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International trade agreements: hazards to health?

Since the 1980s, neoliberal policies have prescribed reducing the role of governments, relying on market forces to organize and provide health care and other vital human services. In this context, international trade agreements increasingly serve as mechanisms to enforce the privatization, deregulation, and decentralization of health care and other services, with important implications for democracy as well as for health. Critics contend that social austerity and "free" trade agreements contribute to the rise in global poverty and economic inequality and instability, and therefore to increased preventable illness and death. Under new agreements through the World Trade Organization that cover vital human services such as health care, water, education, and energy, unaccountable, secret trade tribunals could overrule decisions by democratically elected officials on public financing for national health care systems, licensing and training standards for health professionals, patient safety and quality regulations, occupational safety and health, control of hazardous substances such as tobacco and alcohol, the environment, and affordable access to safe water and sanitation. International negotiations in 2003 in Cancun and in Miami suggested that countervailing views are developing momentum. A concerned health care community has begun to call for a moratorium on trade negotiations on health care and water, and to reinvigorate an alternative vision of universal access to vital services.

Commerce↗

Ethnobotany and intellectual property rights.

Contemporary intellectual property law permits only the patenting of an identified active principle from a plant, not the plant or folk information relating to medicinal properties of a plant. The most significant rights of indigenous peoples are those deriving from physical control of the plants and the knowledge pertaining to their use. This control can provide the basis for trade secret protection. Such agreements are enforceable in developed nations and should become so in developing nations. There have been recent efforts to strengthen indigenous peoples' rights over genetic resources and relevant folk knowledge but the most far-reaching of these are not yet a part of international law. Pharmaceutical patents combined with trade secrecy can allow firms to develop and market products and ensure that the nation and/or people from which the material or information was derived are properly rewarded. This does not provide protection from competition or with respect to derived knowledge nor does it act retrospectively. At present, rights under the United Nations Convention on Biodiversity are prospective only. These rights belong to the nation and there is little legal pressure for recompense to be shared with indigenous peoples. A uniform agreement that deals in a balanced way with the relative rights of indigenous peoples and of their governments should be developed by non-governmental organizations.

Drug Industry↗

Access to data on chemical composition of products used in auto repair and body shops.

Some information on chemical composition of products used in the workplace can be obtained by requesting composition data from product marketers. Workers in auto repair and body shops identified 253 products used in their shops. Full disclosure of composition was obtained for approximately 20% of the 174 products marketed by companies which answered our letters. Composition was partially disclosed for approximately 40% of the products, and about 10% of the product formulations were claimed to be trade secret or confidential. The study reported in this paper was carried out in New York State in 1980, before the effective date of the New York State right-to-know law. The results of this study can be used as a benchmark to judge the effectiveness of worker right-to-know laws and product labeling regulations.

Air Pollutants, Occupational↗

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↗

Pharmacogenomics, genetic tests, and patent-based incentives.

Pharmacogenomics promises to revolutionize medicine by using genetic information to guide drug therapy. Genetic tests should help doctors improve drug safety and efficacy by better matching patients and drugs. This chapter evaluates the effectiveness of patent-based incentives to create genetic tests, and considers the optimal mix of public and private sector pharmacogenomic research and development (R&D). Drug patent owners have a strong incentive to develop genetic tests that predict adverse drug reactions and allow them to market drugs that otherwise would be shelved. Incentives are also strong for genetic tests that are created as part of the drug development process. Incentives tend to be weaker for genetic tests that are used in conjunction with existing drugs. Drug patent owners might gain or lose profit from the introduction of genetic tests into existing drug markets. Profits may fall because of lost sales, or profits may rise because drugs are more valuable to appropriate patients, and because drugs become more differentiated. Public sector R&D should target genetic tests that are likely to be underprovided by the private sector because private returns are low relative to social returns, or private costs are high relative to social costs. Private returns are relatively low when the rate of adoption of a genetic test is apt to be low, when test results increase consumer heterogeneity and consumer bargaining power, and when a test reveals information relevant to the use of more than one drug. Private costs are relatively high when test innovators need to obtain costly patent and trade secret licenses.

Ethics, Medical↗

Academic-industry research relationships in genetics: a field apart.

Academic-industry research relationships (AIRRS) have become widely accepted and increasingly common in the life sciences. Using nationwide surveys from the United States, we found significant differences between the AIRRs of genetics firms and faculty and those of other firms and faculty. Significantly more genetics than non-genetics firms funded AIRRs, and genetics firms' AIRRs were larger and longer. Genetics faculty with AIRRs were significantly more likely than non-genetics faculty to report that patents, licenses, new companies and trade secrets had resulted from their university research; and that they had refused to share research results of biomaterials with colleagues.

Academies and Institutes↗

Participation of life-science faculty in research relationships with industry.

BACKGROUND: Recent research on academic-industrial research relationships in the life sciences has examined their frequency, benefits, risks, and evolution from the standpoint of industrial sponsors of research. We collected information on the extent and effects of academic-industrial research relationships from the standpoint of faculty members who participate in them. METHODS: We used a mailed questionnaire to collect data between October 1994 and April 1995 from 2052 faculty members (of 3169 eligible respondents; response rate, 65 percent) in the life sciences at the 50 U.S. universities receiving the most research funding from the National Institutes of Health. RESULTS: Twenty-eight percent of the respondents received research support from industry. Faculty members receiving industrial funds had more peer-reviewed articles published in the previous three years, participated in more administrative activities in their institutions or disciplines, and were more commercially active than faculty members without such funding. However, faculty members receiving more than two thirds of their research support from industry were less academically productive than those receiving a lower level of industrial support, and their articles were less influential than those by researchers with no industrial support. Faculty members with industrial support were significantly more likely than those without industrial support to report that trade secrets had resulted from their work (14.5 percent vs. 4.7 percent, P<0.001) and that they had taken commercial considerations into account when choosing research topics (35 percent vs. 14 percent, P<0.001). CONCLUSIONS: Faculty members with industrial research support are at least as productive academically as those without such support and are more productive commercially. However, faculty members who have research relationships with industry are more likely to restrict their communication with colleagues, and high levels of industrial support may be associated with less academic activity without evidence of proportional increases in commercial productivity.

Biology↗

Surveillance of smokeless tobacco nicotine, pH, moisture, and unprotonated nicotine content.

Smokeless tobacco is a complex chemical mixture, including not only the components of the tobacco leaf but also chemicals added during the manufacturing process. Smokeless tobacco contains the addictive chemical nicotine and more than 20 cancer-causing chemicals, including the potent tobacco-specific nitrosamines. The National Toxicology Program of the National Institutes of Health has concluded that oral use of smokeless tobacco is a human carcinogen. Therefore, smokeless tobacco is not a safe alternative to cigarettes. In fact, smokeless tobacco use begins primarily during early adolescence and can lead to nicotine dependence and increased risk of becoming a cigarette smoker. Under the Comprehensive Smokeless Tobacco Health Education Act of 1986 (15 U.S.C. 4401 et seq., Pub. L. 99-252), tobacco manufacturers report annually to the Centers for Disease Control and Prevention (CDC) on the total nicotine, unprotonated nicotine, pH, and moisture content of their smokeless tobacco products. This information is considered "trade secret," or confidential, in accordance with 5 U.S.C. 552(b)(4) and 18 U.S.C. 1905 and cannot be released to the public. In an effort to provide consumers and researchers with information on the nicotine content of smokeless tobacco, CDC arranged for the analysis of popular brands of smokeless tobacco. The results of this CDC study show that pH is a primary factor in the amount of nicotine that is in the most readily absorbable, unprotonated form. Furthermore, this study found that the brands of moist snuff smokeless tobacco with the largest amount of unprotonated nicotine also are the most frequently sold brands.

Biological Availability↗

The impact of the IRB on medical centers.

The role of the IRB in a Medical Center is presented with respect to investigations of medical device safety and effectiveness involving human subjects. The prime points presented and discussed are: the reasons (governmental, social, economic, legal-liability, scientific and moral) for the existence of an IRB; the analytical and descriptive documentation which should always precede experimentation; the concepts governing an application to a "typical" IRB; a practical, detailed outline of some special facts and circumstances typically most important to an IRB; and, the question of confidentiality of trade secrets.

Clinical Trials as Topic↗

Industry-funded dermatologic research within academia in the United States: fiscal and ethical considerations.

Private-sector funding of biomedical research within academia may come from industry, foundations, the dermatologists themselves, and the public at large. Industry-funding is of benefit to both academia and industry. Industry may fund clinical and basic research and product testing. Industry is more willing to fund product testing and clinical research than basic research. Funds for dermatologic research may be obtained from manufacturers of drugs, medical devices, cosmetics, soaps, and detergents. Questions of academic freedom arise when research is funded by industry. The results of academic research are in the public domain; the results of intramural industry research are often proprietary, i.e., "trade secrets." When there is industry funding within academia, any restraints on publication should be held to a minimum and be temporary. Publication should occur in a timely fashion, although recognizing the need for delayed publication if the results concern patentable material. When there is a consultantship, pre-arranged terms of agreement may restrict communication. Patents usually are held by the investigator's institution. The funding company may be granted world-wide, royalty-bearing licenses. Conflicts of interest may arise during any research endeavor; this warrants close attention when the research is industry funded. Stock ownership, speaker fees, blind contracts, etc., should be avoided. In any communication, funding agreements should be stated. Indirect costs are a "necessary evil." There are non-research expenditures associated with all research projects for which the institution is justified in requesting compensation. Indirect costs must have definite connections to a project. As industrial funding of research within academia increases, various facets of the academia-industry relationship are receiving increasing attention. Several aspects of conflicts of interest and indirect costs must yet be resolved. When faced openly and directly, all of these issues are manageable and need not reduce the benefits to both industry and academia that are inherent in this relationship. Federal funding of academic research uses tax dollars; industry funding comes from private capital. Academia will benefit from the funding of academic biomedical research by industry. The ultimate beneficiary of the funding of academic research by industry, however, will be society at large as the medical advances derived from sound biomedical research and carefully controlled clinical trials aid patients. A solidly established academia-industry relationship is essential to the effective funding by industry of biomedical research within academia.

Biomedical Research↗

Review: intellectual property aspects of plant transformation.

One of the recurring themes of the debates concerning the application of genetic transformation technology has been the role of Intellectual Property Rights (IPR). This term covers both the content of patents and the confidential expertise usually related to methodology and referred to as 'Trade Secrets'. This review explains the concepts behind patent protection, and discusses the wide-ranging scope of existing patents that cover all aspects of transgenic technology, from selectable markers and novel promoters to methods of gene introduction. Although few of the patents in this area have any real commercial value, there are a small number of key patents that restrict the 'freedom to operate' of new companies seeking to exploit the methods. Over the last 20 years, these restrictions have forced extensive cross-licensing between ag-biotech companies and have been one of the driving forces behind the consolidation of these companies. Although such issues are often considered of little interest to the academic scientist working in the public sector, they are of great importance in any discussion of the role of 'public-good breeding' and of the relationship between the public and private sectors.

Journal Article↗

Cutting fluids and their effects on the skin of mice. An experimental study with special reference to carcinogenicity.

Reports of skin malignancies due to occupational exposure have decreased since the introduction of solvent-refining of mineral oil fraction in the manufacture of oil based cutting fluids. Commercial mineral oil based cutting fluids caused local and general pathological changes after repeated application to the skin of mice in the present study. Forty-eight per cent of the mice exposed to oils showed severe dysplasia or malignancy of the skin on histological examination. The corresponding figure for the control group, where various additives were used was 8 per cent. The frequency of papillomas was also increased in the mice exposed to oils. The systemic lesions included focal necrosis of the liver, associated with amyloid deposition, as well as amyloidosis of the skin, spleen and kidneys. The substances responsible for these apparent carcinogenic properties of the complex mixtures may be polycyclic hydrocarbons; the latter are still present in the commercial products despite solvent refining; on the other hand the carcinogens may be additives to the cutting oils the composition of which is generally a trade secret.

Amyloidosis↗

A comparison of US and Norwegian regulation of coumarin in tobacco products.

OBJECTIVE: This paper examines policy processes regarding why the USA and Norway have not regulated coumarin in tobacco. DESIGN: A qualitative analysis of all tobacco industry documents regarding coumarin since the 1950s from the 1998 US Master Settlement Agreement and subsequent legal settlements. Additional data were collected from newspaper reports, general internet search engines, journal articles, scholarly reports, court cases, statutes, regulations, and informal correspondence with tobacco control experts in Norway. MAIN OUTCOME MEASURE: An overview, summary, and analysis of all documents related to coumarin. RESULTS: In the USA from 1954 until 1985 when coumarin was reportedly removed from domestic cigarettes, but not from pipe tobacco until 1996, and not at all from imported Indian bidi cigarettes, regulatory efforts were stymied. In Norway, from 1973 to the present, the tobacco industry has never disclosed whether its tobacco products contain coumarin. In both the USA and Norway, the extreme delay and lack of vigorous evidence gathering and significant remedies were caused by tobacco industry assertions that revealing tobacco additives was a violation of trade secrets, and by weak regulatory authority and efforts to regulate coumarin. CONCLUSION: Vigorous and expeditious regulatory investigations and remedies for harmful additives in tobacco, such as coumarin, can protect the public health. Astute insider and outsider political advocacy by health advocates is required to hold elected officials and civil servants publicly accountable for failing to enact disclosure laws and to engage in effective regulatory efforts.

Coumarins↗

"Keep a low profile": pesticide residue, additives, and freon use in Australian tobacco manufacturing.

OBJECTIVES: To review the Australian tobacco industry's knowledge of pesticide residue on Australian tobacco and its policies and practices on resisting calls by tobacco control advocates that consumers should be informed about pesticide residue as well as additives. METHODS: Review of previously internal industry documents relevant to pesticides and additives in Australian tobacco located from the Master Settlement Agreement websites. RESULTS: Between 1972 and 1994 Philip Morris Australia was aware that its leaf samples were often contaminated with pesticide residue, sometimes including organochlorine levels described by PM's European laboratories as being "extremely high". Consumers were not advised of the contamination nor products withdrawn. From 1981, the industry also resisted calls to declare fully the extent of use and long term safety data on all additives used in their products. They developed standard public responses that were evasive and misleading and, in 2000, implemented voluntary additive disclosure which allowed the companies to continue to avoid disclosure of any ingredient they deemed to be a trade secret. There was extensive use of ozone depleting freon in Australian tobacco manufacturing. Again, the industry kept this information away from consumers. CONCLUSIONS: Australian smokers are unable to make informed decisions about smoking because pesticide and additive disclosure remains voluntary. The Australian government should regulate tobacco to require full disclosure including information on the likely health consequences of inhaling pesticide and additive pyrolysis products.

Australia↗

Protecting innovation in bioinformatics and in-silico biology.

Commercial success or failure of innovation in bioinformatics and in-silico biology requires the appropriate use of legal tools for protecting and exploiting intellectual property. These tools include patents, copyrights, trademarks, design rights, and limiting information in the form of 'trade secrets'. Potentially patentable components of bioinformatics programmes include lines of code, algorithms, data content, data structure and user interfaces. In both the US and the European Union, copyright protection is granted for software as a literary work, and most other major industrial countries have adopted similar rules. Nonetheless, the grant of software patents remains controversial and is being challenged in some countries. Current debate extends to aspects such as whether patents can claim not only the apparatus and methods but also the data signals and/or products, such as a CD-ROM, on which the programme is stored. The patentability of substances discovered using in-silico methods is a separate debate that is unlikely to be resolved in the near future.

Computational Biology↗

Life forms protectable as subjects of U.S. 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 U.S. 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 a trade secret or utility patent. 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 U.S. 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↗

Universal service order; protective order for non-rural local exchange carriers--FCC. Policy statement.

This protective order for non-rural local exchange carriers (LECs) is intended to facilitate and expedite review of documents containing trade secrets and commercial or financial information submitted by a person or entity that are either privileged or confidential. It reflects the manner in which "Confidential Information," as that term is defined herein, is to be treated in the universal service proceeding to select a mechanism to determine high cost support. The Order is not intended to constitute a resolution of the merits concerning whether any Confidential Information would be released publicly by the Commission upon a proper request.

Confidentiality↗

Occupational Safety and Health Administration--Access to employee exposure and medical records. Final rule.

This final occupational safety and health standard, promulgated today as a revised 29 CFR 1910.20, provides for employee, designated representative, and OSHA access to employer-maintained exposure and medical records relevant to employees exposed to toxic substances and harmful physical agents. Access is also assured to employer analyses using exposure and medical records. The final standard requires long term preservation of these records, contains provisions concerning informing employees of their rights under the standard, and includes provisions protective of trade secret information.

Accident Prevention↗