Role of Litigation in Defining Drug Risks_JAMA / BMJ

Documents uncovered during the course of litigation shed light on real risks of drug-induced harm that would not otherwise be known.Below are excerpts from two timely articles that offer persuasive arguments backed by evidence demonstrating that litigation provides vital drug safety information that physicians and the public need to protect consumers from drug-induced hazards. Documents uncovered during the course of litigation shed light on real risks of drug-induced harm that would not otherwise be known.

The Role of Litigation in Defining Drug Risks by Drs. Aaron Kesselheim and Jerry Avorn is in the current issue of the Journal of the American Medical Association (JAMA). [1] What have we learnt from Vioxx? by Drs. Harlan Krumholz, David Egilman and colleagues appears in the current BMJ. [2] 

1. The authors of the JAMA article examined some 9 case examples finding that: “there are often important gaps in the ascertainment and reporting of adverse effects associated with prescription drugs” that the surveillance system simply does not address.
The case examples: Valdecoxib (Bextra); Olanzapine (Zyprexa); Paroxetine (Paxil); Cerivastatin (Baycol); Trogitazone (Rezulin): Rofecoxib (Vioxx); Defenfluramine (Redux); Cisapride (Propulsid).  Read More….

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The Secret Eli Lilly Zyprexa Documents–A Case For CivilDisobedience

FindLaw columnist, Julie Hilden, a First Amendment lawyer, brings a fresh
perspective to the controversy surrounding the sealed Zyprexa documents.
In general, she notes, “companies’ overprotecting drug-related information
predictably harms patients. It also has other bad effects: Research is
unnecessarily duplicated at different companies, in a waste of time and
effort, and cruel experiments on animals are duplicated, too.”

She challenges the rationale given by  Judge Jack Weinstein for sealing the
documents in the first place.
http://ahrp.blogspot.com/2007/02/zyprexa-documents-court-ruling.html
His contention that the seal “expedited” the discovery process leading to an
expeditious settlement, she argues, is not a sufficient reason to seal the
documents: “it was probably well worth spending the time to go through the
documents more specifically, for there was a strong public interest in what
they contained.”  Read More….