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The Long Line of Responsibility

Pharmas made headlines this weekend: The New York Times reports on charges that Eli Lilly has downplayed serious side effects of its schizophrenia drug Zyprexa. The article says that internal documents indicate company officials were aware of potential health risks -- including links to severe weight gain and increased blood sugar -- and deliberately withheld that information from physicians.

Meanwhile, the Wall Street Journal reports on the latest Vioxx-related trial, in which a jury decided in favor of Merck against a man claiming that the pain medication caused a heart attack. The pharma has to date won eight such trials and lost four; seven more are in progress or scheduled in upcoming months. Merck says it will fight each case, according to the WSJ article ($).

Years ago, some of the major pharmaceutical companies refused to get involved with microarray technology, citing fears that simply having so much data -- without having the time or tools to thoroughly analyze it -- could lay the foundation for lawsuits along these lines. Consider this: each time a new pathway, interaction, or function is discovered, are pharmas obligated to re-analyze their warehouses of data to see whether the new findings reveal any potential side effects or tox problems for drugs already on the market? Where does responsibility begin and end?

Clearly, pharmas have now embraced genomic and proteomic technologies in the interest of populating their pipelines. While the trials mentioned in the NYT and WSJ articles were not brought about by the particular problem pharmas envisioned when microarrays first appeared, they do serve as reminders that we may not fully understand the impact of the 'omics tools -- and that one day, it's quite possible that data from those tools could be at the root of lawsuits like these.

The Scan

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