Children as Big Pharma Guinea Pigs兒童作為大型製藥豚鼠
98 Percent of Drug Trials on Children Have no Safety Checks 98 ％的藥物試驗對兒童沒有進行安全檢查
By通過 David Gutierrez朱古鐵雷斯 | Fewer than 2 percent of drug trials conducted on children have independent safety advisory boards, a review published in the journal Acta Paediatrica has found. |少於2 ％的藥物進行的審判對兒童有獨立的安全諮詢委員會，檢討，刊登在雜誌上學報paediatrica發現。
Researchers from Nottingham University reviewed reports on 739 international drug trials that had been published between 1996 and 2002.研究人員從諾丁漢大學的審查報告，關於739國際藥物的審判已出版了1996年至2002年。 They found that although 74 percent of studies described their safety monitoring procedures, less than 2 percent included an independent safety review committee.他們發現，雖然74 ％的研究，描述了他們的安全監測程序，不到2 ％ ，包括一個獨立的安全檢討委員會。
Such committees are composed of independent health experts who can review the study data as it comes out and warn if the drug appears to be placing study participants at risk.這些委員會的組成，獨立的衛生專家誰可以檢討的研究數據，因為它出來，並警告如果藥物似乎是把研究參與者處於危險之中。
“It is invaluable to have an independent monitor who can swiftly question any adverse drug reactions or differences in illness and death rates between groups taking part in the clinical trials,” said lead researcher Helen Sammons. “這是相當珍貴的有一個獨立的監察誰可以迅速的問題，任何藥物不良反應或分歧，在疾病和死亡的利率之間的團體參加，在臨床試驗中，說： ”帶頭研究員海倫sammons 。 “Parents also need to be made aware of the risks of adverse drug reactions when a child takes any medicine so that they can make informed decisions that balance those risks against the possible benefits the drug may provide their child.” “家長也需要作出意識到的風險，藥物不良反應時，兒童需要任何藥物，使他們能作出明智的決定，這種平衡這些風險，對可能的好處的藥物可能會提供他們的孩子” 。
The Nottingham University review also suggests that independent committees lead to more rigorous safety standards.該諾丁漢大學的審查還表明，獨立委員會的導致更嚴格的安全標準。 Of the 13 studies with independent review committees, six were halted early due to highly toxic drug effects.在13研究與獨立的審查委員會， 6人停止早期，由於高毒性藥物的效果。
None of the studies without independent committees were stopped early.沒有研究，沒有獨立委員會被截停早期。
Although the researchers looked only at studies conducted on children, they said the statistics for adult trials are probably similar.雖然研究人員只能在所進行的研究對兒童，他們說，統計為成年的審判很可能是類似的。
“There is general agreement by pediatric health professionals, regulatory authorities and the pharmaceutical industry, as well as politicians and parents, that “人們普遍同意，由兒科保健專業人員，監管當局和製藥業，以及政界人士和家長， drug trials藥物試驗 are essential in order to improve drug therapies,” Sammons said.是必不可少的，以改善藥物療法， “ sammons說。 “We are calling for all pediatric drug trials to include independent safety monitoring committees to ensure that this vital work is carried out in a way that minimizes risks and maximizes benefits for the children taking part.” “我們呼籲所有兒科藥物的審判，包括獨立的安全監察委員會，以確保這項重要的工作是進行了這樣一種方式最大限度地減少風險和利益，最大限度地為孩子們考慮的一部分” 。
Adverse health effects were reported in the majority of drug trials, although not all of them were thought to be related to the drugs.不利健康影響的報告，在大多數藥物的審判，雖然並非所有的，他們被認為與該藥物。 A total of 70 percent of drug trials reviewed reported adverse effects, and 20 percent reported serious adverse effects.共有70 ％的藥物試驗審查報告的不利影響， 20 ％的報導，造成嚴重的不利影響。 Almost 37 percent of drug trials reported side effects attributed to the drugs; 11 percent of trials reported moderate, severe or life-threatening side effects.幾乎37 ％的藥物試驗報告的副作用是由於藥物; 11 ％的審判報導，中度，嚴重或危及生命的副作用。
Adverse effects reported included bleeding, high blood pressure, seizures, psychosis, acute renal failure and suicide.報告的不良反應包括出血，血壓高的壓力，緝獲，精神病，急性腎功能衰竭及自殺案。
Deaths were reported in 11 percent of drug trials, particularly in those involving premature babies.死亡報告，在11 ％的藥物試驗，特別是在那些涉及早產兒。 A total of 56 percent of studies involving newborns involved deaths.共有56 ％的研究，涉及新生兒所涉及的死亡。 Deaths were also reported in trials for drugs meant to treat infectious diseases and problems with the nervous system, respiratory system and kidneys.死亡人數還報告了在審判中對毒品的意思是治療傳染病和問題，與中樞神經系統，呼吸道系統及腎臟。
Most cases of death were not thought to be caused by the drugs.大多數情況下，死亡沒有想過要造成的藥物。
According to Sammons, the practice of conducting clinical drug trials on children is fairly new.據sammons ，實踐進行藥品臨床試驗對兒童是相當新。 In the past, drug companies only conducted safety tests on adults and doctors were left to guess at what drugs would work for children, and in what doses.在過去，製藥公司只進行安全測試，對成年人和醫生留下猜測什麼藥物會的工作，為兒童，及在何種劑量。
Five years ago, the United States began providing longer exclusive drug licenses to pharmaceutical companies that carry out drug trials on children as well as adults.五年前，美國開始提供更長的獨家授權，以藥物的製藥公司進行藥物試驗對兒童以及成人。 In reaction to this incentive, the number of trials including children has increased.在這個反應的誘因，審判數目包括兒童在內的有所增加。 A similar incentive system is about to go into effect in the European Union.類似的獎勵制度即將生效，在歐洲聯盟。
It is important to conduct these trials, Sammons said, to decide if the benefits of drugs outweigh the risks.這是很重要的進行這些試驗， sammons說，以決定是否帶來的好處藥物大於風險。
“We need to test drugs on children, as the only other options are to use unlicensed drugs or prescribe drugs that have been licensed for adults,” Sammons said. “我們需要測試藥物對兒童，作為唯一的其他選擇是使用無牌經營的藥品或處方藥物已領有牌照的成年人， ” sammons說。 “But we feel that the small number of studies that reported having safety monitoring committees was unacceptable.” “但我們認為，極少數的研究報告有安全監測委員會是不可接受的” 。
Have Your Say: Children as Big Pharma Guinea Pigs 你說：兒童作為大型製藥豚鼠
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2 Responses to “Children as Big Pharma Guinea Pigs” 2反應“兒童作為大型製藥幾內亞豬”
Nora 娜拉
Posted: Aug 19th, 2008 at 7:59 pm 發布時間： 2008年8月19日在下午7點59分Ivor Hughes ivor休斯
Posted: Aug 19th, 2008 at 10:10 pm 發布時間： 2008年8月19日在下午10時10分Reply回复 | Quote selected text引用選定的文本 | Link to this鏈接到本A most timely article that deserves to be widely read.一個最及時的文章，值得廣泛閱讀。
“We need to test drugs on children, as the only other options are to use unlicensed drugs or prescribe drugs that have been licensed for adults,” Sammons said. “我們需要測試藥物對兒童，作為唯一的其他選擇是使用無牌經營的藥品或處方藥物已領有牌照的成年人， ” sammons說。 “But we feel that the small number of studies that reported having safety monitoring committees was unacceptable.” “但我們認為，極少數的研究報告有安全監測委員會是不可接受的” 。
Personally what I find unacceptable are Dr Sammons conclusions.個人是什麼，我覺得是不能接受的是博士sammons的結論。 In the first place these synthetic drugs have unpredictable side effects most of which are horrific and many of them documented as causing more disease complications than are solved.擺在首位，這些合成藥物產生無法預料的副作用，其中大部分是可怕的和他們中的許多文件，造成更嚴重的疾病的並發症比解決的。
We already have a number of alternative treatments that work,some of which are very ancient ..我們已經有一些另類療法這項工作，其中一些非常古老的.. in other words the clinical trials were completed aeon’s ago ..在其他換句話說，臨床試驗已經完成永旺的前.. we already know what is safe and what is not.我們已經知道什麼是安全的和什麼是不。 Herbs elicit every known pharmacological response ..中草藥引起每一個已知的藥理反應.. and I suspect many of which we have no knowledge.我猜想，其中有許多我們沒有的知識。
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This study confirms what a lot of people have suspected - that there is not enough monitoring of Big Pharma activity!本研究證實什麼很多人都懷疑-是有沒有足夠的監測大型製藥公司的活動！
thanks for the post!感謝郵政！