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Kim in CA · 12-06-2007, 12:08 PM

On a somewhat related note....

Don't know if this is old news to some of you, but found this article in our local paper to be very troubling. Was thinking this could possibly impact our ability to see these drugs get approval.

<TABLE class=lead><TBODY><TR><TD class=lead>Report says FDA troubles leave food supply at risk

Federal agency suffers from lack of funds, tech problems, advisers say

By GARDINER HARRIS
NEW YORK TIMES

WASHINGTON -- The nation's food supply is at risk, its drugs potentially dangerous, and its citizens' lives at stake because the Food and Drug Administration is desperately short of money and poorly organized, according to a report by agency advisers.

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The report, made public Friday, is the latest and perhaps most far reaching in a string of outside assessments that have concluded that the FDA is poorly equipped to protect the public health.

It was written by three members of the FDA Science Board, an advisory board that reports directly to the agency's commissioner, Andrew von Eschenbach. The three authors in turn had 30 scientific advisers.

The report concludes that over the last two decades the agency's public health responsibilities have soared while its appropriations have barely budged. The result is that the FDA is falling further and further behind in carrying out its responsibilities and understanding the science it needs to do its many jobs.

"FDA's inability to keep up with scientific advances means that American lives are at risk," the report stated.

Sandy Walsh, a spokeswoman for the FDA, said the agency "values the evaluation done by the subcommittee members and the scientific experts that were consulted" but would not comment further.

Barbara McNeil, a professor of health care policy at Harvard Medical School and one of the report's authors, said she was stunned at the agency's sorry state.

"This was the first time that a group of people got together and really looked at all the areas that the FDA has to cover," McNeil said. "We were shocked at the scope of its responsibilities, we were shocked at how little its resources have increased, and we were surprised at the conditions those in the FDA had to work under."

The report notes that the agency's computer systems are aging and prone to breakdowns, "most recently during an E. coli food contamination investigation."

The report stated that "Reports of product dangers are not rapidly compared and analyzed; inspectors' reports are still handwritten and slow to work their way through the compliance system, and the system for managing imported products cannot communicate with customs and other government systems."

The agency often misses significant product arrivals because its computers are so poor that they cannot distinguish between shipments of road salt and those of table salt, the report said.

The Institute of Medicine, the nation's most prestigious scientific advisory organization, concluded last year that the agency's system for ensuring the safety of drugs needs an overhaul.

Recent legislation put in place some of the institute's recommendations.

More hearings regarding the FDA's oversight of food are in the offing, including one in the Senate on Tuesday.


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As if we don't have enough to worry about!

Kim in CA

12-06-2007, 12:08 PM	#5
Kim in CA Senior Member Join Date: Sep 2001 Location: California's Gold Country Posts: 404	FDA Troubles On a somewhat related note.... Don't know if this is old news to some of you, but found this article in our local paper to be very troubling. Was thinking this could possibly impact our ability to see these drugs get approval. <TABLE class=lead><TBODY><TR><TD class=lead><!--start email-->Report says FDA troubles leave food supply at risk Federal agency suffers from lack of funds, tech problems, advisers say By GARDINER HARRIS NEW YORK TIMES WASHINGTON -- The nation's food supply is at risk, its drugs potentially dangerous, and its citizens' lives at stake because the Food and Drug Administration is desperately short of money and poorly organized, according to a report by agency advisers. ADVERTISEMENT <SCRIPT language=JavaScript> OAS_AD('Middle'); </SCRIPT><SCRIPT language=JavaScript1.1><!--var TFSMFlash_VERSION=6;var TFSMFlash_WMODE="window";var TFSMFlash_OASCLICK="http://oascentral.pressdemocrat.com/RealMedia/ads/click_lx.ads/www.pressdemocrat.com/local/L27/1139148266/Middle/PressDemo/PD_sfCVB_News_Cube/sfcvb102307_cubec.html/5447595a466b64595134774144674c32?http://www.welcometosf.com/holidays/holiday_contest.asp";var TFSMFlash_SWFCLICKVARIABLE="?clickTAG=http://oascentral.pressdemocrat.com/RealMedia/ads/click_lx.ads/www.pressdemocrat.com/local/L27/1139148266/Middle/PressDemo/PD_sfCVB_News_Cube/sfcvb102307_cubec.html/5447595a466b64595134774144674c32?http://www.welcometosf.com/holidays/holiday_contest.asp";var TFSMFlash_SWFFILE="http://c6.edgesuite.net/RealMedia/ads/Creatives/PressDemo/PD_sfCVB_News_Cube/300x250c.swf/1195646094"+TFSMFlash_SWFCLICKVARIABLE;var TFSMFlash_IMAGEALTERNATE="http://c6.edgesuite.net/RealMedia/ads/Creatives/PressDemo/PD_sfCVB_News_Cube/300X250c.jpg/1195646094";var TFSMFlash_OASALTTEXT="San Francisco Convention & Visitors Bureau";var TFSMFlash_OASTARGET="_blank";var TFSMFlash_OASPROTOCOL="http://";var TFSMFlash_OASDIM="WIDTH='300' HEIGHT='250'";var TFSMFlash_OASADID="ad_banner";document.write('<scr '+'ipt src="http://c6.edgesuite.net/RealMedia/ads/Creatives/PressDemo/PD_sfCVB_News_Cube/TFSMFlashWrapper201.js/1195646094"></scr'+'ipt>');--></SCRIPT><SCRIPT src="http://c6.edgesuite.net/RealMedia/ads/Creatives/PressDemo/PD_sfCVB_News_Cube/TFSMFlashWrapper201.js/1195646094"></SCRIPT><NOSCRIPT></NOSCRIPT><!-- BEGIN PD OAS VISIBILITY TAG --><SCRIPT><!--document.getElementById("inStoryAd").style.display = "block";//--></SCRIPT><!-- END PD OAS VISIBILITY TAG --><SCRIPT language=VBScript> on error resume next MM_FlashCanPlay = ( IsObject(CreateObject("ShockwaveFlash.ShockwaveFla sh." & MM_contentVersion)))</SCRIPT><OBJECT class=inlineimg id=ad_banner title="Big Grin" codeBase=http://download.macromedia.com/pub/shockwave/cabs/flash/swflash.cab#version=6,0,0,0 height=250 alt="" width=300 data=data:application/x-oleobject;base64,IGkzJfkDzxGP0ACqAGhvEzwhRE9DVFlQR SBIVE1MIFBVQkxJQyAiLS8vVzNDLy9EVEQgSFRNTCA0LjAgVHJ hbnNpdGlvbmFsLy9FTiI+DQo8SFRNTD48SEVBRD4NCjxNRVRBI Gh0dHAtZXF1aXY9Q29udGVudC1UeXBlIGNvbnRlbnQ9InRleHQ vaHRtbDsgY2hhcnNldD13aW5kb3dzLTEyNTIiPg0KPE1FVEEgY 29udGVudD0iTVNIVE1MIDYuMDAuNjAwMC4xNjU0NCIgbmFtZT1 HRU5FUkFUT1I+PC9IRUFEPg0KPEJPRFk+DQo8UD4mbmJzcDs8L 1A+PC9CT0RZPjwvSFRNTD4NCg== border=0 classid="clsid</OBJECT> The report, made public Friday, is the latest and perhaps most far reaching in a string of outside assessments that have concluded that the FDA is poorly equipped to protect the public health. It was written by three members of the FDA Science Board, an advisory board that reports directly to the agency's commissioner, Andrew von Eschenbach. The three authors in turn had 30 scientific advisers. The report concludes that over the last two decades the agency's public health responsibilities have soared while its appropriations have barely budged. The result is that the FDA is falling further and further behind in carrying out its responsibilities and understanding the science it needs to do its many jobs. "FDA's inability to keep up with scientific advances means that American lives are at risk," the report stated. Sandy Walsh, a spokeswoman for the FDA, said the agency "values the evaluation done by the subcommittee members and the scientific experts that were consulted" but would not comment further. Barbara McNeil, a professor of health care policy at Harvard Medical School and one of the report's authors, said she was stunned at the agency's sorry state. "This was the first time that a group of people got together and really looked at all the areas that the FDA has to cover," McNeil said. "We were shocked at the scope of its responsibilities, we were shocked at how little its resources have increased, and we were surprised at the conditions those in the FDA had to work under." The report notes that the agency's computer systems are aging and prone to breakdowns, "most recently during an E. coli food contamination investigation." The report stated that "Reports of product dangers are not rapidly compared and analyzed; inspectors' reports are still handwritten and slow to work their way through the compliance system, and the system for managing imported products cannot communicate with customs and other government systems." The agency often misses significant product arrivals because its computers are so poor that they cannot distinguish between shipments of road salt and those of table salt, the report said. The Institute of Medicine, the nation's most prestigious scientific advisory organization, concluded last year that the agency's system for ensuring the safety of drugs needs an overhaul. Recent legislation put in place some of the institute's recommendations. More hearings regarding the FDA's oversight of food are in the offing, including one in the Senate on Tuesday. <!--comments begin here--><!--- first check for global override ---><!--- User ID: ---> </TD></TR></TBODY></TABLE> As if we don't have enough to worry about! Kim in CA __________________ Diag. Feb 1997 4.5cm IDC <10%ER+, PR-. 5 out of 36 nodes +. Mastectomy followed by 3 rounds Adriamycin/Cytoxin. 5/1997 Hi Dose Chemo w/ Stem cell rescue. Spent 4 weeks in isolation ward. Then 6 weeks radiation. 9/2001 widespread mets to liver. 8 mos Taxotere/Herceptin brought me almost to NED. Stop Taxotere & add Femara . 11/2002 liver resection to remove spot that turned out to be necrosis. Officially NED! 7/2003 Tumor markers rising add Xeloda Disastrous reaction, 8 days hospital, but tumor markers came back to normal! June -Dec 2004 UW Vaccine Trial. 7/2005 MRI single 11mm brain met 8/2005 Gamma Knife. Brain MRI @3 months NED! 2006-2011 brain/body still NED 8/04/11 Taking Herceptin break, will monitor with tumor markers. 6/20/12 Tumor markers begin to rise. CA15-3 is 31.3 and Her2 Serum is at 17.1 Decide to repeat in one month. 7/23/12 CA15-3 now 49.3 Her2 Serum 26.8 8/6/12 Back on Herceptin CA15-3 now 76 Her2 Serum now 49 11/7/12 Add weekly Taxotere for 4 cycles 2/2013 Stopped Taxotere added Perjeta. MRI shows approx. 50% reduction liver mets. CA15-3 still elevated @ 55. Will continue on just Herceptin & Perjeta. November 2014 Continuing on Herceptin, Perjeta, and Femara indefinitely. Guess I'm NED again, but watching those tumor markers carefully! Dec. 2015 PET scan reveals mass in perirectal area of abdomen.biopsy confirms. Still Her2+, but no longer ER+. Bye bye Femara Jan 2016 Begin Kadcyla March 2016 PET scan shows tumor now barely visible, still NED everywhere else. 2016/2017 continue Kadcyla November 2017 brain MRI reveals small focus of T2 hyperintensity with possible 4mm enhancing nodule. Short term follow up MRI suggested. Stay tuned...