The public money spent on stockpiling the antiviral Tamiflu (oseltamivir) in 2009 has been described as “extremely worrying” by MP Margaret Hodge.

The House of Commons Public Accounts Committee, which Hodge chairs, will conduct a hearing into the £424m spent on Tamiflu during the influenza crisis.

The enquiry shows that despite Roche’s recent promise to release ‘redacted’ trial data to Cochrane researchers, the Tamiflugate scandal has not gone away.

Responding to information from the National Audit Office (NAO), Hodge commented that the decision to stockpile Tamiflu was questionable as NICE had been denied the clinical trial data it needed to make a decision.

The enquiry will question Chief Medical Officer Sally Davies and NICE Chief Executive Andrew Dillon among others.

According to the NAO, there is a “general consensus” that Tamiflu reduces the duration of flu symptoms, but not that it reduces hospitalisations or deaths.

Hodge said the decision to stockpile the Roche drug, given the limited evidence of its effectiveness, was “extremely worrying” – while the wastage of 6.5 million doses of Tamiflu (costing £7.4m) due to poor NHS record-keeping was “a shocking example of incompetence”.

The NAO recommended that “independent research” be commissioned in future to guide decisions over drug stockpiling.

It noted that NICE did not have the statutory power to demand data from manufacturers, so was at risk of making a poor decision in a crisis.

NICE should require manufacturers to confirm that the evidence they have submitted is complete, it said.

Roche has attempted to close Tamiflugate by offering ‘redacted’ clinical trial reports (with confidential commercial and patient data deleted).

However, Cochrane researcher Peter Gøtzsche has claimed the studies contain no confidential data and the condition is “smoke and mirrors”.

New vaccines schedules from the DH and Public Health England include offering a nasal flu vaccine for all children aged two years in England from September.

The NHS will also vaccinate primary school and pre-school aged children from 2014, and secondary school aged children from 2015.

New vaccination programmes for rotavirus, shingles and meningitis C are also planned in the strongest demonstration to date of the priority of disease prevention in the new public health system.

Providing the nasal flu vaccine to all children aged two years, in time for the late autumn seasonal outbreaks, will protect some 650,000 infants.

In addition, babies aged less than four months will be vaccinated against rotavirus – a common cause of diarrhoea and vomiting in infants – from July.

It is estimated that the vaccine will halve the number of cases of rotavirus infection in infants (currently 140,000 per year).

According to Mary Ramsay, Head of Immunisation at Public Health England, the introduction of oral rotavirus vaccine “has had a major impact” on protecting young children from the disease”, resulting in “rapid and sustained reductions in childhood rotavirus hospitalisations”.

At the opposite end of the age scale, an NHS shingles vaccination programme for people aged 70 is planned from September, as well as a catch-up programme for those aged up to 79.

The two programmes will protect some 800,000 elderly people this year from a disease that can cause prolonged neuralgia and disability.

A US study found that vaccinating adults aged 70 or older halved the incidence of shingles and reduced post-herpetic neuralgia by 40%.

Vaccination against meningitis C is also changing from September: a new booster jab at age 12–13 will replace the current booster at four months.

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

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

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

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

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

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

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

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

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

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

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

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

A new quadrivalent (four-strain) vaccine for seasonal influenza has been approved by the MHRA for use in the UK.

Fluarix Tetra from GSK, which has also been approved for use in Germany, is the first vaccine of this type to gain regulatory approval in Europe.

The vaccine is approved by the MHRA for the immunisation of adults and children aged over three years, and was approved in the US in December 2012.

It offers protection against two subtypes of the influenza A virus and two of the B virus, widening the scope of the trivalent flu viruses currently in use.

GSK commented: “As only one influenza B strain is selected for inclusion in trivalent vaccines, there have been seasons when the predominant circulating influenza B strain was different from that chosen for the vaccine.”

The new vaccine is expected to be available to the NHS by autumn 2013, the start of the flu vaccination season.

Sanofi Pasteur and Novartis are both working on quadrivalent flu vaccines, while AstraZeneca has one on the market in the US.

The global market in statins, once the pharmaceutical industry’s lead blockbuster products, is predicted to decline by 40% in the next five years.

The forecast by GBI Research of a negative CAGR of 7.2% up to 2013 for the cholesterol-lowering drugs is based on prospects of generic erosion, weak pipelines and failing prescriber confidence.

The decline in the statins market shows that the shift of healthcare towards prevention and management of long-term conditions is not without pitfalls for the pharma industry.

Statins, which lower cholesterol levels by targeting an enzyme in the liver, have been hailed as ‘wonder drugs’ that could radically reduce the global incidence of cardiovascular events.

Routinely prescribed for ‘high-risk’ patients such as people with high blood pressure or diabetes, statins have also been linked to reduced risk of bowel cancer and reduced death rate from influenza.

However, their global market declined from $23.7 billion in 2004 to $20.5 billion in 2011 (a negative CAGR of 2.5%), due largely to patent expiry.

The report predicts a much steeper decline in the statins market over the next five years, for four reasons:

• Patent expiry – the generic share of the statins market is predicted to grow from 11% in 2011 to 34% in 2018.

• Austerity health budgets – spending on prevention is likely to be cut back.

• Weak product pipelines – the ‘me-too’ nature of most statins betrays a lack of potential for innovation.

• Increased use of alternative drugs.

Medical writer Ben Goldacre has argued that the marketing of statins in terms of relative risk reduction glossed over the low absolute risk reduction they offer, and left the products open to a backlash over side-effects.

Statins are associated with both symptomatic side-effects (including digestive disorders) and potential ones (including increased risk of type 2 diabetes).

As the overall statins market declines, the report says, individual products will struggle to gain or keep a place within it: “The global statins market has reached the competitive stage of its lifecycle, with many branded and generic drugs competing with each other on price.”

Biotechnology giant MedImmune has appointed Bahija Jallal, its current Executive Vice President for R&D, as its new President.

The former President of the Maryland-based company, Peter Greenleaf, will take over leadership of parent company AstraZeneca’s (AZ) Latin American business.

The transition accompanies the formal designation of MedImmune as the global biologics division of AZ, which acquired it for $15.6bn in 2007.

Bahija Jallal is a former researcher at the Max-Planck Institute of Biochemistry in Germany. While VP of Drug Assessment and Development at Chiron, she was headhunted by MedImmune in 2006, becoming its Head of Translational Science.

Commenting on that appointment, Jallal said: “I was struck by MedImmune’s history of innovation. And I looked at who they had on their board of directors and their executives. There were more women than you would see at other companies.”

The fortune paid by AZ to acquire MedImmune surprised many in the industry. The acquisition was followed by investment in its R&D capability, including the development of a new site in Cambridge, England, and the merger of the UK group with Cambridge Antibody Technology.

According to MedImmune spokesman Mike O’Brien, the biotech company’s commercial operation now formally belongs to AZ’s North American business, while its manufacturing operation is part of AZ’s global operations.

“The driver for these changes is not cost but even faster decision-making in key areas of the business and a need to reduce complexity,” he said.

Through MedImmune, AZ plans to deliver an average of one new biologic drug per year from 2013.

MedImmune’s past successes include two innovative vaccines: the first monoclonal antibody approved by the FDA for use against an infectious disease (Synagis, used to prevent the childhood lung disease RSV); and the first intranasal vaccine against influenza (FluMist).

A scheme that used bogus figures for investment in vaccine research to exploit a tax loophole has been exposed by HM Revenue and Customs (HMRC).

Matrix Securities sold a scheme to investors whereby they could gain tax relief at nearly twice their level of investment, using a tax break designed to encourage medical research.

However, HMRC exposed their investment figures as fraudulent and refused most of their tax relief claim, forcing the Matrix Group into administration.

The company raised £28m from 83 investors and borrowed another £86m from banks to fund research into vaccines against HIV, influenza and hepatitis B.

It claimed a first year trading loss of £193m and £77m tax relief, of which £50m would be paid to the investors.

However, HMRC established in a tribunal that only £14m had been spent on R&D and was therefore subject to tax relief.

Matrix Securities and other members of the Matrix Group have gone into administration – though another member, Matrix Asset Management, claims to have invested £107m in the development of a universal flu vaccine.

Clients who invested in the fraudulent scheme are claiming it was misrepresented to them.

David Gauke, Exchequer Secretary to the Treasury, commented that HMRC “will take decisive action to close down schemes with the sole purpose of avoiding paying tax.”

The ‘open data’ campaign led by the Cochrane Collaboration and the BMJ has called for a boycott of clinical trials whose publication is not guaranteed.

The campaigners have launched a public petition to discourage researchers, academic institutions, funding bodies and patients from supporting drug trials whose results may be ‘confidential’.

Other supporters of the petition include the charity Sense About Science; the James Lind Alliance, an alliance of patients and clinicians focused on medical research; the Centre for Evidence-Based Medicine in Australia; and journalist Ben Goldacre (pictured), author of Bad Pharma.

The ‘Tamiflugate’ controversy over the ongoing non-publication of clinical trial results relating to Roche’s influenza drug has fuelled the campaign. The BMJ has campaigned for the medical profession to put pressure on Roche to reveal the missing data since November 2012.

Ben Goldacre’s book claimed that pharmaceutical companies systematically distort the landscape of clinical evidence by withholding the results of less favourable drug trials.

MPs including Conservative MP Sarah Wollaston have called for a public enquiry into the £500m spent by the Government in stockpiling Tamiflu during the ‘swine flu’ crisis.

Tracey Brown, Director of Sense About Science, commented: “There have been years of foot dragging and non-compliance with requirements. We expect regulatory bodies to evaluate the best available evidence, not half of it.”

Launching the petition, the BMJ argued that patients should not participate in ‘confidential’ trials: “Participants in clinical trials assume that they are contributing to the advancement of medical knowledge; non-publication of study results negates this reasonable assumption and betrays those who have volunteered.”

The National Institute for Health and Clinical Excellence (NICE) has been drawn into the ongoing row over Roche’s failure to disclose clinical trial data.

The British Medical Journal’s Editor in Chief, Fiona Godlee, has asked NICE to withdraw its recommendation for antiviral drug Tamiflu (oseltamivir) until the missing data are available.

NICE’s Chairman, Sir Michael Rawlins, has said that Roche could be reported to the General Medical Council (GMC) if the company is found to have withheld data relevant to the NICE appraisal.

The BMJ is campaigning for the release of data from at least 123 clinical trials which, according to the Cochrane Collaboration, were promised by Roche in 2009, when Tamiflu received marketing authorisation in Europe.

The Cochrane researchers recently rejected a proposal from Roche to form a joint panel that would discuss what clinical trial data were needed, in order to balance commercial confidentiality with public interest.

Godlee’s letter to NICE proposed that the regulator withdraw its guidance on Tamiflu until it “has received and reviewed the full clinical trial data”.

She also accused NICE of “colluding with the status quo” by failing to insist on seeing the missing clinical trial data at the time of its approval – and pointed out that the FDA has not given the same approval to the drug because it has “performed a more thorough assessment of the trial data”.

Rawlins replied that if the missing data supported the use of Tamiflu then “patients would be damaged by precipitate withdrawal of our guidance” – thus implying a Catch-22 situation.

However, he noted, if Roche’s medical director had “knowingly” withheld relevant data then NICE would report the matter to the GMC.

In the first of a new series, Pf’s John Pinching meets Novartis’ Senior Brand Manager and Pf reader, Caroline Armstrong. A franchise coffee house in Farnham sets the scene, as she orders an exotic latte, while he opts for an invigorating Americano (with three sugars).

When I meet Caroline – winner of the prestigious Joint Working Award at the Pf Awards 2012 no less – she exudes confidence, charm and style. Indeed, she immediately draws my attention to a famous local sculpture and points out that, viewed from a certain angle, it resembles something entirely unexpected.  I conclude that it must be ‘attention to detail’, which sets this career-climber apart.

What is your background, Caroline? I come from Newcastle and did a degree in Biomedical Science at the University of Newcastle Upon Tyne. During my time there I worked in a lab at Proctor and Gamble. After approximately five minutes I knew it wasn’t the career for me! I needed to do more than just take microscope slides out of a washing machine for the rest of my life.

How did you embark on a career in the selling side of pharmaceutical drugs?
I attended a recruitment drive, was impressed with the potential opportunities and became a medical sales representative, first at AmDel, then Altana Pharma. I know it’s a cliché, but in order to fulfil my ambitions I had to be out there, ‘carrying the bag’; it’s the best way to build a network and discover how the industry really works.

Do you remember your first gig? Yes, it was pretty nerve-wracking. As soon as I arrived at the surgery, I was taken straight to the GP, without any time to compose myself. It was a steep learning curve, but I soon gained confidence and was able to apply my personality when describing products. Showing your human side in medical sales is vital.

How did that enable you to progress further? I joined Novartis initially as a Vaccine Account Manager, before getting the chance to go on a marketing secondment. I really felt like the company believed in my ability and this ultimately led to my roles as the UK Influenza Brand Manager and Travel Vaccines Senior Brand Manager.

What were the most satisfying aspects of your new Novartis ventures?  Getting involved in really broad campaigns was very exciting. With influenza it’s not just a case of painting patient pictures, you are convincing people to purchase products there and then; sign on the dotted line. From a marketing view, delivering an effective strategy is essential, but from a sales view, you’ve effectively got twenty minutes in front of a healthcare professional to deliver, not just a generic pitch, but one that demonstrates empathy, understanding and confidence in your proposition. There’s only one chance, so you have to make every interaction count.

Does it make you appreciate the impact you’re having on society? It’s pretty amazing to think that last year the number of vaccines given through pharmacy alone could fill St. James’s Park. That really puts the number into perspective.

Do you support Newcastle United, by any chance? Yes, I used to go with my dad, when David Ginola was playing (judging by the wistful expression, I think Caroline may have been a great admirer of the aforementioned Frenchman).

I digress, what programmes are you putting into place in preparation for the dreaded reform act? We have been very passionate about implementing vaccination programmes, which enable a more community-based approach to health. We’re training pharmacists to vaccinate in local pharmacies, enabling many more thousands of people to access healthcare. It will certainly relieve some of the pressure from GPs. People will have the convenience of being able to pick up their weekly shop and a vaccine, all in one place.

How do big companies react to changes enforced by new political policies? From an industry perspective you can’t plan too far in advance because you simply don’t know what the NHS will look like in a few years. If Labour get in all the changes might be reversed and we’ll end up going round in circles.

You’re still young, but seem to have ascended up the ranks rapidly I enjoy what I do and like to do it well; then I’m ready for the next challenge. When you reach milestones in your career it’s so important that you have a story to tell, making sure that it’s as fulfilling and successful as it can be. Some people are satisfied to do the same thing for years, but I want each chapter to represent a new adventure and an opportunity to make a difference.

What does the future hold for you? I’m starting a new job in Basel! (Caroline is making the pilgrimage to Switzerland and she’ll be working as Business Franchise Manager in Novatis’ Ophthalmology business unit – which is nice).

That’ll be incredible Yes, I’m going there with my partner and it will certainly be a great experience. It’s a global role so it will be really interesting to see how other health services, like Australia and Canada, operate compare to ours. I hope they don’t have as many acronyms.

There’ll also be some cultural differences in Switzerland too? Yep, for a start, they only serve wine in 100ml measures and that will take some getting used to!

What will you miss? The higher your position, the greater potential there is for you to be removed from the ‘patient’.  I think I will miss the daily coal face interaction you get when you work in a local market, close to the actual health provision. That is why I think it is so important to remember what it is like when you are on the road, bringing products to life. Ultimately, whether you are in a local or a global role, everything you do is still for the patient.