July 28th, 2009 by Dr. Val Jones in Health Policy, Quackery Exposed
Tags: Acupuncture, Chiropractors, Healthcare reform, Homeopathy, Naturopathy, Senate Bill, Senator Harkin, Senator Tom Harkin
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With healthcare costs spiraling out of control, and major rationing efforts under consideration – can we really afford to allow purveyors of pseudoscience to use up scarce Medicare/Medicaid resources? It’s hard to imagine that Obama’s administration would approve of extending “health professional” status to people with an online degree and a belief in magic – but a new amendment would allow just that. What happened to our “restoring science to its rightful place” and why are we emphasizing comparative effectiveness research if we will use tax dollars to pay for things that are known to be ineffective?
I hope someone reads and removes this amendment pronto (h/t to David Gorski at Science Based Medicine):
Here’s the language that Sen. Harkin has slipped into the 615 page Senate version of the health care reform bill:
HEALTH PROFESSIONALS.—The term “health professionals” includes—
(A) dentists, dental hygienists, primary 25 care providers, specialty physicians, nurses, nurse practitioners, physician assistants, psychologists and other behavioral and mental health professionals, social workers, physical therapists, public health professionals, clinical pharmacists, allied health professionals, chiropractors, community health workers, school nurses, certified nurse midwives, podiatrists, licensed complementary and alternative medicine providers, and integrative health practitioners;
Background Reading:
What Do Chiropractors Believe?
Acupuncture Doesn’t Work
Should Naturopaths Be Allowed To Prescribe Medication?
Homeopathy ER
July 23rd, 2009 by Mark Crislip, M.D. in Better Health Network, Quackery Exposed
Tags: CAM, Complementary And Alternative Medicine, Infectious Disease, Internal Medicine, Marshall Protocol, Sarcoidosis, Scam
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While there are many taxonomies of SCAM, one thing almost all alternative therapies have in common is they are originally the de novo discovery of one lone individual. Working outside of the mainstream, they are the gadflies who see farther because those around them are midgets.
Hanneman conceives of homeopathy, the treatment of all disease.
Palmer conceives the cause of all disease and its treatment in chiropractic
Mikao Usui, while having a mid-life crisis, conceives Reiki.
Virgin births all. These pioneers boldly go where no man has gone before.
Others have been less acclaimed after seeking out new life. An example is Virginia Livingston, MD, the discoverer of the cause of all cancer (1). She discovered a bacterium, the cause of cancer, she called Progenitor cryptocides, which, unfortunately only she could grow. Her therapies include an autogenous ‘vaccine” made from your own urine, which will probably preclude widespread use even in alternative therapies circles. I wonder if Jenny would object to vaccines if there were naturally derived from the patients urine?
Discovering a new form of pathogenic microbiology that no one else can see or grow is not uncommon, since people seem to be unable to recognise artifact on slides, be it Oscillococcinum being seen by Joseph Roy 200 years ago or Virginia Livingston in the 1960’s. Sometimes I regret the discovery of H. pylori as a cause of gastritis as it gives the alternative microbiologists a medical Galileo to point at. H. pylori is used as an example, erroneously, of a bacteria causing disease that was laughed at by the medical establishment (Parenthetically, as my flawed memory has it, while I was an Infectious Disease Fellow the data for H. pylori came trickling in. I remember discussing the papers with one of my attendings who was an expert in GI infections. We all thought is was an interesting hypothesis and waited further data with interest. I cannot remember anyone dismissing the idea out of hand with derisive laughter. But then, I remain convinced that infections are the cause of all disease, at least the diseases that matter).
A letter from a reader led me to another lone reseacher who has discovered the cause and treatment of many, if not all, diseases. So may I introduce to you, Trevor Marshall, the developer of the Marshall Protocol. (As I have said many time, I want something in medicine named after me, and it is not the glove breaking during an exam. “Damn, I just had a Crislip. I need to go and clean my nails.” If Swan or Groshong can get some silly little catheter named after them, well, I should be good for some eponym). You have not heard of Trevor Marshall? Often the fate of originality is to languish in obscurity.
The Marshall Protocol has all the characteristics of modern alternative therapy: a single discoverer, a hitherto undiscovered biology, an unproven therapeutic intervention and one of the most aggravating issues in SCAM’s: Taking a scientific truth the size of a molehill and transmogrifying it into a Cascade Range of exaggerated disease etiology and treatment. Unlike most SCAM’s, however, as best as I can tell Dr Marshall does not seem to be in the business of making a business from his discovery, although he does have patent applications for his protocol.
Read more »
*This blog post was originally published at Science-Based Medicine*
July 18th, 2009 by Dr. Val Jones in Expert Interviews, Quackery Exposed
Tags: James Randi, James Randi Educational Foundation, JREF, Magic, Magical Thinking, Paranormal, Psychology, Snake Oil, TAM7
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James Randi, perhaps better known as “The Amazing Randi” has spent most of his life performing magic shows. In 1996 he created the James Randi Educational Foundation (JREF) designed to expose the fraudulent claims made by psychics, faith healers, and snake oil salesmen. The ultimate goal of the JREF is to create a new generation of critical thinkers – people who will not be hoodwinked by the aforementioned hucksters.
I had the good fortune of interviewing Mr. Randi briefly at the recent conference known as “The Amazing Meeting.” I was eager to pick his brain about human behavior and magical thinking. This is what I learned…
Randi identified certain groups of people who seem to be more susceptible to magical thinking and/or belief in the paranormal. According to him, the top two are:
1. News reporters. Although at first I wasn’t sure if Randi meant that reporters like a good story versus they believe a good story – he told me that in his experience, they were some of the most gullible people on earth. In fact, they were more interested in implausible stories than true ones – and Randi said that the more fantastical his explanation for phenomena, the more likely they were to believe it and write about it.
2. Academics. This surprised me since I assumed that this group would actually be less susceptible. Randi suggested that they are more likely to be taken in because they are single-minded about phenomena. They are over confident in their ability to understand how things work, and when something cannot be explained in their framework, they’re willing to attribute it to the paranormal.
Who are the least susceptible? Children. Why? Because they are simple thinkers, and harder to distract. The art of magic is in distraction of the sophisticated mind. Children tend to be very concrete, so they don’t expect things to happen with hand-waving and flourishes. They keep their eye on the coin (or other item being transferred from hand to hand), and are more likely to know where it is at all times.
To wrap up our short interview, I asked Randi if he could explain why people believe in magic, fantasy, and the paranormal? He responded simply:
Ultimately it’s not about intelligence or lack thereof. It’s about people not wanting to accept that life is random, suffering is inevitable, and there is no good reason for bad things happening.
What do you make of Randi’s observations?
July 14th, 2009 by Harriet Hall, M.D. in Better Health Network, Quackery Exposed
Tags: CAM, Cardiology, Complementary And Alternative Medicine, Coronary Bypass, Healing Touch, Pseudoscience, Research
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A study published in Alternative Therapies in Health and Medicine is being cited as evidence for the efficacy of healing touch (HT). It enrolled 237 subjects who were scheduled for coronary bypass, randomized them to receive HT, a visitor, or no treatment; and found that HT was associated with a greater decrease in anxiety and shorter hospital stays.
This study is a good example of what I have called “Tooth Fairy Science.” You can study how much money the Tooth Fairy leaves in different situations (first vs. last tooth, age of child, tooth in baggie vs. tooth wrapped in Kleenex, etc.), and your results can be replicable and statistically significant, and you can think you have learned something about the Tooth Fairy; but your results don’t mean what you think they do because you didn’t stop to find out whether the Tooth Fairy was real or whether some more mundane explanation (parents) might account for the phenomenon.
Theoretical underpinnings
According to the study’s introduction:
Healing touch is a biofield- or energy-based therapy that arose out of nursing in the early 1980s…HT aids relaxation and supports the body’s natural healing process, i.e., one’s ability to self-balance and self-heal.” This noninvasive technique involves (1) intention (such as the practitioner centering with the deep, gentle, conscious breath) and (2) placement of hands in specific patterns or sequences either on the body or above it. At its core, the theoretical basis of the work is that a human being is a multi-dimensional energy system (including consciousness) that can be affected by another to promote well-being.
They cite a number of references to theorists who support these ideas. They cite Ochsman; he wrote a book Energy Medicine: The Scientific Basis which I reviewed, showing that despite the book’s title, there is no credible scientific basis and the “evidence” he presents cannot be taken seriously.
They cite Candace Pert, who said in the foreword to Ochsman’s book that Dr. Oschman “pulled” some energy away from her “stagnant” liver. She said the body is “a liquid crystal under tension capable of vibrating at a number of frequencies, some in the range of visible light,” with “different emotional states, each with a predominant peptide ligand-induced ‘tone’ as an energetic pattern which propagates throughout the bodymind.” Does this even mean anything?
They even cite the PEAR study, suggesting that it is still ongoing (it isn’t) and claiming it shows that “actions in one system can potentially influence actions of another on a quantum energetic level.” (It didn’t.)
This is nothing but imaginative speculation based on a misunderstanding of quantum physics and of what physicists mean by “energy.” It is a truism that electromagnetic phenomena are widespread in the human body, but there is a giant gap between that and the idea that a nurse with intention and hand movements can influence electrical, magnetic, or any other physical processes in the body to promote healing. There is no evidence for the alleged “human biofield.”
Previous Research
They cite several randomized controlled studies of HT over the last few years. One showed “better health-related quality of life” in cancer patients. One, the Post-White study, showed no difference between HT and massage. One small study by Ziembroski et al. that I couldn’t find in PubMed apparently showed no significant difference between HT and standard care for hospice patients. One study showed that HT raised secretory IgA concentrations, lowered stress perceptions and relieved pain, and results were greater with more experienced practitioners; but it only compared HT to no treatment and didn’t use any placebo treatment.
A pilot study compared 4 noetic therapies-stress relaxation, imagery, touch therapy, and prayer, and found no difference.
A larger study showed that neither touch therapy nor masked prayer significantly improved clinical outcome after elective catheterisation or percutaneous coronary intervention.
They cite a review of healing touch studies by Wardell and Weymouth It concluded “Over 30 studies have been conducted with healing touch as the independent variable. Although no generalizable results were found, a foundation exists for further research to test its benefits.” Wardell noted that “the question has been raised whether the field of energy research readily lends itself to traditional scientific analysis due to coexisting paradoxical findings.” This is a common excuse of true believers who find that science is not cooperative in validating their beliefs.
Study Design
237 patients undergoing first-time elective coronary artery bypass surgery were randomly assigned to one of 3 groups: an HT group, a visitor group, and a standard care group. All received the same standard care from the hospital. The HT group received preoperative HT education and 3 HT interventions. Practitioners established a relationship with their patients, assessed their energy fields, and performed a variety of HT techniques based on their assessment, including techniques that involved light touch and those that involved no touch (practitioners’ hands held above body). Sessions lasted 20 to 90 minutes; each patient had the same practitioner throughout the study. The “visitor” group patients were visited by a nurse on the same schedule. The visits consisted of general conversation or the visitor remaining quietly in the room with the patient. They mentioned that some visits were shortened at the patient’s request.
Results of the Study
The six outcome measures were postoperative length of stay, incidence of postoperative atrial fibrillation, use of anti-emetic medication, amount of narcotic pain medication, functional status, and anxiety. HT had no effect on atrial fibrillation, anti-emetics, narcotics, or functional status. The only significant differences were for anxiety scores and length of stay. The length of stay for the HT group was 6.9 days, for the visitor group 7.7 days, and for the routine care group 7.2 days, suggesting that the simple presence of a visitor made things worse(!?). Curiously, for the subgroup of inpatients, the length of stay was HT 7.4 days, visitor 7.7 days and routine care 6.8 days, which was non-significant at p=0.26 and suggested that both HT and visitor made things worse.
The mean decreases in anxiety scores were HT 6.3, visitor 5.8, and control 1.8. They said this was significant at the p=0.01 level. But the tables for results broken down by inpatient and outpatient show no significant differences (p=0.32 for outpatients and p=0.10 for inpatients). If it was not significantly different for either subgroup, how could it be significant for the combined group?
These discrepancies are confusing. They suggest that the significant differences found were due to chance rather than to any real effect of HT..
Problems with this Study
Four out of the six outcomes were negative: there was no change in the use of pain medication, anti-emetic medication, incidence of atrial fibrillation, or functional status. The only two outcomes that were significant were hospital stay and anxiety, and these results are problematic and might have other explanations.
It is impossible to interpret what the difference in length of stay means, because they did not record the reasons for delaying discharge. As far as we can tell from the paper, the doctors deciding when to discharge a patient were not blinded as to which study group the patient was in. It’s interesting that the visitor group length of stay was intermediate in the outpatient subgroup, but higher than control for the combined inpatient/outpatient group. They offer no explanation for this. I was puzzled by the bar graph showing these numbers, because the numbers on the graph don’t seem to match the numbers in the text. The numbers were manipulated: they did a logarithm transformation for length of stay “to handle the skewness of the raw data.” I don’t understand that and can’t comment. The range of hospital days is such that the confidence intervals largely overlap. In all, these data are not very robust or convincing and they raise questions.
They interpret the anxiety reduction scores (HT 6.3, visitor 5.8, and control 1.8) as showing a significant efficacy of HT, but it seems more compatible with a placebo response and a slightly better response for the more elaborate placebo.
There were fewer patients (63) in the visitor group than in the HT and control groups (87 each). This was not explained. The comparison of groups appears to show that the control group had significantly higher pre-op anxiety scores than either of the other groups, which would tend to skew the results
They didn’t use a credible control group. A visitor sitting in the room can’t be compared to a charismatic touchy-feely hand-waving practitioner. Other studies have used mock HT where the hand movements were not accompanied by healing thoughts. These researchers rejected that approach because they didn’t think it would be ethical to offer a sham procedure where the practitioner only “pretended” to help. Hmm… One could argue that they have provided no evidence that HT practitioners are ever doing anything more than pretending to help.
They don’t comment on how practitioners were able to “assess the energy fields” of their patients. Emily Rosa’s landmark study showed that practitioners who claimed to be able to sense those fields couldn’t.
The authors consist of 3 RNs (2 of them listed as healing touch therapists and presumably the ones who provided treatment in the study), a statistician with an MS, and two “directors of research” for whom no degrees are listed. The authors are clearly prejudiced in favor of HT.
They interpret this study as supporting the efficacy of HT. I don’t think it does that. I think the results are entirely compatible with a placebo response. With any made-up intervention presented with strong suggestion, one could expect to find one or two statistically significant differences when multiple endpoints are evaluated. And the magnitude of the improvement here is far from robust. This is the kind of result that tends to diminish in magnitude or vanish when better controls are used. I think the study is Tooth Fairy science, purporting to study the effects of a non-existent phenomenon, but actually only demonstrating a placebo response.
I wonder if better results might be obtained by having a patient advocate stay with the patient and offer reassurance, explanations, massage and other comfort measures – something like the doulas who have been shown to improve childbirth outcomes.
The frightening thing is that during the course of this study, patients increasingly bought into the HT belief system and refused to sign up for the study because they wanted HT and didn’t want to risk being assigned to a control group. And hospital staff bought into the belief system, were treated themselves, and became proponents of offering it to patients for other indications.
The paper ends with a rather incoherent statement one would not expect to find in a scientific medical journal: “At the very heart of this study is the movement toward recognizing that the metaphoric and physical heart are both very real, if we allow them to be.”
*This blog post was originally published at Science-Based Medicine*
July 3rd, 2009 by Dr. Val Jones in Quackery Exposed
Tags: Atherosclerosis, Cardiology, Chelation Therapy, Felony, Fraud, NCCAM, NHLBI, TACT, Treatment
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In one of the most unethical clinical trial debacles of our time, the NIH approved a research study (called the TACT Trial – Trial to Assess Chelation Therapy – a supposed treatment for arteriosclerosis) in which the treatment had no evidence for potential benefit, and clear evidence of potential harm – and even the risk of death. Amazingly, the researchers neglected to mention this risk in their informed consent document. The NIH awarded $30 million of our tax dollars to ~100 researchers to enroll 2000 patients in this risky study (ongoing from 2003-present). Even more astounding is the fact that several of the researchers have been disciplined for substandard practices by state medical boards; several have been involved in insurance fraud; at least 3 are convicted felons.
But wait, there’s more.
The treatment under investigation, IV injection of Na2EDTA, is specifically contraindicated for “generalized arteriosclerosis” by the FDA. There have been over 30 reported cases of accidental death caused by the administration of this drug – and prior to the TACT, 4 RCTs and several substudies of chelation for either CAD or PVD, involving 285 subjects, had been reported. None found chelation superior to placebo.
So, Why Was This Study Approved?
The NIH and the TACT principal investigator (PI) argued that there was a substantial demand for chelation, creating a “public health imperative” to perform a large trial as soon as possible. In reality, the number of people using the therapy was only a small fraction of what the PI reported.
It’s hard to know exactly what happened “behind the scenes” to pressure NIH to go forward with the study – however a few things are clear: 1) the National Heart, Lung, and Blood Institute (NHLBI) initially declined to approve the study based on lack of scientific merit 2) congressman Dan Burton and at least one of his staffers (Beth Clay) and a lobbyist (Bill Chatfield) worked tirelessly to get the study approved through a different institute – NCCAM 3) some of the evidence used to support the trial was falsified (The RFA cited several articles by Edward McDonagh, the chelationist who had previously admitted in a court of law to having falsified his data.) 4) The NIH Special Emphasis Panel that approved the TACT protocol included L. Terry Chappell, whom the protocol had named as a participant in the TACT.
All evidence seems to suggest that political meddling managed to trump science in this case – putting the lives of 2000 study subjects at risk, without any likely benefit to them or medicine.
A formal analysis of the sordid history and ethical violations of the TACT trial was published by the Medscape Journal of Medicine on May 13, 2008. Atwood et al. provide a rigorous, 9-part commentary with 326 references in review of the case. Congressman Burton’s staffer, Beth Clay, published what is essentially a character assassination of Dr. Atwood in response.
The NIH Writes TACT Investigators a Strongly Worded Letter
On May 27, 2009 the Office for Human Research Protections Committee sent a letter to the investigators of TACT, stating that they found, “multiple instances of substandard practices, insurance fraud, and felony activity on the part of the investigators.” The letter describes a list of irregularities and recommends various changes to the research protocol.
It is almost unheard of for a letter from the NIH to state that research study investigators are guilty of fraud and felony activity – but what I don’t understand is why they haven’t shut down the study. Perhaps this is their first step towards that goal? Let’s hope so.
Conclusion
The TACT trial has subjected 2000 unwary subjects and $30 million of public money to an unethical trial of a dubious treatment that, had it been accurately represented and judged by the usual criteria, would certainly have been disqualified. Political meddling in health and medical affairs is dangerous business, and must be opposed as strongly as possible. Congressmen like Tom Harkin and Dan Burton should not be allowed to push their political agendas and requests for publicly funded pseudoscience on the NIH. I can only hope that the new NIH director will have the courage to fend off demands for unethical trials from political appointees.
