NICE, New Drugs and Selective Fury in the Press

 

If you read particular mainstream newspapers, you could be forgiven for thinking that 90% of British residents are asylum seekers and that you are playing Russian roulette with your life if you leave the house after 7pm. You may also be forgiven for thinking that NICE are a bunch of grumpy old men, hell-bent on stifling the inventiveness of drug manufacturers whilst doing all they can to compromise public heath.

NICE, which stands for the National Institute of Health and Clinical Excellence, are actually the rationing body of the NHS. Although they have been accused of pandering to the whims of the corporations that they are meant to regulate, NICE were set up as an independent institution that conduct tests of new drugs and decide whether they offer value for money. As such, their decisions go a long way to deciding whether the NHS coughs up for the new product. Occasionally, they make the ‘wrong’ decision by revealing that useless drug is just that – this is traditionally followed by attacks from newspapers, medical associations and big charities. Even Members of Parliament that ‘consult’ for drug companies have been known to enter the public-relations battle.

However, what you read is the newspapers is not always an accurate reflection of recent events and society in general; it is an image distorted according to the understanding and the agenda of the editors. As such, what is reported may be incomplete or inaccurate account of a story. The question is not so much why they get it wrong, but more who influences editorial policy. Newspapers are capitalist institutions whose income is dependent on advertising revenue. As such, the editorial policy is indirectly dictated with those who spend money on advertisements, especially those that spend big. In this instance, this is the drug companies. Although they cannot (yet) advertise drugs direct-to-consumer in this country, these corporate giants yield power through the massive fees they pay to promote their other products (Panadol, Sensodyne, Lucozade and Ribena are all brands owned by GlaxoSmithKline, Listerine and Nicorette belong to Pfizer, and Proctor and Gamble own an array of brands from Ariel to Vicks, etc). On top this, 90% of the world’s media is owned by just nine companies, which means the money they shell out on the other side of the pond carries weight here. It is not good business to upset those that pay your wages and, more importantly, those that pay the wages of your bosses in HQ.

The big charities are equally dependent on their industry sponsors. Although many take contributions from the public, the amount raised in this way is not nearly enough to cover the cost of executive salaries stretching into six figures, or the fee for limousines to shuttle them around. In return for continued subsidy, the charities are expected to side with the drug companies whenever they chose to wage a PR battle. Selective anger is their remit, just as it is for other individuals that receive money from drug companies, such as medical associations and members of parliament.

In late January, we were treated to the latest example of such hyperbole when the National Institute for Health and Clinical Excellence delivered their verdict on the effectiveness of Sanofi-Aventis’ new drug for atrial fibrillation, dronederone. Essentially, their study found that the drug was next to useless. Because their report means that the new product is now unlikely to be prescribed by the NHS, the decision was met with the usual derision by the drug companies, the doctors and the charities.

176 cardiologists, together with 25 MPs and peers, wrote to NICE to ask them to reconsider their decision. In an open letter, they stated: “The draft guidance is a shocking decision, based on cost saving and will be extremely detrimental to many patients with AF, their carers and their medical professionals – all of whom had looked to this innovative treatment as a chance to restore long-term health and improve quality of life for appropriate-patients.” Strong stuff.

The irony missed by the pro-drug lobby was that, as the rationing body of the NHS, all of NICE’s decisions must be made on the basis of cost saving. They use a score-based system called Quality-Adjusted Life Years (QALY) to assess whether a drug is worthwhile or not. A drug that extends life must, on average, cost less than £36,000 for every year of life gained to be approved; likewise, drug that extends life but with half-the-expected quality of life must come in with a bill of less than £18,000 for every year gained to get the thumbs-up. It figures, therefore, that any ‘cheap’ drug that fails the NICE assessment must be very ineffective indeed. Accordingly, NICE issued a statement to that effect, stating that dronedarone ‘costs more and has not been shown to be more effective than other treatments for atrial fibrillation.’ Concerns were also voiced because of excessive side effects, such as nausea, insomnia and fatigue. In short, the drug is more expensive, less effective and more dangerous than the current breed of expensive, ineffective and dangerous drugs.

This is not the first time that NICE have been subject to criticism from groups who feel their interests are better served by a thumbs-up for the drug in question, and questions have previously been asked about the conflicts of interests that exist within their committees. In any case, the fact remains that they have an important role to play in regulating the pharmaceutical spend of the NHS, which currently stands at £8bn per year. The existence of such an organisation is both logical and necessary to protect the public from ineffective or dangerous drugs.

Not that the charities want to listen to logic. In the above example, the Atrial Fibrillation Association fulfilled their required role, expressing their very selective anger that NICE would not approve the drug. ““Paying out around £60 a month to keep a patient’s condition controlled is a small price to pay compared to the thousands it costs to treat every stroke suffered by an AF patient,” said their spokesperson Trudie Lobban, appealing to hearts and minds. True to form, the Association did not comment on the use of magnesium in treating atrial fibrillation, which would work out at around £10 per month. Are the AFA really that stupid, or could it be that securing the backing of long-term sponsors is more of a priority than the AF patients they claim to care for? The efficacy of magnesium is not debated – the mineral has been shown to reduce atrial fibrillation by 46% and, when tested, was twice as effective as the popular drug digoxin – so the most remarkable aspect of this story remains the extremely selective fury of those now speaking out.

Meanwhile, NICE must remember that you can’t please all of the people all of the time. And you can’t please the press unless you are approving the products of the companies that bankroll them.

References:

Davey MJ, Teubner D (2005). A randomized controlled trial of magnesium sulfate, in addition to usual care, for rate control in atrial fibrillation. Annual of Emergency Medicine, 45(4): 347-53.

Herman and McChesney(1997). The Global Media: The New Missionaries of Corporate Capitalism. Cassell, London.

Miller S, Crystal E, Garfinkle M, Lau C, Lashevsky I, Connolly SJ (2005). Effects of magnesium on atrial fibrillation after cardiac surgery: a meta-analysis. Heart, 91: 618-623.

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