Herbal Medicine

Chaos in the Marketplace

Virginia M Tyler, Rowena Richter

• Publisher: Routledge
• Year: 2013
• Print ISBN: 9780789016195
• eBook ISBN: 9781135420215
• Topic: Medicine
• Subtopic: Alternative & Complementary Medicine

Americans seeking herbal medicines now face confusion and even danger. There is great potential for these medicines to improve the health of consumers--if current regulations can be revised!Herbal Medicine: Chaos in the Marketplace is a prize-winning critique of the regulation and business of herbal medicine in the United States. It is the first book that examines the big picture issues-it tells the story of how the present situation developed, looks at what it means for consumers, compares approaches taken in other industrialized countries, and recommends where we need to go from here. Convenient reference tables provide easy access to information.Concerns about herbal medicines are hitting the headlines regularly, yet no other book has examined the core issues in depth from a public health perspective. Herbal Medicine: Chaos in the Marketplace fills that gap. It is highly relevant today, and you'll find it will continue to be indispensable reading for years to come as the situation plays out.This balanced, unique, and insightful volume will add to your knowledge of herbal medicine regulation and its impact on consumer health by:

• framing the limitations of the current situation with brief examples
• reviewing the regulatory history of herbal medicines in the United States
• placing the situation in an international context by also examining regulations in Canada, Germany, France, and the United Kingdom
• illustrating the practical implications of U.S. regulations with six examples that demonstrate how herbal medicines could contribute more to consumer health--and the public health risks associated with the current regulatory situation
• analyzing the public health issues related to safety, research, clinical practice, consumer interests, business, media, and federal government
• offering key, high-impact recommendations for future policyConsumers, health care professionals, business people in the domestic and foreign herb industries, researchers, health plan executives, food and drug attorneys and policymakers, as well as educators and students, will all find this book essential to their understanding of the workings of the herbal medicine industry. Visit the author's website at http://www.herbalchaos.com

 

 

 

PART I:
INTRODUCTION

Chapter 1

Overview

The use of herbal medicine* in the United States has increased dramatically over the past decade. In 1990, only 2.5 percent of American adults had used at least one herbal medicine in the previous twelve months. By 1997, this figure had risen to 12.1 percent, and Americans were spending $5.1 billion out of pocket for herbal medicines.¹ In 1999, sales began to plateau and remained flat in 2000. However, in a period of just five years herbal medicine products had become as widely available to consumers as vitamins. They are now found in supermarkets, pharmacies, and numerous other mainstream retail outlets. Botanical medicines, similar to all pharmacologically active substances, have the potential to contribute positively, neutrally, or negatively to the health status of the American population. This book argues that the current regulatory and business environment constrains both the potential health benefits and the protection from risk.

Part I frames the problem with two brief examples. Part II begins by reviewing the pertinent U.S. regulatory history. Next, to place the U.S. situation in an international context, Part II considers the regulations in Canada, Germany, France, and the United Kingdom. From this comparison, common themes as well as variations emerge. The three European countries were selected because they have some of the most highly evolved regulations for herbal medicines. Canada is included because it is currently revamping its regulations and has thought through the issues in an exemplary fashion. Each nation's approach is specific to its politics, history, and culture, and the United States would not and should not simply copy them. However, the experience of these other industrialized countries does inform the analysis of the U.S. situation. Part III illustrates practical implications of the U.S. regulations with six examples. The first three illustrations demonstrate how herbal medicines could contribute more to public health. Indeed, two of these botanicals have captured the attention of the National Institutes of Health (NIH) and warranted multimillion-dollar clinical trials. The second set of examples highlights the public health risks associated with the current situation. Part IV analyzes the public health issues related to safety, research, clinical practice, consumer interests, business, media, and federal government. Part V offers a few key, high-impact recommendations.

THE DILEMMA

The public health problem represented by botanicals in the current U.S. regulatory and business environment is framed here with two examples. One situation is potentially beneficial; the other is potentially harmful.

St. John's wort (Hypericum perforatum L.) was the first botanical selected by the National Institutes of Health (NIH) to be the subject of a clinical trial. The NIH study was largely motivated by a meta-analysis published in the British Medical Journal in 1996. That study of 23 randomized clinical trials concluded that St. John's wort may be useful for treating mild to moderate depression, is superior to placebo, and has fewer side effects than pharmaceutical antidepressants. Soon after, in October 1997, the NIH began a 3-year, $4.3 million, multi-center clinical trial on St. John's wort. However, rather than selecting patients with mild to moderate depression to participate in the study, NIH chose patients with moderately severe depression and found both St. John's wort and Zoloft (a best-selling pharmaceutical antidepressant) to be ineffective treatments in this trial. In their report in the Journal of the American Medical Association, the researchers noted that “Hypericum may be most effective in less severe major depression …” and this possibility remains an open question in the United States. In Germany, however, St. John's wort products are commonly prescribed and widely studied. So far in the United States, consumers cannot even be certain that what is on the label will be in the bottle of any herbal medicine they purchase.

In contrast, the potential risks of ephedra (also known as ma huang) have raised widespread public health concerns because ephed-ra products contain ephedrine alkaloids. Two billion doses of botanical ephedrine alkaloids are consumed in the United States annually. Among herbal products, the U.S. Food and Drug Administration (FDA) most frequently receives adverse event reports for products containing ephedrine alkaloids. Based on these reports and the scientific literature, in June 1997 the FDA issued a proposed rule to limit the allowable dose of ephedrine alkaloids in botanical products to 8 mg per serving.³ However, in July 1999 the U.S. General Accounting Office (GAO) issued its response to the FDA's proposed rule.⁴ It questioned the basis for the FDA's conclusions about causation and the proposed dose. The GAO pointed out that even by the FDA's own account, the passive adverse event reports that the FDA cited often lacked information on product identification, doses ingested, duration of use, and medical diagnoses. The scientific data on dosage of ephedrine alkaloids is also incomplete. The FDA's final rule is pending. Meanwhile, legislation on ephedra has been proposed independently in several states (Texas, California, Indiana, Virginia, Vermont, Illinois, Hawaii, Iowa, New York, New Hampshire, Montana, Pennsylvania, and Massachusetts). Proposals range from complete bans on ephedra (in Texas, which was rejected) to exemptions for restrictions of over-the-counter sales of botanical ephedrine products (in Montana). The National Football League, the National Collegiate Athletic Association, and the International Olympic Committee have each banned ephedrine use.

PURPOSE OF THIS BOOK

The public health objectives that are guiding the analysis of botanicals in this book are: (1) to minimize the risk of adverse events (i.e., first do no harm); (2) to enhance the population-wide benefits of the potential favorable contributions (including potential cost savings in some cases, such as with St. John's wort); and (3) to seek ways to develop and provide incentives for a system that allows distinctions to be made among herbal products and treatments on a sound, scientific basis.

* In this book, the terms botanical, botanical medicine, herbal medicine, herbal product, and phytomedicine are considered equivalent. In the United States, botanicals are considered the subcategory of food known as dietary supplements and are not considered drugs, with a handful of exceptions. However, because (a) people generally consume botanicals with the intention of addressing a particular health condition; and (b) the rest of the industrialized world regulates botanicals as drugs, the term herbal medicine will be used in this book.

PART II:
REVIEW OF REGULATIONS

Chapter 2

United States

HISTORY OF REGULATION OF BOTANICALS

According to David Kessler, former head of the Food and Drug Administration (FDA), “regulating supplements that people take for medicinal purposes is one of the most difficult issues for the Food and Drug Administration over the last century.”¹ This section provides a historical context. First, it summarizes the evolution of U.S. regulations that pertained to botanicals prior to 1990. Second, it analyzes the politics of the process that led to the Dietary Supplement Health and Education Act (DSHEA) of 1994. DSHEA, as mentioned, currently governs herbal medicines in the United States.

Regulations Pertaining to Herbal Medicines Prior to 1990

Overview

Many of the herbal medicines that are currently on the market were already in use when the United States began regulating food and drugs in 1906. For that reason, many herbs have been grandfathered from one statute to the next and have been exempted from requirements to prove safety and efficacy for most of U.S. regulatory history. As will be evident from the summary in this section, they have also escaped labeling restrictions until recently.

Pure Food and Drugs Act of 1906

This act was the first U.S. statute to regulate interstate commerce of domestically manufactured food and drug products.² It established minimal standards for quality, purity, and strength, but it did not ad-9 dress safety or efficacy. Under this act the regulating agency had to show deliberate fraud to establish a violation.³ This act was repealed and replaced with the Federal Food, Drug, and Cosmetic Act of 1938.

Sherley Amendment of 1912

This amendment, passed by the U.S. Congress, added labeling regulations to the Pure Food and Drugs Act of 1906. Fraudulent or false claims of therapeutic effects of medications were termed “misbranding” for the first time.⁴

Federal Food, Drug, and Cosmetic Act of 1938

In 1937, seventy-three people died after ingesting Elixir Sulfanilamide, which contained diethylene glycol (also known as antifreeze).⁵Under the 1906 Act,⁶ premarket testing of the elixir had not been required. In response to this tragedy, the U.S. Congress passed the Federal Food, Drug, and Cosmetic Act of 1938 (FDC Act). The FDC Act, similar to the Pure Food and Drugs Act of 1906, still focused on safety, adulteration, and misbranding. It gave the FDA new authority to test a drug for safety in humans and to determine whether a food or drug was safe, even in the absence of fraud. The FDC Act also established the FDA's powers of criminal prosecution, injunction, and seizure.⁷ For new drugs, the FDC Act required proof of safety and submission of a new drug application (NDA). This statute, with its subsequent amendments, currently regulates food and drugs in the United States.

Drug Amendments of 1962

From 1938 until 1962, the FDA was only authorized to regulate drugs when marketing approval was sought, which was generally after human clinical trials had already been conducted to establish safety.⁸ After the thalidomide tragedy^* in Europe and Canada, the public in the United States demanded tighter drug regulation. In response the U.S. Congress in 1962 amended the FDC Act⁹ to shift the burden of proof for both safety and efficacy onto manufacturers, thereby eliminating automatic approval of new drug applications. The 1962 Amendment required manufacturers to prove efficacy in addition to safety prior to marketing a drug. Manufacturers were then also required to obtain FDA approval before conducting the necessary “adequate and well-controlled” clinical investigations to demonstrate efficacy.¹⁰

Botanicals tend to be natural (“works of nature”) or generic products without substantial human innovation involved, which makes patenting difficult.¹¹ The fact that botanicals often contain complex mixtures of compounds also complicates patenting. Without patent protection, the U.S. herb industry lacks an incentive to invest in expensive research on the safety and efficacy of their products.

Review of Over-the-Counter Drugs Begins in 1972

When it was enacted in 1938, the FDC Act required proof of safety and submission of an NDA for new drugs. In 1962, the FDC Act was amen...

Table of contents

• Cover
• Half Title
• Title Page
• Copyright Page
• Dedication
• About the Author
• Table of Contents
• Foreword
• Preface
• Acknowledgments
• Part I: Introduction
• Part II: Review of Regulations
• Part III: Illustrative Examples
• Part IV: Analysis of Current and Potential Impact on Public Health
• Part V: Conclusion
• Appendix A. U.S. Dietary Supplement Health and Education Act of1994
• Appendix B. Recommendations of the Canadian Standing Committee on Health
• Appendix C. Abbreviations and Acronyms
• Notes
• Index