After dozens of failed AIDS vaccine trials, a press release triumphantly announced success — before the actual data had been made public, let alone submitted for peer-reviewed publication (VACCINE WORKS! , 24 September 2009).
No sooner were the data looked at by independent observers than it became obvious that the trial had been no more successful than all the previous ones (HIV/AIDS vaccine trial questioned as experts check data) — unless, of course, one resorts to the HIV/AIDS-style sleight-of-evidence stratagem in which a non-significant difference is referred to as though it were significant (Abuses of statistics in HIV/AIDS research, 14 September 2009).
Perhaps as an alternative to fudged and misinterpreted statistics, the President and CEO of the International AIDS Vaccine Initiative (IAVI), Seth Berkley, pleads that we “Have Faith in an AIDS Vaccine”
(A version of this article appeared in print on October 19, 2009, on page A27 of the New York edition)
That reminded me of the oft-cited “I believe BECAUSE it is absurd”, the popularly misquoted and misinterpreted phrase attributed to Tertullian (see David Lindberg, “Science and the early Church”, chapter 1 in GOD AND NATURE, ed. Lindberg & Numbers, University of California Press, 1986, at p. 26).
In the present instance, however, despite what Berkley wrote, it is not faith that’s at work but cognitive dissonance necessitated by the very existence of IAVI, an enterprise involving hundreds of people whose livelihoods depend on finding donors for AIDS vaccine research.
I had sketched the enormity (in both the correct and incorrect meanings of the word*) of the HIV/AIDS industry in Chapter 15 of my book, especially pp. 143 & 212-215. Tens of billions of dollars annually support publicists, money grubbers (“development officers”), “activists”, and other hangers-on of that ilk in addition to doctors and researchers, including such parasitic ventures as journals about “AIDS” and such diseases as cancer, hepatitis, TB; “AIDS” and Behavior, and Florida Law, and Health News, and Public Policy; “AIDS” Action Policy Brief, Alert, Analysis Africa, Care, Clinical Care, Education & Prevention, Info, Law & Litigation Reporter, Literature & Law Review, …. I didn’t try to count all the journals specializing in something or other connected to “AIDS” or “HIV” that are listed in the Ulrich’s compendium.
The International AIDS Vaccine Initiative is a representative microcosm of this huge industry — if “microcosm” is an appropriate term for an enterprise whose Senior Executive Team reporting to CEO and President Seth Berkley includes three Senior Vice Presidents (General Counsel; CFO; Research & Development) and four ordinary Vice Presidents (Communications; Human Resources; Country & Regional Programs; Public Policy). The many donors include governments, foundations, corporations, and individuals. Ten open positions are currently being advertised, for a Development Coordinator and three Directors as well as research associates and technicians. The Job IDs are numbered between 1338 and 1369, though that does not necessarily indicate the number of people on the payroll. Indeed, it must be less than 1300-odd since IAVI’s annual expenditures in 2008 were less than $100,000,000, very small cheese compared to the interest that drug companies, say, have vested in the HIV/AIDS business. Still, not so bad for a “non-profit” organization that has been in existence since 1996 without a single concrete and relevant accomplishment to its name. Admittedly, only 16% of $96.3 ($15.4 million) spent in 2008 went to administration, though one cannot know from the snapshot budget in the Annual Progress Report (nota bene, “progress”!) how much in the way of salaries, benefits, travel, etc., is hidden within the categories “Vaccine advocacy and education” and “Research and development”.
Let me now stop being snide; I lapse into it periodically because of anger over the HIV/AIDS travesty. Instead, let me emphasize the SHEER ALL-AROUND TRAGEDY of the HIV/AIDS business. These people believe in what they’re doing. Berkley has no option but to have faith. That’s what cognitive dissonance is about. How could he ever face the fact that over more than a dozen years he has been supervising the collecting and spending of a billion or two dollars on a phantom quest? Hundreds of individuals who share his faith, whom he has surely encouraged in that faith, rely on his leadership for their livelihood. If he could acknowledge the truth, it would be spiritual if not physical hara-kiri.
So it’s only natural that Berkley wrote that OpEd piece and meant what he said:
“[A] storm has erupted over the announcement last month that an experimental AIDS vaccine tested in Thailand proved modestly effective”
[It didn’t. There was NO significant effect.]
“But now the trial has been called into question in a way that is overblown and possibly destructive. . . . Even before this controversy erupted, it had been an effort to maintain sufficient support for AIDS vaccine research and development. In 2008, private and public spending on this vital mission declined by 10 percent from the year before. A few fanatical AIDS activists have even called for ending the American government’s considerable support for AIDS vaccine research, and spending the money instead on AIDS treatment. . . . The Thai study was the largest AIDS vaccine trial yet . . . . (The organization I head, a nonprofit that conducts vaccine research and development but was not involved and has no commercial interest in the candidates tested.) The trial partners initially announced that the vaccine combination reduced the risk of infection by 31.2 percent in a statistically significant analysis. A few days later, . . . a second type of analysis . . . indicated the vaccine regimen had been slightly less effective than the first analysis suggested”
[NO. The analysis revealed that the trial showed no significant effect at all.]
“[C]hance, rather than the protective effect of the vaccine candidate, might explain why fewer volunteers in the vaccinated group than in the placebo group were infected with H.I.V.”
[EXACTLY. The statistical analysis found no significant effect, in other words, there were no meaningful results in favor of the vaccine.]
“[W]ith news outlets reporting that the trial results may be a fluke, there is a risk that they will be forever tainted, whatever the final analyses show. What’s more, the stain of dubiousness may remain on all AIDS vaccine research and development. That would be a shame. Although the candidate duo tested in the Thai trial did not prove to be a vaccine ready for the market, it may provide an unprecedented opportunity to learn how an AIDS vaccine can work. A comparison of blood samples from volunteers could indicate what specific immune responses the combination may have activated to provide protection. If so, this knowledge could help scientists improve upon the more promising candidates . . . . Moreover, other noteworthy advances featured at the Paris conference this week will offer fresh hope for an AIDS vaccine. Years of investment and dogged science are providing leads for solving one of today’s most pressing research challenges. . . . no public health intervention is more powerful or cost-effective against infectious disease than a vaccine.”
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In 1984, Gallo had predicted an AIDS vaccine in a couple of years. Yet by 1995, a decade of attempts was summarized as, “Nobody can say the data were encouraging. It’s all smoke and mirrors. There’s nothing there” (John P. Moore, cited by Cohen, at p. 275 in Shots in the dark: the wayward search for an AIDS vaccine, 2001). Another decade on, there had been at least 80 unsuccessful trials of at least 30 vaccines (Ending AIDS: the search for a vaccine, PBS TV, December 2005). Nevertheless, every failed trial has been described by vested insiders as an advance: giving clues, affording important information for further research — there was “great promise in the field of HIV vaccinology” (Berkley, “International perspectives on HIV vaccine development”, Chapter 12 in AIDS Vaccine Research, 2002, ed. Flossie Wong-Staal and Robert C. Gallo) — although somehow one is never told exactly what those clues were, what that information or the gained knowledge was. Promises, promises, nothing but promising promises.
They can never admit that it’s a wild goose chase. They can’t AFFORD to admit it — and I mean they can’t afford it psychologically. They are not especially venal, they are just fanatically wrong. And so they have to keep spouting absurd nonsense about how non-significant differences somehow mean something. Non-significant means not significant, despite the spin artists of the vested interests:
AIDS Vaccine Seen as Modest Help, AP, 20 October
“’This study becomes a landmark. You can put it on a map and begin to figure out where you go from here,’ said Col. Jerome Kim, the U.S. Army doctor who co-led the trial.”
But, as usual, he doesn’t share the secret of where it is on the map and where it points.
“’The bottom line is that those results are real,’ even though they are not good enough to justify using this vaccine now, said Dr. Alan Bernstein, executive director of the Global HIV Vaccine Enterprise”.
No one is questioning whether the results are real, they are just saying that non-significant means not significant; signifying nothing, in other words.
“’We, for the first time, have evidence of protection, and the nitty gritty (arguments) to me don’t matter a damn,’ Bernstein said.”
Non-significant means there is NO evidence of protection.
“’There seems to be some effect. And I think it is an important study. It redirects the field to look at a different kind of vaccine and different kinds of immune responses’ . . . said Dr. Lawrence Corey of the University of Washington. He heads the HIV Vaccine Trials Network”.
But if THIS trial had some effect, why does it “redirect” elsewhere?
“The vaccine appeared nearly twice as effective among those at low or moderate risk for HIV, versus people who share needles, have contact with prostitutes or engage in other risky behaviors. But those results were not statistically significant, meaning they could have occurred by chance.”
How could it appear twice as effective when the difference could be a random, chance occurrence?
Once again:
Don’t bring statistics into it if you’re not going to abide by its conclusions. Something not significant is simply not significant.
The potential value of statistics is that it can prevent us from fooling ourselves, because human beings generally have a very poor intuitive sense of what chance can bring about.
The vaccine fanatics reject that help and substitute intuitive wishful thinking for statistical science.
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* OneLook® Dictionary Search puts it nicely: enormity means an act of extreme wickedness, the quality of extreme wickedness, the quality of being outrageous; “In careful usage the noun enormity is not used to express the idea of great size”.
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