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:
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:
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:
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:
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.
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.Sound familiar? If not, consider this quote:
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.
"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."
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.
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.
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:
Can you picture this sort of scene in an infomercial for an herbal remedy? I can."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?' "
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.
posted by Orac @ 7:25 AM
80 example(s) of insolence returned:
At 8/31/2005 8:33 AM,
It's a shame that doctors fall for this. One would think that doctors would have a better appreciation for the scienfic method. But I suppose it's a symptom of two things: a general ignorance of the scientific method, and human nature. After all, there are some very respected scientists who have fallen for quackery or other superstitions outside of their own field of speciality.
At 8/31/2005 11:15 AM,
Excellent post, very well argued. Unfortunately, the history of medicine shows that doctors are just as vunerable to the pull of tradition, anecdote, and wishful thinking as anyone else.
One comment on the issue of anecdote, though: as you said, the plural of "anecdote" is not "data". However, anecdotal observations can be useful for getting hints about possible correlations that might be useful to study further. For example, a phase I study of chemotherapy is designed to show toxicity, not efficacy. However, if, say, 5 patients with pancreatic cancer were put on one particular trial and three of them showed a response, that might suggest that a phase II trial of the drug in question might be warrented. Of course, most of those correlations are going to disappear in phase II and III trials and one certainly wouldn't want to declare a new standard of care based on the phase I findings, but they can be useful if treated with proper skepticism.
At 8/31/2005 12:54 PM,
Orac,
I read Buttar's pseudo-rebuttal and was intrigued by his "appeal to authority" when he cited the response of his colleague Dr. Steve Coles - who Buttar referred to as "a UCLA doc".
Well, I checked the faculty directory of UCLA and guess what? They don't have a Steve Coles on their faculty - they don't even anyone with the last name of "Coles" on their faculty. Perhaps Buttar meant that the estimable Dr. Coles had attended UCLA.
Big deal - they graduate over a hundred doctors a year and , unfortunately, some of their graduates succumb to the siren call of "alternative" medicine. There are bad apples in every barrel.
Every time he opens his mouth, Rashid Buttar puts his foot in it - it's a wonder he hasn't choked to death by now.
Prometheus
At 8/31/2005 3:30 PM,
Buttar is wonderful, he's just too busy to cite even other people's research, and we know he's far too busy to see what he's actually doing to children's health.
At 8/31/2005 6:10 PM,
It pains me greatly to have to come to the defense of someone like Buttar but I am afraid that in this case he is right and Prometheus is wrong- Steve Coles does indeed seem to be a member of the UCLA faculty.
http://tinyurl.com/7mtkc
At 8/31/2005 7:01 PM,
That's Steve Cole at UCLA (notice not: Coles)
Did Prometheus make a spelling mistake or did Buttar, or is this Cole guy another guy entirely.
I'm sure Prometheus is preparing to fall on his sword if it's his spelling error.
DON'T DO IT Prometheus! :-)
Do we even know if either Cole or Coles said what Buttar is attributing to him?
I notice this Cole has an email address there. :-D We could ask him.
At 8/31/2005 7:35 PM,
My mistake! Sorry! When I searched the UCLA site for "coles," it turned up that innocent Cole fellow because "coles" is part of his email address.
When you search the web for variations of Stephen Coles and UCLA you'll find plenty of references indicating that the gentleman is affiliated with UCLA and is involved in quack-ish sounding projects to prolong human life to ridiculous lengths.
However- after nearly five minutes of dilligent, wearying searching- I could find only one reference to him on the UCLA site. (It's the fifth item down- and it identifies him as being an "assistant researcher")
http://tinyurl.com/ddcpr
At 8/31/2005 7:43 PM,
TO: Kevin Greenlee - I am willing to admit that I was wrong about Steve Coles. As for falling on my sword, how about if I fall on my butter knife and we call it even?
Prometheus
At 8/31/2005 9:00 PM,
"Assistant researcher"? Well, that means he's almost certainly not faculty. The lowest faculty title is usually "Instructor."
At 8/31/2005 9:31 PM,
....I believe that if every American took IP-6 (Inositol Hexaphosphate) our cancer rate would drop dramatically says Dr. L. Stephen Coles...
At 8/31/2005 11:37 PM,
Great post --- and thanks for being honest enough to point out that we in organized medicine have our own issues with treating anecdotal data as "real" data. Unfortunately, it is all too easy to fall into the trap of treating patients based upon what appears to provide benefit, without an adequate trial. The kyphoplasty procedure is one that is tailor made for a good study....but it appears that one will not be done any time soon.
At 9/01/2005 3:23 AM,
First of all, you guys are UNBELIEVABLE at getting off-topic and picking out what is totally irrelevant. SO FRUSTRATING!
"Concerned," I went back to the email that Dr. Buttar forwarded me. It turns out that I did copy and paste correctly and I'm pretty sure "Steve Coles" didn't type his own damn name wrong.
So then Kevin Greenlee contradicts Prometheus, who almost gracefully conceeds that he was wrong (a first for this blog?) and falls on his butter knife, with the following description listed on the UCLA Surgery page:
"...Dr. L. Stephen Coles, M.D., Ph.D., assistant researcher in the Department of Surgery..."
And Orac has the audacity to say that assitant researcher is not faculty position. SERIOUSLY??
Hmm...let's see here. Dr. Coles, MD and PHD? Do you have both an MD and PHD Orac?
Maybe Dr. Coles is just a lowly "assistant researcher" because he's too busy actually making things happen rather than spending his life debating and conjecturing over how things happen and putting down those people that can actually get results.
For my next comment...
- Patrick Sullivan Jr.
At 9/01/2005 3:48 AM,
Orac, my apologies if you think this is rude of me to repost my same comment here as I just did here. But you're lambasting Dr. Buttar in this post for the same exact things as the comments in the last post and therefore, the comment is relevant here as well.
(And the disk space is on Google's nickel anyways.)
There is just one comment that I would add here. In your bloviating explanation about medical studies, boring as they are, you fail to mention even ONCE the word "empirical."
Do a search everyone. The hotkey is Ctrl + F. The first time it's used is in my comments.
Is empirical evidence just not useful in science?
If so, somebody better call Webster:
em·pir·i·cal ( P ) Pronunciation Key (m-pîr-kl) adj.
1.
a. Relying on or derived from observation or experiment: empirical results that supported the hypothesis.
b. Verifiable or provable by means of observation or experiment: empirical laws
2. Guided by practical experience and not theory, especially in medicine.
And all of us alties are the ones ignoring science?
Honestly, are you even really a surgeon? I think I've earned the right to know.
As hard as you try to pull off a "I'm skeptical for the public good" visage, it's just turning you into one of those people who sit back all day and figure out why/what/how.
But you don't want anyone to actually DO anything.
It's the Dr. Buttar's that are the pioneers -- the mavericks -- that say, "I've seen this work enough times with my own eyes...let's keep doing it!"
Or maybe you just lack the confidence to make a decision?
Twenty-five years from now, Buttar will be the Semmelweis of his day. You'll be the, well...actually no one is going to remember you. Not even the LA Times.
- Patrick Sullivan Jr.
At 9/01/2005 3:49 AM,
Orac, you said, "Pat, Pat, Pat, so like your dad."
Guilty as charged -- and proud of it! I'm proud of my dad. I'm proud of the fact that he is a hard-working, humorous, generous, honest, God-fearing man. Being able to launch Jigsaw Health with him has been one of the most challenging and rewarding things of my life.
My Dad was born and raised in East St. Louis, Illinois. The high school he went to, Assumption Catholic High School, is now the Southwestern Illinois Correctional Center (state prison). (Of course, he jokes that all the kids thought it was a prison back then and the only thing that really changed in 1994 was the name! ;-)
My Dad worked his ass off to become successful. When he started ACT! in 1986, his only goal was to make enough money to feed his wife, son and three daughters. And if you read his book -- send me an email and I'll send you a FREE copy Orac -- you'll find out that that while trying to feed his family and build a company, he was silently struggling with recurrent bouts of insomnia, fatigue, anxiety, diarrhea, etc. all of which he has concluded stemmed from poor diet and overuse of broad-spectrum antibiotics which impaired digestion (leading to Leaky Gut Syndrome) AND the 8 grams of mercury in his mouth from his 14 "silver fillings." He had those removed in 1987 and experienced significant improvements right away. But subsequent provocation tests have continued to show high levels of mercury since then. Therefore, he has been trying to find an effective detoxifier/chelator ever since. In his own experience, TD-DMPS has been the most effective by far!
Why the heck am I writing all that? For sympathy? For praise? For self-promotion? Absolutely not!
To show my/our true colors? Absolutely!
And most of you can't even show your real names. HCN, you think "Pat Sullivan" is an common name? Come on guys, we're not in an AOL chatroom circa 1994. (Btw, Hello from "bluerolo42" to anyone who remembers me.) The blogosphere today REQUIRES disclosure or you risk the loss of credibility. As far as I'm concerned, Orac's explanation for his anonymity should only apply to him, unless everyone else in here is a doctor...
So Orac, whether or not your comparison of me to my Dad is meant to be an insult, I wear it as a badge of honor!
Now, Orac I halfway accept your claim of "There's nothing "intellectually dishonest" at all." That's because I thought you had a valid question. And after hearing it on an endless loop I started to think, "Yeah Dr. Buttar! Why not just do a stupid blood test and prove whether or not TD-DMPS gets through the skin?"
So I exchanged several emails back and forth with Dr. Buttar late Tuesday night and into early Wednesday morning. Having no scientific background myself (other than my Bachelor of Science in Marketing), he had to explain himself a couple of times for me to finally "get it."
But I can assure you in all honesty, with my real name and reputation on the line, knowing I had to come back here and face the music regardless of his answer, I was going to make SURE he explained it to me until I absolutely understood him and his position.
I was not going to follow him blindly. His explanation absolutely had to make sense and appeal to my own logic. I refuse to be the mouthpiece for a liar or a con man! If I concluded, or even suspected, after our email exchange that he was lying, I would have come right back here and fessed up to it.
So here is our email conversation. I gave my word to Dr. Buttar that he could read my transcription before I posted it. He sent me a reply email saying "go for it" on 8/31/05 at 11:31pm EST.
Patrick Jr. (8/30/05 11:40pm EST): ...I think there may be a flaw in your "thimerosal challenge" if you choose to use DMPS in TD and IV for chelating out the thimerosal. One of the biggest, most common complaints from your critics is that there is no proof that DMPS is even being absorbed. If you use IV DMPS alongside TD-DMPS, you'll leave them a hole big enough to drive a truck through.
Dr. Buttar (8/31/05 1:06am EST): For acute mercury toxicity, TD-DMPS is not sufficient...for chronic mercury toxicity where mercury absorbed into the the tissues, etc....it is the best. I will be taking a bolus of thimerosal.....I will take the bolus antidote. I don't care about the critics or what they say. We don't know how aspirin works but the entire world uses it anyway! A neurosurgeon friend, and father of a child I am treating, will be writing about this issue anyway...
My purpose is not to prove that TD-DMPS is getting through the skin Patrick. I don't care if it is a placebo, which obviously it isn't....and our lancet paper [based upon the results of my own empirical observation] will show that the more you use the TD-DMPS, the more mercury is coming out. My purpose [for the thimerosal challenge] is different...I want to show that thimerosal is dangerous, and I will take DMPS intravenously to show how safe it is.
It is a "SAFETY" issue I'm talking about....I don't care to prove a damn thing to those people that you have been dueling it out with. The NIH has said our treatment and DMPS specifically is DANGEROUS....so I will take DMPS intravenously to show that it is NOT dangerous. That's why I want the media....to show the world how safe DMPS is. And if it's safe to take intravenously, then it's OBVIOUSLY safer to take it transdermally.
Patrick Jr. (8/31/05 1:49am EST): Dr. Buttar, please forgive me, but I didn't realize that showing the safety of DMPS was your true motivation. Frankly, I thought this was already well established? Isn't it readily used overseas?
And yes, chelation therapy for mercury is coming under fire because of Tariq's death, but I believe that to be a knee-jerk reaction. The data of tens of thousands of parents who have already safely used chelation therapies (like what GenerationRescue reports) will eventually change that mindset.
I assumed your motivation would be to prove that TD-DMPS ("expensive hand lotion" as your critics like to call it!) actually WORKS and to absolutely prove once and for all that it is in fact absorbed into the bloodstream. Otherwise, how could you have cured your son? How could my Dad's last TD-DMPS provocation test show elevated levels of heavy metals? etc. etc. etc.
Honestly, unless DMPS is NOT recognized as a powerful heavy metal chelator (which would be shocking news to me!), I'm confused why you would personally risk death to prove its efficacy in IV form for acute exposure. I believe that a (simple?) test proving that DMPS and GSH do in fact enter the bloodstream transdermally would be BIG TIME ammo for you! It probably won't shut up the Orac's of the world, but it will certainly help to convince parents on the fence who are worried about it's efficacy. Let time and the numbers take care of proving it's safety.
Of course, the upcoming Lancet article will surely make for great ammo as well.
Dr. Buttar, my apologies in advance for asking you to explain this to me and for challenging you on this. Please know that I do it with only the best of intentions!
Dr. Buttar (8/31/05 2:32am EST): Patrick,
First, there is no need to apologize to me. Your intent is clear. This letter that the neurosurgeon friend of mine will write talks about the effectiveness issue from a conventional medicine side of the house.
You see, first, you would have to actually have to have some type of test developed to actually detect the DMPS in it's altered form as it is absorbed. That takes money, effort and time. As my friend says, why do it? Let someone who wants to establish biokenetics and half life do that. It is not necessary to do this from a clinical efficacy standpoint. It would be nice to know how it works, but it is irrelevant. It works based on empirical evidence.
So it's absorption is not an issue for me or for anyone who is a true scientist because the empirical evidence is abundant. Only a pseduo scientist is going to get caught up with levels in serum, which it may not even show, since DMPS is highly neurophillic and may be possibly taken up by the nerves or distributed through the lymphatics...I don't know and I frankly don't care since it has no relevance to the clinical side of the house. But you see how absurd it is to simply assume it has to get into the serum? It most likely does, but it may not. The point is, it gets in and it works....and it works better than anything else out there.
Patrick Jr. (8/31/05 3:11am EST): Ok, it IS clear to me now! You have me convinced, and fired up about it actually!
(snip)
PS - I'm glad my true intention is coming through clearly. I know you are busy and that I am taking up much of your time, but I believe it is time well invested.
PATRICK JR. (8/31/05 12:04pm EST)...I emailed him again before I received a reply back: Dr. Buttar, I had an epiphany this morning and I think I finally get it!! It all boils down to EMPIRICAL EVIDENCE -- your son and 20+ others have been cured from the symptoms of autism following the TD-DMPS protocol. It just works! We don't know *exactly* how it works, and we don't really care because the reward FAR exceeds any alleged risk of DMPS.
Arguing absorption rates, etc. is complete folly b/c no matter what, no one can explain this empirical evidence away!!
I feel a little moronic that I've had to go around in circles with you only to come back to what I now remember was the most convincing aspect of your testimony to Congress when I first read it 10 months ago -- the stuff just works!
...
...
...
And that is the best way to finish this post. Our entire argument really all comes down to one, and one thing only -- EMPIRICAL EVIDENCE. You can certainly try to pretend it doesn't exist, but not a single one of you can explain away the fact that chelation therapy has worked to abate and cure the symptoms of autism. And you never will.
- Patrick Sullivan Jr.
At 9/01/2005 3:50 AM,
Game. Set. Match.
At 9/01/2005 8:15 AM,
Game, set, match, but the winner isn't Dr. Buttar.
Let's see. Lots and lots of verbiage, but no evidence that Dr. Buttar's cream actually gets absorbed through the skin, chelates mercury, or improves autism symptoms. In other words, a lot of sound and fury, signifying nothing--as usual.
You can pull the Galileo gambit with Dr. Buttar all you want, but Dr. Buttar's no Galileo.
And his rationalizations for not doing the blood and urine tests are LAME in the extreme. He claims he doesn't have to prove it gets in the serum, but he's claiming his treatment works by chelating mercury? That's bullshit, pure and simple (pardon my French). If he's claiming he's chelating mercury, then he has to prove that he's actually chelating mercury.
When this is pointed out to him, he then waves his hands and says we don't have to "prove" that it gets into the blood and chelates mercury because we have "empirical" evidence that it works. Only we don't have "empirical evidence that it works," just testimonials and Dr. Buttar's word.
You've obviously missed the point of my post. My post describes the deficiencies of such evidence and why it's so easy to delude oneself into thinking a treatment "works" with little or no evidence, and Dr. Buttar is example #1 of this. We have no randomized controlled studies. Given that the mechanism of Dr. Buttar's concoction is very implausible, it's very highly unlikely that it "works" at alleviating the symptoms of autism.
At 9/01/2005 10:15 AM,
As Dr. Buttar says:
You see, first, you would have to actually have to have some type of test developed to actually detect the DMPS in it's altered form as it is absorbed. That takes money, effort and time. As my friend says, why do it? Let someone who wants to establish biokenetics and half life do that. It is not necessary to do this from a clinical efficacy standpoint. It would be nice to know how it works, but it is irrelevant. It works based on empirical evidence.
No, Dr. Buttar, what IS important from a clinical efficacy standpoint is to determine whether TD-DMPS is more effective than a placebo or other "standards of care" (whatever the case may be) with regards to treating autism. By his own admission, he hasn't done that yet touts it as a cure for autism.
But Dr. Buttar's prior statement is even more oustanding:
We don't know how aspirin works but the entire world uses it anyway!
If that's true (and I doubt it) cinical trials proved that low-dose aspirin, for example, is heart protective. It wasn't done using "empirical evidence", it was done using the rigor of actual studies that determined aspirin was better than a placebo.
Again, I don't buy the "we can't do real trials of these therapies to see if they work" if tens of thousands of kids are already using said therapy. Even if the therapy IS safe (and with chelation that's not always a given) there's good reason to know that is truly is effective.
How many parents of autistic children who tried chelation - at substantial cost? I've heard estimates where biomedical treatments can cost up to $100,000 per year, and I'd bet not a whole lot of that is covered by insurance. I wonder how many would be angry if it turned out that the gains their children made during these therapies would've happened anyway?
At 9/01/2005 10:39 AM,
Since PS Jr seems so keen on full disclosure, it behooves him to post the correct and proper contact information for Rashid Buttar, D.O. - so that those who want to submit to his challenge may reach him straight-away. Is Buttar already in possession of the prepared paper work necessary to proceed with his challenge? Please post his cell phone number or a "hotline" number so he may be easily reached, or YOU lose YOUR "credibility", Patrick.
At 9/01/2005 11:06 AM,
"'We don't know how aspirin works but the entire world uses it anyway!'
"If that's true (and I doubt it) cinical trials proved that low-dose aspirin, for example, is heart protective"
It's not true. We know that aspirin works through inhibition of prostacyclin which in turn inhibits platelet aggregation. We know this because of meticulous and carefully documented research by researchers who were willing to put their egos on the line by actually testing their hypotheses instead of just trying to BS their way through. We also know that aspirin is clinically efficacious through multiple large scale, double blinded placebo controlled clinical trials. Multicenter, double blinded placebo controlled trials are the gold standard of proof of efficacy of any therapy. Anything less is too open to error to be considered definitive. (Of course, even large and well done studies can be wrong, which is why repetition of the studies is important.)
At 9/01/2005 12:57 PM,
Orac, I have been following your site lately, and I am really impressed by your thorough detail. Maybe one day you'll reveal yourself, because you sound like an interesting person. I have so many questions, and I hope you can address these in future posts. If you have addressed these, please refer me to a link. 1) How does chelation relate to amalgam fillings? Pat Sullivan is using transdermal therapy to chelate mercury due to his fillings. So what are your thoughts on the ADA's position of amalgam (that it's safe????) All of this autism stuff reminds me of "Lorenzo's Oil." For those who haven't seen it, rent it. 2) Orac, what are your thoughts about perseverent parents who actually find medical solutions, despite scientific protests? One thing that bugs me about your site is that you and your blog followers appear to be condescending and downright nasty at times. Is this really the purpose of your site? For everyone to slam each other? I have a bachelor of arts degree, and hopefully you won't dismiss my comments because you are the almighty Orac, and I am just too "artsy" for you to take me seriously. Like you, I'm choosing to be annonymous, so I won't be too affected when I get slammed by you and your blog followers!
At 9/01/2005 1:04 PM,
P.S. Orac, hopefully, you will actually address my questions, because I am genuinuely interested on your thoughts about amalgam. Also, have you ever had any patients whose health outcome defied all scientific study or logical explanation? Do you acknowledge any level of "mysticism" in medicine? (Mysticism defined as "A belief in the existence of realities beyond perceptual or intellectual apprehension that are central to being and directly accessible by subjective experience.") And you can call me a fool. I'm still anonymous.
At 9/01/2005 1:34 PM,
Anon said "All of this autism stuff reminds me of "Lorenzo's Oil." For those who haven't seen it, rent it. "
One should not really get medical information from a movie. It is better to register for free in www.medscape.com and read:
http://www.medscape.com/viewarticle/508345
Also, many of us know who Orac is, but there are very serious reasons for being anonymous. See:
http://oracknows.blogspot.com/2005/06/la-times-on-medblogging.html and
http://neurodiversity.com/weblog/article/15/st-paul-saga and
http://www.opinionjournal.com/editorial/feature.html?id=110004700
Also, this is not about amalgam fillings. But about how to differentiate from testimonials versus actual scientific observation in medicine. Even with an example from what may actually be a REAL treatment, but has not yet been qualified as such in reality.
At 9/01/2005 2:30 PM,
Thanks for the links. I'm shot down every time I post to this blog no matter what I say, so I'm out. No more almighty Orac for me.
At 9/01/2005 4:24 PM,
Anon - I see your arty and raise you a 'farty'. I'm a bloody designer for god's sake, you don't get much more arty than that and I like to think Orac takes me seriously.
Getting to know people online is a bit weird but from the times we've spoken via blogs and email, the good Doctor has always seemed like a thoroughly decent chap. I'd take him out for a pint or ten and buy him a pie, chips and mushy peas on the stagger home (not fish and chips of course - gotta watch the old mercury!).
Dr Buttar on the other hand produces arguments and reasoning so circular I think I may actually vomit.
At 9/01/2005 5:01 PM,
Thanks, Kev; with the visuals you provided now I think I finally understand this saying we have here in the U.S. -- "With whom would you rather have a beer?"
At 9/01/2005 6:06 PM,
But Kev, I love fish and chips. Ah, well. Still, I do love a good English brew, such as Boddington's, Bass Ale, Newcastle Brown, or (of course) Guinness every now and then; so I'd gladly lift a pint (or two or three) with you if I ever make it back to the U.K. and your neck of the woods. I've been meaning to get back to London someday; it's been 26 years since the one and only time I've been there, and I was too young to appreciate it properly back then.
At 9/01/2005 6:27 PM,
Though I do love a good Newcastle or Guinness, I have to say you guys make me sick.
HCN: Anonymous wasn’t saying, “get your medical information from a movie.” That aside was simply a matter of opinion. Obviously, Anon just enjoyed "Lorenzo’s Oil." (As did I BTW! It’s a fantastic movie! And though it IS based on a true story, it’s still just a movie...not a double-blind, placebo-controlled, and peer-reviewed study confirming that such things CAN actually happen. So would-be renters, BEWARE.)
HCN, either you’re an idiot for not recognizing that, or you’re deliberately misconstruing Anon’s words to deride the entirety of the post. (Not a very intelligent maneuver (or a humane one)...but I’m getting used to seeing that on this blog.)
Clearly, Anon was just throwing "L’s Oil" out there to introduce one of her 2 questions.
"2) Orac, what are your thoughts about perseverant parents who actually find medical solutions, despite scientific protests?"
A valid and interesting question! Far more interesting than some of the recent blather that’s come out of YOU and other arrogant a**holes here!
Secondly, HCN, obviously TO YOU this is not about amalgams, but since the topic in question here IS mercury, it seems odd that you’d criticize Anon for asking ORAC a question about them (and yet another valid one at that). I would be very interested to hear Orac’s response to this question as well. Especially if it’s true that "72 TONS of mercury is placed in the mouths of over 100 million Americans every single year!" (http://www.patsullivan.com/blog/2005/05/follow_the_mone.html) A frightening fact, if amalgams are harmful as many believe!
Orac, I do hope at some point to hear your opinion on the American Dental Association as well as the potential connection of mercury amalgams to the dramatic rise in the number of neuro-degenerative diseases (i.e. Alzheimer’s, etc.) and chronic illnesses that are becoming epidemic in our country right alongside autism.
Anon, apparently disclaimers on this site are just as futile as trying to raise good questions. Either way you get ripped to shreds. Such a shame. Hope you at least stick around long enough to see if there’s EVER a true answer from Orac instead of the nonsense from these clowns.
At 9/01/2005 6:39 PM,
"We don't know how aspirin works but the entire world uses it anyway! A neurosurgeon friend, and father of a child I am treating, will be writing about this issue anyway..."
#1 "we" do know how aspirin works, someone just explained that, and
#2 it does work better than placebo, that too was shown scientifically.
#3 What do you bet his neurosurgeon friend doesn't even exist. Can we contact him? If you post his name I'll contact him with my real email address and everything.
The man can't open his mouth without prevaricating.
I think he's mercury toxic.
What is he charging per hour this week in Texas? Still $800? You like this man Pat Jr? Why?
Al
At 9/01/2005 6:51 PM,
If you had read the Medscape link you would have seen that there was some real science validating Lorenzo's oil for reducing (not curing) the progression of a particular disease.
I still no reason why amalgams need to be discussed. The subject is NOT mercury... but how to evaluate studies and treatments. How even a trained physician can be swayed by his own pre-conceived notions.
At 9/01/2005 7:02 PM,
Kristi,
HCN's point was that there were published studies that showed Lorenzo's Oil actually made a difference. No such studies exist for things like Buttar's TD-DMPS. It's really just a clever version of the "Galileo gambit".
As others have mentioned, the issue here is not amalgams or mercury, or whether they have links to neurodegenerative disorders. It's about the belief that a medical treatment works in the face of hard evidence that it doesn't. (or at the very least, a lack of evidence that it does)
As to what I (can't speak for Orac) think of perseverant parents who actually find medical solutions, despite scientific protests - I think they're great. And at the end of the day, if treatments like chelation or vitamin supplementation or gold salts end up being a cure for autism, it will be because good scientific study proved it to be so. My objection has never been that one shouldn't pursue those avenues - it's that the claims of success and marketing of such treatments exceeds the current state of the science that supports them.
At 9/01/2005 7:10 PM,
The mercury parents would love to cast themselves as characters in a "lorenzo's oil" film.
Lorenzo's parents were #1 using real science not quackery. They knew actual stuff about the action of the fatty acids on the hormones or whatever is involved there. I don't know what they found exactly.
#2 There's pretty much no way any child could have been harmed by what they were proposing it's a fraction of Canola oil and olive oil or something. Maybe they could have accidently got something that would encourage blood not to clot or something... but it's not likely they could harm a child with oil. They weren't ever going to administer it IV.
The mercury parents are in way over their heads and talking about methylation and stuff they don't even understand. The parrot spoken by quacks like Buttar.
"you don't lay carpeting in a burning house, first you stop the fire".... with my $200 an ounce hand lotion that isn't proven to do a thing.
These parents are suckers for questionable labs. Go look at their home cooked research and see how often "Doctor's Data" lab shows up as their source for lab results.
These parents are so ignorant they think they can just make a statement like, "well, if the kids don't have mercury in their hair then they must not be able to EXCRETE IT!" They all look knowingly and nod, 'YESSSS, that's it. They CAN'T EXCRETE IT." Never mind that such a problem doesn't exist because mercury is never "excreted" in hair.
These parents are so ignorant even Buttar can fool them, and that's pretty ignorant. By the way, he says thousands of children are being chelated. Who says? How do they support such a number, and which ones are getting just oral chelation? How many are only doing TD-dmps? Enough to make Buttar wealthy, no doubt, but HOW many? Buttar is also seeing cancer patients, so we know his schedule must not be totally filled with autistic children. We also have been told that he's doing IV chelation on children...anyone know if that's true? Pat, wanna ask him?
By trying to put the mercury moms and Blaxill in the same category as Lorenzo's parents you despicably insult Lorenzo's parents, though I'm sure that's hard for you to believe, dianne. See: A perfect example of how not to do a study part I"
and part II
http://photoninthedarkness.blogspot.com/2005/07/dr-hornigs-autistic-mice_29.html
http://autismdiva.blogspot.com/2005/07/rain-mouse.html
http://photoninthedarkness.blogspot.com/2005/07/if-you-want-to-drive-bus.html
For the record, I have amalgam fillings and they aren't getting pulled out because some quack says they should be.
These parents are injecting their kids with methyl b12 based on a tiny study that ended up recommending more research into the use of b12 on 'regressed autistic' children ONLY. That's about 25% of all autistic children. What do you bet that non-regressed autistic children are being injected with b12 just for the heck of it? The original study was very weak and yet it was enough to start an industry of selling b12 injections to parents of autistic kids.
What will happen if it turns out that it's no better than placebo? Most likely this bunch will continue to use it.
Just like their friends continued to use secretin when it was shown not to be better than placebo.
What a waste!
At 9/01/2005 8:47 PM,
My apologies for being oblique. Today I just have fleeting chances to read and post while dealing with real life... including in an hour finding out the implications of having a child in a high school marching band, and then we are missing most of the band booster picnic! (one reason to object to the mercury subject).
At 9/01/2005 9:25 PM,
I'll answer your question about amalgams first because I can do so briefly. Also, I've dealt extensively with the whole mercury-amalgam thing on the Usenet newsgroup misc.health.alternative before over the last five years or so before I started blogging, after which I became much less of a regular there. I'm guessing that you're not going to like my a