Analyzing Botanical Safety Concerns

Differences in U.S. and European markets.

By Joerg
Gruenwald

Most European botanicals like ginkgo biloba, garlic, saw palmetto and echinacea as well as vitamins and minerals are nothing new in the U.S. They have undergone constant growth over the last 20 years with better research and more acceptance. In the European market, quality is mostly well controlled and unreasonable claims are restricted. These products have a very positive image, not only with the consumer, but also with the majority of physicians and pharmacists; they belong to mainstream medicine in the major markets like Germany and France.

Safety is really not a major concern, since only those products can be brought to the market that have been proven to be safe and have some data regarding efficacy or an established traditional use. There are many restrictions so that it is practically impossible to market Traditional Chinese Medicines or other plants that are not known in the European countries. Safety of the products is controlled in the same way as regular registered drugs. Many of these products are even prescribed and doctors control their uptake and report if side effects or interactions occur.

For example, two new interactions for St. John’s Wort were recently noted and will become part of the information in the product leaflets. St. John’s Wort may influence the uptake of blood thinners of the cumarin type and of cyclosporin, an immune suppressant drug used in organ transplant. These drug interactions were discovered after more than 10 million inhabitants in Germany took St. John’s Wort, most of them by prescription of physicians. It demonstrates that the reporting system works and that even rare interactions are found and integrated in the informational system immediately.

In general the top botanical products are very safe. Side effect levels are usually at the rate of placebo and much lower than comparable synthetic drugs. Drug interactions are rare, but if they occur they are mentioned on the products and physicians and pharmacists are aware of these problems.

The U.S. Market

In the U.S. the market for dietary supplements and botanicals grew tremendously from 1994 until 1997 with very positive press. From that time on the trend changed. In many journals and articles there are warnings about combining herbs with prescription drugs. The press seems to pick up every negative article on herbs; positive stories seem to be unpopular and are not published to the same degree, even though enough news is available. Extreme examples were headlines like: “Can St. John’s Wort, echinacea, saw palmetto and ginkgo impair fertility?” A poorly designed experimental in vitro study with extremely high dosages of plant extract was completely over-interpreted, but the American press seems to like striking news, not asking for the significance of the findings. There is no relevance to the human situation, but the report probably scared many users.

There is no regulated reporting system about side effects or interactions occurring with dietary supplements/herbals existing in the U.S. and the FDA admits that its existing information about 2500 “adverse reports” may be related to dietary supplements but there is “no certainty that an adverse event can be attributed to a particular product or ingredient.”

These are very low numbers considering that approximately 42% of Americans use some type of alternative medicine and often mix them with prescription drugs and over the counter medicines. It is expected that almost 20% of all prescription drug users also take herbal medicines and/or high dosed vitamins at the same time. These numbers usually should give us confidence that the number of interactions is very low, but there are two typical problems: Most Americans do not tell their physician that they take herbal medicines/dietary supplements in addition to prescription medicine and there is no reporting system established for the category of dietary supplements. These behaviors show that the consumers are afraid of the physicians’ comments. Usually the doctors are not trained and experienced in these new products and have a rather skeptical attitude against them.

Education is important to improve this situation. Our Physicians Desk Reference (PDR) for Herbal Medicines has been well established in the U.S. The first edition was sold to about 150,000 physicians, educating them on herbal medicines, their scientific proof and known side effects or drug interactions and providing full references in case they want to learn more about this new category of products. The literature, however, is often in German, as most clinical trials on botanicals are still done in Europe.

In general we can say that the top botanicals/dietary supplements are very safe and well researched, both in clinical trials and under practical prescription conditions, e.g. in Germany and France. The use in many millions of patients or consumers under a classical drug reporting system can give a high level of confidence about these products.

NW

Dr. Joerg Gruenwald is president of PhytoPharm Consulting, Institute for Phytopharmaceuticals, a specialized business consulting company for herbal medicine and dietary supplements. He can be reached at PhytoPharm Consulting, Olafstr. 6, D-13467 Berlin, Germany; 49-30-405-999-40; Fax: 49-30-405-999-32.; E-mail: [email protected].