Health Select Committee calls for drug trial transparency

by JoelLane 18. January 2013 13:46

Three_wise_monkeys_figure The House of Commons Health Select Committee has called for the publication of all drug trial data to be mandatory.

In a report on the role of NICE, the MPs recommended that pharmaceutical companies should have a “duty of candour” regarding clinical trial results.

David Haslam, who will become NICE’s Chairman in April, told the Committee that it was “impossible to come up with any good argument that all data should not be released.”

The report, triggered by ongoing controversy about Roche’s non-disclosure of clinical trial data regarding its antiviral Tamiflu, said the decision to withhold such data should be considered “neither legal nor ethical”.

All results from trials of licensed drugs should be publicly accessible, the Committee stated, arguing that the selective concealment of trial data undermined the role of NICE.

“This situation cannot be allowed to continue,” said Stephen Dorrell, the Chairman of the Health Select Committee.

In order to enforce this greater transparency, the Committee said, the pharmaceutical industry should introduce a new code of practice.

In addition, the General Medical Council should warn doctors that failure to comply with regulations on the conduct of drug trials could lead to their fitness to practise being legally challenged.

Better together

by IainBate 3. July 2012 12:37

Stephen Whitehead outlines the ABPI’s latest initiatives to facilitate collaboration – and how sales professionals have a key part to play .

Better together - Pharmaceutical Field This year the ABPI is launching a Regional Partnership team to help the industry establish and develop sustainable relationships with the NHS at a regional level. The team, deploying experienced industry professionals in each of the four regional SHA clusters, aims to promote and facilitate collaborative working as a means to improve patient outcomes. Its key objectives are to identify and remove existing barriers to accessing innovative medicines, to help develop regional partnership projects and to share best practice across the country. The initiative reflects the growing recognition that improving patient health in a constrained financial environment will be best achieved by adopting a more collaborative approach. And there is an increasing consensus across both parties that, after years of developing adversarial relationships, the direction of travel towards NHS/industry partnerships is the right one for patient care.

But progress is an incremental process. The perceived cultural barriers that have historically plagued the relationship and impacted access will not be overcome overnight. “Trust and reputation has widely been acknowledged as an issue for industry – but it’s getting better,” says Stephen Whitehead, CEO at the ABPI. “In fact, it has dramatically improved. You can 12 see that from the Innovation, Health & Wealth (IHW) review: the NHS really wants to partner with pharma. In turn, as an industry we know that we are operating within restricted NHS budgets, and that we need to make it clear that we are not always there to sell something. Joint working is not about developing something that can help companies achieve a sales target on a quarterly basis, it’s about establishing a new way of working that will redefine the relationship between us and the customer. That will take time.”

In an evolutionary process, the ABPI appears determined to take the lead – to trail-blaze the concept of partnership working from a top-line strategic position and help ease the concerns of more anxious NHS customers. “The driving platform for joint working from the side of the industry should be the ABPI,” says Stephen. “We established the joint working protocol with the DH, and have developed the code of practice and regulatory infrastructure to enable it to happen. We’ve therefore created the headroom to allow partnerships to be established. Most parts of the NHS have understood and grasped this. It’s now up to us to lead, and for companies to take the opportunities within that.”

IMPROVING ACCESS

With access to NHS customers a perennial problem for UK pharma, the battle to develop the joint working agenda is a challenging one for individual companies. Medical sales professionals are tasked with advancing discussions, but attempts are often stymied due to diminishing levels of customer access. The ABPI believes its NHS Partnerships initiative will play a major part in raising awareness of partnership working, and overcoming access issues on an industry-wide basis. “NHS Partnerships will help industry
engage with key NHS stakeholders in England and ensure partnership conversations happen at a regional level. It’s not about individual products – we will not be talking about those – but we will be a facilitator of dialogue around joint working, aligned with the partnership principles set out by David Nicholson. We will be looking closely at the national issues on uptake and access, and any policy that emerges around that – and reinforcing it locally. Critically, NHS Partnerships isn’t the creation of ‘talking shops’, it’s about being able to facilitate on the key issues – which are fundamentally about access and uptake of innovation.”

NHS Partnerships has already been welcomed by the Department of Health, whose Director of Innovation & Service Improvement, Miles Ayling, said: “The ABPI partnership team will help build stronger links between industry and the NHS, as described in IHW. Beyond medicines, we are also looking at how all concerned can share skills, expertise and knowledge to improve the health of UK patients and help transform lives.”

REPUTATION

The long-standing issue of industry mistrust does, at long last, seem to be fading within the NHS. This was reflected in the ABPI’s seat at the top table of discussions around IHW last year, and has been reinforced by Stephen Whitehead’s involvement on the IHW Implementation Board. In addition to the partnerships initiative, the ABPI (along with ABHI) has also established a series of pilot projects with the NHS Confederation to look at how joint working can make a difference in selected disease areas. Pilots are already underway in mental health, circulatory diseases, diabetes and long-term conditions. “This is about providing examples of best practice within the NHS so customers can understand what we mean and establish that there is nothing for them to be worried about,” says Stephen.

“We have a strong status, but we’ve not yet fully utilised it in the context of joint working capability. That’s what these initiatives have been set up to do. This is a whole new world and a very exciting one – ten years ago we could never have had these relationships. But now that we are here, we need to approach customers gently and appropriately, and work with the NHS collaboratively and co-operatively to ensure that we dispel any of those old misunderstandings.”

And so, in the new environment, what role will sales professionals and Key Account Management play in NHS engagement? “The role of sales is evolving quite rapidly,” says Stephen. “Sales engagement is increasingly about liaison, as well as detailing around a product. It’s about facilitating collaborative working – and the salesforce has a key role to play in this.”

Industry code set for changes

by IainBate 11. May 2012 14:43

Pharma Industry News The ABPI Code of Practice is set to be amended to reflect changes to international guidelines and UK law.

Proposals for 17 amendments result from changes to the IFPMA governing code or are responses to the Human Medicines Regulations 2012.

Several of the amendments include minor adjustments to wording. However, additional proposals, including new clauses relating to pharma’s relations with patient groups, could be significant.

Clause 1 – Scope of the code and definition of certain terms – will see up to five amendments introduced with two modifications also suggested to Clause 2 and Clause 23.

If approved, they would be included in the Code and come into effect on 1 July 2012 before becoming fully operative on 1 November 2012.

As a member of the International Federation of Pharmaceutical Manufacturers and Associations, the ABPI is duty bound to bring its own regulations in line with that of the IFPMA.

The proposals have now been sent to member companies, relevant bodies and the Serious Fraud Office.

Allergan tweet breaches industry code

by JoelLane 27. January 2012 15:21

Pf industry news Careless use of Twitter by an Allergan employee has led to the company being ruled in breach of the ABPI’s Code of Practice.

The employee told a friend working for a patient organisation that Allergan might “do something around stroke rehab” using the company’s Botox product.

The tweet, which was not authorised by Allergan, was read by the followers of the sender and the recipient, including members of the patient organisation.

Because Botox has prescription-only applications in stroke treatment, the tweet was judged to be public advertising of a prescription-only drug.

The employee’s mistake may have been a purely technical one – sending the message as ‘public’ rather than ‘private’ – rather than any misunderstanding of the Code of Practice.

However, the Prescription Medicines Code of Practice Authority (PMCPA) ruled that Allergan had breached clauses 9.1 and 22.1 of the Code.

It commented that the company had been “badly let down by its employee” and further noted: “In the Panel’s view, pharmaceutical company employees needed to be extremely cautious when using social media.”

According to the company’s policy, Allergan’s employees are not allowed to comment on its products or business activity in social media forums.

Allergan has since updated its social media policy and sent its UK employees a copy of the PMCPA’s digital guidance. The company intends to provide its employees with further training on the Code.

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To infinity and beyond

by emma 3. November 2011 15:22

Pharma Field - To infinity and beyond

Despite huge investments into CRM systems some pharma companies still struggle to get all of their staff to embrace and fully interact with them. Pf’s Iain Bate explores why, and what the future holds for technology in the industry.

There’s no doubt that technological developments have changed the way we live and work from year to year – maybe even from month to month in the 21st Century. But has the world of healthcare been travelling in the slow lane of the intergalactic highway?

The potential that technology offers to pharma, and the general world of healthcare, is enormous. But is the pharmaceutical industry, and its staff in particular, using it to maximise the returns of billion-dollar investments?

It would seem that technology is the ‘buzz word’ on the lips of a few of healthcare’s major players at present. The DH recently invited people to nominate their favourite health-related mobile phone ‘app’ – be it for keeping fit, to locate a hospital or chemist, or helping to manage an illness. Creative minds were also asked to design their own health app with a panel of DH judges deciding on their favourite from the most popular entries.

Health Secretary Andrew Lansley says it’s the Government’s intention to give people better access to information using modern technology and the exercise is a “unique opportunity for the NHS and those who develop apps to not only showcase their work, but to bring to life new ideas and realise true innovation in healthcare”.

As part of the DH’s technology revolution, patients may also soon be offered online consultations with their GPs using programmes such as Skype. Clearly the Government is embracing the convenience technology offers to patients, but are other sectors in healthcare as interested? It would seem there is still some way to go.

 

In two minds

Pf ’s 2010/11 annual Company Perception, Motivation and Satisfaction Survey suggests that not all respondents are completely convinced by the power of technology in the workplace. Although the Survey – which relates to 2010 and the early part of this year – found that nearly 90% of respondents have access to a CRM system, only 43% find time to use it in the field and more than a fifth of people fail to accurately record post-call reports with important clients.

Questions have to be asked as to why, despite multimillion pound investment and training by pharma companies, there remains a percentage of staff that still ignore the power and potential of the technology at their finger tips.

Results from the Survey reveal there’s no difference in uptake by key account managers, primary and secondary care representatives, those in primary care roles only, firstline sales managers and secondline sales managers and the use of CRM technology between differing age groups – although surprisingly 10% of respondents in these positions with less than two years of experience said they did not have a CRM system, compared to just 5% more experienced colleagues.

The launch of the iPad in March 2010 promised to revolutionise the way sales representatives, and those in similar roles, use CRM systems in the field. However, nearly three-quarters (70%) of respondents from the Survey are still presently sent out with laptops containing their customer-relationship systems.

When quizzed on what they’d change about the hardware which houses their system, the majority of respondents said that their CRM was too awkward to carry, with poor running systems an issue and that batteries ran out too quickly. Apple claims its second-generation iPad now enjoys ten hours of use away from a plug socket in the field.

Yet the switch to the latest convenient tablet devices may not necessarily be about high levels of investment, it may be down to maximising value for money as Paul Shawah, Vice President, Multi Channel Strategy, Veeva Systems explains. “I would say the life cycle of devices within the industry is generally about three years, sometimes a little bit longer,” he said. “When a company invests in new technology they typically depreciate that over that period, so they don’t want to replace it in the field for that time to maximise their investment.

“However, with the introduction of game changing technology like the iPad, this has changed. We see a number of our pharmaceutical customers are justifying the business case to move to the iPad even before their tablets are fully depreciated. This speaks to the business benefit that pharma expects to achieve from the iPad and the related applications only available on that device.”

Pf Survey demographic and key CRM results

A convenient shield

Despite technology eliminating mundane process in the workplace and offering the potential to assist employees and improve their efficiency at work, it has historically been used as a shield to mask poor performance and abused as a means to waste company time – a recent online survey by AOL found that nearly half of Americans (44.7%) rank surfing the web as their primary activity during the two hours they ‘waste’ each day at work.

But it would seem that a high number of respondents do value the opportunities CRM offers. Almost two-thirds (64%) said they always enter correctly the amount of customer sales they make into their CRM. But 21% admitted they fail to always report face-to-face meetings with clients. More surprisingly, over a fifth of participants said they do not always record the number of products they had sold to clients.

The lack of honest accuracy is surprising considering the amount of time spent using CRM systems each day. A third said they spend between one and two hours a day on their system with a fifth spending three hours or more on their CRM. During their time using the management system, more than half (55%) said that call reporting was the most useful feature.

Although respondents were less impressed with the KAM abilities of their software with only 19% believing it to be the most useful facility. When questioned about what they would change given the chance, 45% said they wanted an improved database, over a quarter (28%) called for their system to be overall more useful, and 18% said they would prefer their CRM to be easier to use.

 

The next level

But what of the future of CRM systems? Will they be easier to use and have improved customer databases? David Round, General Manager, UK, Cegedim Relationship Management, says the regular interaction we now have with technology means we’ve all come to expect the latest developments.

“End users are significantly more ‘technology-savvy’ than their counterparts of even five years ago,” he explained. “If anything, the challenge for companies is to ensure that they provide their end users with the types of technology that they use as consumers. It’s also important to focus on the usability of your software to ensure maximum use. Technology companies – and pharma – must work together to develop a better understanding of the interaction, to ensure it meets users’ needs in the field.”

One main reason that users have become more ‘savvy’ is down to the use and interaction with social media. Whether at home or at work, websites such as Twitter, Facebook, LinkedIn and most recently Google+ have driven an increased use of various forms of technology – especially on devices such as smartphones or tablet devices which reps are calling for in the field.

Pharma companies, both in the US and UK, have flirted with the idea of fully embracing the power social media harnesses, but at present are restricted by the PMCPA’s Code of Practice and by the FDA – who has again delayed the publication of its guidance.

The FDA says it is “difficult to provide a timeframe... due to the extensive work and review process, or ‘Good Guidance Practices’, which ensures that FDA’s stakeholders are provided well vetted guidances articulating FDA’s current thinking on a topic”.

Although the FDA may be unsure on how to direct healthcare companies, David Round believes the introduction, both professionally and personally, of social media has had an impact on staff and their expectations.

“For the modern professional person, much of their everyday life is conducted online – for example on shopping, utilities, insurance or booking a holiday – and many users then want the same level of capability from the tools they use in their job,” he added.

Dan Goldsmith, General Manager, Veeva Europe, agrees there has been a significant shift in the way we operate and interact due to our experiences online through tagged posts or hash-tagged searches. But although the 800 million users on Facebook – more than half which ‘log-on’ every day – and 175 million people on Twitter have no problem saying hello to friends, pharma finds it more difficult reaching out to people.

“Social media create a new avenue for healthcare dialogue and will only continue to pervade our lives,” said Dan. “Consequently, I believe that pharma faces two challenges. The first is to decide how to participate in the online dialogue with stakeholders and then to create those interactions through the channels we’re all familiar with, such as Facebook and Twitter.

“The second is to figure out how to leverage the model of social dialogue internally to support stronger collaboration and more focused communication among employees. Already, we see some companies taking advantage of the latest social business tools to connect employees with one another and to access and share information in real time.”

Clearly CRM solution providers understand the potential modern technology and social media platforms offer to companies. Whether pharma and its workforce get fully up to speed on the intergalactic highway sooner or later remains to be seen.

Top-five CRM benefits

ABPI calls for PMCPA change

by emma 27. September 2011 11:55

ABPI

The ABPI is proposing the PCMPA’s Constitution and Procedure be amended so that any future change to its Code of Practice can be done so without calling a general meeting.

The Association is obliged to implement any amendments the European Federation of Pharmaceutical Industries and Associations (EFPIA) makes but currently has to arrange a formal procedure to do so.

Its Board of Management is now requesting that where “changes arise solely” from amendments to the EFPIA Code they’re introduced without a general meeting.

The ABPI says companies would then be consulted regarding any changes.

The EFPIA recently made amendments to its Code on the Promotion of Prescription-Only Medicines to, and Interactions with, Health Professionals and to its Code of Practice on Relationships between the Pharmaceutical Industry and Patient Organisations.

The proposals have now been sent to the Medicines and Healthcare products Regulatory Agency (MHRA), the British Medical Association (BMA), the Royal Pharmaceutical Society of Great Britain (RPSGB), and the Royal College of Nursing (RCN) as required by the existing Constitution and Procedure.

Although consultations are welcome on the proposals, it is anticipated they will be discussed before the ABPI’s bi-annual general meeting in November, with a view to approval by member companies.

The new measures would then come into effect from 1st January 2012, and become fully operative on 1st May 2012.

Pharma pays US doctors $150m

by emma 31. August 2011 11:50

Pf industry news

Several large pharmaceutical companies have paid US physicians nearly $150m this year, according to analysis by the Financial Times.

Industry data into the controversial marketing and support practices found that $148m has been given to 165,000 doctors so far, including $48m from Eli Lilly and $42m from Pfizer.

A spokesperson for Lilly said the “collaboration with healthcare providers is essential” to improve outcomes for patients and to provide innovative medicines.

In the UK, the ABPI recently changed its Code of Practice meaning companies now have to declare payments to healthcare professionals for their services from 2013 in an attempt to increase transparency. Government agencies in the US are currently finalising similar guidelines as part of the healthcare reforms.

The analysis by the Financial Times, in conjunction with PharmaShine, is designed to allow health authorities, medical institutions and patients better scrutinise and understand the links between doctors and pharma.

But the way current disclosures are made and presented varies and makes comparisons and analysis difficult for both authorities and patients alike.

Allan Coukell, Head of the Pew Prescription Project – a US drug safety watchdog – says that healthcare professionals and the industry needs to work together for research purposes, “but the marketing model is problematic”.

“The first step is transparency and we are not even there yet,” he added.

Research found that collectively the industry paid $437m to 262,000 doctors in 2010. Among the physicians who received the highest level of support was Dr Zale Bernstein, an Associate Professor from the Roswell Park Cancer Institute in Buffalo, New York. Dr Bernstein received $234,000 in 2010 from Cephalon, Eli Lilly and Pfizer and has already received more than $57,000 already this year.

Although the majority of doctors received smaller sums, studies have suggested even modest support by pharma can affect prescribing practices.

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