© 2008 Canadian Medical Association or its licensors
Bibliographic record
Abstract
Concern is growing over the effectiveness of actionstaken by drug regulatory agencies on safety infor-mation that becomes available to them after a drug has been licensed and marketed.1–3 Drug regulators such as Health Canada hope that disseminating information on new safety concerns through “Dear Healthcare Professional ” let-ters will shift how the stakeholders involved in drug utiliza-tion — manufacturers, public and private insurers, pharma-cists, physicians and the public — think about the trade-off between risks and benefits. Ultimately, this should lead to safer prescribing decisions. The introduction of newer, atypical antipsychotic drugs — risperidone, olanzapine and quetiapine — in the 1990s was heralded as a breakthrough in the treatment of schizophrenia and other psychiatric conditions. All 3 of these drugs were ap-proved by Health Canada for the treatment of schizophrenia, but only risperidone was approved for short-term sympto-matic management of inappropriate behaviour due to aggres-sion or psychosis in patients with severe dementia. On Oct. 11, 2002, Janssen-Ortho, the drug company that markets risperidone in Canada, after discussion with Health Canada, sent a letter to health professionals warning of safety concerns with the use of risperidone in elderly patients with dementia. On Mar. 10, 2004, Eli Lilly, the manufacturer of olanzapine, after discussion with Health Canada, sent a letter to health professionals warning of safety concerns with the use of olanzapine in elderly patients with dementia. On June 22, 2005, Health Canada circulated a letter warning health professionals of safety concerns with the use of risperidone, olanzapine or quetiapine in elderly patients with dementia. The content of the 3 warnings is summarized in Table 1; the full text of the letters is available online from Health Canada.4–6 We sought to examine the effects of these warnings on the use of the atypical antipsychotic agents mentioned in the warnings as well as the use of conventional antipsychotic drugs.
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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 | 0.002 | 0.011 |
| Meta-epidemiology (narrow) | 0.001 | 0.001 |
| Meta-epidemiology (broad) | 0.001 | 0.001 |
| Bibliometrics | 0.002 | 0.003 |
| Science and technology studies | 0.005 | 0.002 |
| Scholarly communication | 0.008 | 0.003 |
| Open science | 0.002 | 0.002 |
| Research integrity | 0.008 | 0.004 |
| Insufficient payload (model declined to judge) | 0.812 | 0.746 |
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; the direct Gemma label and the distilled Codex classifier agree on what is shown here.
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".