FDA, MIT To Jointly Develop System To Anticipate Safety Problems With Drugs

scotty · 08-18-2006, 01:00 PM

OK, so we have the FDA admitting that the current drug reported is inadequate, outdated and undereported... . So just where are they getting their "statistics" for decision makings on adverse effects???

http://www.kaisernetwork.org/daily_r...fm?DR_ID=39287
Daily Health Policy Report

Prescription Drugs | FDA, MIT To Jointly Develop System To Anticipate Safety Problems With Drugs, Devices
[Aug 18, 2006]
FDA and the Massachusetts Institute of Technology on Thursday announced plans to co-develop an automated system that will search existing federal and private health care databases to monitor potential problems with prescription drugs and medical devices, Long Island Newsday reports. The current review system involves the manual inspection of reports voluntarily submitted to FDA. According to Scott Gottlieb, FDA's deputy commissioner for scientific and medical affairs, reports often are submitted months or even years after adverse events have occurred, and as a result, problems often are underreported. Gottlieb says a more automated system that would scour multiple databases -- such as those compiled by health insurance providers and agencies including the Veterans Administration -- would be superior in detecting patterns that indicate potential risks. The system would model methods developed to identify infectious disease outbreaks, bioterrorism attacks and the spread of bird flu. FDA also plans to publish reports for doctors that would alert them of the detected problems related to specific drugs and devices, potentially prompting doctors to reciprocate by reporting problems they discover to the FDA, according to Newsday. The reports would be similar to the CDC's Morbidity and Mortality Weekly Report, which regularly alerts doctors to outbreaks of disease (Long Island Newsday, 8/17).

scotty · 08-19-2006, 08:04 PM

When we asked at the FDA hearing about these reports we were told "We don't use them, since they are "anecdotal" in nature" WTF????

08-18-2006, 01:00 PM	#1
scotty Administrator Join Date: Feb 2004 Location: new jersey Posts: 46,985	FDA, MIT To Jointly Develop System To Anticipate Safety Problems With Drugs OK, so we have the FDA admitting that the current drug reported is inadequate, outdated and undereported... . So just where are they getting their "statistics" for decision makings on adverse effects??? http://www.kaisernetwork.org/daily_r...fm?DR_ID=39287 Daily Health Policy Report Prescription Drugs \| FDA, MIT To Jointly Develop System To Anticipate Safety Problems With Drugs, Devices [Aug 18, 2006] FDA and the Massachusetts Institute of Technology on Thursday announced plans to co-develop an automated system that will search existing federal and private health care databases to monitor potential problems with prescription drugs and medical devices, Long Island Newsday reports. The current review system involves the manual inspection of reports voluntarily submitted to FDA. According to Scott Gottlieb, FDA's deputy commissioner for scientific and medical affairs, reports often are submitted months or even years after adverse events have occurred, and as a result, problems often are underreported. Gottlieb says a more automated system that would scour multiple databases -- such as those compiled by health insurance providers and agencies including the Veterans Administration -- would be superior in detecting patterns that indicate potential risks. The system would model methods developed to identify infectious disease outbreaks, bioterrorism attacks and the spread of bird flu. FDA also plans to publish reports for doctors that would alert them of the detected problems related to specific drugs and devices, potentially prompting doctors to reciprocate by reporting problems they discover to the FDA, according to Newsday. The reports would be similar to the CDC's Morbidity and Mortality Weekly Report, which regularly alerts doctors to outbreaks of disease (Long Island Newsday, 8/17). __________________ AKA Laurie "Faith is taking the first step even when you don't see the whole staircase." MLK

08-19-2006, 08:04 PM	#3
scotty Administrator Join Date: Feb 2004 Location: new jersey Posts: 46,985	Re: FDA, MIT To Jointly Develop System To Anticipate Safety Problems With Drugs When we asked at the FDA hearing about these reports we were told "We don't use them, since they are "anecdotal" in nature" WTF???? __________________ AKA Laurie "Faith is taking the first step even when you don't see the whole staircase." MLK

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