While doctors can — and frequently do — prescribe drugs for purposes beyond those approved as “safe and effective” by the Food and Drug Administration, it is illegal for manufacturers to actively market their products for such off-label use.
“Not only did Abbott engage in off-label promotion, but it targeted elderly dementia patients and down-played the risks apparent from its own clinical studies,” Tony West, acting associate attorney general, said in a statement.
In 2009, Pfizer paid the largest settlement to date in such a case — $2.3 billion in connection with its marketing of drugs that included the painkiller Bextra. Last year, British drugmaker GlaxoSmithKline announced that it expects to reach a bigger settlement this year related to its development and promotion of the diabetes drug Avandia, among others.
Abbott’s settlement marks the culmination of a four-year investigation into an array of strategies the Illinois-based multinational employed to vastly expand the market for its neurologic drug Depakote, which the FDA has approved to treat three conditions: epileptic seizures, migraines, and the manic episodes experienced by people with bipolar disorder.
As part of the settlement, Abbott admitted that beginning in 1998 it trained a special sales force to promote Depakote to nursing-home employees as a way to control the agitation and aggression that can occur in elderly patients suffering from dementia.
In 1999, Abbott was forced to discontinue a clinical trial testing Depakote’s effectiveness against dementia when it became evident that the drug increased the incidence of drowsiness, dehydration and anorexia in elderly study participants. Yet the sales team continued to push the drug to nursing homes through 2006.
In its marketing, Abbott highlighted the fact that Depakote was not covered by a 1987 law designed to prevent the use of unnecessary medications by nursing homes. So if nursing homes used it in place of other options, they could avoid the administrative costs and burdens of complying with that law.
The attorney for Meredith McCoyd, one of four former Abbott sales representatives whose whistleblower lawsuits prompted the investigation, said the company offered nursing homes a second rationale.
“Abbott directed its sales force to get Depakote widely used in nursing homes, principally to neutralize older patients as a substitute for proper staffing,” attorney Reuben Guttman said in a statement. “Abbott essentially preyed on . . . the most helpless patient populations.”