Yesterday, The Journal of the American Medical Association published a study titled: Ginkgo biloba for Prevention of Dementia: A Randomized Controlled Trial.

NBJ received countless calls from writers, editors and publishers who are covering this story for Reuters, USA Today and the LA Times asking for clarity on a sentence published in the study which reads:

“In the United States, worldwide sales of Gbiloba exceed $249 million annually.”

Obviously, there is something very wrong with this statement…actually, there are two things wrong. First, it is unclear whether or not the authors are referring to U.S. or worldwide sales. Second, the $249 million figure for sales is incorrect.

The sentence should read: “In the United States, sales of the dietary supplement Ginkgo biloba to consumers totaled $107 million in 2007.”

And for your further reference, I’ve included responses from the American Herbal Products Association, the American Botanical Council and the Natural Products Association to the study below.

NEW JAMA STUDY ON GINKGO BILOBA AND ALZHEIMER’S “MISSES THE BOAT ENTIRELY”

Study Too Limited and Ignores Critical Risk Factors,

Says Natural Products Association

WASHINGTON, DC – A new study questioning the benefits of Ginkgo biloba on preventing dementia and Alzheimer’s disease (AD) late in life “misses the boat entirely” because the universe of people studied is too limited to make broad statements about the benefits of the popular dietary supplement, said the Natural Products Association. The study’s conclusions are also in direct contrast to other peer-reviewed studies that show benefits, and will almost certainly be questioned, the association said.

“This study is not irrelevant, but it can not be used to make broad conclusions about Ginkgo biloba and the general population. In fact, it misses the boat entirely in two critical areas. One, it looks exclusively at people almost 80 years old who are far more likely to have Alzheimer’s, while ignoring those in middle ages, where the risk for developing the disease rises quickly and prevention could best be analyzed. Two, it excludes completely any consideration of the strong and established role that family history plays with Alzheimer’s. You can’t do a study on the weather without looking at wind and rain,” said Daniel Fabricant, Ph.D., vice president for scientific and regulatory affairs at the Natural Products Association.

“This study is also in direct contrast to other research. Unfortunately, there is still no proven treatment to prevent Alzheimer’s, but reputable research has shown that Ginkgo biloba can play a constructive role in improving the symptoms related to this debilitating disease and possibly delaying its onset,” said Fabricant.

BACKGROUND:

• According to the National Institute on Aging, age is the most important known risk factor for AD. The risk of developing the disease doubles every 5 years over age 65. Several studies estimate that up to half the people older than 85 have AD. These facts are significant because of the growing number of people 65 and older. More than 34 million Americans are now 65 or older. Even more significant, the group with the highest risk of AD—those older than 85—is the fastest growing population group in the country.

• A 1997 study in the U.S. suggested that a Ginkgo extract may be of some help in treating the symptoms of AD and multi-infarct dementia, but no evidence exists that Ginkgo biloba will prevent AD.

• Research shows that risk for the disease becomes significant in middle age for most of the population, yet this study ignores that completely.

The Natural Products Association (www.naturalproductsassoc.org), founded in 1936 and headquartered in Washington, D.C., is the largest and oldest non-profit U.S. trade organization dedicated to the natural products industry. Currently, the association represents nearly 10,000 retailers, manufacturers, wholesalers and distributors of dietary supplements, food and health and beauty aids.

Ginkgo’s Benefits for Treatment of Symptoms of Cognitive Decline and Other Uses Are Supported by Scientific Research

Austin, TX (Nov 18, 2008). A vast body of research supports numerous health benefits for ginkgo extracts, particularly for treatingvarious symptoms and conditions associated with declining cognitive performance and poor circulation, says the American Botanical Council, an independent nonprofit research and education organization.

A new six-year clinical trial will be published Wednesday, November 19, in the Journal of the American Medical Association.[1] In the Ginkgo Evaluation of Memory (GEM) trial, a leading ginkgo extract was not effective in preventing the development of dementia in older adults. The ginkgo failed to reduce the overall incidence rate of dementia in a total of 3069 elderly individuals (minimum 75 years; average age 79) with normal cognition or those with mild cognitive impairment (MCI).

Researchers used the world’s most tested ginkgo extract (EGb 761®; made by W. Schwabe of Karlsruhe, Germany). The dosage used by 1545 subjects was 240 mg per day (120 mg twice daily) of the ginkgo tablets or a matching placebo (for 1524 people).

Described as a randomized, double-blind, placebo-controlled trial conducted from 2000 to 2008, [1,2] Steven T. DeKosky, M.D., currently dean of the University of Virginia School of Medicine (at the University of Pittsburgh, PA during the time of the study) and colleagues evaluated 2587 cognitively intact adults plus 482 adults with MCI. They were assessed every 6 months for dementia in 5 academic centers for 6.1 years.

The authors acknowledge that one of possible shortcomings of this trial is “because the delay from initial brain changes to clinical dementia is known to be long, it is possible that an effect of G. biloba, positive or negative, may take many more years to manifest.” [1]

In an accompanying editorial, Lon S. Schneider MD of the University of Southern California, Los Angeles, “Despite 2 decades of research with standardized extracts of Ginkgo biloba, considerable uncertainty about its pharmacology and clinical effects remains.” [3]

ABC’s Response to the GEM trial

“There is an significant body of scientific and clinical evidence supporting the safety and efficacy of ginkgo extract for both cognitive function and improved circulation,” said Mark Blumenthal, the founder and executive director of ABC.

In addition to the issue of a longer duration raised by the authors, ABC noted that another potential weakness of this trial is the lack of an active control, i.e., a potential third arm of the trial in which patients would have used a pharmaceutical medication with known efficacy, to determine to what extent the particular population being tested would respond. This was not possible for this trial since no conventional pharmaceutical drug has ever demonstrated the ability to prevent the onset of dementia or diminish its progression.

Further, the trial notes that that only about 60% of the patients were in compliance with their use of the ginkgo or placebo by the end of the trial. It is unclear whether the poor adherence to the assigned treatment might have had a negative effect on the trial’s results.

According to ABC’s Blumenthal, “Ginkgo’s benefits must be viewed in the context of the entirety of the published clinical data,” a reference to numerous controlled clinical trials that support the use of ginkgo extract for treating symptoms of MCI and even early stage Alzheimer’s disease, as well as the circulatory benefit of increasing the ability of older people to walk distances with less leg pain (a condition known as peripheral arterial occlusive disease or intermittent claudication).

Veteran Maryland psychopharmacologist Jerry Cott, PhD, a member of the ABC Advisory Board,stated in an e-mail to CNN that due to the extreme difficulty and expense in generating useful life-style type clinical research data he often places more value in the basic science, i.e., “the pharmacology, rather than controlled clinical trials. The science for ginkgo says that it has physiological and biochemical effects in human and animal tissues that would surely be beneficial for many chronic illnesses, especially those that have a vascular component.” [4]

ABC also emphasized that the GEM trial is only one of about 5 clinical trials that are being conducted to try to determine if ginkgo extract can have a preventive effect on elderly adults and lessen the potential progression to dementia. Another large trial is currently underway with the results not expected for at least one year. [5]

ABC emphasized that ginkgo extract has been shown to be effective in treating symptoms of dementia in numerous controlled clinical trials as well as in population-based (epidemiological) studies. For example, 2 epidemiological studies conducted in France (known as the EPIDOS & PAQUID studies) have demonstrated a positive effect of the Schwabe EGb 761® ginkgo extract on the onset of Alzheimer’s dementia [6] and the length of patients’ survival. [7]These trials suggest that this ginkgo extract may be beneficial and appropriate therapy for elderly adults.

Further, an NIH sponsored study in the United States in 2008 demonstrated a beneficial effect of a standardized ginkgo extract on the risk of developing dementia in only the trial subjects taking the ginkgo on a regular basis. [8]

In addition to being tested for cognitive impairment, at least 16 controlled clinical trials have demonstrated benefits of various ginkgo extracts for healthy, non-cognitively impaired adults. A comprehensive review has shown that in 11 of these trials, the ginkgo increased short-term memory, concentration and time to process mental tasks. [9]

ABC also noted that ginkgo extract has been shown to be effective in controlled clinical for treating patients with peripheral arterial occlusive disease (PAOD), a condition on older people characterized by pain in the legs while walking due to inadequate circulation. A systematic review of 9 controlled clinical trials found that in at least 7 trials the ginkgo extract exhibited safe and effective benefits compared to placebo. [10]

About Ginkgo Extract

Ginkgo (Ginkgo biloba) is the world’s oldest living tree, dating back about 250 million years. Ginkgo leaves have been used in traditional Chinese medicine for about 500 years. For about the past 30 years the leaves of ginkgo have been made into a highly concentrated (50:1) extract, chemically standardized to compounds unique to ginkgo (ginkgolides and bilobalide) as well as other compounds. The leading German ginkgo extract has been subjected to a vast range of clinical trials documenting its ability to improve peripheral circulation and cognitive function, particularly in patients with early stages of mild cognitive impairment, senile dementia, Alzheimer’s disease, and memory loss. Clinical trials also support the use of ginkgo extract in assisting elderly patients in walking longer distances without leg pain (PAOD, also known as intermittent claudication). Standardized ginkgo extracts are approved for use as medicines in Germany and numerous other countries.

About the American Botanical Council

Founded in 1988 the American Botanical Council is a leading international nonprofit organization addressing research and educational issues regarding herbs and medicinal plants. ABC’s members include academic researchers and educators, universities and libraries, health professionals and medical institutions, botanical gardens and arboreta, government agencies, members of the herb, dietary supplement, cosmetic, and pharmaceutical industries, journalists, consumers, and other interested parties from over 70 countries. The organization occupies a historic 2.5-acre site in Austin, Texas where it publishes the quarterly journal HerbalGram, the monthly e-publication HerbalEGram, HerbClips (summaries of scientific and clinical publications), reference books, and other educational materials. ABC also hosts HerbMedPro, a powerful herbal database, covering scientific and clinical publications on 220 herbs. A clinical monograph on ginkgo, published in The ABC Clinical Guide to Herbs, ABC’s reference book accredited for continuing education for all major conventional health professions, can be accessed here.

ABC is tax-exempt under section 501(c)(3) of the IRS Code. Information: Contact ABC at P.O. Box 144345, Austin, TX 78714-4345, Phone: 512-926-4900. Website: http://www.herbalgram.org/.

References

1. DeKosky ST, Williamson J, Fitzpatrick A, Kronmal RA, Ives DG, Saxton J, Lopez O, Burke G, Carlson M, Fried L, Kuller LH, Robbins J, Tracy RP, Woolard NF, Dunn L, Snitz BE, Nahin RL, Furberg CD for the GEM Study Investigators. Ginkgo biloba for primary prevention of dementia: Results of the Ginkgo Evaluation of Memory (GEM) Study. JAMA Nov 19, 2008;300(19):2253-2262.

2. American Medical Association. Ginkgo biloba does not appear to prevent dementia, Alzheimer’s disease [press release]. Chicago, IL: Nov. 13, 2008.

3. Schneider L. Ginkgo biloba extract and preventing Alzheimer’s disease. JAMA Nov 19, 2008; 300(19):2306-2308.

4. Cott J e-mail to Elizabeth Cohen (CNN), Nov. 16, 2008

5. Andrieu S, Ousset PJ, Coley N, Ouzid M, Mathiex-Fortunet H, Vellas B, GuidAge Study Group. GuidAge study: a 5-year double-blind, randomized trial of EGb 761 for the prevention of Alzheimer’s disease in elderly subjects with memory complaints. I Rationale, Design and baseline data. Curr Alz Res 2008;5:406-415.

6. Andrieu S, Gillette S, Amouyal K, Nourhashemi F, Reynish E, Ousset PJ, Albarede JL, Vellas B, Grandjean H. Association of Alzheimer’s disease onset with Ginkgo biloba and other symptomatic cognitive treatments in a population of women aged 75 years and older from the EPIDOS study. J Gerontol Med Sci 2003;58A:372-377.

7. Dartigues JF, Carcaillon L, Helmer C, Lechevallier N, Lafuma A, Khoshnood B. Vasodilators and Nootropics as Predictors of Dementia and Mortality in the PAQUID Cohort. J Am Geriatr Soc 2007; 55:395399.

8. Dodge HH, Zitzelberger T, Oken BS, Howieson D, Kaye J. A randomized placebo-controlled trial of Ginkgo biloba for the prevention of cognitive decline. Neurology 2008;70:1809-1817.

9. Crews W, Harrison DW, Griggin ML, Falwell KD, Crist T, Longest L, Hehemann L, Rey ST. The neuropsychological efficacy of ginkgo preparations in healthy and cognitively intact adults; A comprehensive review. HerbalGram 2005;67:42-62.

10. Horsch S, Walther C. Ginkgo biloba special extract EGb 761 in the treatment of peripheral arterial occlusive disease (PAOD) a review based on randomized, controlled studies. Int J Clin Pharmacol Ther. 2004 Feb;42(2):63-72.

AHPA Responds to JAMA Study on Ginkgo, Dementia Prevention

Nov. 18, 2008 – A study published in the Nov. 19 issue of the Journal of the American Medical Association finds Ginkgo biloba extract ineffective for the primary prevention of dementia. However, as the authors note, “there are no medications approved for primary prevention of dementia.”

The randomized, double-blind Ginkgo Evaluation of Memory (GEM) trial followed 3,069 individuals assigned to either placebo or 120 mg twice-daily ginkgo extract (Schwabe’s EGb 761®). Out of the 1,545 individuals receiving ginkgo, 2,587 were seniors with normal cognition and 482 of the volunteers aged 75 and over had mild cognitive impairment (MCI).

“The study does not in any way undermine what has already been observed with regard to the usefulness of ginkgo extract, and EGb 761 in particular, in providing symptomatic relief in persons who already suffer from dementia or Alzheimer’s disease,” said American Herbal Products Association President Michael McGuffin. “In fact, Ginkgo extract has been shown to work as well as the available approved drugs to slow the progression of Alzheimer’s disease.”

Additional References

Mazza, M. Gingko biloba and donepezil: a comparison in the treatment of Alzheimer’s dementia in a randomized placebo-controlled double blind study. Eur J Neurol. 2006;13(9):981-5

Wettstein, A. Cholinesterase inhibitors and Ginkgo extracts—are they comparable in the treatment of dementia? Comparison of published placebo-controlled efficacy studies of at lease six months’ duration. Phytomedicine. 2000;6(6):393-401

How will the supplement industry manage an economic downturn? Industry historians will tell you that in the last few recessions, the supplement industry handled slower consumer spending quite well. But is recent economic history a good comparable for how the current supplement industry will handle the foreseeable future? Is it the same supplement industry that it was before?

This critical question is exactly what the 2008 Supplement Business Report addresses with over 400 charts of data and 160 large and small supplement company profiles. Forecasts through 2017 are also included based on most recently available research, so you can chart your company’s growth against our experienced expectations for the industry.

Certainly, 2008 has been a good year for the U.S. supplement industry. Both IRI and SPINS data show solid growth in multivitamins, but a resurgence in herbs and vitamin D sales may drive growth for the overall supplement industry higher than achieved in 2007 (5.9% to $23.7 billion in consumer sales).

But how long will this last? Will private label grow its marketshare in ways we’re seeing it do in organic food? What about consumer pricing? Will prices decline as expected? And what about suppliers, how will they manage through rising ingredient costs, transportation costs and bad debt from customers?

Walking the show floor at Expo East and Supply Side West, one thing was clear. There is confidence that the primary demographic and self-care drivers of the nutrition and supplement industry position it better than most to weather a recession. However, when I asked executives, “Is your business feeling any impact from the economic downturn?” the quick answer was, “No.” But when I probed further and asked about bad debt, late payments and a slowdown in product development - they all confirmed one or all.

So is there a bit of schizophrenia in the U.S. nutrition industry? I feel there is. And if there wasn’t, I would be more concerned. One thing is certain, staying on top of industry trends is what Nutrition Business Journal has made its only business since 1996 and will continue to make its primary business through to the other side of this recession. So if you have any questions about what’s going on in any product segment or sales channel in the nutrition industry, don’t hesitate to call. 303.998.9229 If I don’t have the answer, I’ll find someone that does for you.

All the best,

Patrick Rea

Editorial Director

Nutrition Business Journal

26,000 people attended Natural Products Expo East in Boston last proving the effects of the troubled economy have yet to be painfully felt in the natural products industry. Though time will tell how the nutrition industry manages through this economic downturn, some companies are still doing well. Case in point, large conventional food manufacturers are outpreforming the market with growing sales and profits. General Mills, Campbell Soup and Kraft are just a few CPG firms that have found a way to profitably manage price increases, commodity price increases and changes in consumer shopping behavior.

Servicing the needs of the food industry, the Healthy Foods Conference was held on October 14th and 15th in Boston, MA, just prior to the start of Natural Products Expo East. About 100 executives in the healthy food and ingredient supply market attended the event, which delivered on its aim to bring together though leaders in the supply and manufacture of healthy foods (natural/organic, functional and lesser evil) in the U.S.

Tuesday’s “Delicious Predictions for 2010″ session was particularly notable.

Keynote Jeremy Gutsche of TrendHunter.com laid out a compelling new way to approach innovation and product development, utilizing his experience in online media and how new products capture the attention of various audiences in today’s cluttered media landscape.

Jeremy challenged all in attendance to rethink innovation for today’s online population based on his studies and experiences as the head of TrendHunter.com, challenging the attendees in the audience to a number of “team” challenges.

Jeff Grorr defended Kellogg’s acquisition of Kashi, noting that since the acquisition, Kellogg hasn’t reformulated any of the Kashi products for health reasons. He also thought there was a future for branded ingredients, but at this time, the consumer brands hold more value than the ingredient brands and thus don’t add much incremental value in consumer marketing. Jeff also noted that “the tide” is moving towards healthy foods, in that that the greater populations IS moving towards health and as an industry we need to keep our standards high and hold each other accountable to acceptable standards so not to undermine the growing consumer healthy food opportunity.

Robin Roderick of Ocean Spray noted the special needs of the aging and growing population of baby boomers over 65, detailing the low level of healthy food education and high needs for nutritionally rich products.

Laryn Calloway of Organic Bistro explained that the average American has the equivalent of a 6th grade education when it comes to nutrition. Laryn’s original mission was to reach unhealthy consumers by making her products “cool” and make it cool to eat well. There’s no magic bullet for wellness, she said, but a whole suite of life changes.

Wednesday’s sessions were also very informative, but as a nutrition industry researcher, the “Delicious Predictions for 2010″ was excellent.

-Patrick

During the week of October 4th, I attended my second CRN Conference at the Hyatt Tamayo Resort & Spa, just north of Albuquerque, New Mexico. Including speakers, sponsors, attendees and staff, 160 people joined together to network, enjoy themselves and attend sessions lead by an impressive list of industry leaders.

The Council for Responsible Nutrition out did themselves this year, producing a conference that I feel was an improvement upon a very good event last year in Arizona. The networking began Thursday evening, but the education sessions began Friday morning with a keynote from David Acheson, the Associate Commissioner for Foods at the FDA who outlined their Food Protection Plan introduced in November 2007. With an emphasis on prevention, FDA hopes their new plan will allow them to get ahead of food contamination and adulteration issues that have plagued the U.S. in the last 48 months.

Following David was Dr. Josephine Briggs, the Director of the National Center for Complementary and Alternative Medicine (NCCAM) who presented the results of the new National Health Interview Survey. Surveying 30,000 households and 75,000 people, NCCAM asked about CAM use in 36 therapies and across 81 conditions. The results found that the use of CAM has increased from 36% of the population in 2002 to 38.3% of the population in 2007. Non-vitamin and non-mineral dietary supplement usage remained relatively flat during this time. Interestingly, among other things, the found that CAM use strongly correlated to advanced education, even with income corrections. Most common CAM use was in the western part of the U.S., while consumers in the South were the least likely to use CAM.

One of the most interesting sessions for me was the consumer research panel staring Thom Blishcok of Information Resources Inc. and Maryellen Molyneaux of Natural Marketing Institute. Thom talked mostly about the dynamics of the greater economy in crisis, while diving deep into the surprisingly strong performance of dietary supplements in the food, drug and mass merchandiser markets. Maryellen presented NMI’s 10-year consumer panel research with a focus on defining the “Dr. Me” health opportunity in the United States. Randi Neiner finished up the session presenting CRN’s annual Consumer Confidence Survey that found supplement usage trends flat at 65% versus last year with a small rise in confidence most likely reflecting a drought of negative media coverage of supplements in 2007.

Saturday’s speaking highlight was Dr. Mimi Guarneri of the Scripps Institute for Integrative Health, who presented a holistic review of health and health conditions in the United States. Dr. Guarneri is a true thought leader in the medical field when it comes to integrative health and it shows in her pragmatic and open approach to healthcare, not sickcare.

The 2008 CRN Conference was great for networking and content and I thank the staff at CRN for producing another great event. I look forward to next year’s event, which is rumored to be moving to the West Coast.

Below are a few videos from the event, including a testimonial from Steve Mister, President & CEO of the CRN.

-Patrick

Terms were not disclosed, but North Castle Partners has brought in Nature’s Way owner, Schwabe Pharmaceuticals, to buy the outstanding shares of Enzymatic Therapy.

Terms of the deal were not disclosed, but NBJ pegs Nature’s Way sales in the $130-150 million range and Enzymatic Therapy sales in the $100-130 million range. The combination of Nature’s Way and Enzymatic Therapy creates a major force in the high-end supplement sector, and a new leader in the natural retail channel. Many have wondered if Enzymatic Therapy has thrived under ownership by North Castle Partners who may have found the perfect partner in Nature’s Way/Schwabe - a leader in the category and channel with access to foreign currency.

Lincoln International, a leading mid-market investment bank, acted as the exclusive financial advisor to Schwabe and Nature’s Way on the deal.

The press release noted, “Initial focus will be to further advance product development in bringing highly effective natural health solutions to market to elevate wellness for those critical health concerns of consumers.”

Dr. Dirk Reischig, Chairman and CEO of Schwabe: “We are very delighted that Enzymatic Therapy, Inc. joins the Schwabe group of companies. We do believe that the complementary product portfolios and marketing know-how of Enzymatic Therapy and Nature’s Way will significantly strengthen our presence in the US market, which is one of Schwabe’s strategic key markets for future growth. Natural health care solutions will become increasingly important over the next few decades. The joined forces of Enzymatic Therapy, Nature’s Way and Schwabe will therefore contribute significantly to consumers in the USA and abroad in achieving the best possible health and quality of life.”

Rory Mahony, CEO of Nature’s Way: “We look forward to leveraging the knowledge and expertise resident in our companies and to further enhance the significant business growth that both Nature’s Way and Enzymatic Therapy have enjoyed over the past several years. We believe the dedication of the companies to the development of quality products will benefit our customers in many ways.”

Randy Rose, CEO of ETI: “We are very pleased to align with Nature’s Way and Dr. Willmar Schwabe Pharmaceuticals in elevating the health and well being of consumers and patients by combining the very best know how of each of the companies. The highly ethical approach to delivering true natural medicines that improve lives is a consistent core value for all three entities and we look forward to advancing the natural health care solutions for the benefit of all.”

More to come soon.