I feel that our profession should be aware of the numerous medical journal articles like the following that are routinely printed and regarded as factual information that may then be used to decide the fate of various herbal substances. Most of these are case reports, NOT research articles, in which they do not verify the botanical material and in most instances do not state some of the other Pre-existing conditions that may be at least in part responsible for these reports. These articles suggest, and many times claim, that herbs are unsafe, which frightens not only doctors, who are largely uneducated in herbal medicine, pharmacists, nurses and other healthcare practitioners, but the public as well. It is important to be aware that many times these decisions are being made without any input from industry experts. It is time for our profession to step forward and guard against a growing trend toward the undermining of natural medicine in the United States.

Ephedra was banned because unethical (or uninformed) companies made a concentrated extract of ephedra, mixed it in a non-conventional way with drugs and/or chemicals and marketed it for unproven uses, i.e., weight loss and athletic performance. This is NOT TCM. A small number of consumers with serious Pre-existing health conditions died after using those highly adulterated products in large quantities and/or mixed it with other drugs. The ephedra was singled out as the ‘cause’ and was promptly removed from commerce. The result of such irresponsible behavior by a few rogue companies has resulted in the restriction of the use of ephedra, in a safe and time-tested way, by trained professionals who have been properly instructed in the use of herbal medicine.

I believe that it is time for a new category to be established so that we no longer have the difficult task of trying to make herbal medicine fit into either the food or the drug categories. We need a category for traditional and natural medicines that provides for historical uses by trained and credentialed professionals who will promote safety for the public.

We have seen this campaign against herbal medicine developing for the past 10 years among the predominant medical establishment. They are winning the PR war through scare tactics fueled by calculated misinformation and fear. It is important to understand that herbs and supplements are a multi billion dollar a year business in the U.S. We need to be mindful of the industries that may attempt to undermine and gain control of this market for their own profit and not for the safety and wellbeing of the consumer.

In the following article, the patient was a smoker. Her diet and other aspects of her lifestyle are not included. The authors have assumed that it could be the herbs that caused her heart attack. The truth is, you can take just about any naturally occurring substance on the planet, extract any of its chemical constituents, use it in high quantities, mix it with other agents and create a potentially lethal substance. It only makes sense to have a dedicated category to regulate herbal substances. This will prevent the types of abuses that has put the entire field of herbal medicine in a negative light.

I suspect that the study suggested at the end of the article may never be undertaken. Zhi shi, Bitter orange, could possibly be banned without a fair trial or even a discussion with experts in the Chinese medical field, as in the case of ma huang. If you feel that this is unjust, take action! Write letters, make phone calls, volunteer to help the ISAA’s herbal committee and join the ISAA and AAOM. The AAOM is in formal meetings with the FDA, but they need more financial stability to address the problem on the legislative front.

I believe that every citizen should have the right to choose the type of healthcare which feels right for them, including natural medicine. If we don't follow through with intelligence and action soon, there may not be much to choose from. I invite you to respond to this editorial so that we may start a public forum on this issue. Thank you for your attention to this most important and urgent matter.

1: Ann Pharmacother. 2004 May;38(5):812-6. Epub 2004 Mar 16.

“Possible association of acute lateral-wall myocardial infarction and Bitter Orange supplement”

Nykamp DL, Fackih MN, Compton AL.
Department of Clinical and Administrative Services, School of Pharmacy, Mercer University, Atlanta, GA 30341-4155, USA.
Nykamp_D@Mercer.edu

OBJECTIVE:
To report a possible incidence of acute lateral-wall myocardial infarction (MI) coinciding with the use of a Citrus aurantium L. (bitter orange) containing dietary supplement in a patient with undetected coronary vascular disease.

CASE SUMMARY:
A 55-year old white woman presented to the emergency department with symptoms of dull aching shoulder and chest pain. A review of medications during cardiac rehabilitation revealed the patient had ingested a multicomponent dietary supplement for weight loss containing 300 mg of bitter orange (Edita's Skinny Pill) for the past year. Although the patient's past medical history did not include hypertension coronary disease or hyperlipidemia, an arteriogram revealed a lesion in the left main coronary artery. She did have a smoking history. She was diagnosed with acute lateral-wall MI and hospitalized for 4 days.

DISCUSSION:
Consumers generally consider dietary supplements safe. However, some supplements taken for weight loss contain ingredients that have been associated with cardiovascular events. Although consumers are becoming more aware of the serious adverse effects secondary to products containing ingredients such as Ma huang and ephedra, reports involving other ingredients are increasing. Bitter orange or synephrine, found in bitter orange, has been associated with adverse cardiovascular reactions. Based on the Naranjo probability scale, C. aurantium is possibly associated with this cardiovascular event.

CONCLUSIONS:
The use of C. aurantium containing supplements may present a risk for cardiovascular toxicity; however, additional studies/case reports are needed to validate this conclusion.