Passage A
Global pharmaceutical giant Abbott Laboratories has agreed to pay federal and state governments $1.6 billion in criminal
and civil fines for illegally promoting unapproved uses of its drug Depakote, including to sedate elderly patients in nursing
homes, officials announced Monday.
The settlement, which includes an agreement to plead guilty to a criminal misdemeanor, is the second-largest in a string
of multimillion-dollar payouts in recent years resulting from stepped-up enforcement by the Justice Department and state
investigators against drugmakers that “misbrand” their products.
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.
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. 【題組】43. Which word in the passage is synonymous with “off-label use” in paragraph 3?
(A) pharmaceutical (B) misbrand (C) dementia (D) misdemeanor
寫作批改
VIP與詳解卡管理
私人筆記( 0 )