A lot people it seems have been singing and dancing in the street at news last week that AbbVie the pharmaceutical company that make Humira have dropped a legal action against the European Medicine’s Agency (EMA) that was aimed at blocking any access by researchers or others to their clinical trial data.
Not everyone will be pleased though. Stacy London might wonder whether she should fire her advisers. She could have featured as a Joan of Arc leading a RxISK campaign against oppression had she responded to our Open Letter to Stacy. She might be sitting pretty now had she adopted a position that Humira can be a tremendous drug but hiding clinical trial data is just not acceptable. But we got no response, and it didn’t seem fair to harass her.
AbbVie’s action was set in train several years ago when one of medicine’s most extraordinary figures, Peter Goetszche from the Danish Cochrane Center took a case for access to clinical trial data to the European ombudsman and won a ruling that the European Medicines’ Agency should make the data from clinical trials submitted to them for regulatory purposes available more generally. This was a wonderful breakthrough. In November 2012 EMA convened meetings to work out the ground rules for what was expected to be the new way of doing things.
But on April 30th 2013 just as the post Brand Fascism was posted on davidhealy.org saying that we might all be better off if company efforts to hide their data were successful, a legal action was taken in the European Court against EMA’s data access by two companies. AbbVie and InterMune.
AbbVie applied to block access to two clinical study reports that focused on the safety and efficacy of their blockbuster Humira, responsible for 70% of the company’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.
InterMune tried to block disclosure of data on its only drug Esbriet, an anti-inflammatory drug it hopes to push for the treatment of a lethal – largely drug induced condition – idiopathic pulmonary fibrosis. Esbriet might weirdly become the first drug to become a blockbuster out of managing an adverse effect caused by other drugs.
AbbVie and InterMune claimed that the decision to provide access to all clinical data violates their’ ‘fundamental right to the protection of confidential commercial information’, and their ‘legitimate expectations’, and copyrights they hold. The bottom line is company rights to privacy are being breached.
This legal action led to an enormous brouhaha. RxISK got involved and over 6000 of you from over 120 countries signed our petition calling on AbbVie and InterMune to drop their action – See Extreme Petitioning.
There is a wonderful moral case to be made for transparency of clinical trial data and a compelling case to have a petition to raise awareness of the issues more generally but as we made clear in a number of posts almost anything in this area is hazardous.
Welcoming AbbVie’s apparent dropping of their action feels terribly like the Trojans welcoming the apparent departure of the Greeks and opening a hole in the City Wall to haul in a Wooden Horse. We scream at them not to.
The press coverage of AbbVie’s withdrawn legal action suggests that most major companies have now embraced an option for transparency pioneered by GSK.
All Trials are among those taking credit for pressuring AbbVie into submission. They have aggressively welcomed the offer by GSK to make clinical trial data available with no questioning of the terms on which the data is being produced.
But GSK’s offer is a manoeuvre worthy of Ulysses himself. You’d never guess from company self-congratulation that it was forced on GSK by a New York Court as part of the resolution of a Fraud action. The Fraud Action happened because GSK had written up a positive portrayal of a trial when in fact the company itself thought the trial had shown their antidepressant, Paxil, did not work.
The trial – Study 329 – was test of Paxil in children. As mandated by the Courts in the wake of Study 329, GSK put up company study reports for all of their trials, Paxil and other drugs including the diabetes drug Avandia. These could be downloaded. Steve Nissen of the Cleveland Clinic did just this for the Avandia reports and was able to show that Avandia killed. A company blockbuster was stopped in its tracks.
Putting study results up on the web must have seemed like a very bad idea to GSK. So why are they now championing data access?
GSK and other companies are reaping kudos for apparent transparency. And they can say with a straight face to any TV anchorman or Congressional committee that they are making data available.
But in fact here is what is happening. Having seen what happened with the Avandia study reports GSK now know what to do when writing a Study Report to avoid a repeat. Suitably Doctored Study Reports for other drugs will go up on their website.
The Study Reports however do not contain the data. A first approximation to the data in the case of Study 329 comes in a series of 7 appendices to the 329 Study Report – something GSK did not put up on the company website until the omission was spotted nearly 10 years later by Peter Doshi and New York State required them to do so.
In the case of Study 329, the ghostwritten article that led to GSK being sued for fraud, is 11 pages. The Study Report is over 700 pages. There are then 7 appendices that between them come close to 5500 pages. Even this however is not the raw data. The raw data lies in Clinical Report Forms.
As things stood before GSK’s offer of transparency, the 5,500 page of appendices and 700+ pages of the Study Report could be downloaded and printed off. Finding what went on in a clinical trial from paperwork like this is a bit like playing Memory – where there a bunch of cards with faces or plants or whatever turned face down and if you turn one up you have to remember where the matching face you turned up before is. It can be done with 5,500 pages printed off.
But playing Memory is much harder to do now with the new improved access GSK is offering.
If you apply to access a GSK trial now you are forced to submit an analytic plan which essentially stops an applicant from accessing any adverse events on the drug. Adverse events are the material the company tries hardest to hide.
Should you get access to the full set of appendices that contain company listings of adverse events, there is almost no way to play the Memory Game because access is through a remote desktop. It may be that a younger generation used to playing Digital Memory will be able to work the system, but it’s not easy. It takes multiple passwords to access the desktop. You are logged out regularly. And while on the desktop, GSK can monitor your every keystroke.
But here’s the rub. To really nail down what’s going on, you need access to the approximately 70,000 pages of patient level data. Through a remote desktop this becomes a nightmare.
This scheme to deliver frustration cloaked in the appearances of transparency was devised several years ago. The history of the idea was outlined two years ago in May Fool’s Day. Last year the details of GSK’s scheme were outlined in April Fool in Harlow.
Selling a message to the media and public that the appearances of more transparency are being used to hide the data is not an easy sell. Telling them that companies can devise trials that use a problem their drug causes to hide a problem their drug causes is something that makes the machinations of House of Cards seem innocent. A nice company like GSK or AbbVie wouldn’t do this.
But we are not faced with an insoluble problem. Company efforts reveal their Achilles Heel. They are vulnerable to adverse event data. And this is where the original RxISK campaign to get people to do the AbbVie comes in. The more people who report adverse events in good quality reports and get their doctors on board in helping them grapple with the issues, the more between us we can restore sanity.
This led to the creation last year of an AbbVie – the opposite to a Boycott.
We asked you to pay close attention to these drugs – shine a spotlight on them – and communicate with them and each other rather than shun them. If you are part of any of the patient organization dealing with Crohn’s Disease or Ulcerative Colitis, such as the Great Bowel Movement, or arthritis you may be able to spread the word rapidly and mobilize many people. If you are Stacey London, Phil Mickelson or Mick Jagger you could make a big difference – Mother’s Little Poisoner.
The beauty of this that unlike the nineteenth century Irish tenant farmers who had to endure the hardship of not earning a living off Boycott’s farms, 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. GSK, Lilly, Pfizer and AbbVie want to degrade the quality of your medicine in particular and all our medicines in general by restricting access to key information on the full range of things these drugs do. We need to tell them this is unacceptable. The best way to do this is to share unexpected events on treatment in a forum they can’t block and to shout louder when told to keep quiet.
Illustrations: © 2013 created by Billiam James