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2009/09/16 13:06:17瀏覽1049|回應1|推薦4 | |
紐約時報最近一陣子,針對癌症治療陸續發表了許多文章,並且把他們集結成專輯:Forty Years' War - the Gatekeeper。過去四十年來,人類集合了最頂尖的智慧,試圖擊垮這個生命最頑強的「敵人」。但是耗費鉅資的結果,癌症的致命率仍然是節節升高。美國估計光今年就將會有超過五十六萬人因癌症而走。 雖然如此,但是有鑑於各種暢銷專利藥的保護期限紛紛到期,各大藥廠均集中火力,希望開發出抗癌的新藥。原因無他,得癌的人越來越多。希望能在癌症陰影下逃出生天的患者和家屬們,願意付出龐大代價以謀得一線生機。報紙寫到: Pharmaceutical and biotechnology companies are testing more than 860 new cancer medicines — more than in any other disease category, according to manufacturers. Because patients are desperate and insurers are often forced by law to pay, prices are soaring, making cancer medicines among the best ways for drug makers to make money. But cancer has proven difficult to crack, leading to frustration among executives and advocates who wonder why the Food and Drug Administration is not approving more drugs. 現在各間藥廠正在申請測試的藥物就高達860種以上。這些藥物未必都是仙丹妙藥,但是只要能給病患一絲希望,再貴(據報導某種已經核准的抗癌藥物,大概平均只能延長患者幾週的生命,但是一個月需要一萬美金以上的藥價)也有人捧著錢上門求藥。這也是促成藥廠不管實效如何,卯起來也要搞癌症新藥的主要動力。對美國食品藥物管理局(FDA)的癌症新藥中心來說,不管實效如何,就率爾批准新藥,會被批評降低標準,讓貴而無效的新藥浮濫上市;但是太過嚴苛的審核標準,也讓嗷嗷待治的病患及家屬們痛批FDA草菅人命。 有鑑於社會過高的期待所產生的壓力,美國FDA對癌症的審核標準其實已經十分寬鬆了。Federal law requires that the agency demand two “well controlled” trials before approving a drug; in cancer, the Food and Drug Administration is often satisfied with just one. With many experimental drugs, the agency demands trials with thousands of patients, while for cancer, it has accepted studies with a few dozen. 其他新藥需要進行兩組控制實驗的,到了癌症藥物時,只要求進行一組實驗。其他新藥測試樣本需要到上千名患者的,到了癌症新藥只要求對幾十個患者測試。但即使標準放得如此寬鬆,能真正對患者產生效果的藥物仍然是鳳毛麟角! 另外一段趣聞或許可以給讀者們一點「啟發」。現在FDA負責審核癌症藥物上市的主管是波蘭裔移民Dr. Pazdur,他個人相信「吃素」可以幫助他避免得到癌症,所以他老婆只能趁他出差時,買一塊牛排大快朵頤。至於「吃素」是不是真的能降低罹癌的風險,以下這段話可以博君一笑: An avid gym cyclist who is greyhound thin, Dr. Pazdur does not eat meat because he believes that a vegetarian diet will help protect him from cancer, although the supporting evidence is as thin as vegetable broth. His wife, Mary, said that when he travels, she buys herself a nice steak. |
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