Bibliographic record
Abstract
Health Canada should publicly discloseinformation about the safety and effi-cacy of pharmaceuticals, biologics and medical devices, and should especially disclose the designs and results of clinical trials. This disclosure is necessary to preserve public trust,1 address weaknesses in the evidence base2 and protect Canadians from harm.3 A prime example of the need for this disclosure involves selective serotonin reuptake inhibitors (SSRIs). Health Canada did not authorize SSRIs for sale to people younger than 19 years because of data from clinical trials showing risks of harm, including self-harm, associated with use of SSRIs in that age group. But Health Canada also did not publicly disclose that evidence, and by 2004 SSRIs were being widely prescribed for teenagers. Physi-cians had no idea they were invoking their discre-tion to prescribe “off label ” on the basis of incom-plete information — the balance of which Health Canada had in hand.4,5 Assessing how often harm results from nondis-closure is difficult because reporting of adverse events remains poor.6 What is clear from several analyses is that there is often a chasm between the published scientific literature (which is biased toward positive results) and the information that regulators possess about a given drug.2,7,8 Why does Health Canada not divulge infor-mation from clinical trials until reports surface of widespread off-label prescribing? The reason is legal: the companies that manufacture these ther-apeutic products and devices claim that informa-tion is “confidential business information ” or a “trade secret, ” which they own, and which Health Canada is not free to disclose. I witnessed this pas de deux while attending Health Canada’s “technical discussions on regu-latory modernization ” held between October 2010 and January 2011. Each proposal put on the table by Health Canada to increase trans-parency — from making final decisions regard-ing applications for market authorization pub-licly available, to creating an online register of therapeutic products — was met with proprietary claims from MEDEC, BIOTECanada or Rx&D, the respective associations of medical device, biotechnology and pharmaceutical companies in
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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 | 0.003 | 0.020 |
| Meta-epidemiology (narrow) | 0.001 | 0.000 |
| Meta-epidemiology (broad) | 0.001 | 0.001 |
| Bibliometrics | 0.002 | 0.003 |
| Science and technology studies | 0.001 | 0.000 |
| Scholarly communication | 0.003 | 0.001 |
| Open science | 0.002 | 0.002 |
| Research integrity | 0.002 | 0.002 |
| Insufficient payload (model declined to judge) | 0.568 | 0.192 |
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".