Today I’m attending the National Medicines Symposium in Canberra. It doesn’t seem like two years since I was here for the last one.
Back then, the most notable speech was made by Rohan Hammet, then the new medical director of the Therapeutic Goods Administration.
He said that the TGA needed to be more pro-active and to start taking a more serious look at drug efficacy and adverse events after drugs are marketed.
And what has happened since then?
Well, not a lot, and Dr Hammet, who is now head of the TGA, has gone very quiet.
No doubt he has been given a good talking to by the industry-friendly establishment at the TGA.
Which is a shame because Australia is one of the few countries that lacks a dedicated drug safety organisation.
Yes, we have the Adverse Drug Reactions Advisory Committee, but its role is limited to the reporting of adverse events.
What we need is a body like Medsafe in New Zealand, whose remit is to go much further and to actively investigate ways of preventing drug-related adverse events.
As Dr Libby Roughead said at the conference yesterday, there is a large dataset of PBS prescription figures going back six years and covering 20 million patients that could be mined for useful drug safety and interaction data. But it is not being done yet because there is no framework to direct such research and there are still problems getting access to this data.
And access to data is an area where the TGA makes ASIO look open and accountable.
Unlike the US and European regulatory agencies the TGA doesn’t readily release data on drug applications or drug safety issues.
One conference attendee said he had given up trying to get data from the TGA and now went directly to the pharma companies, who were much more open and co-operative.
This is strange, because the PBAC - which decides on whether a drug gets a PBS subsidy - is very open about its decision making process.
Why can’t we be as open with drug safety and efficacy data?
Perhaps there’s a clue to this bunker mentality in TGA offices in Canberra, which are stuck out in a paddock and surrounded by fences and a moat.
The TGA is supposed to be conducting a review into transparency at the agency, but you won’t find anything about this on the TGA website.
And if you ask, the agency’s response is that they “can neither confirm nor deny” such a review is taking place.
Which says everything.
Senator Jan McLucas, who now has responsibility for the TGA, should take a leaf from Kevin Rudd’s approach to freedom of information and crack open up the TGA.
Comments
MAXIDEX WARNING
I had eye surgery and in the post-op pack was MAXIDEX(dexamethasone) drops by ALCON LABS.
Two days later I was BLIND
Use Google and enter EPOCRATES MAXIDEX REACTION to verify Posted by WWEL on Sunday, 19 October 2008
