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Archive for May, 2009

AA is Faith-Based, Not Evidence-Based

Alcoholics Anonymous is the most widely used treatment for alcoholism. It is mandated by the courts, accepted by mainstream medicine, and required by insurance companies. AA is generally assumed to be the most effective treatment for alcoholism, or at least “an” effective treatment. That assumption is wrong.

We hear about a few success stories, but not about the many failures. AA’s own statistics show that after 6 months, 93% of new attendees have left the program. The research on AA is handily summarized in a Wikipedia article.  A recent Cochrane systematic review found no evidence that AA or other 12 step programs are effective.

In The Skeptic’s Dictionary, Bob Carroll comments:

Neither A.A. nor many other SATs [Substance Abuse Treatments] are based on science, nor do they seem interested in doing any scientific studies which might test whether the treatment they give is effective. (more…)

Posted in: Faith Healing & Spirituality, Science and Medicine

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The case of chemotherapy refusenik Daniel Hauser

I’ve written before about clinical trials as one place where “the rubber hits the road,” so to speak regarding the interface between science-based medicine and actual medical practice. Another critical place where an equal amount of rubber hits an equal amount of road is how the medical system and the law deal with the medical care of minors. In the vast majority of cases, parents take their children to physicians ostensibly practicing science-based medicine and, more or less, follow their advice. One of the more common areas where there is resistance to science-based medicine is, of course, the issue of vaccination, which I and other bloggers at SBM have written about extensively. Another issue, which has not yet been touched upon on this blog, is what to do about parents who refuse chemotherapy for their children with curable childhood cancers or children who refuse chemotherapy whose parents either agree with them or are unwilling to do the hard work of convincing their children that they must undergo therapy. Most often, the reason cited by such “chemotherapy refuseniks” is either religion or a desire to undergo “alternative” therapy rather than conventional therapy. One such case, a particularly high profile one, has been in the news over the last couple of weeks. In this post, I plan to discuss the case of Daniel Hauser, a 13-year-old boy from Minnesota with Hodgkin’s lymphoma who, after one round of chemotherapy, is currently refusing further therapy. This case ended up in court (as these cases often do) and led to a decision that is likely to satisfy no one (as these cases nearly always do).

Before I discuss Daniel’s case in more depth, however, let me make one thing clear. From my perspective, competent adults have the right to choose whatever treatment they wish–or to refuse treatment altogether–for virtually any condition. The sole exception that I can think of would be the case of a highly contagious infectious disease, where society has a right to prevent epidemics and, if necessary, quarantine someone who refuses treatment and refuses to avoid interaction with others. Note, however, that the right competent adults to choose whatever quackery they desire should in no way be construed to imply that quacks have any sort of “right” to provide them with quack treatments. The reason is that providing such treatments inherently involves making claims for them that are not supportable by science. In essence, selling such treatments involves fraud, even if the practitioner is a true believer and just as deluded about the efficacy of the woo he is selling as the person buying it is. Be that as it may, if a competent adult wants to refuse treatment and understands the consequences, then I will call him a fool if what he has is a potentially very curable disease like Hodgkin’s disease and chooses bogus (word choice intentional) alternative “cures” instead, but it’s his call.

However, from my perspective (and that of the law in most states) the key to such self-determination is that the person must be informed of and understand the consequences of his actions, and there are three components to this understanding. First, of course, is mental competence; i.e., no serious untreated mental illness that impairs a person’s ability to perceive reality can be present. Untreated schizophrenia, for example, can definitely interfere with a person’s ability to evaluate information. The second is the ability to understand the disease and what the consequences of treatment or doing nothing are. That is why adults with mental retardation severe enough to prevent them from understanding are in general not considered competent to make such decisions. Indeed, it is why parents are expected to act on the behalf of their normal children to make such decisions. Finally, there is informed consent. A person refusing treatment must be told the consequences of his refusal and acknowledge them. Whether he believes what he is told is another matter, but it is not up to physicians to force treatment on someone just because that person doesn’t believe what they tell him, as long as the first two conditions are met.

The conflict arises when a parent decides to pursue quackery for a life-threatening but potentially curable illness for a child or a child refuses therapy. It is on such occasions that society as represented by the state has a compelling interest in overriding the parent’s decision and making sure that the child gets the best science-based treatment available. It is also a situation when parental rights, rights of self-determination, and the legitimate interest of society in protecting children can all clash in a most chaotic and nasty manner. That is exactly what is at issue in the case of Daniel Hauser, as described in a news report of the testimony given in his case:
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Posted in: Cancer, Faith Healing & Spirituality, Medical Ethics, Science and the Media

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“Acupuncture Anesthesia”: A Proclamation from Chairman Mao (Part I)

James Reston’s Appendectomy

For many Americans, the current wave of public fascination with “complementary and alternative medicine (CAM)” can be traced to a single event: New York Times columnist James Reston’s appendectomy in China during the summer of 1971, which Reston reported in an interesting and amusing article on July 26 of that year. Many of those who noticed the publicity following this event erroneously concluded that Mr. Reston had undergone “acupuncture anesthesia.” A few years ago, a Google search for “acupuncture and Reston” revealed that approximately 50% of the numerous “hits” reported this, as though it were an uncontroversial fact. Other sources have suggested the same, but in veiled language. Here are examples of each: 

In the 1970s, interest in the procedure was sparked when New York Times editor James Reston wrote an article about his experience with acupuncture. Reston was covering Richard Nixon’s visit to China when Reston needed an emergency appendectomy, and acupuncture was used as an anesthetic.—UPenn News 1995 

In 1972 President Nixon opened the doors to China. A New York Times journalist James Reston was in China at the time and had an emergency appendectomy with acupuncture used as the anesthetic.—American Acupuncture 

[Acupuncture] made its official appearance in the U.S. in 1971 when an article by J. Reston was published in the New York Times describing his personal experience with acupuncture. While in Beijing reporting on a Ping-Pong tournament, he underwent an emergency appendectomy. Acupuncture was used as surgical anesthesia and to relieve post-operative pain. —Center for the Healing Arts, P.C.

The first US national media coverage concerning Acupuncture was in 1971 during President Nixon’s visit to China. There, visiting columnist James Reston told of his emergency appendectomy performed under Acupuncture anesthesia.— AZ Multicare

When New York Times columnist James Reston underwent an appendectomy while accompanying the Nixon entourage to Beijing in 1971, he wrote about a medical discovery called “acupuncture anesthesia.” Eisenberg, David, with Thomas Lee Wright: Encounters with Qi (p. 28) 

About a month after his appendectomy, Reston did write about acupuncture anesthesia—but not referring to his own operation.

Those who don’t report that Reston had acupuncture anesthesia are likely to write, also erroneously, that his “intense post-operative pain was relieved by acupuncture”:

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Posted in: Acupuncture, Medical Academia, Science and the Media, Surgical Procedures

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Homeocracy 3

The previous post of this series analyzed the results of the 1994 Pediatrics paper purporting to show a statistically significant effect of homeopathic preparations on acute childhood diarrhea in a population in Nicaragua. That clinical trial followed a pilot study that also had shown a small but statistically significant effect of homeopathic remedies.

A moment here for explanation as to why I am going through these old studies. Reports like the four or five in this series made headlines. They are also so well cloaked in manipulated data and overdrawn conclusions that press and even academicians accept their conclusions – and even overdraw more. This is still going on.

Over the past thirty years some of us informally and gradually developed semi-systematic ways of analyzing these increasingly scientific-appearing claims of sectarians (sCAMmers.) Errors, inconsistencies and falsifications we recognize now were not so obvious decades ago. SCAMmers developed imaginatively new methods as their fields progressed. We in the science-based or knowledge based medicine field have been trailing along, detecting their tricks and twists as they developed, and like street sweepers behind horses, picking up their excrement (metaphor to force attention.)  Yesterday’s lucid post on the latest acupuncture study by Steve Novella exemplifies this expertise (no offense intended.)
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Posted in: Clinical Trials, Homeopathy, Medical Academia, Science and Medicine

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Being Right Versus Being Influential

On May 9th I had the pleasure of lecturing to an audience of critical thinkers at the NYC Skeptics meeting. The topic of discussion was pseudoscience on the Internet – and I spent about 50 minutes talking about all the misleading health information and websites available to (and frequented by) patients. The common denominator for most of these well-intentioned but misguided efforts is a fundamental lack of understanding of the scientific method, and the myriad ways that humans can fool ourselves into perceiving a cause and effect relationship between unrelated phenomena.

But most importantly, we had the chance to touch upon a theme that has been troubling me greatly over the past couple of years: the rise in influence of those untrained in science on matters of medicine. I have been astonished by the ability of “thought leaders” like Jenny McCarthy to gain a broad platform of influence (i.e. Oprah Winfrey’s TV network) despite her obviously flawed beliefs about the pathophysiology of autism. Why is it so hard to find a medical voice of reason in mainstream media?

The answer is probably related to two issues: first, good science makes bad television, and second, physicians are going about PR and communications in the wrong way. We are taught to put emotions aside as we carefully weigh evidence to get to the bottom of things. But we are not taught to reinfuse the subject with emotion once we’ve come to an impartial consensus. Instead, we tend to bicker about statistical analyses, and alienate John Q. Public with what appears to him as academic minutiae and hair-splitting.

I’m not sure what we can or should offer in place of our “business as usual” behavior – but I’ve noticed that being right isn’t the same as being influential. I wonder how we can better advance the cause of science (for the sake of public health at a minimum) to an audience drawn more to passion than to substance?

I would really enjoy your input, dear readers of Science Based Medicine, because I’m at a loss as to what we should do next to reach people in our current culture, and with new communications platforms. What would you recommend?

Posted in: Public Health, Science and Medicine, Science and the Media

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Acupuncture Does Not Work for Back Pain

ResearchBlogging.orgA new study which randomized 638 adults to either standard acupuncture, individualized acupuncture, placebo acupuncture using tooth picks that did not penetrate the skin, and standard therapy found exactly what previous evidence has also suggested – it does not seem to matter where you stick the needles or even if you stick the needles through the skin. The only reasonable scientific conclusion to draw from this is that acupuncture does not work.

But let me back up a minute. Imagine if we were evaluating the efficacy of a new pain drug. This drug, when tested in open trials (no blinding or control) has an effect on reducing pain – it is superior to no treatment. When compared to a placebo, however, the drug is no more effective than the placebo, although both are more effective than no treatment.

Now imagine that the pharmaceutical company who manufactures this drug sends out a press release declaring that their drug is effective for pain, but that their research shows that a placebo of their drug is also effective (FDA applications are pending). Therefore more research is needed to determine how their drug works.  Would you buy it?

That is the exact situation we are facing with acupuncture research.

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Posted in: Acupuncture, Science and Medicine

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Re-evaluating Home Monitoring for Diabetes: Science-Based Medicine at Work

There is no question that patients on insulin benefit from home monitoring. They need to adjust their insulin dose based on their blood glucose readings to avoid ketoacidosis or insulin shock. But what about patients with non-insulin dependent diabetes, those who are being treated with diet and lifestyle changes or oral medication? Do they benefit from home monitoring? Does it improve their blood glucose levels? Does it make them feel more in control of their disease?

This has been an area of considerable controversy. Various studies have given conflicting results. Those studies have been criticized for various flaws: some were retrospective, non-randomized, not designed to rule out confounding factors, high drop-out rate, subjects already had well-controlled diabetes, etc. A systematic review showed no benefit from monitoring. So a new prospective, randomized, controlled, community based study was designed to help resolve the conflict. (more…)

Posted in: Clinical Trials, Science and Medicine

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Define the disease first

My first post on this blog addressed the problem of what I have called “fake diseases” (a problem which needs a more neutral moniker). As I wrote at the time, people suffering from vague ailments are often twice victimized: the medical establishment cannot satisfy them, and quacks prey on them. There’s a certain sense of satisfaction and validation to having your symptoms clearly labeled. While it isn’t a good thing to have heart disease, no one tells you you’re not sick. Not so with people with more vague and protean symptoms. It’s human nature to want answers, to try to understand patterns, and when we, as physicians, cannot help someone understand their symptoms, they’re going to reach out to others for answers.

The Lyme disease community is like that. The internet has helped them to form communities and to share information. This whole idea of “chronic Lyme disease” (CLD) has become a way for people who don’t feel they have a medical home to come together. I understand that impulse. Any human being should be able to understand it.

But the other side of me, the analytic side, has a problem with it. No, not a problem with people supporting each other, but if you read these websites, message boards, etc., you can see a certain commonality—people aren’t getting any better. They are still suffering. Much of that suffering is blamed on a heartless medical community, and when they find a “Lyme literate” doctor, there is a huge sense of relief. But the symptoms often continue.

The very idea of CLD is not implausible (as opposed to Morgellons and other such fake diseases). Other spirochetes give us models for diseases with extended, multi-system effects, syphilis being the most studied. One of the key concepts in science-based medicine is plausibility, because, as Dr. Harriet Hall puts it, no matter how much you study the characteristics of the tooth fairly, you still haven’t proven her existence. But CLD certainly has a plausibility to it, and if an idea is plausible, then it is certainly worth studying and gathering evidence.
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The British Chiropractic Association versus Simon Singh

Simon SinghIf there’s one thing I’ve learned in my years promoting skepticism and science in medicine and writing critically about various forms of unscientific medical practices and outright quackery, it’s that there will always be pushback. Much, if not most, of the time, it’s just insults online. However, occasionally, the pushback enters into the realm of real life. I can remember the very first time this happened to me. It was in 2005, and a man by the name of William P. O’Neill of the Canadian Cancer Research Group sent legal threats to my Department Chairman, my Division Chief, and my Cancer Center Director. The legal threat was clearly vacuous, as Mr. O’Neill seemed upset mainly that I had praised his arch-nemesis, Australian skeptic Peter Bowditch (who even keeps a running tally of threats he receives from Mr. O’Neill under the heading The GAL Chronicles, where GAL stands for “gutless anonymous liar”). I must admit, at the time it scared the crap out of me, but the reaction of my Chairman at the time, Dr. Stephen Lowry, was classic in that he said he did not care what I did in my spare time and referred to Mr. O’Neill as a “cowardly bully.” From then on, every time Mr. O’Neill tried something similar, I simply replied that I was forwarding his e-mail to Dr. Lowry (who was amused by all this) and thanked him for his concern.

More recently, J.B. Handley wrote a rather ugly screed (one of two, actually) about me. Somehow, this screed was e-mailed to my cancer center director. Whether Mr. Handley, one of the crew at Age of Autism, or an AoA reader did it, I don’t know. However, it is typical behavior of the anti-vaccine movement. Based on this history, I’ve concluded that, if you’re going to be a skeptic you’d better be prepared for this sort of thing, and if you’re going to blog under a pseudonym you’d better expect that sooner or later someone will try very, very hard indeed to “out” you and use that against you–which is of course blogging at SBM is in a way liberating in that it removes that threat.

However, whatever obnoxiousness or attempts to harass me at my job I may on occasion have to worry about, one thing I don’t have to worry about (much) is legal threats, at least as long as I keep all my ducks in a row, so to speak. In the U.S., libel is a very difficult charge to prove. The First Amendment gives wide latitude to free speech, and that places the burden of proof on the plaintiff to show that a statement is defamatory, with libel being in essence written defamation. In general, this is what constitutes defamation in the U.S.:

In order for the person about whom a statement is made to recover for libel, the false statement must be defamatory, meaning that it actually harms the reputation of the other person, as opposed to being merely insulting or offensive.

The statement(s) alleged to be defamatory must also have been published to at least one other person (other than the subject of the statement) and must be “of and concerning” the plaintiff. That is, those hearing or reading the statement must identify it specifically with the plaintiff.

The statement(s) alleged to be defamatory must also be a false statement of fact. That which is name-calling, hyperbole, or, however characterized, cannot be proven true or false, cannot be the subject of a libel or slander claim.

The defamatory statement must also have been made with fault. The extent of the fault depends primarily on the status of the plaintiff. Public figures, such as government officials, celebrities, well-known individuals, and people involved in specific public controversies, are required to prove actual malice, a legal term which means the defendant knew his statement was false or recklessly disregarded the truth or falsity of his statement. In most jurisdictions, private individuals must show only that the defendant was negligent: that he failed to act with due care in the situation.

A defamation claim — at least one based upon statements about issues that are matters of public interest — will likely fail if any of these elements are not met.

As you can see, it is a high bar of evidence to overcome to prove libel. Of course, that is a two-edged sword in that it allows J.B. Handley to slime me whenever he wishes, with little I can do about it, but I am also allowed, as I see fit, to respond or not to such attacks. I can also continue to criticize anti-vaccine propagandists like Mr. Handley as I see fit. Unfortunately, for my U.K. colleagues, the same is most assuredly not true in British courts, where the rules are very much weighted against the defendant. Witness this travesty of a ruling on the libel case against Simon Singh, coauthor with Edzard Ernst of Trick or Treatment: The Undeniable Facts about Alternative Medicine (which Harriet Hall reviewed last year) by the British Chiropractic Association, as related by Jack of Kent. This ruling came about because the BCA did not like an article that Singh wrote for The Guardian entitled Beware the spinal trap.
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Posted in: Chiropractic, Medical Ethics, Politics and Regulation, Science and the Media

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How I would run the CAM club

During the past academic year, I have written about CAM on campus for my student newspaper and fancy myself now somewhat notorious among the students who care about the issue. My article in the fall issue was a review of a homeopathy lecture that I described in detail for my first SBM post. In the winter issue I discussed two dueling WSJ opinions and the silliness of the “4 in 10 Americans use CAM” argument, channeling Drs. Gorsky and Crislip. I had a piece planned to wrap up the series, but sadly the spring issue has been canceled because the rest of the editorial staff is studying for USMLE Step 1. This is life at medical school, probably not just mine but universally: huge stresses and time obligations often crowd out extracurricular activities.

I began imagining this essay, an open letter to the campus CAM advocates about how I would direct their programming, just before my run-in with a pair of students unhappy about an SBM post. Before the accusations of unprofessionalism began flying around, I was thinking about how we could find common ground. Are there aspects of CAM that even a self-described skeptic can support? Clearly everyone on campus cares firstly about providing the best possible care for patients. Could the CAM advocates and I be collaborative rather than antagonistic? Some disagreement is inevitable given that I have classmates who have taken coursework in homeopathy and integrative nutrition, but I wondered if I could offer constructive advice on improving the CAM club rather than simply dismissing it as having no place on campus. (more…)

Posted in: Science and Medicine

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