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Archive for Pharmaceuticals

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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Science, Evidence and Guidelines

Disclaimer:  I am a paid Medscape  blogger and writer, and since they are in part supported by advertisements from the Pharmaceutical companies,  indirectly I am in the thrall of Big Pharma.

I found Harriet’s post on the Medscape Connect topic of How do you feel about Evidence-Based Medicine? interesting.

I wondered about the breakdown of the comments by both specialty and opinions about SBM.  So I read the 226  comments and classified them by field and response.  I classified each response as disapprove, approve or nuanced.  It is not, obviously, a legitimate survey and there was more than a little subjective interpretation in deciding how to classify the responses.  I have no doubt that others would get different results; it is not methodologically sound analysis. The discussion was in the Family Medicine & Primary Care section, so it is unlikely to be representative of any population, including that of Family Practitioners and Primary Care Physicians.  I would bet, as in alternative medicine and most topics, Shruggies predominate and are the silent majority.

Even though I belong to what  a commentator referred to as the not so silent “militant wing” of SBM, I was surprised at my results: (more…)

Posted in: Epidemiology, Medical Academia, Pharmaceuticals, Science and Medicine

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How do we avoid harming the elderly with prescription drugs?

Is the best medicine no medicine at all? Sometimes. My past posts have emphasized that the appropriateness of any drug depends on an evaluation of benefits and risks. There are no completely safe interventions, and no drug is free of any side effects. Our choice is ideally informed by high-quality data like randomized controlled trials, with lots of real-world experience so we understand a drug’s true toxicity. But when it comes down to a single patient, treatment decisions are personalized: we must consider individual patient characteristics to understand the expected benefits and potential harms. And in a world with perfect prescribing and drug use, harms wouldn’t be eliminated, but they would be minimized. Unfortunately, we’re not there yet. There is ample evidence to show that the way in which prescription drugs are currently used causes avoidable harms to patients.

The art and science of medicine is a series of interventions to improve health. In making these treatment decisions, we strive to minimize iatrogenic harm — that is, harms caused by the intervention itself. High up on the list of of avoidable harms are adverse events related to drug treatments. Audits of adverse events are astonishing and shameful. Studies suggest 28% of events are avoidable in the community setting, and 42% are avoidable in long-term care settings.  That’s a tremendous amount of possible harm resulting from treatments that were prescribed to help. And the group that is harmed the most? The elderly. (more…)

Posted in: Pharmaceuticals

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Choosing Wisely: Five things Pharmacists and Patients Should Question

Is the health care spending tide turning? Unnecessary medical investigations and overtreatment seems to have entered the public consciousness to an extent I can’t recall in the past. More and more, the merits of medical investigations such as mammograms and just this week, PSA tests are being being widely questioned. It’s about time. Previous attempts to critically appraise overall benefits and consequences of of medical technologies seem to have died out amidst cries of “rationing!” But this time, the focus has changed – this isn’t strictly a cost issue, but a quality of care issue.  It’s being championed by the American Board of Internal Medicine Foundation (ABIM) under the banner Choosing Wisely with the support of several medical organizations. The initiative is designed to promote a candid discussion between patient and physician: “Is this test or procedure necessary?”. Nine organizations are already participating, represent nearly 375,000 physicians. Each group developed its own list based on the following topic: Five Things Physicians and Patients Should Question. Here are the lists published to date:

ABIM has partnered with Consumer Reports to prepare consumer-focused material as well, so patients can initiate these discussions with their physicians. How did this all come to be? A candid editorial from Howard Brody in the New England Journal of Medicine in 2010:

In my view, organized medicine must reverse its current approach to the political negotiations over health care reform. I would propose that each specialty society commit itself immediately to appointing a blue-ribbon study panel to report, as soon as possible, that specialty’s “Top Five” list. The panels should include members with special expertise in clinical epidemiology, biostatistics, health policy, and evidence-based appraisal. The Top Five list would consist of five diagnostic tests or treatments that are very commonly ordered by members of that specialty, that are among the most expensive services provided, and that have been shown by the currently available evidence not to provide any meaningful benefit to at least some major categories of patients for whom they are commonly ordered. In short, the Top Five list would be a prescription for how, within that specialty, the most money could be saved most quickly without depriving any patient of meaningful medical benefit.

Health care professionals are, in general, self-regulating professions. That is, governments entrust them to set the standards for their profession and regulate members, in the public interest. Consequently, attempts by payors of services (i.e., government and insurers) to guide medical practice are usually met with substantial resistance. No-one wants insurers interfering in the patient-physician relationship. That’s why it’s exciting to see this initiative in place -it’s being driven by the medical profession itself.

As a pharmacist I’m also a member of a self-regulating profession, one in which the public places a considerable degree of trust in. In order to maintain the public’s confidence, it is essential that the pharmacy profession maintain the highest professional and ethical standards, and do its part to reduce unnecessary testing and investigations. With this in mind, I’ve taken up Brody’s challenge and developed my own list of Five things Pharmacists and Patients Should Question. While eliminating them may not provide the most savings to patients, they are pharmacy-based, widely offered, and offer little to no benefit to consumers. Here are my top five candidates: (more…)

Posted in: Health Fraud, Pharmaceuticals, Politics and Regulation, Science and Medicine

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Cannibalism?

For all the goofiness that is SCAM, I never thought I would have a post with Cannibalism in the title.  The ability for humans to find imaginary healing properties in everything from duck liver and heart diluted 1:100 200 times, rhinoceroses horns, and waving hands over people to adjust energy fields that do not exist is remarkable.  Somehow I never thought Jeffrey Dahmer would be at the forefront of alternative therapies.

Wednesday evening while my wife was reading me the paper (it is how I usually consume the local newspaper, my wife reads stories she finds of interest out loud.  Otherwise I do not think I would bother with anything beyond the comics and sports page) she let it be known that Korean officials has confiscated medications containing aborted fetuses and stillborn babies.  Instead of the usual distracted, uh huh, that’s interesting, this caught my attention.  Say what?

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Posted in: Herbs & Supplements, Pharmaceuticals, Science and Medicine

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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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Feet of Clay

It has been tough in Portland this year. The Trailblazers, our NBA, and only professional team, started out on a tear, then went right down the toilet. It is painful to see such promise dribbled away. Sigh. Why is elation always followed by disappointment? Everyone and everything has feet of clay. Except Cassius Marcellus.

At the beginning of March the NEJM had a wonderful essay, What’s the Alternative? The Worldwide Web of Integrative Medicine by Ranjana Srivastava. The essay concerns a patient who is ‘diagnosed’ with cancer at an integrative medicine exhibition and the resultant diagnostic and therapeutic debacles that follow.
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Posted in: Health Fraud, Medical Academia, Pharmaceuticals

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The New England Journal of Medicine Sinks a Bit Lower

I suppose it was bound to happen, but it still rankles. Here is the back cover of last week’s issue of the decreasingly prestigious New England Journal of Medicine:

 


Here’s the front cover:

It’s the 200th Anniversary issue, no less. Some might protest that ‘probiotics’—live bacteria of ‘good’ varieties, as far as the gut is concerned—aren’t all that implausible, and that there is some trial evidence that they help for some conditions. That’s true, but as is typically the case even for the somewhat plausible end of the “CAM” spectrum, the hype greatly surpasses the evidence. The abstract of the most recent systematic review that I could find for probiotic treatment of irritable bowel syndrome (IBS: symptoms and signs that best match the claims in the advertisement above) concluded:

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Posted in: Clinical Trials, Herbs & Supplements, History, Legal, Medical Ethics, Pharmaceuticals, Politics and Regulation, Science and Medicine, Science and the Media

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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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