The UK Government has decreed the risks of NHS reform to be a state secret. Maxine Vaccine looks at what the veto on publication of the NHS transition risk register is covering up.

Yesterday’s news is really the WTF to end them all. Having lost two legal battles in its attempt to keep Whitehall’s statement of the risks of the Health and Social Care Bill from meeting the public eye, the UK Cabinet decided to impose state secrecy legislation designed for use in times of war.

This means that the transition risk register, written to advise ministers on what could go wrong with what Sir David Nicholson called “the reform so big it can be seen from space”, will never be published. Its publication would be a crime on a level with the disclosure of state secrets to a military enemy.

According to Andrew Lansley, this “exceptional” measure is necessary to safeguard the policy-making of the future. If the risk register were made public, he claims, all such documents would have to be watered down for public consumption. In other words, our democracy cannot afford transparency even on health reform.

However, the risk register was briefly leaked online last month – so we already know that it predicted a significant risk not only of increasing health inequalities and gaps in service provision, but also of a systemic breakdown of the health service as such.

What kind of breakdown? The kind where a disorientating shift in health service management and responsibility runs into steep funding cuts – and the system breaks apart like a poorly manned sailing ship in a hurricane, leaving millions of people without access to any but the most basic services.

What would happen then? Firstly, Foundation Trusts struggling to keep afloat would be assessed as having failed economically, and taken over by private health providers such as Circle. That has started to happen already, but a breakdown of the system would make it endemic.

Secondly, the new CCGs would be unable to juggle the priorities of health service management with severely reduced funds, and – with the private sector already in charge of their data and administration – would have to surrender their decision-making to private health providers.

This is surely what Lord Howe had in mind when he commented in 2010 that he did not expect GPs to become managers, and that the GP consortia would depend on “their private sector partners” for commissioning functions.

It’s also what former NHS Chief Commissioner and current Government health advisor Mark Britnell had in mind when he told a conference of private healthcare companies back in 2010: “The NHS will be shown no mercy, and the best time to take advantage of that will be in the next couple of years.”

That’s why Andrew Lansley, as the Health Bill was about to become law, abandoned any pretence that the legislation was about “empowering clinicians” and, as every organisation representing clinicians in the UK told him the Bill would damage the NHS, responded with the supreme indifference of a village squire witnessing the Peasants’ Revolt.

And for pharmaceutical sales professionals trying to identify where the new NHS customers are, the message is pretty clear. Your immediate customers are standing, as a GP recently put it, “baffled in the ruins” of the NHS. But your longer-term and most important customers don’t spend much time around here. Their companies are based in the US and Germany, and they are closing in on the NHS like sharks around a harpooned whale.

Maxine’s views are not necessarily those of Pharmaceutical Field.

A cannabinoid drug for the treatment of spasticity associated with multiple sclerosis (MS) has completed the European Mutual Recognition Procedure (MRP).

Sativex, developed by specialist company GW Pharmaceuticals together with Almirall, is the first treatment with this specific indication.

Already approved for sale in the UK and seven other EU member states, Sativex will shortly be available across 18 European countries.

The drug is also undergoing phase III trials as a treatment for cancer pain.

Spasticity occurs in up to 75% of people with MS, a condition affecting an estimated 100,000 people in the UK.

Sativex is an oromucosal spray whose active ingredients are derived from the cannabis plant. The drug binds to receptors in the brain, reducing the nerve activity that causes spastic movements.

The drug is effective in people with MS at all degrees of severity.

GW Pharmaceuticals is a UK company that develops cannabinoid prescription drugs under licence from the Home Office. It partners with Spanish company Almirall for sales and distribution of Sativex.

Bertil Lindmark, Chief Scientific Officer at Almirall, said the completion of the MRP regulatory process “reinforces our commitment to expand this innovative medicine to MS patients across Europe”.

Net revenue was up by a quarter at Teva Pharmaceutical Industries in the first three months of 2012 to more than $5.1 billion.

An increase in sales in the US and Rest of the World saw GAAP income increase to $859 million and non-GAAP net income climb to $1.30bn.

Shlomo Yanai, Teva’s President and CEO, said the company is “off to a good start”.

Teva saw net revenue for generic products increase by 12%, when compared to the same period last year, to $2.6bn and net revenue for its branded products hike by 54% to $2.1bn – mainly due to sales of Cephalon.

In the US, net revenues generated $2.8bn, an increase of 46% compared to Q1 2011, and accounted for 54% of overall sales.

Sales in the Rest of the World were up 21% to $1bn as revenues grew in the region by 23%. But net revenue dipped by 2% in Europe compared to the same quarter of last year due to austerity measures and price reductions.

“We enjoyed a quarter of strong growth for our branded products, in our US generics business, and in the developing markets Teva operates in,” commented Shlomo Yanai. “All of these served to offset weaker generics sales in Europe, which resulted primarily from the macro-economic conditions in that region.”

Lundbeck’s Executive Vice President of Commercial Operations Marie-Laure Pochon has resigned from her position.

She stated the decision to stand down from the role she began in September 2011 was based on family and private reasons.

The outgoing EVP said she has had a “fantastic journey” and leaves Lundbeck with a “strong commercial platform with many product launches in the near-term future”.

Senior Vice President Ole Chrintz, who is currently responsible for Lundbeck’s international markets, will now add European commercial operations to his duties.

“I respect Marie-Laure’s decision and would like to thank her for her dedication and contribution to Lundbeck during the five years she has been with the company,” said Ulf Wiinberg, President and CEO of Lundbeck.

“We will continue the implementation of our commercial strategy to diversify our product portfolio and expand geographically with our strong and very capable commercial leadership team.”

Pfizer’s oral anticonvulsant Lyrica (pregabalin) has failed a phase III trial as a treatment for neuropathic pain in patients with diabetes.

Lyrica is licensed in the EU for treatment of anxiety, but in the US it is also approved for treatment of neuropathic pain, epileptic seizures and fibromyalgia.

The negative trial result is likely to discourage Pfizer’s attempts to widen the product’s use in Europe.

Pfizer has also ended an unsuccessful trial of Lyrica as a treatment for HIV-related neuropathy.

The diabetes study tested patients with painful diabetic peripheral neuropathy, a complication affecting 20% of people with the disease.

Relative to placebo, Lyrica did not achieve the pain reduction specified as a trial endpoint. The HIV study had similar results.

Lyrica is a ‘blockbuster’ drug, with sales of over $3bn in 2010.

Its patent exclusivity will end in 2018, and Pfizer is seeking new indications to extend its lifespan.

GSK will table a hostile $2.6bn takeover bid for Human Genome Sciences after refusing to participate in its strategic review process.

Instead, Glaxo intends to press ahead with its $13 per share offer to HGS’ shareholders, despite the company’s board having previously rejected the same offer.

The bid offers a premium of 81% of HGS’s share price in mid-April, GSK says, and the pharma giant now hopes to evolve its relationship with the Maryland-based firm.

The two are in partnership for the diabetes drug Benlysta. GSK says it “values the long relationship” it has with HSG and would prefer to conduct takeover “on a friendly basis in a timely fashion”.

HSG rejected Glaxo’s initial $13 per share offer on the grounds it undervalued its potential and instructed Wall Street advisors to search for potential suitors, sources claim.

But GSK say their decision not to participate in the review process and to target HGS’s shareholders is unnecessary as there is “clear and strategic logic” to the combination of the companies.

It added that a month has passed since its original offer and that “provides a reasonable amount of time” for HGS to complete its review process.

GSK says it continues to believe that it has made a “full and fair offer” which provides “immediate liquidity” to shareholders in HSG.

An increase in pharmaceutical jobs in Europe helped the total number of life sciences roles increase by 3.7% in the first three months of 2012, according to a report.

ZRG Partners’ Life Science Hiring Index found pharmaceutical jobs increased by 25% in the first quarter in the EMEA region, despite a reduction in sales and marketing and R&D positions.

Job growth in the global medical device industry also increased by 6.8% as roles in the Asia Pacific region jumped by 102% – mainly due to recruitment by Philips and Siemens.

But the report found that outsourcing and CRO positions fell by 5.7% after roles in North America were substantially cut and jobs remained flat in Asia Pacific.

Hiring activity in the Americas decreased by a tenth, however it still recorded its highest level in the past two years, research found.

The EMEA region reversed a trend in the past six months as overall positions increased by 18% with a rise in pharmaceutical and outsourcing roles; medical device positions remained flat.

Regulatory, clinical and quality positions made up more than a third (36%) of jobs in EMEA, followed by IT, finance and general administrative positions (31%). Research and development roles made up nearly a fifth (18%) of overall positions with sales and marketing jobs making up 11% and manufacturing accounting for just 4% of all roles.

Emerging markets in the Asia Pacific region again helped boost the global outlook as the amount of jobs also increased by 18%, despite outsourcing/CRO remaining flat and pharmaceutical jobs falling.

Despite the US already cutting 4,800 jobs this year, according to outplacement consulting firm Challenger Gray & Christmas, the Index found that the Americas still account for 51% of global life science roles, followed by EMEA (28%) and Asia Pacific (21%).

The UK Government has exercised its right of veto to prevent the NHS reform transition risk register from ever being published.

The Cabinet’s veto – normally used on grounds of national security – overrides two legal verdicts that the Government must publish the register.

Health Secretary Andrew Lansley justified the veto by saying that publication of the risk register would weaken the policy-guiding value of such documents.

Details of the register leaked online indicate that it warned of a potential major breakdown of NHS service provision, as well as an increase in health inequalities.

The veto marks the conclusion of the Government’s 19-month struggle to keep the risk register secret in the face of legal challenges from Labour MP John Healey.

The DH lost two legal battles, being ordered to publish the risk register first by the Information Commissioner and then by a first-tier tribunal. Rather than escalate the legal process, it has used its political powers to conclude the issue.

According to Andrew Lansley, this “exceptional” step was necessary to prevent future policy documents being watered down by “civil servants worrying about how they sound to the public”.

John Healey described the veto as “a desperate act” that effectively placed NHS reform on the same footing as a war, while Shadow Health Secretary Andy Burnham called it “a cover-up of epic proportions”.

The BMA commented that it was “disappointed” by the decision, pointing out: “There is still a huge amount of complex and very controversial secondary legislation to go through parliament in relation to the Health and Social Care Act.”

Dr Peter Carter, Chief Executive of the Royal College of Nursing, said the veto was “astonishing” and meant “the public are only being presented with a partial picture of the NHS reforms.”