Editorial note: a slight variation of this appeared last week on The Conversation.
In 2010, the European Ombudsman ruled that the European Medicines Agency should open access to clinical trials data when companies applied to get their drugs on the market. The ombudsman decided public health was more important than considerations of commercial confidentiality.
In February this year, the US pharmaceutical company AbbVie, who make Humira – the best-selling drug in the world today – took legal action against the EMA’s open access policy after they were tipped that competitors had requested access to clinical study reports and the EMA was going to grant it. In one of the most important healthcare legal actions ever taken, the court upheld the pharmaceutical companies’ positions.
On August 27th, EFPIA – The European Federation of Pharmaceutical Industries and Associates – convened a meeting in Bruxelles to look at issues of accessing clinical trial data, at which Neal Parker of AbbVie created quite a fuss, starting off with a wonderful Freudian slip saying that AbbVie’s mission is to discover new diseases.
A video of the meeting is linked to the Trade Wars AbbVie v China post. Close to the middle of the meeting, the director general of EFPIA, Richard Bergström, intervened to say
“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 biologics 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,”
As noted at the time, this comment raises the question as to whether this is what AbbVie’s action against EMA was really all about? The room and the entire commentariat have been debating access to clinical trial data – but was the action elsewhere?
Enter Inflectra stage – left
A little over two weeks after this meeting, EMA provisionally approved Infliximab Biosimilar (Inflectra) for use in Rheumatoid Arthritis, Crohn’s Disease, Psoriasis and related conditions.
Infliximab is the core compound in Remicade. Remicade was developed by Johnson & Johnson. It was one of the first biologics or MABs (monoclonal antibodies), of which AbbVie’s Humira has become the most famous. The branded pharmaceutical industry have always fought hard against generic drugs which eat into their blockbuster profits but they have fought tooth and nail to stop “generic” versions of any biologics being launched.
The argument has been that no generic can be identical to its parent biologic. There are in fact irreducible differences between all original MABs and any derivative biologics. This has given rise to the concept of a Biosimilar. The pipeline for new drugs is so poor that blocking Biosimilars almost seems like a life or death issue for the branded companies.
We must unite against Korea?
Richard Bergström may have let the cat out of the bag mentioning Korea.
Inflimab Biosimilar was made by Celltrion – a Korean company. Celltrion working in collaboration with Hospira, a new kind of pharmaceutical company that has emerged to help develop Biosimilars, based in both the US and UK, filed the application to market Hospira’s Inflectra in America and Europe and Celltrion’s Remsima in other markets.
This could lead to the price of biologics, which can cost anywhere between $20,000 and $500,000 per year falling dramatically, Inflectra – Remsima will likely cost 33% less than Remicade and this will have knock on effects for Humira.
Dr Margaret Chan, Director General of the World Health Organisation, said earlier this year:
“The costs of many new medical products are becoming unsustainable for even the wealthiest countries in the world. [Of the 12 cancer drugs approved last year], 11 were priced above the $100,000 per patient per year. This price is unaffordable, for most patients, most health budgets and most insurance companies. These are problems for all countries, not just the developing world.”
Eastward look, the land is bright?
Up to the MABs, insurance companies like UHG, Humana and others simply paid out on new drugs. They offered a reimbursement rather than an insurance service. But now that biologics are so much more expensive than older drugs, companies in this area, especially larger companies who self-insure like General Motors or WallMart, have to become insurers rather than just reimbursers. And in this arena, a Biosimilar offers insurance companies huge leverage.
Companies like Hospira and Celltrion have a chance to effect huge changes for the better – will they grasp them? Does Salvation lie in the East?
Was AbbVie and EFPIA’s action against EMA a shot across the bows? Was it all about trying to deter EMA from licensing Inflextra – Remsima?
Roger Warren Evans commented on the Conversation version:
“Professor Healy – your insights into the world of Big Pharma and its processes were indeed eye-opening, but to a battle-scarred lawyer like myself, not entirely surprising. The whole system of the ownership of “intellectual property (IP)” (in this case medicinal patents) has moved to the centre of the global corporate exploitation system – partly because of the huge profits which they can generate (provided that the “private ownership” of the IP can be legally upheld) and partly because of their easy “fungibility” – a patent, if properly maintained and defended, is easy to sell and exploit from scratch – it is the ideal capitalist “good” and asset.
The same conditions are found in the world of GM crops, where natural strains of plant are deliberately subject to genetic modification (GM) with the sole purpose of creating a distinctive “new” patentable (=ownable) object – the same is true of commercial “brands” and “copyrights”. They are all eminently fungible assets, and they are moving to the very core of modern capitalism. It is clearly very “old hat” for the corporations (except perhaps Warren Buffett) to worry about the ownership of physical objects and processes – running factories, extracting metals, building buildings. Controlling the world market – therefore the world – via its “intellectual property” is much easier…
Roger Warren Evans Retired lawyer Swansea UK”
After watching the video of that meeting in Brussels, I’m not at all sure that Richard Bergstrom of EFPIA was spilling the beans about the “real” reason for their campaign to hide clinical trial results. It could be just the opposite – Parker had been all too honest about Pharma’s willingness to hide adverse events from patients and their doctors. Bergstrom was swooping in to perform some damage control.
Our friend Neal, he says, is in an unusual situation, because his company makes biologic drugs and is involved in extremely cut-throat competition with potential generic competitors. Those are the people he’s worried about nosing around in the data – not, god forbid, doctors and patients. That’s why the rest of us are “quite relaxed” about opening up the clinical trial data, Bergstrom assured us.
Oh really? Then why is InterMune AbbVie’s partner in this lawsuit? Their drug Esbriet (pirfenidone) is not a biologic, and is brand-new, years away from generic competition. Yet it’s poised to sell for even more than AbbVie’s Humira – at least $40,000 per year compared to Humira’s $25,000. It carries serious risks to patients. And if Humira’s effectiveness for Crohn’s disease (the subject of the studies) is in question, Esbriet’s ability to make a real difference to people with Idiopathic Pulmonary Fibrosis is even more questionable. Nosy doctors and patients would be the main “enemies” on their radar, not generic drugmakers.
Finally, these were clinical studies. If there’s any “special” competitive issue around biologics, it concerns the secrets of how they’re synthesized from living organisms. That’s the big patent issue for AbbVie in the U.S. – Parker and his colleagues have argued that in order to license biosimilars, the FDA will have to give its competitors so much proprietary information about how Humira is made that it will be an unconstitutional “taking” of (intellectual) property without compensation, in violation of the Fourth Amendment.
Clinical trial results don’t give any details about how to spin a monoclonal antibody from a batch of yeast or the blood of Peruvian llamas. They only tell you what happens when the finished product is put into the bodies of patients. And that’s what AbbVie wants suppressed, I think, for very conventional and obvious reasons. That’s why, when Jim Murray pressed Neal Parker about what information AbbVie wanted hidden from doctors, Parker didn’t respond with worries about the details being shared with his rivals’ R&D teams. He told Murray he didn’t want some doctor sharing information about side effects with a goddamn reporter.
I’m sure Bergstrom isn’t exactly lying when he stresses their worries about competitors getting ahold of the data. He just wants us to think EFPIA would never dream of hiding important information from patients – which we’d be fools to believe. If any patient advocates in the room had a rude awakening from Parker’s remarks, Bergstrom was rushing in to sing them back to sleep. Best to stay wide awake.
Jo
All good points. The question is what to AbbVie really want. Asserting Corporate Privacy Rights is something to be desired. But more desirable that exerting the right kind of pressure on EMA that leads to them not licensing Inflectra? Perhaps Mel Gibson could tell us what AbbVie really want.
Humira has been de-throwned as #1.. in the US anyway..
The following is a list of the top 100 prescribed medicines by U.S. National Sales in Q3 2013. Figures include sales through both retail and hospital channels, listed by drug name and sales value in U.S. dollars.
http://www.drugs.com/stats/top100/sales
Fascinating figures – thank you for sending. D