The drug giant Eli Lilly is being targeted by medical activists in the US. They say it has had a history of gross irresponsibility and its corporate charter should be revoked.
On January 15, 2009, Lilly pleaded guilty to charges that it had illegally marketed its blockbuster drug Zyprexa for unapproved uses to children and the elderly, two populations especially vulnerable to its dangerous side effect. Lilly plead guilty to a misdemeanor charge and agreed to pay $1.42 billion, which included $615 million to end the criminal investigation and approximately $800 million to settle the civil case.
One of the eight whistle-blowers in this case, former Lilly sales representative Robert Rudolph, says the settlement will not completely change Lilly's business practices, and he wants jail time for executives. "You have to remember, with Zyprexa," said Rudolph, "people lost their lives."
Rudolph is not exaggerating, points out Bruce E. Levine, a clinical psychologist, writing on the Alternet.
Zyprexa, marketed as an "atypical" antipsychotic drug, has been promoted as having less dangerous adverse effects than "typical" antipsychotic drugs such as Thorazine and Haldol. The atypical antipsychotic agents, sometimes called the "novel" antipsychotic agents are a group of drugs which are different chemically from the older drugs used to treat psychosis.
However, on February 25, 2009, the Journal of the American Medical Association
reported that the rate of sudden cardiac death in patients taking either typical or atypical antipsychotic drugs is double the death rate of a control group of patients not taking these drugs.
Zyprexa, though not nearly as well known as Lilly's previous blockbuster Prozac -- is today one of the biggest-selling drugs in the world. Zyprexa has grossed more than $39 billion since its approval in 1996, with $4.8 billion of that in 2007 (and it was projected to equal or surpass that gross in 2008 when earnings are reported).
Zyprexa is approved by the Food and Drug and Administration (FDA) for schizophrenia and bipolar disorder, but Lilly illegally marketed it for sleep difficulties, aggression, and other unapproved uses. Lilly sales reps aggressively pushed Zyprexa as a wonderful drug to chill out disruptive children and the elderly who were not
schizophrenic or bipolar.
The lawsuit against Lilly stated, "In truth, this was Lilly's thinly veiled marketing of Zyprexa as an effective chemical restraint for demanding, vulnerable and needy patients."
Doctors can prescribe drugs for unapproved uses (called "off-label prescribing"), but drug companies are not allowed to market drugs for unapproved uses. Many drug companies break this rule. "
The company made hundreds of millions of dollars by trying to convince health care providers that Zyprexa was safe for unapproved uses," said Laurie Magid, acting U.S. Attorney for the Eastern District of Pennsylvania where the case was prosecuted. Magid said that Lilly was responsible for "putting thousands and thousands of patients at risk."
One marketing effort consisted of the Lilly sales force urging geriatricians to use Zyprexa to sedate unruly nursing home and assisted-living facilities patients. Lilly sales reps distributed a study claiming that elderly patients taking Zyprexa required fewer skilled nursing staff hours than were necessary for patients taking competing medications. Magid stated that Lilly sales reps were "trained to use the slogan five at five
, meaning five milligrams at 5 o'clock at night will keep these elderly patients quiet." Illegally marketing Zyprexa for elderly patients was especially troubling for prosecutors because Zyprexa increases the risks of heart failure and life-threatening infections such as pneumonia in older patients.
In addition to targeting the misbehaving elderly, Lilly also targeted annoying kids. The company also pressed doctors to treat disruptive children with Zyprexa, court documents show, even though the medicine's tendency to cause severe weight gain and metabolic disorders is particularly pronounced in children ... The children receiving Zyprexa gained so much weight during the study that a safety monitoring panel ordered that they be taken off the drug.
Still earlier Alaska had sued to recoup medical bills it said were generated by patients in Medicaid, a government health services program, who developed diabetes while taking Zyprexa. But on Wednesday it agreed to settle for $15 million.
The impact of the Alaska settlement on Lilly's other legal problems over Zyprexa is not yet clear. Nine other states have sued Lilly with claims similar to those made by Alaska. Another 33 have not yet sued but are investigating the company in a joint action and seeking a single settlement of their claims.
At the same time, federal prosecutors in Pennsylvania are investigating Lilly's marketing of Zyprexa and whether the company hid Zyprexa's dangers from doctors and the Food and Drug Administration.
If the company does seek a broad settlement to resolve all the state and federal investigations at once, the $15 million payment to Alaska, considered per patient, could represent a benchmark for broader talks, International Herald Tribune reported.
Hopefully the January settlement will act as a warning to other drug makers that it ultimately doesn't pay to market off-label uses for one's drug, as eventually it will catch up with you.
Activists are clamouring for a radical action against the firm, but one has to wait and see whether such calls gather momentum.