Damned Heretics

Condemned by the established, but very often right

I am Nicolaus Copernicus, and I approve of this blog

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Qualified outsiders and maverick insiders are often right about the need to replace received wisdom in science and society, as the history of the Nobel prize shows. This blog exists to back the best of them in their uphill assault on the massively entrenched edifice of resistance to and prejudice against reviewing, let alone revising, ruling ideas. In support of such qualified dissenters and courageous heretics we search for scientific paradigms and other established beliefs which may be maintained only by the power and politics of the status quo, comparing them with academic research and the published experimental and investigative record.

We especially defend and support the funding of honest, accomplished, independent minded and often heroic scientists, inventors and other original thinkers and their right to free speech and publication against the censorship, mudslinging, false arguments, ad hominem propaganda, overwhelming crowd prejudice and internal science politics of the paradigm wars of cancer, AIDS, evolution, global warming, cosmology, particle physics, macroeconomics, health and medicine, diet and nutrition.

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Henry Bauer, Peter Breggin , Harvey Bialy, Giordano Bruno, Erwin Chargaff, Nicolaus Copernicus, Francis Crick, Paul Crutzen, Marie Curie, Rebecca Culshaw, Freeman Dyson, Peter Duesberg, Albert Einstein, Richard Feynman, John Fewster, Galileo Galilei, Alec Gordon, James Hansen, Edward Jenner, Benjamin Jesty, Michio Kaku, Adrian Kent, Ernst Krebs, Thomas Kuhn, Serge Lang, John Lauritsen, Mark Leggett, Richard Lindzen, Lynn Margulis, Barbara McClintock, George Miklos, Marco Mamone Capria, Peter Medawar, Kary Mullis, Linus Pauling, Eric Penrose, Max Planck, Rainer Plaga, David Rasnick, Sherwood Rowland, Carl Sagan, Otto Rossler, Fred Singer, Thomas Szasz, Alfred Wegener, Edward O. Wilson, James Watson.
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Many people would die rather than think – in fact, they do so. – Bertrand Russell.

Skepticism is dangerous. That’s exactly its function, in my view. It is the business of skepticism to be dangerous. And that’s why there is a great reluctance to teach it in schools. That’s why you don’t find a general fluency in skepticism in the media. On the other hand, how will we negotiate a very perilous future if we don’t have the elementary intellectual tools to ask searching questions of those nominally in charge, especially in a democracy? – Carl Sagan (The Burden of Skepticism, keynote address to CSICOP Annual Conference, Pasadena, April 3/4, 1982).

It is really important to underscore that everything we’re talking about tonight could be utter nonsense. – Brian Greene (NYU panel on Hidden Dimensions June 5 2010, World Science Festival)

I am Albert Einstein, and I heartily approve of this blog, insofar as it seems to believe both in science and the importance of intellectual imagination, uncompromised by out of date emotions such as the impulse toward conventional religious beliefs, national aggression as a part of patriotism, and so on.   As I once remarked, the further the spiritual evolution of mankind advances, the more certain it seems to me that the path to genuine religiosity does not lie through the fear of life, and the fear of death, and blind faith, but through striving after rational knowledge.   Certainly the application of the impulse toward blind faith in science whereby authority is treated as some kind of church is to be deplored.  As I have also said, the only thing ever interfered with my learning was my education. My name as you already perceive without a doubt is George Bernard Shaw, and I certainly approve of this blog, in that its guiding spirit appears to be blasphemous in regard to the High Church doctrines of science, and it flouts the censorship of the powers that be, and as I have famously remarked, all great truths begin as blasphemy, and the first duty of the truthteller is to fight censorship, and while I notice that its seriousness of purpose is often alleviated by a satirical irony which sometimes borders on the facetious, this is all to the good, for as I have also famously remarked, if you wish to be a dissenter, make certain that you frame your ideas in jest, otherwise they will seek to kill you.  My own method was always to take the utmost trouble to find the right thing to say, and then to say it with the utmost levity. (Photo by Alfred Eisenstaedt for Life magazine) One should as a rule respect public opinion in so far as is necessary to avoid starvation and to keep out of prison, but anything that goes beyond this is voluntary submission to an unnecessary tyranny, and is likely to interfere with happiness in all kinds of ways. – Bertrand Russell, Conquest of Happiness (1930) ch. 9

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Boston Globe prints freelancer half-review of Celia Farber book

Safely praises drug study expose, routinely disparages, dismisses paradigm doubt

A prime example today of the way major media editors and writers fellow travel on board the HIV?AIDS paradigm pops up today in the Boston Globe.

In a lengthy review today (Jul 2 Mon) of “Serious Adverse Events: An Uncensored History of AIDS” (Melville House), a freelancer named Jessica Winter covers Celia Farber’s new collection of articles, which like her “Out of Control: AIDS and the Corruption of Medical Science” in Harper’s March issue, challenges the quality of HIV?AIDS drug studies and notes the many indications that the paradigm is glaringly false in the politics of HIV?AIDS and in the literature.

The second part is noticeably missing from the summary of the article’s contents in the review, as if it was cut out by an editor, and the review features more than one of the routine condemnations of the active dissent in HIV?AIDS science, which holds that the idea that HIV is the cause is a theory entirely without merit.

the outcry that followed the article’s appearance-it stirred general condemnation and point-by-point rebuttals from scientists, physicians, activists, and Farber’s fellow journalists…

In fact, Farber is perhaps the only established American journalist who, in her Harper’s piece and throughout her career, has seriously questioned the proof that HIV causes AIDS, despite overwhelming and decisive scientific evidence to the contrary…

The book won’t reopen the case on AIDS causation, nor should it…

The author also kneels and chants the standard current cliches of dogma demonstrating that she has no awareness of the scientific literature in the field, which now generally contradicts these shibboleths.

In the US, HIV disproportionately afflicts low-income and minority women (Joyce Hafford was an African-American single mother of a 14-year-old). And AIDS is far more deadly in Third World nations than it is in the affluent West.

Thus the major media avoids grasping the nettle in what is sooner or later going to be known as one of the greatest issues of modern science and medicine, and expose most established editors, reporters and writers in the field as having seriously abdicated their responsibilities in a topic where the consequences of neglect are measured in human lives far more numerous than those lost in corrupt drug studies.

In this case, however, it may be beneficial for the book. Like a Trojan horse, it will allow readers who purchase it as an attack on drug studies and corruption in HIV?AIDS to stumble upon the fact that it all makes more sense when the corruption of the underlying science is considered.

(Pic: A South African AIDS patient holds his antiretroviral medication.(Gideon Mendel / Corbis))

The Boston Globe: Ends and means By Jessica Winter July 2 2006

(show)

The Boston Globe: Ends and means

Researchers developing AIDS drugs must balance their pursuit of effective treatments with the well-being of the people they’re testing. Two controversial new books suggest that too often the good of the trial comes before the good of the subject.

By Jessica Winter | July 2, 2006

LAST MARCH, Harper’s Magazine published an article by journalist Celia Farber called “Out of Control: AIDS and the Corruption of Medical Science.” The piece focused on the death of 33-year-old Joyce Ann Hafford, a pregnant, HIV-positive woman in Tennessee who died of liver failure after enrolling in a clinical trial of the drug nevirapine, manufactured by the German pharmaceutical company Boehringer-Ingelheim and intended to prevent transmission of HIV from mother to child. The article also examined a troubled long-term study of nevirapine in Uganda.

To judge by the outcry that followed the article’s appearance-it stirred general condemnation and point-by-point rebuttals from scientists, physicians, activists, and Farber’s fellow journalists-one might have imagined that the venerable left-leaning magazine had run an essay by a climate-change naysayer or a proponent of creationism. In fact, Farber is perhaps the only established American journalist who, in her Harper’s piece and throughout her career, has seriously questioned the proof that HIV causes AIDS, despite overwhelming and decisive scientific evidence to the contrary.

But that’s only part of the story. “Out of Control” now forms a chapter of Farber’s new book, “Serious Adverse Events: An Uncensored History of AIDS” (Melville House). The book won’t reopen the case on AIDS causation, nor should it. But it’s a useful entry point into a broader debate on the methods and motivations of the pharmaceutical industry and the medical establishment at large in the development of AIDS drugs. What was largely obscured amid the Harper’s controversy is that the main characters in this story face choices and risks that crystallize some of the most important issues in medical ethics today.

Drug research that involves human subjects is fraught with moral and practical dilemmas, but these are compounded when it comes to AIDS studies, for a number of reasons. Unlike more equal-opportunity diseases such as heart disease and cancer, AIDS hits hardest among the poorest and most vulnerable people and communities, both here and abroad.

In the US, HIV disproportionately afflicts low-income and minority women (Joyce Hafford was an African-American single mother of a 14-year-old). And AIDS is far more deadly in Third World nations than it is in the affluent West. Studies of AIDS drugs in resource-poor countries have drawn criticism for skirting ethical standards and exploiting defenseless patients, as investigative journalist Sonia Shah observes in her new book, “The Body Hunters: How the Drug Industry Tests Its Products on the World’s Poorest Patients” (New Press), which is arriving in bookstores the same week as Farber’s.

What’s more, because AIDS can be passed on from mother to baby, researchers must gather data from subjects who would rarely be allowed to participate in other drug trials: pregnant women and their unborn children. Potential subjects are often under great psychological and economic stress, in addition to the physical stress of pregnancy. Their ability to give informed consent may therefore be compromised. The prospect of taking potentially toxic drugs to fend off HIV infection can seem both terrifying and necessary to a woman concerned about the future health of her child.Continued…

These pressing ethical issues are of global and local significance. The pharmaceutical giant Bristol-Myers Squibb, which recently announced plans to build a $1.1 billion biotechnology production facility in Devens, will soon be recruiting HIV-positive pregnant women in Boston for a trial to determine adequate dosing regimens of antiretroviral drugs to prevent mother to child transmission. The company will also recruit subjects for two sites in South Africa, where AIDS drug research in local populations have been a divisive topic for a decade.

In advanced clinical drug trials, such as Bristol-Myers Squibb’s proposed project and the nevirapine studies in Uganda, the researcher must tread a fine line: between protecting vulnerable groups from undue research risks and, at the same time, ensuring their participation. If you don’t test pregnant women, for example, how can you develop drugs to help them?

“After a while, the idea that you’re protecting vulnerable subjects actually gives them the worse end of the bargain,” says Daniel Wikler, a professor of ethics and population health at the Harvard School of Public Health. Researchers, Wikler adds, must balance the pursuit of knowledge with the patient’s well-being. “There are two missions: One is a scientific mission and one is a therapeutic mission,” he says.

Where those two missions diverge-and especially when those missions are influenced by economic considerations-is where the medical establishment must confront vexing questions. How does medical science draw a line between research subject and AIDS patient when they are one and the same person? Is it possible to balance the interests of science, patients, and industry? And how does that balance tilt at a time when so many trials are conducted in the developing world?

Central to the design of an ethical drug trial is the principle of “equipoise,” which means that the researcher is truly uncertain about which arm of the study-the control group or the experimental group-will experience greater benefit. Adhering to this principle ensures that researchers will not knowingly administer inferior treatments to subjects when an effective treatment has already been established.

Equipoise can be lost over the course of a trial. In 1994, researchers halted a trial studying the efficacy of the AIDS drug AZT in preventing mother to child transmission of HIV-the early results were so promising that they determined it would be unethical not to provide the control group with the same treatment that was proving so effective in the experimental group. (Last year, a study of the breast cancer drug Herceptin was ended early under similar circumstances.)

Finding equipoise can be especially difficult, or even impossible, when studies involve patients in deprived countries, as is often the case with AIDS-related medications. Both Farber’s “Serious Adverse Events” and Shah’s “Body Hunters” give scathing accounts of the nevirapine trials in Uganda, which were funded by the National Institutes of Health. The study was the focal point of a controversy dating back to 1997, and one that still reverberates in biomedical and bioethical circles.

In the Uganda trial, short courses of AZT and nevirapine were tested on HIV-positive pregnant women against a placebo, even though a long-course AZT regimen had been proven to make deep cuts in the rate of transmission. Some observers argued that both the placebo and the abbreviated regimens were not unethical because poor patients in Uganda would normally receive no treatment at all. Yet others insisted that researchers had a moral obligation to provide the best known treatment to the control group, regardless of what was currently feasible in Uganda.

In The New England Journal of Medicine, then-editor-in-chief Marcia Angell wrote of the Uganda trials, “It seems as if we have not come very far from Tuskegee after all,” referring to the infamous 1932-1972 study in which treatment for syphilis was knowingly withheld from poor black men in a government-funded research program.

The 1964 Declaration of Helsinki, which is a kind of Hippocratic oath for researchers, would seem to back up Angell’s view. The declaration holds that the interests of science cannot come before the interests of the individual subject, and is often interpreted as giving human research subjects the right to the highest available standard of care available. But adapting the Helsinki principles to the age of globalized medicine has proven to be highly problematic. In resource-poor countries such as those of sub-Saharan Africa, basic medical supplies, manpower, and expertise are often in gravely short supply; the “standard of care,” in other words, may be terrible, or nonexistent.

“We can clean up the water supply, provide ancillary care, set up hospitals to give intravenous therapy, make a rule that women are not allowed to breast-feed-we can do all that, but you might as well save the plane fare and conduct the study in Boston, because the results will only be relevant in Boston,” says Robert J. Levine, a professor and bioethics expert at the Yale School of Medicine.

This seems to have been the thinking underlying the Uganda trial. Under pressure from critics, researchers eventually dropped the placebo arm of the nevirapine study, but they did not offer subjects the proven long-course drug regimen. The ethical justification was that the long course was too expensive and difficult to administer in Uganda, but the cheaper, easier short course, while probably not as effective, might be a pragmatic alternative. “They were trying to come up with a treatment that would prevent transmission of AIDS in thousands of babies in the only way that Ugandans could afford,” Wikler said.

. . .

The Uganda AIDS controversy remains significant thanks to the pharmaceutical industry’s continuing presence throughout sub-Saharan Africa and other Third World regions. The FDA has “approved or tentatively approved” 20 AIDS-related products under the President’s Emergency Plan for AIDS Relief, which mostly targets sub-Saharan African countries. In addition to the African work of Bristol-Myers Squibb and Boehringer-Ingelheim, Glaxo-Smith-Kline is now conducting seven clinical trials in 13 resource-poor countries involving 6,000 patients, specifically for prevention of mother to child transmission of HIV.

Big Pharma’s presence in the developing world is heartening to some observers, since treatments benefiting desperately poor, low-status patients don’t necessarily translate into big financial returns for this extremely profitable industry. But others note that the companies aren’t just being magnanimous-and that it’s impossible to consider the ethics of aids drug trials without factoring in economics.

“There’s a public relations benefit for the pharmaceutical companies to be seen doing the right thing in the Third World,” says Jerry Avorn, chief of pharmacoepidemiology and pharmacoeconomics at Brigham and Women’s Hospital and the author of “Powerful Medicines: The Benefits, Risks, and Costs of Prescription Drugs” (2004). “Sub-Saharan Africa is also seen as a more cost-effective and hassle-free environment for clinical trials, and those findings can then be used for marketing in the US.”

Others note that opting for sub-Saharan Africa means that the study will be held to less stringent standards of safety and bookkeeping and allow researchers to enroll subjects who are much less likely to sue if things go wrong.

For Farber, the development of AIDS drugs has become a matter of padding the Big Pharma bottom line, with the profit motive trickling down to the researchers themselves. In “Serious Adverse Events,” she writes that researchers “stand to gain enormously if a trial yields a commercially successful drug, in terms of patents, royalties, credit, and prestige. The bigger their names get, the more money they attract from industry to push new drugs through trials.”

Shah’s “The Body Hunters” draws a two-pronged conclusion about Big Pharma: that it is too aggressive about “body-hunting” vulnerable patients to test some drugs-ones that can be marketed in the West-but not aggressive enough in researching and providing others, particularly those with less profit potential. She cites the example of Gilead Sciences and their patented AIDS drug, tenofovir, which they tested in clinical trials in several sub-Saharan African countries as well as in Thailand and Cambodia, attracting charges of exploitation by some activists. Gilead has faced criticism from Doctors Without Borders for not yet delivering on its 2002 promise to provide a cheap generic version of the FDA-approved tenofovir to developing nations.

“The ethical dilemmas here are already very difficult before you bring conflicts of interest and profit motive into it,” says Wikler. Yet tempting though it may be, it doesn’t simplify matters to cast Big Pharma as the bogeyman. “The presupposition is that the pharmaceutical companies’ primary incentive is to make money,” says Yale’s Levine, “but if we get carried away with acting on presumptions that they’re not honorably motivated, we may end up removing incentives to developing drugs.”

Jessica Winter, a freelance journalist, most recently wrote for Ideas about medical marijuana.

© Copyright 2006 Globe Newspaper Company.

Comments are closed.

Boston Globe prints freelancer half-review of Celia Farber book

Safely praises drug study expose, routinely disparages, ignores paradigm doubt

A prime example today of the way major media editors and writers are cowed into fellow travelers on board the HIV?AIDS paradigm pops up today (Jul 3 Mon) in the Boston Globe.

In a lengthy review of “Serious Adverse Events: An Uncensored History of AIDS” (Melville House), a freelancer named Jessica Winter covers Celia Farber’s new collection of articles, which like her “Out of Control: AIDS and the Corruption of Medical Science” in Harper’s March issue, challenges the quality of HIV?AIDS drug studies and notes the many indications that the paradigm is glaringly false in the politics of HIV?AIDS and in the literature.

The second part is noticeably missing from the summary of the article’s contents in the review, as if it was cut out by an editor, and the review features more than one routine condemnation of the active dissent in HIV?AIDS science, which is otherwise ignored, though almost the entire book is about various aspects of that idea – that HIV as cause is a theory entirely without merit.

the outcry that followed the article’s appearance-it stirred general condemnation and point-by-point rebuttals from scientists, physicians, activists, and Farber’s fellow journalists…

In fact, Farber is perhaps the only established American journalist who, in her Harper’s piece and throughout her career, has seriously questioned the proof that HIV causes AIDS, despite overwhelming and decisive scientific evidence to the contrary…

The book won’t reopen the case on AIDS causation, nor should it…

The author also kneels and chants the standard current cliches of dogma demonstrating that she has no awareness of the scientific literature in the field, which now contradicts these shibboleths if you read it with attention.

In the US, HIV disproportionately afflicts low-income and minority women (Joyce Hafford was an African-American single mother of a 14-year-old). And AIDS is far more deadly in Third World nations than it is in the affluent West.

Thus the major media avoids grasping the nettle in what is sooner or later going to be known as one of the greatest issues of modern science and medicine, and expose most established editors, reporters and writers in the field as having seriously abdicated their responsibilities in a topic where the consequences of neglect are measured in human lives far more numerous than those lost in corrupt drug studies.

In this case, however, it may be beneficial for the book. Like a Trojan horse, it will allow readers who purchase it as an attack on drug studies and corruption in HIV?AIDS to stumble upon the fact that it all makes sense when the corruption of the underlying science is considered.

(Pic above: A South African AIDS patient holds his antiretroviral medication.(Gideon Mendel/ Corbis))

The Boston Globe: Ends and means By Jessica Winter July 2 2006

(show)

The Boston Globe: Ends and means

Researchers developing AIDS drugs must balance their pursuit of effective treatments with the well-being of the people they’re testing. Two controversial new books suggest that too often the good of the trial comes before the good of the subject.

By Jessica Winter | July 2, 2006

LAST MARCH, Harper’s Magazine published an article by journalist Celia Farber called “Out of Control: AIDS and the Corruption of Medical Science.” The piece focused on the death of 33-year-old Joyce Ann Hafford, a pregnant, HIV-positive woman in Tennessee who died of liver failure after enrolling in a clinical trial of the drug nevirapine, manufactured by the German pharmaceutical company Boehringer-Ingelheim and intended to prevent transmission of HIV from mother to child. The article also examined a troubled long-term study of nevirapine in Uganda.

To judge by the outcry that followed the article’s appearance-it stirred general condemnation and point-by-point rebuttals from scientists, physicians, activists, and Farber’s fellow journalists-one might have imagined that the venerable left-leaning magazine had run an essay by a climate-change naysayer or a proponent of creationism. In fact, Farber is perhaps the only established American journalist who, in her Harper’s piece and throughout her career, has seriously questioned the proof that HIV causes AIDS, despite overwhelming and decisive scientific evidence to the contrary.

But that’s only part of the story. “Out of Control” now forms a chapter of Farber’s new book, “Serious Adverse Events: An Uncensored History of AIDS” (Melville House). The book won’t reopen the case on AIDS causation, nor should it. But it’s a useful entry point into a broader debate on the methods and motivations of the pharmaceutical industry and the medical establishment at large in the development of AIDS drugs. What was largely obscured amid the Harper’s controversy is that the main characters in this story face choices and risks that crystallize some of the most important issues in medical ethics today.

Drug research that involves human subjects is fraught with moral and practical dilemmas, but these are compounded when it comes to AIDS studies, for a number of reasons. Unlike more equal-opportunity diseases such as heart disease and cancer, AIDS hits hardest among the poorest and most vulnerable people and communities, both here and abroad.

In the US, HIV disproportionately afflicts low-income and minority women (Joyce Hafford was an African-American single mother of a 14-year-old). And AIDS is far more deadly in Third World nations than it is in the affluent West. Studies of AIDS drugs in resource-poor countries have drawn criticism for skirting ethical standards and exploiting defenseless patients, as investigative journalist Sonia Shah observes in her new book, “The Body Hunters: How the Drug Industry Tests Its Products on the World’s Poorest Patients” (New Press), which is arriving in bookstores the same week as Farber’s.

What’s more, because AIDS can be passed on from mother to baby, researchers must gather data from subjects who would rarely be allowed to participate in other drug trials: pregnant women and their unborn children. Potential subjects are often under great psychological and economic stress, in addition to the physical stress of pregnancy. Their ability to give informed consent may therefore be compromised. The prospect of taking potentially toxic drugs to fend off HIV infection can seem both terrifying and necessary to a woman concerned about the future health of her child.Continued…

These pressing ethical issues are of global and local significance. The pharmaceutical giant Bristol-Myers Squibb, which recently announced plans to build a $1.1 billion biotechnology production facility in Devens, will soon be recruiting HIV-positive pregnant women in Boston for a trial to determine adequate dosing regimens of antiretroviral drugs to prevent mother to child transmission. The company will also recruit subjects for two sites in South Africa, where AIDS drug research in local populations have been a divisive topic for a decade.

In advanced clinical drug trials, such as Bristol-Myers Squibb’s proposed project and the nevirapine studies in Uganda, the researcher must tread a fine line: between protecting vulnerable groups from undue research risks and, at the same time, ensuring their participation. If you don’t test pregnant women, for example, how can you develop drugs to help them?

“After a while, the idea that you’re protecting vulnerable subjects actually gives them the worse end of the bargain,” says Daniel Wikler, a professor of ethics and population health at the Harvard School of Public Health. Researchers, Wikler adds, must balance the pursuit of knowledge with the patient’s well-being. “There are two missions: One is a scientific mission and one is a therapeutic mission,” he says.

Where those two missions diverge-and especially when those missions are influenced by economic considerations-is where the medical establishment must confront vexing questions. How does medical science draw a line between research subject and AIDS patient when they are one and the same person? Is it possible to balance the interests of science, patients, and industry? And how does that balance tilt at a time when so many trials are conducted in the developing world?

Central to the design of an ethical drug trial is the principle of “equipoise,” which means that the researcher is truly uncertain about which arm of the study-the control group or the experimental group-will experience greater benefit. Adhering to this principle ensures that researchers will not knowingly administer inferior treatments to subjects when an effective treatment has already been established.

Equipoise can be lost over the course of a trial. In 1994, researchers halted a trial studying the efficacy of the AIDS drug AZT in preventing mother to child transmission of HIV-the early results were so promising that they determined it would be unethical not to provide the control group with the same treatment that was proving so effective in the experimental group. (Last year, a study of the breast cancer drug Herceptin was ended early under similar circumstances.)

Finding equipoise can be especially difficult, or even impossible, when studies involve patients in deprived countries, as is often the case with AIDS-related medications. Both Farber’s “Serious Adverse Events” and Shah’s “Body Hunters” give scathing accounts of the nevirapine trials in Uganda, which were funded by the National Institutes of Health. The study was the focal point of a controversy dating back to 1997, and one that still reverberates in biomedical and bioethical circles.

In the Uganda trial, short courses of AZT and nevirapine were tested on HIV-positive pregnant women against a placebo, even though a long-course AZT regimen had been proven to make deep cuts in the rate of transmission. Some observers argued that both the placebo and the abbreviated regimens were not unethical because poor patients in Uganda would normally receive no treatment at all. Yet others insisted that researchers had a moral obligation to provide the best known treatment to the control group, regardless of what was currently feasible in Uganda.

In The New England Journal of Medicine, then-editor-in-chief Marcia Angell wrote of the Uganda trials, “It seems as if we have not come very far from Tuskegee after all,” referring to the infamous 1932-1972 study in which treatment for syphilis was knowingly withheld from poor black men in a government-funded research program.

The 1964 Declaration of Helsinki, which is a kind of Hippocratic oath for researchers, would seem to back up Angell’s view. The declaration holds that the interests of science cannot come before the interests of the individual subject, and is often interpreted as giving human research subjects the right to the highest available standard of care available. But adapting the Helsinki principles to the age of globalized medicine has proven to be highly problematic. In resource-poor countries such as those of sub-Saharan Africa, basic medical supplies, manpower, and expertise are often in gravely short supply; the “standard of care,” in other words, may be terrible, or nonexistent.

“We can clean up the water supply, provide ancillary care, set up hospitals to give intravenous therapy, make a rule that women are not allowed to breast-feed-we can do all that, but you might as well save the plane fare and conduct the study in Boston, because the results will only be relevant in Boston,” says Robert J. Levine, a professor and bioethics expert at the Yale School of Medicine.

This seems to have been the thinking underlying the Uganda trial. Under pressure from critics, researchers eventually dropped the placebo arm of the nevirapine study, but they did not offer subjects the proven long-course drug regimen. The ethical justification was that the long course was too expensive and difficult to administer in Uganda, but the cheaper, easier short course, while probably not as effective, might be a pragmatic alternative. “They were trying to come up with a treatment that would prevent transmission of AIDS in thousands of babies in the only way that Ugandans could afford,” Wikler said.

. . .

The Uganda AIDS controversy remains significant thanks to the pharmaceutical industry’s continuing presence throughout sub-Saharan Africa and other Third World regions. The FDA has “approved or tentatively approved” 20 AIDS-related products under the President’s Emergency Plan for AIDS Relief, which mostly targets sub-Saharan African countries. In addition to the African work of Bristol-Myers Squibb and Boehringer-Ingelheim, Glaxo-Smith-Kline is now conducting seven clinical trials in 13 resource-poor countries involving 6,000 patients, specifically for prevention of mother to child transmission of HIV.

Big Pharma’s presence in the developing world is heartening to some observers, since treatments benefiting desperately poor, low-status patients don’t necessarily translate into big financial returns for this extremely profitable industry. But others note that the companies aren’t just being magnanimous-and that it’s impossible to consider the ethics of aids drug trials without factoring in economics.

“There’s a public relations benefit for the pharmaceutical companies to be seen doing the right thing in the Third World,” says Jerry Avorn, chief of pharmacoepidemiology and pharmacoeconomics at Brigham and Women’s Hospital and the author of “Powerful Medicines: The Benefits, Risks, and Costs of Prescription Drugs” (2004). “Sub-Saharan Africa is also seen as a more cost-effective and hassle-free environment for clinical trials, and those findings can then be used for marketing in the US.”

Others note that opting for sub-Saharan Africa means that the study will be held to less stringent standards of safety and bookkeeping and allow researchers to enroll subjects who are much less likely to sue if things go wrong.

For Farber, the development of AIDS drugs has become a matter of padding the Big Pharma bottom line, with the profit motive trickling down to the researchers themselves. In “Serious Adverse Events,” she writes that researchers “stand to gain enormously if a trial yields a commercially successful drug, in terms of patents, royalties, credit, and prestige. The bigger their names get, the more money they attract from industry to push new drugs through trials.”

Shah’s “The Body Hunters” draws a two-pronged conclusion about Big Pharma: that it is too aggressive about “body-hunting” vulnerable patients to test some drugs-ones that can be marketed in the West-but not aggressive enough in researching and providing others, particularly those with less profit potential. She cites the example of Gilead Sciences and their patented AIDS drug, tenofovir, which they tested in clinical trials in several sub-Saharan African countries as well as in Thailand and Cambodia, attracting charges of exploitation by some activists. Gilead has faced criticism from Doctors Without Borders for not yet delivering on its 2002 promise to provide a cheap generic version of the FDA-approved tenofovir to developing nations.

“The ethical dilemmas here are already very difficult before you bring conflicts of interest and profit motive into it,” says Wikler. Yet tempting though it may be, it doesn’t simplify matters to cast Big Pharma as the bogeyman. “The presupposition is that the pharmaceutical companies’ primary incentive is to make money,” says Yale’s Levine, “but if we get carried away with acting on presumptions that they’re not honorably motivated, we may end up removing incentives to developing drugs.”

Jessica Winter, a freelance journalist, most recently wrote for Ideas about medical marijuana.

© Copyright 2006 Globe Newspaper Company.

3 Responses to “Boston Globe prints freelancer half-review of Celia Farber book”

  1. Michael Says:

    Celia, I think you turned this poor woman into a schizophrenic. To me, this piece by Winter was very strange. The statements Truthseeker italisized above were spouted out in a desperate John Mooresque kind of a way, almost as if the zombie like quotes Ms. Winter was writing were expecting the also hypnotized reader to shout AMEN after the sentences.

    The quoting of the standard AIDSMachine party lines seemed to be demanding that there was not even a remote possibility of truth to any dissident beliefs on the causation of AIDS. But Juxtapose this to to the plugs for Celia’s book!

    The article is a very weird but definite plug for Celia’s book, as if Winter is saying, “Celia, You ARE right, but I just can’t go there with you, or I would have to take back things I have already said and I would have to back up on positions I have already taken, and I would really rather just die than be wrong. Sorry kiddo, I just got to uphold my ‘I am always right high society reputation’. Too much at stake, like my ego, you know”.

    I agree with Truthseeker that perhaps the redeeming aspect will be if it comes through as a trojan horse, confronting the unaware reader with a different and far more understandable view of reality to someone whom is not already egoicaly invested in HIV=AIDS beliefs. Plus it is another kick in the rear for Big Pharma HIV drug development.

    I think I may have stumbled on the reason for Ms. Winter being unable to come any closer than she did to Celia’s reasoning. I believe that Jessica Winter is the same Jessica Winter that had done reviews for the Village Voice, and also reported film reviews as well. Not sure, but I think the following is one of her film reviews in opposition to Mbecki’s position in 2003:

    It was done by a Jessica Winter as a critique of films in the Human Rights Watch 2003 film festival. If it is her, it clearly explains her preconceptions in the causation matter of HIV/AIDS:

    The dangers posed by the lone righteous gunman are all too apparent in Elaine Epstein’s State of Denial, which (like Samantha Power’s recent article in The New Yorker) details South African president Thabo Mbeki’s blind, suicidal opposition to HIV-fighting drugs in a country grievously beset by AIDS as well as ignorance. (Health workers report that patients eschew condoms and medication, according to what they interpret as the president’s wishes.) Benefiting from extensive experience in the South African public health sector, Epstein pieces together a textured mosaic of people with AIDS and their families. The remarkable recovery of a little girl named Chipho after entering a drug trial might be proof enough, as if any were needed, to change Mbeki’s mind.

    Ms. Winter says in the Globe: The book won’t reopen the case on AIDS causation, nor should it… cause she would have some explaining to do if it did. If I had Winter’s email address, I’d suggest writing a couple of hundred letters to her concisely listing the reasons it should be reopened. It may help re-open her mind, or at least keep her from “protesting too much” in the future and deepening the quaqmire she seems to be stuck in. And please Ms. Winter, if you do ever respond to an email, present a better case than “well, that’s what everybody else who’s anybody believes”, because it most definitely is not.

    Then again, when the AIDSMachine finally breaks down completely, Ms. Winter can now always say “Well I told everyone to read Celia’s book, I knew the truth all along. They just wouldn’t let me print it! After reading Jessica Winter’s piece, I kind of feel pity for her, she does not seem to know quite which way to go on the HIV issue.

  2. Michael Says:

    And notice in Winter’s film review, she called South African’s president “beset by ignorance” ! That faux pas might be difficult to take back as far as Mbeki’s take on HIV and AIDS drugs! I would hate to have to eat those words along with my tea and crumpets.

  3. Celia Farber Says:

    Michael:Thank you for the sharp observations. I read the Winters piece with a familiar sensation of torpor: These threads of concession, that something is amiss in the pharma-dystopic era, but that “something” is so painstakingly controlled. Winters articulated the newly drawn map of patatable outrage–and this map, in turn, was re-drawn when the film (not the book) “The Constant Gardener” came out. Always, the gridlock centers on how the respectable media can condemn with laser precision those things it has now deemed unsavory (killing people in HIV drug trials has not quite made the cut yet, but close) while sparing the surrounding tissue. This is getting harder and harder. If memory serves, the Boston Globe article did achieve one major correction, which was to point out that it centered on the death of a healthy pregnant woman and on a reeking rotton drug trial called HIVNET 012. The Harper’s article did not seek to “re-open” the case about HIV; It sought to describe what plight had befallen Peter Duesberg since he “re-opened” the case in a paper in 1987. I cannot work out why it is so incredibly hard to sell liberals on the idea of freedom of expression, in science, or better to say, even in science. They seem quite pleased with the primitiveness of the system, that swiftly removes the dissenting scientist, as though through a James Bond film floor trap, when he begs to differ. Not being able to bring about a sense of lament over how the NIH abuses its own, like a controlling, tyrannical father–leads me to suspect we have become almost totally de-sensitized as a culture. That notion of: Next time they may come for my neighbor, and the time after that, for me–etc–what ever happened to that? Anybody who cannot say flatly that was was done to Peter Duesberg is an abomination really cannot be said to be civilized or to have a democratic sensibility. I think this is a fight between freedom and tryanny, just as the other big ones of this past dismal century.Here’s an outtake from “Koba The Dread: Laughter and the Twenty Million,” by Martin Amis. Amis quotes what he calls the “fascist novelist John Braine (proletarian, northern, monotonously drunken, and ridiculously influential, socioculturally but not politically, for at least a generation) used to say to left-wingers: “Why do you love despotism? Why do you yearn for tyranny? And this was more or less the question I put to Hitch:”Rule by yobs. That’s what you want. Why?””Yup. Rule by yobs. What I want is the berks in the saddle. Rule by yobs.”A footnote in ‘Koba’ reveals harrowing, hair-greying, jaw-dropping blindness among our finest minds about Stalin’s USSR, including this clobberer from H.G. Wells, who after meeting Staling in 1934 said he had “never met a man more candid, fair and honest,” and that these qualities explained his “remarkable ascendancy over the country since no one is afraid of him and everyone trusts him.”

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