Marketing Risperdal: Part II

von freakoutcrazy

It would be tough to find a class of drugs prescribed for unapproved uses more frequently than antipsychotic drugs. The use of antipsychotics for unapproved conditions grew rapidly after Johnson & Johnson launched Risperdal in 1993. Johnson & Johnson invented the classification “atypical antipsychotic” to describe this new drug.

Soon after the launch of Risperdal, other pharmaceutical manufacturers, recognizing the huge off-label market potential, launched their own “atypical” antipsychotics. Ely Lilly came out with Zyprexa; AstraZeneca launched Seroquel; Glaxo came out with Geodon, and Bristol-Myers introduced Abilify, These drugs were all initially approved only to treat psychosis, but all were widely prescribed for conditions other than psychosis. Over time these new antipsychotics gained additional indications to treat conditions such manic episodes in Bipolar disorder, aggression, and, in the case of Abilify, depression.

In a previous post, Marketing Risperdal: Part I, I presented some of Johnson & Johnson’s data (gathered by IMS) showing the extensive off-label use of antipsychotics. The data in that post, and the data presented here, is from the period before atypical antipsychotics were approved for conditions other than psychosis.

As you can see from the graphic below, the antipsychotic market grew rapidly as the atypical antipsychotics came on the market. Total antipsychotic sales reached $6.7 Billion in 2002. Annual sales nearly doubled, to about $12 Billion,in 2006.

As a Johnson & Johnson employee who sold Risperdal for 3 1/2 years (1999-2003) and developed marketing programs for Risperdal for four years (2003-2007), I can tell you that the focus of Johnson & Johnson’s marketing strategy for Risperdal was to increase sales by promoting the drug for unapproved uses. J&J sales reps focused most of these off-label marketing efforts on promoting Risperdal for the treatment of anxiety, poor sleep (the so-called “soft symptoms” associated with schizophrenia), and to treat aggression in the elderly and aggression in children.

Big pharma has been very successful in marketing antipsychotics off-label. In 2002, 70% of all Antipsychotics were prescribed off-label.

In 2006, Risperdal (oral), was prescribed for conditions other than schizophrenia 81% of the time.

So who is paying for all of this off-label use of atypical antipsychotics? You are.

About 70% of Antipsychotic prescriptions are reimbursed by Medicaid or Medicare (By the way, it’s illegal to seek Medicaid or Medicare reimbursement for off-label use).

With the implementation of Medicare Part D in 2006, most antipsychotics previously covered my Medicaid, are now covered by Medicare.

Even when atypical antipsychotics are prescribed for the treatment of schizophrenia; they are not really achieving better outcomes for patients than the older, generic antipsychotics. But that fact has not stopped big pharma from marketing atypical antipsychotics as being safer and more efficacious than the much cheaper generic antipsychotics. The CATIE study, released in December 2005, refutes these claims of superiority.

CATIE was an 18-month, double-blind study, funded by the US National Institute of Mental Health (NIMH). It compared an older and much cheaper typical or first-generation antipsychotic, perphenazine (Trilafon), against several newer atypical or second-generation antipsychotic drugs – olanzapine (Zyprexa), quetiapine (Seroquel), risperidone (Risperdal) and ziprasidone (Geodon), among 1460 patients with established, but not refractory, schizophrenia.

CATIE was meant to reveal the truth as to how effective the different drugs were in the real world of everyday clinical practice. Effectiveness was judged by the length of time patients remained on treatment before discontinuing on account of a perceived lack of efficacy, intolerable side effects or for other reasons.

The CATIE results suggested the older cheaper antipsychotic perphenazine was, on balance, just as effective and tolerable as the rest.

For nearly two decades, Johnson & Johnson and other pharmaceutical manufacturers have been promoting atypical antipsychotics as safer, more effective alternatives to the older – much cheaper – conventional antipsychotics, when in fact, the atypical antipsychotics have not been shown to be safer of more effective than conventional antipsychotics.