Tuesday, 7 June 2016

Alcohol Concern, Lundbeck and nalmefene

It was reported yesterday that the anti-drinking drug nalmefene (AKA Selincro) is not particularly effective and that studies cited by its manufacturer Lundbeck are flawed. This is not the first time questions have been asked about this drug and I can't say I'm surprised. When I looked at the evidence in 2014, I was surprised by how weak it was. There are not many studies, for a start, and taken together they suggest that the drug is only marginally more effective than a placebo.

Why, then, was it approved by NICE and dished out at a cost of £3 per dose to the NHS for treatment of so-called 'mild alcoholics'? 

Dr Niamh Fitzgerald, a pharmacist and lecturer in alcohol studies at the University of Stirling, questioned why health watchdogs at NICE (the National Institute of Healthcare and Excellence) gave the go-ahead for the drug to be prescribed based on the evidence provided by the manufacturer.  

She said: "We found multiple problems with the way the trials for this drug were conducted.  

"We can't tell whether it's effective or not and we normally don't licence drugs unless we have really strong evidence that it is effective so that's what we're saying the evidence isn't yet strong enough.
"If the pharmaceutical company believe that it's effective then it should have continued and conducted further trials to prove that.  

"We require people to prove that the drugs are effective rather than just assume that they are based on unplanned analysis.  

"We want to know how the system has failed in such a way that a drug with not good enough evidence has been licensed and has been recommended by NICE."

This news was reported by the BBC yesterday morning and the alcohol research 'community' was abuzz on social media talking about. One group was strangely quiet, however. Neither Alcohol Concern nor its Welsh cousin Alcohol Concern Cymru have said a word about it. This is strange because Alcohol Concern have been very vocal about nalmefene in the past. They responded to the NICE consultation on Lundbeck's drug in 2014 and when NICE approved nalmefene for NHS use, Alcohol Concern came out to bat for Lundbeck, saying the drug was 'a useful addition to the clinician’s toolbox'.

Lundbeck have funded various Alcohol Concern initiatives such as this. In 2014, they gave Alcohol Concern money to produce an Alcohol Harm Map which was released to the press with the highly contentious claim that there are nearly 10 million drink-related NHS admissions per year. Alcohol Concern also runs the All Party Parliamentary Group on Alcohol Abuse 'with the assistance of a grant paid by Lundbeck Ltd'.

Lundbeck funded the Alcohol Concern conference in 2014 and gave them an additional £51,000 last year. At least, that's what Lundbeck's website says now. A few months ago it said £109,000.

Either way, it's a lot of money to be getting from Big Pharma for an organisation that is obsessed with the real or imaginary conflicts of interest of other people. Maybe they don't consider it to be a conflict for some reason? That would explain how Alcohol Concern's president, Ian Gilmore, could co-author a study about nalmefene in 2015 without mentioning any competing interests (how does that work?).

As I said in 2014, I would rather Alcohol Concern get their money from industry than from taxpayers. They may genuinely believe that Lundbeck's drug is a useful product which advances their mission. They may see themselves as commentators on all things alcohol and see nalmefene as being within their remit. If so, why the radio silence now?

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