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LC1

Cochrane cwtching up to Big Pharma

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http://www.sciencemag.org/news/2018/09/evidence-based-medicine-group-turmoil-after-expulsion-co-founder

Cochrane expels co-founder with inconvenient scruples. 

A previous BMJ editor famously described medical journals as part of the advertising wing of pharma companies, and I guess Cochrane (formerly the Cochrane Collaboration!) is going the same way...

Shame. Old Archie must be rolling in his grave.

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It is a shame. The regulators could demand that CSRs are published or at least the adverse events tables. Its not really the fault of pharma that you cant fit that in a journal but they should be available from the FDA/EMA.

Data transparency is improving but you can only get access to the raw trial data as a researcher. Vaccines are a tricky area as the safety side effects are so rare and can be hard to prove causal relationship. 

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1 minute ago, maudit said:

Vaccines are a tricky area as the safety side effects are so rare and can be hard to prove causal relationship. 

Yes, I can see that there are judgements to be made and it isn't always clear cut, but the reporting of harms and transparency of data surely has to be improved? I think that is basically what he was saying, but that made him a troublemaker and so he had to go, by the looks of it!

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8 minutes ago, LC1 said:

Yes, I can see that there are judgements to be made and it isn't always clear cut, but the reporting of harms and transparency of data surely has to be improved? I think that is basically what he was saying, but that made him a troublemaker and so he had to go, by the looks of it!

The reporting of the harms is fine in the CSR as we have to report the AEs and SAEs in detail the problem is this getting published. And he raised a good point about the use of the alu adjuvent as the placebo as if this is causing the harm by using it as placebo you can't see that. I'm surprised that was allowed in all these trials over a saline placebo; I suppose the thinking was they are standard in other vaccines. 

This is where estimands come in. By using the alu as placebo none of the trials actually answered the Q vaccine vs no vaccine. Insted they were estimating trt policy effect of alu adj + hpv vs alu adj alone. 

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