Baldwin's paper was published the same year the new drug application for Paxil was submitted to the FDA on November 10, 1989.
Incriminating Data Destroyed.
During the trial, the jury saw an exhibit showing minutes from a teleconference for a Paxil project team meeting, at which Anne Bell and others were present, on March 26, 1998. Page eight of the minutes stated: "It has already been discovered that raw data from four of the original Ferrosan sponsored toxicology studies conducted at Huntingdon Life Sciences were destroyed by HLS in 1993."
"The idea that I would destroy the data is almost inconceivable," Healy stated.
People may be concerned about a particular study and want to go back and look at the books, he said. "It's a bit like auditing a major company like Enron."
But it's "even more important actually in science," Healy told the jury. "People with a different point of view need to be able to say, look, show me the data."
They may "even suspect that I didn't do the study," he said, "so a defense for me is to be able to say here are the notebooks, here are the clinical records."
So you have to "be prepared to have all sorts of challenges," he told the jury. "But for that to happen, the notebooks, the clinical records, the lab notebooks must be there."
Healy testified that he did not believe the raw data from the original four Ferrosan studies had ever been located. "I believe there were efforts to try and find the microfilms, but they have not been found," he said.
Healy explained that when studies are done, there are a set of procedures called "good laboratory practice," or GLP.
"And it is hoped these days when a company brings a drug to the market," he said, "that the animal work that they do and the human work they do will conform to good laboratory practice and good clinical practice."
"And part of the requirements here of good laboratory practice is that the raw data is maintained," he told the jury.
Later in Healy's testimony, Tracey showed the jury that Study 295 itself, in regard to raw data, under "maintenance of records," stated "this material will be stored," and the "material will not be discarded or released from these laboratories without the sponsor's prior consent."
Initially, Paxil was FDA approved in 1992, with a Category B rating for pregnant women, meaning animal studies failed to demonstrate a risk to the fetus.
(Note: You can view every article as one long page if you sign up as an Advocate Member, or higher).
