History of a gene patent: tracing the development and application of commercial BRCA testing.
Notice bibliographique
Résumé
1. Introduction The patenting and commercialization of human genetic material raises a host of complex social, ethical, and policy issues, such as the potential for discrimination or stigmatization in access to health care services or employment, the exploitation of minority or indigenous communities in DNA prospecting, and the implications for ongoing biomedical research and access to health care services. But in order to conduct a comprehensive analysis of even one of these issues, it is crucial to first develop a detailed understanding of the particular history and context that have shaped the issue. The objective of this paper is to provide such a description of one particular case, namely the patenting by Myriad Genetics of the two genes (BRCA1 and BRCA2) associated with hereditary breast and ovarian cancer. Following a brief discussion of the aetiology of hereditary breast and ovarian cancer, the founding of Myriad Genetics and its transformation into a biopharmaceutical company is examined as part of the larger conte xt of the international race to discover and patent the BRCA genes. The paper then focuses on Myriad's development and control of public and commercial BRCA testing in the United States, their recent moves to enforce the patents and establish markets in Europe and Canada, and the mounting Canadian and international opposition to Myriad's commercialization and control of BRCA testing. The Myriad case is a harbinger of an increasing number of instances where gene patents provide companies with monopolies on the development, marketing, and provision of genetic tests and therapeutics. Not surprisingly, this case has become a focal point in Canada and Europe for debates about the social and ethical implications of DNA patenting and the commercialization of genetic tests. There have been legal challenges of the BRCA patents in Europe, legislation to require compulsory licensing of diagnostic tests introduced in France, and in Canada an almost nationwide rejection of Myriad's monopoly rights to BRCA testing. There is clearly a need for sustained and comprehensive social, ethical, and policy analysis of the issues arising from this and similar cases. These issues will only touched on in this paper, as the primary task is to show how a rich description of a specific exemplar--the Myriad case--is essential groundwork for conducting a comprehensive social, ethical, and policy analysis of the commer cialization of new genetic technologies. 2. Biotechnology and Gene Patenting By the early 1990s, enormous amounts of public and private funds were being invested in genetics research and biotechnology development. (1) The U.S. public expenditure on the Human Genome Project is estimated at greater than US$3 billion. The U.S. biotechnology industry invested US$11 billion in RD (4) Canadian industry invested C$341 million while not-for-profit institutes invested C$115 million. (5) With the creation of Genome Canada in February 2000, the federal government continued its support of biotechnology research by investing a further C$300 million specifically towards genomics R&D. (6) Similar funding initiatives have been launched in the United Kingdom (7) and other European and Asian nations. While the potential health benefits to be derived from biotechnology were clearly a motivating factor for the substantial public investments, this goal was closely parallelled (if not exceeded) by the conviction that developing a strong biotechnology industry is essential for stimulating economic growth and building a 'knowledge-based economy.' (8) Public financial investments in biotechnology were thus also supported by government policies and regulations to facilitate technology transfer and commercialization. (9) The 1980 U. …
Récupéré en direct depuis OpenAlex et désinversé. Les résumés ne sont pas conservés dans cette base de données : les index inversés représentent 8,6 Go des 9,3 Go de texte de la base, et le serveur dispose de 13 Go libres.
Comment cette classification a été obtenuedéplier
Prédiction machine sur la base complète
Imitation des enseignantsNi prévalence calibrée, ni vérité terrain. Validation humaine à venir. Le volet Gemma est une étiquette directe du modèle pour chaque travail de la base, lue sur la notice réduite au titre. Le volet Codex est un classifieur appris des 10 348 étiquettes directes de Codex et calibré sur les taux pondérés de l'échantillon; les champs sans appui suffisant ne portent aucun appel Codex. Le mode candidate est l'union des deux volets; le consensus est leur intersection. Ces sorties portent le statut machine_predicted_unvalidated et ne sont pas des étiquettes humaines.
Scores du classifieur distillé par catégorie (deux têtes)
| Catégorie | Codex | Gemma |
|---|---|---|
| Métarecherche | 0,004 | 0,029 |
| Méta-épidémiologie (sens strict) | 0,000 | 0,000 |
| Méta-épidémiologie (sens large) | 0,000 | 0,000 |
| Bibliométrie | 0,006 | 0,006 |
| Études des sciences et des technologies | 0,004 | 0,009 |
| Communication savante | 0,006 | 0,008 |
| Science ouverte | 0,001 | 0,003 |
| Intégrité de la recherche | 0,005 | 0,004 |
| Charge utile insuffisante (le modèle a refusé de juger) | 0,011 | 0,001 |
Scores machine (provisoires)
Les deux têtes enseignantes du modèle étudiant, lues sur ce travail. Un score ordonne la base pour la relecture; il n'affirme jamais une catégorie, et le statut de validation accompagne chaque rangée tel quel.
Scores de référence d'un modèle non mature (critères de maturité non atteints, 7 itérations). Un score ordonne; il n'affirme jamais une catégorie.
score_only:v0-immature-baseline · tel quel depuis la passe de notation : score_only signifie que le nombre peut ordonner les travaux, et qu'aucune étiquette de catégorie n'en découleClassification
machine, non validéePrédiction automatique; un appel candidat d’une seule source (Gemma direct ou Codex distillé), pas un consensus.
Le détail, modèle par modèle et score par score, se trouve en fin de page sous « Comment cette classification a été obtenue ».