{"id":44354,"date":"2014-02-26T23:45:03","date_gmt":"2014-02-27T04:45:03","guid":{"rendered":"http:\/\/1boringoldman.com\/?p=44354"},"modified":"2014-02-27T00:03:19","modified_gmt":"2014-02-27T05:03:19","slug":"a-very-big-rat","status":"publish","type":"post","link":"https:\/\/1boringoldman.com\/index.php\/2014\/02\/26\/a-very-big-rat\/","title":{"rendered":"a very big rat&#8230;"},"content":{"rendered":"<p align=\"justify\">If you work in the medical field, you know that prescription narcotics have become a major drug of abuse in the US. When I started working in a charity clinic in Appalachia, I was stunned by the number of people on Narcotics and how many times I was asked for a refill. When I renewed my DEA license last time, I relinquished my certification for the opioids altogether. So now when asked, I can simply say, &quot;I am not licensed to prescribe those drugs.&quot; There must be a grapevine, because after a couple of months, they stopped asking. While doing that helped my mental health, it didn&#8217;t do much for drug abuse in the county since I never prescribed them anyway. Up here, illicit drug use is almost a cultural phenomenon [replacing the moonshine made in these mountains a generation ago]. The main drug here was Methamphetamine when I first came a decade ago, but a new Sheriff seems to have shut down most of the meth labs. Now it&#8217;s prescription pills. I don&#8217;t know where they come from exactly &#8211; bad doctors? pain clinics? Mexico? other points south? Thefts? Wherever it is, they&#8217;re plenty available.<\/p>\n<div align=\"justify\">Comes now <a href=\"http:\/\/ir.zogenix.com\/phoenix.zhtml?c=220862&#038;p=irol-newsArticle&#038;ID=1868848&#038;highlight=\" target=\"_blank\">Zohydro&trade;ER<\/a>. It&#8217;s a long acting Hydrocodone with no <span class=\"ccbnTxt\">acetaminophen [No acetaminophen is a good thing. Acetaminophen can be toxic to the liver. It&#8217;s the <em>-cet<\/em> in Preco<em>-cet<\/em>, Darvo<em>-cet<\/em>, etc.]. People are understandably up in arms about this drug coming on the market:<\/span><\/div>\n<ul>\n<li><a href=\"http:\/\/www.npr.org\/2014\/02\/26\/282836473\/critics-question-fdas-approval-of-zohydro\" target=\"_blank\">Critics Question FDA&#8217;s Approval Of Zohydro<\/a><\/li>\n<li><a href=\"http:\/\/www.cnn.com\/2014\/02\/26\/health\/zohydro-approval\/\" target=\"_blank\">New pain pill&#8217;s approval: &#8216;Genuinely frightening&#8217;<\/a><\/li>\n<li><span class=\"tl\"><a href=\"http:\/\/www.medpagetoday.com\/PainManagement\/PainManagement\/44491\" target=\"_blank\"><em>Zohydro<\/em>: Is This Painkiller FDA&#8217;s Fatal Mistake?<\/a><\/span><\/li>\n<li><a href=\"http:\/\/www.myfoxtwincities.com\/story\/24823764\/minn-mom-hopes-to-halt-hydrocodone-only-painkiller\" target=\"_blank\">FDA approves pain killer 10 times stronger than Vicodin<\/a><\/li>\n<li><a href=\"http:\/\/www.huffingtonpost.com\/andrew-kolodny-md\/zohydro-the-fdaapproved-p_b_4855964.html\" target=\"_blank\">Zohydro: The FDA-Approved Prescription for Addiction<\/a><\/li>\n<\/ul>\n<div align=\"justify\">They all say the same thing. Why, in the midst of an opiate use epidemic, would the FDA approve a new, potent, long-acting narcotic? This from <a href=\"http:\/\/www.citizen.org\/pressroom\/pressroomredirect.cfm?ID=4093\" target=\"_blank\">PublicCitizen<\/a>:<\/div>\n<blockquote>\n<div align=\"justify\">Feb. 26, 2014<\/div>\n<div align=\"justify\" class=\"big\"><strong>Dozens of Groups, Experts Call on FDA to Withdraw Its Approval of Zohydro, Supercharged Opioid<\/strong><\/div>\n<p align=\"justify\">WASHINGTON, D.C. &ndash; More than 40 consumer organizations, health care  agencies, addiction treatment providers, and community-based drug and  alcohol prevention programs today <a href=\"http:\/\/www.citizen.org\/hrg2185\">called on<\/a>  the U.S. Food and Drug Administration (FDA) to revoke its approval of  Zohydro, an opioid so powerful that a single dose could kill a child. <strong><font color=\"#990000\">The FDA approved the drug in October against the advice of its own  advisory committee, which voted 11-2 against allowing Zohydro, made by  Zogenix and Alkermes, to be sold.<\/font><\/strong> It is the first single-ingredient  hydrocodone drug ever to be approved. Other drugs, such as Vicodin,  combine hydrocodone and acetaminophen. Zohydro is scheduled to be  available in March.<\/p>\n<p align=\"justify\"> \tEarlier this month, three U.S. senators raised concerns  about the drug and asked the FDA to explain how it will prevent misuse.  Writing on behalf of &ldquo;groups on the front-line of the nation&rsquo;s opioid  addiction epidemic,&rdquo; the organizations said there is no need for another  high-dose opioid. &ldquo;Too many people have already become addicted to similar opioid  medications and too many lives have been lost,&rdquo; said Andrew Kolodny,  president of Physicians for Responsible Opioid Prescribing. &ldquo;The FDA  should exercise its responsibility to protect the public&rsquo;s health by  reversing its approval of Zohydro.&rdquo;<\/p>\n<p align=\"justify\"> \t&ldquo;I&rsquo;m worried about their plan to market the drug for back pain and  other common problems,&rdquo; said Judy Rummler, chair of the FED UP!  Coalition and president of the Steve Rummler Hope Foundation.&nbsp; Judy&rsquo;s  son Steve died of a drug overdose in 2011.&nbsp; He had become addicted to  the painkillers that were prescribed to him for his chronic back pain. Opioid prescriptions have skyrocketed in recent years. The U.S. has  just 5 percent of the world&rsquo;s population but is consuming more than 99  percent of the world&rsquo;s hydrocodone. Opioid addiction and overdose deaths  have increased commensurately.<\/p>\n<p align=\"justify\"> \t&ldquo;The capsules will contain a whopping dose of hydrocodone,&rdquo; said Pete  Jackson, president of Advocates for the Reform of Prescription Opioids.  Jackson lost his 18-year-old daughter to a single dose of OxyContin.  &ldquo;It&rsquo;s crazy to let this drug go on the market as it undoubtedly will  become the next OxyContin that will fuel the opioid addiction epidemic.&rdquo; Added Dr. Michael Carome, director of Public Citizen&rsquo;s Health Research  Group, <strong><font color=\"#990000\">&ldquo;I&rsquo;m amazed that the FDA would approve a dangerous new opioid  over the strong objection of its advisory panel. In the midst of a  severe epidemic of opioid addiction and overdose deaths, this is the  last thing we need.&rdquo;&nbsp;<\/font><\/strong><\/p>\n<div> \tThe letter is available at <a href=\"http:\/\/www.citizen.org\/hrg2185\">http:\/\/www.citizen.org\/hrg2185<\/a>.<\/div>\n<\/blockquote>\n<div>And this from this morning&#8217;s <a target=\"_blank\" href=\"http:\/\/www.npr.org\/2014\/02\/26\/282836473\/critics-question-fdas-approval-of-zohydro\">NPR Morning Edition<\/a>:<\/div>\n<blockquote>\n<div align=\"justify\"><strong><font color=\"#200020\">LAURA SULLIVAN, BYLINE:<\/font><\/strong> When Zohydro is released next month, it will  be one of the most powerful prescription painkillers on the market. It&#8217;s  highest dosage will contain five to 10 times as much hydrocodone as the  widely used Vicodin. The drug company&#8217;s literature says an adult could  overdose on two capsules. A child could die from swallowing just one  pill.<\/div>\n<div align=\"justify\"><strong><font color=\"#200020\">DR. MICHAEL CAROME:<\/font><\/strong> People are going to die from this drug.<\/div>\n<div align=\"justify\"><strong><font color=\"#200020\">SULLIVAN:<\/font><\/strong> Dr. Michael Carome is the director of Health Research for Public Citizen.<\/div>\n<div align=\"justify\"><strong><font color=\"#200020\">CAROME:<\/font><\/strong>  We are in the midst of a public health crisis. There is an epidemic of  opioid addiction resulting in thousands of deaths. And the last thing we  need now is another high-potent, high-dose, long-acting opioid drug,  Zohydro, that will simply feed the epidemic.<\/div>\n<div align=\"justify\"><strong><font color=\"#200020\">SULLIVAN:<\/font><\/strong> Overdose  deaths and addiction rates from prescription painkillers similar to  Zohydro have grown dramatically in recent years. Carome and 41 other  healthcare advocates are asking the FDA to remove its approval of the  drug. Zohydro is a crushable pill. That means it&#8217;s snortable and, some  experts say, more prone to abuse than other drugs like the new versions  of Oxycontin, which are no longer crushable. The drug company Zogenix is  marketing the drug.<\/div>\n<div align=\"justify\"><strong><font color=\"#200020\">DR. BRAD GALER:<\/font><\/strong> There&#8217;s a lot of misinformation being put out there by people who don&#8217;t have all the facts.<\/div>\n<div align=\"justify\"><strong><font color=\"#200020\">SULLIVAN:<\/font><\/strong>  Dr. Brad Galer is the company&#8217;s chief medical officer. He says they  will introduce a non-crushable version of Zohydro in three years. And  the company will closely monitor prescription transfer abuse. But he  says millions legitimately need this drug.<\/div>\n<div align=\"justify\"><strong><font color=\"#200020\">GALER:<\/font><\/strong> We&#8217;re talking  about patients that are in bed, depressed, can&#8217;t sleep, can&#8217;t work,  can&#8217;t interact with their loved ones &#8211; it&#8217;s a very significant medical  health problem that is being ignored.<\/div>\n<div align=\"justify\"><strong><font color=\"#200020\">SULLIVAN:<\/font><\/strong> That argument  isn&#8217;t sitting will with public health advocates. Dr. Andrew Kolodny is  chief medical officer at the Phoenix House Foundation.<\/div>\n<div align=\"justify\"><strong><font color=\"#200020\">DR. ANDREW KOLODNY:<\/font><\/strong> We have many opiate formulations on the market. There&#8217;s absolutely no need for a new opioid formulation.<\/div>\n<div align=\"justify\"><strong><font color=\"#200020\">SULLIVAN:<\/font><\/strong> <strong><font color=\"#990000\"> FDA&#8217;s own advisory panels seem to agree. The panel voted 11-to-2 not to  approve the drug. Then in November, top FDA officials overruled that  panel. And that&#8217;s where things get complicated. Last fall, a series of  emails were made public from a Freedom of Information Act request. They  were emails between two professors who had, for a decade, organized  private meetings between FDA officials and drug companies who make pain  medicine. The drug companies pay the professors thousands of dollars to  attend. And here&#8217;s what has critics concerned. One of those  companies was Zohydro&#8217;s original manufacturer, Elan Corporation. Zogenix  wasn&#8217;t in the picture yet but went on to partner with Elan.<\/font><\/strong><\/div>\n<div><strong><font color=\"#200020\">Dr. Kolodny of <a href=\"http:\/\/www.phoenixhouse.org\/\" target=\"_blank\">Phoenix House Foundation<\/a>.<\/font><\/strong><\/div>\n<div align=\"justify\"><strong><font color=\"#200020\">KOLODNY:<\/font><\/strong> When those emails surfaced, I think for many of us there was a sense of a-ha.<\/div>\n<div align=\"justify\"><strong><font color=\"#200020\">SULLIVAN:<\/font><\/strong> Elan has a new owner and the company did not respond to requests for comment.<font color=\"#200020\"><strong> <\/strong><\/font>In  a statement, the FDA said the meetings did not address specific drugs  and that the FDA took part to develop better research methods. The  statement says those research methods may have benefitted companies  making pain drugs but that they also benefitted patients.<font color=\"#200020\"><strong> <\/strong><\/font>Zohydro&#8217;s Dr. Galer attended the meetings when he worked for another drug company.<\/div>\n<div align=\"justify\"><strong><font color=\"#200020\">GALER:<\/font><\/strong> Those actually were looking at old studies to improve patient care.<\/div>\n<div align=\"justify\"><strong><font color=\"#200020\">SULLIVAN:<\/font><\/strong>  So I asked him: But if the drug manufacturers are sitting in a room  with FDA officials talking about pain drugs, and they&#8217;re there because  they spent 20 to 30 thousand dollars to be in the room, and some of the  other advocates aren&#8217;t allowed in that room at the same time, does that  raise any concerns for you that that could be a conflict of interest?<\/div>\n<div align=\"justify\"><strong><font color=\"#200020\">GALER:<\/font><\/strong>  Well, again, I&#8217;m here as chief medical officer for Zogenix. Zogenix was  not involved whatsoever. All I can say is that this medication, Zohydro  ER, will benefit many patients&#8230;<\/div>\n<\/blockquote>\n<div>We don&#8217;t yet know this whole story, but there&#8217;s a hue and cry so loud that we&#8217;re surely going to know it soon. The smell of a very big rat permeates these reports&#8230;<\/div>\n","protected":false},"excerpt":{"rendered":"<p>If you work in the medical field, you know that prescription narcotics have become a major drug of abuse in the US. When I started working in a charity clinic in Appalachia, I was stunned by the number of people on Narcotics and how many times I was asked for a refill. When I renewed [&hellip;]<\/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":[2],"tags":[],"class_list":["post-44354","post","type-post","status-publish","format-standard","hentry","category-politics"],"_links":{"self":[{"href":"https:\/\/1boringoldman.com\/index.php\/wp-json\/wp\/v2\/posts\/44354","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=44354"}],"version-history":[{"count":10,"href":"https:\/\/1boringoldman.com\/index.php\/wp-json\/wp\/v2\/posts\/44354\/revisions"}],"predecessor-version":[{"id":44364,"href":"https:\/\/1boringoldman.com\/index.php\/wp-json\/wp\/v2\/posts\/44354\/revisions\/44364"}],"wp:attachment":[{"href":"https:\/\/1boringoldman.com\/index.php\/wp-json\/wp\/v2\/media?parent=44354"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/1boringoldman.com\/index.php\/wp-json\/wp\/v2\/categories?post=44354"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/1boringoldman.com\/index.php\/wp-json\/wp\/v2\/tags?post=44354"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}