FDA Investigating Two Canadians for Distributing Fake Avastin
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Since 2011, she's been writing and editing stories for the site. Before taking up blogging, she toiled for many years (more than we can count) producing health stories for television, including\u003cem> Dateline NBC\u003c/em> and San Francisco's CBS affiliate, KPIX-TV. She also wrote up a \u003ca title=\"http://www.kqed.org/news/health/obamacare/obamacare-guide.jsp\" href=\"http://www.kqed.org/news/health/obamacare/obamacare-guide.jsp\">handy guide to the Affordable Care Act\u003c/a>, especially for Californians. Her work has been honored for many awards. Most recently she was a finalist for \"Best Topical Reporting\" from the Online News Association. You can follow her on Twitter: \u003ca title=\"https://twitter.com/laliferis\" href=\"https://twitter.com/laliferis\">@laliferis\u003c/a>","avatar":"https://secure.gravatar.com/avatar/86c339d5cdcb0dcd2b6cf5d7c3f5886b?s=600&d=blank&r=g","twitter":"laliferis","facebook":null,"instagram":null,"linkedin":null,"sites":[{"site":"news","roles":["subscriber"]},{"site":"futureofyou","roles":["subscriber"]},{"site":"stateofhealth","roles":["subscriber"]},{"site":"science","roles":["subscriber"]},{"site":"food","roles":["contributor"]}],"headData":{"title":"Lisa Aliferis | 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Genentech)\u003c/figcaption>\u003c/figure>\n\u003cp>\u003cstrong>By Kamal Menghrajani\u003c/strong>\u003c/p>\n\u003cp>Last month the Food and Drug Administration warned 19 doctors and clinics that counterfeit vials of the chemotherapy drug \u003ca title=\"http://www.avastin.com/patient/index.html\" href=\"http://www.avastin.com/patient/index.html\" target=\"_blank\">Avastin\u003c/a> had been identified in the U.S. \u003ca title=\"http://ww2.kqed.org/stateofhealth/2012/02/16/fda-warns-california-clinics-of-fake-avastin/\" href=\"http://ww2.kqed.org/stateofhealth/2012/02/16/fda-warns-california-clinics-of-fake-avastin/\" target=\"_blank\">Most of those doctors were in California\u003c/a>. Today the \u003ca title=\"http://online.wsj.com/article/SB10001424052970203370604577261343974214110.html\" href=\"http://online.wsj.com/article/SB10001424052970203370604577261343974214110.html\" target=\"_blank\">Wall Street Journal reports\u003c/a> that the FDA is investigating two businessmen from Canada who may be the source of these vials. One of them had admitted to shipping fake Avastin last year, although he says he did not know the vials contained counterfeit drugs. While it is generally illegal for anyone but the manufacturer to import prescription drugs into the U.S., it happens frequently and has proven difficult to police, the Journal reports.\u003c/p>\n\u003cblockquote>\u003cp>\"We're deeply horrified by this counterfeit [product] being sold by one of my companies,\" said Thomas Haughton, a Canadian citizen who runs a network of drug distributors that sell to U.S. doctors. At the same time he said that his business operated legally. \"We're doing everything we can to be sure that this never happens again.”\u003c/p>\n\u003cp>While experts say most U.S. drugs are safe, the probe may raise new concerns about the weakly regulated gray market in foreign drugs aimed at U.S. patients. The importation of foreign drugs by third parties, which takes advantage of the large price differential between the U.S. market and others abroad, is believed to represent a small but growing portion of the $300 billion U.S. prescription pharmaceutical business.\u003c/p>\u003c/blockquote>\n\u003cp>\u003c!--more-->Haughton’s brother-in-law, Kris Thorkelson, is the second man under investigation. Both Haughton and Thorkelson sell low-cost medicines to doctors or directly to patients in the U.S. According to the \u003cem>Journal\u003c/em> their Canada-based businesses are thought to be the end of a supply chain of counterfeit Avastin that may have started in China and made its way through Turkey, Egypt, Sweden, and Denmark before going through Canada to get to Tennessee. Tennessee-based Volunteer Distribution was then suspected of funneling those vials out to various clinics throughout the country, most of which were in Southern California. Again, from the \u003cem>Journal\u003c/em>:\u003c/p>\n\u003cblockquote>\u003cp>In the last several days, the U.S. Attorney in Los Angeles has subpoenaed California physicians for documents about their dealings with and products purchased from Messrs. Haughton and Thorkelson, three people who have worked for them and 12 companies that are affiliated with one or the other man, according to a copy of a subpoena reviewed by The Wall Street Journal.\u003c/p>\n\u003cp>At least some of the doctors who received a subpoena were warned last month by the FDA that they may have purchased fake Avastin from three companies named in the subpoena and linked to Mr. Haughton. The FDA, which is leading the investigation, declined to comment on the subpoenas or the ongoing investigation.\u003c/p>\n\u003cp>The fake Avastin contained starch, salt, cleaning solvents and other chemicals and none of the drug's active ingredient, bevacizumab, according to Roche. The packaging didn't match U.S.-approved labels for the product, regulators said. As of Monday, the FDA hadn't received any reports of the fake Avastin being administered to patients.\u003c/p>\u003c/blockquote>\n\u003cp>The FDA is pursuing a criminal investigation against the Canadian drug sellers for shipping non-FDA approved drugs into the U.S.\u003c/p>\n\u003cp>[ad fullwidth]\u003c/p>\u003cp>\u003c/p>\n","blocks":[],"excerpt":"Last month the Food and Drug Administration warned 19 doctors and clinics that counterfeit vials of the chemotherapy drug Avastin had been identified in the U.S. Most of those doctors were in California. Today the Wall Street Journal reports that the FDA is investigating two businessmen from Canada who may be the source of these vials. One of them had admitted to shipping fake Avastin last year, although he says he did not know the vials contained counterfeit drugs. While it is generally illegal for anyone but the manufacturer to import prescription drugs into the U.S., it happens frequently and has proven difficult to police, the Journal reports.","status":"publish","parent":0,"modified":1331158418,"stats":{"hasAudio":false,"hasVideo":false,"hasChartOrMap":false,"iframeSrcs":[],"hasGoogleForm":false,"hasGallery":false,"hasHearkenModule":false,"hasPolis":false,"paragraphCount":11,"wordCount":547},"headData":{"title":"FDA Investigating Two Canadians for Distributing Fake Avastin | KQED","description":"Last month the Food and Drug Administration warned 19 doctors and clinics that counterfeit vials of the chemotherapy drug Avastin had been identified in the U.S. Most of those doctors were in California. Today the Wall Street Journal reports that the FDA is investigating two businessmen from Canada who may be the source of these vials. One of them had admitted to shipping fake Avastin last year, although he says he did not know the vials contained counterfeit drugs. While it is generally illegal for anyone but the manufacturer to import prescription drugs into the U.S., it happens frequently and has proven difficult to police, the Journal reports.","ogTitle":"","ogDescription":"","ogImgId":"","twTitle":"","twDescription":"","twImgId":"","schema":{"@context":"http://schema.org","@type":"Article","headline":"FDA Investigating Two Canadians for Distributing Fake Avastin","datePublished":"2012-03-07T22:13:38.000Z","dateModified":"2012-03-07T22:13:38.000Z","image":"https://cdn.kqed.org/wp-content/uploads/2020/02/KQED-OG-Image@1x.png"}},"disqusIdentifier":"3585 http://blogs.kqed.org/stateofhealth/?p=3585","disqusUrl":"https://ww2.kqed.org/stateofhealth/2012/03/07/fda-investigating-two-canadians-for-distributing-fake-avastin/","disqusTitle":"FDA Investigating Two Canadians for Distributing Fake Avastin","path":"/stateofhealth/3585/fda-investigating-two-canadians-for-distributing-fake-avastin","audioTrackLength":null,"parsedContent":[{"type":"contentString","content":"\u003cdiv class=\"post-body\">\u003cp>\u003cfigure id=\"attachment_3592\" class=\"wp-caption alignleft\" style=\"max-width: 146px\">\u003ca href=\"http://ww2.kqed.org/stateofhealth/wp-content/uploads/sites/27/2012/03/AvastinVial_20111118.jpg\">\u003cimg class=\"size-medium wp-image-3592\" title=\"(Image: Genentech)\" src=\"http://ww2.kqed.org/stateofhealth/wp-content/uploads/sites/27/2012/03/AvastinVial_20111118-300x615.jpg\" alt=\"(Image: Genentech)\" width=\"146\" height=\"300\">\u003c/a>\u003cfigcaption class=\"wp-caption-text\">(Image: Genentech)\u003c/figcaption>\u003c/figure>\n\u003cp>\u003cstrong>By Kamal Menghrajani\u003c/strong>\u003c/p>\n\u003cp>Last month the Food and Drug Administration warned 19 doctors and clinics that counterfeit vials of the chemotherapy drug \u003ca title=\"http://www.avastin.com/patient/index.html\" href=\"http://www.avastin.com/patient/index.html\" target=\"_blank\">Avastin\u003c/a> had been identified in the U.S. \u003ca title=\"http://ww2.kqed.org/stateofhealth/2012/02/16/fda-warns-california-clinics-of-fake-avastin/\" href=\"http://ww2.kqed.org/stateofhealth/2012/02/16/fda-warns-california-clinics-of-fake-avastin/\" target=\"_blank\">Most of those doctors were in California\u003c/a>. Today the \u003ca title=\"http://online.wsj.com/article/SB10001424052970203370604577261343974214110.html\" href=\"http://online.wsj.com/article/SB10001424052970203370604577261343974214110.html\" target=\"_blank\">Wall Street Journal reports\u003c/a> that the FDA is investigating two businessmen from Canada who may be the source of these vials. One of them had admitted to shipping fake Avastin last year, although he says he did not know the vials contained counterfeit drugs. While it is generally illegal for anyone but the manufacturer to import prescription drugs into the U.S., it happens frequently and has proven difficult to police, the Journal reports.\u003c/p>\n\u003cblockquote>\u003cp>\"We're deeply horrified by this counterfeit [product] being sold by one of my companies,\" said Thomas Haughton, a Canadian citizen who runs a network of drug distributors that sell to U.S. doctors. At the same time he said that his business operated legally. \"We're doing everything we can to be sure that this never happens again.”\u003c/p>\n\u003cp>While experts say most U.S. drugs are safe, the probe may raise new concerns about the weakly regulated gray market in foreign drugs aimed at U.S. patients. The importation of foreign drugs by third parties, which takes advantage of the large price differential between the U.S. market and others abroad, is believed to represent a small but growing portion of the $300 billion U.S. prescription pharmaceutical business.\u003c/p>\u003c/blockquote>\n\u003cp>\u003c!--more-->Haughton’s brother-in-law, Kris Thorkelson, is the second man under investigation. Both Haughton and Thorkelson sell low-cost medicines to doctors or directly to patients in the U.S. According to the \u003cem>Journal\u003c/em> their Canada-based businesses are thought to be the end of a supply chain of counterfeit Avastin that may have started in China and made its way through Turkey, Egypt, Sweden, and Denmark before going through Canada to get to Tennessee. Tennessee-based Volunteer Distribution was then suspected of funneling those vials out to various clinics throughout the country, most of which were in Southern California. Again, from the \u003cem>Journal\u003c/em>:\u003c/p>\n\u003cblockquote>\u003cp>In the last several days, the U.S. Attorney in Los Angeles has subpoenaed California physicians for documents about their dealings with and products purchased from Messrs. Haughton and Thorkelson, three people who have worked for them and 12 companies that are affiliated with one or the other man, according to a copy of a subpoena reviewed by The Wall Street Journal.\u003c/p>\n\u003cp>At least some of the doctors who received a subpoena were warned last month by the FDA that they may have purchased fake Avastin from three companies named in the subpoena and linked to Mr. Haughton. The FDA, which is leading the investigation, declined to comment on the subpoenas or the ongoing investigation.\u003c/p>\n\u003cp>The fake Avastin contained starch, salt, cleaning solvents and other chemicals and none of the drug's active ingredient, bevacizumab, according to Roche. The packaging didn't match U.S.-approved labels for the product, regulators said. As of Monday, the FDA hadn't received any reports of the fake Avastin being administered to patients.\u003c/p>\u003c/blockquote>\n\u003cp>The FDA is pursuing a criminal investigation against the Canadian drug sellers for shipping non-FDA approved drugs into the U.S.\u003c/p>\n\u003cp>\u003c/p>\u003c/div>","attributes":{"named":{},"numeric":[]}},{"type":"component","content":"","name":"ad","attributes":{"named":{"label":"fullwidth"},"numeric":["fullwidth"]}},{"type":"contentString","content":"\u003cdiv class=\"post-body\">\u003cp>\u003c/p>\u003cp>\u003c/p>\n\u003c/div>\u003c/p>","attributes":{"named":{},"numeric":[]}}],"link":"/stateofhealth/3585/fda-investigating-two-canadians-for-distributing-fake-avastin","authors":["240"],"categories":["stateofhealth_14","stateofhealth_13"],"tags":["stateofhealth_47","stateofhealth_48"],"label":"stateofhealth"},"stateofhealth_3112":{"type":"posts","id":"stateofhealth_3112","meta":{"index":"posts_1591205157","site":"stateofhealth","id":"3112","score":null,"sort":[1329762449000]},"guestAuthors":[],"slug":"law-seeks-to-stop-fake-prescription-drugs","title":"Law Seeks to Stop Fake Prescription Drugs","publishDate":1329762449,"format":"aside","headTitle":"State of Health | KQED News","labelTerm":{"site":"stateofhealth"},"content":"\u003cp>\u003cstrong>By: Sarah Varney\u003c/strong>\u003c/p>\n\u003cfigure id=\"attachment_3146\" class=\"wp-caption aligncenter\" style=\"max-width: 597px\">\u003ca href=\"http://ww2.kqed.org/stateofhealth/wp-content/uploads/sites/27/2012/02/ArtyPills_Eric_Flickr_02202012.jpg\">\u003cimg class=\"size-full wp-image-3146\" title=\"(Eric: Flickr)\" src=\"http://ww2.kqed.org/stateofhealth/wp-content/uploads/sites/27/2012/02/ArtyPills_Eric_Flickr_02202012.jpg\" alt=\"(Eric: Flickr)\" width=\"597\" height=\"457\" srcset=\"https://ww2.kqed.org/app/uploads/sites/27/2012/02/ArtyPills_Eric_Flickr_02202012.jpg 597w, https://ww2.kqed.org/app/uploads/sites/27/2012/02/ArtyPills_Eric_Flickr_02202012-400x306.jpg 400w, https://ww2.kqed.org/app/uploads/sites/27/2012/02/ArtyPills_Eric_Flickr_02202012-320x245.jpg 320w\" sizes=\"(max-width: 597px) 100vw, 597px\">\u003c/a>\u003cfigcaption class=\"wp-caption-text\">(Eric: Flickr)\u003c/figcaption>\u003c/figure>\n\u003cp>The \u003ca title=\"http://www.fda.gov/Drugs/DrugSafety/ucm291960.htm?utm_source=fda&utm_medium=website&utm_term=Aspirin&utm_content=f1&utm_campaign=HomePageSpotlight\" href=\"http://www.fda.gov/Drugs/DrugSafety/ucm291960.htm?utm_source=fda&utm_medium=website&utm_term=Aspirin&utm_content=f1&utm_campaign=HomePageSpotlight\" target=\"_blank\">announcement\u003c/a> by the \u003ca title=\"http://www.fda.gov/\" href=\"http://www.fda.gov/\" target=\"_blank\">Food and Drug Administration\u003c/a> last week that \u003ca title=\"http://ww2.kqed.org/stateofhealth/2012/02/16/fda-warns-california-clinics-of-fake-avastin/\" href=\"http://ww2.kqed.org/stateofhealth/2012/02/16/fda-warns-california-clinics-of-fake-avastin/\" target=\"_blank\">sixteen California clinics and physicians were sold bogus vials\u003c/a> of the cancer drug Avastin did not surprise regulators and researchers who study the counterfeit drug trade.\u003c/p>\n\u003cp>Indeed, it was after fake AIDS drugs were discovered in California that state legislators passed the \"\u003ca title=\"http://www.pharmacy.ca.gov/about/e_pedigree.shtml\" href=\"http://www.pharmacy.ca.gov/about/e_pedigree.shtml\" target=\"_blank\">e-pedigree law\u003c/a>\" mandating that all prescription drugs carry an electronic tag. The tag could be scanned to show where the drug was first manufactured and every stop along its way to market.\u003c/p>\n\u003cp>Since the law passed in 2004, biotech and pharmaceutical trade groups fought to delay its implementation. They argued, successfully, that the electronic track-and-trace system would up-end global drug manufacturing.\u003c!--more-->\u003c/p>\n\u003cp>Finally the system is going into effect, says \u003ca title=\"http://www.pharmacy.ca.gov/about/executive_staff.shtml\" href=\"http://www.pharmacy.ca.gov/about/executive_staff.shtml\" target=\"_blank\">Virginia Herold\u003c/a>, head of the state Board of Pharmacy. But it will still be awhile. \"In January 2015, 50 percent of a manufacturer’s products that will be sold into California have to have this unique serialized number of each container,\" she says.\u003c/p>\n\u003cp>[ad fullwidth]\u003c/p>\n\u003cp>The remaining half must have the serialized numbers by the following year -- and in subsequent years the system will become more robust. Herold says the the electronic tags can stop incidents like the recent sale of the adulterated Avastin.\u003c/p>\n\u003cp>\"The wholesaler, when it purchased the product would have had to certify, 'Yes, I just bought this from Roche.' Well, Roche didn’t manufacture the product. Somebody else did.\"\u003c/p>\n\u003cp>But \u003ca title=\"http://anesthesia.ucsd.edu/research/faculty-research/Pages/bryan-liang.aspx\" href=\"http://anesthesia.ucsd.edu/research/faculty-research/Pages/bryan-liang.aspx\" target=\"_blank\">Brian Liang\u003c/a>, Director of the Center for Patient Safety at UC San Diego, says electronic tags won’t end the fake drug business, because counterfeiters often avoid wholesalers. \"These are people who are coming at it from a completely different underground approach,\" he says.\u003c/p>\n\u003cp>Liang says counterfeiters will try to sell directly to clinics and doctors by bombarding them with faxes advertising cheap drugs. But there are resources available now, he says, that clinics and patients can turn to.\u003c/p>\n\u003cp>\"We have authorized wholesalers who are in fact listed by the government and \u003ca title=\"http://www.nabp.net/\" href=\"http://www.nabp.net/\" target=\"_blank\">National Association of Boards of Pharmacy\u003c/a>, they also list wholesalers. If it’s a source you’re not familiar with you really should find out: Is this source legitimate?\"\u003c/p>\n\u003cp>State regulators say about 1 percent of the 400 million prescriptions dispersed in California each year are fake. That’s about four million prescriptions that have too little or too much of the right active ingredients or no active ingredients at all.\u003c/p>\n\u003cp>\u003cstrong>Listen to the Story:\u003c/strong>\u003c/p>\n\u003cp>\u003c/p>\n\u003cp>\u003cobject width=\"335\" height=\"85\">\u003cparam name=\"movie\" value=\"http://www.kqed.org/assets/flash/kqedplayer.swf\">\u003cparam name=\"flashvars\" value=\"file=http://www.kqed.org/radio/archives/R201202200850a.xml\">\u003cembed src=\"http://www.kqed.org/assets/flash/kqedplayer.swf\" type=\"application/x-shockwave-flash\" width=\"335\" height=\"85\" flashvars=\"file=http://www.kqed.org/radio/archives/R201202200850a.xml\">\u003c/embed>\u003c/object>\u003c/p>\n\n","blocks":[],"excerpt":"The announcement by the Food and Drug Administration last week that sixteen California clinics and physicians were sold bogus vials of the cancer drug Avastin did not surprise regulators and researchers who study the counterfeit drug trade.\r\n\r\nIndeed, it was after fake AIDS drugs were discovered in California that state legislators passed a law mandating that all prescription drugs carry an electronic tag. The tag could be scanned to show where the drug was first manufactured and every stop along its way to market.","status":"publish","parent":0,"modified":1329763242,"stats":{"hasAudio":false,"hasVideo":false,"hasChartOrMap":false,"iframeSrcs":[],"hasGoogleForm":false,"hasGallery":false,"hasHearkenModule":false,"hasPolis":false,"paragraphCount":15,"wordCount":419},"headData":{"title":"Law Seeks to Stop Fake Prescription Drugs | KQED","description":"The announcement by the Food and Drug Administration last week that sixteen California clinics and physicians were sold bogus vials of the cancer drug Avastin did not surprise regulators and researchers who study the counterfeit drug trade.\r\n\r\nIndeed, it was after fake AIDS drugs were discovered in California that state legislators passed a law mandating that all prescription drugs carry an electronic tag. The tag could be scanned to show where the drug was first manufactured and every stop along its way to market.","ogTitle":"","ogDescription":"","ogImgId":"","twTitle":"","twDescription":"","twImgId":"","schema":{"@context":"http://schema.org","@type":"Article","headline":"Law Seeks to Stop Fake Prescription Drugs","datePublished":"2012-02-20T18:27:29.000Z","dateModified":"2012-02-20T18:40:42.000Z","image":"https://cdn.kqed.org/wp-content/uploads/2020/02/KQED-OG-Image@1x.png"}},"disqusIdentifier":"3112 http://blogs.kqed.org/stateofhealth/?p=3112","disqusUrl":"https://ww2.kqed.org/stateofhealth/2012/02/20/law-seeks-to-stop-fake-prescription-drugs/","disqusTitle":"Law Seeks to Stop Fake Prescription Drugs","path":"/stateofhealth/3112/law-seeks-to-stop-fake-prescription-drugs","audioTrackLength":null,"parsedContent":[{"type":"contentString","content":"\u003cdiv class=\"post-body\">\u003cp>\u003cp>\u003cstrong>By: Sarah Varney\u003c/strong>\u003c/p>\n\u003cfigure id=\"attachment_3146\" class=\"wp-caption aligncenter\" style=\"max-width: 597px\">\u003ca href=\"http://ww2.kqed.org/stateofhealth/wp-content/uploads/sites/27/2012/02/ArtyPills_Eric_Flickr_02202012.jpg\">\u003cimg class=\"size-full wp-image-3146\" title=\"(Eric: Flickr)\" src=\"http://ww2.kqed.org/stateofhealth/wp-content/uploads/sites/27/2012/02/ArtyPills_Eric_Flickr_02202012.jpg\" alt=\"(Eric: Flickr)\" width=\"597\" height=\"457\" srcset=\"https://ww2.kqed.org/app/uploads/sites/27/2012/02/ArtyPills_Eric_Flickr_02202012.jpg 597w, https://ww2.kqed.org/app/uploads/sites/27/2012/02/ArtyPills_Eric_Flickr_02202012-400x306.jpg 400w, https://ww2.kqed.org/app/uploads/sites/27/2012/02/ArtyPills_Eric_Flickr_02202012-320x245.jpg 320w\" sizes=\"(max-width: 597px) 100vw, 597px\">\u003c/a>\u003cfigcaption class=\"wp-caption-text\">(Eric: Flickr)\u003c/figcaption>\u003c/figure>\n\u003cp>The \u003ca title=\"http://www.fda.gov/Drugs/DrugSafety/ucm291960.htm?utm_source=fda&utm_medium=website&utm_term=Aspirin&utm_content=f1&utm_campaign=HomePageSpotlight\" href=\"http://www.fda.gov/Drugs/DrugSafety/ucm291960.htm?utm_source=fda&utm_medium=website&utm_term=Aspirin&utm_content=f1&utm_campaign=HomePageSpotlight\" target=\"_blank\">announcement\u003c/a> by the \u003ca title=\"http://www.fda.gov/\" href=\"http://www.fda.gov/\" target=\"_blank\">Food and Drug Administration\u003c/a> last week that \u003ca title=\"http://ww2.kqed.org/stateofhealth/2012/02/16/fda-warns-california-clinics-of-fake-avastin/\" href=\"http://ww2.kqed.org/stateofhealth/2012/02/16/fda-warns-california-clinics-of-fake-avastin/\" target=\"_blank\">sixteen California clinics and physicians were sold bogus vials\u003c/a> of the cancer drug Avastin did not surprise regulators and researchers who study the counterfeit drug trade.\u003c/p>\n\u003cp>Indeed, it was after fake AIDS drugs were discovered in California that state legislators passed the \"\u003ca title=\"http://www.pharmacy.ca.gov/about/e_pedigree.shtml\" href=\"http://www.pharmacy.ca.gov/about/e_pedigree.shtml\" target=\"_blank\">e-pedigree law\u003c/a>\" mandating that all prescription drugs carry an electronic tag. The tag could be scanned to show where the drug was first manufactured and every stop along its way to market.\u003c/p>\n\u003cp>Since the law passed in 2004, biotech and pharmaceutical trade groups fought to delay its implementation. They argued, successfully, that the electronic track-and-trace system would up-end global drug manufacturing.\u003c!--more-->\u003c/p>\n\u003cp>Finally the system is going into effect, says \u003ca title=\"http://www.pharmacy.ca.gov/about/executive_staff.shtml\" href=\"http://www.pharmacy.ca.gov/about/executive_staff.shtml\" target=\"_blank\">Virginia Herold\u003c/a>, head of the state Board of Pharmacy. But it will still be awhile. \"In January 2015, 50 percent of a manufacturer’s products that will be sold into California have to have this unique serialized number of each container,\" she says.\u003c/p>\n\u003cp>\u003c/p>\u003c/div>","attributes":{"named":{},"numeric":[]}},{"type":"component","content":"","name":"ad","attributes":{"named":{"label":"fullwidth"},"numeric":["fullwidth"]}},{"type":"contentString","content":"\u003cdiv class=\"post-body\">\u003cp>\u003c/p>\n\u003cp>The remaining half must have the serialized numbers by the following year -- and in subsequent years the system will become more robust. Herold says the the electronic tags can stop incidents like the recent sale of the adulterated Avastin.\u003c/p>\n\u003cp>\"The wholesaler, when it purchased the product would have had to certify, 'Yes, I just bought this from Roche.' Well, Roche didn’t manufacture the product. Somebody else did.\"\u003c/p>\n\u003cp>But \u003ca title=\"http://anesthesia.ucsd.edu/research/faculty-research/Pages/bryan-liang.aspx\" href=\"http://anesthesia.ucsd.edu/research/faculty-research/Pages/bryan-liang.aspx\" target=\"_blank\">Brian Liang\u003c/a>, Director of the Center for Patient Safety at UC San Diego, says electronic tags won’t end the fake drug business, because counterfeiters often avoid wholesalers. \"These are people who are coming at it from a completely different underground approach,\" he says.\u003c/p>\n\u003cp>Liang says counterfeiters will try to sell directly to clinics and doctors by bombarding them with faxes advertising cheap drugs. But there are resources available now, he says, that clinics and patients can turn to.\u003c/p>\n\u003cp>\"We have authorized wholesalers who are in fact listed by the government and \u003ca title=\"http://www.nabp.net/\" href=\"http://www.nabp.net/\" target=\"_blank\">National Association of Boards of Pharmacy\u003c/a>, they also list wholesalers. If it’s a source you’re not familiar with you really should find out: Is this source legitimate?\"\u003c/p>\n\u003cp>State regulators say about 1 percent of the 400 million prescriptions dispersed in California each year are fake. That’s about four million prescriptions that have too little or too much of the right active ingredients or no active ingredients at all.\u003c/p>\n\u003cp>\u003cstrong>Listen to the Story:\u003c/strong>\u003c/p>\n\u003cp>\u003c/p>\n\u003cp>\u003cobject width=\"335\" height=\"85\">\u003cparam name=\"movie\" value=\"http://www.kqed.org/assets/flash/kqedplayer.swf\">\u003cparam name=\"flashvars\" value=\"file=http://www.kqed.org/radio/archives/R201202200850a.xml\">\u003cembed src=\"http://www.kqed.org/assets/flash/kqedplayer.swf\" type=\"application/x-shockwave-flash\" width=\"335\" height=\"85\" flashvars=\"file=http://www.kqed.org/radio/archives/R201202200850a.xml\">\u003c/embed>\u003c/object>\u003c/p>\n\n\u003c/div>\u003c/p>","attributes":{"named":{},"numeric":[]}}],"link":"/stateofhealth/3112/law-seeks-to-stop-fake-prescription-drugs","authors":["240"],"categories":["stateofhealth_14"],"tags":["stateofhealth_47","stateofhealth_48"],"label":"stateofhealth"},"stateofhealth_3091":{"type":"posts","id":"stateofhealth_3091","meta":{"index":"posts_1591205157","site":"stateofhealth","id":"3091","score":null,"sort":[1329441829000]},"guestAuthors":[],"slug":"fda-warns-california-clinics-of-fake-avastin","title":"FDA Warns California Clinics of Fake Avastin","publishDate":1329441829,"format":"aside","headTitle":"State of Health | KQED News","labelTerm":{"site":"stateofhealth"},"content":"\u003cp>\u003cstrong>By Kamal Menghrajani\u003c/strong>\u003c/p>\n\u003cfigure id=\"attachment_3095\" class=\"wp-caption alignleft\" style=\"max-width: 146px\">\u003ca href=\"http://ww2.kqed.org/stateofhealth/wp-content/uploads/sites/27/2012/02/AvastinVial_20111118.jpg\">\u003cimg class=\"size-medium wp-image-3095\" title=\"AvastinVial\" src=\"http://ww2.kqed.org/stateofhealth/wp-content/uploads/sites/27/2012/02/AvastinVial_20111118-300x615.jpg\" alt=\"(Courtesy: Genentech)\" width=\"146\" height=\"300\">\u003c/a>\u003cfigcaption class=\"wp-caption-text\">(Courtesy: Genentech)\u003c/figcaption>\u003c/figure>\n\u003cp>A counterfeit version of the cancer drug \u003ca title=\"http://www.avastin.com/patient/index.html?cid=ava_we_F001059_P000517&c=MBAVUA2500&utm_source=google&utm_medium=cpc&utm_term=Avastin&utm_campaign=Google%20Branded%20(Nov11)&s_kwcid=TC%7C15200%7Cavastin%7C%7CS%7Ce%7C12571636561&gclid=CMzmhtHro64CFQ5_hwodkgz8SQ\" href=\"http://www.avastin.com/patient/index.html?cid=ava_we_F001059_P000517&c=MBAVUA2500&utm_source=google&utm_medium=cpc&utm_term=Avastin&utm_campaign=Google%20Branded%20(Nov11)&s_kwcid=TC%7C15200%7Cavastin%7C%7CS%7Ce%7C12571636561&gclid=CMzmhtHro64CFQ5_hwodkgz8SQ\" target=\"_blank\">Avastin\u003c/a> may have made its way into clinics here in California. The medicine is used to treat colon, lung, and other cancers, but several physicians may have unwittingly been giving patients a useless knock-off.\u003c/p>\n\u003cp>You may remember Avastin because it was considered a blockbuster drug for breast cancer treatment. That was until November of last year, when the \u003ca title=\"http://www.fda.gov/\" href=\"http://www.fda.gov/\" target=\"_blank\">Food and Drug Administration\u003c/a> (FDA) \u003ca title=\"http://ww2.kqed.org/stateofhealth/2011/11/18/fda-says-no-to-avastin-for-breast-cancer\" href=\"http://ww2.kqed.org/stateofhealth/2011/11/18/fda-says-no-to-avastin-for-breast-cancer\" target=\"_blank\">pulled its approval\u003c/a> for treating the disease. However, Avastin is still widely used for other types of cancer.\u003c/p>\n\u003cp>Earlier this month, the FDA sent letters to 19 doctors around the country warning that they may have fake Avastin. Sixteen of these physicians are here in California, all of them in Southern California.\u003c/p>\n\u003cp>The FDA says these clinics purchased the medicine from a foreign supplier under the names \"Quality Specialty Products\" or \"Montana Health Care Solutions.\" Volunteer Distribution, a company based in Tennessee, funneled the fake vials out to clinics. The company was not licensed by drugmaker \u003ca title=\"http://www.gene.com/gene/index.jsp\" href=\"http://www.gene.com/gene/index.jsp\" target=\"_blank\">Genentech\u003c/a> to provide Avastin, and some doctors’ offices were fooled.\u003c!--more-->\u003c/p>\n\u003cp>[ad fullwidth]\u003c/p>\n\u003cp>“I think we’re all shaken up by it. This isn’t like Viagra – this is life and death when you’re dealing with cancer,” said Tracey Butler, Director of Operations for the \u003ca title=\"http://www.bhcancercenter.com/\" href=\"http://www.bhcancercenter.com/\" target=\"_blank\">Beverly Hills Cancer Center\u003c/a>, which received the FDA warning. “We’re in this business so that we can find a cure for cancer, so to think that somebody out there would harm that, is very disturbing.”\u003c/p>\n\u003cp>Despite having had a past contract with Montana Health Care Solutions, Butler’s clinic did not have the counterfeit Avastin. “We looked through our stocks as soon as the FDA notified us about a month ago and we had nothing from them.”\u003c/p>\n\u003cp>Calls to Volunteer Distribution went unanswered. Nobody at the Gainesboro, Tennessee company answered the phone when we called.\u003c/p>\n\u003cp>Andrew Selesnick is a lawyer who represents one of the doctors who received a letter from the FDA. Until this incident, he told me, “I don’t think [doctors] looked at this as an issue to be concerned about, but now I think a lot of physicians are looking at their drug purchasing protocol in a different light.”\u003c/p>\n\u003cp>“It’s a low person who would replace a cancer-fighting drug with a counterfeit,” he added.\u003c/p>\n\u003cp>Genentech has been analyzing the counterfeits to determine what is in the vials. Charlotte Arnold, a spokesperson for the company said, “We do know that it doesn’t have the active ingredient for Avastin or any biologic effective for treating cancer,” she said. “We do know that there’s not anti-cancer medicine in there. … It’s not safe or effective and should not be used.”\u003c/p>\n\u003cp>\u003c/p>\n\u003cp>She says counterfeiting may not be restricted to Avastin, as the FDA is currently investigating whether other fake anti-cancer drugs are circulating in the U.S. “The FDA issued a \u003ca title=\"http://www.fda.gov/downloads/Drugs/DrugSafety/DrugIntegrityandSupplyChainSecurity/UCM287717.pdf\" href=\"http://www.fda.gov/downloads/Drugs/DrugSafety/DrugIntegrityandSupplyChainSecurity/UCM287717.pdf\" target=\"_blank\">notice\u003c/a> [PDF] in January that mentioned Rituxin and Herceptin, but there was no confirmed counterfeit, as there was in this case.\"\u003c/p>\n\n","blocks":[],"excerpt":"A counterfeit version of the cancer drug Avastin may have made its way into clinics here in California. The medicine is used to treat colon, lung, and other cancers, but several physicians may have unwittingly been giving patients a useless knock-off.\r\n\r\nYou may remember Avastin because it was considered a blockbuster drug for breast cancer treatment. That was until November of last year, when the Food and Drug Administration (FDA) pulled its approval for treating the disease. However, Avastin is still widely used for other types of cancer.","status":"publish","parent":0,"modified":1329502593,"stats":{"hasAudio":false,"hasVideo":false,"hasChartOrMap":false,"iframeSrcs":[],"hasGoogleForm":false,"hasGallery":false,"hasHearkenModule":false,"hasPolis":false,"paragraphCount":14,"wordCount":537},"headData":{"title":"FDA Warns California Clinics of Fake Avastin | KQED","description":"A counterfeit version of the cancer drug Avastin may have made its way into clinics here in California. The medicine is used to treat colon, lung, and other cancers, but several physicians may have unwittingly been giving patients a useless knock-off.\r\n\r\nYou may remember Avastin because it was considered a blockbuster drug for breast cancer treatment. That was until November of last year, when the Food and Drug Administration (FDA) pulled its approval for treating the disease. However, Avastin is still widely used for other types of cancer.","ogTitle":"","ogDescription":"","ogImgId":"","twTitle":"","twDescription":"","twImgId":"","schema":{"@context":"http://schema.org","@type":"Article","headline":"FDA Warns California Clinics of Fake Avastin","datePublished":"2012-02-17T01:23:49.000Z","dateModified":"2012-02-17T18:16:33.000Z","image":"https://cdn.kqed.org/wp-content/uploads/2020/02/KQED-OG-Image@1x.png"}},"disqusIdentifier":"3091 http://blogs.kqed.org/stateofhealth/?p=3091","disqusUrl":"https://ww2.kqed.org/stateofhealth/2012/02/16/fda-warns-california-clinics-of-fake-avastin/","disqusTitle":"FDA Warns California Clinics of Fake Avastin","path":"/stateofhealth/3091/fda-warns-california-clinics-of-fake-avastin","audioTrackLength":null,"parsedContent":[{"type":"contentString","content":"\u003cdiv class=\"post-body\">\u003cp>\u003cp>\u003cstrong>By Kamal Menghrajani\u003c/strong>\u003c/p>\n\u003cfigure id=\"attachment_3095\" class=\"wp-caption alignleft\" style=\"max-width: 146px\">\u003ca href=\"http://ww2.kqed.org/stateofhealth/wp-content/uploads/sites/27/2012/02/AvastinVial_20111118.jpg\">\u003cimg class=\"size-medium wp-image-3095\" title=\"AvastinVial\" src=\"http://ww2.kqed.org/stateofhealth/wp-content/uploads/sites/27/2012/02/AvastinVial_20111118-300x615.jpg\" alt=\"(Courtesy: Genentech)\" width=\"146\" height=\"300\">\u003c/a>\u003cfigcaption class=\"wp-caption-text\">(Courtesy: Genentech)\u003c/figcaption>\u003c/figure>\n\u003cp>A counterfeit version of the cancer drug \u003ca title=\"http://www.avastin.com/patient/index.html?cid=ava_we_F001059_P000517&c=MBAVUA2500&utm_source=google&utm_medium=cpc&utm_term=Avastin&utm_campaign=Google%20Branded%20(Nov11)&s_kwcid=TC%7C15200%7Cavastin%7C%7CS%7Ce%7C12571636561&gclid=CMzmhtHro64CFQ5_hwodkgz8SQ\" href=\"http://www.avastin.com/patient/index.html?cid=ava_we_F001059_P000517&c=MBAVUA2500&utm_source=google&utm_medium=cpc&utm_term=Avastin&utm_campaign=Google%20Branded%20(Nov11)&s_kwcid=TC%7C15200%7Cavastin%7C%7CS%7Ce%7C12571636561&gclid=CMzmhtHro64CFQ5_hwodkgz8SQ\" target=\"_blank\">Avastin\u003c/a> may have made its way into clinics here in California. The medicine is used to treat colon, lung, and other cancers, but several physicians may have unwittingly been giving patients a useless knock-off.\u003c/p>\n\u003cp>You may remember Avastin because it was considered a blockbuster drug for breast cancer treatment. That was until November of last year, when the \u003ca title=\"http://www.fda.gov/\" href=\"http://www.fda.gov/\" target=\"_blank\">Food and Drug Administration\u003c/a> (FDA) \u003ca title=\"http://ww2.kqed.org/stateofhealth/2011/11/18/fda-says-no-to-avastin-for-breast-cancer\" href=\"http://ww2.kqed.org/stateofhealth/2011/11/18/fda-says-no-to-avastin-for-breast-cancer\" target=\"_blank\">pulled its approval\u003c/a> for treating the disease. However, Avastin is still widely used for other types of cancer.\u003c/p>\n\u003cp>Earlier this month, the FDA sent letters to 19 doctors around the country warning that they may have fake Avastin. Sixteen of these physicians are here in California, all of them in Southern California.\u003c/p>\n\u003cp>The FDA says these clinics purchased the medicine from a foreign supplier under the names \"Quality Specialty Products\" or \"Montana Health Care Solutions.\" Volunteer Distribution, a company based in Tennessee, funneled the fake vials out to clinics. The company was not licensed by drugmaker \u003ca title=\"http://www.gene.com/gene/index.jsp\" href=\"http://www.gene.com/gene/index.jsp\" target=\"_blank\">Genentech\u003c/a> to provide Avastin, and some doctors’ offices were fooled.\u003c!--more-->\u003c/p>\n\u003cp>\u003c/p>\u003c/div>","attributes":{"named":{},"numeric":[]}},{"type":"component","content":"","name":"ad","attributes":{"named":{"label":"fullwidth"},"numeric":["fullwidth"]}},{"type":"contentString","content":"\u003cdiv class=\"post-body\">\u003cp>\u003c/p>\n\u003cp>“I think we’re all shaken up by it. This isn’t like Viagra – this is life and death when you’re dealing with cancer,” said Tracey Butler, Director of Operations for the \u003ca title=\"http://www.bhcancercenter.com/\" href=\"http://www.bhcancercenter.com/\" target=\"_blank\">Beverly Hills Cancer Center\u003c/a>, which received the FDA warning. “We’re in this business so that we can find a cure for cancer, so to think that somebody out there would harm that, is very disturbing.”\u003c/p>\n\u003cp>Despite having had a past contract with Montana Health Care Solutions, Butler’s clinic did not have the counterfeit Avastin. “We looked through our stocks as soon as the FDA notified us about a month ago and we had nothing from them.”\u003c/p>\n\u003cp>Calls to Volunteer Distribution went unanswered. Nobody at the Gainesboro, Tennessee company answered the phone when we called.\u003c/p>\n\u003cp>Andrew Selesnick is a lawyer who represents one of the doctors who received a letter from the FDA. Until this incident, he told me, “I don’t think [doctors] looked at this as an issue to be concerned about, but now I think a lot of physicians are looking at their drug purchasing protocol in a different light.”\u003c/p>\n\u003cp>“It’s a low person who would replace a cancer-fighting drug with a counterfeit,” he added.\u003c/p>\n\u003cp>Genentech has been analyzing the counterfeits to determine what is in the vials. Charlotte Arnold, a spokesperson for the company said, “We do know that it doesn’t have the active ingredient for Avastin or any biologic effective for treating cancer,” she said. “We do know that there’s not anti-cancer medicine in there. … It’s not safe or effective and should not be used.”\u003c/p>\n\u003cp>\u003c/p>\n\u003cp>She says counterfeiting may not be restricted to Avastin, as the FDA is currently investigating whether other fake anti-cancer drugs are circulating in the U.S. “The FDA issued a \u003ca title=\"http://www.fda.gov/downloads/Drugs/DrugSafety/DrugIntegrityandSupplyChainSecurity/UCM287717.pdf\" href=\"http://www.fda.gov/downloads/Drugs/DrugSafety/DrugIntegrityandSupplyChainSecurity/UCM287717.pdf\" target=\"_blank\">notice\u003c/a> [PDF] in January that mentioned Rituxin and Herceptin, but there was no confirmed counterfeit, as there was in this case.\"\u003c/p>\n\n\u003c/div>\u003c/p>","attributes":{"named":{},"numeric":[]}}],"link":"/stateofhealth/3091/fda-warns-california-clinics-of-fake-avastin","authors":["240"],"categories":["stateofhealth_13"],"tags":["stateofhealth_47","stateofhealth_16","stateofhealth_48"],"label":"stateofhealth"},"stateofhealth_384":{"type":"posts","id":"stateofhealth_384","meta":{"index":"posts_1591205157","site":"stateofhealth","id":"384","score":null,"sort":[1321651306000]},"guestAuthors":[],"slug":"fda-says-no-to-avastin-for-breast-cancer","title":"FDA Says \"No\" to Avastin for Breast Cancer ","publishDate":1321651306,"format":"aside","headTitle":"State of Health | KQED News","labelTerm":{"site":"stateofhealth"},"content":"\u003cfigure id=\"attachment_422\" class=\"wp-caption alignleft\" style=\"max-width: 218px\">\u003ca href=\"http://ww2.kqed.org/stateofhealth/wp-content/uploads/sites/27/2011/11/avastin-218.jpg\">\u003cimg class=\"size-full wp-image-422\" title=\"(Courtesy: Genentech)\" src=\"http://ww2.kqed.org/stateofhealth/wp-content/uploads/sites/27/2011/11/avastin-218.jpg\" alt=\"(Courtesy: Genentech)\" width=\"218\" height=\"290\">\u003c/a>\u003cfigcaption class=\"wp-caption-text\">(Courtesy: Genentech)\u003c/figcaption>\u003c/figure>\n\u003cp>FDA Commissioner Dr. Margaret Hamburg announced this morning that the agency is revoking approval of Avastin as a treatment for metastatic breast cancer. The Agency had \"fast tracked\" the approval of the drug in 2008, based on results of one study, but had requested additional research. Those follow up studies did not support the initial findings, the FDA has decided.\u003c/p>\n\u003cp>\u003ca title=\"http://www.npr.org/blogs/health/2011/11/18/142503630/fda-pulls-approval-of-avastin-for-advanced-breast-cancer?ps=sh_sthdl\" href=\"http://www.npr.org/blogs/health/2011/11/18/142503630/fda-pulls-approval-of-avastin-for-advanced-breast-cancer?ps=sh_sthdl\" target=\"_blank\">NPR's Shots blog\u003c/a> reports on today's events as well as the history behind the decision.\u003c/p>\n\u003cblockquote>\u003cp>Hamburg lays out the reasoning for the rare move in a \u003ca title=\"http://www.fda.gov/downloads/NewsEvents/Newsroom/UCM280546.pdf\" href=\"http://www.fda.gov/downloads/NewsEvents/Newsroom/UCM280546.pdf\" target=\"_blank\">69-page decision\u003c/a>. In a news briefing Friday morning, she said of the drug: \"It's clear there is no benefit to breast cancer patients that would justify its risks.\" She said she didn't \"come to this decision lightly but as a result of a rigorous process.\"\u003c/p>\n\u003cp>Roche's Genentech unit, maker of Avastin said in a statement, \"We are disappointed with this outcome.\" The company said it will help women \"who may be facing obstacles to receiving their treatment\" with the drug through a patient-support program. It's also continuing research on the use of the drug for breast cancer.\u003c/p>\u003c/blockquote>\n\u003cp>\u003c!--more-->Avastin's side effects are serious, including heart attack or heart failure, severe high blood pressure, and perforations in different parts of the body such as the stomach and intestines.\u003c/p>\n\u003cp>In a \u003ca title=\"http://www.nejm.org/doi/full/10.1056/NEJMp1106984#t=letters\" href=\"http://www.nejm.org/doi/full/10.1056/NEJMp1106984#t=letters\" target=\"_blank\">letter to the New England Journal of Medicine\u003c/a>, Dr. Mikkael A. Sekeres, an oncologist with the FDA's Advisory Committee on this issue, summed up the limitations of Avastin in a question he would pose to a patient:\u003c/p>\n\u003cblockquote>\u003cp>“Well, I can offer you a drug that will not make you live longer, won't make you feel better, and may have life-threatening side effects, but it will keep your cancer from worsening by an average of 1 to 2 months.”\u003c/p>\n\u003cp>Hope? Or false hope?\u003c/p>\u003c/blockquote>\n\u003cp>The San Francisco-based advocacy group \u003ca title=\"http://bcaction.org/\" href=\"http://bcaction.org/\" target=\"_blank\">Breast Cancer Action\u003c/a> had opposed the use of Avastin to treat metastatic breast cancer since 2007, before the FDA's initial approval, over concerns about efficacy and side effects. Today, Karuna Jaggar, Breast Cancer Action's Executive Director, applauded the FDA's decision.\u003c/p>\n\u003cp>[ad fullwidth]\u003c/p>\n\u003cp>\u003c/p>\n\u003cp>\"I want to note that we all are on the same side and we absolutely want more effective treatment options for women with metastatic breast cancer. That being said, we cannot allow companies to sell hope and we continue to seek treatments that work.\"\u003c/p>\n\n","blocks":[],"excerpt":"FDA Commissioner Dr. Margaret Hamburg announced this morning that the agency is revoking approval of Avastin as a treatment for metastatic breast cancer. The Agency had \"fast tracked\" the approval of the drug in 2008, based on results of one study, but had requested additional research. Those follow up studies did not support the initial findings, the FDA has decided.","status":"publish","parent":0,"modified":1321651510,"stats":{"hasAudio":false,"hasVideo":false,"hasChartOrMap":false,"iframeSrcs":[],"hasGoogleForm":false,"hasGallery":false,"hasHearkenModule":false,"hasPolis":false,"paragraphCount":12,"wordCount":409},"headData":{"title":"FDA Says \"No\" to Avastin for Breast Cancer | KQED","description":"FDA Commissioner Dr. Margaret Hamburg announced this morning that the agency is revoking approval of Avastin as a treatment for metastatic breast cancer. The Agency had "fast tracked" the approval of the drug in 2008, based on results of one study, but had requested additional research. Those follow up studies did not support the initial findings, the FDA has decided.","ogTitle":"","ogDescription":"","ogImgId":"","twTitle":"","twDescription":"","twImgId":"","schema":{"@context":"http://schema.org","@type":"Article","headline":"FDA Says \"No\" to Avastin for Breast Cancer ","datePublished":"2011-11-18T21:21:46.000Z","dateModified":"2011-11-18T21:25:10.000Z","image":"https://cdn.kqed.org/wp-content/uploads/2020/02/KQED-OG-Image@1x.png"}},"disqusIdentifier":"384 http://blogs.kqed.org/stateofhealth/?p=384","disqusUrl":"https://ww2.kqed.org/stateofhealth/2011/11/18/fda-says-no-to-avastin-for-breast-cancer/","disqusTitle":"FDA Says \"No\" to Avastin for Breast Cancer ","path":"/stateofhealth/384/fda-says-no-to-avastin-for-breast-cancer","audioTrackLength":null,"parsedContent":[{"type":"contentString","content":"\u003cdiv class=\"post-body\">\u003cp>\u003cfigure id=\"attachment_422\" class=\"wp-caption alignleft\" style=\"max-width: 218px\">\u003ca href=\"http://ww2.kqed.org/stateofhealth/wp-content/uploads/sites/27/2011/11/avastin-218.jpg\">\u003cimg class=\"size-full wp-image-422\" title=\"(Courtesy: Genentech)\" src=\"http://ww2.kqed.org/stateofhealth/wp-content/uploads/sites/27/2011/11/avastin-218.jpg\" alt=\"(Courtesy: Genentech)\" width=\"218\" height=\"290\">\u003c/a>\u003cfigcaption class=\"wp-caption-text\">(Courtesy: Genentech)\u003c/figcaption>\u003c/figure>\n\u003cp>FDA Commissioner Dr. Margaret Hamburg announced this morning that the agency is revoking approval of Avastin as a treatment for metastatic breast cancer. The Agency had \"fast tracked\" the approval of the drug in 2008, based on results of one study, but had requested additional research. Those follow up studies did not support the initial findings, the FDA has decided.\u003c/p>\n\u003cp>\u003ca title=\"http://www.npr.org/blogs/health/2011/11/18/142503630/fda-pulls-approval-of-avastin-for-advanced-breast-cancer?ps=sh_sthdl\" href=\"http://www.npr.org/blogs/health/2011/11/18/142503630/fda-pulls-approval-of-avastin-for-advanced-breast-cancer?ps=sh_sthdl\" target=\"_blank\">NPR's Shots blog\u003c/a> reports on today's events as well as the history behind the decision.\u003c/p>\n\u003cblockquote>\u003cp>Hamburg lays out the reasoning for the rare move in a \u003ca title=\"http://www.fda.gov/downloads/NewsEvents/Newsroom/UCM280546.pdf\" href=\"http://www.fda.gov/downloads/NewsEvents/Newsroom/UCM280546.pdf\" target=\"_blank\">69-page decision\u003c/a>. In a news briefing Friday morning, she said of the drug: \"It's clear there is no benefit to breast cancer patients that would justify its risks.\" She said she didn't \"come to this decision lightly but as a result of a rigorous process.\"\u003c/p>\n\u003cp>Roche's Genentech unit, maker of Avastin said in a statement, \"We are disappointed with this outcome.\" The company said it will help women \"who may be facing obstacles to receiving their treatment\" with the drug through a patient-support program. It's also continuing research on the use of the drug for breast cancer.\u003c/p>\u003c/blockquote>\n\u003cp>\u003c!--more-->Avastin's side effects are serious, including heart attack or heart failure, severe high blood pressure, and perforations in different parts of the body such as the stomach and intestines.\u003c/p>\n\u003cp>In a \u003ca title=\"http://www.nejm.org/doi/full/10.1056/NEJMp1106984#t=letters\" href=\"http://www.nejm.org/doi/full/10.1056/NEJMp1106984#t=letters\" target=\"_blank\">letter to the New England Journal of Medicine\u003c/a>, Dr. Mikkael A. Sekeres, an oncologist with the FDA's Advisory Committee on this issue, summed up the limitations of Avastin in a question he would pose to a patient:\u003c/p>\n\u003cblockquote>\u003cp>“Well, I can offer you a drug that will not make you live longer, won't make you feel better, and may have life-threatening side effects, but it will keep your cancer from worsening by an average of 1 to 2 months.”\u003c/p>\n\u003cp>Hope? Or false hope?\u003c/p>\u003c/blockquote>\n\u003cp>The San Francisco-based advocacy group \u003ca title=\"http://bcaction.org/\" href=\"http://bcaction.org/\" target=\"_blank\">Breast Cancer Action\u003c/a> had opposed the use of Avastin to treat metastatic breast cancer since 2007, before the FDA's initial approval, over concerns about efficacy and side effects. Today, Karuna Jaggar, Breast Cancer Action's Executive Director, applauded the FDA's decision.\u003c/p>\n\u003cp>\u003c/p>\u003c/div>","attributes":{"named":{},"numeric":[]}},{"type":"component","content":"","name":"ad","attributes":{"named":{"label":"fullwidth"},"numeric":["fullwidth"]}},{"type":"contentString","content":"\u003cdiv class=\"post-body\">\u003cp>\u003c/p>\n\u003cp>\u003c/p>\n\u003cp>\"I want to note that we all are on the same side and we absolutely want more effective treatment options for women with metastatic breast cancer. That being said, we cannot allow companies to sell hope and we continue to seek treatments that work.\"\u003c/p>\n\n\u003c/div>\u003c/p>","attributes":{"named":{},"numeric":[]}}],"link":"/stateofhealth/384/fda-says-no-to-avastin-for-breast-cancer","authors":["240"],"categories":["stateofhealth_14"],"tags":["stateofhealth_47","stateofhealth_46","stateofhealth_48"],"label":"stateofhealth"}},"programsReducer":{"possible":{"id":"possible","title":"Possible","info":"Possible is hosted by entrepreneur Reid Hoffman and writer Aria Finger. Together in Possible, Hoffman and Finger lead enlightening discussions about building a brighter collective future. The show features interviews with visionary guests like Trevor Noah, Sam Altman and Janette Sadik-Khan. Possible paints an optimistic portrait of the world we can create through science, policy, business, art and our shared humanity. It asks: What if everything goes right for once? How can we get there? Each episode also includes a short fiction story generated by advanced AI GPT-4, serving as a thought-provoking springboard to speculate how humanity could leverage technology for good.","airtime":"SUN 2pm","imageSrc":"https://cdn.kqed.org/wp-content/uploads/2024/04/Possible-Podcast-Tile-360x360-1.jpg","officialWebsiteLink":"https://www.possible.fm/","meta":{"site":"news","source":"Possible"},"link":"/radio/program/possible","subscribe":{"apple":"https://podcasts.apple.com/us/podcast/possible/id1677184070","spotify":"https://open.spotify.com/show/730YpdUSNlMyPQwNnyjp4k"}},"1a":{"id":"1a","title":"1A","info":"1A is home to the national conversation. 1A brings on great guests and frames the best debate in ways that make you think, share and engage.","airtime":"MON-THU 11pm-12am","imageSrc":"https://ww2.kqed.org/radio/wp-content/uploads/sites/50/2018/04/1a.jpg","officialWebsiteLink":"https://the1a.org/","meta":{"site":"news","source":"npr"},"link":"/radio/program/1a","subscribe":{"npr":"https://rpb3r.app.goo.gl/RBrW","apple":"https://itunes.apple.com/WebObjects/MZStore.woa/wa/viewPodcast?s=143441&mt=2&id=1188724250&at=11l79Y&ct=nprdirectory","tuneIn":"https://tunein.com/radio/1A-p947376/","rss":"https://feeds.npr.org/510316/podcast.xml"}},"all-things-considered":{"id":"all-things-considered","title":"All Things Considered","info":"Every weekday, \u003cem>All Things Considered\u003c/em> hosts Robert Siegel, Audie Cornish, Ari Shapiro, and Kelly McEvers present the program's trademark mix of news, interviews, commentaries, reviews, and offbeat features. Michel Martin hosts on the weekends.","airtime":"MON-FRI 1pm-2pm, 4:30pm-6:30pm\u003cbr />SAT-SUN 5pm-6pm","imageSrc":"https://cdn.kqed.org/wp-content/uploads/2024/04/All-Things-Considered-Podcast-Tile-360x360-1.jpg","officialWebsiteLink":"https://www.npr.org/programs/all-things-considered/","meta":{"site":"news","source":"npr"},"link":"/radio/program/all-things-considered"},"american-suburb-podcast":{"id":"american-suburb-podcast","title":"American Suburb: The Podcast","tagline":"The flip side of gentrification, told through one town","info":"Gentrification is changing cities across America, forcing people from neighborhoods they have long called home. Call them the displaced. Now those priced out of the Bay Area are looking for a better life in an unlikely place. American Suburb follows this migration to one California town along the Delta, 45 miles from San Francisco. But is this once sleepy suburb ready for them?","imageSrc":"https://cdn.kqed.org/wp-content/uploads/2024/04/American-Suburb-Podcast-Tile-703x703-1.jpg","officialWebsiteLink":"/news/series/american-suburb-podcast","meta":{"site":"news","source":"kqed","order":"13"},"link":"/news/series/american-suburb-podcast/","subscribe":{"npr":"https://rpb3r.app.goo.gl/RBrW","apple":"https://itunes.apple.com/WebObjects/MZStore.woa/wa/viewPodcast?mt=2&id=1287748328","tuneIn":"https://tunein.com/radio/American-Suburb-p1086805/","rss":"https://ww2.kqed.org/news/series/american-suburb-podcast/feed/podcast","google":"https://podcasts.google.com/feed/aHR0cHM6Ly9mZWVkcy5tZWdhcGhvbmUuZm0vS1FJTkMzMDExODgxNjA5"}},"baycurious":{"id":"baycurious","title":"Bay Curious","tagline":"Exploring the Bay Area, one question at a time","info":"KQED’s new podcast, Bay Curious, gets to the bottom of the mysteries — both profound and peculiar — that give the Bay Area its unique identity. And we’ll do it with your help! You ask the questions. You decide what Bay Curious investigates. And you join us on the journey to find the answers.","imageSrc":"https://cdn.kqed.org/wp-content/uploads/2024/04/Bay-Curious-Podcast-Tile-703x703-1.jpg","imageAlt":"\"KQED Bay Curious","officialWebsiteLink":"/news/series/baycurious","meta":{"site":"news","source":"kqed","order":"4"},"link":"/podcasts/baycurious","subscribe":{"apple":"https://podcasts.apple.com/us/podcast/bay-curious/id1172473406","npr":"https://www.npr.org/podcasts/500557090/bay-curious","rss":"https://ww2.kqed.org/news/category/bay-curious-podcast/feed/podcast","google":"https://podcasts.google.com/feed/aHR0cHM6Ly93dzIua3FlZC5vcmcvbmV3cy9jYXRlZ29yeS9iYXktY3VyaW91cy1wb2RjYXN0L2ZlZWQvcG9kY2FzdA","stitcher":"https://www.stitcher.com/podcast/kqed/bay-curious","spotify":"https://open.spotify.com/show/6O76IdmhixfijmhTZLIJ8k"}},"bbc-world-service":{"id":"bbc-world-service","title":"BBC World Service","info":"The day's top stories from BBC News compiled twice daily in the week, once at weekends.","airtime":"MON-FRI 9pm-10pm, TUE-FRI 1am-2am","imageSrc":"https://cdn.kqed.org/wp-content/uploads/2024/04/BBC-World-Service-Podcast-Tile-360x360-1.jpg","officialWebsiteLink":"https://www.bbc.co.uk/sounds/play/live:bbc_world_service","meta":{"site":"news","source":"BBC World Service"},"link":"/radio/program/bbc-world-service","subscribe":{"apple":"https://itunes.apple.com/us/podcast/global-news-podcast/id135067274?mt=2","tuneIn":"https://tunein.com/radio/BBC-World-Service-p455581/","rss":"https://podcasts.files.bbci.co.uk/p02nq0gn.rss"}},"code-switch-life-kit":{"id":"code-switch-life-kit","title":"Code Switch / Life Kit","info":"\u003cem>Code Switch\u003c/em>, which listeners will hear in the first part of the hour, has fearless and much-needed conversations about race. Hosted by journalists of color, the show tackles the subject of race head-on, exploring how it impacts every part of society — from politics and pop culture to history, sports and more.\u003cbr />\u003cbr />\u003cem>Life Kit\u003c/em>, which will be in the second part of the hour, guides you through spaces and feelings no one prepares you for — from finances to mental health, from workplace microaggressions to imposter syndrome, from relationships to parenting. The show features experts with real world experience and shares their knowledge. Because everyone needs a little help being human.\u003cbr />\u003cbr />\u003ca href=\"https://www.npr.org/podcasts/510312/codeswitch\">\u003cem>Code Switch\u003c/em> offical site and podcast\u003c/a>\u003cbr />\u003ca href=\"https://www.npr.org/lifekit\">\u003cem>Life Kit\u003c/em> offical site and podcast\u003c/a>\u003cbr />","airtime":"SUN 9pm-10pm","imageSrc":"https://cdn.kqed.org/wp-content/uploads/2024/04/Code-Switch-Life-Kit-Podcast-Tile-360x360-1.jpg","meta":{"site":"radio","source":"npr"},"link":"/radio/program/code-switch-life-kit","subscribe":{"apple":"https://podcasts.apple.com/podcast/1112190608?mt=2&at=11l79Y&ct=nprdirectory","google":"https://podcasts.google.com/feed/aHR0cHM6Ly93d3cubnByLm9yZy9yc3MvcG9kY2FzdC5waHA_aWQ9NTEwMzEy","spotify":"https://open.spotify.com/show/3bExJ9JQpkwNhoHvaIIuyV","rss":"https://feeds.npr.org/510312/podcast.xml"}},"commonwealth-club":{"id":"commonwealth-club","title":"Commonwealth Club of California Podcast","info":"The Commonwealth Club of California is the nation's oldest and largest public affairs forum. As a non-partisan forum, The Club brings to the public airwaves diverse viewpoints on important topics. The Club's weekly radio broadcast - the oldest in the U.S., dating back to 1924 - is carried across the nation on public radio stations and is now podcasting. Our website archive features audio of our recent programs, as well as selected speeches from our long and distinguished history. 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On Our Watch brings listeners into the rooms where officers are questioned and witnesses are interrogated to find out who this system is really protecting. 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For one hour a week, the show tries to lift the veil from the process of \"making media,\" especially news media, because it's through that lens that we see the world and the world sees us","airtime":"SUN 2pm-3pm, MON 12am-1am","imageSrc":"https://ww2.kqed.org/radio/wp-content/uploads/sites/50/2018/04/onTheMedia.png","officialWebsiteLink":"https://www.wnycstudios.org/shows/otm","meta":{"site":"news","source":"wnyc"},"link":"/radio/program/on-the-media","subscribe":{"apple":"https://itunes.apple.com/us/podcast/on-the-media/id73330715?mt=2","tuneIn":"https://tunein.com/radio/On-the-Media-p69/","rss":"http://feeds.wnyc.org/onthemedia"}},"our-body-politic":{"id":"our-body-politic","title":"Our Body Politic","info":"Presented by KQED, KCRW and KPCC, and created and hosted by award-winning journalist Farai Chideya, Our Body Politic is unapologetically centered on reporting on not just how women of color experience the major political events of today, but how they’re impacting those very issues.","airtime":"SAT 6pm-7pm, SUN 1am-2am","imageSrc":"https://cdn.kqed.org/wp-content/uploads/2024/04/Our-Body-Politic-Podcast-Tile-360x360-1.jpg","officialWebsiteLink":"https://our-body-politic.simplecast.com/","meta":{"site":"news","source":"kcrw"},"link":"/radio/program/our-body-politic","subscribe":{"apple":"https://podcasts.apple.com/us/podcast/our-body-politic/id1533069868","google":"https://podcasts.google.com/feed/aHR0cHM6Ly9mZWVkcy5zaW1wbGVjYXN0LmNvbS9feGFQaHMxcw","spotify":"https://open.spotify.com/show/4ApAiLT1kV153TttWAmqmc","rss":"https://feeds.simplecast.com/_xaPhs1s","tuneIn":"https://tunein.com/podcasts/News--Politics-Podcasts/Our-Body-Politic-p1369211/"}},"pbs-newshour":{"id":"pbs-newshour","title":"PBS NewsHour","info":"Analysis, background reports and updates from the PBS NewsHour putting today's news in context.","airtime":"MON-FRI 3pm-4pm","imageSrc":"https://cdn.kqed.org/wp-content/uploads/2024/04/PBS-News-Hour-Podcast-Tile-360x360-1.jpg","officialWebsiteLink":"https://www.pbs.org/newshour/","meta":{"site":"news","source":"pbs"},"link":"/radio/program/pbs-newshour","subscribe":{"apple":"https://itunes.apple.com/us/podcast/pbs-newshour-full-show/id394432287?mt=2","tuneIn":"https://tunein.com/radio/PBS-NewsHour---Full-Show-p425698/","rss":"https://www.pbs.org/newshour/feeds/rss/podcasts/show"}},"perspectives":{"id":"perspectives","title":"Perspectives","tagline":"KQED's series of of daily listener commentaries since 1991","info":"KQED's series of of daily listener commentaries since 1991.","imageSrc":"https://cdn.kqed.org/wp-content/uploads/2024/04/Perspectives-Podcast-Tile-703x703-1.jpg","officialWebsiteLink":"/perspectives/","meta":{"site":"radio","source":"kqed","order":"15"},"link":"/perspectives","subscribe":{"apple":"https://podcasts.apple.com/us/podcast/id73801135","npr":"https://www.npr.org/podcasts/432309616/perspectives","rss":"https://ww2.kqed.org/perspectives/category/perspectives/feed/","google":"https://podcasts.google.com/feed/aHR0cHM6Ly93dzIua3FlZC5vcmcvcGVyc3BlY3RpdmVzL2NhdGVnb3J5L3BlcnNwZWN0aXZlcy9mZWVkLw"}},"planet-money":{"id":"planet-money","title":"Planet Money","info":"The economy explained. 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The result is stories that inform and inspire, arming our listeners with information to right injustices, hold the powerful accountable and improve lives.Reveal is hosted by Al Letson and showcases the award-winning work of CIR and newsrooms large and small across the nation. In a radio and podcast market crowded with choices, Reveal focuses on important and often surprising stories that illuminate the world for our listeners.","airtime":"SAT 4pm-5pm","imageSrc":"https://ww2.kqed.org/radio/wp-content/uploads/sites/50/2018/04/reveal300px.png","officialWebsiteLink":"https://www.revealnews.org/episodes/","meta":{"site":"news","source":"npr"},"link":"/radio/program/reveal","subscribe":{"apple":"https://itunes.apple.com/us/podcast/reveal/id886009669","tuneIn":"https://tunein.com/radio/Reveal-p679597/","rss":"http://feeds.revealradio.org/revealpodcast"}},"says-you":{"id":"says-you","title":"Says You!","info":"Public radio's game show of bluff and bluster, words and whimsy. 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