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A New Perspective on the War against Cancer

 Myths and misconceptions about cancer abound. Oncologists are frequently criticized for torturing patients by burning, cutting and poisoning without making any real progress in the war against cancer. Siddhartha Mukherjee, an oncologist and cancer researcher, tries to set the record straight with his new book The Emperor of All Maladies: A Biography of Cancer.  

It is a unique combination of insightful history, cutting edge science reporting, and vivid stories about the individuals involved: the scientists, the activists, the doctors, and the patients. It is also the story of science itself: how the scientific method works and how it developed, how we learned to randomize, do controlled trials, get informed consent, use statistics appropriately, and how science can go wrong. It is so beautifully written and so informative that when I finished it I went back to page 1 and read the whole thing again to make sure I hadn’t missed anything. I enjoyed it just as much the second time.

 Mukherjee says

It will be a story of inventiveness, resilience, and perseverance against what one writer called the most “relentless and insidious enemy” among human diseases. But it will also be a story of hubris, arrogance, paternalism, misperception, false hope, and hype, all leveraged against an illness that was just three decades ago widely touted as being “curable” within a few years. (more…)

Posted in: Book & movie reviews, Cancer, History

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Of SBM and EBM Redux. Part II: Is it a Good Idea to test Highly Implausible Health Claims?

Review

This is the second post in a series* prompted by an essay by statistician Stephen Simon, who argued that Evidence-Based Medicine (EBM) is not lacking in the ways that we at Science-Based Medicine have argued. David Gorski responded here, and Prof. Simon responded to Dr. Gorski here. Between that response and the comments following Dr. Gorski’s post it became clear to me that a new round of discussion would be worth the effort.

Part I of this series provided ample evidence for EBM’s “scientific blind spot”: the EBM Levels of Evidence scheme and EBM’s most conspicuous exponents consistently fail to consider all of the evidence relevant to efficacy claims, choosing instead to rely almost exclusively on randomized, controlled trials (RCTs). The several quoted Cochrane abstracts, regarding homeopathy and Laetrile, suggest that in the EBM lexicon, “evidence” and “RCTs” are almost synonymous. Yet basic science or preliminary clinical studies provide evidence sufficient to refute some health claims (e.g., homeopathy and Laetrile), particularly those emanating from the social movement known by the euphemism “CAM.”

It’s remarkable to consider just how unremarkable that last sentence ought to be. EBM’s founders understood the proper role of the rigorous clinical trial: to be the final arbiter of any claim that had already demonstrated promise by all other criteria—basic science, animal studies, legitimate case series, small controlled trials, “expert opinion,” whatever (but not inexpert opinion). EBM’s founders knew that such pieces of evidence, promising though they may be, are insufficient because they “routinely lead to false positive conclusions about efficacy.” They must have assumed, even if they felt no need to articulate it, that claims lacking such promise were not part of the discussion. Nevertheless, the obvious point was somehow lost in the subsequent formalization of EBM methods, and seems to have been entirely forgotten just when it ought to have resurfaced: during the conception of the Center for Evidence-Based Medicine’s Introduction to Evidence-Based Complementary Medicine.

Thus, in 2000, the American Heart Journal (AHJ) could publish an unchallenged editorial arguing that Na2EDTA chelation “therapy” could not be ruled out as efficacious for atherosclerotic cardiovascular disease because it hadn’t yet been subjected to any large RCTs—never mind that there had been several small ones, and abundant additional evidence from basic science, case studies, and legal documents, all demonstrating that the treatment is both useless and dangerous. The well-powered RCT had somehow been transformed, for practical purposes, from the final arbiter of efficacy to the only arbiter. If preliminary evidence was no longer to have practical consequences, why bother with it at all? This was surely an example of what Prof. Simon calls “Poorly Implemented Evidence Based Medicine,” but one that was also implemented by the very EBM experts who ought to have recognized the fallacy.

There will be more evidence for these assertions as we proceed, but the main thrust of Part II is to begin to respond to this statement from Prof. Simon: “There is some societal value in testing therapies that are in wide use, even though there is no scientifically valid reason to believe that those therapies work.”

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Posted in: Chiropractic, Clinical Trials, Energy Medicine, Health Fraud, History, Homeopathy, Medical Academia, Medical Ethics, Naturopathy, Politics and Regulation, Science and Medicine

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Homeopathy for fibromyalgia: The Huffington Post bombs again

Over the weekend, my wife and I happened to be in the pharmacy section of our local Target store. We happened to be looking for one of our favorite cold remedies, because both of us have been suffering from rather annoying colds, which have plagued both of us for the last week or two. As we perused the Cold and Flu section of the pharmacy, we were struck at how much shelf space was taken up by Airborne (which was “invented by a schoolteacher“). Nearly three years ago Airborne had to settle a case brought against it alleging false advertising to the tune of $23 million. Despite that, Airborne is still being sold, and there are even a whole bunch of knock-off products copying it. Then, as we continued to look for our favored cold remedy, we noted that, sitting right next to the extensive shelf space devoted to the various flavors and types of Airborne supplements, I saw Boiron’s homeopathic remedy for colds containing oscillococcinum, which is derived from duck liver and heart and diluted to 200C (a 10400-fold dilution).

Yes, I was a bit depressed after that. Now I know what my skeptical friends in the U.K. go through every time they walk into a Boots pharmacy.
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Posted in: History, Homeopathy

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Acupuncture and history: The “ancient” therapy that’s been around for several decades

Make the lie big, make it simple, keep saying it, and eventually they will believe it

– A. Hitler

It seems that just about every article about acupuncture makes some reference to it having been used in China for thousands of years. The obvious reason for such a statement is to make the implication that since it’s been around for so long, it must therefore also be effective. Of course, longevity doesn’t argue for efficacy, otherwise everyone would likely agree that astrology is the way to chart one’s life; astrology has been practiced for many more years than acupuncture.

What’s maddening about the acupuncture longevity myth is that it isn’t true, and demonstrably so. In human medicine, “needling” was illustrated in the 17th century by western observers: no points, no “meridians,” just a big awl-like “needle,” driven in with an ivory-handled circular hammer. In addition, the rationale for hammering these little spikes into various spots (of the practitioner’s choosing) was said to be “exactly the same” as Greek humoral medicine (see, Carruba, RW, Bowers, JZ. The Western World’s First Detailed Treatise on Acupuncture: Willem ten Rhijne’s De Acupunctura. J Hist Med Allied Sci (1974) XXIX (4): 371-398).
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Posted in: Acupuncture, History

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Yes, drug companies do pay attention to herbal medicine

I’m only a monthly contributor here but between being a SBM reader and having my own blogs, I often grow weary of the blind criticism that researchers and drug companies couldn’t care less about traditional folk medicines as drug products. My laboratory spends every single day working on natural product extracts in the search for compounds that may have selective effectiveness against cancer. So, this is a bit of a sore spot for me.

Two papers this week from Cancer Prevention Research on the potential anticancer effects of a diabetes drug (Nathan Seppa story here) remind me to tell the story of a Middle Ages European herbal medicine used to treat polyuria that gave rise to one of the most widely prescribed drugs in the world, metformin (Glucophage in the US). Metformin, known chemically as a biguanide, dimethylguanide to be precise, traces its roots to the plant Galega officinalis. Known as goat’s rue, French lilac, or professor weed, this plant was shown to be a rich source of guanidine and a less toxic compound later called galegin or galegine (isoamyline guanidine).

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Posted in: Herbs & Supplements, History, Pharmaceuticals

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The FDA for the Average SBM Consumer

How the Food and Drug Administration came to be is a story that is filled with death, intrigue and dubious characters. It also, like most stories, has its share of heroes and vindications. The list of those who have died to bring us the agency we know today is long, but even today, the death-toll continues. Now this is not the horrible thing it may at first seem. People are all born with a terminal disease known as life, and they will die. The goal of Medicine is to forestall that death as long as possible and to give people good, long, healthy and safe lives. This is where the Food and Drug Administration comes into play. They help guide the pharmaceutical world in the safest manner possible.

The legal quagmire that is the Food and Drug Administration (FDA) is a result of a series of laws which it behooves the Science-Based Medical community, to understand. Many of these laws were a result of deaths, which were themselves the result of either poor safeguards, or, as we will see in one case, lack of information on the part of a company. It began with the Division of Chemistry inside the U.S. Department of Agriculture. The original concern of this group was the misbranding and adulteration of both food and drugs. The first of the laws which came into effect, to give the Bureau of Chemistry as it became known, was the Biologics Control Act of 1902. As is so often the case with FDA regulations, this was a result of deaths in the populous.
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Posted in: History, Medical devices, Politics and Regulation

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Medicine’s Beautiful Idea

For most of human history, doctors have killed their patients more often than they have saved them. An excellent new book, Taking the Medicine: A Short History of Medicine’s Beautiful Idea, and Our Difficulty Swallowing It, by Druin Burch, MD, describes medicine’s bleak past, how better ways of thinking led to modern successes, and how failure to adopt those better ways of thinking continues to impede medical progress.

The moral is not that doctors once did foolish things. The moral is that even the best of people let themselves down when they rely on untested theories and that these failures kill people and stain history. Bleeding and mercury have gone out of fashion, untested certainties and overconfidence have not.

Burch’s conversation with his rowing coach epitomizes the problem:

“I want you to keep your heart rate at 85% of max for the next hour and a half.”
“Why?”
“Because it’s the best way to improve your fitness.”
“How do you know?”
“Because I’ve done it before and it worked. Because that’s what the people who win the Olympics do. I know, I’ve trained some of them.”
“But has anyone actually done an experiment?”
“What on earth are you talking about?”

This book is Burch’s answer to his coach’s question. Medicine’s “beautiful idea” is that we should test all hypotheses and beliefs using the kind of tests that are reliable for determining the truth. Instead of going by tradition, authority, theory, common sense, or personal experience, we now have effective tools to find out for sure whether a treatment really works. (more…)

Posted in: Book & movie reviews, History, Science and Medicine

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Nine Breakthroughs and a Breakdown

In his new book Breakthrough! How the 10 Greatest Discoveries in Medicine Saved Millions and Changed Our View of the World Jon Queijo describes what he believes are the 10 greatest discoveries. 9 of them are uncontroversial discoveries that have been on other top-10 lists, but his 10th choice is one that no other list of top discoveries has ever included. He realizes that, and even admits in his introduction that a former editor of The New England Journal of Medicine refused to review his book because there is no such thing as alternative medicine, only treatments that work and treatments that don’t. But he “respectfully disagrees.”

Hippocrates’ discovery that disease had natural causes, sanitation, germ theory, anesthesia, X-rays, vaccines, antibiotics, genetics, and treatments for mental disorders are all worthy candidates for the list. But Queijo ludicrously lists the “rediscovery of alternative medicine” as the tenth “great discovery.” He presents no evidence (because there is no evidence) that alternative medicine has “saved millions” or that it has saved anyone. He doesn’t realize that alternative medicine represents a betrayal of exactly the kind of rigorous scientific thinking and testing that led to all the other discoveries. His list of ten breakthroughs is actually a list of 9 breakthroughs and one breakdown. (more…)

Posted in: Book & movie reviews, History, Science and Medicine

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H. Pylori, Plausibility, and Greek Tragedy: the Quirky Case of Dr. John Lykoudis

Mark Crislip is on vacation, but through an arduous series of shakings and succussions (beating his head against the wall?) we have channeled part of his essence: This post mostly concerns itself with infectious diseases, thanks to several recent posts on SBM that discussed the plausibility of health claims† and that touched on the recent discovery that most peptic ulcer disease (PUD) is caused by a bacterium, Helicobacter pylori. Several comments and statements quoted in those posts reveal recurrent questions regarding both plausibility itself and the history of the H. pylori hypothesis. In this post I’ll attempt to answer some of those questions, but I’ll also insert some new confusion.

Plausibility ≠ Knowing the Mechanism

Let’s first dispense with a simple misunderstanding: We, by which I mean We Supreme Arbiters of Plausibility (We SAPs) here at SBM, do not require knowing the mechanism of some putative effect in order to deem it plausible. This seems so obvious that it ought not be necessary to repeat it over and over again, and yet the topic can’t be broached without some nebbishy South Park do-gooder chanting a litany of “just because you don’t know how it works doesn’t mean it can’t work,” as if that were a compelling or even relevant rebuttal. Let’s get this straight once and for all: IT ISN’T.

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Posted in: Basic Science, History, Science and Medicine

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Halsted: The Father of Science-Based Surgery

One (dark and stormy?) night in 1882, a critically ill 70 year old woman was at the verge of death at her daughter’s home, suffering from fever, crippling pain, nausea, and an inflamed abdominal mass. At 2 AM, a courageous surgeon put her on the kitchen table and performed the first known operation to remove gallstones. The patient recovered uneventfully. The patient was the surgeon’s own mother.

This compelling story is the beginning of an excellent new biography of William Halsted, the father of modern surgery, Genius on the Edge: The Bizarre Double Life of Dr. William Stewart Halsted, by Gerald Imber, MD.

When Halsted went to medical school, surgeons still operated in street clothes, with bare hands, and major surgical procedures carried a mortality rate of nearly 50 percent. Suppuration of wounds was called laudable pus. Lister had recently introduced carbolic acid dips and sprays (that were irritating and toxic), but hand washing was discouraged because it was thought to force germs into skin crevices. (more…)

Posted in: Book & movie reviews, History, Surgical Procedures

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