No such thing as being ‘European’
There is no such thing as being European when you take a drug like Humira or Depakote and something goes wrong. When something goes wrong on their drug, companies go to extraordinary lengths to make it almost impossible for doctors or patients to report adverse events. It’s part of a larger mission to transform what were poisons to be used with care, into fertilizers to be dished out with abandon. (See American Woman, American Woman 2).
When reports come in from trials or come in spontaneously companies can split up the coding of an event so that a suicidal reaction to a drug might be coded under anxiety, or agitation, or akathisia, or abnormal thoughts, or depression, or suicidal ideation, or suicidal behaviour, or even nausea. They can be miscoded as happening on placebo in trials when in fact they are linked to active treatment or they can be attributed to another drug the patient is on rather than the company’s drug.
Each to their own
Both RxISK and the company making your drug want to find out as much about the reaction as possible but drug company wants to find this out in order to find all possible ways to discount a link to their drug, even if internally the company concedes their drug can cause the problem. On the otherhand RxISK tries to help you establish a link if it’s there.
One of the most potent weapons companies have is nationality. In Europe while there is now a common currency and increasingly talk of common defence forces, when it comes to adverse reactions, the French are and can only be French, and the same applies to the Danes, the Portuguese, the Dutch, the Irish, the Italians and the Germans. Much to their relief no doubt, the Brits are forced by law to remain insular – detached from Europe – on this issue. UKIP (UK Independence Party) rules.
Reports of adverse events in France can only go to the French drugs agency, while the Germans, Swedes, Finns and Spanish can only send reports to their respective national agencies.
This immediately dilutes the impact of any reporting. Imagine if the 50 US States only handled adverse events on a state by state basis. The number of reports from each state would be miniscule compared to the number on a national level and the capacity of anyone to detect what is going on would be correspondingly limited.
Having said this, in practice it makes little difference if Britain’s MHRA had 300 or 3 reports on a problem – there is almost no number that would trigger them into action.
But it’s still convenient to use nationality. Convenient if a regulator can pay no heed to what is happening elsewhere as Anna McCoy found to her cost in Australia – where the TGA only looked at reports sent to them of suicidal problems on doxycycline and said there had been none when in fact there have been extensive reports of suicide and suicidal acts on this drug – just not in Australia.
RxISK went to visit EMA a month ago and found that while they thought the HeatMaps showing the distribution of PSSD cases across Europe looked convincing that there was no way EMA could even think about being interested in the data from RxISK. When it comes to the side effects of drugs EMA have PSSD – they are EMAsculated.
The legal action by AbbVie to prevent EMA making clinical trial data available – in particular adverse event data – risks making them into EUnuchs in the Humiram good and proper.
The only saving grace to the AbbVie action is that it makes the Brand Fascism very clear, whereas GSK’s data access proposals are, in this sense, more dangerous.