(雙語)陳馮富珍博士在英國藥品監(jiān)管局的演講
作者:英文巴士
來源:英文巴士
2016-06-20 10:07
MHRA have offered to support WHO, as needed, in the evaluation of candidate Zika products. NIBSC responded immediately to the WHO request to develop and evaluate reference preparations for anti-Zika antibodies.
藥品和健康保健產(chǎn)品監(jiān)管局向世衛(wèi)組織提供了在評估候選寨卡產(chǎn)品所需要的支持。國家生物標準和控制研究所立即回應了世衛(wèi)組織開發(fā)和評估抗寨卡抗體參考制品的要求。
These reference preparations will provide researchers, product developers, and regulatory authorities with a single standard that can be used to benchmark the multiple diagnostic tests for Zika that are currently under development.
這些參考制品為研究人員、產(chǎn)品開發(fā)商和監(jiān)管部門提供了一個統(tǒng)一的標準,可以用來測試當前正在研發(fā)的寨卡多項診斷檢測。
Better diagnostic tools are urgently and desperately needed. The current PCR test can detect the virus only during the brief window of viraemia. This weakness is further compounded by the fact that the illness is so mild. Many people infected with Zika will not be prompted to seek a test during this brief window of just a few days.
迫切急需的,是更好的診斷工具。當前的聚合酶鏈反應試劑只有在病毒血癥特定的時間內(nèi)才可檢測出病毒。這一弱點又加上病癥很輕微。許多人感染了寨卡后,沒有在僅有幾天的短暫時間內(nèi)及時去進行檢查。
Moreover, the Zika virus frequently co-circulates with dengue and chikungunya viruses. These viruses cross-react in tests for IgM antibodies against Zika virus, making them imprecise.
此外,寨卡病毒經(jīng)常是與登革熱和基孔肯雅病毒共同傳播的。這些病毒在對寨卡病毒進行的免疫球蛋白M抗體的測試中有交叉反應,使得檢測不夠精確。
Imagine the anguish of a pregnant woman living in or returning from an affected country, with no way of knowing whether she and her fetus have been affected. Ultrasound detection of microcephaly is possible only late in pregnancy.
可以想象得出,一名生活在或從一個受到疫情影響的國家歸來的孕婦,在對她和其胎兒是否受到影響一無所知的情況下是何等悲痛。只有在懷孕晚期使用超聲波才有可能檢測出小頭癥。
As with Ebola, Zika has caught the medical and scientific communities largely empty-handed, with WHO left to promote mosquito control as the most immediate line of defence.
如同埃博拉一樣,醫(yī)療和科學界對付寨卡總體上是一無所獲,而世衛(wèi)組織可以做的只能是推廣控制蚊子作為最緊急的防線。
For both of these diseases, we are in the 21st century and yet cannot immediately tap the power of modern medical tools.
對待這兩種疾病,雖然我們身處21世紀,但還是不能立刻發(fā)掘現(xiàn)代醫(yī)療工具的力量。
For Ebola, it was early detection, contact tracing, quarantine, and infection control. For Zika, right now, it is mosquito control at a time when more and more insecticides have been rendered ineffective by the development of resistance.
對于埃博拉,要做到早期檢查、追蹤接觸者、檢疫和控制感染。對于寨卡,當越來越多的殺蟲劑由于抗藥性使之無效而放棄的時候,當前更應控制蚊子。
Zika is a tricky virus that continues to astonish scientists. Who could have imagined that a mosquito bite would be linked to severe birth defects and other serious neurological complications?
寨卡是一種詭異的病毒,不斷使科學家感到吃驚不已。有誰能想象得到,一次蚊子叮咬會與嚴重的出生缺陷和其它嚴重的神經(jīng)并發(fā)癥有關聯(lián)呢?
More than half of the world’s population lives in an area where Aedes aegypti mosquitoes are present. Who knows what the next nasty surprise will be?
世界上有一半以上的人口生活在有埃及伊蚊的地方。誰知道下一次嚴重的意外事件會是什么樣的情景?
We know there will be more nasty surprises, if not from the volatile microbial world, then from some of the other complex threats in this era of global perils.
我們知道會有更多的嚴重意外事件發(fā)生,如果不是發(fā)生在一個反復無常充滿微生物的世界,那么也會在這個充滿全球風險時代的某些其它復雜的威脅中發(fā)生。
Ladies and gentlemen,
女士們,先生們:
The world has changed dramatically since the start of this century, when the Millennium Development Goals became the focus of international efforts to reduce human misery.
自本世紀伊始以來,世界發(fā)生了戲劇性的變化,千年發(fā)展目標成為進行國際努力減少人類痛苦的重點。
At that time, human misery was thought to have a discrete set of principal causes, like poverty, hunger, poor water and sanitation, several infectious diseases, and lack of essential care during pregnancy, childbirth, and childhood.
當時,人類的苦難被認為是由一組抽象的主要原因造成的,例如貧困、饑餓、不良水源和衛(wèi)生、多種傳染性疾病以及在懷孕、分娩和童年期間缺少基本的護理。
The results of that focus, and all the energy, resources, and innovations it unleashed, exceeded the wildest dreams of many. It demonstrated the power of solidarity and brought out the best in human nature.
那個重點的結(jié)果,以及釋放的能量、資源和創(chuàng)造力,超越了許多人最強烈的夢想。它展示出團結(jié)的力量,揭示出人性中的真諦。
Last year, the United Nations General Assembly finalized the new 2030 Agenda for Sustainable Development. The factors that now govern the well-being of the human condition, and of the planet that sustains it, are no longer so discrete. The new agenda, with its 17 goals and 169 targets, will try to shape a very different world.
去年,聯(lián)合國大會出臺了新的2030年可持續(xù)發(fā)展議程。人類福祉條件的治理的種種因素,以及支撐人類福祉條件的星球,再也不是抽象的。這項包含17個目標和169個具體目標的新議程將努力打造出一個嶄新的世界。
More and more we are seeing the worst in human nature: international terrorism, senseless mass shootings, bombings in markets and places of worship, ancient and priceless archaeological sites reduced to rubble, and seemingly endless armed conflicts that have contributed to the worst refugee crisis since the end of the second World War.
我們越來越能看清人性中最丑陋的一面:國際恐怖主義、市場和祈禱地點無情的大規(guī)模的槍擊和爆炸、古老和價值連城的遺跡變成了廢墟、看來無休止的武裝沖突造成了自第二次世界大戰(zhàn)以來最為嚴重的難民危機。
Our world is profoundly interconnected and this, too, has consequences. The refugee crisis in Europe shattered the notion that wars in faraway lands will stay remote.
我們的世界是相互緊密相聯(lián)的,而且這也產(chǎn)生了后果。難民危機打破了那種遠方發(fā)生的戰(zhàn)爭且可隔岸觀火的概念。
The Ebola outbreak shattered the notion that a disease of small African nations will have no consequences elsewhere.
埃博拉疫情打破了那種非洲小國的疾病不會殃及其他的概念。
The explosive spread of Zika virus disease throughout Latin America and the Caribbean shattered the notion that a disease long considered a medical curiosity will stay that way.
暴發(fā)寨卡病毒疫情蔓延了整個拉丁美洲和加勒比,打破了那種早有定論的罕見病例的疾病不可逆轉(zhuǎn)的概念。
And there are other perils. Inequalities, in income levels, opportunities, life expectancy, and access to health care have reached their highest levels seen in more than half a century. Some wealthy nations are losing their middle classes, the backbone of stability for democratic societies.
并且還有其它危害,在半個多世紀,收入水平、機會、預期壽命和獲得健康保健方面存在的不平等,達到了最為嚴重的程度。一些富裕國家正在失去民主社會穩(wěn)定的支柱——中產(chǎn)階級。
The climate is changing, with numerous consequences for health. These consequences are also profoundly unfair. The countries that contributed least to greenhouse gas emissions will be the hardest hit.
氣候正在發(fā)生變化,對健康造成了眾多后果。這些后果也是非常不公平的。對溫室氣體排放貢獻最小的國家受到的沖擊最大。
Chronic noncommunicable diseases have overtaken infectious diseases as the number one killers worldwide. Treatment for chronic conditions vastly increases the need for medical products and raises questions about their constantly rising prices.
慢性非傳染性疾病取代了傳染病,成為世界范圍的頭號殺手。慢性病人口的治療對醫(yī)藥產(chǎn)品的需求量大幅度增加,因而出現(xiàn)了藥品價格不斷攀升的問題。
With most newly approved cancer treatments costing more than $120,000 per patient per year, treatment is becoming unaffordable even for the wealthiest countries in the world. In some developing countries, the management of diabetes alone absorbs more than a third of the entire health budget.
隨著最新的癌癥治療方法的認可,每個患者每年需花費超過12萬美元,這種治療即便是世界上最富有的國家也難以承受。在一些發(fā)展中國家,僅糖尿病管理一項就占全部衛(wèi)生預算的三分之一以上。
We are losing our vital but fragile antimicrobials. The detection last year by Chinese scientists of a new resistance mechanism, the MCR-1 gene, sent shockwaves through the medical and scientific communities.
我們正在失去極其重要的但卻是脆弱的抗微生物藥物。去年中國科學家進行的新的耐藥性檢查機制轟動了整個醫(yī)療和科學界。
The gene is located on a mobile plasmid that transfers easily from one bacterial strain to others. This is a horizontal transfer of resistance, and it is frightening.
基因位于流動的質(zhì)粒中,很容易從一個菌株轉(zhuǎn)移到另一個菌株。這是一次橫向的耐藥性轉(zhuǎn)移,是令人恐懼的。
In the Chinese study, the MCR-1 gene conferred resistance to colistin, the last-resort antibiotic used to treat several life-threatening infections caused by Gram-negative bacteria.
在中國的研究中,MCR-1基因賦予粘菌素耐藥性,是治療由革蘭氏陰性菌引起危及生命感染時使用抗生素的最后手段。
Colistin is a 50-year-old antibiotic that was shelved in the 1970s because of its toxic effects on the kidneys. It was brought back into clinical use when all newer antibiotics began to fail.
粘菌素是一個有50年之久的抗生素,在1970年代被停用,因為它對腎有毒性作用。在所有更新的抗生素開始失敗時,粘菌素重新在臨床中使用。
As colistin had not been widely used, it was still effective. It was also cheap, which encouraged its massive use as a growth promoter in food production in several countries, including China.
由于粘菌素一直未被廣泛使用,所以它仍然有效。粘菌素還很便宜,在包括中國在內(nèi)的一些國家的糧食生產(chǎn)中,鼓勵將其作為一種促生長劑加以大規(guī)模使用。
The Chinese findings, which have been replicated in several other countries, solidify the links between the agricultural use of antibiotics, resistance in slaughtered animals, resistance in food, and resistance in humans. All of the dots are connected.
已由一些其它國家仿效中國的研究成果,將農(nóng)用抗生素、被屠宰牲畜的耐藥性,糧食中的耐藥性和人類耐藥性之間的聯(lián)系具體化了。
If we lose colistin, as several experts are predicting, we lose our last medicine for fighting a number of serious infections.
正如一些專家預測的那樣,如果我們失去了粘菌素,我們就失去了抵抗一些嚴重感染的最后藥品。
Last month, British treasury minister Lord Jim O’Neill, who heads the UK panel reviewing antimicrobial resistance, likened current trends to a “slow-motion car crash” and singled out vaccines as a crucial part of the solution.
上個月,英國財政部國務大臣吉姆?尼爾勛爵帶領了一個專家小組審查了抗微生物藥物的耐藥性,把當前的趨勢比作一次“慢鏡頭的撞車動作”并挑選出疫苗作為解決方案中一個重要的組成部分。
As noted, widespread vaccination against bacterial infections would reduce the need for antibiotics, thus reducing a key driver of resistance at source.
正如前面所說的,廣泛采用疫苗接種防止細菌感染,將減少對抗生素的需求,因此從源頭上減少了耐藥性的一個主要動因。
The panel will publish its final report in May. I am very pleased to know that your Prime Minister, David Cameron, is committed to pushing its recommendations through the UN General Assembly and the G7 group of countries.
專家小組將在五月發(fā)布它的最后報告。我非常高興地得知,你們的首相戴維·卡梅倫承諾通過聯(lián)合國大會和七國集團采納專家組的建議。
Ladies and gentlemen,
女士們,先生們:
The health targets in the new 2030 Sustainable Development Agenda are supremely ambitious.
在新的2030年可持續(xù)發(fā)展議程中的衛(wèi)生目標是極為宏偉的目標。
They aim at nothing less than the elimination of AIDS, tuberculosis, and malaria and an end to preventable maternal and childhood deaths. They also explicitly call on governments to support R&D for new vaccines and medicines.
這些目標并不亞于消除艾滋病毒、結(jié)核病和瘧疾的目標,以及防止孕產(chǎn)婦和兒童死亡的目標。這些目標明確呼吁各國政府支持研發(fā)新的疫苗和藥品。
Yes, we can aim for the moon and, yes, we will have to have new tools to get there. All global strategies, approved by our Member States, for reaching the 2030 health targets stress that success depends on specific R&D breakthroughs.
是的,我們可以制定登月計劃,當然我們必須擁有踏上月球的工具。我們的會員國批準的所有實現(xiàn)2030年衛(wèi)生目標的全球戰(zhàn)略都強調(diào),成功取決于具體研發(fā)的重大突破。
Many of these breakthroughs are broadly beneficial. For example, having reliable and affordable point-of-care diagnostics is another way to make prescribing more precise and thus reduce the overuse of antimicrobials.
這些重要的新發(fā)現(xiàn)中許多是受益面很廣泛的。例如,提供可靠的和可承受的現(xiàn)場即時診斷是另外一種使開具處方更加準確、減少過量使用抗微生物藥物的方法。
The MenAfriVac vaccine, developed and priced specifically for use in Africa, provides a good example of the impact a new vaccine can have.
A群腦膜炎球菌結(jié)合疫苗,專門為在非洲使用而開發(fā)和定價的疫苗,是一個展示了一種新的疫苗可以產(chǎn)生影響的良好典范。
Since 2010, more than 230 million people in 16 countries in Africa’s meningitis belt have been vaccinated against meningococcal meningitis serogroup A, with support from GAVI and the Bill and Melinda Gates Foundation.
自2010年以來,在全球疫苗和免疫聯(lián)盟以及比爾和梅林達·蓋茨基金會的支持下,在非洲腦膜炎發(fā)病地帶的16個國家逾2.3億人為防止患上A群腦膜炎球菌性腦膜炎接種了疫苗。
Given the added impact of herd immunity, the recurring outbreaks of meningitis A that have devastated 26 African countries for decades have been virtually eliminated.
鑒于人群免疫屏障的附加影響,在過去幾十年里毀掉了26個非洲國家的頻繁暴發(fā)的甲型腦膜炎實際上已經(jīng)滅絕了。
Aiming for the moon at a time when most budgets for domestic and international health are shrinking also calls for approaches that use what already exists more wisely. Finding more creative uses for existing vaccines can change patterns of use, with multiple spillover benefits for health.
當用于本國和國際衛(wèi)生方面的大部分預算正在縮減的那一刻,卻瞄準了月球,即使如此,也需要有一個合理利用現(xiàn)有資源的方法。探索更加有創(chuàng)造性地使用現(xiàn)有疫苗可以改變使用的格局,這對衛(wèi)生具有多個溢出效應。
In July 2013, WHO created a stockpile of oral cholera vaccines in response to a critical situation. Cholera epidemics were raging, yet the demand for vaccines was low and manufacturers had little incentive to increase supplies.
2013年7月,為了應對嚴峻的局勢,世衛(wèi)組織建立了口服疫苗儲存。盡管霍亂流行肆虐,但是對疫苗的需求不高,制造商對增加供應量毫無積極性。
Establishing the stockpile, WHO made a commitment to buy and use 2 million doses a year in order to stimulate demand and convince industry that a stable market exists.
世衛(wèi)組織建立了儲存,承諾每年購買和使用200萬劑疫苗,以刺激需求和說服企業(yè),穩(wěn)定的市場是視而可見的。
Although the cholera vaccine stockpile is essentially a vaccine procurement and distribution mechanism, it has generated multiple health benefits well beyond saving lives.
盡管有了霍亂疫苗儲存,基本上是一個疫苗采購和分配的機制,但它帶來的多方面的衛(wèi)生益處遠遠超過了挽救生命的意義。
It improved reporting. In public health, the promise of assistance is one of the strongest incentives to report epidemic-prone diseases immediately and transparently.
它改進報告程序。在公共衛(wèi)生方面,提供援助的許諾是對快速和公開報告有流行傾向疾病最強有力的激勵之一。
As long experience shows, the temptation to cover up a cholera outbreak is great, given the potential impact on trade and tourism.
正如長期經(jīng)驗顯示的那樣,鑒于對貿(mào)易和旅游帶來的潛在影響,那種掩蓋霍亂疫情的誘惑是巨大的。
It improved the speed needed for an emergency response, especially in the context of humanitarian crises. Following receipt of a request, vaccines arrive in the country within a maximum of 10 days.
它提高了緊急反應所需要的速度,特別是在人道主義危機的環(huán)境下亦是如此。在接到要求后,疫苗最多在10天之內(nèi)運達該國。
It increased supplies. Three producers have now been prequalified by WHO, with vaccine supply set to double this year. These vastly increased supplies have opened the first opportunity for pre-emptive campaigns in “hot spots” with repeated outbreaks.
它增加了供應量。世衛(wèi)組織已經(jīng)確定了三個預審合格的生產(chǎn)商,疫苗供應量確定翻一番。大量增加供應量為在疫情頻發(fā)的“熱點地區(qū)”開展先發(fā)制人的運動創(chuàng)造了先機。
It increased access in underserved populations. More cholera vaccines have been deployed to affected areas over the past two years than in the previous 15 years combined.
它為缺醫(yī)少藥的人口增加了獲取服務的渠道。過去兩年調(diào)往受影響地區(qū)的霍亂疫苗數(shù)量超過了前15年的總和。
It decreased costs as more producers entered the market.
由于有更多的生產(chǎn)商進入了市場,成本降低了。
It generated data on vaccine safety, efficacy, and the duration of immunity, thus strengthening the case for further investment.
它建立了疫苗安全、功效數(shù)據(jù),以及免疫期,因此增強了進一步投資的理由。
And it has stimulated the development of better vaccines offering greater protection, a longer shelf life, and fewer logistical challenges.
并且它刺激了開發(fā)具有更強的保護、更長的保質(zhì)期和更少的后勤拖累的更好的疫苗。
In short, a seemingly simple thing, like creating a stockpile, has transformed a vicious cycle of low demand, low production, high price, and inequitable distribution to a virtuous cycle of increased demand, increased production, reduced price, and greater equity of access.
簡而言之,表面看起來是件簡單的事情,如建立儲存,但卻將低需求、低產(chǎn)量、高昂的價格和不公平分配的惡性循環(huán)轉(zhuǎn)變成需求增加、生產(chǎn)增加、調(diào)低價格和更公平合理的獲得疫苗的良性循環(huán)。
A stockpile of rabies vaccine is a logical next step to follow.
下一步是儲存狂犬病疫苗。