Preying On Helpless Patients
From the Washington Post (http://www.washingtonpost.com/national/health-science/abbott-laboratorie...):
Abbott Laboratories agrees to $1.6 billion settlement over marketing of Depakote
By N.C. Aizenman, Published: May 7
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 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.”
The pharmaceutical industry time and again acts brazenly to enhance profits at the expense of patients. Why? Because settlements like this one allow them to get away with it. Profits for this scandal far outweigh any cost to Abbot. Never mind the patients that they killed or seriously harmed. They have a business model and they coldly calculate what behavior will maximize shareholder value. Surely the American public will rise up and demand that somehow society can stop this egregious behavior?
Dr. Joe Jarvis