This was written about 15 years ago, when I was asked to participate in a series of debate forums with a physician and a pharmacist.
Herbal medicine has been at the heart of medicine in every culture in the world, throughout history. Today, according to the World Health Organization, more than 80 percent of the world’s population rely on traditional medicines, mostly plant-based, as their main source of health care. This figure includes not only the large populations of China and India and all of the less-developed countries of the world, but also many modern nations. Even in the United States, about 25 percent of our prescription medicines are still extracted from plants or are synthetic copies of plant chemicals, and at least 57 percent of our top prescription medicines are derived in some way from plants, including semi-synthetics, in which plant chemicals are used as building blocks for synthetic drugs.
Synthesizing drugs in the laboratory is a newer practice than most people realize. The first synthetic chemical was produced in the mid-nineteenth century: aspirin. Still, widespread use of synthetic drugs did not begin in earnest until about 70 years ago. In the United States, natural remedies were replaced by synthetics or highly purified “wonder drugs.” In fact, most synthetic drugs are duplicates or modifications of the same plant chemicals that are found in herbs. These compounds can be made synthetically in a laboratory, but are no more effective than extracts of the plant itself.
In our enthusiasm for modern technology during the post World War II era, we hastily worked to replace plant-based pharmaceuticals with synthetic tablets, at the same time that we abandoned traditional agricultural practices in favor of use of environmentally destructive pesticides and herbicides. As a sidebar, it’s interesting to note the simultaneous human health movement back to phytomedicines and agricultural movement back to bio-dynamic farming- both, based upon science- in defiance of the legal, public policy and marketing efforts of some of the wealthiest corporate industries.
The focus of research in the twentieth century shifted away from the study of whole plants toward perceived single “active principles” and synthetic chemicals. Research into the efficacy of phytomedicines in the United States came to a virtual standstill as medical schools and research laboratories- heavily funded by “philanthropical” organizations which were heavily invested in the pharmaceutical industry- increasingly focused on medicines made in the laboratory. Drug companies focused their research efforts on developing synthetic drugs they could own through patent protection.
Medicinal plant research was conducted in places where they were still considered an important part of health care, such as Europe and Asia. In the United States, researchers concentrated on isolated plant constituents rather than whole herbs or minimally-processed extracts. For example, until very recently, there was little research on the health effects of green tea, but thousands of studies on caffeine. While the “active” isolated compound in green tea was considered to be caffeine, most of us now recognize the fact that many other health-enhancing compounds are present in a simple, aqueous infusion of green tea. I doubt that anyone seeking to benefit from the now-documented, widely-ranging benefits of green tea would hope to reap those rewards with the use of a synthetic caffeine tablet.
Medicinal herb research in Europe accelerated rapidly from the 1960s to the present. The best herb research was performed in Europe primarily because modern medicine in Europe continued the use of complex- ironically referred to as “crude”- plant drugs and minimally-processed extracts during the time when they were eliminated from the practice of medicine in the United States. With favorable treatment from European governments, phytomedicine flourished and European companies developed compounded herb extracts, sponsored research, and built the European phytomedicine field of study that is impacting medicine worldwide. American doctors, scientists, and regulators decried the lack of sound evidence for medicinal herbs –at the very time US regulatory practice made it economically untenable to perform the research. Meanwhile, European scientists – not beholden to the economic stronghold of the pharmaceutical industry on US medical education and legislation- conducted the studies that allowed phytomedicine to prevail as a dominant form of therapy there.
While many believe herbal medicine was displaced as a consequence of the advent of scientific progress, by safer or more effective medicines, the truth is that synthetics overtook natural medicines in the pharmacy as a result of social manipulation, political influence and regulatory practices- not the science of medicine. Last week, we discussed the impact of the Flexner Report in the early 1900’s. Later in the century, with the creation of the FDA and resulting legislation requiring that foods and drugs to be proven safe before they could be sold, much financial investment was required to bring a drug to the marketplace, since the cost of research was imposed upon the manufacturer.
In fact, the FDA regualtions were authoried by the pharmaceutical companies themselves, as a means of insuring that the only profitable means of bringing a medicine to market was via the mechansim of expensive- yet highly lucrative- patent protection. As more sophisticated and expensive research methods were devised, it became increasingly expensive to establish the safety of drugs. In 1962, Congress passed the additional requirement that drugs be proven effective, further increasing the cost of drug approval. Current pharmaceutical industry statistics set the cost at an average of $357 million to prove that a drug is safe and effective, and it takes an average of 5 to 12 years –sometimes more- to gain approval. As most of us are aware, drug companies are very wealthy, because they can -and do- recover research and approval costs through the sale of the drug, but only because the company has the exclusive right to sell it, in accordance with US patent law.
Herbal medicines are simply not patentable: Patent law prevents people from claiming exclusive rights to sell a product or technology that is already known. Common substances such as ginseng, butcher’s broom, golden seal- or ice- can’t be patented. There is absolutely no incentive for meeting the $357 million pricetag to bring a phytomedicine to the marketplace as an FDA recognized and sanctioned drug. The effect of the US method of regulation on the economics of medicine has utterly defined the practice of medicine in the United States, effectively banishing the use of phytomedicine during the majority of the twentieth century. Since 1962, not a single new complex plant drug has been approved in the United States. Because herbs could not be sold as medicines, they were regulated as foods, or sometimes as food chemicals (additives). Today, herbs, as well as vitamins and minerals, are regulated as dietary supplements in the United States.
The relationship between the FDA and the American herb industry has long been adversarial. Then, in 1994, the U.S. Congress unanimously passed a bill called the Dietary Supplement Health and Education Act (DSHEA), which defined dietary supplements as special nutritionals and forbade the FDA from treating them as food chemicals or as drugs, unless manufacturers made drug claims for their products. DSHEA allows dietary supplements to bear health benefit claims called “statements of nutritional support,” commonly referred to as structure/function claims because they may describe the effect of the supplement on the structure or function of the body. By law, these statements must be truthful and not misleading, and must be supported by scientific evidence. Labels must carry a disclaimer that the product is not intended for treating, curing or preventing disease. With the passage of DSHEA, the United States changed virtually overnight from one of the most hostile regulatory environments in the world for herbs to one that rationally regulates supplements. DSHEA allows labeling of products without prior government approval, yet requires a scientific basis and truth in labeling, which- contrary to widespread belief- the FDA is empowered to enforce. There are undoubtedly abuses of the law: this is the result of greed, by opportunists making exaggerated or inappropriate claims, selling supplements which simply do not contain ingredients as claimed, or worse, contain adulterated ingredients.
The European regulatory model has provided greater research incentives for herbs than the FDA model. In fact, European regulations have made European drug companies the leaders in natural product medicine. Meanwhile, US regulation is heading in the right direction: just last week, Friday, March 7, 2003, the FDA announced a proposal devised to regulate and monitor manufacturing standards, to insure that supplements both contain labeled ingredients in the quantity claimed, and are free of contamination.