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I'm happy to post this or other responses if it seems they're not getting posted at BMJ. Also the story has been tweaked to add my academic credential and also a sentence about academics also being concerned, with a link to BMJ's own coverage of last summer's open letter to Lancet. However, I am...

I didn't see this particular criticism. When did he say that?

helpful to see this all in one place. thanks.

I would interpret it to mean the opposite--the one current in 1998. But the phrase is certainly ambiguous. Anyway, it should be a moot point because the protocol promised to adhere to Helsinki, and when the consent forms were signed the version clearly called for the disclosures. Unfortunately...

MRC Guidelines for Good Clinical Practice in Clinical Trials (1998) 5.4.1 The principles of informed consent in the current revision of the Helsinki Declaration and those laid out in the 13 principles at the beginning of this document should be implemented in all RCTs. That's very...

I agree this is a critical need that I need to pay more attention to going forward, and yes, this current situation has distracted me from getting further along on that topic. I can't speculate about people's motivations--well, I can, but in this case I won't publicly.

It came out of the science integrity (or lack of) hearing. I'm not sure if there was a specific request and I don't know if it came directly from Monaghan--could have been the committee.

The recovery criteria were also not mentioned. So was that tantamount to allowing them to drop them as secondary outcomes? They have described their recovery paper as a "secondary analysis," as if it were a secondary analysis of an existing data set--not a report of secondary outcomes form a...

were their industry ties disclosed in the protocol? I don't remember seeing that in it but the HRA report seems to claim that it was.

I would call their logic and level of integrity to be Trump-like.

yes, and here's the issue with that. At the time, there were no prevailing UK requirements that these links be disclosed--the HRA is right about that. However, I have always made the argument not based on the fact that they didn't disclose but that they violated their own protocol in not...

Maybe. I think their remit really is limited, and the report needs to be read in that light. which no one is doing, of course, especially the ideological brigades.

I don't get the feeling that HRA is concerned with whether REC decisions are based on the proper science. I think they're only interested in whether the appropriate procedures were followed, even if the study is garbage.

Just saw this. I need to request a correction. Anyone have an e-mail for Nigel Hawkes?

I think this is true.

Ha! I didn't mean it as an admonition! I like speculating too!

It's impossible to know. Big "long-form" narrative stories, as this appears to be, can take a very long time. It might be a last editor hadn't seen it, it might be the reporter felt they needed to do some subsequent reporting, it might be that Brexit or other news have pre-occupied everyone...

yes, I'll touch base with Bruce and find out what's up with that. thanks for the suggestion.

you're kind of the suspicious type, I gather...

I am holding out some hope for a better outcome than that. but we will have to wait and see.