PERF, The Pulmonary Education and Research Foundation, is a small but vigorous non-profit foundation.  We are dedicated to providing help, and general information for those with chronic respiratory disease through education, research, and information.  This publication is one of the ways we do that.  The Second Wind is not intended to be used for, or relied upon, as specific advice in any given case.  Prior to initiating or changing any course of treatment based on the information you find here, it is essential that you consult with your physician.  We hope you find this newsletter of interest and of help

HERB on HERBALS

Manufacturing Herbal Remedies

Part two of a five part series

By Herbert Webb, MD

Dr. Herbert Webb is a pulmonologist in private practice in San Pedro, CA, and an illustrious graduate of the program at Harbor-UCLA. He is Medical Director of the San Pedro Hospital Pulmonary Medicine Department and their Pulmonary Rehabilitation program. He wrote this article for their Better Breathers' Club newsletter. With their gracious permission, we share it with you.

Let me start by saying that I am definitely not an expert on herbals. My perspective is that of a skeptical, professional, conservative, main-stream pulmonary physician, and my watchwords are "Prove it to me, that it is safe and effective, before I put it into my body or recommend it for you." I approach this task hoping to accommodate an attitude that herbals can be complimentary rather than an alternative to conventional medications.

I think it's quite clear herbs are potentially therapeutic, as well as potentially dangerous. So, as I said last month, I think you should think of herbals and nutritional supplements as drugs. Herbs, just like FDA-approved pharmaceuticals, have side effects, toxicities and drug interactions. Last month, I discussed the aspects of a solid, scientifically useful study and the frustrating lack of research on herbs. Let's talk now about the significant differences in manufacturing between FDA approved medications, dietary sup-Supplements and herbal remedies.

The United States has a wide variety of government commissions that regulate every topic under the sun, so it seems strange to report that U.S. citizens are getting less government protection with herbs than folks in other countries. For example, in Germany, production of herbal medications and the claims made by their manufacturers are tightly controlled. The Germans require absolute proof of safety, as well as reasonable proof that an herb actually works, for the seal of approval from the German equivalent of our FDA. Compare this to the United States. In 1994, the Dietary Supplements Health and Education Act (DSHEA) deregulated the supplement industry so that the FDA has NO control over it at all. Herbal remedies are sold over the counter as dietary supplements, and there are no manufacturing standards. And, in my opinion, for medication to be effective, safe, and predictable, there should be.

Much research regarding herbals has been done in Germany, and is recently being translated into English, making it easier for U.S. physicians to access. That's the good news. Herbal remedies are considered much more legitimate in Germany than in the United States, and there is some incentive to at least perform limited research on German herbal remedies-dies. It costs about 3 to 5 million U.S. dollars for a German manufacturer to get a botanical product tested and approved for use there. In contrast, to get an herbal OK'd by the FDA, it would have to pass the careful scrutiny given to all prescription medications, which would take roughly 350 million dollars. This is bad news for the manufacturers, who would much rather take the easy route and market their products as dietary supplements, rather than drugs. The further bad news? Even if an herb has an outstanding German scientific study, you can't be sure that anything you buy in the U.S. has anything in common with German herbals. Our manufacturing standards just aren't there. It's very frustrating for both consumers and health care providers.

When you consider putting any medication in your body, you should always ask, is it safe and does it work? You can't answer the first question for herbals and supplements in this country currently with our deregulated supplement industry. 

The lack of standards for controlling active ingredients and eliminating contaminants has led to a great deal of concern. Consumer Reports tested a dozen brands of gingko biloba and Echinacea for a March 1999 report and found extreme variations in the amount of herb present in different brands and even in different bottles of the same brand! The brand-to-brand variation was also found for ginseng. Some congressmen are trying to establish controls of the supplement industry, but in the meantime, we have big problems. The FDA has started highlighting some of these, and recently put out an alert that Echinacea can impair the effective-ness of birth control pills --- a warning that came just a tad tardy for one surprised young woman I know! The FDA also reported that weight loss and energy supplements containing Ephedra (mahuhang) can lead to heart attacks, strokes, convulsions, and fatalities in otherwise healthy adults. In addition, many foreign produced herbals contain poisons, including hemlock, strychnine, even heroin and cocaine, as well as heavy metals including lead, mercury and arsenic. Unfortunately, there are pesticide residues in many foreign herbals as well. Herbals have been contaminated with dangerous bacteria and fungi, for example, in alfalfa tablets. For medication to be effective, safe, and predictable, it should pass careful scientific scrutiny and testing.

Herbal medication, however, is regulated under the same laws as the oregano in your spaghetti sauce. Herbs can come in a variety of containers, including unmarked zip lock Baggies. (A bottle marked with "N.F." however, indicates some quality control and a higher level of confidence in the product.) The container may, or may not be, marked with contents and instructions. If dosing directions are vague or instructions are incomplete, then doses will vary widely. Brewing a tea? How much herb in how much hot water? And how long do you let it steep, remembering that the longer it steeps, the stronger it gets? Remember, anything taken in large doses can be dangerous; mega-doses of nutmeg cause hallucinations. Many herbals are directly toxic to your organs. Liver toxicity has been documented to occur with chaparral, gentian, germander and shark cartilage. Unfortunately, intentional adulteration of dietary supplements has been also documented. The Chinese herbal remedy tung shueh recently caused acute kidney failure; it was found to be adulterated with nonsteroidal anti-inflammatory agents as well as Valium. One Chinese ginseng preparation purchased by the Texas Department of Health listed ginseng as the only ingredient, but chemical analysis showed large amounts of caffeine and ephedrine (which quickens heartbeat, acts as a diuretic and bronchodilates) also present.

If the quality is so unpredictable, why doesn't the FDA stop the selling of herbals? For the FDA to halt manufacture of sale of an herbal supplement, the FDA must prove that it can be expected to harm most people who consume it, rather than just a subset of the population. So although they aren't regulating them, the FDA has made several general recommendations about herbal medications. The list goes like this: don't take herbals when you're pregnant, nursing, or attempting to conceive. Don't give herbals to children. Don't expect herbals to be effective in treating serious disease but do expect them to interact with prescription medications.

The bottom line is that the consumer must be aware. There are no manufacturing standards for herbal remedies and supplements. And, I think, for medication to be effective, safe, and predictable, there should be.

Thanks Dr. Webb! We look forward to Part 3, "Misguided Logic", next month. 

We hope that you liked this article as much as we did. Part 3 will be in next month's Second Wind.

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