I love to do these panoramic shots with my iphone. They aren’t perfectly stitched together, but good enough to achieve the intended purpose. I didn’t crop off the uneven margins because I like the raw look.
Honeymoon Island Panoramas via Iphone
It was a beautiful day today on Honeymoon and Caladesi Islands. I took a kayak to the northern tip of Caladesi Island this morning and captured the image above. Then I went to Honeymoon Island and walked the beach for several hours. Thank goodness for the stiff breeze off the Gulf of Mexico. Out of [...]
Golden Island
Ontario Canada has seen an explorsion in it’s island market recently, making it an excellent time to buy if you are looking to purchaser an island property in Canada or Northern US. One of the newest island to come on the international island market is Golden Island a beautiful 2 acre island located in the Lake of the Woods an area world for renowned for it’s beautiful scenery.
The island comes complete with newly renovated main cabin and comfortable guest cabin. The main cabin has had extensive work completed including kitchen cabinets, flooring, walls and ceilings throughout, decks, water pump and filtration and more.
The guest cabin provides plenty of extra room for guests with a sleeping loft and two bedrooms. The low profile property makes it easy to get around. Great protected harbour at both docking areas. Fantastic long sunset views over Whitefish Bay. Regular mainland electricity and phone service on the island and great cell phone signal strength. Island is located about a five minute boat ride from Sioux Narrows.
For more information on this property including listing price visit Private Islands Online.
the candy trail…
This particular ‘candy trail’ is the invention of Michael Robert Powell. He may not hand out sweets as we know them, but between his travel tales and electric artwork, his site fits the title he has chosen. Michael cuts through the proverbial bullshit of travel and the nomadic lifestyle. Please realize you have been warned – but you will also enjoy.
© Gretchen for TravelBlogs, 2011. |
the candy trail… |
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Post categories: Blogs
Post tags: adventure travel, cultural experiences, expat life, long-term travel, Perpetual Travel, photography, Round the world, solo travel, Travel artisan
International doctors get language boost at IUPUI – Chicago Tribune
International doctors get language boost at IUPUI Chicago Tribune Dr. Diana Morales Zelaya, who attended medical school in her native Honduras, said she struggled when she first started her residency and was working in pediatrics. She said she found it challenging to communicate with children and their parents. ... |
Charles Drew medical school released from probation – 89.3 KPCC
Charles Drew medical school released from probation 89.3 KPCC A south Los Angeles County medical school has emerged from a probationary cloud after a review from a regional accreditation body. This development represents a step forward for an institution that's weathered many ups and downs. ... Charles R. Drew University removed from academic probationLos Angeles Times Charles R. Drew University of Medicine and Science off probationLos Angeles Daily News |
Harvard Medical School, Division of Cardiac Surgery BHS, Boston, Mass – The Journal of Thoracic and Cardiovascular Surgery
Harvard Medical School, Division of Cardiac Surgery BHS, Boston, Mass The Journal of Thoracic and Cardiovascular Surgery N Engl J Med 2009;361:235-244.[Medline] Puskas JD, Halkos ME, Balkhy H, Caskey M, Connolly M, Crouch J, et al. Evaluation of the PAS-Port proximal anastomosis system in coronary artery bypass surgery (the EPIC trial). J Thorac Cardiovasc Surg 2009 ... |
Dartmouth Medical School names department head – Boston Globe
Dartmouth Medical School names department head Boston Globe LEBANON, NH—The head of the department of medicine at Dartmouth Medical School is stepping down. Murray Korc is leaving after eight years as chair of department. Richard Rothstein will serve as interim chair until a permanent replacement is found. ... |
UMD program aims to put American Indians on track to med school – Duluth News Tribune
UMD program aims to put American Indians on track to med school Duluth News Tribune Cedar Savage will drive 80 miles every day for six weeks during her summer vacation to be in a program at the University of Minnesota Medical School Duluth campus. Dr. Lorentz Wittmers (right) with the University of Minnesota Medical School-Duluth ... |
Silver Cross adds 11 new physicians – Chicago Sun-Times
Silver Cross adds 11 new physicians Chicago Sun-Times Dr. Sohal Patel: board-certified neurology physician, attended medical school at Southern Illinois University in Springfield. He completed a neurology residency at Rush University Department of Neurological Sciences in Chicago. ... |
Honey
I cram for TAM, and, combined with other commitments, not the least of which is that it is finally sunny and warm in Portland, after a year that has resembled All the Summer in a Day, which leads to a relatively short post. There are just so many hours in a day and if possible those days need to be spent in the sun.
In my first year in practice I was sitting on a nursing station writing a note when a patient started howling in pain. Further investigation revealed that the patient had a chronic, open surgical wound and the (old) surgeon had ordered sugar poured into the wound as part of wound care. The cafeteria mistakenly sent up salt, and a metaphor became reality. It did pique my interest in both sugar and honey for wound care, an area where you have to be careful not to fall prey to all the errors in CAM thinking: a reliance on anecdotes, using suboptimal studies as evidence, mistaking a gobbet of basic science as a meaningful clinical application, and not realizing the warping effect of confirmation bias.
That being said, I have suggested honey and sugar for years for patients, and many patients with prior refractory wounds had healing. And what are the three most dangerous words in medicine? In my experience. I have recommended honey less in the era of the wound vac, but there are not an insignificant number of people with insufficient financial resources who cannot afford even simple wound care supplies. Many of the ointments, creams and special bandages for wound care costs too much. Patients also like honey as it is natural (people do love to fall for the naturalistic fallacy) and inexpensive, and I always tell patients that the data is iffy, but not stupid.
Wound itself is mostly a combination of tradition and hype. One doc learned from his attending who learned from their attending, in a line that stretches back to the first barber-surgeon. I was told as a medical student, never put in a wound what you wouldn’t put in your eye, which seemed to be a good guiding principle, although it is expensive to pack a wound with soft contact lenses. New products, often combinations of old treatments, come out monthly with flashy brochures and little good data.
“There is a lack of large, high-quality published RCTs evaluating debridement per se, or comparing different methods of debridement for surgical wounds, to guide clinical decision-making. ”
So I rely on basic principals. Keep the wound clean, keep the new tissue from drying out, remove the dead meat, and keep the bacteria at bay, and do not let your pet lick it are more or less guiding rules in wound care. That, and no matter what you do, most people will heal. My rule remains: take credit for success, blame nursing when things go wrong. That’s ‘humor’ for the sarcasm impaired.
What is the rationale for sugar and honey for wounds and burns?
Basic Biologic Plausibility
The first is mechanism of action is primarily mechanical. The high osmolality of sugar and honey prevents bacterial overgrowth. Food can be preserved in sugar (jam is a good example) so the honey and sugar can prevent or decrease bacterial colonization of wounds. Honey has a low pH and contains hydrogen peroxide, both of which are antibacterial, but I doubt clinical relevance of the latter. And there may be bee and flower constituents that aid in antibacterial properties, although again I wonder about clinical relevance. Also, sugar and honey do not damage new tissues and when the honey is washed off, it painlessly removes the dead tissues with it, so it is good for debridement.
Honey, and to make sure you can charge a premium amount call it medical grade honey, can kill bacteria and decrease skin colonization. Avoid raw honey, as it can contain C. botulinum and has been the source of botulism in children. I don’t expect it would be of much use on facial wrinkles
At least from a basic science perspective, honey and sugar have mechanical, perhaps biochemical, and certainly financial, reasons it could be beneficial in wound care.
Clinical trials
So how are the clinical trials? There are lots of poor quality studies. Almost 400 references if you are in the mood for cherry picking. The preponderance of the poor quality studies points to benefit.
“Available evidence indicates markedly greater efficacy of honey compared with alternative dressing treatments for superficial or partial thickness burns, although the limitations of the studies included in the meta-analysis restrict the clinical application of these findings.”
and
“Honey may improve healing times in mild to moderate superficial and partial thickness burns compared with some conventional dressings”
From the ever helpful and potentially flawed Cochrane reviews:
Honey dressings as an adjuvant to compression do not significantly increase leg ulcer healing at 12 weeks. There is insufficient evidence to guide clinical practice in other areas.
and as they note
The poor quality of most of the trial reports means the results should be interpreted with caution.”
So be it. I have read many of the 400 references over the years, and the sense is that honey is of some value in wound care.
There is even less information of granulated sugar, where it looks encouraging and has been used to treat mediastinitis , diabetic foot ulcers and sloughing wounds.
Of course, honey is not the end all and bee all of treating soft tissue infections. Depending on the process, surgery and antibiotics will do far more to resolve the infection and promote healing, espcially for acute and/or acutely infected wounds. Relying on only natural products has lead to one death in a complimentary practitioner who treated himself with honey:
“a minor injury became infected with gangrene, the judge was told. He died, aged 52, in April 2007. Instead (of standard care) he used honey and magnesium sulphate.”’
The doctor who treats themself has a fool for a patient and an idiot for a doctor.
So in the end, do I recommend honey and sugar? Yes. The literature is interesting and I give patients a long list of caveats. It is maybe sort of probably useful in patients with chronic wounds who cannot afford other interventions. In my experience it always works. Back to TAM.
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Electrodermal Testing Part II: Legal and Regulatory Aspects
Last week I described electrodermal testing. I’m sure many readers thought, “There oughta be a law against that.” Well, there are laws. Unfortunately, having laws and enforcing them are two different things.
Some of these devices are not approved at all. Most have received 501(k) approval from the FDA as biofeedback devices so similar to previous devices that they do not require new approval — for biofeedback. It is illegal to use the devices for anything other than biofeedback. The FDA has prohibited their sale or importation for unapproved purposes like electrodermal testing; it has sent warnings to companies, raided clinics, and confiscated machines. States have prosecuted users for practicing medicine without a license. Medical boards have chastised licensed providers. The Quackwatch website lists these regulatory actions but points out that there has been no systematic effort to drive these devices from the marketplace.
Excuses, Excuses
One electrodermal testing website admits that what it is doing is illegal and tries to fight back with this specious disclaimer:
It is important to understand that the laws in the USA forbid me from being able to treat, diagnose, cure or prevent disease. The AMA has a patent on those words and only a licensed medical doctor can do that. And although it is legal for a licensed medical doctor to violate the Hippocratic oath and prescribe toxic drugs that cause harm and sometimes even kill patients, it is illegal for me to claim you can be cured using natural, nontoxic remedies, even though thousands of people can testify how they have been healed using natural remedies.
These machines are being used to practice medicine without a license, but they think they can get around the law by offering a disclaimer and by espousing the fiction that they are not diagnosing or treating diseases but only detecting energy imbalances and advising patients about how to restore balance.
Here are some typical protestations:
- I can only find imbalances that may be causing problems. It would be up to a medical doctor to determine if what I am finding IS the cause.
- I wouldn’t call EAV biofeedback “treatment”. You don’t treat anything with EAV. Creating a vial of treated water for a client to take may help balance their energy. Balancing energy is not medical treatment. It is perfectly legal to own one for home usage.
- And the reason all these people are spending money on this equipment is what??? Would they continue to invest in something that is “bogus”?
- EAV is not anything like the medical tests that we are used to. It works by quantum physics not biology.
- Yes, there are a bunch of enforcement actions. I assume that what is listed is about the entire list. Do you also want to list the claims made against regular M.D.s?
- Something that shows up energetically does not necessarily mean that it is a physical condition!
- We are only just now getting the scientific ability to test these [homeopathic] remedies by quantum physics.
In the training videos I mentioned in my previous article, the demonstrator answers questions from the audience that reveal more about the way they operate:
Q: I’m not a doctor. I have to send patients to an MD for IV infusions. What do you say when the doctor questions how you determined the patient needs it?
A: Tell him you determined it by electrodermal testing, similar to muscle testing [applied kinesiology] and ask him if what he does is any better. At least we have some monitoring device.
Q: One remedy you recommended is acid, but she has an acid problem.
A: That seems contradictory but we need it for her circulation, and the body can sort out what it needs.
Q: Is the circulation due to blockage in her superior vena cava?
A: No.
Q: Should she stop other medications or products?
A: Bring in the products and put them on the test tray. Medicine is a legal issue, so we can only show her what it does to her pancreas, we can’t tell her to stop using it. You might be liable if you told them to go off their meds.
Q: Will other medications interfere with our treatment?
A: Our treatment will not be as effective if they stay on their meds. Cancer treatments like chemo and radiation will usually interfere with our efforts. If the patient needs to stay on medication, we can give more products to balance out the effect of prescription meds on liver and to reduce med side effects.
Q: [Something about] cancer showed up on the readings. Does that mean she has cancer?
A: I don’t think she has cancer, but if she doesn’t correct the problems in her body, I can guarantee you down the road she will have problems like that. Cancer loves miasms, acidosis, poor circulation, emotional issues, and immune dysfunction. She’s got ‘em all. It’s just a matter of time. You can’t tell a person they have cancer — just that that matches the picture. Biopsy is needed for medical diagnosis. You can treat it before it gets to the biopsiable stage.
Q: What if the patient says “Every time I come in you give me something different.”
A: Well duh, do you want to be on the same thing all your life if it’s not working? If it’s fixed, why keep taking it? The body prioritizes all the time, so what it needs today will not be what it needs tomorrow.
Regulatory Actions
The FDA, state attorney generals, professional licensing boards, and foreign regulatory agencies have all taken action to stop electrodermal testers. Details of many of these cases can be found on Quackwatch.
An examination of 3 cases from my own state, Washington, highlights some of the problems with regulation.
A licensed physician was using a LISTEN device to diagnose allergies. The findings of fact are interesting:
- After he used the LISTEN machine, he wrapped the probe in tissue paper and had the patient hold the probe with tissue paper wrapped around it. When the patient asked why, he answered that he has done this so long, that he could do what the machine could do, and that he did not need the machine anymore.
- He used the machine not only to diagnose, but to treat allergies.
- He also used applied kinesiology, a phoney muscle testing procedure.
- He used dubious hair and urine tests to determine that the patient had a mineral imbalance, and told him he needed treatment for metal poisoning.
- He used what sounds like a chiropractic “activator” device on acupressure points.
- He prescribed the Metabolic Type Diet, a diet with no scientific justification.
The Washington State Department of Health Medical Quality Assurance Commission suspended his license for 5 years. Only they didn’t, because the suspension was stayed as long as he (a) stops using the device, (b) undergoes quarterly practice reviews, and (c) pays a $5,000 fine. The MQAC’s decision was appealed but the state Supreme Court upheld the decision, saying that Ames had “led patients to believe that LISTEN could diagnose and treat allergies, when in fact it could do neither.” Note that the board and the courts only considered his use of the device and did not even address any of his other questionable practices or his basic competence to practice medicine.
Joyce Trasker was convicted of practicing medicine and veterinary medicine without a license. She used the Orion and the Asyra devices to determine a patient’s “energy signature” and to prescribe homeopathic remedies. She offered testing on saliva and blood samples sent to her by mail. Eventually she began taking these samples and the machine onto an Indian reservation to do the testing, claiming that the State had no jurisdiction there. She claimed she was not practicing medicine. She even claimed that the right to free speech protected what she was doing. Her case went all the way to the state Supreme Court. She was ordered to cease and desist and to pay a fine of $10,000.
No problem: she simply moved a short distance across the state line to Idaho where she is still offering the same electrodermal testing for $295 per test. You can mail in saliva samples, even from Washington State: her website says “Washington may not prohibit its residents from patronizing an Oregon or Idaho business.” She is also involved in a long term campaign for the freedom to choose safe unregulated health care.
A Dropped Complaint
A few years ago I found a website for a local clinic offering electrodermal testing. After I filed a complaint with the medical board, all references to electrodermal testing mysteriously vanished from the website. The doctor and his lawyers threatened the medical board with legal action if they tried to act on the complaint. The complaint was dropped.
Confusing Terminology
The variety of devices and the many variants of terminology make it difficult to identify the magnitude of the problem. These devices are illegal and cannot be sold or imported, but they are still available. On E-bay I found 6 Biomeridian systems for sale. They seem to be going for around $5000 compared to an original price of $12,000 to $17,000.
If these systems do use some kind of frequency analyzer to capture EMF and then use a frequency generator to re-introduce that same signal back into the human body for “testing”, now they have produced what the FDA considers a radiation emitting device and not a galvanic skin response meter. The QXCI, EPFX, or SCIO falls into that category. The FDA banned importation of this device after an embarrassing exposé by investigative reporters in The Seattle Times featuring patients who died because they relied on the device to treat cancer.
What Can We Do?
In his exposé, Quackwatch’s Stephen Barrett says:
The devices described in this article are used to diagnose nonexistent health problems, select inappropriate treatment, and defraud insurance companies. The practitioners who use them are either delusional, dishonest, or both. These devices should be confiscated and the practitioners who use them should be prosecuted. If you encounter any such device, please report it to the state attorney general, any relevant licensing board, the FDA, the FTC, the FBI, the Better Business Bureau, and any insurance company to which the practitioner submits claims that involve use of the device.
I echo his plea. There is an online directory of practitioners that could be helpful in identifying some of the offenders, but there are undoubtedly many more who are avoiding publicity for fear of legal consequences. We have the tools to stop most of these offenders, but first we need to identify the offenders and then we need to actually use the tools.
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Anti-vaccine propaganda in The Baltimore Sun
The hypothesis that vaccines cause autism has been about as thoroughly falsified through research as any health hypothesis can be. Even if, by bending over backward into a back-breaking contortionist pose to be “open-minded”, some people will concede that there’s still a bit of room for reasonable doubt about whether there is no link between vaccines and autism in “susceptible” populations, there is no room for reasonable doubt left over whether vaccines caused the so-called “autism-epidemic” of the last two decades. They did not. Similarly, the mercury-containing preservative thimerosal, which used to be in several childhood vaccines until the end of 2001, when thimerosal was removed from all but some flu vaccines, has been about as cleared of being a cause of autism as it is possible for a substance to be. Basically, if thimerosal-containing vaccines were a cause of autism, we would have expected to see a decrease in autism prevalence beginning three to five years after the removal of thimerosal. Epidemiological studies have failed to find such a decline and have also failed to find evidence of correlation. I realize that anti-vaccine activists argue that there are still trace amounts of thimerosal in some vaccines, but, even so, thimerosal exposure in children fell almost overnight to levels lower than the 1980s, which was before the beginning of the “autism epidemic.” At the very least, one would expect autism rates to fall back to 1980s levels if thimerosal in vaccines were a driving force behind this “epidemic.” They haven’t. Quite the contrary, they’ve continued to climb.
So why does the manufactroversy that vaccines cause autism persist? There is no longer a scientific controversy; by and large, the question has been asked and answered. Vaccines do not cause autism, as far as we can detect. True, it’s impossible to completely prove a negative hypothesis, but if there is any way that vaccines do cause autism, it’s at a level below the ability of large epidemiological studies with tens or even hundreds of thousands of children to detect. Yet the fear persists.
One reason is that it’s very hard to eradicate a false belief, once entrenched. I’ve discussed many times how difficult it is to change people’s minds, as motivated reasoning leads them to seek confirming evidence and discount all else. Disconfirming evidence can even lead people to harden their beliefs even more. In particular, the hardcore anti-vaccine activists who persist in spreading the vaccine-autism myth have an interest and motivation in this mythology at least as potent as the interest pharmaceutical companies have in defending vaccines—more so, arguably, given the emotional attachment people have for their children. After all, all pharmaceutical companies are interested in, according to this mythology, is profit. If a parent, correctly or incorrectly, somehow comes to believe that something or someone has hurt his or her child, it is among the most potent motivations known to do something about it.
Another reason is that the concept has become entrenched in our culture—or at least parts of our culture—to the point where it appears regularly in the media, thus reinforcing the idea among those who don’t pay attention to the issue or those who do but haven’t decided if they believe that vaccines cause autism that maybe there is something to fear. Maybe there is still a controversy. A perfect example appeared in The Baltimore Sun over the weekend entitled We don’t know enough about childhood vaccines and subtitled Researcher asks: Are 36 doses of vaccine by age 2 too much, too little, or just right? I contend that the editors of The Baltimore Sun, by publishing this anti-vaccine propaganda, which would have been at home on the websites of the anti-vaccine blog Age of Autism or on the website of anti-vaccine groups SafeMinds, Generation Rescue, the International Medical Council on Vaccination or the National Vaccine Information Center (NVIC). Examining this article, written by Margaret Dunkle, described as a “senior research scientist at the Department of Health Policy at George Washington University and director of the Early Identification and Intervention Collaborative for Los Angeles County” and as having “a family member who is vaccine-injured,” is what I would consider a “teachable moment” in analyzing the tactics of the anti-vaccine movement.
Anti-vaccine propaganda in a major newspaper
Dunkle’s article begins rather oddly. At least, it could easily strike someone as odd if he isn’t familiar with the rhetorical techniques and bad science favored by propagandists like Dunkle:
The topics of vaccines and vaccine safety spark emotional outbursts at scientific meetings and family dinner tables alike. But many of these debates are remarkably fact-free. Surprisingly few people — not just concerned parents but also doctors, policy makers and even immunization experts — can answer this seemingly simple question: How many immunizations does the federal government recommend for every child during the first two years of life?
The answer is important because most states, including Maryland, faithfully follow the recommendations of the federal Centers for Disease Control and Prevention, codifying CDC guidelines into requirements for children to enroll in school, kindergarten, preschool and child care.
The irony of someone like Dunkle referring to debates over vaccines being “fact-free” is left for the amusement of the reader. Consider the old adage that everyone is entitled to his or her opinions but no one is entitled to his or her own facts. In the case of determining the number of vaccines that the Centers for Disease Control and Prevention recommends for children before age two, the anti-vaccine movement is a master at counting vaccines in such a manner as to make the CDC-recommended vaccine schedule appear to contain as large and scary a number of vaccines as possible. It does this by counting multivalent vaccines, such as the measles-mumps-rubella vaccine (MMR), as individual components, thus multiplying one dose or shot into three vaccines. If you count it up the right way, you can get a total of 36 vaccines, a number and anti-vaccine talking point that appears to date back to a full page ad run in USA Today by Generation Rescue three years ago:
Notice a number of fallacies all rolled up into one big poster-sized ad: “Too many too soon”; the “toxin” gambit; and confusing correlation with causation. Around the same time, Jenny McCarthy started showing up on Larry King Live! using this particular talking point. Prometheus once pointed out that he couldn’t find a way to come up with a total of 36 and thought that Generation Rescue screwed up. Be that as it may, Dunkle continues:
The critical number is how many doses of vaccine a child receives. Why? If a vaccine is strong enough to confer immunity against a disease, it is important enough to count separately.
No, the critical number is not how many doses of a vaccine a child receives. It is the number of antigens to which a child is exposed, and the number of antigens to which children are exposed is much lower than it was 25 years ago as whole cell-derived vaccines have been replaced with acellular vaccines, whatever the “true” number of vaccines as counted by Dunkle is. That’s what really matters.
Going back to find up that old chestnut of an ad on Archive.org, it occurred to me that Dunkle is a bit behind the times. Since that ad ran over three years ago, anti-vaccine groups have managed to find ways to inflate the seeming number of vaccines even higher than 36, such as 48. I tried to find the link, but I’ve even seen a blog post where the blogger was trying to claim that babies get over 60 vaccines before age two. Dunkle needs to get with the program. On the other hand, the number 36 appears to be the “official” talking point number used by most anti-vaccine groups since around 2008; so I’m not surprised that she chose it. I’m also not surprised that she’s bought into the “too many too soon” mantra that groups like Generation Rescue began promoting—surprise, surprise!—about three years ago, when Jenny McCarthy and her then-boyfriend Jim Carrey led a “march on Washington”-style rally under the banner of “Green Our Vaccines” to protest the vaccine schedule.
So where is Dunkle going with all this? Easy. She uses her complaint about the “36 vaccines” or “36 shots” as a prelude to citing a paper that claims to have found that there is a correlation between vaccine uptake and the prevalence of autism spectrum disorders:
A new Journal of Toxicology and Environmental Health study reports that the higher the proportion of infants and toddlers receiving recommended vaccines, the higher the state’s rate of children diagnosed with autism or speech-language problems just a few years later. This analysis is sure to rekindle the debate about vaccine safety.
Not really. It takes solid evidence and a quality scientific paper analyzed well to rekindle a debate. The paper to which Dunkle refers is anything but. Actually, it’s a truly execrable bit of data-mining by Gayle DeLong published earlier this year and entitled A Positive Association found between Autism Prevalence and Childhood Vaccination uptake across the U.S. Population. Prometheus and Sullivan have already had a go at this wretched bit of autism “science,” but I’ll comment as well, given that Dunkle used the paper as ammunition in her op-ed piece, that other anti-vaccine activists point to it as “proof” that “too many too soon” is a valid concern, and that DeLong’s paper has not yet been discussed here on SBM. In this case, better a month or two late than never, I say.
How bad can an epidemiology paper be?
Dunkle is actually a bit late promoting this study, as it’s been floating around the anti-vaccine blog underground for well over a month now. One thing that is very apparent from the article and DeLong’s analysis: DeLong is not a scientist. A quick perusal of almighty Google reveals that she is, rather, a faculty member in the Department of Economics and Finance in the Zicklin School of Business, Baruch College/City University of New York. As always, the fact that DeLong is clearly not a scientist doesn’t necessarily mean that she is wrong. Rather, her poor study design, clear lack of some very basic background knowledge about her study subject, and biased presentation are far more likely to indicate that she is wrong. Even so, somehow DeLong managed to get her manuscript accepted to the Journal of Toxicology and Environmental Health, a journal I only vaguely remember having heard of.
I can’t resist pointing out a bit of misinformation right in the abstract. For example, the reason for the rapid rise of autism in the U.S. is not, as DeLong characterizes it, really much of a “mystery.” It’s very likely the result of diagnostic substitution in the wake of the broadening of the diagnostic criteria for autism and autism spectrum disorders that occurred in the early to mid-1990s, as Paul Shattuck has shown and Steve Novella has discussed. Yes, there may have been a genuine increase in autism prevalence over the last 20 years (although even that is debatable), but, if such an increase has occurred, it appears to be so small that it’s not even clear that there was one.
DeLong carries on this sort of misinformation right in the text. Here’s one thing you should know about reading scientific papers. The introduction is where the authors try to “frame” the issue that led them to do the research and the hypothesis that derives from that issue in the most favorable way possible. To the knowledgeable reader or reviewer, a botched up introduction section that misrepresents the scientific consensus and the issues is almost always a sure sign that the science that follows will either (1) not support the authors’ hypothesis; (2) be of such poor quality that it doesn’t really support or refute any hypothesis at all; or even (3) cast doubt upon the authors’ hypothesis, even though the authors spin it otherwise. In this paper, for instance, DeLong argues that there “are several reasons why vaccines may trigger autism,” after which she lists a veritable laundry list of long-discredited anti-vaccine notions, bringing up (naturally!) old anti-vaccine bogeymen like mercury and aluminum. Nowhere is it mentioned that DeLong’s view is not the scientific consensus. Only one side is presented, the anti-vaccine side.
Another way you can recognize a bad introduction to a research paper is by the quality of the research that is cited. In DeLong’s case, the research cited is awful indeed, with citations to papers by SafeMinds and Age of Autism stalwart Mark Blaxill, the anti-vaccine father-son tag team of Mark and David Geier (otherwise known as the doctor with a suspended license and his son busted for practicing medicine without a license), Russell Blaylock (who counts HIV/AIDS denialism, antivax, and many other forms of pseudoscience as part of his repertoire), and Laura Hewitson, whose “monkey business” research was also published in the very same journal in which DeLong’s study appears. There’s more, but these are just some of the examples, perhaps the most egregious of which is a reference by anti-vaccine homeopath James Compton Burnett writing in 1884.
Then there’s the design of the study itself. First (and most egregious), there’s the issue of why DeLong combined speech or language impairments (SLIs) with autism diagnoses to do her analysis. DeLong appears to have used statistics that states are required to maintain under federal legislation, the Individuals with Disabilities Education Act (IDEA). Under IDEA, every school is required to provide data on children who have an Individual Education Plan (IEP), including the students’ primary classification. As Liz Ditz pointed out, IDEA classifications are not medical diagnoses. A child with a diagnosis of autism under IDEA may or may not actually have autism. Also, children with an IDEA classification of SLI are most commonly children with problems in fluency, articulation, or voice, not autism. Examples include apraxia and aphasias, voice disorders, stuttering, and language-based learning disabilities. It’s not for nothing that James Laidler characterized IDEA data as not being a reliable measure that can be used to track autism prevalence accurately.
Naturally, DeLong cites papers to justify lumping together SLIs and autism for purposes of her analysis. None of them support her hypothesis, and her citing them demonstrates that she does not have even a very basic understanding of her subject. For example, she confuses SLI (speech or language impairment) with SLI (specific language impairment). True, this nomenclature can be confusing, but if you’re going to write a scientific paper involving these topics, you need to know the language. DeLong clearly doesn’t know the language. At the very least, that this remained in her paper is a massive failure of peer review on the part of the journal, whose peer reviewers should have picked up on this. Finally, one of the three papers DeLong cited was apparently an error, but she later stated that she had meant to cite other papers, neither of which actually support her decision to lump SLIs together with autism either.
I’m left with the not-so-sneaking suspicion that the only reason that SLIs were lumped together with autism and ASDs for purposes of correlation with the percentage of children in each state receiving their full vaccine schedule is because the numbers somehow worked out the way that DeLong wanted them to. Otherwise, DeLong’s looking at mostly unrelated phenomena that have some degree of overlap. Certainly there appears to be no valid scientific or medical justification for combining the data from the IDEA classifications of SLI and autism.
Then there’s the methodology chosen for trying to find correlations, described here:
Children who are vaccinated at age 2 years may not develop autism until they are older. To determine the prevalence of autism for a specific cohort of children, the vaccination data from when the children were 2 years old is compared with autism prevalence when they are 8 years old. The relevant vaccination data for children who were 8 years old in 2001 are those from 1995, when the children were 2 years old. For children who turned 8 years old in 2002, the relevant vaccination data are from 1996, and so on. The earliest available data–vaccination data from 1995–were matched with autism prevalence up to 2007.
Besides DeLong’s having fallen for the ecological fallacy (group level comparisons rather than individual-level comparisons), she doesn’t provide much in the way of a good justification for why she chose ages 2 and 8 as their vaccine time point and prevalence time point. Then there’s the issue of confounders. DeLong tried to control for ethnicity, but in explicably she used the CDC’s National Immunization Survey rather than, say, U.S. Census data to derive ethnicity figures. Other potential confounders examined included family income, other disabilities, and the number of pediatricians in each state. Of course, states range in size from small to very large, and it can easily be argued that state level data are not “fine” enough to be used for this purpose. After all, many states are quite large, with huge differences in urbanicity. Think, for instance, California, with several large cities separated by huge swaths of rural and mountainous land. Or think Pennsylvania, which is in essence a 360 mile wide state with two very large cities, one east and one west, and several medium-sized cities clustered mostly in the east, all separated by miles upon miles of farm land or mountains. Urbanicity, as you might recall, can have a huge effect on the number of autism diagnoses, as I discussed three years ago. Naturally, DeLong made no attempt to control for urbanicity.
In other words, there’s no reason to put any real credence in DeLong’s study, especially given how small the observed effect appears to be. After reading this study, I was left wondering why on earth DeLong did it. After all, most of DeLong’s previous work appears to involve the study of banking, the FDIC, and financial risk taking. Why did she embarrass herself so by moving out of her specialty? After all, I would never think of trying to do a paper on economics or business and expect it to be accepted to peer-reviewed journal in the relevant academic discipline. As Dirty Harry Callahan once said, “A man’s got to know his limitations,” and I do, for the most part, know my limitations. DeLong apparently does not, and unfortunately Dunkle doesn’t recognize DeLong’s limitations, either.
Sprinkle in anti-vaccine fallacies, mix, and bring to simmer
Besides the invocation of yet another bad study, the rest of Dunkle’s article is a concise listing of a number of common anti-vaccine fallacies. There is, of course, repetition of the “too many too soon” mantra. Then, of course, there’s the “aluminum” gambit:
In addition to the number of doses, vaccine ingredients can be problematic, especially for susceptible subgroups. First are adjuvants, substances added to boost effectiveness and allow smaller doses of vaccine antigen to be used. The most common adjuvant is aluminum, which is found in vaccines for hepatitis and diphtheria-pertussis-tetanus.
There is no convincing evidence that aluminum adjuvants in vaccines are dangerous or cause autism as administered, and there is a lot of evidence that they are safe.
Dunkle follows this up with a combination of the “mercury” gambit and the “toxins” gambit:
Second are preservatives — such as thimerosal, which is 49.6 percent mercury. Thimerosal is still contained in many flu shots, although it was, except for trace amounts, removed from other child vaccines a decade ago. Many child vaccines (including those for diphtheria-pertussis-tetanus, HIB, and hepatitis) contain formaldehyde, which was just added to the government’s list of known human carcinogens.
The hypothesis that mercury in vaccines somehow causes autism or autism-spectrum disorders is a failed hypothesis.
Moreover, the attempt to scare mothers with claims of all sorts of nasty chemicals in vaccines is nothing more than a toxic myth. I once chastised Santa Monica pediatrician to the stars’ children (including Jenny McCarthy’s son Evan), Dr. Jay Gordon, for invoking the “formaldehyde” bogeyman. Formaldehyde is actually a normal byproduct of human metabolism, and a typical 5 kg two-month-old infant has about 1.1 mg of formaldehyde circulating in his blood, which is five times more than any vaccine contains. As for formaldehyde’s recent addition to the list of carcinogens by the National Toxicology Program, it should be noted that this is for higher exposures. As the National Toxicology Program itself points out on its fact sheet:
Studies of workers exposed to high levels of formaldehyde, such as industrial workers and embalmers, found that formaldehyde causes myeloid leukemia, and rare cancers including sinonasal and nasopharyngeal cancer.
As always, the dose makes the poison, and the tiny amount of formaldehyde in vaccines is not the same thing as the amount of formaldehyde that to which industrial workers are exposed in industries where formaldehyde is manufactured or used extensively or to which embalmers are exposed. If you peruse the scientific report issued by the National Toxicology Program, you’ll see that all the supporting studies involved rather large exposures, far more than any vaccine exposure. Dunkle’s citing formaldehyde as a carcinogen has about as much relevance to vaccine safety as the observation that people can drown in lakes does to discussions of the optimal amount of water people need to drink each day.
Unfortunately, either through advocacy, knowing an editor, or taking advantage of an editor’s desire to publish something interesting and controversial, anti-vaccine groups and activists manage to get articles like this one by Margaret Dunkle into major newspapers. Sometimes, it’s reporters themselves who fall for harmful pseudoscience like this. (Sharyl Attkisson, Steve Higgs, and Steve Wilson, I’m talking to you.) In either case, such articles and reporting represent massive failures of fact-checking, objectivity, and journalistic responsibility, and that’s exactly what The Baltimore Sun is guilty of by publishing Margaret Dunkle’s propaganda.
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Scientific evidence for synergy in a botanical product
So, you’re curious about herbal medicine. Is there any truth to this stuff?
Uncle Howie tells you that he read in the National Enquirer about an herb that has better antibacterial effects on cuts and scrapes than Neosporin ointment — never mind that Neosporin is composed of three different antibiotics that come originally from bacteria themselves.
So you set out on a quest to purchase some of this herb, known colloquially as goldenseal. When you go to your local Whole Hippie Dump-a-Load-of-Cash Emporium you find goldenseal alright, in about twenty different forms. On one side of the aisle are containers with loose, crushed up leaves and roots that look like medical marijuana. On a shelf, you find see-through capsules that seem to contain a powdered version of the herb. Down the aisle a bit you find boxes of blister-packs containing a proprietary extract of free-range goldenseal from the Appalachians harvested under moonlight by bare-breasted virgins. The same company also makes an ointment, allegedly procured the same way.
A scraggly young man with a rainbow-colored Whole Hippie tam comes by and says, “Dude, can I help you?” As you wave away the cloud of patchouli oil and three days of body odor, you ask him, “So, this goldenseal — which one should I buy?”
Hippie Boy looks both ways down the aisle and motions with his finger to come close.
“Dude, all this expensive stuff is just a ploy by The Man trying to make a buck with their fancy scientific words and processes. What you want is the whole herb, man — the stuff given to us by the sprites and spirits. Those capsules miss the point. Part of the magic is missing. You pay extra to get less.”
“But, dude,” you say. “I want to try the ointment, you know, for cuts and scrapes. How do I use this herb?”
The fine young man then explains how to make a poultice, an old-fashioned decoction of plant material that one wraps on a cut — sort of like collard greens.
This really seems like more trouble than it’s worth. You’re about a millisecond away from just heading down to the Done-Rite Drugs, Liquor, and Tobacco to buy a simple tube of Neosporin. But hey, it’s an experiment and you’re curious.
While you’re checking out from the health food store, a local scientist friend is in line at the next register, checking out your stash of goldenseal.
“You know, you should really go read Science-Based Medicine to get the straight dope on that stuff.”
And so, here you are. And I’m here for you.
[Note to readers: Apologies to my hippie friends. I love you all. No hippies were harmed in the drafting of this blogpost.]
Is there any scientific evidence to support a common herbalist claim that whole plant materials are “better” than semi-purified extracts or pure, individual chemicals made by the plant?
And I can tell you this — it depends.
But as long as the National Center for Complementary and Alternative Medicine (NCCAM) is in existence, this is the exactly the kind of work that should be supported by this arm of the US National Institutes of Health. In a recent paper to appear in the Journal of Natural Products, Dr. Nadja Cech and colleagues from the University of North Carolina at Greensboro, Dept. of Chemistry & Biochemistry, used traditional separation chemistry and cutting-edge analytical chemistry techniques to address this very question.
[Update: I neglected to note at the time of posting that Catherine M. Cooney wrote a nice article on this work at the online site for Chemical & Engineering News.]
The medicinal use of goldenseal (Hydrastis canadensis L. (Ranunculaceae)) dates back to Native Americans of the Cherokee and Iroquois tribes. Goldenseal was used externally for skin and eye infections and internally for relief from gastrointestinal symptoms. Today, goldenseal ranks among the 20 top-selling herbal products in the US.
In her group’s paper, Cech demonstrates the cooperative action in goldenseal between berberine, a weak, naturally-occurring antibacterial compound in the plant, and other chemicals that make the berberine more active. Even more fascinating is that these berberine-enhancing chemicals have no antibacterial activity on their own. In other words, these other chemicals potentiate the bacteria-killing effects of berberine. This potentiation is a form of synergy, a process where the combined action of two or more chemicals is greater than the sum of the parts.
(Disclosure: I have a NIH-funded collaboration with co-authors on Dr. Cech’s paper but not with her laboratory.)
Cech and her co-workers had already known that berberine killed Staphylococcus aureus bacteria at relatively high concentrations. Microbiologists use a term called, “minimum inhibitory concentration,” or MIC, to describe the minimum concentration of a drug required to kill a population of bacteria. But Cech had also observed that some parts of the goldenseal plant could increase the action of berberine.
To find out what these chemicals were, Cech’s lab purchased whole goldenseal plants, crushed them up in a series of alcohols and solvents, and separated out the constituents using a process called flash chromatography. Picture a tube filled with a specialized type of sand, silica gel. When you pour a gimmish on top of this column of separation material, some chemicals stick to it and flow through the bottom of the tube rather slowly while others wash past the silica quickly. Other chemicals bind somewhere in between, allowing this complex plant extract to be separated into smaller groups of chemicals.
Each fraction of these chemicals were then tested in multiple combinations alone and together with pure berberine. The research team observed that some of these fractions could increase the antibacterial action of berberine by a factor of 16. This synergistic action was not due to berberine in the plant extract of other related antibacterial alkaloid compounds.
After repeating the separation and antibacterial assay several times, Cech used a molecular sizing technique called mass spectrometry to identify two compounds whose size had not been previously known to occur in goldenseal. The group then used nuclear magnetic resonance spectroscopy to determine the strengths of bonds between individual atoms in the chemicals.
This combination of techniques led to the identification of three flavonoid compounds responsible for this synergy. One of the goldenseal chemicals is called sideroxylin. The other compound turned out to be two isomers that share the same molecular size, 8-desmethyl-sideroxylin and 6-desmethyl-sideroxylin. But how do these chemicals work?
Staphylococcus aureus has a protein that pumps toxic compounds out of the cell. This pump called NorA considers the plant chemical berberine to be toxic to its survival. The siderloxylin compounds block the action of the NorA pump and allow berberine to accumulate in the S. aureus cells to cytotoxic levels. Cech demonstrated that in S. aureus cells lacking the NorA pump, these chemicals could no longer potentiate berberine’s antibacterial action.
Cech’s team then went back to the original plant material to investigate where these synergistic compounds were present. Interestingly, the sideroxylin compounds were up to 50-fold more concentrated in the leaves relative to the root and rhizomes. In contrast, berberine was 5-fold more prevalent in the roots. Cech writes,
The finding that goldenseal leaf extracts have higher levels of synergists while root extracts contain higher levels of alkaloids suggests the potential benefit of using a mixture of root and leaf material in the production of dietary supplements from goldenseal. Further studies would, however, be needed to evaluate the safety and efficacy of goldenseal leaf extracts in vivo.
Indeed, goldenseal still needs to be studied in living models of bacterial infections rather than on laboratory dishes containing an optimal growth medium. Nevertheless, the traditional use of goldenseal alone has caused the plant to be endangered due to overharvesting in the wild. The plants used for this study were instead cultivated in their native environment of hardwood forest understory. Cech’s work provides a strong argument for herbalists and herbal compounds to be more responsible in sourcing their products and use cultivated plants.
But the primary significance of this work is that substantiation of common claims for combined or synergistic action in herbal products requires intensive chemical and biological investigation by a multidisciplinary research team. In this one case of goldenseal, synergy does indeed exist. This synergy-directed fractionation research strategy should be applied to other natural products where similar cooperative activity is suspected.
Reference:
Junio HA, Sy-Cordero AA, Ettefagh KA, Burns JT, Micko KT, Graf TN, Richter SJ, Cannon RE, Oberlies NH, & Cech NB (2011). Synergy-Directed Fractionation of Botanical Medicines: A Case Study with Goldenseal (Hydrastis canadensis). Journal of Natural Products PMID: 21661731
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Vaccine Confidence: Attitudes and Actions
Few groups are more hazardous to public health than the anti-vaccine movement — because there’s a body count affiliated with their actions. When vaccination rates drop, communicable diseases re-emerge, and people suffer. While anti-vaccine sentiment will probably persist as long as vaccines are around, we’re fortunate that vaccination rates, on balance, remain very high. In 2009, U.S. vaccination rates for most childhood vaccines were over 90%. And less than 1% are completely unvaccinated. But do high vaccination rates mean that parents have confidence in the safety and effectiveness of vaccines? Most states and provinces maintain public health regulation that require documentation of vaccination status for school or day care admission. So vaccines may be seen as a requirement or obligation which may override lingering concerns. Do concerns remain? That’s what a recent survey undertook to explore.
I’ve blogged before on antivaccination sentiment, and its drivers. It’s remarkable that viewing anti-vaccination material for even five to ten minutes can increase the perception of risk of vaccination, and decrease the perceived risk of omitting vaccines, leading to lowered vaccination intentions. It tells me that as a health professional, I need to be ready to address vaccines concerns directly, honestly and completely. To do that, I need to be prepared for the common arguments and concerns about vaccinations. The SBM archives are a good resource, serving as a compilation for issues and topics of interest to its authors.
Allison Kennedy, an epidemiologist at the Centers for Disease Control (CDC) and other colleagues at the CDC used a consumer survey of parents to examine intentions, behaviors and concerns about vaccines. The survey also sought to understand common sources for vaccine information.This paper, Confidence about vaccines in the United States: Understanding Patient Perceptions, is unfortunately behind a paywall. So I’ll touch on the highlights of this survey, and what it means for those “in the trenches” of vaccine advocacy.
Kennedy’s analysis is data cut from a large survey on consumer behaviors and intent, the 2010 HealthStyles survey, which included 4,198 households. The analysis was limited only to households with children aged six or younger, shrinking the pool to 376 responses. It’s a small sample size, admittedly, so how representative these data are isn’t clear. In addition, the authors comment that one cannot infer causality: We don’t know if cited concerns preceded or followed vaccination actions.
Intentions
The majority of respondents (94%) intended to vaccinate their child with all recommended vaccines. Only 5% intended to partially vaccinate, and 2% (seven people) intended to leave their children completely unvaccinated. (Number don’t add to 100 because of rounding.) These number look good and seem consistent with the (U.S.) national vaccination goals. Reason to be reassured? Not quite.
Despite an overwhelming majority intending to vaccinate, only 23% reported no concerns about childhood vaccines. The rest reported a number of concerns:
- 38% — painful to receive so many shots during one visit
- 36% — too many vaccines at once
- 34% — too many vaccines during first two years of life
- 32% — vaccines may cause fevers
- 30% — vaccines may cause learning disabilities, such as autism
- 26% — ingredients in vaccines are unsafe
- 17% — vaccines are not tested enough for safety
- 16% — vaccines may cause chronic disease
- 11% — vaccines are given to prevent diseases children are not likely to get
- 9% — my child will not be vaccinated on time because there’s not enough of some vaccines
- 8% — vaccines are given to prevent diseases that are not serious
- 23% — no concerns
This list should look pretty familiar. With the exception of concerns about shortages (which isn’t a negative against vaccines), this is a succinct summary of standard anti-vaccine arguments the contributors to this blog has addressed again and again.
The authors attempted to distill differences in concerns between parents that fully intended to vaccinate their children, and those that stated an intent to reduce or eliminate vaccines. As expected, everyone without concerns intended to fully vaccinate. And as would be expected, there were more concerns among parents who intended to reduce or avoid recommended vaccines. While there were some modest differences in the incidence of some specific concerns between the two groups, the sample size of the latter is too small to draw any meaningful observations.
Sources of Information
Fully 60% of parents sought out “some” or “a lot” of information on vaccine safety prior to any vaccination — not surprising given the movement for patients to become more involved as partners in care decisions. Other people were cited as one of the three most important source of information, including health care professionals (85%), family members (46%) and friends (22%). The internet is a growing source of information, with 24% including it in their top three sources ( I discussed popular sites in a prior post) while traditional media, including television, newspapers, and magazines, are infrequent sources of information. Reassuringly, daytime television was a top information source for less than 1% of respondents, so Dr. Oz, no friend of science, may not have the influence on vaccination that his viewership might suggest.
Among professional organizations, the American Academy of Pediatrics and the Centers for Disease Control were also among the top sources of information. No SBM (yet).
Most respondents, when asked about their relationship with health professionals, gave generally good evaluations. Over half “strongly agreed” they trusted the advice of their health care professional, while 31% “somewhat agreed”.
Implications
We cannot be complacent when it comes to vaccination rates: Concerns about vaccine safety are prevalent in parents, even among those that intend to complete the vaccination schedule for their children. Clearly, anti-vaccination arguments are resonating, though thankfully they’re not translating into vaccine refusal in most parents. Given the dual importance of both the internet, and personal advice, on vaccine confidence, this survey reinforces the need to be aware of the shifting goalposts from the anti-vaccine movement, in order that we can be prepared to proactively discuss these concerns. Moreover, non-professionals that are familiar with and can address typical anti-vaccine concerns should be able to have a meaningful impact on vaccine confidence.
This paper ultimately left me thinking about the complexity of understanding and addressing vaccine concerns. Parental concerns are far more nuanced than can be summed up in a single confidence parameter. As advocates we need to do a better job of understanding the relationship between attitudes and behaviors, recognizing that simply having the facts available is just on component of maintaining confidence in vaccination.
Reference
Kennedy A, Lavail K, Nowak G, Basket M, & Landry S (2011). Confidence about vaccines in the United States: understanding parents’ perceptions. Health affairs (Project Hope), 30 (6), 1151-9 PMID: 21653969
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The Neurontin Seeding Trial
Any institution that is based upon science is also dependent upon the integrity of the scientific process, and must guard that integrity jealously. That is certainly one of the missions of Science-Based Medicine. A particular challenge is that medicine is a massively expensive enterprise, and growing in both absolute and relative terms. This means that there is a great deal of money at stake (to be potentially earned and spent) and this fact constantly threatens to distort the process of science that is supposed to underlie medicine.
In particular, wherever there are millions or billions of dollars to be made, the motivation to find clever and subtle ways to distort the scientific process is huge. We find such behavior among any industry that has a medical product or service to sell. A recent example of this behavior was recently published in the Archives of Internal Medicine – Study of Neurontin: Titrate to Effect, Profile of Safety (STEPS) Trial.
Krumholz et al. reviewed the documents resulting from Harden Manufacturing vs Pfizer and Franklin vs Warner-Lambert and concluded:
The STEPS trial was a seeding trial, used to promote gabapentin and increase prescribing among investigators, and marketing was extensively involved in its planning and implementation.
Seeding Trials
A seeding trial is a pharmaceutical industry term for a clinical trial whose true and stealthy purpose is not to do science but to expose the investigators to a drug. There are often many comparable drugs that can be prescribed for the same indication, and manufacturers therefore want their brand to compete with the others. Also, many drugs are underprescribed and raising awareness among physicians and patients about a disease or condition and the availability of treatments will also serve to increase sales. There are perfectly legitimate ways to accomplish these goals — through honest advertising and medical education, for example.
A seeding trial is a dishonest way to promote a drug. The goal of the trial is to make the physicians who are the investigators in the trial more familiar with the company’s drug. This will demonstrably increase their use of the drug. Further, since “clinical leaders” at academic institutions are often chosen to be investigators, the hope is that they will spread their familiarity and use of the drug to their communities (hence the term “seeding” trial).
The authors of the study make note that marketing was involved in the planning and implementation of the STEPS trial. This is a no-no. Pharmaceutical companies have marketing divisions and research divisions, and they must never “cross the streams.” For example, in optimizing a trial as a seeding trial a company may choose many centers, each of which will recruit a few patients (the STEPS trial had 772 investigators). This maximizes the number of investigators, but is probably not optimal for doing good science.
This type of practice is unethical because it violates the trust of the subjects who enter the trial. As a society we have come to recognize that we have a great responsibility to human subjects of research. People offer themselves up to be experimented on with the understanding — the contract — that the research is legitimate, worthwhile, and every attempt is made to ensure that it is safe and that there is a reasonable probability of benefit. People who entered the STEPS trial did so with the understanding that the study would help improve the practice of medicine, while the real purpose was to promote a product.
The Archives paper gives ample evidence that the STEPS trial was not good science. It was uncontrolled and unblinded, with vague outcome measures. These concerns were even raised prior to implementing the trial. In short — it was bad science, probably because it was designed by marketers.
Conclusion
We can add seeding trials to the list of deceptive practices by industry that distort the science of medicine. This practice was known about prior to the Archives paper — but this is perhaps the best documented instance. I have also written before about companies ghostwriting scientific papers as another example of a deceptive marketing tool. These practices erode the institution of medicine. It seems that eternal vigilance is not only the price of freedom, but scientific integrity as well.
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Electrodermal Testing Part I: Fooling Patients with a Computerized Magic Eight Ball
Remember the Magic Eight Ball toy? You could ask it a question and shake it and a random answer would float up into a window: yes, no, maybe, definitely, etc. There is even a website where you can ask an Eight Ball questions online.
I have been meaning to write about bogus electrodiagnostic machines for a long time. These devices supposedly diagnose diseases and/or energy imbalances, indicate which remedies will correct the problem(s), and sometimes even treat the imbalances by transmitting a balancing frequency to the patient. I knew they were bogus, but I had never really realized the full extent of the deception until I viewed a set of training videos recently sent to me by a correspondent. I had never realized how similar electrodermal testing was to the Magic Eight Ball. I was further amazed at how they managed to combine every kind of alternative medicine into one incoherent package and to bamboozle patients with an appalling display of pseudoscientific babble.
This will be a two-part series. In the first, I will describe what the machines and their operators do. In the second (next week), I will address the legal and regulatory issues.
The History of EAV Devices
The first electrodermal diagnostic device was invented in 1958 by Reinhold Voll, a German medical doctor and acupuncturist. He combined acupuncture theory with measurement of galvanic skin responses in the Dermatron. He thought he had discovered that skin conductance was greater at traditional acupuncture points, and he thought he could show that these measurements correlated to diseases in the associated organs. He found that the measurements were affected by allergic reactions. He observed that readings changed when a patient had a bottle of medicine in his pocket. He concluded that some kind of electromagnetic energy was emitted from the medicine and that changes in skin conductance predicted the effects of ingesting the medicine.
One of his students simplified the diagnostic system and created the Vegatest. Other devices followed, including Accupath 1000, Asyra, Avatar, BICOM, Bio-Tron, Biomeridian, Computron, CSA 2001, Dermatron, DiagnoMètre, Eclosion, e-Lybra 8, ELAST, Interro, Interactive Query System (IQS), I-Tronic, Kindling, LISTEN System, MORA, Matrix Physique System, Meridian Energy Analysis Device (MEAD, MSAS, Oberon, Omega Acubase, Omega Vision, Orion System, Phazx, Prognos, Prophyle, Punctos III, Syncrometer, Vantage, Vegatest, Victor-Vitalpunkt Diagnose, Vitel 618, and ZYTO. This is not a complete list. New devices are constantly appearing.
The testing procedure was originally known as electroacupuncture according to Voll (EAV), but is now called by many other names including electrodermal screening (EDS), electrodermal testing (EDT), bioelectric functions diagnosis (BFD), bio resonance therapy (BRT), bio-energy regulatory technique (BER), biocybernetic medicine (BM), computerized electrodermal screening (CEDS), computerized electrodermal stress analysis (CEDSA), limbic stress analysis (LSA), meridian energy analysis (MEA), point testing, and many more.
How It Works
The machine is a galvanometer that measures the electrical conductance of the skin: the same principle used for lie detectors, Scientology’s E-meter, and biofeedback devices. The patient typically holds a metal bar in one hand while the operator applies a probe to acupuncture points on the patient’s other hand. The probe completes a circuit, and a tiny electrical current is sent through the circuit. It is very responsive, so a series of readings can be obtained rapidly. Both contacts are kept wet to improve conduction. There is a whining sound that rises or falls according to the level of conductance. There is also an audible beep indicating that a skin conductance measurement has been made and the machine is ready for the next test. The operator looks for a conductance reading of 50. (Higher readings indicate inflammation and lower ones indicate organ stagnation and degeneration.) He can control the readings (either consciously or unconsciously) by varying the amount of pressure and the angle of the probe, bunching or stretching the skin, and by adjusting the amount of moisture on the skin. He asks binary yes/no questions: a reading of 50 denotes a “yes” answer. Conveniently, the only meridians and acupuncture points used are on the hands and feet, so the patient doesn’t have to undress.
Systems Using a Hand Cradle
A skilled EAV practitioner uses intuition….On one hand, credibility may be high … because of the impressive amount of information that can be obtained through it (I know one practitioner who used the device to find out precisely how well his kids had obeyed house rules while the parents were away). On the other hand, both the fact that accurate information depends on changes in pressure applied by the practitioner and the fact that practitioner knowledge and bias plays an influential role in the results makes many people more skeptical.
To get around this problem, Zyto and other companies eliminate the probe and use a cradle where the hand rests. These devices supposedly interrogate the body with hundreds of tests in a minute or two, producing a computer graphic showing imbalances. Then the operator selects remedies on the screen and the computer indicates how many imbalanced items that remedy would bring back into balance. Testing can even be done remotely through the Internet by connecting a hand cradle to the client’s computer. They acknowledge that the results are not reproducible; but they explain that away. The first reading is the most accurate. It creates observer interference: the act of measuring or observing changes the body’s energetic profile due to quantum indeterminacy. Stephen Barrett of Quackwatch has written about Zyto as “Another Test to Avoid.”
Since all these machines can basically do is generate a small electrical current, how can that single stimulus be differently interpreted by the body to provide all that complex information? How could the body know whether you are asking it about the liver or about the benefit of a homeopathic remedy? Never mind. They are gathering information from the subconscious mind which “knows” the intention of the machine or the operator. You have to believe this, because if the operator is skeptical, the quantum link between the operator and the patient’s mind will interfere with patient response.
An energy medicine website further explains
Remedy testing works with names, symbols and even thoughts of the item to be tested. In all these cases, there is neither substance nor energy involved and the remedy testing works either when the remedy representation is in close proximity to the patient or miles away, and whether he is electrically connected or not.
A Typical Examination
The training videos I viewed were produced by Standard Enzyme in Bremen, GA; the system used was the CSA2001. My correspondent had downloaded these videos from the Internet a long time ago. They are no longer available online, and the company’s website no longer advertises the CSA 2001; but it does continue to offer training courses and seminars on CEDSA (computerized electrodermal stress analysis). I’m guessing the website has been “sanitized” in an effort to avoid regulatory action.
Note: I apologize for the length and mind-numbing detail of the following description, but I think it is helpful to understand what actually goes on during one of these testing sessions.
In the videos the operator tests a volunteer, an apparently healthy 24 year old woman, to demonstrate how he would do an initial assessment on a new patient. The procedure can be broken down into 3 basic aspects: stress analysis, remedy selection, and other stuff.
![[Diagram]](http://www.sciencebasedmedicine.org/wp-content/uploads/2011/07/pic2.jpg)
Click to enlarge.
Stress Analysis
In the first stage of the demonstration, he assesses various organs and systems by taking readings at different points on her hand and foot (see diagrams above). On her hand, he takes readings for things like the adrenal, circulation, jaw, hypothalamus, ileocecal valve, “organs,” heart, and “triple warmer.” A reading on one side of a finger joint shows allergies; a reading further down the finger shows food allergies. On her foot, he uses points for things like protein metabolism, fiber, uric acid, carbs, triglycerides, joints, skin, fat metabolism, and the ovary/uterus point. The first screen on the computer lists 35 of these points. The operator applies the probe to each. Of 35 readings, every single one tests abnormal on this patient.
Next he pulls up a screen with a list of the numbers from 1 to 10. He asks how many issues the patient has. It’s OK to use any convenient point for this; he picks circulation. He doesn’t have to verbalize what he is doing. He asks One? Two? Three? When he gets to 3, he gets a 50 reading, so she has 3 major issues. He addresses the first of these 3 issues:
- Are her issues are emotional or endocrine? The machine tells him endocrine.
- What major organ is the problem? With yes/no questions he narrows it down to pancreas or intestine. He gets a 50 reading for the pancreas.
- How many vital force issues does she have? One? No. Two? No. Three? Yes: 3 vital force issues for her pancreas.
- “I’m going to ask her right brain if it’s an organ, nerve, lymphatic or circulation problem.” Her right brain, or the machine, or something, answers organ and circulation.
- How much energy will it take to balance out circulation meridian? An 800X dilution.
- How much energy to balance the organ meridian? 1000X.
- Are the islets out of balance? Yes.
He repeats this procedure for the other major issues.
Problem no. 2 is the liver. Its vital force is 1. The organ itself is OK but there is a circulation problem, so he takes measurements at the circulation meridian. He asks if there is a hormone issue and determines that her insulin level is 55% above normal. It’s not clear why insulin comes up under liver rather than pancreas.
Remedy Selection
Using a series of lists, yes/no questions determine what remedies will correct each of the problems he has identified.
- He opens a computer screen showing a group of products, highlights each and uses the probe at the circulation point to determine what will balance the circulation meridian in her pancreas. It says Alpha orthophos. Then he goes back and looks for other products and finds one more: Circuplus.
- Back to the organ meridian. He gets a 50 reading on antioxidants. Yes/no questions identify sangre de drago. Several other immune support remedies come up: 2 IV products and graviola. He comments that this shows she is weak in the immune system.
- He goes back and asks her right brain: is there something more you want to tell us about your pancreas? Yes, some more on organ, but not circulation. Miasm and sycosis show up (miasms were Hahnemann’s homeopathic explanation for the cause of all diseases; sycosis was one of the 3 main miasms).
- Is there a 4th thing? Yes. Digestive enzymes. She needs dydrin forte. He concludes that she has some hypoglycemic issues.
- Is there something else? Yes, trace minerals IV. The IV Minerals checklist includes things like heparin, bicarb, procaine. He comments that you need to be careful to get it right, because putting remedies in veins can cause reactions. She needs germanium. How many cc? One – no, 1 ½, no, 2, 2 ½, 3, 3/12, 4, 4 ½ – all no. 5cc finally gets a yes answer. She needs potassium chloride 3.5 cc. For magnesium chloride she needs 31 cc. This is a lot: it shows she has quite a deficiency of magnesium. She needs molybdenum 4.5 cc. and manganese 8 cc. With manganese deficiency you get a lot of headaches because it is necessary for the hypothalamus and pituitary.
- He asks the machine if that is all for the pancreas? Yes. Finally!
He repeats the process for her other issues. He determines that her adrenals are compromised, with a vital force of 3 and an imbalance on organ and circulation but not on nerve or lymphatics. 1000X balances it. What does this dilution mean? He can’t really explain, but he says it can be measured on consecutive visits and if it goes up it shows she’s getting better. Her adrenal hormone is 5% low. She needs Adrena plus and Norepinephrine. As he goes through more remedies, he comments that “She’s almost a story book case.” I had to laugh: it is certainly more compatible with a storybook than a textbook.
Then he double checks. When you think you’re done, go back to the food allergy point [why that one?] and ask if there’s anything else.
Now he goes back and retests the original 35 points to see which have normalized. Most have, but lymphatics and lung are still high. There’s a problem with the uric acid point: “that would give me some sort of an idea that there’s some acidosis involved.” [Umm… uric acid has nothing to do with acidosis.] There’s also a urinary bladder problem.
Why did these points not balance? Let’s check for drainage and herbs. The Amazon rainforest group matches. Arcazon matches – it’s good “for any viral, bacterial, whatever, might be in the system.” Back to see whether adding arcazon to the remedy list restores balance to the unbalanced items. It does.
Next phase: dosing. Now he has a list of all the remedies she needs – 11 of them (not counting the trace minerals). For each, he asks what dose she should take (for example, 55 drops). Then he asks how many times a day she should take it. Take with meals or between meals? Can we reduce it after the first bottle? 2 are for IVs: is it necessary to give them IV? Yes. How many IVs? Every 4-7 days. Can they be combined with mineral IVs? Yes. Can they be given as a push? Yes.
Other Stuff
He asks the machine when the patient should come back for followup. Typical is 4-6 weeks. For her, it says 11 weeks. Then he asks it how many bottles of each remedy he should dispense. He tells her if she runs out of a remedy before 11 weeks, that means she no longer needs it. If she has some left over, the next evaluation may or may not show that she still needs to take it.
How much water does she need to drink a day? Yes and no questions narrow it down to precisely 50 oz.
He uses a vital force checklist: What is her overall ideal? 86. What is her actual level? 14. He checks vital forces for individual organs: blood 1, immune 3, digestive 2, etc. What do these vital force numbers mean? He explains it is like carrying water in a leaky pail: vital force is leaking through her holes. She needs to plug the holes so she can retain energy.
Yes/no-ing all areas rated under 10 can give more information about factors common to various problem areas, usually a virus, bacteria or toxin. He tells an anecdote about another patient: “radiation” came up as a common factor for her. He was puzzled at first, but then found the explanation: she had been microwaving her coffee and other foods.
But wait! There’s more! He asks it what her biological age is and determines that it is 71. She looks really good for her age!
Her WTL (will to live) is 1 on a scale of 100. She’s given up internally and needs to do some psychological work.
He does a pH assessment. pH is one of the most important things. Overall her ideal pH is 6.7and her actual pH is 0.7. I don’t know what imaginary universe he’s in at this point, but in the real world that pH would be way incompatible with life. Even stomach acid doesn’t have a pH that low. Her urinary ideal pH 6.5, actual 4.6. “Because she’s got so much acidity in the tissues – everything is acid.” Acid people can’t wear rings because they turn jewelry black. Saliva pH ideal 6.8; actual 6.4. Her blood pH is OK at 7.3 [Science tells us homeostatic mechanisms keep blood pH between 7.35 and 7.45, but he don’t need no stinkin’ science.] You could use test strips to measure urine pH, but why bother when you’ve got a machine? The machine might disagree with the test strips, but if you are using one method consistently you will see a response.
Using a checklist for other treatments, he also determines that she needs:
- Footbath – Yes, 3 a week
- BEST/chiropractic treatments – yes
- IV EDTA – no
- Minerals IV
- Alk ash food diet
Now he asks what makes her vital force so low. 5 issues: miasm, circulation, metabolic acidosis, pancreas, immune dysfunction, in order of priority.
He adds pH enhancer and alpha green to her list of remedies.
Now he asks how many issues there are with the pancreas. It says 3: miasm, acidosis, and emotions. She needs to correct emotional stress and strain. Yes/no answers narrow her problem down to: emotional issue, incident in past, 16 years ago (at age 8), involves another person, family member, male, father. This is the most important emotional issue and is affecting her blood sugar, acidosis, etc. He stops investigating at this point and leaves the rest to her psychologist: probably a good idea to stop before the machine can accuse her father of raping her.
Now he asks the machine if the analysis is complete. Yes. But we’re not finished yet.
Back to trace metals: we already knew she needs IV infusions of germanium, potassium, molybdenum, and manganese. He adds vitamin C and B vitamins to the list. Asks how much of each she needs. What is best fluid to mix them in? Water, dextrose, or normal saline? Normal saline. What size bag? 500 cc. Duration? 3-3 ½ hours. How many bags? 11. How often: 1 per week. Does she need a hydrogen peroxide IV? No. Does she need a separate glutathione IV? Yes. At the same time? No, but it could be given at another time later in the same day. Then he asks if she will tolerate this? Yes, you don’t need to worry about side effects.
As silly as this demonstration is, there is even sillier stuff out there. On one website, an operator places a laser pointer on the machine and supposedly imprints it with the needed “balancing” frequencies, then runs the light from the laser across the patient’s ear over all the auricular acupuncture points. You have to do this not once but three times. Three’s the charm. You couldn’t make this stuff up!
Harmful Effects
These tests identify numerous nonexistent problems and offer useless remedies. Some of them are potentially dangerous, like IV chelation and IV infusions of trace minerals and vitamins. Some of them are just laughable, like detoxifying foot baths.
Patients are lured away from science-based medical care. They are told that their prescription medications are interfering with the actions of these alternative remedies that could otherwise restore their energetic balance.
And what about the emotional impact of being told at age 24 that you have a will to live of only 1 (out of 100) and a biological age of 71? And being told that you need a complicated regimen of oral and IV remedies to improve your health. Along with footbaths, psychotherapy, chiropractic, etc. At a cost of several thousand dollars.
On a blog, one patient describes her feelings:
every time I walked out of that office I felt horribly flawed, horribly sick, and doomed, somehow. Like every move I made in my life was bad for me. Let’s face it, it’s hard to be healthy in the modern world. But what a weight I felt on my shoulders… I felt like I was 75 years old after those visits and it took me a few days to recover.
Where’s the Evidence?
There isn’t a shred of prior probability, but even the craziest-sounding methods “might” work. If the evidence showed that it worked, we would have to accept it and then try to figure out how it worked. I think this falls under Carl Sagan’s definition of extraordinary claims that require extraordinary evidence. In this case, there isn’t even any ordinary evidence, only the usual testimonials.
I could find only one study suggesting that electrodermal testing might work for anything: it found that electrodermal testing could discriminate between allergens and non-allergens. But a later study by the same group found it useless for diagnosing allergies And other double blind studies have shown that it could not detect respiratory allergies.
A review of diagnostic methods for allergies classified electrodermal testing among alternative methods that have “no proven benefit and may endanger patients via misdiagnosis.”
Conclusion
Electrodermal testing makes no sense and is not supported by any credible evidence. It is not based on science or grounded in reality; it is more akin to divination with a Magic 8 Ball. It merits a favorite phrase of Orac’s: a fetid load of dingo’s kidneys.
Next week, in Part II, I will discuss legal issues and regulatory actions.
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An open letter to NIH Director Francis Collins regarding his appearance at the Society for Integrative Oncology
Note from the editor: Since today is a holiday in the U.S., I had planned on taking the day off. Then I saw the subject of today’s post and had to respond. Also, please remember that, as always, the usual disclaimers apply. This letter represents my opinion, and my opinion alone. It does not represent the view or opinion of my university or cancer center—or anyone else, for that matter, other than me.
Francis S. Collins, MD, PhD
Director, National Institutes of Health
Dear Dr. Collins:
I am normally not one for writing open letters, but in this case I feel compelled to make an exception. This letter will have little or nothing to do with what seems to be the usual criticism leveled against you, namely your intense religious faith and claims. Personally, as a physician and scientist I don’t much care about what religion you follow and, unlike some writers such as Sam Harris, most definitely do not consider your strong Christian faith a disqualification for holding the position that you now hold. All I care about in an NIH director is how well he or she shepherds the scientific mission of the NIH and runs the organization. As a past (and hopefully future) NIH grantee, I want the NIH to fund and support only the most rigorous science and to be a well-run organization. Thus far in your tenure, I haven’t seen any anything major to worry about on that score.
Recently, however, I was very disappointed to discover that you will be the keynote speaker at the 8th International Conference of the Society of Integrative Oncology (SIO) in November. I hope that, when you agreed to accept this speaking engagement, you didn’t know just what it is that what you were accepting or what the Society for Integrative Oncology is, other than a professional society that was interested in hearing your views on faith and spirituality in cancer. In brief, it is our position that “integrative oncology” is a discipline that, at its core, is dedicated to “integrating” pseudoscience with science. No doubt you will think I am exaggerating, but I am not, as I hope to demonstrate. Worse, by agreeing to speak to the SIO, you will be providing it with the imprimatur of your position as NIH director. The NIH, as you know, is the most respected biomedical research institution in the U.S., if not the world, and that respect rubs off wherever you speak.
So, what is “integrative oncology” and why does it concern me as a cancer surgeon and researcher? I have already discussed it in considerable detail, as has my co-blogger Dr. Kimball Atwood, but I will try to summarize again. On multiple occasions, I’ve referred to “integrative oncology” as a “Trojan horse” that is allowing pseudoscience to infiltrate medical schools and academic medical centers. Here is what I mean. Whenever you see discussions of “integrative medicine” (IM) and in particular “integrative oncology,” chances are, the modalities under discussion will usually focus on various dietary changes and lifestyle interventions, such as exercise. Often recommended exercise comes in the form of yoga, tai chi, and other disciplines that tend to be infused with concepts from Eastern mysticism, such as qi (“life energy”). Other modalities featured often include herbal remedies. In other words, “integrative oncology” rebrands modalities that have no reason not to be counted as part of science-based medicine as “alternative” or “integrative” and points to them as having some promise. After all, if you strip away the Eastern mysticism from yoga and tai chi, among others, all you have left is low impact exercise, and there is no reason to consider low impact exercise to be anything “alternative” or “integrative.” Exercise and diet are within the purview of science-based medicine. Herbal remedies are nothing more than a rebranding of the perfectly science-based subdiscipline of pharmacology known as pharmacognosy. Advocates of CAM/IM then lump together pseudoscience like reiki, “therapeutic touch, acupuncture, naturopathy, and even homeopathy with sensible lifestyle interventions, such as diet and exercise, making the association that, if diet and exercise are “alternative” and work, so, too, do modalities that can at best be considered quackery, such as homeopathy.
Perhaps the best place to begin is with the SIO’s very own practice guidelines, which, I submit to you, represent a masterful package of rebranding of perfectly science-based modalities, such as lifestyle interventions and changes in diet, which are then tied to “energy healing” quackery as if there were an equivalent evidentiary basis to support them. For instance, some of the recommendations of the SIO are, as Dr. Atwood put it, embarrassingly obvious. For example:
- Recommendation 1: Inquire about the use of complementary and alternative therapies as a routine part of initial evaluations of cancer patients. Grade of recommendation: 1C
- Recommendation 6: The application of deep or intense pressure is not recommended near cancer lesions or enlarged lymph nodes, radiation field sites, medical devices (such as indwelling intravenous catheters), or anatomic distortions such as postoperative changes or in patients with a bleeding tendency. Grade of recommendation: 2B
- Recommendation 7: Regular physical activities can play many positive roles in cancer care. Patients should be referred to a qualifi ed exercise specialist for guidelines on physical activity to promote basic health. Grade of recommendation: 1B (1A for breast cancer survivors post-therapy for QoL)
- Recommendation 15: It is recommended that patients be advised regarding proper nutrition to promote basic health. Grade of recommendation: 1B
What is “alternative” about any of these recommendations? Nothing. Physicians routinely ask what supplements or “alternative” therapies their patients are using. It’s simply mind-numbingly obvious common sense not to use deep massage or pressure near cancer lesions, enlarged lymph nodes, radiation field sites, or near medical devices, such as Portacaths or other indwelling implantable devices. What physician would not recommend proper nutrition or regular physical activity, as much as the patient can tolerate, under the guidance of an exercise specialist? Then, coupled with the above sensible recommendations, we find this:
- Recommendation 3: Mind-body modalities are recommended as part of a multidisciplinary approach to reduce anxiety, mood disturbance, chronic pain, and improve QoL. Grade of recommendation: 1B
- Recommendation 8: Therapies based on a philosophy of bioenergy fields are safe and may provide some benefi t for reducing stress and enhancing QoL. There is limited evidence as to their effi cacy for symptom management, including reducing pain and fatigue. Grade of recommendation: 1B for reducing anxiety; 1C for pain, fatigue, and other symptom management
I find it most interesting to note what the SIO considers “1B” evidence:
Strong recommendation, moderate-quality evidence
How on earth can one reasonably make a “strong recommendation” on “moderate-quality” evidence, even assuming one agrees that the evidence is “moderate-quality”? The SIO defines “moderate quality” evidence as:
RCTs with important limitations (inconsistent results, methodological flaws, indirect, or imprecise) or exceptionally strong evidence from observational studies.
Also confusingly, the SIO makes “strong recommendations” based on “moderate” evidence (level 1B). In other places, it makes “strong recommendations” based on “low or very low quality evidence” (level 1C). Doesn’t it make you wonder why the SIO had to make up its own categories of evidence, rather than use accepted evidence-based medicine categories of evidence? Certainly, I wonder. I also wonder how the SIO could categorize instructing patients “regarding proper nutrition to promote basic health” as only category 1B.
As for other recommendations made by the SIO, rating the evidence for “energy healing” methods—or, as the SIO calls them, “therapies based on a philosophy of bioenergy fields”—as grade 1B vastly overestimates the quality and quantity of evidence in favor of “energy healing methods. Moreover these therapies are based on an unproven concept that there is an “energy field” or a “life energy” that can be manipulated for therapeutic intent. Never mind that no scientist has ever been able to measure or detect these “energy fields” or to verify that practitioners can actually manipulate them to therapeutic purpose. Never mind that the very concept is based on a vitalistic, pre-scientific understanding of how the human body works and how disease develops. I note that this includes acupuncture, whose premise is that sticking needles into the skin can somehow alter the flow of this life energy to healing effect. I also note that the totality of evidence regarding acupuncture is that it does no better than placebo when tested in well-designed randomized clinical trials. It doesn’t matter where the needles are placed or even whether the needles are placed. Indeed, even twirling toothpicks against the skin works as well as needles. Truly, as Steve Novella put it, acupuncture is the selling of nonspecific effects. Meanwhile, acupuncture apologists publish papers in which fanciful physiological mechanisms by which acupuncture allegedly works are proposed and poorly supported with evidence.
I note that the title of your talk is “Faith, Spirituality and Science in Oncology.” No doubt your intense religious faith is one reason why the SIO invited you. In actuality, in the world of “alternative” medicine,” “complementary and alternative medicine” (CAM), or IM (or whatever you want to call it), religious faith or “spirituality” is often co-opted to be the “foot in the door” for quackery in a manner very similar to how diet and exercise have been so co-opted. For example, are you familiar with reiki? It is one of the more prevalent of CAM/IM modalities, and it is currently being extensively used in cancer, even though the evidence base for it is virtually nonexistent. I have in the past referred to reiki many times as faith healing substituting Eastern mystical beliefs for Christian beliefs, and that is an accurate description. What is faith healing? It’s the belief that a healer can channel the power of God into the ill to heal them. What is reiki? Reiki involves channeling “energy” from what reiki masters call the “universal source” into the ill to heal them. Like faith healers, who assert that the power doesn’t come from them but from God, reiki masters assert that the power doesn’t come from them but rather from the “universal source.” Indeed, the founder of reiki, Dr. Mikao Usui explicitly patterned reiki on how Jesus healed:
Dr. Usui was a Christian minister in Japan, though Japanese. He was the head of a Christian Boys School in Japan. One day some of the students asked him if he believed in the miracles which Jesus did (healing, etc). Being a Christian minister he answered “Yes”. They asked if he knew how Jesus had done this, “No” he said…
With this he resolved to find the way in which Jesus had healed. This immediately set him on a journey of many years. Studying first at Christian schools in the US, for where else to learn of Jesus, but with no results. In the Christian schools the method was not known.
Dr. Usui even subjected himself to a 21 day fast on a mountain that very much resembled Jesus’ 40 days and 40 nights in the wilderness:
After a few more years of study, he felt he had come to an understanding and that to go further required serious meditation. He went to a nearby mountain declaring his intention to fast and meditate for 21 days and that if he did not come back they should come and get his body.
He went to the mountain and settled in with 21 stones with which to count the days. On the 21st day nothing had come as yet, and he turned over the last stone saying “Well, this is it, either I get the answer today or I do not”. At that moment on the horizon he could see a ball of light coming towards him. The first instinct was to get out of the way, but he realized this might just be what he was waiting for, so allowed it to hit him right in the face. As it struck him he was taken on a journey and shown bubbles of all the colors of the rainbow in which were the symbols of Reiki, the very same symbols in the writings he was studying but had been unable to understand. Now as he looked at them again, there was total understanding.
After returning from this experience he began back down the mountain and was, from this moment on, able to heal. This first day alone he healed an injured toe, his own starvation, an ailing tooth and the Abbots sickness, which was keeping him bedridden. These are known as the first four miracles.
I would respectfully submit to you as a scientist and man of faith that science- and evidence-based medicine should not be concentrating on miracles and faith healing. Yet that is what most “energy healing” modalities (reiki, therapeutic touch, and, yes, acupuncture) boil down to. It’s not for nothing that in 2009 the U.S. Conference of Catholic Bishops warned Roman Catholics to shun the eastern healing art of reiki because it lacks scientific credibility and is dangerous to Christian spiritual health. Some Christians even view reiki as a sin. Moreover, huge swaths of other CAM/IM modalities are based on similar beliefs that are rooted in faith, spirituality, and even outright magic. The common CAM/IM modality of homeopathy, for example, is based on the concepts of sympathetic magic, and naturopathy, which many SIO practitioners recommend, requires homeopathy as part of its training, which is why many naturopaths are also homeopaths.
We at SBM have criticized two institutions of the NIH for promoting and funding unscientific research, quackery even. These institutions include the National Center for Complementary and Alternative Medicine (NCCAM) and the National Cancer Institute’s (NCI) Office of Cancer Complementary and Alternative Therapy. Indeed, Dr. Atwood once wrote an open letter similar to this to NCCAM director Dr. Josephine Briggs when she agreed to speak at the annual conference of the American Association of Naturopathic Physicians last year and for the same reason that I’m writing this open letter now. The difference is that Dr. Briggs’ decision to speak to the AANP was more understandable than your decision to speak to the SIO; the reason is that, as strenuously as I and my fellow bloggers at SBM might object, NCCAM exists to study and promote “alternative” medicine. Consequently, the AANP can reasonably be considered to be within Dr. Briggs’ bailiwick. Moreover, NCCAM is but one center in the huge institution that is the NIH; her appearing at the AANP conference last year says far less about the NIH’s position with respect to unscientific “alternative medicine” modalities than your appearing in front of the SIO does.
I submit to you that SIO is trying to take advantage of your well-known religious faith in order to use your reputation as a scientist and as NIH director to claim for itself the mantle of scientific respectability that it does not merit. Instead of “bait and switch” rebranding science-based modalities such as diet and exercise as “alternative,” the SIO is rebranding religion and spirituality as somehow being “alternative medicine.” That is why I conclude by asking you most respectfully to reconsider. You represent the entire NIH, not just a single center in the NIH or an office in one institute in the NIH. Where you speak matters, and it matters a whole lot more than where Dr. Briggs chooses to speak. If you believe that we here at SBM are exaggerating or being unfair, we and others stand ready to provide you with all the supporting material you might require to be persuaded that we are not. We all strongly believe, as no doubt you do, that cancer patients deserve the best in science- and evidence-based medicine. Unfortunately, “integrative” oncology” provides nothing of the sort. It adds nothing to cancer care other than the rebranding of sensible treatments as “alternative” and the “integration” of unscientific, unproven, and potentially harmful “alternative” treatments with science-based treatments.
Cancer patients deserve better.
Finally, in these days of tight budgets resulting in even tighter paylines not seen in nearly 20 years, with no improvement in sight, please think about this one last thing. Between NCCAM and OCCAM, the NIH spends a quarter of a billion dollars a year studying and promoting a hodgepodge of modalities that range from being sensible science-based treatments, such as diet and exercise, to modalities that can only be referred to as being based on magical thinking (homeopathy, therapeutic touch, reiki, acupuncture, etc.). When budgets are this constrained, does the NIH have the luxury of spending a quarter of a billion dollars a year, or approximately 1% of the total NIH budget, half of which is nearly 3% of the NCI budget, on research that is exceedingly unlikely ever to benefit patients? For example, NCCAM has already spent over $2 billion since its inception in the 1990s and has yet to demonstrate convincingly that a single “alternative” medicine modality provides concrete benefits greater than placebo effects.
You are a man of science and faith. Your current position is a scientific one, and I have no doubt that you want to shape the NIH into a form that is dedicated to the best possible science we can get for the money and to promote that science. I hope you will realize that speaking at the SIO conference does not serve that end, nor does continuing NIH support for NCCAM and OCCAM. The division of medicine into “conventional” and “alternative,” “complementary and alternative,” or “integrative” medicine is a false dichotomy. There should be only medicine, and the scientific standards for determining what is and is not safe and effective medicine should be the same. It is my sincere hope that you, as NIH director, will not by speaking at the SIO conference support the false dichotomy that tries to foist unscientific medicine upon cancer patients as “integrative” medicine.
Sincerely
David H. Gorski, MD, PhD
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Texas House Bill 1841: Hosting and Taxes
Okay, so you’ve read the title and passed out already … but wait – this is good stuff! Well, maybe not “good,” but at least it’s relevant. The esteemed governor of Texas with the big Texas hair (and aspirations of taking his big hair out of Texas) recently signed House Bill 1841 (HB1841) into law, and that law is significant to many of SoftLayer’s customers.
Last year, the Texas Comptroller’s Office amended a regulation and stated that the use of a server in Texas was adequate to establish a nexus, so an e-commerce vendor who used a Texas web host was required to collect sales tax from their customers even if the vendor had no other presence in the state of Texas. This amendment immediately created issues for web hosts with data centers in Texas: Why would customers get servers from a host in Texas and have to worry about this tax obligation, when they could do business with another host outside of Texas and not have this obligation?
Well, the Comptroller’s Office started to realize the effect of this regulation and began to backpedal and say that they didn’t really mean what they said.
HB1841 puts the Texas hosting industry back where it was before the Comptroller made those changes: The use of a server located in Texas without any other presence is not considered a substantial nexus for collecting sales taxes. HB1841 specifically states that “A person whose only activity in this state is conducted as a user of Internet hosting is not engaged in business in this state.” Note: You may be wondering if this bill applies to Amazon in Texas, but HB1841 doesn’t cover Amazon because they had a physical presence in Texas (albeit one operating under a different affiliate with a different name), requiring them to pay sales taxes.
Our very own Brenk Johnson was involved in the effort to pass HB1841. He attended a couple of committee hearings, and he’ll tell you his mere presence got this out of committee and in front of our governor. He is quoted as saying, “I can sit in a meeting with the best of them.”
At the risk of making this blog sound like an Academy Awards reception speech, we would like to thank Jeff Clark and the crew over at TechAmerica for helping to get this bill passed. TechAmerica is a technology advocacy group that we recently joined, and they have a cracker-jack lobby group. Our CFO and I were on the verge of hiring a lobbyist for the 2009 Texas session, but we ended up not doing so. Two years later, we decided to go with this industry group, and the verdict is that TechAmerica has been a great investment … It was also through this group that Lance became a Cloud Commissioner! We also want to thank our competitors over at RackSpace, especially their General Counsel Alan Schoenbaum, for getting us involved and for leading and spearheading the passage of this bill … What was good for the goose was good for the gander on this one.
Because we are back to where we were a couple of years ago in the definition of nexus with relationship to hosts with data centers in Texas, this was not really a game-changing bill. It was important to clarify and undo the damage caused by the waffling that occurred in the State’s Comptroller’s Office, so in that sense this was a good bill for the industry. Next session we’re going to aim for the game-changer: Margin taxes!
-Suzy
Technology Partner Spotlight: The Server Monitor
Welcome to the next installment in our blog series highlighting the companies in SoftLayer’s new Technology Partners Marketplace. These Partners have built their businesses on the SoftLayer Platform, and we’re excited for them to tell their stories. New Partners will be added to the Marketplace each month, so stay tuned for many more come.
- Paul Ford, SoftLayer VP of Community Development
Scroll down to read the guest blog about The Server Monitor from Otto Papp of Blue Panther. The Server Monitor is a featured service in the SoftLayer Tech Partner Marketplace that makes it easy for customers to get a deep view of what is happening on their servers. To learn more about The Server Monitor, visit http://theservermonitor.com/.
Know What’s Happening on Your Servers
The Server Monitor was born when we noticed a need in our company. We have been developing and maintaining online businesses for more than 6 years now, and in that time we encountered all kinds of problems. We know very well that any interruption of a service can have many negative effects, so to track and prevent service interruptions we needed a monitoring tool. We tried both commercial and open-source software, but none of them was suited for the job, so we set out to create a product that met six key requirements:
1. Simple Setup, Simple Configuration and Simple Maintenance
While we were searching for a monitoring tool, we many solutions. Most of them were really painful to install and even worse to configure. If you have a service that needs to be scaled and you need to upgrade servers or change your infrastructure, you don’t want to waste your time repeating a painful job over and over again. The same thing holds true if you simply have to manage more than a few servers.
In response to this need, The Server Monitor’s agent was built to be installed and configured under two minutes on every server. Unlike with some of the other tools out there, you don’t have to be an expert in administration and configuration thanks to the meticulous design of the application and its user interface. Even when this tool evolves and improves, it is easily upgraded via a powerful (and simple) built-in upgrade mechanism.
The tool helps you avoid using your server to store monitoring data and frees you from having to install and maintaining a dedicated monitoring data database. Using an agent also helps The Server Monitor consume less of your server’s computing power in the monitoring process.
2. Ease of Use
We wanted a tool that could be easily understood by our clients, so we built the user experience with very clear visuals like our customizable graphical reports. These reports can help non-technical people understand what’s happening on a given server, and they help seasoned systems administrators track down the root cause of any server problems to any component of their system as well. Unfortunately, some of the best solutions on the market were hard to understand and analyze, even for us, as a technical team. That’s why we focused a lot on clearly presenting only relevant data.
3. Accurate and Advanced Monitoring
Another big issue we ran into was the accuracy of the monitored data. Some solutions offered a 5, 10 or 30 minute reading which is not very helpful when you’re debugging a problem or detecting an outage. Others had second- or minute-based monitoring frequency but delivered inaccurate results.
We built The Server Monitor to provide a high level of accuracy by computing the average variation of the monitored data over one minute. We are developing dedicated monitors to all the major services usually used on servers, and by truly understanding these services, we can customize the readings to offer the best view of what’s happening with each service.
4. Early Warning for Potential Disasters
The most valuable aspect of good server monitoring tools is their ability to notified users of major events. If your monitoring tools are local on the server, if the server goes down, the monitoring system does too, so you didn’t get notified. On the other side, we noticed that the online solutions couldn’t provide very much in the way of detailed information.
This is one of the reasons why we opted for an agent-based solution which notifies you when things start to go wrong so you can take immediate action. The Server Monitor includes a powerful alert system with an unlimited number of configurable alerts that can be sent out in real time via SMS, Twitter or email.
5. A Centralized View
In order to speed up our customers’ routine administration checks, we built a unified interface where all the servers monitored can be seen quickly. That centralize view continues to evolve as we get feedback from customers, and we’ll keep tweaking it to make sure we convey the most relevant data on each server as simply as possible. With that goal in mind, we’ve also built a report-sharing system, that allows customers to check these reports in their own interfaces.
6. Flexibility for Developers
While The Server Monitor is an online service, we also develop highly sophisticated software engines (in our spare time). These programs are very different, so each would need a unique kind of monitoring tool, but creating specialized tools with limited scopes would be time consuming and inefficient. We couldn’t find any existing solution to solve this problem so we came up with our own! The idea is simple, your software collects and computes its specific metrics and gives them to the agent program which sends them to the central system. From there, you can then analyze, compare and follow their information.
Initially, our goal was to build a monitoring platform that worked for us, and in the process, we built a product that could be extremely useful to other developers in our position, so we began offering the service externally. We have a free version of the software that you’re welcome to try on your own servers, and if you want to take advantage of some of the additional features and functionality of the system, we have a 30 day trial to see if it fits your requirements.
-Otto Papp, The Server Monitor