对于季节性和流行性感冒，政府在抗病毒方面浪费大量经费作没有任何价值的事情。最近一个医学专家通过对过去未发表临床研究数据分析的结果。

总部设在英国牛津国际循证医学协作组，在4年前提出对抗病毒药达菲治疗效果的质疑，主要起因是过去的分析资料都是立足于公开发表数据。今天，他们发表了一份长达500页的分析报告，主要是针对达菲有关的未发表数据。

不过也有科学家提出，虽然应该鼓励争议，但这个综述忽略了一些新信息，仍不足以导致囤积药物政策的取消。

根据政府报告，英国花费4.24亿英镑，美国花费15亿美圆用于囤积抗病毒药物达菲。4月7日在伦敦一份简报上，国际循证医学协作组代表提出囤积这种抗病毒药物作用有限，政府应该停止这一做法。牛津大学循证医学中心主任，倡导临床研究透明化运动组织AllTrials的发起人之一文章共同作者Carl Heneghan说，这些钱都打了水漂。英国目前正考虑是否再增加5千万英国相关经费，以更换已经过期的药物。

也有的专家认为这一研究结论距离建议取消囤积达菲政策的建议太远。伦敦大学呼吸系统感染中心主任Peter Openshaw说，我们要求更好的临床研究设计和更公开透明没有错，但我们不能忽视过去5年抗病毒药物的效果，贸然将大众生命推向危险境地。

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'Multi-system failure'

At the press briefing, Heneghan and Tom Jefferson, another author of the study, decried a “multi-system failure” in the way the trials had been conducted by drug companies and incompletely reported in journals. Regulatory agencies were neither clear nor transparent about their decisions to approve the drug, they said. “The system is clearly broken,” added Fiona Godlee, editor-in-chief of the BMJ.

The Cochrane analysis found that Tamiflu shaved about half a day off the week that adults typically feel flu symptoms, and just over a day for children. But it said that there is no evidence that the drug prevents hospitalizations or complications of flu such as pneumonia. This contradicts a meta-analysis published in 2003³, which was influential in governments' decisions to begin stockpiling the drug. But the Cochrane review, which also analysed trials of a similar antiviral, Relenza (zanamivir), agrees with the US Food and Drug Administration’s assessment that the drugs have ‘modest’ performance. The trials also showed that Tamiflu slightly raises the risk of problems such as psychiatric disorders and renal dysfunction.

Jonathan Nguyen-Van-Tam, a public-health researcher at the University of Nottingham, UK, says that he does not dispute the findings, but points out that the trials reviewed by Cochrane had studied mainly otherwise healthy people with seasonal flu. Later evidence gathered on Tamiflu’s use in 2009’s H1N1 pandemic suggests that the drug is useful^{4, 5}, he says. For example, a study⁵ that he led found that in hospitalized patients, the drug reduced mortality by one-fifth compared with no treatment, and was especially effective when given within two days of the onset of symptoms. “They have chosen not to consider the many other observational studies,” he says.

But Jefferson says that such studies were not randomized, controlled trials and so should not be used to measure the drugs’ efficacy. And even if it is true that Tamiflu was useful for patients in hospitals, this is not evidence that it should be stockpiled and taken by healthy people in a pandemic, he adds. Moreover, governments should not be pointing to later observational trials to support earlier decisions to stockpile the drug. “They want to rewrite history,” he says.

Further review

Cochrane's definition of relevant evidence in this case has become “increasingly stringent” over the years, says Marc Lipsitch, an epidemiologist at the Harvard School of Public Health in Boston, Massachusetts, and it now excludes most or all non-randomized data. “A wider swath of data, randomized and not, with varying degrees of public scrutiny, should be considered,” he says, and could lead to different choices.

The Cochrane analysis was funded by the UK National Institute for Health Research, after a British parliamentary committee concluded that there was a lack of consensus over how well Tamiflu, which is made by Swiss pharmaceutical company Roche, actually works. A separate group, the Multiparty Group for Advice on Science (MUGAS), is also reviewing the data, and should report later this year. But the Cochrane investigators have raised concerns over the fact that the MUGAS team is funded in part by Roche.

The authors added that the World Health Organization should consider dropping Tamiflu from its list of essential medicines. The organization said in a statement that it would consider the findings.

“We urge people not to trust in published trials alone or in comment from conflicted health decision-makers,” Jefferson said in a statement, “but to view the information for themselves.”

Journal name:

Nature

DOI:

doi:10.1038/nature.2014.15022