Editorial Note: This post is taken from a more complete article published in BMJ today authored by Nigel Hawkes. It tells of a recent European meeting on access to clinical trial data. The meeting had input from AbbVie who it seems shocked everyone in the room shocked with their disregard for patient safety.
The details here make it very clear why we need to petition AbbVie to drop their legal action against EMA – but it also hints at something else going on that no-one has mentioned up to this – a Pharmaceutical Trade War. AbbVie and other companies are at least rattling their sabres against the Koreans and Chinese – see below.
This should not be a surprise. The FDA Mission Reform Act in the USA was recently introduced to get FDA to take into account job creation in the United States when approving drugs.
Exactly the same has happened in the UK – but no one has noticed. The new Deregulation Bill states that:
“A person exercising a regulatory function to which this section applies must, in the exercise of the function, have regard to the desirability of promoting economic growth”.
The NICE guideline process and the entire NHS is being made fit for corporate purpose. Against this background the notion of a Trade War should not seem too fanciful. Nor for that matter should the idea of sending patients over the top as cannon fodder. Read on…
Sharp differences of opinion have emerged over how much clinical trial data some drug companies are willing to release as the clock ticks down to the transparency deadline of 1 January 2014 set by the European Medicines Agency (EMA).
A meeting in Brussels late last month showed that the industry itself is split, despite the publication of a draft policy by the European Federation of Pharmaceutical Industries and Associations (EFPIA) and the Pharmaceutical Research and Manufacturers of America (PhRMA) which outlined the principles their members should follow.
At the meeting one drug company representative, Neal Parker, of the US company AbbVie, broke ranks by asserting that some data on adverse drug reactions should be treated as commercially confidential.
AbbVie, a research based biopharmaceutical company which split off from Abbott at the beginning of this year, has already taken action in the courts to prevent the European Medicines Agency from releasing to a rival, the Belgian company UCB, data on AbbVie’s rheumatoid arthritis drug adalimumab (Humira). It won an interim judgment preventing release of this data on 30 April this year.
At the Brussels meeting, Parker shocked data transparency campaigners and drug regulators by detailing a range of information AbbVie considered commercially confidential because its release would help competitors to make copies of its drugs.
“internal tactical decisions on how we are going to run a study, engage with regulators, and confront and solve problems and challenges we have uncovered during clinical trials.” he said, according to Scrip Intelligence.
“This information cannot be patented nor have exclusivity, but can give other companies a tremendous competitive advantage by revealing our strategic thinking for proving safety and efficacy of our products.”
This could include adverse drug reactions, he added.
Hans Georg Eichler, the EMA’s senior medical officer, responded by saying,
“I have been a regulator for many years and I am totally flabbergasted.”
Did Parker mean, he asked, that if there was a healthcare concern and your company was asked to give an explanation you would consider your reply commercially confidential?
Aginus Kalis, head of the Dutch Medicines Evaluation Board, said,
“Are you aware you are working in the healthcare industry, with patients and human beings?”
The director general of EFPIA, Richard Bergström, intervened to say that “most of our members are quite relaxed” about data disclosure. For most products there would be no issues, though for highly competitive fields such as biological there might be.
“You might get companies from South Korea or China breathing down your neck trying to copy your technology, then you get extra sensitive,” he said.
So is this what AbbVie’s action against EMA is really all about?
Here is the video from the Brussels meeting. Neal Parker’s (AbbVie) presentation and a brief but interesting discussion with a couple of panelists is just over 12 minutes long – from 13:30 to 25:40 in this video.