New American anti-scientist stamps

A few months ago, the Post Office released a line of stamps devoted to outstanding American scientists. However, given the climate of today, in which 42% of Americans are strict creationists, StayFree thinks it's time for a different set of stamps. Note the Flying Spaghetti Monster in the background of the Bush stamp. As Carrie put it, "We know God isn't precisely 'American,' but try telling that to the evangelicals..."

Download yours today. (Via Boing Boing.)

Avoiding scientific delusions

In all my blogging about altie claims and the alleged (and most likely nonexistent) link between mercury exposure from thimerosal in childhood vaccines and autism, I've been consistent in one thing. I try as much as possible to champion evidence-based medicine. I insist on evidence-based medicine because, with good reason, I believe it to be superior to testimonial-based medicine, which is what practitioners like Dr. Rashid Buttar, who cannot demonstrate that his "transdermal cream" even gets his chelating agent into the bloodstream at concentrations that will chelate anything, much less mercury, much less that it can improve the functional level of autistics in controlled randomized trials, do. (On a side note, I've also learned that Dr. Buttar also doesn't like me very much for saying that, much to my amusement. If this, this, or this inspired him to mention me in the same sentence as "stupidity" or a "brick wall," he really should check out Kev's fantastically sarcastic letter to him or this broadside against chelation therapy for autism. Or better yet, he should read Peter Bowditch's take on the matter. That ought to raise his blood pressure. Then he could chelate himself to get it back down.) I also try to insist on evidence-based medicine because lack of evidence is what quacks like Hulda Clark prey upon in selling their worthless "cures" for diseases like cancer. However, contrary to what some alties will claim, I do not limit my insistence on evidence-based medicine to various alternative treatments. I insist on uniform scientific standards for evaluating the biological mechanism of disease and potential treatments, whether the treatment be "alternative" or "conventional."

Alties are frequently unhappy about medicine's growing insistence on well-designed clinical trials to test their claims, considering it evidence of the "elitism" that they despise in "conventional" medicine. What they don't understand is that the reason that the scientific method and clinical trials are so important is not because scientists and "conventional" doctors are any wiser than "alternative" practitioners or even the general population at large. They most certainly are not; they are just more highly educated and trained. The reason the scientific methods and clinical trials are so important in developing and evaluating new therapies is because doctors are human and therefore just as prone to bias and wishful thinking as the worst pseudoscientist or quack. They are just as prone to falling victim to the trap of wanting so badly to believe that an experimental result is valid or that a treatment is effective that they fool themselves into believing it or to resisting change because "always done it this way." (Altie practitioners tend to be prone to a different kind of self-deception, namely the Galileo gambit, in which they believe themselves akin to Galileo, persecuted because they are so far ahead of their time.)

Last Sunday's New York Times had a very good example of a "conventional" treatment that demonstrates why clinical trials are so important. The treatment is vertebroplasty using spinal cement to treat vertebral fractures due to osteoporosis:

No one is sure why it helps, or even if it does. The hot cement may be shoring up the spine or merely destroying the nerve endings that transmit pain. Or the procedure may simply have a placebo effect.

And some research hints that the procedure may be harmful in the long run, because when one vertebra is shored up, adjacent ones may be more likely to break.

But vertebroplasty and a similar procedure, kyphoplasty, are fast becoming the treatments of choice for patients with bones so weak their vertebrae break.

The two procedures are so common, said Dr. Ethel Siris, an osteoporosis researcher at Columbia University, that "if you have osteoporosis and come into an emergency room with back pain from a fractured vertebra, you are unlikely to leave without it." She said she was concerned about the procedures' widespread and largely uncritical acceptance.

Sound familiar? If not, consider this quote:

"I struggle with this," said Dr. Joshua A. Hirsch, director of interventional neuroradiology at Massachusetts General Hospital in Boston. He believes in clinical trials, he said, but when it comes to vertebroplasty and kyphoplasty, "I truly believe these procedures work."

"I adore my patients," Dr. Hirsch added, "and it hurts me that they suffer, to the point that I come in on my days off to do these procedures."

Dr. Hirsch apparently started with the noblest of motives, wanting to relieve his patients' unremitting pain from spinal metastases due to cancer or fractures due to osteoporosis. He still believes he is helping; otherwise he would probably abandon vertebroplasty. Many altie practitioners start out similarly, no doubt. They come up with a method or a treatment, see what appears to be a good result, become convinced that it works, and thus become true believers. The difference is that, unlike Dr. Buttar, as an academician Dr. Hirsch at least still feels uneasy about advocating this therapy without adequate research or strong objective evidence to show that it really works better than a sham procedure, because doing so goes against his academic training. (Quacks like Dr. Kerry have no such qualms, even though he was educated at the University of Pittsburgh.) Nonetheless, Dr. Hirsch appears to have convinced himself by personal observation and small pilot studies that the procedure works. That the the Director of Interventional Neuroradiology at Massachusetts General Hospital can convince himself that an unproven treatment works on the basis of personal observation and small pilot studies simply shows how easy it is to persuade oneself to believe what one wants to believe. He may or may not be correct in his belief, but we have no way of knowing.

Unfortunately, personal observation is prone to far too many biases, the worst of which is selective thinking or confirmation bias. In short, we remember successes (or seeming successes) and observations that confirm our expectations, and tend to forget or discount failures and observations that do not confirm our expectations. Small pilot studies are also prone to bias and confounding factors, which is why they are generally good only as a means of determining if a treatment shows an inkling of effectiveness worth following up with a larger trial. As the claim spreads, it can then become accepted through communal reinforcement, regardless of the poor quality of the initial data. Apparently this is happening now with vertebroplasty.

In studies of pain relief treatments or procedures, one particularly nasty bias that cannot be eliminated without good placebo controls is regression to the mean:

For example, he said, patients come in crying for relief when their pain is at its apogee. By chance, it is likely to regress whether or not they are treated. That phenomenon, regression to the mean, has foiled researchers time and time again.

Although there was one uncontrolled pilot study that reported 26/29 patients showing pain relief after the procedure, a followup study with placebo control, although quite small, cast doubt on the effectiveness of the procedure:

But Dr. David F. Kallmes, one of her partners, wanted a rigorous test. He began a pilot study, randomly assigning participants to vertebroplasty or placebo. To make it more appealing, he told patients that 10 days later they could get whichever treatment they had failed to get the first time.

It was hard to find subjects, and Dr. Kallmes ended up with only five. For the sham procedure, he pressed on the patient's back as if injecting cement, injected a local anesthetic, opened a container of polymethylmethacrylate so the distinctive nail-polish-remover smell would waft through the air and banged on a bowl so it sounded like he was mixing cement.

In 2002, he reported his results: three patients initially had vertebroplasty and two had the sham. But there was no difference in pain relief. All the patients thought they had gotten the placebo, and all wanted the other treatment after 10 days. One patient who had vertebroplasty followed in 10 days by the sham said the second procedure - the sham - relieved his pain.

In other words, none of the patients got any relief when they thought that they might be getting a placebo the first time around and thus wanted the "real thing." This implies that the pain relief due to the treatment may well be due to a placebo effect. Remember, placebo effects are often more potent the more elaborate or invasive the treatment is, and thus harder to control for. This is one of many reasons that trials for surgical or invasive procedures to relieve chronic pain are often so hard to do. Sadly, Dr. Kallmes trial was so small that we cannot make any definitive conclusions from it, although there is also an Australian trial that found that pain relief at six weeks in the vertebroplasty group was no better than the control group, bringing the long-term effectiveness of the technique into doubt.

It turns out that the bulk of the evidence that is being used to argue that vertebroplasty is effective are in essence testimonials, rather uncomfortably like the "evidence" being used to promote Dr. Buttar's "transdermal chelation" therapy and other altie treatments. We have no idea whether vertebroplasty actually works, for which patients it does and doesn't work, what the long term results are in terms of durable pain relief, whether it increases the risk of additional fractures, or what the potential complications are. To find that out would require clinical trials, and, barring such trials, we can never be certain whether vertebroplasty or kyphoplasty are anything superior to elaborate placebos. The difference, of course, is that at least vertebroplasty has a biologically and anatomically plausible rationale to lead us to think that it might work. The same most definitely does not apply to Dr. Buttar's treatment. Read this and tell me that this story of a doctor giving a talk about vertebroplasty to a skeptical audience of doctors doesn't sound familiar:

"I could tell by looking at the audience that no one believed me," she said. When she finished, no one even asked questions.

Finally, a woman in back raised her hand. Her father, she told the group, had severe osteoporosis and had fractured a vertebra. The pain was so severe he needed morphine; that made him demented, landing him in a nursing home.

Then he had vertebroplasty. It had a real Lazarus effect, the woman said: the pain disappeared, the narcotics stopped, and her father could go home.

"That was all it took," Dr. Jensen said. "Suddenly, people were asking questions. 'How do we get started?' "

Can you picture this sort of scene in an infomercial for an herbal remedy? I can.

So what's wrong with testimonials? Well, as I like to say, the plural of "anecdote" is not "data," and testimonials usually don't even rise to the level of anecdotes. Testimonials are often highly subjective, and, of course, practitioners can and do pick which testimonials they present. Even in the case of cancer "cure rates," testimonials often mean little because they are given for diseases that surgery alone "cured." (Also, dead patients don't provide good testimonials.) Worse, testimonial-based practice tends to preclude the detailed observation and long-term followup necessary to identify which patients benefit from treatments and which do not, complication types and rates, or long-term results of the treatment. Anecdotes are really good for only one thing, and that's developing hypotheses to test with basic scientific experimentation and then clinical trials. Vertebroplasty may indeed be very effective at pain relief with a low risk of complications. Or it may not. We simply don't have the data to know one way or the other, and now we may never have it. What is odd is that Medicare and insurance companies are usually pretty firm about not paying for an experimental procedure (which is what vertebroplasty should be considered), yet somehow third party payers have been persuaded to pay for this procedure.

Science itself and randomized clinical trials are designed to combat such biases. In preclinical studies, the scientific method uses the careful formulation of hypotheses and testing of those hypotheses with experiments that can either confirm or falsify the hypothesis, experiments that include appropriate control groups to rule out results due to factors other than what the researcher is studying. The scientific method, rigidly adhered to, helps investigators protect themselves from their own tendency to see what they want to see, to correct mistaken results, and recover from stupidity faster. The same is true of randomized clinical trials, which accomplish this in much the same way by using four factors: strict inclusion criteria, so that only patients with the disease being studied are admitted; close measurement of endpoints that are as objectively and reproducibly measured as possible; careful, statistically valid randomization, so that the control group and experimental groups resemble each other as closely as possible; and a placebo control (or a comparison against the standard of care treatment for disease in which a placebo control would be unethical, as in cancer trials). Whenever possible, double blinding is advisable, so that neither the patients nor the doctors know which patient is getting which treatment, so that doctors don't treat patients in either group differently or look more closely for (and therefore find) treatment effects in the experimental group and so that patients don't pick up cues from the doctors' interaction with them. This maximizes objectivity and minimizes bias.

It should also be remembered that one study is not enough, either. Single studies can be wrong one-third or even one-half of the time. I've often joked that, if you look hard enough, you can almost always find a study that supports whatever conclusion about a clinical question that you want to make. Alties don't understand this and will cite one or two carefully selected reports that seem to support their claims, ignoring the many that do not. Illustrating this example is chelation therapy for another disease, namely athersclerotic vascular disease, for which chelationists will cite old papers with inadequate controls that seemed to show a benefit. For example, there was one randomized study in 1990 that appeared to show a benefit for chelation therapy over placebo, but this was a study that looked at only 10 patients. Multiple much larger randomized studies have been done since then, such as this one, and none of them has shown a benefit. Guess which studies alties like to cite? (Hint: It isn't any study newer than 1991 or so.) Hopefully an ongoing NCCAM study will resolve the study once and for all, although there is little doubt in my mind that chelationists will not believe the study if, as is likely, it fails to find a beneficial treatment effect.

What really needs to be considered in clinical decision-making is the totality of data from well-designed clinical studies, something the Cochrane Collaboration tries to facilitate by evaluating the literature concerning important clinical questions and synthesizing it into recommendations and a summary of the quality of available evidence to support their recommendations (or the lack thereof). The bottom line is that evidence-based medicine, far from being a way for "conventional" doctors to assert their superiority over "alternative medicine," is a in actuality means for doctors to try to avoid medical and scientific self-delusion about the effectiveness of a favorite treatment. Just because the medical profession all too often doesn't do a good job of practicing evidence-based medicine is not a reason to throw these scientific standards out in favor of fluffy, feel-good, testimonial-based treatments like Dr. Buttar's or to give advocates of such treatments a pass in terms of supporting their claims. Rather, it is a strong reason to strive to do a better job at improving the science behind our treatments and the scientific rigor of our clinical trials. Evidence-based medicine may not be without problems itself (and perhaps I shall try to address some of its shortcomings in future posts). However, it is far better than the alternative.

Last call for submissions to the Skeptics' Circle

Get your best skeptical blogging to Pat at Red State Rabble by tomorrow night, and then join him for the Sixteenth Meeting of the Skeptics' Circle on Thursday!

Grand Rounds #49

Grand Rounds #49 has been posted at Healthy Concerns. Go forth and enjoy the best medical blogging around.

Vacation dispatches, part I: Drivers to avoid

Well, I'm really back in it now, with a full clinic yesterday, my coming back to find that I'm unexpectedly covering for one of my partners for a couple of days (one of the two who usually has the sickest train wrecks of patients in the hospital), which has already produced one admission that I'll have to cover for at least another day. Welcome back, as they say. (On the other hand, it does force me to switch rapidly out of vacation mode and back to work mode.) Fortunately, however, there haven't been any new consults or emergencies--yet. Consequently, I only have time for a brief anecdote from vacation. I have a handful of these that I thought would make amusing blog fodder, some long and some short, and I'll intersperse among the usual blogging about medicine, surgery, skepticism, and science as the next two or three weeks roll by. Assuming things don't get too hairy, I should have time to post at least a couple of more substantive articles about why clinical trials are so important in evaluating conventional medical therapies and perhaps even take on an altie phenomenon that I've been meaning to write about since at least July but that has finally gotten on my nerves enough to motivate me. If I get time to wade through all 150+ comments on Kristjan Wager's excellent guest blog about the Danish autism studies, maybe I'll make a followup post. Hopefully Kristjan will also provide me with a followup.

So...picture this.

Date: Friday, August 12, 2005
Time: Approximately 7 PM
Location, I-75 North in Michigan, approximately 15 miles north of the Ohio border

My wife and I were cruising along, happy that we had finally gotten through the massive traffic jam on the Ohio Turnpike near Toledo, our final destination rapidly drawing nearer, when we noticed it. There, ahead of us, I noticed an RV towing a car. By itself, this was nothing unusual. Lots of people go camping in RVs and tow their car for use as transportation while they are on vacation. I see it all the time on long road trips during the summer.

I wouldn't have even given it another look if it weren't for something odd that I noticed as we gained on the RV. It looked as though the owner had painted some words on the back of the car being towed. It looked as though he or she had used poster paint of the type that teenage kids use to decorate their cars for high school graduation or that young couples use to paint "Just Married" on their car on their wedding day. As I gained on the car, I was able to read the words on the back of the car:

"Car in toe."

I rapidly passed the RV and its towed car. I wanted to stay as far away as possible from the vehicles. I figured that anyone crappy at spelling probably can't read speed limit or road signs very well. I didn't want to be anywhere near them when bad consequences resulted from that.

What I did on my summer vacation: "Proof of "intelligent design" (and an old friend)

Well, I'm back.

Yes, I know I blogged a fair amount while on vacation, my promise to restrain myself notwithstanding. Nonetheless, with the exception of the posts about the traffic wreck that screwed up our trip home and the tragic death of an autistic boy receiving chelation therapy this week, it was mostly fluff or carnival barking. Think of it this way: I enjoy blogging so much that, if I had spent the two weeks at home rather than traveling to various places in the Midwest (and putting over 2,000 miles on my car in the process), I probably would have blogged a lot more than normal because I would have had the time.

One thing about being on vacation is that I had some time to sit back and think about things that I normally take for granted. For example, I spend a fair amount of time poking fun at adherents of "intelligent design" creationism, the claim that there are some biological structures that are too complex to have come about through evolution by natural selection (a concept they term "irreducible complexity") and therefore must have been "designed" by some "intelligence." (Who or what this "intelligence" is, they studiously avoid saying to secular audiences, sometimes going so far as to leave open the possibility of aliens being the force behind evolution, while on the side they admit the truth to fundamentalist Christian audiences. Is the "designer" God? Nahhh. Couldn't be. Wink, wink, nudge, nudge.) Frequently cited examples of biological structures or systems that could not have come about without some "design" include the eye, the bacterial flagellum, and the clotting/complement cascade. Sadly, instead of working to look for actual evidence or to do actual experiments to test their mushy claim (which doesn't even rise to the level of a scientific hypothesis or theory), ID advocates instead use their resources to bring political pressure to bear on scientifically ignorant school boards either to teach the (scientifically nonexistent) controversy, to cast doubt upon how well-supported evolution is as a scientific theory, or to actually teach ID as an "alternative theory" to conventional evolution.

True, ID advocates often richly deserve the mockery that gets sent their way, but (I asked myself) have I ever tried to look at the controversy through their eyes? No! So, I set about to look for evidence of "design" in nature as we tooled about through the Midwest. Anything that looked as though it couldn't have come about through random natural processes alone was what I had in mind. After all, one of the key arguments of ID advocates is that we can recognize "design" in nature when we see it, even though they tend not to be too specific about exactly what criteria can be used to recognize "design." In fact, that High Priest of Intelligent Design, Michael Behe himself, has used Mount Rushmore as an example of how we can "know design when we see it" and distinguish "design" from natural processes. Maybe I could find similar examples if I looked hard enough. Scoff all you want, those of you who point out that such reasoning would lead one to conclude that the Old Man of the Mountain was "intelligently designed"! I would not let my attempt to follow Behe's reasoning be deterred by such annoying intrusions of reality-based thinking! No!

So, at every stop during our last two weeks of travel, from the Detroit area, to Nepessing Lake in Lapeer, to rural Ohio, to Chicago, and all points in between, I looked diligently at every natural object, plant, and creature I saw, searching carefully for evidence of design, evidence that it could not have come about without the intervention of intelligence, without some sort of "design" behind it.

I failed.

Although I had a fine time on vacation, visiting family, old friends, and favorite places, on the drive home, this failure haunted me. It cast a pall over the return trip. OK, the pall wasn't so much due to my failure to find strong evidence of "design" in nature that depressed me, but rather the thought of facing the end of my vacation and having to confront the massive pile of paperwork, various patient problems, and writing tasks that were no doubt waiting for me back at the lab and office, as well as the fact that I would be on call today. But stay with me here for the sake of the story.

On our second day back, after having taken a day to recover from the 11 hour drive, my wife and I were trying to get our neglected yard into some semblance of decent shape. Fortunately, the brown grass hadn't really grown much, given the lack of rain and the fairly hot weather that had predominated the first week we were gone, which made the task a bit easier. I was about to head back inside for a moment, when my wife came up to me. She handed me something.

"Hey, check it out. This looks pretty cool," she said.

It was a rock. but not just any rock. I stared, dumbfounded. "Do you realize what this is?" I said. I was practically giddy with joy, not unlike Gollum at Mount Doom after he bit the One Ring from Frodo's hand and danced his way to the edge of the precipice beyond which lay the fiery lava of the Crack of Doom. (It was all I could do to keep myself from hissing, "My Precioussss!") "It's what I've been looking for all along!"

It was this:

(Actual size: Approximately 1 inch in height)

Could it be? I looked it over at different angles:

I thought. I had been looking all over the Midwest for something like this, and there it was, right in my own back yard, the proof I had been looking for! Look at the face! Surely this could not have been the product of random natural forces. Surely this was evidence of intelligent design in nature! And if there could be "design" in geology to produce a stone like this, a stone that looks like a face, then what about the evolutoin of life? I made plans to send photos of this find to William Dembski and Michael Behe. Surely they would be very interested!

My giddiness at my discovery subsided, and my wife stopped looking at me as though I had lost my mind. It was a difficult feat to accomplish for her. I then took an even closer look at the rock.

And a realization dawned on me.

It wasn't just any face. There was something familiar about that face. Something it reminded me of. But what? I knew it! I immediately went to work. First, a little Magic Marker:

Do you see where I'm going yet? No? (Admittedly, my attempt at artwork didn't turn out too good.) How about a little Photoshop? (I'm not too good at Photoshop, either, but this looks a bit more convincing.)

Do you see it now? Do you?

Yes! It's our old friend the Hitler zombie! Not only had I discovered strong evidence of "design" in nature, but I had discovered who the "intelligent designer" must be! None other than the Hitler zombie, that undead eater of politicians' brains and lover of overblown analogies to Hitler, the Nazi, or the Holocaust to be used to slime one's political opponents with, of course! I know I promised to try to keep the Hitler zombie in his crypt for a while, but this was just too big a coincidence!

So why not the Hitler zombie? It makes just as much sense as any other candidates for the title of the "intelligent designer" of "intelligent design creationism," including even my personal favorite up until this discovery, the Flying Spaghetti Monster. The rotting Führer is even a deliciously appropriate candidate, given how Michael Ruse himself has fallen victim to the monster's hunger for brains, himself bringing up bad Nazi analogies while apparently endorsing the mistaken notion that Darwinian evolution implies atheism.

Perfect!

What, you say? You can't believe that a fictional device created to make fun of people who make exaggerated and inappropriate analogies to the Nazis could be the "intelligent designer"? If you believe William Dembski when he says that the "designer" doesn't necessarily have to be God, then why couldn't the "designer" be the Hitler zombie, space aliens, or even the Flying Spaghetti Monster? If "intelligent design" makes no assumptions about who or what the "designer" is, as many of its adherents claim while trying to argue that it is a scientific, not a religious, idea, then the "designer" could be anything.

And my evidence that the "designer" was the Hitler zombie is just as convincing as the evidence presented by any advocate of "intelligent design." Perhaps it's even more so, given that I actually have a piece of physical evidence. That is better than ID advocates can produce.

The NYT fisks "intelligent design"

Daniel C. Dennett has published a rather nice fisking of "intelligent design" creationism on the Sunday New York Times editorial page. Some choice excerpts:

The focus on intelligent design has, paradoxically, obscured something else: genuine scientific controversies about evolution that abound. In just about every field there are challenges to one established theory or another. The legitimate way to stir up such a storm is to come up with an alternative theory that makes a prediction that is crisply denied by the reigning theory - but that turns out to be true, or that explains something that has been baffling defenders of the status quo, or that unifies two distant theories at the cost of some element of the currently accepted view.

To date, the proponents of intelligent design have not produced anything like that. No experiments with results that challenge any mainstream biological understanding. No observations from the fossil record or genomics or biogeography or comparative anatomy that undermine standard evolutionary thinking.

Precisely. The way for a scientist to win fame and glory is not to be conventional, but rather to take an established theory, look at a phenomenon that it doesn't explain well, and then come up with a better explanation that is supported by data and experimentation. You won't find many Nobel Prize winners who won for just supporting accepted theory of the day. They either find something new or find a new twist on an old theory.

And:

Instead, the proponents of intelligent design use a ploy that works something like this. First you misuse or misdescribe some scientist's work. Then you get an angry rebuttal. Then, instead of dealing forthrightly with the charges leveled, you cite the rebuttal as evidence that there is a "controversy" to teach.

Note that the trick is content-free. You can use it on any topic. "Smith's work in geology supports my argument that the earth is flat," you say, misrepresenting Smith's work. When Smith responds with a denunciation of your misuse of her work, you respond, saying something like: "See what a controversy we have here? Professor Smith and I are locked in a titanic scientific debate. We should teach the controversy in the classrooms." And here is the delicious part: you can often exploit the very technicality of the issues to your own advantage, counting on most of us to miss the point in all the difficult details.

Yes. "Intelligent design" advocates try to convince the lay person, who usually doesn't know much about evolution or even how science operates, that there is a genuine debate when there is not, at least not scientifically speaking (politically speaking, of course, is another matter). Dennett also nails it as far as why ID is not taken seriously by scientists:

To formulate a competing hypothesis, you have to get down in the trenches and offer details that have testable implications. So far, intelligent design proponents have conveniently sidestepped that requirement, claiming that they have no specifics in mind about who or what the intelligent designer might be.

That's what's most infuriating about ID, that it presents no testable hypotheses detailed enough to be falsifiable and presents no experimental evidence supporting those hypotheses. It's just a misstated mish-mash of exaggerations, misrepresentations of, and outright lies about known weaknesses in evolutionary theory with an attitude that, if we can't yet understand how evolution produced this particular biological structure, then an "intelligent designer" must have done it. As philosophy or religion, ID may be interesting to study, but it has no place in a science classroom until its advocates show some actual science to support it.

And what makes ID any more worthy than any other concept that has not yet reached the science classroom? Nothing:

It's worth pointing out that there are plenty of substantive scientific controversies in biology that are not yet in the textbooks or the classrooms. The scientific participants in these arguments vie for acceptance among the relevant expert communities in peer-reviewed journals, and the writers and editors of textbooks grapple with judgments about which findings have risen to the level of acceptance - not yet truth - to make them worth serious consideration by undergraduates and high school students.

SO get in line, intelligent designers. Get in line behind the hypothesis that life started on Mars and was blown here by a cosmic impact. Get in line behind the aquatic ape hypothesis, the gestural origin of language hypothesis and the theory that singing came before language, to mention just a few of the enticing hypotheses that are actively defended but still insufficiently supported by hard facts.

They won't, even though, as Dennett points out:

If intelligent design were a scientific idea whose time had come, young scientists would be dashing around their labs, vying to win the Nobel Prizes that surely are in store for anybody who can overturn any significant proposition of contemporary evolutionary biology.

Quite. Maybe if all the money being spent trying to dupe school boards across the country into including ID in their curriculae as "alternatives" to evolution or to beating students over the head with exaggerated "deficiencies" of evolutionary theory were instead spent on research, maybe some Discovery Institute "fellow" will be in line for that Nobel Prize in 20 years.

Yeah, and monkeys might fly out of my butt.

I'm probably going straight to hell for posting this...

During my vacation, via a friend of my wife's, I discovered changes to the Eucharist made by the new German Pope, Benedict XVI. He sure didn't waste any time...

Kirby tries to cover his posterior

OK, I surrender.

I tried not to write anything during this last weekend of my vacation, but then I became aware of David Kirby's CYA response to the tragic death of a boy during chelation therapy for his autism last week:

But even as the grieving immigrant mother makes funeral arrangements for her beloved boy, opponents of the theory that drew the family to America (the theory that mercury triggers autism, and removing it through chelation may improve symptoms) are holding his death up as proof that the idea is bogus. They claim that the use of chelation to treat autism is foolishly dangerous, and should be shut down at once.

Some people have come perilously close to exploiting this tragedy to further their own political or personal agendas. Some blame the boy’s death on his mother, who has been labeled as reckless and “desperate.” Others blame the Pennsylvania doctor -- and any autism doctor willing to try chelation (the use of certain chemicals to remove heavy metals from the body) – for the tragedy. Some fault me, for writing a book that dared to include the topic of chelation and autism within its pages.

Kirby's probably feeling the heat over this death, as well he should. The popularity of his book, Evidence of Harm, and its favorable treatment of the claim (I refuse to dignify it by calling it a "theory" given that scientific theories require a lot of evidence to support them) that mercury from childhood vaccines causes autism, very likely have played a role in the recent popularization of this bogus "treatment" for autism. As for "exploiting this tragedy to further their own political agendas," Kirby is being rather selective in his criticism. The mercury/autism activists routinely feature autistic children labeled "mercury poisoned" at political rallies to further their agenda. (One could even argue that Kirby's own attempt to spin this tragedy to deflect criticism of chelation is "exploiting this tragedy to further his own political agenda.") In any case, when a boy dies during a dubious treatment that almost certainly doesn't work, of course the incident should be used as an argument to criticize the treatment, no matter how "daring" it was of Kirby to have mentioned it in his book.

Kirby continues:

First of all, only an autopsy will reveal the actual cause of death, and I think it is prudent to wait before jumping to any conclusions about the general safety of chelation and autism. That said, the boy did die while undergoing the procedure, and it’s possible the controversial treatment is what killed him.

Give me a freakin' break! It's way more than "possible" that the chelation treatment killed the boy. It's highly likely. Otherwise healthy five year olds don't just drop dead of cardiac arrest for no apparent reason, particularly while sitting in a doctor's office. It happens, but it's extremely rare. For this boy to have just happened to have droppped dead of a cardiac arrest while he was receiving a therapy that can lower serum calcium and magnesium levels to levels low enough to cause cardiac arrest is one a hell of a coincidence. Unfortunately, the autopsy results may never conclusively show that chelation killed the boy. Electrolyte abnormalities leading to sudden cardiac arrest (the most likely cause of death in this case) can be hard to pin down in an autopsy. If the autopsy fails to find conclusive evidence for this cause of death, it will allow the chelation advocates wiggle room to claim "reasonable doubt" over whether their pet treatment killed the boy.

Worse, Kirby is now trying to blame the scientific community for Abubakar's death, rather than where the blame should be placed if chelation killed him, at the hands of the doctor who administered the chelation for a condition for which it is not indicated and those who support this quackery. (At least he properly asks the question why this doctor was using intravenous EDTA, rather than other, safer methods.)

He goes on:

Just think, if the government had listened to the very IOM report it commissioned back in 2001, we might know a lot more about chelation and autism than we know today. If clinical trials had gotten underway then, we would know with certainty whether chelation could heal, or kill.

Please. We already know whether chelation can kill. We've known it since the 1940's and 1950's. Deaths have been rare since the 1960's, true, mainly due to better cardiac monitoring and more care with infusions, but kidney failure, cardiac complications, and electrolyte deficiencies have not. The correct question is whether chelation can "heal" autism at an acceptable risk-benefit ratio, not the false dichotomy of whether it can "heal or kill." One has to wonder why Kirby chose to quote the 2001 IOM report and its tepid recommendation that chelation therapy should be studied, rather than the more recent 2004 report. Could it be that the evidence developed in the interim that failed to show a link between mercury exposure and autism led the IOM not even to consider chelation as a viable therapy anymore? (I'll have to go back to the 2004 report to check on this.) After all, if mercury is not the etiologic cause of autism, then there's no reason to think that chelation therapy would do any good for it and therefore no reason to waste resources studying it. Even if mercury is involved in the pathogenesis of autism, it's unlikely that chelation treatments given months or years later would do any good, but in that case at least there would be a reason to consider studying it.

Finally, Kirby says:

If hard scientific proof had been uncovered that chelation was 100-percent worthless in the treatment of autism, no parent or doctor would still be pursuing the therapy today. If evidence had surfaced in clinical trials that children could be harmed or even killed by chelation, no one would be using it today. The doctor in Pennsylvania would have halted chelation therapy long ago, and this poor grieving family would never have crossed the ocean from the UK in pursuit of its false promise.

How reasonable-sounding. How charmingly naïve. (I also have to wonder if Kirby is aware that it's pretty rare for a clinical study to provide 100% evidence of any conclusion. Medicine deals with probabilities, and those probabilities only very rarely turn out to be 100%.) Kirby clearly doesn't have much experience with "alternative medicine." Studies don't matter to alties, and that goes triple for conditions for which conventional medicine does not yet have highly effective treatments. Study after study showed that Laetrile didn't help advanced (or even early stage) cancer back in the 1970's and early 1980's. Altie practitioners still use it, and patients still seek it. Recent studies have shown that homeopathy does no better than placebo for a variety of conditions, but do you think that homeopaths will stop using it or people stop seeking it? Studies have come out showing that echinicea doesn't help common colds, but I wouldn't sell my stock in companies selling the herb if I were you. Study after study have shown that chelation therapy does no better than placebo for coronary and peripheral vascular disease. It's still being used, and NCCAM has even funded a large study to see if it works, not because of the science so much but because of its popularity. If the NCCAM study fails to show a benefit for chelation over placebo, you can bet that alties will dismiss the study and that chelation will continue to be used for heart disease. If a study ever conclusively shows that chelation does no good for autism, you can further bet that it won't be believed by the mercury/autism advocates and that chelation will continue. None of this means that we physicians and scientists shouldn't do the studies, of course. That's how science progresses and ineffective treatments are slowly weeded out of our medical armamentarium. However, Kirby's faith that such studies can cause such a rapid halt to the use of dubious treatments is almost touching in its naïveté.

This comment by Kirby, however, is not so touching or naïve:

But what if the opposite were true? What if the “rigorous science” recommended by the IOM had yielded proof that chelation can indeed help some kids -- provided that it’s done with the safest agents, at the safest doses, and through the safest routes of administration (not to mention in combination with other therapies)?

Either way, if America had done its scientific homework, as recommended by its top science professors, Abubakar might still be alive today.

In essence, what Kirby seems to be trying to do here is to deflect the blame for Abubakar's death from chelationists to the scientific community that hasn't studied chelation therapy for autism. Does he even know how clinical studies work? Even if a large randomized, double-blind study had been organized immediately after the 2001 IOM report, four years would probably not be long enough to write the proposal, get it funded, get it approved by the various IRBs necessary at the multiple centers it would have to be done at, accrue enough patients to have enough statistical power to detect the outcomes studied, and have adequate followup to make hard conclusions, and it certainly wouldn't have been long enough to document long-term outcomes of therapy! Preliminary results would probably be available now, maybe even more final short term results, but that would be about it. Also, remember that one negative study would likely not be sufficient to convince doctors (much less activists) who believe that chelation is of benefit in autism (although I'm sure one positive study would be more than enough, even though initial positive studies are wrong 1/3 of the time). It would take more than one study to convince. I would also make the prediction that such a randomized, placebo-controlled study would have an accrual problem. Many parents interested in chelation would likely not want to agree to be randomized to the placebo group. Getting them to sign up might be a hard sell. Such a problem would make a gold standard randomized, double-blind, placebo-controlled study even more difficult to do and take longer.

Sadly, it appears that Kirby is more interested in spinning this tragedy to decrease criticism of him and the mercury/autism hypothesis that he's become so enamored of than in critically looking at the claims that underlie the use of this dubious "therapy" for autism.

ADDENDUM: Peter Bowditch weighs in on the death of Abubakar Tariq Nadama. Stand back. He's really pissed off.

ADDENDUM #2: More information here and here.

ADDENDUM #3: On January 5, 2006, the coroner announced the results of the autopsy, concluding that it was indeed EDTA chelation that killed Tariq.

I want one of these!

Apparently this Flying Spaghetti Monster answer to the antiscience of "intelligent design" creationism is taking off more than anyone could have anticipated, so much so that Boing Boing is now offering Jim Leftwich's Flying Spaghetti Monster T-shirt for sale at its store. All proceeds will go to the National Center for Science Education, which defends the teaching of evolution in public schools. One neat thing is that you can customize your own T-shirt with different color illustrations and backgrounds to make the shirt as cool as you like! (For me this is an issue, given the large number of black T-shirts I've accumulated over the years; a red or blue T-shirt would be nice once in a while...) I also like the rather abstract nature of the logo. It has no words, which is likely to induce people to ask what the picture is supposed to be, allowing the wearer to educate the curious in the ways of His Noodliness.

Check it out, and while you're at it, there's nothing like this logo as well, which is a bit less abstract and more classically artistic.

Sadly, it was only a matter of time: An autistic boy dies during chelation therapy

I started my vacation out with a bit of a bummer of a thought. Unfortunately, it looks as though I'm going to close it with an even bigger bummer. I hadn't planned this. My original plan for today was either to take the day off and post nothing at all (the comment spam issue took care of that) or to post something brief, light, and fluffy, maybe doing the same on Saturday and/or Sunday, using a couple of amusing things I witnessed while traveling the Midwest (other than the Derek Jeter incident, of course). I would then resume regular topics on Monday when, unfortunately, I have to return to work, do clinic, and be on call.

However, this story, e-mailed to me by more than one person, compelled me to do change my plan:

A 5-year-old autistic boy died Tuesday in a Butler County doctor's office while undergoing an increasingly popular though controversial medical treatment touted by some as a cure for the lifelong neurological and developmental disorder.

Abubakar Tariq Nadama died while receiving chelation therapy, an intravenous injection of a synthetic amino acid that latches onto heavy metals and is then passed in the urine.

State police at Butler are investigating Nadama's death, which occurred at about 10:50 a.m. Tuesday in the office of Dr. Roy Eugene Kerry in Portersville.

Authorities said Kerry's office reported that the child was receiving an IV treatment for lead poisoning when he went into cardiac arrest.

An update to this story can be found here. My heart goes out to these parents, who no doubt thought that they were doing something positive for their child. Unfortunately for Abubakar and them, they found out in the hardest way possible that they were not.

Now, I realize that I'm a couple of days late commenting on this topic. I even wondered whether I have anything left to say that hasn't already been said. Indeed, Prometheus, Kev (1, 2, 3), Autism Diva, and numerous others have already commented ably on the story. Given that I've written before about chelation therapy as used to treat atherosclerotic heart and peripheral vascular disease in adults, how randomized double-blind studies have shown it to be no better a treatment than placebo, and how there is not a single study showing that it decreases the size of atherosclerotic plaques or improves blood flow through diseased vessels, I thought I should add my 2 cents.

Sadly, since learning of chelation therapy being used to "treat" autistic children, I've feared that it was only a matter of time before a child died during therapy, and now it has happened. It was inevitable, given that more and more parents of autistics, desperate to do anything to help their children, are opting for this unproven and ineffective therapy. Unfortunately, they usually do so on the basis of incomplete or erroneous information promoted by various organizations like Generation Rescue, whose literature states quite bluntly that "childhood neurological disorders such as autism, Asperger's, ADHD/ADD, speech delay, sensory integration disorder, and many other developmental delays are all misdiagnoses for mercury poisoning" (which also makes it puzzling why it is being reported that Dr. Kerry was treating the child for "lead poisoning," given that even the thimerosal/autism advocates don't generally argue that lead causes autism). If you accept that premise that mercury exposure during infancy causes autism, then chelation therapy sounds reasonable. However, even if that premise were true, one has to remember that brain damage is usually permanent and it is hard to propose a plausible biological mechanism by which removing mercury months or even years later would improve neuronal function.

The purpose of chelation is to bind ("chelate") heavy metals with a molecule that allows them to be secreted more rapidly in the urine. EDTA is fairly avid at chelating calcium ions, and that was the original rationale for the use of EDTA in "dissolving" calcified atherosclerotic plaques by "leeching" the calcium out of them. Given that children tend to develop electrolyte imbalances more easily than adults and to be more sensitive to them, utilizing a therapy designed to chelate electrolytes is not something to be undertaken lightly in children. What most likely happened in Abubakar's case is that he suffered a fatal arrhythmia due to hypocalcemia brought on by chelation of the calcium ions in his bloodstream. It may be possible that he died of another cause and that the timing of his death was merely a coincidence, but that would have to be a hell of a coincidence, given how rare it is for an otherwise healthy 5 year old boy to drop dead suddenly from a cardiac arrest.

I'm not going to get into the issue of whether or not mercury in the thimerosal used to preserve childhood vaccines has a role in the pathogenesis of autism yet again. My position on this issue should be abundantly clear to anyone who's read my blog regularly over the last few months, and, if it isn't, you can always check out some of my older articles (1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16). Suffice it to say that the preponderance of evidence presently existing does not support a role for exposure to mercury as a major cause of autism in the vast majority of cases. Mercury may be a neurotoxin, but overwhelming evidence fails to support a role for it in the pathogenesis of autism. Given that the mercury hypothesis represents a biologically implausible explanation for the pathogenesis of autism, any therapy based on "removing" mercury is likely doomed from the start to be ineffective, and any doctor who administers such a treatment for autism (in this case, Dr. Roy Eugene Kerry) should be considered guilty of negligence at best and malpractice at worst.

For the sake of argument however, let's play Devil's advocate for a moment and discuss this tragic case operating under the assumption that mercury does play a major role in the pathogenesis of autism. Even in that case, if the child's death can be shown to be due to electrolyte imbalances caused by chelation therapy, this doctor still should be considered guilty of unethical conduct at best and malpractice at worst. Why? First, as has been pointed out, in physiologic conditions in the body EDTA is a relatively weak chelator of mercury ions compared to the -SH group-containing proteins in the body's tissues. This means that, at equilibrium, mercury ions will remain preferentially bound to -SH group-containing tissue proteins in the body and EDTA will not be effective at competing for binding mercury. Effective mercury chelators contain -SH groups and have higher affinity for mercury than body tissues. Examples include compounds such as 2,3-dimercaptosuccinic acid (DMSA) and 2,3-dimercaptopropane-1-sulfonate (DMPS). In comparison, EDTA is a poor choice as a therapeutic agent to remove mercury from the body, even though in the test tube it binds mercury more avidly than calcium. (Perhaps this is one reason why Dr. Kerry was