Science Guardian

Power and politics in science and health

Cool examination of hot debates

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Defending the values of science and good scientists in the paradigm wars of HIV/AIDS, cancer, evolution, global warming, nutrition, religious belief and any other disputes over new and different ideas in science, health and politics against subjectivity and self-interest, we mine truths buried in the journal literature and commonly overlooked by the media, and review novel claims without prejudice against modern Galileos, courageous whistleblowers, distinguished mavericks, past or future Nobelists, or any other publicly damned heretics, that is, informed and independent minds (such as the noted scientists Peter Duesberg, James Watson and Kary Mullis) who may question scripture.

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A clash of doctrines is not a disaster but an opportunity. - Alfred North Whitehead.

A SG question for President-elect Obama at his change.gov site, which can be voted on by finding this page and typing "cause of AIDS" into the search slot; it is currently the third listing. Voting tabs are on the right:
“The cause of AIDS has been seriously disputed for 21 years in scientific journals by reputable scientists answered by HIV researchers only with politics (see scienceguardian.com). Will you order objective review to establish proper AIDS policy?”

More Quotations on Science and Belief
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BMJ was misled, apologizes to Dr Rath

September 28th, 2006


But who fed the BMJ false information?

Sleazy actions abound in defense of weak HIV∫AIDS paradigm

Vitamin booster and somewhat loopy world savior Dr. Matthias Rath is still in South Africa, and taking on all comers, even though leading HIV∫AIDS dissenting scientist Dr David Rasnick has returned to the USA, having understandably found him impossible to work for.

Only two weeks ago, Rath leveled a law suit against the British Medical Journal for slander, and today he got results. BMJ backed down, withdrawing the story from its site and issuing an apology.

However, it is not clear at all what the specific falsehoods were, since the original story is gone and they are not specified in the apology, and there is no mention yet of the affair on Rath’s site, which now claims that Bill Gates and Warren Buffett were reacting to Rath’s prediction of pharmacollapse with their recent global charity initiatives (a two year graph shows how many visits from Microsoft the site has collected).

Here’s how the story was described by Knowledgespeak, in its story two weeks ago, “Dutch doctor takes BMJ to court with libel charges - 15 Sep 2006:

Titled ‘Vitamins promoter goes on trial for fraud’, the article is about an alternative medicine doctor, who is blamed for the death of a nine-year-old boy with bone cancer. According to the story, the doctor is sent on trial for fraud in Germany for convincing the boy’s parents to reject conventional medical treatments, and use a ‘miracle cure’ rich in vitamins. The story, which was available online until recently, has been removed on legal advice.

Dr. Matthias Rath of the Netherlands has reportedly filed a lawsuit against BMJ Publishing Group for having published a story in the British Medical Journal, which he alleges is defamatory. He is seeking compensation of over £300,000 for the article published in the July edition of the journal. He has also sought an injunction to prevent any repetition of the allegations.

Titled ‘Vitamins promoter goes on trial for fraud’, the article is about an alternative medicine doctor, who is blamed for the death of a nine-year-old boy with bone cancer. According to the story, the doctor is sent on trial for fraud in Germany for convincing the boy’s parents to reject conventional medical treatments, and use a ‘miracle cure’ rich in vitamins. The story, which was available online until recently, has been removed on legal advice.

Following Dr. Rath’s publicity campaigns, several people have reportedly been giving up antiretroviral drugs to opt for vitamin supplements.

Seems that the BMJ were advised by their lawyers to back down in a hurry, and now they have done so.

Here is the page at BMJ where they have also removed the offending libel - the vanished article page - and here is
28.09.2006″>the BMJ Rath apology page
.

Oh, good, we see it does give the false allegations:

In a news item published in the 22 July 2006 issue of the BMJ (2006;333:166) and on the bmj.com website, it was reported that Dr Matthias Rath had gone on trial in Hamburg “for fraud.”

In this context we suggested that Dr Rath stood accused of the serious crime of fraud in relation to the death in 2004 of Dominik Feld, a 9 year old boy with bone cancer; that he was culpably responsible for Dominik Feld’s death; and, in particular, that he had improperly pressured Dominik Feld’s parents into refusing to allow hospital doctors to amputate the boy’s infected leg in an effort to save him.

We now accept that the allegations we published were without foundation, and in the circumstances the BMJ wishes to set the record straight and to apologise to Dr Rath for publishing these allegations.

Sites such as Health-e which wrote stories based on the BMJ report have also withdrawn the story and apologized to Rath. A search for cached versions on Google shows that most or all of them have been removed.

Defending science with personal smears

Well, fine. A rather unexpected victory, given the circumstances, and the tendency for courts to credit ruling paradigms and conventional medicine as gospel truth, which makes one think the law will never give medical mavericks a fair shake. Whether Dr Rath has the right idea or the wrong idea, or even the right idea for the wrong reasons (we think more the latter), he should not be libelled.

But the residual important question is, who fed the BMJ the wrong information? Could it have been the South African activists who have been trying to drum him out of town? Was John Moore of Cornell involved in any way?

And will Moore et al’s scurrilously misleading AIDS information site, AIDSTruth also now carry this news item?

Poison pen letters as a weapon of science

Just how far are the sleazy group of second tier paradigm defenders prepared to go in combating their rivals on non-intellectual grounds? We note with interest that they indulge in sending letters to the employers of dissenters, hoping to silence them that way. This is a trick which most decent men and women wouldn’t think of, but which has been tried recently in three cases we know of.

Luckily in each case the employer didn’t take very long to work out why he or she was in receipt of such a puerile and perfidious attempt at backstabbing. After all, any sane person immediately recognizes how weak a scientific position has to be, if it must be defended with political means, especially with such ungentlemanly and crude capers.

It reminds us of a letter we were shown years ago by an MIT professor who had offended a certain Nobel prize winner by objecting to his joining the faculty. A libelous piece of trash written behind his back, it had taken a year for him to hear about it.

This kind of behind the back detraction is a standard ploy among the second rate who manoever for position which they do not merit. Scientists who are above board because they deserve their prizes and the respect and position they have earned often have no idea what is going on, and can hardly credit it when they are told.

One known perpetrator in HIV∫AIDS is John Moore of Cornell, and there are others, such as Nancy Padian, and Richard Jefferys, who have defended the paradigm in this way. But of course with Dr Anthony Fauci of NIAID censoring scientific or media review of the conventional wisdom from the very beginning of the HIV∫AIDS era twenty two years ago, perhaps they are merely following his lead and feel that their truth is a Holy War in which the Geneva Convention rules may be ignored.

Smokers, quit or you’ll likely be HIV positive

September 28th, 2006


Smokers often score positive, another baffling paradigm mystery

Could it be the obvious? Not in HIV∫AIDS dreamland

While in the aftermath of the last post we can all contemplate the AIDS industry embarking on an “exciting” and no doubt expensive search for a reason for CD4 counts to go down other than HIV “viral load”, we can add one more possible reason why positive HIV tests may not mean what we think they mean.

Seems smokers (watch out, Martin!) are more like to be “at risk of HIV” than the rest of us, notes the newspaper of HIV∫AIDS record.

The study, which appears in the journal Sexually Transmitted Infections, says it is not clear why smokers would be more likely to become infected with the virus, H.I.V., than nonsmokers.

The difficulty the researchers have in explaining their finding is clear. Apparently their “broad review of earlier research” didn’t include calling up the Perth Group or reading their copious papers on test cross reactions.

They stumble from one speculation to the next, as they ignore the elephant in the room.

The study was based on a broad review of earlier research that looked at the relationship between smoking and H.I.V. or AIDS. The authors, led by Dr. Andrew Furber, a British researcher, said they had found a “striking” consistency in the evidence that smokers were more likely to become infected. They did not, however, find strong evidence that smoking made AIDS worse.

The whole performance reeks of the basic intellectual corruption of the entire field, which is never, ever question the basic premises of the paradigm, in this case that the tests reliably indicate the presence of “the virus that causes AIDS”.

We would suggest quite simply on the basis of everything else that has been established in correcting the HIV∫AIDS paradigm in every respect that there is some reaction that goes on in the body of a smoker which triggers a positive response on the few parameters involved in an HIV test. But heck, what do we know, before reading the paper, and seeing how much more often smokers score positive, which the Times item forgets to mention.

Only that the Perth Group has written papers counting as many as sixty sources of cross reaction leading to a false positive, and we do know for example that pregnant females tend to score positive much more often. In fact we suspect that simply being young and female sends scores up in South Africa, judging from the numbers they give us.

That pregnancy cross reaction is one of the factors that makes a mockery out of the WHO extrapolations of prevalence of HIV from a few neonatal clinics in Durban and Johannesburg to the entire population of the sub-Sahara, according to critics such as Rian Molan and the Perth Group, among others, whom we believe.

Just how reliable HIV tests really are is a topic worthy of expansion here, but we have to sign off at this moment.

The least we can say is, come on guys, wake up. Isn’t it obvious why smokers should rate positive more often, without any other correlation with “AIDS”? Either the tests aren’t accurate, or HIV doesn’t cause AIDS, or both.

The New York Times

September 26, 2006

Vital Signs

At Risk: Smoking Tied to Increased Risk of H.I.V.

By ERIC NAGOURNEY

Researchers have found that smokers may be at higher risk for becoming infected with the virus that causes AIDS.

The study, which appears in the journal Sexually Transmitted Infections, says it is not clear why smokers would be more likely to become infected with the virus, H.I.V., than nonsmokers.

But the authors pointed to growing evidence that smoking increases the risk of all types of infections, perhaps by changing the structure of the lung or weakening the immune system. They also noted that tobacco use tended to be higher among the groups of people most likely to get AIDS, like prostitutes.

AIDS and tobacco use, the study said, are the only two major causes of death that are on the rise, with tobacco projected to play a role in perhaps eight million deaths in a little over a decade.

The study was based on a broad review of earlier research that looked at the relationship between smoking and H.I.V. or AIDS. The authors, led by Dr. Andrew Furber, a British researcher, said they had found a “striking” consistency in the evidence that smokers were more likely to become infected. They did not, however, find strong evidence that smoking made AIDS worse.

“It may be the case,” they wrote, “that smoking contributes little to the risk of developing AIDS. This may be because the immune mechanisms that smoking affects are less relevant in progression to AIDS than in acquiring the infection in the first place.”

JAMA confirms HIV load doesn’t govern CD4 loss

September 27th, 2006


Lynchpin falls out of paradigm

No explanation yet from Dr Fauci, and we think we know why

Interesting JAMA story moving on the UPI ticker just now: HIV measurement is questioned. Seems viral load has little to do with CD4 loss in untreated HIV + patients.

Dr. Benigno Rodríguez of Case Western Reserve University and colleagues conducted a study to estimate the extent to which presenting blood levels of HIV can account for the rate at which CD4 cells are depleted among an untreated HIV-infected population of patients.

The researchers found only a small proportion of the rate at which CD4 cells are lost could be explained by plasma HIV RNA level, suggesting more than 90 percent of the determinants of CD4 cell decline are not reflected in the amount of virus in blood.

So don’t hurry to take HAART just because your HIV count is high. Is that right?

If so, where does that leave the paradigm and Anthony Fauci’s assurance that HIV causes depletion of CD4 cells, directly, indirectly and some other mysterious way as yet undefined but characterised by the paradigm defense team’s head man, Zvi Grossman, as a “conundrum”.

Seems we don’t even have to work out what the conundrum is. HIV doesn’t correlate with CD4 loss, period. Not in untreated patients. Not before HAART messes with your constitution.

Ah well, it’s late, maybe we got it all wrong. But looks to us as if the paradigm is failing on every front. Viral load doesn’t govern CD4 loss. That’s a problem to explain, unless you are a dissenter, ie someone with a few working brain cells left in this field.

Is it time for Gallo et al to pack for Rio? He should buy his ticket, the way things are crumbling.

Still, since Fauci presumably has been forewarned, he probably has an answer for us tomorrow, and Larry will let us know at the Times.

UPDATE: here is an AMA rundown of the paper:

“These findings represent a major departure from the notion that plasma HIV RNA level is a reliable predictor of rate of CD4 cell loss in HIV infection and challenge the concept that the magnitude of viral replication (at least as reflected by plasma levels) is the main determinant of the speed of CD4 cell loss at the individual level. The clinical implications are that in the majority of cases, an individual patient’s plasma HIV RNA level at the time of presentation for clinical care cannot predict, to a significant extent, the rate of CD4 cell decline that he or she will experience over the subsequent years and is therefore of limited clinical value in shaping the decision to initiate antiretroviral therapy,” the researchers write.

(JAMA. 2006;296:1498-1506.)….

“The second and potentially more exciting implication of the findings of Rodriguez et al is that future improvements in the treatment of HIV infection and AIDS may result from improved understanding of the 90 percent of CD4 cell depletion that remains enigmatic,” they write. “A better understanding of the immunologic and genetic factors that drive HIV-associated CD4 cell loss may translate to novel therapeutic approaches that could favorably shift the pathogen-host balance.

So 90 per cent of CD 4 depletion is not driven by HIV? But… but… Dr. Fauci, come to our rescue here. We were under the impression that HIV caused AIDS by depleting CD4 cells. You told the audience that when you appeared in New York with Mathilde Krim and Larry Kramer at the New School to celebrate “AIDS after 25 Years”. Help us here.

Did Dr Fauci censor himself on HIV∫AIDS flaws?

Why was this paper not flagged at NIAID before it could be published? The answer to that question also seems enigmatic. Maybe it was because Dr Fauci thought there might be something in our previous nomination on his behalf for recognition from Stockholm (Dr Fauci finds solution to AIDS - it’s HIV; NAR nominates him for Nobel) on the grounds that he had discovered that HIV actually increased CD4+8 proliferation, and therefore was an antidote to itself.

Readers may note that at the bottom of that post is a Comment by Robert Houston which points out that Dr Fauci himself in a review of HIV∫AIDS quoted from a paper he himself forwarded to the National Academy of Sciences that showed that a huge rise in HIV load of 5,560% resulted in a negligible change in CD4 count of -6%, at the same time as boosting CD8 count 20%.

Is it possible that Dr Fauci is aware of the fact that HIV load has no great influence on CD4 count, and even wrote about it for the information of the medical community, on the basis of a paper he forwarded to the National Academy, and somehow forgot to tell government officials, health workers and the public?

Surely it would be too cynical to imagine that the director of NIAID would censor himself in this way, after censoring the media for twenty two years?

Surely a public servant of the well paid and important kind that Dr Fauci is would never withhold information from members of the public who pay his salary who might then be misled into taking drugs with horrendous side effects for no good reason?

Surely a public servant of the stature of Dr Fauci would not freely acknowledge a flaw in the paradigm which has brought so much funding to his institution among colleagues, and yet somehow neglect to tell the public?

If he did, then it behooves us to wonder just how flawed does Dr Fauci think the HIV∫AIDS paradigm really is. Are there other flaws which he has quietly recognized in chats and talks to his peers in the medical policy fraternity, but has omitted to acknowledge in public?

It already seems clear that his answer to Robert Houston at the “AIDS after 25 Years” panel on how HIV killed CD4 cells was misleading. He repeated the same old claims that there was direct killing and indirect killing which have not only been revealed as specious by mainstream papers which he must have read himself, but he knew himself from his own review and paper that HIV load has very little to do with CD4 count changes.

So today’s revelation in JAMA is nothing new to him, and we don’t really expect him to help us to understand it. Dr Fauci’s policy on informing the public seems to be this: however many reasons there are to doubt that HIV is “the virus that causes AIDS”, it is important not to undermine public confidence by acknowledging them in public.

But it is fine to talk and write about them among colleagues.

We wonder what all the haplessly gullible gays now staggering about with wrecked and ugly bodies, and the ghosts of their dead, will have to say about it when they finally come to their senses?

Maybe they will take up Larry Kramer on his suggestion for a latter day Nuremburg Trial, and put Dr Anthony Fauci in the dock.

AMA rundown:

Libraries

Medical News

Keywords

HIV, CD4 CELLS, IMMUNE RESPONSE

Contact Information

Available for logged-in reporters only

Description

Preliminary research indicates that the initial HIV RNA level in untreated HIV-infected patients appears to have little value in predicting the rate of CD4 cell count decrease, potentially limiting its clinical value concerning the decision of when to begin antiretroviral therapy for an individual, according to a study in the September 27 issue of JAMA.

Newswise — Preliminary research indicates that the initial HIV RNA level in untreated HIV-infected patients appears to have little value in predicting the rate of CD4 cell count decrease, potentially limiting its clinical value concerning the decision of when to begin antiretroviral therapy for an individual, according to a study in the September 27 issue of JAMA.

Depletion of CD4 cells is a characteristic of progressive human immunodeficiency virus (HIV) disease and a powerful predictor of the short-term risk of progression to AIDS, according to background information in the article. Blood levels of HIV are also thought to predict HIV disease progression risk. In addition to their role as predictors of the clinical outcomes of HIV infection, CD4 cell count and plasma HIV RNA level are commonly used as markers of the success of highly active antiretroviral therapy (HAART). Until this study was completed, however, the degree to which blood levels of HIV could predict the rate of CD4 cell loss in HIV-infected individuals with similar demographic characteristics to those seen in clinical practice was unclear.

To address this question, Benigno Rodríguez, M.D., of Case Western Reserve University, Cleveland, and colleagues conducted a study to estimate the extent to which presenting blood levels of HIV can account for or “explain” the rate at which CD4 cells are depleted among an untreated HIV-infected population of patients including women and ethnic minorities. The study included repeated analyses of 2 multicenter groups, with observations beginning in May 1984 and ending in August 2004. Analyses were conducted between August 2004 and March 2006. The participants included antiretroviral treatment–naïve, chronically HIV-infected persons (n = 1,289 and n = 1,512 for each of the 2 groups) who were untreated during the observation period (6 months or greater) and with at least 1 HIV RNA level and 2 CD4 cell counts available. Approximately 35 percent were nonwhite, and 35 percent had risk factors other than male-to-male sexual contact.

The researchers found that only a small proportion of the rate at which CD4 cells are lost (only 4 percent - 6 percent) in a given individual patient could be explained by presenting plasma HIV RNA level, suggesting that in chronic untreated HIV infection over 90 percent of the determinants of CD4 cell decline are not reflected in the amount of virus in blood at the time of initial medical evaluation.

“Our findings confirm previous observations that the magnitude of HIV viremia [the presence of a virus in the blood stream], as defined by broad categories of presenting HIV RNA level, is associated with the rate of CD4 cell loss and extend this observation to patient populations comprising both men and women. Despite this association, however, only a small proportion of the interindividual variability in the rate of CD4 cell decline can be explained by plasma HIV RNA level, even after accounting for the effect of measurement error,” the authors write.

“These findings represent a major departure from the notion that plasma HIV RNA level is a reliable predictor of rate of CD4 cell loss in HIV infection and challenge the concept that the magnitude of viral replication (at least as reflected by plasma levels) is the main determinant of the speed of CD4 cell loss at the individual level. The clinical implications are that in the majority of cases, an individual patient’s plasma HIV RNA level at the time of presentation for clinical care cannot predict, to a significant extent, the rate of CD4 cell decline that he or she will experience over the subsequent years and is therefore of limited clinical value in shaping the decision to initiate antiretroviral therapy,” the researchers write.

(JAMA. 2006;296:1498-1506. Available pre-embargo to the media at http://www.jamamedia.org.)

“The second and potentially more exciting implication of the findings of Rodriguez et al is that future improvements in the treatment of HIV infection and AIDS may result from improved understanding of the 90 percent of CD4 cell depletion that remains enigmatic,” they write. “A better understanding of the immunologic and genetic factors that drive HIV-associated CD4 cell loss may translate to novel therapeutic approaches that could favorably shift the pathogen-host balance.

Editor’s Note: This work was supported in part by the Case Western Reserve University Center for AIDS Research and NIH grants. Please see the article for additional information, including other authors, author contributions and affiliations, financial disclosures, funding and support, etc.

Editorial: Explaining, Predicting, and Treating HIV-Associated CD4 Loss - After 25 Years Still a Puzzle

In an accompanying editorial, W. Keith Henry, M.D., of the University of Minnesota, Minneapolis; Pablo Tebas, M.D., of the University of Pennsylvania, Philadelphia; and H. Clifford Lane, M.D., of the National Institute of Allergy and Infectious Diseases, Bethesda, Md., discuss the findings concerning HIV RNA levels and CD4 cell loss.

“The study by Rodriguez et al may have several important clinical implications. The first and more straightforward is that baseline measurements of viral load alone should have less of a role in driving decisions on when to start antiretroviral therapy for an individual patient; these initial viral load levels cannot predict how rapidly the disease will progress. … The seemingly useful practice of combining a CD4 cell count and plasma HIV RNA levels to assess an individual patient’s prognosis for AIDS progression or response to highly active antiretroviral therapy needs reexamination.”

“The second and potentially more exciting implication of the findings of Rodriguez et al is that future improvements in the treatment of HIV infection and AIDS may result from improved understanding of the 90 percent of CD4 cell depletion that remains enigmatic,” they write. “A better understanding of the immunologic and genetic factors that drive HIV-associated CD4 cell loss may translate to novel therapeutic approaches that could favorably shift the pathogen-host balance. … Discovering and developing therapies that target key nonviral factors has the potential over the decades ahead to build on the success of antiretroviral therapy and expand access to sustainable effective therapy.”

(JAMA. 2006;296:1523-1525. Available pre-embargo to the media at http://www.jamamedia.org.)

Editor’s Note: Please see the editorial for financial disclosures, funding and support, etc.

HIV measurement is questioned

CLEVELAND`, Ohio, Sept. 26 (UPI) — Preliminary U.S. research indicates the HIV RNA level in untreated HIV-infected patients has little value in predicting the rate of CD4 cell count decrease.

Researchers say that potentially limits HIV RNA’s clinical value concerning the decision of when to begin antiretroviral therapy.

Until the new study was completed, the degree to which HIV blood levels could predict the rate of CD4 cell loss was unclear.

To address the question, Dr. Benigno Rodríguez of Case Western Reserve University and colleagues conducted a study to estimate the extent to which presenting blood levels of HIV can account for the rate at which CD4 cells are depleted among an untreated HIV-infected population of patients.

The researchers found only a small proportion of the rate at which CD4 cells are lost could be explained by plasma HIV RNA level, suggesting more than 90 percent of the determinants of CD4 cell decline are not reflected in the amount of virus in blood.

The research appears in the current issue of the Journal of the American Medical Association.

UPDATE: Nick Bennett Replies on his site Viral load paradigm shift? Not really.

Wednesday, September 27, 2006

Viral load paradigm shift? Not really.

An interesting study came out recently (I managed to get a copy of the article from one of the authors) on the predictive value of viral load. It’s well known (at least among those who bother to read and understand the literature) that those people with higher viral loads tend to progress faster, as was shown by John Mellors back in the mid 1990s using the large Multicenter AIDS cohort study (MACS).

This study took things one step further. They replicated the original findings of Mellors by showing again that viral load roughly predicted how fast AIDS occurred in another large cohort composed of people from 3 seperate study sites. For example, in this new paper people with viral loads less than 500 had an average loss of CD4 cells of 20 per year whereas those with viral loads over 40,000 had an average loss of 78 a year (with a smooth change for values inbetween). Basically this data proved that viral load was a reasonable predictor of rate of progression! They compared this analysis with the original MACS cohort and it looks practically identical!

But then they tried to look at the individual rate of progression of each member of the cohort. Unsurprisingly they found that the rough-and-ready estimates of progression rate within a subgroup varied from one individual to another. When they ran complex statistical analysis on the effects of viral load on THIS data they found that only about 5-6% of the inter-individual variation can be explained by the initial viral load. In another words, while viral load predicts that you WILL lose CD4 count, and you can give an AVERAGE loss of CD4 cells per year based on that count, you can’t say for sure what the ACTUAL loss will be for any one person very accurately.

Well, duh. Nothing amazing there.

Now, what’s sad about this whole thing is that is appears as if the dissident websites have jumped all over the mass-media coverage of this without bothering to read the paper. They are assuming that this somehow negates the usefullness of viral load measurements. Ironically if a paper showing that viral load predicted 100% of the CD4 T cell loss (an impossible thing) relied on complex statistical analysis I’m sure they wouldn’t accept it with anything like the same level of naivity!

This is nothing new - we’ve known for years that various other factors can play into AIDS progression, from nutritional status to immune makeup, depression, and viral genetics. We’ve known for years that overall T cell losses include uninfected as well as infected cells, that immune hyperactivation leads to apoptosis but a lack of renewal - both things that are only indirectly due to HIV infection, but not direct cell killing. What we haven’t done before is put a number on anything - to say roughly HOW much influence these things can have on an individual level.

It should also be noted that this should lay to rest any idea that mainstream science is simply laying back and accepting the current paradigm without question. If that were the case, why was this large, comprehensive, complex study performed? Is it because that when dissidents say that scientists ARE sitting back on the current paradigm they are…*gasp*…lying??! And, SHOCK HORROR, this was supported by an NIH grant, the very same NIH that the dissidents are trying to claim is horribly corrupt and under the thumb of pharmaceutical sponsors!

Ahh, is that the sound of cherries being picked?

Anyhow, I will quote from the paper:

“Our findings confirm previous observations that the magnitude of HIV viremia, as defined by broad categories of presenting HIV RNA level, is associated with the rate of CD4 cell loss and

extend this observation to patient populations comprising both men and women.”

In other words, viral load predicts rate of progression to AIDS.

If the dissidents are trying to twist this paper to say anything else, they are managing a feat of astonishing deception. Is there more to the story? Of course! No-one, except the dissidents, is saying anything else. They also state that “In humans, the predictive value of immune activation level on HIV disease course, independent of plasma HIV RNA levels, can be demonstrated even when measured during early infection”, which goes back to what I said above.

And I refer the reader to my older post on HIV pathogenesis.

It should also be mentioned that viral load isn’t used as a clinical criteria for starting treatment unless the load is very high and the CD4 counts are equivocal. Viral load is almost exclusively used for monitoring response to therapy on the individual level, so inter-individual variability isn’t an issue anyway.

This result is very important in that it highlights the need to investigate other factors important in triggering or controlling rate of progression to AIDS, but it won’t really change the current paradigm in terms of understanding AIDS pathogenesis, nor will it change current treatment guidelines, because neither depends on the idea that HIV viral load is the be-all and end-all of AIDS.

Except of course, that it is in the minds of the dissidents.

Which is (one reason) why they’re wrong.

posted by Bennett at 11:18 PM

0 Comments:

Comment: Bravo, Bennett, for defending the paradigm against what looked like a nasty finding judging from the first reports. Now we too have the actual paper in hand, we can see that the point Dr Bennett makes is perfectly correct, this was a paper dealing with variations between individual experiences, not with the overall correlation between the two measures of HIV and CD4 for all the patients in the study. Naturally there can be many other factors accounting for variations in individual experience, as there are many reasons for contracting AIDS symptoms, and reasons for vulnerability.

But he entirely overlooks the thrust of the paper, which demonstrates that the authors are unable to discern what those causes of variation might be. They explored the possibilities that sex, risk factor and/or presenting HIV RNA stratum might be the answer and found nothing that could predict the rate of CD4 loss. In fact, Bennett’s reassurance that everything is fine in HIV∫AIDS la la land is merely the same old reflex denial of the big black headline over the AMA comment by W. Keith Henry, which is that “Explaining, Predicting and Treating HIV-Associated CD4 Cell Loss (is) After 25 Years Still a Puzzle.

Henry et al note that the report “challenges the notion that, at the individual level, a limited number of HIV measurements over a short period of time provide meaningful prognostic information regarding the rate of CD4 cell decline and by extension the risk of opportunistic infections.” Of course, if the medical fraternity would take off their NIAID provided glasses with “HIV is behind everything” etched onto them they would have known this in the first place. If they bothered to read their own literature (or this blog) or even think clearly they would know that it is just as likely that CD4 counts are lower at rest and higher when activated, than vice versa, as Dr Fauci has recently touched on in his extensive review. Moreover, the level of active virus in the blood of patients without AIDS symptoms in the long “latent period” is utterly negligible. It is hard to conceive it has anything at all to do with changes in CD4 count, compared with myriad other influences on the immune system.

The result of the study is in fact utterly predictable, and the only surprise it holds is for those who imagine that the simple minded mechanism of HIV causing AIDS imagined in the first place over two decades ago - HIV killing CD4 cells dirctly - is still part of the paradigm. This includes Dr Fauci, it appears, who doesn’t read his own medical literature according to his public statement at the New School on the ways HIV kills CD4 cells, which repeated this now outmoded idea, as well as the cell suicide theory of “indirect killing”, when both are rejected by his top theoretical thinker Zvi Grossman, who has retreated to the conclusion that how it all happens is a “conundrum”.

What is really the study’s only novel usefulness is its demonstration yet again that no one has any idea how HIV can possibly govern the loss of CD4 cells that is held to be cause of AIDS, and that the obvious alternative - that HIV is merely an opportunistic infection, and rather than governing CD4 count, it is CD4 count that governs the rise and fall of HIV viral load, as CD4 numbers are affected by other factors - the poisons and other assaults that may bring on AIDS symptoms.

It puts yet another nail in the coffin of a paradigm that has never been able to demonstrate its central premise.

Institute slams FDA on drug safety

September 23rd, 2006


Musical chair leadership has left agency in disarray

How about AIDS? Maybe IOM should look at NIAID too?

Hot news two days in a row in the Times: the FDA is on the hot seat, accused of dereliction of duty and letting unsafe drugs onto the market in a damning report it paid the Institute of Medicine $3 million for, following the Merck arthritis drug Vioxx debacle. In this case, the FDA bureaucrats have been poorly rewarded for their patronage, since the IOM has roasted them, demonstrating the problems are systemic.

The report’s conclusions are often damning. It describes the Food and Drug Administration as rife with internal squabbles and hobbled by underfinancing, poor management and outdated regulations.

“Every organization has its share of dysfunctions, unhappy staff members and internal disputes,” the report said. But panel members said that they were deeply concerned about the agency’s “organizational health” and its ability to ensure the safety of the nation’s drug supply.

Gardiner Harris’ story Study Condemns F.D.A.’s Handling of Drug Safety has been moved from the Business Section of the Times yesterday to the front page top right and expanded today (Sat Sep 23), so it is unlikely to be missed by anyone important in Washington or New York City.

The New York Times

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September 23, 2006

Study Condemns F.D.A.’s Handling of Drug Safety

By GARDINER HARRIS

WASHINGTON, Sept. 22 — The nation’s system for ensuring the safety of medicines needs major changes, advertising of new drugs should be restricted, and consumers should be wary of drugs that have only recently been approved, according to a long-anticipated study of drug safety.

The report by the Institute of Medicine, part of the National Academy of Sciences, is likely to intensify a debate about the safety of the nation’s drug supply and the adequacy of the government’s oversight. The debate heated up in September 2004 when Merck withdrew its popular arthritis drug Vioxx after studies showed that it doubled the risks of heart attacks.

Several senators have already proposed significant changes, some of which the report seems to endorse.

The report’s conclusions are often damning. It describes the Food and Drug Administration as rife with internal squabbles and hobbled by underfinancing, poor management and outdated regulations.

“Every organization has its share of dysfunctions, unhappy staff members and internal disputes,” the report said. But panel members said that they were deeply concerned about the agency’s “organizational health” and its ability to ensure the safety of the nation’s drug supply.

The report made these recommendations, most of which would require Congressional authorization:

¶Newly approved drugs should display a black triangle on their labels for two years to warn consumers that their safety is more uncertain than that of older drugs.

¶Drug advertisements should be restricted during this initial period.

¶The F.D.A. should be given the authority to issue fines, injunctions and withdrawals when drug makers fail — as they often do — to complete required safety studies.

¶The F.D.A. should thoroughly review the safety of drugs at least once every five years.

¶The F.D.A. commissioner should be appointed to a six-year term.

¶Drug makers should be required to post publicly the results of nearly all human drug trials.

In a telephone conference with reporters on Friday, top F.D.A. officials struck an awkward balance between thanking the institute for its work and defending their own leadership. They said they needed to study the report before deciding which of its recommendations to endorse.

“While considerable work has been done over the past two years to improve our approach to drug safety, work still needs to be done,” said Dr. Andrew C. von Eschenbach, the acting commissioner of the agency and the nominee for commissioner.

An internal e-mail message sent Friday to agency staff members by Dr. Sandra L. Kweder, deputy director of the Office of New Drugs, was blunter, bemoaning the report’s criticism of what it described as the agency’s dysfunctional culture.

“It is a long, inflammatory section of the report that will certainly generate the most public attention and hit our people hard,” Dr. Kweder wrote, according to a copy provided to The New York Times.

Agency critics were elated.

“The new report validates what the watchdog community has been saying for the last two years,” said Senator Charles E. Grassley, Republican of Iowa, who as chairman of the Senate Finance Committee has overseen investigations into drug safety problems. “Problems are systemic, and solutions must reflect a new mind-set by the agency leadership.”

The drug industry, through its trade organization, reacted warily. “Though there is always room for improvements, it would be a mistake to accept the notion that the F.D.A. drug safety system is seriously flawed,” said Caroline Loew, senior vice president of the Pharmaceutical Research and Manufacturers of America.

The Institute of Medicine is a nonprofit organization created by Congress to advise the federal government on health issues. The report was issued by the Committee on the Assessment of the United States Drug Safety System, led by Sheila P. Burke, deputy secretary and chief operating officer of the Smithsonian Institution.

The report described fierce disagreements between those who approve drugs and those who study their effects after approval, disputes that repeated F.D.A. efforts have not resolved. Indeed, managers’ failure to address such disagreements competently “has played an important role in damaging the credibility” of the agency, it said.

Critics of the food and drug agency have long been divided into two warring camps. Some say the agency fails to approve life-saving medicines quickly enough, while others say that it is so intent on rapid approvals that it fails to ensure the safety of the drugs.

The institute’s report champions the latter view by calling for greater caution. It suggests that one of the agency’s biggest problems is a deal struck in 1992 between Congress and the drug industry in which drug makers agreed to pay millions in fees to speed reviews. This deal has increased pressures on drug reviewers to act quickly, and it has limited “the ability of reviewers to examine safety signals as thoroughly as they might like,” the report said.

“Some also have serious concerns that the regulator has been ‘captured’ by industry it regulates, that the agency is less willing to use the regulatory authority at its disposal,” the report said, criticizing the agency’s regulatory tools as “all-or-nothing.”

“The agency needs a more nuanced set of tools to signal uncertainties, to reduce advertising that drives rapid uptake of new drugs, or to compel additional studies in the actual patient populations who take the drug after its approval,” it said.

The pharmaceutical industry is likely to fight at least some of the proposals, said Charlie Cook, a Washington political analyst.

“One should never underestimate the influence of the drug industry,” Mr. Cook said. “But I would think that at least the outlines of many of these recommendations would have a decent chance of getting through Congress.”

Senators Michael B. Enzi, Republican of Wyoming and chairman of the Health, Education, Labor and Pensions Committee, and Edward M. Kennedy of Massachusetts, the ranking Democrat on the committee, have jointly proposed a bill that would undertake at least some of the changes advocated by the report.

Another bill, sponsored by Senator Grassley and Senator Christopher J. Dodd, Democrat of Connecticut, offers similar proposals.

There is little chance that Congress will act on any of these proposals before next year, when it must reauthorize the 1992 financing deal with the drug industry. Negotiations between the drug industry and agency about the parameters of that deal are already under way.

Despite its fierce criticisms, the report may bolster the confirmation prospects of Dr. von Eschenbach. A Senate committee approved his nomination on Wednesday, but two Republican senators have vowed to block it.

Over the past 10 years, no commissioner has served more than two years, though the term is open-ended. The report deplored this “lack of stable leadership.”

“Without stable leadership strongly and visibly committed to drug safety, all other efforts to improve the effectiveness of the agency or position it effectively for the future will be seriously, if not fatally, compromised,” the report states.

It recommends that the commissioner be nominated for a six-year term, but such a change may not solve the problem of early exits. President Bush has nominated two past commissioners. The first left for another job within the administration; the second left amid accusations of financial improprieties.

The report recommends that Michael O. Leavitt, the secretary of health and human services, appoint an independent board to advise the commissioner “to implement and sustain the changes necessary to transform” the agency’s culture.

It rejects suggestions by Mr. Grassley and others that the F.D.A. create a center for drug safety to monitor drugs after approval.

“Achieving a balanced approach to the assessment of risks and benefits would be greatly complicated, or even compromised, if two separate organizations were working in isolation from one another,” the report concludes.

The F.D.A. asked the Institute of Medicine to review its drug safety system shortly after the Vioxx withdrawal in 2004, and the agency has agreed to pay $3 million for the study.

The original had this nice paragraph in it, subsequently cut but only to expand the point and drive it home:

Couched in formal language and careful footnotes, the report’s boring exterior belies an incendiary heart. With each page, it paints a devastating picture of a dysfunctional agency that is unable to ensure the safety of the nation’s drug supply.

Also it appears that Gardiner has now come into possession of a frantic email from one of the FDA’s cats in the hot seat, responding to the report.

An internal e-mail message sent Friday to agency staff members by Dr. Sandra L. Kweder, deputy director of the Office of New Drugs, was blunter, bemoaning the report’s criticism of what it described as the agency’s dysfunctional culture.

“It is a long, inflammatory section of the report that will certainly generate the most public attention and hit our people hard,” Dr. Kweder wrote, according to a copy provided to The New York Times.

One of the arrangements which has made the FDA and the industry it is meant to watch all too cosy is a deal from 1992 where the drug companies pay millions to hurry their permits through:

…one of the agency’s biggest problems is a deal struck in 1992 between Congress and the drug industry in which drug makers agreed to pay millions in fees to speed reviews. This deal has increased pressures on drug reviewers to act quickly, and it has limited “the ability of reviewers to examine safety signals as thoroughly as they might like,” the report said.

Nice understatement, very discreet. This rather blatant fee setup is under review right now but nothing is likely to be done until next year. Here are the main recommendations of the report on ways to tighten up the reins, which the industry lobbyists now have six months to undermine:

¶Newly approved drugs should display a black triangle on their labels for two years to warn consumers that their safety is more uncertain than that of older drugs.

¶Drug advertisements should be restricted during this initial period.

¶The F.D.A. should be given the authority to issue fines, injunctions and withdrawals when drug makers fail — as they often do — to complete required safety studies.

¶The F.D.A. should thoroughly review the safety of drugs at least once every five years.

¶The F.D.A. commissioner should be appointed to a six-year term.

¶Drug makers should be required to post publicly the results of nearly all human drug trials.

The one we like best is this one: “¶The F.D.A. should thoroughly review the safety of drugs at least once every five years.” Yes, sir. Maybe whenever our federal watchdog shapes up again and gets its bite back it will do more than give the HIV∫AIDS drug companies a free pass, as it has for twenty years, riding on the scientifically blind gay activist support for untested drugs and itself blindly willing despite all signs of trouble to go along with clinical trials that have not once included a placebo controlled, ARV free group.

Or has the FDA now abandoned all oversight to the NIAID, which as Harper’s glaringly exposed in Celia Farber’s stunning article in March this year Out of Control: AIDS and the corruption of medical scienceis in bed with the drug companies with the lights out?

Drugs are key to HIV∫AIDS’ heart of worms

Certainly someone should reexamine the regulatory performance with regard to HIV∫AIDS drugs, whoever retains any responsibility in this regard, since now more than one study indicates that ARV drugs kill at least half the AIDS patients who die in the first year of medication with HAART, instead of rescuing them from sickness and death.

In fact, the atrocious performance of the drugs in AIDS is the key to exposing the clay feet of the paradigm, as Harper’s intimated and we will demonstrate in our next post.

Given that it is the NIAID who bears the responsibility for the way ARV trials have been conducted, and even for rewriting and even reversing their results, as Harper’s reported, maybe the FDA could redeem itself by spending the money for a review and calling on Celia Farber as a highly paid expert consultant, since she has amassed a pile of damning material in this regard, and still hasn’t been paid properly for her twenty years of public service in this regard. NIAID off-and-on employee Harvey Fishbein could also be a consultant, if Dr Fauci can be persuaded to let him.

Come on guys, pay the IOM another $3 million for an independent study on that topic, if you are still on speaking terms after this, which we hope you are. After all, the IOM report was exceedingly polite about your talents:

The Committee believes the staff of the Food and Drug Administration, and of the Center for Drug Evaluation and Research in particular, to be a dedicated and talented group of public servants who currently lack the organization and resources to address all of the challenges before them and perform their crucial role of advancing and protecting public health in an increasing complex environment. We believe that the Congress needs to ensure that the Center for Drug Evaluation and Research is given the authority and assets (human, financial, technological, etc.) it requires. The Center’s leaders have to be prepared to address the underlying cultural problems that divide and impair the optimal functioning of Center staff and effectively use the existing and new authorities and resources to achieve the Center’s public health and regulatory mission.

Sooner or later, the abysmal state of HIV∫AIDS medication, which is a can of worms which cannot be hidden away