Pfizer’s treatment of advanced kidney cancer Inlyta (axitinib) has not been recommended in draft guidance.

NICE’s independent Appraisal Committee questioned the trial data supplied by Pfizer and were left concerned about the drug’s validity and reliability.

Sir Andrew Dillon, NICE Chief Executive, said the Institute will not “divert NHS funds to a treatment that costs more but doesn’t help people live longer.”

The appraisal considered the use of Inlyta for the treatment of advanced renal cell carcinoma after failure of prior treatment with sunitinib or a cytokine.

However, experts told the Appraisal Committee that the use of cytokines in clinical practice is declining with only a handful of patients currently using the treatments. NICE was informed that the majority of patients are now being treated with sunitinib or pazopanib – both recommended by NICE.

Pfizer supplied NICE with trial data comparing Inlyta to sofafenib, a drug not recommended by NICE and not identified in the scope. “The trial also lacked a comparison to ‘best supportive care’, which is what the majority of patients receive at the moment; therefore an ‘indirect’ and ‘simulated’ comparison was made using separate data from another trial,” Sir Andrew Dillon said.

The recommendation is now open for consultation. Pfizer has also been invited to comment on the evidence it supplied as part of the appraisal.

More than 300 GPs have withdrawn from partnerships with Virgin Care due to a potential conflict of interest between their provider and commissioner roles.

The 25 local provider companies, known as GPCos, set up since 2006 to provide NHS community services, will now be run by Richard Branson’s Virgin Care alone.

The GPCos were half-owned by GPs and half by Virgin Care (under its original name, Assura), and provided services including rheumatology, ophthalmology and dermatology.

A spokesperson for Virgin Care said: “Many of our GPs have become increasingly worried about the perception of potential conflicts of interest. Moving away from our partnership model removes this concern.”

According to Ian MacDonald, former Chair of the Assura Coventry GPCo, “The world has changed since we began working with Virgin Care, particularly in light of recent developments such as the Health and Social Care Act, and as GPs we want to ensure that there is a clear division between provision and commissioning.”

All of the former GPCos will be GP-free by April 2013, when the CCGs formally begin their commissioning role.

The Medical Research Council (MRC) has committed £7m funding to support 15 academic drug research projects using compounds from AstraZeneca.

The collaborations are expected to improve our knowledge of ways to treat major diseases such as dementia and cancer, as well as rare diseases such as motor neurone disease.

AstraZeneca made 22 pharmaceutical compounds, which it had validated as suitable for further research, available to medical researchers in December 2011.

Eight of the research projects will involve clinical trials of new drug candidates, while the other seven will involve laboratory and animal models.

“This landmark collaboration will see our leading scientists working with industry to find new insights into disease,” added David Willetts, Minister for Universities and Science. “It will speed up the search for innovative treatments and keep the UK at the forefront of biomedical research, which will in turn drive growth and deliver benefits for patients.”

The MRC received 23 full funding proposals, which it assessed independently of AstraZeneca. The recipients include research teams at universities in Manchester, Leeds, Sheffield, London, Glasgow, Birmingham, Edinburgh and Bristol.

The announcement was welcomed by the BioIndustry Association (BIA), whose Chief Executive Steve Bates said: “Today’s funding announcement signals the beginning of an exciting coming together of academia, industry and government to create new pathways to develop novel therapies for a range of serious conditions.

“The prospect of de-risking private investment in this way and supporting the development of these products for patients through innovative ways of working shows how the biopharmaceutical sector is responding creatively to the challenge of getting more treatments to market.”

Major pharma companies are paying multi-million dollar fines for alleged bribery in emerging markets, but these markets remain highly profitable.

Recent payments by Pfizer ($60m) and Johnson & Johnson ($70m) to settle charges under the Foreign Corrupt Practices Act (FCPA) represent only a small fraction of their revenue from the countries where the alleged offences took place.

However, steep increases in FCPA fines have been threatened if evidence suggests that pharma corporations regard them as a manageable cost.

Comparable European legislation, such as the Bribery Act in the UK, is tightening the net around overseas sales operations that pander to a culture of ‘goodwill’ gifts and other inducements.

Pfizer’s income from emerging markets is predicted to reach $10bn, while J&J has reported $6.5bn sales in Brazil, Russia, India and China.

Global Data analyst Michael Leibfried said: “The $60 million fine for Pfizer to a lay person sounds like quite a bit of money, but in perspective it took less than two days of Lipitor sales during its peak. It’s really just chump change for them.”

However, according to Kara Brockmeyer, chief of FCPA investigations within the Securities and Exchange Commission, no FCPA prosecution has so far needed to be repeated.

“I would hate to think the companies view enforcement actions as the cost of doing business,” she commented. “If we find that out, it will certainly increase the size of the penalty.”

In relation to the Pfizer settlement, she noted that a number of the company’s overseas subsidiaries “had bribery entwined in their sales culture”. Pfizer has since introduced an anti-corruption audit programme.

Novo Nordisk and Teva have also undergone FCPA investigations, with Latin American markets being a particular focus.

NICE has reversed its original decision on the use of Pharmaxis’ Bronchitol and now backs the use of the mannitol dry powder for treating cystic fibrosis in certain adult patients.

The final draft recommendation states Bronchitol may be used for patients who do not use inhaled standard treatment options, those for whom other osmotic agents are not considered appropriate and those whose lung function is rapidly declining.

Professor Carole Longson, Health Technology Evaluation Centre Director at NICE, said the positive recommendation resulted from “helpful responses” during the initial consultation period.

The previous draft guidance concluded that Bronchitol could not be recommended as a treatment option for the NHS because of “gaps and uncertainties in the evidence of its effectiveness,” Professor Longson said. Concerns were also raised about the long-term effect on lung function.

But after analysing the responses during the initial consultation period, NICE’s Appraisal Committee now concludes that the treatment is a “good use of NHS resources”.

The final draft guidance is now with consultees, who have the opportunity to appeal against NICE’s recommendation. Final guidance is expected to be published in November 2012.

Widely prescribed drugs including insulin, warfarin and aspirin are less effective in patients who take herbal medicines and dietary supplements.

A systematic review of relevant studies showed that popular OTC products such as St John’s wort and magnesium and calcium supplements interact with many prescribed drugs.

The researchers have recommended that GPs find out and record any OTC medicine use by patients for whom they are prescribing.

The review covered 85 studies of interactions between prescribed medicines and herbal medicines or dietary supplements, finding 882 distinct interactions.

The prescribed drugs with the greatest number of reported interactions were warfarin, insulin, aspirin, digoxin and ticlopidine.

The herbal medicines and supplements with the most interactions were St John’s wort, magnesium, calcium, iron and ginkgo – found to interact with 147, 102, 75, 71 and 51 prescribed drugs respectively.

In 42% of cases, the drug interaction was caused by the OTC product altering the pharmacokinetics of the prescribed drug.

Where the interaction meant an outright contraindication (25% of cases), the most frequent involved treatments for gastrointestinal disorders (16.4%), followed by neurological disorders (14.5%).

Professor Edzard Ernst of the University of Exeter said: “We have to become vigilant and finally agree to monitor this sector adequately. Each individual doctor can contribute to this process by routinely including questions about alternative medicine use.”

Dr Tonio Borg looks set to take over as European Commissioner for Health and Consumer Affairs following John Dalli’s resignation from the post in mid-October.

The current deputy prime minister and minister of foreign affairs of Malta has been named by the Maltese government as their preferred candidate to fill the vacancy.

Speaking in the Times of Malta, Dr Borg said that “close contact” with European MPs is “crucial for the Commission to produce the best legislation possible for European citizens.”

A representative from Malta must fill the position until 2014 under the presidency of Portugal’s José Manuel Barroso.

Mr Dalli stood down from his position after an anti-fraud inquiry linked him to an attempt to influence tobacco legislation.

The European Union’s anti-fraud office found that a Maltese business attempted to use his contacts with Mr Dalli for financial gain. Mr Dalli categorically rejected the investigation’s findings.

New research by UK scientists has identified distinct cell types that may be responsible for pre- and post-menopausal breast cancers.

A team at Cancer Research UK’s Cambridge Research Institute (CRI) has determined that the immature ‘progenitor’ cells in mammary glands are of two types, only one of which responds to oestrogen.

The discovery points to the potential for new chemotherapy drugs targeting the oestrogen-positive and oestrogen-negative progenitor cells – which are thought to cause breast cancer in older and younger women respectively.

Progenitor cells, which have the potential for a limited number of cell divisions, are likely ‘roots’ for tumours. The researchers found that some progenitor cells in the human breast have oestrogen receptors while others do not.

The oestrogen-positive progenitor cells survive better in low-oestrogen tissue such as the breast tissue of post-menopausal women, so it may be linked to tumour development in these women.

The oestrogen-negative progenitor cells have a similar genetic makeup to the cells of basal-like tumours – an aggressive form of breast cancer that mostly affects younger women.

Study author Dr John Stingl of the CRI said: “This exciting discovery reveals that mammary glands are much more complicated than scientists initially thought. Uncovering new types of ‘mother’ cells may explain why there are different types of breast cancer, and why young and older women tend to get different types.

“It could also provide new starting points for ways to diagnose and treat the disease in the future.”

Two Novartis vaccines for seasonal influenza have been temporarily banned in six EU countries due to a suspected quality fault.

Batches of Agrippal and Fluad were reported by the company to contain tiny solid particles due to protein aggregation.

The ban on the two flu vaccines in Italy, France, Germany, Austria, Spain and Switzerland may delay vaccination programmes in some regions, though alternatives are available.

The safety and efficacy of the suspect batches has been affirmed by Novartis, and there is no contrary evidence: the ban is a precautionary measure.

The Italian Medicines Agency (AIFA), which is investigating the suspect batches on behalf of the EU, said the Swiss pharmaceutical company knew of the production fault three months before reporting it.

According to Novartis spokesman Eric Althoff, it was necessary for Novartis to investigate the suspect batches first.

The defect is a harmless by-product of the manufacturing process that does not affect the quality or safety of the vaccines, Althoff said.

Demand for seasonal flu vaccines has increased across the EU due to the increasing numbers of people in high-risk categories, such as the elderly and people with diabetes.

All EU member states will evaluate the potential impact of losing the Novartis vaccines on their seasonal flu vaccination programmes for the autumn.

Cancer patients whose disease has spread from a solid tumour to their bones have now been given a new treatment option after NICE backed the use of Amgen’s Xgeva (denosumab).

Xgeva has been recommended to treat the condition known as bone metastases in people suffering from breast cancer or solid tumours other than prostate who would otherwise be prescribed bisphosphonates.

Professor Carole Longson, Director of the Centre for Health Technology Evaluation at NICE, said Xgeva was a “welcome addition” alongside existing treatment options.

Final guidance states that Xgeva should only be prescribed under the terms agreed between the Department of Health and Amgen as part of a patient access scheme.

Amgen estimates there are around 150,000 patients in the UK with solid tumours and bone metastases, of which breast and prostate cancer account for more than 80%.

“We’re pleased to be able to recommend another treatment option for people with bone metastasis from most solid cancer tumours,” said Professor Longson. “This type of metastasis can reduce a person’s mobility and quality of life in general, increasing the risk of complications from bone weakness.”