Steve Turley, Managing Director of Lundbeck, has been re-elected Chair of the European Medicines Group (EMG), the UK voice of pharmaceutical companies based in continental Europe.

Robin Bhattacherjee, General Manager of Actelion, was re-elected vice-Chair of the EMG; and Mike Sumpter, CEO of Servier Laboratories, was elected Treasurer.

Issues highlighted at the EMG’s twelfth AGM included the impact of NHS reform on European-based companies and European perceptions of the UK as a pharmaceutical market and research base.

The EMG’s 15 member companies are Actelion, Almirall, Bayer, Boehringer Ingelheim, Ferring, Lundbeck, Menarini, Merck Serono, Norgine, Novartis, Novo Nordisk, Roche, Sanofi, Servier and UCB.

Steve Turley (pictured) commented: “We have members ranging from the UK’s biggest pharmaceutical companies, through biotechnology specialists to emerging organisations. Yet we all share common challenges and can benefit from being able to view these through a European-focused lens.”

“How the implementation of the NHS reforms affects European-based companies is a key issue this year,” noted Robin Bhattacherjee.

“Upwards of 60% of the medicines our members have introduced in the last decade have not been subject to a NICE health technology appraisal, so... local decision making in the CCGs about the use of these remains a major focus for EMG.”

Mike Sumpter noted: “Globally the UK is viewed as a tough market where innovative new medicines aren’t adopted as readily as similar economies.

“We want to work closely with our NHS stakeholder partners to demonstrate that the UK and the NHS is worth investing in.”

Lundbeck is based in Denmark, Actelion in Switzerland and Servier in France; all three companies have major UK operations.

The European Medicines Agency (EMA) has been told to accept the gagging orders of two US pharma companies pending a decision by the EU General Court.

Legal challenges by AbbVie and InterMune to the EMA’s policy of publishing clinical trial data relevant to its drug assessments must be accepted until a final judgement is made, the court said.

The US companies’ action contrasts with the growing trend in European pharma, with GSK and Roche both pledging to improve their clinical trial data transparency.

In accordance with a policy declared in 2010, the EMA is granting access to all clinical and non-clinical information (including clinical study reports) submitted by companies in their applications for marketing authorisation.

This is the first time that its policy of full disclosure of clinical trial data following the authorisation decision has been legally challenged.

The EMA is considering whether to appeal the interim decision that the AbbVie and InterMune clinical trial data cannot be made public. It has stated the need for clinical data transparency to enable scrutiny of its recommendations.

Since the filing of the two legal challenges in March, the EMA has received statements of support from the European Ombudsman, national competent authorities, members of the European Parliament, academic institutions and scientific journals.

The Agency will continue to draft its policy on clinical trial data.

GSK and Roche have discussed clinical data transparency in a House of Commons Science and Technology Committee session.

Both companies expressed a commitment to greater disclosure of clinical trial results, acknowledging that public opinion on this issue had changed.

Leading medical academic Dr Ben Goldacre (pictured), author of Bad Pharma, questioned the speakers on how effectively these ideals would be realised by industry.

The issue of access to clinical trial data was highlighted by recent controversy over Roche’s trials of the antiviral Tamiflu, data from which were promised but not delivered to the Cochrane research group.

A campaign for the publication of all clinical trial data was fronted by Goldacre and supported by Cochrane, NICE and the BMA.

In recent months, GSK has pledged to publish all clinical trial data relevant to its currently available drugs, while Roche has promised to make redacted versions of the ‘missing’ Tamiflu trials available to Cochrane.

The Parliamentary session debated the industry’s principles and practices in this contentious area.

James Shannon, GSK’s Chief Medical Officer, said the company would only submit clinical study reports to a regulator if it were applying for a product licence – but “all of those studies would be published in a peer-reviewed journal”.

That might be true for GSK, Goldacre commented, but it was not generally true for the industry.

William Burns, a director at Roche, stated: “What we’ve seen is an increasing requirement over recent years for more stakeholders to have more access to the data, and if society wants that to happen, then we have to respond.”

Goldacre replied that Roche was “making exactly the right kind of noises” about transparency, but had not yet delivered on its “aspirations”.

Both companies reiterated that they were committed to meeting clinical demands for data transparency.

Classified drugs, which are potentially dangerous and liable to abuse, have legitimate uses but also turn up on the black market. What does this mean for industry – and how has the internet affected this problem?

Take a look at any list of ‘drugs’ banned in the context of recreational use – or more accurately, abuse – noted by the Home Office, social services or avant-garde novels. They fall into three categories. Drugs made from natural sources – marijuana, opium and magic mushrooms. Synthetic drugs that have no medical function – ecstasy (MDMA) is the classic example. And drugs that have been patented by pharmaceutical companies and released for medical use – that’s all the rest.

Heroin, cocaine, amphetamines, tranquillisers, barbiturates – you name it, doctors have prescribed it and addicts have taken it, with or without prescription, and often with bad consequences. In the past, many psychoactive drugs were shifted from medical sources to the black market via theft or bribery. Today, they are more likely to be manufactured in secret labs in Latin America, the Far East or that odd little house in your street with the blacked-out windows. You might be surprised at how strong the UK pharmaceutical manufacturing base really is.

You may wonder why that’s a problem for industry. When you’re talking about drugs that affect the nervous system – killing pain, inducing sleep or keeping people awake – the subjective factor is important. If a patient knows the drug they get on prescription is also available on the street corner, they may react in various ways. They may decide, on the basis of news or hearsay, that the drug is too dangerous to take. Alternatively, they may decide they want more of it than their GP will provide – and their friends want some too. Either way, the drug’s value chain gets tangled up with barbed wire. It’s not your fault, but that doesn’t mean it’s not your problem.

Two recent events reflect the pervasiveness of this issue. Firstly, the Advisory Council on the Misuse of Drugs recommended that the painkiller tramadol should be made a Class C drug – with penalties of up to two years for possession and 14 years for supply. Tramadol has both opioid and antidepressant properties, making it a potent euphoric but increasing the clinical dangers of overdose.

Secondly, Roche took Valium off the market after fifty years of iconic status as ‘mother’s little helper’. Forty years after patent expiry, the black market had finally pushed the brand into the red.

The only chemistry

The UK’s classification system for ‘dangerous drugs’ is based on the Misuse of Drugs Act 1971, which gave the Home Offie a role in drug licensing by defining the boundaries between legitimate and illegal use of medicines. The Act defined four types of drug crime: unlawful possession; possession with intent to supply; supplying, even if no money changes hands; and allowing your premises to be used for producing or supplying a controlled drug.

The Act also divided controlled drugs into three classes in terms of the penalties for illegal use:

• Class A – up to seven years’ imprisonment for possession, up to life imprisonment for supply

• Class B – up to five years’ imprisonment for possession, up to 14 years’ imprisonment for supply

• Class C – up to two years’ imprisonment for possession, up to 14 years’ imprisonment for supply

An unlimited fine can be imposed instead of, or in addition to, any of these sentences. The law is designed to come down most heavily on illegal manufacturers and suppliers – in other words, the people doing illegally what you do within a legitimate business framework. In practice, of course, it’s mostly the end users who get caught, tried and jailed.

Down at the doctor’s

What should pharmaceutical sales professionals keep in mind when working with controlled drugs? I won’t insult your intelligence by telling you not to break the rules. It’s the things that can happen that aren’t your fault you need to worry about.

Doctors and pharmacists have strict guidelines about using only legitimate suppliers. However – as the recent scandal of counterfeit cancer drugs being found in US pharmacies proved – the pressure to use cheaper suppliers means the audit trail of many drug supplies is extremely complex. If the drug is a controlled one, the threat of illicit sources to the supply chain is much greater.

It’s important to distinguish between ill-effects of drug abuse and potential side effects of legitimate drug use. The negative impact of abuse on a drug’s reputation is considerable – and, in addition, studies of abuse provide genuine insight into the risks and benefits of a drug. So be prepared for that side of things to make your discussions with customers more complex – maybe more difficult, but also maybe more fruitful if you’re well informed.

The internet has made the supply network for illegal drugs both more diverse and more immediate. The user can access a global black market without needing to hang out in dangerous places or carry cash. Every bedroom is a car park now: the black market in drugs has no limits as regards time, place or who is involved.

Be aware of security issues. Andrew Bolan at ABPI comments: “All activities related to the legitimate manufacture, distribution, supply and storage of controlled drugs are subject to the regulations made under the Misuse of Drugs Act. All actors in the legitimate supply chain will hold the appropriate licences and have the necessary facilities and systems to ensure the secure supply of these products to patients, and all these elements are subject to scrutiny and control by the appropriate authorities.

“While every effort is made via these systems to prevent the illicit diversion of these products, the issue of theft is a concern and, despite the best efforts of all in the supply chain, there will always be a risk of such events. The pharmaceutical industry is always willing to work with other partners in the supply chain to seek to enhance the already high level of security that is applied to the movement of controlled drugs.”

Blues run the game

One of the great blockbuster drugs, Valium (diazepam) helped to make Roche a leading global pharma company. While known primarily as a tranquilliser, it has also been used as an anti-convulsant, a muscle relaxant and an anti-depressant. The brand’s popularity among the general public as a means of coping with stress earned it the nickname ‘mother’s little helper’, and kept Valium on the market for forty years after its patent expiry.

However, the addictiveness of Valium soon became notorious, with some experts arguing that it induced serious physical dependency. This, combined with the emergence of SSRIs as more successful anti-depressants, led to diazepam being increasingly used only for short-term sedation, where branded Valium had less commercial traction over generic equivalents.

But users – in both senses – rush in where doctors fear to tread, and ‘blues’ are now a staple of the illegal drug world. Their widespread legitimate use has helped to fuel an illegal supply chain via many forms of theft and fraud. While Roche gave the long-term effect of patent expiry as its reason for taking the brand off the market, it would appear likely that a fuller explanation lies both in Valium’s dwindling legitimate market and in its rapidly growing online illegal market.

Diazepam tablets that look like Valium, thus retaining elements of brand appeal, are being marketed by MSJ Industries, a subsidiary of the Sri Lankan manufacturer J.L. Morison Son & Jones (Ceylon) PLC. Stamped ‘MSJ’, they are legitimate pharmaceutical products, but are being diverted to the black market – where they are known as ‘MSJs’, ‘vals’ or ‘blues’ – in large quantities.

As an example of the information available, Pf found an easily accessible online forum with a thread titled ‘MSJ blue pills (Vals?)’, featuring comments from people around the UK. One forum member offered to supply MSJs at the remarkably cheap rate of £20 for a hundred 10mg pills, or £80 for 500. Others commented:

• “I took two of them last night meaning it should have been a 20mg dose. But these two I took sent me well off.  It was like I had just taken 60mg or something. Couldn’t move.”

• “the msj are from sri lanka mate. they are the real mccoy. due to no standards and/or no quality control means that some msj tabs have 8mg-28mg per pill. i hope this helps you.”

• “msjs are the best valium about beat roche hands down”

 These words leave you wondering what ‘controlled drugs’ really means. For the pharmaceutical industry, that’s not a comforting thought.

Draft guidance from NICE does not recommend Avastin (bevacizumab) for treatment of recurrent advanced ovarian cancer.

NICE’s appraisal committee determined that the Roche drug, when used in combination with the chemotherapy drugs gemcitabine and carboplatin, did not represent good value for the NHS.

The main reason for the decision was that clinical data were unavailable for a third of clinical trial participants, for reasons unknown to NICE.

Recurrent advanced ovarian cancer, when the cancer has returned following initial treatment and has spread beyond the ovaries, is terminal. However, NICE did not accept that Avastin qualified as an end of life treatment.

Roche’s submission highlighted the fact that Avastin together with chemotherapy offers a median progression-free survival benefit of four months more than chemotherapy alone.

However, NICE stated that “the data from around 30 of the patients had been censored” and the impact of that on progression-free survival rates was “unclear”.

The committee further noted that Roche’s estimated ICER of £149,050 per QALY gained “was likely to be optimistic”.

In addition, it said, there was insufficient evidence of overall survival benefit, and there was no patient access scheme. The latter has become a key deal-breaker for NICE in recent years.

Ovarian cancer affects around 7,000 new patients in the UK each year, and Roche estimates that over 2,000 women would be eligible for treatment with Avastin if it were approved in this indication.

Avastin has received several NICE rejections in recent years, as it offers some progression-free survival benefit but is costly. Many UK patients currently receive it via the Cancer Drugs Fund, which is soon to be discontinued.

Roche has offered to release edited versions of “all 74 Roche sponsored trials” of its influenza drug Tamiflu to the Cochrane Collaboration researchers.

The Swiss company said the clinical study reports would be “edited by Roche to ensure patient confidentiality and to protect legitimate commercial interests”.

After three years of public argument and a recent campaign to end secrecy over clinical trial data, Roche’s offer means a potential end to the ‘Tamiflugate’ scandal.

Roche has also offered the Cochrane group a place in its new Multiparty Group for Advice on Science (MUGAS), of which the other three partners are consultants or scientific advisors to Roche.

The Cochrane group has welcomed the offer of Tamiflu data, and has asked for clarification of the MUGAS proposal.

In 2009, Roche promised to release the full trial data to the Cochrane researchers in order to enable them to address concerns about the efficacy of Tamiflu as an antiviral.

However, the company stated in 2011 that enough data had been released (from 10 clinical trials), and to disclose more would violate both commercial and patient confidentiality.

The Cochrane group’s campaign to have the data released was taken up by the BMA, Sense about Science and writer Ben Goldacre, growing into a wider campaign for clinical data transparency that recently won the support of GSK.

In a bid to end the damaging controversy, Don MacLean, life cycle leader for Tamiflu at Roche, has proposed providing the missing clinical study reports (in edited form) over the next few months.

Cochrane researcher Carl Heneghan commented that Roche had dropped its past arguments against disclosure: “The very fact that the 74 studies are now being released undermines these original statements: that we had all the detail we needed and that it wasn’t necessary and it has become increasingly clear that this is not the case.

“It then follows that regulators were in the same situation as we were: lacking data to come to firm conclusions.”

The MUGAS proposal constitutes an offer by Roche to work with the Cochrane group on resolving concerns over the efficacy of Tamiflu. The researchers rejected the same offer as long as the trial data were withheld – however, the issue may now be open to a negotiated solution.

NICE has again failed to recommend Roche’s cancer drug Avastin (bevacizumab) – this time in new draft guidance for the treatment of metastatic ovarian cancer.

An independent Appraisal Committee decided that Avastin is not a cost-effective treatment option after a consultation period, following initial draft guidance issued in December 2012.

Roche said it was “disappointed” by NICE’s decision and claims that Avastin is the only drug proven to improve outcomes in women with ovarian cancer in the last 15 years.

Avastin recently failed to gain a recommendation as a treatment option for advanced ovarian cancer in separate guidance with NICE again citing cost reasons.

The most recent appraisal assessed whether Avastin, when used in combination with the chemotherapy treatments paclitaxel and carboplatin, would be a cost-effective option for the NHS. Avastin’s licensed dose is 15mg per kilogram of body weight – although many doctors use lower dosages when treating patients.

NICE’s assessment considered the treatment according to its marketing authorisation and not in line with current practice, which saw its cost-effectiveness analysis fall outside the range considered for NHS use.

Roche, who did not submit a patient access scheme to lower the cost of the drug, said that women will now have to rely on the Cancer Drugs Fund (CDF) to access the treatment.

But it raised questions around the “considerable uncertainly” on how medicines currently funded by the CDF will be available to patients when the scheme ends in March 2014. Roche has called for “a clear transition plan” for such medicines to reassure patients currently using these treatments.

The updated draft guidance is now subject to a two-week appeal period.

The Scottish Medicines Consortium (SMC) has declined to recommend the use of Avastin (bevacizumab) for women with recurrent ovarian cancer.

According to SMC, Roche’s drug confers up to four months’ additional progression-free survival when combined with standard chemotherapy, but the benefit does not justify the high cost.

NICE provisionally made the same decision in December – but in England, the Cancer Drugs Fund (soon to be cancelled) makes the drug available for this indication in selected patients.

SMC, like NICE, has already decided not to recommend Avastin for treatment of newly-diagnosed advanced ovarian cancer.

Avastin is given in combination with standard chemotherapy, as a three-weekly infusion, to patients with recurrent ovarian cancer after first-line treatment. It works by blocking the growth of new blood vessels to the tumour cells.

SMC noted that patients in a clinical trial showed an extra four months’ survival without cancer progression when Avastin was added to their chemotherapy. However, it said, there was “uncertainty” regarding the effect on overall survival.

In addition, “the cost in relation to the health benefit was significantly above the threshold normally accepted by SMC”.

Avastin has a history of being licensed for cancer treatment, but not recommended as cost-effective.

Medical writer Ben Goldacre has argued that the profusion of indications for which the drug has been proposed is a result of recurrent “sub-group analysis”, while so far Roche has only published the results of 10 out of 24 phase III studies.

However, the question of what price can be paid for months of progression-free survival is also crucial at a time of increasing pressures on health service budgets.

Professor Charlie Gourley, Honorary Consultant in Medical Oncology, University of Edinburgh, commented: “It is extremely disappointing that oncologists in Scotland who treat women with recurrent ovarian cancer do not have access to Avastin. The negative SMC decision and the lack of a Cancer Drugs Fund in Scotland will prevent patients benefitting from an extra four months without the signs and symptoms of their disease.”

The UK has one of the highest rates of incidence of ovarian cancer in Europe – as well as one of the highest mortality rates, with the disease killing over 4,000 women each year.

Franz Humer has told Roche he will not stand for re-election as Chairman of the company’s board of directors next year.

The 67-year-old announced his decision at Roche’s annual general meeting that he intends to end his 28-year association with the Swiss-based company when his term ends in 2014.

He said that Roche is in “excellent shape and well positioned to meet future challenges” and now is a “good time to hand over to a successor”.

Roche will now nominate Humer’s replacement this autumn. The Board has said the new chair will also serve as Non-Executive Chairman, continuing the separation of the offices of chair and CEO.

Humer joined the company in 1995 as Head of the Pharmaceuticals Division and a member of the Board of Directors. Prior to that, he worked as the UK general manager for Schering Plough Corporation and in similar high ranking positions for Glaxo. He became Roche Chairman in 2001, after being appointed CEO two years earlier.

“I am looking forward to the next 12 months, and I intend to perform my duties as Chairman with enthusiasm and drive,” he added.

Humer is the third high-profile chair to confirm his departure this year. Dr Daniel Vasella called time on his association with Novartis back in January, followed by Mats Pettersson’s announcement last month that he was departing Lundbeck.

We’re often plagued by the idea that somehow – perhaps in a different city, company or even civilisation – we could be reaching new, higher, dizzier heights. Especially when you see rival colleagues using the latest mobile, tablet devices or driving off into the sunset in that brand new hatchback – yes, the one with the heated seats you saw on Top Gear last month – and giving you an obscene salute as they do so.

But is there any definitive way of knowing if you’d be better off somewhere else? Of course, there are those generic online tools that give you the average salary of every Londoner under the age of 90. But they are probably not the best benchmarking tools to use when plucking up the courage to ask your boss for a pay rise, during one of those awkward appraisals. Although, there is another way.

The Pf Company Perception, Motivation and Satisfaction Survey – which is now in its 12th year – provides a comprehensive temperature check on the essential elements of everyday working life for those toiling away in the medical sales sector. It gives those working within the pharmaceutical industry in the UK the opportunity to have their say on what matters the most to them.

The Survey has now been completed by more than 14,000 medical sales professionals since it was first launched in 2001. It accurately portrays the views of the industry on important motivation and satisfaction factors such as remuneration, bonuses, work-life balance, job security and company culture. Pharmaceutical bosses can also see how long their staff actually spend on CRM systems whilst in the field and also discover whether employees have had their head turned by that eye-catching aqua blue sports car and are ready to jump ship.

Yet it’s not just pharmaceutical companies who bene t from the results. The Survey is a friend to all. Much like a Swiss army knife, it has various tools and attributes to help those who access it. It’s a pen knife one minute slashing dated contracts of employment then a bottle opener the next popping open the bubbly to celebrate an improved Employer of Choice ranking place.

The Employer of Choice

Another facet to the Survey is the coveted Employer of Choice rankings. Respondents are asked to choose the company they’d most like to work for within the industry – bar their own of course! ­The company chosen the most wins the Employer of Choice gong. Simple.

In recent years it’s been a two horse race for the EoC accolade. Boehringer Ingelheim and Roche have got toe-to-toe for the top spot since 2007. But it’s been Boehringer which has come out on top for the last six years as the company which is deemed to be the most desirable to work for within the industry. Nick Doe, Sales Director, BI, says the credit must be placed at the company’s skilled workforce for keeping the company in the prized top spot for so long. “It is a real credit to everyone in our field force, our managers and all at Boehringer Ingelheim who are dedicated to putting the patient at the centre of the everything we do.”

The Employee

One experienced key account manager – who wished to remained anonymous, from a medium-sized pharmaceutical company – used the salary comparison tool to negotiate an improved deal after finding out she was being paid less than her industry counterparts. “I was quite surprised actually when I first read in Pf that I was being paid less than other people doing my job in the industry. In fact, I always considered myself to be well paid for the job that I do. For that reason I’d never really explored what other KAMs with the same level of experience were on – especially as I’d been with my company for a few years. I just assumed we’d all be on around the same figure. However, when I read one of the articles on salary in Pf and realised I could be getting more money elsewhere I couldn’t just ignore that fact.

“I went to speak with my superior to discuss a pay rise and showed him the comparison with other key account managers with my level of experience and how much more money they were receiving compared to me. Discussing money is always a tricky subject but the facts and figures were there in black and white to support my case. Thankfully the matter was addressed pretty swiftly. I’m so glad I took part in the survey and read the survey articles. Without the Pf Survey results I’d still be underpaid and none the wiser.”

Anonymous Key Account Manager from a medium-sized pharmaceutical company: you’re welcome.

The Employer

€The results from the Survey may have seen certain pharma companies having to dig a little deeper into their pockets to ensure valued staffŠ members are kept happy and motivated. But the data resulting from the survey results is valued in other ways. It’s not only field-based employees who keep a keen eye on the main motivating factors which matter to respondents. Pharma companies use these to entice hot talent away from competitors and keep their own main players happy.

When employees at Astellas raised concerns around a recent change to the car policy one year, the survey witnessed the biggest ever shift in one parameter when it acted upon the suggestions of staŠff and improved its company car scheme. Astellas wasn’t the only pharma company to listen to its staffŠ after the survey results were published.

Lundbeck UK calls upon its staffŠ to voice opinions on important decisions – a move which has seen them outscore industry rivals in a number of parameters. “€The scores that we have had for the latest survey results are significantly higher than that of our industry colleagues,” Helen Carberry, Lundbeck UK Head of Human Resources and Development said.

“We consistently outperform in the industry averages. Ratings for ‘belief in products’ is really strong and that is our highest satisfactory score. Also, for ‘company culture’ we are almost double the score across the industry in that parameter,” Helen added.

Yet these top-of-the-table rankings have not come about by chance, as explained by Helen. “We do have a real focus on people here at Lundbeck UK,” she said. “It’s something which is important to us because that is ultimately how we achieve our results. We have high levels of loyalty and commitment within the organisation, and our own internal satisfaction survey highlights that.

“In terms of our strategy, there are three pillars which support everything that we do. One of those pillars is being great place to work. We set out this year, very much like the 12 months prior to that, that our focus is on delivering excellent results, delivering value to customers, whilst also being a great place to work. As part of that, developing people and living our culture are the two main foundations which support that strategic pillar of being a great place to work. People are really, really important to us.”

This was re™flected as Lundbeck UK was awarded the Best Companies One Star Accreditation in 2012. € The company now aims to build on the success of its survey results as it adapts to the changing market place in the UK. “We are a lean organisation, which means we are very, very ™ exible. We have developed a structure that can be either built on as and when new products come through or simply added to over time. Lundbeck UK can only go from strength to strength.”

€The 2013 Company Perception, Motivation and Satisfaction Survey can now be completed at www.pharmasurvey.co.uk. It is managed by Dr B Payne of Conker Statistics (a fellow of the Royal Statistical Society) and provides a benchmark of field force remuneration, motivation, satisfaction, perception and recruitment. Confidentiality is of paramount importance and your anonymity is therefore guaranteed. It takes only minutes to have your say at pharmasurvey.co.uk.