European Agency Should Release Side Effect Reports
8 CommentsBy Ed Silverman // May 11th, 2010 // 7:42 am
The European Medicines Agency (EMEA) recently refused to release documents containing suspected adverse reactions caused by Accutane (which is called Roaccutane in the UK), after a law firm in two years ago Ireland requested info that dated back to 1992. At issue were reports linking the acne drug to suicidal tendencies, a topic that has been the subject of controversy and litigation for years (see here).
And so European Ombudsman Nikiforos Diamandouros yesterday vigorously disagreed with the EMEA argument that transparency rules do not apply to these reports. “EMEA plays a crucial role in the approval and monitoring of medicines placed on the market,” he said in a statement. “Since its work has a direct impact on the health of European citizens, it is of utmost importance for EMEA to give the widest possible access to documents and also to pursue a pro-active information policy for the benefit of citizens.”
The EMEA had argued that EU transparency rules don’t apply to suspected serious adverse reaction reports and their release wouldn’t benefit citizens because circulating such data could be misleading or unreliable. Diamandorous agreed that such reports don’t have to be automatically available, but exceptions may be warranted. And he suggested that the EMEA could provide additional explanations designed to make the data and their significance “more readily understandable by the public” (this is the complete background on the case and his decision).
Having been put on the defensive, the EMEA issued a response saying that agency has since launched “a number of major initiatives to increase transparency of its operations, including public consultations on: an access policy regarding data on adverse drug reactions held in EudraVigilance, the European Union database on adverse drug reactions; the agency’s policy on access to documents (read the draft); and a new transparency policy setting out the agency’s vision on its level of openness towards its stakeholders (read the policy).”
In addition, since December 2009 the agency has been proactively publishing regular information about the safety of pandemic vaccines. The experience gained in this pilot project will be taken into account in the finalization of the agency’s transparency initiatives, which are currently under review, the EMEA continued. In closing, the EMEA plans to respond to Diamandouros by July 31.
Salient point
This post has been up almost 2 hours without anyone commenting on it. Something tells me that if it were about FDA, there’d be almost a dozen comments by now, most of them beginning “Only in the US,” “Our government protects big pharma,” etc.
Funny how when European regulatory is involved, no one has anything to say.
harpy
so, you’re bitching about how people aren’t bitching about something? that’s constructive.
epatientgr
Comments may not flow in because those concerned have not yet noticed it and patients using it may not even heard of adverse effects. Wait and see..
patrons99
I’ve been following the risk benefit ratio of accutane fairly closely and I must say that it’s a fairly-close call. Full “sunlight” on the worldwide safety database would be helpful in knowing how strong the association between accutane and depression is. Certainly not all teenager’s moods “tank” while on accutane. Many teenager’s moods would have bottomed-out without it.
It’s certainly not a lifestyle med. It’s more of a major quality of life matter for those many patients stricken with scarring-type acne. To go without treatment can be debilitating. Many patients have undergone treatment without known long term detrimental sequelae.
Personally, I’d hate to see it outlawed. I’d be concerned that teenagers would be forced to seek treatment off-shore. There might then be QC/QA issues. Obviously, the medication needs close supervision and monitoring by a licensed dermatologist, experienced in treatment with accutane.
Mr. Experience
Salient,
You assume that we all anxiously wait by our computers for the next article to be released.
You also assume we have nothing else to do but hang out for the last word in medicine and then make inane comments.
Some of us just don’t feel obligated to make talk about every subject that is printed.
This one deserved an answer.
Stephanie
Patrons99, one huge problem I have witnessed first hand with Accutane is that the dermatologist are not reserving their prescriptions of this med to just the scar causing acne. I remember the first dermatologist I took my son to (who had pimples, but not really scar causing acne)within the first few minutes was already looking to use Accutane and when I questioned him, he fairly arrogantly stated that “If it is needed that is what will be done”. Suffice it to say, we never went back. And happily my son has outgrown his acne without one scar!
patrons99
Stephanie - with that kind of arrogance, I would have sought out another dermatologist, immediately.
X
This is typical with psychiatrists.