tailieunhanh - A Methodology for the Health Sciences - part 10

Tuy nhiên, tiến bộ quan liêu [sic] phải được đánh giá đối với các chi phí thực thế giới trong việc giữ chất này ra khỏi phòng cấp cứu của quốc gia. Các hậu quả cá nhân, xã hội và kinh tế của bệnh tim ở đất nước này là rất lớn | 794 PERSONAL POSTSCRIPT tested against a placebo later citing ethical reasons the researchers dropped the placebo and now all heart patients in the TIMI trial are receiving TPA. It is for these reasons that we call TPA the most noteworthy unavailable drug in the . The FDA may believe it is already moving faster than usual with the manufacturer s new-drug application. Nonetheless bureaucratic progress sic must be measured against the real-world costs of keeping this substance out of the nation s emergency rooms. The personal social and economic consequences of heart disease in this country are immense. The American Heart Association estimates the total costs of providing medical services for all cardiovascular disease at 71 billion annually. By now more than 4 000 patients have been treated with TPA in clinical trials. With well over a thousand Americans going to their deaths each day from heart attack it is hard to see what additional data can justify the government s further delay in making a decision about this drug. If tomorrow s meeting of the FDA s cardio-renal advisory committee only results in more temporizing some in Congress or at the White House should get on the phone and demand that the American public be given a reason for this delay. The publicity before the meeting of the advisory committee was quite unusual since companies are prohibited from preapproval advertising thus the impetus presumably came from other sources. The cardiorenal advisory committee members met and considered the two thrombolytic drugs streptokinase and tPA. They voted to recommend approval of streptokinase but felt that further data were needed before tPA could be approved. The reactions to the decision were extreme but probably predictable given the positions expressed prior to the meeting. The Wall Street Journal responded with an editorial on Tuesday June 2 1987 entitled Human Sacrifice. It follows in its entirety Last Friday an advisory panel of the Food and Drug .

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