Medicinal and Botanical Products
SIC 2833
NAICS 325411
Closely tied to the pharmaceutical industry, medicinal and botanical processors create saleable forms of organic and inorganic chemicals as well as botanical drugs and herbs.
Throughout the history of civilization, cultures have relied on the curative and preventive qualities of medicinal and botanical products. With little more than word-of-mouth testimony, traditional folk-concoctions and blends of herbal remedies reportedly cured the sick, perpetuated the aura of optimal health, and supposedly released thousands from the clutches of fatalistic demons. But as tales of these self-medicated, miraculous cures fueled communal fireside chatter, they also prompted rigorous scientific investigations to pinpoint the mysterious therapeutic values of herbal medicine. These vigorous investigations elevated the status of medicinal and botanical products from being of interest to a relatively narrow counterculture, to an industry that produced plant-derived prescription drugs valued at US$17 billion annually during the 2000s. Not surprisingly, approximately one-quarter of drugs prescribed in the United States contained at least one compound derived from plants. The National Nutritional Foods Association estimated that 100 million people in the United States—more than one-third of the entire population—used herbal dietary supplements regularly.
Some observers estimate that two-thirds of the world's population uses medicinal botanicals as a primary source of health care. The Medical Association of South Africa reports that 80 percent of black South Africans rely on herbal healers. The Nepal Department of Drug Administration has 495 traditional herbal remedies on file, and 566 modern drugs. In Canada, surveys show that 57 percent of the population has used alternative therapies and 25 percent would trust an herbal remedy more than a medical prescription. In addition, representatives of the Centre for Scientific Research into Plant Medicine (CSRPM), located at Mampong in Ghana, West Africa, has touted the economic benefits of plant derived medicines in Ghana, which is home to an estimated 10 percent of available medicinal plants—potentially worth up to US$1.7 billion annually.
According to the World Health Organization, the global market for traditional medicines in the early 2000s exceeded US$60 billion and was growing fast. Spending on traditional medicines in the United States reached US$17 billion, and sales in the United Kingdom totaled US$230 million. The U.S. market expected robust growth through the mid-2000s, driven by the aging baby boomers segment. In addition to comprising the largest segment of the population, baby boomers also were comfortable with plant-derived pharmaceuticals. The majority of the medicinal plants harvested for the multi-billion dollar industry were harvested from the wild in the early and mid-2000s, causing significant concern about species extinction.
Historically, most medicinal botanicals were drawn from ordinary wild plants that proved adaptable to cultivation outside their natural environment. Void of any fanfare, tribal healers, communal caretakers, herbal doctors, and other folk healers came to possess the knowledge of plant identification, location, and appropriate application. The fanfare emerged only after pharmaceutical companies validated the therapeutic values of herbal medicines and their ensuing profits. Until the 1950s, almost all pharmaceutical research relied on vascular plants as sources for medicines. Soon after the discovery of sulfa drugs, antibiotics such as penicillin, and synthetic drugs, interest in medicinal plants declined. Pharmaceutical companies placed their hopes for miraculous cures in the accumulation of huge databases of synthetic chemicals; however, the synthetics panacea never pivoted the drug market. Consequently, pharmaceutical companies once again returned, foraging the world for new and expanded sources of herbal medicine.
Newer methods of medicinal plant screening reflected several methodology refinements. During the 1960s, a standard screening assay to determine the potential of drugs for medicinal application consisted of injecting test material into a rodent and assessing subsequent reactions. Modern bioassay, occasionally automated, produced more precise, less time-consuming, feedback. Tiny amounts of material could be screened rapidly against an array of up to 60 distinct human tumor cell lines. Other assays determined the ability of an extract to influence the activity of a single enzyme involved in the biochemical interactions that underlie a disease. Once an extract displayed significant activity in a bioassay, investigators returned to the source site to collect bulk samples (normally 50 to 100 kilograms) of the original plant.
Organizationally, the medicinal and botanical industry in the mid-1990s consisted of a growing number of multi-sized companies involved in the research and manufacturing of medicinal and botanical chemicals. The industry also consisted of ethnobotanists, mostly from emergent countries, who identified botanical medicinal sources. The industry investigated plant and herbal medicines frequently identified by consumers under the heading of alternative medicine, folk medicine, homeopathy, chiropractic, naturopathy, and sometimes even supernatural healing. According to the World Health Organization (WHO), medicinal plants are important because they serve as sources of direct therapeutic agents; function as a raw material base for the elaboration of more complex semi-synthetic chemical compounds; provide chemical structures usable as models for new synthetic compounds; and can be used as taxonomic markers for the discovery of new compounds.
Pharmaceutical raw materials include crude drugs such as botanical, animal, or other biological products, inorganic elements and compounds, and organic compounds. A source substance designated "official" indicates that the material has been the subject of a monograph in a pharmacopoeia or national formulary, that specifies the minimum acceptable degree of chemical purity. The term "crude drug" applies to plant or animal organs, and whole organisms or exudations, either in fresh or dried state, ground or not ground, that derive from cultivated or wild sources.
Production methods differ for inorganic and organic compounds. Organic compounds used as pharmaceuticals are either extracted from natural sources or prepared by chemical synthesis. In contrast to inorganic and organic materials, uncovering the therapeutics of crude drugs requires an extensive harvesting process. After identification of potential therapeutic value, a cleaning process removes direct and undesired plant components. Next, in order to activate the plant's therapeutic ingredients, plants are cured via sweating or drying for a period of up to a year. Either procedure halts the weakening effect of chemical reactions and also reduces the weight and bulk of plants.
Despite the demonstrated therapeutic advantages of medicinal products, companies encounter several obstacles in the mass production of medicinal botanicals. One of the earlier problems of mass production related to determining a uniform measurement of dosage. To solve this problem, researchers assumed that only a certain part of the crude drug, known as "the active principle," had the ability to act on the body. The active principle was identified and standardized so that definite quantities could be converted to powders, tablets, capsules, and other medicinal vehicles. This knowledge also enabled physicians to prescribe precise drug quantities and to be knowledgeable about the anticipated effects.
Another key problem for the industry stemmed from the difficulty of obtaining financially worthwhile patent property in botanical products. In 1994, the United States granted five patents related to plant medicinal products. Without patent protection, opportunities for clinical trials and funding are practically impossible. In response, drug companies sometimes perform clinical trials in countries in which there are fewer testing restrictions. Pharmaceutical firms also test drugs abroad because they fear involvement with herbals might adversely affect regulatory approval of their conventional drugs. In some instances plants aren't patentable, but their extracting processes are. Procedures to determine efficacy of botanical products sold in the United States included clinical trials and safety testing for each constituent. According to drug industry figures, the total package of FDA licensing procedures carried a US$300 million price tag in the mid-1990s. On the other hand, segments external to the drug companies discounted the US$300 million clinical trial label as an inflated cost, perpetuated by the drug industry's attempts to justify an unrealistic cost of doing business. Detection of modest but valuable benefits in botanical medicines requires random clinical trials conducted with 30,000 to 50,000 respondents at a cost of around US$231 million, according to some experts.
Europe's much simpler regulatory system for botanical medicines recognizes plant extracts as a whole unit, thereby eliminating testing requirements of each individual component. Considerations of costs and other circumstances prompted some researchers to suggest that historical evidence of reasonable effectiveness should be acceptable as U.S. marketing criteria. For instance, standards for Germany's marketing criteria blended historical/traditional use with modern scientific information.
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