Abbott Laboratories pleaded guilty earlier this month in federal court to marketing an anti-seizure drug called Depakote for unapproved purposes. The company will pay $1.5 billion in civil and criminal penalties to settle the case with the federal government, along with 49 states and the District of Columbia.
Depakote is an anti-seizure and mood-stabilizing drug that the Food and Drug Administration (FDA) approved only for treatment of bipolar disorder. But Abbott Laboratories thumbed its nose at the FDA by marketing the drug for many other purposes, including schizophrenia, dementia and autism.
Justice Department investigators also found that Abbott paid rebates — kickbacks — to health care providers and pharmacies to increase the off-label use of Depakote in nursing homes, even though they knew the severe side effects the drug can have on the elderly.
The U.S. Attorney for the Western District of Virginia, Timothy J. Heaphy, charged that Depakote was marketed and sold without adequate directions to control agitation, aggression, and other behavioral problems exhibited by elderly patients with dementia. In addition, the label lacked adequate directions for use in the treatment of schizophrenia.
“They (Abbott) pushed an ineffective medication to a population particularly vulnerable to the demonstrated side effects, including somnolence, malnutrition and dehydration,” said Heaphy, who added that the case should “help shine a light on the practice of off-label marketing and encourage physicians, hospitals, pharmacists and health care consumers to be more skeptical about the information they receive from pharmaceutical sales representatives.”
Heaphy’s office is experienced in prosecuting “the bad guys.” In 2007, U.S. Attorney John Brownlee (Heaphy’s predecessor) successfully prosecuted Purdue Pharma, the maker of OxyContin, for misleading physicians and patients about the addictive and abusive qualities of the painkiller. Purdue Pharma pleaded guilty before the case went to trial and paid an enormous fine. Many of the same individuals involved in the investigation and prosecution of Purdue Pharma were instrumental in the charges brought against Abbott Laboratories.
Purdue Pharma settled out of court because it didn’t want its dirty laundry aired during a public trial. Abbott probably settled for the same reason. The illegal marketing of Depakote went on for a long time – from 1998 to at least 2006 – and, according to Heaphy, it was not the work of some rogue salesman. It was approved at the highest levels of the company.
What does Abbott have to say about this costly case?
“The company takes its responsibility to patients and health care providers seriously and has established robust compliance programs to ensure its marketing programs met the needs of health care providers and legal requirements,” said Laura J. Schumacher, Executive Vice President and General Counsel to Abbott Laboratories.
We may never know how many people suffered or died from the off-label marketing of Depakote — just as we’ll never know how many suffered and died from the illegal marketing of OxyContin.
It’s time for the FDA to crackdown on Big Pharma when it uses phony marketing tactics to push dangerous drugs for other than approved purposes.
A few years ago, while speaking with an FDA official, I was told, “We don’t have enough manpower to police Purdue Pharma.” My reply to them was, “And you don’t think they know that?”
Maybe U.S. Attorney Heaphy and his investigators should set up an office in the FDA and “get the job done” that obviously the FDA can’t do itself.
Marianne Skolek is an activist and investigative reporter for Salem-News.com who lost a daughter to prescribed OxyContin in 2002. Marianne writes from the perspective of families devastated by the prescription drug epidemic.
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