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Record W2948160928 · doi:10.1111/bcp.13993

Innovation and off‐label use, the French case and more

2019· letter· en· W2948160928 on OpenAlexaffabout
Alain Braillon, Joel Lexchin

Bibliographic record

VenueBritish Journal of Clinical Pharmacology · 2019
Typeletter
Languageen
FieldMedicine
TopicPharmaceutical studies and practices
Canadian institutionsYork University
Fundersnot available
KeywordsAgency (philosophy)DilemmaPaymentOff-label useQuality (philosophy)MedicineHealth careMedical prescriptionBusinessPublic relationsPolitical scienceLawFinanceNursingPharmacology

Abstract

fetched live from OpenAlex

The review by Borysowski et al does not deal with all of the issues surrounding off-label use in France.1 Indeed, Borysowski et al agree that the medical professional codes that they reviewed do not adequately address the problem of how new and innovative drugs are used.1 Finally, off-label use is only one way that the quality of prescribing is being compromised. On one hand, more and more drugs are granted accelerated approval by regulatory agencies on the basis of surrogate outcomes (with tenuous or unknown links for relevant clinical outcomes such as morbidity and quality of life) and on the promise of post-marketing studies which are only performed in two thirds of cases, and with a median delay of four years.12 On the other hand, market withdrawal is often unreasonably delayed, even in the case of drug-related deaths.13 Finding a prudent, middle ground to protect patient interests is an ongoing dilemma for drug regulators and prescribers, but moving too fast with approvals or prescriptions and too slow for withdrawals is the wrong path to follow. A.B. is a member of several task forces at the French Medicines Agency (Agence Nationale de Sécurité du Medicament). J.L. was a paid consultant on indication-based prescribing (United States Agency for Healthcare Research and Quality) and received payment for being on a panel that discussed a pharmacare plan for Canada (Canadian Institute, a for-profit organization). He is currently a member of The Jean Monnet Network in Health Law and Policy funded by the European Union (http://jmhealthnet.org/).

Fetched live from OpenAlex and de-inverted. Abstracts are not stored in this database: the inverted indexes are 8.6 GB of the frame’s 9.3 GB of text, and the host has 13 GB free.

How this classification was reachedexpand

Full frame distilled prediction

Teacher imitation

Not 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.

metaresearch head score (Codex)0.002
metaresearch head score (Gemma)0.003
Version: codex-gemma-dda1882f352aValidation status: machine_predicted_unvalidated
Candidate categoriesResearch integrity
Consensus categoriesnone
DomainCandidate signal: none · Consensus signal: none
Study designCandidate signal: Not applicable · Consensus signal: Not applicable
GenreCandidate signal: Commentary · Consensus signal: Commentary
Teacher disagreement score0.340
Threshold uncertainty score0.996

Codex and Gemma teacher scores by category

CategoryCodexGemma
Metaresearch0.0020.003
Meta-epidemiology (narrow)0.0000.000
Meta-epidemiology (broad)0.0010.000
Bibliometrics0.0000.000
Science and technology studies0.0000.001
Scholarly communication0.0000.000
Open science0.0000.000
Research integrity0.0010.006
Insufficient payload (model declined to judge)0.0000.000

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.

Opus teacher head0.204
GPT teacher head0.496
Teacher spread0.292 · how far apart the two teachers sit on this one work
Validation statusscore_only:v0-immature-baseline · verbatim from the scoring run: score_only means the number may rank works, and no category label ships from it

Classification

machine, unvalidated

Machine predicted; a candidate call from one teacher head, not a consensus.

Study designNot applicable
Domainnot available
GenreCommentary

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".

Quick stats

Citations2
Published2019
Admission routes2
Has abstractyes

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