临床试验
临床试验研究中的人和事
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临床试验
临床试验研究中的人和事 |
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2007-7-31
星期二(Tuesday)
晴
Source: Standard & Poor's Industry Investment Reviews By Herman B. Saftlas; 28 July 2007
Our fundamental outlook for the S&P Pharmaceuticals Index is positive. Second quarter sales and EPS performances by most big pharma names have either met or exceeded expectations. Top line growth has reflected positive foreign exchange, price increases and contributions from new products, while EPS comparisons continue to benefit from aggressive cost cutting and common share buybacks. With positives trends likely to continue in the second half, many companies also raised EPS guidance for 2007. We think investors will probably continue to favor this sector, given what we see as its recession resistant characteristics and anticipated positive EPS momentum over the coming quarters. Key positive drivers, in our view, include improved new product flow and cost streamlining measures. We expect that the number of new molecular entities (NMEs) to be approved in 2007 will be comparable to 2006's 18. We also think many drug stocks offer attractive P/Es and dividend yields. Our recommendations comprise what we see as attractively valued companies with above-average total return potential. Despite near-term uncertainties over pricing and patent expirations, we think pharmaceuticals remain one of the healthiest and widest-margin U.S. industries. We see longer-term prospects being enhanced by demographic growth in the elderly (which account for about 33% of industry sales) and by new therapeutic products from discoveries in genomics and biotechnology. In our view, merger cost savings and synergies should also bolster profits at many companies. Year to date through July 20, 2007, the S&P Pharmaceuticals Index was up 3.3%, versus an 8.6% increase in the S&P 1500. We see prospects for the generic/specialty pharmaceutical segment remaining favorable. We see a large number of blockbuster drugs losing patent protection over the next few years providing significant opportunities for this sector. We also think the new Medicare drug plan will be especially beneficial to generic firms. We favor companies with rich generic pipelines, especially with first-to-file generics with the potential for 180 days of marketing exclusivity, and competence in litigating complex patent issues.
2007-7-28
星期六(Saturday)
晴
看到一则关于临床试验注册中心的新闻。
难道以后所有国内的试验都要在http://www.chictr.org这上面注册？ 会不会与http://www.clinicaltrials.gov/上面重复注册呢？ http://news.xinhuanet.com/society/2007-07/25/content_6429319.htm 世界第四个临床试验注册中心在中国成都设立 新华网成都７月２５日电（记者 刘海）通过世界卫生组织国际临床试验注册平台的认证，２５日，世界第四个临床试验注册中心在中国成都开始运行。 据了解，所有在人体实施的试验均属于临床试验。中国临床试验注册中心主任李幼平说，任何临床试验都应该先注册后实施。临床试验注册是为了尊重和珍惜所有试验参 与者的贡献。公开临床试验信息，并将其置于公众监督之下，不仅能确保追溯每个临床的结果，还有助于减少不必要的重复研究。 中国临床实验注册中心运行后，将接受中国地区及全球的临床试验注册申请，同时接受二级注册机构输送的注册资料，并向世界卫生组织国际临床试验注册平台中央数据库输送注册信息供全球检索。此外，该中心作为整个联合机制唯一的注册数据库，一旦中国１１００余家医学期刊都加入协作网，将核查到稿件的投送和发表状况，避免一稿多投。 世界卫生组织总干事陈冯富珍博士为中国临床实验注册中心成为一级注册机构发来贺信。贺信中说，认证的成功，充分展示了中国卫生部努力与临床试验透明化和伦理行为规范化国际标准接轨的决心和实力，这将最终改善中国临床研究的质量，并提升公众对临床研究的信任。 ２００７年５月，世界卫生组织国际临床试验注册平台正式运行，澳大利亚—新西兰临床试验注册中心、美国国立医学图书馆临床试验注册中心、英国国际标准随机对照试验号注册库成为首批一级注册机构。２００５年１０月，中国临床试验注册中心由四川大学华西医院卫生部中国循证医学中心组建。
2007-7-22
星期日(Sunday)
晴
May 1, 2007 By: Kenneth A. Getz Applied Clinical Trials The CRO market is going through major and unanticipated structural changes. Given high sponsor dependence on contract clinical services, it is essential that biopharmaceutical companies monitor and anticipate these changes in order to anticipate and manage them effectively. Financial analysts and outsourcing consultants predicted that niche and mid-sized CROs would steal a growing share of the market for contract clinical research services between 2000 and 2005. They anticipated that sponsors would increasingly seek higher levels of specialization and service quality that could only be offered by niche companies. The opposite occurred—according to the results of a recent study that Julia Wenger and I conducted at the Tufts Center for the Study of Drug Development (Tufts CSDD). In our study, we arranged CROs into one of three segments: Largest, Next 10, and All Other Companies, based on their annual revenues from clinical services. Tufts CSDD compiled and analyzed financial and headcount data on companies in the three segments. The largest CROs  We found that the Largest CROs—primarily publicly-traded companies with the exception of Quintiles—have expanded their dominant position in the outsourcing market. The Largest companies captured nearly 80% of the market in 2005. Companies in this segment saw their revenues increase 15.7% annually—from $3.4 billion in 2002 to $5.2 billion in 2005 (see Table 1 for a list of companies in this segment). The Largest segment accounted for 76% of total headcount employed by CROs to provide contract clinical research services in 2005. The Next 10 The second segment, the Next 10 companies—also primarily publicly-traded entities—captured 11.5% of the total outsourcing market in 2005 and generated approximately $754 million, up from $495 million in 2002. Companies in this segment grew 14.9% annually between 2000 and 2005. Analysts projected that the middle market for contract clinical services would struggle the most to maintain revenue growth through its inability to dominate either full or niche positioning. These projections were mistaken. The Next 10 segment accounted for 11.9% of total headcount employed by CROs for clinical research outsourcing services in 2005 (Table 1 lists companies in this segment). All Other Companies Very little is known about the All Other Companies segment. This group is highly fragmented, comprising nearly 100 organizations of which most are niche service providers, founded in the mid-1990s or later. This segment is also comprised of more than 100 freelance consultants. Companies in this segment are privately-held, making it difficult to compile information about them. Tufts CSDD gathered data on 93 representative companies in this group. In 2005, the typical company in this segment generated average revenues of $3.1 million. This compares with average 2005 revenues of $568 million per company in the Largest segment and $42 million in 2005 revenues per company in the Next 10 segment. The All Other Companies segment captured an 8.5% share of the total market for contract clinical research services in 2005. Contrary to analyst projections, this third segment is growing at a substantially slower rate than the other two. In 2005, companies in this segment generated a total of $561 million in revenue. This represents 6.6% annual revenue growth since 2002—less than half the average annual growth rate for the CRO market overall. This segment accounted for 12.1% of the total headcount employed by the CRO market for clinical research services in 2005. Drivers of growth Since 2001, development sponsors ranging from biotech companies to mid-sized and large pharmaceutical companies have all become more dependent on outsourcing. In total, biopharmaceutical companies spent $6.6 billion on contract clinical services in 2005 (net of pass-through costs, such as central lab fees and investigator grants). The rate of growth in outsourcing spending by sponsor companies has outpaced the growth rate in overall global development spending—16% and 11% annual growth respectively since 2001. There are many drivers of demand for outsourcing drug development activities: Biopharmaceutical companies have largely frozen their global development headcount to contain rising fixed costs while maintaining earnings growth. Most of the headcount growth among sponsors has been in Phase IIIb–IV functions. Phase I–III headcount growth has been essentially flat during the period 2000 to 2005. During this same period, the volume of clinical trials conducted worldwide increased substantially, as did the number of geographically dispersed locations of clinical trials. There has been a dramatic proliferation of small- and mid-sized biotechnology and pharmaceutical companies engaged in clinical trials around the world. Smaller companies, many of them biotechnology firms, typically outsource greater proportions of their clinical research budgets, as they look to contract expertise that falls outside their core capabilities. And according to the results of a Tufts CSDD study conducted last year, high levels of CRO usage are translating into greater efficiencies for sponsors, including faster development cycle times with comparable data quality. Higher relative growth in sponsor spending on CRO services provided by companies in the Largest and Next 10 segments—typically more mature companies—is driven by a number of key factors. Whereas some sponsors are moving toward functional service provider models that may favor niche CROs, a growing number of biopharmaceutical companies are outsourcing broader combinations of contract clinical services that can be provided on a global basis. Leading full-service companies offer infrastructure and experience in conducting large-scale clinical trials worldwide. Demand has been particularly strong from sponsors currently engaged in multinational Phase III and Phase IV programs. Sponsor companies—particularly the largest biopharmaceutical companies—also strive to deliver continuous improvements in efficiency. Companies in the Largest and Next 10 segments may be well positioned to offer more favorable pricing, as they can spread their costs across scaled operations. Many sponsors have entered into preferred pricing arrangements with many of the larger CRO companies. In all, the CRO market is doubling the headcount capacity of clinical research personnel engaged in managing Phase I–IV global drug development programs. Tufts CSDD estimates that in 2005, there were a total of 50,877 people employed by the Largest, Next 10, and All Other Companies combined. This is up from 41,510 in 2002 and represents an annual headcount growth rate of 7% between 2002 and 2005, more than three times the rate of growth in clinical research personnel employed by PhRMA member companies during the same period. Forecasts and predictions Slower relative growth among the small companies that make up the All Other Companies segment is indeed a surprise. Being relatively resource poor, many companies in this segment are pursuing a variety of strategies to stimulate growth and differentiate themselves. Based on our analysis of reports from companies in this segment, there are four primary strategies being pursued: acquisitions of, or joint ventures with, site management organizat
2007-7-14
星期六(Saturday)
多云
http://www.fdc-intl.com/detail_info/detail_160.html
美国食品和药品法律的历史 美国食品和药品法律的历史文明伊始,人们就开始关心食品和药品的质量和安全性。1202年，英国国王John颁布了英国第一个食品法──《面包法》（Assize of Bread），规定严禁在面包里掺入豌豆或蚕豆粉造假（adulteration）。美国食品依法监管的历史可追溯到殖民统治的早期,而联邦政府对药品供给的控制始于1848年对进口药品的检查。下列年表记载了美国食品和药品依法监管的一些里程碑。 1820年： 11位医师在华盛顿特区召开会议，共同制订《美国药典》（U.S. PHARMACOPEIA）。这是美国第一部标准药品（standard drugs）的法典。 1848年： 美国国会通过的《药品进口法》（DRUG IMPORTATION ACT），要求美国海关通过检查防止海外掺假药物（adulterated drugs）的进入。 1862年： 林肯（LINCOLN）总统任命化学家（chemist）Charles M. Wetherill在新的农业部任职。这便是FDA的前身──化学局（Bureau of Chemistry）的开始。 1880年： 美国农业部首席化学家PETER COLLIER在亲自对掺假食品作调查后，建议通过一部全国性的食品和药品法。该议案当时被驳回，但之后的25年中，国会提出的关于食品和药品的议案达100多个。 1883年： HARVEY W. WILEY博士成为首席化学家后，加大了化学局对掺假食品的研究力度。由于发起了联邦立法运动，Wiley博士被称为“十字军化学家”（Crusading Chemist）和“纯食品和药品法之父”（Father of the Pure Food and Drugs Act）。他于1912年从政府机构退休，1930年与世长辞。 1897年： 通过《茶叶进口法》（TEA IMPORTATION ACT），规定所有进入美国口岸的茶叶都要由海关检查，费用由进口商支付。 1898年： 官方农业化学家协会（Association of Official Agricultural Chemists），现在的国际官方农业化学家协会（AOAC International）成立一个由Wiley博士领导的食品标准委员会（COMMITTEE ON FOOD STANDARDS）。州开始将这些标准编入其食品法规。 1902年： 通过《生物制品控制法》（BIOLOGICS CONTROL ACT）以保证血清、疫苗及用于预防和治疗人的疾病的类似产品的纯度（purity）和安全性。 国会拨款5000美元给化学局以研究化学防腐剂和色素（CHEMICAL PRESERVATIVES AND COLORS）及其对消化和健康的影响。Wiley博士的研究引起对食品掺假问题的广泛关注。公众对通过一部联邦食品和药品法的支持率增加。 1906年： 6月30日，首部《食品和药品法》（FOOD AND DRUGS ACT）由国会通过，并由Theodore Roosevelt总统签署。该法禁止冒牌和掺假的（misbranded and adulterated）食品、饮料和药品的州间贸易。 《肉类检查法》（MEAT INSPECTION ACT）在同一天通过。 对肉类加工厂的不卫生条件，食品中有毒防腐剂和染料（dyes）的使用，以及对无效和危险的专利药品（patent medicines）的万能药声称（cure-all claims）的种种令人震惊的问题披露，是导致这些法律制定的主要原因。 1907年： 应制造商和使用者的请求，第一部《经许可的色素规章》（CERTIFIED COLOR REGULATIONS）列出了7种适合用于食品的色素。 1911年： 在“美国对Johnson诉讼案”（U.S. v. JOHNSON）中,最高法院判决：《1906年食品和药品法》对错误的疗效声明（false therapeutic claims）不禁止，但是禁止有关药品的成份的错误和误导的声明。 1912年： 国会制定《Sherley修正案》（SHERLEY AMENDMENT）以解决“美国对Johnson诉讼案”判决的问题。该修正案禁止用意欲欺骗消费者的虚假治疗声称(一种难以证明的标准)来标示药物。 1913年： 《Gould修正案》(GOULD AMENDMENT)要求食品包装内含物“以重量、容量或数量的方式，明白而显著地标在包装的外面。” 1914年： 在“美国对Lexington压榨机和升降机公司诉讼案”（U.S. v. LEXINGTON MILL AND ELEVATOR COMPANY）中,美国最高法院对食品添加剂（food additives）作出其首次判决。该判决主要内容是：为禁止向食品中掺入含亚硝酸盐残留（nitrite residues）的漂白粉，政府必须说明化学添加剂和它据说对人体引起伤害的关系。法院还提到：仅仅这样一种成份的存在不足以使得食品违法。 《Harrison麻醉剂法》（HARRISON NARCOTIC ACT）要求：超出麻醉剂的可允许限度的处方，应增加调配麻醉剂的医师和药师保存记录时间。 1924年： 在“美国对95桶苹果酒声称为醋的诉讼案”（U.S. v. 95 BARRELS ALLEGED APPLE CIDER VINEGAR）中，最高法院作出如下判决：《食品和药品法》处罚在产品标签上可能误导或欺骗的任何说明、设计或图案（即使技术上是真实的）。 1927年： 化学局重组为两个单独的实体：监管职能归于食品、药品和杀虫剂管理局（FOOD, DRUG, AND INSECTICIDE ADMINISTRATION）；非监管研究归于化学和土壤局（BUREAU OF CHEMISTRY AND SOILS）。 1930年： 《McNary-Mapes修正案》（McNARY-MAPES AMENDMENT）授权FDA关于罐装食品的质量和容器的装填的标准。肉类和牛奶制品除外。 食品、药品和杀虫剂管理局这一名称按一部农业拨款法（agricultural appropriations act）简称为食品和药品管理局（FOOD AND DRUG ADMINISTRATION，FDA）。 1933年： FDA建议彻底修正已过时的《1906年食品和药品法》。从将第一项议案提交给参议院开始，开始了一场为期五年的立法之战。 1937年： 磺酰胺酏剂（ELIXIR OF SULFANILAMIDE），因含有有毒溶剂二甘醇（diethylene glycol），导致107人服药后死亡，其中大部分是儿童。这戏剧性地阐明了上市前确定药品安全及制定出切实可行的食品和药品法的必要性。 1938年： 国会通过1938年的联邦食品、药品和化妆品法（FEDERAL FOOD, DRUG, AND COSMETIC ［FDC］ ACT）。该法包含如下新条款： 1．管理范围扩大至化妆品（cosmetics）和医疗器械（therapeutic devices）。 2．要求新药上市前被证明是安全的。此项规定开创了药品监管的新体制。 3．取消《Sherley修正案》在药品冒牌案件（drug misbranding cases）中要求证明欺骗意图的条件。 4．规定对于不可避免的有毒物质，要定出安全耐受性限度（safe tolerances）。 5．授权对食品的特性（identity）、质量和容器装填（fill-of-container）标准。 6．授权工厂检查（factory inspections）。 7．对先前的扣押（seizures）和起诉（prosecutions）的处罚，增加法院指令的救济（remedy of court injunctions）。 按照《Wheeler-Lea法》（WHEELER-LEA ACT），联邦贸易委员会（Federal Trade Commission）负责监督与FDA监管的产品有关的广告，但处方药除外。 1939年： 第一个食品标准（FIRST FOOD STANDARDS）颁布（罐装番茄、番茄泥［tomato puree］和番茄酱［tomato paste］）。 1940年： FDA从农业部划归联邦安全署（Federal Security Agency），Walter G. Campbell 被任命为第一任食品和药品专员（Commissioner of Food and Drugs）。 1941年： 《胰岛素修正案》（INSULIN AMENDMENT）要求FDA对此种糖尿病人的救命药（life-saving drug）进行检验并保证其纯度和效力（potency）。 1943年： 在“美国对Dotterweich诉讼案”（U.S. v. DOTTERWEICH）中，最高法院判决：公司的负责官员及企业本身，可能因为违法而被起诉。但无需证明该官员是故意或者甚至是知道违法。 1944年： 通过《公共健康服务法》（PUBLIC HEALTH SERVICE ACT）。该法涉及广泛的健康问题，包括生物制品（biological products）的监管和传染病（communicable diseases）的控制。 1945年： 《青霉素修正案》（PENICILLIN AMENDMENT）要求FDA检验并保证所有青霉素制品的安全性和有效性。后来，修正案将该要求扩展到所有抗生素（antibiotics）。直到1983年，发现此种控制已无必要，于是该法案被废除。 1948年： 《Miller修正案》（MILLER AMENDMENT）确认《联邦食品、药品和化妆品法》适用于由法定机构监管的货物，这些货物已由一州运至另一州并已到达消费者手中。 1949年： FDA首次出版行业指南（GUIDANCE TO INDUSTRY）。此指南，名为《食品中化学制品的毒性评价程序》（Procedures for the Appraisal of the Toxicity of Chemicals in Food），史称“黑皮书”（black book）。 1950年： 在“Alberty食品公司对美国的诉讼案”（ALBERTY FOOD PRODUCTS CO. v. U.S）中，某上诉法院判决：药品标签上的使用说明（directions for use）必须包括该药品出售的目的（purpose）。这样，那些无效的药物就无法再以“某药物未声称应当治疗的情况”为借口而逃脱法律的制裁。 《人造奶油法》（OLEOMARGARINE ACT）要求有色的人造奶油有明显的标识，以与奶油（butter）区别。 Delaney委员会（DELANEY COMMITTEE）开始对食品和化妆品中所含化学制品安全性的国会调查，为《1954年Miller杀虫剂修正案》（1954 Miller Pesticide Amendment）、《1958年食品添加剂修正案》（1958 Food Additives Amendment）和《1960年色素添加剂修正案》（1960 Color Additive Amendment）奠定了基础。 1951年： 《Durham-Humphrey修正案》（DURHAM-HUMPHREY AMENDMENT）定义无医学监督不能被安全使用的药品种类并将其销售限制于有执照的开业医师（licensed practitioner）的处方。 1952年： 在“美国对Cardiff诉讼案”（U.S. v. CARDIFF）中，最高法院判决：《1938年食品、药品和化妆品法》（1938 FDC Act）的工厂检查条款（factory inspection provision）太含糊，因此不能作为刑法（criminal law）强制执行。 在每个辖区（field district）任命FDA消费者顾问（FDA CONSUMER CONSULTANTS）以保持与消费者的交流，保证FDA能考虑到消费者的需求和问题。 1953年： 联邦安全署（FEDERAL SECURITY AGENCY）成为健康、教育和福利部（Department of Health, Education, and Welfare，HEW）。 《工厂检查修正案》（FACTORY INSPECTION AMENDMENT）进一步明确先前的法律，并且要求FDA为制造商提供检查过程中观察到的情况及工厂样品分析的书面报告。 1954年： 《Miller杀虫剂修正案》（MILLER PESTICIDE AMENDMENT）明确对在原始农业商品（raw agricultural commodities）上的杀虫剂残留设置安全性限度的程序。 FDA进行第一次大规模的食品放射性检查（RADIOLOGICAL EXAMINATION OF FOOD）。当时，FDA收到举报，怀疑带有放射性的金枪鱼正在从经过太平洋原子弹爆炸后的日本进口。从此，FDA开始日夜不停的监视以应对突发事件。 1955年： 健康、教育和福利部部长（HEW SECRETARY）OVETA CULP HOBBY任命一个14人委员会以研究FDA的机构和项目是否完备。该委员会提出一项关于FDA的实质性的扩充建议，即增加职员和机构，新的总部大楼，以及教育和信息项目的更多使用。 在被认为是已失活的脊髓灰质炎疫苗（polio vaccine）与大约260个脊髓灰质炎病例有关联后，国家健康研究所（National Institutes of Health）的生物制品管理职责（biologics control function）重新设置为FDA中的生物制品管理处（DIVISION OF BIOLOGICS CONTROL）。 1958年： 《食品添加剂修正案》（FOOD ADDITIVES AMENDMENT）制定。该修正案要求新食品添加剂的制造商证实安全性。Delaney条款（Delaney proviso）禁止批准任何可能导致人或动物癌症的食品添加剂。 FDA在《联邦登记簿》（Federal Register）中发表《通常被认为是安全的物质》（SUBSTANCES GENERALLY RECOGNIZED AS SAFE，GRAS）的第一批清单。该清单收载近200种物质。 1959年： 美国野樱桃（U.S. CRANBERRY CROP）在感恩节前三周被从市场撤回，以供FDA试验检验氨基三唑（aminotriazole）――一种发现可引起实验动物癌症的除草剂。干净的浆果被允许贴上标签注明该产品已经过试验并通过FDA检查，这是FDA曾使用过的对一种食品的唯一的一种担保。 1960年： 《色素添加剂修正案》（COLOR ADDITIVE AMENDMENT）制定。该修正案要求制造商证实食品、药品和化妆品中色素添加剂的安全性。Delaney条款（Delaney proviso）禁止批准任何可能导致人或动物癌症的色素添加剂。 由FDA强制执行的《联邦危险物质标识法》（FEDERAL HAZARDOUS SUBSTANCES LABELING ACT）要求在危险的家用化学产品（hazardous household chemical products）上有明显的标签警告。 1962年： 反应停（THALIDOMIDE），一种新的安眠药，被发现已在西欧引起几千名婴儿的出生缺陷。关于FDA医学官员Frances Kelsey博士在使美国市场免受反应停危害中的作用的新闻报道，唤起公众对更强有力的药品监管的支持。 通过《Kefauver-Harris药品修正案》（KEFAUVER-HARRIS DRUG AMENDMENTS）以保证药品功效（efficacy）和更好的药品安全性。第一次，药品制造商被要求在药品上市前向FDA证明其产品的有效性。这项新法律还豁免于Delaney条款（Delaney proviso）兽药或饲料添加剂（显示可致癌，但在人的食物供给中没有留下可监测水平的残留物）。 在John F. Kennedy(肯尼迪)总统给国会的咨文中宣布了“消费者权利议案”（CONSUMER BILL OF RIGHTS），包括安全性的权利，被告知的权利，选择的权利，以及听证的权利。 1965年： 制定《药物滥用控制修正案》（DRUG ABUSE CONTROL AMENDMENTS）以处理滥用镇静剂（depressants）、兴奋剂（stimulants）和致幻剂（hallucinogens）所引起的问题。 1966年： FDA与国家科学院（National Academy of Science）/国家研究理事会（National Research Council）协议，评价在1938至1962年间仅仅以安全性作为基础而批准的4000种药物的疗效。 《儿童保护法》（CHILD PROTECTION ACT）扩大《联邦危险物质标识法》（Federal Hazardous Substances Labeling Act）的管理范围，禁止危险的玩具以及其他如此危险以至没有足够的标签警告可以标明的物品。 《正确包装和标识法》（FAIR PACKAGING AND LABELING ACT），与FDA对食品、药品、化妆品和医疗器械（medical devices）的强制执行条款一起，要求州间贸易中的所有消费品有诚实和内容详细的标示（honestly and informatively labeled）。 1968年： FDA药物滥用控制局（FDA BUREAU OF DRUG ABUSE CONTROL）和财政部麻醉药局（Treasury Department Bureau of Narcotics）划归司法部（Department of Just
2007-7-14
星期六(Saturday)
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FDA药品评价和研究中心（CDER）的历史 药品评价和研究中心（Center for Drug Evaluation and Research ［CDER］）向美国人民承诺可用上安全和有效的药品。在《1906年食品和药品法》（1906 Pure Food and Drugs Act）出台前，该中心仅由个人操作且只对市场上重大药品问题进行评价，至今已在职责和组织上发生了变化。这种变化部分地反映了药品法的演变和20世纪化学疗法的革新――以及FDA的职责的变化。但这种变化也反映了对于如何更好地向病人提供安全有效的药品的外部和内部的决定。政府的各个部门，和一些利益受FDA政策所影响的部门，对FDA的药品管理发挥了一定的作用。以下简述在过去的90年中FDA药品管理职能的变化，尤其是组织上的剧变。 在1902年的美国药物协会（American Pharmaceutical Association）年会上，化学局（Bureau of Chemistry）的首席药剂师（Chief Chemist）Harvey Wiley,宣布在其下面成立一个药品实验室（Drug Laboratory）。Wiley希望这个实验室会有助于药物标准化并统一分析结果。Lyman Frederic Kebler，是法国Smith Kline的首席药剂师，以及公认的假药鉴别专家，被任命为该实验室的领导者之一。他于1902年12月被任命为药品实验室主管，于1903年三月上任。 起初，药品实验室从事各种不同的项目。其一是对该局所用试剂的调查，很快Kebler发现试剂不纯。他还花大量时间寻求改进药物分析的方法。Kebler还提醒公众关注通常的药品供应中存在的问题。 三年后，在Wiley的长期游说下，《食品和药品法案》成为法律。它禁止冒牌的和掺假的药品和食品（mislabeled and adulterated drugs and food）在州际贸易。Wiley自身强调食品是关系健康的一个重要因素，但他同时也对专利药（patent medicines）和处方药（prescription drugs）给予了一定的关注。他的继任者――Carl Alsberg,提高了药物的重要性。1908年，药品实验室经历了第一次重要的重组，更名为药品处（Drug Division），下设四个实验室：1、药品检查实验室（Drug Inspection Laboratory），由George Hoover主管；2、合成成品实验室（Synthetic Products Laboratory），由W. O. Emery 主管；3、提炼油实验室（Essential Oils Laboratory），由E. K. Nelson主管；4、药理学实验室（Pharmacological Laboratory），由William Salant 主管。Kebler仍是处长。 提炼油实验室是对油类进行分析检测，无论是单独用于治疗还是与其它化合物结合在一起的，如Root-beer提炼物，和鹿蹄草（wintergreen）提炼油；合成实验室负责对合成药物的检查，包括普通头痛药物，以及原料药中的活性成分；药理学实验室负责调查药品对动物的生理影响，主要是针对咖啡因，这是Wiley很感兴趣的一个课题；药品检查实验室是该处的一个主要执行部门，比如，从1909―1910年，这个实验室仔细考察了900多个国内药品的样品，大约1000个进口样品，并检举了115个样品。 在1910年，根据1906年的法案管理药品时，出现了较大的冲突，当局查获了大量的“Johnson的温和治癌药”（Johnson's Mild Combination Treatment for Cancer），其实是一种无用的产品，但其标签上对其疗效作了虚假的声明。审讯时，法官判定这种虚假声明不在食品和药品法管理范围之内，并作出了不利于政府的裁定。1912年，国会颁布了修正后的法律。《Sherley修正案》（Sherley Amendment）中将疗效声明归入食品和药品法的管理权限内，但在判定其违法之前，要求该局出示其声明是错误的或是虚假的证明。 到这时，药品检查实验室的工作范围增加了。比如，他们不仅对检测吗啡、硝化甘油的方法进行调查，还同美国药典会（U.S. Pharmacopeia［USP］）一起研究药品标准。药品处的工作不仅局限于国内药品，还针对进口药品、化合物以及进口的疗效可疑的产品。该处室还花大量时间调查受污染的氯仿。一些制造商用马口铁容器装氯仿，使其容易分解，而USP规定氯仿必须贮存在玻璃容器中。 1910年代中期，药品处新增了两个部门。其中一个是生药学实验室（Pharmacognosy Laboratory），创立于1914年。它除了调查原料药成品以外，还研究如何改进原料药工艺以减少浪费。1916年在Sherley修正案的影响下,又成立了一个办公室专门调查药品的错误和虚假标识（false and fraudulent labeling of drugs）,由M.W.Glover主管，他是美国公众健康服务部（U. S. Public Health Service［USPHS］）的一位内科医师。 1920年该局成立了独立的药品管理办公室（Office of Drug Administration），由Glover主管，协助药品处管理药品标签的发行细节。1923年由于Glover被召回USPHS，这个办公室就取消了。同时，成立了一个自主的特别合作调查办公室（Office of Special Collaborative Investigations），由Kebler主管，与邮政部（Post Office Department）一起调查有假发行物的邮件，药品处也改组了。1923年，药品控制办公室（Office of Drug Control）代替了药品管理办公室和药品处，由George Hoover主管，它在组织上与新成立的食品控制办（Office of Food Control）保持平行，它对药品（包括原料药、药品组分、药物制剂和专利药品）控制中的所有工作负责。 药品控制办继续与相关方保持合作，如贸易协会和USP。提高制造业正确度的愿望使协会间形成了联系委员会。当委员会完成提高正确度的方法的研究后，在商业期刊上就会刊登出来。1926年，该局与USP合作通过一个共同的项目。该项目是为了提供生物分析药品的标准化产品样品，例如洋地黄（digitalis）作为对照品的研究，该项目一直持续到1930年。 接到涉及不纯麻醉剂导致几起死亡的报告后，该办着手调查原因。当时市场上有好几种麻醉剂，但他们主要是对乙醚和乙烯的调查。该调查一直持续到1930年代中期。通过调查分析，药品控制办确定麻醉剂的分解是由于制造工艺较差引起的。作为调查的一部分，药品控制办设立了一个实验室专门致力于药品分析。 1928年起，药品、食品和杀虫剂管理局（Food, Drug and Insecticide Administration）下的药品管理部门，经历了几次重大的人事变动。George Hoover在主管药品控制办公室5年后离开了该局，Lyman Kebler被重新任命为特别合作调查办主任。从而特别合作调查办就成为药品控制办下面的一个组，此时它下面已有一个化学小组（Chemical Unit）、医学小组（Medical Unit）、兽药小组（Veterinary Unit）和药理学小组（Pharmacology Unit）。新主管是James J.Durrett,他与Kebler一样是一个内科医师和药师；当时Durrett是Tennessee大学的公众健康学教授。 由Marvin R.Thompson 指导的对麦角碱（ergot）药理的研究是该办的一项重要研究工作。起初，他们注意的是麦角碱的分解；分析表明这主要出现在运送过程中。但在这个调查中，对麦角碱药理缺少了解成了突出的问题。为此Thompson开始了他的工作。在1929年，由于他的论文在药理方面有突出贡献，从而获得了美国药物协会的Ebert奖。Tompson的论文在很多领域具有突破性进展。他建议修改麦角碱的分析方法，且表明通过改变麦角碱 的制备工艺可以改进USP规定的麦角碱标准。 自从《食品和药品法案》成为法律后，它的缺点变得明显了。其中一个缺点是无权阻止声称减肥的危险的制剂的销售。1934年，药品控制办（从1931年以来一直由Frederick J.Cullen主管）开始调查含二硝基酚（dinitrophenol）的产品。这是饮食处方中的一个成分，能使新陈代谢率上升到危险水平，并引起许多死亡和伤害。由于该法律没有对药品安全作出规定，因此，药品控制处无权没收产品，只能提出警告。 1935年，Jame J. Durrett回到FDA（Food and Drug Administration）主管药品管理部门，该部门再次被命名为药品处（Drug Division）。同年，以前一直属于药品处的药理学实验室成了一个独立的办公室，由Erwin E. Nelson主管。Nelson是作为该办的唯一的顾问，而同时从1919―1937年又是Michigan大学的教员，从1937―1943年是Tulane大学药理系的主任。该办公室的独立是为了适应食品工业中不断上升的对药理学方面的需求。尤其是在调查食品中的有毒物质和杂质的时候。 因不符合食品和药品法的危险药品而产生的问题越来越多，如1937年的磺胺酏剂（Elixir Sulfanilamide）大灾难，从而引起了国家的关注。Massengill 没有经过安全性试验就销售该产品（法律中也未作此要求）。由于其中用二甘醇（diethylene glycol）作为媒介物，一种抗冻剂的化学相似物，导致100多人死亡，其中大部分为小孩。1938年，罗斯福总统签署了《联邦食品、药品与化妆品法》（Federal Food, Drug and Cosmetic Act），该法律要求新药上市前必须经过安全性试验，其结果应列在新药申请（new drug application［NDA］）中提交给FDA。法律还要求药品标签中应充分说明如何安全使用，所有药品广告都需经联邦贸易委员会（Federal Trade Commission）批准。 该法律签署三个月后，在Harvard接受了医药培训并在Yale 大学任教的Theodore Klumpp接替了Durrett的位置，开始主管药品处。到这时为止，其下面已有四个部门：化学组（Chemical Section）、合作组（Collaboration Section）、医学组（Medical Section）和兽药组（Veterinary Section）。此时它们的大部分工作集中在新药申批，第一年内就接受了1200份新药申请。 1940年代初期，FDA在药品领域新增了3个职责。1941年通过《胰岛素修正案》（Insulin Amendment），要求所有批次的胰岛素在上市前必须经过纯度（purity）、浓度（strength）、质量（quality）和特性（identity）检测。该检测由药理处（Pharmacology Division）下面的一个组指导。同年，FDA要求处方者（prescriber）为所有新药贴上与使用说明书相应的标签，且应符合1938年的法规的有关药品使用规定。1945年通过了《青霉素修正案》（Penicillin Amendment），参照《胰岛素修正案》。它要求全部或部分由青霉素组成的药品应进行批认证（batch certification）。后来要求其它的抗生素也进行批认证。其测定由另一个独立的部门执行，即青霉素管制和免疫学处（Division of Penicillin Control and Immunology）。该处下设四个组：青霉素认证组（Section of Penicillin Certification）、免疫学组（Sections of Immunology）、防腐剂组（Sections of Antiseptics）和抗生素组（Sections of Antibiotics），它的职责远远超过青霉素的检测，1949年它被更名为抗生素处（Division of Antibiotics）。 这时药品处由Robert P.Herwick主管，他是1941年上任的，曾接受过化学、药理学、毒物学、医学和法律方面的培训。在新管理体制下，药品处保留了原来的几个组：医学组、化学组和兽药组。医学组负责评价新药安全和标签，并为法庭案件提供咨询。兽医组职责与医学组类似，只是其对象是兽药。化学组负责分析药品并通过化学家改进分析方法。 到1945年为止，药品处主管同时还是FDA首席医学官员（Chief Medical Officer），这以后不久，药品处（Drug Division）被更名为药物处（Division of Medicine）。1947年由Robert Stormont接替Herwick主管药物处。Stormiont曾接受过药理学和医学方面的培训，在1946年进入FDA工作以前曾在Naval医药公司工作。 Stormont离任后，由从1947年起任新药组（New Drug Section）主管的Erwin E Nelson接替他的工作。而Ralph Smith成为新药组主管，并一直持续至60年代中期。Ralph Smith既是一个医学博士（M.D）又是一个哲学博士（Ph.D.），进入FDA工作前，他是Tulane大学医学院的药理系主任。在Smith的领导下，新药组批准了7000多个新药申请。在Nelson和Smith任职后不久，国会通过了一个对药品管理有重大影响的法律。1951年，这个法律中的《Durham-Humphrey修正案》明确了处方药和非处方药的界限。该修正案特别指出由一些参数定义为危险药品的销售必须有处方，且必须标明：“注意：联邦法律禁止无处方销售（Caution: Federal law prohibits dispensing without prescription）” 1955年，FDA对药品不良反应报告（adverse drug reaction reporting）作了实验性研究，使药品销售管理更进了一步。在与美国医院药师学会（American Society of Hospital Pharmacists）、美国医学会（American Medical Association）和其它部门的合作下，该研究着重于医院和药剂师的用药反应报告。此时的不良反应报告是自愿的，报告往往缺少。1957年，为有助于评价上市后的新药，对不良反应报告试验扩大了范围。到1963年，已有200家左右医院加入了自愿报告体系。 1955年健康、教育和福利部部长（Secretary of Health, Education, and Welfare）任命了一个公民咨询委员会（Citizens Advisory Committee），对FDA的行为进行评估，并对如何提高资源利用提出建议。它有14个成员，由行业领导和消费者组成，并由G.Cullen Thomas 主管。1955年6月他们提出了100多条建议，其中24条是明确针对药品的。绝大多数有关药品的建议是关于新药申请程序，尤其建议加速评审程序。委员会建议FDA成员应至少增加3倍，预算应增加4倍。 1955年，由于公民咨询委员会的建议，药物处经历了一次大调整，并于1957年成为药物局（Bureau of Medicine）。此时 ，药物局由Albert Holland主管，他以前曾是纽约大学医学院和Armour实验室的医学主管。1952年Nelson辞去药物处主管后，1954年由Holland主管。 这次机构大调整后，不但成立了药物局，而且还成立了生物和自然科学局（Bureau of Biological and Physical Sciences），由FDA内的7个科学处组成。这些处室，包括药理和抗生素，涉及很多课题，既包括食品，也包括与药品有关的（比如，如何改进胰岛素和可认证抗生素的分析方法和规格）。1959年，它开始发行内部刊物――《Bureau By-Lines》,旨在加强各部门和各实验室之间的联系，并一直发行到1982年。在50年代末期，药物局由5个组组成，包括新药组（New Drug Branch）、药品及器材组（Drug and Device Branch）、兽药组（Veterinary Medicine Branch）、医用抗生素组（Medical Antibiotics Branch）以及研究和参考组（Research and Reference Branch）。新任主管是William Kessenich,他于1959年进FDA工作，以前曾任职于Georgetown 大学内科医学系。 1960年6月举行的参议院听证会的焦点是加强1938年法令中的药品条款。这些听证会，由司法委员会（Committee on the Judiciary）的反托拉斯和垄断小组委员会（Subcommittee on Antitrust and Monopoly）的Estes Kefauver参议员主持，并导致了S.3815议案。该议案旨在通过制定一定的生产规范、对所有抗生素进行认证以及其它的一些措施，来保护公众的健康。 在Kefauver主持听证会期间，FDA收到了药品Kevadon的新药申请书，Kevadon是反应停（thalidomide）的商标，是由William Merrell 公司生产并准备在美国上市的一种镇定剂。尽管公司方面不断施加压力，可医学官员Frances Kelsey 仍拒绝了他的新药申请，因为它的安全性资料不够。1962年，人们注意到反应停会对新生儿产生危害。尽管Kevadon未被批准上市，但Merrell 仍发送了200万片用于调查研究，法律和法规未对这种使用加以控制。当知道了反应停的危害后，FDA立刻从医生、药师和病人手中收回药品。由于他的努力，1962年Kelsey得到了总统突出贡献联邦公民服务奖（President's Distinguished Federal Civilian Service Award），这是政府官员的最高荣誉。 由于反应停引起的悲剧，参议员Kefauver再次提出他的议案。1962年10月10日肯尼迪总统发布《药品修正案》，又称《Kefauver-Harris修正案》。这些修正案要求药品上市前其制造商必须向FDA提供安全性和有效性的证明，同时还要求所有抗生素必须经过认证，并授权FDA管理处方药广告。按新法，抗生素的NDAs评审由新药处（
2007-7-14
星期六(Saturday)
多云
http://www.actmagazine.com/appliedclinicaltrials/content/printContentPopup.jsp?id=439804
Today's CRAs must redefine their roles in the face of changing industry expectations and new technologies. Jul 1, 2007 By: Kenneth A. Getz Applied Clinical Trials Based on recent interactions with pharmaceutical, biotechnology, and CRO companies, it appears that the role of the clinical research associate (CRA) is undergoing intense examination and revision, driven largely by the adoption of e-clinical technologies and new study conduct practices. Several companies have noted the transition of their CRAs into data managers with an increasing amount of their administrative activities handled by electronic technology solutions. But mounting study conduct performance pressures during the past five to seven years are also pushing CRAs to redefine their roles all together: from monitor and taskmaster to trainer, helpdesk, and active site collaborator and motivator. Communication, e-technology savvy, and interpersonal skills have never been more critical to CRA effectiveness. Changing job demands Companies' expectations of CRAs have changed in several tangible ways. Standard operating procedures (SOPs) today, for example, tend to give CRAs less time to visit and to follow up with investigative sites. SOPs also require more detailed documentation of monitoring activities, including more elaborate enumeration of items contained in study binders. "CRAs across the board have been working longer hours than they did before 9/11, largely as a result of increased airport security," added Lorry Witte, RN, BA, CCRA, CCRC, a Twin Cities, MN-based study monitor. "Yet the pressure to beat deadlines is as tight as it has ever been, requiring CRAs to spend more time working on laptops in airplanes and in hotels and airports." Heavy travel burdens, rising airline-related costs, and delays have prompted many companies to decentralize CRA functions, including creating regional CRA positions and limiting travel within specific territories. "Regional CRAs, on average, spend 60% to 80% of their time traveling. But many now stay in the same time zone, so there are less connection issues and it's quicker and easier to get where they need to go," explained Sandra O'Donnell, MA, MT (ASCP), CCRA, senior regional CRA for ZARS Pharma. New regional positions can significantly reduce overhead costs. According to CRA managers in several major pharmaceutical companies, a large percentage of regional CRAs operate out of home offices. Doing so means, however, that CRAs need to be even more computer-savvy than their office-based counterparts because the bulk of communications and training happens electronically. It also means telephone and e-mail messages have to be more skillfully composed and delivered to prevent miscommunication. On the regulatory front, CRAs need to be prepared for more comprehensive tracking of protocol deviations and adverse events observed in new source documentation formats. "Clinical trial teams must decide upfront and agree with health authorities on what constitutes source documentation on studies involving remote data transfer, machines with memory, and patient reported outcomes," said Giovanni Della Cioppa, head of methodology and innovation in development at Novartis. "It's not always clear. But if it is not obvious and if the clinical teams don't spell it out, CRAs will each have their own view or they may not be prepared to track and report properly," he said. eCT gurus Without a doubt, CRAs today need to be a lot savvier about information technology than most veteran study monitors ever anticipated. They also need to embrace more regular and formal means of communicating with study coordinators and investigators rather than through sticky notes and memos. "It has been a tough—and dramatic—transition for many paper loving CRAs," said Laurie A. Halloran, BSN, MS, CCRA, a Boston-based clinical trial consultant. "I have seen monitors who could only monitor if they printed out the entire electronic case report form [eCRF] on paper. But those days are pretty much gone at this point." "Most CRAs, once they've done one trial using electronic data capture (EDC) never want to go back to paper. But study coordinators can be fiercely resistant, especially clinic nurses who aren't dedicated to research," said Minnesota-based CRA Witte. "To overcome the inertia, CRAs need to be contagiously enthusiastic about EDC. They also need to be proficient at using a variety of technology solutions if they are to champion speed-enhancing technology and troubleshoot with study coordinators," she said. "Electronically-based source documentation is a huge driver of change for study monitors," said senior regional CRA O'Donnell. "We see many sites still habitually printing out all source documents because they don't know how to set the security level on the electronic medical records (EMRs) to limit data access only to what monitors actually need to see," O'Donnell said. "For privacy reasons alone, study staff may not be able to accommodate techno-phobic CRAs by printing out patient records much longer." "CRAs not only have to have technological expertise but they must be more solutions oriented in their application of the technologies," said Halloran. "This is especially true when it comes to the problem of subject recruitment. It is no longer enough for study monitors to merely ask for enrollment head count. CRAs need to understand what attracts volunteers to a particular site or study. CRAs need to identify and to quickly react to participation barriers, such as transportation and the study visit schedule, which they often can do something about," she said. CRAs of the future Looking ahead, it's likely that CRAs will have to meet certain minimum qualifications to be a study monitor—be it certification or licensure. Many sponsor and CRO companies, at the moment, remain unconvinced that passing a certification exam means a study monitor is better qualified and thus deserving of higher pay. "Even the Association of Clinical Research Professionals (ACRP), the leading CRA certifier, is still trying to define what the minimum education and training requirements for study monitors ought to be," said Halloran. Apparently, many CRAs are responding by seeking additional qualification from academic programs and advanced certification designations. "Certified CRAs go back for 24 credit hours of new learning every two years to retain their designation," said Witte. "But many are also looking to add new areas of qualification in study methods, for example, drug metabolism and regulatory, to set themselves apart." "And this training is imperative because, ideally, CRAs are passing on some of that knowledge at every site visit," added Witte. "Monitoring has evolved into more of a collaborative effort with study coordinators and investigators to get the job done better. Increased regulatory scrutiny has demanded that those encounters happen more frequently." "Increased use of technology, coupled with new clinical trial models, will eventually compel a new role definition for CRAs that includes greater IT knowledge and patient contact," predicted Novartis's Della Cioppa. "More and more, data will be transferred directly from the patient to the study database via portable devices and mobile phone technology. In terms of emphasis, CRAs in the future will move from raw data to the infrastructure that generates that data, including portable and patient-worn devices. They will need to ensure those devices are in order, those that break down are replaced, quality control is done, and that individual patients know how to use them." Forging ahead There is wide
2007-7-9
星期一(Monday)
小雨
http://www.actmagazine.com/appliedclinicaltrials/article/articleDetail.jsp?id=431920
Release of final Guidance is a step in the right direction for Agency and trials. Jun 1, 2007 By: Paul Bleicher Applied Clinical Trials After waiting until the very last possible day before writing this month's column, I was about to begin when an email appeared, announcing that the FDA had released the final Guidance for Computerized Systems Used in Clinical Invest ......
2007-7-5
星期四(Thursday)
晴
http://www.telegraph.co.uk/money/main.jhtml?xml=/money/2007/07/03/ccafrica103.xml
By Katherine Griffiths Last Updated: 10:20am BST 04/07/2007 Drugs companies believe that helping poor countries in times of need can reap rewards later. Katherine Griffiths looks at the changes in the pharmaceuticals industry. Unless delegates to a high-profile summit on diabetes in Kenya last week knew it had been paid for by the world's biggest maker of insulin, they would have been none the wiser when they left. The conference, in the lush surroundings of a four-star hotel outside Nairobi and attended by ministers from three African governments, eminent scientists and health policy specialists, was organised by the World Diabetes Foundation, a private fund set up in 2002 by Denmark's Novo Nordisk. Novo established the Foundation with $100m (£50m) to tackle the emerging crisis of diabetes in poor countries, which is growing because of changes in diet and lifestyle. Yet at the conference the company's logo was nowhere to be seen. Lars Rebien Sorensen, Novo's chief executive and one of Denmark's most dynamic company leaders, merely listened to the speakers as a guest. "When we set the foundation up people were suspicious it was just a marketing tool. We have to be very low-profile," he said. That is changing now, partly because the Foundation is trying to put pressure on the World Health Organisation and private funders, such as Bill Clinton's Foundation to co-ordinate fighting Aids with tackling the rapid growth of diabetes in developing countries. Big Pharma also increasingly believes that after years of being tarred by the controversial practices of some - such as using Africa and Asia to test experimental drugs - there could be an economic benefit to engaging constructively with the world's poorest countries. Mr Rebien Sorensen was quick off the mark because of his involvement in one of the drugs industry's biggest public relations disasters in recent years: the 1997 lawsuit against the South African government which was over patent rights, but which grew into an international row over the country's need for HIV drugs. "I was heavily criticised in Denmark for being part of the lawsuit. I felt we were obliged to do something on diabetes and that we had a vested interest," Mr Rebien Sorensen said. He is confident Novo's involvement with the diabetes foundation gives it a competitive advantage, including attracting and retaining top talent. He also believes it marks Novo out among the community of scientists and doctors working on diabetes worldwide. The big hope is that by helping the poorest countries in their time of need, Novo will be well-placed to make profits when their economies improve and they can afford to pay higher prices. "I couldn't say what the net present value is. But in 20, 30, or 40 years, we will be seen as an early investor in the emerging economies of Asia and Africa," said Mr Rebien Sorensen. "I believe people feel a sense of loyalty to those who have helped them get off the ground." Another company which has built a bigger presence than most in the developing world is Britain's GlaxoSmithKline. GSK, the world's largest supplier of Aids drugs, was a high-profile target in the outcry over the South African lawsuit. Since then, it has transformed many of its policies, including taking one of the most difficult decisions for a drugs company, relaxing its intellectual property rights under certain circumstances. GSK is the only major drugs company which manufactures products in East Africa, which means it has more leverage with the government because of the jobs it has created, according to John Musunga, GSK's general manager in the region. Mr Musunga, a native of Kenya, said GSK could easily pack its bags in Africa and there would be almost no difference to its bottom line. "Sub-Saharan Africa accounts for less than 1pc of turnover. We sell to the government at preferential prices - sometimes with 30 or 40pc off - but most people cannot afford even the reduced price," he said. However, he believes the value of doing business there now is "social responsibility", and the fact that sales are slowly growing. Mr Musunga, who is also chairman of the Kenyan Association of the Pharmaceutical Industry, noted that other international drugs makers, including some American giants, were starting to open offices locally. While Africa might be many years from offering the prospect of profits, GSK's businesses in other developing countries are doing quite well. GSK India is producing an earnings margin of about 30pc, despite it selling drugs at the equivalent of a fraction of a penny per pill. GSK has developed different models in developing countries, including forming joint ventures with local manufacturers, striking voluntary licensing agreements with generics companies, and setting tiered-pricing schemes, under which the same drug is sold in a poor country at a fraction of its price in places such as America and Britain. Observers believe these types of initiatives have not come too soon for the pharmaceuticals industry, which has been in a downward spiral of regulatory crackdowns and mounting attacks on its ethics. The industry also faces a crisis of several blockbuster drugs losing their patents in the next few years with little in the pipeline to replace them. Many believe the gloom is a backlash against the excesses of the 1990s. Stewart Adkins, a former pharmaceuticals analyst at Lehman Brothers, said: "There was an almost invincible sense of self-belief among drugs companies in the mid to late 1990s because of the failure of the Clinton administration to reform healthcare and because other checks and balances weren't working. "Drugs companies were aggressively marketing, raising prices and pushing up volumes by driving people into their doctors' offices. This led to top-line growth of 10, 12 or even 15pc in some years." The industry was now scrambling to recover its reputation, he added, and one way was by becoming better corporate citizens in emerging markets. As well as GSK, Switzerland's Novartis has made its malaria drug, Coartem, available in many countries at cost. Meanwhile, Roche, also Swiss, has sacrificed some profits on Tamiflu to make it available to the poor. Critics say companies could do far more. They also point out that drugs companies are still bringing controversial cases against developing countries over patents. Novartis has been criticised by Oxfam for a continuing case against the Indian government over its cancer medicine, Glivec. Yet, analysts believe, in the absence of their pipeline of new drugs picking up, searching out new markets in rapidly growing parts of the world is in drugs companies' best interests.
2007-7-2
星期一(Monday)
多云
有很多朋友对于CODING好像不是很了解，有次在论坛上居然有看到求MEDDRA的LLT的，如果这都能随便找到最新的版本，MSSO靠什么吃饭呀。
Coding Dictionaries and Subscriptions/Licenses By: Lynda Hunter, CCDM, Drug Safety Center, Manager, PRA International Two common coding dictionaries currently in use are the Medical Dictionary for Regulatory Activities (MedDRA) and the WHO Drug Dictionary (WHO-DD). Both of these dictionaries are used by pharmaceutical and biotechnology companies, device manufacturers, regulatory authorities, clinical r ......
2007-7-1
星期日(Sunday)
多云
长时间没有做过翻译的工作了。现在做的不管是LOCAL还是GLOBAL的都是E文的资料，感觉上中英互译现在基本上已经废掉了。。。
网友推荐的一个翻译的网站：译言 http://www.yeeyan.com/ 进去翻译了两篇文章以后就感觉有些力不从心，长篇的翻译起来太过吃力，而且有时不知所云。本来用英文理解起来没有什么问题，但硬要用中文说明白就蛮困难了。。。 感觉上这个网站上活跃的医药专业的同好还是比较少的，有兴趣的朋友可以去添砖加瓦 ...... |
Our fatigue is often caused not by work, but by worry, frustration and resentment.
- Dale Carnegie
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