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 (一任阶前点滴到天明)》之铭言：
: 然根据美国食品药物管理局去年公布的《减少血品传播人类免疫缺乏病毒之修正建议》，
: 其中承认：禁止男性间性行为者捐血是一种歧视；而随着医疗进步，此防堵策略的好处也
原文是 the indefinite policy is perceived by some as discriminatory
有些人觉得和FDA认为好像是两回事...
1.MSM危险性多高?
原文第4页
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过半,但MSM只占人口7%,估计危险性应该远远远高于多重异性伴侣者?
2.美国MSM捐血者有效自我筛选
第6页
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.澳洲比较从终身改成1年限制前后5年资料
第6页
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).
从13.3%变成31.2%,然后说统计上没有显著差异...
要是一个新糖尿病药物做个100人trial然后发现两组没统计差异,FDA会放他过吗?
从那个数字来看odds ratio(OR)=(5/11)/(2/13)=2.95, RR=(5/16)/(2/15)=2.34
不管是OR还是RR都远大于1.3,不可能通过non-inferiority标准
(至少要落在1.3以下才有可能通过1.3的non-inferiority ratio检定)
所以如果美国用这个数据来说一定不会增加基本上是错误的,只能说没证据显示会增加
话说回来,所谓实证的举证责任到底该归于哪一方?
是要由赞成终生禁止者来证明只禁止1年会增加风险才该继续禁止?
还是由反对终生禁止者来做non-inferiority trial来证明绝对不会增加风险才能解禁?
美国FDA在糖尿病药物上是要求药商负举证责任做心血管风险trial来证明
之前的食安事件多数人也会选择让食品商负举证责任,而非没实证证明有害就放行...
而不同文化因素也可能影响结果,美国MSM有效自我选择才没有酿成大祸,
若放在酒驾盛行的台湾岛上,不知结果是否还能一样?
当然还有一种方法就是做完整"血品履历",然后健保卡中加一格血品倾向字段,
愿意接受各种高风险捐血者的受血人填书面意愿书给健保署登录,
然后当需要输血时,这些人优先使用其选定的高风险族群血品使用...