The FDA held a public hearing on June 12 and 13, 2007, to obtain feedback on the FDA's Medication Guide program. Medication Guides contain the FDA-approved patient information for a drug and are handed out by pharmacists to help prevent adverse events.
Ellen Bleecker Liversidge appeared at this hearing as a board member of the Alliance for Human Research Protection to offer feedback for the Medication Guide on Zyprexa, an atypical antipsychotic marketed by Eli Lilly. She began her talk by explaining why the testimony that she had planned to give had to be changed at the last minute.
"I sat down and read over the material provided for this hearing and was all set to speak on content as well as delivery systems," she told the FDA panel. "However, I didn't get very far because, believe it or not, there was no Zyprexa MedGuide."
"Nor were there MedGuides for the other atypical antipsychotics," Ellen said, "all of which have two black box warnings."
"I went back to ask myself why there would be no FDA MedGuide in 2007 for Zyprexa, after all that has happened with this drug, and after all these years," she said, "And that's when I came up with the title of this testimony, 'Too Little, Too Late.'"
Ellen's son, Robert Liversidge III, died of profound hyperglycemia on October 5, 2002, as a result of taking Zyprexa. After finding that there was no MedGuide for Zyprexa, Ellen says she searched the FDA website to see what information was available to patients at that location and found that the black box warning about diabetes, hyperglycemia and death, that she and others had fought so hard to have added to the label 4 years ago, had been watered down. The warning was not listed in a black box, she told the panel, and it was not first on the list.
According to FDA briefing materials for the hearing, a MedGuide is required if a drug has even one of the following characteristics: (1) Patient labeling could help prevent serious adverse effects; (2) It has serious risks (relative to benefits) which patients should be made aware because the information could affect a patient's decisions to use, or continue to use, the drug; or (3) It is important to health and patient adherence to directions for use is crucial to the effectiveness of the drug.
Experts say Zyprexa qualifies for a MedGuide under all 3 categories: (1) The labeling would definitely help prevent serious adverse events; (2) Few patients would be willing to take the drug and risk developing diabetes given that numerous studies have shown Zyprexa to be no more effective than the older class of antipsychotics that do not cause diabetes; and (3) Most patients on Zyprexa would learn that the drug is not FDA approved to treat the condition they have.
In reading the list of adverse events on the FDA website, Ellen says, she found "high blood sugar and diabetes," mentioned in the number 4 position, even though the wording in the warning in late 2003, specifically included diabetes, hyperglycemia, and death.
"Why was this wording changed?" she asked the panel. "And whose decision was it?"
The current document on the FDA website, Ellen said, is basically useless. Although it did mention that people should get frequent blood glucose monitoring, "There was no indication of how often blood glucose monitoring should take place, nor was there mention of what symptoms of diabetes should be watched for," she noted.
There is no mention that the CATIE study found Zyprexa to have the most lethal side effects out of all the new atypical antipsychotics, Ellen pointed out, or that the American Diabetes Association clearly stated that the risk is the highest with Zyprexa.
There is also no mention, Ellen said, that the use of the drug for treating mania should be brief. When Lilly obtained FDA approval for the sale of Zyprexa in the US in September 1996, the only approved indication was for the treatment of adults with schizophrenia. In 2000, the drug was approved to treat the manic phase of bipolar disorder.
Ellen's son was diagnosed with bipolar disorder years before his death but had always done fine with lithium. However, in 2000, Rob had to apply for Medicaid to help pay his medical expenses and this was his downfall, she says.
During the 1990s, Lilly and the other makers of the new class of atypical antipsychotics, had been successful in corrupting the state Medicaid programs by influencing top officials in state agencies all over the country to write prescribing formularies for doctors that listed the new expensive drugs as the first line of treatment for all patients covered by Medicaid, and that is how Rob ever ended up on Zyprexa.
In 2006, Pennsylvania official Steven Fiorello, former Chief Pharmacist and Head of the state drug formulary committee, was indicted on felony and misdemeanor charges for his conflicts of interests with drug companies and was charged with other ethics violations for accepting "educational grant money" and failing to disclose the payments.
