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Zeo Personal Sleep Coach

 Sleep that knits up the ravelled sleeve of care
The death of each day’s life, sore labour’s bath
Balm of hurt minds, great nature’s second course,
Chief nourisher in life’s feast.   
 -William Shakespeare, Macbeth

Zeo

The company that makes the Zeo Personal Sleep Coach  kindly sent me one of their devices to try out. It’s a nifty little gadget, and if you are a techno geek, you would probably love it. It’s a fascinating toy; but for insomnia, there’s no evidence that it provides any benefit over standard treatment with sleep logs and sleep hygiene advice.

Polysomnography is done overnight in a sleep lab and costs around $1000. It records multiple parameters: EEG, EKG, EMG, breathing, O2, CO2, and limb movements. It is most commonly used to diagnose obstructive sleep apnea (OSA), a serious condition that is linked to hypertension, heart disease, diabetes, metabolic syndrome, stroke, and increased mortality. OSA can be effectively treated with CPAP and other measures. About 50% of snorers have sleep apnea. We typically think of it as a disease of obese, loudly snoring older men, but even young children can have it: snoring is probably never normal in children and should be investigated.

The Zeo is the first sleep monitor available for consumers to use at home. It doesn’t pretend to do what polysomnography does. It can’t diagnose sleep apnea. It is billed as an educational and motivational tool, not intended for the diagnosis or treatment of sleep disorders. A unit that looks sort of like an alarm clock sits on your bedside table and communicates wirelessly with a comfortable soft elastic headband that positions embedded sensors over your forehead to pick up your brain waves. (more…)

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The Winkler County nurse case and the problem of physician accountability

A MISCARRIAGE OF JUSTICE THAT HAD A (SORT OF) HAPPY ENDING

Back in September and then again last week, I wrote briefly (for me) about an incident that I considered to be a true miscarriage of justice, namely the prosecution of two nurses for having reported the dubious and substandard medical practices of a physician on the staff of Winkler County Hospital in Kermit, Texas. The physician’s name is Dr. Rolando Arafiles, and he happened to be a friend of the Winkler County Sheriff, Robert Roberts, who also happened to have been a patient of Dr. Arafiles and very grateful to him for having saved his life. The nurses, Anne Mitchell and Vickilyn Galle, were longtime employees of Winkler County Hospital, a fifteen bed hospital in rural West Texas. Although some of you may have seen extensive blogging about this before, I thought it very important to discuss some of the issues involved on this blog. Moreover, there is an aspect to this case that the mainstream media reporting on it has missed almost completely, as you will see. Finally, this case showed me something very ugly about my profession, not just because a doctor tried to destroy the lives of two good nurses through his connections to the good ol’ boy network in Winkler County

Let’s recap what happened, a story that reached its climax last Thursday. In 2008, Dr. Arafiles joined the staff of Winkler County Hospital (WCH). It did not take too long for it to become apparent that there were serious problems with this particular doctor. Mitchell and Galle, who worked in quality assurance were dismayed to learn that Dr. Arafiles would abuse his position to try to sell various herbal remedies to patients in the WCH emergency room and the county health clinic and to take supplies from the hospital to perform procedures at a patient’s home rather than in the hospital. No, it wasn’t the fact that Dr. Arafiles recommended supplements and various other “alt-med” remedies, it’s that he recommended supplements and various other “alt-med” remedies that he sold from his own business–a definite no-no both ethically and, in many states, legally. Mitchell reported her concerns to the administration of WCH, which did pretty much absolutely nothing. Consequently, on April 7, 2009, Mitchell and Galle anonymously reported their concerns to the Texas Medical Board (TMB). In June, WCH fired the two nurses without explanation.
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Posted in: Health Fraud, Homeopathy, Politics and Regulation, Science and the Media, Vaccines

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The autism “biomed” movement: Uncontrolled and unethical experimentation on autistic children

Ever since I first discovered the anti-vaccine movement, first on Usenet, specifically on a Usenet newsgroup devoted to discussing alternative medicine (misc.health.alternative, or m.h.a. for short) and then later on web and on blogs, there have been two things that have horrified me. First, there are the claims that children suffer all sorts of harm from vaccines, be it being made autistic (with the attendant “autism epidemic” caused by vaccines), suffering neurological damage, immune system damage, and all manner of other adverse consequences. There is no good evidence for these claims (although, as has been documented right here on this very blog time and time again, anti-vaccine activists will trot out all manner of awful studies to support their contentions), but that doesn’t keep useful celebrity idiots like Jenny McCarthy, Jim Carrey, Don Imus, or Bill Maher from repeating the same myths over and over again. Worse, the permeation of society with these myths about vaccines has led to declining vaccination rates and the resurgence of potentially deadly vaccine-preventable diseases. It began first in the U.K. in the wake of Andrew Wakefield’s trial lawyer-funded, incompetent, and possibly fraudulent “research,” and has spread to the U.S., thanks to Jenny McCarthy and her ilk, who won’t take responsibility for their words and actions.

Even worse, the myth that vaccines cause autism has led to ideas. Dangerous ideas, and not because they “challenge” medical orthodoxy. These ideas are dangerous because they have direct consequences for children with autism. These consequences take the form of subjecting children to unscientific treatments that are ineffective at best and harmful at worst, sometimes even life-threatening. Indeed, I have written about case histories in which children were subjected to injections of “stem cells” into their cerebrospinal fluid by lumbar puncture and various other “treatments,” as well as chemical castration in combination with chelation therapy. That latter bit of quackery is something I wrote about years ago, but that the mainstream press only just noticed earlier this year. Better late than never, I guess. Even better than that, though, the same reporting team at the Chicago Tribune that reported on Mark and David Geier’s advocacy of Lupron to treat autistic children back in May. Sadly, the result of that story does not appear to have been actions by the State of Maryland to take away Dr. Mark Geier’s medical license or to go after his son David for practicing without a license. Neither does it appear to have resulted in insurance companies going after them for prescribing an expensive drug for an indication for which it is not appropriate. What it does appear to have done, however, is to inspire the same journalist, Trine Tsouderos, along with another journalist from the Chicago Tribune, Patricia Callahan, to pursue an even bigger target that Mark and David Geier, namely the entire “autism biomed movement,” which is for the most part rank quackery, in the following articles:

This is another rare case of excellent reporting on this issue, and I hope that this report (another installment of which was published early this morning after I had written this post) will grab the attention of more reporters and news outlets, leading to shining a light on the dark underbelly of the autism biomed movement.
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Posted in: Health Fraud, Herbs & Supplements, Public Health, Vaccines

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A Case Study In Aggressive Quackery Marketing

With some degree of sadness I recently “outed” a former co-resident of mine who has turned to the dark side and begun putting money-making before truth and science. Without any clear evidence of benefit beyond placebo, platelet-rich plasma (PRP) is now being marketed aggressively as a cure-all for sports injuries. And at about $300 per injection (the NYT reports $2000/treatment), there’s plenty of money to be made.

Like the fake “stem cell” clinics in Russia (where, according to Sanjay Gupta’s recent book, Chasing Life, a person’s fat cells are harvested, washed, and re-injected into their blood stream), PRP also involves injection of autologous body fluids. Essentially, a small amount of blood is drawn from the patient, centrifuged, and the plasma supernatant is then injected directly into tendons and/or joints. After a series of 3 injections (one/month), most sports injuries are “cured.” Of course, most injuries would heal themselves in three months anyway. (more…)

Posted in: Clinical Trials, Dentistry, Health Fraud, Surgical Procedures

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Health Care Bills: More Mischief in Washington

Forgive the departure from my usual verbosity. I’m on my way to a meeting, and I don’t have the time. Today I’ll report disturbing content found in health care bills that are competing for passage in Washington. Thanks to Linda Rosa for keeping our attention on language in one of the Senate bills: S.1679 – Affordable Health Choices Act,” sponsored by (guess who?) Senator Tom Harkin (D-IA). According to Linda, Harkin and supporters will attempt to merge his bill with Baucus’s. Here are some of the choice passages in Harkin’s 800+ page bill (emphasis added):

SEC. 2713. NON-DISCRIMINATION IN HEALTH CARE.

A group health plan and a health insurance issuer offering group or individual health insurance coverage shall not discriminate with respect to participation under the plan or coverage against any health care provider who is acting within the scope of that provider’s license or certification under applicable State law. This section shall not require that a group health plan or health insurance issuer contract with any health care provider willing to abide by the terms and conditions for participation established by the plan or issuer. Nothing in this section shall be construed as preventing a group health plan, a health insurance issuer, or the Secretary from establishing varying reimbursement rates based on quality or performance measures.

SEC. 212. GRANTS TO ESTABLISH COMMUNITY HEALTH TEAMS TO SUPPORT THE PATIENT-CENTERED MEDICAL HOME.

…(4) ensure that the health team established by the entity includes an interdisciplinary, interprofessional team of health care providers, as determined by the Secretary; such team may include medical specialists, nurses, nutritionists, dieticians, social workers, behavioral and mental health providers (including substance use disorder prevention and treatment providers), doctors of chiropractic, licensed complementary and alternative medicine practitioners, and physicians’ assistants;

…(c) Requirements for Health Teams- A health team established pursuant to a grant under subsection (a) shall–

(1) establish contractual agreements with primary care providers to provide support services;

(2) support patient-centered medical homes, defined as mode of care that includes–

(A) personal physicians;

(B) whole person orientation;

…(F) provide coordination of the appropriate use of complementary and alternative (CAM) services to those who request such services;

…(H) provide local access to the continuum of health care services in the most appropriate setting, including access to individuals that implement the care plans of patients and coordinate care, such as integrative health care practitioners; (more…)

Posted in: Faith Healing & Spirituality, Health Fraud, Politics and Regulation, Religion

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The “Iron Rule of Cancer”: The dangerous cancer quackery that is the “German New Medicine”

Given that I trained as a cancer surgeon, do laboratory and translational cancer research, and spend my clinical time taking care of breast cancer patients, not surprisingly one topic that gets me the most irritated and provokes a lot of my verbiage for SBM is cancer quackery. As I was perusing my list of posts the other day, it occurred to me that there’s one huge topic that in the more than a year and a half I’ve been blogging for SBM I’ve never covered. It’s a particularly pernicious and dangerous quackery. Indeed, it’s a quackery I mentioned during part of my talk at the Science-Based Medicine Conference, which Steve organized and where several SBM bloggers spoke the day before TAM7 started.

I’m referring to the dangerous and vile quackery known as the German New Medicine (Die Germanische Neue Medizin). Pioneered by Ryke Geerd Hamer, it is a quackery that claims lives. So what is this German New Medicine? Well, it appears to be a Theory of Everything Medical, and in particular everything having to do with cancer:

THE GERMAN NEW MEDICINE provides us with illuminating explanations about the origin, development and healing of both physical and mental disorders. In 1981, Dr. Hamer discovered that every DISEASE is caused by a shock experience that catches us completely off guard. He found that this shock not only occurs in the psyche but simultaneously in the brain and on the organ level. At the moment the unexpected trauma takes place the shock impacts a specific area in the brain causing a lesion that is clearly visible on a brain scan as a set of sharp concentric rings. With the impact the affected brain cells communicate the disturbance to the corresponding organ. Whether the organ responds with a tumor growth (cancer), with tissue degeneration, or with functional loss, is determined by the exact type of conflict shock. Based on the analysis of over 40,000 case studies Dr. Hamer is the first to provide scientific proof that cancer is not caused by a malfunctioning organism producing deadly cancer cells but is rather the result of an innate meaningful survival program that has been successfully practiced for millions of years. Since HEALING can only occur after the conflict has been resolved, the GNM-therapy focuses on identifying and resolving the original conflict. By understanding healing symptoms such as painful swelling, infections, fever, or inflammation in their psychological, biological and evolutionary context, we are able to liberate ourselves from the fear and panic that often come with the onset of an illness. Dr. Hamer’s findings offer a completely new understanding of so-called diseases. His scientific discoveries revolutionize entirely our view of medical conditions and their causes.

The German New Medicine presents a comprehensive system that allows us to understand what type of conflict causes the onset of a particular disease, how the disease manifests itself in the conflict active phase, what can be expected in the healing phase, and how all the developments are connected to the brain, verifiable with a brain scan.

The German New Medicine is a natural science, based on FIVE empirically disovered BIOLOGICAL LAWS that apply, in a strong scientific sense, to each and every case of disease of man and mammal.

The repository of quackery known as Mercola.com describes the “Five Biological Laws” of German New Medicine thusly:
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Posted in: Cancer, Health Fraud, Science and Medicine

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The price of anti-vaccine fanaticism: Case histories

One of the major themes of SBM has been to combat one flavor of anti-SBM movement that believes, despite all the evidence otherwise, that vaccines cause autism and that autism can be reversed with all sorts of “biomedical” quackery. Many (but by no means all) of these so-called “biomedical” treatments are based on the false view that vaccines somehow caused autism. I and my fellow SBM bloggers have expended huge quantities of verbiage refuting the pseudoscience, misinformation, and outright lies regularly spread by various anti-vaccine groups and two celebrities in particular, namely Jenny McCarthy and her boyfriend Jim Carrey. Most of the time, we discuss these issues in terms of the harm to public health that is done by falling vaccination rates due to the fear engendered by the message of the anti-vaccine movement and the threat of the return of vaccine-preventable diseases that once wreaked havoc among children.

There is another price, however. There is a price that is paid by autistic children themselves and their parents. It is a price paid in money and lost time. It is a price paid in being subjected to treatments that are highly implausible from a scientific standpoint and for which there is no good scientific evidence. It is a price that can result in bankruptcy, suffering, and, yes, even death.

It is a price, I think, that is best demonstrated through a few case studies. This is a situation when anecdotes have their use.
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Posted in: Health Fraud, Public Health, Science and the Media, Vaccines

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Bill Maher endorses cancer quackery

Over the last five years or so, I’ve often asked, “Is Bill Maher really that ignorant?” I’ve come to the conclusion that he is, and a couple of weeks ago laid out the evidence why right here on this very blog. (Lately Maher has been issuing Tweets that call people who get flu shots “idiots.”) Indeed, I even included in the post perhaps the most hilariously spot-on riposte to Maher’s crankery. This occurred when Maher proclaimed that he never gets the flu and wouldn’t get the flu on an airplane, which his guest Bob Costas to exclaim in exasperation, “Oh, come on, Superman!”

Bob Costas won my respect that day. My favorite part was when Maher looked at his guests, who were shifting in their seats, all embarrassed and unsure of what to say, and observed, “You all look at me as though I’m crazy.”

Why, yes, Bill, we do. Let’s put it this way. When Age of Autism likes you, you have a serious problem when it comes to being credible about medical science.

In that same post, I complained about Maher’s being awarded the Richard Dawkins Award by the Atheist Alliance International (AAI). I liken giving Bill Maher an award that lists “advocates increased scientific knowledge” anywhere in its criteria, not to mention being named after Richard Dawkins, to giving Jenny McCarthy an award for public health, given that, at least when it comes to medicine, Maher is anti-science to the core. Along the way, I’ve ruffled the feathers of some of both Dawkins’ and Maher’s fans.

I regret nothing.

Not only do I regret nothing, but on September 18, a mere two weeks before the AAI Convention, Maher provided me with more ammunition. In fact, this is probably the most blatant bit of crankery I’ve seen from Maher in a long time. Watch and learn. The “alternative medicine” nuttery begins at around the 0:50 mark:

Laetrile? Really? Laetrile?? How 1970s cancer quackery!
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Posted in: Cancer, Faith Healing & Spirituality, Health Fraud, Science and the Media, Vaccines

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“Gonzalez Regimen” for Cancer of the Pancreas: Even Worse than We Thought (Part II: Loose Ends)

Last week I discussed the dismal results of the “Gonzalez Trial” for cancer of the pancreas,* as reported in an article recently posted on the website of the Journal of Clinical Oncology. I promised that this week I’d discuss “troubling information, both stated and unstated [in the report],” and also some ethical issues. More has come to light in the past few days, including Nicholas Gonzalez’s own voluminous, angry response to the JCO article. I’ll comment upon that below, but first a brief review.

The trial was begun in 1999 under the auspices of Columbia University, after Rep. Dan Burton had pressured NCI Director Richard Klausner to fund it. It was originally conceived as a randomized, controlled trial comparing the “Gonzalez Regimen” to standard chemotherapy for cancer of the pancreas. In the first year, however, only 2 subjects had been accrued, purportedly because those seeking Gonzalez’s treatment were not willing to risk random assignment to the chemotherapy arm. In 2000, the protocol was changed to a “prospective, cohort study” to allow potential subjects to choose which treatment they would follow. Gonzalez himself was to provide the ‘enzyme’ treatments.

After that there was little public information about the trial for several years, other than a few determination letters from the Office of Human Research Protections and a frightening account of the experience of one subject treated by Gonzalez. By 2006 or so, those of us who pay attention to creeping pseudomedicine in the academy were wondering what had become of it. About a year ago we found out: the trial had been quietly “terminated” in 2005 after it met “pre-determined stopping criteria.” As explained here, that meant that the Gonzalez group had not fared well.

Four years after the trial’s ‘termination,’ the report was finally published: The Gonzalez cohort had not only fared much worse than the cohort that received chemotherapy, but it had fared worse than a comparable group of historical controls. Here, again, is the survival graph from the JCO paper:

Snapshot 2009-09-11 16-16-15

The Gonzalez group had also fared much worse in ‘quality of life’ scores, which included a measure of pain.

Now let’s read between the lines. Forgive me for taking shortcuts; I’m a little pressed for time. (more…)

Posted in: Clinical Trials, Health Fraud, Herbs & Supplements, Medical Academia, Medical Ethics, Science and Medicine, Science and the Media

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“Gonzalez Regimen” for Cancer of the Pancreas: Even Worse than We Thought (Part I: Results)

ResearchBlogging.org

Review

One of the more bizarre and unpleasant “CAM” claims, but one taken very seriously at the NIH, at Columbia University, and on Capitol Hill, is the cancer “detoxification” regimen advocated by Dr. Nicholas Gonzalez:

Patients receive pancreatic enzymes orally every 4 hours and at meals daily on days 1-16, followed by 5 days of rest. Patients receive magnesium citrate and Papaya Plus with the pancreatic enzymes. Additionally, patients receive nutritional supplementation with vitamins, minerals, trace elements, and animal glandular products 4 times per day on days 1-16, followed by 5 days of rest. Courses repeat every 21 days until death despite relapse. Patients consume a moderate vegetarian metabolizer diet during the course of therapy, which excludes red meat, poultry, and white sugar. Coffee enemas are performed twice a day, along with skin brushing daily, skin cleansing once a week with castor oil during the first 6 months of therapy, and a salt and soda bath each week. Patients also undergo a complete liver flush and a clean sweep and purge on a rotating basis each month during the 5 days of rest.

Veteran SBM readers will recall that in the spring of 2008 I posted a series of essays* about this regimen and about the trial that compared it to standard treatment for subjects with cancer of the pancreas. The NIH had funded the trial, to be conducted under the auspices of Columbia, after arm-twisting by Rep. Dan Burton [R-IN], a powerful champion of quackery, and much to the delight of the “Harkinites.”

In the fall of 2008 I posted an addendum based on a little-known determination letter that the Office for Human Research Protections (OHRP) had sent to Columbia during the previous June. The letter revealed that the trial had been terminated in October, 2005, due to “pre-determined stopping criteria.” This demonstrated that Gonzalez’s regimen must have been found to be substantially worse than the current standard of care for cancer of the pancreas, as ineffective as that standard may be. I urge readers who require a review or an introduction to the topic to read that posting, which also considered why no formal report of the trial had yet been made available.

Now, finally, the formal report has been published online by the Journal of Clinical Oncology (JCO):

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Posted in: Cancer, Clinical Trials, Health Fraud, Herbs & Supplements, Medical Academia, Medical Ethics, Politics and Regulation, Science and Medicine

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