Successful brain pharma: gennaio 2014

A team of scientists has found that a protein involved in promoting tumour growth and survival is also activated in surrounding blood vessels, enabling cancer cells to spread into the bloodstream. The investigation was undertaken by principal investigator Dr David D. Schlaepfer of the University of California (UC).

Blood vessels are tightly lined with endothelial cells, which form a permeability barrier to circulating cells and molecules. Schlaepfer explained: “Our studies show that pharmacological or genetic inhibition of the endothelial protein focal adhesion kinase, or FAK, prevents tumour spread by enhancing the vessel barrier function.”

The researchers found that selective FAK inhibition within endothelial cells prevented spontaneous tumour metastasis without alterations in tumour size. Schlaepfer, with colleagues at the UC San Diego Moores Cancer Center, is exploring whether inhibiting targets like FAK, which has important regulatory functions in both tumour cells and blood vessels, might provide a dual mechanism for preventing both cancer growth and spread.

Using mouse models of breast, ovarian, and melanoma tumours, first author Dr Christine Jean showed that FAK activity was elevated in the blood vessels surrounding tumours, compared to normal tissue. FAK modifies the function of other cellular proteins and researchers identified a previously unknown FAK target: a protein called vascular endothelial cadherin (VE-cadherin) that helps endothelial cells fasten tightly together.

When modified by FAK, VE-cadherin complexes fall apart and blood vessels become leaky. Inactivating FAK within endothelial cells prevented this unwanted permeability and helped block the ability of tumour cells to pass through endothelial cell barriers.

Schlaepfer said the research has major clinical implications. Metastasis – the spread of a cancer from its originating site to other parts of the body – is responsible for 90% of cancer-related deaths. He noted that several FAK-inhibitors are currently being tested in clinical trials.

The findings have been published in the Journal of Cell Biology and were part funded by the European Research Council.

eHealth Action Plan endorsement welcomed

Commissioner for Digital Agenda Neelie Kroes has welcomed the support of the European Parliament for the eHealth Action Plan, which address barriers to the full use of digital solutions in Europe’s healthcare systems.

MEPs voted on a resolution in support of the plan to improve healthcare for the benefit of patients, give patients more control of their care, and bring down costs.

Welcoming the vote, Kroes said: “I want to thank Pilar Auyso for her positive approach to the eHealth Action Plan for 2012-2020. Her report and Parliament’s support underlines and strengthens the EU’s common vision on eHealth. In particular, I welcome the Parliament’s insistence on the importance of interoperability of eHealth systems and the need for the Commission to take a leading role in establishing international standards and an EU eHealth Interoperability Framework.”

She added: “Plainly speaking, eHealth will only have a future in Europe if our homes, hospitals, healthcare centres and public services can connect to affordable high-speed internet connections. eHealth needs ultra-fast broadband. For this we need a connected continent and we need a stronger telecoms single market. I look forward to the support of MEPs on this in the coming weeks.”

The Commission presented the eHealth Action Plan 2014-2020 in response to the 2009 request of member states. To prepare the new plan, the Commission ran a public consultation in 2011. The Digital Agenda for Europe includes three specific actions on eHealth aimed at widespread deployment of telemedicine, patients’ access to their health data and interoperability.

Parliament adopts IMI2

The European Parliament Committee on Industry, Research and Energy (ITRE) has adopted a second public private partnership under Horizon 2020, the Innovative Medicines Initiative (IMI2).

IMI is a public-private partnership between the European Commission and the European Federation of Pharmaceutical Industries and Associations (EFPIA). The objective is to improve the process of developing new drugs and treatments by supporting co-operation in research and development.

French MEP Françoise Grossetête, of the European People’s Party (EPP), said that the partnership addressed the key challenges for public health in Europe. IMI2 will contribute to the fight against the emergence and potential resurgence of infectious diseases, including increased antimicrobial resistance.

In a statement, the MEP said: “It is through this type of initiative that we will meet the health challenges of the 21st Century.”

The first IMI initiative, which took place from 2007-2013, funded 40 projects and developed new therapies for patients, as well as created nearly 1,500 jobs. It had a budget of €2bn, with half the funding coming from the Commission and the other half from EFPIA.

The second initiative, spanning the period 2014-2024, has seen its budget rise to €3.45bn. It will focus on the development of treatments that contribute to lifelong health and wellbeing, which are expected to gain importance due to an ageing population and rising levels of chronic and degenerative diseases

martedì 28 gennaio 2014

En el sector farmacéutico, innovas o no sobrevives

Nasce pool di specialisti per la sclerosi multipla

È stato costituito a Catania il consorzio “Sclerosi multipla Sicilia – Sicilian Multiple Sclerosis (Sms) a cui afferiscono tutti i 19 centri per la diagnosi e cura della malattia riconosciuti dalla Regione siciliana.
La nascita del consorzio è stata tenuta a battesimo nel corso dell’incontro, che si è tenuto alla clinica neurologica del Policlinico dell’Università di Catania, alla presenza dei professori Mario Zappia dell’università di Catania e Giuseppe Vita dell’Università di Messina.
In Sicilia i pazienti con sclerosi multipla sono circa 6 mila. Oltre la metà riceve trattamenti con farmaci biotecnologici che rappresentano una delle principali spese sanitarie della Regione.
Il Consorzio si propone di mettere a disposizione le proprie competenze tecniche e biomediche per le complesse scelte di politica sanitaria e di settore; di costituire un gruppo unico per portare in Sicilia tutte le sperimentazioni cliniche più avanzate in sviluppo per la SM; di favorire lo sviluppo di una rete per i pazienti più gravi che non traggono più vantaggio dalle terapie farmacologiche e di unificare i criteri di diagnosi e terapia nell’ambio del territorio siciliano.
La prossima riunione, del neonato “gruppo”, si terrà al San Raffaele Giglio di Cefalù il prossimo 8 febbraio alle ore 11.

Erano presenti alla riunione istitutiva i seguenti medici:

Antonina Aloisio (Civico, Palermo)
Iole Bongiorno (neurologia ospedale Arezzi, Ragusa)
Placido Bramanti Placido e Edoardo Sessa (Bonino Pulejo, Messina)
Maria Buccafusca / Giuseppe Vita (Policlinico, Messina)
Antonio Cappellani / Roberto Conigliaro (Asp Siracusa)
Salvatore Cottone (Villa Sofia, Palermo)
Rosa Maria Gaglio (ospedale Agrigento)
Luigi Grimaldi (Istituto Giglio, Cefalù)
Francesco Iemolo (ospedale Vittoria)
Carmela Lo Presti (ospedale Enna)
Davide Maimone (Garibaldi, Catania)
Roberto Marziolo (Cannizzaro, Catania)
Sonia Milone (Papardo, Messina)
Francesco Patti / Mario Zappia (Policlinico, Catania)
Maria Santoro (Papardo, Messina)
Giovanni Savettieri / Giuseppe Salemi (Policlinico, Palermo)
Luigi Sicurella (ospedale Trapani)
Nunzio Storaci / Anna Iacona (infettivologia ospedale Arezzi, Ragusa)
Michele Vecchio (ospedale S Elia, Caltanissetta)

Pfizer's Q4 sales drop, but top analyst estimates

Pfizer announced Tuesday that fourth-quarter sales fell 2 percent year-over-year to $13.6 billion, although the figure beat analyst estimates of $13.4 billion. Meanwhile, net income reached $2.6 billion, down 59 percent versus the year-ago three-month period when the company recorded a gain of approximately $4.8 billion following the sale of its nutrition business to Nestle.

The drugmaker completed the spin-off of its animal-health unit Zoetis in June last year and also revealed plans to separate its internal commercial operations into three business segments, two of which will focus on patent-protected branded drugs. The moves have fuelled speculation that Pfizer may further breakup its operations. "The last big lever management has to pull is to split up the drugs side of the business - this would be unprecedented and shareholders are likely to reward this bold action," commented Sanford C. Bernstein & Co. analyst Timothy Anderson.

In the fourth quarter, sales of Lyrica jumped 11 percent year-over-year to $1.3 billion, while revenue from Enbrel, which Pfizer markets with Amgen, increased 5 percent to $1 billion. In addition, sales of Prevnar/Prevenar vaccines rose 3 percent to $1.1 billion. ISI Group analyst Mark Schoenebaum noted that results from the Capita study investigating whether Prevnar 13 should be used in adults, as well as children and the elderly, are expected in the next several weeks. Schoenebaum suggested that positive results from the trial may add $1 billion in new sales of the vaccine.

For other products, three-month sales of Celebrex were up 6 percent to $798 million, while revenue from Viagra slipped 14 percent to $476 million, due to lower sales in overseas markets. Pfizer posted quarterly sales for Xeljanz, which was approved by the FDA in 2012 for the treatment of patients with moderately to severely active rheumatoid arthritis, of $46 million.

For 2014, the drugmaker indicated that sales are expected to be between $49.2 billion and $51.2 billion, with earnings of $2.20 per share to $2.30 per share. Chief financial officer Frank D’Amelio noted that the guidance "reflects the anticipated negative impact of approximately $3 billion due to recent and expected product losses of exclusivity." Analysts forecast sales of around $49.7 billion, on earnings of $2.28 per share.

JP Morgan analyst Chris Schott said the results were "solid" and driven by unexpectedly strong sales and lower than expected expenses. The analyst noted that investors remain focused mainly on Pfizer's drug pipeline, including the breast cancer therapy palbociclib. In April last year, the FDA granted the oral cyclin-dependent kinases 4 and 6 inhibitor breakthrough therapy status for the treatment of breast cancer.

(Ref: Chicago Tribune, FOX Business, The Wall Street Journal, EuroNews, Bloomberg, ABC News, NASDAQ, MarketWatch, StreetInsider, Investing.com)

January 28th, 2014

By: Matthew Dennis

Article NICE rejects "wider societal benefit" test for new drugs

Article ABPI/NHS England Clinical Reference Groups joint working accord

Article Novo and King's Health Partners launch diabetes scheme

Article UK launch for Takeda's Vipidia

Article Pfizer's dacomitinib fails two Phase III trials

domenica 26 gennaio 2014

Protein behind Alzheimer's spread found

WASHINGTON: Indian-origin scientists have found for the first time that declining levels of a protein in the brain may play a key role in the advance of Alzheimer's disease.

The new study from the Florida campus of The Scripps Research Institute, US, identified a critical regulator of a molecule deeply involved in the progression of Alzheimer's disease.

The regulator is known as Rheb, a protein that many believe may be active in neural plasticity, the ability of the brain to change in response to learning.

The scientists found that Rheb binds and regulates activity of a molecule known as BACE1, an important enzyme in Alzheimer's disease pathology, establishing for the first time a new molecular link between Rheb and BACE1.

"We found that Rheb regulates BACE1, which is a major drug target in Alzheimer's disease," said Srini Subramaniam, a TSRI biologist who led the study.

"Studies of the autopsied brains of Alzheimer's patients have found a significant reduction in Rheb, so it is possible that an increase in Rheb could reverse the buildup of amyloid plaque," said Subramaniam.

The study noted that in some genetically modified animal models, an increase of Rheb has already been shown to reduce BACE1 levels and the production of amyloid plaque.

"If we can uncover the mechanism by which Rheb alters BACE1 levels, that would be a very good drug target," said Neelam Shahani, a first author of the study with William Pryor, both research associates in the Subramaniam lab.

The new study indicates that Rheb degrades BACE1 through a number of pathways, but more research needs to be done before drug candidates can be developed.

"We're very interested in the disease process and plan to keep moving forward to understand precisely how Rheb regulates BACE1," said Pryor.

The study was published in the Journal of Biological Chemistry.

Does your spouse have diabetes? You may be at risk too

TORONTO: You may be at a higher risk of developing type 2 diabetes if your spouse has it, scientists, including one of Indian-origin, have found.

Researchers found that a person is at 26 per cent increased risk of developing type 2 diabetes if their spouse also has the condition. The team from the McGill University Health Centre (MUHC) in Montreal has found, through combined analyses of several studies, evidence that spousal diabetes is a diabetes risk factor. "We found a 26 per cent increase in the risk of developing type 2 diabetes if your spouse also has type 2 diabetes," said senior author of the study, Dr Kaberi Dasgupta, researcher at the Research Institute of the MUHC and an associate professor of medicine at McGill University. "This may be a platform to assist clinicians to develop strategies to involve both partners. Changing health behaviour is challenging and if you have the collaboration of your partner it's likely to be easier," Dasgupta said. Researchers wanted to see if diabetes in one partner could lead to diabetes in the other partner because many of the risk behaviours that lead to diabetes, such as poor eating habits and low physical activity, could be shared within a household. Researchers analysed results from six selected studies that were conducted in different parts of the world and looked at key outcomes such as age, socioeconomic status and the way in which diabetes was diagnosed in 75,498 couples. Most of the studies used in the meta analysis relied on health records which may not always accurately record diabetes, researchers said. Those that used direct blood testing suggested that diabetes risk doubles if your partner has diabetes. A strong correlation with pre-diabetes risk was also found. "When we look at the health history of patients, we often ask about family history. Our results suggest spousal history may be another factor we should take in consideration," said Dasgupta. "The results of our review suggest that diabetes diagnosis in one spouse may warrant increased surveillance in the other," she said. "Moreover, it has been observed that men are less likely than women to undergo regular medical evaluation after childhood and that can result in delayed diabetes detection. As a result, men living with a spouse with diabetes history may particularly benefit from being followed more closely," she said. The study was published in the journal BMC Medicine.

Developed cancer drug for 'western patients' who could afford, not 'for Indians': Bayer's CEO

NEW DELHI: Global medical charityMedecins Sans Frontieres slammed on Friday a statement by Bayer's chief executive that the giant German firm only developed its cancer drug Nexavar for people who could afford the medicine, not "for Indians".
India's controller general of patents angeredBayer in March 2012 when he authorized a local drugmaker to produce a generic copy of Nexavar, saying the German company charged a price that was too costly for most Indians.
"We did not develop this medicine (Nexavar) for Indians," Marijn Dekkers said at a little reported pharmaceutical forum last month, according to the January 21st edition of Businessweek.
"We developed it for western patients who can afford it," Dekkers said, and called the Indian regulator's action "essentially theft".
Bayer said the statements attributed to Dekkers were accurate and forwarded written comments made later by the German chief executive seeking to explain his remarks.
Dekkers said the comment had been a "quick response" at the industry forum to the Nexavar issue and added Bayer wants "all people to share the fruits of medical progress regardless of their origins or income".
But Dekkers added in the written comments he had been "particularly frustrated" by the Indian regulator's decision, which marked the first time a so-called compulsory licence of a patented drug had been awarded in India.
Medecins Sans Frontieres (MSF) said on Friday that the Bayer chief's remarks summed up "everything that is wrong" with the multinational pharmaceutical industry.
"Bayer is effectively admitting the drugs they develop are deliberately going to be rationed to the wealthiest patients," Manica Balasegaram, executive director of MSF's Access Campaign, said.
The medical charity said big pharmaceutical companies believe "research and development (R&D) can only be rewarded by a patent and through high prices to recoup the R&D costs. "Those who can't afford to pay are basically cut out of the system," Balasegaram said.
The Indian government gave local pharmaceutical house Natco Pharma a licence to produce a copy of Nexavar, used to treat liver and kidney cancer, at a 97% discount to the original selling price of the Bayer product in India.
Global drugmakers say India's powerhouse generics industry and strict patent filtering reduce commercial incentives to produce cutting-edge medicines.

Article UK early drug access plan under "active discussion:" Minister

Article Amgen lipid-lowerer evolocumab impresses again

Article CHMP positive on GSK diabetes drug Eperzan

giovedì 23 gennaio 2014

UK heart-attack survival rate 'should have been better'

Thousands of heart attack victims could have been saved if the UK had adopted similar treatment methods to Sweden, research suggests.

The study, outlined in the Lancet, looked at the quality of care and outcomes for heart patients in the UK and Sweden between 2004 and 2010.

Researchers believe more than 11,000 lives could have been saved if the UK had adopted similar technology sooner.

Heart experts say the UK is catching up but still needs to do more.

The researchers, from Sweden and the UK, compared data on the treatment of almost 120,000 patients in hospitals in Sweden and more than 390,000 in the UK over the seven years.

Sweden and the UK have similar health systems.

Both are universally available, funded by tax and free at the point of use - and have national guidance for the management of heart attacks.

They differ in size significantly: the population of the UK is more than 63 million, whereas Sweden's is between nine and 10 million.

“Start Quote

The uptake and use of new technologies and effective treatments recommended in guidelines has been far quicker in Sweden”

Prof Harry HemingwayUniversity College London

Results showed that 30 days after a heart attack, death rates for UK patients were more than a third higher than for Swedish patients - 10.5% for UK patients compared with 7.6% for Swedish.

The difference in death rates decreased over time, but mortality was always higher in the UK.

'Cause for concern'

The researchers took into account factors including age, sex, the severity of heart attacks, smoking, blood pressure and diabetes.

But even then, they estimated that 11,263 deaths over the seven years studied could have been "delayed or prevented" in the UK if patients had received the same care as their Swedish counterparts.

The main reason for the difference was found to be Sweden's pattern of introducing new technologies, such as developments in angioplasty treatments for blocked or narrowed arteries, faster.

In addition, Swedish doctors were more likely to prescribe the recommended treatments, such as beta blockers, when patients were discharged.

It also had "a more established system for evaluating and reporting the qualities and outcomes of care", the researchers said.

Prof Harry Hemingway, from University College London, who was one of those leading the work, said: "Our findings are a cause for concern. The uptake and use of new technologies and effective treatments recommended in guidelines has been far quicker in Sweden.

"This has contributed to large differences in the management and outcomes of patients".

He told the BBC the UK had made progress in the last few years.

“Start Quote

We need to be led by the research and introduce pioneering practices quickly and on a large scale”

Dr Mike KnaptonBritish Heart Foundation

But he added: "It is plausible that the mortality gap persists. It is important to carry out these ongoing comparisons between countries.

'Complex reasons'

"The NHS has shown improvement compared to the past. What this study shows robustly is that isn't enough."

Dr Mike Knapton, associate medical director at the British Heart Foundation, said: "The reasons behind the differing survival rates are complex, but one explanation could be the speed with which the two countries adopted primary angioplasty (treatment for blocked arteries) as an emergency treatment.

"Sweden's early adoption meant they saw the benefits quicker and this is reflected in the figures.

"However, the UK has caught up and last year the majority of patients received this treatment.

He added: "The lesson here for the UK is that we need to be led by the research and introduce pioneering practices quickly and on a large scale."

Prof Adam Timmis and Iain Simpson, of the British Cardiovascular Society said the difference in size between the two countries potentially explained some of the difference in the speed with which technologies were introduced.

But they said the study was a "timely lesson" of the importance of "responding more promptly to emerging technologies and treatments, particularly those that can improve outcomes for patients with life-threatening disorders".

South African pharma firms accused of planning to delay patents law reform Leaked documents reveal lobbying proposals to delay laws that would allow fast introduction of generic medicines

Sarah Boseley, health editor
The Guardian, Friday 17 January 2014

Drug companies in South Africa have been accused of planning a covert, well-funded campaign to delay the introduction of laws that threaten their profits. Leaked documents show that pharmaceutical companies planned a $450,000 campaign, involving a high-profile consultancy based in Washington, DC, against changes to intellectual property laws that would enable their patents on new medicines to be bypassed in the interests of public health. This would allow the manufacture of cheaper copies of their medicines.

Campaigners accused the international drug giants of trying to derail life-saving legislation. The trade body IPASA (Innovative Pharmaceutical Industry Association South Africa), which was coordinating the campaign, said on Thursday the plans were no longer going ahead – although it was legitimate for drug companies to promote their views in this way.

One of the leaked documents is an email dated 10 January from a member of IPASA's executive to representatives of most of the big-name drug companies operating in South Africa. As agreed in December, it says, "we have moved ahead in identifying a high-calibre consultancy group to work with us", naming Washington-based Public Affairs Engagement (PAE).

The second document is the proposed PAE strategy, involving the creation of an alliance of businesspeople and academics, the placement of prominent editorials in newspapers, and a bid to "distract" access to medicine campaigners "from their own aggressive campaign".

The document later names Médecins Sans Frontières (MSF) and the Treatment Action Campaign (TAC), calling them a "coalition that was formed to pressure the government into producing [the draft IP policy] in the first place".

The stakes are high, says the document. "South Africa is now ground zero for the debate on the value of strong IP protection. If the battle is lost here, the effects will resonate. Clearly MSF and similar NGOs understand that ... Without a vigorous campaign, opponents of strong IP will prevail – not just in South Africa but eventually in much of the rest of the developing world."

Campaigners said they were shocked. "What is surprising to us is that it is done so subversively," said Julia Hill of MSF. "We have really made an effort to be very transparent. It is disappointing that this is being done in secret and that such an extraordinary amount of money is being spent to interfere with the democratic process."

Lotti Rutter, a senior researcher at TAC, said: "We have got massive concerns over what appears to be quite a covert and well-funded atempt from foreign industry to delay an essential law reform process happening here in South Africa."

Val Beaumont of IPASA said the discussions had taken place but the PAE proposal had not been accepted. "It is a very, very important issue to us and it will be to any of the knowledge-based organisations," she said. "There was a huge concern that it would be rushed." It was OK for an organisation to have a PR agency to help put across its views, she said.

Pill class action: about 600 Australian women express interest in joining case Adelaide law firm flags action against makers of Yasmin and Yas, alleging reactions including blood clots and strokes

About 600 Australian women have expressed an interest in a potential class action against the manufacturers of the contraceptive pills Yasmin and Yas, reporting adverse reactions including blood clots and strokes after taking the pills.

The women approached the Adelaide law firm Tindall Gask Bentley after staff posted a notice on their website calling for expressions of interest last year. About 600 women have since responded, some of whom have had reported significant reactions after taking the pills, the firm said.

Many of the women who have approached the law firm have had experiences after taking Yasmin or Yas that do not relate to thrombosis (clotting), and may not be part of the class action, should it go ahead.

“The important thing to understand is the significant complications that some women have had with blood clotting following taking either of these tablets,” Tindall Gask Bentley lawyer Tim White told Guardian Australia.

“What we’re talking about are complications like deep vein thrombosis, pulmonary embolism, stroke or heart attacks. They’re typically the sorts of things that have resulted in a lot of these women who have approached us being hospitalised.”

Studies over the last few years have said the popular contraceptives have a risk of blood clotting up to two or three times higher than other contraceptives.

Professor Michael Permezel, president of the Royal Australian and New Zealand College of Obstetricians and Gynaecologists (Ranzcog), told Guardian Australia that the studies being cited were retrospective, and while there was an increased risk of thrombosis with oral contraceptives, the risk was small, and actually far higher during pregnancy.

“I think on balance most doctors would believe there is a slight increase of risk with newer contraceptive pills than older ones,” he said.

“The main issue is that all oral contraceptive pills carry a small risk of thrombosis. The risk is very small, probably less than one in 1,000 women per year. Nevertheless if you’re the one in 1,000 … it can be quite important.

“Given that we’ve known for around 40 years that the oral contraceptive increases the risk [of thrombosis] a bit, are there some pills that increase it more than others? That remains controversial.”

Women could help minimise their risk of thrombosis by not smoking, avoiding excessive weight gain, and taking precautions such as keeping up movement during long travel and informing doctors that they are on the pill before undergoing procedures, he said.

Permezel said Ranzcog’s position was that a woman’s decision to take an oral contraceptive was a “risk-benefit equation” to be made with a doctor, as pills have different side-effect profiles, some of which suit many women.

Some US legal proceedings against manufacturer Bayer over reported adverse reactions after taking the pills have resulted in settlements.

“We are [confident]. They’re very different laws that are governed in the US compared to Australia. But it’s exactly the same medication,” said White.

“What one of the central issues in Australia – as in the US – was was whether or not consumers were fully informed of a number of potential risks … the more significant risk being the blood clotting.”

In December, the Australian Therapeutic Goods Administration said it would investigate Bayer over claims the company breached laws which prevented it marketing the pill Diane-35 as a contraceptive. Diane-35 was temporarily banned in France last year following a number of deaths there.

In Australia it is only permitted to be prescribed as a short- or medium-term treatment for acne and hormonal conditions, ABC reported.

Helen Davidson
theguardian.com, Wednesday 8 January 2014

Better funding call for vital drug approval programme

Aids drugs arrived in Africa, in spite of the sceptics. They came at a price that the international donors felt they could pay and have saved hundreds of thousands of lives. But had it not been for a small and normally unlauded unit of the World Health Organisation, the huge effort and large sums of money could have been wasted.

The prequalification of medicines programme (PQP) of the WHO, launched in 2001, was set up to assess the quality of the generic medicines for HIV and other diseases made by companies in India, China and elsewhere. These were affordable versions of the big brand drugs. Aids drugs that cost $10,000 a year per person could and were manufactured eventually for $100. But it is no good having the drugs if they don't work. In infectious diseases, it is worse than no good. Poor quality drugs can allow bacteria, viruses or parasites to develop resistance and that can undermine the efficacy of the high-quality medicine.

The PQP has been a fantastic success story, giving a stamp of approval to good quality generics and allowing the governments of developing countries to buy effective versions of essential drugs they can afford. But, say four respected experts in the Journal of Public Health Policy, the programme is endangered by its insecure funding. It lurches from one grant to another. Two organisations keep it going - UNITAID and the Bill and Melinda Gates Foundation. The experts argue that a unit as important to public health as the PQP should not be dependent on just two sources of funds.

The article is written by Ellen 't Hoen, a regular consultant to the WHO medicines programme and former director of the Medicines Patent Pool, Hans Hogerzeil, Professor of Global Health at Groningen University in the Netherlands, Jonathan Quick, former director of the Essential Medicines programme at WHO, of which the PQP is part, and Hiiti Sillo, director general of the Tanzania Food and Drugs Authority. They have all been deeply involved in issues around the supply of good quality drugs to low income countries.

The PQP is not in danger at the current moment, 't Hoen told me when I spoke to her. Things were looking rocky towards the end of last year, until UNITAID's December board meeting, which granted it funding for three years. But their point, she said, is that such a valuable resource ought not to be worrying about where the next dollars are coming from.

It came very close. When we sent the article [for publication], they were out of money and did not know whether UNITAID was going to renew.

Having more donors would mean they could expand their activities beyond the immediate preoccupations of their current donors, 't Hoen said, to include, for instance, cancer drugs and hepatitis C treatment.

The PQP saves huge amounts of money for donor governments and others by ensuring they spend their money safely and wisely, argues the article:

The WHO PQP has become a global public good that has helped save millions of lives. Most international organizations and many governments that procure and supply medicines depend on the WHO PQP. Yet very few choose to contribute financially to its work. The Global Fund spends around $610 million per year on medicines and other pharmaceutical products... PEPFAR spent $1.2 billion on medicines procurement over 5 years. The $15 million annual budget for the WHO PQP represents less than 2 per cent of the annual amount spent on medicines by these two organizations alone. Reliance on two donors is risky. It is time a consortium of public and private global health donors create a sustainable funding base. WHO PQP is essential to assure their products' quality. It is the strongest mechanism currently in place to create sustainable regulatory systems in low- and middle-income countries. This alone justifies investment in WHO PQP.

NHS patient data to be made available for sale to drug and insurance firms Privacy experts warn there will be no way for public to work out who has their medical records or how they are using it

Randeep Ramesh, social affairs editor
The Guardian, Sunday 19 January 2014 21.34 GMT

Drug and insurance companies will from later this year be able to buy information on patients – including mental health conditions and diseases such as cancer, as well as smoking and drinking habits – once a single English database of medical data has been created.

Harvested from GP and hospital records, medical data covering the entire population will be uploaded to the repository controlled by a new arms-length NHS information centre, starting in March. Never before has the entire medical history of the nation been digitised and stored in one place.

Advocates say that sharing data will make medical advances easier and ultimately save lives because it will allow researchers to investigate drug side effects or the performance of hospital surgical units by tracking the impact on patients.

But privacy experts warn there will be no way for the public to work out who has their medical records or to what use their data will be put. The extracted information will contain NHS numbers, date of birth, postcode, ethnicity and gender.

Once live, organisations such as university research departments – but also insurers and drug companies – will be able to apply to the new Health and Social Care Information Centre (HSCIC) to gain access to the database, called care.data.

If an application is approved then firms will have to pay to extract this information, which will be scrubbed of some personal identifiers but not enough to make the information completely anonymous – a process known as "pseudonymisation".

However, Mark Davies, the centre's public assurance director, told the Guardian there was a "small risk" certain patients could be "re-identified" because insurers, pharmaceutical groups and other health sector companies had their own medical data that could be matched against the "pseudonymised" records. "You may be able to identify people if you had a lot of data. It depends on how people will use the data once they have it. But I think it is a small, theoretical risk," he said.

Once the scheme is formally approved by the HSCIC and patient data can be downloaded from this summer, Davies said that in the eyes of the law one could not distinguish between "a government department, university researcher, pharmaceutical company or insurance company" in a request to access the database.

In an attempt to ease public concern, this month NHS England is sending a leaflet entitled Better Information Means Better Care to 26m households, to say parts of the care.data database will be shared with "researchers and organisations outside the NHS" – unless people choose to opt out via their family doctor.

However, a leading academic and government adviser on health privacy said pursuing a policy that opened up data to charities and companies without clearly spelling out privacy safeguards left serious unanswered questions about patient confidentiality.

Julia Hippisley-Cox, a professor of general practice at Nottingham University who sits on the NHS's confidentiality advisory group – the high-level body that advises the health secretary on accessing confidential patient data without consent – said that while there may be "benefits" from the scheme "if extraction [sale] of identifiable data is to go ahead, then patients must be able find out who has their identifiable data and for what purpose".

Hippisley-Cox added that "there should be a clear audit trail which the patient can access and there needs to be a simple method for recording data sharing preferences and for these to be respected".

Davies, who is a GP, defended the database, saying there was "an absolute commitment to transparency" and rejecting calls for an "independent review and scrutiny of requests for access to data". "I am tempted to say that we will have 50 million auditors [referring to England's population] looking over our shoulder."

He said it was necessary to open up medical data to commercial companies especially as private firms take over NHS services to "improve patient care". Davies said: "We have private hospitals and companies like Virgin who are purchasing NHS patient care now. This is a trend that will continue. As long as they can show patient care is benefiting then they can apply."

But Davies accepted there was now a "need to open a debate on this".

He pointed out that a number of private companies – such as Bupa – already had access to some sensitive hospital data, although none had been able to link to GP records until now. He added: "I am not sure how helpful in the NHS the distinction between public and private is these days. Look at Dr Foster [which] is a private company that used data to show significantly how things can be improved in the NHS and revealed what was going wrong at Mid Staffs. The key test is whether the data will be used to improve patient care."

Campaigners warned many members of the public would be uneasy about private companies benefiting from their health data – especially when the spread of data will not be routinely audited. Phil Booth, co-ordinator at patient pressure group medConfidential, said: "One of people's commonest concerns about their medical records is that they'll be used for commercial purposes, or mean they are discriminated against by insurers or in the workplace.

"Rather than prevent this, the care.data scheme is deliberately designed so that 'pseudonymised' data – information that can be re-identified by anyone who already holds information about you – can be passed on to 'customers' of the information centre, with no independent scrutiny and without even notifying patients. It's a disaster just waiting to happen."

Booth said the five listed reasons data can be released for are exceptionally broad: health intelligence, health improvement, audit, health service research and service planning. He said: "Officials would have you believe they're doing this all for research or improving care but the number of non-medical, non-research uses is ballooning before even the first upload has taken place. And though you won't read it in their junk mail leaflet, the people in charge now admit the range of potential customers for this giant centralised database of all our medical records is effectively limitless."

NHS England said it would publish its own assessment of privacy risks this week and pointed out that one of the key aims of care.data was to "drive economic growth by making England the default location for world-class health services research".

A spokesperson said: "A phased rollout of care.data is being readied over a three month period with first extractions from March allowing time for the HSCIC to assess the quality of the data and the linkage before making the data available. We think it would be wrong to exclude private companies simply on ideological grounds; instead, the test should be how the company wants to use the data to improve NHS care."