Researchers who submitted a plan to Health Canada last year to improve drug-safety monitoring complain that the federal department has been too slow to act on it.
Over the past year, as concerns grew around the heart risks of popular cox-2 painkillers, including Vioxx, Health Canada was processing a proposal from university researchers to cull information about drug safety and drug use from the health-care system’s databases.
FDA whistle-blower scientist David Graham used similar information from a health management group to reach the conclusion last summer that Vioxx could have caused more than 80,000 heart attacks in the United States.
Toronto researchers also used database information in 2003 and found that Ontario seniors who took Vioxx faced an 80-per-cent increased risk of being hospitalized for heart failure.
The databases contain information doctors and hospitals submit for reimbursement to provincial governments about their patients and the treatments they receive.
Analyzing the information allows researchers to make connections between drugs and potential side effects.
Health Canada officials were receptive to the plan at meetings that began last winter, but “long pauses” followed with department staff not returning e-mails or phone calls on the issue.
“It was just silence,” said Muhammad Mamdani, a senior scientist at the Institute for Clinical Evaluative Sciences in Toronto. “There was an incredible amount of frustration from academics [involved in the plan] about how quickly they weren’t moving.”
Only in the wake of the public controversy that has erupted over Vioxx, which Merck & Co. stopped selling last fall after finding it doubled the risk of heart attack and stroke, has Health Canada renewed correspondence on the safety plan, said Dr. Mamdani, citing an e-mail that department officials sent Jan. 31.
“Had the cox-2 drug controversy not happened, it’s my opinion that Health Canada might still not be moving quickly,” he said.
But Health Canada spokeswoman Jirina Vlk defended the department, saying officials have been in communication with the researchers and, “the idea of a network is very much alive.”
She said Health Canada officials are to meet provincial drug-plan managers next week and academic experts on drug safety in the spring.
“The [Health] Minister and the department take the issue of drug safety very seriously,” she said, adding that the network could complement other reforms under consideration.
Health Minister Ujjal Dosanjh said last fall, for example, that he may make it mandatory for doctors to report adverse drug reactions. Physicians now report such information on a voluntary basis.
John Hoey of the Canadian Medical Association said the current system tends only to turn up the very unusual, or rare and unexpected adverse reactions.
“How do you connect the dots [to a drug] if someone is 65 or over, and maybe at risk of a heart attack anyway?” Dr. Hoey asked, in reference to the difficulty of spotting the heart-risk link that cox-2 drugs carried.
Geoffrey Anderson, a University of Toronto professor in the faculty of medicine, and one of the lead architects of the national drug monitoring proposal sent to Health Canada, said data base information could allow researchers to recognize trends in adverse events and conduct studies about the way a drug is used and what happens to patients who use it.
He noted that the plan, estimated to cost $2-million a year, with researchers’ salaries covered by their institutions, is not an expensive one.
Dr. Anderson said he is aware that Health Canada officials are gathering input from provincial officials, and called such consultation “laudable.” But, he said, “safety is clearly a federal mandate.”
“They are doing something, but they could do more and they could do it faster,” he said. “It’s particularly frustrating if you are an academic and you want to do [work] that really affects policy and the safety of Canadians.”
He noted, for example, that after Health Canada released a public advisory on Jan. 21 about cardiovascular risks linked to the dementia drug Reminyl, researchers called the department offering to study databases for information on adverse events.
“There really hasn’t been much of a response. We weren’t asking them for money, we were just asking to be partners in this,” Dr. Anderson said. “It shouldn’t be like us phoning them up and asking them if we can help them. There should be a linking between the academics who do this work and the people who have to make the decisions to protect the Canadian public.”
Regulators have been harshly criticized for failing to act sooner on safety concerns surrounding cox-2 drugs and doctors are now considering various ways to boost drug-safety monitoring.
Claire Bombardier, director of rheumatology at the University of Toronto and a key consultant to Merck on the Vioxx file, said in a recent interview with The Globe and Mail that Health Canada should perhaps grant only conditional approval to new drugs. The condition, she said, would be based on large, long-term patient studies demonstrating the medication is relatively safe.
But Dr. Mamdani cautioned that any postmarket studies of a medication should be carried out by an independent body: “Health Canada just doesn’t have the people to keep track of what information they would need and they are not organized to do that.”