By Genevieve Clapp, Second Year, Medicine
The NHS and pharmaceutical company Vertex are in a dispute over the extortionate cost of Orkambi. This new cystic fibrosis drug could save thousands of lives, but what good are medicines if we cannot afford them?
How much would you spend to save a family member? Most of us would say 'everything I could', but what if that was still not enough? This is the problem facing the families of around 10,500 cystic fibrosis sufferers in the UK.
Cystic fibrosis (CF) is a genetic condition that causes viscous mucus to accumulate in the lungs and digestive tract, which makes it very easy for bacterial infections to develop. Due to the frequency of infections and poor lung function, the average life expectancy for someone with CF in the UK is under 37, not to mention the fact that their quality of life will be significantly reduced.
Since 2018, the NHS has been attempting to forge a deal with Vertex Pharmaceuticals, a company that manufactures the world’s most promising CF drug. The drug, Orkambi, would tackle the root cause of CF by decreasing the activity of the mutated protein causing the disease and increasing the activity of the effective protein. It is an incredible medical breakthrough that performed very well during recent clinical trials; unfortunately, the deal hasn’t been straightforward.
Despite having sole ownership of the patent for Orkambi, meaning they will have no competition when it comes to sales, Vertex is asking for just over £100,000 per patient per year – an amount the NHS could never afford. The company even turned down an offer of £500 million for five years’ access in 2018 – the largest offer in NHS history.
Many have taken this to be an act of greed, and evidence that the pharmaceutical industry is fuelled by capitalism. This is an easy assumption to make when a paper published this June by Professor Aidan Hollis from the University of Calgary revealed that Vertex is set to make a profit of £17 billion from Orkambi and an earlier drug called Kalydeco.
Cystic fibrosis: the patients facing shorter lives due to drug's expense https://t.co/q51jcuoHkf— The Guardian (@guardian) February 3, 2019
However, Vertex have said that the cost is justified because they invested £9.58 billion in the development of CF medications. They claim that without the sums that they are suggesting, they will be making a loss and that the development of new products will be hindered.
It is also important to recognise that this £17 billion profit also includes Kalydeco (which is already available to the NHS) and had a huge increase in revenue between 2017 and 2018, whilst there was a fall in revenue for Orkambi.
Nonetheless, the Cystic Fibrosis Foundation in the US invested heavily in the development of Kalydeco, which is also known as Ivacaftor. Ivacaftor just happens to be one half of Orkambi, meaning that a significant portion of the research was publicly funded. This has been used as one of the main arguments against Vertex and makes the high price especially upsetting for CF suffers in the US.
In June, the Cystic Fibrosis Trust led protests around the UK begging Vertex’s CEO, Jeff Leiden, to make the medicine more affordable. Although the protests didn’t affect Vertex’s pricing, it did win the support of MPs, in particular Conservative MP Bill Wiggin, who is backing calls for a Crown Use License.
Invoking a Crown Use License means that the UK would ignore Vertex’s patent and start manufacturing a cheaper version of the drug. Although this sounds like a good solution, it would break down trust between the NHS and pharmaceutical companies, potentially preventing future sales of other medications to the UK.
NHS England is “committed to exploring and developing alternative routes” to enable people with cystic fibrosis to access Orkambi on the NHS if Vertex, the US company that markets it, does not price the drug “fairly and responsibly,” says spokesperson https://t.co/clu1XoGmam— The BMJ (@bmj_latest) September 17, 2019
NHS Scotland has already deemed the drug too expensive and threw in the towel with negotiations on August 12th. The question now is whether NHS England will be able to come to an agreement with Vertex, or whether billions will have been spent developing a drug that no-one can afford. Amid negotiations, 7,880 packets of this lifesaving drug went out of date and had to be destroyed; this was called a “desperate waste” by David Ramsden, head of the Cystic Fibrosis Trust.
The wastage has increased the public’s anger towards Vertex and makes negotiations even harder. Robert Long, whose nine-year-old son Aiden has CF, wrote a Guardian article saying that he became so desperate that he’s been paying Vertex £8000 per month to access to the medicine for his son.
In some ways, the media coverage of this issue has posed more questions than answers, with there being conflicting information of just how much the drug cost to develop and how successful it will be.
But regardless of whether Vertex’s board members are being honest, two problems have been highlighted that need to be immediately addressed: transparency in the pharmaceutical industry, and the cost of developing drugs.
The necessity of the billions invested in drug development and how this affects prices is currently a hotly debated topic, and one that will most likely affect us all at some point in our lifetimes.
Featured: Flickr/ Chris Bertram
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