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What’s all that other stuff in my medicine?

If you read enough supplement advertisements, like I do, you’ll often see the purity of  a product often cited as one of its merits. It’s usually some phrase like:

Contains no binders! No fillers! No colours! No excipients! No starch! No gluten! No coatings! No flow agents!

It’s a point of pride for supplement manufacturers to advertise that their product contains nothing but the labelled ingredient. And that’s also seen as an important benefit to many that purchase supplements. The perception from many consumers (based on my personal experience) seems to be that products are inferior if they contain non-drug ingredients. By this measure, drug products are problematic. Pharmaceuticals all contain an array of binders, coatings, supplements and fillers.  Even (gasp) artificial ingredients and sweeteners! And they’re often, though not always, disclosed on the package label.

But rather than being a negative feature, these supplementary, non-medicinal ingredients play a critical role in ensuring that drug products are of consistent and reproducible quality. Without them, we’d have products that are potentially unstable, we’d be unclear if they were actually being absorbed, and we wouldn’t know if they actually delivered any active ingredients into the body. In short, we’d be in the same situation we’re currently in with many herbal remedies and other types of supplements.

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Posted in: Pharmaceuticals

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Understanding and Treating Colic

Parenting an infant can be totally overwhelming. One of the earliest challenge many face is learning to deal with periods of intractable crying. I often speak with sleep deprived parents when they’re looking for something — anything — to stop their baby from crying. They’ve typically been told by friends of family that their baby must have “colic” and they’ve come to the pharmacy, looking for a treatment. Colic is common, affecting up to 40% of babies in the few months of life.

While distressing, colic is a diagnosis of exclusion — that it, it is given only after other causes have been ruled out (hunger, pain, fatigue, etc.). The most common definition for colic is fussing or crying for more than 3 hours per day, more than 3 days per week, for more than 3 weeks. These criteria, first proposed by Morris Wessel in 1954, continue to be used today. However, scientific evidence to explain the cause is lacking. Ideas proposed include:

  • changes in gastrointestinal bacteria/flora
  • food allergies
  • lactose intolerance
  • excess gas in stomach
  • cramping or indigestion
  • intolerance to substances in the breast milk
  • behavioural issues secondary to parenting factors

Despite its intensity, colic resolves on its own with no interventions. By three months of age, colic has resolved in 60% of infants. By four months, it’s 90%. It sounds harmless and short-lived, but colic’s ability to induce stress in parents cannot be overstated. Parents may be angry, frustrated, depressed, exhausted, or just feel guilty, ascribing their baby’s cries to some parenting fault. (more…)

Posted in: Clinical Trials, Pharmaceuticals, Science and Medicine

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Caffeine for ADHD

“I don’t want to give my child any drugs or chemicals for their ADHD,” says a parent. “Instead, I’m thinking about using caffeine. Sound strategy?”

It may be dispensed by a barista and not a pharmacist, and the unit sizes may be small, medium and large, but caffeine is a chemical and also a drug, just as much as methylphenidate (Ritalin) is. Caffeine is even sold as a drug — alone and in combination with other products. But I regularly speak with consumers who are instinctively resistant to what they perceive as drug therapy — they want “natural” options. Caffeinehas been touted as a viable alternative to prescription drugs for ADHD. But is caffeine a science-based treatment option? This question is a good one to illustrate the process of applying science-based thinking to an individual patient question. (more…)

Posted in: Herbs & Supplements, Science and Medicine

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Who’s to Blame for Drug Shortages?

All the best effort to practice science-based medicine are for naught when the optimal treatment is unavailable. And that’s increasingly the case – even for life-threatening illnesses. Shortages of prescription drugs, including cancer drugs, seem more frequent and more significant than at any time in the past. Just recently manufacturing deficiencies at a large U.S.-based contract drug manufacturer meant that over a dozen drugs stopped being produced. This lead to extensive media coverage, speculating on the causes and implications of what seems like a growing problem. So who’s to blame? (more…)

Posted in: Pharmaceuticals, Politics and Regulation

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Oh yeah? Thalidomide! Where’s your science now?

Online discussions on the merits of alternative medicine can get quite heated. And its proponents, given enough time, will inevitably cite the same drug as “evidence” of the failings of science. Call it Gavura’s Law, with apologies to Mike Godwin:

As an online discussion on the effectiveness of alternative medicine grows longer,  the probability that thalidomide will be cited approaches one.

A recent comment on my own blog, regarding the homeopathic product Traumeel, is typical:

If the scientific method is all that separates an accepted claim, ie Thalidomide, Vioxx, Bextra, Darvon, from mere anecdote, of what benefit is the Science?

As a non-scientist consumer, I’ll take the anecdotes and my own experience. Thank you.

If scientists want to be taken seriously, they must stop selling themselves to the highest bidder becoming corporate whores without a shred of decency. To my mind, that’s how the claims for Thalidomide, Vioxx, Bextra, Darvon were accepted, making the scientific method utterly worthless.

To this commenter, “science has been wrong before.” And that invalidates science, and apparently validates homeopathy. It’s a fallacious argument. But does thalidomide actually represent a failing of science-based medicine? No, not even close. It’s so wrong, it’s not even wrong. Thalidomide is good example of the importance of science-based medicine and why allowing alternative medicine to be sold in the absence of good science is a concern. (more…)

Posted in: History, Pharmaceuticals, Politics and Regulation, Science and Medicine

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Tylenol: Safe painkiller, or drug of hepatic destruction?

What do Tylenol, Excedrin Extra Strength, Nyquil Cold & Flu, Vicodin, and Anacin Aspirin Free have in common? They all contain the drug acetaminophen. Taking multiple acetaminophen-containing drugs can be risky: while acetaminophen is safe when used at appropriate doses, at excessive doses, it is highly toxic to the liver. Take enough, and you’ll almost certainly end up hospitalized with liver failure. Acetaminophen poisonings, whether intentional or not, are a considerable public health issue. In the USA, poisonings from this drug alone result in 56,000 emergency room visits, 26,000 hospitalizations, and 458 deaths per year. [PDF] This makes acetaminophen responsible for more overdoses, and overdose deaths [PDF], than any other pharmaceutical product.

Last week, Johnson & Johnson announced that it’s lowering the maximum recommended daily dose for its flagship analgesic, Extra Strength Tylenol, from 8 tablets per day (4000mg) to 6 tablets per day (3000mg). Why? According to the manufacturer,

The change is designed to help encourage appropriate acetaminophen use and reduce the risk of accidental overdose.

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

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Salt: More confirmation bias for your preferred narrative

Judging by the recent press reports, the latest Cochrane review reveals that everything we’ve been told about eating salt, and cardiovascular disease, is wrong:

The New York Times: Nostrums: Cutting Salt Has Little Effect on Heart Risk

The Daily Mail: Cutting back on salt ‘does not make you healthier’ (despite nanny state warnings)

Scientific American: It’s Time to End the War on Salt

Sometimes it’s possible to completely miss this point. And that’s what’s happened here.

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Posted in: Science and Medicine

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Vaccine Confidence: Attitudes and Actions

Few groups are more hazardous to public health than the anti-vaccine movement — because there’s a body count affiliated with their actions. When vaccination rates drop, communicable diseases re-emerge, and people suffer. While anti-vaccine sentiment will probably persist as long as vaccines are around, we’re fortunate that vaccination rates, on balance, remain very high. In 2009, U.S. vaccination rates for most childhood vaccines were over 90%. And less than 1% are completely unvaccinated. But do high vaccination rates mean that parents have confidence in the safety and effectiveness of vaccines? Most states and provinces maintain public health regulation that require documentation of vaccination status for school or day care admission. So vaccines may be seen as a requirement or obligation which may override lingering concerns. Do concerns remain? That’s what a recent survey undertook to explore. (more…)

Posted in: Vaccines

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Et tu, Biomarkers?

Everything you know may be wrong. Well, not really, but reading the research of John Ioannidis does make you wonder. His work, concentrated on research about research, is a popular topic here at SBM.  And that’s because he’s focused on improving the way evidence is brought to bear on decision-making. His most famous papers get to the core of questioning how we know what we know (or what we assume) to be evidence. (more…)

Posted in: Basic Science, Clinical Trials, Diagnostic tests & procedures, Epidemiology, Science and Medicine

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Placebos as Medicine: The Ethics of Homeopathy

Is it ever ethical to provide a placebo treatment? What about when that placebo is homeopathy? Last month I blogged about the frequency of placebo prescribing by physicians.  I admitted my personal discomfort, stating I’d refuse to dispense any prescription that would require me to deceive the patient. The discussion continued in the comments, where opinions seemed to range from (I’m paraphrasing)  “autonomy, shmatonomy, placebos works” to the more critical who likened placebo use to “treating adults like children.”  Harriet Hall noted,  “We should have rules but we should be willing to break them when it would be kinder to the patient, and would do no harm.” And on reflection, Harriet’s perspective was one that I could see myself accepting should I be in a situation like the one  she described. It’s far easier to be dogmatic when you don’t have a patient standing in front of you. But the comments led me to consider possible situations where a placebo might actually be the most desirable treatment option. If I find some, should I be as dogmatic about homeopathy as I am about other placebos?

Nicely, Kevin Smith, writing in the journal Bioethics, examines the ethics of placebos, based on an analysis of homeopathy. Homeopathy is the ultimate placebo in routine use — most remedies contain only sugar and water, lacking a single molecule of any potentially medicinal ingredient. Smith’s paper, Against Homeopathy — A Utilitarian Perspective, is sadly behind a paywall.  So I’ll try to summarize his analysis, and add my perspective as a health care worker who regularly encounters homeopathy.
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Posted in: Homeopathy, Medical Ethics

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