Two cholesterol-lowering drugs were launched relatively recently, these are known as PCSK9 inhibitors. Repatha is being produced by Amgen and Praluent from Sanofi.
These drugs have some issues.
1. They have no outcome data - they have not been shown to reduce the risk of heart attacks, strokes.
2. They have been launched purely on their ability to lower LDL to extremely low levels, which we already know is not protective against heart-disease.
They are, however, good news for the balance sheets of the drug companies that manufacture them.
In the UK Praluent, one of these drugs, was expected to cost between £4,000 to £8,000 per year, depending on the dose.
This means that the NHS may end-up paying £8,000 a year or more for a drug that does not actually do anything positive for its patients.
According to Malcolm Kendrick, "If everyone that is currently on statins in the UK, changed to these PCSK9 inhibitors it would cost the NHS £56 billion pounds a year".
That is half of their entire budget.
It may be unreasonable to assume that all statin-users would be switched to PCSK9 inhibitors, but what if only the people with very high, inherited cholesterol (Familial Hypercholesterolemia) were prescribed them?
It is estimated one in five hundred people has FH.
With 65 million people in the UK, that means we have a FH population of approximately 130,000.
If every one of these people is prescribed the higher dose of one of these new drugs, the total sales would be £1 billion per year in the UK alone.
A fantastic new money-making opportunity for the drug companies like Amgen, who produce them.
Of course, it would be even better if more people had FH...then they could increase their sales....but how can you make more people suffer from a genetically high cholesterol level!??
Convince the organisation responsible for setting the levels of cholesterol considered “normal” to adjust their guidance so that high cholesterol and FH start at a lower point.
Then we will all believe that more of us have dangerous LDL levels, and more of us will qualify for treatment of the new drugs that will be prescribed at a greater rate, and the market size for these drugs increases!
Surprise, surprise, the less than impartial American Heart Association, shortly after the drugs release, stated that the level of LDL at with FH can be diagnosed is to be lowered:
Marilyn Mann, a respected and highly knowledgeable FH patient advocate was concerned!
“More people may be diagnosed with familial hypercholesterolemia (FH) using criteria contained in a new scientific statement published by the American Heart Association. The expanded definition could also mean more patients will be eligible to receive expensive cholesterol-lowering drugs, including the new PCSK9 inhibitors".
The new AHA advice is that 400mg/dL will now be considered an FH diagnosis, not the previously used 500mg/dL.
According to Mann, 3% of the population will meet this level, but “less than 1% of the population has FH". "You could have doctors diagnosing people with FH solely so that their insurance will cover a medication, such as PCSK9 inhibitors. That could be very confusing for patients.”
The UK will inevitably follow US recommendations, we always do.
In one simple stroke, the market for PCSK9 inhibitors had trebled.
The UK market for these drugs goes up from 130,000 people to 400,000 as a consequence, and another £2 billion a year gets re-directed to these drugs and away from other NHS treatments.
And this to lower cholesterol, in an effort to protect the public from heart disease that isn't caused by high cholesterol!
Do you think that the American Heart Association’s (AHA) decision here may have been affected by commercial sponsorship?
Here is one statement from the AHA site. ‘Amgen is a proud sponsor of the American Heart Association’s Heart360 Toolkit3’.
Amgen are also ‘proud’ sponsors of various AHA meetings, and sponsor of the FH Foundation.