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PubMed2003

Restoring balance to industry-academia relationships in an era of institutional financial conflicts of interest: promoting research while maintaining trust.

Economic partnerships between industry and academia accelerate medical innovation and enhance patient access to medical advances, but such partnerships have sometimes eroded public trust in the research enterprise. There is particular risk for conflict of interest when economic partnerships extend beyond a university's corporate interests to involve institutional decision makers. Institutions and institutional decision makers should fully disclose industry-related financial interests and relationships. Without legitimate justification for such interests, individuals should divest themselves from these interests or recuse themselves from responsibility for research oversight. Management of institutional partnerships also might entail the physical separation of certain facilities, the placement of restrictions on information shared between investment and research staffs, and provision of oversight by independent review panels made up of persons who have expertise in intellectual property, finance, and research, but who are not financially or otherwise dependent on the institution. Through these means, it is possible to restore balance to industry-academia relationships, thereby promoting progress while maintaining public trust in research.

Academies and Institutes↗
PubMed1996

Mythos and logos in Hesiod's Theogony, circa 700 B.C.

Hesiod's Theogony, a completely preserved poem, is dated from about 700 B.C. It depicts partly a development, partly a situation that has arisen in the course of time in the world. It constitutes an attempt to understand the cosmos as the product of a genealogical evolution, which can be seen as a process of successive separation, differentiation, and hierarchization. In this attempted picture of the world myth and reality are inextricably interwoven. Observations of natural phenomena as far as of congenital malformations are accordingly exaggerated and undergone mythical transformation. Entities enumerated in this genealogical poem, no matter whether they stand for parts and concrete phenomena of the physical world or intellectual properties and abstract concepts, behave, think, and act, and are accordingly though of, in anthropomorphic terms. Monogamy, polygamy, endogamy, exogamy, asexual and sexual reproduction, multiple conceptions and births, dominantly and recessively inherited traits, normal and abnormal offspring, and perceptions and notions on cosmogony, isogamy, and teratogenesis could be observed in the writing of the Theogony and interpreted by rational modern concepts.

Genetics↗
PubMed2000

Sequence variation database project at the European Bioinformatics Institute.

The sequence variation project at EBI aims to create a unified resource for browsing and searching sequence differences. Technical advances in reading in new data types and in validating and cross-referencing entries are reported. It is suggested that the hardest problems in unifying mutation databases are related to intellectual property rights. The concept of copylefting is introduced as a potential solution to these.

Computational Biology↗
PubMed1990

Commercial exploitation of the human genome: what are the problems?

Commercial activities frequently take place against a background of the ownership of intellectual property, for example patents or know-how. This is particularly true of human health care companies and companies operating in the field of biotechnology, where the high cost and long time frames of research and development demand a degree of exclusivity in order to achieve an acceptable return on the investment. It follows that any company with an interest in using biotechnology to generate human health care products will have a strong interest in the ownership of property, much of which will have its origins in knowledge of the human genome. Claims to the ownership of portions of the human genome have been made public in recent times and these have been treated with everything from disgust to derision. However, a more considered analysis of this question will be found to turn on the relationship between discovery and invention in this field. This paper examines this question in relation to current commercial activities where information from the human genome is being used and attempts to draw some conclusions about what may be the impact of knowledge of the genome on commercial activities in the future.

Biotechnology↗
PubMed1990

Human genetic information: the legal implications.

This paper provides a brief summary of some of the key legal issues raised by human genetic information and research as viewed from a British common law standpoint. The law is basically reactive rather than prospective and problems posed by futuristic medico-scientific discoveries are likely to be dealt with by reference to established legal principles and analogies made with decided cases. The acquisition and research into human genetic information in the form of DNA profiling may have wide-ranging legal implications. Human genetic information may provide an evidential tool in the legal process when the identity of a specific individual or his family connections and relationships are called into question. It may also pose problems of confidentiality which could conflict with a duty of disclosure. In the future it may be possible to identify a propensity to develop a disease which may be seriously disabling or terminal long before any symptoms are detectable. This sensitive information could be of considerable interest to any prospective employer, insurer, marriage partner or family member and is of serious concern to the individual himself. How far should or could such information lawfully be made available and to whom? Legal debates are also likely to focus on ownership of human genetic information, the patenting of techniques to unravel it, and therapies and medicines developed therefrom. The law will be invoked to safeguard any intellectual property which may exist and to patent any inventive steps in the field.(ABSTRACT TRUNCATED AT 250 WORDS)

Confidentiality↗
PubMed2007

Phytochemical, pharmacological and ethnobotanical studies of Rhazya stricta Decne.

Rhazya stricta Decne. is an important medicinal species that is rich in alkaloids containing anticancer alkaloids also. This paper reviews phytochemical, pharmacological and ethnobotanical studies of R. stricta. Phytochemical and pharmacological aspects of the species have been thoroughly explored. Over 100 alkaloids have been isolated from R. stricta, but the pharmacological activities are known for only a few of these compounds. Very few ethnobotanical studies of R. stricta have been done, and there is a particular need for such studies in various regions of South Asia and in Middle Eastern countries where the species grows. These ethnobotanical studies should investigate herbal recipes of R. stricta and their use for curing diseases. The genetic diversity, chemotaxonomy and allelopathy of R. stricta have not yet been explored, and these studies are recommended, with the ultimate goal of benefiting local communities in regions where R. stricta grows. This should be achieved by sharing knowledge and through the manufacture of herbal drugs from R. stricta's active chemical constituents, while protecting intellectual property rights and following the World Health Organization's guidelines for safety and efficacy.

Animals↗
PubMed1997

Database challenges and solutions in neuroscientific applications.

In the scientific community, the quality and progress of various endeavors depend in part on the ability of researchers to share and exchange large quantities of heterogeneous data with one another efficiently. This requires controlled sharing and exchange of information among autonomous, distributed, and heterogeneous databases. In this paper, we focus on a neuroscience application, Neuroanatomical Rat Brain Viewer (NeuART Viewer) to demonstrate alternative database concepts that allow neuroscientists to manage and exchange data. Requirements for the NeuART application, in combination with an underlying network-aware database, are described at a conceptual level. Emphasis is placed on functionality from the user's perspective and on requirements that the database must fulfill. The most important functionality required by neuroscientists is the ability to construct brain models using information from different repositories. To accomplish such a task, users need to browse remote and local sources and summaries of data and capture relevant information to be used in building and extending the brain models. Other functionalities are also required, including posing queries related to brain models, augmenting and customizing brain models, and sharing brain models in a collaborative environment. An extensible object-oriented data model is presented to capture the many data types expected in this application. After presenting conceptual level design issues, we describe several known database solutions that support these requirements and discuss requirements that demand further research. Data integration for heterogeneous databases is discussed in terms of reducing or eliminating semantic heterogeneity when translations are made from one system to another. Performance enhancement mechanisms such as materialized views and spatial indexing for three-dimensional objects are explained and evaluated in the context of browsing, incorporating, and sharing. Policies for providing the system with fault tolerance and avoiding possible intellectual property abuses are presented. Finally, two existing systems are evaluated and compared using the identified requirements.

Animals↗
PubMed2003

Phytoremediation of heavy metals from soils.

Phytoremediation offers owners and managers of metal-contaminated sites an innovative and cost-effective option to address recalcitrant environmental contaminants. The use of plants or plant products to restore or stabilize contaminated sites, collectively known as phytoremediation, takes advantage of the natural abilities of plants to take up, accumulate, store, or degrade organic and inorganic substances. Although not a new concept, phytoremediation is currently being re-examined as an environmentally friendly, cost-effective means of reducing metal contaminated soil and other substrates throughout North America and Europe. Processes include using plants that tolerate and accumulate metals at high levels (phytoextraction) and using plants that can grow under conditions that are toxic to other plants while preventing, for example, soil erosion (phytostabilization). Governments worldwide are establishing research and demonstration programs to use this potential. Environment Canada has developed a database (PHYTOREM) of 775 plants with capabilities to accumulate or hyperaccumulate one or several of 19 key metallic elements. This chapter addresses key research, potential benefits and limitations, and the potential future needs for phytoremediation. Issues related to intellectual property law, commercialization and public acceptance are touched on.

Animals↗
PubMed2003

NMR-based screening methods for lead discovery.

Diversity and robustness of NMR based screening methods make these techniques highly attractive as tools for drug discovery. Although not all screening techniques discussed here may be applicable to any given target, there is however a good chance that at least one of the described methods will prove productive in finding several medium affinity ligands. A comparison of each of the methods is given in Table 1. For drug targets of molecular weight < 30 kDa SAR by NMR appears to be the method of choice since it yields detailed information about the location of the binding site. It remains to be seen whether 15N-1H-TROSY based screening techniques will prove useful for larger protein targets, especially considering the added effort needed for spectral assignment and the increased complexity due to spectral overlap. Nevertheless, with the application of new cryo-cooled NMR probes, 15N-1H-HSQC based screening can now be considered a high throughput method. Ligand-based NMR screening methods can be used for protein targets of virtually any size, but are restricted in the ligand's binding affinity range. Because sufficient ligand-protein dissociation rates are needed, only binding of ligands with low (milimolar) to intermediate (micromolar) affinities is detectable. It is expected that cryo-cooled NMR probe technology will also advance ligand detected NMR screening to the high throughput level. Certainly protein and ligand concentrations can be lowered drastically and experiment times can be shortened with increased sensitivity. However, spectral overlap will be of major concern when mixtures of up to 100 compounds are to be screened. For such applications only techniques for which the signals of bound ligands survive will be useful, and sophisticated software will be needed to deconvolute the spectra of multiple bound ligands. Although only ligands with medium to low affinities can be found, ligand based NMR screening has been used as an effective prescreening tool for assay based high throughput screening. Identifying a large ensemble of medium affinity ligands may not only aid in building a binding site pharmacophore model (see Chapter 11), but also may yield crucial information for overcoming tissue availability, toxicity, or even intellectual property related problems. Although NMR based screening is only one of the more recent additions to the bag of tools used in drug discovery [1, 2], its simplicity and wide range of application (including protein-protein and protein-nucleic acid interactions) has attracted much attention. Advances in NMR instrumentation and methodology have already paved the road for NMR based screening to become a high throughput technique. In addition to this, NMR is exceptional in the amount of detailed structural [table: see text] information it can provide. Not only can NMR readily reveal the binding site (15N-1H-HSQC screening) or the conformation of the bound ligand (transfer NOE), but it can also supply information that enables precise docking of the ligand to the protein's binding pocket (isotope-filtered NOESY). NMR data can therefore provide a natural connection between experimental HTS and combinatorial chemistry techniques with computational methods such as 3D-database searching (see Chapter 10), virtual screening (docking) and structure-based ligand design (see also Chapter 8).

Animals↗
PubMedDate not supplied

Life forms protectable as subjects of US patents--microbes to animals (perhaps).

Scientists, businessmen, universities, and industries with fundamental or peripheral interests in technology as applied to life processes will be keenly interested in recent US Patent Office decisions. These decisions indicate that new higher life forms, animal or plant, are proper subjects of patents if they are not naturally occurring (and are not human, in the case of animals). In contrast to plants and other organisms, genetically modified animals have had no mode of protection as intellectual property except possibly as trade secrets or utility patents. The Ex parte Allen decision, reached by the Patent Office Board of Appeals and Interferences, directly addressed the issue of animal patentability in view of the broad reading of 35 U.S.C. section 101 by the US Supreme Court in the Chakrabarty decision. The subject invention concerned polyploid oysters. Claims directed toward polyploid oysters produced by a particular process were rejected under 35 U.S.C. section 103 and section 101. The Board, reversing the 35 U.S.C. section 101-based rejection in view of the Chakrabarty decision, indicated that the claimed polyploid oysters were non-naturally occurring manufactures or compositions of matter within the confines of patentable subject matter under 35 U.S.C. section 101. A similar decision affecting the patentable status of plants or segments thereof had previously been reached by the Patent and Trademark Office in the case of Ex parte Hibberd, 227 U.S.P.Q. 443 (Bd. Pat. App. 1985). The Hibberd utility patent application concerned "genetically engineered" maize which had high levels of the tryptophan.

Animals↗
PubMed2002

The World Health Organization and the Pharmaceutical Industry. Common areas of interest and differing views.

No article published in the scientific press in the last 10 years reviews the various areas of interest common to the World Health Organization (WHO) and the pharmaceutical industry. Despite a vast amount of information in the public domain, the policies expound the views only of the bodies they represent rather than comparing differing views. An understanding of the factors which affect the interaction between these organisations as well as the organisational structures and the actual areas of intersecting interest, may help to find ways for the industry to assist the WHO in its endeavours in developing countries. Modern drug development is performed initially in and for western society, leaving the areas of infectious or tropical diseases with relatively less industry investment than cancer and cardiovascular disorders. Aspects of the development of an ethical drug, regardless of its therapeutic class (selection of drug name, intellectual property rights, drug safety, marketing and pricing, quality assurance and counterfeiting, generic use, emerging drug donations) are influenced to varying degrees by the triad of money, politics and medical need and the perspectives (each defensible) placed thereon by the WHO and industry. Instead of simply defending their positions combining the best of these strategies to optimise drug development for the needs of developing countries appears logical. Similarly, via its philanthropic initiatives, industry will have donated over $US1 billion in drug and research aid in the period 1995 to 2005. These charitable projects should yield useful information for planning and organising future aid efforts. Global warming, only recently given serious governmental consideration, is an area not yet addressed in drug development policy although along with geographical effects, it is likely to have an impact on the epidemiology of diseases e.g. malaria returning to the Mediterranean, worldwide. With changing disease patterns (and particularly if the western world is affected directly), a shift in emphasis on future medical needs and drug development can be anticipated. Furthermore, given the increased modern interest in herbal medicines and the fact that poorer countries rely heavily on traditional medicines, archiving of botanicals under threat would preserve plants for future medicinal testing or use. Coupled with the environmental and poverty issues that the WHO already attempts to address in developing countries, it is timely for both bodies to work towards certain agreed mutual aims. To work effectively, it is realistic that both bodies must benefit and also make concessions in this interactive process.

Developing Countries↗
PubMed2000

Human genetics in health care.

UNLABELLED: The Human Genome Project, the mapping of our 100,000 genes and the sequencing of all of our DNA, will have major impact on biomedical research and the whole of therapeutic and preventive health care. The tracing of genetic diseases to their molecular causes is rapidly expanding diagnostic and preventive options, while the increased insights into molecular pathways open tremendous perspectives for pharmacological and genetic therapies. The design of animal model systems for the functional study of disease and development and the use of bioinformatics and biostatistics to improve our pattern recognition abilities are greatly accelerating progress. However, the optimal value from the current explosion of 'data mining' possibilities will only be gained when the basic data are made and kept publicly accessible, while at the same time safeguarding the protection of intellectual property arising from downstream inventions. This is one of the goals of the international Human Genome Organisation, established 10 years ago to assist coordinating data acquisition and exchange and societal implementation of the genome project. Additional points of major attention in this historic endeavour are the safeguarding of a worldwide balance in the contribution and benefits to countries and populations, the prevention of stigmatisation and discrimination of individuals and groups and the maintenance of respect for the diversity of our world's cultures and traditions. CONCLUSION: The acquisition and use of genomic information for health care benefit should be seen in the light of a worldwide improvement without prejudice.

Ethics, Medical↗
PubMed2006

Building collaborative networks for HIV/AIDS vaccine development: the AVIP experience.

The need for an effective HIV/AIDS vaccine is imperative to halt a pandemic that involves more than 40 million individuals worldwide as of 2005 and is causing enormous socio-economic losses, especially in developing countries (DC). The overall failure of more than two decades of HIV vaccine research justifies the demands for a concerted effort for the rapid development of new and efficacious vaccines against HIV/AIDS. In this context, building international collaborative networks is a must for speeding up scientific research and optimizing the use of funding in a synergistic fashion, as resources for HIV/AIDS are limited and do not involve most of the biggest Pharmas that are more interested in drug discovery. The AIDS Vaccine Integrated Project (AVIP) consortium is an example of synergistic partnership of international European Union and DC experts with a common research goal. AVIP is a European Commission-funded (FP-6), consortium-based, 5-year program directed to the fast development of new HIV/AIDS vaccine candidates to be tested in phase I clinical trials in Europe for future advancement to phase II/III testing in DC. To ensure their rapid development, AVIP novel combined vaccines include both regulatory and structural HIV antigens, which have already been tested, as single components, in phase I clinical trials. In particular, such combination vaccines may be superior to earlier vaccine candidates, the vast majority of which are based only on either structural or regulatory HIV products. In fact, the generation of immune responses to both types of viral antigens expressed either early (regulatory products) or late (structural products) during the viral life cycle can maximize immune targeting of both primary or chronic viral infection. Further, the rational design of combined vaccines allows exploitation of immunomodulatory functions of HIV regulatory proteins, which can improve immunity against structural vaccine components. The building of the AVIP consortium and its scientific strategy will be reviewed in this paper as an example of the establishment of a consortium regulated by a specific intellectual property agreement.

AIDS Vaccines↗
PubMed2007

Assessment of the pharmaceutical market in Poland after accession to the European Union.

The Republic of Poland joined the European Union (EU) on 1 May 2004. The EU accession brought new opportunities to the Polish health care system and the pharmaceutical market. However, there are still barriers to overcome such as bureaucracy, lack of transparency in pricing and reimbursement, decision-making processes, the short period of data exclusivity, respect for intellectual property rights, favorisation of local companies and low health care investment. Additionally, drug costs outpace overall economic development, a trend which is universally valid for almost all EU countries and which forms one of the most serious factors in health care expenditure. A systematic cost-effective assessment, the so-called fourth hurdle (after quality, efficacy and safety), of prescription drugs seems a necessity in most EU countries. The Polish Ministry of Health has defined aims for the future health care system in the National Drug Policy 2004-2008, including health economical criteria and instruments. However, it is to be expected that for some time there will be more a reimbursement hurdle instead of a fourth hurdle in controlling drug expenditure. This review focuses on the Polish pharmaceutical market with special consideration of the history of the Polish health care system. It will highlight the present situation of the Polish health care system after EU accession and provide an outlook to its possible future.

Cost-Benefit Analysis↗
PubMed2002

Managing financial conflicts of interest in clinical research.

Upholding public trust in clinical research necessitates that human subjects be protected from avoidable harm and that the design, interpretation and reporting of research results be shielded from avoidable bias. On both counts, managing financial conflicts of interest is critically important, especially in the modern era when the opportunities for investigators to benefit personally from the commercialization of their intellectual property are overtly encouraged and rapidly expanding. Efforts are underway in the United States to provide more useful guidance to universities and medical schools for purposes of strengthening the oversight and management of financial conflicts of interest in clinical research.

Biomedical Research↗
PubMed2005

Industry, innovation and social values.

Remaining important tasks in finding and developing new drugs and vaccines for HIV/AIDS, malaria, cancer and other diseases require continued industry research and development. Industry's research and development pipeline has produced drugs that have saved AIDS victims previously facing certain death, but still no cure nor vaccine is yet available. Experience with the process of research and development indicates that it requires more than a decade of development to produce a new drug with costs in the hundreds of millions of dollars. Intellectual property protection is critically important in assuring that drug development continues. Partnerships between industry and the public sector have increased access to new therapies in developing countries and promise to enhance access to both patented and generic medicines in the future.

Chemistry, Pharmaceutical↗
PubMed2005

Making human research safe: why we cannot afford to fail.

This paper was given as a keynote address at the International Conference on Ethics of Intellectual Property Rights and Patents held in Warsaw, Poland on April 23-24, 2004. The address was the introductory presentation to the important topic of protecting individuals who participate in research as research subjects.

Biomedical Research↗
PubMed2005

Surgical patents and patients--the ethical dilemmas.

It is obvious that every inventor should be rewarded for the intellectual effort, and at the same time be encouraged to successively improve his or her discovery and to work on subsequent innovations. Patents also ensure that patent owners are officially protected against intellectual piracy, but protection of intellectual property may be difficult to accomplish. Nevertheless, it all comes down to this basic question: Does a contradiction exist between medical ethics and the "Medical and Surgical Procedure Patents" system? It may well turn out that medical-procedure patents can have a negative influence on the standard of medical care. Medical-method patents may also interfere with the physician-patient relationship. At present, physicians do not question the usefulness of patent protection for medicines, biotechnology, equipment and devices, but they strongly oppose it for surgical procedures.

Ethics, Medical↗