HIV/AIDS Skepticism

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

Posts Tagged ‘informed consent’

HIV testing without specific informed consent

Posted by Henry Bauer on 2009/10/08

I didn’t know that
“Massachusetts is one of only eight states that still require separate written consent between patients and health care providers to authorize a HIV test. Unlike cholesterol counts or cancer screening, which fall under the ‘general consent’ form for all other blood tests, a doctor in Massachusetts cannot legally test for HIV without separate, specific written consent from a patient” [“Outdated laws block earlier detection, treatment of HIV”, by Patricia Jehlen and Calvin Cohen, 6 October 2009]

So in 42 states, the “informed” consent document we all have to sign when being admitted to hospital for anything at all, and which I suspect others sign without reading, as I do, exposes us to the clear and present danger of being “HIV”-tested.

“In 2006 the CDC recommended that HIV tests be made more common and routine, prompting 15 states to update their laws. . . . Studies by scientists at CDC and elsewhere have already shown that, when the hurdle of additional written consent for HIV testing is removed, more cases are identified earlier”.
Yes, of course. More testing –> more positive tests.

“Senate Bill 821, which was introduced earlier this year and comes up for a hearing on Beacon Hill today, will fully implement the CDC’s recommendation on HIV/AIDS testing and remove the outdated barriers that have discouraged patients from accessing the full host of health benefits available to them. The bill maintains the strong existing privacy protections around the disclosure of an individual’s health status. Anyone who tests positive for HIV would be guaranteed access to post-test counseling, as well as referrals to support services” [emphasis added].
That’s exactly what is to be feared, that “full host of health benefits”. See what Karri Stokely has to say about that from personal experience; or Audrey Serrano.

“The bill will not lead to people being tested against their will or without their knowledge, as a patient’s general consent for medical care is still required to conduct an HIV test.”
Has anyone tried to get the care they actually need in a hospital in the United States — colonoscopy, hernia operation, whatever —  WITHOUT signing such a form?

“Patricia Jehlen, lead sponsor of Senate Bill 821, represents the Second Middlesex District in the Massachusetts Senate. Dr. Calvin Cohen is clinical research director at the Community Research Initiative of New England and Harvard Vanguard Medical Associates.”

It’s always nice to get opinions and proposed legislation from people who know what they’re talking about and have no conflicts of interest.

Posted in experts, HIV risk groups, HIV skepticism, HIV tests, Legal aspects, uncritical media | Tagged: , , , , , , , | 6 Comments »

Ethics “experts” and clinical trials

Posted by Henry Bauer on 2009/02/02

Ethical and other problems have been prominent with clinical trials of several aspects of HIV/AIDS: drugs, microbicides, vaccines. It’s understandable, then, that AIDS conferences would concern themselves with these matters, for instance at the XVIth International AIDS Conference in Toronto, August 2006:

Rapporteur reports

Science Track C: Epidemiology, Prevention and Prevention Research report by Dr. Quarraisha Abdool Karim

This session examined ethical issues in clinical research for HIV prevention in three ways – 1) through case study descriptions of the experiences around the abandoned/cancelled PEP trials [TUAE0301, TUAE0303, TUAE0305], 2) a philosophical/ethics-based analysis of clinical HIV prevention research [TUAE0302], and 3) a description of a study on a particular aspect of clinical trials, informed consent [TUAE0304]. The main theme emerging from the case studies and ethical analysis was a recommendation to further develop systematic approaches to build community involvement/consultation, and community long-term benefits from clinical trial participation so that trials will be accepted and promoted. While it was concluded that provision of long-term treatment to those who seroconvert during a study was not morally necessary, it was felt to be morally praiseworthy and politically necessary. As well, it was felt that power dynamics between community members and researchers needed to be addressed through mechanisms such as research literacy for the HIV advocates in the community. The study on informed consent concluded that the measure of participant understanding of aspects of trial participation was largely influenced by measurement instruments – with closed-ended response formats (checklists, self-report) yielding higher comprehension scores than open-ended methods (vignettes, narratives). In discussion, it was suggested that whatever the measurement method, trial participants consistently show fairly low levels of understanding of study processes and impacts, and that informed consent should not be relied upon as the protection of participants, but rather an emphasis should be placed on other ethical study requirements, such as a balance of harms and benefits” [emphases added].

After a lifetime spent in academe, I’m rather sensitive to nuances that reflect some of its less attractive aspects: theorizing in a vacuum totally removed from human experience; biased views on what various types of “literacy” mean; periodic re-discovery of the obvious. In the above:

“Moral necessity”: No matter what philosophers may “conclude”, the situation with clinical trials is quite plain. Without the trials, the researchers cannot pursue their research and the drug companies cannot develop their products. Therefore the human beings who agree to take risks on behalf of the researchers and the industries should be compensated fully. In the usual case of indigent folk, that ought to mean lifetime health care and nourishment, whose costs in the pertinent places are trivial in comparison to the monetary benefits reaped by the drug companies.

“Research literacy”: Perhaps it’s a paranoid interpretation, but I read this to mean brainwashing activist groups about the absolute necessity of clinical trials.

“Informed consent”: Even in “developed” countries it’s absurd to imagine that lay people can exercise genuinely good judgment about the experiments or treatments being suggested to them. That’s why there exist institutional boards that are supposed to review proposed experiments involving human subjects. It’s the individuals who serve on those boards who need education on matters of research literacy and ethics.

“KC 1: Accelerating research to end the HIV/AIDS epidemic report by Stephanie Nixon
TUAE03 – Ethical Issues in Clinical Trials: Tenofovir and Beyond

This session explored various legal and ethical dimensions of prevention trials.

Anna Forbes, from the Global Campaign for Microbicides, described her organization’s efforts to ensure future access to microbicides.  She reflected on the failure of the recent tenofovir trials and identified the absence of promise to ensure ARVs for participants who seroconvert during the trial as the “deal-breaker”.

An audience member raised the issue of undue inducement if the only access to quality care and treatment in a community is through participation in a trial.  Forbes proposed that this difficult decision ultimately needs to be answered by the community where the candidate is being tested so that they may determine what represents an inducement that is undue.

Charles Weijer, from the University of Western Ontario, Canada, provided an ethical analysis of obligations to provide treatment in the context of HIV prevention trials in developing countries.  He rejected the notion that there is a moral obligation based on the principle of reciprocity to provide treatment to seroconverters because of their unique role in proving the efficacy of, for instance, an HIV vaccine.  He proposed instead that all participants play an equally important role.  Instead of a moral obligation, Weijer proposed that a “moral negotiation” is required based on the ethical principle of respect for communities.  Within this framework, communities would contribute to trial design, influence study results, and share in the study benefits.  He argued that because health priorities and values vary among communities, the idea of a predetermined obligation to communities does not respect their unique perspectives. Counter views were raised by audience members regarding the fact that negotiations between researchers and communities will not take place on a level playing field, and that there may still be benefit to having a bare minimum set of obligations from which communities can begin the negotiations. . . .
New ideas for accelerating research to end the epidemic:
. . . .
Charles Weijer, University of Ontario, talked of these guidelines not being a moral obligation but a moral negotiation between communities and the researcher and sponsor. He said “To impose a pre-determined benefits package seems paternalistic.” He argued that communities were in the best place to decide what benefits were most appropriate in their setting [emphases added].”

Weijer’s appointments at the University of Western Ontario are listed in “Epidemiol & Biostats”,   Medicine, & Philosophy. Whether or not other philosophers or moralists would agree that there is no “moral obligation based on the principle of reciprocity”, certainly there would not be universal agreement over whether the principle of reciprocity should be the infallible guide to what’s proper in human affairs; this is what I call a (moral) “vacuum totally removed from human experience”. Similarly, the argument that community values should be respected and paternalism eschewed is beside the point in these matters. The whole business of HIV/AIDS is paternalism writ large: communities are not asked whether they prefer food to antiretroviral drugs, they are not asked whether they believe that the deaths their communities experience are from this new scourge or from their traditional burdens of tropical diseases. Indeed, when the leader of such a community, President Mbeki, sought to reach an independent judgment on the matter, a huge apparatus of international paternalism swung into action to oppose him. We respect community values only when they fit with our own wishes: for example, since participants in clinical trials are supposed to be offered no less than the normal standard of care in their communities, First-World industries rush to carry out their clinical trials in places where the normal availability of health care is low or non-existent — note the very valid issue of “undue inducement” raised above.

It strikes me as far worse than disingenuous, it’s exceedingly immoral to enlist academic, theoretical, arguments in the attempt to make it appear that the practices that seem standard in so many clinical trials in Third-World countries are moral or ethical — moral or ethical in the way most human beings understand what those concepts mean.

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Posted by Henry Bauer on 2007/12/25

A modest proposal:
Billions of dollars have been promised to provide antiretroviral drugs to Africans, and some of those promises have even been met. Do an experiment. Divert a small percentage of that money—say 10%—to buy food and vitamins. Allow Africans to choose between nutrition and antiretroviral drugs. Compare, over time, the health of those making the different choices.

That suggestion appears at p. 228 of my book. I was reminded of it by today’s report from David Tuller in the New York Times (“Cases without borders”): antiretroviral drugs are being provided to Africans who are being left to starve and to suffer “side” effects of those drugs made even worse because they are taken on empty stomachs: “families scramble to survive from meal to meal, never far from the edge of starvation. Many say their H.I.V. drugs have drastically increased their appetites and made them crave food even more”.

The reporter is part of a team of researchers organized by the University of California, San Francisco, in collaboration with Mbarara University of Science and Technology, Kampala, Uganda. The rationale for the study would easily have qualified for one of Senator Proxmire’s “Golden Fleece” awards. It is seeking to discover “whether ‘food insecurity’—a persistent difficulty in finding enough to eat—undermines the effectiveness of H.I.V. treatment. . . . [and] whether costs related to treatment limit their ability to cover basic foods and whether hunger forces women to offer men ‘live sex,’ or intercourse without condoms, in exchange for food or money. . . . Other patients will be followed for two years to monitor how food insecurity affects their drug regimens, and illness and death rates.”

Do we really need a study to find out whether starving people fare worse than properly fed ones, especially when they are taking drugs with nasty side effects? Do we really need a study to discover whether starving women will sell their bodies to feed their families?

And, Oh!, how George Orwell would have relished that “food insecurity” in place of “on the edge of starvation”!

I’m curious to know, among a number of other things: Who dreamed up this study? How are the “Informed Consent” documents phrased? Which oversight bodies approved those documents—and for that matter, this whole study?

What is the ethical warrant for spending money on research whose outcome is already known and that requires observing rather than feeding people? Could not some of the resources being expended in the study be diverted to the provision of food to some of the starving ones?

Apparently, the study’s obvious outcome isn’t obvious to everyone, the investigation is needed “to demonstrate that packaging food aid with H.I.V. drugs or reimbursing patients for travel can actually improve health and save lives”. Demonstrate to whom? To the “international donors [who] demand data and documentation. They want proof that an intervention will reduce the total misery index before they will shell out millions of euros for new programs, even if the need appears self-evident”. [How George Orwell would have relished that “total misery index”!]

Concerned lest we appear to waste resources, elaborate and expensive studies are carried out to “demonstrate” what everyone already knows—because common sense and experience are not sufficient to justify official actions, there must be the paperwork at hand to guard the policy-makers and the bureaucrats against any suggestion that they might actually be responsible for the decisions for which they are responsible.

Merry Christmas and a Happy New Year. I trust that all the researchers, and those who approved this study and those who are funding it, and those who profit from the sales of antiretroviral drugs, will enjoy their customary seasonal feasts.

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