在1998年至2013年进行的至少57项临床试验中，美国食品和药物管理局发现了造假的证据、报告副作用的问题、记录保存不足等等。但在今天的报告所监测的78份出版物中，只有3份提到了检查中发现的不当行为。出版后未添加任何更正、撤回或其他评论。今天这份报告的作者将这一失误归咎于“监管俘虏”，或者说是一种**，即公共机构保护的是它本应监管的群体的利益，而不是广大公众的利益。

这种不当行为并不奇怪；fda的沉默是违反研究方案-研究人员没有遵循他们所说的方法-是最常见的，发生在四分之三的试验，根据今天的报告在JAMA内科。而且许多患者在同意接受研究之前没有得到适当的通知，或者他们参与的试验在一半以上的研究中缺乏监督。三分之二的试验记录保存不充分或错误。同样常见的是：伪造或提交虚假信息，这在39%的审判中发生。在四分之一的试验中，报告不良事件时出现了问题，即试验组或对照组中可能出现的严重副作用健康问题。

研究报告作者、纽约大学新闻学教授查尔斯·塞夫（Charles Seife）写道，这种不当行为本身并不令人惊讶。不过，他说的话令人惊讶：

When the FDA finds scientific fraud or misconduct, the agency doesn’t notify the public, the medical establishment, or even the scientific community that the results of a medical experiment are not to be trusted. On the contrary. For more than a decade, the FDA has shown a pattern of burying the details of misconduct. As a result, nobody ever finds out which data is bogus, which experiments are tainted, and which drugs might be on the market under false pretenses. The FDA has repeatedly hidden evidence of scientific fraud not just from the public, but also from its most trusted scientific advisers, even as they were deciding whether or not a new drug should be allowed on the market. Even a congressional panel investigating a case of fraud regarding a dangerous drug couldn't get forthright answers. For an agency devoted to protecting the public from bogus medical science, the FDA seems to be spending an awful lot of effort protecting the perpetrators of bogus science from the public.

在一个病例中，伪造的数据导致病人死亡。在一个比较化疗方案的试验中，至少有一个病例，伪造的数据导致病人死亡。在另一项对26名患者进行干细胞治疗的试验中，所有患者的病情都有所好转，尽管其中一名患者在接受治疗两周后不得不截肢一只脚。在另一个案例中，FDA认为整个临床试验不可靠，这在出版物中没有提到。

这意味着病人和医生被保护他们的机构忽视了。Seife的文章及其附带的社论都建议FDA的检查报告应该附在Clinicaltrials.gov数据库中，这样任何人都可以找到它们。

FDA告诉路透社，它“致力于提高合规和执法活动的透明度，目的是提高公众对FDA决定的理解，促进FDA的问责制，以及促进受监管行业对持续安全和高质量产品需求的理解。”

Seife对FDA表示失望，他为Slate写的文章值得全文阅读：

The sworn purpose of the FDA is to protect the public health, to assure us that all the drugs on the market are proven safe and effective by reputable scientific trials. Yet, over and over again, the agency has proven itself willing to keep scientists, doctors, and the public in the dark about incidents when those scientific trials turn out to be less than reputable. It does so not only by passive silence, but by active deception. And despite being called out numerous times over the years for its bad behavior, including from some very pissed-off members of Congress, the agency is stubbornly resistant to change. It’s a sign that the FDA is deeply captured, drawn firmly into the orbit of the pharmaceutical industry that it’s supposed to regulate. We can no longer hope that the situation will get better without firm action from the legislature.