[e-drug] Data mining for ADRs?

["Wilbert Bannenberg" <wjb@wxs.nl>]

E-DRUG: Data mining for ADRs?
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[The FDA is hoping to find earlier signals of unexpected/unknown ADRs by datamining various databases. This might generate a lot of data, but whether proper information can come out we will have to see? Copied as fair use. Thanks to Andrew for spotting this. WB]

http://www.forbes.com/technology/feeds/ap/2006/08/17/ap2957882.html

Associated Press
FDA, MIT to Collaborate on Drug Safety
08.17.2006, 09:01 PM

The Food and Drug Administration and Massachusetts Institute of Technology
announced Thursday an agreement to develop an automated system to detect
unanticipated problems with prescription drugs and medical devices.

The system would scour federal and private health care databases in real
time for unusual and emerging patterns that could indicate potential safety
concerns.

The current system relies on the largely manual assessment of reports
voluntarily submitted to the FDA, sometimes months or years after an event
has occurred. As a result, potential problems typically are underreported,
said Dr. Scott Gottlieb, the FDA's deputy commissioner for scientific and
medical affairs.

A more automated system capable of mining on the fly multiple databases,
including those compiled by health insurance providers and agencies like the
Veterans Administration, would be better at recognizing patterns suggestive
of emerging problems, Gottlieb said.

The system would build on methods developed to identify infectious disease
outbreaks, detect bioterrorism attacks and model the spread of bird flu, he
said.

The FDA also plans to begin publishing reports for doctors that would alert
them to potential problems with drugs and devices, Gottlieb said. That could
prompt doctors to watch for similar problems and report them when found to
the FDA. The reports would resemble the Centers for Disease Control and
Prevention's Morbidity and Mortality Weekly Report, which regularly alerts
doctors to outbreaks of disease.

Lawmakers and others have stepped up their criticism of FDA safety
monitoring efforts in the wake of the pain killer Vioxx being pulled from
the market in 2004.

One problem is the FDA cannot require that drug makers conduct studies on
the safety of prescription medications already on the market, a recent
Government Accountability Office report concluded.

Gottlieb said he did not think the FDA needed additional authority to
improve its safety monitoring, according to a copy of a speech he gave
Thursday at MIT's Center for Biomedical Innovation.

Ione

Ione Auston, Librarian
National Information Center on Health Services Research & Health Care
Technology (NICHSR)
National Library of Medicine
8600 Rockville Pike
Mail Stop Code 3833
Bethesda, MD  20894
Phone: 301/435-2241
Fax: 301/402-3193
Email: auston@nlm.nih.gov
Web site:  http://www.nlm.nih.gov/nichsr/