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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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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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When what to my wondering eyes should appear….

…but an actual pro-science post at The Huffington Post in which the blogger, Jacob Dickerman, actually correctly describes why homeopathy is quackery! For instance:

Homeopaths will tell us that water has a memory. That it vibrates in a certain way and thus knows exactly what the homeopath put into it. The thing is, if Hahnemann is somehow right about homeopathy, then it doesn’t only fly in the face of all those sciences I listed above (physiology, physics, chemistry, germ theory, hydro-dynamics), it flies in the face of public safety. Because the Florine in our water will have less of an effect than the 65-million year old dinosaur feces that have been naturally distilled for millennia. They say that it has no side effects, and they’re right. What they don’t say is that it doesn’t have any primary effects either.

I still can’t believe I’m reading HuffPo after my prolonged screed yesterday about all the psuedoscience that’s appeared in Arianna Huffington’s little project since its inception in 2005. Best to head on over there before Patricia Fitzgerald, the homeopath who’s the new “Wellness Editor” at HuffPo finds out.

Posted in: Homeopathy, Science and the Media

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Threats to science-based medicine: Big pharma pays a publisher to produce a fake journal

It’s times like these when I’m happy that I haven’t published in too many Elsevier Journals during the course of my career. Actually, I’m not sure if I’ve ever published in an Elsevier journal, although I have reviewed manuscripts for them. In any case, I say that because on Thursday, it was revealed that pharmaceutical company Merck, Sharp & Dohme paid Elsevier to produce a fake medical journal that, to any superficial examination, looked like a real medical journal but was in reality nothing more than advertising for Merck. As reported by The Scientist:

Merck paid an undisclosed sum to Elsevier to produce several volumes of a publication that had the look of a peer-reviewed medical journal, but contained only reprinted or summarized articles–most of which presented data favorable to Merck products–that appeared to act solely as marketing tools with no disclosure of company sponsorship.

“I’ve seen no shortage of creativity emanating from the marketing departments of drug companies,” Peter Lurie, deputy director of the public health research group at the consumer advocacy nonprofit Public Citizen, said, after reviewing two issues of the publication obtained by The Scientist. “But even for someone as jaded as me, this is a new wrinkle.”

The Australasian Journal of Bone and Joint Medicine, which was published by Exerpta Medica, a division of scientific publishing juggernaut Elsevier, is not indexed in the MEDLINE database, and has no website (not even a defunct one). The Scientist obtained two issues of the journal: Volume 2, Issues 1 and 2, both dated 2003. The issues contained little in the way of advertisements apart from ads for Fosamax, a Merck drug for osteoporosis, and Vioxx. (Click here and here to view PDFs of the two issues.)

This is wrong on so many levels that it’s hard to know where to begin.
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Posted in: Basic Science, Clinical Trials, Medical Ethics, Science and the Media

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The Huffington Post‘s War on Medical Science: A Brief History

I realize that our fearless leader Steve Novella has already written about this topic twice. He has, as usual, done a bang-up job of describing how Arianna Huffington’s political news blog has become a haven for quackery, even going so far as to entitle his followup post The Huffington Post’s War on Science. And he’s absolutely right. The Huffington Post has waged a war on science, at least a war on science-based medicine, ever since its inception, a mere two weeks after which it was first noticed that anti-vaccine lunacy ruled the roost there. Because I’ve had experience with this topic since 2005, I thought I’d try to put some perspective on the issue, in order to show you just how pervasive pseudoscience has been (and for how long) at the blog whose name is often abbreviated as “HuffPo.”
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Posted in: Cancer, Health Fraud, Herbs & Supplements, Homeopathy, Politics and Regulation, Science and the Media, Vaccines

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Human subjects protections and research ethics: Where the rubber hits the road for science-based medicine

Arguably the most difficult aspect of science-based medicine is where the rubber hits the road, so to speak. That’s where scientists and physicians take the results of preclinical studies performed in vitro in biochemical assays and cell culture models and in vivo in animal models to humans. There are numerous reasons for this, not the least of which that preclinical models, contrary to what animal rights activists would like you to believe, do not predict human responses to new therapeutic agents as much as we would like. However, the single biggest reason that we cannot answer questions in human studies as easily as we can in cell culture and animal studies is ethics. Of course, answering questions using cell culture and animal studies is not “easy,” either, but performing studies using human beings as subjects is an order of magnitude (at least) more difficult because the potential to cause harm exists, and if harm is caused by the experimental treatment under study, that harm will be done to human beings, rather than cells in a dish or mice bred for research.

The “gold standard” type of study that we do to test the efficacy of a new drug is known as the randomized, placebo-controlled, double-blinded study, often abbreviated RCT. Indeed, this remains the gold standard and is accorded the highest level of “power” in the framework of evidence-based medicine. Of course, as we have argued time and time again, using the RCT to test therapies that are incredibly implausible on a strictly scientific basis (homeopathy or reiki, for instance) inevitably leads to numerous “false positives” in which the therapy appears to produce results statistically significantly better than the control. John Ioannidis has done numerous clever analyses that demonstrate how easily clinical research is led astray if it is not grounded in scientific plausibility. Indeed, the probability of false positive studies increases, the more improbable the modality. It is for these very reasons that we have proposed the concept of science-based medicine, which takes into account estimates of prior probability based on preclinical studies and basic scientific principles, rather than evidence-based medicine, which does not. Indeed, Wally Sampson has even proposed a “plausibility scale” for rating RCTs, and Steve Novella has pointed out how difficult it can be to interpret the medical literature.
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Posted in: Clinical Trials, Medical Ethics, Politics and Regulation, Surgical Procedures, Vaccines

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J.B. Handley, Generation Rescue, and attacks on critics

I am writing this because a colleague of mine has been attacked, specifically, our fearless leader Steve Novella. J.B. Handley, Founder of “Jenny McCarthy and Jim Carrey’s Autism Organization – Generation Rescue” (whose usurpation by Jenny and Jim was apparently done in an opportunistic fashion but has had a consequence that must be galling to J.B., namely that some interviewers apparently think that Jenny McCarthy and Jim Carrey, not J.B. and his wife, are the true founders of Generation Rescue), did not like something that Steve wrote and in his characteristic fashion, has responded with a vicious ad hominem attack. Normally I wouldn’t feel obligated to put my two cents in, as Steve is more than capable of taking care of himself in a scientific argument and quite able to refute anything J.B. can throw at him. Moreover, whenever J.B. Handley attacks someone in a fashion this nasty, it is an excellent indication that the person he is attacking has scored some serious points against him. Indeed, I have twice been on the receiving end of J.B.’s tirades on the Generation Propaganda blog Age of Autism. On one occasion, he referred to me as the “worldwide wanker of woo,” and on another occasion seemed to think that I criticized Generation Rescue so harshly because I “don’t like full page ads,” rather than because I hate pseudoscience and anti-vaccine nonsense. When criticism really hits a nerve with J.B. Handley, he lashes out in a characteristic fashion. Clearly Steve’s reasoned, level-headed criticism of the latest Generation Rescue anti-vaccine propaganda initiative did just that.

In this case, however, I feel some explanation is in order because I feel a bit responsible for having brought J.B.’s wrath down upon Steve. First, a little history (albeit recent history) is in order. As I described in detail last week and the week before, Generation Rescue, with Jenny McCarthy and Jim Carrey at the fore, sometimes with J.B. himself, has mounted an impressive anti-vaccine propaganda effort. It started with a media tour promoting her most recent paean to anti-vaccine pseudoscience and autism quackery written with “co-author” Dr. Jerry Kartzinel. The book is entitled Healing and Preventing Autism: A Complete Guide, and three weeks ago Jenny McCarthy and her boyfriend Jim Carrey showed up on Larry King Live to tout a truly incompetent and intellectually dishonest “study” that purported to find that U.S. children are the “most highly vaccinated children in the world” and that that’s correlated with our higher autism rates. I would have none of it. Next, Generation Rescue introduced its equally intellectually dishonest “Fourteen Studies” website, which launched dubious attacks from pseudoexperts on fourteen of the major studies that failed to find a correlation between vaccines and autism or thimerosal-containing vaccines and autism. I wrote a lengthy post for SBM describing the utter intellectual and scientific bankruptcy of the entire enterprise.
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Posted in: Public Health, Science and the Media, Vaccines

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Mathematically modeling why quackery persists

ResearchBlogging.orgIt’s often puzzled me (and, I daresay, many other skeptics and boosters of science- and evidence-based medicine) why various forms of quackery and woo that have either about as close to zero prior probability as you can get and/or have failed to show evidence greater than placebo in clinical trials manage to retain so much traction among the public. Think homeopathy. Think reiki. The former is nothing more than sympathetic magic prettied up with science-y sounding terms, while the latter is nothing more than faith healing given a slant based on Eastern mysticism and religion instead of Christianity. Indeed, reiki was even inspired by stories of Jesus’ healing powers, complete with a trip into the wilderness for fasting and prayer, resulting in revelation. Or consider acupuncture, a modality that is seemingly more popular than ever, even invading the very sanctum sanctorum of the ivory towers of academic medicine, yet every study of which that is done under rigorous conditions with proper placebo controls shows it to be no more efficacious than a placebo. It’s easy enough to shake one’s head and chalk it up to irrationality, ignorance of science, or even religious faith, but I’ve always been dissatisfied with such glib explanations, even though admittedly I have myself used them on occasion.

That’s why a study released last week in PLoS One by Mark M. Tanaka, Jeremy R. Kendal, Kevin N. Laland out of the Evolution & Ecology Research Centre, School of Biotechnology & Biomolecular Sciences, University of New South Wales, the Department of Anthropology, University of Durham, and the School of Biology, University of St Andrews, Fife, respectively, entitled From Traditional Medicine to Witchcraft: Why Medical Treatments Are Not Always Efficacious. Besides loving the title, I also like the methodology, which in essence adapts the tools of modeling evolution and the spread of traits throughout a population and asks the question: Why do ineffective or even harmful (or, as the authors characterize them, “maladaptive”) treatments for various illnesses persist in populations? The results are surprising and counterintuitive, yet ring true. In essence, the authors conclude that the most efficacious self-treatments are not always the ones that spread and that even harmful treatments can spread. Both of these observations are entirely plausible based on the prevalence of usage of common woo and quackery, and what the authors have done, in essence, is to model mathematically why quackery persists.

Indeed, the authors set the stage:
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Posted in: Basic Science, Clinical Trials, Science and Medicine

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Welcome back, my friends, to the show that never ends, part II: Generation Rescue, the anti-vaccine propaganda machine, and “Fourteen Studies”

I hadn’t planned on writing about the antivaccine movement again this week, so soon after having had to subject myself to yet another round of Jenny McCarthy on Larry King Live and a truly execrable Generation Rescue “study.” I really hadn’t. For one thing, there’s just so much nonsense laid down by antivaccinationists these days that it’s utterly impossible for one blogger to keep up with it all. I could write about them every single day and still not counter the sheer mass of pseudoscience, misinformation, and general ignorance that antivaccine activists spout each and every day, and because this is Autism Awareness Month lately the misinformation has been coming particularly fast and furiously. Sometimes, however, there arrives a bit of misinformation that is so egregious that it requires some response, regardless of how burned out on the topic I might be; so I guess I’ll just have to suck it up and plunge into the morass again.

The reason is that, in retrospect, I now realize that the Jenny and Jim antivaccine propaganda tour was clearly merely phase I of Generation Rescue’s April public relations offensive. In rapid succession last week, courtesy of J.B. Handley, the founder of Generation Rescue, who in order to have a couple of famous faces fronting his organization has allowed himself to be displaced, so that Generation Rescue has now been “reborn” as Jenny McCarthy and Jim Carrey’s Autism Organization (the better to capitalize on her D-list celebrity yoked to Jim Carrey’s formerly A-list (but rapidly plunging) celebrity), announced Generation Rescue’s latest initiative in a post on its antivaccine blog Age of Autism entitled Fourteen Studies? Only if you never read them.:
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Posted in: Politics and Regulation, Public Health, Science and the Media, Vaccines

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This one’s for you, Dana

As you may have noticed, everybody’s “favorite” homeopath, Dana Ullman, has made a return visit to our humble little blog, where he is laying down his usual list of logical fallacies and irrelevencies (such as attacking Oliver Wendell Holmes) in defense of homeopathy. Consequently, now’s as good a time as any to unveil what is perhaps the best ready-for-a-poster criticism of homeopathy I’ve ever seen:

HN09poster1A

Clicking on the picture will lead you to a blog post where you can download a high resolution version suitable for printing up and either distributing or posting on a bulletin board or wall. I particularly like that it was made by The American Institute for the Destruction of Tooth Fairy Science. Truly, a nod to SBM blogger extraordinaire Harriet Hall!

My only objection to the poster is the use of the word “shit.” Don’t get me wrong here. Yes, it’s accurate. No, I’m not some sort of prude who never uses the word and wilts at the very sight or sound of it. My problem with it is that its inclusion on the image means that I can’t actually print up and post this beautiful (and brief) mockery of homeopathy on my lab door or on the bulletin board in my office. I can’t put something like that up in public at work. It also made me a little leery of posting it here, which led me to check with our fearless leader before doing it. So I started thinking of alternatives that get the message across but without any curse words.

Clearly, a version of the poster suitable for a G (or at least PG) audience is required.

How about something like:

If water has a memory, then homeopathy is full of crap
Homeopathy: Potentizing poo by flushing.

After all, flushing should “succuss” the remedy as well as hitting it against a Bible.

Yes, I do watch Dirty Jobs a lot, with its host, Mike Rowe, who likes to use the word “poo” a lot. Come to think of it, perhaps Mike Rowe should do a segment of Dirty Jobs segment at a manufacturer of homeopathic remedies. Why? Think of the potentized poo!

Posted in: Homeopathy, Humor

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