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Herbs and Food Supplements: Promise Amid Perils Bernard Lown, MD

Abstract: Many important drugs derive and continue to be harvested from botanical plants the world over. Early in my career I pretended some expertise and extensively researched that remarkable drug digitalis that has been in continuous use for more than two centuries. Digitalis, of course, comes from the foxglove plant. A British physician, William Withering, introduced digitalis to the medical profession in 1785. The discovery was not his, however. Withering noted that an old woman herbalist had successfully cured the dropsy (edema) by using the foxglove plant when regular medical practitioners had failed. Being an astute botanist, Withering soon determined the active ingredient to be digitalis. There are a host of other effective medicines derived from folk usage: opium from poppy seed for pain relief; quinine from chincona bark for malaria; aspirin from willow bark for fever; and recently taxol from the tropical yew tree for cancer. If little else supports their use, the mere fact that they have persevered at least since the Stone Age as panaceas for human afflictions commands respect. The Ice Man, whose ancient remains were discovered frozen in the Alps in 1991, carried a bit of fungus believed to be used against a parasite that infested his gut. Almost half of the 20 current best-selling drugs are either natural products or their semi-synthetic derivatives. The search for medically active botanicals engages some of the world's leading pharmaceutical companies. One may justly ask, "If herbs are safe and make one feel better, why is the medical profession so skeptical?" Profound conceptual issues divide those who promote alternative healing methods and those who support scientific medicine. Essentially doctors demand of any medicinal agent, herb, drug or new procedure, proof of safety, evidence of efficacy, and a plausible biological theory for action.

©2000 by The Journal of BioLaw & Business. All Rights Reserved.

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Abstract: Biotechnology is now beginning to revolutionize all major sectors of industrial activity in the developed world. Innovation capability in biotechnology is increasingly viewed as a key ingredient in maintaining and, in some instances, expanding the national share in a global economy. The driving force of advanced biotechnology is the exceptional dynamism of the science-technology interface. The intertwining of science and technology has created a situation in which technology is simultaneously highly dependent upon its scientific underpinnings, and, constantly pushing the knowledge base forward, thus creating the grounds for further technological breakthroughs. The rapid pace of scientific and technological advancement has been such that many powerful and sophisticated technologies and equipment are now used routinely, not only in industrial countries but also in an increasing number of laboratories in the developing world. Routine use of recombinant technologies, however, does not automatically translate into applications relevant to solving problems specific to the developing world. This article addresses emerging applications of biotechnology and the policy issues associated with the integration of biotechnology in developing industrial sectors.

©2000 by The Journal of BioLaw & Business. All Rights Reserved.

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Abstract: The collapse of talks in Seattle in December 1999, which had been intended to launch a new Round of multilateral trade negotiations, leaves the international treatment of biotechnologically modified foodstuffs in limbo. The main industrial powers hold conflicting views as to the role of the World Trade Organization (WTO) in regulating, or even monitoring, genetically modified organisms. The scenario is complicated by heated, pending negotiations for an international Biosafety Protocol, and the role which the precautionary principle should play in trade in genetically-modified organisms (GMOs). Commenting on the failure of talks in Seattle, this article considers the conflicting regulation of GMO trade under existing WTO rules and future multilateral environmental agreements.

©2000 by The Journal of BioLaw & Business. All Rights Reserved.

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Abstract: Functional foods and nutraceuticals are subject to several layers of government regulation. In the United States, the agencies most active in overseeing these products are the Food and Drug Administration (FDA) and the Federal Trade Commission (FTC). The FDA regulates food and drug products, including product labeling; the FTC regulates product advertising and promotion. The FDA regulates health messages on food labels according to a significant scientific agreement standard. While the FDA and the FTC often rely on one another'ís expertise, the FTC enforces a standard defined as truthful and non-misleading representation that is broader and slightly more liberal than the FDA's interpretation. The laws under which the FDA regulates do not officially recognize functional foods or nutraceuticals as a distinctive product category. These terms do not appear anywhere within the Federal Food, Drug, and Cosmetic Act (FFDCA). Thus, these products have no unique regulatory status or identity, nor are they expected to become recognized by the FDA in the near future. The dilemma faced by companies hoping to market bioactive ingredients is further confounded by the fact that functional foods and nutraceuticals often can be commercialized as either foods or drugs, two of the major defining categories within the law.

©2000 by The Journal of BioLaw & Business. All Rights Reserved.

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Abstract: Agricultural biotechnology presents a growing and challenging social controversy for the biotechnology industry. Consumer acceptance of the first round of products is fundamental for the success of the biotechnology enterprise. This article reviews a variety of surveys to document the trends in consumer awareness and acceptance within the United States (US) and the European Union (EU). Recommendations are presented for improving communication and education with the public about a range of issues, including labeling of foods produced through biotechnology.

©2000 by The Journal of BioLaw & Business. All Rights Reserved.

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Abstract: Agriculture is in the throes of a new revolution that will have an impact on the future of world food production to a greater extent than almost any of the previous agricultural revolutions. This new revolution follows those of mechanization, genetic hybrids, and the "green revolution" which dramatically changed agriculture in the last century. However, unlike the cycle times of 30 to 50 years of the previous revolutions, this knowledge-based revolution will occur in next 5 to 10 years. This article describes several confluent forces accelerating the rate of change in agriculture: economic conditions, the need for new products, opportunity, and the early success of new biotech products.

©2000 by The Journal of BioLaw & Business. All Rights Reserved.

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Abstract: Americans tend to see the difficulty in exporting crops grown from genetically modified plants to the European Union (EU) in terms of European protectionism. However, the action of the EU may also be seen as the outcome of its emphasis to reconcile regulatory discrepancies among member countries' political cultures and their respective framing of the "biotechnology problem." Public perception varies from country to country and has its impact on the regulatory practice. Since consumer trust in food regulation and in experts decreased after events like the BSE crisis, the EU Commission has become extremely careful. However, the debate cannot be reduced to a simple risk controversy. The issue of food from modern biotechnology elicits deeper concerns with many Europeans about, for example, the relationship between regulation and the environment and about aspects of modernisation itself. Different rationalities compete for a more conservative (Blue) and a more environmentalist (Green) critique. In the light of other controversies, the biotechnology problem can even be interpreted as the ìnormal case. The EU tries to accommodate social and political concerns implicitly while retaining the rhetoric of riskbased scientific argumentation. Nevertheless, as an answer to increasing critique, a more culturally determined rationality gains influence on practical decision making.

©2000 by The Journal of BioLaw & Business. All Rights Reserved.

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Abstract: Foodstuffs from genetically modified organisms (GMOs) are entering the worldwide markets at an increasing rate. Many of these products are produced in the United States (US) and Europe which have widely different systems for regulating the products. These regulatory differences hamper international trade. In the US, GMOs are regulated according to their type of use. GMOs used as pesticides, for example, are regulated differently from those that are considered "novel foods" derived from new plant varieties. In Europe, GMO- specific regulations are in place. Directive 90/220/EEC regulates the marketing of genetically modified organisms which can reproduce. The directive addresses risk assessment, safety measures, monitoring and labeling. Products derived from GMOs, such as food or feed stuff, seeds or even vaccines, are then regulated in product specific regulations such as those which cover Novel Food or novel seed products. This article analyzes the regulation of GMOs in Europe and addresses the recent amendments and their impact on trade.

©2000 by The Journal of BioLaw & Business. All Rights Reserved.

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Abstract: New developments in molecular genetics hold much promise for society. Gene therapy research is underway with the aim of helping to fight, and perhaps even eliminate some diseases. DNA data can be used as evidence to help free innocent people and put guilty ones in jail. Agricultural biotechnology can make crops and pesticides more productive. And cloning may offer exciting potential. There is little doubt that further developments in the areas of genetics and biotechnology will change our lives in unanticipated ways. Despite the potential benefits to society, there exist valid and serious concerns about the potential for misuse of genetic information. This article addresses new attempts to use genetic information in personal injury litigation and the unique ethical, legal, and social issues raised by the "genetic defense."

©2000 by The Journal of BioLaw & Business. All Rights Reserved.

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Abstract: The Biomaterials Access Assurance Act of 1998 (Biomaterials Act) offers a high level of protection from liability in products liability actions brought against biomaterials suppliers. Originally part of a comprehensive federal tort reform package in previous sessions of Congress, the Biomaterials Act was enacted in response to a crisis caused by the shortage of biomaterials for medical devices. This shortage was due to the exit of biomaterials suppliers from the market due to the high risk of expensive products liability litigation. Congress recognized that the biomaterials supply industry often supplies only small amounts of raw materials and component parts for medical devices and that the medical device market often comprises a small proportion of the total market for those materials. The shortage of biomaterials, according to Congressional findings, is in part caused by the deterrent effect of strict products liability actions brought against such suppliers, even though the suppliers have rarely been held liable. Congress concluded that the protections for biomaterials suppliers created by the Act were necessary to assure uninterrupted supply of materials for lifesaving medical devices. Congress also sought to leave negligent suppliers unprotected through the Biomaterials Act. This article provides an overview and analysis of the Biomaterials Access Assurance Act of 1988.

©2000 by The Journal of BioLaw & Business. All Rights Reserved.

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Abstract: The public debate on genetically modified (GM) foods, already fervent in Europe and parts of Asia, has intensified in the United States (US) in recent months. Concerns about the environmental impact of genetically modified organisms, and, the safety of these foods are being raised. Many of the highly publicized media stories, including paid advertisements, evoke "what if?" questions. In some instances, these stories seek to scare rather than provide balanced information. Sensationalizing the issues, while successful in generating attention, does not provide a service to consumers who ultimately will have to make a decision about the foods they eat, the medicines they take, and the products they use. Instead, consumers and producers would be better served if both sides were able to inform about their approach to the subject and an open discussion of facts were to take place. This article describes the National Agricultural Biotechnology Council's (NABC) approach to opening dialogue about GM foods.

©2000 by The Journal of BioLaw & Business. All Rights Reserved.

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Abstract: With rapid world development and changing consumer demands, sustained economic and social growth will depend upon a secure supply of raw material inputs for manufacturing needs. Use of biobased energy production is likely to reduce our need for imported petroleum thereby favorably impacting national and international security concerns. This will ensure our access to energy and may influence balance of trade issues, jobs, and military expenses that are used to ensure our access to oil. Increased use of crop-based agriculture for supplying inputs to a biobased economy may also influence the carbon cycle impacting global warming. This column describes the impacts of agriculture expanding into various biobased enterprises including the health, energy, chemical and material industriesŠand highlights the key issues that mustaddressed as we approach thebio-based economyofthe 21st century.

©2000 by The Journal of BioLaw & Business. All Rights Reserved.

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