刚刚追随薛宇教授的足迹，看到了中医学院士李连达所撰写的博文<<新药解燃眉之急>> 2013-04-08 http://blog.sciencenet.cn/home.php?mod=space&uid=715370。其中有如下一段文字“当前迫切需要研制对H7N9有针对性的特效药、强效药（当然也包括广谱抗病毒药，且对H7N9有特效的新药），我国专家研制成功的帕拉米韦注射液，经国家食品药品监督管理局快审快批，迅速使新药发挥作用，解燃眉之急，是件大好事，可喜可贺。”

该文在科学网受到广泛关注，并有华中科大生命科学与技术学院薛宇教授对这位院士爷的文章予以背书：<<新药解燃眉之急>> 2013-04-08。薛宇教授言简意赅:“院士爷发了不少博文，刚发的“新药解燃眉之急”这一篇总算体现水准了。值得读，推荐。”

然而，我则持完全相反的观点，李院士的此文内容经不起论证，而且对普通大众或非专业人员有很强的误导,与人们对中医药院士的头衔的认知程度相差极其悬殊！

为什么呢? 从李院士的前后行文中，可以推定帕拉米韦注射液属于中药不同方剂配伍而成。非常难以理解，中药起这么一个洋名字，而且完全是不伦不类的洋名，也不知道从这个名字中要说明点啥? 难道这种拉郎配的中药名称也大行其道了? 给定和批准使用此名字的有关人员骨子里崇尚的是什么? 您是中医学界的泰斗级别的人物，为中华文化的中的精华→中医的弘扬有无责任? 我想，您没有法定的责任是肯定的，但道义的责任应不应有呢?

李院士为其叫好，应不应该? 我个人的看法是完全不应该的。一个新药之所以成为新药，它应该具备了特定的疗效这一最基本的前提。然而，李院士在他的文章中告诉我们“达菲、奥司他韦等药对H1N1、H3N2、H5N1等多种流感病毒有效，但对H7N9流感病人不一定是有针对性的特效药、强效药。李院士又说“当前迫切需要研制对H7N9有针对性的特效药、强效药。”

我非常难以理解为什么李院士把帕拉米韦注射液如此迫不及待地定位成“我国专家研制成功的字样”。 这样极其不负责任的定位带来的祸患无穷，无形中让大众把帕拉米韦注射液当成了H7N9有针对性的特效药、强效药。

可客观事实是这样吗? 帕拉米韦注射液已经治疗了谁? 取得了什么效果? 在各方数据都严重不足的情况下，您的言语是否是会因中国人普遍的从众心理而为帕拉米韦注射液注射一针强心剂? 至于您那三点建议普通百姓是无心考虑的，他们只关心药效好还是不好，所以也就成了您那篇博文的点缀而已。

这不免让(难)我疑惑:您李连达院士的这种言论是否会把中医学彻底打夸的步伐加快一点? 如果只是知识储备更新上的问题，还可以理解，但您确实需要谨慎，可我真的不理解您为什么把您经不起推敲的逻辑摆放到大庭广众之下，导致连年轻后学的薛宇教授都受到了误导。

根据评论的有关补充内容

谢谢薛宇教授的提示

http://en.wikipedia.org/wiki/Peramivir

Peramivir is an experimental antiviral drug developed by BioCryst Pharmaceuticals for the treatment of influenza. It has been authorized for the emergency use of treatment of certain hospitalized patients with known or suspected 2009 H1N1 influenza.^[1]

Peramivir is a neuraminidase inhibitor, acting as a transition-state analogue inhibitor of influenza neuraminidase and thereby preventing new viruses from emerging from infected cells.

The development of peramivir is supported by the US Department of Health and Human Services as part of the US government's effort to prepare against the threat of an influenza pandemic.^[2]

Peramivir is already available in Japan as RAPIACTA (R) and also available in South Korea as PERAMIFLU. Peramivir is currently the only intravenous option for treating swine flu. The drug is in Phase III studies in US.^[3][4]

1. ^"Peramivir authorized for Emergency use". LifeHugger. 2009-12-04. Retrieved 2009-12-04.

2. ^"HHS Pursues Advance Development of New Influenza Antiviral Drug" (Press release). US Department of Health and Human Services. 2007-01-04. Retrieved 2007-05-25.

3. ^"Evaluation of the Efficacy and Safety of Peramivir in Subjects With Uncomplicated Acute Influenza". National Institutes of Health. 2007-03-16. Retrieved 2007-05-25.

4. ^"Evaluation of the Efficacy and Safety of Peramivir in Adults With Acute Serious or Potentially Life-Threatening Influenza". National Institutes of Health. 2007-03-28. Retrieved 2007-05-25.

新华网有关报道帕拉米韦注射液的报道

http://news.xinhuanet.com/fortune/2013-04/08/c_124553929.htm

广州南新制药有限公司介绍

1993年，广州南新制药有限公司成立，由印度RANBAXY与广州白云山制药集团侨光制药有限公司、香港企宁有限公司共同投资组建，成为我国第一家中印合资企业。

1997年，广州南新制药有限公司获得中国药品GMP认证，是第一批通过国家GMP认证的企业，年产大输液500万瓶，片剂与胶囊各7500万、儿童干混悬剂200万瓶及粉针500万支。

2005年，印度RANBAXY在广州南新工厂投资设立“技术发展实验室”（TDL），以加速新产品投产。南新公司已上市的有53种注册药品，包括10种《国家基本药物》、两种单独定价产品、以及RANBAXY专利产品“悉复欢OD”（CifranfranOD）。

2009年中国五矿下属湖南有色凯铂生物药业有限公司收购广州南新，为南新发展带来了新的机遇，随着与国家军事医学科学院的密切合作，不久将有一批原研与首仿药上市。

来自FDA的信息

http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm216252.htm

Peramivir Information

Peramivir Emergency Use Authorization Disposition Letter and Question and Answer Attachment

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

Silver Spring MD 20993

June 22, 2010

Thomas R. Frieden, MD, MPH

Director

Centers for Disease Control and Prevention

1600 Clifton Rd., MS D-14

Atlanta, GA 30333

Re: Disposition of Peramivir

Dear Dr. Frieden:

This letter responds to your request regarding the disposition of peramivir upon termination of the authorization of emergency use that was issued on October 23, 2009, pursuant to section 564(b)(1) of the Federal Food, Drug, and Cosmetic Act (the Act), 21 U.S.C. § 360bbb-3. Attached are Questions and Answers Regarding Termination of the Emergency Use Authorization for Peramivir IV.

Sincerely,

_____________________________
Margaret Hamburg, M.D.
Commissioner of Food and Drugs

ATTACHMENT

Questions and Answers for Hospitals and Healthcare Professionals Regarding Termination of the Emergency Use Authorization for Peramivir IV

On June 21, 2010, the U.S. Food and Drug Administration (FDA) notified the Centers for Disease Control and Prevention (CDC) that the Emergency Use Authorization (EUA) allowing for the use of the unapproved drug, Peramivir IV will terminate when the Public Health Emergency determination for 2009 H1N1 Influenza expires on June 23, 2010. Therefore, after June 23, 2010, Peramivir IV will no longer be available through the CDC under the EUA, and, except as described in Q&A 2 below, will no longer be authorized for use.

Q1. What is an EUA and what does EUA termination for Peramivir IV mean?A. An Emergency Use Authorization (EUA) may be issued by the Food and Drug Administration (FDA) to allow either the use of an unapproved medical product or an unapproved use of an approved medical product during certain types of emergencies with specified agents.

Section 564 of the Federal Food, Drug, and Cosmetic Act (the Act), amended by the Project BioShield Act of 2004, permits authorization of such products for use in diagnosing, treating, or preventing serious or life-threatening diseases or conditions caused by biological, chemical, radiological, or nuclear agents, if certain statutory criteria are met.

Once the EUA for Peramivir IV is terminated, healthcare professionals will no longer be able to access this unapproved drug from the CDC.

Q2. Can patients who started treatment with Peramivir IV before or on June 23, 2010 complete their treatment course after the EUA termination? A. Yes. For any patient who began a treatment course of Peramivir IV before or on June 23, 2010, the authorization shall continue to be effective after June 23, 2010, to allow completion of that treatment course, as prescribed by their healthcare professional.

Q3. Can Peramivir IV be retained at the hospital for future use under another EUA? A. No. Peramivir IV is an unapproved drug and was only authorized to treat certain hospitalized adult and pediatric patients with suspected or laboratory confirmed 2009 H1N1 influenza infection or infection due to nonsubtypable influenza A virus suspected to be 2009 H1N1 based on community epidemiology under the EUA that terminates on June 23, 2010. After the EUA terminates, hospitals and healthcare professionals may no longer hold or store Peramivir IV received from CDC under the EUA.

Q4. What should hospitals do with remaining stocks of Peramivir IV upon EUA termination? A. Hospitals that have remaining stocks of Peramivir IV should destroy them by utilizing their institutions' pharmaceutical destruction procedures and should retain adequate records regarding the receipt, use, and disposition of Peramivir IV.

Hospitals should also be aware of their responsibility regarding product accountability for Peramivir IV received from CDC under the EUAand respond to the product accountability survey from CDC, sent via e-mail to the hospital pharmacies, that requests information regarding the total quantity of Peramivir IV received; the quantity dispensed; patient age, gender, number of vials dispensed and duration of therapy for each patient treated with Peramivir IV; the quantity remaining unused; and the quantity and the date of on-site final disposal of product. Please make sure to respond to the survey no later than July 15, 2010.

Q5. Is there any other way healthcare professionals can obtain Peramivir IV now that the EUA is terminated? A. Yes, clinical trials of Peramivir IV are currently being conducted. Healthcare professionals considering whether a patient would be appropriate for inclusion in a clinical trial should review the available clinical trials involving IV antiviral products at http://www.clinicaltrials.gov.

Q6. Is there any other way healthcare professionals can obtain other IV antiviralsfor emergency use now that the Peramivir EUA is terminated? A. Currently there are no FDA approved IV antiviral drugs for influenza. However, IV formulations of peramivir, oseltamivir and zanamivir are being evaluated in clinical trials. Additional information on these clinical trials can be found at www.clinicaltrials.gov. In special circumstances, manufacturers of these products may agree to make IV formulations of antiviral drugs available for use for individual patients pursuant to FDA's Emergency Investigational New Drug (E-IND) application (a type of expanded access) procedures.

Q7. Who can healthcare professionals contact for further information?

A. For PeramivirIV specific questions or questions related to CDC's survey contact, 1-800-CDC-INFO (1-800-232-4636). For EUA related questions, contact eua.ocet@fda.hhs.gov.