In part 2 of the Science-Based Medicine 101 series we take a look at the second pillar of good science: plausibility. This blog post was written for a lay audience so more advanced readers will need to indulge me here…
I really enjoy sci-fi action movies. I love the convincing special effects and the fact that heroes can accomplish the physically impossible without skipping a beat. Implausible events unfurl with convincing reality, and you never know what might happen with the plot.
I also enjoy the TV show, America’s Funniest Home Videos, for different reasons. The mundane nature of actual reality, and the often predictable, but hilarious mistakes made by those I relate to result in some pretty hearty laughs.
But there is a big difference between these two forms of entertainment: science-fiction requires the suspension of belief in plausibility, while home videos are based on plausible outcomes. When it comes to medical research, though, plausibility can mean the difference between science fiction and reality.
In discussions of that bastion of what Harriet Hall likes to call “tooth fairy science,” where sometimes rigorous science, sometimes not, is applied to the study of hypotheses that are utterly implausible and incredible from a basic science standpoint (such as homeopathy or reiki), the National Center of Complementary and Alternative Medicine (NCCAM), I’ve often taken Senator Tom Harkin (D-IA) to task, as have Drs. Novella, Lipson, and Atwood. That’s because Senator Harkin is undeniably the father of that misbegotten beast that has sucked down over $2.5 billion of taxpayer money with nothing to show for it. NCCAM is the brainchild of Senator Harkin, who foisted it upon the National Institutes of Health not because there was a scientific need for it or because scientists and physicians cried out for it but rather because Senator Harkin, who believed that alternative medicine had healed a friend of his, wanted it, and he used his powerful position to make it happen, first as the Office of Unconventional Therapies, then as the Office of Alternative Medicine, and finally as the behemoth of woo that we know today as NCCAM. The result has included a $30 million trial of chelation therapy in which convicted felons were listed among the investigators and a totally unethical trial of the Gonzalez therapy for pancreatic cancer. It’s not for naught that Wally Sampson called for the defunding of NCCAM, as have I and others. Not surprisingly, alternative medicine practitioners are appalled at this idea.
Most recently, Harkin has been most disturbed by the observation that NCCAM’s trials have all been negative, going so far as to complain that NCCAM hasn’t produced any positive results showing that various alternative therapies actually work. This is, of course, not a surprise, given that vast majority of the grab bag of unrelated (and sometimes theoretically mutually exclusive) therapies are based on pseudoscience. One of the only exceptions is the study of herbal remedies, which is a perfectly respectable branch of pharmacology known as pharmacognosy. Unfortunately, as David Kroll showed, in NCCAM the legitimate science of pharmacognosy has been hijacked for purposes of woo. Meanwhile, earlier this year, Senator Harkin hosted a hearing in which Drs. Dean Ornish, Andrew Weil, Mehment Oz, and Mark Hyman (he of “functional medicine“) were invited to testify in front of the Senate. Add to that other powerful legislators, such as Representative Dan Burton (R-IN), trying to craft legislation in line with his anti-vaccine views and pressure the NIH to study various discredited hypotheses about vaccines and autism. Clearly, when it comes to quackery, there are powerful legislative forces promoting pseudoscience and studies driven by ideology rather than science.
I love the British comedy duo Mitchell and Webb, and this is just one reason why. They totally get homeopathy, as this video e-mailed to me by a reader demonstrates:
Pay close attention to the signs in the A & E.
No doubt Dana Ullman will show up to cry foul over how Mitchell and Webb are totally “misrepresenting” homeopathy…
On June 16th the FDA issued a warning advising consumers not to use Zicam Nasal Gel or Nasal Swabs because of reports that it can damage the sense of smell, a condition called anosmia. This event highlights some problems with current regulations of health products.
There have been 130 cases reported to the FDA of decreased sense of smell following the use of one of these Zicam products – sometimes after a single use, sometimes after repeated use. All of these cases were reported by patients or their doctors; none were reported by the company, Matrixx Initiatives. According to reports, the FDA has asked Matrixx to turn over 800 consumer complaints regarding to Zicam. There is a 2007 law that requires company to report such complaints to the FDA, although the FDA has not said whether Matrixx violated this law.
Anosmia is a serious medical condition. The senses of smell is one of those things we take for granted until it is gone. People who lack a sense of smell cannot tell if milk has gone sour or if their food is bad. They cannot smell smoke to warn of a fire, nor can they smell a gas leak. The FDA fears that some of the cases of anosmia associated with Zicam use may be permanent.
In the three prior posts of this series I tried to analyze some of the defects in the randomized clinical rials (RCTs) of homeopathic remedies for childhood diarrhea. The first entry showed that the first two RCTs’ (done in Nicaragua) methods could not produce a meaningful result because of the way the RCTs were set up (methods.) The second entry showed that the results obtained in the first two trials were meaningless clinically even if assumed to have resulted from more legitimate methods. The same applied to the third trial in Nepal, analyzed in the third entry.
This entry will suggest that the authors’ fourth paper (Jacobs J, Jonas WB, Jimenez-Perez M, Crothers D. Homeopathy for childhood diarrhea: combined results and metaanalysis from three randomized, controlled clinical trials. Pediat Inf Dis J, 2005;22:229-234.)- a meta-analysis (MA) of the data from the three RCTs resulted in conclusions equally as meaningless as those of the three trials.
The MA authors – several of the same workers from the three RCTs – begin by agreeing that the data from the RCTs, taken individually, were of borderline significance:
In our previous three studies, we evaluated the use of individualized homeopathic treatment of childhood diarrhea … The results of the two larger studies (n = 81, n = 116) were just at or near level of statistical significance. Because all three studies followed the same basic study design , […] we analyzed the combined data from these three studies to obtain greater statistical power. In addition we conducted a meta-analysis of effect-size difference […] to look for consistency of effects.
MAs and systematic reviews (SRs) are the two consensus methods for summarizing data from multiple individual studies. The inclusion and search methods of RCTs for SRs and MAs are similar, but the objectives of the two are a bit different, as are the forms of the reports. In SRs, the results are summarized in more in narrative form, whereas in MAs the data are treated mathematically and the results are defined in statistical terms. Thus authors of SRs are freer to speculate on the degree of confidence that a method is effective based on what is shown by the numbers of positive and negative RCTs collected. Authors of MAs usually limit their comments to what the mathematical formulation of the summarized data show.
It had once been suggested in the comments section of the blog that homeopathy is useful in the treatment of diseases that are not self limited. Homeopathy is effective therapy for diseases that do not get better on their own, that homeopathy has a real effect on real diseases.
One example given was for the treatment of sepsis.
“Frass M, Linkesch, M, Banjya, S, et al. Adjunctive homeopathic treatment in patients with severe sepsis: a randomized, double-blind, placebo-controlled trial in an intensive care unit. Homeopathy 2005:94;75–80. At a University of Vienna hospital, 70 patients with severe sepsis were enrolled in a randomized double-blind, placebo-controlled clinical trial, measuring survival rates at 30 days and at 180 days. Those patients given a homeopathic medicine were prescribed it in the 200C potency only (in 12 hour intervals during their hospital stay). The survival rate at day 30 was 81.8% for homeopathic patients and 67.7% for those given a placebo. At day 180, 75.8% of homeopathic patients survived and only 50.0% of the placebo patients survived (p=0.043). One patient was saved for every four who were treated.”
I am, as I have mentioned before, but I mention again for those who might be new to the blog, an Infectious Disease physician. My job is to diagnosis and treat infectious diseases and sepsis is up there at the top of the list of diseases I take of. Sepsis butters my bread, and I consider myself knowledgeable about sepsis.
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.)
Perhaps you have discovered for yourself that I am always the last to write a post on a ‘hot’ topic. I am definitely the slowest writer (and thinker?) on this blog, starting each post at least a week before it is up. So the faster writers weigh in first and I am left with clean up.
As I finish writing on Thursday, there have been 892 cases of H1N1 aka Swine flu and 2 deaths in the US. Looks like the world has avoided a disastrous pandemic like the 1919 flu that killed off 2 to 5% of the world. For now. Maybe. I hope.
However, the flood of nonsense about the flu far exceeds the infection rates from H1N1. This entry will be the limited by necessity. The quantity of quackery (9) far exceeds my ability to type. I thought that influenza virus replicated and spread fast. It pales next to the flu woo.
Having grown up on a dairy farm, I am one of the least likely people to object to the deification of yogurt. However, as a critical thinker, I cannot help but resist the idea (promoted by some health sites) that probiotics are a reasonable alternative to chemotherapy in the treatment of colon cancer. And there are many other equally unhelpful claims being made all the time. Fish oil for ALS anyone?
What amazes me about the “cherry yoga” camp (as my friend Bob Stern likes to call it), is that they aggressively market CAM as “harmless” and “natural.” They point to the warning labels and informed consents associated with science-based medicines as evidence that the alternative must be safer. In reality, many alternative practices are less effective, and can carry serious risks (usually undisclosed to the patient). For your interest, I’ve gathered some examples of risks associated with common alternative practices that have been described by the CDC and in the medical literature:
…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.