Unit 55
When Ellen M. Roche, 24, volunteered for the asthma experiment, she didn't expect to benefit from it——except for the $365 she'd be paid. Unlike clinical trials, in which most patients hope that an experimental therapy will help them, this study was designed just to answer a basic question: how does the way a normal lung reacts to irritants shed light on how an asthmatic lung responds? To find out, scientists led by Dr. Alkis Togias of Johns Hopkins University had Roche and other healthy volunteers inhale a drug called hexamethonium. Almost immediately Roche began to cough and feel short of breath. Within weeks her lungs failed and her kidneys shut down. On June 2 Roche died——a death made more tragic by the possibility that it was preventable. Last week the federal Office for Human Research Protections (OHRP) ruled that Hopkins's system for protecting human subjects is so flawed that virtually all its U.S.-supported research had to stop.
The worst part is that Hopkins, one of the nation's premier medical institutions, is not alone. Two years ago the inspector general of the Department of Health and Human Services warned that the system safeguarding human subjects is in danger of a meltdown. The boards that review proposed studies are overburdened, understaffed and shot through with conflicts of interest. Oversight is so porous that no one knows how many people volunteer to be human guinea pigs (21 million a year is an educated guess), how many are hurt or how many die. "Thousands of deaths are never reported, and adverse events in the tens of thousands are not reported," says Adil Shamoo, a member of the National Human Research Protections Advisory Committee and professor at the University of Maryland. Greg Koski, head of OHRP, has called the clinical-trials system "dysfunctional."
The OHRP findings on Hopkins are nothing short of devastating. After a three-day inspection last week, OHRP concluded that the Hopkins scientists failed to get information on the link between hexamethonium and lung toxicity, even though data were available via "routine" Internet searches and in textbooks. The drug is not approved for use in humans; the hexa-methonium Togias used was labeled [F]OR LABORATORY USE ONLY. The review board, OHRP charges, never asked for data on the safety of inhaled hexamethonium in people. The consent form that Roche signed states nowhere that hexamethonium is not approved by the FDA (the form describes it as a "medication") and didn't warn about possible lung toxicity.
Hopkins itself concluded that the review board did not do all it could to protect the volunteers, and suspended all 10 of Togias's studies. Still, the university——whose $301 million in federal grants for 2,000 human studies made it the largest recipient of government research money last year——is seething. "Hopkins has had over 100 years of doing clinical trials," says Dr. Edward Miller, CEO of Johns Hopkins Medicine. "We have had one death in all of those years. We would have done anything in the world to prevent that death, but [suspending the studies] seems out of proportion." Hopkins calls the shutdown of its experiments "unwarranted, unnecessary, paralyzing and precipitous." OHRP is letting trials continue "where it is in the best interests" of subjects. The rest of the studies can resume once Hopkins submits a plan to restructure its system for protecting research subjects. How quickly that happens, says a government spokesman, depends on Hopkins.
注(1):本文選自Newsweek; 7/30/2001, p36;
注(2):本文習(xí)題命題模仿對象2005年真題Text 1;
1.In the opening paragraph, the author introduces his topic by
[A]explaining a phenomenon
[B]justifying an assumption
[C]stating an incident
[D]making a comparison
2. The statement “The OHRP findings on Hopkins are nothing short of devastating.”(Line 1, Paragraph 3) implies that
[A]The OHRP findings on Hopkins are much too impressive.
[B]The OHRP findings on Hopkins are much too shocking.
[C]The OHRP findings on Hopkins are much too convincing.
[D]The OHRP findings on Hopkins are much too striking.
3. The main reasons for Roche's death are as following, except that _______.
[A]the protecting system hasn't been set up
[B]the review board has neglected their duty
[C]the research team was not responsible enough for its volunteers
[D]the possibility of lung toxicity was overlooked
4. The OHRP has found that
[A]Hopkins has loose control over the experiment.
[B]the volunteers knew nothing about the experiment.
[C]there is something wrong with every aspect of the experiment.
[D]there exist many hidden troubles in human subjects safeguarding system.
5. What can we infer from the last paragraph?
[A]Hopkins had no fault in this accident.
[B]Hopkins seemed not to quite agree with The OHRP
[C]Togias's studies shouldn't be suspended.
[D]Hopkins wanted to begin their experiments as soon as possible.
答案:CBACB
篇章剖析
本文采用提出問題——分析問題的模式,著重分析了約翰-霍普金斯大學(xué)參與醫(yī)學(xué)實驗的自愿者死亡事件發(fā)生的原因以及產(chǎn)生的后果。第一段指出一名自愿者在人體實驗中不幸死亡;第二段指出人體實驗保護系統(tǒng)存在的漏洞和缺陷;第三段指出人類研究保護辦公室在霍普金斯大學(xué)令人震驚的發(fā)現(xiàn);第四段指出霍普金斯大學(xué)的態(tài)度和反應(yīng)。
詞匯注釋
crackdown on sb/sth 制裁;取締
therapy[5WerEpI]n.治療
irritant[5IrItEnt]n.刺激物
shed light on sth. v.使某事清楚明白地顯示出來
inhale[In5heIl]vt.吸入vi.吸氣
hexamethonium[9heksEme`WEJnIEm]n.[藥]六甲銨(降血壓藥)
premier[5premIE(r); (?@) pri:5mIEr]adj.第一的, 首要的
inspector general n.檢查長, 監(jiān)察長
meltdown n. 徹底垮臺
overburden[EJvE5b\:d(E)n]vt.裝載過多, 負擔(dān)過多, 使過勞
understaffed[QndE5stB:ft; (?@) -5stAft]adj.人員不足的, 人手不足的
shot through with sth 很有(某氣質(zhì));充滿著
conflict of interest 違背公眾利益的行為,利益沖突
guinea pigs n.豚鼠
adverse[5Adv\:s]adj.不利的, 敵對的, 相反的
clinical trial n.臨床試驗
dysfunction[dIs5fQnkF(E)n]n.[醫(yī)] 機能不良, 功能紊亂, 官能障礙
nothing short of 簡直不比…差,簡直可以說…
devastating[5devEsteItIN]adj.令人十分震驚的;具有強大沖擊力的
toxicity[tCk`sIsEtI]n.毒性
FDA abbr.Food and Drug Administration(美國)食品及藥物管理局
medication[medI5keIF(E)n]n.藥物治療, 藥物處理, 藥物
suspend[sE5spend]vt.吊, 懸掛v.延緩
recipient[rI5sIpIEnt]n.容納者, 容器
seething[`si:TIN]adj.沸騰的, 火熱的
CEO abbr.Chief Executive Officer 執(zhí)行總裁
out of proportion 不合情理的
shutdown[5FQtdaJn]n.關(guān)門, 停工, (廣播電臺)停播(時間)
paralyze[5pArElaIz]制止,破壞阻礙進展或發(fā)揮功能;使無效或無力:
precipitous[prI5sIpItEs]adj. 急躁的, 魯莽的, 輕率的
in the interests of 為了…的利益;為了…的緣故:
submit to v.使服從, 使受到, 服從, 忍受;呈遞,提交
restructure[ri:5strQktFE(r)]vt.更改結(jié)構(gòu), 重建構(gòu)造, 調(diào)整, 改組
難句突破
Unlike clinical trials, in which most patients hope that an experimental therapy will help them, this study was designed just to answer a basic question: how does the way a normal lung reacts to irritants shed light on how an asthmatic lung responds?
主體句式:… this study was designed to answer a basic question…
結(jié)構(gòu)分析:“Unlike clinical trials”做句子的伴隨狀語,介詞“unlike”的意思是“不象…一樣”,后面跟“in which”引導(dǎo)狀語從句來修飾“clinical trials”;狀語從句中“hope”后面跟的是“that”引導(dǎo)的賓語從句:“how does the way a normal lung reacts to irritants shed light on how an asthmatic lung responds?”是“a basic question”的同位語;其中“a normal lung reacts to irritants”做后置定語來修飾“the way”;詞組“shed light on”意思是“使某事清楚明白地顯示出來”。
句子譯文:在臨床實驗中,大多數(shù)病人都希望實驗性的療法能夠緩解他們的病情。但是這項研究跟臨床實驗有所不同,它旨在回答一個基本的問題:如何利用正常的肺對刺激物的反應(yīng)方式來弄清楚哮喘病人的肺的反應(yīng)。
題目分析
1.答案為C,屬事實細節(jié)題。文章開頭作者以科學(xué)實驗的一個犧牲者為例引出論題。
2.答案為B,屬推理判斷題。文中“nothing short of”和“devastating”是本句的語言難點:“nothing short of”意思是“完全是; 簡直可以說”:“devastating”意思是“令人十分震驚的;具有強大沖擊力的”。即使沒有這些語言知識,根據(jù)上下文也能作出判斷,分析如下:“The OHRP findings on Hopkins are nothing short of devastating.”是所在段落的中心句,后面給出的事例是為了進一步說明這一論點。我們從所給事例可看出這起事故出自多方的責(zé)任,也存在一些違歸操作,其中出現(xiàn)的失誤真是令人震驚。
3.答案為A,屬事實細節(jié)題。原文對應(yīng)信息是“Last week the federal Office for Human Research Protections (OHRP) ruled that Hopkins's system for protecting human subjects is so flawed that virtually all its U.S.-supported research had to stop.”從這個句子我們可以看出雖然存在保護系統(tǒng),但是這一系統(tǒng)漏洞百出,缺陷太多。因此選項A不正確。選項B、C、D在文中第三段可找到所對應(yīng)信息。
4.答案為C,屬推理判斷題。人類研究保護辦公室在霍普金斯大學(xué)發(fā)現(xiàn)了實驗過程中存在的很多問題。
5.答案為B,屬推理判斷題。從句子“but [suspending the studies] seems out of proportion”和“Hopkins calls the shutdown of its experiments "unwarranted, unnecessary, paralyzing and precipitous."”我們可看出霍普金斯大學(xué)就此事的觀點和態(tài)度。
參考譯文
當(dāng)24歲的Ellen M. Roche決定做一項哮喘病研究試驗的志愿者的時候,她并沒有期望從中獲取什么好處——除了應(yīng)支付她的365美元。在臨床實驗中,大多數(shù)病人都希望實驗性的療法能夠緩解他們的病情。但是這項研究跟臨床實驗有所不同,它旨在回答一個基本的問題:如何利用正常的肺對刺激物的反應(yīng)方式來弄清楚哮喘病人的肺的反應(yīng)。為了尋找答案,約翰-霍普金斯大學(xué)的Alkis Togias博士讓Roche和其他一些健康志愿者吸入一種叫做六甲銨的藥物。Roche剛一吸入就開始咳嗽,并且感覺呼吸急促。幾周之后,她的肺功能減弱,而且腎臟衰竭。六月二號Roche死亡——這起死亡事件完全有可能避免的,這更加重了它的悲劇色彩。上周,聯(lián)邦人類研究保護辦公室(OHRP)作出裁決:霍普金斯大學(xué)對實驗人體的保護體系缺陷太多,所有美國支持的研究項目都必須停止。
最糟糕的是,這種情況并不單單只發(fā)生在作為全國的醫(yī)療機構(gòu)之一的霍普金斯大學(xué)。早在兩年前,健康與人類服務(wù)部監(jiān)察長就曾警告說,保護實驗人體系統(tǒng)有陷于崩潰的危險。負責(zé)審閱那些建議性研究的委員會負荷過重,人手不足,充滿利益沖突。監(jiān)管方面漏洞百出,無人確切知曉到底有多少人自愿象實驗用的豚鼠一樣成為實驗對象(根據(jù)經(jīng)驗作出的猜測大概是每年2,100萬),有多少人受傷,或有多少人死亡?!皵?shù)千起死亡案例從來沒有被公之于眾,好幾萬例不利事件也從未被報道過。”國家人體研究保護咨詢委員會成員,同時又是馬里蘭大學(xué)教授的Adil Shamoo如是說。人類研究保護辦公室主任把臨床試驗體系稱為“功能失?!?。
人類研究保護辦公室在霍普金斯大學(xué)的發(fā)現(xiàn)簡直可以說是令人震驚萬分。上周,經(jīng)過為期三天的檢查之后,人類研究保護辦公室得出如下結(jié)論:霍普金斯大學(xué)的科學(xué)家沒能獲得六甲銨與肺毒性之間存在著聯(lián)系這方面的資料,雖然這些資料可以通過“常規(guī)”因特網(wǎng)搜索和教科書來獲得。這種藥物還未經(jīng)準(zhǔn)許用于人體,而且Togias使用的六甲銨藥品上還標(biāo)注有“只用于實驗室”的字樣。人類研究保護辦公室還指控復(fù)核委員會從未索要有關(guān)人體可吸入的六甲銨的安全用量方面的數(shù)據(jù)。Roche簽署的同意表格里并沒有注明六甲銨藥品未經(jīng)美國食品及藥物管理局批準(zhǔn)使用(表格里只說明它是一種“藥物”),更沒有告知有可能會出現(xiàn)的肺毒性。
霍普金斯大學(xué)自己做出的結(jié)論是復(fù)核委員會沒有盡全力保護好自愿者,并且中止了Togias多達十項的所有研究項目。這所大學(xué)——聯(lián)邦政府授予的高達3.01億美元用于人體研究的撥款使它成為去年接受政府研究資金最多的學(xué)?!F(xiàn)在仍然為此事感到義憤不平?!盎羝战鹚勾髮W(xué)做臨床試驗的歷史長達100多年,” 約翰-霍普金斯醫(yī)學(xué)院執(zhí)行總裁愛德華·米勒博士說,“這么多年來我們只出現(xiàn)了這么一起死亡事故。如果能避免這起死亡事故,讓我們做什么事情我們都愿意。但是,中止研究這樣的作法似乎有些不近情理。” 霍普金斯大學(xué)把中止實驗這種做法稱為“無根據(jù)的、不必要的、阻礙進展的、輕率的”行為。人類研究保護辦公室準(zhǔn)許繼續(xù)進行那些對實驗對象“最為有利的實驗”。至于其它研究,只要霍普金斯大學(xué)提出重組保護研究對象體系的方案,就可以繼續(xù)進行。政府發(fā)言人說,這究竟還需多久,全在于霍普金斯大學(xué)他們自己了。
When Ellen M. Roche, 24, volunteered for the asthma experiment, she didn't expect to benefit from it——except for the $365 she'd be paid. Unlike clinical trials, in which most patients hope that an experimental therapy will help them, this study was designed just to answer a basic question: how does the way a normal lung reacts to irritants shed light on how an asthmatic lung responds? To find out, scientists led by Dr. Alkis Togias of Johns Hopkins University had Roche and other healthy volunteers inhale a drug called hexamethonium. Almost immediately Roche began to cough and feel short of breath. Within weeks her lungs failed and her kidneys shut down. On June 2 Roche died——a death made more tragic by the possibility that it was preventable. Last week the federal Office for Human Research Protections (OHRP) ruled that Hopkins's system for protecting human subjects is so flawed that virtually all its U.S.-supported research had to stop.
The worst part is that Hopkins, one of the nation's premier medical institutions, is not alone. Two years ago the inspector general of the Department of Health and Human Services warned that the system safeguarding human subjects is in danger of a meltdown. The boards that review proposed studies are overburdened, understaffed and shot through with conflicts of interest. Oversight is so porous that no one knows how many people volunteer to be human guinea pigs (21 million a year is an educated guess), how many are hurt or how many die. "Thousands of deaths are never reported, and adverse events in the tens of thousands are not reported," says Adil Shamoo, a member of the National Human Research Protections Advisory Committee and professor at the University of Maryland. Greg Koski, head of OHRP, has called the clinical-trials system "dysfunctional."
The OHRP findings on Hopkins are nothing short of devastating. After a three-day inspection last week, OHRP concluded that the Hopkins scientists failed to get information on the link between hexamethonium and lung toxicity, even though data were available via "routine" Internet searches and in textbooks. The drug is not approved for use in humans; the hexa-methonium Togias used was labeled [F]OR LABORATORY USE ONLY. The review board, OHRP charges, never asked for data on the safety of inhaled hexamethonium in people. The consent form that Roche signed states nowhere that hexamethonium is not approved by the FDA (the form describes it as a "medication") and didn't warn about possible lung toxicity.
Hopkins itself concluded that the review board did not do all it could to protect the volunteers, and suspended all 10 of Togias's studies. Still, the university——whose $301 million in federal grants for 2,000 human studies made it the largest recipient of government research money last year——is seething. "Hopkins has had over 100 years of doing clinical trials," says Dr. Edward Miller, CEO of Johns Hopkins Medicine. "We have had one death in all of those years. We would have done anything in the world to prevent that death, but [suspending the studies] seems out of proportion." Hopkins calls the shutdown of its experiments "unwarranted, unnecessary, paralyzing and precipitous." OHRP is letting trials continue "where it is in the best interests" of subjects. The rest of the studies can resume once Hopkins submits a plan to restructure its system for protecting research subjects. How quickly that happens, says a government spokesman, depends on Hopkins.
注(1):本文選自Newsweek; 7/30/2001, p36;
注(2):本文習(xí)題命題模仿對象2005年真題Text 1;
1.In the opening paragraph, the author introduces his topic by
[A]explaining a phenomenon
[B]justifying an assumption
[C]stating an incident
[D]making a comparison
2. The statement “The OHRP findings on Hopkins are nothing short of devastating.”(Line 1, Paragraph 3) implies that
[A]The OHRP findings on Hopkins are much too impressive.
[B]The OHRP findings on Hopkins are much too shocking.
[C]The OHRP findings on Hopkins are much too convincing.
[D]The OHRP findings on Hopkins are much too striking.
3. The main reasons for Roche's death are as following, except that _______.
[A]the protecting system hasn't been set up
[B]the review board has neglected their duty
[C]the research team was not responsible enough for its volunteers
[D]the possibility of lung toxicity was overlooked
4. The OHRP has found that
[A]Hopkins has loose control over the experiment.
[B]the volunteers knew nothing about the experiment.
[C]there is something wrong with every aspect of the experiment.
[D]there exist many hidden troubles in human subjects safeguarding system.
5. What can we infer from the last paragraph?
[A]Hopkins had no fault in this accident.
[B]Hopkins seemed not to quite agree with The OHRP
[C]Togias's studies shouldn't be suspended.
[D]Hopkins wanted to begin their experiments as soon as possible.
答案:CBACB
篇章剖析
本文采用提出問題——分析問題的模式,著重分析了約翰-霍普金斯大學(xué)參與醫(yī)學(xué)實驗的自愿者死亡事件發(fā)生的原因以及產(chǎn)生的后果。第一段指出一名自愿者在人體實驗中不幸死亡;第二段指出人體實驗保護系統(tǒng)存在的漏洞和缺陷;第三段指出人類研究保護辦公室在霍普金斯大學(xué)令人震驚的發(fā)現(xiàn);第四段指出霍普金斯大學(xué)的態(tài)度和反應(yīng)。
詞匯注釋
crackdown on sb/sth 制裁;取締
therapy[5WerEpI]n.治療
irritant[5IrItEnt]n.刺激物
shed light on sth. v.使某事清楚明白地顯示出來
inhale[In5heIl]vt.吸入vi.吸氣
hexamethonium[9heksEme`WEJnIEm]n.[藥]六甲銨(降血壓藥)
premier[5premIE(r); (?@) pri:5mIEr]adj.第一的, 首要的
inspector general n.檢查長, 監(jiān)察長
meltdown n. 徹底垮臺
overburden[EJvE5b\:d(E)n]vt.裝載過多, 負擔(dān)過多, 使過勞
understaffed[QndE5stB:ft; (?@) -5stAft]adj.人員不足的, 人手不足的
shot through with sth 很有(某氣質(zhì));充滿著
conflict of interest 違背公眾利益的行為,利益沖突
guinea pigs n.豚鼠
adverse[5Adv\:s]adj.不利的, 敵對的, 相反的
clinical trial n.臨床試驗
dysfunction[dIs5fQnkF(E)n]n.[醫(yī)] 機能不良, 功能紊亂, 官能障礙
nothing short of 簡直不比…差,簡直可以說…
devastating[5devEsteItIN]adj.令人十分震驚的;具有強大沖擊力的
toxicity[tCk`sIsEtI]n.毒性
FDA abbr.Food and Drug Administration(美國)食品及藥物管理局
medication[medI5keIF(E)n]n.藥物治療, 藥物處理, 藥物
suspend[sE5spend]vt.吊, 懸掛v.延緩
recipient[rI5sIpIEnt]n.容納者, 容器
seething[`si:TIN]adj.沸騰的, 火熱的
CEO abbr.Chief Executive Officer 執(zhí)行總裁
out of proportion 不合情理的
shutdown[5FQtdaJn]n.關(guān)門, 停工, (廣播電臺)停播(時間)
paralyze[5pArElaIz]制止,破壞阻礙進展或發(fā)揮功能;使無效或無力:
precipitous[prI5sIpItEs]adj. 急躁的, 魯莽的, 輕率的
in the interests of 為了…的利益;為了…的緣故:
submit to v.使服從, 使受到, 服從, 忍受;呈遞,提交
restructure[ri:5strQktFE(r)]vt.更改結(jié)構(gòu), 重建構(gòu)造, 調(diào)整, 改組
難句突破
Unlike clinical trials, in which most patients hope that an experimental therapy will help them, this study was designed just to answer a basic question: how does the way a normal lung reacts to irritants shed light on how an asthmatic lung responds?
主體句式:… this study was designed to answer a basic question…
結(jié)構(gòu)分析:“Unlike clinical trials”做句子的伴隨狀語,介詞“unlike”的意思是“不象…一樣”,后面跟“in which”引導(dǎo)狀語從句來修飾“clinical trials”;狀語從句中“hope”后面跟的是“that”引導(dǎo)的賓語從句:“how does the way a normal lung reacts to irritants shed light on how an asthmatic lung responds?”是“a basic question”的同位語;其中“a normal lung reacts to irritants”做后置定語來修飾“the way”;詞組“shed light on”意思是“使某事清楚明白地顯示出來”。
句子譯文:在臨床實驗中,大多數(shù)病人都希望實驗性的療法能夠緩解他們的病情。但是這項研究跟臨床實驗有所不同,它旨在回答一個基本的問題:如何利用正常的肺對刺激物的反應(yīng)方式來弄清楚哮喘病人的肺的反應(yīng)。
題目分析
1.答案為C,屬事實細節(jié)題。文章開頭作者以科學(xué)實驗的一個犧牲者為例引出論題。
2.答案為B,屬推理判斷題。文中“nothing short of”和“devastating”是本句的語言難點:“nothing short of”意思是“完全是; 簡直可以說”:“devastating”意思是“令人十分震驚的;具有強大沖擊力的”。即使沒有這些語言知識,根據(jù)上下文也能作出判斷,分析如下:“The OHRP findings on Hopkins are nothing short of devastating.”是所在段落的中心句,后面給出的事例是為了進一步說明這一論點。我們從所給事例可看出這起事故出自多方的責(zé)任,也存在一些違歸操作,其中出現(xiàn)的失誤真是令人震驚。
3.答案為A,屬事實細節(jié)題。原文對應(yīng)信息是“Last week the federal Office for Human Research Protections (OHRP) ruled that Hopkins's system for protecting human subjects is so flawed that virtually all its U.S.-supported research had to stop.”從這個句子我們可以看出雖然存在保護系統(tǒng),但是這一系統(tǒng)漏洞百出,缺陷太多。因此選項A不正確。選項B、C、D在文中第三段可找到所對應(yīng)信息。
4.答案為C,屬推理判斷題。人類研究保護辦公室在霍普金斯大學(xué)發(fā)現(xiàn)了實驗過程中存在的很多問題。
5.答案為B,屬推理判斷題。從句子“but [suspending the studies] seems out of proportion”和“Hopkins calls the shutdown of its experiments "unwarranted, unnecessary, paralyzing and precipitous."”我們可看出霍普金斯大學(xué)就此事的觀點和態(tài)度。
參考譯文
當(dāng)24歲的Ellen M. Roche決定做一項哮喘病研究試驗的志愿者的時候,她并沒有期望從中獲取什么好處——除了應(yīng)支付她的365美元。在臨床實驗中,大多數(shù)病人都希望實驗性的療法能夠緩解他們的病情。但是這項研究跟臨床實驗有所不同,它旨在回答一個基本的問題:如何利用正常的肺對刺激物的反應(yīng)方式來弄清楚哮喘病人的肺的反應(yīng)。為了尋找答案,約翰-霍普金斯大學(xué)的Alkis Togias博士讓Roche和其他一些健康志愿者吸入一種叫做六甲銨的藥物。Roche剛一吸入就開始咳嗽,并且感覺呼吸急促。幾周之后,她的肺功能減弱,而且腎臟衰竭。六月二號Roche死亡——這起死亡事件完全有可能避免的,這更加重了它的悲劇色彩。上周,聯(lián)邦人類研究保護辦公室(OHRP)作出裁決:霍普金斯大學(xué)對實驗人體的保護體系缺陷太多,所有美國支持的研究項目都必須停止。
最糟糕的是,這種情況并不單單只發(fā)生在作為全國的醫(yī)療機構(gòu)之一的霍普金斯大學(xué)。早在兩年前,健康與人類服務(wù)部監(jiān)察長就曾警告說,保護實驗人體系統(tǒng)有陷于崩潰的危險。負責(zé)審閱那些建議性研究的委員會負荷過重,人手不足,充滿利益沖突。監(jiān)管方面漏洞百出,無人確切知曉到底有多少人自愿象實驗用的豚鼠一樣成為實驗對象(根據(jù)經(jīng)驗作出的猜測大概是每年2,100萬),有多少人受傷,或有多少人死亡?!皵?shù)千起死亡案例從來沒有被公之于眾,好幾萬例不利事件也從未被報道過。”國家人體研究保護咨詢委員會成員,同時又是馬里蘭大學(xué)教授的Adil Shamoo如是說。人類研究保護辦公室主任把臨床試驗體系稱為“功能失?!?。
人類研究保護辦公室在霍普金斯大學(xué)的發(fā)現(xiàn)簡直可以說是令人震驚萬分。上周,經(jīng)過為期三天的檢查之后,人類研究保護辦公室得出如下結(jié)論:霍普金斯大學(xué)的科學(xué)家沒能獲得六甲銨與肺毒性之間存在著聯(lián)系這方面的資料,雖然這些資料可以通過“常規(guī)”因特網(wǎng)搜索和教科書來獲得。這種藥物還未經(jīng)準(zhǔn)許用于人體,而且Togias使用的六甲銨藥品上還標(biāo)注有“只用于實驗室”的字樣。人類研究保護辦公室還指控復(fù)核委員會從未索要有關(guān)人體可吸入的六甲銨的安全用量方面的數(shù)據(jù)。Roche簽署的同意表格里并沒有注明六甲銨藥品未經(jīng)美國食品及藥物管理局批準(zhǔn)使用(表格里只說明它是一種“藥物”),更沒有告知有可能會出現(xiàn)的肺毒性。
霍普金斯大學(xué)自己做出的結(jié)論是復(fù)核委員會沒有盡全力保護好自愿者,并且中止了Togias多達十項的所有研究項目。這所大學(xué)——聯(lián)邦政府授予的高達3.01億美元用于人體研究的撥款使它成為去年接受政府研究資金最多的學(xué)?!F(xiàn)在仍然為此事感到義憤不平?!盎羝战鹚勾髮W(xué)做臨床試驗的歷史長達100多年,” 約翰-霍普金斯醫(yī)學(xué)院執(zhí)行總裁愛德華·米勒博士說,“這么多年來我們只出現(xiàn)了這么一起死亡事故。如果能避免這起死亡事故,讓我們做什么事情我們都愿意。但是,中止研究這樣的作法似乎有些不近情理。” 霍普金斯大學(xué)把中止實驗這種做法稱為“無根據(jù)的、不必要的、阻礙進展的、輕率的”行為。人類研究保護辦公室準(zhǔn)許繼續(xù)進行那些對實驗對象“最為有利的實驗”。至于其它研究,只要霍普金斯大學(xué)提出重組保護研究對象體系的方案,就可以繼續(xù)進行。政府發(fā)言人說,這究竟還需多久,全在于霍普金斯大學(xué)他們自己了。