The US Judicial Panel on Multidistrict Litigation said the return of thousands of consolidated cases to judges’ home courts would delay settlement negotiations. The cases are currently in federal court in Florida.

“A remand at this juncture would likely disrupt the settlement dialog,” US District Judge Anne Conway told the panel. Returning the cases would “stall negotiations altogether,” she added.

The pharma company still faces at least 8,000 cases in both state and federal courts alleging Seroquel causes diabetes. AZ has already agreed to pay nearly $200 million to 17,500 plaintiffs.

AstraZeneca officials said they were ‘committed’ to resolving the remaining lawsuits despite the multi-million payouts.

“We remain committed to a strong defence effort, but will continue to participate in the court-ordered mediation process,” said Tony Jewell, a US spokesperson for AZ.

Seroquel is the pharma company’s second-biggest seller.

FoldRx’s portfolio includes clinical and pre-clinical programs for investigational compounds to treat diseases caused by protein misfolding.

Its lead product tafamidis meglumine, a disease-modifying therapy for TTR amyloid polyneuropathy (ATTR-PN), is currently being considered for marketing authorisation by the European Medicines Agency.

Richard Labaudiniere, President and CEO of FoldRx, said the expertise of Pfizer would help bring tafamidis to patients.

“Pfizer’s strong clinical and regulatory resources, global marketing reach, and commitment to the treatment of rare diseases will significantly enhance the ability to pursue the goal of efficiently bringing tafamidis to all patients affected by this devastating neurodegenerative disease,” he said.

Although no specific financial terms were disclosed for the deal, Pfizer will make an upfront payment and contingent payments if milestones are achieved.

The completion of the transaction is subject to regulatory approval in the US, which is expected later this year.

The investigation will study whether there is a link between cases of narcolepsy and the vaccination after a number of reported instances, mainly in Sweden and Finland.

The Agency’s Committee for Medicinal Products for Human Use (CHMP) will assess all available data and consult experts across the EU to determine whether there is evidence for a causal association.

Pandemrix has been used since September 2009 for vaccine against H1N1 influenza in more than 30 million Europeans.

Narcolepsy causes an individual to fall asleep suddenly and unexpectedly. Although cases have been reported in temporal association with the use of Pandemrix, it is not known if the vaccine causes the disorder.

The CHMP will also consider the so-called background rate for narcolepsy to assess possible safety concerns and any impact on the benefit-risk balance of Pandemrix.

The EMA is also liaising with the European Centre for Disease Prevention and Control (ECDC), international regulatory partners and the World Health Organization (WHO) before considering at its September meeting the need for any provisional measures to complete the review.

Findings from the SHIfT (Systolic Heart failure treatment with the If inhibitor ivabradine Trial) trial showed how the use of Procoralan (ivabradine) over a two-year period reduced the risk of death by more than a quarter. Results also showed a similar impact on the number of hospital admissions.

Professor Martin Cowie, the UK lead investigator for the study, said the evidence represents a “significant clinical breakthrough”.

Patients in the UK suffering with angina can be proscribed Procoralan, but currently only one in ten uses the drug.

The trial involved more than 6,500 patients in 37 countries already on standard treatments with chronic heart failure and a high heart rate of 70 beats per minute or more. Those randomly assigned additional varying doses of ivabradine saw their risk of death reduced by 26%.

“We now know that more lives can be saved and improved simply by adding ivabradine to their current treatment in order to take some of the strain off the heart,” said Professor Cowie. “It is vital that the results of this study are implemented and ivabradine is used as part of standard heart failure treatment as soon as possible.”

The Consultant Cardiologist and specialist in heart failure at the Royal Brompton Hospital added he will now prescribe patients the drug “as soon as possible”.

More than 700,000 people over the age of 45 live with heart failure, with an estimated 68,000 new cases each year. Around 40% of those affected are dead after a year. Heart failure accounts for up to 2% of the total NHS budget, with direct medical costs amounting to £625 million a year.

Procoralan costs the NHS £1.40 per day.

The intravenous (IV) formulation of Brinavess (vernakalant) has been given the green light in the EU, Iceland and Norway for the conversion of recent onset atrial fibrillation to sinus rhythm in adults.

The drug is manufactured by MSD and Cardiome Pharma, and is the first product in a new class of pharmacologic agents for cardioversion of AF to launch in the EU.

“Brinavess is the first and only agent that acts preferentially in the atria. This medicine offers physicians, patients and hospitals an important new therapy option to use for the rapid treatment of recent-onset AF, and we are pleased to add this to our strong portfolio of medicines for cardiovascular disease,” said Patrick Magri, Senior Vice President, General Manager, Cardiovascular Franchise, Merck.

Doug Janzen, President and CEO of Cardiome, added: “This success was made possible through the commitment and hard work of our employees and our partner Merck, the support of our shareholders, and the efforts of many dedicated medical professionals and patients who have taken part in the clinical program.”

Archimedes Pharma’s PecFent, an innovative fentanyl nasal spray, has been granted a marketing authorisation to treat BTCP in adults who are already receiving maintenance opioid therapy for their chronic cancer pain.

Breakthrough cancer pain affects 24% to 95% (average 62%) of all cancer patients despite background pain medication, and many of these experience several episodes a day. In clinical trials, PecFent demonstrated onset of pain relief as early as five minutes, as well as clinically meaningful pain relief within 10 minutes.

Prof. Marie Fallon, St Columba’s Hospice Chair of Palliative Medicine, Edinburgh Cancer Research Centre (CRUK) Western General Hospital, commented: “The availability of this significant innovation is very important. Being a nasal spray, its ease of use allows patients to treat their breakthrough cancer pain episodes conveniently, wherever they are, and its unique delivery system provides fast onset of pain relief meaning so they can manage these episodes effectively. This is absolutely crucial for cancer patients and PecFent offers real hope for an improvement in their quality of life.”

Fentanyl is a highly potent opioid analgesic, which is delivered in a rapid but controlled manner using a delivery system called PecSys.

Jeffrey H. Buchalter, President and Chief Executive Officer of Archimedes Pharma, added: “The grant of European marketing authorisation for PecFent provides a new therapy to improve the treatment options for adult patients with breakthrough cancer pain. This is also a transformative milestone for Archimedes Pharma as we have established commercial operations in Europe and look forward to launching PecFent in major European markets in the coming months.”

In a letter from Chairman and CEO Henri Termeer to his counterpart Chris Viehbacher he said that the proposition in the “second unsolicited letter” was “identical to last month’s offer”.

Mr Termeer revealed how each member of the Genzyme board had “unanimously” rejected the offer after the “opportunistic takeover proposal” failed to recognise manufacturing challenges or the potential of new and existing products.

However, he still expects another bid from SA, saying: “You and your advisors claim you are willing to pay more but that you are unwilling to ‘bid against yourself’”.

The letter also revealed that Genzyme bankers had met with financial advisors from SA to highlight the progress and improvement the company has made recently in its manufacturing capacity and current products.

But Mr Termeer said Genzyme board members are not prepared to commence any negotiations until an offer which met their valuation of the biotech company had been matched.

“The Genzyme board is not prepared to engage in merger negotiations with sanofi based upon an opportunistic proposal with an unrealistic starting price that dramatically undervalues our company,” the Chairman continued.

“Our board has worked actively to understand the true value of our company and is unanimous and resolute in its commitment to maximise Genzyme’s future value for all of our shareholders.”

In a letter from Chairman and CEO Henri Termeer to his counterpart Chris Viehbacher he said that the proposition in the “second unsolicited letter” was “identical to last month’s offer”.

Mr Termeer revealed how each member of the Genzyme board had “unanimously” rejected the offer after the “opportunistic takeover proposal” failed to recognise manufacturing challenges or the potential of new and existing products.

However, he still expects another bid from SA, saying: “You and your advisors claim you are willing to pay more but that you are unwilling to ‘bid against yourself’”.

The letter also revealed that Genzyme bankers had met with financial advisors from SA to highlight the progress and improvement the company has made recently in its manufacturing capacity and current products.

But Mr Termeer said Genzyme board members are not prepared to commence any negotiations until an offer which met their valuation of the biotech company had been matched.

“The Genzyme board is not prepared to engage in merger negotiations with sanofi based upon an opportunistic proposal with an unrealistic starting price that dramatically undervalues our company,” the Chairman continued.

“Our board has worked actively to understand the true value of our company and is unanimous and resolute in its commitment to maximise Genzyme’s future value for all of our shareholders.”

The Kosterlitz Centre for Therapeutics will be officially opened by the University of Aberdeen next month.

The Centre will offer various kinds of support to researchers and clinicians, from helping with grant applications and filing patents, to approaching industry, pharma companies, investors and philanthropists for financial backing.

Centre Director Professor Ruth Ross, Chair in Molecular Pharmacology at the University, said: “Scientists and clinicians can be working on research or be involved in patient care when they discover something that might suggest a possible new way of treating a medical condition. However the journey from what is called ‘bench to bedside’ is a laborious one, which is incredibly time consuming, may involve expertise that the scientist or clinician does not have, and will certainly require funding.”

The Centre is named after one of the University of Aberdeen’s most famous scientists, Professor Hans Kosterlitz, who joined the University in 1933 and co-discovered how endorphins affect humans.

Dr Iain Greig, Deputy Director of the Kosterlitz Centre and a medicinal chemist at the University, added: “We want to ensure that ‘eureka moment’ a scientist or clinician may have in the lab or in a medical setting, perhaps when they identify a new receptor or pathway, doesn’t fizzle out because they don’t have the support to translate that finding into a new therapy that could help patients.

“We have already got several pharma companies on board for projects in the pipeline which we hope will pave the way for the development of new therapies for cancer, heart disease, infection and pain. We are also looking at obesity and neurodegenerative diseases.”

Marketing authorisation has been granted for Shire’s VPRIV (velaglucerase alfa), a human cell line derived enzyme replacement therapy (ERT).

The approval was based on data from the largest ever clinical data set for this Gaucher disease. In total, over 100 Gaucher patients at 24 sites in 10 countries around the world participated in the clinical studies, all of which met their primary endpoints.

“Gaucher disease is a rare and often debilitating condition,” said Professor Tim Cox from the Department of Medicine, University of Cambridge, and founder of the largest UK Gaucher clinic at Addenbrooke’s Hospital.

“The European approval of VPRIV is important in that we now have an alternative, licensed therapeutic enzyme. For type 1 patients the availability of VPRIV provides further opportunities to individualise treatment options for this complex disorder.”

Due to high demand, Shire has implemented a program to monitor demand and manage requests from physicians and patients to ensure long-term, uninterrupted treatment with VPRIV.

“The marketing authorisation for VPRIV in the EU is an important milestone for Shire,” said Sylvie Gregoire, President, Shire Human Genetic Therapies. “Our efforts to accelerate our manufacturing, clinical and regulatory timelines have resulted in VPRIV’s approval in Europe and the US months ahead of schedule.”

VPRIV was approved by the US Food and Drug Administration in February 2010.

ARBs are recommended as an alternative first line therapy in patients with chronic heart failure (CHF) who are unable to tolerate an ACE inhibitor (ACE-I). For patients who are still symptomatic despite first line therapy with an ACE-I and beta-blocker it is also recommended that an ARB licensed for heart failure is added in.

Currently available angiotensin receptor blockers include candesartan, eprosartan, irbesartan, telmisartan, valsartan, losartan and olmesartan.

Dr Alan Begg, Montrose, commented, “This partial update brings NICE guideline CG5 into line with the SIGN guideline 95 published in February 2007, confirming the first line use of ARBs as an alternative to ACE-Is if the latter are not tolerated and for additional use if not controlled with a ACE-I and beta-blocker.

“If using an ARB in heart failure, candesartan stands out as the obvious choice when taking into account the CHARM Alternative and CHARM Added trials, data that is also discussed in the guideline.”

Candesartan (brand name Amias, manufactured by Takeda) is the only ARB licensed to treat CHF both as an add-on therapy to ACE-Is or in patients who are ACE-I intolerant and also taking concomitant beta-blocker therapy.

In the CHARM-Alternative study, in 2028 CHF patients who were ACE-I intolerant, treatment with candesartan resulted in a 23% reduction in the risk of death from a cardiovascular cause. The CHARM-Added study, in 2548 CHF patients who were already taking an ACE-I, showed that the addition of candesartan resulted in a further risk reduction of 15%.

Marketing authorisation for the vaccine has now been adjusted to show its efficacy goes beyond the human papilloma virus strains (HPV) 16 and 18 to provide protection against 80% of all cervical cancers.

The changes reflect the scope of protection the vaccine offers patients following recent positive results from the Papilloma Trial against Cancer in Young Adults (PATRICIA). The study demonstrated that Cervarix is effective against HPV strains 16, 18, 31, 33 and 45, which was not highlighted in its original indication.

The summary of product characteristics for the drug will now be updated to include the prevention of precancerous lesions and cervical cancer causally related to certain strains of HPV.

Seven out of ten employees at AZ’s site in Macclesfield decided on the walkout over changes to pension benefits.

Alan Black, GMB National Officer, said the strikes were the “last thing” members wanted but felt little choice after the cuts.

AZ defended the changes, saying the defined benefit scheme (DB) has a deficit of £1.4 billion, despite the pharma company contributing £645 million over the last ten years.

Employees are now set to down tools for two hours on 8^th September, followed by a four-hour strike on 15^th September and 24-hour action on 22^nd September.

AZ has offered members of the DB scheme the choice between continuing to pay into the scheme but with their pensionable salary frozen at current levels, or moving to a defined contribution scheme. However, the GMB called the offer “draconian”, insisting both options devalued pensions.

In a statement, AZ said it was “disappointed” and believed the strikes were unnecessary.

“It is our firm belief that industrial action would not be in anyone’s best interests,” the statement said.

“AstraZeneca remains committed to providing a very competitive level of pension benefit, and the changes made ensure all employees continue to have access to pension arrangements that compare favourably to other organisations in the UK.”

The Macclesfield plant is AZ’s second largest in the world.

He succeeds Sir Leszek Borysiewicz and will hold the position for the next three years.

Commenting on his appointment, Sir John spoke about joining the MRC at an exciting time. “I am thrilled at a time when there are such bright prospects for the UK to play a leading role in the international effort to beat disease through interdisciplinary discovery science,” he said.

“To ensure rapid translation into health and wealth gains, I look forward to working through the Office for Strategic Coordination of Health Research (OSCHR), with the National Institute of Health Research (NIHR), the devolved administrations and the Technology Strategy Board (TSB).”

Sir John Chisholm has also been reappointed chair of the MRC for another two-year term by the Government. The pair will commence their roles on October 1^st.

Celgene’s Thalidomide (thalidomide) and Velcade (bortezomib), manufactured by Janssen-Cilag, have both been recommended by the independent Appraisal Committee.

The Committee heard from experts how the clinical effectiveness of the two regimens were equivalent; but Thalidomide regimens were more cost effective than Velcade.

Dr Carole Longson, Health Technology Evaluation Centre Director of NICE, said the Institute was ‘pleased’ to recommend the duo and help prolong patients’ lives.

Thalidomide in combination with an alkylating agent and a corticosteroid is recommended for first-line treatment when high-dose chemotherapy with stem cell transplantation is inappropriate.

Velcade in combination with an alkylating agent and a corticosteroid is recommended as a treatment option if patients are unable to tolerate or have contraindications to Thalidomide.

“We are pleased to be able to provisionally recommend these two treatments for people with multiple myleloma,” Dr Longson said. “The evidence clearly showed that both thalidomide and bortezomib regimens are more effective at delaying disease progression and improving patients’ life expectancy than the current treatment of an alkylating agent and corticosteroid alone.”

Approximately 3,600 cases of multiple myeloma are diagnosed every year in the UK.

Final guidance is expected to be published in October.

The Appraisal committee said that whilst imatinib after surgery, as adjuvant therapy, could delay the recurrence of GIST, concerns over key aspects of the drug’s clinical effectiveness contributed to the decision.

NICE will conduct an additional appraisal when “more mature evidence” becomes available.

Questions over whether adjuvant imatinib extends life expectancy, how long treatment should be continued for and whether resistance develops were all raised by the Appraisal Committee.

Sir Andrew Dillon, Chief Executive of NICE, said: “Although there is some evidence that imatinib may delay cancer recurring in certain people who have had surgery to remove their tumours, it is not clear that it increases survival or that it improves patients’ quality of life,” he said.

“The Appraisal Committee did, however, recommend that an early review date should be set for this appraisal so that evidence on the impact of adjuvant imatinib treatment on overall survival can be considered as soon as results from ongoing trials become available.

“NICE already recommends imatinib for patients with chronic myeloid leukaemia and for those with gastrointestinal stromal tumours that cannot be removed by surgery.”

There are approximately 791 new cases of GIST per year in England and Wales.

Results of further studies are expected next year.

NICE has now recommended rituximab (MabThera), adalimumab (Humira), etanercept (Enbrel), infliximab (Remicade) and abatacept (Orencia) as treatment options for RA. In separate guidance, tocilizumab (RoActemra) was also given the green light.

The National Rheumatoid Arthritis Society (NRAS) backed the decision after a ‘long battle’ with NICE over access to biologic therapies.

In 2007, NICE failed to recommend infliximab, etanercept and adalimumab as first-line treatments based on data available.

The latest guidance adds to instructions issued by NICE in June in regard to sequential use of anti- tumour necrosis factor (TNF) therapies and abatacept.

NRAS said they were delighted the treatments had been recommended after ‘strenuously campaigning for a long period of time’ and would enable sufferers to now lead active and productive lives.

“It’s been a long battle but it makes economic sense because it will enable people to remain independent and working, and gives patients and clinicians more choice and control over management of their disease which is what we need,” said Ailsa Bosworth, CEO of the Society.

Guidance now recommends rituximab, in combination with methotrexate, for adults that have responded inadequately to other disease-modifying anti-rheumatic drugs (DMARDs), including at least one TNF inhibitor, or who are intolerant of other DMARDs.

The other treatments have all been recommended for those who are intolerant of other DMARDs and where rituximab cannot be taken due to contraindication, or when rituximab is withdrawn because of an adverse event.

In separate guidance, tocilizumab, in combination with methotrexate, is recommended in people who have responded inadequately to one of more TNF inhibitors and whose condition has failed to respond to rituximab or has been contraindicated or withdrawn due to an adverse effect.

Dr Carole Longson, Director of the Health Technology Evaluation Centre at NICE, said she hoped the extended options will allow people to manage their condition more effectively.

NICE’s independent Appraisal Committee heard from patients and clinical experts that, despite it being less effective than other treatments, dronedarone had fewer side-effects than other current anti-arrhythmic drugs.

The committee also accepted evidence that the drug did not lead to an increased risk of mortality compared with other anti-arrhythmic drugs.

Atrial fibrillation is one of the most common heart rhythm disturbance conditions. In the UK, more than 46,000 new cases are diagnosed each year.

The guidance recommends dronedarone as an option for the treatment of non-permanent AF in people who have one of the following cardiovascular risk factors:

· hypertension requiring drugs of at least two different classes

· diabetes mellitus

· previous transient ischaemic attack, stroke or systemic embolism

· left atrial diameter of 50 mm or greater

· left ventricular ejection fraction less than 40% (noting that the summary of product characteristics [SPC] does not recommend dronedarone for people with left ventricular ejection fraction less than 35% because of limited experience of using it in this group) or

· age 70 years or older, and

· who do not have unstable New York Heart Association (NYHA) class III or IV heart failure1.

Standard baseline therapy for AF may include drugs to maintain sinus rhythm with beta-blockers usually the first choice.

Her role will include new business processes after joining from Zibrant.

Graham McIntosh, Global Managing Director, said her experience in the events industry will offer clients a tailor-made service.

“Lynsey brings a wealth of creative & technical expertise to our business,” he said. “She will strategically build upon the great work already undertaken in developing integration, between the business development, account management, venue finding and operations teams, to deliver bespoke customer solutions rather than a ‘one size fits all’ approach.”

Sandy Royden, who has been an active member of the Society for the last ten years, has been named as the new chair. Dr Beverly Barr joins Rachel Farrow as vice-chair.

Royden has more than 20 years’ experience in the pharma industry covering clinical research and development, marketing and sales and was previously the CEO Europe at Huntworth Health.

“I am delighted to be appointed as chair,” said Sandy. “It’s a great honour to be able to work with the PM Society Committee to drive forward our educational initiatives in an ever changing environment and recognise the great work the Pharmaceutical industry delivers.”

She succeeds Steve Clark as chair.

The Swiss company now owns 77% of Alcon shares, following the acquisition of Nestlé’s 52% stake for $28.3 billion.

A full takeover by Novartis still hangs in the balance, however, as minority shareholders dispute the price they have been offered for their 23% stake.

The companies have complementary eye car portfolios – Alcon is a global leader in ophthalmic surgical products, while Novartis has a broad contact lens portfolio and advanced technologies.

“We are delighted to become majority owners of Alcon. Together, both companies can achieve their strategic priorities to deliver against patient needs through innovative and differentiated products,” said Joseph Jimenez, CEO of Novartis.

“I believe that Alcon will benefit from having a majority owner that is a global leader in health care,” added Kevin Buehler, President and CEO of Alcon. “With this change, Alcon and Novartis can seek out opportunities to create greater value through arm’s-length agreements that leverage our combined strengths and capabilities.”

The companies are already forging plans to combine their complementary field forces for the potential launch of Novartis drug Lucentis in the treatment of Diabetic Macular Edema.

Novartis has also offered to buy the remaining 23% of Alcon held by minority shareholders, many of which are Alcon employees. A direct merger of Alcon into Novartis AG is proposed under the Swiss Merger Act at a fixed exchange ratio of 2.8 Novartis shares for each remaining Alcon share.

However, the three independent directors on Alcon’s board have resisted this final stage of the takeover, insisting that minority shareholders should receive the same rate for their shares as was offered to Nestlé.

More than £200 million was paid to NHS consultants in Clinical Excellence and Distinction Awards last year.

Health Minister Andrew Lansley said the Department of Health wanted to continue to reward staff but the new system must be ‘effective and affordable’.

The scheme was introduced in 1948 to reward research and innovation or outstanding commitment to leadership and patient care, and has since remained largely unchanged.

New awards for more than 500 consultants accounted for £20 million of the total sum last year, with nearly 60% of the 29,000 consultant-grade doctors receiving bonus payments of up to £76,000 a year.

The DH said the review would bring the scheme ‘up-to-date and in line with other public sector pay schemes’. It will be led by the independent review body on Doctors’ and Dentists’ Remuneration (DDRB); recommendations will be published by July 2011.

“We want to continue to reward and recognise those individuals who give outstanding patient care and go beyond the call of duty, but we must ensure that the system is effective and affordable,” said Andrew Lansley.

“The NHS must recognise its responsibilities in the current financial climate as the largest public service in the country and this review will ensure that Clinical Excellence and Distinction Awards are in line with other public sector pay and incentive schemes.

“A more transparent and sustainable awards system will allow the NHS to focus its resources to benefit patients and drive up standards to give us a health service that delivers outcomes among the best in the world.”

The Health Minister added that any savings would be used to enhance patient care and choice.

Bill McMillan, Head of Medical Pay and Workforce for NHS Employers, said consultants welcomed the review and hoped to achieve a fairer system for all.

“We welcome the announcement, which reflects the view of NHS organisations that a review is needed into the system of rewarding clinical excellence,” he said. “We will be consulting them about the fairness, efficacy and affordability of the current arrangements.
“The question is very much alive regarding whether a consistent scheme can be devised that provides employers with the flexibility to reward consultants in a way that is integrated into local systems and needs.”

Anybody with an interest in health is welcomed to submit their ideas for potential new topics based on NICE guidance or NHS Evidence accredited sources in a new online facility.

Dr Fergus Macbeth, Director, NICE Centre for Clinical Practice, said the invitation would allow a variety of people and groups from all backgrounds and interests to make their ‘opinion heard’.

The move comes after a number of potential diabetes indicators for the 2011/12 QOF were questioned by Diabetes UK for contradicting clinical guidelines.

The first phase of topic suggestions commences on 23rd August for a four-week period. When the period closes, NICE has said each suggestion will be reviewed against criteria provided in the submission form and suitable suggestions will be presented to an independent advisory committee to consider.

“We recognise the importance of making sure professional groups, patients and community and voluntary organisations have a clear opportunity to contribute to the development of indicators at every stage of the NICE process for QOF,” said Dr Macbeth.

“For this reason, our topic suggestion facility will encourage anyone with an interest in health to make their opinion heard. We actively encourage any recommendations and look forward to considering them at the QOF advisory committee meeting in December 2010.”

QOF indicators were initially introduced in 2004, and NICE took over the management and development of them in April 2009.

NICE will publish a proposed list of indicators for the 2013/14 QOF, together with recommendations on indicators to be considered for retirement, in 2012.

The union claims that the Government’s refusal to consult the public on the proposals in its White Paper, Equity and Excellence: Liberating the NHS, is unlawful and “lip service of the worst kind”.

The day after the White Paper was published, NHS Chief Executive Sir David Nicholson told all NHS chief executives to start implementing the proposals “immediately”. UNISON wrote to Sir David arguing that no steps should be taken until the public have had the opportunity to consider them.

The plans include handing £80 million to GPs to commission care and abolishing Strategic Health Authorities and PCTs.

Sir David agreed that no changes should be made until after the consultation period, but added that the consultation only covers to how the proposal should be implemented, not whether it should be implemented at all.

Karen Jennings, UNISON Head of Health, said: “I find it incredible that the NHS Chief Executive would say he believes there is no legal duty on the Secretary of State to consult on the merits of the proposals in the White Paper.

“The White Paper contains sweeping changes to the NHS and how it should be run. The NHS Constitution enshrines the principle that the public, staff and unions have an absolute right to be consulted. The Department of Health’s refusal to recognise this clear and important legal duty leaves us no option but to issue legal proceedings as a matter of urgency.”

The Government has rejected the accusations and says that it will defend against the legal action. A spokesperson said: “The Government has already launched public consultations on specific elements of the White Paper, and further documents will be published this year.”

UNISON has said that this legal action is the start of its campaign to prevent such large-scale changes to the NHS. In a statement it said: “This must be supported by health workers and public sector workers across the country. The true message of what is happening must be exposed to the public so they can hold this Government to account for its broken promises, and to stop the decimation of the NHS.”

Prequalification has been granted to Prevenar 13 (Pneumococcal polysaccharide conjugate vaccine) for the immunisation of infants and children from six weeks to five years of age against the 13 pneumococcal serotypes contained in the vaccine.

This decision applies to global use of the vaccine in a single-dose vial and allows for the use of vaccine in national programs by United Nations agencies, including the United Nations Children’s Fund (UNICEF), governments and other organisations.

“We are pleased to receive WHO prequalification as recognition that Prevenar 13 meets the organisation’s high standards for quality,” says Emilio Emini, Chief Scientific Officer, Vaccine Research, Pfizer. “This is an important step towards our goal of making Prevenar 13, which offers the broadest serotype coverage of any pneumococcal conjugate vaccine, available to infants and young children globally.”

Pfizer previously entered into a 10-year agreement to provide Prevenar 13 to infants and young children in the world’s poorest countries under the terms of the Advance Market Commitment (AMC) for pneumococcal disease, a program piloted by the GAVI Alliance.

WHO prequalification applies unified standards of acceptable quality, safety and efficacy to vaccines and other medicinal products and will mean Prevenar 13 can participate in this program.

“Now that we have WHO prequalification for Prevenar 13, Pfizer will work with GAVI and UNICEF to finalize arrangements for first orders and shipments under the AMC,” added Mark Swindell, President of Vaccines, Pfizer.

Manufacturer Roche and Bowel Cancer UK both questioned the decision after tests showed an increased survival rate of almost two years.

Critics argued the decision would see the UK fall ‘even further behind’ other countries for cancer treatment and hoped the new Interim Drugs Fund would finally bring widespread access to patients.

NICE’s independent Appraisal Committee considered the treatment too expensive and questioned Roche’s calculations on a proposed Patient Access Scheme.

The UK is now one of a handful of developed countries that don’t provide Avastin to patients. Roche said the decision was ‘further evidence’ the current system was not appropriate after the cost-effectiveness and not clinical effectiveness of the drug contributed to the outcome of the appraisal.

“The recent International Variations Report has shown that patients in the UK have significantly poorer access to cancer medicines when compared to their European counterparts,” a statement from the pharma company said.

“The launch of the Interim Cancer Drugs fund will help address this ‘passport prescribing’ situation in the short term and is further recognition that the current drug evaluation process disadvantages end of life cancer medicines.”

Roche also highlighted how NICE has failed to recommend more than half of cancer drugs since January 2007 and hoped to see a ‘pricing and reimbursement system in the longer term that may be more mindful to the challenges of evaluating end of life therapies’.

Bowel Cancer UK revealed its disappointment at NICE’s decision, claiming the effectiveness of Avastin far outweighed its cost.

“I know that NICE has to be rigorous in its appraisal of treatments and that it looks in detail at individual drug trials to assess cost-effectiveness,” said Rob Glynne Jones, Chief Medical Adviser of the charity.

“However, as a practicing oncologist, if we simply look at survival in the UK, I can see that in even the most up-to-date national drug trials, such as COIN, patients with advanced bowel cancer have an average 19 months’ survival. This compares to up to 27 months’ survival for patients in countries that use bevacizumab (Avastin), such as in mainland Europe and the United States.
“I can’t argue with NICE’s decision, but I am disappointed. These statistics tell their own story and imply that we are likely to fall even further behind in worldwide league tables.”

It is estimated that around 6,500 patients a year in the UK could benefit from Avastin. The drug is currently used in the US and across Europe, but patients in the UK have to purchase the treatment privately or appeal to their local health authority for funding.

ProStrakan Group plc, Cephalon UK Ltd and GlaxoSmithKline Consumer Healthcare will now be highlighted in advertisements after the breach of Clause 2 of the Code – bringing discredit upon and reducing confidence in the pharmaceutical industry.

In total, five clauses were broken by ProStrakan and GSK in relation to the promotion of Abstral and the mailing of NiQuitin respectively. Cephalon breached three clauses for providing free stock of Effentora without sufficient controls.

Only Cephalon decided to appeal against the decision.

Alongside Clause 2, the ABPI ruled that ProStrakan and GSK had both been making misleading claims, failing to maintain high standards and failing to comply with an undertaking.

The complaint about the promotion of Effentora related to the product being sent to an NHS nurse instead of directly to a pharmacy department. The ABPI agreed that a representative had failed to maintain high standards.

The adverts will be included in the medical, pharmaceutical and nursing press.

Mr Bousbib succeeds current Chairman and CEO David Carlucci, who will continue to serve as Chairman for a transitional period.

“I welcome the opportunity to help grow this franchise,” said Mr. Bousbib. “Through the innovative use of information, IMS Health has become an integral part of global healthcare. David has built an impressive organisation, and I look forward to leading this team as we continue to enhance the depth, scope and reach of our offerings and as IMS seeks new ways to make a difference in healthcare.”

Mr Bousbib joins after a successful 14-year career with United Technologies Corporation (UTC). In May 2008, he was also appointed by the President of the United States to serve on the President’s Commission on White House Fellowships, America’s most prestigious program for leadership and public service.

In an interview with the Financial Times, Sir Rawlings said that taking a third off the price of drugs sold to the NHS would be simpler than complex pricing schemes and rebates.

“These schemes can sometimes be complicated for NHS trusts to implement due to factors such as difficulties of measurement or associated costs,” he said. “In such cases, a simple discount may eliminate the need to put in place complicated schemes that require substantial management input.”

However, pharma companies have responded that it is in their interests to maintain these high prices for international sale, while at the same time, providing discounts for the NHS.

The first risk sharing scheme of this type was agreed for multiple sclerosis treatments in 2002, when it was decided that the drugs would be provided but the price would be cut if it was later proved they did not meet the claims of the manufacturers. There has never been substantial evidence of their failure, so the price has remained consistent, the Financial Times points out.

The DH has promised that the way drugs are paid for will be reviewed in 2013 when the current Pharmaceutical Price Regulations scheme comes to an end.

“It is essential that any proposed discounts also be fair to the pharmaceutical industry and so would need to be balanced by pharma companies being able to recover some of that discount if the drug proves cost effective for the NHS,” comments Janet Knowles, partner and head of the UK BioPharma team at international law firm Eversheds.

“NICE has pressed for patient access schemes to be based on the cost effectiveness of a drug but Sir Michael’s comments seem to suggest that the NHS is not yet able to easily determine this. Perhaps the NHS should shift its focus towards developing ways to easily and effectively do this, which would satisfy both the NHS and the pharmaceutical industry.”

Love and Other Drugs, starring Jake Gyllenhaal and Anne Hathaway, is loosely based on Jamie Reidy’s ‘kiss and tell’ account of selling Viagra for Pfizer, published in March 2005, Hard Sell: The Evolution of a Viagra Salesman.

The original book paints a humorous, but occasionally shocking, picture of the US industry at the time the writer is working for Pfizer – the negative portrayal cost Reidy his job as a sales training executive at Eli Lilly when it was published.

However, due to the feel-good nature of the film, industry analysts do not predict it being as hard-hitting as anti-pharma films like The Constant Gardener. A company spokesperson said: “Pfizer is aware that a film is in development. We were not involved in any way in the making of the movie.”

It remains to be seen whether the film will have a positive or negative effect on sales of Viagra.

Another light-hearted look at the US pharma industry starring Reese Witherspoon, Pharm Girl, is still rumoured to be in production with no set release date.

The recently-released trailer for Love and Other Drugs is available on YouTube here: http://www.youtube.com/watch?v=TO0X4DQZKqk&feature=related

The independent Appraisal Committee considered the treatment too expensive and questioned Roche’s calculations on a proposed Patient Access Scheme (PAS).

Sir Andrew Dillon, NICE Chief Executive, said the Institute was ‘disappointed’ not to recommend Avastin but highlighted a number of other treatments currently available.

Irinotecan, oxaliplatin, capecitabine, tegafur with uracil and cetuximab have all previously been recommended for various stages of colorectal cancer by NICE.

Roche originally proposed Avastin in a PAS where the drug would be free after 12 months of treatment. The cost of oxaliplatin would also be reimbursed. The new scheme included the same proposals plus an additional upfront payment to the NHS. But the Committee said the complexity and administrative costs were both likely to be higher than Roche had predicted.

“We have recommended several treatments for various stages of colorectal cancer, including cetuximab for the first-line treatment of metastatic colorectal cancer,” said Sir Andrew Dillon. “We are disappointed not to be able to recommend bevacizumab as well but we have to be confident that the benefits justify the considerable cost of this drug.”

The draft guidance has now been issued for consultation.

Financial analysts said the opposition was an attempt to clear the way for a future product in development by the Swiss giant.

Alexion has now applied for supplementary protection certificates (SPCs) in the 14 European countries where the patent is issued. The SPCs include a prohibition on the sale or use by third parties of Soliris until May 1, 2020 for all approved indications.

Soliris is a treatment for paroxysmal nocturnal hemoglobinuria, a rare blood disorder, but has yet to be appraised by NICE.

Alexion obtains all its revenue from the product which Forbes named as the single most expensive drug with a price tag of $409,500 earlier this year.

Despite the large revenue, Salveen Richter of Collins Stewart, a leading financial advisory group, said the opposition filing may not be driven by potential profits.

“We do not believe Novartis is threatening to compete against Soliris,” she said.

"We believe Novartis initiated this opposition to have the patent invalidated so it can pursue the development of its own C5 antibody for the treatment of age-related macular degeneration," Richter said.

Novartis refused to comment on the matter.

Seven out of ten employees at AZ’s site in Macclesfield decided to take strike action over what the GMB called ‘draconian proposals to, in effect, end its final salary pension scheme for 2,500 staff’.

The pharma giant insisted only a small percentage of workers called for action and said the benefit remained attractive compared to competitors.

Shop stewards are now set to announce the dates for industrial action unless a compromise can be reached.

In a statement, AZ said it remained “committed to providing a very competitive level of pension benefit and the changes made ensure all employees continue to have access to pension arrangements that compare favourably to other organisations in the UK.”

“We understand that 165 employees have voted in favour of action, which represents about a third of the GMB members and less than 2% of the UK employee population,” it continued.

But Alan Black, National Officer of GMB union, called for AstraZeneca to reassess its stance before walkouts take place.

“This clear mandate for a strike in the midst of the current economic circumstances ought to be a wake-up call to AstraZeneca to resume negotiations with GMB,” he said. “They have to understand that unless they take this opportunity then strike action will be the consequence.”

The Macclesfield site is AZ’s second largest in the world.

Overall, in the US, sales calls to practitioners decreased 1% in the first half of 2010 compared with the previous 6 months, according to a study by healthcare market insight and analytics firm SDI.

The study also found that sales rep calls and details accounted for 36% of the industry’s investment during the first four months of 2010, making it the second most common form of promotion after drug sampling.

Pfizer, Merck (MSD in the UK), and GlaxoSmithKline, which made the most sales calls in the first six months of 2010, each registered declines from the second half of 2009. Pfizer sales calls decreased 2%, while Merck and GlaxoSmithKline experienced larger declines at 16% and 7%, respectively.

In contrast, calls made by Novartis sales representatives actually increased 7%. Valturna, a product that combines the active ingredients in Diovan and Tekturna, and was approved by FDA to treat hypertension in December 2009, was the subject of 19% these calls.

“With the number of pharmaceutical sales reps being scaled back dramatically over the last few years, it’s no surprise that sales calls across the industry are also declining,” said Jason Fox, Associate Director of Syndicated Analytics at SDI.

“However, companies with new drugs or newly approved indications for existing drugs need to get the information into the hands of physicians and other practitioners, and in-person calls are still the most popular type of promotion, outside of product sampling.”

SDI provides patient-level data to pharmaceutical, biotech, retail pharmacy, and medical device companies, enabling them to better understand the healthcare market.

The GPC’s first  statement on GP commissioning since the publication of the White Paper says that these principles should be used to “define policy, inform debate and negotiations, and ensure that good medical practice is enshrined within the changes proposed in Liberating the NHS”.

Dr Laurence Buckman, Chairman of the BMA’s GPs Committee, said: “Even though there is still little detail about how commissioning will work we know that many Primary Care Trusts are pushing ahead trying to make arrangements. We are therefore producing a series of documents aimed at helping GPs during this critical phase.”

These fundamental principles include that GPs must not personally profit from commissioning budgets, that freed up resources will be reinvested in patient care and that a contract held by a GP should never be allowed to conflict with their professional responsibilities in providing care for patients.

Regarding the new GP consortia, the document states that they:

• should ensure that, wherever possible, NHS providers are the providers of choice
• should include public and patient involvement
• must be committed to reducing healthcare inequality, wherever possible
• must be democratically accountable to practices within the consortium.

Dr Buckman added: “If GP commissioning is to bring real change and benefit to patients and the NHS then time needs to be given to planning how it should work, based on the principles we’ve outlined. I would urge GPs to resist pressure to move too quickly, send questions and concerns to us and keep an eye on the BMA website as we will be producing practical guidance on a regular basis.”

The MHRA approved the drug whilst acting as the Reference Member State for 16 EU countries.

Pitavastatin is indicated for adults in addition to diet for the treatment of primary hypercholesterolaemia or combined dyslipidemia.

Drummond Paris, President at Kowa Research Europe, commented: “Pitavastatin has been the leading product in our cardiovascular portfolio in Asia since 2003, we are therefore thrilled to reach this European milestone and look forward to achieving the ongoing national marketing authorisations (MA) within the EU.”

Kowa says that one of Pitavastatin’s strengths is that its potential for cytochrome P450-mediated drug-drug interactions is low.

“Since many patients treated for elevated cholesterol may be on multiple medications, it is important that physicians caring for these patients understand how treatment with a cholesterol medication, such as a statin, may potentially interact with the other drugs the patient may be taking,” added Professor John Betteridge, Department of Diabetes and Endocrinology, UCLH, London.

The Global Life Science Hiring Index shows that 15% of sales and marketing positions are now hired out across Europe, the Middle East and Africa.

Flexible staff numbers and cheaper labour costs, which also result in a reduction in company benefits, were all believed to contribute to the rise of temporary workers.

Thirty global organisations, widely considered leaders in their respective field, participated in the study including GlaxoSmithKline, Pfizer, Roche and sanofi-aventis.

The Index, the first of its kind, was developed after an overwhelming industry demand for a simple indicator into the state of hiring within the life sciences and medical industry.

The results provide a critical insight into regional hiring trends, skill shortages and talent gaps across the world. For life sciences/pharma, the highest area for hiring includes accounting, finance and IT with nearly three out of ten employees on a temporary contract.

Medical devices and supplies was the most active sector for hiring across the world, providing 46% of job opportunities to contractors.

The overall figure for life science/pharma reflects nearly four positions in ten across the globe are now farmed out.

A total of 1,742 drugs were recalled by the FDA in 2009 – an increase of 309% on the year before.

New FDA leadership, increased enforcement by Commissioner Margaret Hamburg and poor manufacturing controls were all held responsible for the increase.

Recalls continued to rise for the first six months of this year and were expected to exceed 600 by the end of 2010 if levels continue.

More than a thousand of the recalled products involved drugs from Advantage Dose – a repackager which has since ceased trading.

However, even if the Advantage Dose products were removed, recalls still increased by 50% last year.

Bowman Cox, Managing Editor of Gold Sheet, a trade publication that focuses on FDA data, said the results continued a trend of high recalls in recent years since figures started being analysed more than two decades ago.

"We’ve seen a trend where the last four years are among the top five for the most number of drug recalls since we began tallying recalls in 1988,” he said.

FDA policy on generic drugs, where approval results in a 180-day marketing exclusivity, was also highlighted as one of reasons for the recalls. “They (pharma companies) get the application but they could still have problems down the road if they haven’t really understood the optimum way to make that drug,” Mr Cox added.

The analysis of PBC since its inception in 2005 found that GPs will take on budgets faced by a hugely uneven playing field, depending on whether GP commissioning has become established in the local health economy.

Across the 100 trusts, the report reveals, £290m has been spent on PBC since its launch in 2005, but only £133m was saved.

The report claims that just a handful of GPs have saved a significant amount of money, while the vast majority of the 100 PCTs who responded to Freedom of Information Act requests, have spent far more on PBC than they have saved.

GPs in NHS Telford, NHS Bradford and Airedale and NHS City and Hackney have together commissioned more than 800 new services, and delivered £3.9m, £20.2m and £6.5m in savings respectively. GPs in NHS Northamptonshire and NHS Nottingham City saved £12.7m and £2.5m respectively in tandem with significant service redesign.

However, the report finds that the overall picture was far less positive, with 83% of trusts unable to demonstrate any savings, and many struggling to commission new services.

Richard Hoey, Editor of Pulse, said: “Practice-based commissioning was hamstrung by bureaucracy, inadequate financial information and the reluctance of NHS managers to hand over control. Its failures do not mean that the more radical form of GP commissioning proposed by the new Government cannot be a success.”

A study by the Medical Research Council (MRC) found that patients who were actively screened can expect to live an average of four years longer than if they were diagnosed by their GP.

Study leader Dr Greta Rait said GPs “must get better” at detecting the condition with cases set to double by 2040.

The report is the first to analyse life expectancy after dementia is recorded by GPs.

The study analysed health records of more than 135,000 people aged over 60 in the UK from 1990 to 2007. Results showed that GPs are recording dementia in a non-specific way, leading to implications for long-term management.

Findings showed that mortality rates are more than three times higher in people with dementia in the first year after GP diagnosis than in those without dementia. Researchers suggest this shows diagnoses are being made late in the life cycle of the disease.

Professor Steve Field, Chairman, Royal College of General Practitioners, said GPs needed to know the latest information to improve early detection rates.

“The number of patients with dementia coming to see their GPs is increasing year on year, and it will have an enormous impact on the patients, their families, the work of health professionals and the economy in years to come,” he said.

“It’s crucial that GPs have the appropriate knowledge and skills – learning about dementia is an important part of a GP’s training – but GPs need to maintain this knowledge, and keep up-to-date so that they can identify patients with dementia at the earliest opportunity, and offer them early intervention so as to help them live high-quality, fulfilling lives for as long as possible.”

Dementia currently affects approximately 570,000 people in the UK, at a total cost of £15.9 billion a year.

The study looked at how many organisations received corporate sponsorship and their compliance with the EMA’s criteria on financial disclosure between 2006 and 2008.

It found that fewer than half of the 23 organisations met reporting guidelines and two thirds had received partial or significant funding from manufacturers or industry associations.

HAI said that complete disclosure provided a ‘qualitative and quantitative’ base to assess potential conflicts of interest that could influence decisions around medical regulation.

Patient & Consumer Organisations at the European Medicines Agency: Financial disclosure & transparency found that 15 organisations received between 0.2% and 99% of their annual income from corporate sources. Only seven were funded from alternative sponsors.

In those 15, the average corporate contribution continued to rise at a rate greater than inflation and accounted for 57% of average annual revenue.

The EMA introduced transparency guidelines in 2005, but by March 2010, 20 organisations had failed to report their 2006 income online.

The report called for further research to realise complete transparency and said that insufficient funding had led to the pharmaceutical industry becoming the ‘patient voice’ at the EMA.

A number of recommendations were made, including enforcing precise reporting outlined in existing criteria and fixed deadlines for the submission of financial disclosure reports.

Colin Stewart has been appointed as President, CEO and a member of the company’s board of directors.

Amarin is a biopharmaceutical company with a focus on cardiovascular disease and is approaching the launch of its new lead product, a drug currently in Phase 3 clinical trials for the treatment of high triglycerides.

Mr Stewart has more than 30 years of experience in executive management and commercial positions for pharmaceutical companies, including five years as President and CEO of CollaGenex Pharmaceuticals, Inc.

In addition, Mr Stewart served ten years with the ASTA Medica Group, where he managed several business units in the US and internationally. He began his career in sales and marketing for Winthrop Laboratories in the UK and held a number of positions of increasing responsibility within the Sterling-Winthrop Group.

Dr Declan Doogan, who has been serving as the company’s Interim CEO, will become Chief Medical Officer.

Amarin’s Chairman of the Board, Joseph Zakrzewski, commented: “We are very excited by the addition of Colin Stewart to the Amarin team. He brings a wealth of commercial and executive management experience, which complements the already strong technical and financial functions within the Company. Colin is expected to play a key role as we weigh our various alternatives for commercialisation of AMR101.”

Mr Stewart added: “I am very impressed by the progress Amarin has made since being restructured and recapitalised late last year. With Phase 3 studies of AMR101 for two indications advancing well and scheduled to report in 2011, we will continue to explore every opportunity to maximise the potential commercial value of this promising drug, including potentially through one or more collaborations with larger pharmaceutical companies.”

The Mathilda and Terence Kennedy Institute of Rheumatology Trust filed the case against Belgian company UCB for infringing its 2001 patent on combining drugs like Cimzia with methotrexate.

The trust’s patent relates to treating arthritis by co-administering methotrexate and drugs that block receptors to an inflammation-causing protein called tumor necrosis factor alpha (anti-TNFa), such as Cimzia.

Amgen and Wyeth were sued by the trust for infringing the same patent with their arthritis drug Enbrel last year. The case was withdrawn, but the lawsuit for the current case claims that Amgen and Wyeth, as well as Abbott Laboratories and Centocor, have paid “tens of millions of dollars” to the trust in loyalties.

Cimzia is one of UCB’s three key hopes for growth after patents expire on some of its big-selling drugs. The company has said annual Cimzia sales could top €1.5 billion in the coming years.

The lawsuit, demanding royalties and damages from UCB, was filed earlier this month in US federal court in Delaware.

The Mathilda and Terence Kennedy Institute of Rheumatology Trust (the KIR Trust) was founded in 1965/66 and was the first research institute dedicated to Rheumatology.

Many of us only update our CVs when we decide it is time to look for another job. This then consists of taking five minutes to add another line of text to highlight the current position and a few lines to highlight role duties.
We then send this off to a few agencies, upload it onto a jobs website and hope for the ‘ideal position’ to coming floating into our inbox. After getting a minimal response at best, we say, “all those job websites and company/agency sites are a waste of time; I submit my CV and it gets lost in a black hole!”
Your CV is your ‘window to the world.’ It needs to create an impact that makes the person reading your CV respect your achievements and want you at the same time!

Follow the Redhunt Resume Rules™ of Layout, Content, Clarity and Conciseness and create a CV with impact:
Name, Address, Contact details
Personal Profile: a summary of the key relevant skills, experience and qualifications that shows the manager that you are the person for the job and encourages them to read on.
Career Profile: this should list your main jobs (most recent first) and key achievements in each role (try to limit this to no more than 5 achievements in each role). Steer away from listing only your role duties, as managers already know general role profiles. It is your achievements and successes that get you an interview (and subsequently, a position) and not the duties you were paid to do.
Education & Qualifications: this should be used to supplement and reassure your hiring manager of your academic credentials and industry/jobspecific qualifications and training (e.g. ABPI, CIM, CIPD, MBA etc).
Product Experience to Date: highlight any relevant therapy areas you have worked in, and any launch experiences you may have. This can differentiate you from the competition and show the breadth and depth of your product/therapy area knowledge. This is especially helpful for contract sales reps, to highlight the broad therapy experience gained as syndicated teams.
References: include these in the footer to your CV as ‘available upon request.’

That’s it! Clear, concise and to the point; just wait for the interviews!

Som Jandu is Managing Director of Redhunt Ltd

It is common wisdom that what goes around, comes around. Which can make lying on your CV one of the scariest experiences of your whole life – what if it actually works?
What if, like the man who applied for a position out East as an English language expert, you actually get the job, complete with impressed “oohs” and “aahs” at your amazing capabilities? Wonderful isn’t it, that good fortune smiles on you? So easy to forget – and life goes on.
The years pass. You rise up through the ranks – head of section, head of department, all the way up to the very highest position. And now, as a special accolade – and with famous Oriental courtesy – your employer celebrates your appointment to top office by inviting you to lead a group of respected colleagues back to the UK to visit your old alma mater, say, the University of Kent at Canterbury.
All that honour and privilege; a very public salute to your brilliant career. You’ll have to show them the sights, take them to your old drinking-holes. Except that you’ve never been to Canterbury ever – that was just a little tweak to make your CV sparkle.

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An Employer’s Perspective on your CV
Things to think of when you write it:

• I don’t know who you are.
• I don’t know your background.
• I don’t know if you can be trusted.
• I don’t know who you’ve worked for.
• I don’t know your performance record.
• I don’t know what your capabilities are.
• I don’t know your professional reputation.

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Found out!

The ultimate horror? Count on it, it WILL happen. If not now, then at some time in the future. It’s become an unfortunate fact of life; so many people lie to get ahead that running a background check is already routine.
OK, so there’s the short-term gain of actually landing the job. But it’s a long way to fall after forty years of success – with a family, friends, a house and brand-new Toyota Prius to lose.
Of course that lie could be a mistake, a little over-claim so that maybe something looks like more than it should. Heaven knows, there are mistakes enough in most CVs – so many, in fact, it’s a wonder any are accepted.
Your name, for instance, is that a lie or a spelling mistake? Don’t laugh, so many people forget to check their own information, getting their own name wrong just happens.

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Items to support your CV:

Cover letter
Like the CV itself, it needs to be short, sharp and businesslike. One page only, three short paragraphs maximum – and loaded with keywords to turn your recruiter on. Why? Because although they’re essential, cover letters get even less attention than CVs. They’re also scanned rather that read, the only way to get through thousands of them quickly. Read the job spec carefully and use keywords to make you look like an asset.
References
So many people misrepresent themselves, you need reliable proof that you’ve worked where you say you have, done what you say you’ve done, and your ex-boss thinks you’re a good bet. Like the rest of your package, references should be short and to the point. And no pally stuff from friends, this is business.
Proof of ID
There is an increasing number of people who are not necessarily who they say they are and do not have the necessary permit to work in UK. Even if you’ve lived here for generations, make sure you have yours.
Qualifications
In the computer age it’s become too easy to dummy up a degree, so genuine copies are going to come in handy. O-levels/GCSEs, A-levels and NVQs might be checked too – no employer can afford to take chances any more. Provide copies of course, not originals (as long as they’re authentic!), you don’t want them to go astray.
Competency certificates
Look at yourself carefully from the capabilities angle. You’re more than the person you were when you started work, aren’t you? And somehow you’ve picked up a whole load of skills, all of which are necessary in modern business, particularly working with computers. Through an online test facility like ClickATest.co.uk, you can now verify these skills and prove them with internationally-recognised ISO 9001-2000 certificates – hard evidence of your work-related capabilities.

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Step away from your desk, sir

Actually, if you do lie on your CV there’s a pretty good chance it won’t get picked up – unless you’re going through an agency. That’s because CVs get scanned more than read, and with sometimes upwards of 3,000 applicants applying for the same job, that’s hardly surprising. Agencies are more likely to check you out. They could get hit for fraud if they misrepresent you, enough to put them right out of business. Which means they have to be sure. They have to verify your ID by law in any case, so checking your qualifications, job history and references is par for the course.
Because CVs are scanned more than read, a lie can get both missed by a HR manager under pressure to get results and picked up by a computer doing a routine background check.

Doing it the hard way

Your CV is also scanned to assess your match against a job, so don’t go creating screeds of persuasive prose. It won’t get read anyway – and without nice relevant subheads to classify your claims by category, a computer will miss it too – or dismiss it as irrelevant. In fact, praise be for those systems that ask you to input section by section, line by line – where ‘all boxes are mandatory and do not exceed 1,400 characters’. Because all those fields demand values against them, your skills can be picked up and noticed, your track record recognised and recommended.
Fill them in and you stand a better chance of being found, matched against a job specification and offered a position. Yes, it’s a pain, but do you want the job or don’t you?
You should in fact be thankful. All those boxes prevent waffle – and just maybe discourage you from lying in the first place. Not that you ever would of course, but it’s good to reduce the temptation.

Plane common sense

Don’t try sexing up that personal image of yourself either, even the smallest throwaway can bring you down. One hopeful put down skydiving as a leisure activity, intending to look like a determined go-getter. Three days later – surprise, surprise – the interview panel included a skydiving enthusiast. Exposed by questions about conical canopies versus PDAs and how to exit a Twin Otter DHC6, another otherwise promising career hit the ground hard.
So how DO you come across well in a CV? If it’s scanned not read and everything is going to be checked, how do you stand out from the possibly hundreds of others applying for the same position?
One sure way is to point to your achievements, what you actually did in your previous jobs when you had them. Even the lowliest job can demonstrate initiative and drive. Just stick to the facts, without embellishment. Think about it as if you were the boss. You don’t really want to know what somebody HAS done, do you? You want to know how much they CAN do.
It’s about attitude. The world’s most brilliant whiz-kid scores zero if there’s no heart behind the talent, or passion to drive forward. Show commitment and staying power, and suddenly you’re just as competitive as anyone else.

Peter Fryer is PR & Communications Executive at ClickAJob.co.uk. ClickAJob is one of the UK’s largest online job search engines, with over a million job vacancies. The company is part of a dedicated Human Resources group that includes ClickATest, an online test centre and CAJ:Associates, a highly personal recruitment consultancy that combines traditional face-to-face service with web-based back-up and access 24/7.
Peter can be contacted on 01932 871 904 or pfryer@freshactionpr.co.uk.

The company has revealed top-line results from a Phase 3 trial evaluating Vectibix as a first-line treatment in patients with recurrent and/or metastatic squamous cell head and neck cancer which showed that Vectibix did not improve overall survival in.

The data showed that the drug’s addition to platinum-based chemotherapy did not result in a statistically significant improvement in overall survival compared to chemotherapy alone (median 11.1 months versus 9.0 months).

“The outcome of this study is disappointing. However, Vectibix remains an important monotherapy treatment option for patients with metastatic colorectal cancer whose disease has progressed on other therapies,” said Roger M. Perlmutter, Executive Vice President of Research and Development at Amgen.

The SPECTRUM study enrolled 658 patients who were randomised to receive a standard platinum-based chemotherapy with or without Vectibix every three weeks. The primary endpoint was overall survival. The secondary endpoints included progression-free survival, objective response rate, duration of response, time to progression, time to response, patient reported outcomes and safety.

Detailed results from the study will be presented at the 35th European Society for Medical Oncology (ESMO) Congress on October 8-12 in Milan, Italy.

Dr Paul Symonds from the Department of Cancer Studies and Molecular Medicine has demonstrated that adding cisplatin gives significantly better results than radiotherapy alone.

Dr Symonds said: “The addition of cisplatin to radiation has literally saved the lives of hundreds of women with locally advanced cancer in the East Midlands. What the national audit has shown is that the addition of cisplatin improves survival. The addition of cisplatin in routine UK practice reduces the odds of death by 23%. As this is curative treatment we can genuinely say that this is a reduction in the odds of death.”

The study used the case histories of 1,412 patients from 42 different cancer treatment centres, which were collected in 2001-2 as part of an audit which Dr Symonds led for the Royal College of Radiologists. This information included the treatment used and follow-up notes for an average of five years on whether or not the cancer returned.

Although it was already known that radiotherapy and cisplatin is more effective than radiotherapy alone in this type of cancer, the new research, supported by the Medical Research Council (MRC), aimed to provide reliable data on the long-term effects of the combined treatment.

Dr Symonds added: “This audit showed a marked improvement in five year survival of locally advanced cervix cancer compared to the last national audit of patients who were treated in 1993. Moreover, the UK results, as derived from a total of 42 centres (most district general hospitals), show that the results in the UK are now compatible with the best international practice.”

The study will be featured in the September issue of the publication Clinical Oncology.

The European drug regulator will now supply reports of drug side-effects when requested.

The decision is one of a number of initiatives by the Agency to increase the transparency of its operations. Public consultations on its policy for access to documents and its level of openness towards stakeholders are other measures set to be applied.

Former requests were denied by the EMA due to individual adverse drug reaction reports containing personal information on individual patients. The Agency will now delete personal data that would allow identification before documents are released.

These procedures also apply to current proposals for proactive access to Eudravigilance, the European drug safety database, which is currently under discussion with patients’ and health care professionals’ representatives.

The new levels of transparency offered by the EMA could see an increase in drug-liability litigation to support patients in their claims against pharma companies.

The selection was referred to NICE by the Department of Health following advice from the National Quality Board (NQB).

Breast cancer, Type 1 and 2 diabetes and chronic kidney disease were all included on the latest list.

Dr Fergus Macbeth, Centre for Clinical Practice Director, said he hoped the management of the conditions would “improve future services” for the NHS and the public.

The quality standards set out the structures and processes of care, as well as the best outcomes for patients that the standards are likely to achieve.

End of life care, glaucoma, depression and chronic heart failure were also included in the standards. The treatment of alcohol dependence and chronic obstructive pulmonary disease completed the selection.

NICE has already produced similar criteria on stroke, dementia and venous thromboembolism (VTE) prevention.

The results of the study published on bmj.com today challenge claims that breast cancer survival is actually worse in the UK than elsewhere in western Europe.

Breast cancer mortality rates have been falling in many European countries since the late 1980s, thanks to early diagnosis, including breast screening, and effective treatment.

From 1989 to 2006, breast cancer mortality decreased by 20% or more in 15 European countries. In the UK, mortality rates fell by about 30%, more than in any other major European country. In France, Finland and Sweden, countries that have also invested in screening and new cancer drugs, mortality rates decreased by 10-16%.

Women aged under 50 showed the biggest reductions in mortality rates, which the authors suggest may reflect better targeting of effective treatments.

Hilary Tovey, UK Policy Manager at Cancer Research, commented on the findings: “The UK has seen greater decreases in the number of women dying from breast cancer than many other European countries over this period, though this is partly because death rates were relatively high in the 1980s. Reorganising breast cancer services, screening, improved awareness and better treatments, made possible as a result of excellent research, have all had a role to play.”

In an editorial accompanying the research, Valerie Beral and Richard Peto, at the University of Oxford, point out that previous apparently poor UK survival rates were due to “shortcomings in the way cancers are registered” in the UK, while the population-based mortality rates are reliable.

The team of researchers from the International Prevention Research Institute in France reached their conclusions by examining changes in breast cancer mortality rates in women living in 30 European countries from 1980 to 2006. Then, using WHO data, mortality rates were calculated for all women and by age group.

The new draft guidance reflects the extension to the licensed indications for peginterferon alfa.

NICE said the new information, which recommends shorter treatment durations, would reduce the extent of side effects and give clinicians and patients a wider choice of treatments.

The standard treatment for the majority of patients is a combination of ribavirin and either peginterferon alfa-2a or peginterferon alfa-2b.

The guidance recommends the combination therapy for adults who have previously been treated with peginterferon alfa (2a or 2b) and ribavirin in combination; or with peginterferon alfa monotherapy in those who did not respond to initial treatment, who relapsed or who are infected with HIV.

It also recommends shortened courses of peginterferon alfa (2a or 2b) and ribavirin in adults who have a rapid virological response to treatment.

Dr Gillian Leng, NICE Deputy Chief Executive, said the new guidelines would benefit current patients. “Hepatitis C is a potentially debilitating condition and the treatments available have some side effects,” she said. “Therefore, recommending shorter treatment durations is obviously good news for some people with this condition. The draft guidance also widens access to these drugs, giving clinicians and people living with hepatitis C more treatment options.”

Final guidance is expected to be published next month.

The decision on Novartis’ Xolair (omalizumab) came after tests showed little benefit compared to existing treatments and a lack of value for money.

Dr Mike Thomas, Chief Medical Adviser to Asthma UK, said the decision was a “massive blow” for children and the charity would continue to fight for Xolair’s approval for all ages.

NICE currently recommends Xolair under specific circumstances for children aged 12 and above.

Asthma UK said youngsters across the country would be affected by the rejection, which would continue the ‘postcode lottery’ for patients after the drug’s recent approval by the SMC in April.

“Hundreds of children across England with the most severe, allergic asthma will now be denied a pioneering treatment that could free them from crippling daily asthma symptoms, endless trips to hospital and huge amounts of time off school,” Dr Thomas said.

“As the Scottish Medicines Consortium (SMC) has already approved Xolair for use in children aged 6–11 in Scotland, patients will once again be faced with a treatment postcode lottery depending on where they live in the UK.”

Dr Gillian Leng, NICE Deputy Chief Executive, defended the decision, insisting the evidence found by the Independent Appraisal Committee demonstrated no reduction in hospitalisation rates, unscheduled doctor visits or total emergency visits for children in the age group.

She also revealed that the committee had recommended a single piece of guidance for Xolair covering recommendations for all age groups at the earliest opportunity.

Final guidance is expected in September 2010.

Onbrez Breezhaler (indacaterol) is the first new treatment for COPD available in the UK for eight years.

Commenting on the launch, respiratory physician Professor Paul Jones of St. George’s Hospital, London, said: “This is the first new treatment for COPD patients for years and offers another option to treat the many COPD patients who suffer from breathlessness. It is required only once a day but improves the patients’ lungs for a full 24 hours, leading to reduced breathlessness during their daily activities and an improved quality of life.”

The new treatment conforms with NICE’s recently updated COPD clinical guideline, which recommended “long-acting bronchodilators as the first maintenance step in the pharmacological management of COPD”.

Dr Steve Holmes, GP with a specialist interest in COPD, chair of the Primary Care

Respiratory Society and a member of the British Thoracic Society Education Committee, added: “There are always issues in clinical practice with patients taking medication. This new treatment is great news as it offers a once daily treatment for people with COPD suffering from breathlessness. The early research shows significant improvements in patients’ quality of life.”

An estimated 3.7 million people in the UK have COPD and the disease kills more people every year in the UK than either bowel cancer, breast cancer or prostate cancer.

The GSK drug has an innovative mode of action which increases platelet production, in contrast to traditional ITP treatments, which reduce platelet destruction.

The SMC has ruled that eltrombopag treatment should be restricted in Scotland and should remain under the supervision of a physician who is experienced in the treatment of haematological diseases.

Eltrombopag is indicated for adult chronic ITP splenectomised patients who are refractory to other treatments. It may also be considered as second-line treatment for adult non splenectomised patients who cannot have surgery. The SMC has restricted its use to patients with severe symptomatic ITP or at a high risk of bleeding.

Scotland is the first place in the UK to recommend eltrombopag as a cost effective treatment for the NHS. NICE ruled that there was not sufficient evidence to recommend it in draft guidance in June this year.

Dr Mark Drummond PhD FRCPath, Consultant Haematologist & Honorary Senior Clinical Lecturer, Gartnavel General Hospital, commented: “This is fantastic news for patients in Scotland and we are delighted with the decision from the SMC.

“Eltrombopag is an innovative treatment option which represents a big step forward in the management of ITP – it is relatively easy to take and offers a reduced risk of bleeding during treatment, something that we know worries patients and has an impact on their quality of life.”

Ablative therapies destroy abnormal cells without the need to remove sections of the oesophagus.

Dr Damien Longson, Guideline Development Group Chair, hailed the guidance, saying it was “a real step forward in clinically and cost effective treatment for this condition.”

Barrett’s affects the lower oesophagus and can cause cancer. It currently affects about 1% of the population.

Barrett’s oesophagus does not present any symptoms in itself, but can be associated with frequent and longstanding heartburn, difficulty swallowing (dysphagia), vomiting blood and pain under the breastbone where the oesophagus meets the stomach.

Current NHS treatment surgically removes all or part of the oesophagus. But that procedure is set to end after development of less invasive techniques such as endoscopic resection (ER) and ablative treatments.

Guidelines now recommend clinicians should consider offering patients ER of high-grade dysplasia and intramucosal cancer as an alternative.

Dr Fergus Macbeth, Centre for Clinical Practice Director at NICE, said the new guidance had resulted from the serious risk of the condition. “This will be the first national guideline to cover the use of ablative therapies, and will ensure that the widest range of options is considered for patients suffering with this serious condition,” he said. “The recommendations may lead to less costly treatments, and fewer recalls and complications after treatment. Additionally, because more patients are eligible or fit enough to undergo endoscopic procedures than surgery, future savings for the NHS might come from cases of oesophageal cancer avoided.”

As part of its recommendations on implementing the Cancer Drugs Fund, the Rarer Cancers Foundation (RCF) has warned that as many as 3,600 patients will be denied treatment if even half the promised amount is provided.

Despite promises of £200 million being available from April 2011, ministers are now saying that the figure was “aspirational”. Responding to the RCF report, a DH spokesperson said: “The resources available to support the Cancer Drugs Fund next year will be considered alongside other policies in the Spending Review, and will be determined in part by evidence drawn from the interim funding arrangements this year. It is only right that we draw on this real-world evidence to inform the exact level of resources required.”

The report, Exceptional Funding: Recommendations for improving access to cancer medicines and delivering better value for money for the NHS, argues that the Cancer Drugs Fund should be used as a “pilot for value based pricing, ensuring that the price paid by the NHS for cancer treatments better reflects the value they deliver to the NHS”.

It is also suggested that pharma companies should be forced to agree a profit cap, limiting the total amount they can earn from the NHS for a particular treatment.

On this, the DH spokesperson added: “To ensure that effective drugs for all conditions are affordable, the Government will introduce a new, more cost-effective, system of paying drugs companies according to the value of new medicines, from the end of 2013 when the current pricing scheme expires.”

Others have criticised the fund for focusing only on cancer, when patients suffering with diseases such as dementia and multiple sclerosis, who can also struggle to access treatments. An editorial in The Lancet claimed the fund is the product of “political opportunism and intellectual incoherence” rather than the victory for patients groups some are claiming.

The assessment will explore its strategic future with the aim of increasing the use of healthcare informatics to create better care, improved outcomes and reduced costs.

Health Minister Simon Brown said the review was to ensure the full potential of DFI was being maximised and to meet challenges outlined in the White Paper.

The review is in line with the Government’s policy to fully utilise the value of assets and commercial opportunities explained in the Arm’s Length Bodies Review.

DFI was first launched in 2006 between the NHS Information Centre and Dr Foster Holdings LLP. It provides NHS organisations with quality information to help them improve patient care and gain better value for money. The DH owns a 48.75% stake with the rest held by Dr Foster Holdings LLP.

Dr Foster Research was recently acquired by DFI, increasing its scope and growth opportunities outside of the NHS, including local government, the independent sector, the pharmaceutical industry and internationally.

Tom Moloney, Dr Foster Intelligence Chief Executive, welcomed the review. “As one of the most respected brands in the healthcare sector, Dr Foster Intelligence offers comprehensive data to health and social care organisations to help them make better decisions about their budgets and patient care,” he said. “With the increased emphasis on healthcare information in the White Paper, this is the right time to embark a review of Dr Foster Intelligence. We will work with our partners to consider the best options for the company and the shareholders.”

KPMG is to support the DH in the review. The results are expected this autumn in an information strategy paper.

Findings show how GPs have issued expensive drugs instead of cheaper generic options, costing the NHS tens of millions of pounds each year.

Practitioners have now been advised to review and revise 15 therapeutic areas that adhere to current guidelines in a bid to help the NHS make £20bn in efficiency savings.

The Department of Health welcomed the findings but insisted they must be observed across the country should ‘significant’ savings be made.

The report found a number of expensive drugs had been overprescribed by GPs. Since NICE guidance was published in November 2007, the annual spend on cholesterol-lowering drug Ezetrol has increased from £48m to £68m.

Dr Neil Maskrey, Director of Evidence-Based Therapeutics at the NPC, said the report identified some “key therapeutic medicines management options” and would improve patient care in the future.

“Importantly, whilst the purpose of this piece of work was to identify topics that would increase the efficiency of primary care prescribing, the evidence base for all the topics identified has been carefully examined to ensure that safety and clinical effectiveness would be maintained, or in some cases even improved, if they were incorporated into prescribing practice with less variation than at present,” he said.

Peter Rowe, lead for the quality, innovation, productivity and prevention (QIPP) programme at the Department of Health, insisted that while changes to certain therapeutic areas would not be great the overall impact could generate huge savings.

“Some of the topics here improve quality but have little or no associated cost savings,” he said. “Others, when considered alone locally, can deliver relatively small cost savings, but when aggregated nationally and implemented with much less variation than currently, the savings become very significant.”

Diabetes UK asked for a delayed withdrawal to ensure a co-ordinated response could be arranged and suitable alternative treatments for patients found.

But Novo Nordisk, who announced in June it was to withdraw the drug citing commercial reasons, denied the request saying they were focusing resources on the next generation of insulins and advancing diabetes care.

The move, which could cost the NHS up to £9 million, is expected to affect up to 90,000 patients with type 1 and 2 diabetes that rely on the treatment.

Current NICE guidelines recommend human biphasic insulin as the treatment of choice for type 1 and 2 diabetes. Although alternatives are available, they’re all more expensive than Mixtard 30.

The withdrawal will also leave thousands of patients dependent on others to help administer insulin. The biphasic insulin will no longer be available in the ergonomic InnoLet device, with those with poor eyesight or reduced manual dexterity left dependent on others.

Douglas Smallwood, Diabetes UK Chief Executive, insisted there was no need for patients to panic but advised them to see a doctor before the withdrawal in December 2010. “We are very disappointed about this withdrawal as it is not in the best interests of people with diabetes,” he said.

“We think this is wrong and asked Novo Nordisk to reconsider their decision, considering the 90,000 or so people currently using Mixtard 30, but they argued they are committed to withdrawing all older types of human insulin over time.

“We then asked for a longer withdrawal period to ensure a properly co-ordinated response to this, but that proposal was also turned down.”

Novo Nordisk recently posted net profits of £390 million for the second quarter of 2010. The company revealed higher sales of insulin were a factor.

“Novo Nordisk is committed to fighting diabetes and advancing diabetes care for the benefit of the growing numbers of people living with diabetes in the UK,” said Viggo Birch, Managing Director, Novo Nordisk. “We must continue to make progress in the fight against the diabetes pandemic. Modern treatments are needed to improve care for people with diabetes and it is vital that we continue to invest in researching new therapies.”

Stella Valerkou, Senior Policy Officer for Diabetes UK, welcomed the inclusion of foot care indicators but raised concerns over blood pressure ones which “contradict clinical guidelines”.

“While Diabetes UK welcomes the inclusion of the foot care indicators which are more closely aligned to clinical guidelines, we have concerns about the blood pressure indicators which contradict clinical guidelines and could impact negatively on the care of some people with diabetes with existing complications,” she said.

The charity also said that other indicators were contrary to recommendations and existing clinical guidance and could see patients lose their incentives to control their condition.

NICE’s ‘menu’ of indicators, which was published this month, aims to improve GP patient care and help reduce health inequalities. Potential indicators on the 2011/12 Framework include a new indicator for dementia to highlight people with a treatable cause; six new mental health instructions to improve GP care for patients with schizophrenia, bipolar affective disorder and other psychoses; and the diabetes indicators.

The QOF Advisory Committee said they hoped the new markers would improve the quality of care across general practice.

Colin Hunter, QOF Advisory Committee Chair, said: “I’m confident these potential new indicators for 2011/12 QOF will drive up quality of care across general practice. NICE has a key role for QOF and our recommendations will help tackle health inequalities and, importantly, target resources where they are most needed.”

The indicators will be decided by NHS Employers and the General Practitioners Committee (GPC of the British Medical Association) and be published later this year.