Wednesday, September 5, 2012

「糖尿病網膜症」初期症状を薬で進行抑制 東北大グループ

河北新報 95()610分配信東北大大学院医学系研究科の中沢徹教授(眼科)らの研究グループが、糖尿病の代表的な合併症で、失明につながることもある「糖尿病網膜症」の初期症状の進行を薬剤で遅らせることに成功した。同疾患の新たな治療法として注目される。 糖尿病になると、血流の悪化から視覚に直接かかわる網膜神経細胞が減少する。網膜神経細胞は再生できず、保護する方法も不明だった。グループは、細胞死が起きる際に活性化する特定の酵素と酸化ストレスに着目。酵素の活性化を抑制したり、酸化ストレスを防御したりする機能を遺伝子操作でなくしたマウスと通常マウスを、高脂肪食を与えるなどして、糖尿病に近い状態にして比較した。その結果、遺伝子操作マウスは、網膜神経節細胞が20%以上減少したが、正常マウスは変化がなかった。糖尿病に似た状態で培養した網膜に、酸化ストレスと酵素の働きを抑える薬剤を投与した場合と、投与しなかった場合の生存細胞数も比べた。投与しなかったマウスは細胞数が大幅に減少。投与したマウスは細胞の生存率が向上し、薬剤に細胞を保護する効果があることを確認した。中沢教授は「病状が悪化してからの治療は、患者の心身の負担も大きい。薬剤による早期治療に重点を置くことは、患者の負担軽減につながる」と話している。最終更新:95()610

15万印度医药代表 反业贿 !!!


印度15万医药代表全国罢工 抵制药企商业贿赂 发布时间:2012-9-6 来源:药品资讯网信息中心  印度15万多名医药代表在印度医药代表协会(FMRAI)的号召下,进行了全国范围罢工,要求联邦政府针对制药企业商业贿赂采取严格措施、加强政策监管,并且完善有效控制药品价格的监督机制。印度医药代表协会也通过各自分会向所有地方邦政府提出了相应政策建议。在提交联邦政府的解决建议中,印度医药代表协会指出,政府早该建立一套针对制药企业规范销售和营销规则的标准法规,着手解决反对商业贿赂和制定规范企业经营的法规制度,特别是药品价格控制和医药代表规范工作流程。与此同时,协会各邦分会也要求地方政府有效实施1976年颁布的《促销雇员(服务条件)法》,包括已经修订发布的销售促销雇员身份授权书规定。销售人员一致反对某些地方邦政府发布的限制在公立和民营医院、学术机构进行促销活动的行政指令,期望能够收回此类指令。协会希望制药公司停止不道德、不合法的销售与市场活动,确保上述工作环境下促销活动的有序进行。泰米尔纳德(Tamil Nadu)邦分会秘书长拉梅什·桑达(Ramesh Sundar)向印度医药经济信息网分析道,在制度措施没有严格执行的情况下,药品生产企业继续进行商业贿赂,而联邦政府却袖手旁观。制药产品营销道德规范早已出台,但作为一项义务而不是强制规定其实施效果大打折扣。协会和各邦分会反对制药公司促销活动商业贿赂行为已经十余年,并向联邦立法会人民院委员会提交了针对制药公司商业贿赂活动进行调查的请愿书。关于定价问题,不是品牌药或仿制药引起药品高价,而是政府政策管理不完善使然;医药代表协会要求推动所有国家基本药物按照基于成本定价原则控制。

台腫瘤專家研發新治療技術

2012-09-05 台灣旅美放射腫瘤醫生趙坤山成功研發全球第一台即時診斷影像的腫瘤放射治療系統,效果更好、費用更少。紐約哥倫比亞大學醫學院放射腫瘤學系教授兼系主任、紐約長老會醫院放射腫瘤科主任趙坤山表示,這項技術已臻完善,隨時可以量產。這款名為「弧刀」(Arc-Knife)的腫瘤放射治療系統,是趙坤山研發近5年的心血。儘管外國投資人感興趣,但他希望能將技術帶回台灣,為台灣生技發展盡一分心力。趙坤山說,傳統的腫瘤放射採取平線式照射,比較不容易完全切除腫瘤,也容易傷害正常組織,檢查與治療的儀器也十分龐大,醫院需要相當的醫療空間。而全方位照射的質子治療,儘管能較為全面照射,也能減少對正常組織的輻射劑量,但醫院要引進一台質子放射器,連同醫院改建所需的成本,在紐約至少需要3000萬美元,不是一般醫院負擔得起。為了解決這個問題,趙坤山開始設計便宜好用的「弧刀」。趙坤山說,「弧刀」的設計將過去檢查與治療兩個過程整合為一,「弧刀」後方是電腦斷層掃描攝影,在病人治療的同時,可以進行生物醫療影像,將腫瘤特性凸顯出來。「弧刀」保有質子治療所有的多角度放射,減少周邊正常組織的照射劑量,還因為弧刀小而巧,只有22.5高,比一般動輒3.55高的腫瘤放射治療設備輕巧得多,可以輕易放進醫院診療間。此外,「弧刀」的輻射照射對角也設計防阻裝置,能成功阻絕輻射線,讓醫院治療室的防輻射牆從150厘米大幅減少到25厘米,大大減少醫院改建成本,這讓「弧刀」的設置成本只有一般照射的1/40,更只有質子放射治療的1/60

國健局推 孕產婦 ’雲”!!


國健局成立關懷中心-- 新手孕產婦 雲端照護妳  2012/9/6 作者:陳玲芳 【記者陳玲芳台北報導】國民健康局成立「孕產婦身心關懷中心」,提供孕產婦雲端照護平台,由專業團隊免費電話諮詢。國健局長邱淑媞表示,希望落實五全目標(全人、全程、全隊、全家、全社區),朝「新世紀孕產婦全人照護」邁進一大步。國健局長邱淑媞表示,現代準父母有「三缺一沒有」的特質—大多新手上路(缺經驗)、小家庭(缺親友支持)、經濟剛起步(缺錢)、上班族(沒有時間),也比過去更重視寶寶的健康。需要門診醫療以外,提供更全面(包含身、心、社會層面)及全程的輔助和支持,而且,必須具備專業、方便、不限時空、免費等特色。國健局成立「孕產婦身心關懷中心」,由專業團隊提供免費電話諮詢,以及推出個人化的關懷網站(孕產婦關懷網站http://www.bhp.doh.gov.tw/mammy/)。國健局免費專線號碼,改為孕產婦關懷專線「○八○○八七○八七○」,擴大諮詢議題,幫助新手爸媽及家人早日上手。國健局正在收集國際經驗,就門診、生產、家庭、社區等四大面向,規畫全套的孕媽寶貝呵護方案,亦考慮建立「產前登錄」與「個別化需求評估」,以期建立更完全的個別化照護計畫。邱淑媞表示,相關細節將徵詢民眾、醫界與各界之看法後,深入研議。

植牙跟刀手 變操刀人!!


植牙怪象 竟是廠商業務操刀!2012/09/05 【聯合晚報╱記者李樹人╱台北報導】 植牙價格昂貴,但幫你植牙的人,確實是牙科醫師嗎?牙醫師透露,有不少植牙技術有待加強的老醫師,或經驗不夠的年輕醫師,在進行植牙手術時,居然由植體廠商的業務(俗稱跟刀手)來操刀,根本是罔顧病患權益。開業牙醫師葛建埔強烈建議,民眾接受植牙手術時,最好由親友陪同,並實地觀察。否則自己處於麻醉狀態下,加上眼睛被消毒巾給遮住,根本就無法得知是誰在執刀植牙。「由跟刀手實際操作,這在牙科領域已經行之多年,是個不能公開的秘密!」中部開業牙科醫師宋開書無奈地說,基於成本及人力考量,許多牙科診所評估後由跟刀手來執行植牙,因為可以賺更多。宋開書指出,依照醫師法規定,只要涉及醫療行為,就一定要由牙科醫師執行,即使是護士、助理,也不得幫病人看牙。相較之下,跟刀手(植體廠商業務)協助醫師幫患者植牙,甚至在病患不知情的況狀下,為病患進行人工植牙,這類行為已嚴重違反醫師法。宋開書說,這類「教學兼販售」行銷方式在國內相當普遍,中部一家植體進口廠商就以這種方法到處推廣植體,部分懶得進修植牙技術的醫師,在有人代勞的情況下,當然樂得輕鬆。葛建埔分析,跟刀手代為操刀弊端猖獗,主要在於年輕醫師植牙技術還不夠純熟,但有些年紀較長的老醫師,雙手不夠靈活,但又想跨足植牙領域,只好由跟刀手代為執行。另外,廠商為了推銷販售植體,會派出手藝精細的跟刀手業務,私下協助醫師幫病患植牙,既能與醫師打好關係,還可以提高植體的銷售量。事實上,許多「跟刀手」植牙經驗豐富,技術並不亞於一般牙科醫師。但宋開書認為,即使技術不錯,不是醫師就不能幫病人做植牙,只要從事醫療行為就已經是違法。醫師如果技術不夠好,就應該參加培訓課程,怎麼可以找廠商業務代勞。

醫師爆料 植牙竟是由廠商業務操刀 2012/9/5 17:51 〔本報訊〕據媒體報導,國內有牙科醫師爆料,許多植牙技術欠佳的老醫師,或是經驗不夠的年輕醫師,進行植牙手術時,竟是由植體廠商的業務來操刀,形同密醫植牙。衛生署聞訊後強調,若真有未具醫師資格的廠商業務來操刀,此舉已觸法,依法可處6個月以上、5年以下有期徒刑,並罰30萬元以上、150萬元以下的罰鍰。

「教學兼販售」方式 相當普遍 報導指出,有牙醫透露這種類似「教學兼販售」的方式在國內早已相當普遍,其中有中部某家植體進口商,就以類似這樣的手法四處推銷植體,專找國內部分植牙技術欠佳的醫師,讓這些醫師輕鬆、還樂得另賺外快。 據了解,某些廠商為賣出更多植體,會與部分牙科醫生打好關係,常派植牙手藝精細的業務,俗稱「跟刀手」,表面上是提供醫生協助和諮詢,實際上卻是代替牙科醫師植牙,當起密醫,枉顧病患權益。 國內牙醫師透露,這些「跟刀手」具有豐富的植牙經驗,技術不比一般牙醫師差,但他認為,即使技術好,但沒有醫師執照,就不可幫人植牙,這行為已是違法。

建議民眾植牙時找人陪同 詳察動刀情形 這位牙醫師建議民眾,在接受植牙手術時,最好有親友陪同,並詳細觀察,他認為病患處在麻醉的情形下,加上眼睛被消毒巾蓋住,難以知道是誰在動刀。 衛生署對此表示,「跟刀手」的行為等於是密醫,嚴重違法,根據醫師法第28條規定,可處6個月以上、5年以下有期徒刑,並罰30萬元以上、150萬元以下的罰鍰,同時也會把相關的藥物和器材給沒收。 衛生署強調,密醫除會被直接送往地檢署外,另外醫師本身依法也會被處10萬以上、50萬以下罰鍰,同時還會被限制執業地點、勒令停業1個月以上1年以下,情節嚴重者甚至會被廢止執照或是醫師證書,終生不可再當醫生。

Taiwan's health care market boosted by aging population

 September 2012Although a challenge for the national government, a growing aging population combined with the country's universal health care system means that Taiwan's health care market can expect to expand in the future, says the latest report by industry experts GlobalData. According to the latest study, Taiwan's pharmaceutical industry is predicted to climb from a value of $3.8 billion in 2011 to $4.8 billion by 2020, while the medical devices industry is expected to reach $3 billion by the end of the decade from a 2011 valuation of $1.9 billion. GlobalData's report states that the country's aging population will be an important factor in driving this growth, with just under 11% of Taiwan's residents above the age of 65 last year. Taiwan's population increased slightly between 2005 and 2010, from 22.8 million to 23.2 million, but this growth was mainly down to a longer national life expectancy, as the birth rate fell from 9.1 per 1,000 population in 2005 to 7.2 per 1,000 population in 2010.Taiwan's over-65 population will expand still further, states GlobalData, accounting for 13% of the country's people by 2020. Correspondingly, Taiwan's disease burden is forecast to increase, placing greater strain on the National Health Insurance (NHI) system and its commitment to universal healthcare. According to Taiwan's Department of Health (DoH), health care expenditure as a percentage of Gross Domestic Product (GDP) will climb from 6.6% in 2011 to 7.2% by 2020. However, despite Taiwan's compulsory insurance policy, out-of-pocket expenditure in the country is high, representing 36.4% of total health spending in 2010, says GlobalData.

To be seventh largest pharma market in Asia-Pac region In a separate recent report from Espicom Business Intelligence, which notes that Taiwan will have the sixth highest proportion of population aged 65 or over in the Asia Pacific region, equal to over one-tenth of the total population, the Taiwanese pharmaceutical market is projected to expand at a high single-digit compound annual growth rate (CAGR) in dollar terms during the forecast period. In 2017, Taiwan will be the seventh largest pharmaceutical market in the Asia Pacific region, and the fourth highest in per capita terms.Many multinationals are active in Taiwan, although the majority of them only have sales and marketing operations as they are deterred from establishing manufacturing operations due to the unequal drug pricing system. Taiwan is heavily dependent on the imports of retail medicaments, which represent over three-quarters of the total imports. Combined with limited pharmaceutical exports, the balance of pharmaceutical trade will remain considerably negative and the deficit is likely to increase in the forecast period.The government is investing heavily in biotechnology research capability and this has helped to encourage growth in the Taiwanese biologic sector, notes Espcom. The government's "Diamond Action Plan for Biotech Takeoff" program aims to double the annual output of the country's biotechnology industry by 2013.There were a number of competitive strategies completed in 2011: the government-sponsored Supra Integration and Incubation Centre (Si2C) was opened for business, which provides support for pharmaceutical companies to develop biologic drugs; Polaris Group revealed plans to invest $50.0 million in a new protein-injection factory; and TaiMed Biologics signed a definitive agreement with Ambrilia Biopharma for protease inhibitor and integrase inhibitor programs for HIV.

Stem Cell Therapy Gaining Ground And Investor Attention

 August 11, 2012 In the U.S., the approval process for a drug, therapy, or medical device is a tedious, sluggish and drawn-out process. The FDA is often criticized for its lack of urgency when reviewing innovative therapies, in particular cancer drugs-- and then the FDA is even more criticized when it denies the approval of these drugs for reasons such as the trial not being "flawlessly executed." In 2011, an article in the Wall Street Journal described the FDA as "an agency that cares more about its regulatory prerogatives than about the thousands of patients who might benefit and will die waiting (for new drugs)." Although this might sound somewhat harsh, some could argue that there is some measurable truth to this opinion.For a small biotechnology company, the regulatory path is a costly, risky, and time-consuming venture. It is even more so for innovative or breakthrough treatments that may differ from what's considered traditional in terms of technology or drug delivery. In some ways, the FDA process is needed, as all measures must be taken to ensure safety for the patients who suffer from life-threatening diseases. However, with so many suffering from these diseases or injuries, and many without viable treatment options, I can assume that many patients would be more than willing to risk a new, unproven treatment regimen than to simply be treated for the complication's symptoms and still allow the disease or injury to "run its course".

Finally, a U.S. Company Stem Cell Therapy Approval Currently, there are numerous cell therapies in development with promising results that look to treat conditions with large unmet needs that traditional medicine or surgery cannot treat. Additional good news for patients is that cell therapies have been widely discussed and buzz is growing. There is a lot of interest surrounding the space, especially after Canada's May 18th approval of Osiris Therapeutics' (OSIR) Prochymal for the treatment of graft-vs. -host in children, only the second worldwide approval for a stem cell therapy. It's hard to say when more approvals will occur in the future. However, at this moment, cell therapies have the growing support of patients and healthcare providers who were previously without options for many indications. The support surrounding the therapy continues to grow, therefore, forcing the FDA to acknowledge its potential.

Aastrom's Emerging Orthodontic Contribution Last week, Aastrom Biosciences (ASTM) made headlines due to its 24-patient trial and its collaboration with the University Of Michigan School Of Dentistry. The small biotechnology company was testing a cell therapy on patients who needed jawbone reconstruction following a tooth extraction. The patients were treated with tissue repair cells or a guided bone regeneration therapy, with the idea being that a patient will respond better to his/her own cells being used to regenerate tissue. After 6 and 12 weeks, the patients who received tissue repair cells had greater bone density and did not require as much bone grafting. Aastrom's technology was utilized by processing the cells taken from the bone marrow in the patients' hips, then planting them throughout the mouth and jaw. This therapy could possibly provide orthopedic surgeons with an easier method of treatment, and allows patients to avoid reconstructive surgery that may or may not be effective. Although at least five years away from being used in practice, it is yet one more space that stem cell therapies are proving to be effective.

American Athletes Bring Stem Cell Treatment into the Spotlight The most controversial stem cell therapy, though the therapy that is also gaining the most wide-spread use, is in sports. Just recently, Oakland Raiders LB Aaron Curry had told CSNCalifornia.com that he has been receiving stem-cell treatments on both his knees extracted from bone marrow from his hip. He went on to state that the therapy was the only thing that has been able to help him. He's not the only player in the NFL reaping the benefits of cell therapies. In fact, he's not the only person on his team, as former first round pick Rolando McClain has also used stem cell therapies for injuries related to his knees and legs-an increasingly prevalent procedure among athletes in all three major American sports. Unfortunately, these athletes are often forced to seek treatment in other countries. The stem cell therapy's acceptance from professional athletes could very well create a sense of urgency, or at least put pressure on regulators, to approve cell therapies in the U.S. When Americans are treated with cell therapies in other countries, it means potential revenue to the American healthcare sector is being lost. If the use of stem cell therapies continues to grow in sports and is adopted among the general public as a way to treat disorders with unmet needs, then it could lead to a large number of approvals in the near future by helping to put pressure on regulators to look at even more effective cell therapies with large revenue potential for the budding stem cell sector.Two Investment-Quality Companies with Novel Cardiovascular Disease Treatment TherapiesThe process of using stem cell therapies for regenerative purposes is still an emerging technology. Although cell therapies in sports and in dentistry may help to push regulators to approvals (and may educate the general public on the benefits of cell therapy), the most successful and most advanced cell therapy is still for cardiovascular disorders. At this time, there are two companies leading the charge in the cardiovascular space for cell therapies, and I expect that both will ultimately earn approvals: Baxter International (BAX) and NeoStem, Inc. (NBS). Both of the companies' candidates are strikingly similar. However, the technologies and indications differ somewhat. Baxter's CD34+ stem cell candidate treats patients who currently have chronic heart conditions, while NeoStem's AMR-001 treats patients following a heart attack.In Baxter's Phase 2 trial, its stem cell therapy achieved success in increasing exercise capacity while reducing angina in patients with chronic heart conditions. The reason this was so significant is because it was the first time that these endpoints had been reached, by any treatment. This provided more clinical evidence that stem cell therapies can treat diseases with unmet needs that have no other treatment alternatives. The company is now evaluating the cell therapy in a 450-patient trial. Ironically, NeoStem's PCT division is the company that is manufacturing the cells for Baxter's cell therapy.NeoStem is currently enrolling its own trial, a 160-patient Phase 2 PRESERVE study, as it will attempt to address yet another large unmet medical need and improve perfusion, preserve cardiac function, and improve clinical outcomes. The targeted market for AMR-001 is quite large, with over 160,000 patients annually in the U.S. alone. If proven effective, it and Baxter shall force regulators to acknowledge the benefits of cell therapy, and return massive gains to shareholders. The interim study results are expected in the second-half of 2013, and if effective, AMR-001 will enter a market that some estimate could be worth over $700 million in annual sales.The interesting aspect to NeoStem is that it has two ways to grow with the advancements of the space: It has its own promising cell therapy and it is the leader in manufacturing of cell therapies, with over 65,000 square ft. of manufacturing capacity and has manufactured over 30,000 cell therapy products. Baxter is just one of NeoStem's many clients, and Baxter's cell therapy just so happens to be very similar to NeoStem's AMR-001. These two cell therapies are each making huge strides in advancing the space, with regenerative benefits for the heart, but for different conditions, and with huge upside potential.

The Future Common sense dictates that, if clinical data is significant enough, regulators will have no choice but to approve cell therapies for the treatment of diseases with large unmet needs. Most are unaware of the lawsuit between the FDA and Regenerative Sciences, which was to determine whether or not autologous stem cells are drugs. This litigation has been ugly at times, and has been in the works for the last four years. Last month the U.S. federal court finally ruled and gave the FDA explicit power to regulate stem cells as drugs. This could be the start of a new era for the approval of stem cell therapies whether for cardiovascular conditions, athletic injuries (or for Texas governor Rick Perry who was injected with stem cells following back surgery), or in dental procedures. The possibilities are seemingly endless. With stem cell therapies staying in the news and making progress beyond the laboratories, I don't think it will be long until we see wide-spread adoption of cell therapies, and patients will have a fighting chance with diseases and injuries that currently have no viable treatment options.Disclosure: I am long NBS, BAX. 

葉明功…台灣用藥過量 !雖有制度,但沒執行


不當用藥 我比美國高7.2倍【台灣醒報╱記者劉運╱台北報導】 2012.09.06 09:02 am 國人一年吃15,000萬顆藥,洗腎率是全球之冠!立委江惠貞今天在公聽會表示,台灣人用藥過量問題嚴重,政府雖有制度,但醫療人員沒有實際執行,政府也欠缺整體完善的用藥政策。對此,健保局局長黃三桂表示,如果病患使用安眠藥等特殊用藥、就診次數過多,健保局會追蹤,並適時輔導。為避免多重用藥產生危險,美國民眾服用藥品達5種以上,依法須由藥師進行監控;儘管如此,美國每年因「用藥不當」的受害人數仍高達150萬人,其中有19萬人因此喪命。藥師公會理事長李蜀平指出,台灣的用藥量是美國的7.2倍,也沒有基本的「用藥把關機制」,每年因用藥不當的受害者遠超過美國。有醫師背景的立委蘇清泉今天提出一個用藥過量的典型例子:一位年事已高的老榮民,身體有各式各樣的疾病,且抱持「有病就要看醫生」的舊式思想,自己還會上網掛號,每天上不同的醫院看病,然後拿各種藥品回家;台灣此類例子比比皆是,政府應建立制度,要求藥劑師介入輔導。衛生署副署長戴杜英指出,台灣的確有「多重用藥的危機」,而藥師應該擔任「用藥把關」的角色。她說:「藥師未來將是藥政管理、二代健保推動的重要夥伴。」中華民國藥師公會全國聯合會祕書長曾中龍表示,醫師和藥師應該要有相互監督的機制,這樣醫藥分工,不讓醫師兼藥師的情況發生。健保局局長黃三桂指出,健保卡上都會顯示民眾看病紀錄,對於1年看病超過200次的民眾會追縱調查。然而,消基會衛生保健委員暨國防醫學院教授葉明功表示,台灣雖然有制度,但沒執行,否則就不會有民眾用藥過量的情況發生。他呼籲政府提出完善的用藥政策、規畫及管理【2012/09/05 台灣醒報】

WuXi PharmaTech Celebrates Dr. Joseph Vacca's Induction into American Chemical Society's Medicinal Chemistry Hall of Fame

 By WuXi PharmaTech (Cayman) Inc. Published: Tuesday, Sep. 4, 2012 - 1:34 pm SHANGHAI, Sept. 4, 2012 -- /PRNewswire/ -- Dr. Joseph Vacca, Senior Vice President of the Early Success Sharing Partnerships (ESSP) business unit of WuXi PharmaTech (Cayman) Inc. (NYSE: WX), a leading research and development outsourcing company serving the pharmaceutical, biotechnology, and medical device industries, was inducted into the Medicinal Chemistry Hall of Fame of the American Chemical Society (ACS), the world's largest scientific society with more than 164,000 members. The induction was held in August 2012 during the 244th ACS National Meeting in Philadelphia.Dr. Vacca was honored for his outstanding contributions to the discovery of novel therapeutics, including CRIXIVAN™, Isentress™, and many compounds in advanced clinical studies.In the spirit of celebrating excellence, WuXi hosted a special luncheon to honor Dr. Vacca, attended by many colleagues, collaborators, and distinguished guests of WuXi's global network.At the event, several leading chemists praised Dr. Vacca's accomplishments."Dr. Vacca sets the standard of leadership in the discipline of drug discovery," commented Dr. Paul Anderson, former Merck Chemistry Site Head, past ACS President, and winner of the ACS Priestley Medal."Advancing innovative science to effective therapies is an enormous challenge that requires strong partnership between academia and industry," added Dr. Chi-Huey Wong, the 2012 ACS Arthur C. Cope Award recipient, Ernest W. Hahn Professor of Chemistry at the Scripps Research Institute, and President of Academia Sinica."Expertise from veterans like Dr. Vacca will be vital to speed translation of discoveries into medicines for patients.""We are particularly delighted that ACS has recognized Dr. Vacca's contributions to the chemical society and to industry through his leadership in the discovery of important, ground-breaking therapies," commented Dr. Ge Li, Chairman and CEO of WuXi PharmaTech."Today more than ever, our industry needs a strong collaborative ecosystem to improve R&D productivity for the benefit of our patients.Dr. Vacca exemplifies WuXi's mission of providing the very finest industry expertise across our open-access platforms to enable anyone and any company to discover and develop drugs more efficiently and cost-effectively."Dr. Vacca has had a distinguished career in medicinal chemistry and drug discovery. Prior to working at WuXi, Dr. Vacca held positions within the Merck Research Laboratories Chemistry organization as Vice President of Chemistry at the Kenilworth, New Jersey, site and as the Global Head of Structural Chemistry. He retired from Merck in November 2011.Dr. Vacca is the author of more than 100 publications and patents and has received many awards, including the Merck Directors Award given by the Merck Board of Directors (1998); the Pharmaceutical Research and Manufacturers of America Discoverers Award (1999); the Intellectual Property Owners' National Inventor of the Year Award (1997); the European Patent Office's European Inventor of the Year for non-European inventors (2007); the ACS Award for Creative Invention (1999); and designation as a Merck Research Laboratories Presidential Fellow (2008).

Taiwan doctor develops Arc-Knife for cancer treatment

 2012/09/05 18:29:29    New York, Sept. 4 (CNA) A New York-based Taiwanese radiation oncologist said Tuesday he has developed a high-precision robotic image-guided therapy system called Arc-Knife, which offers the best and most cost effective cancer treatment.K.S. Clifford Chao, chairman of the Combined Program in Radiation Oncology at New York's Presbyterian Hospital, said the therapy system can map the exact location of a tumor and accurately direct radiation toward malignant cells without damaging surrounding healthy tissue.After five years of painstaking development, Arc-Knife's breakthrough technology is now mature enough for mass production, Chao said.The technology has already drawn interest from foreign investors, but Chao said he wishes to bring the system to Taiwan to contribute to the country's biotechnology sector. Traditional radiation therapy uses X-ray beams that go through the cancerous tissue, destroying both healthy and cancerous areas along the path of the beam, he said. In order to block the radioactive beams, thick walls are built around the therapy equipment, which takes up a huge chunk of space in a hospital, Chao added.As for the more advanced proton therapy, it enables targeted radiation beams that kill the cancerous tissues while avoiding hurting healthy tissues, he said. But from the hospital end, this therapy costs at least US$30 million just to introduce one proton device to a hospital in New York, which is not affordable for most general hospitals, he added.In contrast, Arc-Knife enables both targeted radiation beams and costs 1.6 percent and 2.5 percent of the cost of traditional radiation therapy and proton therapy devices, respectively, Chao said. It is cheaper because "beam stoppers" are inserted in Arc-Knife equipment, which drastically reduce the thickness of the concrete shield walls, from 150 centimeters in other devices to 25 cm, he said.That means the equipment no longer needs to be placed in a bunker-like room, making the technology easily adoptable in most hospitals without having to remodel their existing facilities, which drives down costs dramatically, Chao said. In addition, Arc-Knife is more compact in size. It is about 2.5 meters high, compared to traditional radiation therapy equipments that are up to 5 meters high, he said. Chao, who has nearly 30 years of experience in oncology care, received his medical degree from Kaohsiung Medical School in Taiwan.He is also a director and professor at the prestigious Weill Cornell Medical College and Columbia University Medical Center. (By Leaf Chiang and Ann Chen) 

中國天狮….建構健康产业!!


天狮十七周年:立足大健康产业 坚持全球化发展 来源:天津北方网作者:2012-09-04 00:05天津北方网讯:82893,为期7天的天狮集团十七周年庆典系列活动,在位于天津新技术产业园区武清开发区的天狮国际健康产业园举行。来自全球的不同肤色、不同国籍、不同民族的天狮事业伙伴约两万人齐聚天狮国际健康产业园,共同见证天狮集团隆重热烈的辉煌盛典。本届庆典以"超越梦想引领未来"为主题,突出"家.天下"的企业文化以及发展"大健康产业"的战略思想,不但汇聚了一场场精彩绝伦的文艺演出,更对天狮营销精英们进行表彰和奖励,同时展示和发布了天狮新产品,举办了富有针对性的专场精英培训。828,"2012天狮国际产品展示会"拉开了天狮十七周年庆典系列活动的序幕。此次产品展示会历时7天,以"自然·科技·生命之旅"为主题,品牌之全、形式之新、互动之强,均超越了往届规模。展示会上,新老产品交相辉映,令人目不暇接。以专题形式对老产品进行介绍,通过新颖的形式和风格,突出各系列的特色。对新产品的宣传则由图文宣传结合现场试服展开,动静相宜,使来宾深层次、全方位地感受天狮产品的魅力。通过此次展示会,充分彰显了天狮集团强大的科技研发、生产物流与国际营销实力,吸引了众多参会者的目光。纳米远红外线床上用品、体感音乐坐垫、钛金手链等一款款卓越产品更是吸引了大批来自世界各地嘉宾的现场咨询、体验,购买产品的来宾络绎不绝。长期以来,天狮立足大健康产业,以传播"中华五千年养生文化"为已任,心怀"共存、共好、共赢"的品牌主张,将天狮特有的"清调补防"养生理念与现代化高新科技相融合,形成独特的以"养"为核心的"养体、养颜、养环境"的健康养生体系,倡导"知行合一、天人合一"的健康"新养道",为不同年龄、不同生活背景的人们提供多元化的产品选择和服务,为追求健康的和谐、家庭的和谐、社会的和谐、自然万物的和谐而不懈努力奋斗。天狮产品通过了HACCPISO9001GMPISO17025ISO10012等多项认证,拥有完善的质量保障体系,产品安全管理达到国际先进水平,更为"中国制造"赢得了良好的国际声誉。831晚,在天狮国际健康产业园气势恢弘的洪雲广场上,灯火绚烂、人声鼎沸、热情高涨,盛大的"天狮集团十七周年庆典大会"在这里隆重举行。鲜花、掌声、呐喊、欢笑、泪水……历经了17年艰苦创业飞速发展的天狮集团,如今承载着五千年中华养生文化,承载着千万家庭的美好生活向往,承载着引领大健康产业发展的梦想,敞开怀抱,又一次拥抱来自五洲四海的朋友们!作为在中国总部举办的全球性庆典,本次大会中华元素贯穿其中,异域风情别开生面:在非凡创新的天狮人精心策划下,独具匠心的节目安排让人目不暇接,精彩不断。一个个由天狮人自己参与演出,体现天狮全球大家庭和中国文化底蕴与现代风貌的精彩节目,博得全场掌声阵阵,知名音乐人郭峰、"美丽教主"伊能静、藏族歌手次仁尼玛、马来西亚歌手Irena Barr等演艺明星的到场,也将现场气氛一次次带向高潮。更值得一提的,此次天狮盛会在全球事业伙伴的共同参与下,在大会现场创造了一次历史性的世界记录,在世界记录协会的见证下,来自全球50多个国家的2万余名天狮伙伴共同手拉手,欢歌载舞,创造了"最大规模企业集体舞蹈"的世界纪录。更加引人瞩目的是天狮集团对优秀事业伙伴的大力度褒奖,使得他们频频成为华丽舞台上的焦点,他们身着盛装,神采奕奕地走上舞台,接受李金元董事长的授奖,接受在场事业伙伴们的欢呼与祝福。会上,李金元董事长发表精彩演讲,对社会各界17年来给予天狮的支持与帮助表示感谢,回顾了天狮立足大健康产业,坚持全球化发展,坚持打造国际化品牌的创业历程,并详尽阐释了天狮大健康产业发展战略布局与未来发展规划,向全球天狮人描绘了第三次创业的美好前景与壮丽画面。

 

 

Lower Costs and Less Radiation Exposure

 BY JAMAL, ON SEPTEMBER 5TH, 2012 The establishment of regional trauma systems where patients are transferred from non-tertiary emergency departments (EDs) to major trauma centers has been shown to improve survival. Transfer patients are often critically ill, with higher mortality rates and longer hospital stays than patients who undergo treatment at the hospital of first arrival. However, imaging utilization, especially computed tomography (CT) scans and X-rays, on transferred patients may be considered high."The purpose of our study was to evaluate the use of the Internet and immediate CD importation to transfer images to a level I regional trauma center on imaging repeat rate, cost, and radiation dose and compare this with previously published repeat rates, all of which are from trauma centers without the capability to electronically transfer images," said Martin L. Gunn, author of the study. Five hundred consecutive trauma patients transferred to a level I trauma center were included in the study. Images were transferred from an outside facility to the trauma center using the Internet and CDs and uploaded to the trauma center's Picture Archiving and Communication System (PACS). Repeat rate, costs, and radiation doses of transferred and repeated CT scans were calculated.Four hundred ninety-one patients met the inclusion criteria. Three hundred eighty-three patients had 852 CT studies and 380 non-extremity X-rays imported into the trauma center's PACS. At the trauma center, 494 completion CT scans and 2,924 X-ray studies were performed on these patients. Sixty-nine repeat CT scans were performed on 55 patients, equaling a 17 percent repeat rate. The total value of imported studies was 244,373.69 Dollars. Repeat imaging totaled 20,494.95 Dollars."Our study shows that repeat rates using electronic transfer of imaging are lower than those in the literature and that because of this, patients are exposed to less radiation and the imaging charges are lower to the health care system as a whole," said Gunn."Further studies to evaluate the effect of this technology on transfer time and patient morbidity and mortality are necessary to accurately determine the full impact on health care costs and outcomes," he said.MEDICA.de; Source: American College of Radiology

 

血寶..缺血性腦中風臨床 收案已180人 !!


懷特 新藥銷量將躍增【經濟日報╱記者黃文奇/台北報導】 2012.09.06 02:35 am 懷特(4108)昨(5)日公布8月營收1.55億元,月增1.84%,年增近三成;今年前8月受惠於旗下新藥「血寶」上市挹注,年增也近三成,今年第4季銷售可望躍增。懷特表示,「血寶」已經在台各大醫學中心開始銷售,由於該藥物為目前台灣第1個獲食品藥物管理局(TFDA)核准的新藥,且針對難以對付的「癌因性疲憊症」,潛力可期。昨日股價收50元,上漲0.5元。血寶於2010年正式取得藥證後,遲於今年4月才正式進軍各大醫學中心銷售,目前該產品每個月挹注公司約500萬元營收,但國內因癌症化療進而有「癌因性疲憊症」需求者甚殷,以直接讓該藥物複合成長率達到20%。法人指出,該藥物是針對癌因性疲憊症所開發的藥物,目前全球同類型藥物極少,因此血寶注射劑具有相對競爭優勢;若依目前銷售狀況,第4季起可望放大銷售量,而明年營收有機會達到1億元。懷特說,血寶注射劑目前每針售價約1.2萬元,一次療程建議使用20支;未來,將繼續開發23個新適應症,如治療「缺血性腦中風」,目前已經和中國醫藥大學合作,並進入「先導性臨床」,預估將收300名病患,目前收案率已經超過六成。2012/09/06 經濟日報】

Merck Serono spins-off biomarker services into Quartz BioGeneva, Switzerland

 

Tuesday, September 04, 2012, 10:00 Hrs[IST] Merck Serono, a division of Merck, has created Quartz Bio, the second spin-off company resulting from its Entrepreneur Partnership Programme launched in April 2012. Quartz Bio will offer biomarker data management and exploratory biomarker analysis services for the pharmaceutical industry.Biomarker analysis is a critical step in the drug development process as it enables the identification of patient profiles that are most responsive to a given treatment."This second company creation through our Entrepreneur Partnership Programme shows the great diversity of activities that can be developed in the field of life sciences. Highly specialized service companies are essential actors of the drug-development process, and they are very complementary to the activities and structures of large pharmaceutical companies." said François Naef, chairman of the Board of Directors of Merck Serono SA. "The launch of Quartz Bio also illustrates the dynamism of Merck Serono employees, and I am convinced that the Geneva regional economic fabric will benefit from it."Quartz Bio will be headed by Jérôme Wojcik, a seasoned expert in bioinformatics, and will employ four highly specialized scientists with in-depth understanding of biology and bioinformatics as well as extensive experience in drug-development processes. The company will be hosted in the Blue Box offices of FONGIT, a start-up accelerator located in Plan-les-Ouates, Geneva, and supported by the Geneva authorities. Merck Serono intends to use the services provided by Quartz Bio and is planning work orders amounting to around €2 million for the next two or three years."An increasing number of pharmaceutical companies are integrating a stratified medicine approach in their drug development process in order to predict how patients will respond to a specific therapy," said Jérôme Wojcik, founder and CEO of Quartz Bio. "Biomarker analyses are at the heart of stratified medicine and we believe that Quartz Bio's flexible and highly specialized services will bring added value to pharmaceutical companies for the development of new drugs."Announced in April 2012 in the framework of the efficiency measures being taken by Merck Serono, the Entrepreneur Partnership Programme (EPP) is part of a €30 million commitment to support the creation of spin-off and start-up companies focused on continuing activities and compounds that originated at Merck Serono. This programme is aimed at reducing the impact on employment following closure of the Geneva headquarters due to restructuring, and already has resulted in the creation of another company, Prexton Therapeutics, besides the today announced Quartz Bio.Merck Serono is the biopharmaceutical division of Merck KgaA. Merck Serono offers leading brands in 150 countries to help patients with cancer, multiple sclerosis, infertility, endocrine and metabolic disorders as well as cardiovascular diseases. Merck Serono discovers, develops, manufactures and markets prescription medicines of both chemical and biological origin in specialist indications.

 

 

HL7 (醫療電子資料交換標) Free use for public good !!!


HL7使用年費取消 有助於醫療資訊交換之發展 吳明宜 / 編譯 2012/09/05 25年來醫院和診所都必須支付1,200美元年費才能合法使用HL7醫療電子資料交換標準, 2013年第一季開始將完全免費。25年來醫院和診所都必須支付1,200美元年費才能合法使用HL7醫療電子資料交換標準。本周二負責開發HL7的非營利組織Health Level Seven International表示,自2013年第一季開始,這項智慧財產將可免費使用。「這項宣佈是過去十年來最重要的標準進展,它讓所有相關人士都可在『有意義使用』前提下,得以取得所需的內容標準,真要感謝所有推動的工作人員,」Beth Israel Deaconess醫療中心CIO暨哈佛醫學院醫學教授John Halamka說。HL7是一系列醫療資訊交換的標準和規則,像是電子病歷等。HL7推手還包括Integrating the Healthcare Enterprise (IHE),旨在促進電腦系統資訊分享。HL7還用來描述以Open Systems Inteconnection (OSI)模式發展的標準。美國聯邦政府對電子病歷「有意義使用」的原則是根據HL7而制定。為要能獲得eHR系統建置成本的補貼,並避免不使用電子病歷的罰則,醫院及服務供應商必須遵守三階段「有意義使用」的原則。第二階段的使用原則於上周公佈。 第二階段(Stage 2)有意義使用原則最重要一點是要求醫療服務供應商得以和其他單位透過醫療資訊交換機制,共享病患的資訊。HL7組織CEO Charles Jaffe表示,取消會員費有助於加速HL7的普及,促進醫療資訊的共享。2010年,美國只有20%的醫院以電子形式交換臨床記錄,美國全國醫療資訊科技協同辦公室州級醫療資訊交換(HIE)計畫主任Claudia Williams說。目前美國政府已投入數百萬美元制訂地方和州政府層級的醫療資訊交換機制,以利供應商交換病患資訊。聯邦政府也正在建立全國式醫療資訊網路,以利病患資訊跨州傳遞。此外,電信業者如Verizon也建立雲端醫療資訊交換的架構。「HL7的願景是實現協同、消費者導向的標準運用於健康照護。去除導入障礙後,我們將更離目標更近一部,降低醫療IT的成本,提升照護品質,」Jeffe說。

 

Botox: Medical and cosmetic use

  GP Mohanta, PK Manna and K. Saravanan Wednesday, September 05, 2012, 08:00 Hrs[IST] Botox is a trade name with active ingredient Botulinum toxin A administered as injection for either therapeutic or cosmetic use. Botulinum toxin is an exotoxin produced by the bacterium Clostridium botulinum and is known as the most toxic substance known. It has been estimated that one mg is enough to kill about 20 million mice. The LD50 of this toxin is estimated to be 40-56 ng [intravenous] in monkeys. Expressing the potency of toxicity, it has been reported that four kilograms of this toxin is enough to kill the entire human race. Though research exploiting this toxin for therapeutic purpose has been initiated in late 1960s, it got first the United States Food and Drug Administration (US FDA) approval in 1989 as treatment for two rare eye muscle disorders and in 2002 as a wrinkle reducer. In 2011, the US FDA further approves Botox for treatment of urinary incontinence in patients with neurological conditions like spinal cord injury and multiple sclerosis. With this new indication, there are seven medical conditions: cervical dystonia (neuromuscular disorder involving head and neck), excessive sweating, chronic migraine, uncontrollable blinking of eyes, increased muscle stiffness with upper limb spasticity, visual defects with eyes not properly aligning with each other, and urinary continence; where Botox find usefulness. In India Botox is approved for use in the year 2006.

Botox for cosmetic use In addition to the above seven medical indications, Botox is approved for cosmetic use to improve the look of moderate to severe frown lines between the eye brows. This helps in augmenting the facial appearance of a person by reducing the wrinkles present on the face thus making a person look younger.The face is frozen in time and feel good factor about self becomes the driving force for this cosmetic use. The treatment result lasts about four months and requires continuing further treatment."The 48 year old bollywood queen looks gorgeous – the cheeks look fuller than the usual". "The legendary actor had cosmetic injection to look like a college boy in one of the most impressive movies of recent times." These are some of the headlines of news supplements of reputed daily newspapers. Yes, these are the success of Botox. It has helped people all over the world to look young than what they are! But not without the risks!The product is injected into the concerned muscle. It works by blocking the transmission of nerve impulses to muscles, causing those muscles to relax. It decreases the muscle activity by blocking the release of acetylcholine from the neuron by preventing the vesicles where the acetylcholine is stored from binding to the membrane where the neurotransmitter can be released. This effectively weakens the muscles. Relaxation of the muscles between the eyes causes wrinkles to disappear. Injection of Botox to the bladder results in relaxation of the bladder increasing storage capacity and decreases urinary incontinence. These cosmetic and therapeutic effects are due to local effects of the Botox.Unfortunately the Botox is not just restricted to the site of injection. Its propensity to spread to the parts of the body distance from injection site is a cause of concern as it affects the other system. In particular, if the gastrointestinal tract is affected, the ability to swallow could be impaired; the patient might regurgitate, inhale some stomach contents, and develop aspiration pneumonia. Loss of control of oesophagus leads to uncontrolled, abnormal swallowing, called 'dysphagia'. This can be serious enough where the patients can no longer eat or drink and need hospitalization. Independent of swallowing problems, the drug can additionally impair breathing. The common toxic effects observed due to spread of the toxin to other parts include: loss of strength and muscle weakness throughout the body, double vision, blurred vision and dropping eyelids, hoarseness or change or loss of voice, trouble saying clearly, loss of bladder control, trouble breathing, trouble swallowing. These are the symptoms of botulinum toxin commonly known as botulism. The problems of swallowing, breathing, or speaking may appear even after several weeks of injection.This occurs due to weakness of the muscles required for speaking, swallowing and breathing. These conditions are often life threatening leading to deaths.

Adverse events There has been report of 554 suspected cases of adverse events occurred during November 1997 to December 2006 in USA due to Botox. This included 25 deaths that appeared directly linked to medicine in use. Public Citizen Group of USA urged the US FDA to issue strongest warning on the Botox's label warning the physicians on its propensity to spread to other parts of the body distant from the site of injection. The mild reactions occur at the site of injection are pain and bruising, redness, light swelling etc. can be easily managed with application of ice before and after injection. However, the allergic reactions like rash or itchy welts, wheezing or difficulty breathing or swallowing, dizziness or faintness, experiencing muscle weakness, difficulty speaking, double or blurred vision, or lose of bladder control may require immediate medical attention and even hospitalization. The patients or the clients (cosmetics users) need to be informed to understand the serious adverse events so that they can avail the medical help without delay.Like all other medicines, the Botox too has risk. Therapeutic use involves higher doses of drugs than cosmetic use. The drug has been widely used and the adverse events have been observed with approved and unapproved indications. The careful consideration of benefit – risk ratio and clear understanding of this both by the physician and the patients (and clients) would promote safe and effective use of this prescription medicine for therapeutic and cosmetic purposes.

 

 

空服人員熱衷 4D訂書針雙眼皮術


空服員眼睛狀況多 雙眼皮手術需求夯空姐是許多女性夢寐以求的工作,也是令許多男性內心怦然心動的角色,雖說空服人員為看似外表光鮮亮麗的夢想行業,孰不知其背後必須承受及克服多少辛勞。據調查,空姐這一行仍是許多大學畢業新鮮人最愛的工作,更是許多畢業生十分嚮往的飛翔生活,也因此就算錄取率僅有平均2%,還是吸引許多畢業生搶破頭,但這樣的衝動看在許多空服人員的心理,不禁吶喊:「一定要三思呀!許多空姐為展現自信及美麗的一面,不僅在服裝講究,首要迎人的眼妝更是不容忽略,但漫長的飛行時間及艙壓內乾燥的空氣,不僅時常讓眼睛水嫩的妹妹們變乾妹妹,〝雙眼妹變單眼妹〞的狀況更是層出不窮。空姐們因工作關係需長時間配戴隱形眼鏡,或習慣戴上假睫毛與雙眼皮膠,呈現精神及自信的一面,但眼睛因艙壓或是乾燥空氣的影響,常會有發癢或是不適的狀況產生,且長時間在機艙內工作,眼妝或是假睫毛與雙眼皮膠會有脫落的窘境。 因此資深空服人員Nancy就說,為了節省化妝時間與避免工作上眼妝的脫落困擾,多半同事都會去進行雙眼皮手術,一方面讓眼睛比較有神,二方面就是希望能在工作環境中,保持最佳精神狀態。 雙眼皮手術雖手術簡單,但不少民眾往往還是擔心術後眼皮不自然而躊躇不前,為此佳醫美人整形外科張至德醫師便表示,現今頗受好評的4D訂書針雙眼皮術可大幅降低民眾的疑慮。張至德醫師進一步說明,比起傳統縫線雙眼皮較易鬆脫,維持期短,而一般訂書針雙眼皮又多半僅用三點作支撐,線條不深,眼頭、眼尾線條也較不流暢漂亮;因此自韓國習得全新4D訂書針雙眼皮,於眼頭眼尾再加強兩點,使五個訂點能夠拉長範圍,讓縫線連接能更加緊密與牢固,眼皮的線條也更加自然,大大改善了過去縫雙眼皮維持短暫的問題。且手術時間短、傷口小,同時還具有割雙眼皮的功能 對於空服人員的職業需求,張至德醫師也建議不只空服人員,許多民眾也因工作時間長等因素需要長期配戴隱形眼鏡、假睫毛或長期貼雙眼皮膠,易使眼睛感到不適,並使眼皮鬆弛下垂,因此建議可透過雙眼皮手術進行改善,但術前還是要多和醫師溝通與諮詢,選擇適合自己的手術方式,才能擁有一雙明亮電眼。

 

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