Drug industry to challenge Nice over new cost limits

New drugsImage copyright Thinkstock

The drug industry is going to court to challenge the authority of the National Institute for Health and Care Excellence (Nice).

The public body authorises spending by the NHS on expensive new treatments.

In March it announced a new policy to hold back spending on new drugs that might cost more than £20m a year in any of their first three years of use.

Now, the Association of the British Pharmaceutical Industry (ABPI) will challenge this via a Judicial Review.

The ABPI's chief executive, Mike Thompson, said:"These new arrangements will delay access to cost-effective medicines and deny treatments to patients suffering from rare diseases."

"After many months of raising concerns with Nice, NHS England and the Department of Health and offering to work constructively on alternative proposals, we have applied to formally challenge these proposals in court," he said.

"We hope that the government will reverse the changes and work with us to find a solution that works for everyone," he added.

Are NHS patients getting the best medicines?[1]

NHS to introduce £20 cap on new drugs[2]

Image copyright Science Photo Library

Nice said it had no comment to make yet on the threat of a legal challenge.

But in April it explained that the point of the new system was not to place an absolute cap on spending on any new drug, but to stop new drugs suddenly hoovering up large chunks of the NHS budget to the detriment of other health services such as general practice or psychiatry.

"When the impact on budgets is very high, it makes sense for special arrangements to be put in place so that the NHS can manage the introduction of new drugs in a way that doesn't impact unfairly on other services," Nice said at the time.

The new system therefore allows for Nice and NHS England to negotiate with drug companies to persuade them to drop the cost of their new medicines if they look likely to breach the initial £20m-a-year limit.

If agreement cannot be reached, then the use of the new medicine will be phased in by the NHS in England - potentially over three years - instead of being made universally available for doctors to prescribe within the normal 90 days of the drug's formal introduction.

The ABPI said the new approach would affect one-in-five of all new approved medicines.

The trade body described the way Nice assessed drugs for very rare diseases as "inappropriate and unworkable" and wants the policy reversed....

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Charlie Gard case explained - BBC News

Charlie GardImage copyright PA Image caption Specialists at Great Ormond Street say there is no accepted cure for Charlie's rare disease

Doctors have asked the High Court to hear new evidence in the case of terminally ill Charlie Gard.

The 11-month-old is on life support at Great Ormond Street Hospital (GOSH).

What is wrong with Charlie?

Charlie has an exceptionally rare genetic condition called encephalomyopathic mitochondrial DNA depletion syndrome (MDDS).

Although he appeared perfectly healthy when he was born, his health soon began to deteriorate.

Charlie now has severe brain damage.

He cannot open his eyes or move his arms or legs.

His condition also means he is unable to breathe unaided, which is why he needs to be on a ventilator.

Charlie's heart, liver and kidneys are also affected, and his doctors say it is not clear if he feels pain.

Can't he be treated?

Charlie's parents, Connie Yates and Chris Gard, from Bedfont in west London, want Charlie to have an experimental treatment called nucleoside therapy.

A hospital in the US has agreed to offer Charlie the treatment, and Charlie's parents have raised funds to take him there.

Image copyright PA Image caption Connie Yates and Chris Gard raised more than £1.3m for experimental treatment for Charlie

But Charlie's doctors at GOSH do not think this is the right care for Charlie.

They say they have explored various treatment options, including nucleoside drug therapy, and none would improve Charlie's quality of life.

They say Charlie's life support should be switched off and he should be allowed to die.

How did Charlie's doctors reach this decision?

Charlie's doctors say his brain is extensively damaged at a cellular level.

They say the US clinician offering the experimental treatment agrees it will not reverse this brain damage.

GOSH applied to the High Court for judges to decide Charlie's future.

The High Court agreed with the GOSH doctors.

Charlie's parents then appealed against the decision, but courts ruled that the original decision should stand and that it would be in Charlie's best interests to be allowed to die with dignity.

Why is the case back in the courts?

GOSH says it has applied to the High Court for a fresh hearing "in light of claims of new evidence" relating to potential treatment for Charlie's condition.

Two international hospitals and their researchers have been in touch with GOSH with more information about nucleoside therapy - drugs designed to help treat MDDS.

Meanwhile, the Pope and US President Donald Trump have offered to intervene and support Charlie's parents' plea.

The president of the Royal College of Paediatrics and Child Health, however, says such interventions from high-profile figures, no matter how well-intended, are "unhelpful".

Charlie's doctors say their view has not changed - they still think the experimental treatment would be unjustified.

But they believe it is right to seek the High Court's view again.

What is nucleoside therapy?

The therapy is a treatment, not a cure.And it is highly experimental.

It has been used on some patients, but none with Charlie's type of MDDS.

There haven't yet been any trials in mice to see if it would work in Charlie's condition, which is caused by a mutation of a gene called RRM2B.The faulty DNA means Charlie's cells can't easily make energy to power his muscles and brain.

Doctors say it doesn't look as though there will be time to run such tests before reaching a decision about Charlie's care.

GOSH did apply for ethical permission to attempt nucleoside therapy on Charlie.

By the time that decision was made, however, Charlie's condition had greatly worsened and the view was that his brain damage was too severe and irreversible for the treatment to help.

Prof Julian Savulescu, an independent ethics expert at the University of Oxford, said:"More than six months have passed since experimental therapy was first considered.We don't know how bad Charlie's brain damage is now.Whether experimental therapy is still warranted depends on whether there remains any prospect of any meaningful life."

The High Court is now being asked to judge the evidence on this crucial point....


  • 3 March 2017:Mr Justice Francis starts to analyse the case at a hearing in the family division of the High Court in London
  • 11 April:He says doctors can stop providing life-support treatment
  • 3 May:Charlie's parents ask Court of Appeal judges to consider the case
  • 23 May:Three Court of Appeal judges analyse the case
  • 25 May:The Court of Appeal judges dismiss the couple's appeal
  • 8 June:Charlie's parents lose their fight in the Supreme Court
  • 20 June:Judges in the European Court of Human Rights start to analyse the case, after lawyers representing Charlie's parents make written submissions
  • 27 June:Judges in the European Court of Human Rights refuse to intervene
  • 3 July:The Pope and US President Donald Trump offer to intervene
  • 7 July:Great Ormond Street Hospital applies for a fresh hearing at the High Court

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Kidney cancer drug approved for NHS use in England

Sallyann AllenbyImage copyright Sallyann Allenby Image caption Sallyann says the new drug is another option to treat her kidney cancer

A drug which could prolong life for people with advanced kidney cancer has been approved for use on the NHS in England and Wales.

Cabozantinib has the potential to switch off tumours in some patients and could give them many months of good-quality life, doctors said.

Kidney cancer is the seventh most common cancer in the UK with around 12,000 new cases every year.

The drug has already been approved for use in Scotland[1].

A charity, Kidney Research UK, said treatment options for kidney cancer were limited and the newly-approved drug would offer patients "more hope and more time with their loved ones".

'Another hope'

Sallyann Allenby, 61, from Surrey is being treated for renal cell carcinoma - the most common type of kidney cancer - at Guy's Hospital in London.

She had a kidney removed in 2013 after finding blood in her urine on holiday and then collapsing on the flight home.

Sallyann has tried several different treatments, one of which gave her unpleasant side-effects, and she has also participated in a clinical trial which did not work for her.

In July, she began another new treatment and said cabozantinib gave her another option.

"This is really another hope for people like me, it's something else to look forward to...

"It's bad enough having the cancer, but if you know there's something else you can try then that keeps you going.

"I've got two lovely granddaughters.I want to be around for a while yet."

Silencing tumours

In trials, the drug was shown to be useful in patients whose kidney cancer had spread around the body and had become resistant to other treatments.

The way cabozantinib works means it can target molecules on drug-resistant cancer cells, stopping the tumours or at least silencing them for a while.

It works very differently to chemotherapy drugs and also immunotherapy drugs such as nivolumab, which is approved to treat advanced kidney cancer on the NHS.

Nivolumab harnesses the power of the patient's own immune system to destroy their cancer cells.

Symptoms of kidney cancer can include blood in the urine, persistent pain in the side of the body just below the ribs and a lump or swelling in the kidney area.

The cancer usually affects adults in their 60s or 70s and is rare in people under 50.

If it's caught early, kidney cancer can often be cured but a delay in diagnosis means a cure is less likely.

A spokesman from Kidney Research UK said:"We are pleased to see cabozantinib has been approved by National Institute for Health and Care Excellence, offering patients with renal cell carcinoma an increased chance of improved progression-free survival, compared to the standard therapy."...


  1. ^ been approved for use in Scotland (www.bbc.co.uk)

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Oral sex spreading unstoppable bacteria

KissingImage copyright Getty Images

Oral sex is producing dangerous gonorrhoea and a decline in condom use is helping it to spread, the World Health Organization has said.

It warns that if someone contracts gonorrhoea, it is now much harder to treat, and in some cases impossible.

The sexually transmitted infection is rapidly developing resistance to antibiotics.

Experts said the situation was "fairly grim" with few new drugs on the horizon.

About 78 million people pick up the STI each year and it can cause infertility.

The World Health Organization analysed data from 77 countries which showed gonorrhoea's resistance to antibiotics was widespread.

Dr Teodora Wi, from the WHO, said there had even been three cases - in Japan, France and Spain - where the infection was completely untreatable.

She said:"Gonorrhoea is a very smart bug, every time you introduce a new class of antibiotics to treat gonorrhoea, the bug becomes resistant."

Worryingly, the vast majority of gonorrhoea infections are in poor countries where resistance is harder to detect.

"These cases may just be the tip of the iceberg," she added.

Throat infection

Gonorrhoea can infect the genitals, rectum and throat, but it is the last that is most concerning health officials.

Dr Wi said antibiotics could lead to bacteria in the back of the throat, including relatives of gonorrhoea, developing resistance.

She said:"When you use antibiotics to treat infections like a normal sore throat, this mixes with the Neisseria species in your throat and this results in resistance."

Thrusting gonorrhoea bacteria into this environment through oral sex can lead to super-gonorrhoea.

"In the US, resistance [to an antibiotic] came from men having sex with men because of pharyngeal infection," she added.

A decline in condom use, which had soared because of fears of HIV/Aids, is thought to help the infection spread.

What is gonorrhoea?


The disease is caused by the bacterium called Neisseria gonorrhoea.

The infection is spread by unprotected vaginal, oral and anal sex.

Symptoms can include a thick green or yellow discharge from sexual organs, pain when urinating and bleeding between periods.

However, of those infected, about one in 10 heterosexual men and more than three-quarters of women, and gay men, have no easily recognisable symptoms.

Untreated infection can lead to infertility, pelvic inflammatory disease and can be passed on to a child during pregnancy.

The World Health Organization is calling on countries to monitor the spread of resistant gonorrhoea and to invest in new drugs.

Dr Manica Balasegaram, from the Global Antibiotic Research and Development Partnership, said:"The situation is fairly grim.

"There are only three drug candidates in the entire drug [development] pipeline and no guarantee any will make it out."

But ultimately, the WHO said vaccines would be needed to stop gonorrhoea.

Prof Richard Stabler, from the London School of Hygiene &Tropical Medicine, said:"Ever since the introduction of penicillin, hailed as a reliable and quick cure, gonorrhoea has developed resistance to all therapeutic antibiotics.

"In the past 15 years therapy has had to change three times following increasing rates of resistance worldwide.

"We are now at a point where we are using the drugs of last resort, but there are worrying signs as treatment failure due to resistant strains has been documented."

Follow James on Twitter[3].

Is oral sex more common now?By BBC World online

It's hard to say if more people around the world are having more oral sex than they used to, as there isn't much reliable global data available.

Data from the UK and US show it's very common, and has been for years, including among teenagers.

The UK's first National Survey of Sexual Attitudes and Lifestyles, carried out in 1990-1991, found 69.7% of men and 65.6% of women had given oral sex to, or received it from, a partner of the opposite sex in the previous year.

By the time of the second survey during 1999-2001, this had increased to 77.9% for men and 76.8% for women, but hasn't changed much since.

A national survey in the US, meanwhile, has found about two-thirds of 15-24 year olds have ever had oral sex.

Dr Mark Lawton from the British Association for Sexual Health and HIV said people with gonorrhoea in the throat would be unlikely to realise it and thus be more likely to pass it on via oral sex.

He recognises that while condoms would reduce the risk of transmission, many people wouldn't want to use them.

"My message would be to get tested so at least if you've got it you know about it," Dr Lawton said....


  1. ^ BBC Radio 1 - Myth-busting STIs (www.bbc.co.uk)
  2. ^ Pubic hair grooming 'STI risk from cuts' (www.bbc.co.uk)
  3. ^ on Twitter (twitter.com)

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Social media firms urged to tackle online body shaming

Harnaam Kaur Image caption Campaigner Harnaam Kaur said she received death threats

Internet companies should do more to tackle body shaming online, social media users have told an inquiry into how body image affects young people.

One told Parliament's annual Youth Select Committee that "so many" young people were suffering from online abuse and feelings of inadequacy.

There should also be greater diversity in the media, the committee heard.

A Facebook and Instagram policy manager said the sites were committed to making sure users had positive experiences.

'Mean comments'

The Youth Select Committee, which comprises 11 members aged 13 to 18, chose the topic of body image to consider after nearly one million people voted it as one of the top 10 issues in the UK Youth Parliament's "make your mark" ballot in 2016.

Danny Bowman, who once claimed to be the "world's first selfie addict", told the committee he saw "so many young people who are suffering online" from being bullied or body shamed.

He said his own experiences of social media led him to have a mental health problem over his body image and to him being housebound for six months.

Image caption Danny Bowman told the committee he saw "so many young people" being bullied or body-shamed online

Mr Bowman said he thought Instagram - and the images it has of "six packs left, right and centre" - was "becoming more detrimental, especially to young men".

He added:"I think it translates into the idea of success and failure - a lot of young men are looking at these images and feeling they are inadequate, a failure…

"If we want to solve this problem we have to go directly to social media networks."

Image copyright Paul Michael Hughes/Guinness Wor Image caption Harnaam Kaur is a body positivity campaigner

Harnaam Kaur, a body positivity campaigner, said there was a lack of diversity in the media.

Ms Kaur, who has claimed a Guinness world record for her beard[1], said this had encouraged her to set up an Instagram page.

"That is why Instagram is so important for me, to do photo shoots and show people it is ok to look different.

"I do also feel that companies need to open up their doors to people who do look different and actually stop photo-shopping images…

"The way that women's bodies and men's bodies that are being portrayed are not actually their natural form."

Image caption Stephanie Teboah said it was "difficult to find models of colour"

Stephanie Teboah, a plus-size model, said a "Westernised standard of beauty" dominated the media, and called for a greater variety of ethnicities and body types.

However, she credited Instagram as a site that also hosts "body-positive" content, too, adding that users can curate their feeds to see the content they want to see.

Karim Palant, Facebook and Instagram's UK public policy manager, told the committee Instagram was "absolutely committed" to making sure its community is "as positive as possible".

He added that the companies wanted to make sure policies and tools were in place so that "negatives are dealt with as quickly as possible".

The committee, which next meets on 14 July, will also hear from academics, mental health experts, education professionals, and government officials....

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