We called the series Faint Warning because of the lack of information Canadians receive from key players in the health care system about the prescription drugs they take. The week-long series, which launched Feb. 16, 2004, on CBC Radio, CBC Television’s Disclosure, The National and CBC.ca, used the examples of children who got very sick or died because Health Canada, drug companies, doctors and other health care providers failed to warn them about the prescription drugs they assumed were safe.

The lives of these families had been ruined forever because they had faith in a system that never did deserve their ultimate trust. Using Health Canada’s adverse drug reaction database, we were able to spot a trend: that the number of adverse reactions of children – people under 18 – being reported to Health Canada had tripled since 1997. When we told a department official about our findings, it was clear that neither she, nor her department, had used the database to detect these kinds of trends and warn Canadians; hence, the title of the series, Faint Warning.

What’s even more disturbing about this trend is that drugs, be they heartburn pills, anti-depressants or acne medications that double as birth control pills, are seldom, if ever, tested in children. Doctors give them to kids using a practice called off-label prescribing. While there are a number of children who have benefited from this practice, it is one that still deserves further scrutiny by Health Canada, the provinces and doctors themselves.

Using the trend involving children and the number of adverse reactions as our backdrop, our next challenge was to find people to illustrate a tragedy that seemed to take Health Canada by surprise. We all knew about the tragic case of Vanessa Young, the Oakville teenager who died after taking the stomach pill Prepulsid. The family was never warned about the heart problems the pill could cause. The warnings from Health Canada came too late, despite the fact that the department’s own database showed that there were at least 10 deaths linked to the drug since it hit the market a decade before. To be sure, there were other families experiencing the same heartache that the Youngs endured.

With the help of listservs, discussion groups and lawyers, we were able to locate many families who shared their stories, which we used illustrate a trend that surprised and angered the thousands of Canadians who visited our website and contacted us with their outrage and personal stories.

Putting the series together turned out to be challenging, in large part because it took us so long to obtain the database from Health Canada. Five years, to be exact.

The department was quite happy to give us adverse reactions of individual drugs, as had been their practice with other media outlets, health care providers and advocacy groups.

But CBC News wanted more. We wanted to identify trends, as journalists in the United States had been doing with the databases to which they had access. We knew, for instance, that in the United States, Health Canada’s counterpart ― the Food and Drug Administration ― makes its adverse drug reaction database available.

If that was the case in the United States, why not in Canada? We were forced to complain to the Information Commissioner, who eventually sided with our arguments about the need to make this adverse drug reaction database public. John Reid’s officials gave the department an ultimatum: negotiate with CBC News. Those negotiations, which continue to this day and may end up in federal court, resulted in Health Canada releasing more than 35 years worth of data, going back to 1965.

We cleaned up the database, understood what it could and couldn’t tell us, and ran our findings past experts.

Although media outlets in Canada have been using databases to tell important stories for at least a decade, computer-assisted reporting is still a fairly new concept within the CBC. Key members of our investigative team had to explain the trends we uncovered to CBC management, and make a strong case for giving Canadians access to this database by posting it on our website.

The need for these explanations persisted right up to the day before our Faint Warning was broadcast. Some of our colleagues were concerned that Canadians wouldn’t know what to make of this information, become panicked and stop taking their medication. We explained that we had placed all the necessary caveats and precautions in place, and pointed out that the database is a mere tip sheet that doesn’t prove that a drug actually caused the adverse reaction. We urged peopled to consult their doctors before taking any action.

The reaction to our series was overwhelming.

During the first 48 hours, 15,000 Canadians visited our website. We received a countless number of e-mails from Canadians who shared their own stories, and thanked us for bringing attention to the under-reported topic of adverse drug reactions. Months after the series ran, Health Canada continued to receive an increasing number of adverse reaction reports, an important trend, given that only a fraction (from one to 10 per cent) of adverse reactions are ever reported to Health Canada in the first place. As well, the Toronto Star, one of the true pioneers in computer-assisted reporting in Canada, used our database to tell similar stories, thus helping to keep an important issue alive.

We continued mining the database for information, and in the spring of 2004, we told a similar story of seniors in a series we called Prescribed to Death. Reacting to our series, federal Health Minister Ujjal Dosanjh pledged to have the department examine the possibility of setting up a special office to monitor prescription drug use among seniors, as is now being done for children. And just before the politicians headed home for the summer break after narrowly avoiding another trip to the polls, the health minister announced that that his department was posting its adverse drug reaction database online, which is now part of a beefed-up government website to enhance the profile of adverse drug reactions.

The system is far from perfect. So we must stay vigilant. Doctors still remain unaccountable for their lack of knowledge about adverse drug reactions, their unwillingness to report reactions, and their general dismissal of the role that the database can play in making Canadians aware of the dangers of drugs when they are over-prescribed and mis-prescribed.

The biggest piece of advice we would have for anyone contemplating this kind of endeavour is refuse to take no for an answer. Government data of all kinds can help spot important trends that can lead to important discussions about everything from drug safety to food safety to air safety. So don’t be shy to ask, and then be rigorous in your analysis of the data, realizing that there will be things that the numbers can tell you and things that the numbers can’t, either because the figures are incomplete or wrong.

We feel we made a difference in the lives of Canadians with these stories on adverse reactions and thank the CAJ for its recognition. The challenge for us at the CBC is to keep going with the help computer-assisted reporting techniques we’ve learned over the past few years.  

David McKie is a member of the CBC News Investigative Unit. He edits Media magazine and teaches computer-assisted reporting and investigative research techniques at Carleton University’s School of Journalism. And, finally, he maintains a web site that monitors federal access to information requests.

Don McGillivray Award for the Best Investigative Report of 2004

David McKie
Bob Carty
Susanne Reber
Mike Gordon
Paddy Moore
Sandra Bartlet

Faint Warning

CBC

CCN Matthews/ CAJ Computer-Assisted Reporting (CAR)

By
David McKie