I don't know much of anything about the controversial use of chelation therapy in the treatment of heart disease except that it is controversial. Chelation is one of those topics that has been deemed to be "woo" by the medical wing of the "Skepticism" industry. But I don't know enough to know if it might be one of those cases when, oddly enough, their listing it on their Index of Prohibited Ideas is valid. But a story by Karen Weintraub in the Boston Globe on April 22 was interesting because it cast a light on the idea of "woo" itself.
A study showing a small but positive result for chelation as therapy for heart disease was conducted under the supervision of the federal government, a rather large study. You would think that having some unanticipated validation of a treatment that is used, unofficially by about 50,000 Americans a year, would be welcomed by cardiologists and others involved in treating heart disease and public health. But that's not nearly the case.
The positive result triggered a firestorm of opposition from come cardiologists who dismissed the study as junk science; while others defended the study, published in the prestigious Journal of the American Medical Association as no more flawed than any other.
The emotional debate reinforces the importance of scientific research, several doctors and ethicists said, even as it shows weakness in the scientific process. And it raises questions about the attitudes many doctors have shown toward alternative medicine.
"It challenges the foundation of western medicine to accept alternative medicines," said Felician Cohn, bioethics director for Kaisar Permanete Orange County.
The results surprised even the researchers conducting the research, who had expected it to give the negative results predicted by the current beliefs of doctors and researchers.
No one was more surprised by the results in the TACT trial than the researchers who conducted it.
A photo of the meeting where they first learned the results shows shock and dismay, said Gervasio A Lamas, chief of Columbia University's division of cardiology at Mt. Sinai Medical Center in Maimi Beach, Fla.
" We really do look astonished," Lamas said. "Some people had their head on the table saying; 'no you've got to be kidding me.'"
Lamas said he felt he had to study chelation after a patient came to him asking whether to use the therapy. His first reaction was "of course not!" Then he began to research the treatment and realized that the "only correct answer was: I don't know."
You can look up the reaction online, I have not, yet. I suspect it will be dominated by the "Skeptical" rejection by people who "know" it can't be true, some of them media doctors such as Steven E. Nissen who is given prominent mention in the story in the Globe . And, as I said, they might be right, though, with this study, there is more reason to believe they may not be. Though the question remains as to why these doctors wouldn't be thrilled to have evidence that they had another possible means of preventing second and third heart attacks in their patients that wouldn't make them more willing to look at the possible effectiveness of a widely used unofficial therapy? What does that say about their value of patient care as opposed to their preexisting bundle of beliefs on the basis of no such study?
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Yesterday's reading brought up something about medical science that is far more stunning and disturbing, which opens far more of "the foundation of western medicine" and much more of biology into far more basic doubt. [Note: Sorry, just realized I'd forgotten the link.]
New scientific research has cast grave doubt on the safety testing of hundreds of thousands of consumer products, food additives and industrial chemicals.
Everyday products, from soft drinks and baby foods, to paints, gardening products, cosmetics and shampoos, contain numerous synthetic chemicals as preservatives, dyes, active ingredients, or as contaminants. Official assurances of the safety of these chemicals are based largely on animal experiments that use rabbits, mice, rats and dogs. But new results from a consortium of researchers and published in the Proceedings of the National Academy of Sciences suggest such assurances may be worthless (Seok et al. 2013).
The results of these experiments challenge the longstanding scientific presumption holding that animal experiments are of direct relevance to humans. For that reason they potentially invalidate the entire body of safety information that has been built up to distinguish safe chemicals from unsafe ones. The new results arise from basic medical research, which itself rests heavily on the idea that treatments can be developed in animals and transferred to humans.
The research originated when investigators noted that in their medical specialism of inflammatory disease (which includes diabetes, asthma and arthritis), drugs developed using mice have to date had a 100% failure rate in almost 150 clinical trials on humans.
According to Kristie Sullivan, Director of Regulatory Testing Issues at the Physicians Committee for Responsible Medicine (PCRM), this is not unusual “about 90% of all pharmaceuticals tested for safety in animals fail to reach the market, or are quickly pulled from the market”. Wanting to understand why this might be so, the consortium decided to test the effects of various treatments that lead to inflammation, and systematically compare results between mice and humans. This postulated correlation across different animal species is sometimes known as the concordance assumption.
"The concordance assumption" is something I never encountered in any of the biology classes I took in high school or college, nor do I remember it being mentioned in anything I've read in the matter of animal research, just about every single one of which featured either research or experiments conducted on animals, most of which explicitly asserted some rather broad assertions about human beings and between different species on the basis of this unstated "assumption". How serious is the problem with it?
In a first set of experiments the researchers looked at acute inflammation in mice brought on by various stimuli. These stimuli were bacterial toxins (endotoxaemia), trauma, and burns. To measure responses the authors quantified positive or negative changes in gene activity for thousands of individual genes. The researchers found that changes in activity of a particular mouse gene after treatment typically failed to predict changes in activity in the closest related human gene. This was not the expected result. If humans and mice are meaningfully similar (i.e. concordant) then gene activity changes in mice should have closely resembled those in humans after a similar challenge. But they did not.
In further experiments, the researchers identified another difference. While humans responded with similar patterns of gene changes to each of the three different challenges (trauma, burns, and endotoxaemia), mice did not. The three treatments in mice each resulted in a distinct set of gene activity changes. This confirmed the initial results in the sense that mice and humans responded differently. It also implied that the differences in gene response between mice and humans are attributable not so much to a lot of detailed ‘noise’ but to fundamental differences in the physiology of mice and humans in dealing with these challenges.
Next, the researchers examined the activity of specific biological signaling pathways after similar treatments. These too were highly divergent between mice and humans. Surprised by the consistently poor correlations between the two species, the authors then tested other human/mouse models of inflammatory diseases. Again, the similarity between mice and humans was low.
In summary, repeated experiments confirmed that, when it comes to inflammation, mice and humans have little in common, a finding important enough in itself given the prevalence of inflammation-related diseases in humans. These include allergies, celiac disease, asthma, rheumatoid arthritis, and autoimmune diseases.
Of the two articles mentioned here, this one really has immediate and extremely disturbing potential for harm.
Thus the Seok study is not the first to conclude that mice are poor models for human disease, but it is notable for being by far the most comprehensive. Combined with results of previous experiments, its conclusions suggest researchers should expect that mouse, and probably other animal testing, is of little use in advancing the treatment of human illnesses, including heart disease and cancer.
In other words, the public is probably being badly served by much of the money spent on medical research. According to PCRM’s Kristie Sullivan, “the National Institutes of Health is giving researchers billions of dollars every year for research on animals”. While missing out on potential cures, the public is also likely being exposed to dangerous or ineffective pharmaceuticals. Animal testing nearly prevented the approval of valuable drugs such as penicillin and subsequent antibiotics, but it did not prevent the thalidomide disaster of the 50s and 60s (Greek and Swingle Greek, 2003).,,
... If animals are not useful predictors of important disease responses in humans it is unlikely they are useful as test subjects for toxicological safety. In other words, lack of concordance means that the synthetic chemicals that are found in industrial products, incorporated into food, and otherwise spread throughout the environment, are essentially untested. The regulatory process through which they passed was never a scientifically validated and evidence-based system, but now the evidence shows it to have been functioning as a system of random elimination. “We are not protecting humans” says Kristie Sullivan, noting that “even a National Academy study agrees that many toxicological tests are not human-relevant.”
The effect of this is nothing less than shocking to someone who was brought up with the faith that all of that horrific and cruel animal testing was scientifically valid and a hard but necessary evil. Now it would seem that even the scientific character of its basic theory was more faith than science. I will not try to tease out its origins and ancestry, not just now, but will repeat that this article is about the most disturbing thing I've read in years not related to climate change.
What else it means for the enormous faith in a far less demonstrable "concordance" between the minds of animals as remotely related to us as other mammals and us, never mind the ever popular one between human beings and ants, it calls it into the most fundamental question. If science missed the issues discussed in this article for all of those decades, there is absolutely no reason to have any faith in the wild speculations by those who find human consciousness and thought inconvenient for their "scientific" faith. Unless they can account for it with science as clear as this, it should be considered to be rank superstition based in something far less valid than human experience, ideology.
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