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The drug expiry date: A necessary safety measure, or yet another Big Pharma conspiracy?

Consider this scenario: You’re in good health and take no prescription drugs. You use the following remedies occasionally:

  • Excedrin for the rare migraine
  • Arnica 30CH for bumps and bruises
  • Echinacea capsules, when you feel a cold coming on

Today you look in your cupboard, and notice all three products expired last year. Would you still consider taking any of them? Why or why not?

Your answer is probably influenced by a number of factors, including perceptions of risk and benefit. I’ve encountered patients who believe that drugs are less active as they near the expiration date, and others who see expiry dates solely as marketing ploy from Big Pharma. Few understand how they’re calculated.

Over the past few months I’ve written several posts on different aspects of drug development and testing, including drug interactions, fillers and excipients in drug products, the equivalence testing of generic drugs, and the management of drug allergies. I’ve done this for two reasons. The first is to develop a SBM-oriented resource for common questions and misconceptions about the mechanics of modern medicines. The second, less obvious reason for these posts has been to illustrate the serious credibility gaps with CAM therapies. Largely because of a lax regulatory framework, the CAM industry has ballooned into a multi-billion dollar market without answering basic questions that should be asked of any supplement or drug, “alternative” or otherwise. What’s not well known to consumers, but is glaringly obvious to SBM advocates, is that CAM largely ignores issues of  pharmacology: understanding how a chemical substance, once consumed, behaves in the body. It’s critical to scientific medicine, but an unnecessary step for CAM, where there’s no need to determine if a product has a beneficial biological effect before selling it. Fundamental tests in medicine, like the identification and isolation of an active ingredient, or understanding dose-effect relationships, are simply ignored. As David Gorski and Mark Crislip have pointed out over the past week, we have a reality bias at SBM.  And this bias is equally jarring when it comes to considering expiry dates for products: real drugs, and also CAM.

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Posted in: Basic Science, Herbs & Supplements, Pharmaceuticals

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Gold mine or dumpster dive? A closer look at adverse event reports

All informed health decisions are based on an evaluation of expected risks and known benefits. Nothing is without risk. Drugs can provide an enormous benefit, but they all have the potential to harm. Whether it’s to guide therapy choices or to ensure patients are aware of the risks of their prescription drugs, I spend a lot of time discussing the potential negative consequences of treatments. It’s part of my dialogue with consumers: You cannot have an effect without the possibility of an adverse effect. And even when used in a science-based way, there is always the possibility of a drug causing either predictable or idiosyncratic harm.

An “adverse event” is an undesirable outcome related to the provision of healthcare. It may be a natural consequence of the underlying illness, or it could be related to a treatment provided. The use of the term “event” is deliberate, as it does not imply a cause: it is simply associated with an intervention. The term “adverse reaction,” or more specifically “adverse drug reaction,” is used where a causal relationship is strongly suspected. Not all adverse events can be be causally linked to health interventions. Consequently, many adverse events associated with drug treatments can only be considered “suspected” adverse drug reactions until more information emerges to suggest the relationship is likely to be true.

Correlation fallacies can be hard to identify, even for health professionals. You take a drug (or, say, are given a vaccine). Soon after, some event occurs. Was the event caused by the treatment? It’s one of the most common questions I receive: ”Does drug ‘X’ cause reaction ‘Y’?” We know correlation doesn’t equal causation. But we can do better than dismissing the relationship as anecdotal, as it could be real. Consider an adverse event that is a believed to be related to drug therapy: (more…)

Posted in: Epidemiology, Pharmaceuticals

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Systemic Enzyme Therapy

One of the recurrent themes in alternative medicine is the practice of simplifying complex medical conditions, and then offering up equally simple solutions which are positioned as still being within the realm of science. This approach allows the practitioner to ignore all of the complexity and difficulty of practicing real medicine, yet offer nostrums that, on first glance, can sound legitimate. Science-y, even.

I’ve discussed this before in non-science-based approaches to food intolerances, whether it’s using clinically useless IgG blood tests, or declaring the universal dietary enemy to be gluten. David Gorski elaborated on the same theme just a few days ago in the context of cancer treatment, contrasting the simplistic views of alternative medicine purveyors with the facts of cancer research. Cancer is stunningly complex – each of the hundreds of different variants of the disease. I’m always amazed when I speak with oncologists about how treatment regimens have been established. They describe how the results of dozens of clinical trials, led by different trial groups around the world have each contributed to establishing the current “best” regimens for each cancer: the appropriate drugs, doses, intervals and treatment intensities. Good evidence speaks all languages, and as new data emerges, practices change quickly to build upon whatever new evidence has emerged. The complexity of treatments continue to increase. Overlay the genetic and genomic complexity David described, and you get a sense of the challenges (and opportunities) cancer researchers face in order for science continue to improve outcomes for patients with cancer.

So it’s a bit of a shock when you shift your attention to the alternative medicine “literature”, where simple solutions abound. One that’s popular among patients I speak with, particularly those with European backgrounds, is the use of what are called systemic enzymes – enzymes, consumed orally, with the intent of whole-body effects. These products are not used as part of “conventional” medicine but are popular supplements recommended by alternative practitioners. I was recently asked about a product called Wobenzym N, a product with German roots which is advertised with the following claims [PDF]: (more…)

Posted in: Herbs & Supplements

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Anti-anti-vax: Getting to the gist

I’m currently putting the finishing touches on a presentation for the The Ontario Public Health Convention next week, where I’ll be speaking, with occupational therapist Kim Hébert, about the anti-vaccine movement and social media (SM): how antivaccine advocates use it, and the challenges and opportunities for public health advocates. I’m pleased to see Seth Mnookin, author of The Panic Virus and someone whose work is likely known to many SBM readers, is one of the keynote speakers – his perspective will be valuable for the public health crowd which has traditionally relied on fairly static “key messages” for disseminating information on vaccine safety and effectiveness. The panel discussion of which I am a part will be an examination of challenges and opportunities presented to public health advocacy, and particularly vaccine advocacy, in a Web 2.o environment. What seems clear is that the old public health channels don’t cut it anymore: these methods are distant and insufficient to address the wide and rapid spread of misinformation in an era of social media. We all remember the anxiety over H1N1 just a few years ago – and judging by the poor uptake of the vaccine, it seemed the anti-vaccine movement had some success in propagating fear, uncertainty, and doubt. I’d almost forgotten about this chestnut from the Health Ranger himself:

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Posted in: Vaccines

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Adherence: The difference between what is, and what ought to be

One of the most interesting aspects of working as a community-based pharmacist is the insight you gain into the actual effectiveness of the different health interventions. You can see the most elaborate medication regimens developed, and then see what happens when the “rubber really hits the road”: when patients are expected to manage their own treatment plan. Not only do we get feedback from patients, there’s a semi-objective measure we can use — the prescription refill history.

The clinical trial, from where we derive much of our evidence on treatments, is very much an idealized environment. The relationship to the “real world” may be tenuous. Patients in trials are usually highly selected, typically those that are able to comply with the intervention planned. They may need to be free of any other diseases which could complicate evaluation. Patients that qualify for enrollment enter an environment where active monitoring is the norm, and may be far more intense than normal clinical practice. All of these factors mean that trial results may be meaningful, but not completely generalizable to the patient that may eventually be given the intervention. It’s for this reason we use the term “efficacy” to describe clinical trial results, while “effectiveness” is what we’re more interested in: those real-word effects that are far more relevant, yet more elusive to our decision-making.  Efficacy measures a drug’s effect on an endpoint, and estimates risk and benefit in a particular setting. Effectiveness adds in real-world tolerance, the ability to tolerate the regimen, and all the other factors that are present when real patients take a drugs under less-than-ideal conditions. Consequently, effectiveness is a much more useful predictor of outcome than efficacy. Unfortunately, measurements of real-world effectiveness, possibly as a “phase 4″ or real-world trial, are rarely conducted.

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Posted in: Science and Medicine

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Is gluten the new Candida?

Much of the therapeutics I was taught as part of my pharmacy degree is now of historical interest only. New evidence emerges, and clinical practice change. New treatments replace old ones – sometimes because they’re demonstrably better, and sometimes because marketing trumps evidence. The same changes occurs in the over-the-counter section of the pharmacy, but it’s here marketing seems to completely dominate. There continues to be no lack of interest in vitamin supplements, despite a growing body of evidence that suggests either no benefit, or possible harm, with many products. Yet it’s the perception that these products are beneficial seem to be seem to continue to drive sales. Nowhere is this more apparent than in areas where it’s felt medical needs are not being met. I covered one aspect a few weeks ago in a post on IgG food intolerance blood tests which are clinically useless but sold widely. The diagnosis of celiac disease came up in the comments, which merits a more thorough discussion: particularly, the growing fears over gluten consumption. It reminds me of another dietary fad that seems to have peaked and faded: the fear of Candida.

It wasn’t until I left pharmacy school and started speaking with real patients that I learned we are all filled with Candida – yeast. Most chronic diseases could be traced back to candida, I was told. And it wasn’t just the customers who believed it. One particular pharmacy sold several different kits that purported to eliminate yeast in the body. But these didn’t contain antifungal drugs – most were combinations of laxative and purgatives, combined with psyllium and bentonite clay, all promising to sponge up toxins and candida and restore you to an Enhanced State of Wellness™. There was a strict diet to be followed, too: No sugar, no bread – anything it was thought the yeast would consume. While you can still find these kits for sale, the enthusiasm for them seems to have waned. Whether consumers have caught on that these kits are useless, or have abandoned them because they don’t actually treat any underlying medical issues, isn’t clear.

The trend (which admittedly is hard to quantify) seems to have shifted, now that there’s a new dietary orthodoxy to question. Yeast is out. The real enemy is gluten: consume it at your own risk. There’s a growing demand for gluten labeling, and food producers are bringing out an expanding array of gluten-free (GF) foods. This is fantastic news for those with celiac disease, an immune reaction to gluten, where total gluten avoidance is essential. Only in the past decade or so has the true prevalence of celiac disease has become clear: about 1 in 100 have the disease. With the more frequent diagnosis of celiac disease, the awareness of gluten, and the harm it can cause to some, has soared. But going gluten free isn’t just for those with celiac disease. Tennis star Novak Djokovic doesn’t have celiac disease, but went on a GF diet. Headlines like “Djokovic switched to gluten-free diet, now he’s unstoppable on court” followed. Among children, there’s the pervasive but unfounded linkage of gluten consumption with autism, popularized by Jenny McCarthy and others. Even in the absence of any undesirable symptoms, gluten is being perceived as something to be avoided. (more…)

Posted in: Basic Science, Diagnostic tests & procedures, Nutrition, Science and Medicine

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Drug Interactions, Polypharmacy, and Science-Based Medicine

As I write this, the American news cycle is firmly focused on the issue of drug harms. It’s in the headlines not because of the thousands of cases of drug toxicity, hospitalizations, and even deaths that are documented each year, but because of the untimely death of singer Whitney Houston. While the cause of Houston’s death has not yet been identified,prescription drugs and alcohol are suspected to have played a role. If that’s the case, she’ll join a long list of celebrities whose deaths have been attributed to the abuse of prescription drugs. Over at Natural News, Mike Adams has already added her name to the list of “celebrities killed by Big Pharma“. He elaborated on drug-related deaths back in 2009 when actor Brittany Murphy died, deeming her death to be due to “Acute Pharmaceutical Toxicity“: (more…)

Posted in: Herbs & Supplements, Science and Medicine, Science and the Media

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IgG Food Intolerance Tests: What does the science say?

I spend a lot of time as a pharmacist discussing side effects and allergies to drugs. For your own safety, I won’t recommend or dispense a drug until I know your allergy status. I don’t limit the history to drugs—I want to know anything you’re allergic to, be it environmental, food, insects, or anything else. Allergies can create true therapeutic challenges: We can’t dismiss any allergy claim, but as I’ve blogged before, there’s a big gap between what many perceive as an allergy and what is clinically considered a true allergy. My concern is not only avoiding the harm of an allergic reaction, but also avoiding the potential consequences from selecting a suboptimal therapy that may in fact be appropriate. You may need a specific drug someday, so  I encourage patients to discuss vague drug allergies with their physician, and request allergist testing as required.

Food allergies can be as real as drug allergies, and are arguably much harder to prevent. We can usually control when we get penicillin. But what about peanuts, eggs, or milk, all of which can also cause life-threatening anaphylaxis?  Food allergies seems to be growing: not only anaphylaxis, but more people believe they have some sort of allergy to food.  Allergy is sometimes confused with the term “intolerance”, which seems more common, possibly as the availability of “food intolerance testing” grows. Food intolerance testing and screening is particularly popular among alternative practitioners. Testing can take different forms, but generally the consumer is screened against hundreds of food products and food additives. They are then provided with a list of foods they are “intolerant” to. I’ve spoken with consumers who are struggling to overhaul their diet, having been advised that they are actually intolerant to many of their favourite foods. These reports are taken seriously by patients who believe that they’ll feel better if they eliminate these products. In the pharmacy, I’ve been asked to verify the absence of trace amounts of different fillers in medications because of a perceived intolerance.  Children may be tested, too, and parents may be given a long list of foods they are told their child is intolerant of. I’ve seen the effects in the community, too. Think going “peanut free” is tough? A public school in my area sent home a list of forbidden food products: dairy, eggs, bananas, tree nuts, peanuts, soy, sesame, flax seed, kiwi, chicken, and bacon. Were these all true allergies? It’s not disclosed. Anaphylactic or not, the parents had informed the school, and the school had banned the food product.

But can a simple blood test actually identify and eliminate food intolerance? That’s the question I wanted to answer.

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Posted in: Basic Science, Diagnostic tests & procedures, Health Fraud, Herbs & Supplements, Naturopathy, Science and Medicine

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Podcast Interlude

I’m traveling this week, checking out pharmacy practice internationally, and looking for signs of science-based medicine. Instead of a post, here are the links to two podcasts I recently recorded that will be of interest to SBM readers. Sit back, press play, and enjoy.

Point of Inquiry: Dispensing Skepticism

I recently spoke with Karen Stollznow for the Point of Inquiry podcast. This discussion focused on the role of the pharmacist and the need for science-based pharmacy practice. We touched on a lot of issues including the changing role of the pharmacist, the ethical responsibilities of pharmacists when it comes to products like homeopathy, what compounding pharmacies do, what generic drugs are, what an expiry date means, what pharmacists think about vitamins and other supplements, and more. You can listen to the podcast here.

Skeptically Speaking: The Common Cold

I was recently the guest of Desiree Schell on Skeptically Speaking, where we spent an hour discussing the prevention and treatment of the common cold. You can listen to the podcast, and I’ve compiled a long list of related links and references on cold treatment for your reading pleasure too.

 

 

 

Posted in: Announcements

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Generic Drugs: Are they Equivalent?

With healthcare costs continuing to rise, generic drugs are looking more attractive than ever. The prospect of getting the same drug at a lower cost is tempting to anyone with a large drug bill — patient or insurer alike. The savings are massive: Lipitor lost patent protection last month — it was a $10 billion drug, and the generic versions are priced at a fraction of the original cost. In 2012, Plavix and Seroquel, two other blockbusters, will lose patent protection too — that’s another $10 billion in drug costs that will shrink. This “patent cliff” will shrivel about $255 billion in worldwide patented drug sales over the next five years. If you’re taking a prescription drug and not already on a generic, you probably will be soon. And depending on where you live, you may be automatically switched to a generic version of your prescription drug as soon as it’s available.

Pharmacists are responsible for most of the switches from brand to generic drugs. In Ontario, where I work, regulations specify which drugs and brands may be automatically substituted — that is, without patient or prescriber consent.  This doesn’t mean a  lack of transparency, however, so I spend a lot of time speaking with patients about generic drugs. Misconceptions are common, ranging from manufacturing standards (“they’re weaker!”) to efficacy (“the drugs don’t work!”). I’ve seen a number of questions and comments about generic drugs in the comments section here at SBM as well. So today’s post is an overview of the science of evaluating generic drugs. Specifically, I want to review the concept of bioequivalence, the confirmation of which assures us of the interchangeability of different drugs — that is, one can be substituted for another. (more…)

Posted in: Basic Science, Pharmaceuticals

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