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.

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“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.

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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."

Pfizer's new smoking-cessation study assessing efficacy and safety of varenicline meets primary and secondary endpoints

Pfizer Inc. announced that a new smoking-cessation clinical study assessing the efficacy and safety of varenicline (Chantix/Champix) has met its primary and secondary endpoints. This is the first study of varenicline using the approach of reducing smoking prior to quitting.

Smokers in this study were unwilling or unable to abruptly quit smoking within four weeks, but were willing to reduce smoking over a period of 12 weeks, with the goal of quitting by the end of that period. Smokers in the study were treated for a 12-week reduction phase followed by a 12-week abstinence phase (for a total of 24 weeks of treatment).

“Setting a fixed quit date can be daunting to smokers, which is why reducing the number of cigarettes smoked is a commonly-used approach to quitting,” said Steven J Romano, MD, senior vice president and medicines development group head, Global Innovative Pharmaceuticals, Pfizer Inc. “This study was designed with this quitting approach in mind.”

In the study of smokers (N=1,510) who were willing to gradually reduce smoking with a goal of quitting within 12 weeks, patients were randomized to either varenicline (Chantix/Champix) 1mg BID or placebo for 24 weeks of treatment, followed by a 28-week non-treatment phase. All patients received brief smoking-cessation counselling throughout the study. Preliminary results demonstrated that continuous abstinence rates (CAR) at weeks 15 through 24, the primary endpoint, were significantly higher in patients treated with Chantix/Champix than in patients treated with  placebo (32.1 per cent vs. 6.9 per cent, Odds Ratio [OR]=8.74, p=<0.0001).

The safety and tolerability of varenicline in this study were generally consistent with findings seen in previous clinical studies. The most common treatment-emergent all-causality adverse events reported in over 10 per cent of patients in either the varenicline or placebo treatment group were (varenicline versus placebo): nausea (27.8 per cent vs. 9.0 per cent), nasopharyngitis (13.0 per cent vs. 12.0 per cent), abnormal dreams (11.5 per cent vs. 5.8 per cent) and insomnia (10.7 per cent vs. 6.9 per cent).

This study was a 52-week, randomized, double-blind, placebo-controlled, multinational, parallel group study evaluating the efficacy and safety of varenicline 1 mg BID for smoking cessation using the reduce-to-quit approach. Patients included in this study were adult smokers (N=1,510) who were unwilling or unable to quit within four weeks, but were willing to reduce their smoking with the ultimate goal of quitting within 12 weeks.

Participants were treated with varenicline (n=760) or placebo (n=750) for 24 weeks and targeted at least a 50 per cent reduction in the number of cigarettes smoked by the end of the first four weeks of treatment, and a further 50 per cent reduction after the following eight weeks of treatment, with the goal of complete abstinence by 12 weeks. Smokers who had not made a quit attempt in the 12-week reduction phase of the study were encouraged to do so in the next 12 weeks of treatment.

The study inclusion criteria allowed for enrollment of smokers with certain psychiatric diagnoses, with appropriate monitoring throughout the study.

These are preliminary data and are subject to additional analyses. Results from this study will be submitted for publication in a peer-reviewed journal.

CHANTIX was approved by the US FDA in May 2006 as an aid to smoking- cessation treatment in adults 18 and older. CHANTIX has been shown to increase the likelihood of abstinence from smoking for as long as one year compared to treatment with placebo. Adults who smoke may benefit from smoking-cessation support programs and/or counselling during their quit attempt. It’s possible that patients might slip up and smoke while taking CHANTIX. If patients slip up, they can stay on CHANTIX and keep trying to quit.

Pfizer strives to set the standard for quality, safety and value in the discovery, development and manufacture of health care products and works across developed and emerging markets to advance wellness, prevention, treatments and cures that challenge the most feared diseases of our time.

Article Asia-Pacific healthcare's "urgent need for business process change"

Article Asia-Pacific healthcare's "urgent need for business process change"