The new UK life science strategy and NHS innovation review, launched by the Government this month, has been praised by the UK medical technologies sector for its promotion of innovative research and the rapid uptake of high-value technologies.

The NHS Chief Executive’s review Innovation, Health and Wealth: accelerating adoption and diffusion in the NHS outlines a number of measures the NHS will take to work in partnership with industry in order to implement effective new medical technologies throughout the NHS.

The document draws in attention, in particular, to the potential of telehealth systems to improve the management of long-term conditions, reducing hospital admissions and GP visits and so reducing the overall cost of care while improving patient outcomes, as demonstrated by the recent Whole Systems Demonstrator project.

Other areas of medical technology highlighted by the innovation document include the use of fluid monitoring in acute care and the use of assistive technologies, including wheelchairs, to improve the access of disabled people to working and other everyday environments.

Peter Ellingworth, Chief Executive of the Association of British Healthcare Industries (ABHI), the leading UK medtech trade association, said: “I welcome the Government’s focus on the life science industry. As highlighted by the Prime Minister our sector is part of ‘the virtuous circle of health, wealth and well-being’ – a real growth area for the Government as well as having the potential to make a difference to patients through the innovation we bring.

“Measures such as reform to the tariff system, enforcement of NICE guidance and the development of a procurement strategy, if done properly, could make a real difference to the medical technology sector.

“ABHI will work with the Government to make sure that the measures outlined in the Innovation Review are translated into firm actions. The measures could make a real difference to the SMEs in our sector and it is crucial that we are able to take advantage of them and continue to grow.”

Doris-Ann Williams MBE, Chief Executive of the British in Vitro Diagnostics Association (BIVDA) and a member of the Innovation Review’s External Advisory Group, commented that the Government’s announcements “represent a crucial opportunity for the life sciences sector” – and that the life science strategy and the innovation review in combination “will reinforce a genuine partnership between industry, the NHS and government.”

“To accelerate the use of innovative technologies to benefit patients and the NHS, tangible and realistic proposals were needed,” she added. “The NICE Implementation Collaborative, an innovation scorecard and a commitment to examine reimbursement mechanisms for diagnostics will all help the IVD industry to do what it needs to do to turn the vision into reality.”

Tony Davis, Chair of health technology business support organisation Medilink UK, noted that the new life science strategy “sets the stage for telehealth and telecare technologies to be made available to every person with a long-term condition or in need of care in the UK, helping them manage their health while maintaining their independence.”

“Medilink UK has been working with industry, other trade associations and the Department of Health to accelerate the roll-out of telehealth and telecare services in the NHS and social care, which will enhance the lives of three million people over the next five years,” he concluded.

Daiichi-Sankyo has agreed a $500m legal settlement with the US Food and Drug Administration (FDA) for manufacturing violations by its Ranbaxy unit.

The Japanese company, which acquired India-based company Ranbaxy at the end of 2008, has halved its net income forecast for this tax year.

The FDA charges include falsification of data to cover up inadequate and potentially dangerous manufacturing controls at two Ranbaxy factories in India making generic drugs.

To help compensate for the company’s income loss, Daiichi’s board of directors have agreed to cut their individual pay for the next six months, with directors losing between 5% and 30% of their salaries.

The settlement is subject to approval by the US District Court for the District of Maryland, but Daiichi expects that it will resolve all civil and criminal charges raised by the FDA.

The FDA investigation into Ranbaxy’s at Ranbaxy’s Dewas and Paonta Sahib plants in India began in September 2008, when the FDA warned the company that ‘serious manufacturing deficiencies’ could be affecting over 30 generic products.

Problems reported included inadequate protection against cross-contamination of drugs; inadequate control records; and inaccurate written records of the cleaning and use of equipment.

Daiichi acquired Ranbaxy in November 2008.

In February 2009 the FDA halted reviews of drugs manufactured at the Paonta Sahib site, commenting that that there was a “pattern of questionable data raising significant questions”.

Ranbaxy has said that it will address the issues raised by the FDA by improving its manufacturing and data management practices.

Arun Sawhney, CEO of Ranbaxy, commented: “While we were disappointed by the conduct that led to the FDA’s investigation, we are proud of the systematic corrective steps we have taken to upgrade and enhance the quality of our business and manufacturing processes.”

Pfizer has been crowned the leading pharmaceutical company for their presence on Facebook and Twitter, a new study has found.

Cegedim Strategic Data (CSD) found the pharma-giant had the third-most ‘likes’ on Facebook and had more followers on Twitter than industry rivals. Novartis were ranked overall in second with Merck & Co in third position.

Christopher Wooden, Vice President, Promotion Audits for CSD, says the audit highlights how the industry is improving its social media footprint.

The study was conducted worldwide and focused on the top 100 pharmaceutical companies in terms of traditional sales force and marketing channel spending. CSD then identified the top 30 pharma companies for their presence and healthcare-focused activities on Twitter and Facebook.

Behind Pfizer, Novartis was ranked seventeenth for ‘likes’ on Facebook and overall fifth on Twitter for its number of followers. Merck – which came first for the number of pages on Facebook – ranked tenth for the number of ‘likes’ it has received, third for the number of ‘tweets’ it has made on Twitter and fifteenth for its followers.

CSD found that J&J is second for the number of ‘likes’ on Facebook with Roche occupying the same position for its number of followers on Twitter.

“The CSD social media audit shows clearly that most major life science companies are establishing a presence in social media – but coverage, methods and sophistication do vary significantly,” said Christopher Wooden.

“In broad terms we see an attempt by companies to reach out and create a positive, on-going message about their contribution to better health. The ability to target that message and encourage constructive dialogue through social media will bring value to companies developing this new channel.”

There has been a lot written about the industry’s apparent move to Key Account Management and its impact on call rates and targeting. David Round provides a welcome break from the rhetoric and concentrates instead on the facts.

Mark Twain famously said that people often use statistics as a drunk uses a lamppost: for support rather than illumination. But when used properly, data can be incredibly illuminating – not least for the UK pharmaceutical industry. And analysis of pharma’s ongoing modification of its sales and marketing model is well worth putting under the spotlight.

In the past few years, experienced pharma commentators have looked in vain for evidence to support an inexorable, yet often anecdotal, march towards Key Account Management (KAM). The rhetoric said that pharma was taking a more sophisticated approach to sales and marketing activity and, in the process, delivering a more efficient and effective commercial model using a targeted KAM methodology. But the reality, and indeed the numbers, seemed to suggest otherwise.

The UK pharmaceutical industry may have taken the surgeon’s knife to its collective sales force and cut back on the volume of field-based staff. It may also have rebranded its sales representatives as ‘Account Managers’ and encouraged them to take a more measured approach to targeting key customers. But, until very recently, the number of GPs being seen by medical sales professionals across the year remained as high as ever – belying the claim that companies were moving away from the apparently inefficient ‘share of voice’ model that had served them so well in the past. Critics claimed that the traditional sales rep had simply been issued an Account Manager’s business card and given the accountability and autonomy to be more selective in targeting key customers – as well as a call rate target that was directly at odds with the KAM philosophy. And the statistics did little to quell the debate.

Data from Synmetrics, Cegedim Relationship Management’s activity benchmarking tool, shows that between December 2009 and December 2010 – and in the thick of widespread opinion preaching the gospel according to KAM – 92.7% of UK GPs had a face-to-face call or meeting with a representative from a pharmaceutical company. This indicates that, far from adopting a more considered approach to targeting its customers, the industry was still carrying out almost blanket coverage of GPs. What’s more, the 2010 data merely continued a similar trend from the years that preceded it – with annual industry coverage in the past decade consistently reaching over 90% of the total prescriber population.

But the past 18 months seem to represent a watershed for pharma sales operations in the UK. Something, it would appear, is happening. In the 12 months from July 2010 to June 2011, Synmetrics data show that the number of GPs who have had a face-to-face call or meeting with an industry representative has dropped to 85% – a fall of some 7%. Alongside this, in the first six months of 2011 the total number of GPs who have had a similar contact has slumped to 73%.

Whilst the half-year figure may not be wholly indicative, the July 2010 to June 2011 full-year data appear to represent a trend. And upon closer scrutiny, it’s a trend that’s been developing incrementally over the course of the past decade. Figure 1 shows that the total number of contacts on GPs has, apart from an uncharacteristic spike in 2008, been gradually declining since 2001.

Contact is classified as either a traditional face-to-face call or a meeting, and analysis of the contact rates for each of these methodologies is equally revealing. The number of face-to-face calls (per rep, per day) has been steadily falling year-on-year. Conversely, the number of meetings (per rep, per day) has gradually risen – and in fact grew disproportionately between 2007 and 2008. The Synmetrics data show that there are more meetings taking place today than at any point in the past ten years; and that, crucially, in 2010 the number of meetings per day overtook the number of face-to-face calls for the first time.

Significantly, the number of face-to-face calls being made each day has halved over the course of a decade. That’s a pretty spectacular statement. So spectacular that it’s worth repeating just to reflect on it: the number of face-to-face GP calls, per rep, per day, has halved since 2001. This has nothing to do with field force size and the fall in the number of representatives – it’s literally the number of calls per rep.

Moreover, data shows that 17,000 GPs – around 35% of the total population – have not received a face-to-face call in the past twelve months. In truth, this is another staggering revelation: the bread-and-butter, conventional pharma approach of face-to-face engagement between GP and representative has reached a point where more than a third of GPs have not received a call in the last year.

And so the ‘real world’ data are piling up. There are now fewer representatives, who are collectively making fewer calls. There’s an increase in the number of meetings, but a significant drop in activity, with daily call rates halved and over a third of pharma’s traditional customer population not receiving a single face-to-face call. It is a breathtaking decline, but it has not just happened overnight.

The implications
So what does all this mean? Does the 7% drop in GP coverage over the last 12 months provide the first conclusive evidence that Key Account Management is beginning to take hold in the UK? Or does the incremental decline in contact activity over the course of the past decade merely confirm that customer access, for reasons that are well documented, has shrunk considerably? Have GPs increasingly decided to close their doors to industry representatives, or have pharmaceutical companies taken a more measured approach and chosen not to target them? Drawing a distinction between the two is difficult. It’s most likely to be a combination of both factors.

What we do know, of course, is that the industry’s customer-base has broadened extensively in the past few years with the emergence of a new breed of decision-makers – loosely classified as payers. As a
result, pharmaceutical companies have been forced to balance activity between traditional customers and more influential stakeholders in medicines management and commissioning functions. With GP call rates
falling by half it would be easy to assume that sales professionals are spending up to half of their time refocusing on payer engagement. But this may be too simplistic a conclusion. The payer population has rapidly earned a reputation for being difficult to access, and building relationships with the new stakeholders is widely accepted to be a long-term process that will take time and effort.

However, it would be disingenuous to conclude that half a sales professional’s day is being spent calling upon payers, and to use this presumption as the ultimate proof that Key Account Management has finally
established itself is probably a leap too far – it would perhaps be more realistic to assume that the effort and preparation required to see these payers is what is taking up a greater part of the sales professional’s day.

Yes we KAM?
It’s still too early to make definitive claims that the KAM model is firmly embedded in UK pharma. The indications are that the approach is beginning to take shape, but there is perhaps still some way to go before companies finally feel confident enough to entirely let go of the traditional share of voice model. But while that transition continues, the need for a more sophisticated approach to targeting customers remains as strong as ever. Pharma companies need to use all of the available data to drive their promotional plans, and use every available channel to reach their customers.

The industry needs to be as targeted as it can be, and sales professionals must be as smart as possible in their approach. Quantity is being replaced by quality. As the number of daily contacts being made continues to decrease, it’s vital to make sure that every face-to-face call or meeting actually counts. As
Account Managers are encouraged to develop their own call plans and become more accountable for their
own business, the need for robust and effective data to help make informed targeting decisions in the process is paramount.

Statistics can, of course, be used to provide reassurance and justification for a decision; but when considered more carefully, robust data can stimulate much greater illumination. For UK medical sales professionals, gaining access to information that enables you to shine a light on all of your customers and establish which ones provide the greatest potential, could make the difference between staggering around in the dark and giving your sales figures that extra spark. Don’t allow yourself to become the drunk at the lamppost – it only ever leads to a headache the following day.

David Round is UK General Manager, Cegedim Relationship Management.

The Chief Executive of Macmillan Cancer Support, Ciarán Devane, will join the NHS Commissioning Board Authority as a Non-Executive Director from 1^st January 2012.

Mr Devane will work with the Commissioning Board’s Chair Professor Malcolm Grant in developing the Authority and a new clinical commissioning system.

Mr Grant said the appointment was “great news” and that the new director will be a “strong source of knowledge and advice”.

The NHS Commissioning Board – which will be an independent, statutory body – will officially become operational subject to the Health and Social Care Bill becoming law.

Health Secretary Andrew Lansley – who will remain responsible for promoting a comprehensive health service, and retain ultimate accountability for securing the provision of services under the reforms – backed the appointment. “Ciarán Devane has a strong track record of success and a passionate commitment to improving care for patients. I am delighted that he is bringing his unrivalled expertise to this important role. I am confident that he is the right person for the job.”

Mr Devane joined Macmillan as Chief Executive in May 2007. He currently serves as a member of the Cancer Outcomes Strategy Implementation Advisory Group and is a member of the health and work network of the Responsibility Deal. He also co-chairs the National Cancer Survivorship Initiative and sits on the board of the National Cancer Intelligence Network.

Pharmaceutical giant AstraZeneca (AZ) has discontinued its cancer drug olaparib and scaled back plans for its depression drug TC-5214, at a total cost of $381.5 million, following clinical trial failures.

Phase II studies of olaparib have been halted after an interim analysis indicated that despite its known progression-free survival benefit, the drug did not confer an overall survival benefit in treatment of ovarian cancer.

The company has also had difficulty in finding a suitable tablet formulation for the drug.

TC-5214 has failed to reach its primary endpoint in two out of four phase III trials as a treatment for major depressive disorder:

• It failed to perform significantly better than placebo in patient measures on the Montgomery-Asberg Depression Rating Scale.

• It failed as an adjunct therapy to an antidepressant in patients who did not respond well to the antidepressant alone.

The two remaining phase III trials of TC-5214, together with a long-term safety study, will be continued. If they are successful, AZ will submit a new drug application to European regulators in 2015.

AZ has had to pay $285 million for terminating the olaparib trials and a $96.5m fee to continue the remaining TC-5214 trials. The latter payment will be doubled if the trials fail.

Santa’s little helper Maxine Vaccine offers some festive thoughts on the good, the bad and the ugly in the world of pharmaceuticals.

This week’s most eye-catching pharma news is that the leader of a Texan counterfeit drugs outfit who smuggled thousands of fake Viagra and Cialis pills into the US from China and sold them online was jailed for 13 months and ordered to pay $140,000 in restitution to Pfizer and Eli Lilly.

In the USA, Viagra pills are sold legitimately for about $20 each – but the bogus pills were sold for half that. However, they probably did work in the most literal sense. Bill Donnelly, Pfizer’s chief of anti-counterfeiting for North America, commented that drug counterfeiters “are more likely to put too much active ingredient” so that “people will buy it again”.

What the counterfeiters ignore is the regulatory framework that ensures product safety and consistency. Given that Viagra can cause violent headaches and nausea, and is dangerous for anyone with a heart condition, only an idiot would take even the real thing without a prescription.

But there are quite a few idiots out there. Over four million counterfeit Viagra tablets were seized worldwide in 2010.

Of course, you’re not an idiot, and there won’t be any counterfeit drugs in your Christmas stocking. But this is a good time to reflect on what the pharma industry does well and what it’s capable of getting wrong.

This year we’ve seen progress towards the development of a vaccine against HIV infection, while the impact of anti-retroviral drugs has seen rates of HIV infection begin to fall worldwide.

Intensive R&D in the cancer therapy field has seen the evolution of a long-term condition treatment model for a disease that, in previous generations, had few survivors.

The UK government has highlighted the potential of stratified medicine, using genetic analysis to develop targeted drugs, to transform healthcare and create major commercial opportunities for UK life science companies.

While the swine flu vaccine may, in retrospect, have been overused, it’s good to know that the industry came up with a rapid solution to what could in theory have been a much greater problem.

So why do thousands of people click ‘like’ at every scandal story involving a pharma company? If pharma were a person its Facebook relationship status would vacillate between ‘single’ and ‘it’s complicated’. What’s wrong?

For a start, before the advent of ‘designer drugs’ every illegal drug on the black market was developed as a pharmaceutical product. Heroin, amphetamine, cocaine, barbiturates, tranquillisers – they were all on prescription once, and some of them still are. Addiction is something the industry, the medical professional and the public are still learning about.

The Verve song ‘The Drugs Don’t Work’ was indeed about chemotherapy, not narcotics – and there’s another reason drug companies are unloved. Drugs don’t always work, because people and their diseases are not predictable. Every patient is unique, and we ignore that at our peril. Medicine is not about spreadsheets and statistics, it’s about the human body – which nobody can control.

The trouble with drugs is that people see them as quick-fix solutions to problems that have complex causes. Instead of recognising that any drug can affect only certain narrow chemical parameters, increasing this and reducing that, shifting the balance of a complex dynamic system, we continue to look for ‘magic bullets’. That’s as much a problem with patients and doctors as with suppliers – but we get the blame, and we may sometimes deserve it.

The pharma industry’s future doesn’t lie in more blockbuster drugs, in corporate branding, or in NLP. It lies in consultation and the sharing of knowledge, in open innovation, in honest engagement between professionals with different areas of expertise. Only bad sales professionals try to get around the customer’s knowledge. Good sales professionals engage with it and add to it.

Drugs are imperfect. People are imperfect. All we can do is make connections, identify problems and work together towards solving them. The more we can do that, the less pain there will be.

Or maybe I’ve just opened the sherry a few days early.

Have a great Yuletide break and I’ll see you next year.

Private healthcare providers in the UK are restricting competition through monopolistic control, lack of transparency and loyalty payments to consultants, a study by the Office of Fair Trading (OFT) has found.

The OFT proposes to refer the market for private healthcare services in the UK to the Competition Commission for investigation.

The UK private healthcare market is currently worth £5 billion and is likely to expand greatly in the near future – but according to the OFT report, the sector’s mantra of ‘patient choice’ is undermined by its own practices.

Aspects of UK private healthcare that prevent, restrict or distort competition, according to the OFT, include:

• Local concentrations of influence where a private healthcare provider owns the only hospital or an essential facility.

• A lack of comparative information for patients, GPs and insurers on the quality and costs of private healthcare services, meaning that they are unsure of the full cost of a treatment or how it compares with alternatives.

• Barriers to new competitors entering the market, such as loyalty payments to consultants and price rises imposed on insurers who recognise new healthcare providers.

As a result of these concerns, the Financial Services Authority (FSA) intends to work with health insurance providers to make it clearer to patients when they may face extra payments.

OFT Chief Executive John Fingleton said: “Our provisional findings suggest that private patients in the UK don’t have access to easily comparable information on quality and costs and that competition is also restricted by barriers to new private healthcare providers.

“It is important that patient demand and choice are able to drive competition and innovation in this market with a view to better value for all patients. We have provisionally decided that these significant concerns merit a more in-depth investigation by the Competition Commission.”

The OFT has requested comments on its provisional findings by 30 January, and expects to reach a final decision by 31 March 2012.

The Marketing Authorisation Application for Gilead Sciences Quad single-tablet regimen for the treatment of HIV-1 has been validated by the EMA.

The application is supported by results from two Phase III studies which demonstrated the tablet’s safety and efficacy data and by clinical data for the individual components of the Quad and Chemistry, Manufacturing and Controls (CMC) information.

Norbert Bischofberger, Executive Vice President, Research and Development and Chief Scientific Officer, Gilead Sciences, says Gilead is working with the regulator “to bring this new single-tablet regimen to physicians and patients as quickly as possible”.

The regimen contains elvitegravir, cobicistat, emtricitabine and tenofovir disoproxil fumarate and was submitted to the EMA in November 2011. The submission to the FDA was made in October 2011.

Gilead’s first single-table regimen, Atripla, was approved in the EU in 2007. Its second single-tablet regimen, Eviplera – which combines its Truvada and Tibotec Pharmaceutical’s rilpivirine – was approved in the EU in November 2011.

“Based on the safety and efficacy data from the Phase 3 pivotal studies, we believe the Quad single-tablet regimen has the potential to be a convenient treatment option for patients new to HIV therapy,” said Norbert Bischofberger.

Immediate antiretroviral therapy (ART) following diagnosis of HIV-1 infection is more effective than waiting until symptoms appear, according to a new US study published in the Journal of Infectious Diseases.

A multicentre clinical trial found that immediate ART slowed the rate of disease progression without leading to drug resistance.

The study suggests that immediate ART may reduce the patient’s overall need for drug therapy, reducing the long-term cost of treatment.

The AIDS Clinical Trials Group Setpoint Study, conducted at the Medical College of Wisconsin, divided 130 men and non-pregnant women who had contracted HIV within the previous six months into two groups: one receiving ART for 36 weeks and the other with ART deferred.

The investigators found that the immediate treatment group had a better outcome than the deferred group – half of whom required the start of HIV treatment before the study endpoint.

The report commented that “if immediate therapy is not begun, progression to meeting standard criteria for ART initiation may occur more rapidly than expected, especially with changing treatment paradigms.”

They also noted that immediate treatment conferred protection both during ART and for some time afterwards, and that it had little negative effect in terms of toxicity or drug resistance.

Harout Tossonian and Brian Conway of the University of British Columbia, Canada, concluded that “immune preservation and reduction in the latent pool of HIV-1-carrying CD4 T-cells seems to require intervention at the earliest possible time of acute infection.”

They also commented: “The initial course of 36 weeks of treatment may delay the need for re-starting it more than the 36 weeks spent on it from the time of initial presentation. Thus over the lifetime of the patient, there will be less cumulative drug exposure.”