DRUG BUST Alan Cassels

photo illustration by Peter Sircom Bromley

This year, I’m making a wish list and sending it to Health Canada instead of Santa.

It’s not like I haven’t got better things to do, but they asked for it. You see, last year, Health Canada created a committee tasked with advising the government on informing Canadians about the risks related to health products. The government named the committee the Expert Advisory Committee on the Vigilance of Health Products (or EAC-VHP, which I pronounce “Eek Vip”). The committee will meet in Ottawa on December 9 and attendees were asked to formulate their answers to the following three questions:

1) What is your role in risk communications? 2) What could Health Canada do to improve the distribution and reach of its risk communications? 3) How could we better measure the effectiveness and reach of these communications?

You might be wondering what “risk communications” is. If I may be so brazen as to translate Eek Vip’s non-committal bureaucratese for a moment, what it is trying to say is that there is potential harm in taking drugs. Drugs can hurt you and they can even kill you. Frankly, when health agencies talk about “risk” (for example, when they refer to a drug’s benefit/risk profile), they act as if the opposite of benefit is risk. It’s not. The opposite of benefit is harm. So let’s call things what they are. In this case, the real question is what can the regulator do to better ensure that the information about the harms of drugs gets out to Canadians.

For starters, my advice to Health Canada is simple: it needs to think like an alcoholic. That’s right; recognize that it has a problem and get help.

Despite the many fine people employed at Health Canada, driven by the noblest of missions – to help Canadians maintain and improve their health – my sense is that they actually have no idea how poorly they communicate risk information to the very people they are supposed to be protecting. Clueless. My advice: start by admitting that Health Canada’s communications activities on the drug harm file barely pierces the media clutter, and that professional help is required. How often have you raced to the Health Canada website when searching for drug safety information in Canada? Is our regulator top-of-mind when it comes to getting a complete picture of a drug’s safety? Mmm, maybe not.

In terms of how to measure the “effectiveness of risk communications,” Eek Vip recommends we consider the following questions: “How do we best measure the effectiveness (uptake, impact of our risk communications) and reach (extent of distribution) of Health Canada’s risk communications to the public, the media and health professionals? How could we measure whether the right people are getting the right information at the right time?”

My advice here to Health Canada is also uncomplicated, bordering on the simplistic: think like a marketer. In other words, do what the drug companies do: spend money on what has proven to have an impact on physicians and patients – marketing and advertising – in order to maximize the impact of your messages. If you want to monitor whether your message is having any impact, why not look at the impact of your communications on drug sales? You need to talk to the “end users,” the people who put the pill in their mouths. Find those people and engage them and make that engagement a daily part of the drug takers’ life. And if you want to be as successful as the drug companies, use their metrics for evaluating the effectiveness of your messaging.

So in the spirit of giving some helpful advice to Eek Vip, I thought I’d send it some free ideas on how to advance drug safety in Canada:

A proper product monograph: If you buy a new car, you’ll find an owner’s manual in the glove box. Do you get one when you buy a new drug? Not in Canada, one of the few developed countries in the world where there is no federally mandated or regulated patient-oriented leaflet that outlines the benefits, harms, side effects, etc, of your drug. The information you get from the pharmacy is largely unhelpful fluff. (We’ve studied these in detail so this is not just my fanciful opinion.) They don’t provide the balanced information you need to take your drug safely. If you’re going to take a drug for a test ride, I say you need a proper owner’s manual.

Less volume, more meat: In terms of volume of communications, Health Canada produces a prodigious load of stuff and sends it out to consumers and health professionals. It issues public warnings and advisories, information updates, foreign product alerts and “Dear Doctor” letters (directed at health care professionals or hospitals) that come directly from the manufacturers of drugs. There are also product recall notices and the Canadian Adverse Reaction Newsletter, which you can sign up to receive by email. Does anyone read these? Do they make any difference? Does the volume of communications from Health Canada confuse and overwhelm? Why not send a single “Health Canada Drug Safety Update” newsletter once a month, packing it with every new thing they learn into that one issue?

More soundbites and tag lines. People learn through repetition, something every advertiser knows. Use simple, compelling messages that can be easily reinforced through repetition. Why is it that the prescribing of antipsychotic medications to elderly patients with dementia continues to increase despite warnings sent out by Health Canada? Why does antidepressant use in teenagers continue when the practice is thoroughly advised against? Is it because the regulatory warnings fail to deliver a clear action-oriented message to the public and health professionals? That’s my reading of things. Why not issue a single, strong and provocative soundbite? “Hey Doc, don’t use XXX drugs for old people or teenagers!” Follow up that headline with your more nuanced and complete message in smaller print.

Use a standard disclaimer: For any drug product, my preferred disclaimer would read something like this: “All drugs have the potential to harm you, make you sicker or even cause your death. There is no way to predict these potential harms with any certainty. You should always consider that any drug could cause a new health problem, a problem that may even be worse than the original complaint, which necessitated the first prescription. Reassess your drug regime with your physician at every visit.”

Less broadcast, more narrowcast: If you send out a weak message to the entire public, you’re wasting your time. Why not target your message to those doctors who prescribed the product in question? This can be done through provincial databases, which track prescribing, and it can be done in ways that guarantee confidentiality. This is especially important for new products when the information we have about their safety profile is abysmally inadequate.

Follow the money: One way to measure whether information about harms of products is reaching the public – and the physicians who prescribe those products – is to look at sales. If drug sales are going up, information about the harm related to the drug is either not reaching prescribers or they are not acting upon the information they have. Let’s take the example of Avandia (rosiglitazone), one of the newest diabetes drugs on the market, and recently the subject of numerous warnings and advisories. Did the new risk information issued on that drug have an effect? We have seen sales decline, but is this a result of direct risk communications work commissioned by Health Canada or because of something else? We researchers can help you tease out the truth.

Better feedback from consumers: Think outside the box in terms of getting consumers to report Adverse Drug Reactions (ADRs) to the regulator. Why not hand out a postcard to someone getting a new drug for the first time? They can use it to note their experiences after, say, six months and mail it back to Health Canada. We need better real-world experience of drugs in real people so we need to strenuously encourage people to file Adverse Drug Reports (ADRs) with Health Canada. Is a new drug causing you to bark like a dog? Call Canada’s Adverse Reaction hotline at 1-866-234-2345 or email cadrmp@hc-sc.gc.ca

And the last item on my wish list:

Enforce regulations against drug ads: Because the taxpayer can never outspend drug companies in advertising, make it harder for them to do so. In 2006 alone, Pfizer spent nearly $7 million on a Celebrex advertising campaign directed at Canadians. Can Health Canada compete with this? It might have helped if the regulator started by reining in the potentially illegal advertising on a drug that had at least three public advisories on the airwaves (May 2002, December 2004 and September 2005). Canadians were advised that old people needed the lowest dose possible and that the drug should be used with caution in patients with heart failure hypertension or edema, and so on. Even if Canadians saw the Health Canada warnings, they would have been completely overwhelmed by the Celebrex ads.

Maybe Health Canada should advertise too. If it’s important for them to get their ”brand” out there and become a trusted source of information about drug safety, why shouldn’t we see their ads on billboards and TV? Better yet, why not consider sponsoring a Formula One racecar or a Tour de France team? Wouldn’t that be neat?

Imagine seeing someone in a yellow jersey on the podium wearing the slogan, “Your prescription drug could kill you – A message brought to you by Health Canada.”

Now that’s thinking outside the box. Happy New Year to all.

Alan Cassels is a pharmaceutical policy researcher at the University of Victoria and the author of the newly published ABCs of Disease Mongering. This little pink book full of whimsy and pharmaceutical verse would fit into your loved one’s stocking for less than $10.

cassels@uivic.ca