The last post ended on this note:
Over 18 months ago, RxISK attempted to open up a debate on the ambiguities and conflicts at its heart. Doing what it does, could it operate as a business in the marketplace or should it be a Foundation or an Occupy your Doctors’ Office movement?
It seems clear that although legally obliged to access any adverse event data they are aware of, pharmaceutical companies seem unlikely to endorse RxISK in the way they have endorsed AllTrials. They seem to be pushing us toward finding something more co-operative – perhaps something that is not out there yet – perhaps something that David Graeber or Thomas Piketty might have views on.
Over the next few weeks on RxISK, we will be featuring a series of just published articles based on RxISK data – one on what is now a Ninety-Nine + case series of SSRI induced Alcoholism. A second on what is an over one hundred and twenty case series of persisting sexual dysfunction following SSRIs, isotretinoin or finasteride. The Third will be on a novel ethical dilemma linked to reports of QT-interval changes.
There are several hundred cases embodied in these articles covering most antidepressants and a number of other drugs. Companies who are interested in the safety of their drugs, or companies simply keeping to the letter of the pharmacovigilance law should be contacting us to enquire further whether their drug was involved , as might also the companies gearing up to market S-3 antagonists for alcoholism. How do we deal with this? Who pays for the work involved in establishing which version of paroxetine was involved?
Quite possibly. Industry can capture almost anything – they may have captured AllTrials. They are making great efforts to capture, defang or otherwise manage patient adverse event reporting systems. GSK’s ability to hide clinical trial data pales compared to the subtlety of their approach to and lengths to which they appear to go to block or otherwise hide adverse event reporting – See American Woman, American Woman2.
The main tool to move things forward is the RxISK report. When some anomalous event happens on the street, its axiomatic that the police get as many eye-witnesses as they can. In clinical practice this means you don’t want to leave reporting to hurried and disengaged doctors and you definitely don’t want to leave it to pharmaceutical companies for whom collecting details on a case is all about collecting excuses to rule out an effect of their drug.
It makes much more sense if a doctor or pharmacist or nurse comes to an agreed account with the person affected who has usually spent time with the problem and is motivated to nail down what is going on.
Its about medicine as it needs to be if its going to survive. Leaving reporting to doctors alone has not worked – at present only 1% of adverse events are reported. The question is whether doctors have what it takes to save themselves by insisting on the evidence of their own eyes and reporting adverse events. Saving themselves will do more to save their patients than anything else could.