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.
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 early 2000s. In Texas, prescription rates for kids rose 141% between 1996 and 2001 and in another program in the Midwest, usage grew 304% over the same time period, the report stated.
The authors said the analyses reveals that the drugs are used to treat a broad spectrum of disorders, and some of these disorders, such as attention deficit hyperactivity disorder and major depression, "clearly do not call for antipsychotic treatment."
The study found that in the 0 to 5 age group, 53.8% of the antipsychotics were prescribed for ADHD and in the age group 6 to 12, 48% were prescribed for ADHD.
The report noted that the use of antipsychotics with children under 6 is generally not recommended and "should be considered only in very rare circumstances."
A September 2007 study in the Archives of General Psychiatry, reported that the number of children in the US diagnosed with bipolar disorder had increased from about 20,000 in 1994 to roughly 800,000 in 2003.
One of the world's leading experts on psychopharmacology, UK psychiatrist and professor, Dr David Healy, author of, "The Latest Mania: Selling Bipolar Disorder," says bipolar disorder in children is all but unrecognized outside the US and it is unlikely that a significant proportion of these children would actually meet the DSM criteria for the disorder.
Former Federal fraud investigator, Allan Jones, says the atypical makers were able to turn the schizophrenia drugs into cash cows by influencing the doctors and state officials involved in the approval of formularies that specify the drugs that can be used by persons covered by public health care programs.
Lilly's off-label marketing of Zyprexa has come under scrutiny in the past several years, in large part, because lawmakers and law enforcement agencies became suspicious about the skyrocketing costs of a drug approved to treat such limited conditions being prescribed to so many patients in public health care programs.
According to Lilly's SEC report, Medicaid fraud lawsuits filed against Lilly thus far include the states of Alaska, Louisiana, Mississippi, Montana, New Mexico, Pennsylvania, South Carolina, Utah, and West Virginia. Arkansas is the latest state to file a lawsuit.
The Medicaid fraud allegations include that Lilly illegally marketed Zyprexa for off-label uses while concealing the serious health risks associated with the drug, and most specifically high blood sugar levels, extreme weight gain and diabetes.
The lawsuits seek to recover not only the money paid to purchase Zyprexa for patients on Medicaid but also for the medical care of persons injured by the drug. Mississippi alleges that about 10% of the Medicaid patients who took Zyprexa in that state have developed diabetes which will require life-long care.
In private litigation, since June 2005 Lilly has entered into settlements with approximately 30,200 claimants in the US for about $1.2 billion and there were still about 350 lawsuits covering about 540 claims pending in the US at the time of the August 2007 filing.
However, off-label prescribing has obviously not ceased because in 2006, Zyprexa sales were $4.3 billion and for the second quarter and first half of 2007, US sales of Zyprexa increased 4% and 5%, respectively, and international sales increased 14% during both periods, according to Lilly's SEC filing.
by Evelyn Pringle adapted with permission
