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General News    H4'ed 3/3/10

Cold Case Files - Paxil Birth Defects

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"These are, therefore, only our opinions of the likely consequences of positive findings in such studies," they pointed out.

"What you want from this kind of study is that there is no harm to the fetus," Healy explained to the jury.

"A positive outcome means there has been a harm," he said. "So they're here trying to plan if things go wrong, how do we handle it."

Healy testified that, "regulatory implications elsewhere," refers to the fact that the market in Japan is extremely small and the market in the US is huge. "They really have to work out if it is a worthwhile risk being asked to do particular studies which might cause a problem which we would then have to report back to the FDA," he said.

"And the implications for the market here in the U.S. may mean that it's just not worth our while trying to go to Japan at all," Healy testified.

Indeed, throughout page one they discussed the "consequences" of positive findings in the plans for "such studies" if done for Japan. For instance, they stated at one point: "A change in the pregnancy category from B to C is a possibility."

"This may have commercial implications as the other SSRIs have a B categorization," they pointed out.

After reviewing the first page and explaining several statements to the jury, Healy was asked whether it appeared that anybody had considered the safety of Paxil. "It appears to me actually as a scientist that this is the opposite to what one would do," he said, "if the point of view from the scientific end of things is we want to find out what happens."

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Evelyn Pringle is an investigative journalist and researcher focused on exposing corruption in government and corporate America.
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