admirably — has apparently tried to choose people with top credentials. The trouble is that HIV/AIDS is one of those “hard cases” for which the usual rules are not a good guide. I’ve said at various times that what we need is A CHAIN OF COMMUNICATION, from one personally trusted person to another, leading from a knowledgeable dissident to an influential indvidual in politics or BIG media. One has to seduce an influential person into taking seriously something that is universally regarded as like believing the earth to be flat. Moreover, to absorb the strength of the dissident case takes time, so one needs the influential person — who is almost certainly too busy to spend the necessary time — to designate an assistant who can spend weeks essentially full-time looking into the whole business under dissident guidance.

      Tall order.

      I have the same worry, by the way, about economic policy. The top advisors don’t really know what they’re doing, because economics isn’t a science and this is an unprecedented mess.

  6. Martin said

    The fact that virtually all medical and scientific personnel working for the government are fiscally connected with the HIV=AIDS paradigm, and a president (and his wife) very publicly got the “test” which, as a puzzle to me, they both were reported to have come out “clean”. With the economic mess we’re in now, a systemic collapse of the medical/pharmaceutical industries if the public’s perception of them as liars — we have the possibility of a very toxic stew.

    • Henry Bauer said

      Martin:

      In some recent comment, I mentioned that “Laboratory Detection of Human Retroviral Infection”, by Stanley Weiss & Elliott Cowan, says that the most important part of “HIV” tests comes before the tests are made, assessing the “pre-test” probability, which is essential to determining the “post-test” probability after the numbers are in. In other words, if you’re in a high-risk group, just about any “positive” number on the test means you’re judged to be infected; but if you’re in a low-risk group, it takes a much higher laboratory number before you’re judged to be possibly infected. Therefore it’s quite safe for prominent individuals to take tests, because their “pre-test” probability is judged to be virtually zero.
      Any generic African American is 5-20 times more likely to test “positive” than the average American; but PROMINENT African-Americans are very unlikely to be judged to have tested positive.

  7. lahuesera said

    If I were really cynical, I might think that they’re using disenfranchised populations as lab rats, as well as coerced consumers. This bit in “Fear of the Invisible” jumped out at me, but I haven’t been able to find any other information on the incident.

    “That year Gallo also got into trouble in Africa. His laboratory had developed a vaccine based on transplanting into the shell of another virus a putative part of HIV. It seems this was easier than using HIV itself as it was difficult to find. This vaccine was injected into a few Congolese in Africa and Paris and three of them died. It was then discovered that his vaccine had only been approved for use on animals! But Gallo escaped with only a mild reprimand.”

    A mild reprimand? Well, Congolese, animals… same difference right? If anyone has more background on this, I’d be interested to see it.

    LaVaughn

    • Henry Bauer said

      LaVaughn — lahuesera:

      From p. 218 of ,y book:
      “Robert Gallo collaborated with French scientist Daniel Zagury to test a vaccine in Zaire, but the trial was stopped when it came to the attention of the Office of Protection from Research Risks in the United States, whose regulations it violated (Crewdson 2002, 405–7).”
      Crewdson, John. 2002. Science fictions: a scientific mystery, a massive coverup and the dark legacy of Robert Gallo. Boston: Little, Brown
      Crewdson’s book documents Gallo’s misdeeds in excruciating detail.

  8. Cytotalker said

    Even in light of scientific evidence, most African-American leaders would be most wary of being subjected by the mainstream media to the defamatory and bullying treatment already dealt to Thabo Mbeki. The thought of a biased genocide accusation on the pages of the New York Times would dampen any dissident impulses in those who wish to continue serving their communities without their reputations being devastated in this extremely bitter debate.

    Perhaps focusing on unnoticed mainstream reporting of the
    harmful consequences
    of the current paradigm is a first step in publicizing the real stakes. People must understand the extent to which Bono and his misguided pro-pharmaceutical campaigns do cause real harm.

  9. dale said

    Henry,
    Your identification of those “doubly at risk” whether black and gay — or black and pregnant — takes on heightened importance in light of the following New Scientist article revealing discussions taking place at the highest levels (WHO and national health institutes) to eliminate “HIV infection” through mandatory testing and (prophyactic) treatment. In light of growing evidence challenging the HIV/AIDS paradigm, a cynic might view this as a way to maximize pharmaceutical profits and protect reputations while allowing HIV to disappear as yet another “conquered” infection. Since the burden of this medical experiment will fall heavily on the human population that is both poor and black, the uproar against this human-rights abuse may well be minimal. As David Jones points out, the voices of those most likely to be identified and targetted in this global project have been silenced (in their embarassment and fear) by the army of HIV promoters who have set up shop in their communities.

    The following is quoted from the New Scientist website and refers to an editorial in issue 2696 of the New Scientist entitled “Ridding the world of AIDS” (note the inaccuracies within many generalizations made)

    “…It is the benefits of early treatment, combined with the perils of late diagnosis, that have convinced many doctors and patient groups to urge that HIV tests be used more widely. For example, last year the UK government’s Health Protection Agency endorsed guidelines saying that in urban areas of the UK where people with undiagnosed infections are likely to be concentrated, HIV tests should be more widely available. In these places, everyone from 15 to 60 should have the test routinely when they register with a primary care doctor or are admitted to hospital. “We want normalisation of testing,” says Barry Evans, an epidemiologist at the HPA. “They should get tested like they get their blood pressure checked.”

    Earlier HIV diagnosis not only helps the infected person, it also benefits everyone else. Once someone knows they are HIV positive, they are less likely to pass the virus to others through unsafe sex or sharing needles. The really important factor, though, is that therapy stops viral replication, so that much less virus reaches an infected person’s bodily fluids.

    Just how much this reduces the risk of transmission is a matter of great debate. Most of the evidence comes from studies of monogamous heterosexual couples who are “serodiscordant” – in other words one person is HIV positive and the other is not. Some studies have found a transmission rate of zero, but only in people who scrupulously take their tablets, so that no virus is detectable in their blood, and who are free of other sexually transmitted infections.

    No condoms needed
    Last year, a group of HIV specialists on the Swiss government’s AIDS commission (EKAF) announced that HIV-positive people who met these conditions were “sexually non-infectious”. For the first time serodiscordant heterosexual couples got official approval to bin their condoms. Other experts disagree with the Swiss decision, pointing out that the virus can sometimes be found in semen and vaginal fluid even if it is undetectable in blood. Also, as the research results come from straight couples, it is unclear how the advice applies to gay men. Despite these doubts, some doctors now see patients with normal CD4 counts asking to start therapy purely to avoid passing on the virus.

    While it is debatable just how small the transmission risk really is, it is indisputably much lower for patients taking antiretroviral therapy than for those who are not. That has led researchers to start speculating about expanding testing and treatment to everyone with HIV. In November 2008, a paper published in The Lancet, written by five of the WHO’s leading AIDS specialists, drew the widest attention so far (vol 373, p 48).

    The researchers looked at the case for elimination in South Africa, which has the highest number of HIV cases in the world. They modelled what would happen if everyone over 15 were given annual tests, with all those who tested positive offered free antiretroviral treatment immediately, regardless of their CD4 count. They plugged in actual figures from a free treatment programme in Malawi to factor in people who decline therapy, stop because of side effects or switch drugs because of resistance.

    The team found that within 10 years, the scheme would slash new HIV infections from the 1 in 50 people at present to less than 1 in 1000. Within 50 years, as people with HIV died (mainly from other causes), prevalence in the general population would fall from about 10 per cent to less than 1 per cent.

    That all sounds great, but the cost of the scheme would initially be about $3.5 billion a year. That might sound prohibitive, but the key comparison to make is with the cost of alternative plans. Today, aid programmes can fund antiretroviral treatment for only about one-third of people in the developing world with a CD4 count below 200. All the major HIV organisations, such as UNAIDS and the WHO, and several western governments including the UK’s, are now calling for universal access to therapy, by which they mean getting the drugs to everyone with a count below 200. Some want the threshold to be raised to 350 in the developing world too.

    However, the problem with this form of universal access is that it would do little to curb transmission, because everyone with CD4 counts above the threshold would still be spreading the virus. The cost of such a scheme would almost certainly rise over time as more people became infected, unlike the WHO experts’ more ambitious scheme. “The [elimination] strategy becomes cost-saving in the future, despite initially increased costs,” says Kevin De Cock, director of the WHO’s HIV/AIDS department and one of the paper’s authors. By 2030 it would become cheaper than using a 350 threshold (see graph).

    The idea is still very much in its early stages, with De Cock stressing they are “not suggesting a change in policy but stimulating a discussion”. In the next few months, the WHO will bring together scientists, policy-makers and funders to discuss employing the strategy in developing countries.

    In some ways it might be easier to attempt universal treatment in a developed country. For example, the UK could, if it chose, afford to put every one of its estimated 73,000 HIV-positive residents on antiretroviral therapy. On the other hand with HIV only affecting 0.1 per cent of the UK population, universal testing would be hard to justify. The modelling from The Lancet paper would have to be redone for the UK, where, unlike in South Africa, transmission is primarily among gay men. (Cases among heterosexuals are rising; these are mainly immigrants who have caught the virus abroad.) “We’re trying to focus more on certain population groups or areas,” says Tim Chadborn of the HPA.

    Conant, however, argues that testing everyone would help to further reduce the stigma around AIDS. HIV may no longer be an automatic bar for health insurance but there is still an image problem for a disease that in the west is still seen as affecting mainly gay men, immigrants, prostitutes and drug addicts. Conant advocates mass testing in the US at churches and meetings of professional groups such as doctors – as happens today at gay bars. “It has got to be universal,” he says.

    Mass HIV testing at churches and meetings of professionals such as doctors would reduce stigma
    Perhaps the most medically contentious part of the elimination plan, in any country, is that all those diagnosed positive would begin antiretroviral treatment immediately. At present there is no firm evidence that HIV does any damage to an individual as long as their CD4 count is above 350. “There are great big ethical problems about recommending treatment to someone when it’s not clinically beneficial to that person,” says Chadbourn.

    Sex abroad
    Still, no one really knows what the effects of starting treatment earlier are. This question should be answered by a large international trial called START, organised by the US National Institutes of Health, to compare the health of people who start therapy at 350 with that of people who start at over 500. The results will not be in for six years, though.

    If the people in the over-500 group do best, the main medical objection to elimination disappears. “If we can establish that there’s a benefit, I would imagine that we would try to do exactly what’s being proposed in The Lancet paper,” says Andrew Phillips, an epidemiologist at the Royal Free and University College Medical School in London who is involved in START.

    If a western country introduces widespread testing and immediate treatment, new infections should dwindle. “If there are benefits for the individual and benefits for the population, I would very strongly support that,” says Evans. He would contemplate elimination even if the over-500 group in the START trial does no better than the 350 group, as long as it does no worse.

    Perhaps the biggest obstacle would be the importation of HIV from abroad. The HPA now recommends that migrants from countries with high HIV rates be offered a test when they access any health service, such as registering with a primary care doctor. The agency frowns on testing at ports of entry in case it encourages discrimination.

    Residents also import HIV by having unsafe sex while abroad. People would have to be persuaded to take the test when they returned. For Brian Gazzard, one of the UK’s leading HIV specialists, based at the Chelsea and Westminster Hospital in London, this makes elimination on a country-by-country basis unfeasible. “It’s got to be done worldwide,” he says. “A public debate about that issue would be wonderful.”

    Western countries without state-funded healthcare would hit bigger problems. In the US, for example, many people with HIV delay starting therapy because they pay part or all of the cost. “The government would have to pay,” says Conant.

    Treatment standards would also have to improve in the US. Some health insurers insist that patients see primary care doctors rather than more expensive specialists. According to Conant, some non-specialists fail to use drug regimens that totally block viral replication, so the virus can still be transmitted. “That’s the most common mistake I see,” he says.

    There are many obstacles to be overcome if any form of elimination plan, national or global, is to be attempted. Yet the damage done by AIDS is so huge that the chance to rid just some places of it has to be worth considering.

    What is certain is that, however and wherever it is attempted, such a scheme will be controversial. Hard-line religious groups that view AIDS as divine retribution are unlikely to help out. Some liberals, on the other hand, might resist the idea of mass testing. “Should we try a social intervention which infringes on people’s civil liberties?” asks Conant. “AIDS infringes upon people too. If we’re going to stop this epidemic, this is a responsibility that society has to shoulder.”

    Read our related editorial: Ridding the world of AIDS

    Clare Wilson is the medical features editor at New Scientist

    From issue 2696 of New Scientist magazine, page 38-41.

  10. David Jones, M.S.P.H. said

    Dale,

    Thank for posting the article on this universal-testing and universal-treatment idea. This is very scary! Nowhere do they say treatment would be mandatory, but how else would it work? These AIDS bureaucrats and activists are like the DEA. Their job will, by definition, not allow them to back off in their quest for mandatory participation in a war on their target. If we end the war on AIDS or the war on drugs, think of how many people will lose their job and life purpose. It is so ironic that, in a time when AIDS has supposedly become a more chronic and manageable condition, they are more obsessed than ever in their quest to “defeat” HIV. And the ends seem to justify the means in their minds.

  11. dale said

    David,

    You are right, “nowhere do they say treatment would be mandatory, but how else would it work?

    If you google “DOT hiv infection” you will find numerous articles on research or feasibility studies in support of DOT (directly observed treatment)in the context of HIV infection. It was first used to monitor TB treatment and involves treatment drugs taken in the presence of a public health official. The following article that appeared in medscape being just one example.

    DOT for HIV: An Idea Whose Time Has Come?
    Disclosures

    Michael Tapper, MD

    Adherence to the complex regimens required for long-term suppression of HIV replication has proven to be a major stumbling block to individual case management and to public health efforts to slow the spread of HIV infection. Similar problems were faced during the resurgence of tuberculosis (TB) in the United States in the late 1980s and the early 1990s. Widespread institution of directly observed therapy (DOT) for tuberculosis is generally credited with reversing the upsurge in TB case rates in cities such as New York, and in bringing them down to the lowest levels in the modern era.

    Directly observed therapy is also credited with the successful control of multidrug-resistant (MDR) TB, the scourge of HIV-infected patients in cities such as New York.[1] Indeed, directly observed therapy has been adopted by the World Health Organization as a standard of care for all TB control programs, in both developed and lesser developed countries.

    The success of DOT strategies for the control of tuberculosis and the more recent availability of simplified once-daily or twice-daily regimens for HIV therapy have suggested to many clinicians and public health authorities the potential of DOT for the management of HIV disease — particularly in populations likely to be challenged by the complexities of self-administered treatment (SAT).

    Margaret Fischl[2] from the University of Miami presented a retrospective analysis of the results from 4 separate nonrandomized trials conducted simultaneously in the AIDS Clinical Research Unit (ACRU) of the University of Miami and its satellite program which provides care to HIV-infected prisoners in the Florida state prison system. Individuals receiving care at the ACRU received intensive education and ongoing adherence counseling, and self-administered all of their medications. HIV-infected inmates in 4 Florida prisons received all of their medications under direct observation by a nurse in the prison satellite unit. Regimens included 3 or 4 drugs comprising 2 nucleoside analogue reverse transcriptase inhibitors (NRTIs) plus 1 or 2 protease inhibitors (PIs) or the nonnucleoside reverse transcriptase inhibitor (NNRTI) efavirenz. There were approximately 50 patients each in the DOT group and the SAT group. Prisoners (the DOT group) differed from the ACRU group with greater numbers of men (94% vs 80%), African Americans (84% vs 28%), and injection-drug users (32% vs 4%). In addition, the prisoners had higher mean viral loads (5.6 vs 5.3 log10 copies/mL) and lower mean CD4+ cell counts (216 vs 329 cells/mm3) at the time of study entry.

    At 24 weeks, all patients in the DOT group had plasma viral loads less than 400 copies/mL. Two prisoners elected to stop all medications and their viral loads subsequently rebounded; after reinstitution of DOT, both prisoners’ plasma HIV-1 RNA levels again became undetectable. In the self-administered group, 80% had plasma HIV-1 RNA less than 400 copies/mL by week 24. With an ultrasensitive assay (less than 50 copies/mL), over 90% of the DOT group had undetectable plasma HIV-1 RNA, as did 77% of the SAT group. These differences persisted through 90 weeks of follow-up.

    Four-drug regimens had a lower response rate in the SAT group than did 3-drug regimens at 48 weeks (57% vs 81% for 4-drug and 3-drug regimens, respectively) but resulted in a 100% response rate in the DOT group. Overall, simpler regimens had better response rates than did more complex regimens; the best results were achieved with Combivir and efavirenz. In summary, individuals receiving DOT had better short-term and long-term virologic outcomes than did patients receiving identical but self-administered regimens, despite intensive educational programs provided to the latter. Simplified regimens overall produced better results in the SAT group than did more complex regimens.

    What might be the future role for DOT in the management of HIV disease? Analogies to the management of drug-sensitive and drug-resistant TB are obvious. So are some important differences: standard courses of therapy for drug-sensitive TB last for only 6 months — or perhaps 9 months in TB/HIV coinfected patients. Standard therapy for tuberculosis can be given once-daily from the outset; therapy thereafter can be given twice weekly or thrice weekly in the continuation phase of treatment. Public health officials have accepted the responsibility for assuming the cost of drug delivery and, in many cases, the cost of the drugs themselves. Still, several potential sites for DOT of HIV disease come to mind: methadone maintenance programs, daycare centers, assisted-living programs, nongovernmental organizations (NGOs), local pharmacies, and, of course, prisons. Several demonstration projects besides the program described by Fischl are already in existence.

    The recent availability of potent once-daily regimens will surely facilitate these efforts. As discussed in a separate report, once-daily regimens combining didanosine/lamivudine/efavirenz[3] or didanosine/emtricitabine/efavirenz[4] were described at this meeting. The latter trial is particularly noteworthy for its high success rate (over 90% with plasma HIV-1 RNA below 400 copies/mL), its durability (data reported out to 64 weeks), and its tolerability. Other available agents available for daily use include the NNRTI nevirapine and combinations of ritonavir/saquinavir, ritonavir/amprenavir, and ritonavir/indinavir. Further pharmacokinetic studies of these combination PIs (including lopinavir/ritonavir) are necessary to validate their activity on a once-daily basis. The nucleotide tenofovir is also being developed as a once-daily agent.

    Operations research on the feasibility of DOT for HIV disease is clearly needed before large-scale programs can be undertaken. But this low-tech approach to the management of HIV disease clearly merits further study and support by public health and the pharmaceutical industry, to address the urgent problems of drug access and adherence in medically disadvantaged groups in the United States and the underdeveloped world as a part of society’s response to the HIV epidemic.

    References
    Fujiwara PI, Larkin C, Frieden TR. Directly observed therapy in New York City. History, implementation, results, and challenges. Clin Chest Med. 1997;18:135-148.
    Fischl M, Castro J, Monroig R, et al. Impact of directly observed therapy on long-term outcomes in HIV clinical Trials. Program and abstracts of the 8th Conference on Retroviruses and Opportunistic Infections; February 4-8, 2001; Chicago, Illinois. Abstract 528. Available online at: http://www.retroconference.org/2001/abstracts/abstracts/abstracts/528.htm
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    Copyright © 2001 Medscape Portals, Inc.

  12. David said

    Does this article say that testing for HIV would be mandatory as well? I found it too depressing to read with close attention. We really need a libertarian revolution in this country. Neither the Democrats nor the Republicans will safeguard our civil liberties.

    • Henry Bauer said

      David (Jones):

      The authorities seem to be careful not to openly demand mandatory testing of everyone, but there may be something of a “slippery slope” possibility. For example, re CD4 counts and tolerating antiretroviral drugs, there’s a move from using the supposed state of the immune system (CD4 level) as a criterion for when treatment should begin, to using as a criterion how well antiretrovirals can be tolerated by perfectly healthy people with high CD4 levels. An analogy from social policy, which I observed at first hand during my years as an academic administrator: the slide from persuading to mandating in the way that hoped-for “goals” for affirmative action became in practice fixed quotas determined by considerations of political correctness.

  13. Dave said

    Q: How are you doin’ these days?

    A: Well, that’s a silly question. I’m HIV+

    Q: Oh, I’m terribly sorry to hear that. How are you feeling?

    A: Well, my CD4 count is 300/ml and my viral load is 48,324/ml

    Q: Ok, well you’ve given me the results of 3 lab tests. How are you feeling?

    A: I’m HIV+

    Q: I understand that. But what clinical symptoms do you have?

    A: Well, I’m taking Atripla, Lamuvidine, Kaletra, Combivir and Tenovir, so I’m pretty exhausted, some diarrhea, some loss of appetite. It’s hard to get up in the morning, but hard to sleep at night.

    Q: Did these symptoms exist before or after you started on the drugs?

    A: Mostly after, but my viral load is way down, so the drugs are saving my life.

    Q: Did you have any clinical symptoms before you started taking the drugs?

    A: Well, I was HIV+

    Ad nauseum, Ad Infinitum, Ad nauseum, Ad Infinitum

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