That Dr. Mehmet Oz uses his show to promote quackery of the vilest sort is no longer in any doubt. I was reminded yet again of this last week when I caught a rerun of one of his shows from earlier this season, when he gazed in wonder at the tired old cold reading schtick used by all “psychic mediums” from time immemorial, long before the current crop of celebrity psychic mediums, such as John Edward, Sylvia Browne, and the “Long Island Medium” Theresa Caputo, discovered how much fame and fortune they could accrue by scamming the current generation of the credulous. Speaking of Theresa Caputo, that’s exactly who was on The Dr. Oz Show last week (in reruns), and, instead of being presented as the scammer that she is, never was heard even a hint of a skeptical word from our erstwhile “America’s doctor,” who cheerily suggested that seeing a psychic
medium scammer is a perfectly fine way to treat crippling anxiety because, well, Caputo claims that it is. Even worse, apparently it wasn’t even the first time that Dr. Oz had Caputo on his show, and Caputo wasn’t even the first psychic whose schtick he represented as somehow being a useful therapeutic modality for various psychological issues. “Crossing Over” psychic John Edward was there first in a segment Oz entitled Are Psychics the New Therapists? I could have saved him the embarrassment and simply told him no, but apparently Oz is too easily impressed. As I said before, if he’s impressed by clumsy cold readers like Browne, Caputo, and Edward, it doesn’t take much to impress him. Also, apparently his producers aren’t above editing science-based voices beyond recognition to support their quackery.
I was further reminded how Dr. Oz promotes quackery by an article in Slate yesterday entitled Dr. Oz’s Miraculous Medical Advice: Pay no attention to that man behind the curtain. I suppose it would be mildly hypocritical of me to snark at the rather obvious “Wizard of Oz” jokes aimed at Dr. Oz. After all, I’ve used the same joke myself at one time or another and, in light of the Slate.com article, couldn’t resist using it in the title of my post. However, I wasn’t about to let that distract me from the article itself, which is very good. The reason is that there are two aspects to Dr. Oz’s offenses against medical science. There is the pure quackery that he features and promotes, such as psychic scammers like John Edward and Theresa Caputo, faith healing scammers like Dr. Issam Nemeh, and “alternative health” scammers like reiki masters, practitioners of ayruveda, Dr. Joe Mercola, who was promoted as a “pioneer” that your doctor doesn’t want you to know about. Never was it mentioned that there are very good reasons why a competent science-based physician would prefer that his patients have nothing to do with Dr. Mercola, who runs what is arguably the most popular and lucrative alternative medicine website currently in existence and manages to present himself as reasonable simply because he is not as utterly loony as his main competition, Mike Adams if NaturalNews.com (who has of late let his New World Order, anti-government, “Obama’s coming to take away your guns” conspiracy theory freak flag fly) and Gary Null.
“One of the most important discoveries I believe we’ve made that will help you burn fat – green coffee bean extract” – Dr. Oz, September 10, 2012, Episode “The Fat Burner that Works”
Dr. Mehmet Oz may be biggest purveyor of health pseudoscience on television today. How he came to earn this title is a bit baffling, if you look at his history. Oz is a bona fide heart surgeon, (still operating 100 times per year), an academic, and a research scientist, with 300+ or 400+ (depending on the source) publications to his name. It’s an impressive CV, even before the television fame. He gained widespread recognition as the resident “health expert” on Oprah, and went on to launch his own show in 2009. Today “The Dr. Oz Show” is a worldwide hit, with distribution in 118 countries, a massive pulpit from which he offers daily health advice to over 3 million viewers in the USA alone. For proof of his power to motivate, just look at the “Transformation Nation Million Dollar You” program he launched in 2011, enrolling an amazing 1.25 million participants. Regrettably, what Oz chooses to do with this platform is often disappointing. While he can offer some sensible, pragmatic health advice, his show’s content seems more focused on TV ratings than medical accuracy, and it’s a regular venue for questionable health advice (his own, or provided by guests) and poorly substantiated “quick fixes” for health issues. (And I won’t even touch Oz’s guests like psychic mediums.) One need only look at the number of times the term “miracle” is used on the show as a marker of the undeserved hyperbole. Just this week, Julia Belluz and Stephen J Hoffman, writing in Slate, itemized some of the dubious advice that Oz has offered on his show, with a reality check against what the scientific evidence says. It’s not pretty. (more…)
Isagenix is a wellness system sold by multilevel marketing. It consists of a suite of products to be used in various combinations for “nutritional cleansing,” detoxification, and supplementation to aid in weight loss, improve energy and performance, and support healthy aging. It allegedly burns fat while supporting lean muscle, maintains healthy cholesterol levels, supports telomeres, improves resistance to illness, reduces cravings, improves body composition, and slows the aging process. And makes millions for distributors who got on the bandwagon early and are high on the pyramid.
I have written about it before and have been roundly criticized by its proponents. It generated my all-time favorite insult: “Dr Harriet Hall is a refrigerator with a head.”
My biggest concern with Isagenix was that it had not been clinically tested. They claimed that clinical tests were in progress (funded by Isagenix). An e-mail correspondent recently told me I should take another look at Isagenix, since a clinical study had been completed. It had not yet been published, and I asked her to get back to me when it was. Ask and you shall receive (but you may be sorry!). She contacted me when the study by Kroeger et al. was published in the journal Nutrition and Metabolism. The full study is available online and I urge readers to click on the link and look at Table 2, which I will be referring to later. The journal is peer-reviewed but, as will become painfully obvious, the peer reviewers did not do a competent job. It is an open-access online journal with a low impact factor. The authors had to pay to get their article published: it cost them $1805.
When we refer to “science-based medicine” (SBM), it is a very conscious choice to emphasize that good medicine should be based on a solid foundation of science. The name was coined to contrast the difference between the current evidence-based medicine (EBM) paradigm, which fetishizes randomized clinical trial evidence above all else and frequently ignores prior plausibility based on well-established basic science, and the SBM paradigm, which takes prior plausibility into account. The purpose of this post will not be to resurrect old discussions on these differences, but before I attend to the study at hand I bring this up to emphasize that progress in science-based medicine requires progress in science. That means all levels of biological (and even non-biological) basic science, which forms the foundation upon which translational science and clinical trials can be built. Without a robust pipeline of basic science progress upon which to base translational research and clinical trials, progress in SBM will slow and even grind to a halt.
That’s why, in the U.S., the National Institutes of Health (NIH) is so critical. The NIH funds large amounts of biomedical research each year, which means that what the NIH will and will not fund can’t help but have a profound effect shaping the pipeline of the basic and preclinical research that ultimately leads to new treatments and cures. Moreover, NIH funding has a profound effect on the careers of biomedical researchers and clinician-scientists, as having the “gold standard” NIH grant known as the R01 is viewed as a prerequisite for tenure and promotion in many universities and academic medical centers. Certainly this is the case for basic scientists; for clinician-scientists, having an R01 is certainly highly prestigious, but less of a career-killer if an investigator is unable to secure one. That’s why NIH funding levels and how hard (or easy) it is to secure an NIH grant, particularly an R01, are perennial obsessions among those of us in the biomedical research field. It can’t be otherwise, given the centrality of the NIH to research in the U.S.
A few weeks ago I reviewed Ben Goldacre’s new book, Bad Pharma, an examination of the pharmaceutical industry, and more broadly, of the way new drugs are discovered, developed and brought to market. As I have noted before, despite the very different health systems that exist around the world, we all rely on private, for-profit, pharmaceutical companies to supply drug products and also to bring newer, better therapies to market. It’s great when there are lots of new drugs appearing, and they’re affordable for consumers and health systems. But that doesn’t seem to be the case. Pipelines seem to be drying up, and the cost of new drugs is climbing. Manufacturers refer to the costs of drug development when explaining high drug prices: New drugs are expensive, we’re told, because developing drugs is a risky, costly, time consuming endeavor. The high prices for new treatments are the price of innovative new treatments, both now and in the future. Research and development (R&D) costs are used to argue against strategies that could reduce company profitability (and presumably, future R&D), be it hospitals refusing to pay high drug costs, or changing patent laws that will determine when a generic drug will be marketed.
The overall costs of R&D are not the focus in Goldacre’s book, receiving only a short mention in the afterword, where he refers to the estimate of £500 million to bring a drug to market as “mythical and overstated.” He’s not alone in his skepticism. There’s a fair number of papers and analyses that have attempted to come up with a “true” estimate, and some authors argue the industry does not describe the true costs accurately or transparently enough to allow for objective evaluations. Some develop models independently, based on publicly available data. All models, however, must incorporate a range of assumptions that can influence the output. Over a year ago I reviewed at a study by Light and Warburton, entitled Demythologizing the high costs of pharmaceutical research, which estimated R&D costs at a tiny $43.4 million per drug – not £500 million, or the $1 billion you may see quoted. Their estimates, however, were based on a sequence of highly implausible assumptions, meaning the “average” drug development costs are almost certainly higher in the real world. But how much higher isn’t clear. There have been at least eleven different studies published that estimate costs. Methods used range from direct data collection to aggregate industry estimates. Given the higher costs of new drugs, having an understanding of the drivers of development costs can help us understand just how efficiently this industry is performing. There are good reasons to be critical of the pharmaceutical industry. Are R&D costs one of them?
About a year ago, I became interested in a physician named Stanislaw Burzynski who has been treating cancer with compounds that he calls “antineoplastons” for over three decades without, in my opinion, ever having ever produced any compelling evidence that antineoplastons have significant anticancer activity. Although I had been vaguely aware of Burzynski and his activities, it was the first time that I had looked into them in a big way.
Having found very few skeptical, science-based takes on Burzynski and having noted that the Quackwatch entries on Burzynski (1, 2, 3) were hopelessly out of date, I wrote a trilogy of posts about him, starting with a review of an execrably bad movie made by a simultaneously credulous yet cynical independent writer, producer, and director named Eric Merola whose primary business, appropriately enough, is mainly marketing. The movie was Burzynski The Movie: Cancer Is A Serious Business, a “documentary” (and I’m being polite here) that I characterized at the time as a bad movie and bad P.R. In brief, I saw this movie as a hagiography, a propaganda film so ham-fisted that, if she were still alive, it would easily simultaneously make Leni Riefenstahl blush at its blatantness and feel nauseated how truly awful it was from a strictly film making standpoint. It was also chock full of highly dubious science, in particular Burzynski’s latest venture, which is to sell “personalized gene-targeted cancer therapy” similarly lacking in oncological insight, so much so that I observed at the time that it was as though Dr. Burzynski read a book called Personalized Cancer Therapy for Dummies and decided he is an expert in genomics-based tailoring of targeted therapies to individual cancer patients. Finally, I completed the trilogy by pointing out that lately Burzynski has been rebranding an orphan drug that showed mild to moderate promise as an anticancer therapy.
Journal of Clinical Oncology (JCO) is a high impact journal (JIF > 16) that advertises itself as a “must read” for oncologists. Some cutting edge RCTs evaluating chemo and hormonal therapies have appeared there. But a past blog post gave dramatic examples of pseudoscience and plain nonsense to be found in JCO concerning psychoneuroimmunology (PNI) and, increasingly, integrative medicine and even integrations of integrative medicine and PNI. The prestige of JCO has made it a major focus for efforts to secure respectability and third-party payments for CAM treatments by promoting their scientific status and effectiveness.
Once articles are published in JCO, authors can escape critical commentary by simply refusing to respond, taking advantage of an editorial policy that requires a response in order for critical commentaries to be published. An author’s refusal to respond means criticism cannot be published.
Some of the most outrageous incursions of woo science into JCO are accompanied by editorials that enjoy further relaxation of any editorial restraint and peer review. Accompanying editorials are a form of privileged access publishing, often written by reviewers who have strongly recommended the article for publication, and having their own PNI and CAM studies to promote with citation in JCO.
Because of strict space limitations, controversial statements can simply be declared, rather than elaborated in arguments in which holes could be poked. A faux authority is created. Once claims make it into JCO, their sources are forgotten and only the appearance a “must read,” high impact journal is remembered. A shoddy form of scholarship becomes possible in which JCO can be cited for statements that would be recognized as ridiculous if accompanied by a citation of the origin in a CAM journal. And what readers track down and examine original sources for numbered citations, anyway?
Hundreds of desperate combat veterans with Post-Traumatic Stress Disorder (PTSD) are reportedly seeking experimental treatment with an illegal drug from a husband-wife team in South Carolina. The Bonhoefers recently published a study showing that adding MDMA (ecstasy, the party drug) to psychotherapy was effective in eliminating or greatly reducing the symptoms of refractory PTSD. It was widely covered in the media, for instance in this article in the NY Times. It was only a small preliminary study, and the treatment is not yet ready for prime time; but media reports have sparked enthusiasm not justified by the evidence. (more…)
A loan officer sets up a meeting with an aspiring entrepreneur to inform him that his application has been denied. “Mr Smith, we have reviewed your application and found a fatal flaw in your business plan. You say that you will be selling your donuts for 60 cents apiece. “Yes” says Mr. Smith, “that is significantly less than any other baker in town. This will give my business a significant competitive advantage!” The loan officer replies, “According to your budget, at peak efficiency the cost of supplies to make each donut is 75 cents, you will lose 15 cents on every donut you sell. A look of relief comes over Mr. Smith’s face as he realizes the loan officer’s misunderstanding. He leans in closer, and whispers to the loan officer “But don’t you see, I’ll make it up in volume.”
If you find this narrative at all amusing, it is likely because Mr. Smith is oblivious to what seems like an obvious flaw in his logic.
A similar error in logic is made by those who rely on anecdote and other intrinsically biased information to understand the natural world. If one anecdote is biased, a collection of 12 or 1000 anecdotes multiplies the bias, and will likely reinforces an errant conclusion. When it comes to bias, you can’t make it up in volume. Volume makes it worse!
Unfortunately human beings are intrinsically vulnerable to bias. In most day to day decisions, like choosing which brand of toothpaste to buy, or which route to drive to work, these biases are of little importance. In making critical decisions, like assessing the effectiveness of a new treatment for cancer, these biases may make the difference between life and death. The scientific method is defined by a system of practices that aim to minimize bias from the assessment of a problem.
Bias, in general, is tendency that prevents unpredjudiced consideration of a question (paraphrased from dictionary.com). Researchers describe sources of bias as systematic errors. A few words about random and systematic errors will make this description clearer.
As hard as it is to believe, the Science-Based Medicine blog that you’re so eagerly reading is fast approaching its fifth anniversary of existence. The very first post here was a statement of purpose by Steve Novella on January 1, 2008, and my very first post was a somewhat rambling introduction that in retrospect is mildly embarrassing to me. It is what it is, however. The reason I mention this is because I want to take a trip down memory lane in order to follow up on one of my earliest posts for SBM, which was entitled The National Center for Complementary and Alternative Medicine (NCCAM): Your tax dollars hard at work. Specifically, I want to follow up on one specific study I mentioned that was funded by NCCAM.
Even though I not-so-humbly think that, even nearly five years later, my original post is worth reading in its entirety (weighing in at only 3,394 words, it’s even rather short—for me, at least), I’ll spare you that and cut straight to the chase, the better to discuss the study. It is a study of homeopathy. Yes, in contrast to the protestations of Dr. Josephine Briggs, the current director of NCCAM, that NCCAM doesn’t fund studies of such pure pseudoscience as homeopathy anymore (although she does apparently meet with homeopaths for “balance”), prior to Dr. Briggs’ tenure NCCAM actually did fund studies of the magic water with mystical memory known as homeopathy. Two grants in particular I singled out for scorn. The principal investigator for both grants was Iris Bell, who is faculty at Andrew Weil’s center of woo at the University of Arizona. The first was an R21 grant for a project entitled Polysomnography in homeopathic remedy effects (NIH grant 1 R21 AT000388).