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What does a new drug cost?

Despite the variety of health systems across hundreds of different countries, one feature is near-universal: We all depend on private industry to commercialize and market drug products. And because drugs are such an integral part of our health care system, that industry is generally heavily regulated. Yet despite this regulation, little is publicly known about drug development costs. But aggregate research and development (R&D) data are available, and the pharmaceutical industry spends billions per year.

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Posted in: Clinical Trials, Pharmaceuticals, Science and Medicine

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The benefits and risks of folic acid supplementation

Could a vitamin with proven benefits in one group cause harm to another? That’s the growing concern with folic acid, the vitamin that dramatically reduces the risk of neural tube birth defects such a spina bifida. Studies designed to explore the possible benefits of folic acid for heart disease, stroke and cancer are giving out some worrying signs: At best, folic acid is ineffective, and at worst it may be increasing the risks of some cancers. So what does this say about routine supplementation for the typical healthy individual, and its overall risk and benefit?

Folate (vitamin B9) is an essential nutrient found green, leafy vegetables, broccoli, peas, corn, oranges, grains, cereals, and meats. Folate has important roles in the synthesis of DNA, and consequently cell division. Significant folate deficiency can lead to macrocytic anemia. Folic acid, a synthetic form of folate, is used in multivitamins supplements because it is better absorbed.

Folic acid’s benefits in pregnancy are well documented. Supplementation before conception, and in the first few weeks of pregnancy, significantly and substantially lower the risk of several different birth defects, including neural tube defects (NTDs). The neural tube is the embryonic precursor to the brain and spinal column. NTDs include very serious defects like spinal bifida and anencephaly, birth without part of the brain.

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Posted in: Clinical Trials, Epidemiology

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Topical NSAIDs

I have a mental basket of drugs that I suspect may be placebos. In that basket were the topical versions of non-steroidal anti-inflammatory drugs (NSAIDs). When the first products were commercially marketed over a decade ago, I found the clinical evidence unconvincing, and I suspected that the modestly positive effects were probably due to simply rubbing the affected area, or possibly due to the effects of the cream or vehicle itself. Frankly, I didn’t think these products worked. So when I recently noticed a topical NSAID appear for sale as an over-the-counter treatment for muscle aches and pains (seemingly only in Canada, for now), I was confident it would make a good case study in bad science.

It’s not that I’m partial to the oral NSAIDs. Yes, they’re among the most versatile, and probably most well-loved drugs in our modern medicine cabinet. They offer good pain control, reduce inflammation and can eliminate fever. We start using it in our sick and feverish infants, through childhood and adulthood for the aches and pains of modern life, and into our later years for the treatment of degenerative disease like osteoarthritis, which affects pretty much everyone as we age. An astonishing 17 million Americans use NSAIDs on a daily basis, and this number is expected to grow as the population ages. In the running groups I frequent, ibuprofen has the affectionate nickname “Vitamin I”, where it’s perceived as an essential ingredient for dealing with the consequences of training.

But NSAIDs have a long list of side effects. Not only do they cause stomach ulcers and bleeding by damaging the gastrointestinal mucosa, there are heart risks, too. It was the arrival (and departure) of the drugs Bextra and Vioxx that led to documentation of the potential for cardiovascular toxicity. And now there’s data to suggest that these effects are not limited to the “COX-2″ drugs – almost all NSAIDs, including the old standbys we have used for years, seem capable of raising the risks of heart attacks and strokes.

So despite my initial skepticism, I took another look at the topical NSAIDs. The data were not what I expected.

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Posted in: Pharmaceuticals, Science and Medicine

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Are you sure you’re allergic to penicillin?

As a pharmacist, when I dispense medication, it’s my responsibility to ensure that the medication is safe and appropriate for the patient. There are numerous checks we go through including verifying the dose, ensuring there are no interactions with other drugs, and verifying the patient has no history of allergy to the product prescribed. Asking about allergies is a mandatory question for every new patient.

Penicillin is one of the oldest antibiotics still in use despite widespread bacterial resistance. Multiple analogs of penicillin have been developed to change its effectiveness, or improve its tolerability. And other classes of antibiotics (e.g., cephalosporins) share some structural features with penicillin. These products are widely used for both routine and serious bacterial infections. Unfortunately, allergies to penicillin are widely reported. Statistically, one in ten of you reading this post will respond that you’re allergic to penicillin. Yet the incidence of anaphylaxis to penicillin is estimated to be only 1 to 5 per 10,000. So why do so many people believe they’re allergic to penicillin? Much of it comes down to how we define “allergy.”

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Posted in: Basic Science

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The risks of CAM: How much do we know?

Working in pharmacies where supplements are sold alongside traditional (over-the-counter) medications, I’m regularly astonished at the different perceptions consumers can have about the relative efficacy and safety of different types of products. Once, speaking with a customer about a medical condition she wanted to treat, I indicated that there were no effective non-prescription therapies — she needed to see a physician for access to an effective treatment by prescription — and I gestured behind the counter. “Back there?!” she pointed. “That’s where you keep the stuff that kills people! I want something natural!” Suggesting that my patients with heart disease or HIV had a somewhat different perspective, I tried (unsuccessfully) to talk her out of a questionable-looking supplement (Hint: avoid anything from a company with a P.O. box as a mailing address.) This appeal to nature, combined with a perception that natural products are safe, and conventional drugs are unsafe, is pervasive. (more…)

Posted in: Herbs & Supplements, Pharmaceuticals

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Energy Drinks

My stimulant of choice is coffee. I started drinking it in first-year university, and never looked back. A tiny four-cup coffee maker became my reliable companion right through graduate school. But since I stopped needing to drink a pot at a time, an entirely new category of products has appeared — the energy drink. Targeting students, athletes, and others seeking a mental or physical boost, energy drinks are now an enormous industry: from the first U.S. product sale in 1997, the market size was $4.8 billion by 2008, and continues to grow. (1)

My precious coffee effectively has a single therapeutic ingredient, caffeine. Its pharmacology is well documented, and the physiologic effects are understood. The safety data isn’t too shabby either: it’s probably not harmful and possibly is even beneficial. (I’m talking about oral consumption — no coffee enemas. Please.) In comparison, energy drinks are a bewildering category of products with an array of ingredients including caffeine, amino acids, vitamins, and other “natural” substances and assorted “nutraceuticals,” usually in a sugar-laden vehicle (though sugar-free versions exist). Given many products contain chemicals with pharmacologic effects, understanding the risks, signs of adverse events, and potential implications on drug therapy, are important.

So are energy drinks just candied caffeine delivery systems? Or are these syrupy supplements skirting drug regulations?

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Posted in: Herbs & Supplements, Nutrition, Politics and Regulation

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Vaccines are a pain: What to do about it

As much as I support vaccines, I see the short term consequences. Vaccines can be painful. Kids don’t like them, and parents don’t like seeing their children suffer. That this transient pain is the most common consequence of gaining  protection from fatal illnesses seems like a fair trade-off to me. But that’s not the case for every parent.

Today’s post isn’t going to focus on the extremes of the anti-vaccination movement. Rather, it’s going to look at ways to make vaccines less painful and more acceptable to children. The pain of vaccines can lead to anxiety, fear, and even nonadherence with vaccination schedules. Fear of needles and injections is not uncommon, it’s estimated that 10% of the population avoids vaccinations for this reason.

The vaccine schedules are intense. Where I live, the public vaccination schedule specifies seventeen injections of six different products over six visits in the first 18 months of life, plus influenza vaccinations and one-offs like H1N1. That’s a lot of visits, and a lot of tears if a child doesn’t handle them well.

In light of what’s known about the prevalence of needle fears, their potential effect on vaccination adherence (that could persist through adult life), and the possible impact on public health because of unvaccinated individuals, it makes sense to do whatever we can to minimize the pain and discomfort of vaccines, increasing their acceptance to children and their parents. But what works? I’ve personally found Smarties (the real ones) and Dora the Explorer stickers are effective distractions and bribes. But I’m not about to call my n=2 trial good science. Nicely, there’s much more evidence to guide our recommendations.

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Posted in: Vaccines

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Good Idea, Bad Execution: Dosing Errors, A Preventable Harm

We spend a lot time at SBM discussing different elements of the art and science of medicine, and how we believe that practice can be improve. Yet our science-based intentions can be thwarted at the last possible moment – in the form of dosing errors. The workup may have been comprehensive, the diagnosis could be correct, the most clinically and cost-effective intervention chosen, and whammo. An overdose or underdose, possible toxicity, and a failure to achieve the desired outcome. It’s a completely avoidable, but often overlooked aspect of the practice of medicine.

In my last post, I noted how cough and cold products for children have largely been withdrawn from the market due to their lack of efficacy, and the risks related to toxicity. Today’s post is going to dive a little more deeply into factors that can contribute to toxicity in the pediatric population. Let’s start with a vignette that may be familiar to parents:

The new father is wakened from a blissful, deep sleep by a crying child. Once Dad realizes when and where he is, and the source of the crying, he silently curses the short duration of action of the acetaminophen liquid he gave his child at bedtime. It has probably worn off already, and the fever is back.  Stumbling into his child’s room in the dark, he can feel the heat radiating off his body.  He fumbles around for the Tylenol, and something to measure it with. He can’t find the dropper bottle, but finds a bottle of syrup. It’s hard to measure the dose in the dark, and the medicine cup he finds is hard to read. “I think the dose is a teaspoon..that’s 5mL”.  He pours the medicine into his child’s throat, tucks him back into bed, and both are back asleep within minutes.

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Posted in: Science and Medicine

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What’s with the new cough and cold products?

One of my earliest lessons as a pharmacist working in the “real world” was that customers didn’t always act the way I expected. Parents of sick children frequently fell into this category — and the typical vignette went like this for me:

  1. Parent has determined that their child is sick, and needs some sort of over-the-counter medicine.
  2. Parent asks pharmacist for advice selecting a product from the dozens on the shelves.
  3. Pharmacist uses the opportunity to provide science-based advice, and assures parent that no drug therapy is necessary.
  4. Parent directly questions the validity of this advice, and may ask about the merits of a specific product they have already identified.
  5. Pharmacist explains efficacy and risk of the product, and provides general non-drug symptom management suggestions.
  6. Parent thanks pharmacist, selects product despite advice, and walks to the front of the store to pay.

In many ways, a pharmacy purchase mirrors the patient-physician interaction that ends with a prescription being written — it’s what feels like the logical end to the consultation, and without it, feels incomplete. It’s something that I’m observing more and more frequently when advising parents about cough and cold products for children.

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Posted in: Homeopathy, Legal, Science and Medicine

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Improving Our Response to Anti-Vaccine Sentiment

As Vaccine Awareness Week draws to a close, I thought it might be instructive to step back and look at the tactics, impact, and successes of the anti-vaccine movement. Yesterday, Orac questioned the best approach to counter the anti-vaccine movement. With today’s post, I’ll summarize two pertinent papers on the effectiveness of their tactics, and suggest some possible approaches.

There’s overwhelming evidence that vaccines have provided us with tremendous health benefits. Smallpox has been eliminated (except, apparently, for homeopathic nosodes), polio is almost gone, and occurrences of diseases like measles or rubella are now rare. In use for over a century, they are a public health triumph: diseases that terrified us a generation ago are now never seen.  Epidemiologic evidence demonstrates that vaccines have a remarkable safety record, and are exceptionally cost-effective interventions. Yet in spite of this, concerns about vaccine safety seemingly continue to mount.  And as we see time and time again, when vaccination levels drop, diseases reappear. So what’s driving anti-vaccine sentiment, and why is it successful?

The H1N1 pandemic of 2009/10 is now about a year past its peak, and is instructive as a case study on communication on  vaccine safety and efficacy. Remember the H1N1 vaccine? Judging by the anti-vaccine rhetoric of just last year, by now we should all have been rounded up by the army, given forced injections, and if the vaccine didn’t kill us right away, or make us walk backwards, we’d be immunosupressed (from the aluminum adjuvant), or have Gulf War Syndrome (from the squalene). And not only did it not work, it doubled our odds of getting H1N1.  All we needed was vitamin D and a proprietary supplement formula to avoid the flu, they said.

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Posted in: Science and the Media, Vaccines

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