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Naturopaths and the anti-vaccine movement: Hijacking the law in service of pseudoscience

Time and time again, we’ve seen it. When pseudoscientists and quacks can’t persuade the scientific and medical community of the validity of their claims, they go to the law to try to gain the legitimacy that their claims can’t garner through proving themselves by the scientific method. True, purveyors of pseudoscience and unscientifically-derived medical practices do crave the respectability of science. That’s why they try so hard to take on the trappings of science. The problem is that they just can’t do it right, try as they might, or when they do it right their methods are shown to be no more effective than a placebo, aside from the occasional seeming “positive” results that would be expected based on random chance alone. However, failing to achieve the respectability that the mantle of science provides, practitioners and advocates of pseudoscience frequently try to codify their woo into the law.

The reason that they would do this is not too hard to discern. Few legislators and politicians are scientists, and even fewer are scientifically inclined. Back when I still lived in New Jersey, I may have been lucky enough to have had a Congressional Representative who really was a rocket scientist (well, a physicist, actually), but now that I live in Michigan I’ve gone from having a scientifically inclined Congressional representative to having one of the dimmest bulbs in Congress representing me. What that means is that it’s far easier to persuade politicians that this woo or that woo deserves to be permitted or even licensed. That’s how we now have many states licensing acupuncturists, naturopaths, and even “homeopathic physicians,” as Arizona does. The pressure for this sort of acceptance of unscientific medical modalities is building, as well, as Kimball Atwood has documented. Another example is the Dietary Supplement Health and Education Act (DSHEA), which was passed in 1994 and in essence ties the FDA’s hands when it comes to regulating most supplements. Indeed, the very existence of the National Center for Complementary and Alternative Medicine (NCCAM) is a testament to the success of this approach, as a powerful Senator (Tom Harkin, D-IA) almost single-handedly foisted this scientific atrocity on the NIH against the desires of scientists. The results have included a $30 million scientific boondoggle of a trial to test chelation therapy and a profoundly unethical trial of Dr. Nicholas Gonzalez’s “protocol” for pancreatic cancer patients that a recent clinical trial has shown to be worse than useless. The most recent example of this trend is the way that CAM supporters have tried to hijack President Obama’s health insurance reform initiative to insert coverage for everything from any licensed “alternative medicine” practitioner to Christian Science prayer healing.

Recently, two new fronts have been opened up in this battle. One is disturbingly close to me, as it involves the Canadian province of Ontario whose north shore on the Detroit River is less than two and a half miles from my office, the other in Oregon, which, although it’s happening nearly 2,000 miles away from where I live and practice, could portend a new and disturbing tactic of the anti-vaccine movement to do what various other purveyors of pseudoscience have done before and try to win in state legislatures where they can’t win in science or the courts. Of course, in a democratic republic, it is the right of everyone, even supporters of quackery, to try to petition his or her legislators, but it is equally the responsibility of those of us supporting science-based medicine to try to educate legislators why allowing them to alter the law to protect their pseudoscience has the potential to result in great harm.
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Posted in: Herbs & Supplements, Politics and Regulation, Public Health, 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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Cancer prevention: The forgotten stepchild of cancer research?

The New York Times has been periodically running a series about the “40 years’ war” on cancer, with most articles by Gina Kolata. I’ve touched on this series before, liking some parts of it, while others not so much. In particular, I criticized an article one article that I thought to be so misguided about how the NIH grant system leads researchers to “play it safe” and how we could cure cancer if we could just fund “riskier” research that I had to write an extended screed about the misconceptions in the article. The latest installment, Medicines to Deter Some Cancers Are Not Taken, also by Kolata, is much better in that it discusses a problem at the heart of cancer, namely that we have developed drugs that can decrease the risk of specific cancers but they are not as widely used as they could be.

The first part of the article contrasts a seeming incongruity:

Many Americans do not think twice about taking medicines to prevent heart disease and stroke. But cancer is different. Much of what Americans do in the name of warding off cancer has not been shown to matter, and some things are actually harmful. Yet the few medicines proved to deter cancer are widely ignored.

Take prostate cancer, the second-most commonly diagnosed cancer in the United States, surpassed only by easily treated skin cancers. More than 192,000 cases of it will be diagnosed this year, and more than 27,000 men will die from it.

And, it turns out, there is a way to prevent many cases of prostate cancer. A large and rigorous study found that a generic drug, finasteride, costing about $2 a day, could prevent as many as 50,000 cases each year. Another study found that finasteride’s close cousin, dutasteride, about $3.50 a day, has the same effect.

This is indeed a contrast. Think about it. Millions of Americans take statins, for instance, to lower their cholesterol and thereby try to prevent the complications of elevated cholesterol, such as heart disease, vascular disease, and strokes. Yet, for at least two common cancers, there are proven effective drugs that will lower the risk of cancer considerably with a side effect profile at least as favorable as that of statins.
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Posted in: Cancer, Clinical Trials, Herbs & Supplements, Nutrition, Politics and Regulation

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Resveratrol: Of Mice and Men

We would all like to live longer. The most promising longevity research indicates that severe calorie restriction might extend life span, but such a diet is difficult to follow. Resveratrol, a phytochemical found in red wine, has been evaluated as a possible way out of the dilemma. When given to obese mice on a high calorie diet, it produced a number of changes associated with improved health, such as increased insulin sensitivity, and it increased survival. Perhaps by taking resveratrol you could eat as much as you want and get fat without suffering the usual consequences. Perhaps you could get the longevity benefits of severe calorie restriction without restricting calories.

In addition to fat mice, resveratrol also extends the life of Saccharomyces cerevisiae, Caenorhabditis elegans and Drosophila melanogaster (yeast, nematodes, and fruit flies). But a study in non-obese mice found no increase in survival (although it did find several signs of improved health). Besides the anti-aging claims, there is also some evidence from in vitro and animal studies that it might have cardiovascular effects and anti-cancer effects. (more…)

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The Science Fiction of Nutritional Genomics

EDITOR’S NOTE: Dr. Gorski is currently in Chicago attending the American College of Surgeons Clinical Congress. As a result, he has not prepared a post for this week (although he doesn’t feel too guilty about missing this week, given that he did write two rather hefty posts last week, one on the cancer quackery known as the German New Medicine and the other on a rather dubious monkey study being promoted by the anti-vaccine movement). Fortunately, we have Ben Kavoussi to fill in with a post on some of the more exaggerated claims of advocates of nutritional interventions for various diseases and conditions. Enjoy!

A centipede was happy quite,
Until a frog in fun
Said, “Pray, which leg comes after which?”
This raised her mind to such a pitch,
She lay distracted in the ditch
Considering how to run.

Anonymous

Just like complementary and alternative medicine (CAM), nutritionism — meaning the unexamined assumption that food is only a conveyor of the substances it contains 1,2 — has evolved independently of science and medicine since the 1970s, and has caused so much wondering and confusion about food and diet that many Americans have become unable to eat properly. Today, there isn’t a popular magazine that doesn’t have a “health and nutrition” section that — often with the backing of very little science — promises many health benefits of a nutrient or warns against the harms of another; and then provides a list of foods that contain it. The same publication might time and again write the exact opposite, further adding to the already-prevalent nutritional confusion. Nutritionism is thus an ideology sourced by popular beliefs, academic reveries, and the food and dietary supplements industry, where food is simply seen as a mean to achieve a specific health goal. In its latest form, however, coupled with genomics and biomedical informatics, and called “nutrigenomics” or “nutritional genomics,” nutritionism takes academic reveries to such an extent that it could be accurately described as “science fiction.” The Center of Excellence for Nutritional Genomics at UC Davis writes indeed (in bold) on its website that:

“The promise of nutritional genomics is personalized medicine and health based upon an understanding of our nutritional needs, nutritional and health status, and our genotype. Nutrigenomics will also have impacts on society — from medicine to agricultural and dietary practices to social and public policies — and its applications are likely to exceed that of even the human genome project. Chronic diseases (and some types of cancer) may be preventable, or at least delayed, by balanced, sensible diets. Knowledge gained from comparing diet/gene interactions in different populations may provide information needed to address the larger problem of global malnutrition and disease.”

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Posted in: Herbs & Supplements, Nutrition

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Red Yeast Rice to Lower Cholesterol

The Medical Letter,  a highly respected source of reliable independent evaluations of drugs and therapeutics, has just published an evaluation of red yeast rice (Vol 51, Issue 1320, P 71-2, Sept 7, 2009). It has been widely promoted as a “natural” alternative to prescription medications for lowering blood LDL cholesterol levels. Studies have indeed shown that red yeast rice reduces LDL cholesterol levels and reduces the rate of major coronary events. The Medical Letter consultants concluded that it works, but they don’t recommend it. Why?

It’s Just Another Statin

When rice is fermented with the yeast Monascus purpureus, the resulting product contains numerous monacolins, which are naturally occurring HMG-CoA reductase inhibitors. One of these is identical to the prescription drug Mevacor (lovastatin). So it isn’t an alternative to prescription drugs, it’s just an alternative way of providing the same thing. (more…)

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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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Report a doctor’s dubious practices, go to jail?

Althought I and other SBM bloggers have criticized state medical boards for not doing enough to protect patients from physicians who practice pseudoscientific medicine and quackery, they do nonetheless serve a purpose. Moreover, critical to medical boards doing even the limited amount of enforcement that they do is the ability of health care providers or other citizens to submit anonymous complaints against physicians who are not practicing up to the standard of care or who may be in other ways taking advantage of patients. Unfortunately, the other day I found out via one of the that I frequent of a very disturbing case in Kermit, Texas. Two nurses who were dismayed and disturbed by a physician peddling all manner of herbal supplements reported him to the authorities. Now, they are facing jail:

In a stunning display of good ol’ boy idiocy and abuse of prosecutorial discretion, two West Texas nurses have been fired from their jobs and indicted with a third-degree felony carrying potential penalties of two-to-ten years’ imprisonment and a maximum fine of $10,000. Why? Because they exercised a basic tenet of the nurse’s Code of Ethics — the duty to advocate for the health and safety of their patients.

The nurses, in their 50s and both members of the American Nurses Association/Texas Nurses Association, reported concerns about a doctor practicing at Winkler County Memorial Hospital in Kermit. They were unamused by his improperly encouraging patients in the hospital emergency department and in the rural health clinic to buy his own herbal “medicines,” and they thought it improper for him to take hospital supplies to perform a procedure at a patient’s home rather than in the hospital. (The doctor did not succeed, as reportedly he was stopped by the hospital chief of staff.)

How can this be? This is how:
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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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Protandim: Another Kind of Antioxidant

Four years ago I received an e-mail inquiry about Protandim. I had never heard of it; but I looked it up and wrote a quick, informal, somewhat snarky answer that got posted on the Internet. It got a lot of attention. Googling for Protandim now brings up my critique right after the Protandim website itself: that can’t be good for sales. Over the years, several e-mails and blog comments have informed me that I was wrong (usually offering testimonials or calling me closed-minded), and recently I’ve been getting inquiries asking if I’ve changed my mind now that a clinical study has been published. I haven’t.

Instead of providing antioxidants directly, Protandim is supposed to stimulate the body to produce its own antioxidants. The website tells us it is “the only supplement clinically proven to reduce oxidative stress by 40%, slowing down the rate of cell aging to the level of a 20 year old.” It provides “thousands of times more antioxidant power than any food or conventional antioxidant supplement.” It signals the body’s genes to produce the enzymes SOD (superoxide dismutase) and CAT (catalase) that act as catalysts to neutralize free radicals and are not “used up” like ingested antioxidants are. It “creates a cascade of your body’s natural catalytic antioxidants that are able to destroy millions of free radicals per second.” It raises the level of glutathione by 300%. Glutathione is good, apparently.

What is Protandim? It’s a combination of Milk thistle, Bacopa extract, Ashwagandha, Green tea extract, and Turmeric extract. I looked these up in the Natural Medicines Comprehensive Database. None of them is known to have any significant clinical benefit from antioxidant effects. Some of them are listed as “not enough information” to know if they are safe. One has estrogenic properties and more than one has known side effects and potential interactions with other drugs. The only one that even sounds remotely like it might have some pertinent data behind it is green tea. Green tea contains antioxidant catechins that are “thought to possibly have a protective effect against atherosclerosis and heart disease” and contains flavonoids that “might reduce lipoprotein oxidation; however benefits have not yet been described in humans.”

A Pubmed search for “Protandim” yielded only 3 studies: One in mice, one in cell cultures and one in humans. (more…)

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