Interferon, part of the standard treatment for hepatitis C, is a major cause of depression in patients with the disease.

A new study has linked the high rate of suicide among hepatitis C patients to side-effects of interferon, which is usually taken together with ribavarin.

These findings will increase clinicians’ interest in alternatives to interferon in the treatment of the life-threatening infectious disease.

Researchers at Loyola University, Chicago, observed: “Depression is a relatively frequent and potentially serious complication of interferon therapy for hepatitis C virus infection.”

Hepatitis C is an increasingly widespread infection worldwide, causing pain, fatigue, disability and death.

The standard treatment is a combination of ribavirin and pegylated interferon. The latter can relieve muscle and joint pain and reduce fatigue.

However, interferon affects serotonin levels and is consequently associated with depression. The study reports that between 10% and 40% of hepatitis C patients receiving interferon experience depression and may be at risk of suicide.

The study authors recommend that patients with a personal or family history of depression or suicide attempts should be carefully assessed and possibly treated for that condition before treatment with interferon begins.

There is conflicting evidence about the effectiveness of antidepressants in patients who are receiving interferon – they may help to reduce the symptoms, but do not seem reliably able to prevent the condition.

Interferon also has flu-like symptoms, and the new study will increase the pressure to develop alternative treatments such as the combination therapy involving drugs from Gilead and BMS that recently demonstrated strong clinical efficacy in a phase II trial.

GSK has appointed Lynn Elsenhans and Jing Ulrich as Non-Executive Directors to its Board.

The two will join the company from 1 July 2012 after being recommended by GSK’s Nominations Committee.

Sir Christopher Gent, GSK Chairman, said the appointments will help take “GSK’s global business forward”.

The former Chair, President and CEO of Sunoco Inc, a leading transportation fuel provider in the US, from 2009 to 2012, Lynn Elsenhans previously served at Royal Dutch Shell for nearly 30 years.

Ms Jing Ulrich, currently the Managing Director and Chairman of Global Markets, China at J.P. Morgan, serves as an advisor to global organisations across various industries and asset classes. She also advises Chinese institutions making investments overseas. 

“I am delighted to welcome Lynn and Jing to the Board of GSK,” said Sir Christopher.

He added the appointments reflect GSK’s “priority of appointing candidates who have deep knowledge of Emerging Markets or experience of running global companies.”

GSK has also made two additions to its Remuneration Committee and two to its Nominations Committee. Sir Deryck Maughan will join the Remuneration Committee from 1 July 2012 and be joined by Judy Lewent from 1 January 2013. Tom de Swaan and Professor Roy Anderson will join the Nominations Committee from next year onwards.

Three leading pharmaceutical companies are working with the US National Institutes of Health (NIH) to find new indications for failed drugs.

Pfizer, AstraZeneca and Eli Lilly have joined a research programme that aims to speed innovative drug development by using existing compounds.

The programme will seek to match these compounds to newly discovered genetic disease pathways to identify accidentally pre-targeted drugs.

NIH Director Dr Francis Collins pointed to a familiar example: the first effective HIV treatment, AZT, was an unsuccessful cancer drug.

Such discoveries, he said, have been “sort of serendipitous” – but the goal of the new research programme is to replace serendipity with systematic analysis.

Recent research has identified the genetic causes of 4,500 diseases, but so far targeted treatments have only been developed for 250 of these.

The three drug companies have agreed to each make available at least 24 ‘failed’ drugs (withdrawn or never launched) that passed safety tests, making their testing in new indications relatively easy.

Scientists will apply for NIH grants to study specific drugs.

To simplify the legal framework, the programme allows the companies to retain ownership of their drugs while the researchers can patent their own discoveries.

The NIH will invest about $20m in the programme in its first year, and hopes for support from more pharmaceutical companies in the future.

Results from Roche’s SUMMACTA study have shown the subcutaneous (SC) formulation of Actemra (tocilizumab) met its primary endpoint when compared with an intravenous (IV) version.

The two-year study included 1,262 patients and found that the weekly convenient SC formulation showed comparable efficacy and safety to the IV monthly formulation.

Dr Hal Barron, Chief Medical Officer and Head Global Product Development, said the results may provide patients and their doctors in the future with an “important additional treatment option.”

Roche will now complete a further clinical trial, the BREVACTA study, and plans to submit data from both to the US FDA ahead of obtaining a license for the SC formulation.

Actemra is approved for the treatment of adults with moderately to severely active rheumatoid arthritis (RA) who have had an inadequate response to one or more tumour necrosis factor (TNF) antagonist therapies. It is also approved for the treatment of active Systemic Juvenile Idiopathic Arthritis (SJIA) in youngsters aged two years or older.

Also in the SUMMACTA study, a similar number of patients with RA achieved an ACR20 response after 24 weeks – a measurement indicating improvement in the number of tender and swollen joints, pain scale and patients’ and physicians’ assessment of improvement, and certain laboratory markers.

“We are very pleased with these data showing that subcutaneous administration of Actemra provides clinically meaningful and comparable results to the IV infusion,” said Dr Barron.

The results of the BREVACTA study are expected later in the year.

The UK Government is to provide a research portal offering open access to data from publicly-funded research.

The new Gateway to Research portal is intended to promote collaboration between the life sciences industries and the academic and voluntary sectors.

Wikipedia co-founder Jimmy Wales will help to develop the £2m project and ensure that it effectively supports innovation.

The working group responsible for the portal was set up following the publication in December 2011 of the Government’s innovation strategy, which emphasised the need for open access to research data.

David Willetts (pictured), Minister for Universities and Science, said: “Giving people the right to roam freely over publicly funded research will usher in a new era of academic discovery and collaboration.”

He added that the project would “develop new online channels that enable researchers to collaborate and share data and build new research partnerships”.

Jimmy Wales will provide advice on the format and data standards for the research to be available via the portal, which will include both published papers and underlying data.

The funding of the portal has still to be decided, but may involve the funders of research paying the costs or the publishers paying after an initial closed period during which they can recover the costs.

Open access is already benefiting the public and voluntary sectors, according to two recent reports from the Open Access Implementation Group (which consists of several life science research organisations).

In particular, the public sector could save £26m in access fees and £2.6m in time costs, while improving its analytical and decision-making powers.

GSK Chief Executive Sir Andrew Witty has ruled out a takeover bid for AstraZeneca.

Sir Andrew told shareholders at the company’s annual general meeting yesterday not to expect any major takeovers in the future as GSK focuses on the potential of its pipeline.

In response to a question over a possible merger, Sir Andrew said a deal for AZ would be “very distracting” at a time when experimental drugs in its pipeline are entering an exciting period.

The future of AstraZeneca remains uncertain as the company battles against generic competition, setbacks in drug development and the loss of its CEO David Brennan after he retires on June 1.

Revenue was down by 8% in the first three months of this year at AZ with sales in the US, Western Europe, Established Rest of the World and Emerging Rest of the World all falling.

David Brennan announced his retirement to coincide with the publication of the Q1 results after admitting that the pharmaceutical sector is “experiencing pressures none of which I’ve witnessed in my 36 years in the industry”.

AZ shareholders had criticised his leadership in recent years after the company had failed to compensate for the loss of revenue with mergers and acquisitions.

As a result, industry analysts have speculated that AZ may become a takeover target for one of pharma’s biggest companies.

A merger of GSK and AZ, the two largest pharma companies in the UK, would provide big cost savings. It led one GSK shareholder to raise the issue with the Chief Executive claiming it would be more effective than the recent $2.6bn offer for Human Genome Sciences.

Sir Andrew said GSK believes it can “deliver an extraordinary return to shareholders through this acquisition. I think we waited until exactly the right moment to make this offer, but nonetheless this is a compelling offer for shareholders at HGS to consider,” he said.

The $13 per share offer was rejected by HGS – who have now instructed Goldman Sachs and Credit Suisse to help explore strategic alternatives to GSK’s bid. Sir Andrew declined to comment on whether he had made contact with HGS’ management since GSK’s offer was rejected.

Vectura Group has appointed its Chief Operations Officer, Dr Trevor Phillips, onto the Board of Directors.

Trevor Phillips joined Vectura as President of US Operations in 2010, becoming COO in July 2011.

Before joining Vectura, he gained extensive international experience in pharmaceutical company leadership and drug development, including the roles of COO and CEO at US company Critical Therapeutics as well as senior positions at Sepracor, Accenture and GlaxoWellcome.

Jack Cashman, Chairman of Vectura, commented: “We welcome Trevor’s addition to the Board, where his extensive industry experience in both European and US public listed pharmaceutical companies will be an asset to us as we evolve on the next stage of growth, positioning ourselves as a key player in the respiratory market.”

Based in Chippenham, Vectura specialises in developing drugs to treat respiratory diseases.

Critics have claimed that private healthcare firm Circle is putting profits before patients after documents showed it will received at least the first £2 million Hinchingbrooke Hospital makes annually.

A contract obtained by HSJ shows Circle will receive an initial two million pounds as well as more than half of the trust’s annual profits, unless this exceeds £6 million.

Christina McAnea, Head of Health at UNISON, called the agreement a “disgrace” and said patients and staff will “pay the price” for such a deal.

Circle began its ten-year contract in February 2012 and became the first private company to manage an NHS hospital and its full range of services.

Hinchingbrooke Hospital in Cambridgeshire has debts of around £40m. At the time of the deal, Circle said it would invest millions of pounds into the hospital in an attempt to clear the debts.

When the deal was announced, Circle Chief Executive Ali Parsa likened management of the hospital to the John Lewis chain.

Management at the hospital claim it has already made substantial improvements and transformed its A&E department from one of the worst in the region to one of the best.

However, Shadow Health Secretary Andy Burham aired concerns about the terms of the contract. He commented: “The structure of this deal holds worrying implications for the future of the NHS. It gives Circle a financial incentive to make eye-watering cuts.”

A spokesperson for the Department of Health said the deal has preserved this “valued local service – had it not been agreed, the hospital may have had to close.”

Campaigners against privatisation of the NHS have said the money earned by Circle should’ve been reinvested into improving services or treatments, or reducing the debt.

The erectile dysfunction drug market is shaped by the parallel needs of consumers and industry, with both demanding faster and more reliable performance. Maxine Vaccine explores the fine line between medicine and desire.

This week’s most exciting drug news was the FDA approval for Stendra (avanfil) from Vivus: an erectile dysfunction drug that can take full effect within 15 minutes.

Stendra is the youngest and studliest member of the Viagra family (PDE5 inhibitors), all of which have generic names ending in ‘fil’. Whether that is a play on ‘phile’ (lover) or, more crudely, on ‘fill’ is a question for chemists. It definitely has nothing to do with Phil Mitchell.

The greater speed of action of Stendra prompted urologist Dr Ira Sharlip to make the slightly double-edged comment: “Quick onset of action is important to men.” He added that Stendra would appeal predominantly to ED sufferers “whose opportunities for sexual activity are more casual”.

The new kid in town has the classic side-effects of the PDE5 inhibitor family: headache, lack of sensation, insomnia. But it doesn’t have the rare side-effect observed with Viagra of blue-tinged vision – about which Dr Sharlip said:

“Blue vision with Viagra is uncommon and at worst annoying. Most men who get the blue vision with Viagra don’t care about it.”

Perhaps it just reinforces their sense of living in a blue movie.

But is the impatience of male patients to get it on resonating with the sales professional’s hard-on for the next customer – leaving the clinician as the odd one out in the commercial three-way?

Let’s be honest about this. ED drugs restore reliable sexual functionality to men in whom age and/or circulatory problems have made such functionality unreliable or impossible. They are clinically suitable for men who are in late middle age or old age or have certain medical conditions.

They are not clinically suitable for young and healthy men who want to have more sex for longer, to have sex while drunk or stoned, or to be able to make porn films or imagine they are doing so. Yet that is the natural ‘market’ driven by their brand positioning as performance-enhancing products rather than as medicines helping to restore normality.

The ambiguity of the Viagra brand – is it a medical product or a consumer sex aid? – is reflected in the online market that exists for stolen pills or counterfeit versions of the drug. Just how big is that market? Well, this week it was reported that British fraudster Martin Hickman has been ordered to pay back £14.4 million earned by selling fake Viagra online.

The investigation – one of the biggest ever undertaken by the MHRA – uncovered more than 30 bank accounts scattered around the world, with customers across Europe served via a website hosted in Germany but run by Hickman from his Staffordshire home.

The pharmaceutical industry makes no money from counterfeit drugs – and indeed, it loses custom since those customers will not seek prescriptions. But the question the industry has to ask itself is: does its brand positioning create images and expectations that help to drive a black market in fake drugs?

Remember: a sales rep can do it all night, but only a key account manager can make your breakfast in the morning.

Maxine’s views are not necessarily those of Pharmaceutical Field.