He admitted that the two central allegations in the underlying lawsuits was that Zyprexa was marketed off-label and that when Lilly sought FDA approval of the drug that Lilly had information that showed that there were dangers in regard to the drug.
Near the end of the hearing, Attorney Milstein argued that the foundation for the injunction was that the Lilly documents were trade secrets and "yet in all of the papers they filed, all they do is say, without any kind of support, that they are trade secrets."
He objected to the blanket court order for 11 million documents. "You heard the testimony of the plaintiffs' attorney," he told the judge, "who said to his knowledge, that virtually every document produced by Lilly in this case is marked confidential."
In one of the latest development in this bizarre legal battle, Judge Weinstein has issued a court order with the word "Invitation" asking Mr Berenson to appear in court, apparently to guarantee him a front row seat at his own hanging, by giving testimony on whether he participated in what the judge called a "conspiracy" with Dr Egilman and Mr Gottstein to violate the order that sealed the secret documents to begin with.
On the other side of the coin, if the documents remain sealed, Mr Franks warns that users of the drug, doctors, and the public are still almost totally in the dark about the clinical trials and what he calls, "Zyprexa's shameful history."
He says Zyprexa was approved based on the results of a six-week clinical trial that involved 2,500 subjects, and two-thirds of them did not even successfully complete it. "Among those who stuck it out," he reports, "22 percent of the Zyprexa subjects suffered a "serious" adverse effect, compared to 18 percent in the group taking Haldol."
Besides severe weight gain, Mr Franks says, other adverse effects included shaking, spasms, sedation, diabetic complications, rapid heartbeat, restlessness, constipation, seizures, liver problems, white blood cell disorders, and decreased blood pressure.
There were a total of 20 deaths, including 12 suicides, in the Zyprexa group. Information documenting these deaths was obtained from FDA files using the Freedom of Information Act, by one of the currently muzzled journalists, Robert Whitaker, who wrote that one in every 145 subjects who entered the trials for Zyprexa, and the other atypicals, died in his best selling book, "Mad in America: Bad Science, Bad Medicine, and the Enduring Mistreatment of the Mentally Ill."
According to Mr Frank, Lilly has another perverse reason for pushing Zyprexa. "It's a cruel irony," he says, "that while the company is filling its coffers by selling a drug that can cause diabetes, four of its top-selling drugs are treatments for diabetes."
"Eli Lilly gets the customer coming and going," he states.
A big hurdle with the Zyprexa issue is Lilly's credibility over their continuous PR on how they are going to pay out $1.2 billion in damages.As long as they keep up this rhetoric and don't actually pay the issue won't go away.
Think about the need to 'put their money where their mouth is'.
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Daniel Haszard
by
Danny Haszard (2 articles, 0 quicklinks, 0 diaries, 52 comments)
on Monday, February 5, 2007 at 11:34:19 AM
1 comments
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