Trump"s Mar-a-Lago club cited for serious food safety violations

Mar-a-Lago, Donald Trump’s exclusive Palm Beach country club where the US president has an increasing fondness for entertaining world leaders with dinner and diplomacy, has been cited for a number of serious food safety violations by Florida’s restaurant inspectors.

During a routine visit in January, just days before Trump hosted a now infamous meal on the terrace with the Japanese prime minister Shinzo Abe, inspectors found three “high priority” violations, including offering diners potentially parasitic raw fish and storing meat in broken coolers at too high a temperature.

Ten other noted violations, which include the presence of rusty shelves in a walk-in cooler and kitchen staff being unable to sanitise their hands properly because of an absence of hot water at sinks, were deemed less serious under Florida’s stringent food safety regulations, yet still damaging to the reputation of the upmarket club that charges a $ 200,000 initiation fee, and $ 14,000 a year for membership.

The multiple violations from the 26 January inspection visit are described in a recently published report on the Florida department of business and regulation’s website, and uncovered by the Miami Herald on Wednesday.

According to the report, almost all of the violations were immediately corrected. In the case of the refrigerators, in which poultry, duck, beef and ham were recorded at “potentially hazardous” temperatures up to 16F warmer than the required 41F maximum, Mar-a-Lago staff told the inspectors that one cooler had been incorrectly set to defrost, and called a technician to restore the correct temperature.

The inspectors also wrote that “nonexempt fish offered raw or undercooked has not undergone proper parasite destruction”. They stated the violation had been “corrected on-site” by kitchen staff either fully cooking or discarding the fish.

The more minor hygiene infractions included a food preparer not wearing a hairnet and another employee drinking from an open container in a food preparation area.

State inspectors concluded that Mar-a-Lago’s kitchen did meet minimum standards.

But the columnist Jose Lambiet, who wrote the Miami Herald report, told the Guardian in February that he had never been a fan of the catering at Mar-a-Lago. Trump entertained the Chinese premier, Xi Jinping, there last weekend, and will be spending the upcoming Easter break on his seventh visit “home” since his inauguration 11 weeks ago.

“The food is borderline cafeteria food,” Lambiet said. “The food I got at Mar-a-Lago over the years was sometimes embarrassing. At one point we had lamb, but it wasn’t lamb that you cut in slices and that melts in your mouth, it was like lamb over a bone. [They’re], like, in their tuxedos, eating bones with a little bit of lamb on it.

“You should never be able to go to a party at Mar-a-Lago with subpar food, and it happens a lot.”

Lambiet noted that the club had only two violations in 2015. The increase could be explained in part, he believes, because Trump as president no longer has the time to personally supervise his kitchen staff.

“He’s a hands-on guy, he goes in the kitchens, he goes and makes sure everyone’s served. He’s hands-on when it comes to this kind of business, when it comes to Mar-a-Lago,” Lambiet said.

Bernd Lembcke, Mar-a-Lago’s managing director, did not return the Guardian’s call seeking comment.

Trump"s Mar-a-Lago club cited for serious food safety violations

After my suicide crisis I set up a centre to give others a safety net | Joy Hibbins

It took just minutes for a deeply traumatic experience in March 2012 to fracture my life. I experienced such terror during those moments that I couldn’t sit with my back to a door for weeks. I was convinced that someone would come in and harm me. The event replayed constantly in my mind. I couldn’t escape. I was in the grip of severe post-traumatic stress disorder and within days I was at the point of suicide.

I called my out of hours GP and was referred to a mental health crisis and home treatment team, but I found it hard to connect with the number of different people involved in my care. Their methods were very practical. They would tell me to distract myself when I felt suicidal. But what I wanted was emotional support from a team who knew and understood me as an individual. The clinical distance of psychiatric staff left me feeling detached and alone

On a summer’s day in that year I started to picture in my mind what would have helped me: a suicide crisis centre. It would be a place I could visit every day. If I was at imminent risk of suicide, I could be supported there over a number of hours. The staff would be highly trained, skilled professionals – but they would also be kind, caring and empathic.

In the months that followed I worked tenaciously to make that picture a reality: focusing on setting up the crisis centre gave me a reason to live. There are now 25 of us working there, and we will soon be marking four years of providing services. A high proportion of our clients are men, and this is significant; nationally, three times (pdf) as many men die by suicide as women.

We never set out to achieve zero suicides. That would have been a massive pressure on all of us. We simply set out to do everything that we could for each individual to help them survive. We have never had a suicide of a client under our care.

One of our clients says he carries us in his pocket. He feels that we are always with him

We don’t just provide a static centre for people to visit when they are in crisis. If they are very distressed, they may not be able to get to us, so sometimes we need to go out to them. The combination of an accessible crisis centre, home visits and our emergency phone lines places a safety net around our clients.

The quality of the relationship is so important when you’re supporting someone at risk. We work hard to build a strong connection with our clients. It’s the reason they call our emergency line at 3am, when they might not have called another service. They get through to someone they know and that makes a difference. Clients often say they wouldn’t have called an anonymous service at that point.

If you build a strong connection with clients, it can “hold” them even when you are not with them. One of our clients says he carries us in his pocket. He feels that we are always with him.

I sometimes get asked how I cope with the emotional intensity of the work. Firstly, we get excellent support and supervision from senior staff who are available at very short notice. Secondly, I see such wonderful personal qualities in our clients and that’s a source of optimism. They will go out into the world and affect other people in a positive way. That gives me huge hope for the future.

When I started to talk about my plans back in 2012, people were sceptical. It seemed such an ambitious project for a person who had recently been in crisis. But I knew it had to be set up.

MPs on the Commons health select committee recently asked us to provide evidence about our suicide crisis centre for an inquiry into suicide prevention. Their final report has just been published.

We are contacted by people from all over the country who would like a similar centre in their area. I hope that will be possible. I know how much they are needed.

• Joy Hibbins is founder and director of Suicide Crisis, which runs a suicide crisis centre in Cheltenham, Gloucestershire.

In the UK, the Samaritans can be contacted on 116 123. In the US, the National Suicide Prevention Hotline is 1-800-273-8255. In Australia, the crisis support service Lifeline is on 13 11 14. Hotlines in other countries can be found here.

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The day I made a difference is the Guardian Voluntary Sector Network’s series that showcases the work of people involved with charities. If you have a story to share about a landmark moment in your life, email voluntarysectornetwork@theguardian.com.

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After my suicide crisis I set up a centre to give others a safety net | Joy Hibbins

NHS correspondence review puts safety first | Letters

Your leading article (1 March) was wrong to suggest the government has not prioritised patient safety in the handling of a serious failure by NHS Shared Business Services to deliver patient correspondence. We set up a national incident team immediately, reviewed every piece of correspondence and have nearly completed a second clinical review of all the higher-risk cases. So far no patient harm has been identified. I was advised last March not to make the issue public because it could have led to GP surgeries being deluged with queries by patients, slowing down the vital work of going through the higher-risk cases. I then chose, against advice, to highlight the issue in a statement to parliament before summer recess as I felt it was important that MPs were informed – and far from minimising the issue, it was described as a serious incident in my department’s annual report and accounts.

But where your article was right was in saying that improving patient safety cannot be a matter of rhetoric alone. The NHS deserves credit for making huge progress on patient safety over recent years. Since Mid Staffs, 31 trusts have been put into special measures, and 16 have come out – seven of them now with “good” ratings. MRSA rates have halved since 2010 – and are now lower than France, Germany or Spain. Stillbirths are down 10% and neonatal deaths down 14%. Your leader urged ministers to learn the lessons on safety taught by the airline industry – and we are. Next month, we will launch the Healthcare Safety Investigations Branch to give the NHS independent safety reports modelled on the way air crashes are investigated. And today we are publishing plans to reform the litigation process when children suffer a brain injury at birth so we get earlier compensation to families and avoid legal processes which prevent appropriate lessons being learned.

My ambition as health secretary is simple: I want our NHS to be the safest and highest-quality healthcare system in the world. That this progress is happening despite significant pressures on the frontline is a tribute to NHS staff working very hard in exceptionally tough circumstances.
Jeremy Hunt MP
Health secretary

NHS correspondence review puts safety first | Letters

Worcestershire hospitals trust ordered to urgently improve patient safety

The NHS watchdog has ordered a troubled hospital trust to urgently overhaul patient safety or face sanctions weeks after two patients died after enduring long waits on trolleys in a corridor.

The Care Quality Commission has given Worcestershire Acute Hospitals Trust six weeks to make significant improvements at the three hospitals it runs in Worcester, Redditch and Kidderminster.

The regulator has served the trust with a section 29A notice, which sets out changes it must make by 10 March or risk penalties such as a special administrator being brought in to start running it.

Caragh Merrick, the trust’s chair, admitted to staff in an email after the CQC’s move that the trust had “lost sight of the basics [of caring for patients]. As staff we must all be held accountable for our actions,” she added.

Previous lapses means that from now action to improve patient safety will be taken from “the ward to the board” in an attempt to “guarantee consistent high professional standards”, said Merrick.

The trust was in the headlines recently when two patients died, reportedly on 1 and 3 January, in the A&E unit at the Worcestershire Royal hospital in Worcester when it was struggling to cope with the sheer number of patients needing care.

In one of the cases, a female patient on an emergency trolley in a corridor within A&E suffered an aneurysm and died later in a resuscitation bay. The second patient died after suffering a cardiac arrest on another A&E trolley within the department after waiting 35 hours for a ward bed elsewhere in the hospital.

The trust was put into special measures in December 2015 after CQC inspectors raised concerns about safety in its A&E, children’s care, and maternity and gynaecology services.

It was embroiled in another controversy last year when CQC staff found that 10,000 patients’ x-rays had not been assessed, which prompted concern that serious illnesses had been missed.

Worcestershire Royal hospital recently became so busy that it had to divert A&E patients to its sister Alexandra hospital in Redditch during the NHS “winter crisis”.

The trust is due to end 2016-17 with a deficit of £37.5m, down significantly on its £59m overspend in 2015-16.

A major consultation to shake up healthcare at the trust’s hospitals is under way.

Worcestershire’s three NHS clinical commissioning groups (CCGs) launched the consultation in January which, if the option proposed was picked, would move many planned operations to the Alexandra, but concentrate most emergency care at the main Worcester hospital.

More day-case and short-stay surgery would go to the county’s smaller Kidderminster hospital.

Worcestershire hospitals trust ordered to urgently improve patient safety

By ignoring sex education, ministers are risking children’s safety | Joan Smith

It’s a long time since Theresa May and most of her cabinet were at school. When she was doing her O-levels, no one was sexting and teenage boys weren’t goggling at violent porn on smartphones. I think it’s unlikely that the future prime minister had to wear shorts under her school skirt to protect herself from being groped, as some teenage girls have taken to doing. But that doesn’t mean May and her colleagues have any excuse for ignoring what’s going on in schools today, from sexual harassment to homophobic bullying.

They’ve been warned by MPs on the women and equalities committee, in an excoriating report that revealed the “shocking scale” of sexual harassment in schools. They’ve been told by the campaigning organisation Stonewall, which published a survey three years ago in which 86% of secondary teachers said they had encountered bullying of gay pupils. They follow the news, like the rest of us, and they must know about dreadful cases in which girls and boys have been tricked into meeting paedophiles who disguised themselves as teenagers online.

They have also been told by just about everyone that the best way to keep children safe is to insist that every school in the country teaches high-quality sex and relationships education (SRE) and the broader subject of personal, social, health and economic (PSHE) education – no ifs, no buts, and no exemptions for faith schools. Teachers’ or parents’ embarrassment is not a reason to deny children absolutely essential information about how to avoid sexual predators, online or in real life.

After the “grooming” scandals in Rotherham, Rochdale, Oxford and other cities, you might think this was a no-brainer. Yet ministers have done everything but stand on their heads to avoid it. Last week Conservatives in the House of Commons were accused of filibustering a bill sponsored by Green co-leader Caroline Lucas, calling for PSHE to be made compulsory in all state-funded schools, by making lengthy speeches about the bill that preceded it. A change in the law isn’t necessary, ministers have claimed, because Ofsted is checking that the subject is being covered and will pick up any inadequacies during inspections. Just over a year ago a Home Office minister, Lord Bates, said: “We expect sex and relationships education to be taught in all schools. In fact, it is inspected by Ofsted as such.” A similar point was made last year by Lady Evans, then a government whip and now leader of the House of Lords.

Presumably they had in mind Ofsted’s latest inspection framework, introduced in 2015, which made considering the effectiveness of PSHE “more crucial than ever” to the judgments made by inspectors. Now, though, that argument (like all previous ones) has been blown out of the water. It turns out that Ofsted is barely looking at SRE when it inspects schools, according to a detailed analysis by the British Humanist Association.

The headline finding, from a study of more than 2,000 primary and secondary school inspection reports for 2015-16, is that sexual health, safe sex and related subjects were almost entirely absent. Sexual harassment and sexual violence were not mentioned at all, while sexting appeared in just 17 reports, despite having been identified as an area of major concern by the government. Porn was mentioned in a single report, as was HIV/Aids, which appeared in relation to “emerging economies” in a geography lesson. Only one in seven reports referred to LGBT issues.

Back in 2013, Ofsted said that the provision of PSHE was “not yet good enough” in 40% of schools. It is hard to believe there has been a massive improvement in the meantime, yet fewer than 1% of the inspection reports examined by the BHA made any criticism of schools’ coverage of the subject. To be fair to Ofsted, it should never have been given the job of making up for the government’s failure in this area. If SRE isn’t compulsory, some schools will say they don’t want to divert scarce resources from other subjects or that they can’t find room in the timetable. Others will use it as an excuse to avoid topics, such as homosexuality and safe sex, that they find uncomfortable for religious or ideological reasons.

What all this means, in blunt terms, is that the government is coming up with one excuse after another to avoid doing one of its most basic jobs: protecting the next generation. We know girls are being sexually harassed at school, pressured into posing for photos that may be used to threaten or humiliate them, and suffering abuse from boyfriends whose expectations have been warped by online porn. We know that gay kids are being bullied, and children of both sexes are vulnerable to predatory sex offenders.

For several years now, senior police officers in London have been telling me that compulsory sex education is vital to keep children safe. A few months ago, I heard a senior civil servant talk about the staggering number of crimes against children that are being facilitated by the internet. This is not the cosy world May grew up in, when sex and reproduction were covered in biology lessons and mobile phones didn’t exist.

It is not even the world of 17 years ago, when the government published its outdated official guidance on SRE. Children are encountering sex at a much younger age than in earlier generations, but a head-in-the-sand government is refusing to make sure they are well-informed and safe.

By ignoring sex education, ministers are risking children’s safety | Joan Smith

Vaccination skeptic Robert F Kennedy Jr to chair vaccine safety commission

Donald Trump has asked Robert F Kennedy Jr, a prominent skeptic regarding the use of vaccines, to chair a commission on vaccination safety.

“President-elect Trump has some doubts about the current vaccine policies and he has questions about it,” said Kennedy, speaking with reporters after a meeting with the president-elect at Trump Tower on Tuesday.

“His opinion doesn’t matter but the science does matter, and we ought to be reading the science and we ought to be debating the science,” said Kennedy, the son of the late attorney general Robert Kennedy and nephew of late president John F Kennedy.

Childhood vaccines have been falsely linked to autism in recent years, despite multiple scientific studies proving that incorrect.

During a 2015 Republican debate, Trump claimed that a child of some employees of his had become autistic after getting vaccinated.

“People that work for me, just the other day, two years old, beautiful child went to have the vaccine and came back and a week later, got a tremendous fever, got very, very sick, now is autistic,” Trump said in September 2015.

According to Kennedy, an environmental activist, radio host and attorney who has written for the Guardian, Trump has created a commission “on vaccine safety and scientific integrity” and asked him to chair it.

“Everybody ought to be able to be assured that the vaccines that we have – he’s very pro-vaccine, as am I – but they’re as safe as they possibly can be,” Kennedy added.

Although Kennedy calls himself “pro-vaccine”, he has pushed hard against the use of thimerosal, a preservative used in vaccines made from mercury, launching a group called the World Mercury Project, backed by anti-vaxxers. He advocates that parents should choose whether their children are vaccinated.

In 2014, he edited a book titled Thimerosal: Let the Science Speak: The Evidence Supporting the Immediate Removal of Mercury – a Known Neurotoxin – from Vaccines.

In 2015, he said Congress was stalling on investigating links between autism and the mumps, measles, and rubella (MMR) vaccine because it was scared of Big Pharma, a trillion-dollar industry and the biggest employer of lobbyists.

When questioned what his father and uncle – leading lights in the 1960s Democratic party – would make of Trump as president, Kennedy said on Tuesday that Trump “can be any kind of president he wants to be”.

“He probably comes into office less encumbered by ideology or obligations than anybody that has been in political office or won the presidency,” Kennedy said.

The Guardian has contacted the Trump transition team to ask them to confirm the commission has been set up and to give further details.

Vaccination skeptic Robert F Kennedy Jr to chair vaccine safety commission

Maternity wards in England to be rated by safety record

The government is to release new ratings for maternity wards across England to allow prospective parents to compare and contrast services in NHS hospitals, as part of a drive to reduce instances of stillbirth and brain injuries during labour.

Maternity data detailing the frequency of accidents within clinical commissioning groups and the health prospects of expectant mothers – including the percentage of smokers, for example – will be collated to form England-wide ratings.

In a major speech on Monday, Jeremy Hunt will also unveil proposals to allow the NHS to offer compensation automatically to parents of babies left stillborn or brain-damaged because of poor care. The health secretary wants parents of children starved of oxygen at birth no longer to endure a wait of about 11 years for compensation.

Stillbirth rates are still among the highest in western Europe, according to Jeremy Hunt. Photograph: Carl Court/Getty Images

At present parents often become embroiled in lengthy and costly legal action against the NHS, forcing grieving families to fight for months or even years before the health service agrees to compensation.

Bereaved parents often have to instruct solicitors to determine the cause of their child’s death, with health bosses sometimes denying any liability until they are ordered to pay compensation by a judge.

Under the new scheme, which was first recommended by Tory peer Baroness Cumberlege earlier this year, an independent rapid resolution and redress scheme will be set up to investigate tragedies in childbirth, which would quickly decide whether compensation should be paid.

The launch comes as figures showed that the cost of settling claims with parents whose children are damaged at birth has reached more than £0.5bn. The NHS as a whole pays out more than £1bn a year in negligence compensation, and reducing that cost is seen a key way of mitigating the financial crisis facing the service.

In February this year, Cumberlege recommended the investigations into maternity cases and any subsequent payouts are made by the trusts without any court involvement. The recommendation was one of several made by Cumberlege, who has been chairing an independent review of maternity services in England.

The new proposals are modelled on a Swedish scheme, which has reduced serious avoidable birth injuries by about 50% in the past six to seven years.

Health secretary Jeremy Hunt said he hoped to end the culture where going to court was an automatic “first step” and instead foster a culture of transparency so the NHS can learn from its mistakes.

Under the plans, claims by parents who believe medical errors have caused severe damage to their children – such as cerebral palsy or brain damage – would be assessed by investigators working independently of the NHS trust. The investigators would quiz NHS staff and parents and look at medical records.

Compensation for errors around the time of birth has reached more than £500m a year. Photograph: Sturti/Getty Images

Their findings would be presented to a panel of legal and medical experts who would decide whether any compensation is warranted and arrange for payments to be made to the family.

The government hopes the scheme – which would assess about 500 cases a year – will help dismantle what it sees as a “litigation culture”. It would work out far cheaper for the NHS than the current route, in which cases go to court or are settled out of court, often for millions of pounds.

Data from the NHS Litigation Authority shows the compensation bill to the NHS for errors around the time of birth is rising, reaching £509.3m in 2015/16 – up from £393.2m in 2014/15.

A spokeswoman for the Department of Health said the plan, which will be the subject of a consultation, would not “lock” parents into the scheme and would let them bring their own legal case against the trust if they were unhappy with the outcome.

The new maternity ward ratings follow Hunt’s recent creation of similar schemes to help patients and families compare the quality of cancer and dementia care. However, once they start being published, they will set out details for services within each of the NHS’s 209 GP-led clinical commissioning groups rather than the 156 acute hospital trusts with maternity services. Hunt said that openness about the quality of care will help empower patients and reduce wide variation in care quality.

In a speech at the Royal College of Obstetricians and Gynaecologists, Hunt will also set out £8m for training, with at least £40,000 available to each NHS trust in England.

A £250,000 maternity safety innovation fund will pilot new ideas for improving care, while maternity ratings for every part of England – using data that already exists – will be published together to encourage greater transparency.

Other measures being unveiled include a new Healthcare Safety Investigation Branch, modelled on the Air Accidents Investigation Branch. A new tool will also standardise the investigation of every stillbirth and early baby death so lessons can be learned.

Hunt said: “Our NHS maternity staff do a fantastic job under huge pressure. But even though we have made much progress, our stillbirth rates are still among the highest in western Europe and many on the frontline say there is still too much of a blame culture when things go wrong – often caused by fear of litigation or worry about damage to reputation and careers.

“These comprehensive measures will give practical support to help trusts improve their approach to safety – and help to foster an open and transparent culture so that the courts become a last resort not an automatic first step.”

In May this year a new report revealed figures that 15 babies are dying every day in the UK from stillbirth, during labour or within four weeks of being born.

The report was published by MBRRACE-UK (Mothers and Babies: Reducing Risk through Audits and Confidential Enquiries in the UK), which is a collaboration of academics and medical experts.

It found that there were big variations in death rates across the country, from 4.1 to 7.1 per 1,000 births. Women from the poorest backgrounds and black and Asian mothers run a higher risk that their baby will die in the womb or soon after birth.

In nearly half of all stillbirths (46%), the causes of death are unknown, said the report. The biggest causes of death in the early weeks of life are complications following birth (32%) and congenital anomalies such as heart defects (28%), and very premature birth (13%).

The MBRRACE team flagged up the need for research into premature births and also called for every maternity unit to review and record the causes of death in the same way to try to discover why there are such stark variations around the country.

James Taylor, head of policy and public affairs at disability charity Scope, said of the new plans: “Finding out that your child has been affected by a birth injury can be a very traumatic time for parents.

“So it is very positive that the government will be listening to disabled people and their parents on how the NHS can better support families when serious issues do occur during birth.”

Maternity wards in England to be rated by safety record

Victoria to overhaul health system after hospital safety review over baby deaths

Victoria’s health department is not giving quality and safety in healthcare the attention it needs to protect patients from harm, a hard-hitting review of hospital safety, published on Friday, has said.

The findings have prompted Victoria’s health minister, Jill Hennessy, to announce an overhaul of the state’s health system.

The review was led by the health program director at the Grattan Institute, Stephen Duckett, and was ordered after 11 newborn and stillborn deaths at Bacchus Marsh hospital were found to have been potentially avoidable.

The hospital’s maternity ward had a higher than average perinatal mortality rate despite catering for low-risk births, a previous review of the deaths and Djerriwarrh health services, which managed the hospital, found.

“Basically, we need a change in the culture and approach to monitoring safety and quality in Victoria,” Duckett told Guardian Australia.

“The health department in the past has left the safety and quality issue primarily to individual hospitals, and this meant many hospitals were left reinventing the wheel when it came to issues, and there was also a lack of support to those hospitals from the department.”

Duckett’s review found that many safety and quality issues identified across the state were due to cumulative budget cuts over time that had “gutted many departmental functions”.

“While the cuts were portrayed as improving government efficiency, the decline in the department’s ability to perform its core functions was lost to public view,” the report found.

Duckett said the cluster of baby deaths that prompted the review were harrowing and that his team’s recommendations, some of which have already been implemented, would help the department’s goal of eliminating avoidable harm to patients.

“When my daughter was born I cried for joy,” he said. “I can’t imagine what it must be like to lose a baby and then be told that death was potentially avoidable. The premise of this review was really to make sure we learn as much from those deaths as possible.”

Hennessy said on Friday the government accepted all recommendations made by the review. She announced a series of reforms, among them a new health information agency to overhaul the way data and information is shared across the health system; the creation of a Victorian Clinical Council to provide clinical expertise to government and health services; and that consultation would begin on a “duty of candour” law which would see health services made to apologise to any person harmed while receiving care and to explain what went wrong and what action would be taken.

Many of the reforms will be implemented within 12 months.

“We want to do everything we can to reduce avoidable harm in our hospitals, and make them as safe as they can possibly be,” Hennessy said.

“A goal of zero avoidable harm is an ambitious target, but one we have an obligation to do everything we can to achieve.”

She announced an additional $ 13m to fund the reforms, and the formation of a new agency, Safer Care Victoria, tasked with monitoring and improving quality and safety in the health system. The agency will be headed by world-leading clinician and researcher Prof Euan Wallace.

Victoria to overhaul health system after hospital safety review over baby deaths

Junior doctors suspend strike plans due to "patient safety" concerns

Junior doctors have suspended plans to go on a series of five-day strikes to protest against changes to their contracts after a “vigorous debate” following a change in leadership.

The British Medical Association’s junior doctors committee (JDC) said it would not go ahead with the industrial action, but was “planning other actions over the coming weeks”.

The decision follows a challenge to the leadership of Dr Ellen McCourt, chairwoman of the committee, by doctors from Justice for Health.

McCourt fought off the challengers but there were changes to other members of the junior doctors leadership, who held a summit on Saturday to discuss their new strategy.

“After a vigorous, passionate, thoughtful and wide-ranging debate this afternoon, the JDC has decided to suspend industrial action while planning other actions over the coming weeks,” the committee said in a statement.

The decision was prompted by “feedback from members from every region in England, as well as the views of the wider profession, patients and the public in considering the next steps on the dispute”.

“Our primary consideration in coming to this decision has been our overriding concern about patient safety, the care we provide every day and the ability of the health service to deliver this care,” it added.

“To be absolutely clear, the JDC still opposes the implementation of the contract … The past few months have been difficult and frustrating and we know that members are anxious for information and practical support.”

Junior doctors have been in a long-running dispute with the government over its decision to change their contracts to make it cheaper for the NHS to provide weekend cover.

The health secretary, Jeremy Hunt, decided to impose the new contract on junior doctors, five of whom last week sought to have the decision overturned in the high court. Lord Justice Green’s ruling on that is due on Wednesday.

Union sources say hundreds of trainee medics voicing their concern about the proposed walkouts had led to serious fears that strike turnout would be poor and that the BMA would end up divided, weakened and lowered in public esteem as a result of the stoppages.

Many junior doctors were also concerned that the long duration of the planned strike would put patients’ safety at risk and risk a backlash from the public if anything untoward happened in a hospital while they were protesting outside. Medics have also voiced confusion about the objectives of the stoppages, given that the union’s leadership backed in the early summer the new contract they had negotiated, only to see grassroots juniors reject the improved terms and conditions by 58% to 42%.

McCourt was elected as interim chair after the former leader, Johann Malawana, resigned after 58% of junior doctors rejected a compromise contract.

One senior BMA official said: “Junior doctors don’t want to put patients at risk and don’t want to go ahead with a five-day strike. Quite a few don’t want any more strike action at all. Even the few JDC members who still think that they can’t give up totally wanted the 5-day strike scaled down.

“Junior doctors don’t have the heart or the stomach for this anymore. They don’t see the point of industrial action. They feel let down and blame both Jeremy Hunt and the BMA equally.”

There is also mounting anger and confusion among junior doctors at what many see as the BMA’s lack of clear strategy in first electing to hold all-out stoppages of unprecedented duration without defining what their purpose was.

The Department of Health welcomed the suspension of the strikes, saying: “The best way to rebuild trust now is for industrial action to be called off permanently in the interests of patients – and we urge the BMA to do so.”

The strike action was originally planned for this month, but the first five-day walkout was cancelled after opposition from other members of the medical profession.

Opposition to the planned strikes came from the Academy of Medical Royal Colleges, which represents all the doctors’ professional bodies.

Junior doctors suspend strike plans due to "patient safety" concerns

Hospitals and care homes fail food safety inspections

More than 500 care providers in the UK, including 19 hospitals and other NHS facilities, have failed hygiene and food safety inspections, Guardian analysis reveals.

Food Standards Agency (FSA) data shows that care homes fail to meet food hygiene standards more than any other type of care provider, with more than 200 residential, nursing and care homes receiving low grades at their latest food safety inspections.

This was closely followed by nurseries, childcare centres, playgroups and out-of-school care providers, more than 200 of which failed to meet hygiene standards, as well as a handful of hospices, homeless shelters, churches and youth centres.

The FSA ranks all food providers, giving them a score of zero to five. Zero means the establishment “urgently requires improvement”, one or two is considered a failing grade, and three to five is satisfactory.

An overwhelming majority (more than 98%) of hospitals and other care providers achieve a food hygiene rating of three or better. Despite this overall success, Michael Harding, a food hygiene rating scheme support officer at the FSA, said any instance of a care organisation receiving a low score was “a cause for concern”, due to the fact that vulnerable people, including children, older people and people who are ill, were more likely to use their services.

“The food safety officer will be taking the necessary action to ensure that the issues identified at caring premises with a lower rating are addressed and that vulnerable people are not put at risk,” he said.

Eight care providers still in operation scored zero, including six residential care homes, one nursery and one after-school care facility, which has since stopped preparing food for children.

A ninth, Fairy Tales day nursery in Glen Parva, Leicestershire, received a score of zero in May after inspectors found a mouse infestation. The nursery closed and has since reopened under new management. The new business is yet to be inspected, but a spokesman from Blaby district council, which conducts inspections in the area, said Ofsted visited the site in mid-August and confirmed that it was clean and tidy with no evidence of mice.

The Stay and Play after-school care service at Millbrook primary school in Newport, south Wales, scored a zero rating in June after it provided high-risk food, such as ham and salad wraps, despite not having the facilities to safely prepare them, Newport city council’s environmental health team said. The centre has since stopped serving food that requires preparation and gives children cereal or biscuits instead.

Several care homes were given zero ratings for issues including mouldy and expired food found in fridges, evidence of cross-contamination between raw and cooked food, lack of hand-washing facilities, poor cooking equipment and no food safety management documentation.

Businesses awarded a zero rating are either immediately shut down or given 28 days to tackle urgent issues, with visits to check that work has been carried out. They can then either pay £160 to be rescored or wait until their next scheduled assessment, usually about six months later, to potentially be given a new score.

Nineteen hospitals nationwide received scores of between zero and two, or “improvement required” in the case of Scotland, which uses a different grading system.

Hand washing is an important factor in effective hygiene and limiting the transfer of harmful bacteria. Photograph: Graham Turner for the Guardian

According to the FSA, the hospital inspections look at meals served in canteens as well as those served to patients, but do not cover independent retailers based at hospitals, which are inspected separately.

In almost all cases, spokespeople for the low-scoring hospitals and the councils that inspected them said the hospital administrations had taken steps to improve food safety.

Eight hospitals in Scotland received the grade of “improvement required”, in some cases because of repeated minor contraventions, such as chipped plaster on kitchen walls, water damage on floor coverings and the lack of a thermometer to monitor fridge temperatures.

One of these hospitals, Albyn hospital in Aberdeen, a 30-bed private hospital run by BMI Healthcare, received a rating of “improvement required” in May, with the food safety inspector citing issues with cleanliness, temperature control and paperwork. The inspector also mentioned concerns with cross-contamination from the storage of raw and cooked foods together, use of the same aprons by staff throughout the day and in particular the use of the same machine to vacuum-pack raw food, such as sausages, and cooked food, such as chicken and smoked salmon.

“I am extremely concerned that … the vacuum packer was being used for ready-to-eat foods,” the inspector wrote in their report. “Your customers are patients of the hospital and as such have heightened vulnerability and may be immunocompromised [have a weakened immune system].”

Stuart Storrie, the interim executive director of BMI Healthcare, said that since the inspection the company had worked with suppliers and staff to “correct every single one of the problems cited in the report” and he was confident they had addressed all issues raised.

Two hospitals in Birmingham received failing grades at their inspections in March. The Royal Orthopaedic and West Heath hospitals were awarded scores of two and one respectively.

The catering company that prepares food for two units at Kingsley Green’s NHS site in Shenley, Hertfordshire – Oak unit, a 10-bed psychiatric intensive care facility, and Beech unit, a 15-bed rehabilitation ward – received a score of one in December 2015. Another inspection of the wards was imminent, St Albans city and district council said.

An NHS eating disorder unit in Stockton-on-Tees was given a score of one in March 2015. The facility runs shopping and cooking workshops with clients, and an inspection found that during these activities, there were problems with food hygiene, such as hand washing and not wearing aprons.

A spokesperson for the NHS trust said that since the inspection, it had had further talks with inspectors and put in place “robust actions” to improve food safety.

Hospitals and care homes fail food safety inspections

Patient safety at risk because language tests for medics "not stringent enough"

Patient safety could be at risk because doctors, nurses and dentists from elsewhere in Europe are not facing stringent enough language tests, leading medics have said.

In only one year, 29 medics from the European Economic Area faced allegations of “inadequate knowledge of English language”, according to data obtained by the Royal College of Surgeons.

By contrast, only 10 doctors from outside the EEA faced the same accusations during 2014/15, the figures obtained by the RCS from the General Medical Council show.

Under current EU rules, doctors coming to Britain from the EEA only have to show they have general English language skills. Those arriving from further afield have to prove their language abilities in a clinical context – showing they can talk fluently about symptoms and equipment. Brexit negotiations pose an “excellent opportunity” to ensure language checks are up to scratch, the RCS said.

Professor Nigel Hunt, dean of the faculty of dental surgery at the RCS, said: “The NHS would struggle to provide care in hospitals, clinics and dental practices without the very skilled doctors, dentists and nurses that come from both the EU and non-EU countries.

“It’s absolutely vital that the government find ways to ensure they can remain working in the NHS post-Brexit. That said it’s unquestionable that such staff should be able to communicate clearly with patients in English about their clinical problems, illnesses and treatment.

“While the professional regulators are able to require proof of the clinical language skills of non-EU applicants, the same checks do not apply to EEA applicants and our fear is that this could be putting patients at risk. We want the same rules to apply to all non-UK professionals, regardless of where in the world they come from.”

During 2014/15, 145 allegations were made about poor communication by dentists from the EEA compared with 27 about dentists from the rest of the world, according to data from a freedom of information request to the General Dental Council by the RCS.

A new briefing paper from the faculty of dental surgery at the RCS warns that despite attempts to improve language checks, EU law still prevents regulators from systematically testing EEA applicants’ language skills in a clinical setting, including on medical terms, ensuring consent, describing a procedure and possible side-effects.

A Department of Health spokesman said: “Patient safety is of the utmost importance, and we expect all healthcare professionals working in the UK to have a good command of the English language.

“That is why we have tough rules, allowing the GMC and individual employers to test employees at and beyond the initial point of employment – and these cases represent just 0.002% of NHS staff.”

Niall Dickson, chief executive of the General Medical Council, said: “Our language requirements are among the toughest in the world, and we keep them under regular review to make sure they continue to be effective.

“We have twice raised the standard in recent years and have secured a change in the law to allow us to take action against doctors who cannot communicate effectively.

“In the past we were not able to check doctors from Europe. Now we can and the difference is clear – this has been a huge step forward for patient safety. Since 2014 nearly 1,100 doctors from Europe have not met our English language requirements and cannot therefore practise in the UK.

“We have always argued that we should have the right to test the competence of European doctors as well as language and that remains our position.”

Patient safety at risk because language tests for medics "not stringent enough"

2016 Honda Pilot: Prime Safety Engineering Earns Pilot a Top Security Rating

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VideoWhile Honda has constantly had a robust dedication to engineering and creating secure autos, it wasn&rsquot right up until a current journey to the Insurance Institute for Highway Safety (IIHS) facility in Virginia that we saw why Honda is so passionate about car safety. This trip permitted journalists to observe, live and [...]

2016 Honda Pilot: Prime Safety Engineering Earns Pilot a Top Security Rating

Legalization of Recreational Marijuana: Profits Before Safety?

As recreational use of marijuana not too long ago became legal in Washington state, many concerned dad and mom and educators feel this determination is sending the incorrect message to our youth and teens.  While product sales carry on to be brisk in Colorado, a single expert voices concern about the drug serving as a gateway for youth and teenagers browsing for tougher drugs.

“It’s actually a shame that however yet another state has permitted and is now peddling recreational marijuana,” mentioned Janina Kean, substance abuse and addiction specialist and President and CEO of Large Observe Recovery Center.  “Allowing the sale of recreational marijuana in Washington will only perpetuate drug use in the state and offer a gateway for our youth for undertaking more hardcore, illicit drugs this kind of as heroin, which is presently plaguing the nation.”

Logo of the United States National Institute on Drug Abuse, element of the National Institutes of Well being. (Photo credit score: Wikipedia)

Kean is on the front lines in the war towards substance abuse. Her interaction with youth, teens and mothers and fathers in excess of the previous 16 many years in her treatment method facility has shaped her views about the recently approved legislation legalizing recreational use of marijuana in Washington State. As an internationally recognized specialist and spokesperson in the field of substance abuse, Kean led the initial AA meeting to ever take spot in the Opiate Triangle of the Globe, the Yunnan Province of China, exactly where she was invited to teach doctors how to appropriately care for individuals with heroin addiction.

Keen has firsthand knowledge that marijuana is not as benign a drug as most folks feel, and contrary to well-known belief, marijuana is addictive.

She explains that many of her present opiate addicts she treats, who began using marijuana only a decade earlier, often stated “Marijuana is safe, it’s not addictive, it can’t hurt you.”

“Well, the recent legalization of recreational marijuana has only reinforced the belief of adolescents—that this is a safe drug,” explains Kean.

“If it employed for medicine or medicinal purposes”, her sufferers argue, and is legal, “it can not harm me.”

Estimates from the Nationwide Institute on Drug Abuse indicate that about 9 % of consumers turn out to be addicted. The number increases to 1 in six, or 17 percent, in end users who start off in their teenagers, and to 25-50 percent in day-to-day end users.

Kean explains that numerous sufferers she taken care of, whom only “casually” utilised  marijuana, have given that gone on to use more difficult drugs such as cocaine, heroin, and MDMA or Molly following reaching a plateau, and finish up back at her therapy facility.

In truth, in accordance to a 2010 Nationwide Survey on Drug Use and Wellness (NSDUH), marijuana accounted for 4.5 million of the estimated 7.one million Americans who had been addicted to, or abusing illicit medication. Data from 2009 in a related examine signifies that marijuana was the primary drug of abuse in these 12 many years and older entering drug therapy plans. And 61 % of individuals under the age of 15 also reported marijuana as their principal drug of abuse.

In response to permitting recreational use of the drug, Kean feels that states such as Washington and Colorado that want to make money off the sale of recreational marijuana want to incorporate statutes in their legislation which dictate that a specified fixed percentage of recreational marijuana profits be directed toward treatment method beds and study on the use and misuse of marijuana in every single state.

In truth, in accordance to an report in USA Right now, Colorado has previously collected practically 24 million in marijuana taxes from state licensed shops, and Washington State seems forward to collecting up to 190 million dollars in the up coming 4 many years based mostly on government projections.

“These states are only allowing use and revenue of marijuana because there is funds to be made and as such, they need to have to pay out for the consequences of their revenue, improved drug abuse and addiction amid the youth,” added Kean.

As of now, there is no allocation of funds as element of legislation in Washington or Colorado which dictates (or mandates) care or study to examine and measure abuse and addiction that may stick to from marijuana use.  Kean feels this is the moral thing to do if these states will be allowed to carry on to sell the drug for recreational functions.

With two deaths straight stemming from marijuana edibles (1 suicide and 1 murder case) in the past 12 months, along with the ever-present query regarding “legal” or “allowable” quantities of marijuana in drivers, defining the potential of recreational marijuana use in the US continues.

Legalization of Recreational Marijuana: Profits Before Safety?

Safety worries continue to be above three-man or woman IVF | Ted Morrow

Human embryo at forty days. Photograph: Carolina Biological/Corbis

Later on this year, parliament is anticipated to debate a alter to the law that would let a reproductive treatment named mitochondrial substitute (MR) into fertility clinics. A current review of proof by the United kingdom fertility regulator, the Human Fertilisation and Embryology Authority, stated that this experimental strategy is “not unsafe”. But although the aim of the process is noble – to eliminate human mitochondrial ailments, which have an effect on around 1 in four,000 men and women – a amount of essential safety issues continue to be unresolved.

Evolutionary concept predicts a mismatch in between the DNA in the donor’s mitochondria and the mother’s nuclear DNA, with potentially serious and unpredictable consequences for any embryo designed utilizing MR, an concern my colleagues and I wrote about last 12 months. When MR is carried out experimentally, it has been proven to alter the metabolic process and cognitive capacity of mice. In other species it benefits in male sterility, diminished survival, accelerated ageing and modifications the expression of numerous hundreds of genes. But there is a lack of data from species a lot more closely connected to humans – a gap in our information that we felt would be sensible to fill before proceeding to clinical trials.

The issue of mismatching arises due to the fact of the peculiar way mitochondrial DNA (mtDNA) is inherited through mothers only, offering an possibility every generation for the mtDNA and some of her nuclear DNA to be passed on collectively. This allows organic assortment, nature’s good quality control mechanism, to weed out combinations of interacting mitochondrial and nuclear DNA that are not compatible with a single one more. Over prolonged evolutionary timescales within populations, the two genomes will become matched or “coadapted” to one yet another. MR breaks these coadapted genomes apart, providing rise to a range of damaging results. The particular style of the experiments needed to detect mismatching is particularly essential. They normally involve manipulating a number of distinct mitochondrial types and creating observations in many people. With no these attributes the capacity to detect mismatching is bad. So whilst demonstrations that MR is technically feasible (with the production of four macaques in 2009), it is not ample to rule out the probability that the types of effects seen in other species will not be located in primates or people.

The HFEA appear unconvinced that the coevolutionary process for which there is evidence is true, contemplating “this kind of hypothetical issues to be extremely unlikely”.

The report, passed to the Department of Health on the 2 June 2014, discusses a number of other technical issues connected to the security of the technique, and even outlines a quantity of areas for which far more data is essential. But for the issue of mismatching, they do not advise any more study. This is regarding, as it appears a realistic security concern is getting ignored.

From my perspective as an evolutionary biologist, a frequent thread in the debate so far is that people are somehow particular circumstances, despite the reality that the same set of mitochondrial genes are found from yeast to humans, and that the evolutionary theory is a general one, applying even to plants. This suggests to me that greater exposure to and integration of current evolutionary ideas in the training of biomedical scientists would be beneficial. This is not a new suggestion a whole discipline called Darwinian medication is gradually gaining traction, with the aim of providing health care professionals the capacity to far better predict ailment threat.

It also appears that if evolutionary biologists were incorporated earlier in the consultation procedure, there may have been far more cautious conclusions about the security of MR. The inertia behind the regulatory procedure, collectively with the resistance from biomedical researchers to contemplate evolutionary arguments, is substantial. I propose that in the long term policy makers would do effectively to cast a broader net when searching for experience and evolutionary biologists themselves ought to engage much more with policy makers.

Scientists are usually urged to grow to be more concerned in building proof-primarily based policy, and so it is relatively perplexing to see that when concept and proof are presented they are roundly dismissed as irrelevant or trivial. Evolutionary biology can offer you a excellent deal of understanding about the planet around us, such as ourselves. We need to make use of that expertise.

• Ted Morrow is an evolutionary biologist at the University of Sussex

Safety worries continue to be above three-man or woman IVF | Ted Morrow

New Evidence Fuels Issues About The Safety Of Niacin

The string of failures– for HDL therapies in general and for niacin in particular– continues unabated.  The publication of the main results of the HPS2-THRIVE trial, along with new information from the AIM-HIGH trial, provide no evidence of a beneficial effect for niacin but do fuel concerns that it may cause serious adverse effects.

In HPS2-THRIVE, published in the New England Journal of Medicine, the combination of extended-release niacin and laropiprant (Tredaptive, Merck) was compared to placebo in more than 25,000 high risk patients already receiving statin therapy. Patients in the treatment group had significant reductions in LDL cholesterol (10 mg/dL), significant increases in HDL  (6 mg/dL), and significant reductions in triglycerides (33 mg/dL). But there was no difference in the rate of major vascular events (13.2% for niacin-laropiprant versus 13.7% for placebo, RR 0.96, CI 0.90 – 1.03, p=0.29).  There was also no significant difference in an exploratory analysis of patients with low HDL and high triglyceride levels who might be expected to benefit the most from niacin therapy.

There were signs of harm associated with niacin-laropiprant. Serious adverse events occurred more often in the combination group (55.6% versus 52.7%, p < 0.001). Diabetes complications were especially concerning. Among patients who had diabetes at the start of the trial, serious complications related to diabetes occurred in 11.1% of patients in the treatment group versus 7.5% of patients in the control group, a 55% increase. Among patients who did not have diabetes at the start of the trial, there was a 32% increase in the diagnosis of diabetes in the treatment group (5.7% versus 4.3%).

Niacin therapy was also associated with significant increases in infections (8% versus 6.6%, p< .001) and bleeding (2.5% versus 1.9%, p < 0.001). These findings came as a surprise to the investigators. There were also significant increases in other, previously known adverse effects of niacin, including gastrointestinal, musculoskeletal, and skin-related adverse events.

The troubling findings of HPS2-THRIVE were not contradicted, and were at least partially confirmed, by a new analysis from the AIM-HIGH trial published in the correspondence section of NEJM. The trial randomized more than 3,400 patients with stable coronary artery disease to extended-release niacin (Niaspan, AbbVie) or placebo in addition to simvastatin and, if needed, ezetimibe. The trial was stopped early for lack of efficacy.

In their new analysis the AIM-HIGH investigators report a significant increase in serious infections (8.1% versus 5.8%, p=0.008) and a nonsignificant increase in serious bleeding events (3.4% versus 2.9%, p=0.36). But there was also a significant increase in all bleeding events in AIM-HIGH (10.1% versus 8.1%%, p=0.04).

The AIM-HIGH authors were reluctant to conclude that the new adverse effects seen in HPS2-THRIVE were also a genuine problem in AIM-HIGH. The findings, they wrote, “should be considered to be provisional and exploratory.” But the HPS2-THRIVE authors were more certain:

In light of the consistency of the results with those from previous trials of niacin alone, we believe that the findings from HPS2-THRIVE are likely to be generalizable to all high-dose niacin formulations. Although niacin might still be relevant for particular patient groups (e.g., patients at high risk for vascular events who have high levels of LDL cholesterol), any potential benefits should be considered in the context of the observed hazards.

Much of the initial discussion about HPS2-THRIVE revolved around the relative importance of the niacin and laropiprant components of the drug. In an accompanying editorial, Donald-Lloyd Jones writes that  ”the consistency of the overall findings with earlier trials of niacin alone suggest that niacin is the major problem.”

What now should we make of niacin and the HDL cholesterol causation hypothesis? On the basis of the weight of available evidence showing net clinical harm, niacin must be considered to have an unacceptable toxicity profile for the majority of patients, and it should not be used routinely.

The failure of the niacin trials, as well as other HDL-related trials, “lends further credence to the notion that HDL cholesterol is unlikely to be causal.”

Sanjay Kaul said that because the results of these trials have been known the lack of efficacy “is not surprising.” The safety findings, however, are “noteworthy.”

The increase in adverse events, including infections and bleeding, observed in HPS2-THRIVE likely represents an underestimate given that only about 50% of those screened were enrolled in the trial (one-third withdrawals on active drug). I do not agree with the AIM-HIGH investigators assertion that the significantly increased risk of infection and numerical excess in serious bleeding should be considered provisional and exploratory. AIM-HIGH, like most other lipid lowering trials, was powered for efficacy and not safety assessments. Lack of a significant difference in safety outcomes in inadequately powered studies should not be viewed as reassuring. Instead, safety should be assessed by examining the 95% CI and ruling out unacceptable harm. The difference in serious bleeding of 3.4% vs 2.9% results in a risk ratio of 1.19 (0.82, 1.73). In absence of any efficacy outcome benefit, I would argue that not being able to rule out a 73% increase in serious bleeding is unacceptable and points to an unfavorable benefit-risk balance. One has to also take into consideration that an absolute difference in the serious bleeding rate of 0.55% was observed in about 1/8th the number of patients enrolled in HPS2-THRIVE (difference in bleeding risk was 0.7%). Had AIM-HIGH enrolled as many patients as were enrolled in HPS2-THRIVE, this difference would have been statistically significant. If one were to count bleeding events of any severity in AIM-HIGH, the increase in risk would be statistically significant: 174 vs 137, risk ratio 1.25 (1.01, 1.55), p=0.04.

Bottom line, given the undesirable benefit-risk balance of extended release niacin, it is hard to make a case for it as frontline therapy in patients evaluated in these trials.

Another interesting observation is lack of efficacy in patients with mixed dyslipidemia (elevated TG and low HDL) in HPS2-THRIVE. In contrast, a beneficial effect was observed in AIM-HIGH. This could be related to different cutoffs for elevated TG or low HDL used in the 2 studies. Alternatively, the positive finding in AIM-HIGH might be spurious (false positive) given the overall null result!

New Evidence Fuels Issues About The Safety Of Niacin

New Proof Fuels Considerations About The Safety Of Niacin

The string of failures– for HDL therapies in basic and for niacin in particular– continues unabated.  The publication of the primary results of the HPS2-THRIVE trial, along with new details from the AIM-Higher trial, provide no evidence of a advantageous impact for niacin but do fuel concerns that it may lead to serious adverse results.

In HPS2-THRIVE, published in the New England Journal of Medicine, the blend of extended-release niacin and laropiprant (Tredaptive, Merck) was compared to placebo in far more than 25,000 higher danger sufferers previously receiving statin treatment. Patients in the treatment method group had important reductions in LDL cholesterol (ten mg/dL), considerable increases in HDL  (six mg/dL), and substantial reductions in triglycerides (33 mg/dL). But there was no variation in the fee of significant vascular occasions (13.2% for niacin-laropiprant versus 13.7% for placebo, RR .96, CI .90 – 1.03, p=.29).  There was also no substantial variation in an exploratory examination of patients with low HDL and higher triglyceride levels who may possibly be expected to benefit the most from niacin treatment.

There were indicators of harm linked with niacin-laropiprant. Critical adverse events occurred a lot more frequently in the mixture group (fifty five.six% versus 52.seven%, p &lt .001). Diabetes complications were specifically regarding. Amongst sufferers who had diabetes at the begin of the trial, serious complications relevant to diabetes occurred in eleven.1% of patients in the treatment method group versus 7.5% of patients in the handle group, a 55% enhance. Among patients who did not have diabetes at the start of the trial, there was a 32% increase in the diagnosis of diabetes in the treatment method group (5.seven% versus 4.three%).

Niacin therapy was also connected with important increases in infections (8% versus six.six%, p&lt .001) and bleeding (two.five% versus 1.9%, p &lt .001). These findings came as a shock to the investigators. There had been also considerable increases in other, previously known adverse results of niacin, which includes gastrointestinal, musculoskeletal, and skin-connected adverse events.

The troubling findings of HPS2-THRIVE have been not contradicted, and had been at least partially confirmed, by a new analysis from the AIM-High trial published in the correspondence section of NEJM. The trial randomized a lot more than three,400 sufferers with secure coronary artery condition to extended-release niacin (Niaspan, AbbVie) or placebo in addition to simvastatin and, if essential, ezetimibe. The trial was stopped early for lack of efficacy.

In their new evaluation the AIM-High investigators report a important increase in significant infections (8.one% versus five.8%, p=.008) and a nonsignificant improve in critical bleeding occasions (3.4% versus 2.9%, p=.36). But there was also a significant boost in all bleeding occasions in AIM-Higher (ten.1% versus eight.1%%, p=.04).

The AIM-Large authors had been reluctant to conclude that the new adverse results witnessed in HPS2-THRIVE have been also a genuine issue in AIM-Large. The findings, they wrote, “should be regarded to be provisional and exploratory.” But the HPS2-THRIVE authors were a lot more specific:

In light of the consistency of the final results with people from preceding trials of niacin alone, we think that the findings from HPS2-THRIVE are likely to be generalizable to all substantial-dose niacin formulations. Though niacin may nonetheless be pertinent for certain patient groups (e.g., sufferers at higher chance for vascular events who have higher levels of LDL cholesterol), any possible benefits need to be regarded as in the context of the observed hazards.

Much of the first discussion about HPS2-THRIVE revolved all around the relative importance of the niacin and laropiprant components of the drug. In an accompanying editorial, Donald-Lloyd Jones writes that  ”the consistency of the all round findings with earlier trials of niacin alone suggest that niacin is the main problem.”

What now ought to we make of niacin and the HDL cholesterol causation hypothesis? On the basis of the excess weight of offered evidence displaying net clinical harm, niacin need to be considered to have an unacceptable toxicity profile for the bulk of individuals, and it must not be employed routinely.

The failure of the niacin trials, as well as other HDL-related trials, “lends further credence to the notion that HDL cholesterol is unlikely to be causal.”

Sanjay Kaul said that due to the fact the benefits of these trials have been acknowledged the lack of efficacy “is not surprising.” The security findings, nonetheless, are “noteworthy.”

The boost in adverse occasions, which includes infections and bleeding, observed in HPS2-THRIVE very likely represents an underestimate offered that only about 50% of these screened had been enrolled in the trial (1-third withdrawals on lively drug). I do not agree with the AIM-Higher investigators assertion that the substantially elevated risk of infection and numerical excess in serious bleeding need to be regarded provisional and exploratory. AIM-Large, like most other lipid decreasing trials, was powered for efficacy and not safety assessments. Lack of a considerable variation in safety outcomes in inadequately powered research should not be viewed as reassuring. Rather, safety must be assessed by examining the 95% CI and ruling out unacceptable harm. The distinction in serious bleeding of three.4% vs 2.9% outcomes in a threat ratio of 1.19 (.82, one.73). In absence of any efficacy end result advantage, I would argue that not currently being able to rule out a 73% boost in significant bleeding is unacceptable and factors to an unfavorable advantage-chance balance. One has to also take into consideration that an absolute variation in the critical bleeding price of .fifty five% was observed in about one/8th the quantity of patients enrolled in HPS2-THRIVE (difference in bleeding chance was .seven%). Had AIM-Substantial enrolled as many patients as were enrolled in HPS2-THRIVE, this variation would have been statistically important. If 1 were to count bleeding events of any severity in AIM-Higher, the enhance in risk would be statistically substantial: 174 vs 137, danger ratio one.25 (one.01, one.fifty five), p=.04.

Bottom line, given the undesirable advantage-chance balance of extended release niacin, it is tough to make a case for it as frontline therapy in sufferers evaluated in these trials.

Another intriguing observation is lack of efficacy in individuals with mixed dyslipidemia (elevated TG and lower HDL) in HPS2-THRIVE. In contrast, a useful impact was observed in AIM-High. This could be connected to different cutoffs for elevated TG or lower HDL employed in the two research. Alternatively, the positive discovering in AIM-Substantial might be spurious (false optimistic) offered the all round null consequence!

New Proof Fuels Considerations About The Safety Of Niacin

Massachusetts prepares bill for more powerful safety at abortion clinics

Massachusetts governor Deval Patrick said Wednesday he expects to have a bill on his desk by the finish of the month that would strengthen safety close to abortion clinics in the state.

The legislation is a response to the US supreme court’s unanimous determination final week striking down the state’s 35ft buffer zone law, deeming it an unconstitutional restraint on the cost-free-speech rights of protesters.

The determination has been praised by anti-abortion activists but decried by abortion rights supporters and the top elected official in Massachusetts, who say the zones assisted safeguard public safety.

Patrick referred to as the ruling “a setback for reproductive freedom”, but stated the court also gave the state a roadmap for attainable legislative action the state could get that would survive a constitutional challenge.

“That genuinely produces the framework,” Patrick explained.

Lawyer common Martha Coakley explained she has begun functioning with lawmakers to craft legislation to assist shield females coming into clinics whilst respecting the rights of protesters.

Individuals possibilities consist of giving police much more power to disperse crowds, Coakley stated. Operators of the clinics, which also offer you companies other than abortion, have pointed to efforts by some protesters in the previous to block entranceways.

The legislation could also assist guard entry to driveways major to clinics and adopt on a state degree some of the protections included in the federal Freedom of Access to Clinic Entrances Act, she mentioned.

“Ladies should not be afraid or as well stressed out to look for essential health-related care,” explained Coakley, a Democratic candidate for governor. “The supreme court may well not have liked our buffer zone, but they did not lessen our commitment to guarding women’s access to reproductive overall health care.”

Anti-abortion protesters say they are just exercising their very first amendment rights as they consider to counsel females.

“Females frequently seek out out abortion as a last resort,” mentioned Eva Murphy of Massachusetts Citizens for Daily life. “They are frightened. They are pressured by family members or a boyfriend or a spouse. They want assist, and we offer that.”

“We need to be cost-free to walk all around and try out to persuade females to talk to us, and if they do not want to talk to us, fine,” she additional.

But Marty Walz, president and CEO of Planned Parenthood League of Massachusetts, mentioned the court doesn’t realize the gauntlet females had to run prior to the buffer zone was enacted. She said that integrated protesters screaming at girls and attempting to block entranceways.

“That is the globe that the supreme court has brought us back to,” mentioned Walz, who as a former state lawmaker sponsored the buffer zone law.

Lawmakers will have to move swiftly. The legislature’s formal session ends 31 July. After that, the objection of a single lawmaker can stall legislation for the rest of the year.

To get a bill to Patrick ahead of then, lawmakers will have to publish it, file it and hold public hearings. They bill will also have to win final approval in both the Residence and Senate.

Massachusetts prepares bill for more powerful safety at abortion clinics

FDA Ends Olmesartan Safety Review, But...

The FDA announced on Tuesday that it had completed its safety assessment of the antihypertensive drug olmesartan (sold as Benicar and other names). The investigation was initiated in 2010 when final results from the ROADMAP trial showed that individuals with type two diabetes taking olmesartan had an enhanced threat of cardiovascular death.

Now the FDA says that it “has found no clear proof of enhanced cardiovascular hazards associated” with olmesartan in diabetic sufferers. The FDA stated that it would not adjust the recommendations for the use of olmesartan but it will consist of new information about the drug in the drug’s label.

A cautious reading of the FDA announcement, even so, suggests that although the agency did not uncover clear evidence of increased cardiovascular chance it also did not find clear proof of safety. Only 1 study examined by the FDA focused on the “subgroup of interest, i.e., diabetic patients taking substantial-dose olmesartan,” and it did not offer any reassurance. Here is the FDA’s description of the review:

A massive (a lot more than 300,000 patient-many years) observational review of Medicare individuals 65 many years and older examined the price of death in individuals taking olmesartan in contrast to other ARBs. In a chosen group of diabetic patients―patients who received only the highest dose of olmesartan (forty mg every day) for longer than six months―olmesartan was related with an increased threat of death (HR 2., 95% confidence interval: 1.one to 3.8) compared to related sufferers taking other angiotensin receptor blockers. In contrast, the identical evaluation in non-diabetic individuals located that substantial-dose olmesartan was associated with a decreased chance of death (HR .46, 95% self confidence interval: .24 to .86) in contrast to equivalent patients taking other ARBs. The conflicting results in diabetics and non-diabetics are challenging to reconcile and raise uncertainty about the credibility of the findings in either group. Additionally, no distinctions were identified amongst the groups getting reduced doses of olmesartan and groups receiving other angiotensin blockers or in people getting therapy for much less than 6 months.

Right here is the FDA’s conclusion about the study:

The final results appear to help the discovering in ROADMAP however, there are issues with regards to the credibility of the benefits of the Medicare review due to the fact of the discrepant findings in diabetics and non-diabetics. The observation of a massive lower in survival in patients with diabetes taking high doses of olmesartan, coupled with a large improve in survival in non-diabetic individuals taking olmesartan—all relative to other drugs of the very same class—is not a plausible locating.

 Comment: This FDA communication is fairly odd, in my view. It does not sound like there is a lot robust evidence both way in this situation. But it appears to me that if the FDA will take four years to carry out a safety evaluation, and if the only appropriate proof it analyzes appears to help the earlier issues, then it shouldn’t just conclude the security assessment. If something the safety concern has increased, not decreased.

FDA Ends Olmesartan Safety Review, But...

Jeremy Hunt vows to tackle unreporting of safety incidents in hospitals

An global review final week identified that the NHS was the safest well being care technique in the planet, but Well being Secretary Jeremy Hunt says that ”we have to not be complacent”.

He would like to inspire all trusts to have an ”open and honest reporting culture” so that concerns can be shared by doctors and nurses at an early stage.

Mr Hunt believes that this will boost patient care across the country and comes as a lesson learned from the tragedy that happened at Mid-Staffs.

Jeremy Hunt vows to tackle unreporting of safety incidents in hospitals

European Regulators Investigate Cardiovascular Safety Of Ibuprofen

The European Medicines Agency announced on Friday that it had initiated a overview of the cardiovascular safety of ibuprofen when taken in high doses over  an extended period of time. The review will be carried out by the Pharmacovigilance Risk Assessment Committee (PRAC).

The EMA explained that people taking ibuprofen ought to proceed to take it as extended as they follow the package deal label or the guidelines of their doctor or pharmacist.

The cardiovascular threat of all non-steroidal anti-inflammatory medicines (NSAIDs) have been below near scrutiny for a amount of years. The enhanced danger connected with a single group of NSAIDs, the COX-two inhibitors, has been acknowledged for much more than a decade. Researchers have also located evidence for cardiovascular difficulties with the NSAID diclofenac.

The agency mentioned it had located no proof for a problem in men and women taking doses significantly less than two,400 mg/day or for quick periods of time. ”Ibuprofen is one of the most broadly employed medicines for soreness and inflammation and has a properly-known safety profile, specifically at normal doses,” the EMA explained.

European Regulators Investigate Cardiovascular Safety Of Ibuprofen