healthy4u: drug surveillance

Presidential candidate Newt Gingrich, who I recall hearing in person as an an invited speaker at a health IT meeting some years ago (AMIA, I believe), has been pushing health IT rather uncritically in recent years. However, he seems to have backed off that position at the election cycle heats up: <blockquote><a style="font-weight: bold;" href="http://www.ihealthbeat.org/articles/2011/12/16/as-campaign-ramps-up-gingrich-plays-down-support-for-health-it.aspx">As Campaign Ramps Up, Gingrich Plays Down Support for Health IT</a> iHealthbeat.org Friday, December 16, 2011 Now that he is a frontrunner in the race for the Republican presidential nomination, former House Speaker Newt Gingrich (R-Ga.) is downplaying his previous support for health IT adoption, The Hill's "<a href="http://thehill.com/blogs/healthwatch/politics-elections/199643-gingrich-moves-away-from-electronic-health-records" target="_blank">Healthwatch</a>" reports (Pecquet, "Healthwatch," The Hill, 12/15). History of Supporting Health ITDuring the George W. Bush administration, Gingrich worked with former CMS administrator Mark McClellan and former National Coordinator for Health IT David Brailer on federal efforts to promote health IT, according to the <a href="http://www.nytimes.com/2011/12/16/us/politics/gingrichs-health-care-policy-history-at-odds-with-gop.html?pagewanted=2" target="_blank">New York Times</a> (Rutenberg/McIntire, New York Times, 12/16). Gingrich also worked with former Senate Majority Leader Tom Daschle (D-S.D.) to co-author the forward of a book titled, "Paper Kills 2.0," which gives examples of how federal funds for health IT could be used in pilot projects to improve health care (Rowland, <a href="http://bostonglobe.com/news/politics/2011/12/16/clients-gingrich-firm-benefited-from-his-support-stimulus-funds/Egk68IClYJMtuVYWr1Iz9K/story.html" target="_blank">Boston Globe</a>, 12/16). Shortly before the passage of the 2009 federal economic stimulus package, Gingrich criticized the legislation as a "big politician, big bureaucracy, pork-laden bill." However, at the same time, Gingrich praised a provision of the stimulus package that allocated $19 billion to promote the use of health IT. He said, "I am delighted that President Obama has picked this as a key part of the stimulus package."</blockquote><div style="BORDER-BOTTOM: medium none; TEXT-ALIGN: left; BORDER-LEFT: medium none; BACKGROUND-COLOR: #ffffff; COLOR: #000000; OVERFLOW: hidden; BORDER-TOP: medium none; BORDER-RIGHT: medium none; TEXT-DECORATION: none"><div style="BORDER-BOTTOM: medium none; TEXT-ALIGN: left; BORDER-LEFT: medium none; BACKGROUND-COLOR: #ffffff; COLOR: #000000; OVERFLOW: hidden; BORDER-TOP: medium none; BORDER-RIGHT: medium none; TEXT-DECORATION: none"><div style="BORDER-BOTTOM: medium none; TEXT-ALIGN: left; BORDER-LEFT: medium none; BACKGROUND-COLOR: #ffffff; COLOR: #000000; OVERFLOW: hidden; BORDER-TOP: medium none; BORDER-RIGHT: medium none; TEXT-DECORATION: none">His views have apparently changed somewhat: <blockquote>... Campaign Plays Down Health IT Support On Wednesday, Gingrich unveiled a new brain science initiative that does not include any mention of EHRs, even though the technology was a major component of the brain science proposals he discussed over the summer.</blockquote> Politics aside (it is probably not too far from the truth to say that all politicians hold out their fingers to see what direction the wind is blowing, although Mr. Gingrich is probably becoming more aware of HIT downsides thanks to lobbying of both sides of the aisle by people such as myself and like-minded experts [1]), I cannot disagree with this: <blockquote>In August, Gingrich said he aimed to bolster brain science research in part by modernizing FDA through the use of EHRs. Gingrich said EHRs would allow for "much faster [FDA] approval times because you can monitor in real time everyone who uses the drug. And if you start getting inappropriate responses, you can change within weeks" ("Healthwatch," The Hill, 12/15).</blockquote> In fact, I was championing exactly this idea ca. 2001 when I was employed at Merck Research Labs in the Research Information Systems division. Unfortunately, the answer from more senior personnel was that doing so would be "impossible" due to inability to blind, to control the data quality, etc., responses I considered unreasonable at the time but did not argue with to avoid getting on the Short List early in my employment there. I also tried to present the idea to Merck as a former employee in Nov. 2006, at an invited presentation to the Clinical Risk Management & Safety Surveillance department of MRL entitled “<a style="font-weight: bold;" href="http://www.ischool.drexel.edu/faculty/ssilverstein/silverstein_merck_informatics_nov2006.ppt">Medical Informatics Perspectives on Leveraging the EMR in Pharma</a>" (PPT). Also see my 2007 paper "<a style="font-weight: bold;" href="http://www.ischool.drexel.edu/faculty/ssilverstein/Silverstein_Drug_Surveillance.pdf">A Medical Informatics Grand Challenge: the EMR and Post-Marketing Drug Surveillance</a>" where I address a number of issues related to using EHR's in this fashion (PDF). Using EHR's (e.g., with special screens and training) for well-defined Phase IV post-marketing surveillance studies would be one of the best uses for the technology [2]. Finally, I note that we need post-marketing surveillance of EHR's, CPOE's and other clinical IT systems themselves, not just drugs. Information technology cannot improve healthcare until it itself is improved significantly regarding its current deficiencies (see "reading list" <a href="http://www.ischool.drexel.edu/faculty/ssilverstein/cases/?loc=cases&sloc=readinglist">here</a> for illustrations). -- SS Notes: [1] Health IT risks are a non-partisan issue. [2] I should note that while I believe EHR's could facilitate postmarketing surveillance of drugs and devices, I take a dim view of more grandiose proposed uses of EMR's such as for comparative effectiveness research (CER). See my essay in the Journal of the American Association of Physicians and Surgeons (AAPS) entitled "The Syndrome of Inappropriate Overconfidence in Computing: An Invasion of Medicine by the Information Technology Industry?" <a href="http://www.jpands.org/vol14no2/silverstein.pdf">here</a> (PDF). </div></div> </div>

As U.S. Presidential Campaign Ramps Up, Newt Gingrich Plays Down Support for Health IT

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