Cancer Chemoprevention and Cancer Preventive Vaccines—A Call to Action: Leaders of Diverse Stakeholder Groups Present Strategies for Overcoming Multiple Barriers to Meet an Urgent Need

University of Pittsburgh, Pittsburgh, Pennsylvania, United States
Cancer Research (Impact Factor: 9.33). 01/2007; 66(24):11540-9. DOI: 10.1158/0008-5472.CAN-06-4122
Source: PubMed


The emerging field of cancer prevention through chemoprevention agents and cancer vaccines offers significant promise for reducing suffering and death from cancer. However, that promise may not be kept unless major barriers to progress are lowered or eliminated. Among the most significant barriers are the relatively small investment from government and industry in research and development of cancer preventive agents; a predominant emphasis of translational cancer research on therapeutic interventions for metastatic or advanced cancer; complexities of prevention trial design; a relatively uncharted Food and Drug Administration (FDA) approval process for preventive agents; insufficient public and patient understanding of the importance and potential for cancer preventive measures, with consequent unpredictable public and patient willingness to take preventive agents; an uncertain reimbursement from payors; and limitations in patent law, liability protection, and data package exclusivity that undermine the opportunity for recouping investment. Viewed individually or collectively, each of these barriers serves as a substantial deterrent to intellectual and financial investment by all sectors of the cancer community. In an effort to ultimately overcome these barriers, a Cancer Prevention Research Summit was assembled June 12-13, 2006 in Bethesda, Maryland, organized by C-Change with support from the AACR. The Summit brought together some 120 leaders from private, public, and not-for-profit entities, including cancer researchers and clinicians; federal health officials; regulatory agency representatives; pharmaceutical, biotech, and food industry leaders; patent attorneys; economists; public and private provider group executives; and advocates. Participants engaged in a detailed process to more carefully define the major barriers, identify potential solutions, and formulate initial priorities and recommendations for action. At the conclusion of this dialogue among experts, the following recommended actions were outlined: define policy solutions to patent, intellectual property, and liability law barriers; create an advisory document about the approval process for cancer chemopreventive agents and vaccines for the FDA; develop new design models for cancer chemopreventive clinical trials; outline the business case for chemopreventive agents and vaccines for federal research agencies, payors and investors; and implement a communications strategy to increase public awareness about the importance of chemoprevention and cancer preventive vaccines.

Download full-text


Available from: David Samuel Alberts,
  • Source
    • "The effect of physician recommendation also had been assessed 6,9. All these factors impact on persons' decision and multiple barriers exist 8. We assumed that besides these characteristics, different study designs are also relevant factors to consider. "
    [Show abstract] [Hide abstract]
    ABSTRACT: Chemoprevention could significantly reduce cancer burden. Assessment of efficacy and risk/benefit balance is at best achieved through randomized clinical trials. At a periodic health examination center 1463 adults were asked to complete a questionnaire about their willingness to be involved in different kinds of preventive clinical trials. Among the 851 respondents (58.2%), 228 (26.8%) agreed to participate in a hypothetical chemoprevention trial aimed at reducing the incidence of lung cancer and 116 (29.3%) of 396 women agreed to a breast cancer chemoprevention trial. Randomization would not restrain participation (acceptability rate: 87.7% for lung cancer and 93.0% for breast cancer). In these volunteers, short-term trials (1 year) reached a high level of acceptability: 71.5% and 73.7% for lung and breast cancer prevention respectively. In contrast long-term trials (5 years or more) were far less acceptable: 9.2% for lung cancer (OR=7.7 CI(95%) 4.4-14.0) and 10.5 % for breast cancer (OR=6.9 CI(95%) 3.2-15.8). For lung cancer prevention, the route of administration impacts on acceptability with higher rate 53.1% for a pill vs. 7.9% for a spray (OR=6.7 CI(95%) 3.6-12.9). Overall healthy individuals are not keen to be involved in chemo-preventive trials, the design of which could however increase the acceptability rate.
    International journal of medical sciences 02/2008; 5(5):244-7. · 2.00 Impact Factor
  • Source
    • "Gardasil was approved to prevent infection from some of the most common strains of human papillomavirus that cause cervical cancer (Herberman 2006; Sobol 2006). Another HPV vaccine, Cevarix, is close to approval in the U.S. (Berton 2007). "

  • [Show abstract] [Hide abstract]
    ABSTRACT: One practical way to control cancer is through chemoprevention, which refers to the administration of synthetic or naturally occurring agents to block, reverse or delay the process of carcinogenesis. For a variety of reasons, the most important of which is human acceptance, for chemopreventive intervention naturally occurring diet-based agents are preferred over synthetic agents. For a long time, the prevailing mantra of cancer chemoprevention has been: "Find effective agents with acceptable or no toxicity and use them in preventing cancer in relatively healthy people or individuals at high risk for developing cancer". In pursuing this goal many naturally occurring phytochemicals capable of affording protection against carcinogenesis in preclinical settings in experimental animals have been described. However, clinical trials of single agents have yielded disappointing results. Since carcinogenesis is a multistage phenomenon in which many normal cellular pathways become aberrant, it is unlikely that one agent could prove effective in preventing cancer. This review underscores the need to build an armamentarium of naturally occurring chemopreventive substances that could prevent or slow down the development and progression of prostate cancer. Thus, the new effective approach for cancer prevention "building a customized mechanism-based chemoprevention cocktail of naturally occurring substances" is advocated.
    Chemico-Biological Interactions 01/2008; 171(2):122-32. DOI:10.1016/j.cbi.2007.03.001 · 2.58 Impact Factor
Show more