The Washington Post recently published an article asserting that vitamin D is shaping up to be the nutrient of the year, if not the decade. The article started factually strong but weakened at the end when it made specific recommendations.

The Post references an article in Consumer Reports titled “Most people get insufficient Vitamin D, but extra supplements may not be needed.” That article correctly notes that vitamin D blood levels in U.S. residents are on average below what is now thought by some experts to be what is needed for optimal health; the magazine perhaps overstates the case by writing that “…77% of Americans have insufficient amounts.”

In an article published last year in the American Journal of Clinical Nutrition, Elizabeth Yetley uses NHANES data to show approximately 6 percent of adults are below the traditional cut-off defining vitamin D deficiency and 77 percent are below what some nutritionists now opine to be the preferred target of 80 nmol/L.

The Consumer Reports article also points out what is putting the U.S. population at risk, primarily increases in obesity (fat sequesters some of the vitamin D synthesized in the skin) and less skin exposure to sunlight’s ultraviolet radiation.

The Institute of Medicine is currently reviewing the Dietary Reference Intake value for vitamin D, which was last updated in 1997. A final report is expected this May.  Currently, people 19 to 50 years of age are advised to consume at least 200  International Units per day,  those 51 to 70 at least 400 units, and those over 70 at least 600 units. Estimates are that adults get 100 to 150 units daily from food.

Consumer Reports goes astray when it writes: that people don’t need a special supplement; that overdosing is unlikely; and who should be advised to have their blood levels tested. Although makers of nutritional supplements are planning reformulations of their multivitamin products pending the institute’s report, most of what is on the shelves now is still at only 400 units.

What defines overdosing is up in the air. Officially, the Tolerable Upper Intake Level is 2,000 International Units per day. While bets are that the Institute will raise the adequate intake to 1,000 units per day, it is less clear whether the upper limit will also be increased. Writing in the American Journal of Clinical Nutrition, John Hathcock and his colleagues make a case for 10,000 units as a safe limit. The Institute has a conservative approach to upper limits.

Finally, people should not wait to get a blood test until they are diagnosed with weak bones or an absorption problem, contrary to what Consumer Reports says. Better advice would be for all adults to start taking 1,000 units per day from supplements. If you are in a higher-risk group for low vitamin D levels (obese, female, older, bypass surgery, Hispanic, African-American), get tested a few months later.

David A. Mark, Ph.D., is president of dmark consulting LLC, a science consulting company serving the dietary supplement and functional food industry. Contact him at david@dmarknutrition.com or 978-897-0890.

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Jin Hua Qing Gan Fang made in lab.

The rules are different here in the United States. Hyde Park Holistic Center in Cincinnati recently received a warning letter from the Food & Drug Administration that read like many others having to do with nutritional supplements and the H1N1 virus. In China, though, the same admonishment could not be heard.

First, the FDA’s message to Hyde Park, which operates the Web site drdahlman.com: “The FDA has determined that your website offers a product for sale that is intended to diagnose, mitigate, prevent, treat or cure the H1N1 Flu Virus in people. This product has not been approved, cleared, or otherwise authorized by FDA for use in the diagnosis, mitigation. prevention, treatment, or cure of the H1N1 Flu Virus.”

The product in question is “4 Life Transfer Factor Plus Tri Factor,” which is sold in a password-protected store on the site. The product apparently supports immune system health or, as the FDA quotes Dr. Dahlman on one of his Web pages, “I firmly believe that use of this product will sufficiently upregulate your immune system and should be a primary part of your strategy to avoid the dangers of swine flu (H1N1 virus).”

It’s worth noting that Dr. Dahlman is not an M.D. His online biography says he is “a Chiropractic Physician with a degree in Nutrition, is Director of The Hyde Park Holistic Center in Cincinnati, Ohio and specializes in treatment of chronic health problems using nutritional, herbal and homeopathic therapies.”

If Dr. Dahlman were in China, he might have gotten praise rather than criticism. On Dec. 16, Chinese medical specialists said they had developed a Chinese herbal medication to treat H1N1. An article from the official Chinese news agency, Xinhua, quotes Wang Chen, president of Beijing’s Chaoyang Hospital, as saying the medication “can shorten patients’ fever period and improve their respiratory systems. Doctors have found no negative effects on patients who were treated in this way.”

The article adds that the herbal formula, called “Jin Hua Qing Gan Fang,” had been tested at 11 hospitals on 410 people who exhibited mild symptoms of H1N1. With success in treatment over a five-month period, the makers were seeking international patents.

The herbal medication is being positioned as a lower-cost alternative to Tamiflu, which WHO recommends for the treatment of H1N1.
Interestingly, the article quotes Cris Tunon, a senior officer at the WHO office in China, as saying that “WHO welcomes the clinical results.”

It’s unlikely the herbal medication would get the same greeting in the United States. The FDA has warned a number of companies with herbal products to stop making H1N1-related claims. Twice in 2009, the AHPA has advised against the use of dietary supplements to prevent or treat the flu. What happens when “Jin Hua” is marketed on American shores?

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New Rules: Endorsements & Testimonials in Marketing (The Business of Marketing)

“Those were the days – the days when a marketer could use an actual quote from a real person that has used your product as a marketing endorsement or testimonial to capture the aspirations of your potential customers. As of December 1, 2009, those days are gone.”

What You Need to Know About the New FTC Endorsement Rules — and Why (Ad Age)

“Revlon won’t be able to give away its product to mommy bloggers without asking them to disclose it in their writings. And if Jennifer Love Hewitt claims her blemish-free skin is the result of Proactiv, she had better be telling the truth.”

FTC Wants To Clarify: Bloggers Probably Won’t Get Dinged $11,000 (Washington Post)

“…the FTC would most likely send an [sic] warning letter to a blogger who pitches for Jiffy but doesn’t disclose receiving funds from Virginia peanut farmers.”

Do the FTC’s New Endorsement/Testimonial Rules Violate 47 USC 230? (Technology & Marketing Law blog)

“…the FTC apparently has made the same analytical error that the SEC recently made in the SEC’s proposal to hold securities issuers liable for third party content they link to.”

FTC Orders More Disclosure in Consumer Testimonials, Celebrity Endorsements (National Law Journal)

“(Attorney Anthony DiResta is) not as positively inclined toward the decision to do away with the “results may vary” disclaimer in favor of describing typical results. “Whenever there is going to be a claim of typicality, then there’s going to have to be substantiation.” And that can be costly and timely, DiResta added.”

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Blackburn and Greider

Three Americans won Nobel Prizes in physiology or medicine today for their research on telomeres, the endcaps of chromosomes that protect genetic material from being erased. Understanding how telomoeres work is enlightening scientists on aging and disease. Nutritional supplement companies should pay special attention to this research as it may relate to their products.

The scientists were: Elizabeth Blackburn, a professor of biology and physiology at the University of California, San Francisco; Carol Greider, a professor in the department of molecular biology and genetics at Johns Hopkins University School of Medicine in Baltimore; and Jack Szostak, a professor of genetics at Massachusetts General Hospital in Boston. They had worked separately and together to show that when parts of telomeres were missing, DNA would eventually become shorter and cut off when replicated. Shorter telomeres lead to slower cell division and thus premature aging, the scientists discovered.

What can a person do to support the health of their telomeres? Research conducted National Institute for Environmental Health Sciences in the Research Triangle Park suggests that multivitamin supplements represent a major source of micronutrients, which may affect telomere length by moderating oxidative stress and chronic inflammation. (Disclosure: My mother was a research scientist at NIH in the Research Triangle Park.)

In a paper published in June issue of the American Journal of Clinical Nutrition, Qun Xu and her colleagues reported that multivitamin use was associated with longer telomeres. This is the first research to produce those results. While supplement makers cannot make aging-related health claims, they should take note of what the world is recognizing today and how it might affect their business in coming years.

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This is a tale of two types of weight-loss products and how the Food and Drug Administration had different responses to similar problems with them. The separate, but not equivalent treatment raises questions about how the FDA operates.

On Aug. 24, the FDA issued a statement about an ongoing safety review of orlistat based on reports of liver injury in people taking the weight-loss drug. It is marketed as the prescription drug Xenical and the over-the-counter medication Alli.

The FDA said it had received 32 reports of serious liver injury in patients taking orlistat between 1999 and 2008.  Of those cases, 27 required hospitalization and six resulted in liver failure.

Sound familiar? It should. On May 1, the FDA issued a warning about the danger of Hydroxycut based on 23 reported liver problems over seven years, including 16 hospitalizations. One person died in February 2007 after taking that weight-loss product.

That is where the stories diverge. For orlistat, the FDA is conducting a review because, “no definite association between liver injury and orlistat has been established at this time,” according to the release. “Consumers taking Xenical should continue to take it as prescribed, and those using over-the-counter Alli should continue to use the product as directed.”

In contrast, the FDA told consumers to stop immediately using Hydroxycut even though the agency acknowledged in a health hazard evaluation board report that “The Board does not know what ingredient(s) of Hydroxycut are responsible for producing liver toxicity. In addition, there is insufficient information to determine whether there is a dose-response effect between Hydroxycut ingestion and liver disease or whether its effects are cumulative over time.”

Despite a lack of direct evidence, the board concluded “that the ingestion of the dietary supplement, Hydroxycut, presents a severe potentially life-threatening hazard to some users.” The makers of Hydroxycut immediately ordered a recall.

What might the same health board members think about orlistat? It has caused liver injuries for a longer time period and has put more people in the hospital with similar ailments — jaundice and liver failure.

Does the FDA give greater weight to the patient death? If so, it seems to us that the product would have been recalled in 2007.

Is the difference the way the products are regulated? The FDA approved Xenical in 1999 and Alli in 2007. None of the ingredients in Hydroxycut were identified in the report as needing FDA review.

If the distinctions are not clear from a review of the facts, then what are we to expect the next time a weight-loss product is associated with health problems?

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Placebos don’t work when you are asleep. Or if you have Alzheimer’s disease. But they do seem to make a difference in research and clinical practice, as I found when preparing a recent article for Nutraceuticals World.

In clinical trials for subjectively reported symptoms such as pain or mental state, the placebo effect is roughly 30%. But the average varies from condition to condition. For chronic fatigue syndrome or Crohn’s disease. the average reported improvement across multiple clinical trials was 20%; for osteoarthritis it was 40%.

And for any of the nearly dozen conditions tabulated for the article, the range from trial to trial was large. In 20 studies of bipolar mania, the average was a 31% improvement in the placebo groups, but the range was from 9% to 59%.

The placebo effect is impacted by variables in the design and conduct of clinical trials. For example, a larger placebo effect was reported when subjects had higher expectations of being successfully treated, or if the trial itself was larger, longer, or had more visits per trial. Use of the opiate antagonist naloxone reverses placebo-induced pain relief, suggesting production of endogenous opioids as a mechanism

At the medical practice level, the worst-case scenario is a charismatic doctor who invents or champions a novel treatment (or surgical procedure) – and then writes a book. The certainty of the healer-researcher raises expectations in the patients, leading to positive results. Sports performance products are also subject to a strong placebo effect.

The lesson? Testimonials and open-label trial results should never be provided as sole evidence of efficacy when a product marketing campaign is challenged by a regulatory authority.

Mark

David A. Mark, Ph.D., is president of dmark consulting LLC, a science consulting company serving the dietary supplement and functional food industry. Contact him at david@dmarknutrition.com or 978-897-0890.

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Vitamin C

The popular view that supplements contribute to nutrition got a boost from a study published by the American Dietetic Association. In the March issue of the ADA’s journal, scientists based in Seattle, Atlanta and Minneapolis found that supplements help middle-aged and older Americans meet their daily intake requirements. Results varied by population group, the study found.

Specifically, the research found that many adults do not meet the daily required intake guidelines even with the help of dietary supplements, and the effect of supplementation can vary according to ethnicity and sex. Also, high-dose supplement use is associated with intakes above upper limits for intake levels for calcium, magnesium, and vitamin C.

The study looked at 6,814 subjects aged 45 to 84 in six regions spanning the nation from Forsyth County, North Carolina, to Los Angeles County. About 38% of participants were white, 28% African American, 22% Hispanic, and 12% Asian American. Participants were classified based on whether they were users or nonusers of supplements and again based on whether they used multivitamins or high-dose supplements.

The results:

• Overall, median dietary intake of calcium, magnesium, and vitamin C was similar between supplement users and nonusers among both men and women.
• In men, calcium supplementation increased median calcium intake by 56% and for magnesium supplementation by 42%.
• Vitamin C supplementation had the largest effect on median intake in men, ranging from a 160% increase in Chinese men to 235% in African-American men.
• For all women, magnesium supplementation increased median magnesium intake by 61% and vitamin C supplementation by 181%.
• Calcium supplementation produced a 101% increase in median calcium intake among Hispanic women and a 151% increase in Chinese women.

The benefits of increased intake came with a warning from the study’s authors: those who consumed high-dose supplements were more likely than nonusers to exceed upper intake limits. The overage could lead to health problems, such as kidney stones from too much calcium.

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Companies keen on product development will likely get a boost from the compromise version of the stimulus bill that the House was set to vote on Friday. There are billions of dollars for government research grants and millions for construction of research buildings. The final legislation did pull back in areas such as agriculture. Here are the highlights, according to Inside Higher Ed:

• National Science Foundation: $3 billion, including $2.5 billion for research, $400 million for infrastructure and $100 million for education.
• National Institutes of Health: $10 billion, including $8.5 billion for research and $1.5 billion for university research facilities.
• National Institute of Standards and Technology: $180 million for competitive grants for research building construction.
• Energy Department: $2 billion for research, including $1.6 billion for Office of Science, $400 million for Advanced Research Project Agency-Energy; no money for infrastructure.

For a perspective on what the funds could mean for research, read or listen to this NPR report. Another view comes from a blog at The Scientist under the headline, “NIH wins stimulus jackpot.” Because there are so many versions of the bill, read it here in PDF format.

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A report published on the web site of the Minneapolis-based nonprofit Institute for Agriculture and Trade Policy (IATP), http://www.iatp.org indicates some well-known foods and drinks rich in high-fructose corn syrup may contain detectable levels of mercury.

This report comes on the heels of a new study published in the journal of Environmental Health, http://www.ehjournal.net/content/pdf/1476-069x-8-2.pdf which shows mercury in some samples of commercial high-fructose corn syrup tested in 2005.

To read the entire IATP report click here.

Meanwhile, the website HFCSFacts.com begs to differ.  The site, titled “The Truth About High Fructose Corn Syrup,” offers a counterpoint in its document entitled Mercury Study Seriously Flawed and Outdated; Fails to Meet Standards for Scientific Research. The organization is even running Google AdWords ads with links directly to documents challenging the mecury study.

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Research at Yale

Nestled in the $800 billion-plus economic stimulus bills that Congress is considering are billions of dollars for non-profit research centers, universities and possibly private firms. The Chronicle of Higher Education breaks down the House and Senate bills into categories that range from NSF to NIH. The monies present opportunities for private and non-profit firms that understand how to tap into the funding.

Here are some of the particulars:

• National Science Foundation:  House bill (in XML format) bill — $2 billion for research grants, $900 million for equipment and facilities, and $100 million for science education; Senate bill (available by searching the PDF) — $1.2 billion for research grants, $150 million for infrastructure, $50 million for education.
• National Institutes for Health: House — $1.5 billion for biomedical research, $2 billion for facilities renovation and capacity building; $2.7 billion for biomedical research; $300 million for shared equipment.
• Agriculture Department Cooperative State Research, Education and Economic Service: House — no money; Senate — $100 million for Agriculture and Food Research Institute.
• National Institute of Standards and Technology: House — $300 million to construct research buildings at colleges; Senate — no funding.
• Agricultural Research Service: House — $209 million for facilities; Senate — no funds.

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