Revised Recommendations for Reducing the Risk of Human
Immunodeficiency Virus Transmission by Blood and Blood Products
http://tinyurl.com/zf4zdcb
http://www.fda.gov/downloads/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/Guidance/Blood/UCM446580.pdf
※ 引述《RayBoku (一任階前點滴到天明)》之銘言：
: 然根據美國食品藥物管理局去年公布的《減少血品傳播人類免疫缺乏病毒之修正建議》，
: 其中承認：禁止男性間性行為者捐血是一種歧視；而隨著醫療進步，此防堵策略的好處也
原文是 the indefinite policy is perceived by some as discriminatory
有些人覺得和FDA認為好像是兩回事...
1.MSM危險性多高?
原文第4頁
MSM ... a small percentage of... U.S. male...(approximately 7% of men ...
ever...MSM, approximately 4% ...MSM activity...in...last 5 years)
Among persons...with HIV...2012, ...56% were MSM.
In 2010, majority of new HIV attributed to male-to-male sexual...
63% among all adults and 78% among men,
新HIV感染者中MSM過半,但MSM只佔人口7%,估計危險性應該遠遠遠高於多重異性伴侶者?
2.美國MSM捐血者有效自我篩選
第6頁
prevalence...HIV infection in male blood donors...reported...MSM...0.25%,
...much lower than...11-12% HIV prevalence in ...regular MSM behavior
This indicates...considerable self-selection likely took place in individuals
who presented to donate.
3.澳洲比較從終身改成1年限制前後5年資料
第6頁
During the five years before and five years after a change from a lifetime
deferral to a one-year deferral in Australia, there was no change in
risk to the blood supply, defined by the number of HIV positive donations
per year and the proportion of HIV-positive donors with male-to-male sex
as a risk factor.
https://www.ncbi.nlm.nih.gov/pubmed/20663106
The proportion of HIV-positive donors with male-to-male sex as a risk factor
in Period 1 was 2 in 15 (13.3%), which was not significantly different from
the proportion in Period 2, 5 in 16 (31.25%; p=0.22).
從13.3%變成31.2%,然後說統計上沒有顯著差異...
要是一個新糖尿病藥物做個100人trial然後發現兩組沒統計差異,FDA會放他過嗎?
從那個數字來看odds ratio(OR)=(5/11)/(2/13)=2.95, RR=(5/16)/(2/15)=2.34
不管是OR還是RR都遠大於1.3,不可能通過non-inferiority標準
(至少要落在1.3以下才有可能通過1.3的non-inferiority ratio檢定)
所以如果美國用這個數據來說一定不會增加基本上是錯誤的,只能說沒證據顯示會增加
話說回來,所謂實證的舉證責任到底該歸於哪一方?
是要由贊成終生禁止者來證明只禁止1年會增加風險才該繼續禁止?
還是由反對終生禁止者來做non-inferiority trial來證明絕對不會增加風險才能解禁?
美國FDA在糖尿病藥物上是要求藥商負舉證責任做心血管風險trial來證明
之前的食安事件多數人也會選擇讓食品商負舉證責任,而非沒實證證明有害就放行...
而不同文化因素也可能影響結果,美國MSM有效自我選擇才沒有釀成大禍,
若放在酒駕盛行的台灣島上,不知結果是否還能一樣?
當然還有一種方法就是做完整"血品履歷",然後健保卡中加一格血品傾向欄位,
願意接受各種高風險捐血者的受血人填書面意願書給健保署登錄,
然後當需要輸血時,這些人優先使用其選定的高風險族群血品使用...