Re: Biotech’s – Full Disclosure can take weeks if not months
in response to
by
posted on
Nov 13, 2019 08:52AM
With reference your para 5, as a former clinical investigator, I can say that the reason for DM witholding the data is none of the three possibilities you listed. When companies want to do a clinical trial, they need the enthusiastic involvement of academics - to help design the trial, set it up, conduct it, analyse and interpret the data, etc. For those investigators it is not a commercial exercise. It is academic medical research, no different from doing studies of cell metabolism in the lab, transgenic mice, or whatever. They are in it because it is their job to help make medical progress, and that is what drives them. They have no financial interest other than perhaps in some cases as a consultant. It is not a simple fee-for-service arrangement. The company covers the costs of the trial (paid to the university) but usually no more than that.
Accordingly, the investigators (and their universities) expect that the company will permit them to present and discuss the data at professional meetings and report them in journals. In most if not all cases there will be a contractual agreement between the company and the investigators concerning all these matters before the trial starts.
So RVX has no choice. It has to allow the investigators to present the data at congresses, even if it means waiting weeks or months. The investigators write the abstract and submit it from their universities, and they in turn have to comply with the rules set by the AHA and other professional associations that organise the meetings. These are the rules of the game, and everyone involved understands that.
We need also to remember that the purpose of presenting clinical trial data at congresses is not merely to make an announcement or for publicity purposes. It is not comparable to a press conference. The purpose two-fold: for the results to be made available to a wide audience, yes, but also (and more importantly) for them to be assessed, interpreted, critiqued, and discussed objectively by hundreds or thousands of independent experts.