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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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Rejecting cancer treatment: What are the consequences?

One of the points I’ve tried to emphasize through my contributions to Science-Based Medicine is that every treatment decision requires an evaluation of risks and benefits. No treatment is without some sort of risk. And a decision to decline treatment has its own risks. One of the challenges that I confront regularly as a pharmacist is helping patients understand a medication’s expected long-term benefits against the risks and side effects of treatment. This dialogue is most challenging with symptomless conditions like high blood pressure, where patients face the prospect of immediate side effects against the potential for long-term benefit. One’s willingness to accept side effects is influenced, in part, by and understanding of, and belief in, the overall goals of therapy. Side effects from blood-pressure medications can be unpleasant. But weighed against the reduced risk of catastrophic events like strokes, drug therapy may be more acceptable. Willingness to accept these tradeoffs varies dramatically by disease, and are strongly influenced by patient-specific factors. In general, the more serious the illness, the greater the willingness to accept the risks of treatment.

As I’ve described before, consumers may have completely different risk perspectives when it comes to drug therapies and (so-called) complementary and alternative medicine (CAM). For some, there is a clear delineation between the two: drugs are artificial, harsh, and dangerous. Supplements, herbs and anything deemed “alternative”, however, are natural, safe, and effective. When we talk about drugs, we use scientific terms – discussing the probability of effectiveness or harm, and describing both. With CAM, no tentativeness or balance may be used. Specific treatment claims may not be backed up by any supporting evidence at all. On several occasions patients with serious medical conditions have told me that they are refusing all drug treatments, describing them as ineffective or too toxic. Many are attracted to the the simple promises of CAM, instead. Now I’m not arguing that drug treatment is always necessary for ever illness. For some conditions where lifestyle changes can obviate the need for drug treatments, declining treatment this may be a reasonable approach – it’s a kick in the pants to improve one’s lifestyle. Saying “no” may also be reasonable where the benefits from treatment are expected to be modest, yet the adverse effects from treatments are substantial. These scenarios are not uncommon in the palliative care setting. But in some circumstances, there’s a clear medical requirement for drug treatment – yet treatment is declined. This approach is particularly frustrating in situations where patients face very serious illnesses that are potentially curable.  This week is the World Cancer Congress in Montreal and on Monday there were calls for patients to beware of fake cancer cures, ranging from laetrile, to coffee enemas, to juicing, and mistletoe. What are the consequences of using alternative treatments, instead of science-based care, for cancer? There are several studies and a recent publication that can help answer that question. (more…)

Posted in: Cancer, Herbs & Supplements

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Cinnamon for diabetes? The consequences of “natural alternatives”

A customer strolled up to the counter one night when I was working in a retail pharmacy:

“My doctor says I have prediabetes. I don’t want to take any drugs. Do you have something natural I can use to cut my blood sugar?”

I looked at him in the eye, and pointed at his sizeable midsection. “Sir, if you’re at risk for diabetes, and you don’t want to take medication, the single best thing you can do for yourself is lose some weight.”

He grinned and asked, “Great – what supplement can I take to help me?”

This type of discussion occurs all the time. A patient has been assessed by their physician, and informed that they have a medical problem of some sort. The patient, reluctant to accept the physician’s evaluation, heads to the pharmacy for a second opinion. In some cases, the patient may question the physician’s advice: “All my physician wants to do is prescribe drugs.” Yet there’s a disconnect when it comes to strategies for management. More often than not, non-drug approaches are rejected out-of-hand (probably because the sample I speak with have already made the decision to buy something). And in those that are leery of medical management, there’s often a willingness to consider anything that’s available without a prescription – particularly if it’s perceived as “natural.” Natural products are gentle, safe, and effective, while medicine is thought of as unnatural, harsh, and potentially dangerous. This is the naturalistic fallacy, nothing more. Purveyors of supplements leverage the naturalistic fallacy into the marketing strategy of choice for almost all supplements and “alternative” medicines.  And it leads to bad health care decisions. (more…)

Posted in: Herbs & Supplements

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Book Reviews: “The Cure for Everything” and “Which comes first, cardio or weights?”

Do you have any skeptical blind spots? I’ve had a skeptical perspective for a long time (my teenage cynicism wasn’t just a phase) but the framework for my thinking has developed over years. Professionally, the blind spot that the pharmacy profession has towards supplements and alternatives to medicine was only clear after I spent some time working in a pharmacy with thriving homeopathy sales. In looking for some credible evidence to guide my recommendations, I discovered there was quite literally nothing to homeopathy. Once I discovered blogs like Respectful Insolence, the critical thinking process, and scientific skepticism, took off. (more…)

Posted in: Book & movie reviews, Naturopathy

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The HCG Diet: Yet another ineffective quick fix diet plan and supplement

I contribute biweekly to Science-Based Medicine and could easily devote every post to writing about weight loss supplements, and never run out of topics. As soon as one quick fix falls out of favour, another inevitably replaces it. Some wax and wane in popularity. And pharmacies don’t help the situation. I cringe every time I walk down the aisle where weight loss products and kits are located. Detox? Hoodia? The “fat blaster”?  Here are pharmacists, well educated and perfectly positioned to provide good advice to consumers, but standing behind a wall of boxes with ridiculous weight loss promises.  Yet pharmacists tell me that these products are not only sought out by customers, but they actually sell well. It’s a lost opportunity to provide good advice, and consumers pay the price.

Perhaps because consumers associate these products with pharmacies, I get regular questions about weight loss programs. I end up developing some degree of familiarity with many of them, if only to be able to credibly redirect away from some of the more harmful plans and approaches. It’s that philosophy that I used recently when I was asked about how to best to manage a “plateau” on the HCG diet. I’d never dispensed human chorionic gonadotropin (HCG) before, but knew of its use for the treatment of infertility, where it promotes egg release. But weight loss? I couldn’t think of a mechanism for how HCG could promote weight loss. So I did some digging, and found a long, rich vein of pseudoscience that dates back decades. (more…)

Posted in: Health Fraud, Herbs & Supplements, Naturopathy, Pharmaceuticals

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Dr. Oz and Green Coffee Beans – More Weight Loss Pseudoscience

I can’t keep up with Dr. Oz. Just when I thought the latest weight loss miracle was raspberry ketone, along comes another weight loss panacea. This time, it’s green coffee beans.

Eveyone knows Dr. Oz, now. Formerly a guest on Oprah, he’s got his own show which he’s built into what’s probably the biggest platform for health pseudoscience and medical quackery on daytime television. In addition to promoting homeopathy, he’s hosted supplement marketer Joe Mercola several times to promote unproven supplements. He has been called out before for  promoting ridiculous diet plans, and giving bad advice to diabetics. And don’t forget his failed attempt to actually demonstrate some science on his show, when he tested apple juice for arsenic which prompted a letter from the FDA about his methodology.  His extensive track record of terrible health advice is your caution not to accept anything he suggests at face value. So when the sign in front of my local pharmacy started advertising “Green coffee beans – as seen on Dr. Oz”, I tracked down the clip in question. The last time I saw Dr. Oz in action when when he had SBM’s own Steven Novella as a guest, where there was actually a exchange (albeit brief) about the scientific evidence for alternative medicine. Replace Dr. Novella with a naturopath, and you get this: (more…)

Posted in: Herbs & Supplements, Naturopathy

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No, sugar pills won’t repel insects, and other consequences of regulating nonsense

As a group blog, Science-Based Medicine brings a variety of perspectives to issues of science in medicine. However we align around a few core principles which define what science-based medicine is, and how it should be practiced. One principle we emphasize is the importance of subjecting the evaluation of all health interventions and treatments to a single, science-based standard. One of the biggest successes of the alternative medicine industry, worldwide, has been the embedding of different regulatory standards for the evaluation and approval of so-called “non-drug” products such as supplements, herbal products, and non-scientific treatment systems like homeopathy or traditional Chinese medicine (TCM). The implications cannot be overstated: this different and lower standard is now so firmly entrenched in most health systems that few seem to question its rationale, or consider the consequences. As a practicing pharmacist I spent the first decade of my career working within this regulatory framework without ever stepping back to question why we regulate some products differently. I started reading, took the red pill, and here I am today. (more…)

Posted in: Homeopathy, Science and Medicine

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