Montana’s mental health community was given a multimillion-dollar boost Wednesday through a settlement agreement between the state and pharmaceutical giant Eli Lilly over the marketing and sale of the antipsychotic drug Zyprexa.
The settlement, announced Wednesday by Attorney General Steve Bullock, calls for Lilly to pay $13 million to the state of Montana, with about $9.5 million being put into a newly formed Montana Mental Health Trust. The rest of the money will cover the state’s costs in pursuing the lawsuit, and $616,000 will reimburse the state Department of Public Health and Human Services for money spent through the Montana Medicaid Program that purchased Zyprexa for off-label uses.
Recently retired Montana Supreme Court Justice John Warner will head the trust and appoint a seven-member committee to consider grant requests for the funds. The agreement calls for the money to be used for crisis intervention services; training and education for law enforcement personnel and health care officers; funding for patients transitioning to independent living environments; children’s mental health programs; and peer-to-peer services.
Given the specific use mandates, it’s unlikely the money will counter or offset any of the proposed 5 percent cuts to state agencies such as DPHHS. Those cuts potentially could impact mental health treatment services, among others.
The trust money is supposed to be spent by December 2012. However, Bullock said that’s “not a hard and fast rule.
“But I think the need is out there and hopefully the money will go to fill some holes as soon as possible,” Bullock added. “This has the ability and the potential to do an amazing amount of good for those who are among the most vulnerable members of our society and who often suffer the most, individuals with mental illnesses.”
Montana’s Attorney General office filed the lawsuit against Lilly in 2007, alleging consumer protection violations and Medicaid fraud. More specifically, the state claimed that although Lilly’s medical experts were internally questioning the safety of Zyprexa — licensed to treat symptoms of schizophrenia and bipolar disorder — the company told its representatives to minimize and misrepresent the drug’s dangers.
The state also alleged that the company created a 280-person sales team whose sole function was to push Zyprexa for unapproved off-label uses including dementia, Alzheimer’s, autism and depression, particularly in long-term care facilities with elderly patients.
That use put some patients at risk for developing severe and harmful health conditions including hyperglycemia, significant weight gain, diabetes, pancreatitis, cardiac problems and death, but the state claimed Lilly didn’t warn physicians or consumers of those problems.
Instead, the lawsuit argued, Lilly encouraged and authorized the unlawful payment of illegal kickbacks to doctors in order to continue generating Zyprexa sales.
The lawsuit alleged that the company hid the risks associated with Zyprexa because it could harm sales of the popular drug, which by 2004 was prescribed to more than 12 million people worldwide, with sales exceeding $4.4 billion.
Marnie Lemons, a spokeswoman for Lilly, said the company didn’t admit to any wrongdoing as part of the settlement.
“We are pleased to put this behind us and move forward with what we do best — discovering and delivering life-saving medications,” Lemons added.
Bullock noted that beyond the monetary payments, Lilly also agreed to undertake business reforms to prevent false, misleading or deceptive advertising and promotions.
Warner said he is honored to be appointed as the trustee. He’ll be paid $125 per hour for his services, according to the trust settlement document.
He noted that with 41 years as a lawyer, then judge, he’s seen firsthand the difficulties in trying to help a person in the midst of a mental illness crisis in a large state with only limited services.
“I doubt there are very many people in this state where a mental illness hasn’t somehow touched themselves and their families,” Warner said. “I know this isn’t going to solve all the problems, but it will help and is something we can be proud of doing.”
Ravalli County Attorney George Corn and Sweetgrass County Sheriff Dan Tronrud added that law enforcement typically is the first responder in many cases, and the difficulties are compounded in far-flung locales.
“It’s a minimum five-hour trip to (the state hospital in) Warm Springs,” Corn said. “This grant allows local communities to develop facilities and nonprofit organizations to help people suffering from a mental health crisis stay in their communities. That’s so much more humane and so much less traumatic.”
Montana’s lawsuit was originally filed in district court in Helena but eventually was moved to the U.S. District Court in New York. Montana is one of 13 states to sue over the drug, and settlements have been reached in Alaska, West Virginia, Connecticut, New Mexico, Idaho, Utah, South Carolina, Mississippi and Arkansas. Lawsuits are pending in Minnesota, Louisiana and Pennsylvania.
Lilly also has paid a $1.4 billion settlement to the federal government, after admitting in January 2009 that it had promoted Zyprexa in elderly populations for treatment of dementia between 1999 and 2001. That agreement settled civil suits with several states and ended a criminal investigation.
Most of Zyprexa’s sales in the United States are paid for by government programs because many of those using it are poor or disabled. Each pill can cost up to $25, and in 2007 Zyprexa had sales of $4.8 billion, making it the biggest seller for Lilly. It’s also one of the top selling drugs in the world, with more than $39 billion in sales since it was first approved in 1996 for use.
Gary Mihelish, a Helena dentist and leader in the crusade to provide better mental health care in Montana, noted that 45,000 people in the state suffer from a severe, disabling mental illness at some point in their life. That’s one out of every five families.
“They live with guilt, grief and shame due to the lack of education about mental illness that continues today,” Mihelish said. “Somehow we have to change the way things are done. This settlement will do a great deal to help people obtain appropriate treatment, appropriate medications and the hope of recovery.”
Reporter Eve Byron: 447-4076 or email@example.com