Health Canada Taking too Long to Review on Safety Concerns about Drugs on the Market: Auditor General
Bibliographic record
Abstract
Health Canada takes too long to assess and publicly communicate on potential safety issues with pharmaceuticals once they are on the market, according to the annual fall report from the Auditor General of Canada. In the report tabled in the House of Commons November 22, 2011, Interim Auditor General John Wiersema said the Federal Health Department frequently takes up to 2 years to complete postmarket reviews of possible safety concerns and to provide updated safety information to Canadians. “It needs to get safety information out to Canadians more quickly,” he said in a news release. The audit also pointed to Health Canada's lack of transparency in decision-making — for example, not disclosing information on drug submissions that it has rejected or information on the status of the drugs it has approved with conditions. In addition, said the report, the department has failed to act on a long-standing commitment to release more information about clinical trials it has authorized, stating, “This increases the risk that Canadians may be unaware of new treatment options or may unknowingly participate in an unauthorized trial.” The audit flagged the case of parents who had enrolled their child in a trial advertised as being authorized by Health Canada; they later complained to Health Canada about their concerns about the trial and learned it had not been authorized by the regulator. The Auditor General made 10 recommendations targeted at improving Health Canada's timeliness and transparency and the department has agreed to implement all of them. The report's audit of Health Canada's regulation of pharmaceutical drugs is available at www.oag-bvg.gc.ca/internet/English/parl_oag_201111_04_e_35936.html#hd3a.
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How this classification was reachedexpand
Full frame machine prediction
Teacher imitationNot calibrated prevalence, not ground truth. Human validation pending. The Gemma side is a direct model label for every work in the frame, read from the title-only record. The Codex side is a classifier learned from the 10,348 direct Codex labels and calibrated to design-weighted sample rates; fields without enough sample support carry no Codex call. Candidate is the union of the two sides; consensus is their intersection. These outputs are machine_predicted_unvalidated and are not human labels.
Distilled classifier scores by category (both heads)
| Category | Codex | Gemma |
|---|---|---|
| Metaresearch | 0.062 | 0.194 |
| Meta-epidemiology (narrow) | 0.001 | 0.002 |
| Meta-epidemiology (broad) | 0.001 | 0.002 |
| Bibliometrics | 0.005 | 0.007 |
| Science and technology studies | 0.012 | 0.006 |
| Scholarly communication | 0.013 | 0.005 |
| Open science | 0.005 | 0.004 |
| Research integrity | 0.016 | 0.020 |
| Insufficient payload (model declined to judge) | 0.012 | 0.005 |
Machine scores (provisional)
The two teacher heads of the student model, read on this work. A score orders the frame for review; it never asserts a category, and the validation status ships verbatim with every row.
Baseline scores from an immature model (maturity gate not passed, 7 training rounds). Scores rank; they never assert a category.
score_only:v0-immature-baseline · verbatim from the scoring run: score_only means the number may rank works, and no category label ships from itClassification
machine, unvalidatedMachine predicted; a candidate call from one source (direct Gemma or distilled Codex), not a consensus.
How this classification was reached, model by model and score by score, is at the end of the page under "How this classification was reached".