NHS boss rejects claim of "humanitarian crisis" in hospitals

The NHS has rejected claims it is facing a “humanitarian crisis” as it deals with winter pressures after it emerged that two patients had died on trolleys in one accident and emergency department in the last week.

The Red Cross said it had stepped in to help the NHS in England deal with the increased demand put on the service over the colder months. The charity’s chief executive, Mike Adamson, said extra cash was needed for health and social care to make the system sustainable.

“The British Red Cross is on the front line, responding to the humanitarian crisis in our hospital and ambulance services across the country,” he said. “We have been called in to support the NHS and help get people home from hospital and free up much-needed beds.”

Keith Willett, director of acute care for NHS England, said the health service had worked with the charity over recent winters, funding and supporting its “excellent service at home and ambulance service”.

“But on the international scale of a humanitarian crisis, I do not think the NHS is at that point,” Willett said.

More details soon …

NHS boss rejects claim of "humanitarian crisis" in hospitals

Scottish court rejects appeal against minimum alcohol pricing

Scottish judges have rejected an appeal against the Holyrood government’s plans to introduce minimum pricing for alcohol.

The ruling by the court of session in Edinburgh is the latest in a long-running legal battle led by the Scotch Whisky Association after the Scottish parliament voted in favour of minimum pricing in 2012.

Ministers set the minimum price at 50p per unit of alcohol, a measure that would mean whisky could be no cheaper than £14 a bottle.

Last year the European court of justice ruled that the policy was in breach of EU free-trade laws. The European court of justice said the policy could be justified on health grounds under EU law only if it was more proportionate and effective than using general taxation.

However, in a written judgement issued at the court of session on Friday, the three judges ruled that the government’s policy was not illegal. In the judgement, Scotland’s most senior judge, the Lord President Lord Carloway, wrote that the policies didn’t contravene laws set by the ECJ.

Quoting from the judgement issued by the judge who earlier considered the matter, Lord Doherty, Carloway wrote that drinking was important to Scots.

“For many, the consumption of alcohol is a great social lubricant. It’s use in a responsible manner is an important and positive feature in Scottish culture. The general intent, as the Lord Ordinary noted (Opinion para 54) is to ‘get people to build a healthy and sensible relationship with alcohol’; not to stop them drinking altogether or even to drink moderately at all times.”

More details soon …

Scottish court rejects appeal against minimum alcohol pricing

Labor rejects tobacco industry claim of plain packaging policy failure

Labor has rejected tobacco sector figures that display more cigarettes are becoming sold considering that the introduction of plain packaging.

The tobacco business British American Tobacco Australia has jumped on the figures as proof the plain packaging policy has failed but they are contradicted by Australian Bureau of Statistics information as effectively as by preliminary research into the affect of plain packaging on smoking routines. Labor launched necessary plain packaging in 2012 to significantly protest from tobacco companies.

Figures from InfoView, which are backed by the cigarette businesses Philip Morris and BATA, ran on the front webpage of the Australian on Friday, displaying an improve of .3% in the volume of cigarettes getting offered, but have not been adjusted to account for population development. The study also showed the yearly decline in the amount of men and women smoking more than halved.

When Guardian Australia contacted InfoView for the information it was directed to BATA, who sent a press release quoting the figures and slamming plain packaging.

“With development in sector volumes, fewer individuals quitting and a leap in the amount of cheap illegal cigarettes on the streets, you could draw the conclusion that folks are really smoking far more now than prior to plain packaging came into effect,” a spokesman, Scott McIntyre, stated.

When asked to present the raw information of the analysis, McIntyre replied it was “commercially sensitive”.

“It’s not BATA study,” he stated. “It’s purchased from third-celebration suppliers Roy Morgan and InfoView. We acquire data about our products, just like any other company that sells quick-moving consumer goods.”

Australian Bureau of Statistics figures demonstrate a decline in smokers in Australia since 2001, a trend that continued in 2011-twelve, when the percentage of female smokers dropped to 16.three% and male smokers decreased to twenty.four%.

ABS figures also record a decline in the total home expenditure on tobacco and cigarettes.

South Australia has recorded an improve in the smoking fee in the past 12 months, with 19.4% of the population smoking, up from 16.seven%, in accordance to government figures. The state is in the approach of banning smoking in alfresco places which the government is hoping will help reduced the rate.

The opposition wellness minister, Catherine King, referenced the ABS figures when commenting on the sector figures.

“Only the tobacco market thinks plain packaging is a poor factor – that is because they know they will be selling fewer cigarettes to fewer people,” she mentioned. “It is incumbent on the government to express its unqualified assistance for plain packaging.”

In BATA’s release it explained it was “very clear all information available” in excess of the past 12 months showed the plain packaging policy was a failure.

Most researchers agree it is as well early to correctly measure the impacts of the policy but preliminary investigation has shown men and women have been turned off by the plain packaging, which demonstrates graphic photos of effects of smoking, this kind of as rotting teeth.

Analysis into the influence of the initial 3 months of the policy, published in the British Medical Journal and funded by Cancer Council Victoria, identified 30.6% of smokers utilizing plain packaging perceived their cigarettes to be of decrease top quality than a yr earlier, in contrast with 18.1% of smokers using branded cigarettes.

It was also reported that 26.2% of plain-package smokers were much less satisfied by their cigarettes than they have been a year earlier, in contrast with 14.9% of branded-packet smokers.

Labor rejects tobacco industry claim of plain packaging policy failure

NHS rejects expats returning from Spain

Katrina Osman of IHC Employee Advantages explained: “Many people really do not realise that as soon as they move abroad then they can’t just return for a vacation or to go to family members and use the NHS for non-emergency treatment method. If you dwell abroad for a lot more than 3 months you really don’t instantly qualify for NHS treatment method, even if you nevertheless have a Uk passport.”

She mentioned people returning from Spain essential to be resident in Britain for at least six months prior to they could entry NHS services. They would then require to register with a GP and be place on the waiting checklist for treatment method, which could result in a further six to twelve-month wait.

Although the principles have been in area for a number of many years, Ms Osman explained “it is only in the final two many years we’ve seen them getting much more widely implemented”.

Andrew Apps, a director of ALC Healthcare, a professional overall health insurer, stated it was becoming more difficult for expats to get health-related problems taken care of on the NHS. “As is frequently the situation it is a bit of a postcode lottery, with some health authorities currently being tougher about this rule than other people. Considerably will rely on what treatment you need, how prolonged you have lived abroad and how great you are at pleading your situation.”

EU principles state that if you are living abroad you ought to get health-related treatment method in the country in which you now dwell. But this is where retired expats can efficiently get caught in a Catch‑22 – having paid Nationwide Insurance only in a nation in which they no longer reside.

With many European nations encountering prolonged economic problems, some are restricting entry to state wellness care. In a lot of instances hospitals will want documentary evidence that residents have both paid into the local method (by means of tax or National Insurance) or have ample insurance in area ahead of they will authorise therapy.

For expats doing work abroad this could not be a difficulty. Several will be having to pay tax in that nation so will qualify for state well being care positive aspects. In addition, a lot of companies will also supply personal wellness insurance for their staff. Mr Apps mentioned he had observed a number of instances the place operating visas were granted only when there was proof that personal overall health care cover was in location, both by way of an employer or as an individual policyholder.

But this won’t apply to people who have retired overseas or who move overseas but then discover themselves unemployed. If they do not have the required S1 varieties they could uncover themselves unable to get therapy or liable for the total expense themselves.

To make matters worse, numerous in this age group can struggle to get affordable insurance, as their age is likely to push up premiums, and any current problems would be immediately excluded.

Teresa Rogers of Aviva International explained the company had noticed a shift above the past couple of years, with numerous European countries now charging for overall health care companies that had previously been provided totally free.

“These alterations can be really localised, and charging is not often consistent,” she mentioned. “For instance, in some components of Spain expats and holidaymakers may possibly be asked to spend for prescription medicines, a single room in a hospital or diagnostic exams.

“If you have a heart assault, you may possibly locate that emergency remedy to stabilise you is covered. But if you need a stent in three months’ time this will not automatically be covered by the Spanish authorities.”

Ms Rogers explained for people moving or residing overseas it wasn’t always clear what health care treatment method they would get cost-free, and what they would be expected to shell out for. Even if you certified for cost-free state wellness care, this may possibly not be as in depth as the care supplied by the NHS.

She added: “It is clear that many countries’ state overall health care programs are getting to be overburdened. This is putting pressure on numerous of these reciprocal arrangements and as a result several expats are being asked to spend far more.”

Expats living in Spain are not the only ones facing this dilemma. Modifications to the French wellness care method 5 years ago successfully suggest that anyone retiring there now wants to have personal insurance in location if they want accessibility to overall health care companies.

Mr Apps said: “When individuals move abroad the final factor they feel about is their health. And even when folks qualify for cost-free state well being care it is not often simple accessing these solutions.”

He said economic pressure in Spain had led to underinvestment in hospitals in some components of the country, with lengthy waiting lists and an emerging variety of private amenities.

“In an emergency you could locate you are taken to a private rather than a public hospital and finish up with a substantial bill to pay as a end result.”

What paperwork do you need?

• European Health Insurance coverage Card (EHIC) This offers British holidaymakers and expats accessibility to emergency health-related treatment in other EU countries. However, it will only give accessibility to solutions that would normally be free of charge to the country’s residents – so in some instances Britons will have to spend for therapy that would be cost-free on the NHS.

• Residual S1 form Spanish expats who are unemployed or have taken early retirement ought to apply for one of these. This will ensure totally free well being care for thirty months. After this, appear to get personal insurance coverage. Apply at gov.united kingdom/healthcare-in-spain.

• S1 form This is the equivalent form for people who have reached state pension age. Those who have retired abroad need to have to signal this to accessibility free state overall health care.

• Insurance Those who have moved overseas could want to contemplate private health-related insurance. Distinct policies are available which will both pay for treatment in a neighborhood hospital, or for treatment back in the Uk. Fees differ dependent on age, in which you reside, prior well being situations and what extra you opt to shell out.

• For more expat information, go to telegraph.co.united kingdom/expatmoney

NHS rejects expats returning from Spain

FDA Rejects Novel Novartis Drug For Acute Heart Failure

Novartis Novartis said today that the FDA had issued a full response letter for the biologics license application for RLX030. The drug, also identified as serelaxin, is a recombinant form of the naturally taking place human hormone relaxin-two, which has been identified to assist ladies modify to the cardiovascular changes that arise during pregnancy.

The FDA selection was not unexpected considering that earlier this 12 months its Cardiovascular and Renal Medicines Advisory Committee voted unanimously towards approval. The rejection occurred despite the reality that the drug received a ”breakthrough therapy” designation from the FDA final yr. Serelaxin was also turned down for approval in Europe earlier this yr.

Novartis mentioned it plans to carry on advancement of the drug. ”We continue to feel RLX030 has the potential to be an essential treatment method for AHF and have been encouraged by feedback from FDA advisory committee members noting the information are intriguing,” explained a business executive. “In accordance with the FDA’s tips we will carry on to expedite our clinical trial system to construct the supporting physique of proof.”

The BLA relied heavily on data from the the pivotal phase III Loosen up-AHF research. Novartis stated it was “continuing to expand the data supporting the efficacy of RLX030 in acute heart failure with an comprehensive global clinical plan, like the Relax-AHF-two trial which will enroll more than 6,300 sufferers.”

FDA Rejects Novel Novartis Drug For Acute Heart Failure

FDA Once Yet again Rejects New Indication For Johnson & Johnson"s Xarelto

The third time wasn’t the charm. The FDA these days turned turned down– for the third time– the supplemental New Drug Application (sNDA) for rivaroxaban (Xarelto, Johnson &amp Johnson Johnson &amp Johnson) for use in acute coronary syndrome individuals to lessen MI, stroke or death. In addition, the FDA– for the second time– turned down the sNDA for rivaroxaban in the same population for the reduction of stent thrombosis.

The complete response letters come as minor shock, considering that an FDA advisory panel final month strongly recommended against approval for the indications. As I’ve reported right here on several occasions, the huge sum of missing data from the pivotal ATLAS ACS 2-TIMI 51 trial has been the source of the company’s inability to acquire the ACS indications. Though J&ampJ has produced significant efforts to fill in the missing data, the FDA reviewers and panel members did not think the information was reliable sufficient to attain firm conclusions about the relative safety and efficacy of rivaroxaban for use in ACS.

“We remain committed to delivering sufferers who have suffered from acute coronary syndrome with additional safety towards stent thrombosis and secondary lifestyle-threatening cardiovascular occasions,” mentioned a J&ampJ executive in a statement. “We are evaluating the contents of the letters and will establish the acceptable up coming actions.”

FDA Rescinds Xarelto REMS

In a separate improvement, the FDA has rescinded the Xarelto REMS (Risk Evalaution and Mitigation Technique). The company had been required to communicate the risks of an increased threat of thrombotic events when the drug was discontinued without having an ample alternative anticoagulant and of decreased efficacy when not taken with the evening meal.

FDA Once Yet again Rejects New Indication For Johnson & Johnson"s Xarelto

Watchdog rejects "societal benefit" test on NHS medicines

Assorted capsules. Photograph: Alamy

The medicines watchdog has rejected government-proposed modifications to the way it determines which drugs the NHS ought to pay for, saying they danger penalising girls and elderly and less affluent individuals.

The National Institute for Overall health and Care Excellence (Nice) will seek advice from following month on an update to its methodology for assessing medication. It had been asked by the Department of Health to make judgments on the “wider societal advantage” of medicines before recommending them for NHS use.

But a board meeting this week determined it would be incorrect to make an evaluation that effectively would put a monetary worth on the contribution to society of the people most likely to be taking the medication. That would imply scoring younger folks with a lifetime of function ahead of them greater than their elders, and males, who earn much more on average, larger than women.

Any evaluation of “wider societal advantage” would inevitably finish up taking age into account, say papers from the meeting. “However broadly the notion is drawn, our age has an influence on what we are capable to contribute and what we take from society.

“However, it would be quite wrong for Great to use the easy truth of the age distribution of people with particular circumstances as the basis for deciding whether or not or not the NHS must supply new treatments, just as it would be incorrect to use gender or any of the other protected characteristics under the equalities legislation. Regardless of the way the proposals in this paper are integrated into the appraisal procedure, Good will not permit age itself to tip the balance of a recommendation against the use of a remedy.”

But Good will still get into account the benefit to society of restoring a youthful man or woman to their full wellness when determining how considerably the NHS is willing to pay out for a drug. The recent restrict is £20,000 per patient for a drug that offers a excellent quality year of life. Under the new proposals that could rise to £50,000, and probably even a lot more for a drug that is effective, delivers value for society and is progressive as effectively.

At the moment the only discretion Nice has in its value-effectiveness formula is in excess of medicines for patients at the end of lifestyle. Wonderful can approve such drugs even if they are above the £20,000 threshold. That will carry on, but it will also be achievable to take account of the potential that medicines will give folks years of productive existence in the cost.

Nice’s chief executive, Sir Andrew Dillon, mentioned he hoped the Department of Wellness would not be unhappy with the determination. “I feel they will respect the reality that we have thought about it carefully and haven’t just said it is not a notion we are interested in,” he advised the Guardian. I believe they will almost certainly appreciate that we have taken their pondering and exposed it to the rights and wrongs of decision-making.”

He mentioned it was valid to get into account the benefit to society of a new drug, but excellent care had to be taken in the way it was completed, so that an 85-year-outdated was not regarded as less essential than a 25-12 months-old. 1 group of sufferers need to never be compared with yet another. But, he said, “all of this is a challenge”.

Watchdog rejects "societal benefit" test on NHS medicines

FDA Panel After Once more Rejects New Indication For J&J Drug

(Photograph credit: Wikipedia)

The FDA’s Cardiovascular and Renal Drugs Advisory Committee once once again turned down the supplemental new drug application for an acute coronary syndrome indication for Johnson &amp Johnson’s Xarelto (rivaroxaban). The virtually unanimous vote (10-, with one abstention) was in line with a hugely adverse overview from FDA workers members.

Although originally the topic of higher praise when it initial came out, the pivotal ATLAS ACS two-TIMI 51 trial has been bedeviled by criticism because the FDA drew consideration to the unusually massive sum of missing trial information. Previous discussions of the trial at the FDA brought the word “missingness” into widespread utilization in the health-related local community. Although J&ampJ made efforts to supply some of the missing data this time around, in the end the panel members agreed with the most latest assessment from the FDA reviewers that the huge quantity of still-missing data made it unattainable to reach firm conclusions about the relative security and efficacy of the drug in the setting of ACS.

Panel member Linda Fried, from the University of Pittsburgh, gave voice to a view adopted by many of the committee members. ATLAS, she mentioned, was most likely “an all round optimistic study” but, since of the big sum of missing information and the absence of a confirmatory research, was “not robust enough” to support the ACS indication. Speaking on behalf of the sponsor, cardiologists C. Michael Gibson and Marvin Konstam attempted to persuade the panel to accept their numerous constructive analyses of the trial. But panel members, such as outspoken critics like Steve Nissen and Sanjay Kaul, left small doubt all through the day’s meeting that they have been unlikely to vote in favor of the new indication.

“We enjoy the thoroughness of the committee’s evaluation and proceed to feel rivaroxaban, in addition to the recent normal of care, might aid provide sufferers with ACS further safety against lifestyle-threatening cardiovascular occasions this kind of as death, heart assault and stroke. We will operate with the FDA to tackle questions raised nowadays,” mentioned J&ampJ’s Paul Burton, in a statement.

FDA Panel After Once more Rejects New Indication For J&J Drug