To borrow one of her company’s slogans, Dr. Jacqueline Shan “trusts the science” behind the popular cold and flu treatment Cold-FX, which she coinvented as president, CEO, and chief scientific officer for Edmonton-based CV Technologies, Inc.

In a presentation given at University of Toronto’s Leslie Dan Faculty of Pharmacy last Thursday, Dr. Shan described Cold-FX’s development process, highlighting some of the clinical trials demonstrating its ability to enhance the immune system.

Some scientists question the science behind Cold-FX, as they claim the data supporting the product is open to interpretation. The original study sponsored by the company has not been independently confirmed or critically analyzed in peer-reviewed journals.

Cold-FX is a proprietary extract from North American ginseng, a plant native to East Asia. It has widespread use as an antioxidant, aphrodisiac, and natural stimulant, classified as an adaptogen to increase the body’s resistance to stress and anxiety. Cold-FX is the first natural health product to be approved by Health Canada to make a specific scientific claim. According to its makers, Cold-FX “helps reduce the frequency, severity, and duration of cold and flu symptoms by boosting the immune system.”

Due to the fact that Cold-FX is a patented product, the “natural product number” assigned by Health Canada was in the non-traditional category—a category that requires a level of scientific support typically associated with pharmaceutical products.

“We spent a couple of years with the Edmonton Oilers and got some pretty good results,” commented Shan with reference to their first human subjects.

In addition to demonstrating enhanced immune function in these professional athletes, Cold-FX has been put to the test in six additional clinical trials, involving a variety of populations during its 12 years of development. In a double-blind, placebo-controlled study of Canadian adults lasting four months, Cold-FX led to a 26 per cent reduction in the number of colds, a 31 per cent decrease in their severity, and a 35 per cent decrease in their duration. Cold- FX has no known side effects.

The backbone of CV Technologies, Inc., which was originally a spin-off company founded within University of Alberta’s Department of Physiology, is known as ChemBioPrint. Chem- BioPrint is the patented method used by CV Technologies to identify the chemical components responsible for the health effects of ginseng extracts, ultimately used to isolate CVT-E002 (the “active ingredient” in Cold-FX). This technology has also been used to isolate Remember-FX from the same source extracts as Cold-FX, and Cell- FX from shark cartilage extracts.

ChemBioPrint has allowed CV Technologies to avoid the batch-to-batch variability in composition and effect, common in many natural health products. It is common to standardize the amount of product, contained in each dose of a given natural health product to a very limited number of chemicals within the original extract. St. John’s Wort, used as a natural antidepressant, is commonly standardized to hypericin— a substance no longer believed to be involved in the purported health benefits of the product. The consistent isolation of CVT-E002 has played a major role in Dr. Shan’s ability to scientifically validate CV Technology’s claims.

When asked about future prospects for Cold-FX, Shan responded, “We just finished a clinical study on children to prove that [Cold-FX] is safe, and eventually we want to develop a children formulation.”

“In three years our products have gone all the way from $1 million to $45 million, which has totally outsold [cold and flu] products like Advil and Tylenol. Of course we’re happy from a business point of view but what this also tells you is that, like it or not, people like it. Investing in the science evidence and clinical study, although it is challenging, is totally worth it,” said Shan.

The power of marketing-driven science is not a new phenomenon, as many biologists, immunologists, and biochemists wish to see reasonsed debate over the claims made by the makers of Cold-FX. Considering the lack of solid evidence and a lack of understanding for how it works, it seems that more research is required