Paxil - Time Delay
The FDA first issued a safety advisory about Paxil in 2005, commenting on the potential relationship between the drug and birth defects when prescribed to pregnant mothers. The announcement came following the early results of a particular clinical study attempting to examine this very phenomenon.
It was early this year, nearly five years later, that Paxil's manufacturer finally settled out of court for an amount pushing into the billions of dollars on just such a number of cases, though the settlement was structured so that the company in no way accepted the claim that this medicine was specifically responsible for the defects.
As part of the announcement, Glaxo Smith Kline was asked to change the labeling on Paxil to indicate it had been moved from a category C pregnancy rating to a category D rating, reflecting the increased risk when taking the medicine during pregnancy. Yet again, in the recent settlement Paxil declined to take responsibility for the birth defects.
This half-decade of elapsed time, and the fact that Paxil is still on record denying the potential relationship between their medicine and the onset of birth defects, illustrates just how hard it is to resolve these kinds of cases.
They aren't as simple as a more direct criminal case, in which there is a specific event that happened with evidence lying about to be gathered. Even a retrospective study, wherein scientists simply look at existing data, takes a long time. For example, they would have to look at a number of women in a given population who gave birth. Then they'd need to see how many were or weren't on Paxil, then how many actually admitted to taking it consistently, and then how many had children born with birth defects — and even then they still have to compare and quantify the numbers.
Proper clinical trials, in which double blind studies are done specifically on women taking the medicine, are even more difficult to organize and take up a great deal of time.
So while it is not easy to look at the sheer scale of time involved in finding relief for these mothers and their children, it is perhaps easier to understand when considering the massive amount of effort required to get solid facts.
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