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LegaL eye
‘ In 2013 Lundbeck had paid a 93.8m euro fine imposed by the European Commission after being found to have paid rivals manufacturing generic antidepressants to “ stay out of its market ...”.’
justified a published analysis focused on these drinkers and led to costeffectiveness analyses based on the sub-sample , leading the National Institute for Health and Care Excellence ( NICE ) to say the NHS must make the product available for these types of drinkers .
Each link in the chain retained the original analysis ’ s vulnerability to bias and its questionable applicability to patients in general . To this , NICE added acceptance of the company ’ s argument that it was neither appropriate nor possible to compare nalmefene with naltrexone , its cheaper parent drug . One strand in the argument ( justified by the unreliable sub-sample analysis ) was that nalmefene was licensed to reduce drinking , but naltrexone to promote abstinence . In fact , naltrexone usually promotes reduced drinking , and does so among the same types of drinkers .
The other argument which led NICE to discount naltrexone was the company ’ s assertion that required data was lacking from trials , and that these were so different from the nalmefene trials that comparison would have been invalid . Contradicting their own case , Lundbeck later sponsored and co-authored just such a comparison . Its findings were broadly but not always significantly in favour of nalmefene , but were undermined by the sub-sampling decision . In the three largest of the four nalmefene trials , this gifted the drug an advantage not replicated for naltrexone . The dice were stacked against naltrexone , but only a reader familiar with the source studies would have known .
Eliminating naltrexone from Selincro ’ s therapeutic ball-park or finding it less effective was vital to Lundbeck . Financially , the company had suffered from the expiring of patent protection , leaving its medications open to competition from cheaper , non-branded , ‘ generic ’ equivalents . Selincro was meant to help plug the resulting revenue gap , but this would not happen if it too faced competition from generic naltrexone . An indication of how crucial this kind of issue was , in 2013 Lundbeck had paid a EUR 93.8m fine imposed by the European Commission after being found to have paid rivals manufacturing generic antidepressants to ‘ stay out of its market and delay the entry of cheaper medicines ’.
Beyond naltrexone – and beyond this abridged version of the story – is whether any medication is appropriate for the kinds of drinkers at whom nalmefene is targeted .
Full story and supporting citations at http :// findings . org . uk / PHP / dl . php ? file = Palpacuer _ C _ 1 . txt & s = dd
Mike Ashton is editor of Drug and Alcohol Findings , http :// findings . org . uk
Joanna Sharr of Ridouts answers your legal questions
Our residential rehab has a good reputation but is the target of a negative online campaign by a disgruntled resident . How can we challenge this ?
JOANNA ANSWERS : The advent of social media and the ability of individuals to make online reviews has placed significant power into the hands of those who may wish to damage a service ’ s reputation . Even if your contract with the service user has regard to the use of social media while resident , engaging contractual provisions does not remedy the underlying issue .
This is a sensitive issue and should be handled with care ; if dealt with in a heavy-handed manner , not only could the service be perceived to be unreasonable , but the online campaign could easily escalate to cause further damage to the service ’ s reputation .
For whatever reason , the resident did not seek to raise their concerns with the service directly but went to social media to vent their concerns . Perhaps the resident did not feel that their issues would be taken seriously , but they should be reassured by the service that they are . We would therefore treat the online campaign as a complaint .
A service ’ s formal complaint procedure should involve particularising the concerns and recording them , exploring the issues and possible resolutions and ultimately responding to the complaint . It may be helpful to include the resident ’ s family ( or advocate if there is any capacity issue ) in any discussions to ensure that the resident feels supported throughout the process . The service should discuss the outcome of the matter with the resident and ensure that the situation is resolved to the resident ’ s satisfaction . This will also help evidence CQC ’ s key questions , ‘ well-led ’ and ‘ responsive ’ in any future CQC inspections .
The resident should be encouraged to raise any future concerns or complaints with the service directly . The service could request the resident removes their negative comments from social media and ask that the resident desists from using social media to vent any future concerns about the service , particularly if the matter had been resolved to their satisfaction .
There will always be cases where , no matter what a service does , a resident will simply be unhappy and will seek to maintain their damaging course of action online . If that happens , and all conciliatory routes are exhausted , the service may wish to consider its contractual options to serve notice to the resident . This course of action will not necessarily quell the negative social media campaign and may lead to an increase in posts . We would advise taking specific legal advice regarding contractual remedies and the implications and subsequent actions that could be required if the matter cannot be resolved amicably .
Joanna Sharr is a solicitor at Ridouts LLP , a practice of health and social care lawyers , www . ridout-law . com
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