Servier and its president are on trial in France, charged with misleading patients and health authorities about a weight loss drug.

Mediator (benfluorex), widely prescribed as an appetite suppressant, is believed to have caused over 500 deaths by heart valve failure.

The drug was withdrawn in France a decade after its withdrawal on safety grounds in Spain, Italy and the US.

Servier is accused of misleading French doctors about the risks of Mediator, whose prescription was supported by a government subsidy.

In addition to the criminal charges, several hundred civil plaintiffs are seeking damages of €100,000 each.

Servier’s President Jacques Servier, aged 90, and four other executives risk prison sentences of up to four years.

A second French trial, dealing with allegations of negligence and corruption, may follow.

Mediator, originally developed as a diabetes drug, was taken by up to 5 million people in France between 1976 and 2009 to assist weight loss.

The alleged failure of the French healthcare regulator to investigate the drug’s risks has prompted comparisons with the PIP implant scandal.

As with that case, the Mediator scandal has prompted questions about safety regulation at EU level.

Lawyer Charles Joseph Oudin commented: “Servier let people use a toxic product for years. There is no debate about it.”

India’s health ministry has claimed that ‘systemic improvements’ in the country’s drug approval procedures are needed, following a report on alleged corruption.

The parliamentary report alleges irregularities in the approval of drugs from major pharmaceutical companies, including major gaps in clinical evidence.

Companies including Eli Lilly and Bayer have challenged the accuracy of the report, which focuses chiefly on the failings of India’s drug regulator.

The Central Drugs Standard Control Organization (CDSCO) lacked adequate staffing or resources, the report found, and there was evidence of a “collusive nexus” between its officials, drug companies and medical experts.

An example cited was CDSCO’s acceptance of three expert opinions on Bayer’s anti-thrombosis drug rivaroxaban that were identical copies. Bayer responded that it had not played “any role in selecting these experts or evaluating their opinions”.

The report also claimed that CDSCO routinely approved drugs that were not approved in the EU or the US due to lack of clinical evidence.

Critically, it said that of 39 CDSCO-approved drugs it surveyed, 11 had not been tested on patients in different ethnic groups – a key requirement of approval in India.

An example was Lilly’s lung cancer drug pemetrexed – but the company insisted the drug had been tested on a large multi-ethnic patient base.

Irregularities claimed in the approval of drugs from Lundbeck, GSK and Novartis were similarly denied by the companies concerned.

The controversy reflects the growing importance of India and other ‘emerging markets’ for the global pharma industry.

Emergent regional organisations to provide GP commissioning support services are struggling to meet the assessment criteria, with three out of 26 failing outright.

Another nine CSS plans are said to need “rigorous management”.

Of 26 CSS organisations, only 14 robustly met all three of the NHS Commissioning Board’s criteria: quality of leadership, business plans and focus on CCG customers.

CSS plans for West Mercia and the Devon and Cornwall peninsula have been scrapped, together with plans involving a national communications service, after satisfying none or only one of the criteria.

The following regional plans only “marginally” passed the Board’s tests, and will be developed further by the Board’s business development unit:

Greater East Midlands

Greater Manchester

Cumbria & Lancashire

Birmingham & the Black Country

Essex

South London

Surrey & Sussex

Central Southern (Bucks, Oxon, Berks, Gloucs, Swindon)

Hertfordshire

The NHS Commissioning Board commented that for the rejected CSS structures, “robust plans” would be put in place “to ensure that CCGs have confidence in their commissioning support arrangements and that they can choose the best service that meets their needs.

“In these cases, it is clear that there will still be a significant need for locally-based staff to deliver support services to CCGs and that the main impact will be to senior management arrangements and organisation shape rather than to the roles that are available to NHS staff.”

The nine CSS organisations said to have significant weaknesses would be developed through “rigorous management”, the Board said, emphasising that all CCGs must have CSS arrangements in place when they apply for authorisation.

Bristol-Myers Squibb has expressed its disappointment after the Scottish Medicines Consortium (SMC) failed to recommend its skin cancer drug Yervoy (ipilimumab).

The SMC decided against approving the treatment for advanced (unresectable or metastatic) melanoma in adults who have received prior therapy after questioning its clinical benefits in relation to its cost.

Amadou Diarra, European Vice-President and General Manager, BMS UK and Ireland, said the company would continue to work with the SMC to “enable Scottish patients to access this potentially life-extending treatment.”

Around 1,200 people in Scotland are diagnosed with malignant melanoma each year. Its incidence is rising in the country at an epidemic rate.

Within the appraisal submitted by BMS, the SMC recognised how Yervoy is the first licensed medicine in the UK to demonstrate survival benefits in patients with skin cancer who have received prior treatment.

Data from a pivotal Phase III trial demonstrated how almost half (46%) of patients treated with Yervoy were still alive after 12 months of treatment compared to 25% taking the vaccine gp100.

The median overall survival was 10.1 months in those receiving Yervoy, compared with 6.4 months among those receiving gp100.

However, despite BMS also providing the treatment under the terms of a Patient Access Scheme to reduce the cost of Yervoy, the SMC did not believe it offered value for money to the NHS in Scotland.

“Ipilimumab is a prime example of an innovative medicine that has the potential to offer significantly improved outcomes,” said Amadou Diarra. “We are disappointed that the SMC has failed to recognise the value of Ipilimumab.”

Since it was licensed in Europe in July last year, eligible patients in England have been able to receive the treatment. During the same period, a number of patients have attempted to access Yervoy through an Individual Patient Treatment Request (IPTR). But, as far as BMS is aware, no IPTRs have been approved.

Leigh Smith, Chair of the Melanoma Action and Support Scotland, called the decision “incredibly disappointing” and said the decision by the SMC will drive patients south of the border.

“It leaves many Scottish patients suffering from this devastating disease with no option but to consider moving to England where funding for the treatment can potentially be accessed,” she said. “We hope that the SMC will consider all options available that might enable Scottish patients to benefit from this treatment.”

The Department of Health says it will prioritise improving health, care and value amongst its main objectives in the next twelve months.

Its Corporate Plan 2012–2013 outlines how the DH will complement the Secretary of State’s five strategic objectives with six priority areas of its own.

These include:

• Better health; Better care; Better value
• Successful change – delivering the transition to the new system
• Working with our partners
• Transforming the DH itself.

Una O’Brien, DH Permanent Secretary, said the priorities are a result of a “great deal of planning”.

Following the passage of the Health and Social Care Act, the DH says it now has a “firm platform” from which is can “build clarity” about the direction of the health and social care system.

The objective to improve health, care and value relate directly to the Department’s “enduring purpose”, it says, in supporting key business priorities until April 2013.

The Department aims to continue the work it does towards the changes outlined in the Health and Social Care Act to the structure of the NHS, whilst recognising the different methods required to work alongside partners.

Finally, it aims to transform the organisation to “develop its capability”.

“We have important work to do in the next 12 months to engage all staff in a vision for the new DH and in helping you to understand the practical changes needed to behaviours and working practices to reflect our changing role,” said Una O’Brien.

“I believe that the plans set out here reflect the realism and creativity of all the teams across the DH and I look forward to working with you throughout this important year ahead.”

The first proven drug for prevention of HIV infection has been recommended for FDA approval by an expert panel.

Truvada from Gilead Sciences, an oral combination therapy used since 2004 to treat HIV infection, may shortly be available as a preventative therapy.

The panel emphasised that the drug is less effective in women than in men, and must not be used in place of other preventative strategies.

Adherence was also highlighted as an issue, since Truvada is ineffective if not taken every day.

Truvada was recommended for prescription to people at high risk of HIV infection, including gay and bisexual men and heterosexual couples with one HIV-positive partner.

The medication is a combination of two anti-HIV drugs, Emtriva and Viread. Its off-label use to prevent HIV infection is already widespread.

In 2010, a three-year study by the US government found that daily doses of Trevada together with condom use reduced the risk of HIV infection by 42% in gay and bisexual men. In 2011, a similar study found that it reduced infection by 75% in heterosexual couples where one partner was HIV-positive.

The drug’s value is contested among people working to control HIV infection, due to concerns that Trevada will give people who are not compliant with the need for condom use and/or daily dosage a false sense of security.

While the cost of widespread prescription is not a factor in whether the FDA grants marketing approval for Trevada, it will clearly affect its uptake by health workers relative to other strategies.

A new quick-start reference guide to joint working to help address potential barriers to NHS/industry collaboration has been launched.

The ABPI guide maps the journey of identifying and establishing joint working projects, and offers guidance on how to implement, monitor and evaluate their success.

Stephen Whitehead, ABPI Chief Executive, said the guide aims to overcome “challenges whether you are an NHS or industry professional”.

The guide, Joint Working – A Quick Start Reference Guide for NHS and Pharmaceutical Industry Partners, was developed by combining materials published by the ABPI and the DH.

It was created in response to feedback from ABPI members and NHS partners to tackle typical challenges faced when developing joint working schemes.

The flowchart structure offers advice across the life cycle of a joint working project, from idea generation through to approval, recommendations and evaluation.

Mike Farrar, Chief Executive of the NHS Confederation, said the guide would be a “useful tool in helping build the foundations between the NHS and industry partners”.

Thousands of patients across the UK have already benefited from joint working between industry and the health service. The ABPI now hopes the guide will help stakeholders overcome any future obstacles that may prevent improvements in patient care as a result of joint working.

Shares in Arena Pharmaceuticals increased in price by 80% after advisors to the FDA backed the approval of the obesity drug lorcaserin.

The FDA’s Endocrinologic and Metabolic Drugs Advisory Committee voted in favour of recommending lorcaserin after deciding data demonstrated that benefits outweighed long-term risks.

Jack Lief, Arena CEO, said the decision “supports our belief in lorcaserin as a potential new treatment option for the medical management of overweight and obesity”.

The Prescription Drug User Fee Act (PDUFA) date for the FDA’s final decision on lorcaserin is now expected on 27 June.

Lorcaserin was initially rejected by the FDA back in 2010 when concerns were raised over its clinical effectiveness and around its side-effects.

Arena refiled the drug at the end of 2011 with new data ruling out excessive risk of valvular heart disease.

The decision on Lorcaserin comes a month after the same committee supported the use of Vivus’ rival obesity drug Qnexa (phentermine/topiramate) with its PDUFA data extended from April 17 to July 17.

Contrave (naltrexone/bupropion), another rival weight loss drug from Orexigen Therapeutics and Takeda, is currently being evaluated in a cardiovascular outcomes trial after it was rejected by the FDA over heart risks.

After the positive decision by the FDA’s advisors, Arena and its marketing partner Eisai expanded their marketing and supply agreements for the treatment to cover the US, Canada, Mexico and Brazil.