Wednesday, September 17, 2008

Medicaid programs should put antipsychotic drugs higher on the radar

Pharmalot: Florida is an example where there’s controversy over antipsychotics given kids with ADHD.
Stallard: I think they shouldn’t be experimenting when it’s never been tested on children. It’s a big mistake. Sometimes, legislators say they need to be liberal with vulnerable segments of society to give them medicines that may have some benefit. I turn it around and say we shouldn’t be experimenting with the most vulnerable segments of our society.

Antipsychotics & State Lawsuits: Stallard Explains
By Ed Silverman
David Stallard, Assistant AG Utah

More states are filing lawsuits against drugmakers over allegations they failed to disclose side effects caused by their antipsychotics and improperly marketed the pills, therefore, causing state Medicaid programs to overpay for the medications. Meanwhile, many of these same state programs have been paying for antipsychotic prescriptions for unapproved uses in children, such as ADHD. We spoke with David Stallard, a special assistant attorney general in Utah, which sued Eli Lilly last year, about a state’s view of the problem…

Pharmalot: How’d you get involved in this litigation?
Stallard: I was working as an assistant attorney general for about five years and, most of that time, I was working in the Medicaid fraud control unit, spending a large part of my time, almost exclusively the last two years, on civil medicaid fraud, specifically, pharmaceutical fraud with respect to Medicaid.

Pharmalot: There’s that much fraud?
Stallard: There’s a lot of fraud. These are pretty intensive cases and take a lot of time. My opinion it’s because Medicaid drugs are such a huge part of the business for pharmaceutical companies and it’s very attractive market - feeding at the taxpayer trough. I’m kind of a skeptic having worked in the trenches, but pharmaceutical companies try to get as much reimbursement as they can from Medicaid, because it’s a big payer. And not just on price, but utilization. As many pills as they can, and the highest price they can engineer.

Pharmalot: Why did Utah sue Lilly?
Utah has chosen to sue on behalf of its state Medicaid program only two companies for what I call failure to warn - risks we allege were known early on by the company but concealed - Merck’s vioxx and Lilly’s zyprexa. In my opinion, there was a common theme. If they got what was going to be a blockbuster, they focus on the positives, but not give the FDA the negatives. And they would also train reps to dodge questions from docs. Separately, there was pricing fraud - overcharging medicaid - they falsely inflated list prices to First Databank and other compendia relied on by Medicaid and other third-party payors for medicaid reimbursement prices.

But with Lilly specifically, there was a lot of off-label use that was promoted by Lilly improperly. It’s actually illegal under Federal Food Drug & Cosmetic Act. But under state law, we’re claiming Lilly improperly marketed the drug and caused us to pay more than we should have.

Pharmalot: But there was another issue raised, right?
Stallard: Yes, and in fact, I wrote a memo that has to do with a second component - medically accepted indications for proper use. My legal analysis of federal Medicaid law is that, in order to be eligible for Medicaid reimbursement, the drug must be covered outpatient drugs. It’s basically a threshold requirement. There is a limitation on the definition of covered outpatient drugs that is tied to use of drug and it does not include ‘a drug or biological used for a medical indication which is not a medically accepted indication.’

Pharmalot: So you’re saying, under that definition, a state Medicaid program shouldn’t be paying.
Stallard: To me, it means that to be eligible for reimbursement for Medicaid - to be a covered outpatient drug - it has to be used for a medically accepted indication. Under that provision, it’s not a covered outpatient drug unless its used for a medically accepted indication. It’s not just a term of art. It’s specifically defined in the federal statute. It has to be FDA approved for use supported by specific compendia.


Monday, September 15, 2008

Controversy Intensifies in Child Psychiatry over Antipsychotics

New York Times
Risks Found for Youths in New Antipsychotics
September 15, 2008

A new government study published Monday has found that the medicines most often prescribed for schizophrenia in children and adolescents are no more effective than older, less expensive drugs and are more likely to cause some harmful side effects. The standards for treating the disorder should be changed to include some older medications that have fallen out of use, the study’s authors said.

The results, being published online by The American Journal of Psychiatry, are likely to alter treatment for an estimated one million children and teenagers with schizophrenia and to intensify a broader controversy in child psychiatry over the newer medications, experts said.

Prescription rates for the newer drugs, called atypical antipsychotics, have increased more than fivefold for children over the past decades and a half, and doctors now use them to settle outbursts and aggression in children with a wide variety of diagnoses, despite serious side effects.

A consortium of state Medicaid directors is currently evaluating the use of these drugs in children on state Medicaid rolls, to ensure they are being prescribed properly. 


The study compared two of the newer antipsychotics, Zyprexa from Eli Lilly and Risperdal from Janssen, with an older medication and found that all three relieved symptoms of schizophrenia, like auditory hallucinations, in many young patients. Yet half of the children in the study stopped taking their drug within two months, either because it had no effect or was causing serious side effects, like rapid weight gain. The children receiving Zyprexa gained so much weight that a government oversight panel monitoring safety ordered that they be taken off the drug.

The long-anticipated study, financed by the National Institute of Mental Health, is the most rigorous, head-to-head trial of the drugs in children and adolescents with this disorder.