Is there a path for approval of an antiobesity drug
Bibliographic record
Abstract
PURPOSE OF REVIEW: Obesity continues to increase in prevalence in the USA and throughout the world. It is clearly a major contributor to morbidity and mortality. Unfortunately, effective prevention strategies are few. As a contributor to cardiovascular disease, obesity is an important treatment objective. However, before approval, all drugs must meet safety and efficacy concerns of the US Food and Drug Administration. RECENT FINDINGS: Since July 2010, the Food and Drug Administration's Endocrine and Metabolic Advisory Committee has reviewed three new drug applications and one previously approved drug for the treatment of obesity. This review examines in detail the Advisory Committee's consideration of the risk-benefit equation of the four drugs with a concentration on sibutramine and its key study, Sibutramine Cardiovascular Outcomes Trial. SUMMARY: Future development of drugs for the treatment of obesity will be dependent on whether they can survive review for safety and effectiveness. The Food and Drug Administration continues to be highly concerned with proposed obesity drugs increasing cardiovascular or any risks and may require changes to clinical research protocols.
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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 | 0.003 |
| Meta-epidemiology (narrow) | 0.001 | 0.000 |
| Meta-epidemiology (broad) | 0.002 | 0.001 |
| Bibliometrics | 0.001 | 0.001 |
| Science and technology studies | 0.000 | 0.001 |
| Scholarly communication | 0.002 | 0.003 |
| Open science | 0.001 | 0.001 |
| Research integrity | 0.002 | 0.003 |
| Insufficient payload (model declined to judge) | 0.009 | 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".