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The Dr. Oz Red Palm Oil (non-) Miracle

Red Palm Oil Dr. Oz

If there is an antithesis to the principles of science-based medicine, it’s probably the Dr. Oz show. In this daytime television parallel universe, anecdotes are evidence. There are no incremental advances in knowledge — only medical miracles. And every episode neatly offers up three or four takeaway health nuggets that, more often than not, seem to leave the audience more ill-informed about health and medicine than they were 30 minutes earlier.

After I completed my post on Dr. Oz’s prolonged embrace of the “miracle” that is green coffee bean extract, a number of readers brought me up to speed. Green coffee beans are yesterday’s miracle. The new weight loss miracle for 2013 is red palm oil. This constant drive for miracles must keep the producers in a perpetual panic. They need at least five miracles per week. Having now watched a few episodes, I’m reminded of the classic “That Mitchell and Webb Look” skit where two nutritionists pick a new superfood. It could be just a matter of time until we see white veal profiled as a superfood in a future Dr. Oz episode.

If there is a common characteristic of complementary and alternative medicine (CAM) proponents who believe themselves to be scientific (and I include Dr. Oz in this group), it is that they extrapolate from weak clinical evidence to grandiose claims by cherry picking the most supportive strands of evidence to give the impression of being evidence-based. They have the belief, and then they look for the supporting evidence to bolster the claim. In short, to paraphrase a quote attributed to Hahns Kuhn, they use scientific evidence like a drunkard uses a light post: for support, not for illumination. As I noted with green coffee bean extract, Dr. Oz extrapolated from ambiguous, preliminary data to recommendations to consume green coffee bean extract as a weight loss strategy. Frankly, the evidence isn’t there, so I didn’t have high expectations with the latest miracle. All I knew going in about palm oil is that it’s used in most industrial food production and the demand for it is linked to massive destruction of tropical rainforests. But who doesn’t want longevity? So I sat down and watched another episode.

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Posted in: Nutrition

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Dr. Oz Doubles Down on Green Coffee Bean with a Made-for-TV Clinical Trial

“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…)

Posted in: Clinical Trials, Herbs & Supplements, Medical Ethics

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Bodytalk: Medical theater

If there were an icon of Science-Based Medicine, I think it should be Sisyphus: pushing a boulder uphill, only to watch it roll down again. Forever. Blogging about pseudoscience in medicine can feel that way at times. There is no end to the variations of nonsense, most health professionals are indifferent at best, and sometimes I wonder if blogging is just preaching to the converted. Compared to the media presence and web traffic of those that promote pseudoscence, I do wonder what to make of SBM. Does it have a bigger impact. Occasionally something comes along to give you some hope that the key concepts of SBM are having some resonance.

To effect meaningful change, we need to teach the concepts of SBM -  the process is the product, not the topics we blog about. This all came to mind as I was reading an open letter from TED organizers. TED talks are now iconic, but if you’re unfamiliar with them, the conferences started as a means of colliding speakers in the technology, entertainment and design fields to talk about big ideas. With a slogan of “ideas worth spreading,” perhaps it’s not surprising that TED talks can be provocative: that’s the point. TED talks are posted online and their success is remarkable: some talks get hundreds of thousands of views. The TED template has become so popular that it spawned TEDx, independent but licensed events that bring TED-like talks to smaller cities and venues. I’ve seen several TED talks and while many are compelling speakers, it’s clear the content is not always grounded in evidence. For all the talks by science advocates like Ben Goldacre, or James Randi, there’s the consciousnessbabble from Deepak Chopra. I’ve never seen TEDx presentations, but recently there’s been some very public criticism of its speaker standards. Anyone, it seems, can be a TEDx speaker including anti-GMO crusaders and naturopaths. Stung by recent criticism that the TED brand is losing credibility with its questionable presenters, TED HQ recently advised TEDx organizers to stop featuring pseudosicence:

It is your job, before any speaker is booked, to check them out, and to reject bad science, pseudoscience and health hoaxes.
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Posted in: Energy Medicine

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What does a new drug cost? Part II: The productivity problem

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?

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Posted in: Clinical Trials, Pharmaceuticals, Politics and Regulation

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Bad Pharma: A Manifesto to Fix the Pharmaceutical Industry

“There is no medicine without medicines” write Ben Goldacre in his new book Bad Pharma. To Goldacre, an author, journalist and physician, this cause is personal. The title, a reference to both his first book, Bad Science, as well as the pharmaceutical industry’s nickname Big Pharma, is a bit of a misnomer. While the focus is pharmaceutical companies and their actions, there are a number of enablers in the health care system – medical journals, regulators, and even medical professionals, all of whom have put the industry’s needs ahead of good medicine. According to Goldacre, the damage is pervasive and deep, right to the roots of modern medicine. These problems know no borders, and affect us all. Despite the different health care systems that exist worldwide, we all depend on for-profit pharmaceutical companies to develop and market new medicines. These companies collectively wield enormous clout, due in part to the remarkable success of medicines over the past several decades. The global pharmaceutical market will probably top $1 trillion (yes, 12 zeros) this year. And Goldacre argues the industry is not only compromised, it is broken. And over 400 pages, he defends the following paragraph:

Drugs are tested by the people who manufacture them, in poorly designed trials, on hopelessly small numbers of weird, unrepresentative patients, and analysed using techniques that are flawed by design, in such a way that they exaggerate the benefits of treatments. Unsurprisingly, these trials tend to produce results that favour the manufacturer. When trials throw up results that companies don’t like, they are perfectly entitled to hide them from doctors and patients, so we only ever see a distorted picture of any drug’s true effects. Regulators see most of the trial data, but only from early on in a drug’s life, and even then they don’t give this data to doctors or patients, or even to other parts of government. This distorted evidence is then communicated and applied in a distorted fashion. In their forty years of practice after leaving medical school, doctors hear about what works ad hoc, from sales reps, colleagues and journals. But those colleagues can be in the pay of drug companies – often undisclosed – and the journals are, too. And so are the patient groups. And finally, academic papers, which everyone thinks of as objective, are often covertly planned and written by people who work directly for the companies, without disclosure. Sometimes whole academic journals are owned outright by one drug company. Aside from all this, for several of the most important and enduring problems in medicine, we have no idea what the best treatment is, because it’s not in anyone’s financial interest to conduct any trials at all. These are ongoing problems, and although people have claimed to fix many of them, for the most party they have failed; so all of these programs persist, but worse than ever, because now people can pretend that everything is fine after all.

We all have our own biases, and I should disclose mine. I’m a pharmacist who has seen HIV go from a death sentence to a chronic disease, thanks to newly developed drugs. I’ve watched cancers like leukemias be effectively cured, thanks to medication. And I’m amazed that surgeries like double-lung transplants, impossible in the past, are now a reality, thanks in part to drug treatments. Yet I’ve also spent more than a decade reviewing the efficacy and safety of prescriptions drugs. Regrettably few are truly innovative. Many are approved with lingering questions about long-term safety and effectiveness. The value some offer can be questionable. I’ve also seen tremendous harms caused by drugs – from individual patients who have suffered horrible adverse drug reactions to population-level disasters like the Vioxx (COX-2) debacle. And I haven’t ignored the countless fines levied on pharmaceutical companies for bad, and sometimes even criminal, behavior. With its repeated capacity for self-sabotage, the pharmaceutical industry is its own worst enemy. My colleagues who work in the pharmaceutical industry agree. They’re smart, honest people that genuinely want to help get good treatments to patients. They’re embarrassed by what they see. So while I have no doubts about the astonishing track record of innovative new drugs that have transformed medicine, I also have no illusions that drug companies always behave in ways that support science-based medicine. And I think there is the potential for the industry to do much better. So how do we get this? (more…)

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It’s time for true transparency of clinical trials data

What makes a health professional science-based? We advocate for evaluations of treatments, and treatment decisions, based on the best research methods. We compile evidence based on fair trials that minimize the risks of bias. And, importantly, we consider this evidence in the context of the plausibility of the treatment. The fact is, it’s actually not that hard to get a positive result in a trial, especially when it’s sloppily done or biased.  And there are many ways to design a trial to demonstrate positive results in some subgroup, as Kimball Atwood pointed out earlier this week. And even when a trial is well done, there remains the risk of error simply due to chance alone. So to sort out true treatment effects, from fake effects, two key steps are helpful in reviewing the evidence.

1. Take prior probability into account when assessing data. While a detailed explanation of Bayes Theorem could take several posts, consider prior probability this way: Any test has flaws and limitations. Tests give probabilities based on the test method itself, not on what is being tested. Consequently, in order to evaluate the probability of “x” given a test result, we must incorporate the pre-test probability of “x”. Bayesian analysis uses any existing data, plus the data collected in the test, to give a prediction that factors in prior probabilities. It’s part of the reason why most published research findings are false.

2. Use systematic reviews to evaluate all the evidence. The best way to answer a specific clinical question is to collect all the potentially relevant information in a structured way, consider its quality, analyze it according to predetermined criteria, and then draw conclusions. A systematic review reduces the risk of cherry picking and author bias, compared to non-systematic data-collection or general literature reviews of evidence. A well-conducted systematic review will give us an answer based on the totality of evidence available, and is the best possible answer for a given question.

These two steps are critically important, and so have been discussed repeatedly by the contributors to this blog. What is obvious, but perhaps not as well understood, is how our reviews can still be significantly flawed, despite best efforts. In order for our evaluation to accurately consider prior probability, and to be systematic, we need all the evidence. Unfortunately, that’s not always possible if clinical trials remains unpublished or are otherwise inaccessible. There is good evidence to show that negative studies are less likely to be published than positive studies. Sometimes called the “file drawer” effect, it’s not solely the fault of investigators, as journals seeking positive results may decline to publish negative studies. But unless these studies are found, systematic reviews are more likely to miss negative data, which means there’s the risk of bias in favor of an intervention. How bad is the problem? We really have no complete way to know, for any particular clinical question, just how much is missing or buried. This is a problem that has confounded researchers and authors of systematic reviews for decades. (more…)

Posted in: Clinical Trials, Politics and Regulation

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Weak drug regulation and patient tragedies: We’ve seen this story before

Plenty of new drugs, but few that are truly innovative. Growing costs from their use. Physicians deemed “Dupes of Big Pharma” for their interactions with the pharmaceutical industry. A call to produce better information on which drugs work best. Finally, shoddy drug manufacturing is injuring and even killing patients. These stories could be lifted from today’s headlines — but they’re actually from 1962. Problems with the behavior of the pharmaceutical manufacturing industry, and our relationship with it, are not new. Nor are they restricted to one country. Every developed country’s health-care system is different, but one feature is near-universal: none have a public pharmaceutical industry. Ever nation relies on for-profit, private companies to supply its population with drug products.

Blog posts here can get pretty wonkish about health policy, as many of the substantial challenges to science-based medicine have their roots in regulation — whether it’s DSHEA which implemented a regulatory double-standard for supplements, or the state-by-state legislative alchemy that Jann Bellamy has documented, which transforms magical thinking and pseudoscientific practices into registered and regulated health practitioners. Federal food and drug regulations have also come under some scrutiny (and praise). The FDA’s under fire again; this time over its responsibility to oversee pharmaceutical manufacturing. But in this case, it’s not Big Pharma that’s the villan — it’s pharmacies. (more…)

Posted in: Pharmaceuticals, Politics and Regulation

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Don’t call CAM “cost-effective” unless it’s actually effective

Your health insurance plan probably covers anti-inflammatory drugs. But does it cover acupuncture treatments? Should it? Which health services deliver good value for money? Lest you think the debate is limited to the United States (which is an outlier when it comes to health spending), even countries with publicly-run healthcare systems are scrutinizing spending. Devoting dollars to one area (say, hospitals) is effectively a decision not to spend on something else, (perhaps public health programs). All systems, be they public or private, allocate funds in ways to spend money in the most efficient way possible. Thoughtful decisions require a consideration of both benefits and costs.

One of the consistent positions put forward by contributors to this blog is that all health interventions should be evaluated based on the same evidence standard. From this perspective, there is no distinct basket of products and services which are labelled “alternative”, “complementary” or more recently “integrative”. There are only treatments and interventions which have been evaluated to be effective, and those that have not. The idea that these two categories should both be considered valid approaches is a testament to promoters of complementary and alternative medicine (CAM), who, unable to meet the scientific standard, have argued (largely successfully) for different standards and special consideration — be it product regulation (e.g., supplements) or practitioner regulation.

Yet promoters of CAM seek the imprimatur of legitimacy conferred by the tools of science. And in an environment of economic restraint in health spending, they further recognize that showing economic value of CAM is important. Consequently they use the tools of economics to argue a perspective, rather than answer a question. And that’s the case with a recent paper I noticed was being touted by alternative medicine practitioners. Entitled, Are complementary therapies and integrative care cost-effective? A systematic review of economic evaluations, it attempts to summarize economic evaluations conducted on CAM treatments. Why a systematic review? One of the more effective tools for evaluating health outcomes, a systematic review seeks to analyze all published (and unpublished) information on a focused question, using a standardized, transparent approach to evidence analysis. When done well, systematic reviews can sift through thousands of clinical trials to answer focused questions in ways that are less biased than cherry-picking individual studies. The Cochrane Review’s systematic reviews form one of the more respected sources of objective information (with some caveats) on the efficacy of different health interventions. So there’s been interest in applying the techniques of systematic reviews to questions of economics, where both costs and effects must be measured. Economic evaluations at their core seek to measure the “bang for the buck” of different health interventions. The most accurate economic analyses are built into prospective clinical trials. These studies collect real-world costs and patient consequences, and then allow an accurate evaluation of value-for-money. These types of analyses are rare, however. Most economic evaluations involve modelling (a little to a lot) where health effects and related costs are estimated, to arrive at a calculation of value. Then there’s a discussion of whether that value calculation is “cost-effective”. It’s little wonder that many health professionals look suspiciously at economic analyses: the models are complicated and involve so many variables with subjective inputs that it can be difficult to sort out what the real effects are. Not surprisingly, most economic analyses suggest treatments are cost-effective. Before diving into the study, let’s consider the approach:

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Posted in: Acupuncture, Chiropractic, Energy Medicine, Herbs & Supplements, Homeopathy, Naturopathy, Science and Medicine

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Iron supplements for fatigue

How are you feeling today? Tired? Is it your active lifestyle wearing you down? Or is it a sign of something more serious? Complaints about fatigue seem ubiquitous. Perhaps it’s a product of a culture with little downtime. Yet from a medical perspective, fatigue can’t be dismissed with a simple instruction to “get more sleep”. When approached in the pharmacy, I take the perspective that anyone actively seeking advice on treatment probably needs a medical assessment. That’s not something I can offer, but I try to impress upon patients the importance of finding the cause, rather than reaching for any quick fix that may be for sale. (5-hour Energy, anyone?) And I can use the opportunity to discuss the appropriate role of supplements for treating fatigue. (more…)

Posted in: Herbs & Supplements, Science and Medicine

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Magnesium: The cure to all disease?

Having spent many evenings and weekends working in a retail pharmacy with a thriving vitamin and supplement aisle, I’m no longer surprised at the purchasing habits of consumers. The setting gave me not only the opportunity to learn about the latest supplement fads, but also to speak with consumers that place great faith in these products. A recent paper suggests 25% of CAM users account for 75% of all expenditures on CAM. And that’s consistent with what I saw in the pharmacy. Some consumers spend hundreds per month on supplements, so the belief that these products are beneficial must be very strong. So I like to ask about reasons for use. Many attribute their current health status to supplements, and usually tell me that their supplements are for preventing disease, optimizing health, or “boosting” the immune system. And while I’m encouraged to see these consumers take an active interest in maximizing their own health, I’m often puzzled by the decision-making that’s occurring. In some cases, beliefs about health, medicine, or the effectiveness of their supplements are misguided, or flat-out wrong. They’re getting expensive urine and positive feelings, but there’s little evidence to suggest the supplementing is having any objective benefits. More surprisingly, some consumers take products for which there is no medical indication at all – it’s intended as “primary prevention” of a medical condition they believe they can avoid through supplement use. Afraid of macular degeneration? Take lutein. Or worried about Alzheimer’s? Grab some ginkgo biloba. No matter your anxiety, there’s a supplement marketed for your. One supplement with enduring popularity is magnesium.  It cures cancer. And depression. Throw away your inhalers, because it cures asthma too. Read enough online, and you’ll conclude that magnesium is quite possibly the prevention and the cure to all disease. (more…)

Posted in: Herbs & Supplements

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