Neti Pots for Sinus Congestion: Validated science?

Neti pots have moved from the fringe to the mainstream over the past few years. Traditionally used to treat sinus problems, their popularity exploded in 2007 when Oprah covered them on her show. Requests flooded the pharmacy I worked at. The pharmacy’s owner ordered in a case, and they  disappeared in days. Given Oprah’s poor record at identifying credible sources of medical information, I was skeptical. But given the limited efficacy of drugs for congestion, physical removal with water seemed reasonable, whether with a neti pot, or simply snorting water out of the sink. It was clear to me that uncontrolled sinus congestion problems were not rare, because pouring a cupful of water into your nostril isn’t something one will do on a whim.

Pharmacies Targeted in Mass Homeopathy Overdose

Hundreds of protesters will gather outside Boots pharmacies on January 30 to swallow entire bottles of  homeopathic remedies and embarrass a profession that sells them in the absence of any evidence of efficacy.

A few weeks ago, I blogged about the 10:23 protest which was gathering momentum in the United Kingdom. Recall that in late 2009, a senior executive from Alliance Boots, a UK pharmacy chain, admitted that there is no clinical evidence to support homeopathic products, yet Boots sells these products strictly because of consumer demand.

Homeopathy is an elaborate placebo system of “remedies” with no active ingredients.  Based on the absurd notion of “like cures like”, proponents of homeopathy believe that any substance can be an effective remedy if it’s diluted enough: raccoon fur, the sunlight reflecting off Saturn, even pieces of the Berlin Wall are all part of the homeopathic pharmacopeia.  And when I say dilute, I mean dilute. The 30C “potency” is common – it’s a ratio of 10^-60.  You would have to give two billion doses per second, to six billion people, for 4 billion years, to deliver a single molecule of the original material. That’s dilute.

On Mentors and Memes

As we meander through life, there are inflection points – decisions and events that dramatically affect our future. It may take years to recognize them.  In 1993, I found out I’d been selected for a hospital pharmacy residency at Victoria Hospital in London, Ontario. I didn’t realize it until years later, but this was one of those events. In London, I had the privilege to spend a year learning from Dr. Charles (Charlie) Bayliff, the residency coordinator. I’ve been reflecting on Charlie’s impact on my life over the past few days. On Sunday evening, Charlie passed away after a battle with cancer.  I’m proud to call Charlie a mentor and a huge influence on my career, and philosophy towards pharmacy practice.

Unapproved Natural Health Products Banned from Ontario Pharmacies

In a stunning move, the Ontario College of Pharmacists has prohibited Ontario pharmacies from selling health products that are not approved for safety and efficacy by Health Canada. This directive, which takes effect immediately, banishes some of the most questionable “alternative” health products from pharmacy shelves. This message was sent to all pharmacies and pharmacists on January 20, 2010:

New UK Campaign: “Homeopathy: There’s nothing in it”

http://www.1023.org.uk/

A few weeks ago I blogged about some very public criticism of pharmacy practice in the United Kingdom. I noted that pharmacies were being publicly criticized for selling homeopathy, and this was causing a public relations disaster for Boots, one of the UK’s leading pharmacy chains, and a proud vendor of homeopathy.  The mockery of Boots has continued. And there’s now a new public campaign to raise awareness of the fact that homeopathy is an elaborate placebo system, and has no place in pharmacies.

Cleverly (but somewhat confusingly) called “10:23″  (Remember what that number means?) the campaign has the following goals:

The 10:23 campaign aims to raise awareness of the reality of homeopathy – how it can be proven not to work, how it can be shown to be impossible, and why it’s important to give patients the right information to allow them to make an informed decision on their healthcare.

The campaign starts in a few weeks – and they’ve already posted their open letter to Boots - here’s an excerpt:

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.

If you’re interested in the campaign, you can sign up and find out more.  And follow the chatter on Twitter.  I suspect the PR problems for homeopathy-selling pharmacies may be just beginning.

Forget to take your Ginkgo biloba? Turns out, it doesn’t matter

Among the natural products on pharmacy shelves, I was rooting for Ginkgo biloba for the prevention of dementia. For one, dementia is a horrible illness. Secondly, currently available drugs for Alzheimer’s disease (AD) have little meaningful effect. Thirdly, preliminary data with ginkgo for AD looked encouraging. I recall reading this systematic review back in 2000. One sentence jumped out at me (the bolding is mine):

We conclude that for selegiline, vitamin E, lecithin, linopirdine, and propentofylline the published data do not provide support for efficacy. Based on the evidence we reviewed, it is our conclusion that donepezil, metrifonate and rivastigmine, however, all provide statistically significant modest benefit on cognitive performance and global functioning to the elderly with probable AD who are eligible for inclusion in clinical trials. The magnitude of the effect is similar for all of the medications. The results from the trials of ginkgo biloba are promising but the effects are smaller than those from the above mentioned therapies.

So the effect, while weak, was just about as bad as the prescription alternatives. For a “natural” remedy, that’s pretty good. But as with most small clinical trials, what appears to be clinically and statistically significant usually disappears when larger, more rigorous trials are conducted. And that seems to be the case now, with a publication in the December 23, 2009 issue of the Journal of the American Medical Association. But before we dive into the trial, let’s look at why ginkgo is even being studied at all.

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.

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.

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.

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.