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Health Canada too slow with drug alerts: AG

Health Canada is too slow to warn the public about emerging drug risks because of an archaic monitoring system, the auditor general said in his fall. While Health Canada does a good job of keeping tabs on available drugs and new data about them, the federal department is simply too slow at updating the information for Canadians, Auditor General John Wiersema stated. “Those assessments take too long. In some cases it can take up to two years to conduct the assessment and get the updated info out to Canadians, and we think that’s along period of time.
In his report, Wiersema cited the example of a drug that was prescribed for epilepsy, migraines, psychiatric conditions and weight loss. After the drug was linked to birth defects, it took six months for the brand-name version to include a warning and almost two years went by before generic producers were notified that they had to change their warnings and labels.
“Their problem is they are not able to make their timelines, with respect to reviewing those drug submissions. They’ve set their own service standards for how quickly they should be able to do that, and they’re not able to,” he said. Given the ongoing logjam, Wiersema said the department must figure out how to get the most important cases of potential drug safety issues to the front of the line. “I think it’s important that Health Canada have mechanisms to prioritize these safety issues, to determine which ones are most important to investigate,” he during an earlier press conference.
“And for those that pose a significant risk to Canadians, to get that information out to Canadians as quickly as possible.” The report said the department must provide more information on why it rejects, or requires changes to drugs. This information is invaluable to doctors who may prescribe a drug for conditions that have not yet been authorized.
Liberal Treasury Board critic John McCallum demanded answers from the government on drug safety during question period in the House of Commons. “All rhetoric and politics aside, how can this prime minister tolerate such a sloppy approach to the health of Canadians and what is this government going to do to fix this critical problem,” McCallum asked.
Health Minister Leona Aglukkaq said the government “agrees with the auditor general’s findings” and said work is underway to address her department’s shortcomings. “My department is making the improvements on how Health Canada responds concerning products that are on the market,” Aglukkaq said. “The health and safety of Canadians is a priority for our government, and we are putting a protocol in place to ensure that the products on the market are safe, efficient and reliable for all Canadians.”
The review also had concerns with the way Health Canada handles clinical trials. Wiersema said the department was holding back information about authorized trials, which deprived Canadians from having the opportunity to participate in treatments they may want to pursue. Conversely, the auditor general said Health Canada is turning a blind eye to unauthorized trials, which could put Canadians at risk.
The health-related finding was just one of several in the report. Another key issue in the fall report card is Canada’s visa system, which needs to be tightened as incoming visitors and immigrants are not being adequately screened. “We’ve been reporting some of these problems with visas for 20 years and I find it disturbing that fundamental weaknesses still exist,” Wiersema said.
The audit found that visa officers are using outdated criteria when looking at high-risk applicants. And these same officers are getting security advice from border agency analysts who often lack the right training to be advising them. In terms of medical screening that is required in some circumstances, the process is overly focused on tuberculosis and syphilis, despite the fact that there are 56 diseases that must be legally reported by doctors in Canada.
The audit said both departments lack quality assurance systems that will help them evaluate their performance when screening applicants. $1B stimulus fund lacked ‘reliable performance information’ Wiersema also took a close look at how Ottawa managed some of the massive federal stimulus programs that were brought in during the recession. In the case of the Community Adjustment Fund, Ottawa designed the $1-billion program to save or create jobs in smaller communities. But the auditor general said it will be very hard for the government to analyze how effective the program was.
The program lacked “reliable performance information on job creation,” making it difficult to track how much employment was created. NDP Industry Critic Peter Julian said the report calls into question the government’s job-creation numbers.
“The (Economic Action Plan) was so badly monitored that no one knows if it was effective, and we now know that 72,000 full-time jobs were lost last month thanks to policies from this government,” Julian said in question period. “So, now that the truth is out, when will this government put aside bogus and unsubstantiated job claims and take real and immediate action to create jobs here in Canada for Canadian families?”
Finance Minister Jim Flaherty countered that the “600,000 net new jobs” created since the end of the recession are evidence that the stimulus plan “was a good plan and it worked.” The report also examined the $4-billion Infrastructure Stimulus Fund and the $2-billion Knowledge Infrastructure Fund.
The audit found that in a number of cases, the progress being made on stimulus programs was reported in a confusing matter. “In our view, the fragmented presentation made it difficult for parliamentarians and Canadians to obtain an overall picture of results achieved against the planned performance expectations and public resources spent.”
Military not setting aside enough for maintenance Wiersema also examined concerns with the way the military has been handling contracts and its plans for future maintenance. With Ottawa intending to buy up to $60 billion in new planes, ships and vehicles, there will be a corresponding need to spend money to keep the fleet in good repair. The problem is that the $140 billion budgeted for training, spare parts and maintenance over the next two decades may not be enough.
“National Defence has indicated it is likely that its long-term investment plan for new equipment has allocated insufficient funds for equipment life-cycle costs,” the auditor general’s report said. The Defence Department continues to have a long-standing issue with keeping track of its repair costs, a problem that was flagged in a previous audit in 2001. Because of this, the department “lacks complete, reliable and integrated information on the total cost of maintenance and repair because some of the costs — salaries and infrastructure — are not captured in its asset management information systems,” the report said.
Wiersema also warned of the “significant risks” the department faces in awarding long-term, in-service maintenance contracts to defence manufacturers. Doing so leaves the Defence Department with less options when maintenance needs arise, less repair expertise within its own ranks, and makes the department highly dependent on single suppliers.

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