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Tuesday, October 21, 2014

非醫藥的衛福部長 (蔣丙煌: 食品專家) 國防級食安佈署 !!!

蔣丙煌:有信心月底前平息黑心油風暴  【聯合晚報╱記者李樹人/專訪】2014.10.17 11:28 pm被外界視為燙手山芋的衛生福利部部長,終於有人願意接下,前台大食品科技研究所特聘教授、現任行政院政務委員蔣丙煌,成為我國首位食安專家出任衛福部長;他在上任前接受晚報獨家專訪表示,「有信心在月底平息這場黑心油風暴,讓國人逐漸重拾食安信心。」蔣丙煌指出,為了解決食安問題,上任後首推四項要務:落實源頭管理、三級品管制度、利用食品雲(ICT)來協助整體管理,以及確實執行油品分流管理。蔣丙煌說,油品分流管理是目前最重要的課題,包括食用油、飼料油、工業用油及廢棄油,都須納入分流系統,未來將由專人管理及掌握流向。蔣丙煌表示,行政院食安辦公室已經開始運作,扮演參謀總部的角色,負責整體規畫及分析各項食安風險,今天下午人員就會陸續到位;衛福部、農委會及經濟部則是重要的三軍,共同協同作戰,致力維護國人健康。蔣丙煌指出,食安辦公室配置20名人力,除了從公務體系調派人力,也從衛福部、農委會、經濟部等單位調派專才,另外,延攬外界專家,齊心推動完整研究及改革。除了食安議題,未來台灣還可能面臨伊波拉疫情,對此,蔣丙煌說,目前負責督導衛福部業務,也主持過疫苗會報,對於疫情防制並非完全陌生,他一定會盡全力保障國人生命安全。蔣丙煌坦言,每個人都有專長,不可能是全面性的,可以熟悉所有的事物,但他相信要把事情做好,關鍵在於領導及能力。他的專才在於食品安全,有信心在月底前平息這場黑心油風暴。除了油脂之外,未來優先處理重點為進口的大宗食品原料,已請專家評估中,由於食品範圍太過廣泛,體系繁雜,但他會盡所有努力,逐漸讓國內食品體系健全。國內食安事件頻傳,重創台灣形象,蔣丙煌接任衛生福利部部長一職,將成為首任從食品界出身、無醫藥或公衛背景的衛福部長。蔣丙煌曾擔任台大教務長七年,期間閣揆江宜樺則曾擔任過兩年的副教務長,當時兩人關係為上司、下屬;在江宜樺力邀之下,他於今年2月底入閣,擔任政務委員,負責督導科技及食安業務。

 

醬缸文化? 誰都很難 !

蔣丙煌接衛福部長 綠委諷醬缸中找人 2014101715:53    政務委員蔣丙煌確定上任衛福部長職務,但朝野立委對他評價兩極,藍委覺得他出身食品科技教授,身段柔軟,接任部長可先救急;但綠委直言,蔣過去就曾多次主持跨部會食安會議,但食安風暴仍持續不斷,痛批是在醬缸中找人。綠委田秋堇抨擊,蔣丙煌雖曾是台大食品科技研究所教授,但就她了解,全台灣的食品科系都沒有食安將關課程,從蔣的經歷甚至可看到他去美國普渡大學的化工系當訪問學者,看不出他有何食安專業。田秋堇也抨擊,蔣擔任政委期間主持過跨部會的食安會議,但召開這麼多次,問題還是這麼多,「責任搞不好比邱文達還大」,怎麼沒一起去職?況且,食品科技教授都與食品業者關係良好,甚至接受業者捐助做研究,上任後能否雷厲風行改造,是一大問號。 綠委趙天麟怒批,邱文達為食安風暴下台,甚至各界也都在討論行政院長江宜樺是否也該請辭,但過去負責居中協調食品科技學者,督導食安成這副模樣,竟然還成為部長,明顯是在醬缸中找人。趙直言,蔣上任後的第一件事,應該是要釐清之前的行政怠惰的政治責任。 藍委蘇清泉表示,蔣本來就是在做跨部會食安小組與辦公室,由他來擔任部長,可以先救命、救急,加上蔣的身段柔軟,應該可以勝任;藍委蔡錦隆指出,蔣本來就是相關專業出身,又是擔任台大特聘教授,也在行政院督導黑心油業務,由蔣來接任部長比較容易接手,面對第一線業務問題,將過去所學貢獻給國家,適得其所。(郭建伸、陳培煌/台北報導)

 

罕病 中央如何分工(三署: 國健署/食藥署/健保署) 年給付藥費30億元

衛福部擴大罕病病友之照顧與保障行政院會通過「罕病防治及藥物法」部分條文修正案 為提供罕見疾病病人更完善之照護,衛生福利部經徵詢立法委員及病友團體等各方意見後,擬具「罕見疾病防治及藥物法」部分條文修正草案,於今日(821日)順利通過行政院院會,將送立法院接續進行審議。衛生福利部邱文達部長表示,本次修法草案,在確保罕病醫療照護部分,強化了罕見疾病用藥之健保給付收載程序,新增藥商除因不可抗力之情形外不當停止供應罕藥之罰則,增列支持性及緩和性照護之補助,並協助診療醫院及罕病病人取得維持生命所需之特殊營養食品及罕藥之緊急取得等。同時,為強化罕病全人及家庭照護,將派專業人員進行訪視,提供病人及家屬心理支持、生育關懷與照護諮詢等服務;罕病患者就醫、就學、就養時,主管機關也應協調相關機構協助。

台灣是全世界第5個立法保障罕病的國家 為了提供罕見疾病病人更多照顧,早在89年,台灣就已經通過並施行「罕見疾病防治及藥物法」,作為保障罕見疾病病人基本醫療生存權的法源依據。跟其他先進國家相比,我國的「罕見疾病防治及藥物法」獨具特色,因為立法內容結合了罕病防治與罕藥法,堪稱世界首見。除協助罕病病人順利取得治療所需之藥物、特殊營養食品及提供相關醫療補助外,亦從防治層面預防罕見疾病之發生,並訂定「罕見疾病藥物專案申請辦法」、「罕見疾病藥物供應製造及研究發展獎勵辦法」及「罕見疾病醫療補助辦法」,以簡化罕見疾病藥物之許可審查程序、對罕藥許可證的保障達10年、獎勵相關藥物供應製造及研究發展之貢獻。目前衛生福利部由所屬的國民健康署、食品藥物管理署和中央健康保險署等三個單位共同提供罕病病人照護,其業務分工如下1 國民健康署:負責罕病防治法規、罕病認定、病患服務、研究發展、宣導教育。2 食品藥物管理署:負責罕藥法規、罕藥認定、罕藥的查驗登記、罕見疾病特殊營養食品專案申請、罕藥及特殊營養食品之供應、製造與研發獎勵。3 中央健康保險署:負責罕病患者就醫之醫療費用給付、核發罕病屬重大傷病證明,就醫免部分負擔。

國民健康署邱淑媞署長表示,該署截至1033月業公告201種罕見疾病、86種罕見疾病藥物名單及40項之罕見疾病特殊營養食品品目,接獲通報罕病病人8855人,並將罕病納入健保給付之重大傷病範圍,免除病患就醫之部分負擔,健保給付罕病醫藥費,每年給付罕病藥費約計30億元。此外國民健康署,並提供依全民健康保險法依法未給付之罕病醫療補助,每年預算約2.1億元,補助服務包括:提供罕見疾病個案國外代檢服務、擴大補助國內確診檢驗、居家醫療器材租賃、營養諮詢、緊急用藥、治療、藥物等醫療費用80%之補助,如為中、低收入戶全額補助醫療費用;另全額補助罕見疾病維生所需特殊營養食品及緊急醫療之費用,設置罕見疾病個案特殊營養食品暨緊急需用藥物物流中心,統籌供應特殊營養食品計37品項和儲備緊急需用藥物10品項,上述服務102年總計補助2026人次。此外,在國民健康署邱淑媞署長的帶領下,並進行數項支持擴大照護政策的實證研究,包括:罕見疾病病人及家屬對罕見疾病防治政策之認知與期待之調查、各國罕見疾病防治與照護及政策研究、罕見疾病個案審查標準機制建置計畫及罕病醫學研究等相關計畫。

罕病法修法,提供更完善之罕病醫療照護及家庭支持 邱文達部長表示,本次「罕見疾病防治及藥物法」部分條文修正草案,可以加強罕病病人完整的醫療照護及家庭支持,將能為罕病病人減除更多經濟負擔、提昇國內罕見疾病照護品質。未來,政府將持續推動罕見疾病防治工作,讓罕病病友能在最低經濟負擔的情況下,及早且持續接受治療,並提升生活品質。更新日期:1030822

tax inversion, 美國製藥 被政府盯上 !

美國製藥廠相繼收購海外同業 力拼減輕稅務負擔  文/黃齊元(台灣併購與私募股權協會理事長)-2014-07-21美國製藥廠為了減輕稅務負擔,相繼收購海外同業。邁蘭藥廠(Mylan)周一宣布收購亞培藥廠(Abbott Laboratories)的海外品牌學名藥業務,艾伯維(Abbvie)也即將與英國同業希爾(Shire)達成收購協商,金額接近540億美元。美國製藥業常用「稅負倒置」(tax inversion)手法,藉由海外購併交易將公司移至國外低稅率地區,以減輕稅務負擔。艾伯維擬出價逾310億英鎊(約536.2億美元)收購希爾,可望寫下美國企業尋求「稅負倒置」金額最高的收購交易之一,同時角逐年度最大收購案。若希爾同意出嫁,艾伯維打算將公司移至英國,享受較低的稅率。此外,亞培同意將已開發市場的品牌學名藥業務出售予同業邁蘭,亞培將獲得價值53億美元的股票,雙方預計在2015年第1季完成收購事宜。邁蘭將在荷蘭成立新的上市公司,但總部仍設在美國匹茲堡,新公司將包含邁蘭現有業務,以及亞培已開發市場的品牌學名藥業務。亞培將獲得新公司約21%的股權,或1.05億股,不過亞培並不打算當長期股東。這筆全股票交易除了讓邁蘭享受較低的企業稅,還可協助邁蘭拓展美國市場以外的業務。新公司名稱將為邁蘭(Mylan N.V.),股票仍將以現行的代碼MYL繼續在那斯達克交易,邁蘭目前的管理團隊將領導新公司。亞培本次出售的業務包括在歐洲、日本、加拿大、澳洲和紐西蘭販售的學名藥和特殊學名藥,2013年的銷售額約為20億美元。亞培將保留在新興市場的品牌學名藥業務和產品,以及已開發市場的其他業務和藥品。亞培董事長暨執行長懷特(Miles D. White)指出,本交易亦能為公司帶來額外的策略彈性,公司日後的品牌學名藥業務將專注於新興市場。

我們的看法:第一、全球醫藥產業正以前所未有的速度進行整合,並且許多是跨洲案件。第二、美國製造業因為有"tax inversion"法規,可以透過海外M&A將公司移到國外低稅率地區,引起一連串美國大藥廠的海外併購行動第三、台灣的生技股發光發熱,與其讓本土不肖的炒家以生技為炒作題材,吸引無知大眾的資金,不如鼓勵世界一流的大藥廠到台灣來設點,併購或合資,將可以將台灣生技產業推高到一個新的境界和層次

Effect of new inversion rules on Mylan's deal with Abbott unclear  September 24, 2014 12:00 AM  Jeff Swensen  Inversion loophole puts U.S. tax policy in a jackpot  By Patricia Sabatini / Pittsburgh Post-Gazette Generic drug giant Mylan Inc. remained mum Tuesday about how the U.S. Treasury Department's new rules might affect the Cecil company's plans to reincorporate in the Netherlands to lower its tax bill, as experts offered different opinions on whether the pending transaction was in jeopardy. The Obama administration this week announced new rules aimed at curbing so-called corporate inversions under which U.S. companies move their designated headquarters to tax-friendlier countries without actually moving their operations. The increasingly popular maneuver, which firms typically accomplish through the takeover of a smaller foreign company, has raised the ire of the president and some lawmakers, who view it as a tax dodge costing the federal government billions in revenue. On Monday, Treasury Secretary Jacob Lew unveiled measures that would make some inversions more difficult and less profitable. The changes do not apply to inversions that have been completed."For some companies considering mergers, today's action will mean that inversions no longer make economic sense," Mr. Lew said. Robert Willens, an independent tax adviser in New York City, didn't think Mylan's deal would be affected by the changes."I think it's full speed ahead" for the transaction, he said. In July, Mylan announced that it was acquiring a major chunk of Chicago-based Abbott Laboratories' generic business outside the U.S. in an all-stock transaction that would use the acquired assets to form a new parent company called Mylan NV, based in the Netherlands. The deal is slated to close early next year. Although some experts previously have referred to Mylan's transaction as a "spinversion," which Treasury's new rules appeared to block, Mr. Willens said technically speaking it wasn't one."The Mylan transaction is not a spinversion … as that term is being described," he said in an email."We draw investors' attention to the 'spinversion' item addressed in the newly announced rules, which will likely preclude Mylan's ability to consummate its proposed transaction … in our view," she wrote in a note to clients that was reported by The Wall Street Journal's MarketWatch blog. The spinversion issue aside, Mr. Willens said key portions of the new inversion rules that target specific tax-lowering strategies aren't as important for Mylan as they are for other companies."The Mylan deal is primarily about reducing the worldwide effective tax rate, rather than repatriating previously accumulated foreign earnings without U.S. tax cost," he said. Mylan did not respond to requests for comment Tuesday and, as of press time, had not issued a public response to the new inversion rules. Mr. Lew said more action was needed to stop inversions, and reiterated the administration's call to Congress to pass specific anti-inversion legislation."These first targeted steps make substantial progress in constraining the creative techniques used to avoid U.S. taxes," he said. "While comprehensive business tax reform … is the best way to address the recent surge of inversions, we cannot wait to address this problem." Mylan's shares closed Tuesday at $46.61, up 8 cents, or 0.17 percent.

 

 

對與不對深度看法! 用藥看病VS用病看藥 (ADHD 過動症)

Doctor: ADHD Does Not Exist  Dr. Richard Saul  March 14, 2014  TIME   Over the course of my career, I have found more than 20 conditions that can lead to symptoms of ADHD, each of which requires its own approach to treatment. Raising a generation of children — and now adults — who can't live without stimulants is no solution. This Wednesday, an article in the New York Times reported that from 2008 to 2012 the number of adults taking medications for ADHD increased by 53% and that among young American adults, it nearly doubled. While this is a staggering statistic and points to younger generations becoming frequently reliant on stimulants, frankly, I'm not too surprised. Over my 50-year career in behavioral neurology and treating patients with ADHD, it has been in the past decade that I have seen these diagnoses truly skyrocket. Every day my colleagues and I see more and more people coming in claiming they have trouble paying attention at school or work and diagnosing themselves with ADHD.

And why shouldn't they? If someone finds it difficult to pay attention or feels somewhat hyperactive, attention-deficit/hyperactivity disorder has those symptoms right there in its name. catchall phrase. But can we really lump all these people together? What if there are other things causing people to feel distracted? I don't deny that we, as a population, are more distracted today than we ever were before. And I don't deny that some of these patients who are distracted and impulsive need help. What I do deny is the generally accepted definition of ADHD, which is long overdue for an update. In short, I've come to believe based on decades of treating patients that ADHD — as currently defined by the Diagnostic and Statistical Manual of Mental Disorders (DSM) and as understood in the public imagination — does not exist.

Allow me to explain what I mean. Ever since 1937, when Dr. Charles Bradley discovered that children who displayed symptoms of attention deficit and hyperactivity responded well to Benzedrine, a stimulant, we have been thinking about this "disorder" in almost the same way. Soon after Bradley's discovery, the medical community began labeling children with these symptoms as having minimal brain dysfunction, or MBD, and treating them with the stimulants Ritalin and Cylert. In the intervening years, the DSM changed the label numerous times, from hyperkinetic reaction of childhood (it wasn't until 1980 that the DSM-III introduced a classification for adults with the condition) to the current label, ADHD. But regardless of the label, we have been giving patients different variants of stimulant medication to cover up the symptoms. You'd think that after decades of advancements in neuroscience, we would shift our thinking. Today, the fifth edition of the DSM only requires one to exhibit five of 18 possible symptoms to qualify for an ADHD diagnosis. If you haven't seen the list, look it up. It will probably bother you. How many of us can claim that we have difficulty with organization or a tendency to lose things; that we are frequently forgetful or distracted or fail to pay close attention to details? Under these subjective criteria, the entire U.S. population could potentially qualify. We've all had these moments, and in moderate amounts they're a normal part of the human condition. However, there are some instances in which attention symptoms are severe enough that patients truly need help. Over the course of my career, I have found more than 20 conditions that can lead to symptoms of ADHD, each of which requires its own approach to treatment. Among these are sleep disorders, undiagnosed vision and hearing problems, substance abuse (marijuana and alcohol in particular), iron deficiency, allergies (especially airborne and gluten intolerance), bipolar and major depressive disorder, obsessive-compulsive disorder and even learning disabilities like dyslexia, to name a few. Anyone with these issues will fit the ADHD criteria outlined by the DSM, but stimulants are not the way to treat them. What's so bad about stimulants? you might wonder. They seem to help a lot of people, don't they? The article in the Times mentions that the "drugs can temper hallmark symptoms like severe inattention and hyperactivity but also carry risks like sleep deprivation, appetite suppression and, more rarely, addiction and hallucinations." But this is only part of the picture. First, addiction to stimulant medication is not rare; it is common. The drugs' addictive qualities are obvious. We only need to observe the many patients who are forced to periodically increase their dosage if they want to concentrate. This is because the body stops producing the appropriate levels of neurotransmitters that ADHD meds replace — a trademark of addictive substances. I worry that a generation of Americans won't be able to concentrate without this medication; Big Pharma is understandably not as concerned. Second, there are many side effects to ADHD medication that most people are not aware of: increased anxiety, irritable or depressed mood, severe weight loss due to appetite suppression, and even potential for suicide. But there are also consequences that are even less well known. For example, many patients on stimulants report having erectile dysfunction when they are on the medication. Third, stimulants work for many people in the short term, but for those with an underlying condition causing them to feel distracted, the drugs serve as Band-Aids at best, masking and sometimes exacerbating the source of the problem. In my view, there are two types of people who are diagnosed with ADHD: those who exhibit a normal level of distraction and impulsiveness, and those who have another condition or disorder that requires individual treatment. For my patients who are in the first category, I recommend that they eat right, exercise more often, get eight hours of quality sleep a night, minimize caffeine intake in the afternoon, monitor their cell-phone use while they're working and, most important, do something they're passionate about. Like many children who act out because they are not challenged enough in the classroom, adults whose jobs or class work are not personally fulfilling or who don't engage in a meaningful hobby will understandably become bored, depressed and distracted. In addition, today's rising standards are pressuring children and adults to perform better and longer at school and at work. I too often see patients who hope to excel on four hours of sleep a night with help from stimulants, but this is a dangerous, unhealthy and unsustainable way of living over the long term. For my second group of patients with severe attention issues, I require a full evaluation to find the source of the problem. Usually, once the original condition is found and treated, the ADHD symptoms go away. It's time to rethink our understanding of this condition, offer more thorough diagnostic work and help people get the right treatment for attention deficit and hyperactivity. Dr. Richard Saul is a behavioral neurologist practicing in the Chicago area. His book, ADHD Does Not Exist, is published by HarperCollins.

 

 

 

 

過動症 並不存在! ADHD Does Not Exist

ADHD真的是心理疾病嗎?藥商不敢告訴您的事實!/陳昭銘醫師撰文 中央日報 (2014-08-26 19:49) 最近在看一本書,「The Truth about the Drug Companies, How They Deceive Us and What to Do About It 作者是Marcia Angell,她是一名非常資深的醫師,七十五歲了,同時也是美國醫界最負盛名、歷史最攸久的《新英格蘭期刊》數十年的總編輯,看遍醫界冷暖。書名直譯為:製藥公司的真相,他們如何欺騙我們,而我們該如何因應。作為一位醫師,每天使用藥物,我們應該是藥商的好朋友。碰到醫師批評藥廠,您一定會覺得很奇怪。從實習醫師開始,我們就常常與藥商代表混在一起稱兄道弟或認乾姐妹。在業界,我們戲稱藥商代表為PROPA,也就是「宣傳人員(PROPAGANDIST)」的簡稱。醫師一向很習慣被這些PROPA人前人後地簇擁,噓寒問暖,幫忙跑跑腿,找找資料,提供免費的醫藥資訊。這樣的日子,不知不覺地我也度過了二十寒暑。有些PROPA做得更勤,還會幫我們照顧小孩,免費接送孩子上下學、洗車。至於偶爾上大飯店吃吃大餐,也可以請PROPA們幫忙安排一下。這全部都是藥商以「公費」支出,您懂吧?藥商請吃飯,席間不免要上個課,看看投影簡報,告知我們目前醫藥界的最新資訊,還有他們家的藥品有那些好處,與其他業者的相似產品,究竟有何不同?種種行銷辭令,無非是希望醫師治療病人時,多開點他們家的藥品。這似乎是良好的共存共榮關係。只要在法律及道德的容許範圍內,為了病人好,我們當然樂意與他們維持良好的關係。但是看了手邊的這本書(英文版,可能還沒有中譯本),雖然只讀了幾章,已經令我毛骨悚然。原來這幾年製藥業大發利市,有很多原因。而這些原因,已經與當初製藥業高尚的存在價值,也就是要研發新藥來造福人群、幫助人類治療疾病,扯不上太大關係了。製藥工業已經搭上了暴利的列車。從一九七○年代開始至今,利潤成幾何級數爆增!而困擾人類的疾病,卻沒有因此減少,反而增加,您不覺得奇怪嗎?原因很簡單,本書的作者分析,很多真正對人類有貢獻、創新的藥品,居然不是由大製藥公司研發出來的,反而是由美國政府出資支持的小型研發單位,或是由小型的獨立製藥公司及學術單位所研發。這些大富豪藥商,每年的利潤驚人,高達數兆美元,排名《財星》雜誌世界前五百大富豪之列,通常前三名就有他們的身影。另一方面,排名前十大的製藥商總利潤加起來,超過了其餘四百九十家的利潤總和!背後這麼雄厚的資本,怎麼會在研發上輸給小型製藥公司,或是學術單位呢?答案很簡單,這幾年來,大藥廠很多的新藥物,只是舊藥重新包裝,就拿來治療新創的病。為的是避免舊藥物專利期即將失效,造成市場真空,以及怕其他廠商的學名藥競爭,失去市場地位及利潤。其填補之道就是,把舊藥用化學方法,刪除或是加上一些化學基,以研發之名,再重新申請專利,再繼續稱霸幾十年!舉個例子,阿斯特捷利康的Nexium取代了自家的Prelosec,這兩者都是用來治療逆流性食道炎的。它們的成份相近,其實是表兄弟,算不上什麼新藥。再舉一個醫藥界有名的例子,也很令人咋舌,就是輝瑞公司治療憂鬱症的「百憂解」。當藥物專利期過了,它用同一種藥,成份改都不改,就重新上市,名字換成了Sarafem,一周服用一次即可,而新藥的功能是治療新病症-Premenstrual dysphoric syndrome,講白一點,就是「經前症候群的憂鬱症狀」。以上這兩種方式,研發費用趨近零,只要把大錢花在動員大醫師教育小醫師,說服他們「世上存在某種新病」。發明新病名花樣千奇百怪,目的只要能讓大家開藥就對了。這些賺大錢的病及藥,多是「預防」罹病,所以要長期服用。換句話說,這些身體上的小問題,通常治不好,但也絶不會馬上死人。例如抗高血壓、高血脂的藥即為一例。製藥公司發明的「濟世救人」新藥,實與病人健康關聯甚少,只要讓「新藥」用各種名義,為它們錢滾錢即可。我們的病人,或可稱「消費者」,被大量的廣告轟炸之後,永遠都只能吃「很貴的新藥」,藥物的價格,也一直居高不下。由於媒體及醫師的宣傳,所以大眾一直相信,新藥確實藥效比較好。而Marcia告訴我們的實情卻是:藥商只是把舊藥改裝,劑量提高,重新包裝。劑量提高表面上藥效較好,但效果提高的同時,副作用及毒性通常也隨之提高!

掛羊頭當然為的是把狗肉全賣出去。最近還有一本書,書名也蠻勁爆,叫做《「過動症」並不存在!》(ADHD Does Not Exist),作者是Richard Saul,一名德高望重的神經內科醫師,在業界已經服務超過五十年了,專長在於處理過動症的神經行為科學。在藥廠大發利市的一九七○年代,他曾經堅信有所謂過動症的存在。但是五十年之後呢?這想法已完全破滅。他發現大部分「過動兒」的症狀,其實可以歸因於二十幾種其他的疾病。只要仔細的問診,找出這二十幾種其他的診斷,並加以治療,那「過動症」就會改善!而且每一種疾病,治療方式都不同!這些疾病,很多必須經過詳細的問診、抽血檢查等等,而不是只要符合症狀,就不假思索,反射式開立處方。孩子真正的問題其實林林總總,包括:視力問題、聽力問題、睡眠不好、情緒問題、藥物濫用、學習障礙、感知處理疾患、天資非常聰慧、癲癇、強迫症、衝動症、妥瑞症、亞斯伯格症、神經傳導物質不足引起的衝動與分心、精神分裂症、胎兒酒精症候群,還有更多更多。糟糕的是,目前精神科對過動症的治療方式,是開立有中樞神經刺激劑作用的藥物如利他能等。這些藥物本身有成癮性(藥物成癮,係指某些藥物,特別是精神科藥物,一旦服用後即不能停止,停止就會無法忍受的現象)。證據非常明顯,服用藥物一旦成癮,就會連帶出現耐藥性現象,很多病童,當原來劑量已不足以壓制過動症狀時,精神科醫生就得加量。另外,利他能這類的處方藥物,還有很多的副作用,甚至會惡化原來的過動症狀:過度焦慮、食慾不振、體重減輕、注意力無法集中、記憶力減退、情緒更加不穩、甚至是有自殺行為或意念,最嚴重會導致死亡或生命提早結束!有了以上副作用的學童,通常是沒辦法更專心上課的!這樣的精神科藥物,掩蓋了原來的問題,甚至惡化了問題來源!舉個例子,如果孩子是因為在學校的學習問題,造成他過動、不乖,我們如果沒有處理他看不懂的地方、提供更多圖像、道具輔助,卻開始服用藥物,那學習問題只會更加嚴重,或是掩蓋了他原來的學習問題,失去處理的先機。這叫作飲鴆止渴。幾十年的經驗讓作者終於明白,嘗試用一種發明出來的病名,把所有的症狀一網打盡的化約行為,是極度危險的。他把所有這些過動的小孩分成兩類,一種是注意力是在正常範圍內,只是因為生活上的壓力難以處理,讓他表現出某些過動症狀;另一種是真的有生理問題,並且問題會追溯到二十幾種不同的疾病。第一種人,他建議只要把注意力多多外放,找一些有興趣的事來做,讓壓力下降,讓自己有成就感,狀況就會改善。另一類身體真的有狀況的孩子,醫師就應該專心的問診、抽血檢查,直到正確病因被找到為止,然後針對那二十多種疾病,作專業治療,問題便會迎刃而解。作者五十年的看診經驗,讓他對「過動症」疾病的存在完全改觀。那麼一般人呢?還有未來新進的醫師呢?是否還要繼續相信大藥商及廣告的宣傳?我想我們不需要另一個五十年的經驗,答案已經揭曉。讓我們回歸本源,相信每個孩子都是不同的靈魂,有不同的成長方式,不能用唯一的標準,要求每個人都乖乖坐在課堂上,即使他在教室已經非常不耐煩,極度無聊。這些天資聰穎的孩子,不該被老師、家長,強迫帶去看精神科/兒童心智科醫師(而非內科、小兒科或營養師),然後服用成癮性不亞於街頭毒品的精神科藥物。難道真要等到孩子的腦部受到不可逆的傷害,家長才來怨天尤人?那豈不太晚!十幾年前,我曾去美國接受訓練,在當地戒毒中心幫助毒癮者的戒治。我遇到一位十七歲的大男孩,稚氣未脫。他小時候被迫吃「利他能」治療過動症,後來國中時,染上了安毒。他告訴我,他的家長正在跟美國其他好幾千個家庭,控告美國的利他能製藥商。家長認為是利他能造成孩子染上了安非他命毒癮,因為安非他命跟利他能結構上非常近似。我當時只是聽聽,也不以為意。大概三年前,我得知美國有幾家超大型製藥商包括葛蘭素史克等,都在股東會上宣布,不再研發有致命副作用的精神科藥物,原因就是:這些精神科藥物雖然帶來巨大的利潤,但是在美國被告的機率也增高;付出去的賠償金,讓利潤大幅縮減。看著這則新聞,再回過頭想想十幾年前那個染上安毒的大男孩,他的故事言猶在耳,突然覺得,這場製藥商與醫師共舞的春夢已然醒了。我醒了,看文章的您呢?【中央網路報】

 

莊立民: 糖尿病藥 愛妥糖(Pioglitazone)顯著減少17%肝癌發生率

研究證實 糖尿病用藥 未增加膀胱癌風險 2014-08-28 記者邱宜君/台北報導 口服治療糖尿病藥物「愛妥糖Actos(或稱胰島素增敏劑Pioglitazone)」的一項動物實驗研究曾發現,雄性大白鼠使用該藥後,膀胱癌增加,引發全球關注。各國的藥物主管機關除要求加註警語,也要求藥廠針對膀胱癌發生率較高的西方人展開10年大型研究,在今年完成。糖尿病學會前理事長莊立民昨天表示,研究結果為「愛妥糖」做了「平反」。 賓州大學與北加州凱撒醫療中心(KPNC)研究部追蹤27千人長達10年,結果發現曾使用口服「愛妥糖」的第2型糖尿病患,罹患膀胱癌的風險並未增加。分析使用時間長短、累計劑量等,也未發現會增加膀胱癌風險。 莊立民指出,台灣糖尿病患多死於心血管疾病,但肝癌、大腸直腸癌、肺癌的發生率,也較無糖尿病的人高。至於膀胱癌的部分,台灣的發生率則低於西方國家上述癌症 莊立民分析606千多名30歲以上第2型糖尿病病患的資料發現,使用「愛妥糖」可以顯著減少17%肝癌發生率,服藥3年以上,也不增加罹患大腸直腸癌、肺癌、膀胱癌的風險。 莊立民表示,「愛妥糖」提高身體對胰島素的敏感性,提高血糖利用效率,在台灣是第二線用藥,而且大多合併多種藥物治療,很少單獨使用。過去因擔心膀胱癌而停藥的病人和醫師不少,最新研究結果應能使醫師開藥、病人服藥更加安心。 台灣武田藥品公司藥師張子彬表示,全球大約有1千萬人服用「愛妥糖」,目前台灣大約占3萬到5萬人,除了原廠藥,也已有許多學名藥。武田總公司近期將把研究資料上呈各國主管機關,希望美國食品藥物管理局(FDA)重新考慮「仿單(即說明書)」是否還需要加註有關「膀胱癌」風險的警語。

 

Novartis跨世紀心臟衰竭新藥(RAAS-NEP inhibitor) 或是重溫舊夢 (BMS/ Pharmacia)

治療心臟衰竭 出現更有效新藥【聯合晚報╱記者黃秀媛╱即時報導】 2014.08.31 11:01 am諾華藥廠(Novartis)的實驗性藥物LCZ696,在受到各方密切注意的臨床研究,效果非常顯著,能把因心臟血管疾病死亡和住院的風險降低20%,並可能取代用於治療心臟衰竭已四分之一世紀的現有藥物。調查研究結果的德州大學醫學教授佩克對其效果表示驚異,並宣稱LCZ696對現有藥物擁有很大的存活優勢,因此一旦這種藥物上市,會讓人很難瞭解醫生為什麼還用傳統藥物治療心臟衰竭。慢性心臟衰竭會使心臟無法把足夠血液輸送到全身,而這方面的治療已有10多年沒有進展,因此出現更有效的新藥使醫生和投資者感到興奮。心臟衰竭與心臟病發作不同,病情會逐漸惡化,可是治療展望很差。對LCZ696與現有藥物進行比較的研究,因患者對新藥反應非常有利,在五個月前提早結束,不過29日才在歐洲心臟病學會 (ESC)召開的全球最大規模心臟病年會公開。由於研究發現非常顯著,ESC敦促快速完成對治療準則的檢討程序,讓新藥得以提早上市。諾華藥廠治療高血壓的得安穩 (Diovan)專利期滿,面對價格低廉的學名藥競爭,亟需新產品提振業績,並把希望寄託在LCZ696對超過8400名患者進行的研究顯示,與現有治療心臟衰竭的藥物ACE抑制劑伊納普利 (enalapril)相比,LCZ696不但能夠減少死亡和住院,也能使患者感覺顯著改善。參加研究的患者約有32%曾出現必須使用LCZ697,以免心臟血管疾病發作喪生的情況。這表示如改用新藥,美國和歐洲一年可能保全大約九萬人的生命。每天服用兩次的LCZ696,結合得安穩的主成分valsartan和腦啡太脢抑制劑 (neprilysin inhibitor)與伊納普利相比,其副作用包括比較可能出現低血壓和不嚴重的腫脹,可是較少腎臟受損、高鉀和咳嗽。美國和歐洲約有2600萬人罹患心臟衰竭。分析家認為LCZ696在美國一天用量約需七元,在藥價較便宜的歐洲約需四元,而德意志銀行分析師預測這種藥物一年營業額可能高達100億元。【2014/08/31 聯合晚報】

Is Novartis' LCZ696 "revolutionary" or just a marginal improvement?   Daniel R. Hoffman, Ph.D., President, Pharmaceutical Business Research Associates

POSTED: WEDNESDAY, SEPTEMBER 10, 2014, 1:02 PM Over the Labor Day weekend, Novartis presented the results of a trial for its cardiovascular compound, LSC696, at the European Society of Cardiology (ESC) meeting in Barcelona, Spain.  Reactions to those results were the number one topic on the pharma blogosphere for several days afterward. Prior to the presentation, Wall Street's sales projections for the drug were in the vicinity of $1 billion per year by 2020. Immediately afterward the forecasts skyrocketed, especially among the most bullish analysts. Morningstar analyst Damien Conover raised his forecast from an annual peak of just over $1 billion to approximately $6 billion. Leerink Swann's Seamus Fernandez doubled his estimate from $3.2 billion a year to $6.4 billion. Sanford C. Bernstein's Timothy Anderson was especially exuberant, predicting annual sales as high as $8 billion. So do these enormous sales projections for LCZ696, following its Labor Day splash, indicate that the product is a "revolutionary breakthrough" for treating heart failure, as its lead investigator calls it?  Or is this just one more instance where a pharma company promotes a small, tweaked improvement as a breakthrough to justify squeezing payers for premium dollars?

First, a bit of background.  LSC696 actually combines two compounds: valsartan (which is currently sold by Novartis under the name Diovan) and the neprilysin inhibitor, sacubitril. The valsartan works within a physiological pathway known as the RAAS cascade.  Researchers classify it as an angiotensin II receptor blocker (ARB) because it opposes the action of angiotensin II, a naturally occurring substance in the body that raises blood pressure and forces the heart to work harder.  ARBs help relax and widen blood vessels, thereby lowering blood pressure and making it easier for the heart to pump blood. The sacubitril is a neprilisyn inhibitor, which means it decreases the body's neprilysin enzyme that, in turn, helps control blood volume and lower blood pressure.  Given this combined mode of action, researchers call LSC696 a RAAS-NEP inhibitor. Amid all the Wall Street drumbeating, Novartis' design for the study presented in Barcelona was the first thing that aroused skepticism.  Novartis compared the new regimen to enalapril.  Enalapril acts on the RAAS cascade differently than ARBs.  It prevents the conversion of angiotensin I to angiotensin II.  As such it is classified as an ACE inhibitor.  Within this treatment group, enalapril is actually one of the oldest and weakest ACE inhibitors, having been approved in 1985 as branded Vasotec.  Although matching the LCZ696 test drug/regimen against another compound is preferable to pharma's usual approach of comparing something new to placebo, a comparison to something that is less than state of the art seems to stack the deck in favor of the new medication. Just as importantly, contributing authors in the New England Journal of Medicine pointed out that the enalapril dose used in the trials was lower than the one generally recommended.  At the same time, investigators had the liberty to increase dosing on the valsartan portion of LCZ696 to its maximum level.  That means Novartis' researchers may have compared a full dose of valsartan to a moderate dose of enalapril, in which case something other than LCZ696's use of a NEP inhibitor is what produced a better result.  This observation is part of what led several cardiologists who attended the meeting in Barcelona to ask why LCZ696, if it represents a truly improved level of care, failed to reduce atrial fibrillation, a key characteristic of worsening heart failure. Some observers question yet another aspect of the LSC696 study design.  They point out that patients who received the Novartis test regimen had significantly lower systolic blood pressure before the study than those who received enalapril.  The higher ingoing blood pressure among enalapril users may have created a more advanced cardiovascular condition that made their hospitalizations or deaths more likely. Other cardiologists at ESC questioned the part of Novartis' study plan that included a "washout" period for patients enrolled in the trial.  Investigators switched patients from the heart medications they were taking prior to the study and gave them either enalapril or the LSC696 duo before starting the trial.  Those patients that could not tolerate the therapies were not enrolled.  That means the incidence of side effects and other adverse events in the study was likely lower than what cardiologists would see in real world practice because the enrollment was skewed to favor patients who can tolerate valsartan+sacubitril. After considering the study's design, a second reason for skepticism relates to interpreting the results. The press releases tout the fact that LCZ696 confers a 20% relative risk reduction versus enalapril for developing the study endpoints of heart failure hospitalization or death. What that actually means is there was a 26.5% chance for hospitalization/death with enalapril versus a 22% chance with LCZ696.  Now a 4.5% smaller risk can make a huge commercial difference, because that was the approximate extent to which Plavix reduced risk versus aspirin.  Plavix went on to become the world's second highest selling product behind Lipitor.  Clinically and epidemiologically, however, that represents a good but not a great difference. Thirty-two people need to be treated (NNT) with LCZ696 to prevent one death and the rule of thumb is that an NNT of 50 or higher means something is fairly useless.  In other words, LCZ696 may represent yet another marginal, incremental improvement rather than any sort of revolutionary breakthrough. In addition to issues related to the study's design and interpretation, a number of cardiologists and other researchers raise an issue about sacubitril's mode of action:  inhibiting the neprilysin enzyme.  They fear the process could affect other metabolic pathways and produce harmful consequences.  For example, some researchers argue that neprilysin seems to play a role in reducing beta-amyloid in the brain.  Beta-amyloid forms the clumps and tangles characteristic of Alzheimer's disease and reducing the neprilysin enzyme may raise the risk of patients developing Alzheimer's.  Novartis ended the study reported in Barcelona too early to assess such side effects. LSC696 is not the first RAAS+NEP inhibitor promoted by its developer as something that will revolutionize the way cardiologists treat the hypertension-to-heart failure process.  The same earth-shaking predictions for Bristol-Myers Squibb's omapatrilat (Vanlev) were all over the media a decade ago.  Novartis's lead investigator on LSC696 is Dr. Milton Packer from the University of Texas Southwestern in Dallas.  Ten years ago the same Dr. Packer, then at Columbia University in New York, was BMS's lead investigator on Vanlev and he was equally effusive in touting that product as a revolutionary breakthrough.  Alas, Vanlev never even made it to the market.  The FDA decided against approving it because a number of patients in the studies developed potentially serious angioedema, a swelling of the lips and throat. Around the same 2004-2005 timeframe, Pharmacia was developing another RAAS-NEP inhibitor, eplerenone (Inspra), one that did receive FDA approval.  Nonetheless, its modest benefits led Pfizer to promptly bury Inspra as soon as they bought Pharmacia. Is LCZ696 sufficiently different from these other RAAS-NEPs to be more effective in controlling heart failure while avoiding their side effects and safety-tolerability problems?  The Novartis therapy replaces an ACE inhibitor with an ARB and it uses a different neprilisyn inhibitor.  But as often happens in pharmacology, the several different compounds within a chemical class produce the same clinical effect. Whether LCZ696 lives up to its projections for pulling in $6-8 billion a year will also depend on how Novartis prices the product.  In the past, the company has been remarkably tone deaf on that factor, as witness the launch of its MS product Gilenya.  Novartis has about six or seven years all to itself for using this RAAS-NEP inhibitor before a competitor potentially can bring another one to market.  That's both an advantage and a disadvantage.  The advantage of working without a competitor is obvious, but the disadvantage is that Novartis will have to generate the primary demand for a RAAS-NEP all alone.  Acting by themselves, they will have to provide data that satisfactorily answer all the questions about the study.  Without competing RAAS-NEP brands on the market, Novartis will be the only company looking to demonstrate and publicize better long-term outcomes that can justify premium pricing.  It remains to be seen how well they will do all of this before a competitor or two come along.  Finally, it seems questionable whether any branded pharma company would pair either omapatrilat or eplerenone with an off-patent ARB and sponsor the studies needed to obtain regulatory approval.  Eplerenone is already a generic and omapatrilat will likely lose patent protection this year.  Nonetheless, it is worthwhile speculating whether a Teva, an Actavis or a Dr. Reddy's – all of which know how to make good margins on generics – might be willing to sponsor and conduct the studies that test how well one of them, combined with a generic ARB, treats heart failure. If one or more generics companies did make that play, the sales projections for LCZ696 would likely fall back to what they were before Labor Day or possibly even lower. When the FDA shot down Vanlev, some observers predicted that it was unlikely another RAAS-NEP would ever see the light of day.  Perhaps the public relations Novartis manufactured for LCZ696 might provide its most important benefit if all the talk inspires the development of an all-generic medication for heart failure, one where its slightly better effect is matched by a commensurately modest price.

 

龍燈 農業藥證948張

F-龍燈Q4戰新高 全年EPS 4元在望 20140904 04:10 記者杜蕙蓉/台北報導 F-龍燈(4141)上半年交出EPS 1.82元佳績,創101年來最好表現。昨(3)日法說會中,協理金保華表示,現有藥證數已達948張,隨著含金量高藥證的產品推出,加上填補國際大廠除草劑缺口,第三季營運持平,第四季營收有機會挑戰新高。法人預估,龍燈今年EPS有機會從4元起跳,將重回高獲利行列,龍燈昨日在生技股的回檔整理中,股價逆勢收紅,以66.5元作收,漲幅1.06%。金保華表示,藥證是龍燈最重要資產,現藥證數量已由2012811張,增加到2014年第二季948張,受惠今年含金量高的藥證新產品學名藥RephonMazotam等已取得阿根廷與巴西藥證,預計下半年陸續推出下,未來營運樂觀。法人指出,第三季歐美及中國對農藥需求轉淡,單季業績將略受影響;不過,由於含金量高的產品芬普尼,開始從巴西大豆栽植進入,成為新成長動能,因此第三季營收約季減5%。但因毛利率偏低的麥草畏營收占比降低,預估毛利率將回升至首季表現。至於第四季,除了進入傳統拉丁美洲旺季外,歐洲及北美需求也會拉高,單季營收將較第二季營收成長20%,有機會改寫歷年單季新高,營收可望季增2025%,毛利率預估維持38%。匯率部分,上半年龍燈匯兌收益超過1億元,近日美元走強,巴西幣轉貶,勢必造成些許匯損,第四季仍需觀察。法人表示,如下半年匯損能控制在2億元以內,龍燈今年EPS將由4元起跳。展望2015年,金保華表示,新產品「芬普尼」已取得主要市場拉美中的巴西、阿根廷藥證,開始貢獻業績,明年中南美其他國家藥證陸續取得,加上該產品現只用在大豆上,明年將擴大至甘蔗用量將成長。

 

 

 

 

 

 

 

 

台田藥品Pitavastatin 申請健保 (降血脂+穩定糖化血色素)

  全民健康保險藥事小組會議參考資料(Livalo Tablets 2mg) : pitavastatin 在降低 LDL-C 的程度上,當給予受詴病患 pitavastatin 2mg/day 的情況下,pitavastatin 的療效與 atorvastatin 相當或較 simvastatin 為佳;當給予受詴病患 pitavastatin 4mg/day 的情況下,pitavastatin 的療效與 atorvastatinsimvastatin 相當。在降低 non-HDL-C 部份,則顯示出 pitavastatin 不差於 atorvastatin 的結果。在藥物安全性部份,在與受藥物相關的不良事件上,詴驗結果並無明顯值得注意之處。除此之外,在此次文獻搜尋的過程中,我們也看到有一些文獻在討論pitavastatin 對於病人血糖控制的影響、對於急性冠狀動脈症候群 (acute coronary syndrome, ACS) 病人的冠狀動脈粥樣硬化 (coronary atherosclerosis) 的影響、對於穩定性冠狀動脈疾病 (stable coronary artery disease) 病人餐後血管內皮功能(postprandial endothelial function) 的影響等各個方向的研究報告。其中,有數個試驗顯示 pitavastatin 在減少急性冠狀動脈症候群病人的冠狀動脈內斑塊之體積(coronary plaque volume) 的效果(觀察期從 8 個月到 12 個月不等);然而以上這些詴驗都沒有將心血管事件列入療效分析。另外,針對 pitavastatin 對於高脂血症合併第 2 型糖尿病之患者的葡萄糖耐受 (glucose tolerance),也有 2 篇試驗文獻,簡述如下:Yamakawa 等人於 2008 年發表 (J Atheroscler Thromb 2008;15:269-75),回溯分析 279 位有第 2 型糖尿病及高脂血症的病人,使用不同 statin 類藥物 3 個月後,其血糖值的變化。詴驗結果顯示:Fasting plasma glucose levels changed from 147±51 to 176±69 mg/dL in the atorvastatin group (n=99), from 136±31 to 134±32 mg/dL in the pravastatin group(n=85), from 155±53 to 154±51 mg/dL in the pitavastatin group (n=95).HbA1c levels changed from 7.0±1.1% to 7.4±1.2% in the atorvastatin group, from6.9±0.9% to 6.9±1.0% in the pravastatin groupfrom 7.3±1.0% to 7.2±1.0% in the pravastatin group.以上兩項相關血糖值,只有 atorvastatin 組在治療 3 個月後,有統計上顯著的增加;pravastatin  pravastatin 兩組的改變量皆未達統計上顯著Yokote 等人於 2009 年發表 (J Atheroscler Thromb 2009;16:297-8),為期 12週、45 位有第 2 型糖尿病及高脂血症之病人的詴驗結果顯示:在 atorvastatin (n=22),其受詴者的血清糖化白蛋白 (serum glycoalbumin) 值與基期 (baseline)做比較,呈現顯著升高的情形,而 pitavastatin  (n=23) 的增加並未達統計上顯著 (absolute change 0.67±1.31% in the atorvastatin group, p=0.026; 0.34±1.31% inthe pitavastatin group, p=0.218詳細詴驗結果請參考附錄一之圖表)。

Pitavastatin: 本案申請藥品 Livalo 的藥品分類 ATC 碼為 C10AA08C10A 為單純的降血脂類藥物,C10AA 為單純的降血脂作用類藥物中的 HMG CoA 還原酶抑制劑類藥物 (HMG CoA reductase inhibitors),在此一分類之下,藥品計有 8種(僅列出單方藥品部份):C10AA01 simvastatin 共已支付 33 個品項/C10AA02 lovastatin 共已支付 9 個品項/C10AA03 pravastatin 共已支付 20 個品項/C10AA04 fluvastatin 共已支付 3 個品項/C10AA05 atorvastatin 共已支付 18 個品項/C10AA06 cerivastatin 共已支付 0 個品項(查無我國藥品許可證資料)/C10AA07 rosuvastatin 共已支付 3 個品項/C10AA08 pitavastatin 共已支付 0 個品項(本案申請藥品)

本會與台田藥廠合辦Ideal Statin for High Risk Patient with T2DM」學術研討會,請踴躍報名參加。說明:()時間:103611(星期三)PM1230~143 ()地點:高雄市醫師公會四樓禮堂 ()主講人:彰化基督教醫院內科部 謝明家 副院長 ()積分:內科、家醫科、一般科學分申請中。

台田藥品股份有限公司簡介 日本田邊製藥是日本知名大藥廠之一,每年投入研發新藥行銷,不餘遺力,民國五十一年與台灣合作成立了台灣田邊製藥股份有限公司,迄今已四十多年。公司制度健全福利佳,在民國七十六年採取專業分工的方式,成立台田藥品股份有限公司往專業的業務行銷邁進,一起為新世紀台灣的健康生活而努力。 以五燈標誌,享譽台灣田邊製藥股份有限公司, ... more 醫院藥局診所之醫藥品、保健品的製造及銷售,各種食品之進口及經銷業務 主要產品:愛必賜康錠、合必爽錠、康肯錠、凱帝心錠、膚潤康軟膏、妥膚淨軟膏、羅膚格凝膠。

 

 

友霖& Actavis(Watson)布局P4 (Pitavastatin) 降血脂+穩定糖化血色素

友霖攜手Actavis搶攻美降血脂藥市場 今富族網記者吳泓駿/報導2014-09-05友霖生技(4166)於昨(4)日宣佈和全球第三大藥品製藥商 Actavis 正式簽約,雙方攜手合作以拓展降血脂學名藥Pitavastatin的美國市場。友霖已向美國FDA申請該藥品專利,一旦未來取得FDA核發的藥證,不只能擁有在美國市場的180天獨家專賣權,同時可藉由Actavis的通路佈建,搶攻每年約1.55億美元的商機。友霖生技成立於2008年,為友華生技(4120)旗下轉投資事業,專注於藥物研發及製造。友霖表示,本次開發的藥品Pitavastatin是一種降血脂用藥,療效佳且副作用低,同時和糖尿病藥物併用,較不會增高糖化血色素,目前該藥品在美國挑戰原廠專利大有進展,在國內也已經取得上市許可,現正於各大醫療院所進藥中。Actavis plc為美國上市製藥公司,專注於研發、製造與銷售各種學名藥以及創新產品給全球病患。友霖本次與Actavis plc簽訂合約,友霖將依據合約在不同里程碑向Actavis取得授權金,未來雙方將共同面對挑戰專利的經費與司法程序。藥品核准上市後,友霖生技擁有藥證與專利技術獨家持有權,並負責藥物生產製造,Actavis將負責全美的通路與銷售,銷售利潤則由雙方共享。友霖生技目前股本16.81億元,根據合併財報,2012年營收1.49億元,稅前虧損2.48億元,每股稅後虧損1.17元;2013年營收1.8億元,稅前虧損2.12億元,每股稅後虧損1.05元;累計2014年上半年營收8,950萬元,稅前虧損9,693萬元,每股稅後虧損0.47元。

Actavis, Inc.(安斯泰來;ACT.US前身「Watson Pharmaceuticals Inc.(WPI.US)」為全球前三大學名藥廠,總部位於瑞士楚格州,主要業務為學名藥、專利藥和配銷業務等,產品包括:口服避孕藥、心血管疾病、泌尿科、腎臟藥品等,其中學名藥佔公司營收比重最高。20124月,美國製藥行業巨頭華生製藥Watson Pharmaceuticals Inc宣佈以42.5億歐元收購瑞士Actavis,從而擴大該公司在歐洲和亞洲市場上的佔有率。公司於201310月收購Warner Chilcott plc(WCRX.US),該公司為婦女保健、皮膚疾病的處方藥專業製藥公司。20146月收購競爭對手Forest Laboratories, Inc.(FRX.US)

 

美時 抗炎藥物MFC (原發性經痛) 銷美

美時 美訂單挹注營收 20140907 04:10 杜蕙蓉 美時(1795)繼抗癲癇學名藥Levetiracetam後,抗炎藥物MFC也正式銷往美國,預計首批訂單貢獻營收2,400萬元。由於下半年來自於艾威群旗下事業體將可挹注營收,並出現獲利,備受法人關注。上周五股價收135元,小跌0.5元,目前KD指標雖轉空,但量能並未失控。MFC是一種非類固醇抗炎藥物,主要用來緩解類風濕性關節炎、骨關節炎、原發性經痛、經血過多等引發的輕至中度疼痛,全球年銷售額達2.2億美元(約合新台幣66億元)。美時MFC已取得美國藥證,獲美國合作行銷夥伴下單採購。

 

南光折舊攤提費 估1.4-1.5億元

南光本季營收拚新高;國際佈局苦漸轉甜 MoneyDJ新聞 2014-09-11 10:06:39 記者 蕭燕翔 報導 日本客戶抗癌學名藥出貨暢旺,製劑廠南光(1752)8月營收創下新高,法人預期,本季營收有機會挑戰單季新高,下半年營運將明顯優於上半年。而因該公司近三年都處布局海外的耕耘階段,折舊攤提與申請藥證費用導致獲利波動,隨資本支出高峰近尾聲,明年攻入美國學名藥市場開始漸入收成,獲利動能可望跟上,力拼營運一年好過一年。南光屬專業製劑廠,也是這幾年投入廠房設備升級與國際查廠相對積極的廠商,目前該公司外銷比重已突破兩成,主要銷售市場包括日本及中國,特別是日本市場,切入當地首仿學名藥的一顆抗癌藥,現正式出貨雖僅1家日本藥廠,但潛在合作的廠家至少3-5家,成為近年銷日營業額成長的關鍵。不過,南光這幾年積極投入國際布局,也造成折舊攤提費用上揚,另方面,近兩年累計送出7件以上的美國藥證申請,亦為費用上揚的關鍵。以今年上半年來說,光折舊攤提費用就有7,300萬元,亦即全年折舊攤提費用將有1.4-1.5億元,也讓該公司近六季獲利都陷入損益兩平之際,今年上半年每股稅後小虧0.06元。但隨南光的資本支出高峰已過,未來經營團隊將改採隨實際需求逐步性的擴建產能,未來幾年的折舊攤提支出可望持穩,對獲利衝擊降低。更重要的是,除日本市場往後幾年還可望有抗癌、抗病毒等新藥證入手外,在全球最大的藥品市場-美國,布局也將漸入收成。其中進度最快的骨科用藥,雖屬利基產品,終端市場銷售額不大,但今年專利到期後,切入的學名藥廠還有限。南光是在去年第三季獲美國FDA查廠,今年上半年取得正式通知函,以時間點估算,今年底、明年初有機會取得藥證,開始登美銷售。另外近兩年累計已送出的7張美國藥證申請,南光除負責前段產品研發與送件布局外,也與3-4家當地銷售夥伴合作,如攜手CANDA Pharma旗下德州子公司即為一例。市場也預期,以美國藥證等待期來看,明年下半年至後續二年將進入取證的高峰蜜月期,帶動南光外銷營業額逐年成長,朝具國際競爭力的學名藥廠邁進。法人估計,南光9月營收有機會維持相對高峰,第三季營收可望季增15-20%,創下單季新高,獲利也將達近幾季最佳水準,下半年營運將明顯優於上半年,明年在外銷帶動下,營收可望維持兩位數的高成長,獲利也將跟進,逐年增溫。

 

 

南光 FDA查廠通過 挑戰P3學名藥

南光Q3營收季增上看2 拚新高 20140916 04:10 記者杜蕙蓉/台北報導 南光(1752)受惠日本客戶抗癌學名藥出貨暢旺,8月營收創下新高後,9月初估也將維持高峰,法人預估,該公司第三季營收可望季增1520%,創下單季新高,且獲利也將達近幾季最佳水準,下半年營運將明顯優於上半年。明年起則因有美國藥證挹注,未來獲利將一年好過一年。積極佈局外銷市場的南光,由於折舊攤提費用上揚,導致上半年每股稅後小虧0.06元,但相較於去年同期,營運已明顯成長,法人預期,南光在陸績接獲日本藥廠代工訂單,且明年攻入美國學名藥市場開始漸入收成下,營運樂觀。就初步統計,南光近兩年累計已送出7張美國藥證申請,除負責前段產品研發與送件布局外,也與34家當地銷售夥伴。目前送出的申請案,涵蓋的範圍包括骨科、抗癌、抗感染、血液系統及神經系統等,部分還屬挑戰原廠專利的P4學名藥。進度最快也是 該公司首個銷美藥證的骨科學名藥,原廠專利今年 9月到期,南光送件時屬P3學名藥(送件時還屬專利保護期、正式上 市時專利已過),該藥品現切入學名藥廠有限,美國市場規模至少12億美元。 由於南光去年第三季即獲美國FDA查廠,今年上半年取得正式通知函,法人認為,就時間點估算,南光今年底、明年初有機會取得藥證,開始登美銷售。南光在大陸市場,除了急救科及降腦壓的用藥,營業額穩定成長外,下半年有機會再取得血液系統相關的藥證。日本市場則切入當地首仿抗癌學名藥,現正式出貨雖僅1家日本藥廠,但潛在合作的廠家至少3-5家。

益得 氣喘吸入複方新藥 Phase IIa 2014Q4報告出爐

益得複方新藥 取得美國專利 20140918 04:11 記者杜蕙蓉/台北報導 益得生技(6461)營運再獲捷報!繼月前以9.28億購入前諾華在台子廠後,昨日又宣佈HFA MDI(氫氟烷定量噴霧吸入劑)複方氣喘新藥取得美國專利,未來將搶進全球超過300億美元的市場。益得為健喬持有49.98%的子公司,目前已拿到2張台灣MDI(定量噴霧吸入劑)藥證並取得健保價銷售外,開發的2項新藥也符合向FDA申請新藥,其中1項將搶首仿學名藥(First Generic),另1項則為全球新藥。益得發言人林倩如表示,該公司擁有國內唯一HFA MDI技術平台,該技術平台所發展的複方新藥「用於氣喘之吸入性複方組合物」,為短效乙二型協同劑(支氣管擴張劑)與類固醇的複方產品,目前進行用藥後6小時肺功能測試中,Phase IIa將於2014年底報告出爐,預計2015年下半年可進入Phase III,並規劃進行多國多中心試驗,目前正與國外廠商洽商授權合作。

陳桂恒介紹湯竣鈞 進 寶齡富錦(班友集團: 江宗明/謝德夫/黃英俊)

班友集團旗下3公司合併 寶齡富錦存續 20140918 09:51 杜蕙蓉 班友集團旗下的公司中,寶齡算是交出最佳的成績單,這是江宗明先後併購寶齡製藥、富錦製藥,三合興公司儀器代理部門後,以寶齡富錦為存續的公司。主導營運策略的江宗明,當年從台北醫學院藥學系畢業後,先後任職於美商必治妥及英商嬌生等國際藥廠,被認為是超級業務大將的他,有雄才大略,因此,即使是比謝德夫、黃英俊等班友創始學長們晚了兩屆,卻被他們相中是最佳夥伴人選,剛好那時他也很想創業,因此,加入班友後,即規劃寶齡富錦的成立和後的營運策略方向。產品線齊全的寶齡,最初是以西藥為發展基礎,初期做學名藥與代理起家,後來再切入醫美保健等市場,就他們的說法裡,在醫院除了床單不做外,舉凡藥品、消毒等所有能想的品項,他們都有涉獵。有鑑於學名藥的紅海市場,在健保不斷砍價下,班友公司成員都是藥學系專業背景,很清楚寶齡雖然賺錢,但利潤有限,只有研發新藥才有大機會下,2001年,寶齡決定切入新藥開發。於是,江宗明決定自美國密西根大學技轉許振興博士的Nephoxil,並邀請第一位在美國食品藥物管理局(FDA)任職的華人,目前為寶齡研發顧問的陳桂恒,負責評估這個新藥,陳桂恒並找來現任鑽石基金副總裁湯竣鈞負責開發工作。江宗明說,寶齡選擇研發腎臟病藥,主要是因為腎臟病與肝病是台灣兩大「國病」,台灣染患末期腎病的洗腎病人逾七萬人,在全世界腎臟病人口比例排名第一,每年健保洗腎支出超過3百億元,是健保支出第二大類。根據統計,目前全球洗腎病人每年平均以七%的速度成長,等於是十年就成長一倍,寶齡富錦14年前決定開發Nephoxil時,全球洗腎人口約90萬人,現在卻暴增至目前的二OO萬人以上,預估二OO年將再倍增至四百萬人。此外,美國洗腎人口目前約有六十萬人,是全世界最多的國家,也是全世界人口比例排名第二高的。中國是全球洗腎人口成長最快的市場,2020年預估洗腎人口將達150萬人。加上日本和韓國各超過10萬、6萬人下,也讓亞太區成為最嚴重的腎病市場,對於腎臟病新藥「Nephoxil」需求增添龐大的想像空間。不過,寶齡這一個有做華人疾病的新藥,並沒有預期順利,從開始投入研發,到完成台灣的三期臨床實驗,十二年來共燒掉三億多元,不斷地燒錢,讓大家都快受不了,寶齡原本的學名藥及保健品等收入,無法支撐龐大開銷,有好幾次都快無以為繼。身為寶齡總經理,江宗明兼負公司盈虧,壓力大到晚上都睡不著覺,幸好這群每個月都要吃飯相聚的同學,大家願意到處去張羅資金,才讓公司勉強支撐下來。於是為了降低龐大研發費用,寶齡除了完成台灣的三期臨床結果,並在去年向台灣衛生署食品藥物管理局(TFDA)申請新藥上市外,早在2005年,寶齡就將進入臨床二bZerenex(在歐美日是以Zerenex為名,至於其他亞太地區則以Nephoxil為名)的歐、美、日市場授權予美國上市生技製劑公司Keryx2007年經由Keryx再授權日本的Torii(鳥居藥廠)進行日本市場開發,各自負責美、日市場的三期臨床。Torii的母公司是日本菸草公司(Japan Tobacco),有了這些大公司的友持,今年1月,日本JT/Torii宣佈Nephoxil已取得日本藥證,並獲得單顆(250mg)99.8日幣的保險給付價,上市首季度的銷售約2.7億日幣,約當300萬美元,Torri預期,下半年銷量將跳增至12億日幣。至於美國,則在Keryx於美東時間95日取得藥證後,該新藥也將在未來12個星期內上市,搶攻全球約15億美元市場。寶齡因為授權,未來可享受的利益,包括:一是銷售權利金,也就是依據藥品銷售乘以一定比例的進帳收入,二是進度達成里程金,第三則是原料藥的收入,由於寶齡富錦仍掌握原料藥的專利與生產製造技術,又可從銷售原料藥上獲利。另外,根據寶齡當初與發明人許振興合約,未來的里程金,其中的33.4%須分享給原發明人。而產品上市銷售權利金拆解,除大陸由寶齡獨享外,歐美日等七個地區 50%歸許振興所有。

 

 

Decitabine美國2014市場$251 million !!

InnoPharma Announces FDA Approval of Decitabine for Injection, a Generic Version of DACOGEN® Published: Aug 29, 2014 10:13 a.m. ET  PISCATAWAY, N.J., Aug. 29, 2014 /PRNewswire/ -- InnoPharma, Inc. today announced the approval from the U.S. Food and Drug Administration (FDA) for its Abbreviated New Drug Application (ANDA) for decitabine for injection, a generic version of Eisai Inc.'s DACOGEN®.  InnoPharma developed the generic formulation of decitabine for injection and entered into an agreement with Sandoz, Inc., pursuant to which Sandoz will sell, market and distribute decitabine for injection in the United States.  According to IMS data, aggregate U.S. sales of DACOGEN were approximately $251 million for the twelve months ending in April 2014. Decitabine for injection is indicated for the treatment of patients with myelodysplastic syndromes (MDS) including previously treated and untreated, de novo and secondary MDS of all French-American-British subtypes (refractory anemia, refractory anemia with ringed sideroblasts, refractory anemia with excess blasts, refractory anemia with excess blasts in transformation, and chronic myelomonocytic leukemia) and intermediate-1, intermediate-2, and high-risk International Prognostic Scoring System groups. "We are excited to see this important product reach the market.  This approval further emphasizes InnoPharma's ability and commitment to develop and bring to market complex generic and innovative specialty pharmaceutical products," stated Navneet Puri, Ph.D., President and Chief Executive Officer of InnoPharma. Decitabine for injection will be marketed in 20 mL single dose glass vials containing 50 mg decitabine, the same size and strength as the brand. The dosing regimen is identical to the brand. On July 16, 2014, Pfizer Inc. PFE, -0.17% and InnoPharma announced that they have entered into an agreement under which Pfizer will acquire InnoPharma. The closing of the transaction is subject to U.S. regulatory approval and is expected to occur during the third quarter.

About InnoPharma, Inc. InnoPharma is a privately held, sterile product development company, focused on developing complex generic and innovative products in injectable and ophthalmic dosage forms. The Company has a broad portfolio of products under development, with formulations including solutions, suspension, lyophilized, emulsions, liposomes, micelles and lipid complexes. InnoPharma's pipeline includes small molecules with solubility and stability challenges, as well as difficult to produce and characterize polypeptides and carbohydrates. The Company has a comprehensive infrastructure for the development of its products in its state of the art R&D facilities in New Jersey, with the capability to handle potent and cytotoxic molecules. More information can be found at www.innopharmainc.com.

About Sandoz Sandoz, the generic pharmaceuticals division of Novartis, is a global leader in the generic pharmaceutical sector. Sandoz employs over 26,500 employees across more than 160 countries, offering a broad range of high-quality, affordable products that are no longer protected by patents. With USD 9.2 billion in sales in 2013, Sandoz has a portfolio of approximately 1,100 molecules, and holds the #1 position globally in biosimilars as well as in generic injectables, ophthalmics, dermatology and antibiotics, complemented by leading positions in the cardiovascular, metabolism, central nervous system, pain, gastrointestinal, respiratory, and hormonal therapeutic areas. Sandoz develops, produces, and markets these medicines, as well as active pharmaceutical and biotechnological substances. Nearly half of Sandoz's portfolio is in differentiated products, which are defined as products that are more difficult to scientifically develop and manufacture than standard generics. In addition to strong organic growth since consolidating its generics businesses under the Sandoz brand name in 2003, Sandoz has benefitted from strong growth of its acquisitions, which include Lek (Slovenia), Sabex (Canada), Hexal (Germany), Eon Labs (US), EBEWE Pharma (Austria), Oriel Therapeutics (US), and Fougera Pharmaceuticals (US). DACOGEN® is a registered trademark used by Eisai Inc. under license from Astex Pharmaceuticals, Inc.

 

神隆生產Decitabine原料藥(Dacogen for myelodysplastic syndrome) ,Celgene如何穩住MDS市場?!

焦點股~神隆抗癌藥在美上市 股價奔漲停 2014091911:56台灣神隆(1789)股價早盤奔上62元的漲停價,不僅帶動健亞(4130)、和康生(1783)等新藥股攻高,拉抬生技類股指數的漲幅居早盤各類股表現之冠,也有力支撐店頭市場指數早盤持穩,不像加權指數的早盤漲幅幾乎吐光。媒體報導,神隆近期在美國推出抗癌新藥Decitabine,是神隆拿下全球第27個藥證的原料藥。神隆是全球抗癌原料藥龍頭,在全球擁有674個原料藥主檔案(DMF,原料藥藥證),在美國食品藥物管理局(FDA)登記有47DMF,其中抗癌原料藥DMF就佔22張。不過,神隆上午發布重訊澄清,抗癌學名藥Decitabine是神隆上市的第27個產品,而非手中拿到的全球第27張藥證。(劉煥彥/台北報導)

Dr. Reddy's introduces generic version of Dacogen in US PBR Staff Writer Published 12 July 2013 India-based Dr. Reddy's Laboratories has introduced generic version of Dacogen (Decitabine for Injection) used to treat myelodysplastic syndrome in the US. Following the approval by the USFDA of Dr. Reddy's ANDA for Decitabine for Injection 50mg is available as a single dose vial. Decitabine that belongs to a class of medications called hypomethylation agents works by helping the bone marrow produce normal blood cells and by killing abnormal cells in the bone marrow. Myelodysplastic syndrome is a group of conditions in which the bone marrow produces blood cells that are misshapen and does not produce enough healthy blood cells. The sales of Dacogen brand in the US were approximately $260m MAT for the most recent twelve months ending in July 2013, according to IMS Health data.

MGI PHARMA, Inc/ Dacogen (Decitabine) The overall response rate (CR+PR) in the ITT population was 17% in Dacogen-treated patients and 0% in the SC group (p<0.001). (See Table 3) The overall response rate was 21% (12/56) in Dacogen-treated patients considered evaluable for response (i.e., those patients with pathologically confirmed MDS at baseline who received at least 2 cycles of treatment). The median duration of response (range) for patients who responded to Dacogen was 288 days (116-388) and median time to response (range) was 93 days (55-272). All but one of the Dacogen-treated patients who responded did so by the fourth cycle. Benefit was seen in an additional 13% of Dacogen-treated patients who had hematologic improvement, defined as a response less than PR lasting at least 8 weeks, compared to 7% of SC patients. Dacogen treatment did not significantly delay the median time to AML or death versus supportive care.

l   Vidaza (Azacitidine) Injection from Celgene

l   Dacogen (Decitabine) IV from Eisai/MGI Pharma

l   Revlimid (Lenalidomide) from Celgene.

 

旭富營收>15億元 日本市場客戶 幫大忙 !

旭富拚蟬聯API獲利王;抗憂鬱系列展望轉強 MoneyDJ新聞 2014-09-23 11:18:33 記者 蕭燕翔 報導 低調穩穩賺,原料藥(API)廠商旭富(4119)今年前8月自結稅前獲利年增近五成,法人估計,該公司今年全年每股稅後盈餘可望有3.8-3.9元,有望蟬聯族群獲利王。而旭富佈局已久的抗憂鬱症明星用藥原料藥及中間體,近日傳出印度潛力客戶洽商積極,法人預期,最快明年有機會擴大供貨,帶動系列產品成長速度加快,並朝打造下個明星產品的方向邁進。旭富早期以中間體起家,近幾年整合至原料藥的出貨比重也不少,客戶群囊括國際大廠。該公司今年主力產品中,成長最大來自銷日抗發炎藥、配合客戶臨床階段的骨髓癌新藥及帕金森氏症應用,今年前8月營收成長17%,在毛利率轉佳與一次性收入入帳下,累計自結稅前盈餘2.46億元,年增48.7%,以目前股本計算,每股稅前盈餘3.52元。 而旭富今年營運的高成長,抗發炎、帕金森氏症與骨髓癌臨床新藥挹注最大,相較之下,本來在專利到期後被外界寄予厚望的抗憂鬱症明星用藥千憂解的原料挹注,反倒相對遜於預期,僅有透過東歐製劑廠交貨的該系列中間體,法人估計今年全年挹注約23千萬元,反倒是原料藥今年前8月只有小量出貨1百萬元以內,今年全年恐拉升動能也有限,還不及去年的700萬元以上。內部分析,千憂解原廠禮來在專利未到期的全球銷售有39億美元,屬明星級用藥,美國及歐洲專利分別於去年底與今年中到期,至少美國市場已有7家學名藥廠送件申請藥證(ANDA),但初期因不確定能搶下原廠多少市佔,因此原料藥多由製劑廠內產能因應,鮮少向專業原料藥廠採購,這也是該公司今年原料藥銷量不如預期的主因。不過,在美國市場歷經半年以上的競爭後,態勢漸明朗,7家學名藥廠中,兩家以上的印度藥廠搶市相對積極,據了解,其一家本來就是旭富的客戶,只是還處小量交貨狀態,但近日該客戶洽商更趨積極,法人評估,有可能是為正式下單預作準備,最快明年挹注可期。 法人認為,旭富在千憂解原料藥及中間體製程上,享有一段自行研發專利,不僅得以避開原廠,在已開發國家也有成本優勢。而明年旭富來自抗憂鬱症系列的產品,除東歐製劑廠中間體銷量將持續成長外,包括有望擴量的印度客戶及歐洲為TEVA等代工的製劑大廠等,都有機會挹注營收,成為明年的明星產品線,也有機會繼抗癲癇系列後,再打造一個明星產品,成為全球主要供應商。 法人預估,旭富今年營收會超過15億元,稅後盈餘2.7億元,以目前資本額估算,每股稅後盈餘3.8-3.9元,坐穩原料藥族群獲利王。

 

 

分裝藥不給付(原瓶交付) 診所難有模糊空間!

分裝藥 明年起健保不給付2014/9/24作者:陳玲芳【記者陳玲芳台北報導】衛福部中央健康保險署昨天宣布,自明年一月一日起,健保將不再給付分裝藥,要求所有醫療院所必須「原瓶交付」,且若發現有診所巧立名目、額外轉嫁成本給民眾,將嚴格開罰。不過,此舉引發不少醫師反彈,認為徒增民眾疑慮。民眾到皮膚科、小兒科診所看病,都曾拿過圓型塑膠盒、塑膠軟瓶的分裝軟膏、咳嗽糖漿,如此「大瓶換小瓶」的做法,在國內行之有年,較常見為皮膚科開出的各式軟膏,以及內科、家醫科、小兒科、耳鼻喉科開出的口服咳嗽糖漿等,據健保署統計,健保每年給付分裝藥的藥費約為八千九百萬元。健保署醫審及藥材組專門委員陳尚斌指出,醫療院所將大包裝藥品分裝成小包裝,多半是為了壓低進貨價格、節省成本,然而分裝藥品有諸多缺點,包括易造成不同藥品的交叉污染,細菌或黴菌等微生物汙染、劑量準確性也不易掌握,就連醫師、藥師、病患也都不知道藥品可存放多久,且有些藥水若分裝不均勻,濃度不一,若拿到濃度低的藥水,藥效一定不佳。陳尚斌說,目前藥廠都有依臨床實際需要,生產可用的小包裝藥品,健保都有給付,加上今年八月召集醫界、消費者、藥界及專家學者共同討論取得共識,決定明年一月一日起,正式取消給付分裝藥。他強調,健保署早自二○○八年開始鼓勵醫療診所「原瓶交付」,只要給一整條藥膏、一瓶藥水者,健保都有付,醫療院所不會虧本,應無理由反對。外界憂心醫療院所巧立名目將成本轉嫁給民眾,陳尚斌強調,健保署絕不允許,未來只要發現醫療院所在藥品部分負擔外,以「分裝費」等項目額外收費,一定嚴懲,除了扣點,最重可解除健保特約。民間監督健保聯盟發言人滕西華表示,分裝藥品在診所極為普遍,突然取消給付,有些醫療院所可能來不及應變,應予「過渡期」並宣導,倘若診所未進小包裝藥品,應交付民眾處方箋到藥局領藥。新制上路後,不少皮膚科開業醫師擔心,原裝藥膏容量較大,民眾可能一時用不完,會自行分裝、「分享」親友共用藥膏,「亂擦」出問題。書田診所皮膚科主任醫師鄭惠文則說,只要醫師善盡「衛教」責任,應可將上述疑慮將至最低。此外,鄭惠文說,「分裝藥」的問題仍屬「枝微末節」,健保署應當關注、改善的是在其大量調降藥品價格後,不論原廠進口藥或學名藥都給付相同價格,多數中盤藥商不願高價進貨增加負擔,導致診所醫師用不到「原廠藥」,社區藥局也大缺藥。她強調,唯有比照「食安」問題,看待醫師「開藥」,才能真正創造醫病雙贏。