HEALTH

HHS says ginkgo biloba may not be effective in helping treat dementia

BY Michael Johnsen

WASHINGTON The Department of Health and Human Services on Thursday suggested that the dietary supplement ginkgo biloba is not able to prevent the disease state of dementia, including Alzheimer’s disease, through its HHS HealthBeat, a service launched in 2005 that provides health promotion and disease prevention tips five days a week in audio and text formats.

The Department cited a study of more than 3,000 people over the age of 75 who had normal thinking ability at the start who were either given a ginkgo supplement or a placebo. “The test results showed us that, under these circumstances, ginkgo don’t appear to have any effect of slowing down thinking changes in late life,” stated Steven DeKosky of the University of Virginia, who conducted the study while at the University of Pittsburgh.

The study, published in the Journal of the American Medical Association, was supported by the National Institutes of Health.

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Airborne completes settlements for marketing, product labeling suit claims

BY Michael Johnsen

BONITA SPRINGS, Fla. Airborne Health on Tuesday completed the last of three settlements regarding past marketing and labeling of its products, agreeing to pay $7 million to settle investigations by 32 state attorneys general and the District of Columbia, the company announced.

“We’re putting the dietary supplement industry on notice—snake oil sales pitches will no longer be given free reign,” Connecticut Attorney General Richard Blumenthal said in a statement, according to published reports. “Our strong coalition of states will continue to investigate and pursue companies that make false claims about dietary supplements and other products.”

Settlements to date total $30 million.

The settlement with the Attorneys General—which involves no admission of wrongdoing on Airborne’s part, the company stated—is the last of three settlements involving similar claims regarding older advertising and labeling of Airborne dietary supplements. On Oct. 6, 2008, a U.S. District Judge approved a $23.5 million settlement of a class action lawsuit. On Sept. 5, the District Judge approved an additional $6.5 million settlement with Federal Trade Commission that would be paid only if the class action settlement does not cover all consumer claims. The class action and FTC settlement funds are being divided among consumers who joined the class action and filed for refunds.

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P&G challenges Schering Plough’s claim on proton-pump inhibitor

BY Michael Johnsen

CINCINNATI Procter & Gamble last month challenged Schering Plough’s ability to market its pending switch of the proton-pump inhibitor Zegerid as “immediate release,” arguing that the term is likely to be confused with “immediate relief” among lay consumers.

“Consumers, without the benefit of physician supervision, will likely interpret ‘immediate release’ as synonymous with ‘immediate relief,’” P&G argued in a Nov. 17 Citizen’s Petition filed with the Food and Drug Administration. “Not only do ‘release’ and ‘relief’ sound strikingly alike, but they have similar implications to consumers in the OTC drug context.”

In support of its Citizen’s Petition, P&G commissioned an online survey of 1,000 consumers, including 214 who were identified as frequent heartburn sufferers. As many as 65 percent of those frequent sufferers associated “immediate release” with speed of relief, P&G said. As many as 74 percent of the frequent sufferers indicated they would prefer an immediate release product over a delayed release product, suggesting that the majority of consumers may choose a Zegerid OTC product touting “immediate release” over Prilosec OTC or store brand omeprazole if Zegerid is approved for sale over-the-counter.

More than 89 percent of those frequent sufferers expected any “immediate release” product to provide symptomatic relief within 30 minutes.

Zegerid contains sodium bicarbonate in addition to the PPI omeprazole, which Santarus claims helps neutralize stomach acid and speeds absorption of the omeprazole within 30 minutes. However, P&G challenges that even with speedier absorption, the omeprazole active could take between one and four days before providing symptomatic heartburn relief. When Prilosec OTC was approved for switch, P&G noted, FDA required the marketer to include in its labeling: “Not intended for immediate relief of heartburn; this drug may take 1 to 4 days for full effect.”

On zegerid.com, Santarus claims: “Except for Zegerid, all proton pump inhibitors are delayed-release acid reflux drugs. Delayed-release proton pump inhibitors use a coating, called an enteric coating, to protect the acid reflux medicine from acid degradation while passing through the stomach. This coating delays the acid reflux medicine from getting into the bloodstream. Zegerid does not have an enteric coating and the acid reflux medicine is rapidly absorbed into the bloodstream. That’s why Zegerid is the first and only immediate-release oral proton pump inhibitor.”

Approximately 276,000 prescriptions for Zegerid were filled in the third quarter of 2008, Santarus reported, an increase of 20 percent versus total prescriptions in the year-ago period. That corresponded to sales of $28.1 million for the quarter, up 44 percent.

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