{"id":51033,"date":"2014-10-22T12:30:42","date_gmt":"2014-10-22T16:30:42","guid":{"rendered":"http:\/\/1boringoldman.com\/?p=51033"},"modified":"2014-10-22T12:30:42","modified_gmt":"2014-10-22T16:30:42","slug":"restoring-pharma-i","status":"publish","type":"post","link":"https:\/\/1boringoldman.com\/index.php\/2014\/10\/22\/restoring-pharma-i\/","title":{"rendered":"restoring pharma I…"},"content":{"rendered":"\n
I want to say some things about this article later…<\/div>\n
\n
Restoring the pharmaceutical industry’s reputation<\/a><\/div>\n
by Mark Kessel<\/div>\n
Nature Biotechnology<\/font><\/strong> 2014 32[10]:983–990.<\/div>\n
[full text on-line<\/a>] <\/div>\n<\/blockquote>\n
… but first, here’s a graphic and table to ponder:<\/div>\n

<\/p>\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n
Date <\/font><\/strong><\/td>\nPharma <\/font><\/strong><\/td>\nFine [$M]<\/font><\/strong><\/td>\n Infringement<\/font><\/strong><\/td>\n<\/tr>\n
\n
<\/td>\n<\/tr>\n
02\/2014<\/td>\nEndo
<\/strong> <\/td>\n		193<\/td>\ncriminal<\/font><\/strong> and civil liabilities arising from Endo’s marketing of the prescription drug Lidoderm [lido-caine]. As part of the agreement, Endo admitted that it intended that Lidoderm be used for unapproved indications and that it promoted Lidoderm to healthcare providers this way.<\/td>\n<\/tr>\n
11\/2013<\/td>\nJ&J<\/strong><\/td>\n2,200<\/td>\ncriminal<\/font><\/strong> and civil allegations relating to illegal promotion of the prescription drugs Risperdal [risperidone], invega [paliperidone] and Natrecor [Nesiritide] for uses not approved as safe and effective by the FDA, the targeting of elderly dementia patients in nursing homes, and the payout of kickbacks to physicians and to the nation’s largest long-term care pharmacy provider, Omnicare.<\/td>\n<\/tr>\n
12\/2012<\/td>\nAmgen<\/strong><\/td>\n762<\/td>\ncriminal<\/font><\/strong> and civil charges that the company illegally introduced and promoted several drugs, including Aranesp [darbepoetin alfa], a drug to treat anemia. Amgen pleaded guilty to illegally selling Aranesp to be used at doses that the FDA had explicitly rejected, and for an off-label treatment that FDA had never approved.<\/td>\n<\/tr>\n
<\/td>\nSanofi<\/strong><\/td>\n109<\/td>\nAllegations that company gave doctors free units of Hyalgan [hyaluronate injection to relieve knee pain] to encourage sales, lowered the effective price by promising doctors free samples, while at the same time obtaining inflated prices for the drug from government programs by submitting false price reports.<\/td>\n<\/tr>\n
10\/2012<\/td>\nBoehringer Ingelheim<\/strong><\/td>\n95<\/td>\nAllegations that company promoted several drugs including Aggrenox [aspirin\/dipyridamole], Atrovent [ipratropium], Combivent [Ipratropium\/albuterol] and Micardis [telmisartan] for nonmedical ly accepted uses.<\/td>\n<\/tr>\n
07\/2012<\/td>\nGSK<\/strong><\/td>\n3,000<\/td>\nCivil and criminal<\/font><\/strong> liabilities regarding misbranding of Paxil for treating depression in patients under 18, even though the drug had never been approved for that age group as well as failure to disclose safety information about Avandia to the FDA.<\/td>\n<\/tr>\n
05\/2012<\/td>\nAbbott<\/strong><\/td>\n1,500<\/td>\nillegal promotion of Depakote [divalproex] in indications for which it had never been approved: schizophrenia and control of aggression and agitation in elderly dementia patients.<\/td>\n<\/tr>\n
11\/2011<\/td>\nMerck<\/strong><\/td>\n950<\/td>\nillegal promotion of Vioxx as a treatment for rheumatoid arthritis before it had been approved for that use and misrepresentation of the drug’s heart safety to increase sales.<\/td>\n<\/tr>\n
04\/2010<\/td>\nAstra-Zeneca
<\/strong> <\/td>\n		520<\/td>\nAllegations of illegal promotion of Seroquel [quetiapine] for a variety of unapproved uses, such as aggression, sleeplessness, anxiety and depression. The company paid the fine but denied the allegations.<\/td>\n<\/tr>\n
09\/2009<\/td>\nPfizer<\/strong><\/td>\n2,300<\/td>\nMisbranding Bextra with "the intent to defraud or mislead," promoting the drug to treat acute pain at dosages the FDA had previously deemed dangerously high. Bextra was pulled from the market in 2005 due to safety concerns. The government alleged that Pfizer also promoted three other drugs illegally: Geodon [ziprasidone], Zyvox [linezolid]and Lyrica [pregabalin].<\/td>\n<\/tr>\n
01\/2009<\/td>\nEli Lilly<\/strong><\/td>\n1,420<\/td>\nOff-label promotion of Zyprexa [olanzapine] to elderly populations to treat dementia. The US government also alleged that Lilly targeted primary care physicians to promote Zyprexa for unapproved uses and "trained its sales force to disregard the law."<\/td>\n<\/tr>\n<\/table>\n","protected":false},"excerpt":{"rendered":"

I want to say some things about this article later… Restoring the pharmaceutical industry’s reputation by Mark Kessel Nature Biotechnology 2014 32[10]:983–990. [full text on-line] … but first, here’s a graphic and table to ponder: Date Pharma Fine [$M] Infringement 02\/2014 Endo 193 criminal and civil liabilities arising from Endo’s marketing of the prescription drug […]<\/p>\n","protected":false},"author":2,"featured_media":0,"comment_status":"open","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"_bbp_topic_count":0,"_bbp_reply_count":0,"_bbp_total_topic_count":0,"_bbp_total_reply_count":0,"_bbp_voice_count":0,"_bbp_anonymous_reply_count":0,"_bbp_forum_subforum_count":0,"footnotes":""},"categories":[5],"tags":[],"class_list":["post-51033","post","type-post","status-publish","format-standard","hentry","category-opinion"],"_links":{"self":[{"href":"https:\/\/1boringoldman.com\/index.php\/wp-json\/wp\/v2\/posts\/51033","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/1boringoldman.com\/index.php\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/1boringoldman.com\/index.php\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/1boringoldman.com\/index.php\/wp-json\/wp\/v2\/users\/2"}],"replies":[{"embeddable":true,"href":"https:\/\/1boringoldman.com\/index.php\/wp-json\/wp\/v2\/comments?post=51033"}],"version-history":[{"count":30,"href":"https:\/\/1boringoldman.com\/index.php\/wp-json\/wp\/v2\/posts\/51033\/revisions"}],"predecessor-version":[{"id":51066,"href":"https:\/\/1boringoldman.com\/index.php\/wp-json\/wp\/v2\/posts\/51033\/revisions\/51066"}],"wp:attachment":[{"href":"https:\/\/1boringoldman.com\/index.php\/wp-json\/wp\/v2\/media?parent=51033"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/1boringoldman.com\/index.php\/wp-json\/wp\/v2\/categories?post=51033"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/1boringoldman.com\/index.php\/wp-json\/wp\/v2\/tags?post=51033"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}