Top Science-Based Pharmacy Events of the Decade

There have been a few “best of the decade” lists circulating, with both KevinMD and Medpage Today giving their perspective on the biggest medical events of the past ten years. Here’s my own list of what I think influenced or impacted the drive to make pharmacy a more science-based profession. This is a fairly Canadian-centric list: I apologize to all of all SBP’s international readers. I invite your critique and suggestions on anything I missed, or any relevant events/trends in your pharmacy practice. These items are in no particular order. Continue reading

Do the Natural Health Products Regulations Benefit Canadians?

How much confidence do you have in natural health products?

Shortly after I started practicing as a pharmacist, I began giving two disclaimers whenever speaking with patients purchasing herbal products:

Compared to drugs, there is little regulation of herbal products. Variation could exist between what it says on the label and what it actually contains.

And if they have medical conditions or are taking prescription drugs, I would add,

Compared to prescription and over-the-counter drugs, the information we have on these products limited. They could have the potential to interact with other medications and medical conditions that we are not aware of. They should be used with caution.

I would give a similar disclaimer for other types of supplements and “alternative” products.

Why a disclaimer, with every patient, every time? Because the Canadian regulatory framework does not give me the confidence that natural health products available for sale in Canada are either safe or effective. Most importantly, I could not even tell patients with confidence that what was on the label was actually in the bottle.

Change is Coming. Slowly.

Until several years ago, Canadian natural health products fell into a regulatory grey zone.  Products were treated either as drugs, or as foods. Consultation began in the late 1990′s on a new framework to provide appropriate levels of  regulation and oversight to these products. In 2004, the Natural Health Product Regulations (NHPR), under Canada’s Food and Drugs Act, became a reality.  Rather than fully regulating these products as drugs, or leaving them virtually unregulated (as is done in the United States), the NHPR were a regulatory compromise: Implementing manufacturing quality and safety standards, while significantly relaxing the standards for product efficacy claims.  If randomized, double-blind, placebo-controlled trials are not conducted, (the standard for drugs), manufacturers can make claims based on “traditional uses” and other sources that are essentially anecdotal in nature. The NHP regulations include products such as nutritional supplements, probiotics, traditional Chinese medicine, vitamins, herbal products, and homeopathy.

One of the most important elements of the NHP regulations was the implementation of pre-marketing registration requirements. Only products reviewed and deemed to meet minimal standards of product quality, safety, and the (relaxed) standard for efficacy claims would be permitted to be sold as of 2010. Manufacturers were given six years to meet these requirements.

I was all set to update my disclaimer. Until now. Continue reading

Libel Reform: Canada vs. the U.K.

Libel chill is an huge concern for advocates of science-based pharmacy and science-based medicine.  It is critically important that there be an open and public debate about the science and evidence informing personal decisions about our health, as well as decisions affecting how we direct resources in our health care system. Unfortunately, some groups seeks to quash debate, rather than engaging in a discussion of evidence. Without the freedom to make open, critical comments about science and the scientific process, we give free reign to those that promote pseudoscience or seek to subvert the scientific process.

As I’ve previously blogged, Simon Singh is currently being sued by the British Chiropractic Association for libel. The British Chiropractic Association could have provided evidence to refute Singh’s comments. But it did not, and turned to legal means to silence criticism of its practices. He is appealing an initial court ruling, and is leading a campaign to reform English libel law.  See his recent update here:

“It has been 18 months since I was sued for libel after publishing my article on chiropractic. I am continuing to fight my case and am prepared to defend my article for another 18 months or more if necessary. The ongoing libel case has been distracting, draining and frustrating, but it has always been heartening to receive so much support, particularly from people who realise that English libel laws need to be reformed in order to allow robust discussion of matters of public interest. Over twenty thousand people signed the statement to Keep Libel Laws out of Science, but now we need you to sign up again and add your name to the new statement.

The new statement is necessary because the campaign for libel reform is stepping up a gear and will be working on much broader base. Sense About Science has joined forces with Index on Censorship and English PEN and their goal is to reach 100,000 or more signatories in order to help politicians appreciate the level of public support for libel reform. We have already met several leading figures from all three main parties and they have all showed signs of interest. Now, however, we need a final push in order to persuade them to commit to libel reform.

Finally, I would like to make three points. First, I will stress again – please take the time to reinforce your support for libel reform by signing up at www.libelreform.org. Second, please spread the word by blogging, twittering, Facebooking and emailing in order to encourage friends, family and colleagues to sign up. Third, for those supporters who live overseas, please also add your name to the petition and encourage others to do the same; unfortunately and embarrassingly, English libel laws impact writers in the rest of the world, but now you can help change those laws by showing your support for libel reform. While I fight in my own libel battle, I hope that you will fight the bigger battle of libel reform.”

English libel law is an international problem, because you can be sued for libel English court for statements you make in Canada, if it appears in print in the UK. And not only are the defence costs prohibitive, the onus is on the defendant to prove they didn’t libel. Consequently, these laws have an impact all over the world. The Libel Reform Campaign is asking for signatures from people all over the world, to illustrate how absurd these laws are. Please consider adding your signature today.

Happily, the news is much much better in Canada for bloggers, skeptics, and advocates for science. Continue reading

Recommended Podcast

If you don’t listen to the Skeptic’s Guide to the Universe, you should. It’s the biggest and best skeptical and pro-science podcast out there. Their occasional slagging of pharmacy and pharmacists was one of the reasons I started this blog – to demonstrate that not every pharmacist is a shruggie when it comes to alternative medicine.

I want to draw your attention to a pharmacy-related discussion this week, in episode 229.  The Q&A segment starts with a discussion about a homeopathic advertisement that is posted all over Toronto (I think it’s this one).  The discussion progresses into a recap of the British homeopathic hearings that have been a public relations disaster for Boots Pharmacy). And then the hosts discuss the role of the pharmacist and pharmacy with respect to the sale of homeopathic products. It’s an interesting discussion, and highly recommended for pharmacists. The discussion starts at around 52:36.

(And on the same topic, check out this excellent article by Simon Perry that appeared in the Leicester Mercury, entitled, Boots, homeopathy, and a matter of trust.)

The episode also included a discussion about a position paper on vitamin supplementation, released by the American Dietetic Association, which states the following:

It is the position of the American Dietetic Association that the best nutrition-based strategy for promoting optimal health and reducing the risk of chronic disease is to wisely choose a wide variety of foods. Additional nutrients from supplements can help some people meet their nutrition needs as specified by science-based nutrition standards such as the Dietary Reference Intakes.

Vitamin supplementation will be scrutinized by this blog in 2010. There is lots to cover. Stay tuned.

Interested in contributing to SBP?

This week heralded SBP’s first guest post, on cranberry. If you’re interested in contributing to the discussion about science-based pharmacy, please contact the Editor at sciencebasedpharmacy [at] gmail [dot] com. You do not need to be a pharmacist to contribute. If you want, you can write under a pseudonym. The topic should be somewhat related to pharmacy practice. If you’ve been following this blog for a while, you’ll know what we’re looking for here.

Cranberry for the Treatment and Prevention of Urinary Tract Infections

Editor’s Note:

Urinary tract infections (UTIs) are among the most common infections in women: one in three will have an infection in their lifetime. Many seek medical advice. And recurrent UTIs, while rarely serious, can be troublesome. Their ubiquity costs the health care system millions of dollars per year. Cranberries and cranberry juice have been touted as a preventative and treatment option of UTIs for decades. Today’s guest post is from a pharmacist who blogs under the pseudonym Avicenna, who looks at the evidence supporting the use of cranberries for urinary tract infections (UTIs).

In my short career in pharmacy, I’ve been approached many times by patients about the merits of cranberry supplements. Adolescent, adult and elderly women who have a soft spot for alternative therapies are generally curious about cranberry. Since their sources are usually anecdotal, like friends, family, and alternative health magazines, I’m happy to summarize the evidence for them. Continue reading

Two more picks for your library

Here’s two other great references that I neglected to mention in my last post. Both would make great gifts as well…

An Apple a Day – This book on nutrition is written by Joe Schwarcz, Director of McGill University’s Office for Science and Society. It covers the gamut of nutritional questions that come up. From tomatoes and lycopene, to flax, to oats and soluble fibre, to artificial sweeteners, fluoride, organic food, acrylamide and hormones in meat. He also examines (and dismisses) alt-health nostrums such as detox and alkali diets.  Each chapter is about 6 pages, so Schwarcz gets right to the point, summarizes the science, and then makes some bottom-line recommendations. It’s all done in an easy-to-read and accessible style. My only complaint is that while Schwartz does mention the sources of most of his data, he does not use formal citations, which would help a reader verify his conclusions. Overall, Schwarcz’s approach is cautious and pragmatic and appears consistent with the science.  As a general reference, for a non-health-professional (or health professional) curious about food controversies, you probably can’t do better than this book. And check out the Office for Science and Society’s web page, where they debunk the idea that homeopathy can be useful for the flu.

They Might Be Giants – Here Comes Science (CD/DVD) – This fantastic CD/DVD combo is highly recommended for any parent – and even if you don’t have kids, it’s a great package. TMBG is an alternative rock band that’s been together since the 1980s. Once they started having kids, they started producing some family-friendly music. And with Here Comes Science, they hit it out of the park. If you want your kids to get excited about science, this is a great start. Check out a few of their videos below – from singing about the periodic table, to the scientific method (Put it to the Test).  But the title track pretty much says it all, and sums up nicely the underlying theme of Science-Based Pharmacy: Science is Real. Continue reading

Homeopathy in UK Pharmacies: PR Disaster

Look at the headlines:

Boots: Homeopathic Remedies Please Customers Rather Than Cure

Distrust me, I’m a Pharmacist (registration required):

So why are so many nonsensical products available from Boots, our trusted family chemist? Has Boots become UK’s largest purveyor of placebos? Are pharmacists shopkeepers, only out to make a profit, or healthcare professionals keen to improve public health?

The NHS should not waste our cash on homeopathy:

Placebos, including homeopathy, don’t work as well as the therapies that have been tested against them and been found to be significantly more effective. The NHS has a fixed budget each year: if £4 million is spent on homeopathy, it means that £4 million is not available for more clinically effective treatments.

And check out this open letter to Boots from Merseyside Skeptics.

The Boots brand is synonymous with health care in the United Kingdom. Your website speaks proudly about your role as a health care provider and your commitment to deliver exceptional patient care. For many people, you are their first resource for medical advice; and their chosen dispensary for prescription and non-prescription medicines. The British public trusts Boots.

However, in evidence given recently to the Commons Science and Technology Committee, you admitted that you do not believe homeopathy to be efficacious. Despite this, homeopathic products are offered for sale in Boots pharmacies – many of them bearing the trusted Boots brand.

Not only is this two-hundred-year-old pseudo-therapy implausible, it is scientifically absurd. The purported mechanisms of action fly in the face of our understanding of chemistry, physics, pharmacology and physiology. As you are aware, the best and most rigorous scientific research concludes that homeopathy offers no therapeutic effect beyond placebo, but you continue to sell these products regardless because “customers believe they work”. Is this the standard you set for yourselves?

The majority of people do not have the time or inclination to check whether the scientific literature supports the claims of efficacy made by products such as homeopathy. We trust brands such as Boots to check the facts for us, to provide sound medical advice that is in our interest and supply only those products with a demonstrable medical benefit.

We don’t expect to find products on the shelf at our local pharmacy which do not work.

Not only are these products ineffective, they can also be dangerous. Patients may delay seeking proper medical assistance because they believe homeopathy can treat their condition. Until recently, the Boots website even went so far as to tell patients that “after taking a homeopathic medicine your symptoms may become slightly worse,” and that this is “a sign that the body’s natural energies have started to counteract the illness”. Advice such as this directly encourages patients to wait before seeking real medical attention, even when their condition deteriorates.

We call upon Boots to withdraw all homeopathic products from your shelves. You should not be involved in the sale of ineffective products, because your customers trust you to do what is right for their health. Surely you agree that your commitment to excellent patient care is better served by supplying only those products whose claims can be substantiated by rigorous scientific research? Or do you really believe that Boots should be in the business of selling placebos to the sick and the injured?

The support lent by Boots to this quack therapy contributes directly to its acceptance as a valid medical treatment by the British public, acceptance it does not warrant and support it does not deserve. Please do the right thing, and remove this bogus therapy from your shelves.

I would not be surprised to see pharmacists bumped off the top of the “Most Trusted” professional list, as a result of press like this.

Are pharmacists going to take responsibility for their own profession, advocate for science-based pharmacy, and stop selling homeopathy? Or will we be complacent, until we’re called out for allowing placebos to sit on pharmacy shelves?

 

 

Recommended Skeptical References

I’m a voracious reader, and I thought I’d share some of my favorite books over the past year that have challenged, inspired, or enriched me. Whether you’re a health professional or not, I strongly recommend you put these on your reading list. They’ve helped me a lot in refining my philosophy about pharmacy practice, and improving my skeptical viewpoint.

The Demon-Haunted World – Science as a Candle in the Dark – If you read only one book on this list, make it this one.  It is Carl Sagan’s challenge to us to fight pseudoscience. The book describes the scientific method as an awe-inspiring method of discovery.  It will encourage a skeptical and critical mindset, and challenge you to think carefully about your own assumptions. Some of the book is spent discussing logical fallacies, which has helped me improve my criticism skills.

On Being Certain This is a great book that deals the feeling of certainty that we have about things. Written by a neurologist, the book makes a convincing argument that “certainty” is a mental sensation, and not evidence of fact. In fact, Burton argues that it’s actually independent of active reasoning. Certainty, he concludes, is actually not biologically possible. We must use science as a method to evaluate data according to its likelihood of being correct.  An enjoyable and challenging read. Here’s a review at Science-Based Medicine.

Snake Oil Science This book does a fantastic job of explaining the rise of alternative medicine, as well as how health professionals are challenged to avoid making logical inferences. But the finest section of the book deals with the placebo effect – it’s the best explanation I’ve ever read. The book concludes with a dissection of systematic review of alt-med, and illustrates what high-quality systematic reviews really say about various complementary and alternative practices. Highly recommended. Here’s a review at Science-Based Medicine.

Autism’s False Prophets Until dealing with H1N1 this year, I had no idea about the level of antivaccination sentiment in Canada. And the “manufactroversy” about vaccines and autism baffled me.  I watched Orac battle the antivaxxers almost daily, but didn’t have a good sense of how this irrational and dangerous cult became established. For a succinct summary of how different organization and individuals have mislead the autism community, and established the modern antivaccination movement,  this book is a fantastic resource. Having read this book, you’ll understand the history of the antivax movement, and have a better understanding of their tactics. I believe it should be mandatory reading for every pharmacist. I also highly recommend you also read Amy Wallace’s recent article in Wired magazine, where Offit is profiled in the article “An Epidemic of Fear”.

Fooled by Randomness This book, by Nassim Nicholas Taleb, deals with luck and chance: How we understand it, and how it shapes our decision-making. Taleb, a mathematical trader “obsessed with uncertainty”, is a natural skeptic. The book focuses on different type of what he calls “thinking deficits” and makes a persuasive case for how we favour the visible and the personal, and minimize or ignore the abstract. It’s why one anecdote can convince someone of the value of an intervention ( like “homeopathy worked for me“) despite persuasive evidence that it’s placebo.

Trick or Treatment -Written by Edzard Ernst, a professor of complementary medicine, and Simon Singh, an author and science journalist now infamous for being sued by the British Chiropractic Association, this book doesn’t pull any punches. “The Undeniable Facts About Alternative Medicine” is the subtitle. It’s a fantastic read. The book opens with a review of the scientific method with some interesting historical facts. The book then dedicates a chapter each to acupuncture, homeopathy, chiropractic, and herbal medicine. The book concludes with a discussion of placebo therapies and their place in patient care. The appendix includes one-page summaries of dozens of alternative health modalities, with a short summary of their effectiveness. Highly recommended for everyone. Here’s another review from Science-Based Medicine.

How We Know What Isn’t So Why do people believe in the absurd, like homeopathy, despite all evidence? This book will help answer that question. Another good overview of critical thinking, this book outlines how human reason is fallible, and what to do about it.  While the books is over 15 years old, it’s still completely relevant. This book will likely force you to consider your own thought processes and beliefs -it did for me.

Why People Believe Weird Things – This book by skeptic Michael Shermer, looks at alien abduction, Creationism, psychics, recovered memories, Holocaust, and more. He explores why even well-educated people can hold beliefs that seem utterly baffling to others.

 

 

Those are my recommendations for anyone interested in pseudoscience, skepticism, and critical thinking. If you have any related books you’d recommend as a must-read, please list them in the comments. I’m compiling my “to read” list for 2010.