Damned Heretics

Condemned by the established, but very often right

I am Nicolaus Copernicus, and I approve of this blog

I am Richard Feynman and I approve of this blog

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

(Click for more Unusual Quotations on Science and Belief)

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New York researchers did abuse children—HHS

The abuse of foster children at the Incarnation Children’s Center in Harlem (see earlier post The Council will fight NIH over AIDS trial children) is apparently not the only case where the city’s Administration for Children’s Services served up foster children in its care to researchers to act as guinea pigs for potentially lethal doses of anti-AIDS medicines.

According to the New York Sun’s Daniel Hemel (p3 today Fri June 17 issue)), Federal investigators from the Department of Health and Human Services have confirmed that Columbia University Medical Center and New-York-Presbyterian Hospital violated protocol in the same way between 1998 and 2001, when doctors tried out experimental AIDS drugs on foster children at the center.

In a letter dated May 23 the HHS gave them till June 30 to say how they were going to clean up their act with a “corrective action plan”.

The ACS acknowledged in April that “465 HIV-positive and AIDS-infected (sic) foster children” received treatments not yet approved by the FDA. It was all part of the NIH project where pediatric AIDS drug tests were conducted on 13,000 children in at least seven states.

Quite what “HIV-positive and AIDS-infected” means exactly in the minds of Hemel and his editors at the Sun is interesting to contemplate, but given the lack of interest shown by the Times in this scandal we are not going to quibble when the Sun takes up the cudgels on behalf of children caught up in the AIDS machine. (The Times’ tentative article today trying to catch up with this story is reproduced at the end of this post).

And guess what the arguments used in their defense by the officials of these respected institutions were? Right, you got it the first time. They didn’t feel they had to appoint special advocates to represent the childrens’ interests because the treatments carried “the prospect of direct benefit” for patients with HIV and AIDS.

“These studies were instrumental in extending life saving HIV treatments to children,” a Columbia medical center spokeswoman, Marilyn Castaldi, assured Hemel.

In other words, the drugs would be good for the children�somehow the scientists knew this in advance of the experiments designed to establish the fact�so they didn’t need any guardians to clog up the works.

Bioethicists are appalled at this high handed approach even though they have no idea of the flimsy foundation to the science of these drugs, damned in the best AIDS peer-reviewed scientific review literature, which indicates that the trials of such drugs are needless and endanger the lives of the children without any justification at all.

There is “an obvious conflict of interest”, the director of the Stanford Center for Biomedical Ethic, David Magnus, told the reporter Daniel Hemel.

Under fire already from members of the City Council such as Harlem’s William Perkins, who calls it “shocking disregard for the rights and well-being of foster care children by the ACS,” the ACS has contracted with the non profit, Manhattan-based Vera Institute for Justice to review city practices in this regard. In other words, they will pay someone to review their performance. Such sensitivity to conflict of interest!

The ACS officials also told the Sun that none of the city’s foster children are currently enrolled in drug experiments. But th NIH spokesman, John Burklow, said it is “likely” to be happening somewhere in the US.

The HHS letter demands that troves of documents be turned over by officials at the hospitals so that the hospitals’ review boards can themselves be scrutinized.

In other words, the officials and scientists involved in this underhanded experimentation on children without leave are going to get their come-uppance, unless they succeed in their strenuous efforts to whitewash their mistake by appealing to the global assumption that HIV drugs are good for patients of alll kinds, even pregnant mothers-to-be and children.

This will go over well with the AIDS mainstream but to AIDS skeptics this is one more horrific result of a modern superstition which irresponsible scientists have sold to the world and which now with its mismedication of patients ailments endangers even the lives of children in the care of the state.

To anyone not in either camp it suggests powerfully how very urgent it is to make sure that AIDS science makes sense before continuing with the policies and treatments based on this deeply suspect paradigm.

As the mainstream itself is always so happy to say, “lives are at stake.”

Here is the actual article (click “show).

(show)

June 17, 2005 Edition > Section: New York > Printer-Friendly Version

Health Officials: Hospital Broke AIDS Drug Rules

BY DANIEL HEMEL – Special to the Sun

June 17, 2005

URL: http://www.nysun.com/article/15595

Federal investigators have concluded that Columbia University Medical Center and New York-Presbyterian Hospital violated protocol on the use of human research subjects between 1988 and 2001, when doctors at the center administered experimental AIDS drugs to foster-care children.

In a letter dated May 23, the Department of Health and Human Services gave Columbia and New York Presbyterian until June 30 to develop a “corrective action plan” to bolster safeguards protecting children in clinical trials.

According to the HHS investigators, the medical center’s institutional review board – which vets experiments involving human subjects – failed to determine whether it had proper consent to administer cutting-edge treatments to foster-care children.

The city’s Administration for Children’s Services acknowledged in April that approximately 465 HIV positive and AIDS-infected foster children received treatments that had not yet been approved by the Food and Drug Administration. The experiments at the Manhattan hospitals were funded by the National Institutes of Health, which has conducted pediatric AIDS drug tests on more than 13,000 children in at least seven states. An estimated 5-10% of patients in these trials were wards of the foster-care system.

“These studies … were instrumental in extending lifesaving HIV treatments to children,” a Columbia medical center spokeswoman, Marilyn Castaldi, said in a statement yesterday. She said that since the center is currently formulating a response to the HHS letter, “it would not be appropriate to comment further at this point.”

In previous correspondence with the HHS, Columbia and New York-Presbyterian officials argued that researchers did not have to appoint special advocates to represent the foster children’s interests because the treatments carried “the prospect of direct benefit” for patients with HIV and AIDS.

But federal investigators said that the review board didn’t gather enough information to make such an assessment.

Bioethics experts told The New York Sun yesterday that institutions conducting medical trials should never be the only judges of questions regarding young patients in clinical trials.

“The researchers obviously have a conflict of interest that would prevent them from being the sole protector of the child,” said the director of the Stanford University Center for Biomedical Ethics, David Magnus.

The fact that many of the patients in the Manhattan hospitals’ trials were foster children should have prompted the institutional review board to consider “extra precautions,” the editor of the journal IRB: Ethics & Human Research, Karen Maschke, said.

“These are by definition vulnerable subjects,” Ms. Maschke said.

According to Ms. Maschke, the HHS investigators “dodged” a central issue in the inquiry: whether the research would have been permissible even with advocacy oversight. “If the answer is no, then the ‘advocate’ question is moot,” Ms. Maschke said.

Several of the drugs administered in the NIH-funded studies were in the first phase of development. Mr. Magnus said that Phase 1 research seeks to determine a drug’s “maximum tolerable dosage,” and he said it is “dubious” that such trials are ever in the best interests of child patients.

Meanwhile, local politicians are demanding to know how the ACS allowed infants and youngsters under its watch to be enrolled in drug trials.

The ACS has also weathered criticism for failing to stem alleged abuses at the Incarnation Children’s Center in Harlem. According to a BBC documentary that aired last November, HIV-infected children at the center allegedly received potentially lethal doses of anti-AIDS medicines, sometimes being force-fed the drugs through stomach tubes.

Council Member William Perkins, a Democrat who represents Harlem, said the HHS letter “confirms a shocking disregard for the rights and well-being of foster care children by the ACS.”

Mr. Perkins called on the ACS to conduct a “vigorous investigation” into the use of foster children in medical experiments. But according to ACS officials, the agency has already contracted the Vera Institute for Justice, a Manhattan-based nonprofit group, to review city’s practices regarding medical experiments that use foster children as subjects.

The ACS said it “intends to make all of Vera’s findings fully available to the public.”

Officials at the ACS told the Sun yesterday that none of the city’s foster children are currently enrolled in drug experiments. But NIH officials yesterday could not confirm or deny that foster children are still being used in ongoing federally funded medical experiments.

“It is likely” that foster care children currently being treated in federally funded AIDS drug trials, NIH spokesman John Burklow told the Sun, but he added, “the decisions about who can enroll into a clinical trial are made at the local IRB level.”

Officials at Columbia and New York-Presbyterian told the HHS last August that they were taking several steps to protect young patients in clinical trials – including a mandatory training program for staff on the use of children in research.

Last month’s letter requires officials at the hospitals to turn over troves of documents to the HHS so that investigators can scrutinize the hospitals’ institutional review boards.

June 17, 2005 Edition > Section: New York > Printer-Friendly Version

Here is the Times article today, with Janny Scott trying to catch up with the situation but not doing much reporting on it. For those who like the incisive reporting and arts pages of the intellectually vigorous New York Sun, it seems another good example of how the Sun is covering the city better. It may also be another example of how conservative papers tend to treat scientists with a little less collegial deference than the liberal ones do. at least in AIDS.

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The New York Times

June 17, 2005

Drug Trials on Children Broke Rules, Officials Say

By JANNY SCOTT

Federal officials have found that a Columbia University Medical Center committee that oversees the use of patients as subjects in medical research violated federal regulations in the 1990’s in the case of four research projects. In the projects, experimental drugs were tested in children, including foster children, with AIDS or who were H.I.V.-positive.

The Office for Human Research Protections informed Columbia in a letter last month that the medical center’s institutional review board had “failed to obtain sufficient information” concerning the selection of foster children as subjects, the process for getting their parents’ or guardians’ permission and certain additional safeguards.

The exact nature and significance of the violations were unclear yesterday. A spokeswoman for the agency, Pat El-Hinnawy, declined to say what information the review board had failed to obtain, whether the information would have affected the board’s decision to approve the projects and whether any children were harmed.

The findings come at a time when questions have been raised nationally about the participation of foster children in drug trials during the 1980’s and 1990’s, when hundreds of babies in New York City alone were born H.I.V.-positive and when there were at first no treatments approved for children.

The city’s Administration for Children’s Services has hired the Vera Institute of Justice to investigate charges that the city inappropriately allowed foster children to take part.

The agency has said that it has found no evidence that it acted wrongly. Some 465 foster children took part between 1988 and 2001, the agency says.

Under federal regulations, foster children may participate in clinical trials as long as a parent or guardian has given permission, and if the risk is minimal or there is some prospect of direct benefit for the child. All clinical trials, even with adults, must have the approval of the institutional review board in the center where the trial is taking place.

The four trials cited in the letter were supported by the National Institutes of Health and involved dozens of medical centers nationwide. They occurred between 1993 and 2002. In a statement, a Columbia spokeswoman said the studies “were instrumental in extending lifesaving H.I.V. treatments to children.”

“We stand behind the clinical aspects of these trials,” Marilyn Castaldi, the spokeswoman, said in an interview. “It’s not an issue of safety or harm.”

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