On Saturday, June 14 and Sunday, June 15, Albany College of Pharmacy will host the inaugural Nature-ceuticals Conference that will bring together scientists, clinicians and manufacturers to share and interpret information about the use of natural products and their impact on health care.

 David M. Eisenberg, M.D. and director of the division for research and education in complementary and integrative medical therapies at Harvard Medical School, will give the keynote address for this special, natural product symposium, which is sponsored by Maruzen Pharmaceuticals. Register online.

 

ACP Professor Dudley Moon, Ph.D. Discusses

the Evolution of the Natural Products Market

Q: Terms used to describe natural products or their related fields include: Nutra-ceuticals (nutritional products used for health benefits), Pharmacognosy (identification of plants used for medical purposes), Phyto-medicinals (plant materials used for medical purposes) and Ethno-botanicals (use of plants by different cultures). So what are Nature-ceuticals?

A: As you can tell from the long list of names, these fields have become very specialized. For those in the industry, ‘natural product' is often equated with natural chemistry. The term Nature-ceuticals was coined to connect the chemistry and science of natural products with how people use them in their everyday lives.

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Q: In 2000, the estimated market for natural products and herbal compounds was $10 billion. Today, the market is valued at $19 billion. What do you think is causing the remarkable surge in interest for these products?

A: These numbers reflect an evolution of sorts whereby patients are taking a more active role in their own health and treatment, which is a good thing. However, this shift carries important implications for both patients and physicians.

Clinicians always worry about drug interactions (and rightly so). That is why when you go to a physician the first question you are asked is, “Are you taking any medicine?” As these statistics show, a clinician today should also ask if that person is using any natural products. Because the fact is that most patients don't consider natural products to be drugs or medicines in the conventional sense.

And therein lays the danger. Regardless of whether one believes in the efficacy of natural products, these products do cause reactions in the body, and to deny or minimize this reality can put a patient's health at risk, especially when an alternative treatment is prescribed. A clinician needs to know if a given course of treatment could be impacted by a patient's use of natural products, and if so, stress the importance of stopping one form of treatment before starting the other.

The medical community historically has taken a ‘Just Say No' approach to the use of natural products. That is changing, but we need to arm pharmacists and physicians with better information about natural products in order to assist with their diagnoses and treatments.

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Q: The shelves of pharmacies are lined with more over-the-counter drugs than natural products. If patients are taking a more active role in their health, why are they increasingly being drawn to natural products?

A: From 1950-2000, there was a huge increase in the number of synthetic drugs made and used. What is happening now with FDA hearings on a variety of prescription and OTC drugs is that many people have become wary of synthetic drugs. Of course, the issues surrounding drug discovery and testing are extremely complex, but the public perception is that synthetic drugs are causing a lot of problems, and that maybe it's best to stay away from them.

The other factor that comes into play is cost. If you are looking at a problem where you can take a natural product that costs less than the synthetic alternative, that certainly is going to be a strong incentive.

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Q: You are part of the organizing team for the first-ever Nature-ceuticals Conference, taking place June 14-15 at Albany College of Pharmacy. The event is described as “bridging science and practice.” What do you hope to achieve from this event?

Clinicians make judgments based on long histories and training. When it comes to natural products, there is a fundamental lack of training that exists today, particularly in the U.S. We hope this event will help serve as a first step in bridging that gap by sharing information on new products that might show up in a physician's practice.

Take Cat's Claw, for example. What are the potential safety concerns? How is it used? Is there any evidence that it is effective? Does it interact with other natural products or drugs? The event is intended to discuss these types of questions from the perspectives of different health care professionals and hopefully identify methodologies for addressing these concerns.

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Q: Are natural products completely safe?

A: The FDA published standards in 2007 on what constitutes Good Manufacturing Practices for natural products. But that agency is really low on inspection staff, and has a real backlog of products to test. So as a consumer or purchaser or clinician, it's hard to know for sure what is in these products.

There was some research done a few years ago on St. John's Wort, and it found a huge variation in the active ingredients in each pill – even within the same bottle! Sometimes it was a stronger concentration than what was on the label, sometimes less, and sometimes none at all. That's why pressure is heavily on the FDA to begin enforcing these standards. Up until the late 20th century, it was not that big of deal. Now that people are investigating and using these products in much larger numbers, the need for more stringent regulation has increased dramatically. It's really amazing to many people that this has slipped under the regulatory radar in the U.S.

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Q: What type of research has been done on the efficacy of natural products?

A: A lot has been done at the chemistry level. Some of that has been taken to the next level for testing on cells and animals. The really big jump is to do clinical testing (on humans). Some of this work has been done in Europe . In the last few years, there have been an increasing number of American-based studies published. Many are turning out negative in terms of the beneficial effects of these products, but these studies often rely on off-the-shelf products, which as I said before, vary wildly in terms of their active ingredient concentrations. So it's hard to know how much credibility to invest in these results.

There is no question that much more work needs to be done before any definitive conclusions can be made. That is why it is so important to bring together the scientists, clinicians and producers to share and interpret information.

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Dudley Moon, Ph.D., is a professor of Biological Sciences at Albany College of Pharmacy and Chair of the Organizing Committee of the inaugural Nature-ceuticals Symposium. He recently completed a chapter on "Herbals and Natural Products" for the next edition of Zack Hanan's Pharmacy Technician's Handbook. Each year he directs student rotations in Japan at Maruzen Pharmaceuticals, a natural products extraction company.