Researchers Use Data Mining To Find Possible Rare Side Effects Of Prescription Drugs

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Prescription Drug Data Mining

The Wall Street Journal on Wednesday examined prescriptiondrug data mining, a process by which sophisticated software enableshealth officials to search through large databases looking for possibledrug dangers. Data mining software allows health authorities toidentify "rare side effects that didn't show up in clinical trials,"the Journal reports. However, "it can also raise falsealarms and force regulators to divert time and money from more pressingdangers," according to the Journal.

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The Journal profiled the experience of World Health OrganizationDrug Monitoring Center Director Ralph Edwards. Edwards and his team inthe mid-1990s developed software to mine drug data, and national drugagencies, including FDA,in 2002 allowed the center to publish and share data mining findingswithout permission. Edwards, who receives about 200,000 adverse-eventreports and identifies about 60 serious signals annually, last yeardiscovered a possible link between cholesterol-lowering statins andamyotrophic lateral sclerosis, or Lou Gehrig's disease.

However,the analysis based on data mining did not "prove anything," and Edwardswas "wary of creating a drug scare and mindful that statins have beenshown to reduce heart attacks significantly," the Journal reports. After "months of hesitation," Edwards published his findings in the journal Drug Safety and recommended that patients taking statins consult their physician if they experience any neuromuscular symptoms.

FDAalso studied the connection between statins and ALS but determined that"it didn't need to issue any caution" about the drug, the Journalreports. Robert Temple, medical director at the FDA division thatevaluates drugs, said, "People reach different judgments on when toshout and when not to shout. It's the hardest single thing -- the valueand danger to screaming early."

Edwards said his paper isintended to prompt more research of the possible connection, addingthat FDA's clinical trial data might not show the risk for ALS becauseit is so rare (Johnson, Wall Street Journal, 7/3).

Reprinted with permission from kaisernetwork.org. Youcan view the entire Kaiser DailyHealth Policy Report, search the archives, and sign up for email deliveryat kaisernetwork.org/email. The Kaiser Daily Health Policy Report is published for kaisernetwork.org, afree service of The Henry J. Kaiser Family Foundation.

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