{"id":49355,"date":"2014-09-04T12:08:30","date_gmt":"2014-09-04T16:08:30","guid":{"rendered":"http:\/\/1boringoldman.com\/?p=49355"},"modified":"2014-09-06T20:18:56","modified_gmt":"2014-09-07T00:18:56","slug":"an-echo-that-needs-to-keep-reverberating","status":"publish","type":"post","link":"https:\/\/1boringoldman.com\/index.php\/2014\/09\/04\/an-echo-that-needs-to-keep-reverberating\/","title":{"rendered":"an echo that needs to keep reverberating&#8230;"},"content":{"rendered":"<div align=\"justify\" class=\"small\"><img decoding=\"async\" width=\"120\" vspace=\"5\" hspace=\"4\" align=\"right\" border=\"1\" src=\"http:\/\/www.the-alcoholism-guide.org\/images\/zoloft2.jpg\" \/>Dr. Roy Poses of <a href=\"http:\/\/hcrenewal.blogspot.com\/\" target=\"_blank\"><font color=\"#0033ff\">Healthcare Renewal<\/font><\/a> often writes about a concept &#8211; the <em><strong><font color=\"#200020\">anechoic effect<\/font><\/strong><\/em> [see <a href=\"http:\/\/1boringoldman.com\/index.php\/2013\/03\/30\/themes\/\" target=\"_blank\">themes&hellip;<\/a>]. We all know about it. Some big story comes along and there&#8217;s a big reaction, outrage around, but then interest peters out and it&#8217;s forgotten &#8211; worse, nothing is done about it. It happens all the time. And in keeping up with the antics of the pharmaceutical companies, it&#8217;s the rule rather than the exception. There ought to be a registry of things to keep on the front burner. In my case, the registry is some phrases scratched on the back of a coffe stained envelope pinned to the wall. One of them says &quot;<em>Plumlee &#8211; Zoloft?<\/em>&quot; Back in the beginning of 2013, I ran across a suit, <a target=\"_blank\" href=\"http:\/\/www.baumhedlundlaw.com\/pdf\/zoloft-class-action-efficacy-lawsuit.pdf\">Laura A. Plumlee et. al. v. Pfizer<\/a> [see <a href=\"http:\/\/1boringoldman.com\/index.php\/2013\/02\/05\/a-wide-net\/\" target=\"_blank\">a wide net&hellip;<\/a>], that was intriguing. It alleged that Zoloft didn&#8217;t work and asked that Pfizer refund the money to those taken in by the drug&#8217;s ads. At first, it seemed far fetched, but not after I read the case. So I went looking for the NDA on the FDA site, but it wasn&#8217;t there. So I submitted an FOIA request to the FDA and when it showed up, it gave me plenty to write about:<\/div>\n<ul> <span class=\"small\">             <\/p>\n<li><a target=\"_blank\" href=\"http:\/\/1boringoldman.com\/index.php\/2013\/02\/17\/zoloft-the-approval-i\/\">zoloft: the approval I&hellip;      <\/a><\/li>\n<li><a target=\"_blank\" href=\"http:\/\/1boringoldman.com\/index.php\/2013\/02\/18\/zoloft-the-approval-ii\/\">zoloft: the approval II&hellip;      <\/a><\/li>\n<li><a target=\"_blank\" href=\"http:\/\/1boringoldman.com\/index.php\/2013\/02\/18\/zoloft-the-approval-iii\/\">zoloft: the approval III&hellip;      <\/a><\/li>\n<li><a target=\"_blank\" href=\"http:\/\/1boringoldman.com\/index.php\/2013\/02\/19\/zoloft-beyond-the-approval-i\/\">zoloft: beyond the approval I&hellip; <\/a><\/li>\n<li><a target=\"_blank\" href=\"http:\/\/1boringoldman.com\/index.php\/2013\/02\/19\/zoloft-beyond-the-approval-ii\/\">zoloft: beyond the approval II&hellip;<\/a><\/li>\n<li><a target=\"_blank\" href=\"http:\/\/1boringoldman.com\/index.php\/2013\/02\/19\/zoloft-the-epilogue\/\">zoloft: the epilogue&hellip; <\/a><br \/>   &#8230;<\/li>\n<li><a target=\"_blank\" href=\"http:\/\/1boringoldman.com\/index.php\/2013\/11\/30\/graphic-reflections\/\">graphic reflections&hellip;<\/a><\/li>\n<p>             <\/span><\/ul>\n<p align=\"justify\" class=\"small\">They submitted six studies [only one made the grade, and it was a very weak showing]:<\/p>\n<table align=\"center\" cellspacing=\"0\" cellpadding=\"0\" border=\"0\" class=\"small\">\n<tr>\n<td align=\"center\" colspan=\"7\"><strong><font color=\"#200020\">Placebo Controlled Clinical Trials<\/font><\/strong>                       <\/p>\n<hr size=\"1\" \/><\/td>\n<\/tr>\n<tr>\n<td align=\"center\"><strong><font color=\"#200020\">Study<\/font><\/strong>                       <\/p>\n<hr size=\"1\" \/><\/td>\n<td width=\"25\" rowspan=\"7\">&nbsp;<\/td>\n<td align=\"center\"><strong><font color=\"#200020\">Site<\/font><\/strong>                       <\/p>\n<hr size=\"1\" \/><\/td>\n<td width=\"25\" rowspan=\"7\">&nbsp;<\/td>\n<td align=\"center\"><strong><font color=\"#200020\">Type<\/font><\/strong>                       <\/p>\n<hr size=\"1\" \/><\/td>\n<td width=\"25\" rowspan=\"7\">&nbsp;<\/td>\n<td align=\"center\"><strong><font color=\"#200020\">Outcome<\/font><\/strong>                       <\/p>\n<hr size=\"1\" \/><\/td>\n<\/tr>\n<tr>\n<td align=\"left\"><sup><strong>protocol 103<br \/>            <\/strong><\/sup><\/td>\n<td align=\"left\"><sup><strong><font color=\"#660033\">outpatient<\/font><\/strong><\/sup><\/td>\n<td align=\"center\"><sup><strong>fixed dose<\/strong><\/sup><\/td>\n<td align=\"left\"><sup><strong>questionable<\/strong><\/sup><\/td>\n<\/tr>\n<tr>\n<td align=\"left\"><sup><strong><\/strong><strong>protocol<\/strong> 101<br \/>            <\/sup><\/td>\n<td align=\"left\"><sup><strong>inpatient<\/strong><\/sup><\/td>\n<td align=\"center\"><sup><strong>fixed dose<br \/>                 <\/strong><\/sup><\/td>\n<td align=\"left\"><sup><strong>negative<\/strong><\/sup> <\/td>\n<\/tr>\n<tr>\n<td align=\"left\"><sup><strong><\/strong><strong>protocol<\/strong> 310<br \/>            <\/sup><\/td>\n<td align=\"left\"><sup><strong>inpatient<\/strong><\/sup><\/td>\n<td align=\"center\"><sup><strong>fixed dose<br \/>                 <\/strong><\/sup><\/td>\n<td align=\"left\"><sup><strong>negative<\/strong><\/sup> <\/td>\n<\/tr>\n<tr>\n<td align=\"left\"><sup><strong><\/strong><strong>protocol<\/strong> 104<br \/>            <\/sup><\/td>\n<td align=\"left\"><sup><strong><font color=\"#660033\">outpatient<\/font><\/strong><\/sup><\/td>\n<td align=\"center\"><sup><strong>titrated dose<br \/>                 <\/strong><\/sup><\/td>\n<td align=\"left\"><sup><strong>positive<\/strong><\/sup><\/td>\n<\/tr>\n<tr>\n<td align=\"left\"><sup><strong><\/strong><strong>protocol<\/strong> 315<br \/>            <\/sup><\/td>\n<td align=\"left\"><sup><strong>outpatient<\/strong><\/sup><\/td>\n<td align=\"center\"><sup><strong>titrated dose<br \/>                 <\/strong><\/sup><\/td>\n<td align=\"left\"><sup><strong>negative<\/strong><\/sup> <\/td>\n<\/tr>\n<tr>\n<td align=\"left\"><sup><strong><\/strong><strong>protocol<\/strong> 320<br \/>            <\/sup><\/td>\n<td valign=\"top\" align=\"left\"><sup><strong><font color=\"#660033\">outpatient<\/font><\/strong><\/sup><\/td>\n<td align=\"center\"><sup><strong>open label, relapse<\/strong><\/sup><\/td>\n<td valign=\"top\" align=\"left\"><sup><strong>whatever<\/strong><\/sup> <\/td>\n<\/tr>\n<\/table>\n<p align=\"justify\" class=\"small\">The FDA reviewers did not recommend approval. The committee was on its way to denying approval when the head of the FDA [Dr. Paul Leber] who had assured Pfizer he could get it approved entered the discussion with a speech and, as he predicted, he got &quot;it through.&quot; It was hardly an exemplary day for the FDA. Reading it, I could easily see why the suit was filed. The plaintiff was right on target. Oh. by the way &#8211; it had been turned down already in Europe, but the FDA committee didn&#8217;t know that [because Pfizer didn&#8217;t tell them].<\/p>\n<div align=\"justify\" class=\"small\">I posted this in <a target=\"_blank\" href=\"http:\/\/1boringoldman.com\/index.php\/2013\/02\/19\/zoloft-beyond-the-approval-ii\/\">zoloft: beyond the approval II&hellip;<\/a>:<\/div>\n<blockquote>\n<div align=\"justify\">This graph is number of prescriptions written by  year. Zoloft passed Prozac in 2000 [about halfway through its patent  life], and it continued to dominate the market share until going generic  in 2006 [when it was replaced at the top by generic Zoloft]. It was a  $30 B drug:     <\/div>\n<div align=\"center\"><img loading=\"lazy\" decoding=\"async\" width=\"392\" height=\"234\" border=\"0\" src=\"http:\/\/1boringoldman.com\/images\/zoloft-sales-1.gif\" \/> <\/div>\n<\/blockquote>\n<div class=\"small\">I&#8217;ve checked along the way occasionally, but true to the anechoic effect&#8217;s power, I missed this report in March and only saw it on a <em>back-of-the-envelope registery<\/em> inventory this morning [sorry about the length, but I thought it deserved a full read]:         <\/div>\n<blockquote>\n<div align=\"center\" class=\"big\"><a href=\"http:\/\/www.lawyersandsettlements.com\/articles\/pfizer-faces-zoloft-consumer-fraud-class-action\/drug-side-effects-medical-device-companies-dangerous-13-19628.html#.VAhwsmOOpOw\" target=\"_blank\">Proposed Zoloft Class-Action Defective Drug Lawsuit Down but Not Out<\/a><\/div>\n<div align=\"center\" class=\"big\"><strong><font color=\"#200020\">Lawyers and Settlements<\/font><\/strong><\/div>\n<div align=\"center\" class=\"middle\">by Gordon Gibb<\/div>\n<div align=\"center\" class=\"small\">March 24, 2014<\/div>\n<p align=\"justify\">A proposed <a target=\"_blank\" href=\"http:\/\/www.bigclassaction.com\/lawsuit\/pfizer-faces-zoloft-consumer-fraud-class-action.php\"><em>Zoloft class-action lawsuit<\/em><\/a>  alleging Zoloft is a defective drug because it offers little more  efficacy than a placebo, or so it is alleged, was recently tossed by a  federal judge due to a time-barring issue and other legal implications.  However all is not lost; the presiding magistrate left the door open a  crack for a possible continuation of the complaint, with some revisions.<\/p>\n<p align=\"justify\">In <em>Plumlee v. Pfizer Inc.,<\/em>  Case No. 5:13-cv-00414, in the US District Court for the Northern  District of California, plaintiff Laura Plumlee took Zoloft manufacturer  Pfizer to task for marketing a drug that was alleged to be ineffective,  with questionable efficacy, due to a claim that most clinical trials  found that Zoloft was no more effective than a placebo, or so Plumlee  claimed. Her lawsuit alleges that Pfizer purposely omitted, in Zoloft labeling,  any studies that showed Zoloft to be ineffective, while favoring studies  that showed Zoloft was, indeed, more effective than a placebo. Plumlee  also alleged that Pfizer&rsquo;s marketing and advertising was also misleading  in touting Zoloft, an antidepressant, as effective.<\/p>\n<div align=\"justify\">However, Plumlee&rsquo;s claim was dismissed not on her argument of  effectiveness, but due to time barring. It has been reported that  Plumlee brought her defective drug lawsuit under two statutes observed  by the state of California: that of the Unfair Competition Law, and the  Consumer Legal Remedies Act and False Advertising Law.<\/div>\n<\/blockquote>\n<div class=\"small\">Gulp!<\/div>\n<blockquote>\n<div align=\"justify\"><u><strong>Was plaintiff&rsquo;s claim time-barred?<\/strong><\/u><br \/>                The two aforementioned statutes, under California law, carry limitations  of four years and three years, respectively. In her ruling dismissing  the plaintiff&rsquo;s claim, US District Judge Lucy Koh ruled that Plumlee&rsquo;s  complaint went beyond the limitation boundaries, given the plaintiff&rsquo;s  claim that she last used Zoloft in 2008 but waited until January 2013 to  bring her lawsuit.<\/div>\n<p align=\"justify\">lumlee challenged that such limitations were tolled until 2012, the  point at which Plumlee first discovered that Zoloft had been  misrepresented. The judge, however, held that Plumlee&rsquo;s claim to  discovering Zoloft&rsquo;s inadequacies in &ldquo;early 2012&rdquo; was too general a  frame of time. Judge Koh also was not satisfied with the detail  supporting the time and surrounding circumstances of her discovery.<\/p>\n<div align=\"justify\">To that end, the judge pointed to the existence of various scientific  articles &#8211; cited by the plaintiff &#8211; that had been published long before  Plumlee brought her drug defects lawsuit, and thus did not accept the  plaintiff&rsquo;s claim. However, the judge left the door open.<\/div>\n<\/blockquote>\n<div class=\"small\">Hope springs eternal&#8230;        <\/div>\n<blockquote>\n<div align=\"justify\"><u><strong><font color=\"#200020\">All is not lost for this Zoloft defective medical products action<\/font><\/strong><\/u><br \/>              In dismissing the plaintiff&rsquo;s claim, Judge Koh is allowing Plumlee to  amend her complaint going forward. It is telling, as well, that the  California judge ruled that Pfizer has the freedom to access certain  aspects of the plaintiff&rsquo;s medical history. Plumlee had sought to block  Pfizer&rsquo;s access to her medical records. A previous magistrate&rsquo;s ruling  that allowed Pfizer access was supported by Judge Koh on grounds that  Plumlee had waived any privilege of protecting her medical history when  she argued that the statutes of limitations were tolled due to her  learning of Zoloft&rsquo;s alleged deficiencies only in early 2012.<\/div>\n<p align=\"justify\">Plumlee, according to various reports, had sought to represent a  proposed class of plaintiffs who may have used Zoloft from the point at  which it was introduced to market in 1991, through to present day.  However, the judge suggested that Plumlee may not be typical of the  class, given that she claims to have used Zoloft for a period of three  years even though it did not appear to be working for her. Records also  demonstrated that the lead plaintiff relied more upon Zoloft marketing  and advertising, than the advice of her doctor.<\/p>\n<p align=\"justify\">Pundits suggest that in leaving the door open, the judge feels the  proposed class-action lawsuit may have merit, in spite of deficiencies  exhibited by Plumlee&rsquo;s claim. The potential, thus, is for Plumlee to  amend her claim that satisfies time-barred limitations and other  deficiencies as articulated by the presiding judge. Could the proposed  class-action lawsuit proceed with a different lead plaintiff?<\/p>\n<p align=\"justify\">Harmful drugs are often shown to carry risks, in spite of the position  of the US Food and Drug Administration (FDA) that holds that a drug&rsquo;s  benefits outweigh the risks for the class or constituency of patients to  which the drug is targeted. In the same vein, however, drug defects can  also include deficiencies that suggest a drug is not worth the  financial outlay, either by an individual or group, in exchange for potentially limited effectiveness.<\/p>\n<div align=\"justify\">The aforementioned Zoloft lawsuit alleges Zoloft does not live up to its  promises. The proposed class action, alleging defective medical  products (Zoloft, as ineffective), could continue with amendments &#8211; but  perhaps not in its present form.<\/div>\n<\/blockquote>\n<div align=\"justify\" class=\"small\">I can&#8217;t find anything else. I&#8217;ll write <strong><font color=\"#200020\">Baum&middot;Hedlund&middot;Aristei&middot;Goldman<\/font><\/strong>, the firm handling the case, to see what I can find out. This is an echo that needs to keep reverberating&#8230;       <\/div>\n<hr size=\"1\" \/>\n<div class=\"small\"><u><strong><font color=\"#200020\">UPDATE<\/font><\/strong><\/u>: Nosing around looking for email addresses, I ran across this:<\/div>\n<blockquote>\n<div align=\"center\" class=\"big\"><a target=\"_blank\" href=\"https:\/\/www.law360.com\/articles\/572777\">Pfizer Ducks Zoloft False-Ad Claims In Calif.<\/a><\/div>\n<div align=\"center\" class=\"big\"><strong><font color=\"#200020\">Law360<\/font><\/strong><\/div>\n<div align=\"center\" class=\"middle\">By Sindhu Sundar<\/div>\n<div align=\"center\" class=\"small\">September 02, 2014<\/div>\n<p align=\"justify\"> Pfizer Inc. on Friday defeated for the second time allegations that it greatly exaggerated the efficacy of its antidepressant Zoloft, when a federal judge in California ruled the proposed class action claims are time-barred and dismissed the suit with prejudice.<\/p>\n<p align=\"justify\">  U.S. District Judge Lucy H. Koh, who in February had dismissed Laura Plumlee&#8217;s suit but allowed the plaintiff to amend her suit to address the court&#8217;s timeliness concerns, granted Pfizer&#8217;s motion to dismiss the suit with prejudice Friday&#8230;<\/p>\n<p align=\"justify\">Plumlee last bought Zoloft or its generic equivalent in 2008, and by the  time she brought her suit in 2013, she had exceeded by at least seven  months the statutes of limitations under the various California consumer  protection laws she invoked, Judge Koh ruled.<\/p>\n<p align=\"justify\"> &quot;The court finds that each of plaintiff&rsquo;s claims is time-barred and that  despite being granted an opportunity to amend her complaint, plaintiff  has still not met her burden of showing that the statutes of limitations  have been tolled by the delayed discovery rule,&quot; Judge Koh said in her  opinion.<\/p>\n<p align=\"justify\">Plumlee, who had filed her original suit in January 2013, claimed that  she did not learn about Pfizer&#8217;s alleged over-representation&#8217;s about  Zoloft&#8217;s effectiveness until she watched a &quot;60 Minutes&quot; segment in May  2012, according to the order.<\/p>\n<p align=\"justify\">&quot;We are pleased with the decision and believe the court applied  California law correctly in ruling to dismiss the case with prejudice,&quot;  Pfizer spokesman Steven Danehy said in a statement Tuesday. &quot;Pfizer has  always believed that the plaintiff&rsquo;s amended complaint fails to  adequately address the deficiencies of the original complaint, which was  previously dismissed.&quot;<\/p>\n<p align=\"justify\">An attorney for Plumlee could not immediately be reached for comment Tuesday.<\/p>\n<p align=\"justify\">Plumlee had sought to represent a proposed class of patients who used  Zoloft made by Pfizer between the drug&#8217;s launch date in 1991 through the  present. She claimed that Zoloft&#8217;s labeling failed to mention the  studies showing it to be ineffective, that Pfizer favored researchers  who showed Zoloft to be effective, and that the company&#8217;s advertisements  misleadingly touted the drug as effective, among other allegations.<\/p>\n<div align=\"justify\">She claimed for instance, that Pfizer buttered up doctors with  blandishments including ski trips and &quot;fancy&quot; meals, to encourage them  to prescribe Zoloft, according to court documents.<\/div>\n<\/blockquote>\n<div class=\"small\">Damn! And look at the date! I must&#8217;ve heard it in my sleep last night. Back to the drawing board&#8230;<\/div>\n","protected":false},"excerpt":{"rendered":"<p>Dr. Roy Poses of Healthcare Renewal often writes about a concept &#8211; the anechoic effect [see themes&hellip;]. We all know about it. Some big story comes along and there&#8217;s a big reaction, outrage around, but then interest peters out and it&#8217;s forgotten &#8211; worse, nothing is done about it. It happens all the time. And [&hellip;]<\/p>\n","protected":false},"author":2,"featured_media":0,"comment_status":"closed","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-49355","post","type-post","status-publish","format-standard","hentry","category-politics"],"_links":{"self":[{"href":"https:\/\/1boringoldman.com\/index.php\/wp-json\/wp\/v2\/posts\/49355","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=49355"}],"version-history":[{"count":29,"href":"https:\/\/1boringoldman.com\/index.php\/wp-json\/wp\/v2\/posts\/49355\/revisions"}],"predecessor-version":[{"id":49428,"href":"https:\/\/1boringoldman.com\/index.php\/wp-json\/wp\/v2\/posts\/49355\/revisions\/49428"}],"wp:attachment":[{"href":"https:\/\/1boringoldman.com\/index.php\/wp-json\/wp\/v2\/media?parent=49355"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/1boringoldman.com\/index.php\/wp-json\/wp\/v2\/categories?post=49355"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/1boringoldman.com\/index.php\/wp-json\/wp\/v2\/tags?post=49355"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}