HEALTH

Surrogate endpoints could be beneficial to dietary supplement industry

BY Michael Johnsen

WASHINGTON The use of surrogate endpoints to help measure efficacy in clinical trials would be of benefit to the dietary supplement industry, Andrew Shao, SVP scientific and regulatory affairs for the Council for Responsible Nutrition, testified before the Institute of Medicine of the National Academies Monday during a discussion forum around the use of biomarkers and surrogate endpoints in clinical trials.

“The lack of validated biomarkers for exposure to nutrition interventions and as surrogate endpoints for chronic disease limits the amount of research that can be conducted, especially using prospective randomized, controlled intervention trials, due to cost and logistical issues,” Shao said. “This, in turn, limits the ability to derive answers to important questions relating to the ability of diet, food and food components to promote health and reduce the risk of chronic disease.”

And that translates into fewer actionable health claims that either patients or their healthcare professionals can reference when constructing a disease-state-preventative wellness diet.

“We anticipate that a formal biomarker evaluation process will add clarity to product development,” Shao told the panel consisting of members of IOM’s Food and Nutrition Board, Board on Health Care Services and Board on Health Sciences Policy.

Surrogate endpoints are used in place of clinical endpoints in the evaluation of a health benefit  — whether it’s used to establish that benefit for new allopathic medicines or the use of dietary supplements — in large part because of the number of years and/or the large patient population necessary to establish that benefit, such as establishing a clinically evaluated benefit against hip fracture rates, for example.

“Therefore, to replace such a clinical endpoint by another that could be measured earlier, more conveniently or more frequently  — and that would adequately reflect the benefit of new treatments on the true endpoint  — seems an attractive alternative,” wrote Tomasz Burzykowski, senior statistician MSource, in a paper explaining the terminology.

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One condoms arrive at Target

BY Allison Cerra

BOSTON A new condom brand has hit store shelves at Targets nationwide.

One condoms offer unmatched sensitivity without compromising strength, the company said. More than 1,700 Target stores now carry three styles of One premium condoms: Super Sensitive, Mixed Pleasures and  Zero, a new product made from more natural, ultra-purified latex and is 25% thinner than standard condoms.

“For years, our customers have been asking when their favorite One condoms would be available at Target,” said Davin Wedel, CEO of One. “We are thrilled that day has finally come.”

To celebrate this milestone and thank its loyal customers, One is giving away free music to 1,000,000 fans. The free music downloads are available while supplies last by becoming a member of the One community in any of several ways:

  • Join the One mailing list;
  • Become a fan on Facebook;
  • Follow One on Twitter;
  • Complete an online survey at OneCondoms.com; or
  • Sign the Safer Sex Oath online

For more information, visit OneCondoms.com.

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‘Life…supplemented’ campaign saluted for PR work

BY Allison Cerra

WASHINGTON Consumer wellness initiative “Life…supplemented” was the recipient of an award that recognizes organizations that do exemplary work in the field of public relations.

Considered the highest honor within the public relations industry, the Silver Anvil award — sponsored by the Public Relations Society of America — was given to CRT/tanaka, the creators of the campaign, and to the CRN Foundation, the education affiliate of the Council for Responsible Nutrition, which managed the campaign.

“Life…supplemented” encourages consumers to focus on the three pillars of health — healthy diet, dietary supplements and exercise — along with other smart, healthy lifestyle choices. The campaign was recognized in the reputation/brand management (associations) category. The ceremony was held June 3 in New York.

“This consumer wellness initiative is an extraordinary effort by an industry that is passionate about its consumers and eager to educate the public about the valuable role dietary supplements play as part of a comprehensive approach to wellness,” said Judy Blatman, SVP communications at CRN. “It’s an honor to share this award with CRT/tanaka, our Steering Committee and funders, and our Social Media Advisory Board and other campaign advisors.”

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