Anita Allen has written extensively about the AIDS debate and the scientific fields in which it is embedded since 1999.
Antiretroviral Treatment: Where Is The Data?
By Red Flags Columnist, Anita Allen
When an article is published in a reputable journal purporting to show the efficacy of antiretroviral (ARV) treatment in managing HIV/AIDS, it is of vital interest. Strange as it may be, since the first ARV, namely Glaxo's AZT, was licensed in 1987, there has been no convincing data demonstrating efficacy. In South Africa, some 48,000 people have been on free ARV treatment in the public health system since the rollout started on April 1, 2004. Another 60,000 are reported to be receiving ARVs through medical schemes. So far, there has been no data of any kind released on these patients. In fact, it is not certain that there is any effective monitoring from which to get such data.
Beyond South Africa, UNAIDS has set a target of 3 million people worldwide on ARVs by the end of this year. So the question of the efficacy of ARVs is of vital interest to us all, not least American taxpayers, who pay for about half of global funding for ARV treatment.
This week, The Lancet published a study purporting to show that ARVs were, in fact, "a medical miracle" — as it headlined its Comment piece by Brian Gazzard. The British study was ignored by international media, which should have provided a clue about the importance of its results. In South Africa, one newspaper, Business Day, and the national broadcaster SABC (South African Broadcasting Corporation) hailed the study as the end of any questioning of ARV efficacy.
As a subscriber to The Lancet, I downloaded the study and comment. When I could not understand what the research was about, even after several readings, alarm bells rang. I phoned the reporter of the Business Day article, Chris van Gass, and asked him if he had read the study. He had not.
Instead, he said, he wrote his article based on something the researchers sent him. Apparently the fact that the researchers received travel and research grants from pharmaceutical companies did not alert him. I was prevented from asking further questions because van Gass was on deadline. He promised to phone back but never did.
These details are important for someone like me, who seeks only to find the truth. Facts, that's what I want. When it comes to ARVs, it is extremely difficult to get anything other than anecdotal stories.
David Rasnick, a member of President Thabo Mbeki's Presidential AIDS Advisory Panel, wrote a letter to the editor of Business Day giving his analysis of The Lancet study. That letter is published here.
A Scientist Rebuts Business Day’s Praise Of AIDS Drugs
By David Rasnick, Ph.D.
David Rasnick, a professor of molecular and cell biology at the University of California at Berkeley, is currently a visiting scholar in South Africa. The following is a letter he wrote this week to Business Day.
The headline on an August 2 story by Chris van Gass in Business Day about a study published in The Lancet announced, “TAC welcomes U.K. study showing AIDS drugs prolong life.”
The article in the July 30 issue of The Lancet did say, "Treatment Action Campaign (TAC) has welcomed research by British scientists showing that cocktails of AIDS drugs cut the rate of progression from HIV infection to full-blown AIDS by 86 percent compared with patients not receiving treatment."
The article also begins by saying, "For ethical reasons, there has been no placebo-controlled randomized trial of HAART (Highly Active Antiretroviral Therapy). The effectiveness of this treatment over several years is therefore unknown."
This is what I, and many other "dissidents," have been saying for years. In other words, after American taxpayers have spent a total of $170 billion on AIDS (through 2005), there is still no controlled clinical study showing that people taking the antiretroviral drugs live longer, or at least better, lives than a similar group of people not taking the drugs. And, as The Lancet authors acknowledge, their study doesn't qualify either.
The authors state, "Without trial evidence, this information must come from observational cohort studies. However, estimation of treatment effects in observational studies is not straightforward…." Indeed it is not, yet that is exactly what the authors did by using a "novel methodology to overcome this problem.”
To generate the results that so heartened TAC, the authors had to resort to a statistical method that they acknowledge "is not widely used in clinical research" and, in fact, "may not be widely known in the clinical research community.” Yet, their results are not obtainable without this unused and unknown methodology.
Furthermore, their "results depend on the assumption that treated and untreated individuals with the same values of measured prognostic factors were similar. Prospective information about the reasons that patients remain untreated is not recorded in the database, so we cannot address this issue directly."
They also "assumed that once on therapy, a patient remains on therapy."
Finally, the authors wrote that they "used a combined endpoint of AIDS or death from all causes, which has been widely used in clinical HIV/AIDS research. We would have liked to examine the two endpoints separately. In the era of HAART, an increasing proportion of deaths is not associated with recent AIDS-defining events, and the current definition of AIDS is no longer a near-complete marker for overall progression. We could not do so for two reasons: the number of deaths during follow-up was small, and good information on causes of deaths is lacking in the Swiss and other cohort studies."
With the help of these assumptions, considerable hand waving and an unused and unknown methodology, the authors concluded in the absence of basic mortality data that "HAART reduced the rate of progression to AIDS or death by 86 percent, and that its effectiveness compared with no treatment increased with time since initiation.”
The authors' chart titled "Estimated effect of HAART from unweighted (standard) and weighted Cox models" captures the artificialness of their results. It shows four different results for the same data ranging from marginal, if any, effect to their 86 percent effect based on their "novel methodology.”
Why would anyone uncritically accept such a conclusion based on flimsy data and unproved methodology, when doing so entails tremendous consequences? Only a placebo-controlled randomized trial can determine whether or not a therapy prolongs or improves life compared to no therapy.
*****
Links:
http://www.businessday.co.za/articles/article.aspx?ID=BD4A75773
Red Flags welcomes further comment and analysis from readers on this very important subject.