HEALTH

Natural Products Association responds to TV segment regarding black cohosh

BY Michael Johnsen

WASHINGTON The Natural Products Association on Monday wrote a letter to the producers of a PBS NewsHour report that last week ran a segment critical of the herbal supplement industry.

Specifically, the segment attacked black cohosh supplements, citing research funded by the Alfred P. Sloan Foundation. Researchers David Baker, professor of obstetrics, gynecology and reproductive medicine at SUNY Stony Brook School of Medicine, and Dennis Stevenson, a staff scientist at the New York Botanical Garden, procured 26 random samples of black cohosh from the Internet and random, unnamed retailers across New York City and Long Island, N.Y., and found that 30% — or between seven and eight — of the samples did not contain black cohosh.

The research is part of to the Sloan Foundation’s “Barcode of Life” research grant, which is exploring “the development of DNA bar codes for plants by operating an international research network and by leading the effort for the 100,000 tree species of the world.” Specifically, Stevenson has been mapping a DNA bar code for black cohosh.

PBS correspondent Paul Solman noted that the DNA-bar-coding had been getting some “high-profile press” of late, stating that “a couple of years ago, two high school students used it to uncover the fishy truth about New York sushi.”

“The Natural Products Association urges you to release the product names you tested and all accompanying relevant data on the material, including how it was sampled and the test methodology, to the Food and Drug Administration so that proper action can take place,” the association wrote in its letter addressed to Solman.

Solman opened the PBS segment with, “Though we rarely do consumer stories, at the New York Botanical Garden not long ago, we happened on one we just couldn’t resist: that in one of America’s fastest-growing and least-regulated industries, medicinal herbs, what you see may not be what you get.”

Tagging the dietary supplement industry as “least regulated” isn’t the only inaccuracy within the report; Solmon also identified black cohosh as one of the “fastest-growing” supplements, joining “ginkgo and ginseng as America’s dietary supplement best-sellers.” However, according to recent SymphonyIRI Group data, sales of each of these supplements were on the decline for the 52 weeks ended June 13 across food, drug and mass (minus Walmart) outlets, and none of these supplements cracked the top-three best-sellers within the herbal category — gingko biloba ranked No. 5, black cohosh No. 9 and ginseng No. 10.

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Arena, Eisai receive complete response letter for lorcaserin

BY Alaric DeArment

SAN DIEGO The Food and Drug Administration declined to approve a regulatory approval application from Arena Pharmaceuticals and Eisai for a drug to treat obesity, the two companies said Saturday.

 

The FDA issued a complete response letter for the drug lorcaserin, designed for weight management and weight loss in patients who are overweight or obese and have at least one co-morbid condition. The FDA issues a complete response letter when it finishes reviewing an approval application, but issues remain that preclude final approval.

 

 

The FDA told the companies that it found problems regarding tumors in the mammary glands of rats receiving the drug and issues surrounding the efficacy of the drug in some patients.

 

 

“This is an important step for us toward the FDA’s approval of lorcaserin,” Arena president and CEO Jack Lief said. “While the complete response letter provides us with recommendations from the agency, we intend to meet with the FDA to obtain further clarity on the approval path and timeline.”

 

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CHPA names Melville its new president

BY Michael Johnsen

WASHINGTON —Scott Melville has been named the new president of the Consumer Healthcare Products Association, succeeding Linda Suydam, who is retiring after eight years with CHPA. The news becomes official Nov. 1.

Prior to the announcement, Melville served as SVP government affairs and general counsel for the Healthcare Distribution Management Association. Before joining HDMA, Melville was as an attorney and head of government relations for Cephalon. A veteran facilitator, familiar with health care and the vital role over-the-counter medicines and natural products play in today’s healthcare system, Melville also is a former staffer for Rep. Jerry Lewis, R-Calif.

At CHPA, Melville will have an opportunity to bring all of his decades of experience as a healthcare sector advocate to bear. With healthcare reform on the line and millions of baby boomers hitting their 60s, CHPA chairman Christopher DeWolf said that Melville’s “experience in public policy, coalition building and working with government officials and key stakeholders will be invaluable in guiding the industry through the rapidly changing healthcare environment.”

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