Monday, February 04, 2019

UK to challenge Big Pharma?

"New drugs emerge not according to need, but when companies know they can make sizable profits from them." so explains a Guardian article.  Patients and shareholders are likely to draw the line that distinguishes a fair reward from greedy profiteering in very different places.

Government healthcare ministries and patients around the world are struggling to cope with escalating costs. Last year a report suggested that the average annual price of new cancer drugs had almost doubled in the US between 2013 and 2017 – and would double again by 2022. 

There exists an "intuitive sense of wrongness when people reap lavish rewards thanks to products others cannot live without, is twofold. Some diseases or conditions – particularly those prevalent in poorer countries – are ignored, while treatment for other health problems may come at a heavy price."

Pharmaceutical companies blame the cost of development and say they need to recoup their investment before rivals are able to pile in with generic competitors. They are less keen to acknowledge their often sky-high profits, the fact that some put more into share buy-backs than research and development, and the reality that many new offerings are “me-too” variations rather than game-changing innovations.

The problem is especially acute for drugs that do not have a large market – either because the aim is to use them only as a last resort to preserve their efficacy; or because the disease or condition is an uncommon one.

A US manufacturer has set the price of a drug called Orkambi, which could extend the lives of thousands of children with cystic fibrosis, at more than £100,000 a year. Britain is home to 10,400 a tenth of the 100,000 people worldwide affected by the life-limiting genetic disorder. People with cystic fibrosis have faulty genes that stop production of a protein governing the movement of salt and water between cells. It causes a build-up of mucus in the lungs, meaning it is hard for them to breathe and they are susceptible to infections. Orkambi is not a cure, but it offers stability.

But the NHS cannot afford Orkambi: the National Institute for Health and Care Excellence (Nice) says it is simply so expensive that it is not cost effective. Other companies have budged in similar circumstances; but the drug’s maker, Vertex, refuses to do so. It rejected an offer of £500m over five years for access to its cystic fibrosis drugs as inadequate and unfair. Vertex did not pay for the earliest research. Much of the money came from donations to the Cystic Fibrosis Foundation in the US and from the federally funded National Institutes of Health. Vertex bought the patents for $3.3bn. It has already earned $2.5bn from sales. Analysts conservatively estimate they will generate profits of $13bn on Orkambi and another related drug, Kalydeco, alone.

A group of 24 US doctors and researchers involved in the development of Kalydeco wrote to Vertex’s CEO.
“We have invested our lives and careers toward the success of these inspiring therapeutic agents. We also write with feelings of dismay and disappointment that the triumph and honor that should be yours is diminished by the unconscionable price assigned to Kalydeco,” they said in their letter.

Kalydeco (ivacaftor, which can help only 5% of patients) and Orkambi (ivacaftor with lumacaftor can help 40%) remain unavailable in New Zealand. In the US, where the company developed the drugs, patients struggle with affordability due to the level of co-pays [the excess demanded by insurers]. The situation is tragic because these are the first and only drugs to tackle the root cause of CF, extending the lives of people with the cruel, genetic condition.
Parents and the medicines group Just Treatment are urging the government to invoke “crown use”, allowing it to make cheap versions and pay Vertex a smaller sum in compensation. This would be very unusual, but not unprecedented. The principle that intellectual property rules cannot automatically outweigh health considerations is well established, and not only in public opinion; it is recognised in the WTO’s Doha declaration of 2001.

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