CBC Tamiflu probe sparks drug policy review
The Public Health Agency of Canada is looking to make public the drug company affiliations — and therefore any potential conflict of interest — of its expert advisers, CBC News has learned.
This new direction was set out in an email over the holiday weekend to CBC/Radio-Canada reporter Frédéric Zalac and follows a months-long investigation by reporters from three different news organizations in three different countries into the effectiveness of the anti-viral drug Tamiflu and how it has been promoted.
Made by the giant Swiss-based pharmaceutical company Hoffman-La Roche Ltd., now known as Roche, Tamiflu was seen by some as a front-line defence in the H1N1 flu outbreak of 2009.
The company has sold roughly $10-billion worth of Tamiflu in the 10 years since the drug was launched, much of that in the years surrounding the avian and H1N1 flu scares. In Canada, the federal and provincial governments stockpiled nearly $180-million worth of anti-viral drugs, most of that Tamiflu from Roche Canada.
These stockpiles came about largely on the recommendations of the Public Health Agency of Canada and its expert advisers, as well as some independent flu experts.
Now, nearly half of the Tamiflu in the National Antiviral Stockpile is about to expire and Ottawa and the provinces will have to make a decision whether to reinvest.
A CBC documentary, which was broadcast on The National on Monday night, reports that certain other researchers in Canada, Italy, Britain and the U.S. are now challenging the claims by Roche that Tamiflu can significantly reduce complications or hospitalizations due to the flu.
The documentary also raises concerns about possible side effects surrounding the drug — strange behaviours and psychiatric delusions — that some countries, Japan in particular, have reported.
Using freedom of information requests, the investigation found hundreds of similar cases in Canada and the U.S., which were reported to health authorities but have not been made public.
It’s often difficult to establish a clear causal link between a drug and rare adverse reactions. Roche says its research suggests that these side effects result from the flu itself and high fevers, not the medication.
In the course of the CBC investigation, Zalac also reported that three of Canada's most prominent flu experts — Dr. Donald Low and Dr. Allison McGeer of Mount Sinai Hospital in Toronto, and Dr. Fred Aoki of the University of Manitoba — had received research funding or acted as a consultant or speaker for Roche during the period when Tamiflu was being promoted.
Their research involvement with Roche and other anti-viral drug makers was not a secret within the industry.
All three would sign the now standard conflict-of-interest declarations when speaking at professional events or publishing papers. And the Public Health Agency says it has always been aware of the drug industry affiliations of its private sector advisers and takes these into account.
But these relationships were rarely reported in broader public forums, in the media or even when some of these individuals would appear in marketing videos or flu-warning commercials on television produced by Roche.
Responding to these concerns, Low told Zalac that he doesn't feel the drug companies influenced him in any way.
"I do a lot with industry," he said. "And it doesn't take long to catch up to you if you are making statements that in your heart you don't believe and you don't have the data to support."
As for the Public Health Agency of Canada, it released a statement that said it would be inappropriate at this point to release the drug company connections of its advisers without their consent.
PHAC says that its advisory committees provide advice but that the agency makes the final decisions. However, because of the questions raised in the CBC documentary, the agency said it "intends to establish a policy on the release of information relating to members of its expert or advisory groups/committees."
The documentary "Tamiflu Inc." was a joint international project involving the CBC/Radio-Canada and NPR (National Public Radio) in the U.S. and RSI (Swiss-Italian Television) in Europe. Its primary reporters were Frédéric Zalac for CBC, Serena Tinari for RSI and Sandra Bartlett for NPR.