Healthy Skepticism Library item: 12026
Warning: This library includes all items relevant to health product marketing that we are aware of regardless of quality. Often we do not agree with all or part of the contents.
Publication type: Journal Article
Tuma RS.
Business barriers slowing the pace of cancer immunotherapy research and development.
J Natl Cancer Inst 2007 Nov 7; 99:(21):1570-3 Epub 2007 Oct 30.
http://jnci.oxfordjournals.org/cgi/content/extract/99/21/1570
Abstract:
No cancer vaccines and only a handful of antitumor immunotherapies have gained regulatory approval, despite several decades of effort. Experts think that increased knowledge about the immune system and better agents are starting to change this.
However, regulatory and intellectual property issues currently hinder development of such therapies, they say, and will continue to cause problems unless researchers have better access to agents that are still under investigation. Two recent government-sponsored meetings highlighted these concerns, and some scientific leaders are even calling for the U.S. Congress to step in.
Testing agents together in combinations, as immune-system therapies often require, is a particular problem. Companies fear that their drug applications will be slowed down if they let outside researchers use their investigational drugs in any trial that might link the agent with side effects. But that approach often leaves agents to languish for years-agents that researchers say could be successfully attacking . . .
Raising the Issues
Identifying Key Agents
Adjuvants
Examples May Illuminate the Mounting Cancer Vaccine Development Problem
Keywords:
Publication Types:
News
MeSH Terms:
Adjuvants, Immunologic*/economics
Animals
Antineoplastic Agents*/adverse effects
Antineoplastic Agents*/economics
Biomedical Research/economics*
Cancer Vaccines*/economics
Drug Approval
Drug Design
Drug Industry
Drugs, Investigational*/adverse effects
Drugs, Investigational*/economics
Financing, Government*
Humans
Immunotherapy/economics*
Male
National Institutes of Health (U.S.)
Neoplasms/economics*
Neoplasms/immunology
Neoplasms/therapy*
Prostatic Neoplasms/economics
Prostatic Neoplasms/therapy
United States
United States Food and Drug Administration
Substances:
Adjuvants, Immunologic
Antineoplastic Agents
Cancer Vaccines
Drugs, Investigational
