Wednesday, April 14, 2010

The drugs policy don't work

I was going to write a long piece on the misguided, populist Tory policy on the NHS supply of drugs to treat cancer, but Unity has done it for me and done it with his usual aplomb. What the Tories currently propose is a massively retrograde step in health public policy and surrender to the financial power of the pharmaceutical companies over the science. They kicked off last week with Andrew Lansley being criticised - the latest in a long line of criticisms directed at the Tories by apolitical figures - after he alleged that since ministers had pledged to make a wider range of cancer drugs available, none of the fifteen drugs assessed had been fully approved.

Sir Andrew Dillon, the Chief Executive of NICE responded
It's wrong to recommend the use of treatments where the additional benefit is uncertain. This is misleading for patients and wastes scarce NHS resources. Not all patients with a particular condition benefit from a drug and some drugs only work well for some patients or at a particular stage in a disease. That's why we target the use of some new drugs, or make a partial recommendation.... patients who can really benefit can get access to treatment and the NHS can spread its resources to provide other treatments and services
Despite what the tabloids would have you believe, NICE is not there to restrict access to effective remedies - it actually carries out a task surprisingly rare in healthcare suppliers across the globe by comparing the efficacy of a new treatment against that of those currently used. We have been conditioned to think that the drug companies are out there, beavering away to produce new and exciting treatments for new diseases. In fact, as Ben Goldacre has written in his excellent expose of the standard of scientific knowledge in the media and beyond, Bad Science, and confirmed by a comment on the Unity posting from 'a&e charge nurse,' the golden age of drug development is largely done and to get past the time limits on patented medication, the drug companies rely on slight improvements to create new medicines and maintain profits. To ensure that these drugs get licensed, they encourage and assist patients with lobbying to get funding for a new drug from the health authority.

Unity explains that Dronedarone (Multaq) was touted around as the new wonder drug for treating atrial fibrillation as it was initially claimed that it could prevent 10,000 strokes a year if given to the 300,000 sufferers, although when the story resurfaced some 16 months later, it was considered to be suitable for some 40,000. The media stories slamming NICE for their delays didn't report that
even before it was licensed, the trial results for Dronedarone had failed to live up to early expectations. In fact what the manufacturers own data showed was that, for the vast majority of patients with atrial fibrillation, Dronedarone was only half as effective as existing drug treatments for this condition, all of which are considerably cheaper because their patents expired several years ago, allowing them to be produced as generics.
Indeed, for patients who suffer from a couple of particular heart conditions, the drug is absolutely contra-indicated because it has been show to actually double the mortality rate. It is a worthwhile treatment for a small percentage of patients who have one or more conditions that are additional risk factors and has been licenced for that

Sometimes, the manufacturers find out that a drug licensed for a particular treatment is actually effective in treating something else, so they pull a clever trick - tweaking the formula, renaming it and getting it relicensed. Richard Blogger explains the Avastin/Lucentis switcheroo thus
In short Avastin is a bowel cancer drug but was found to halt “wet” age-related macular degeneration. So the manufacturer altered the drug to remove the cancer active part and called it Lucentis. The two drugs have the same effect on “wet” age-related macular degeneration, but Avastin was only put forward for licensing for treating bowel cancer in the UK and Lucentis was put forward for licensing for treating “wet” age-related macular degeneration. The company decided to cost Lucentis according to how much the patient would pay to retain their sight. That is, £1000 per treatment, and (a local eye surgeon told me) about ten treatments are needed. Although Avastin is expensive as a bowel cancer drug (that’s another story) the volumes needed are so small that the cost for treating “wet” age-related macular degeneration is £1 per treatment. NICE can only approve licensed drugs, so for “wet” age-related macular degeneration it can only approve Lucentis. They came to a deal with the manufacturers that the NHS would pay for the first 14 treatments and after that the manufacturer would provide the drug for free. But as I mentioned above, most people need just 10 treatments. The eye surgeon I spoke to said that in his clinic he offers patients the choice of having the licensed Lucentis or the unlicensed Avastin, pointing out that they are the same, but the former is a thousand times more expensive than the latter. Half of patients choose Avastin. The Tories use the case of Lucentis (but not the details I have provided) as an example of the way that they want NICE to work.
What has been proposed is breaking the idea that science should be at the heart of decisions over drug spending. We can expect more pressure from the drug companies, more heart-rending stories and more occasions when political direction overrules the scientists and their pesky search for evidence, the best scientific model yet devised and one that the Tories can't wait to throw out for the sake of cheap votes. What is even worse is that this will give people false hope - NICE won't approve drugs unless they can be shown to have benefits additional to existing treatments and a good PR campaign combined with questionable data from a manufacturer is no substitute for a drug that does what it is supposed to.

Rather than trying to accuse Labour of spreading fear by talking about the real risks that a Tory government poses for healthcare in this country, Lansley and his colleagues should first remove the planks from their own eyes about what their policy really means for healthcare.

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