Slightly over three months ago, the idea of an AbbVie was born. She was named after the pharmaceutical company AbbVie – until recently Abbott Laboratories. She was born from the union of a legal action taken by AbbVie in the European Court against the European Medicines Agency’s (EMA) data access policy.
As a result of Peter Gøtzsche’s efforts in 2010 the European ombudsman had issued a ruling that the European Medicine’s Agency should make available the data from clinical trials submitted to them for regulatory purposes. EMA’s new open access policy appear to be working well until AbbVie applied to block access to two clinical study reports that focused on the safety and efficacy of their blockbuster Humira. Humira is responsible for 70% of AbbVie’s profits. The reports were on its use for the treatment of Crohn’s disease. Another clinical study report concerned safety risks linked to combinations of Humira and corticosteroids.
The AbbVie Company’s legal action is a claim for Corporate Privacy Rights. They want us to treat them just as we treat each other when we agree we each have the right to make up our own mind what we believe in. In this case AbbVie want a similar right but in order to to shape OUR beliefs about what we take into our bodies. This is a point where our and their Privacy Rights conflict.
There may be all sorts of other reasons why AbbVie took this legal action – one being a trade war between East and West. Whatever the reason, the upshot was a suspension of all access to clinical trial data – particularly adverse event data.
The loss of Adverse Event data led to the birth of AbbVie. AbbVieing is another word for reporting adverse events on drugs.
Although RxISK has a conflict of interest here, we think you should report these and all adverse events through RxISK from where they can be sent on to your national regulator. If you report directly to your national regulator only, your report will be binned. RxISK on the other hand will take it and where it looks like there could be a causal link will help you and your doctor join the dots.
AbbVieing is the opposite to Boycotting. A boycott would mean shunning and not mentioning AbbVie or their drugs. To AbbVie means to pay close attention to AbbVie’s drugs – shine a spotlight on them – and communicate with them and each other rather than shun them. Face the company with a question ‘Can We Talk’.
The beauty of this is that unlike the Irish tenant farmers who had to endure hardship of not earning a living off Boycott’s farms, while they were boycotting him, doing the AbbVie will not hamper your treatment or access to treatment in any way. Just the opposite – it will improve your treatment. A good medicine is a chemical plus good information.
AbbVie want to degrade the quality of the medicines they provide in particular and all medicines in general. We need to tell them this is unacceptable.
As outlined in Witty A: Report to the President, the structure and functions of company boards means that the only thing a Pharmaceutical Company behaving egregiously has ever listened to has been a Boycott. It would be nice for them and us to have something more constructive.
After setting up RxISK’s AbbVie, we also indicated we would petition AbbVie the Company. Over the last two months the petition has been live on Change.org and later on RxISK.org, which has hosted translations in Chinese, Hindi, Telegu, Urdu, Arabic, French, German, Swedish, Bosnian, Italian, Spanish, Kannada, Czech, Portuguese, Dutch, Russian and Welsh.
The country that has led the way has been the Isle of Man – thanks to one very motivated person who has Crohn’s disease. (We might put an invoice into the Isle of Man Tourist Board for putting it on the global map).
There have been other astonishing inputs – with Kyrgyzstan beating the USA; the State of Washington beating all other States easily.
There has been political subversion – we have tried to introduce people to the concept of the Western European Archipelago (WEA) but no-one has got in touch to ask us what the hell WEA is.
The highlight of the campaign was a Letter to Stacy London, written by Johanna Ryan and Kim Witczak. Stacy hasn’t taken the opportunity offered for instant health care activism sainthood – but her influence can be seen in the petition poster and of course in Joan of Arc.
Stacy’s role shows the power of modern marketing – brought out best in Johanna Ryan’s post Welcome to the Humiraverse.
We have tried to sign off in style by calling for extreme petitioning. In due course when the Rest of the World catches up, extreme petitioning will catch on – you heard of it here first.
The petition pictures that have resulted have gone on the Facebook page along with a copy of all the AbbVie posts from the first – Let’s do the AbbVie Again. There is also Humira@RxISK Facebook Group.
One of our key targets was to raise awareness of this legal action worldwide. Researchers from all over the world had been accessing the data through EMA so this is a worldwide issue. At present we have 120 countries of the roughly 180 countries with populations over 100,000, who have signed.
Even after the European judgement, we will keep the petition open looking to get every country on earth signed up. There are special RxISK teeshirts for anyone who can get North Korea or Bhutan – or that other secret fortress The Vatican.
Unlike the tongue in cheek invoice we will soon be putting in to AbbVie for PR work done for them, there really are RxISK teeshirts for anyone willing to raise sponsorhip for RxISK.
Go into RxISK.org, enter Humira, and look under the Reported Side effects tab.
All the side effects including Kaposis Sarcoma come up under the A-Z Side Effects tab.
Using the location tab you can see where these come from.
Meanwhile there will never be a closure date on your opportunity to AbbVie. As with voting, you need to do early and often to make a difference.
File a report on any adverse events you have had on treatment.
If possible outline the economic impact of these events.
Generate a RxISK Report and take it to your doctor. Let her know that this is partly about an adverse event you may be having on treatment but also about company behavior that she more than anyone else is well placed to influence. She can do this by adding to your report and filing reports on other patients she sees or getting them to file reports.
As soon as reports come in to us, we will create HeatMaps showing where the reports are coming from and this may help generate media stories that will swell and make AbbVieing a real political force – one of the most constructive forces around.
I wish you would ban the phrase “side effects”. It is simply a euphemism, much loved by drug companies, for the official term “adverse reaction”