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PubMed2006

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.

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.

Anticarcinogenic Agents↗

PubMedDate not supplied

Scientific journals and their authors' financial interests: a pilot study.

BACKGROUND: The credibility of modern science is grounded on the perception of the objectivity of its scientists, but that credibility can be undermined by financial conflicts of interest. The US Public Health Service and the National Science Foundation issued regulations effective October 1, 1995, regarding the disclosure of financial interests in the submission of grant proposals. Several scientific journals have also established pertinent policies for authors and editors. The objectives of this study were: (1) to select a set of published articles and observe the degree to which a sample of authors hold a financial interest in areas related to their research that are reportable under current standards, and (2) to examine the hypothesis that significant numbers of authors of articles in life science and biomedical journals have verifiable financial interests that might be important for journal editors and readers to know. This paper measures the frequency of selected financial interests held among lead authors of certain types of scientific publications and assesses disclosure practices of authors and journals. METHOD: These objectives were applied to a pilot study of Massachusetts academic scientists who were cited as first or last author in at least one article published in 1992 in 14 leading journals of cell or molecular biology and medicine. We created a database of every original article published in 1992 by 14 leading life science and biomedical journals, supplemented by data sets consisting of (1) Massachusetts biotechnology firms, including their officers and scientific advisory boards, and (2) scientists listed as inventors on patents or patent applications registered with the World Intellectual Property Organization. RESULTS: We examined 1,105 university authors (first and last cited) from Massachusetts institutions whose 789 articles, published in 1992, appeared in 14 scientific and medical journals. Authors are said to 'possess a financial interest' if they are listed as inventors in a patent or patent application closely related to their published work; serve on a scientific advisory board of a biotechnology company; or are officers, directors, or major shareholders (beneficial owner of 10% or more of stock issued) in a firm that has commercial interests related to their research. Applying the criteria to the reference population of journals and Massachusetts academic authors, we measured the following frequencies for lead authors: 0.20 for serving on a scientific advisory board; 0.07 for being an officer, director, or major shareholder in a biotechnology firm, and 0.22 for being listed as an inventor in a related patent or patent application. The joint frequency of articles in the journals reviewed with a lead author that meets one of the three conditions is 0.34. CONCLUSIONS: One of every three articles in our sample has at least one Massachusetts-based author with a financial interest, and 15% of the authors in our sample have a financial interest relevant to one of their publications. For the year 1992, the rate of published voluntary disclosures of financial interest (as defined in our study) is virtually zero, but relatively few scientific and biomedical journals at that time required any such disclosure to journal editors and reviewers. Further research is needed to determine the effectiveness of mandatory disclosure requirements by some journals.

Authorship↗

PubMed2000

Population genetics and benefit sharing.

The majority of international or national guidelines, specific to human genetics concentrate on actual or potential clinical applications. In contrast, the Ethics Committee of the Human Genome Organisation (HUGO) attempts to provide guidance to the bench scientists engaged in fundamental research in genomics prior to any clinical applications. Often confused as constituting the Human Genome Project (HGP) itself, HUGO's (Human Genome Organization) ultimate goal is to assist in the worldwide collaboration underpinning the HGP. It is an international organisation with 1,229 members in approximately 60 countries. The Ethics Committee is one of HUGO's six international advisory committees. Composed of experts from a number of countries and disciplines, the HUGO Ethics Committee promotes discussion and understanding of social, legal, and ethical issues as they relate to the conduct of, and knowledge derived from, the Genome Initiative. Currently, it has 13 members from 11 difference countries. It has produced statements on the conduct of genetic research, on cloning, and, has most recently presented a 'Statement on Benefit-Sharing', April 11, 2000. The Intellectual Property Committee of HUGO has been active in the controversial area of patenting. The issue of benefit-sharing is one that has its source in the mandate of both committees. How to avoid both commodification of the person through payment for access to DNA and biopiracy with no return to benefits to the families or community? While patents are a legitimate form of recognition for innovation, there seems to be no therapeutic exception to some of its stringent rules and the 'morality' exclusion has lain dormant. The HUGO 'Statement on Benefit-Sharing' examines the issues of defining community, common heritage, distributive justice and solidarity before arriving at its conclusions in benefit-sharing. This communication reviews some of these issues.

Genetics, Population↗

PubMed2002

Ethical, legal and economic issues raised by the use of human tissue in postgenomic research.

Ethical, legal and economic framework issues concerning human samples, genetic data and bioresources are rapidly evolving. In most cases, international standards have not been defined. National legislations on the use and exploitation of human sample collections differ widely. Legislations relating to intellectual property rights, access to database information for public or private bodies, of national or foreign origin, are similarly diverse. Importation and exportation rules, concerning in particular data protection, biosafety and protection of individual rights, have not always been defined. This article makes a short assessment of the legal, ethical and economic framework in selected EC countries (Germany, France and UK), and compares them with the conditions in the USA. On the basis of the information collected, it is obvious that the use of human cells, tissues and organs in medical research has to be considered as a global, worldwide question. Such use has profound ethical, cultural and economic consequences not only in the country of origin, but also globally. Biotechnology and pharmaceutical companies conducting research with human samples are facing different framework conditions in the area of data protection, policy measures, economic support, exportation, etc., that already influence trade activities and investments of such firms at the international level. Over the 3 last years, a trend towards harmonization can be recognized: the World Health Organization has recognized the problems of postgenomic medical research as a priority. The OECD has created a taskforce on centers for biological resources. Biobanks are a common theme of the French and the German National Ethic Councils. A lack of international harmonization and consistency might not only present a challenge to biotechnology and pharmaceutical companies, but can also endanger the goals the laws and regulations seek to achieve.

Culture Techniques↗

PubMed2005

Balancing innovation and access to healthcare through the patent system--an Australian perspective.

This article examines the enforcement of gene and other research tool patents in Australia. An empirical analysis of patenting practices in the Australian medical biotechnology industry showed heightened concern about the impact of patents on research and diagnostic testing, but provided little evidence to support these concerns at that time. Since then, the Australian company Genetic Technologies Ltd. has been enforcing its patents for non-coding DNA sequences. The governments of Australia are encouraging the biotechnology industry to better protect and enforce intellectual property rights, but recognize these needs to be balanced against access to healthcare. The article discusses proposals made by the Australian Law Reform Commission to adjust the balance, both by tightening the requirements for obtaining patents and by introducing various options to assist providers of diagnostic services and others in using patented inventions, but at the same time maintaining the incentive to innovate.

Australia↗

PubMed2006

From hype to mothballs in four years: troubles in the development of large-scale DNA biobanks in Europe.

This paper analyses the difficulties experienced by three large European DNA biobanks. The first, Icelandic-based deCode, generated immense commercial interest and intense ethical controversy. As a biotechnology company, deCode succeeded, but the Icelandic Health Sector Data Base failed. The second firm, Swedish UmanGenomics, marketed itself as the 'ethical' biotech company. Management problems including the inadequate recognition of intellectual property issues led to the company failing to secure adequate investment. The third and largest, UK Biobank, has, as a non-profit organization, not experienced these problems. But when the product - bio information--is marketed, the issue of ethically acceptable purchasers could well become contentious.

Computational Biology↗

PubMed2001

Neuroimaging consortium workshop: development of novel PET and SPECT ligands for brain imaging.

It was clear from the levels of participation in this panel discussion and from the levels of interest expressed in the upcoming NIMH tracer Consortium Workshop that there is a great deal of potential benefit to public health from the development of new PET and SPECT (and, perhaps, MRI?) tracers. For extramural NIH programs, the tool guidelines for grantees are in fact only that--guidelines--but they could become specific regulations if unacceptable threats to basic research are perceived. This is because the benefits of collaboration among basic scientists are considered essential for the success of research programs. On the other hand, intramural programs at NIH are considered by some to be the "beta test site" for emerging issues and policies, regardless of the specific scientific topic. This may well be true for research tools and presents an opportunity to find new ways of working. As for the industry, threats to intellectual property arise from myriad sources. The magnitude of these threats can only be appreciated from the perspective of long-term investment in research-based industries with significant regulation. In particular, the pharmaceutical industry enjoys only a relatively short period of time during which investments in the last medicament can be recouped to support the development of the next. A great deal of commitment and sophistication will be required if the United States shall succeed in finding new ways of translating basic into applied science for the practical benefit of currently underserved patient populations.

Brain↗

PubMed2001

Use of videotaped interventions in research.

Evaluating conceptual and methodological issues are important considerations when developing a videotape for research intervention. The process of developing a videotape for research involves several critical steps to maintain scientific rigor during the project. Establishing content validity of the videotape script and maintaining scientific integrity while producing the videotape are key components. Issues such as copyright and intellectual property are important considerations. The use of videotape provides a consistent method of providing information to research subjects. Careful attention to the research process during each phase of development of the videotape will enhance the success of the project.

Audiovisual Aids↗

PubMed2006

Effective partnering of academic and physician scientists with the pharmaceutical drug development industry.

This manuscript briefly addresses the drug discovery and development process. It is a long road from the formulation of a good discovery idea to the acceptance of a new drug in the marketplace, and there are many challenges faced along the way to the patient. Collaborations and partnerships are an important part of this process. There are a variety of partnering opportunities, ranging from the discovery of novel technologies and drug targets to lead discovery, compound gifts, and external sourcing. These partnerships help increase confidence and improve decision making on issues of safety and efficacy preclinically, which can reduce attrition and expedite the provision of new quality drugs to patients more quickly and at lower costs. Collaborations involve addressing multiple issues that include infrastructure, safety, regulatory matters, intellectual property, technical and personnel considerations, source document capture and data analysis issues, and legal and strategic alliances. A number of success factors are identified as important for quality collaborations in the drug development process.

Drug Industry↗

PubMedDate not supplied

Who's afraid of national laws? Pesticide corporations use trade negotiations to avoid bans and undercut public health protections in Central America.

The agrochemical industry is using trade agreements to block proposed bans on pesticides identified as the worst occupational health hazards by a multi-country illness surveillance program in Central America. Through privileged access to closed-door negotiations, industry inserted deregulatory mechanisms, including a regional pesticide registry that invalidates national laws, investors' rights protection, and increased intellectual property protections, into the draft Central American Customs Union and the Central American Free Trade Agreement. These agreements undermine health-based national pesticide registration requirements; weaken health ministries' role in pesticide control; block marketing of cheaper, less toxic pesticides; and have a chilling effect on future pesticide regulatory activity. So long as corporations have privileged access to the trade negotiations and civil society is excluded, the resulting agreements will benefit special interests at the expense of public health.

Agriculture↗

PubMed2003

Evolutionary algorithms for the selection of single nucleotide polymorphisms.

BACKGROUND: Large databases of single nucleotide polymorphisms (SNPs) are available for use in genomics studies. Typically, investigators must choose a subset of SNPs from these databases to employ in their studies. The choice of subset is influenced by many factors, including estimated or known reliability of the SNP, biochemical factors, intellectual property, cost, and effectiveness of the subset for mapping genes or identifying disease loci. We present an evolutionary algorithm for multiobjective SNP selection. RESULTS: We implemented a modified version of the Strength-Pareto Evolutionary Algorithm (SPEA2) in Java. Our implementation, Multiobjective Analyzer for Genetic Marker Acquisition (MAGMA), approximates the set of optimal trade-off solutions for large problems in minutes. This set is very useful for the design of large studies, including those oriented towards disease identification, genetic mapping, population studies, and haplotype-block elucidation. CONCLUSION: Evolutionary algorithms are particularly suited for optimization problems that involve multiple objectives and a complex search space on which exact methods such as exhaustive enumeration cannot be applied. They provide flexibility with respect to the problem formulation if a problem description evolves or changes. Results are produced as a trade-off front, allowing the user to make informed decisions when prioritizing factors. MAGMA is open source and available at http://snp-magma.sourceforge.net. Evolutionary algorithms are well suited for many other applications in genomics.

Algorithms↗

PubMed2003

A format for databasing and comparison of AFLP fingerprint profiles.

BACKGROUND: Amplified fragment length polymorphism (AFLP) is a PCR-based technique that involves restriction of genomic DNA followed by ligation of adaptors to the fragments generated and selective PCR amplification of a subset of these fragments. The amplified fragments are separated on a sequencing gel and visualized by autoradiography or fluorescent sequencing equipment. AFLP allows high-resolution genotyping but the lack of a format for databasing and comparison of AFLP fingerprint profiles limits its wider applications in profiling large numbers of biological samples. RESULTS: A scheme is described to represent a DNA fingerprint profile with a nucleotide sequence-like format in which the information line contains the minimal necessary details to interpret an AFLP DNA fingerprint profile. They include technique used, information on restriction enzymes, primer combination, biological source for DNA materials, fragment sizing and annotation. The bodylines contain information on size and relative intensity of DNA fragments by a string of defined alphabets or symbols. Algorithms for normalizing raw data, binning of fragments and comparing AFLP DNA fingerprint profiles are described. Firstly, the peak heights are normalized against their average and then represented by five symbols according to their relative intensities. Secondly, a binning algorithm based loosely on common springs and rubber bands is applied, which positions sequence fragments into their best possible integer approximations. A BLAST-like reward-penalty concept is used to compare AFLP fingerprint profiles by matching peaks using two metrics: score and percentage of similarity. A software package was developed based on our scheme and proposed algorithms. Example of use this software is given in evaluating novelty of a new tropical orchid cultivar by comparing its AFLP fingerprint profile against those of related commercial cultivars in a database. CONCLUSIONS: AFLP DNA fingerprint profiles can be databased and compared effectively with software developed based on our scheme and algorithms. It will facilitate wider use of this DNA fingerprinting technique in areas such as forensic study, intellectual property protection for biological materials and biodiversity management. Moreover, the same concepts can be applied to databasing and comparing DNA fingerprint profiles obtained with other DNA fingerprint techniques.

Algorithms↗

PubMed2005

Harnessing genomics to improve health in the Eastern Mediterranean Region - an executive course in genomics policy.

BACKGROUND: While innovations in medicine, science and technology have resulted in improved health and quality of life for many people, the benefits of modern medicine continue to elude millions of people in many parts of the world. To assess the potential of genomics to address health needs in EMR, the World Health Organization's Eastern Mediterranean Regional Office and the University of Toronto Joint Centre for Bioethics jointly organized a Genomics and Public Health Policy Executive Course, held September 20th-23rd, 2003, in Muscat, Oman. The 4-day course was sponsored by WHO-EMRO with additional support from the Canadian Program in Genomics and Global Health. The overall objective of the course was to collectively explore how to best harness genomics to improve health in the region. This article presents the course findings and recommendations for genomics policy in EMR. METHODS: The course brought together senior representatives from academia, biotechnology companies, regulatory bodies, media, voluntary, and legal organizations to engage in discussion. Topics covered included scientific advances in genomics, followed by innovations in business models, public sector perspectives, ethics, legal issues and national innovation systems. RESULTS: A set of recommendations, summarized below, was formulated for the Regional Office, the Member States and for individuals.* Advocacy for genomics and biotechnology for political leadership;* Networking between member states to share information, expertise, training, and regional cooperation in biotechnology; coordination of national surveys for assessment of health biotechnology innovation systems, science capacity, government policies, legislation and regulations, intellectual property policies, private sector activity;* Creation in each member country of an effective National Body on genomics, biotechnology and health to:- formulate national biotechnology strategies- raise biotechnology awareness- encourage teaching and training of biotechnology- devise integration of biotechnology within national health systems. CONCLUSION: The recommendations provide the basis for a road map for EMR to take steps to harness biotechnology for better and more equitable health. As a result of these recommendations, health ministers from the region, at the 50th Regional Committee Meeting held in October 2003, have urged Member States to establish national bodies of biotechnology to formulate a strategic vision for developing biotechnology in the service of the region's health. These efforts promise to raise the profile of genomics in EMR and increase regional cooperation in this exciting new field.

Editorial↗

PubMed2005

Good old days?

Alternative models of subsidizing scholarly publishing and dissemination have germinated and gathered momentum in the fertile soil of dissatisfaction. Like the stubborn spring dandelion that needs but a small crack in the sidewalk to flower boldly, the first flowers of Open Access in library literature, including Biomedical Digital Libraries, have sensed their opportunity to change the existing paradigm of giving away our scholarship and intellectual property, only to buy it back for the privilege of knowing it can be read. Will biomedical digital library and informatics researchers understand their role in a new era of Open Access simply by desiring an immediate uninhibited global audience and recognizing the necessity of open access peer-reviewed literature to become self-sufficient?

Journal Article↗

PubMed2005

Medicines and vaccines for the world's poorest: is there any prospect for public-private cooperation?

This paper reviews the current status of the global pharmaceutical industry and its research and development focus in the context of the health care needs of the developing world. It will consider the attempts to improve access to critical drugs and vaccines, and increase the research effort directed at key public health priorities in the developing world. In particular, it will consider prospects for public-private collaboration. The challenges and opportunities in such public-private partnerships will be discussed briefly along with a look at factors that may be key to success. Much of the focus is on HIV/AIDS where the debate on the optimal balance between intellectual property rights (IPR) and human rights to life and health has been very public and emotive.

Journal Article↗

PubMed2005

Assessing the impact of the Australia-United States Free Trade Agreement on Australian and global medicines policy.

On 1 January 2005, a controversial trade agreement entered into force between Australia and the United States. Though heralded by the parties as facilitating the removal of barriers to free trade (in ways not achievable in multilateral fora), it also contained many trade-restricting intellectual property provisions and others uniquely related to altering pharmaceutical regulation and public health policy in Australia. The latter appear to have particularly focused on the world-respected process of federal government reimbursement after expert cost-effectiveness evaluation, popularly known as the Pharmaceutical Benefits Scheme ('PBS'). It remains uncertain what sort of impacts--if any--the Australia-United States Free Trade Agreement ('AUSFTA') will have on PBS processes such as reference pricing and their important role in facilitating equitable and affordable access to essential medicines. This is now the field of inquiry for a major three year Australian Research Council ('ARC')-funded study bringing together a team of senior researchers in regulatory theory from the Australian National University and pharmacoeconomics from the University of Newcastle. The project proposes to monitor, assess and analyse the real and potential impacts of the AUSFTA in this area, providing Australian policy-makers with continuing expertise and options. To the extent that the AUSFTA medicines provisions may represent an important precedent in a global strategy by industry on cost-effectiveness evaluation of pharmaceuticals, the study will also be of great interest to policy makers in other jurisdictions.

Journal Article↗

PubMed2005

TRIPS, the Doha Declaration and increasing access to medicines: policy options for Ghana.

There are acute disparities in pharmaceutical access between developing and industrialized countries. Developing countries make up approximately 80% of the world's population but only represent approximately 20% of global pharmaceutical consumption. Among the many barriers to drug access are the potential consequences of the Trade Related Aspects of Intellectual Property Rights (TRIPS) Agreement. Many developing countries have recently modified their patent laws to conform to the TRIPS standards, given the 2005 deadline for developing countries. Safeguards to protect public health have been incorporated into the TRIPS Agreement; however, in practice governments may be reluctant to exercise such rights given concern about the international trade and political ramifications. The Doha Declaration and the recent Decision on the Implementation of Paragraph 6 of the Doha Declaration on the TRIPS Agreement and Public Health may provide more freedom for developing countries in using these safeguards. This paper focuses on Ghana, a developing country that recently changed its patent laws to conform to TRIPS standards. We examine Ghana's patent law changes in the context of the Doha Declaration and assess their meaning for access to drugs of its population. We discuss new and existing barriers, as well as possible solutions, to provide policy-makers with lessons learned from the Ghanaian experience.

Journal Article↗

PubMed2006

Toward a treaty on safety and cost-effectiveness of pharmaceuticals and medical devices: enhancing an endangered global public good.

Expert evaluations of the safety, efficacy and cost-effectiveness of pharmaceutical and medical devices, prior to marketing approval or reimbursement listing, collectively represent a globally important public good. The scientific processes involved play a major role in protecting the public from product risks such as unintended or adverse events, sub-standard production and unnecessary burdens on individual and governmental healthcare budgets. Most States now have an increasing policy interest in this area, though institutional arrangements, particularly in the area of cost-effectiveness analysis of medical devices, are not uniformly advanced and are fragile in the face of opposing multinational industry pressure to recoup investment and maintain profit margins. This paper examines the possibility, in this context, of States commencing negotiations toward bilateral trade agreement provisions, and ultimately perhaps a multilateral Treaty, on safety, efficacy and cost-effectiveness analysis of pharmaceuticals and medical devices. Such obligations may robustly facilitate a conceptually interlinked, but endangered, global public good, without compromising the capacity of intellectual property laws to facilitate local product innovations.

Journal Article↗