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Dear Juan, Colleagues, 10+ y ago in the Cochrane Collaboration (it was not yet Corporation Cochrane) there was a discussion, connecteв to the famous breast ca screening review, as I remember, on the necessity to have the content specialist in the review group. The outcome was: desirable, but not necessary, because the strict application of the Cochrane methods assures the appropriate result. I believe that the mentioned review is an extreme example of how the accurate (more or less) application of Cochrane methods led to the outrageous outcome. Probably it may be different in the presence of the content specialist in the group (was (s)he in it?). Different not because of the results of the review, but because of the straightforward authors' conclusion. Virus is a cause of the this disease and unpleasant consequences of the chronic infection depends from the presence of virus. This is simple and probably safe to presume that absence of (this) virus is a solution for the late complications. Is it desirable to have longer trials with mortality/cancer incidence outcome? Yes. Is it reasonable to require the longer trials (about 5+ years long, I think) and postpone the marketing authorization? No. This case looks different from the notorious HPV vaccine, isnt it? Vasya On 2017-07-02 17:31, Manitoba Hunter wrote: > > Thanks Juan. Where’s Donald Trump’s tweets when you need them to > respond to the EASL’s letter… FAKE NEWS! No sources! Sponsored by > industry… > > What’s unfortunately not funny is that the authors of the letter are > so ridiculously short-sighted, and show a lack of understanding of why > long-term outcomes are important. Their statement “A meta-analysis > should only evaluate the primary endpoint selected by the clinical > studies. The trials were not designed or powered to capture long-term > outcomes such as hepatitis C-related morbidity or all-cause mortality, > but to establish whether infection, reflected by persistent viremia, > could be safely and effectively terminated.” So using their logic… > since drug companies that make DAAs (in their infinite wisdom) have > decided not to do long-term trials to show that they work, so > therefore we just have to believe that the surrogate outcomes are > enough evidence and start spending billions on these drugs from > national budget. Remind anyone of the influenza vaccine debacle. > > *From:*Evidence based health (EBH) > [mailto:[log in to unmask]] *On Behalf Of *Juan Gérvas > *Sent:* Friday, June 30, 2017 4:41 AM > *To:* [log in to unmask] > *Subject:* EBM and hepatitis C > > Systematic review. Cochrane. > Overall, DAAs (direct-acting antivirals) on the market or under > development do not seem to have any effects on risk of serious adverse > events. Simeprevir may have beneficial effects on risk of serious > adverse event. In all remaining analyses, we could neither confirm nor > reject that DAAs had any clinical effects. DAAs seemed to reduce the > risk of no sustained virological response. _The clinical relevance of > the effects of DAAs on no sustained virological response is > questionable, as it is a non-validated surrogate outcome. All trials > and outcome results were at high risk of bias, so our results > presumably overestimate benefit and underestimate harm. The quality of > the evidence was very low. > _http://onlinelibrary.wiley.com/doi/10.1002/14651858.CD012143.pub2/full > > -in line with: > http://hcrenewal.blogspot.com.es/search/label/Sovaldi > http://www.bmj.com/content/350/bmj.g7809 > http://hcrenewal.blogspot.com/2014/04/knee-deep-in-hoopla-triumph-of-medical.html > http://hcrenewal.blogspot.com/search/label/Sovaldi > -interesting also to see the "experts" opinion > Crítica a la revisión Cochrane sobre los antivirales en la hepatitis > C. European Association for the Study of the Liver. > *Serious concerns after the recent publication of a Cochrane Review > “Direct acting antivirals for chronic hepatitis C”.* > http://www.journal-of-hepatology.eu/pb/assets/raw/Health%20Advance/journals/jhepat/CochraneEASLJMP003.pdf > > -un saludo juan gérvas @JuanGrvas > > > -- \/.\/.\/. Vasiliy V. Vlassov, MD Professor, National Research University Higher School of Economics e-mail: vlassov[a t]cochrane.ru snail mail: P.O.Box 13 Moscow 109451 Russia Phone Russia +7(965)2511021 Подпишись на новости на osdm.org