Lyrica Runs Into More Problems

Today's post from pulsetoday.co.uk (see link below) may be of interest to those neuropathy patients who have been prescribed, or are currently taking, Lyrica (pregabalin). As has been mentioned many times on this blog, two years ago, Pfizer themselves withdrew their recommendations for Lyrica for HIV- and diabetes-related neuropathy (thanks to both ineffectiveness and rising problems with side-effects). Since then, they have not officially changed their position regarding those two diseases but under the rising threat of generic versions and patents running out, they have realised their cash-cow is going to lose its profit margins and have been exerting pressure on doctors, health insurers and health authorities to continue prescribing the named version (Lyrica) irrespective of the consequences and their own advice. This article looks at the issue in the UK but it's being repeated across the world. It gives insight into the workings of the pharmaceutical world and shows yet again that patients' best health often takes a back seat. If your doctor is prescribing Lyrica for you, ask the necessary questions - there are alternatives and they need to be discussed.

Pfizer apologises ‘for causing GPs concern’ over pregabalin patent enforcement 
8 June 2015 | By Caroline Price

Drugs giant Pfizer has written an open letter apologising for ‘causing GPs concern’, after its legal action led to practices being forced to re-issue prescriptions for pregabalin with the branded form Lyrica.

Pfizer said it recognised that ‘discussion and media reporting’ about the policy had caused some clinicians concern, adding that ‘we apologise if this has been the case’.

And the company said it had been working hard with the Government and NHS policy makers for the past 12 months to ‘find the best way of supporting healthcare professionals’.

Pfizer is in the process of taking Actavis and other generics manufacturers of pregabalin to court, to prevent infringement of a ‘second medical use’ patent it claims to hold for the drug’s use specifically in neuropathic pain.

As a result, a recent interim High Court judgment ruled that GPs should be told they must now only prescribe pregabalin by its brand name – Lyrica – when giving it to patients for neuropathic pain, although they may continue to prescribe by the generic name for anxiety or epilepsy.

However GPs have reacted angrily to the directive, which they say encroaches on their fundamental prescribing rights and principles, and LMCs recently voted to push the Government to stop companies from enforcing second medical patents in the future.

The letter from Dr Berkely Phillips, medical director at Pfizer UK, and Seema Patel, established pharma medical director at the company, states: ‘There has been some discussion and media reporting about our patent for the use of Lyrica (pregabalin) in pain over recent months. We recognise this has been the cause of concern for some of you; and we apologise if this has been the case.

‘We hope this letter will help to bring further clarity and reassurances to all concerned.’

Related stories

Pfizer: ‘We wish we could have explained this pregabalin situation earlier and better’

Pregabalin is just the beginning…

GPs told to carry out review of patients taking pregabalin ‘as soon as possible’

The letter adds that Pfizer has done over 50 clinical studies of pregabalin specifically for the treatment of neuropathic pain and that ‘it is only as a result of our investment in this additional research programme that millions of patients have had access to this important treatment’.

It goes on to acknowledge that ‘the evolving R&D model and the forging of new ways are not without challenges for the NHS or industry’, adding that ‘we have been working with senior Government officials and NHS policymakers in England and the devolved administrations for almost 12 months to identify the best way of supporting healthcare professionals and communicating this relatively unusual and complex patent situation’.

And it concludes that Pfizer is ‘committed to doing the right thing for patients and the NHS, and we will continue to work with policymakers to find ways of supporting implementation at a local level’ and that ‘we hope that any framework that is put in place as a result of this work makes things easier for all and, ultimately, ensures that patients have access to life-saving and life-changing medical innovations of the future’.

LMCs recently dismissed the case for manufacturers to enforce such second patents at the LMCs Conference last month.

Dr Andrew Green, chair of the GPC’s clinical and prescribing committee, said: ‘At the LMC conference there was a debate about patent protection at which I took care to ensure the position of the drug companies as outlined in this extraordinary letter were aired; having heard this GPs were clear in their opposition to this behaviour.

‘GPs are experts at reading between the lines of what is said and drawing their own conclusions as to the true motives behind peoples’ actions, and I leave it up to my colleagues to decide whether Pfizer is demonstrating by its actions as well as this letter that it is committed to doing the right thing for patients and the NHS.’

Liverpool GP Dr Andrew Mimnagh said it was ‘gratifying that Pfizer acknowledges the additional workload from the company’s action, leaving the Department of Health starkly isolated from reality in maintaining that it had no significant detrimental impact on GPs.’

The full High Court hearing into Pfizer’s action to uphold the patent on neuropathic pain will take place on 29 June.

http://www.pulsetoday.co.uk/clinical/prescribing/pfizer-apologises-for-causing-gps-concern-over-pregabalin-patent-enforcement/20010189.article#.VXatl0b43EQ