WellPoint research leads to limits on use of Boniva; FDA spars with tobacco company

News outlets report on policies in the drug and tobacco industries.

"WellPoint Inc. (WLP), the largest U.S. managed-care concern by membership, made it harder last year for its members to gain approval for use of the Boniva osteoporosis drug after internal research linked it to higher fracture rates, lower patient compliance and higher total costs of care than two other drugs, a WellPoint executive said Thursday," Dow Jones Newswires/The Wall Street Journal reports. "WellPoint, which conducts its own research into the comparative effectiveness of various treatments, studied 26,000 members on osteoporosis drugs. The health insurer sought to compare Boniva … with two others in the same class," Actonel and Fosamax. Based on its research, in mid-2009 WellPoint began requiring "that members of its commercial health plans with osteoporosis try other drugs in the class before they can be approved for Boniva. The drug remains where it was in the company's formulary, or list of covered drugs, on tier 3, which is a nonpreferred level."

"Last month, WellPoint announced it had developed standardized comparative effectiveness research, or CER, guidelines to evaluate drugs' ability to improve health outcomes. This type of research has come into the spotlight as the nation prepares to implement an overhaul of its health-coverage laws. The economic stimulus bill provided more than $1 billion for CER, and the Obama administration supports the use of such data to help doctors and patients make informed health-care decisions" (Brin, 6/24).

Meanwhile, The Food and Drug Administration has asked Altria for market research behind the selling of Marlboro Golds, which used to be called Marlboro Lights, Bloomberg Businessweek reports. The FDA, "which as of last year regulates tobacco products, banned the use of the words 'mild,' 'light,' or 'low tar' on packages effective on June 22. The agency says such cigarettes are just as harmful as regular ones. Before Altria made the switch, it used the old packs to tell smokers that while the look of Marlboro Lights would change, the 'cigarette stays the same.' That got the FDA's attention. The agency argues many consumers will continue to assume Marlboro Golds are safer than regular smokes and has ordered Altria to hand over market research showing why it used the tactic. … Pharmaceutical companies frequently skirmish with the FDA, and Big Tobacco is widely expected to do the same" (Miles, Burritt and Peterson, 6/24).

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This article was reprinted from khn.org with permission from the Henry J. Kaiser Family Foundation. Kaiser Health News, an editorially independent news service, is a program of the Kaiser Family Foundation, a nonpartisan health care policy research organization unaffiliated with Kaiser Permanente.