Wednesday, May 09, 2012

Granny Bird Award: Abbott Laboratories

Last December, I issued a Granny Bird Award (given from time to time to those who have an adverse effect on the health, welfare, and rights of elders) to those doctors, nursing home operators, and pharmaceutical companies who allow the off-label use of powerful antipsychotic drugs to pacify nursing home patients with dementia.

It now turns out that not only antipsychotic drugs are being used off label for this purpose. And it also turns out that Abbott Laboratories, the current recipient of this award, went out of its way to sell Depakote for such a dangerous off-label use.

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. ...

“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. ...

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.”
[Emphasis added]

Depakote is a drug which is designed for neurological disorders such as epilepsy, not to pacify dementia patients. Further, the company's own clinical studies showed that such use was dangerous and had disastrous side effects such as dehydration. That didn't stop it from touting the benefits of keeping such difficult patients loaded to save nursing home staffing costs, nor did it stop it from offering some bakshish to pharmacies which service such nursing homes rebates for increasing sales to them.

The fine is a stiff one relatively speaking (you know the old saying, "a billion here, a billion there, pretty soon you're talking real money), but don't worry about Abbott Labs. They are doing just fine according to last year's numbers:

Revenue $39 billion
Net Income $5 billion

While it is gratifying to see such a large "fine" levied, I would have been happier with really serious criminal sanctions. I would like to have seen the marketing guru who came up with this scam and all of his superiors right up the line arrested and facing years in prison for fraud and everything else the states and feds could come up with. That's the only way PHARMA will get the message.

But I guess that's asking too much right now.

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