By Malcolm Kendrick
That old adage ‘Fool me once shame on you, fool me twice shame on me’ looks like a perfect description of why the heart disease establishment should be hanging its collective head. Having totally bought into one cholesterol-lowering class of drug – statins – it now looks ready to open its arms and pockets equally wide to embrace a new improved more powerful son of statin drug – the PCSK9 inhibitors – that will drive that deadly fatty stuff right to the floor.
By now it should be clear to any independent medical expert that the benefits of statins have been massively exaggerated and their problems dangerously minimised. Hundreds of people who haven’t had a heart attack have to take one of these pills daily for years for just one to benefit. No one knows the true level of side effects because even the limited data from the company trials has never been properly analysed. Statin supporters claim as few as 1% of those on the drugs suffers any harmful effects; recent reports say it could be 25%.
Just how good are they? For years gung-ho cardiologists have claimed they could cut the risk of a heart attack by 25 or even 40 percent; in fact a one percent drop is optimistic. This highly misleading picture was created by deliberately manipulating statistics. Equally mendacious was the claim that these drugs saved lives – maybe 10,000 a year in the UK. No drug saves a life because we all die. What they can do is to prolong lives. So the question becomes: by how much? Two studies out this year suggest about three to four days a year and that’s for those in the highest risk category.
Lowering cholesterol increased the risk of death from heart disease
One of the triumphs of statin promotion has been to turn one of the most useful substances in our bodies – cholesterol – into a killer such as smog or dirty water. Most statin drugs were licenced simply on the basis that they lowered cholesterol, condemned because it raised heart disease risk. This was despite the fact that many drugs that lowered cholesterol, such as the fibrates, oestrogen and one called ezetimibe, either increased the risk or had no effect on it. Recently a study of people admitted to hospital after a heart attack found that those with the lowest cholesterol were ten times more likely to die than those with higher levels.
Data supporting all these claims is widely available. Now even GPs, who are paid for every patient they put on statins, have been rebelling at the latest outrageous guidelines from NICE that doubles the number eligible for statins and simply refusing to follow them.
But instead of having some sort of statin truth and reconciliation commission to sort out these widely differing competing claims, the cheap off-patent statins are about to be replaced by and new stronger and vastly more expensive cholesterol exterminator. What is profoundly depressing is that most of the tried and tested techniques used to push statins to the top of the drug charts are being cynically rolled out to fool us once again.
Here we reprint a post from redoubtable Dr Malcom Kendrick, who Van Helsing-like has spent a decade attempting to drive a stake through the heart of the cholesterol-lowering myth. Our slightly edited version of Dr Kendrick’s post describes how one of the most effective techniques for boosting drug sales is already being employed to ensure the returns on the PCSK9 drugs match the rewards collected by their forerunners.
Expanding the market for a new drug at the stroke of a pen
By Malcolm Kendrick
As you may know two new cholesterol lowering drugs have now launched. Two PCSK9 inhibitors. I call them the ‘dreaded’ PSCK9 inhibitors. I have written about them a few times. There has been surprisingly little noise about them so far, at least in the UK. Not sure about the US or the rest of the world. They are called Repatha and Praluent. Catchy eh!
These drugs have two major problems at present, at least from a money making perspective. They have no outcome data, by which I mean that they have not been shown to reduce the risk of heart attacks, strokes… or anything else for that matter. (They have been launched purely on their ability to lower LDL to violently low levels). They are also extraordinarily expensive. In the UK Praluent will cost between four thousand to eight thousand pounds ($6 – $12K) per year, depending on the dose1.
Which means that the NHS can, if it so wishes, pay eight thousand pounds a year for a drug that does not actually do anything – other than lower a surrogate marker for heart disease. Now this may not be seen as bargain of the year. I can imagine great battles are going on right now between the pharmaceutical companies and NICE (the organisation that decides if a drug is cost effective, or not.)
Exactly what is this drug good for?
At present I would think that the response of NICE would be ‘Are you out of your tiny little minds. Why the [(****) insert swear work of choice here], would we fund this?’ At least I would certainly hope this would be their response. Imagine if everyone on statins in the UK, around seven million, changed to PCSK9 inhibitors. This would cost £56 billion pounds [$80Bn] a year. A tidy little sum. Half of the entire NHS budget in fact.
So the drug companies involved have a problem. They have these amazing cholesterol lowering super-drugs on which they’ve spent hundreds of millions developing that do nothing and are enormously, eye-wateringly expensive. Come on, come on. Think!
To be frank, I thought that the primary marketing tactic would be to claim that statins actually have many, many horrible side-effects – that no-one noticed until…. there were new drugs to be launched of course. Which would mean that all those people who were ‘statin intolerant’ would need to take PCSK9 inhibitors instead. To get that horrible, damaging LDL level down. There is no doubt that the attack on statins is currently happening, but there has been more resistance to this than expected.
So, what else can you do? Well, there is one population for whom cholesterol lowering is seen as absolutely essential – people who have familial hypercholesterolemia (FH). This group has always been considered at such a high risk of dying from heart attacks and strokes, that no clinical trials have even been done. You just do anything, and everything, to get the cholesterol (LDL) levels down, no questions asked. [No evidence of benefit needed either]
A big money spinner but it’s still not enough
Current estimates of the number of people with FH range between 1/200 and 1/500 hundred. When I started thinking about, I realised that this is really a big enough market for PCSK9 inhibitors. Just to do some simple sums. There are sixty-five million people in the UK at present. If one in five hundred has FH, that gives you an FH population of 130,000. If every single one of these people goes on the higher dose of one of these drugs, the total sales would be £1bn/year. In the UK alone. That is a blockbuster by anyone’s definition.
If we transpose these figures to the US, the sales start to look really healthy. The US population is three hundred and twenty million, giving you 640,000 people with FH, generating potential sales for, say, Praulent of $9Bn/year. Worldwide we are talking tens of billions a year.
This might seem very good news for Amgen – the manufacturer – but in fact it’s not nearly enough. There are rival PSCSK9 inhibitors in the pipeline and not everyone will take an injectable medication every two weeks, no way. Realistically, you might get a maximum of a quarter of those with FH on your drug. This would mean Amgen actually would be left with piddling sales of $10Bn/year worldwide.
Making sure more need to take it
So what’s the simplest strategy if a market isn’t big enough? Make it bigger of course. And the easiest way to do this is what NICE did for statins – change the diagnosis so more people can be identified as suffering from FH.
And lo, it has come about. The American Heart Association has stated that it is lowering the level of LDL needed to diagnose FH. The new criteria for heterozygous FH sets an LDL level (note that is just LDL, not total cholesterol which is what your doctor usually orders) of at least 190 mg/d L (4.9mmol/l) for adults who have a similarly affected first-degree relative, premature coronary artery disease, or a positive genetic test.
In one simple stroke, the market for PCSK9 inhibitors in the US has been increased from 640,000 to 1,920,000. Or, in monetary terms, $9Bn to $27Bn. There, that’s more like it. In the UK the market goes up to 400,000, with max PCSK9 sales going from one billion to three billion pounds sterling. A clever little trick.
I must say that I, possibly the most cynical human on the entire planet, never thought they would do this. I discounted as just too brazen. It would just be likely to be laughed out of court. Silly me. No-one is laughing. Experts are rubbing their chins and nodding sagely at the wisdom of this move. New swimming pools all round, is what they are probably thinking.
Follow the money
Do you think that the American Heart Association’s (AHA) decision here may have been affected by commercial sponsorship? This, of course, would be impossible to say – without getting sued senseless for libel.
However, I had a little look around the AHA, and Amgen, also the ‘non-profit’ FH Foundation and Amgen, and suchlike. Here is one statement from the AHA site. ‘Amgen is a proud sponsor of the American Heart Association’s Heart360 Toolkit3. Ho hum Needless to say. Amgen are also ‘proud’ sponsors of various AHA meetings.
In addition, Amgen are also a foundation ‘corporate sponsor’ of the FH foundation4. They are probably very proud of that too. Finding these financial relationships can be a little tricky, as they are usually hidden in the depths of various websites. Perhaps other might care to improve on this list… Probably not that hard to do.
‘Money makes the world go around, the world go around, the world go around.’