This conversation is closed.
That doctors and the public are misled by unpublished drug trials
I believe this presentation is misleading for the follwoing reason.
I worked in the drug industry for 20 years conducting Phase II and III (Premarketing) trialson new drugs. The data from these trials were submitted to the national drug licensing agencies (e.g. FDA in the USA). It was incumbent upon us to submit ALL data from these trials and serious efforts were made to do so. It is on the basis of these data, NOT the published data, that a drug is given a licence for marketing or not. If a drug comapanyfails to submit all the data it has, it is obviously culpable and may have committed fraud (though given the amount of data, human error is also possible - usually several large trucks were required to carry the volumes of paper to the regulators.)
The problem of publication bias is another problem altogether and it is serious for the reasons Ben Goldacre gives. But it's probably true that most doctors are less 'nerdy' than him and don't feel the need to personally examine all the trial results, being content to leave this task to the agencies set up for the purpose. I ran several nagative trials and was keen to get them published. I provided the results of our analyses to the investigators, they had their own copies of the original data, but few were interested in doing the work necessary to produce a publication because they knew that the chances of a journal accepting it were very low. THis problem was compounded by another factor that Dr Goldacre does not mention. Most of these trials were multicentre studies where many doctors co-operated on the same study protocol in order to obtain sufficient patients to achieve a statistically reliable result. Doctors need publications to pad out their CVs and get ahead in their careers. So, oftentimes, doctors wrote up and published the results obtained in their own small subset of patients, especially if that subset happened to give a positive result in the context of an overall negative study. I couldn't stop this.
Closing Statement from John Collier
Yes, the User fees are a big problem because of the conflict of interest they create. In theory our public servants should be abovethis influence but these days it's hard to have this confidence any more. If I understand correctly, even if the industry pays for the review of its data (and in a way, what's so wrong with that?) the review of the data still rpoceeds independently and there are no penalties that the FDA might be subject to. If that's not so, then there really is a problem which goes right back to the democratic process in the US.
The other comment about not adding anything: if every individual doctor wants to make his or her own assessment of the value or otherwise of a new drug this is individualism gone mad and moreover hints at delusions of grandeur in the doctor. The amount of data and the several different disciplines (not just medicine but pharmacology, toxicology, pharmacy, etc) involved make this a ridiculous idea. Having worked with my fellow physicians I know that there are those who consider themselves to be multidimensionally omnicompetent but most of us would rather delegate this analysis to a team of specialists working in a non-commercial setting e.g. FDA or the Medicines Control Agency. SO, whether or not a drug is approved for marketing should require that all the data on the drug are submitted to the agency that makes the decision not necessarily that they are all published, even though this is a good idea - not that all data are published but perhaps at least the medical trial data. Still this begs a question: what about the toxicology data?