Evelyn Pringle November 15, 2007
For the first four years Zyprexa was sold in the US, the promotion of the drug for any use other than adult schizophrenia was illegal. When the FDA approves a drug
Evelyn Pringle November 15, 2007
For the first four years Zyprexa was sold in the US, the promotion of the drug for any use other than adult schizophrenia was illegal. When the FDA approves a drug for a specific use, it can only be marketed for that use. Eli Lilly gained approval for schizophrenia in 1996 and the drug was not approved to treat bipolar disorder until 2000.
Zyprexa belongs to a class of drugs known as “atypical” antipsychotics, which arrived on the market in the US beginning in 1993. Other drugs in this class include Seroquel, sold by AstraZeneca, Risperdal marketed by Johnson & Johnson subsidiary Janssen, Geodon, sold by Pfizer, Abilify, from Bristol-Myers Squibb and Clozaril manufactured by Novartis.
Schizophrenia is considered the most severe of all mental illnesses and is said to occur in only about 1% of the population. The definition of the disorder in the Diagnostic and Statistical Manual of Mental Disorders, IV, reads as follows:
Schizophrenia is a disorder that lasts for at least 6 months and includes at least 1 month of active-phase symptoms (i.e. two [or more] of the following: delusions, hallucinations, disorganized speech, grossly disorganized or catatonic behavior, negative symptoms.)
Experts say it would be highly unlikely that a competent psychiatrist could misdiagnosis this condition because the symptoms are so extreme and distinct.
Once a drug is approved to treat one condition, it is legal for doctors to prescribe the drug for other uses. These unapproved uses are referred to as “off-label,” and can mean prescribing a drug for a longer duration than specified, at a different dose, in combination with other drugs, or with a different patient population than listed on the label.
The Food, Drug, and Cosmetic Act prohibits companies from promoting a drug for uses other than those approved and the Federal Anti-Kickback Statute prohibits companies from providing remuneration to induce or reward doctors for prescribing products for beneficiaries of Federally funded health care programs such as Medicare and Medicaid.
Accordingly, during the first four years that Zyprexa was sold in the US, Lilly sales representatives were not allowed to discuss any use other than adult schizophrenia and discussions of other uses were not allowed in any company funded event. Lilly itself noted at a July 20, 1995 presentation that the market for Zyprexa was limited the year before it was approved, estimating the total schizophrenia market to be only about $1 billion.
However, the drug was Lilly’s best selling product by 2000, with worldwide sales of $2.35 billion, according to Lilly’s 2001 Annual Report filed on January 28, 2002.
Zyprexa was approved for adults with bipolar disorder in 2000 and US sales rose 23% over 1999, to $1.69 billion in 2000. The next year, it became Lilly’s first product to have sales in excess of $3 billion worldwide, and US sales rose 29% to $2.18 billion, according to the Report.
Experts say there is no way that Zyprexa could have become Lilly’s most widely prescribed drug in the US without influencing doctors to prescribe the drug off-label. For instance, even though Zyprexa was approved to treat the manic phase of bipolar disorder only, which is typically brief, patients were kept on the drug for years.
According to Ellen Liversidge, her son was prescribed Zypexa for bipolar disorder and he remained on the drug for two years, during which time he gained about 100 pounds, until he went into a coma and died of profound hyperglycemia on October 5, 2002.
Ms Liversidge says she later learned that other countries had required Lilly to add warnings about the risk of drastic weight gain, hyperglycemia, and diabetes to the label of Zyprexa in the spring of 2002, months before her son died.
On February 12, 2006, due to increased antipsychotic use, the Florida Agency for Health Care Administration announced a plan to study their use by children in the Florida Medicaid program. The agency stated in a press release that close to 18,000 children took antipsychotics in 2005 and more than 475,000 prescriptions were written in the past 5 years.
On October 7, 2007 the AHCA released a report entitled, “The Use of Antipsychotic Medications with Children,” that said pediatric use of antipsychotics increased in the late 1990s and early 2000s after a decline in the 1980s and stable use in the early 1990s. The increases were largely attributed to the arrival of the atypicals, starting in 1993.
The report noted that both commercial and Medicaid populations experienced increased use and that one study documented a 75% increase in the commercially insured population of 0-17 years from 1997 to 2001, and another study of use in the commercial managed care population from 1996 to 2001 found a 127% increase among children aged 0 to18.
The study found that antipsychotic use in the Medicaid populations in the late 1990s was already 3-4 times higher than commercial populations but also grew in the 