对于2021年美国预防服务工作组 (USPSTF) 乳腺癌筛查指南计划的意见
USPSTF筛查指南历史
1. 2005年，USPSTF支持对40岁及以上所有女性进行年度筛查(1)。
2. 2009年，USPSTF放弃对40-49岁女性进行筛查的支持，并建议每两年对50-74岁女性进行筛查(2)。
3. 尽管USPSTF承认从40岁开始乳腺癌筛查可挽救最多生命，但2016年版的仍然建议每两年对50-74岁的女性进行筛查(3)。他们承认“USPSTF发现足够的证据表明，乳腺X射线摄影筛查可以降低40至74岁女性的乳腺癌死亡率”(4)。
4. 显然，现在USPSTF再次准备审查其乳腺癌筛查指南。
回避专家的建议
最近的COVID-19病毒大流行展示出：在伪专家指导下，忽视科学，忽视证据和忽视专家分析和建议，导致的悲剧性恶果。为了避免所谓的有利益冲突成员的偏见，USPSTF禁止在乳腺癌筛查和相关问题上具有实际专业知识的任何人在工作组服务。因此，USPSTF成员没有能力严格地对现有数据进行分析，也无法真正理解所审查的资料，鉴别其是否具备有效性。
这也使所谓的“顾问们”发挥了非凡的影响力，“指导”了一个经验和事实上不成熟的专家组。在过去，USPSTF审查乳腺癌筛查的所谓“顾问”，绝大部分是曾表示反对筛查的人，他们对工作组产生了严重的影响。很多顾问被视为没有利益冲突，然而事实并非如此。如果没有明显的“利益冲突“，一个人就不可能具备某领域的专业性。乳腺癌专家，例如我自己，是以乳腺癌筛查行业谋生的，具有明显的且公开的利益冲突。然而，那些已经获得，并持续获得研究资助的顾问们却被视为没有利益冲突。实际上，他们的利益冲突只是很不明显。美国国家癌症研究所（NCI）在内的资助机构和基金会，都有其未宣布的偏见。当被资助人的工作支持资助人偏见时，资助很可能会持续获得。与公开的利益冲突相比，这些研究经费和基金会支持是更为阴险的利益冲突。
排斥专家的做法应该停止。涉及的利益冲突的人应该详细公开，但不应该被排斥；专家对于准确分析数据以提供最真实和基于证据的建议至关重要。指南制订组（包括USPSTF）应让顶级专家参与其决策，并且如果存在无法解决的分歧，应向公众提供“少数派”报告。
事实：
1. 乳腺癌筛查的随机对照试验（RCT）证明，筛查和早期发现乳腺癌可以降低40-74岁（参与试验的女性年龄）的死亡率(5)。1993年，由于不正确地使用亚组分析(6)，NCI错误地声称筛查对40-49岁的女性没有好处，这造成了混乱。1993年NCI声明忽略了一个事实：定期筛查不能立即体现出收益(7)。NCI的此立场被后来时间更长的随访结果所驳斥(8)：对40-49岁的女性进行筛查具有显著的益处。因此乳腺癌筛查对40-74岁的所有女性（RCT的目标平均人群）都有好处。尽管有人说这些试验为时已久，但它们提供了基本证据：早发现可以减少死亡。
2. 由于“不合规”和“污染”，这些RCT实际上低估了早期发现的益处，其结果应视为可能获益的估值低端。
3. USPSTF应该意识到，由于参与者的社会经济因素明显不平衡，RCT不再引用爱丁堡试验。
4. 加拿大全国乳腺癌筛查研究（CNBSS）也应该在几年前从指南分析中删除。他们的结果不仅是RCT中的主要异常值，而且这些年来，许多重要的分析都对其有效性提出了质疑(9-23)。试验受到低质量乳腺X射线摄影(24, 25)的损害，并且它们采用的非盲分配流程违反了RCT的基本要求(26, 27)：这导致统计学上显著过量的晚期癌症女性被分配到CNBSS1筛查组(28, 29)。据称，CNBSS试验显示出22％的重大“过度诊断率”。而事实上，他们自己的数据显示，两组之间被诊断出的癌症仅有4％的差异(30)。CNBSS结果受到损害且不可靠，因此不应纳入USPSTF审查(31)。
5. 大量观察性研究证实，筛查从40岁开始在普通人群中筛查女性的益处，使死亡人数减少超过40％(32-49)。
6. 在对瑞典超过500,000名女性的死亡率回顾研究中，治疗的改善带来了一些益处；但参加乳腺X射线摄影筛查人群，在10年内，比未参与筛查人群的乳腺癌死亡风险降低了41％(50)。
7. 没有数据（零数据）显示乳腺癌筛查任何参数在50岁或任何其他年龄(51)会有突变。RCT证明的是：筛查可以降低40-74岁女性的死亡率。在没有科学支持的情况下，决定50岁开始筛查完全是任意的。将数据分组和平均来定义“法定阈值”是错误做法，数据没有显示存在这个分界。使用50岁作为“法定阈值”的唯一原因是基于分析人的偏见、科学上不支持的偏见。实际上，包括USPSTF在内的所有主要团体都同意：从40岁开始每年进行筛查可以挽救最多的生命。与50-59岁女性相比，40-49岁女性因乳腺癌丧生的时间更长(52)。
8. 乳腺X射线摄影（几乎没有影响任何其它人体易感器官）对乳房的放射风险随着年龄的增长而迅速下降。因此到40岁时，此风险是无法测量的，或者可能根本不存在。即使数据外推的风险也远低于筛查带来的最小收益(53,54)。
9. NCI/CISNET所有的模型预测都显示：从40岁开始，每年进行乳腺癌筛查可以挽救最多的生命(55)。
10. 尽管有很多相反的论点，但已经证明筛查可以降低晚期癌症的发生率（见下文）(56-67)。因为这些癌症是无法治愈的，因此被用作死亡率分析的替代。
11. 在哈佛大学医院中，尽管有现代治疗方法，71％的乳腺癌死亡发生在未参加乳腺癌筛查的20％女性中(68)。Spencer等人的研究显示相似结果(69)。
12. 声称RCT并未降低“全因死亡率”的说法是错误的(70)。只有在所有人都患有乳腺癌且大多数死因归于乳腺癌的治疗试验中，“全因死亡率”才是适合的。你需要确定该治疗不会引起不可预见的风险：比如放射治疗试验中，这揭示了放射治疗损害冠状动脉的意外风险。然而，在筛查试验中，大多数死亡将归因于其他原因，因为乳腺癌每年仅占“所有原因”死亡的3％。如果将乳腺癌的死亡率降低30％，那么这将使“全因死亡率”降低1％。如果要显示乳腺癌死亡人数的下降显著降低了“全因死亡率”，那么需要250万女性参与这个试验。在RCT中观察已经患有乳腺癌女性的“全因死亡率”会更合适，这确实表明筛查降低了“全因死亡率”(71)。
13. CISNET模型显示：30多岁的女性中，如果等到50岁才开始2年一次的筛查，那么约100,000女性会死于乳腺癌；而如果40岁开始每年筛查，这些生命可以被挽救 (72)。40岁女性中，如果等到50岁才每两年进行筛查，将会有13,770人死于乳腺癌；而如果40岁开始每年筛查，这些生命可以被挽救(73)。
14. 有关“乳腺X射线摄影筛查造成大量过度诊断”的说法是靠“猜测”制造出来的：即随着筛查进行，乳腺癌的发病率没有显示稳定增长。按照这个逻辑，由于从未见过在乳腺X射线摄影检查中发现的浸润性乳腺癌会自行消失（即使这样的“奇迹”极少，也会在临床上明显地被关注），且Arleo等人研究表明，近250种浸润性癌症未经治疗也都不会消失(74)，那么等到50岁再进行每两年一次筛查也不会减少“过度诊断”（即使“过度诊断”真的存在的话），因为那些癌症仍然存在着。
15. 延迟筛查年龄将会降低筛查召回数量（有时“筛查召回”被不正确地称为“假阳性”）。筛查召回案例需要一些额外的乳腺X射线摄影影像，或超声检查。乳腺癌筛查召回率约为10％（大约与宫颈癌的Pap-检测的召回率相同），并且使用局部麻醉进行影像引导的穿刺活检的可能性很小，而活检病理发现癌症的几率很高。实际上，接受筛查的女性中大约有2-4％会进行影像引导的穿刺活检，活检案例中20-40％发现是恶性的。
毫无疑问，筛查召回使我们所有人都感到焦虑，但是对于大多数人来说，焦虑是短暂的(75)。鉴于筛查的主要“危害”（“危害”是贬义词，应称之为“风险”）是被召回的焦虑，但难道为了避免筛查召回的焦虑，宁可劝其死于本可避免之事吗！！？
16. 最后，有人建议：只有40-49岁的高危女性才能参加筛查。尽管高风险女性的风险要比平均人群风险高，但尚无RCT数据证明仅筛查高风险女性可以挽救生命。RCT试验没有根据风险分层，因此鉴于RCT是“证明”收益的唯一途径，没有“证据”表明仅筛查高危女性可以挽救生命。此外，每年高风险女性仅占诊断出乳腺癌的所有女性的25％，因此仅筛查高风险女性将排除75％患乳腺癌的女性(76, 77)。目前只能说所有女性都处于风险之中，应鼓励她们参加筛查。根据CISNET模型（尚无RCT比较筛查间隔），年度筛查可最大程度地减少死亡率。应鼓励所有40-74岁的女性每年接受筛查。高危女性，有可能会在每年乳腺X射线摄影筛查之外，加做MRI或超声检查中受益，但是，这个做法实际上也无临床证实。
USPSTF 2021审查计划中存在的问题
1. 工作组并未将NCI /CISNET模型纳入来预测各种筛选方案的潜在结果。没有这些，工作组将无法做出预测。现在看来，CISNET建模似乎已被工作组排除，因为所有模型都表明，从40岁开始每年进行筛查可以挽救最多的生命。
2. 虽然检测到晚期癌症的减少可能是有用的“替代终点”，但必须谨记：这里所有乳腺癌阶段中被诊断出的女性都丧生了(78)。已经表明，在同级癌症中，检测到癌症尺寸的减少也是筛查降低死亡率的主要好处（79-81）。
3. 一个极为重要的事实，反复被分析忽略，并错误地得出“筛查导致大量过度诊断”，且用来贬低筛查的价值，就是错误的声称“背景乳腺癌发病率没有随时间增加”。这一直是错误信息的根基，并且依此推崇“大量过度诊断”的错误概念，和“没有减少晚期癌症”的错误声明。
数据清楚地表明，至少从1940年开始，乳腺癌的基线发病率每年稳定增长1-1.3％(82)，这远早于1980年代中期才开始的筛查。如果使用正确的递增基线，不仅不会明显地发现浸润性癌的“过度诊断”，而且看来浸润性癌的发生率已经大大降低了(83)。尽管未经证实，但这很可能是由于去除了导管原位癌（病变几乎完全由乳腺X射线摄影发现），从而排除了未来发展为浸润性癌。通过使用正确的基线发病率和外推法，很明显晚期癌症的发生率也已大大降低。
结论
1. USPSTF应包括乳腺癌筛查专家。
2. USPSTF应该为女性提供基于科学和证据的事实。
3. USPSTF指南不应基于工作组成员的偏见和主观意见
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