The patient's perspective on the recall of Vioxx.
Bibliographic record
Abstract
OBJECTIVE: Rofecoxib was recalled in September 2004 when studies identified increased cardiovascular risk compared with placebo among patients taking rofecoxib. We examined the reactions of people with arthritis to this recall. METHODS: Telephone interviews were conducted between December 2004 and February 2005 in a previously assembled community based cohort (n = 1085) with disabling hip/knee osteoarthritis (OA) residing in 2 regions of Ontario, Canada (one urban, one rural). Respondents' self-reported experience with cyclooxygenase (COX-2) selective nonsteroidal antiinflammatory drugs (NSAID; coxibs), issues around communication of the recall, attitudes about pain medications, and understanding of the rofecoxib-associated cardiovascular risks were assessed. Participants were also asked about contraindications for traditional NSAID use (specific clinical conditions, use of blood thinners and glucocorticoids, and history of gastrointestinal (GI) ulcer and/or bleeding). RESULTS: The response rate was 93.5%; 968 completed the survey. Half (53.0%) had used a coxib for arthritis; 277 (28.6%) had used rofecoxib. Only 3.8% of "ever" coxib users reported previous GI ulcer or hemorrhage. 94.8% of respondents had heard about the recall; most (94.7%) had heard via television. Among the 83 individuals taking rofecoxib at recall, 90.4% had been offered another pain medication, mainly another coxib. Most of the 968 participants (> 60%) were unfamiliar with rofecoxib-associated cardiovascular risks. Of those with an opinion, most overestimated the absolute risk associated with rofecoxib (55.7% cited a risk > 5 events/100 people/year). CONCLUSION: In an elderly community cohort with OA, the prevalence of coxib use was high despite few major contraindications to NSAID. Many were unaware of or overestimated the absolute risks associated with rofecoxib use, highlighting the need for strategies by which physicians/pharmacists can provide their patients with timely and accurate drug safety information.
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How this classification was reachedexpand
Full frame distilled prediction
Teacher imitationNot calibrated prevalence, not ground truth. Human validation pending. Learned from the 10,348 direct Codex labels and 10,348 direct Gemma labels. Candidate is the union of thresholded teacher heads; consensus is their intersection. These outputs are machine_predicted_unvalidated and are not human labels or direct frontier model labels.
Codex and Gemma teacher scores by category
| Category | Codex | Gemma |
|---|---|---|
| Metaresearch | 0.000 | 0.000 |
| Meta-epidemiology (narrow) | 0.000 | 0.000 |
| Meta-epidemiology (broad) | 0.000 | 0.000 |
| Bibliometrics | 0.000 | 0.000 |
| Science and technology studies | 0.000 | 0.000 |
| Scholarly communication | 0.000 | 0.000 |
| Open science | 0.000 | 0.000 |
| Research integrity | 0.000 | 0.000 |
| Insufficient payload (model declined to judge) | 0.000 | 0.000 |
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 teacher head, 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".