3 drugmakers dominated opioid supplies as epidemic raged: report


2019-07-17 13:30:36 pharma


As the nation’s opioid epidemic spiraled out of control at the turn of the decade, parts of rural America seemed awash in prescription drugs. But the extent to which drug distributors and manufacturers pumped opioids into those communities was unknown to the public—until now. The 10 most prolific drug distributors together shoveled around 62.3 billion opioid pills into American pharmacies between 2006 and 2012, at the height of an addiction crisis that caused nearly 100,000 overdose deaths in that span, according to previously sealed data compiled by the U.S. Drug Enforcement Agency (DEA). Meanwhile, three drugmakers produced 85% of the supply.  The government’s database, known as ARCOS, was previously held under federal seal as part of a Multi-District Litigation (MDL) in Cleveland, which pits some 2,000 towns, cities and counties against about 20 drugmakers and distributors. According to the Washington Post, which sued to gain access to the database, McKesson led the way among distributors, sending out 14.1 billion pills in a six-year span—or roughly 18.4% of the opioid supply. Rounding out the top five on the distributor list were Walgreens, Cardinal Health, AmerisourceBergen and CVS. All told, those five distributors controlled around 75% of the opioid supply during that time, although consolidated distribution among a small group of companies is not unusual in the drug industry. On the manufacturing side, three companies—SpecGx, a subsidiary of what is now Mallinckrodt; Actavis Pharma, the former generics giant now owned by Teva; and Par Pharmaceutical, a then-independent company now owned by Endo—turned out 85% of the opioid pills that made their way into U.S. pharmacies. Purdue Pharma, the developer of the most notorious opioid brand, OxyContin, came in fourth place with 3% of the market. Generic versions of the med, from Teva and Endo, were first approved in 2004.  A Mallinckrodt spokesman told the Washington Post in a statement that the company's opioid production was government-controlled and that the company only sold to DEA-approved distributors. Teva, which acquired Actavis in 2016, did not comment on Actavis' activity. Endo declined to comment to the Post.  RELATED: Lawyers pitch massive opioid negotiation plan to bring 'global peace' to legal battle The behemoth Cleveland MDL is the only consolidated litigation attempting to hold the top of the drug industry’s supply chain accountable for its alleged role in creating and fueling the opioid epidemic. While individual cases have netted settlements from companies like Purdue Pharma and Teva, the MDL has prosecutors and the bench judge searching for novel ways to wrap up the litigation. In early June, prosecutors proposed a “global peace” process that would rope all 2,000 or so plaintiffs into a single “negotiation class”—with an opt-out clause—in an attempt to net a single large settlement in the litigation. The proposal could be a win-win for both sides: Cities and counties would receive a settlement proportionate to the number of opioids distributed there and the number of overdose deaths, and drugmakers could settle a case that “legally forecloses” any future litigation. RELATED: J&J called 'kingpin' of Oklahoma opioid epidemic. Will a judge agree? In the event the MDL does go to trial, a verdict in a case involving Johnson & Johnson and the state of Oklahoma could have major implications for how the trial will take shape. On Monday, both parties presented closing arguments in a bench trial in which J&J was described as the “kingpin” of drugmakers responsible for the state’s opioid crisis. The state’s argument revolves around J&J’s aggressive marketing of its own opioid products as well as its role in providing other drugmakers with a cheap “mutant poppy” to boost production. J&J has denied its role in the epidemic, saying the facts of the case “simply don’t align with what the state is claiming,” according to CFO Joe Wolk. RELATED: As Purdue settles first opioid case, analysts say the company could face billions in total costs J&J’s case is unique in that it is the first time a drugmaker has actually gone to trial on charges it helped spur a public health crisis. The state of Oklahoma previously secured a combined $355 million in settlements from Purdue and Teva, which kept them out of the courtroom. Purdue and its billionaire founding family, the Sacklers, have been the focus of hundreds of lawsuits for their marketing of OxyContin. After the Sacklers and Purdue settled with the state of Oklahoma for $270 million, analysts said future settlements could run into the billions and potentially require Purdue to file for bankruptcy to cover the expense.
随着十年之交美国鸦片类流行病失控,美国农村地区似乎充斥着处方药。但是,直到现在,药品分销商和制造商向这些社区注入阿片类药物的程度还不为公众所知。 根据美国缉毒署( U.S . Drug Enforcement Agency , DEA )此前密封的数据,2006年至2012年间,10家最多产的药品分销商共向美国药店提供了623亿粒阿片类药物,这是在成瘾危机最严重时期,在这一时期造成了近10万人的过量用药死亡。与此同时,三家制药商生产了85%的供应。 政府的数据库被称为 ARCCOS ,以前是作为克利夫兰地区多地区诉讼( MDL )的一部分,由联邦政府密封保存的,该诉讼将大约2000个城镇和县与大约20家制药商和经销商进行对决。 据华盛顿邮报报道, McKesson 为了获得数据库的访问权限而起诉,在分销商中占据领先地位,在六年时间里共发放141亿粒药丸,约占阿片类药物供应量的18.4%。在经销商名单上排在前五位的是沃尔格林、红衣主教健康、美国人源贝根和 CVS 。 总之,这五家分销商控制了当时约75%的阿片类药物供应,尽管少数公司之间的合并分销在制药业并不少见。 在制造业方面,有三家公司—— SpecGx ,现在是 Mallinkrodt 的子公司; Actavis Pharma ,现在由梯瓦(Teva)拥有的原仿制药巨头; Par Pharmaceutical ,现在由远藤(Endo)拥有的独立公司——生产出了85%的阿片类药物,它们进入了美国药店。 最臭名昭著的阿片类药物品牌 OxyContin 的开发商 PurduePharma 以3%的市场份额位居第四。来自梯瓦(Teva)和远藤(Endo)的 med 的通用版本于2004年首次获得批准。 Mallinkrodt 发言人在一份声明中告诉《华盛顿邮报》,该公司的阿片类药物生产是由政府控制的,该公司只向经 DEA 批准的经销商销售。2016年收购 Actavis 的梯瓦(Teva)没有对 Actavis 的活动发表评论。恩多拒绝对《邮报》发表评论。 相关报道:律师们提出了大规模的阿片类药物类谈判计划,以使“全球和平”合法化 规模庞大的克利夫兰 MDL 公司( Cleveland MDL )是唯一一宗试图让制药业供应链最高层对其涉嫌在制造和助长阿片类疾病流行方面的作用负责的合并诉讼。尽管个别案件已经从普渡制药( Purdue Pharma )和梯瓦( Teva )等公司获得了和解,但 MDL 的检察官和法官都在寻找新的方法来结束诉讼。 今年6月初,检察官提出了一个“全球和平”进程,将所有2000名左右的原告拖入一个单一的“谈判班”——带有“选择退出”条款——以求在诉讼中达成单一的大规模和解。 这一提议可能对双方都是双赢的:城市和县将获得与分布在那里的阿片类药物类药物数量和过量用药死亡人数成比例的和解,制药商可以解决一个“合法取消”任何未来诉讼的案件。 相关报道: J & J 被称为俄克拉何马类阿片类药物泛滥的“金针病”。法官会同意吗? 如果 MDL 真的接受审判,在涉及强生和俄克拉荷马州的案件中做出的判决可能会对审判的形成产生重大影响。 周一,两党在一次庭审中都提出了结束辩论的理由。在这次庭审中,强生(J&J)被描述为负责政府阿片类药物危机的制药商的“王牌”。美国政府的论点围绕着强生(J&J)积极推销自己的阿片类药物类产品,以及它在为其他制药商提供廉价的“突变罂粟”以促进生产方面的作用展开。 首席财务官乔•沃尔克( Joe Wolk )表示,强生(J&J)否认自己在这场流行病中扮演的角色,称此案的事实“与政府声称的完全不符”。 相关报道: Purdue 解决了第一个阿片类药物的案件,分析人士说,该公司可能面临数十亿美元的总成本 强生(J&J)的案例之所以独特,是因为它是制药商首次真正接受审判,因为它帮助引发了一场公共卫生危机。俄克拉何马州之前从普渡和梯瓦(Teva)获得了总计3.55亿美元的定居点,使他们无法进入法庭。 普渡和它的亿万富豪家族萨克勒家,一直是数百个诉讼的焦点,他们的营销 OxyContin 。在 Sacklers 和 Purdue 以2.7亿美元与俄克拉荷马州达成和解后,分析师表示,未来的和解可能会达到数十亿美元,并可能要求 Purdue 申请破产以支付这笔费用。