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Nine years of HAART brings AIDS earlier, same mortality


Lancet study shows HAART fails to save more lives

The pills that give you AIDS

No one is keener to take HAART drugs than gay activists, but now there is a new trapdoor beneath the activists’ confidence in the deadly drugs.

HAART boosters are going through new contortions explaining away the new 2006 Lancet study of HAART, released Aug 5 just in time for the Toronto World AIDS Conference. This shows that in ten years death rates under HAART haven’t improved for the first year or two of treatment, and that overall mortality and AIDS sickness may both have risen, with more AIDS occurring earlier. All this despite great success in controlling the virus, which has been steadily reduced to ever lower levels in the blood.

The study, May MT et al. HIV treatment response and prognosis in Europe and North America in the first decade of highly active antiretroviral therapy: a collaborative analysis. Lancet. 2006 Aug 5;368(9534):451-8 is a huge review of the experience of 22,217 patients, impossible to ignore. It is from the Antiretroviral Therapy (ART) Cohort Collaboration, and has a list of hundreds of signatories longer than your arm, using up two double column pages of the Lancet in fine print, naming hundreds of researchers from everywhere from British Columbia to Lisbon and Poland. All of them swear they have no conflict of interest at work in reporting their findings. The study has 38 references.

You can read it on The Lancet’s page 451 of Vol 368, August 5, 2006. This is the last line of the summary:

“Interpretation: Virological response after starting HAART improved over calendar years, but such improvement has not translated into a decrease in mortality.”

In other words, patients’ viral count goes down, but in the first year or two they die as often as before. In fact, more often than before in recent years, especially from tuberculosis. This, despite the development of regimens involving fewer pills and allegedly reduced toxicity, which have resulted in no improvement in mortality overall since 1998 – after a jump in deaths in 1995-1997 – and a significantly higher risk of AIDS sickness and AIDS deaths.

The study involved 22,217 HIV positive people in Europe and North America, including many from sub-Saharan Africa, who had never taken ARVs before, and about 75% had no AIDS symptoms at the start of medication. As the Lancet says in its own comment, HAART’s first decade: success brings further challenges ,p 427, “The major findings are that, despite improved initial HIV virological control (percentage there were no significant improvements in early immunological response as measured by CD4-lymphocyte count, no reduction in all-cause mortality, and a significant increase in combined AIDS/AIDS related death risk in more recent years.” Not a brilliant record. Less HIV, the same dismal results.

The editorial comment notes that “importantly, the recent increase in AIDS risk seemed largly because of increase tuberculosis incidence.” That means simply that they are giving HAART medication to people flowing in from sub Saharan regions where more people suffer from TB, as well as among the poor in the West, who offer an expanding market in the eyes of those anxious to help deliver these palliatives.

The unfortunate Africans arriving in the West from the sub-Sahara are thus welcomed with the additional burden of ARVs to cope with, or not as the case may be. As this study makes plain, all too often not. “We noted that the median time to the first AIDS event after starting HAART decreased over time”.

This ineffectiveness in staving off early (within two years) AIDS and early deaths (which, of course, could also be interpreted as effectiveness in causing death) occurred although the groups taking medication shifted away from high risk gays with drug abuse histories to heterosexual males and females, usually poor and black.

Also despite the move away from protease inhibitors to non-nucleoside reverse-transcriptase inhibitors, toxicity seems to be roughly the same. The study says that HAART has reduced the latent period of HIV before AIDS symptoms to two months after the first intake of the politically popular medications.

In other words, sicker quicker. People have been growing ill with AIDS symptoms earlier, almost as soon as they start taking the drugs: “Another intriguing finding was a reduction in the median time to AIDS, with half of AIDS events in the 2000-03 cohort occurring in the first 2 months of the 12-month follow up.”

Those with sensitivity to style will notice the deplorable arms-length untroubled objectivity of the word “intriguing”, as if this was a board game and the pieces were poor people and Africans that the writer need never encounter as he/she sits at the Lancet desk puzzling over the next move to make with their lives.

Since all these hundreds of AIDS researchers are infected with the AIDS meme, they of course don’t conceive – publicly, at least – of the possibility that the reason no one is getting provably better from HAART and in fact dying as quickly as before may be that the drugs are harmful and HIV is the wrong target. After all, with HIV under better control and no accompanying improvement in health history, the disconnect is rather obvious to anyone not infected with the AIDS meme. But HIV/=AIDS researchers are universally infected, and so having found that people are getting AIDS faster than ever and TB is a growing factor, they suggest that “immune restoration syndrome is a contributing factor.”

Apparently this is the fashionable, upside down cell suicide theory developed to explain why an increase in immune cell count from ARVs doesn’t seem to help after all. A stronger immune system may not be a good thing, and you might prefer that your T cell count hadn’t improved, because the immune system goes awry, and kills off its own cells. This rather fantastic idea is a staple of AIDS think now, seen in many papers which view a decline in health despite a decline in viral load as a “paradox”.

As always a “greater understanding” is sought to explain why none of this makes sense – “a greater understanding of emerging patterns and pathogenesis of HIV-related morbidity” – rather than using a swift stroke of Occam’s Razor to chop the centipede of endless rationalization in two, and admit the obvious, which is that all of it makes instant sense if the basic paradigm premise, HIV=AIDS, is abandoned.

The study did come up with one mysterious sign that HAART may be good for you, in that drug holidays don’t seem to benefit patients. People are dying faster from interrupted anti-retroviral therapy, as compared with continuous antiretroviral therapy. Perhaps the patients do initially benefit from the antibiotic effect and immune boosting effect of ARVs, which seem undeniable at the beginning of therapy. If so, ARVs take over and act as a substitute for the immune system attacks on pathogens. Interrupt the “therapy”, and the battered immune system loses its crutch but cannot recover its strength by itself.

Or it could be the simple fact that for some of the patients antobiotics were being administered along with HAART. In the earlier 1998 study mentioned above, that’s what was going on for half the patients, under the name “chemoprophylaxis,” with the antibiotics aimed at the particular problems the patient exhibited. Perhaps the initial impact of HAART, trumpeted as enabling swallowers to leap off their sickbeds and climb mountains, or at least go back to the office, has something to do with the antibiotics given them in tandem with the drugs, which also have some rotorooter effect.

Whatever is going on, the recognition of a death rate unimproved over ten years certainly seems to dent claims of great benefits of HAART. As the dissenters in AIDS never tire of pointing out, the improvement in AIDS mortality was visible by 1992 and 1993, when it plateaued before a decline since. The new protease inhibitors weren’t given to more than 2% of patients in mid 1995, when HAART came in. It was mid 1997 before they reached 86%, according to the Palella study (referenced just below). So the fewer deaths were too early for HAART to gain credit If anything the improvement was due to cutting AZT dosage by three times or more.

This study doesn’t seem to add any improving trend at all, as far as deaths go. According to this study, the risk of AIDS and deaths went up noticeably from 1995 to 1997, though the figures are not statistically significant (at 95% CI). It is hard to see how it bolsters claims that HAART enhances health straight away and then cuts the death rate by as much as 80%, so you can “live for ten years or longer”.

In 2003 Duesberg pointed out the death rates claimed for HAART in “saving lives” were actually higher than would be the case if everybody with AIDS dropped dead within the year. In the Palella et al paper above referenced by Duesberg in his Journal of Biosciences Paper of June 2003 (p 410), “Declining morbidity and mortality among patients with advanced human immunodeficiency virus infection. HIV outpatient Study Investigators.”, New England Journal of Medicine 338 853-860, for example, it was claimed that mortality was reduced to 8.8%, and another study (Hogg et al 2001 “Rates of Disease Progression by Baseline CD4 Cell Count and Viral Load After Initiating Triple-Drug Therapy”, JAMA 286 2568-2577) found it was 6.7%.

But Duesberg pointed out that even if all the 471,451 AIDS cases counted by the WHO in 2000 when 34.3 million were “living with HIV” were soon fatal ie all of them dropped dead within the year, the rate would still be only 1.4%. So no treatment at all might be the best bet.

Toxicity of ARVs exposed by panel and FDA in 2000

Meanwhile the toxic effects of ARVs became so obvious by 2000 – “nerve damage, weakened bones, unusual accumulations of fat in the neck and abdomen, diabetes, … heart disease” as Larry Altman put it in the Times in U.S. Panel Seeks Changes In Treatment Of AIDS Virus” February 4, 2001 (referenced in error in the Biosciences paper as “US Warns doctors to limit use of anti-HIV drugs”, January 5 p A12, when Altman actually published a different warning not to use nevirapine for needle stick cases, “U.S. Warns On Some Use Of a Fighter Against H.I.V.”) that a government panel warned prescribing the medications should be delayed as long as possible and the FDA ordered drug manufacturers to stop exaggerating benefits and minimizing risks in their ads.

Now we have the HAART study in the Lancet confirming that anyone who embarks on this regimen will be jumping on a conveyor belt to death that is running faster than before, and passing through the same sickening side effects – along with the famous buffalo humps and faces are so drained of fat that expensive cosmetic restoration is needed to be socially acceptable.

This even though the make up of the drugs has been changed somewhat and now finally there is the One Big Pill, instead of the bowl full of pills which was one of the most striking images of early AIDS (though with pills added for “non AIDS” ailments and specifically directed against other targets than HIV replication, perhaps this bowl is otherwise as full as ever, we don’t know).

So where does this leave earlier reports saying that HAART cut death rates by up to 80 per cent? For example, news of a GlaxoSmithKline funded study in 2003 was headlined MRC study shows highly active anti-retroviral therapy dramatically cuts deaths from AIDS.

A dramatic increase in life expectancy for people infected with HIV has been achieved since the introduction of Highly Active Anti-Retroviral Therapy (HAART), say Medical Research Council (MRC) scientists today (Friday 17 October 2003).

New research conducted at the MRC Clinical Trials Unit in London and published in this week’s issue of The Lancet shows that in the first four years after the introduction of HAART, death rates from AIDS fell by over 80%.

Independent observers can only wonder at this dramatic revision two years later, although it only applies for the first two years of AIDS. Perhaps as always in AIDS the confounding element of hardiness intervenes – those that don’t succumb rapidly to assaults on their systems can live with them a long time.

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A dramatic increase in life expectancy for people infected with HIV has been achieved since the introduction of Highly Active Anti-Retroviral Therapy (HAART), say Medical Research Council (MRC) scientists today (Friday 17 October 2003).

New research conducted at the MRC Clinical Trials Unit in London and published in this week’s issue of The Lancet shows that in the first four years after the introduction of HAART, death rates from AIDS fell by over 80%.

More than 50,000 people in the UK are living with HIV and worldwide, more than 40 million people have been infected with the virus.

Anti-retroviral drugs work by attacking the virus (HIV) that causes AIDS, slowing the progression of the disease and prolonging life. HAART is the name given to anti-retroviral combination treatments that include three or more drugs.

Using data from CASCADE*, a large collaboration of 22 different studies across Europe, Australia and Canada, scientists led by Dr Kholoud Porter of the MRC Clinical Trials Unit assessed the effect of HAART on life expectancy and development of AIDS in people with a known date of HIV infection.

The researchers found that when HAART was introduced in 1997, death rates immediately halved. By 2001, death rates had been cut by over 80%. Over this four year period, use of HAART therapy increased from one in five patients to over half the people infected with HIV.

Before 1997, the risk of developing AIDS was much higher in those aged 45 years or older when they were infected with HIV compared with people who were 16-24 years old. The study found that older people infected with HIV no longer appear to have a reduced life expectancy compared with younger people.

However, the researchers also found that people with HIV who were infected through injecting drug-use were four times more likely to die of AIDS than men infected through sexual contact. Similarly, people infected through other routes, such as haemophiliacs, were three times more likely to die. The researchers suggest that these findings could be due to these groups of people spending less time on HAART, or benefiting less from therapy because of reduced adherence or other existing infections such as Heptatitis.

Dr Porter said: “The introduction of highly active anti-retroviral therapy has been a tremendous success. Before this therapy was introduced, about half of those infected were expected to live for ten years after diagnosis, much less if they were, say, 40 years old when infected. Now, people treated with these combinations of drugs can almost all expect to live at least ten years after diagnosis, regardless of their age at infection.

“However our findings do point to the importance of an early diagnosis so that people can access the best treatments at the right time. We also need to continue to explore what happens when therapy starts to fail, for example due to resistance to anti-retroviral drugs, if we are to maintain improved life expectancy for people living with HIV.”

The collaboration is funded through a grant from the European Union and has received additional funding from GlaxoSmithKline.

ENDS

To interview Dr Porter contact the MRC Press Office on 020 7637 6011. For a copy of The Lancet paper, contact Richard Lane on 020 7424 4949 or richard.lane@lancet.com.

NOTES TO EDITORS

* Concerted Action on Seroconversion to AIDS and Death in Europe.

The Medical Research Council (MRC) is a national organisation funded by the UK tax-payer. Its business is medical research aimed at improving human health; everyone stands to benefit from the outputs. The research it supports and the scientists it trains meet the needs of the health services, the pharmaceutical and other health-related industries and the academic world. MRC has funded work which has led to some of the most significant discoveries and achievements in medicine in the UK. About half of the MRC’s expenditure of over £413 million is invested in its 40 Institutes, Units and Centres, where it employs its own research staff. The remaining half goes in the form of grant support and training awards to individuals and teams in universities and medical schools. Web site at: http://www.mrc.ac.uk.

HAART helps, it’s just the patients are sicker, blame that

As mentioned, the media reports have followed the line that the drugs are still doing patients good, and the unchanged mortality reflected the spread of their benefits to people from geographic (in Africa) or financial (poor) regions where people are sicker to start with by the time they are medicated, with their initial CD 4 counts much lower in recent years than before.

For example, from medicine.net, the good news is this:

All agree that today’s drug regimens are remarkably effective. So effective, in fact, that one study found the nine out of 10 patients who stay on the treatment can expect to live for more than a decade.

Rather, the findings seem to reflect the changing face of HIV infection in Europe and North America, experts say…

He says many of the HIV-infected patients he now treats also have mental health and substance abuse issues.

“For these patients, HIV is just one more problem in an already problem-filled life,” he says. “They may be dealing with schizophrenia, drug abuse, or any number of other issues. Many refuse therapy or don’t stay on it.”

The fact that mortality has not improved, even though treatments for AIDS have improved, underscores the need to focus more on preventing HIV infection, del Rio says.

“HAART has made a big difference, but we can’t rely on therapy alone in this population,” he says.

Faith in God and secular faith are lovely to behold, unless you want your researchers to focus on reality, perhaps because you are “on the meds”, as they say.

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MedicineNet.com

HIV Drugs Improve, but Not Death Rate

‘HAART’ Treatment Is Effective, but Many Patients Are Now Sicker When They First Get Treated

By Salynn Boyles

WebMD Medical News

Reviewed By Louise Chang, MD

on Thursday, August 03, 2006

Aug. 3, 2006 — Ten years after the introduction of highly active antiretroviral therapy (HAART), HIV treatment continues to improve, with today’s drug regimens eliciting better viral control than those of the past with far fewer serious side effects.

Yet despite the steady evolution of HIV therapy, a newly released study shows no corresponding decline in death rates or progression to AIDS among patients from North America and Europe who were followed for up to a year.

Just over 22,000 patients starting therapy for the first time were included in the study, which appears tomorrow in the journal The Lancet.

The findings do not mean that HAART is not saving lives or keeping HIV-infected people from developing AIDS.

All agree that today’s drug regimens are remarkably effective. So effective, in fact, that one study found the nine out of 10 patients who stay on the treatment can expect to live for more than a decade.

Rather, the findings seem to reflect the changing face of HIV infection in Europe and North America, experts say.

Changing Demographics

Researchers found that in 2003, patients tended to be sicker when they started treatment than those beginning treatment in 1995. And that the number of AIDS cases seen in recent years is related to an increase in cases of tuberculosis.

Compared with patients starting HAART for the first time in 1995, those starting therapy in 2003 were far more likely to be female and infected with HIV through heterosexual rather than homosexual contact.

Specifically:

* The percentage of female patients starting therapy increased from 16% in 1995-1996 to 32% by 2002-2003.

* During the same period, the percentage of men who became infected through sexual contact with men declined from 56% to 34%.

* The percentage of patients presumed to have become infected via heterosexual contact increased from 20% in 1995-1996 to 47% in 2002-2003.

* The percentage of patients infected via injected drug use declined from 20% in 1997 to 9% in 2002-2003.

The study suggests that homosexual men have benefited the most from HAART. The best viral responses to therapy have been seen among this group, while women and men infected via heterosexual contact have not benefited as much.

‘Disease of Poverty’

HAART has transformed HIV infection from a sure killer to a largely manageable disease among patients who begin treatment early and stay on it.

But many patients in the U.S. have not benefited, says Carlos del Rio, MD, because AIDS is increasingly a disease of the poor and medically underserved.

Del Rio is a professor of medicine and infectious disease at Emory University in Atlanta and co-director of the Emory Center for AIDS Research.

“Twenty years ago AIDS was a disease of middle class, white, gay men, but it is increasingly a disease of poverty,” he tells WebMD. “Patients today are less likely to have access to good medical care, so it is not surprising that they are sicker when we first see them.”

He says many of the HIV-infected patients he now treats also have mental health and substance abuse issues.

“For these patients, HIV is just one more problem in an already problem-filled life,” he says. “They may be dealing with schizophrenia, drug abuse, or any number of other issues. Many refuse therapy or don’t stay on it.”

The fact that mortality has not improved — even though treatments for AIDS have improved — underscores the need to focus more on preventing HIV infection, del Rio says.

“HAART has made a big difference, but we can’t rely on therapy alone in this population,” he says.

SOURCES: Antiviral Therapy Cohort Collaboration report, The Lancet, Aug. 5, 2006; vol 368: pp. 451-458. Margaret May, research fellow, department of social medicine, University of Bristol, U.K. Carlos del Rio, MD, professor of medicine and infectious diseases, Emory University School of Medicine; co-director, Emory Center for AIDS Research. WebMD Medical News: “HAART Adds Years for People with HIV.”

© 2006 WebMD Inc. All rights reserved.

Why heterosexual men and women should benefit less from ARVs than gay men is not explained, except by saying that immigrants from Africa and residents of the poorer neighborhoods may be sicker to start with, from malnutrition or TB, though drugs are not the cause, it seems, since they play a much reduced role now:

Specifically

* The percentage of female patients starting therapy increased from 16% in 1995-1996 to 32% by 2002-2003.

* During the same period, the percentage of men who became infected through sexual contact with men declined from 56% to 34%.

* The percentage of patients presumed to have become infected via heterosexual contact increased from 20% in 1995-1996 to 47% in 2002-2003.

* The percentage of patients infected via injected drug use declined from 20% in 1997 to 9% in 2002-2003.

The study suggests that homosexual men have benefited the most from HAART. The best viral responses to therapy have been seen among this group, while women and men infected via heterosexual contact have not benefited as much.

In this search for other, non-HIV reasons for the health decline in AIDS patients, the paradigm apologists are once again adding to the list of factors which cause AIDS which have nothing to do with HIV.

And with the decline of HIV viral load that has gone along with the success of HAART in that respect, the link between HIV and AIDS is once again weakened if not broken outright.

The residual question is, what are the claimed benefits of HAART in the early phase of the treatment due to? That’s the subject of another post, but a quick answer would include a) the antibiotics administered to many, often half, the patients for very specific reasons, b) the antibiotic effect of HAART itself, which may clear the intestine of parasites and allow better absorption of nutritional elements vital to the immune system, and c) food (in the case of starving Africans who may sign up for HAART simply to get food , and d) the anitoxidant effect of HAART, pointed to by Al-Bayati and others.

But whenever told of the benefits of HAART, it always reminds us of the fact that AIDS in North America and Western Europe has been decreasing since it topped out 1992 and 1993, not later, 1995, when HAART came in.

AZT was lowered in dose from 1992 onwards, or even earlier, and further when it was included in the HAART regimen with protease inhibitors came in in 1995. The decline in AIDS cases matched the decline in lethal medication, AZT, not the arrival of HAART, the new regimen.

Now we learn that the death rate for the first two years of AIDS certainly hasn’t improved from 1995 to 2003. All that happens is that viral count improves a little, making no difference in your unrelenting progress toward a fatal end brought on by adding noxious drugs to the burden of disease and other medications AIDS patients are heir to.

Death rates have if anything worsened, according to a close reading of the paper, and the rate of AIDS sickness and death has gone up, at least in the first two years of treatment.

The bottom line seems clear. Lowering the dose of AZT cut the death rate, and HAART has served to maintain it, after initial benefits which are easily accounted for by factors other than its success in lowering viral load.

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