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…
AbbVie and trade secrets
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.
These included
“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. [No longer at https://vimeo.com/73495040]. 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.
See Lets Do the AbbVie Again and RxISK’s Petition to AbbVie asking them to drop their legal action against EMA.
In a strange way AbbVie is doing us all a favor … tearing off the mask from the drug industry as a whole. They make it abundantly clear: their priority is their own profits. They’re equally happy to sell us drugs that do tremendous good, drugs that do terrible harm, or drugs that do nothing much at all. Just so it pays the same! Thank you, Neal Parker, for showing us your company’s real face.
Clearly they are determined to penetrate new markets in Asia, and to fight off generic competition both at home and abroad. But there’s another form of “imperialism” if you will that’s at least as important to them: pushing into new disease markets. I notice most of the press has described Humira, their flagship biologic medication, as a Rheumatoid Arthritis drug. That’s because most of the biologics on the market were first developed to treat RA, and severe RA is probably where the benefits of these drugs make them worth the risks (at least while we wait for better approaches).
That’s not how AbbVie and its parent co Abbott see it, however. They recognized early on that the path to growth was not fighting several other Pharmas over the limited RA market, but expanding into other auto-immune disorders—whether it makes good medical sense or not. That’s why they’re targeting psoriasis and inflammatory gut disorders like Crohn’s and ulcerative colitis – and pushing the boundaries of “moderate-to-severe” disease to lure in any patient who’s frustrated with a chronic illness that can be managed but not cured.
That’s where Stacy London and her AbbVie-sponsored psoriasis awareness campaign come in. Stacy gets to talk about empowerment and self-acceptance, and never has to say the word Humira. But the campaign draws people into AbbVie’s sphere of influence – where this very risky drug is more and more blatantly positioned as a beauty product! Take a look at their latest US ad:
http://www.ispot.tv/ad/7qTz/humira-salon
It seems US patients (women especially) are now just another “emerging market” to exploit.
1913 signers.
You have hit the nail on the head.
Serendipity is here……..
Sagaciousness has to follow.
I don’t think people outwith the business world realise how ruthless businessmen can be. No matter what carnage they have left behind them, they carry on desperate to invade new markets and desperate not to have their trade secrets discovered.
When this causes loss of life and they still carry on allowing people to die like nine pins at a bowling alley and are then given accolades such as Knight, then night has turned into day and David Healy has a nice shiny buff of cleanliness and honesty and integrity and thank the lord is here to drag all this up and tell it how it is.
I can’t do Gsk bashing, but I really, would dearly, love to find out how a nice girl like me ended up being so mentally battered because ‘her persistent complaints about Seroxat side effects leads me to think this is not a depressive illness’ but still allowed me to drop through the net of patient care is really quite beyond me and, I, too, am flabbergasted. I have tried to fathom my lady doctor’s logic and there is none. Hence, her criminality, in my, particular, case…..
Is there anyone at the top who appreciates what is going on here or are we surrounded by duped dullards who don’t engage brain and whose naivety is so expressly foolish.
The cost of all this is so gigantic and so scandalous which is probably why it does not penetrate. What is happening *here* should reverberate all over the world.
It is cheap, it is a slap in the face and Witty should wet his pants……..how dare he not face up to his company being accused of manslaughter charges. Fines do not bring back dead bodies.
Knighthoods are being stripped left, right and centre….for sexual crimes, for banking crimes and, for, pharmaceutical crimes?…..the clock is ticking…
Somethin STINKS, bad, people are dying where I am, doctors are playing games, they bare refusing to help. And, I know what it is. and what it is is so evil, so underhanded, it cannot stand the light of day.
It is a religion, a people who dont cvare about life. I would be VERY carefull, what meds you take. VERY. I may not be able to stay alive much longer, but i am no coward, but a man of morals.
We do have some pigs in the medical system, and when their turn comes, when they get sick, they MIGHT understand. One thing I have seen in life, what goes aroiund, comes around, and the best laid plans, backfire. O ship of fools, so sad. Thanz to Dr. Healy, a good man.
See: http://www.youtube.com/watch?v=54OY1auPQqU#t=1192
In particular, minutes 19:41-20:47.
Here’s my transcript:
The detail of the give and take of the problem solving which is reflected in the narratives of some of these clinical study reports is internal sensitive information which is nowhere reflected in the label.
A company’s,…the process of getting these products approved with the regulatory agencies is a give and take of issues, challenges, um, REWORKING OF DATA in response to regulators’ concerns or concerns that we have identified and raised ourselves, which needs to be explained and articulated in documents that we submit to regulators to get products approved.
And if I’m a competitor to Abbvie, and I’m in a competitive landscape, where there are a lot of products on the market, and I want to enter that market, the first thing I want is Abbvie’s clinical study report, ‘cause I want to know what problems I am gonna have to confront when I try to get a product approved, and that is a competitive advantage, and that’s why we consider this information, depending on the circumstances, CCI. (Capitalization mine)
It’s that “reworking of data” that no one outside the company has access to that really worries me.
My input.
Minutes 22.16 – 23.39
“Is that what you mean in the white circle?” asks a clearly bemused gentleman.
Neal:
They are internal………….blah blah ……….to frame data…………blah blah ……is confidential……..blah blah ……….to get other products approved.
Gotcha, in one, Mr. blah blah; have you ever heard anything like this tripe in your entire life??
The women weren’t much better; boring, yawn; two gentlemen who asked the questions got it in one – is this healthcare we are talking about…………………..it takes me back to telling them all about Seroxat and yawn; get over yourself, Annie, and just go away and leave me alone. Sort yourself out….blah blah…..it is nothing to do with me that you were nearly annihilated by Seroxat…..blah blah
Blue circles, white circles, yellow circles – get a grip, Neal.
Draft Deregulation Bill is not yet an Act but going through Parliament.
http://www.official-documents.gov.uk/document/cm86/8642/8642.pdf
Hidden away near the end is this very short section:
Section 58 (1) and (2), Section 59, Section 60 (1) and (4) make it law for regulators to do as they told by government ministers who “must” seek advice on what they are to tell regulators to do – from anyone they choose.
59 says that the Minister “must consult” anyone he likes.
60 (1) says that the Minister can decide on what regulators must do to fulfill the “duty to promote growth”.
60(4) appears to say that as a regulator’s duty is to do what government ministers tells them to do and (59) has made it clear that government ministers may be advised by anyone they like on what the regulator’s “duty to promote growth” means.
Does this give interested parties (industry?) a legal right to have their advice considered by ministers on setting limits on regulators where regulators ask questions that might affect the economic activity of interested parties?
This raises some very interesting questions.
If government ministers have a duty to promote economic growth (not sure if this is so) or a duty to promote innovation (this is now a duty of SoS for Health) – then would a minister be breaking the law with regard to “promoting economic growth” if he did not do as industry advised him with regard to regulation – as it would harm market growth, even though it might reduce public risk?
Text of Sections 58-60:
“58 Exercise of regulatory functions: economic growth
“(1) 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.
“(2) In performing the duty under subsection (1), the person must, in particular, consider the importance for the promotion of economic growth of exercising the regulatory function in a way which ensures that –
“(a) regulatory action is taken only when it is needed, and (b) any action taken is proportionate
“59 Functions to which section 58 applies
“(1) A Minister of the Crown may by order specify the regulatory functions to which section 58 applies.
“(2) Before making an order under subsection (1), the Minister must consult –
“(a) any person exercising functions to be specified in the order, and
“(b) such other persons as the Minister considers appropriate…….
“60 Guidance on duty under section 58
“(1) A Minister of the Crown may from time to time issue guidance as to the performance of the duty under section 58(1)…
“(4) A person who has a duty under section 58(1) must have regard to any guidance issued under subsection (1). ”
Notes on page 172:
“224. The background to these provisions is the post-implementation review of the Regulators’ Compliance Code which found that regulators had a tendency to regard the promotion of economic growth as subsidiary to their statutory duties, the Focus on Enforcement reviews which found that businesses experience inconsistent or disproportionate enforcement decisions and Lord Heseltine’s independent report entitled ‘No stone unturned: in pursuit of growth’ which recommended that the government should impose an obligation on regulators to take proper account of the economic consequences of their actions.
“228. Clause 60 provides a power for a Minister of the Crown to issue guidance on: the meaning of economic growth; how regulatory functions can be exercised so as to promote economic growth; and how persons subject to the duty can demonstrate compliance with the duty. The draft guidance is subject to consultation requirements set out at clause 60(6)… ”
However it also states:
“230. The government recognises the importance of preserving the independence and integrity of prosecutorial decisions and the duty under clause 58 is not intended to affect this. ”
(But that seems to be about your rights to sue someone after the event).
Regulation protects the public from risk.
Less regulation increases the risk of expensive international industrial accidents that would harm economic growth, surely?
Safety regulation is less of a burden on industry than the no-win, no-fee Personal Injury legal claims industry that is replacing Legal Aid.
Legal Aid acted as a filter for bounty-hunters. It is the PI claims industry that is having a negative impact on economic growth, surely. Regulation is there to protect the public from risk, it is not a liability.
Founder of Easy Jet Stelios Haji-Ioannou says: “If you think safety is expensive, try an accident”.
http://www.dailymail.co.uk/home/moslive/article-1252249/The-secrets-success-Sir-Stelios-Haji-Ioannou.html