On February 23, 2007, a new grass roots advocacy group issued a press release to rally support for attorney, Jim Gottstein, in his legal battle with Eli Lilly over his role in providing secret company documents obtained in litigation to the media to alert the public about the health risks associated with Zyprexa that were kept hidden since the mid-90s.
In turning the document over to the press, Mr Gottstein's goal was also to alert the public about Lilly's illegal off-label marketing schemes aimed at getting doctors to prescribe Zyprexa, a drug FDA approved only for adult patients with schizophrenia or bipolar disorder, to patients of all ages for uses that were not approved as safe and effective.
Although a doctor may prescribe a drug for an unapproved use, it is illegal for Lilly to promote Zyprexa for an off-label use. The illegal marketing in this case includes influencing doctors to prescribe the drug to millions of consumers for conditions not listed on the label, prescribing Zyprexa in combination with other drugs or for a longer duration than recommended, and prescribing a drug for children that was only approved for adults.
Activists say most consumers are not even aware that it is legal for a doctor to prescribe a drug for an off-label use and take for granted that a prescribed drug picked up at a pharmacy is approved to treat their condition and their children.
The recent overdose death of 4-year-old, Rebecca Riley, in Massachusetts, demonstrates the dire need to educate the public about the practice of prescribing drugs for unapproved uses and the dangers of prescribing drugs like Zyprexa to children.
At 2-and-a-half-years-old, Rebecca was diagnosed with attention deficit disorder and bipolar disorder and was prescribed Zyprexa's atypical cousin, Seroquel, along with Clonidine, an adult high blood pressure drug, and Depakote, a drug approved to treat adults with epilepsy. None of these drugs were approved for children and they were prescribed in a combination that has never been tested even with adults.
From age 2 on, Rebecca remained on this daily drug off-label concoction until she was found dead on the floor in her parent's home on December 13, 2006. The autopsy report stated that she died of the "combined effects" of the drugs and that her lungs and heart were damaged by "prolonged abuse of these prescription drugs, rather than one incident."
Experts say, this case reinforces the assertion that judges have got to quit allowing drug makers to seal documents with court orders that show the side effects of drugs and the illegal conduct of promoting the sale of drugs for unapproved uses.
With the Zyprexa documents, as soon as the New York Times began running articles about Lilly's off-label marketing scheme and the side effects of Zyprexa, Lilly went to court and got the judge in the underlying litigation to issue a permanent injunction against Mr Gottstein, and other persons who obtained the documents from Mr Gottstein, ordering them to return the documents to the court.
However, after a couple months of legal wrangling, the court recognized that it could not restrain the world because the documents were all over the internet and lifted the part of the injunction that enjoined certain web sites from revealing the documents.
One of the documents that Lilly fought to keep secret, is a November 12, 1999, letter from a psychiatrist at the Ventura County Behavioral Health Department, Dr Albert Marrero, to Lilly's medical director, and describes the blood sugar problems occurring specifically with Zyprexa patients stating: "We have had eight patients out of possibly thirty-five patients on Zyprexa show up with high blood sugars."
Dr Marrero further informed Lilly that, "Two patients had to be hospitalized due to out of control diabetes....We have certainly never seen this with Haldol, Navane, Risperdal and others to this extent."
And yet, despite this clearly stated notification of these serious adverse events in 1999, Lilly did not revise the labeling on Zyprexa to include a warning about high blood sugar and diabetes until the fall of 2003, and then it was only because the FDA said do it.
With the health risks of Zyprexa concealed for all that time, doctors were led to believe Lilly sales representatives who said they could safely prescribe Zyprexa and Lilly gained millions of new customers.
With this in mind, the new advocacy group has launched, "The Just Say "Know" to Prescription Drugs Campaign," with a goal of getting one million people to stop and reevaluate the medications they are taking. It is also supporting Mr Gottstein in his battle with Eli Lilly over the release of the Zyprexa documents.
"If there is a case that dramatically highlights the need to stop blindly taking prescriptions drugs, this is it," says Dr Greg Tefft, co-founder of the Just Say "Know" Campaign. "We're talking 20 million people potentially at risk and more being added daily," he says.
