ROCHESTER, Minn.—More than 15 million people in the U.S. consume herbal remedies or high-dose vitamins, according to a recent review article published in the Journal of the American College of Cardiology that is stirring up controversy in the natural products industry (2010;55:515-525). Complementary and alternative medicine office visits exceeds the number of trips to primary care doctors, generating an annual out-of-pocket cost of $30 billion. Researchers said, “Use of herbal products forms the bulk of treatments, particularly by elderly people who also consume multiple prescription medications for comorbid conditions, which increases the risk of adverse herb-drug-disease interactions. Despite the paucity of scientific evidence supporting the safety or efficacy of herbal products, their widespread promotion in the popular media and the unsubstantiated health care claims about their efficacy drive consumer demand.” The review highlighted commonly used herbs and their interactions with cardiovascular drugs, as well as a discussion on health-related issues of herbal products and suggestions on how to improve their safety to better protect the public from untoward effects.
In response to the review article, Douglas MacKay, N.D., vice president of scientific and regulatory affairs for the Council for Responsible Nutrition (CRN), said: “We question how a peer-reviewed publication would even accept an article such as this, given the fact that the authors make conclusions about ‘herbal remedies’ based on their own uninformed, inaccurate and outdated interpretation of the law which covers dietary supplements, including herbal supplements. The article contains sweeping generalizations, often not backed by relevant citations, and copious factual errors, including a reference to products—some of which are not actually herbal supplements—that produce adverse effects on the cardiovascular system. In particular, the article does not acknowledge important changes in the law and regulations governing dietary supplements that make many of the statements in the article irrelevant or flat-out wrong.”
The Natural Products Association (NPA) also issued a comment regarding the recent review. Daniel Fabricant, Ph.D., vice president for scientific and regulatory affairs at NPA, said: “The authors fail to understand the risk needs to be attributed to the riskier product, which all would agree is the pharmaceutical. The risk they speak of, while nice in theory, in reality does not add up. When considering FDA’s adverse event reporting (AER) system being in place for dietary supplements, and the amount of counseling both physicians and pharmacists are required to undertake on all things that interact with cardiovascular medications, if there was a verifiable increased risk, data would exist that that clearly points to such. Without such data, any article of this nature is as scientifically significant as Chicken Little’s assessment of the sky.”