醫保藥品新一輪降價方案將出爐 四大類藥品領跌 鉅亨網新聞中心 (來源：財匯資訊，摘自：第一財經日報) 2012-03-01 時隔近一年，國家基本醫療保險藥品目錄(下稱"醫保目錄")又面臨調整。《第一財經日報》獨家獲悉，新一輪醫保目錄藥品調價方案計劃在本周公布。 抗腫瘤等四大類藥品領降 抗腫瘤藥、免疫調劑類藥物、血液制品和消化系統用藥四大類品種將是此次重點降價。 盡管還未有最終平均降幅的確切數字，但就此次降價重點品種而言，由於抗腫瘤、血液制品等均屬高定價品種，因此，此輪降幅將超出上年抗感染和心血管類藥物21%的平均降幅。 2011年3月28日，國家發改委決定，醫保目錄內162個品種、近1300個劑型規格的藥品最高零售價格即日下調，抗感染和心血管疾病的抗生素和循環系統類藥品重點降價，平均降幅是調整前規定價格的21%;同時取消了20余個品種的單獨定價。發改委預計，每年可減輕群眾用藥負擔近100億元。 而2011年的這一次降價，也成為國家發改委藥物價格管理歷史上的第27次降價。數據顯示，歷次降價平均降幅均在15%~20%，部分藥品最高降幅甚至達60%左右。 "上一次降價已經看到了一些不同的降價思路，比如取消了單獨定價，根據臨床不同類別的實際使用需要進行價格調整。"中國醫藥(600056)企業管理協會會長於明德昨日接受本報采訪時表示，特別是對外資、合資企業與國內企業同品種價差過大的問題，將是下一步價格調整的一個重要方面。 對此，上周參加發改委溝通說明會的某企業負責人也向記者表示，盡管去年3月取消外資、合資公司和部分國內企業品種"單獨定價"，引起了相關企業的一些反應，"但是，對於同品種價差過大的問題，當事企業也明白，這種享受高定價權的日子已經慢慢過去了。"他說。 按照慣例，此次外資和合資企業也參加了溝通說明會，由於此前對這一價格調整的敏感問題已經分別召開過數次小規模討論，這最後一次的討論，對更多企業的品種降價來說，已經是"箭在弦上，不得不發"。 "價格差別不會最終取消，專家們都認為，應該對同一品種的不同質量有價格體現。"昨日，發改委藥品價格調整專家組成員之一的某專家告訴本報，專家們的意見很一致，一定要通過價格差別來體現質量優劣，以鼓勵創新，同時降低藥品負擔"但是，價差不適合過大，以什么為標準，其實現在還沒有結論。"他說。 根據記者了解到的信息，自去年末起，發改委就開始著手進行相關藥品的價格調研。但是，這一復雜龐大的問題，如何抽樣，如何截取企業的真實數據，顯然不是在短期內就能得出結論的課題。 受醫改目錄定期可能公布的影響，包括中恒集團(600252)(600252.SH)在內的數家抗腫瘤藥物公司股價有所下跌。
新進醫保品種或再降價 本報了解到，相比2011年的降價，今年的價格調整也將新進醫保目錄品種的價格控制作為重點。 "提出再降5%的想法，是因為新進入品種的價格空間還是有的，從這些品種上擠出水分也相對比較容易。"昨天，有接近國家發改委的消息人士向記者透露。 據《價格法》、《藥品管理法》及《藥品管理法實施條例》，現階段，我國對藥品實行三種定價形式——政府定價、政府指導價和企業自主定價。由財政購買免費向特定人群發放的藥品，實行政府定價，目前約有100種，占已批準上市藥品數量的0.8%;其他藥品實行政府指導價，具體形式為最高零售限價，約2600種，占22%左右;政府定價和政府指導價以外的藥品，實行市場調節，由企業自主定價，占77%左右。 政府定價和指導價格，實行中央和省兩級管理體制。在上述定價范圍內，屬於國家基本藥物及國家醫保目錄中的處方藥，壟斷生產經營的藥品，由國家發改委定價，約1900種。屬於國家醫保目錄中的非處方藥，及地方醫保增補的藥品，由各省(區、市)價格主管部門定價，約800種。 對於醫保目錄藥品定價而言，由於有國家和地方兩級定價機制，事實證明，確實在執行過程中出現了一些問題。 本報曾重點調查報導了部分地區醫保目錄突擊漲價的問題，國家發改委在隨后的調查中也證實存在過這一情況。正是因為這一系列事件的發生，國家發改委隨后對於新進醫保目錄品種的價格管控更加嚴格，也才最終促成了此次新進品種"多砍一刀"的價格調控思路。 此前，國家發改委價格司藥價處相關負責人接受本報采訪時曾表示，盡管進行了3年企業呈報數據采集、參考地方物價部門登記備案價格、各地中標價、重點省份重點城市醫院購進價格，以及大型商業公司交易價格等隱私，甚至也邀請了專業注冊會計師事務所等第三方幫助收集相關成本信息，"但價格復核、確認的工作依然是定價中耗時最長的工作。" 而於明德認為，對即將進行的第28次降價來說，如果始終不能配合醫院改革的核心問題進行，隔靴搔癢式的改革只會更加惡化行業環境。 "價格調整對整個費用控制能起到一定作用，但確實是治標之策，解決看病貴，還是要深化醫藥體制改革。"對此，國家發改委價格司醫藥價格處處長宋大才此前接受本報采訪時表示。Pages
Thursday, March 1, 2012
其他癌症標靶治療 健保給付仍須努力!!
醫美醫師專業度知多少??
皮膚專科醫師批醫美亂象叢生 【2012/03/01 聯合報】醫學美容風行、醫療糾紛也跟著增加，台南市醫師公會理事長王正坤今天表示，連許多有名的醫師都會因為經驗不夠，或是接受錯誤的資訊，造成求診者毀容，消費者在接受醫美前，應該多蒐集資料，不要貿然進行，才不會花錢又受氣。 同時是皮膚專科醫師的王正坤對於目前「不管是哪一科的醫師都能從事醫美」的情況，很不以為然，他表示，衛生署目前發給專科醫師執照，與醫美相關的只有皮膚科與整形外科，其他科的醫師多數是拿到醫學美容相關學會的會員證，卻號稱自己是醫美專科醫師，已經觸法。 王正坤表示，經常有醫美失敗的個案，到他的診所中要求補救，很多情況相當離譜，卻沒有專業醫師願意出面糾正，大家都怕「把不會的醫師教會」，反而成為自己的競爭對手。
La mejor medicina esta dentro de uno
雙美膠原蛋白植入劑 直銷醫學美容通路!!
王修含醫師 介紹血管雷射運用!!
血管雷射是什麼？ . 分類：皮膚雷射光電 2012/03/01 皮膚科 王修含 醫師 血管雷射(vascular laser)是用來清除皮膚紅色病灶的雷射，包括染料雷射、氬雷射、長脈衝銣雅克雷射......等。
血管雷射原理： 血管中的紅血球具有含氧血紅素，可吸收脈衝式染料雷射的波長，並將光能轉化為熱能，達到加熱血管管壁，選擇性破壞血管病變的效果，並且只影響血管病灶，而不傷害週邊的正常組織。 適應症： 1. 發炎性的青春痘、紅痘疤 2. 臉部血管絲，例如常見於鼻翼兩側與鼻孔的微血管擴張。 3. 酒糟 4. 血管瘤 5. 葡萄酒色斑 6. 伴隨血管擴張特性的肝斑 7. 回春(刺激膠原蛋白新生、緊緻膚質) 類別： ‧染料雷射 染料雷射是最常被使用的血管雷射，它是波長介於577到600奈米的黃光，較常使用的波長為595奈米。有冷卻系統配合，比較不痛，適用於治療血管瘤，也有人用來治療臉上微血管擴張造成的血管絲及改善黑眼圈，是目前血管雷射的最佳選擇。染料雷射亦可用於治療發炎性青春痘與「紅痘疤」，此治療亦具同時殺菌的作用，故對青春痘具治療效果。其它應用包括酒糟、 葡萄酒色斑，同時可結合銣雅克雷射，治療伴隨血管擴張症狀的肝斑。 傳統的染料雷射由於脈衝時間很短，容易造成血管破裂，造成嚴重淤青，因此新型的染料雷射提供多種長脈衝模式，改善這個問題，最著名的就是VBeam II機型，在台灣又稱為「櫻花雷射」。 ‧長脈衝銣雅各雷射 又稱「柔絲光雷射」，波長1064奈米，可用於除毛和回春。 ‧氬雷射 波長為418奈米的藍光和514奈米的綠光，是最早期的血管雷射，有色素永久性脫失、肥厚性疤痕等副作用，目前已經很少用於臨床上的治療
source: http://tw.myblog.yahoo.com/skindr-wang/article?mid=3214浩鼎生技OPT-822, 研發到臨床全程Made in Taiwan??
新藥群聚效應成型，產業發展漸趨正向精實新聞 2012-03-01 國內新藥授權利多頻傳，提高台灣生技新藥產業在國際的能見度，產業界也逐步走出不同的發展之路，除以往主流完成臨床二、三期後尋求授權或策略合作外，也有廠商規劃將獨立完成人體臨床試驗，並自力申請藥證，成為真正「Made in Taiwan」的新藥，群聚效應儼然成型。 台灣發展新藥不算是一條順遂的路，主要的挑戰包括相關廠商資本規模較小、欠缺足夠的內需市場及缺乏法規市場的行銷通路，因而多數廠商多在完成臨床一、二期後，尋求國際授權或合作，一方面取得下階段臨床試驗的資金，未來也將依照不同的階段時程(Milestone)，收取一定比例的權利金。 據業界統計，目前全球有能力完成新藥研發的國家不超過十家，而台灣新藥蓬勃發展也是近三年的事，較為人熟知的關鍵里程碑包括永豐餘(1907)集團下的新藥廠太景生技2010年10月將抗生素新藥奈諾沙星(Nemonoxacin)授權給國際知名藥廠WC；台灣醣聯大腸癌用藥也授權日本大塚製藥，未來可依合約收取2億美元的授權金及未來新藥銷售拆帳。 而點燃市場此波對新藥廠的關愛，當屬去年5月智擎(4162)則將癌症用藥PEP02授權給美商Merrimack，除已有第一筆1千萬美元前金外，未來還將依據臨床試驗至新藥上市的不同進度，總計將認列2.2億美元收入，創下國內生技藥廠對外授權金額的新高，上市後還可根據銷售額拆帳。 而目前手中有新藥完成階段進度、等待授權的新藥廠不少，法人點名今年可望見到的包括台微體(4152)、中裕新藥(4147)等，其中中裕後腺愛滋病新藥TMB355已完成FDA臨床二期，正尋求授權合作。而台微體與安成藥業合作的專利學名藥Doxisome也已通過美國Bio IND，今年國際授權可期。 值得留意的是，除尋求國際授權外，也有廠商靠自立完成臨床一至三期，並申請藥證。該等代表商為美國OPTIMER（浩鼎）創辦人張念慈領軍的浩鼎生技，目前手中癌症標靶藥物OPT-822，進度最快的乳癌適應症人體美、台同步臨床二期已近尾聲，內部規劃將自行完成臨床三期，新藥力拼兩年上市，成為正港「Made in Taiwan」的新藥，並讓台灣成為全球「唯十」以內有能力完成新藥上市的國家之一。 業者也指出，國內生技新藥利多頻傳，確實有助產業籌資及尋求國際夥伴，不過，台灣更需要引進美國那斯達克完整的新藥股定價模式，如帳上Pipeline產品隱含價值折現回推等，如此一來，才能避免走向2004-2006年間美國生技股暴漲暴跌後的人氣盡失，讓產業發展更趨健康。
太醫去年EPS 5.39元
東洋.. 永豐投顧持續看好!!
永豐投顧：東洋股價具題材激勵 維持買進 【2012/03/01 經濟日報】 永豐投顧指出，東洋2012年業績在授權金與常態性業務的穩健成長帶動下，獲利動能佳，加以微脂體藥品簽約金的挹注，對公司未來獲利還有調升空間。 另轉投資公司東生華及智擎生技第二季將轉上櫃掛牌及Lipo-AB三月將取得藥證下，對東洋股價亦具題材激勵效果，維持買進建議，目標價143元。
不開葷 吃錠劑 實際操作難?
不想吃膠囊開葷 可吃同成份錠劑 【2012/03/01 聯合報】 為治療疾病，不少患者會服用動物膠製成的膠囊藥物，若素食者不想開葷，該怎麼辦？和信醫院藥學進階教育中心主任陳昭姿表示，許多學名藥有生產膠囊與錠劑不同劑型，民眾就醫時，可請醫師改開同成份錠劑，如降血壓的鈣離子拮抗劑，就有軟膠囊及長效錠劑。若部分醫院沒有錠劑藥物，可請醫師釋出處方箋，讓民眾藥局領藥。
Celltex只有儲存幹細胞 沒有治療運用??
Stem-cell therapy takes off in Texas A boom in unproven procedures is worrying scientists. David Cyranoski 29 February 2012 Updated: 01 March 2012 Celltex hosts the largest stem-cell bank in the United States. With Texas pouring millions of dollars into developing adult stem-cell treatments, doctors there are already injecting paying customers with unproven preparations, supplied by an ambitious new company. The US Food and Drug Administration (FDA) has not approved any such stem-cell treatment for routine clinical use, although it does sanction them for patients enrolled in registered clinical trials. Some advocates of the treatments argue, however, that preparations based on a patient's own cells should not be classed as drugs, and should not therefore fall under the FDA's jurisdiction. There are certainly plenty of people eager to have the treatments. Texas governor Rick Perry, for instance, has had stem-cell injections to treat a back complaint1, and has supported legislation to help create banks to store patients' harvested stem cells. One company that has benefited from this buoyant climate is Celltex Therapeutics, which "multiplies and banks" stem cells derived from people's abdominal fat, according to chairman and chief executive David Eller. Its facility in Sugar Land, just outside Houston, opened in December 2011 and houses the largest stem-cell bank in the United States. Celltex was founded by Eller and Stanley Jones, the orthopaedic surgeon who performed Perry's procedure, and it uses technology licensed from RNL Bio in Seoul. Because clinical use of adult-stem-cell treatments are illegal in South Korea, RNL has since 2006 sent more than 10,000 patients to clinics in Japan and China to receive injections. Celltex says that although it processes and banks cells, it does not carry out stem-cell injections. It declined to answer Nature's questions about whether its cells have been used in patients. But there is evidence that the company is involved in the clinical use of the cells on US soil, which the FDA has viewed as illegal in other cases. In addition to the publicity surrounding Perry's treatment, a woman named Debbie Bertrand has been blogging about her experiences during a five-injection treatment with cells prepared at Celltex. Her blog (http://debbiebertrand.blogspot.com) hosts photographs of herself alongside Jones; Jennifer Novak, a Celltex nurse; Jeong Chan Ra, chief executive of RNL Bio; and her doctor, Jamshid Lotfi, a neurologist who works for the United Neurology clinic in Houston. Another photo is captioned: "My cells are being processed in here for my next infusion!!!" A third shows Bertrand, Lotfi and a physician called Matthew Daneshmand, who is, according to the caption, injecting Bertrand's stem cells into an intravenous drip, ready for the infusion. Nature has been unable to contact Bertrand. Lotfi says that he has administered cells processed by Celltex to more than 20 people. "Five or six" — including Bertrand — have multiple sclerosis and "four or five" have Parkinson's disease, he says. Lotfi explains that patients sign up for treatment by contacting Novak, and that cells are prepared by removing about five grams of fat — containing roughly 100,000 mesenchymal stem cells — from the patient's abdomen. Over a three-week period, the cells are cultured until they reach about 800 million cells. Lotfi says that patients get at least three injections of 200 million cells each, and that the cells do not take effect for a few months. According to Lotfi, Celltex charges US$7,000 per 200 million cells, and pays Lotfi $500 per injection. Lotfi says that most of his patients claim to get better after the treatment, but he admits that there is no scientific evidence that the cells are effective. "The scientific mind is not convinced by anecdotal evidence," he acknowledges. "You need a controlled, double-blind study. But for many treatments, that's not possible. It would take years, and some patients don't have years." "The worst-case scenario is that it won't work," he adds. "But it could be a panacea, from cosmetics to cancer." He says that Celltex is conducting a trial in which patients "will be their own control". "If you can compare before and after and show improvement, there's no need for a placebo," he explains. "How can you charge people, and then give them a placebo?"
Standard practice The answer, according to most biomedical researchers, is to follow the normal strategy for an unproven medicine: conduct a placebo-controlled clinical trial in which patients are not charged. "This is crucial for clinical trials to yield meaningful data and to avoid the placebo effect," says Joshua Hare, director of the Interdisciplinary Stem Cell Institute at the University of Miami in Florida, who worked with the biotechnology company Osiris Therapeutics in Columbia, Maryland, to conduct a trial of adult mesenchymal stem cells in patients who have had a heart attack2. The FDA does exempt some "compassionate use" procedures from these requirements, but only for very small numbers of patients with life-threatening disorders that demand immediate intervention.
"The scientific mind is not convinced by anecdotal evidence." Eller says that Celltex has "initiated a programme of clinical research" that has been approved by an independent review board in Texas and is designed to meet the standards set by the International Society for Stem Cell Research (ISSCR) in Deerfield, Illinois. "Our clinical trials are led by physician investigators who have completed training in both the use of autologous mesenchymal stem cells and in research ethics," he explains. But he would not say whether the trials had started or been approved by the FDA, nor who would run them, what disorders would be targeted or whether patients would be charged. Meanwhile, RNL has published a phase I trial showing that its treatment for spinal-cord injury is safe3, and plans a phase II trial in South Korea to establish efficacy. It has also applied to the FDA to conduct a clinical trial in the United States. Stem-cell scientists contacted by Nature are concerned by Celltex's activity. "Because we know so little about mesenchymal stem cells and whether they are indeed effective for treating any condition, I'd be very wary of how they are being infused into patients, and certainly concerned if practitioners are charging patients for medical procedures that haven't been proven to work and could in fact be harmful," says George Daley, director of the Stem Cell Transplantation Program at Harvard Medical School in Boston, Massachusetts, who helped the ISSCR to draft its guidelines. In the opinion of Arnold Kriegstein, director of the Eli and Edythe Broad Center of Regeneration Medicine and Stem Cell Research at the University of California, San Francisco, "the very nature of Celltex's business plan, which involves charging patients considerable fees for so-called treatments for diseases and disorders for which there is no good clinical evidence of efficacy, crosses an ethical line". Celltex recently brought in Glenn McGee, the editor-in-chief of the American Journal of Bioethics, to be its first president for ethics and strategic initiatives4. "I am working to build a programme of Celltex-run clinical trials that exceed the ethical standards promulgated by the best document to date on the matter, that from the ISSCR," says McGee. However, like Eller, McGee declined to answer Nature's questions about the company's knowledge of or involvement in the clinical use of its stem cells, nor would he talk about the legality and ethical nature of such practices. The legal standing of stem-cell treatments is currently being debated in a court case brought by Regenerative Sciences of Broomfield, Colorado, which was ordered by the FDA in 2010 to stop administering mesenchymal stem cells to patients5. One of the key issues being debated is whether the cells are "minimally manipulated" before being reinjected into the patient. Treatment with the patient's own, unprocessed tissue does not always require FDA approval.
Degree of manipulation In a previous version of his LinkedIn profile, McGee asserted that Celltex "minimally modified" its cells. But Rita Chappelle, a spokeswoman for the FDA's Center for Biologics Evaluation and Research in Silver Spring, Maryland, contends that any "expanded" cells cannot be considered minimally manipulated. Another source, who used to work for the FDA's cellular therapy division and requested anonymity because they now work in the private sector, says that any cells kept outside the body overnight before injection are considered more than minimally manipulated. The Texas Medical Board, which regulates physicians in the state, has now stepped into the fray. On 10 February, it approved draft rules that will require physicians to gain approval from an independent review committee before treating patients with adult stem cells. This stipulation, expected to become law in April, is meant to ensure patient safety and give physicians "a reasonable and responsible degree of latitude in the kinds of therapies they offer their patients", the draft rule says. But Douglas Sipp, an expert in stem-cell regulations and ethics at the RIKEN Center for Developmental Biology in Kobe, Japan, believes that the Texas Medical Board is merely delegating the regulation of adult-stem-cell treatments to local review boards, which have little accountability, when the responsibility should lie with the FDA. It is also unclear how Celltex will be affected by the rules. Lotfi, for one, does not think that they will hamper his treatments greatly. "It will be just a little more red tape," he says.