Surrogate endpoints could be beneficial to dietary supplement industry
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.
McNeil recalls continue; this time for Benadryl, Extra Strength Tylenol
FORT WASHINGTON, Pa. McNeil Consumer Healthcare once again is recalling certain lots of its products as it is probed by federal investigators for its recall of children’s cough-cold products and manufacturing plant closure.
The J&J subsidiary announced Wednesday morning that four lots of Benadryl allergy ultratab tablets (100 count) and one lot of Extra Strength Tylenol rapid-release gels (50 count) would be added to its initial Jan. 15 product recall. This recall, McNeil said, is a follow-up to the product recall because the products were inadvertently omitted from the initial recall action.
Benadryl allergy ultratab tablets are designed to provide relief of such allergy-associated symptoms as sneezing, runny nose, itchy throat and itchy and watery eyes. Extra strength Tylenol rapid-release gels are sold over-the-counter and are indicated for the temporary reduction of fever, as well as for the temporary relief of minor aches and pains due to headache, muscular aches, backache, minor arthritis pain, the common cold, toothache, premenstrual and menstrual cramps, and flu.
Consumers who purchased product from the lots included in this recall should stop using the product and contact McNeil Consumer Healthcare for instructions on a refund or replacement, the company said.
The Committee on Oversight and Government Reform is continuing its probe of the J&J subsidiary.
One condoms arrive at Target
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