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Health groups warn Brexit drugs supply risk at code red

The U.K. governments preparations for maintaining drug supplies in the event of a no-deal Brexit are..

The U.K. governments preparations for maintaining drug supplies in the event of a no-deal Brexit are so lacking that the warning level should be raised to “red,” a group of health organizations has said.

National Health Service providers, pharmaceutical companies and patient groups wrote to the government to warn that Britain is seriously unprepared to maintain access to medicines if there are border delays after Brexit.

In the letter to Health and Social Care Secretary Matt Hancock obtained by POLITICO, eight organizations say industry has done all it can in preparing for a cliff-edge Brexit — and that the government needs to take action to prevent widespread drug shortages.

“If this is the reality of U.K. government preparation for No Deal we do not believe that the current medicine supply plans will suffice, and we will have widespread shortages if we do not respond urgently,” the letter dated October 31 says.

Expressing support for Hancocks “efforts to raise the warning level in Government,” the organizations say: “Only when we start to work through options will we all know where we are, but on medicines supply, on what we know and can glean from public information, we think we are at red.”

The groups calls on the government to be more transparent “and reveal what cover we have by therapy area and where there are gaps,” so that the signatories can “find further creative solutions to shortages, but we need the data to engage.”

They also request an urgent meeting in the form of a roundtable between ministers and industry.

A spokesperson for the Department of Health and Social Care said in a statement: “The Government is confident of reaching a deal with the EU that benefits patients and the NHS. However, as a responsible Government we are also preparing for a range of potential outcomes in the unlikely event of a no deal.

“As part of our contingency planning, we continue to work closely with pharmaceutical companies and storage providers to ensure the continued supply of critical drug and medicine supplies,” the spokesperson said.

The letter to Hancock is backed by, among others, the Association of the British Pharmaceutical Industry (ABPI), the Association of British HealthTech Industries (ABHI), the BioIndustry Association and the Brexit Health Alliance — a conglomerate of NHS, medical research, industry, patients and public health groups.

“When an incredibly broad group of medical organizations and bodies are telling the government we are at warning level red, it shows the preparations government has made are both shockingly inadequate and woefully behind,” said Liberal Democrat Brexit spokesperson Tom Brake.

The government in August asked drugmakers to stockpile an extra six weeks-worth of drug supplies in preparation for delays in importing medicines, but companies have since warned storage will be a major hurdle.

Speaking Wednesday evening on ITVs Peston show, Hancock said that in the event of six weeks of extra supplies not being enough, “then we will have to do things differently,” because “you cant have stockpiles for enormous lengths of delays.”

“All of this is doable. It is difficult. Theres a lot of work going on already to make it happen,” he said, adding that the government is “building refrigerator capacity right now.”

Companies advising the government on how to maintain supplies after a no-deal Brexit have signed strict non-disclosure agreements (NDAs) barring them from revealing information.

Outlining the extent of potential disruptions at Britains borders, the letter cites reports that U.K. minister David Lidington told the Cabinet the Dover-Calais trade route could be limited to 12 percent of normal capacity for six months after Brexit.

The letter points to a recent report from the National Audit Office that concluded 11 out of 12 critical upgrades to IT systems at the border are at risk of not being delivered on time, and that there is a high risk of failure in the government departments border programs for “day one of no deal” due to their scale, complexity and urgency.

With much of the necessary infrastructure unable to be built before March, the timescale is too tight for companies to make the necessary changes, it adds.

This article has been updated to add Health Secretary Matt Hancocks interview with ITV.

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NHS ‘should not prescribe acne drug’

The parents of young people who have killed themselves and patients unable to have sex are calling f..

The parents of young people who have killed themselves and patients unable to have sex are calling for the NHS to stop prescribing acne drug Roaccutane.

Ed Henthorn said it had caused him erectile dysfunction, psychosis and suicidal thoughts.

And one man who believes his son killed himself after taking the drug said the risks "are just too high".

Manufacturer Roche said "millions of patients worldwide have benefited from taking the drug".

The majority of those who take the drug have a positive experience.

'Pretty overwhelming'

"I used to think about girls… but my feelings, thoughts, just faded away," Ed Henthorn told the BBC's Victoria Derbyshire programme.

He was 19 when he took Roaccutane. He describes his acne as mild but bad enough to want to treat.

After three weeks he started to experience side-effects, including reduced energy and sex drive.

Then he experienced erectile dysfunction.

"That was why I decided to stop taking it," he said. (more…)

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Spina bifida: Keyhole surgery repairs baby spine in womb

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In a UK first, doctors have used keyhole surgery to su..

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In a UK first, doctors have used keyhole surgery to successfully repair the spine of a baby with spina bifida while it was still inside the womb.

Surgeons at King's College Hospital say the procedure is not a cure, but could be the difference between some children learning to walk or not.

Sherrie Sharp and her son Jaxson had the operation 27 weeks into the pregnancy.

Spina bifida was diagnosed after the routine 20-week pregnancy scans.

They showed Jaxson's spine and spinal cord were not forming correctly.

Gaps in the developing spine meant the cord was bulging out of his back and was left exposed to the amniotic fluid in the womb.

This damages the crucial nerves in the spinal cord and could lead to paralysis, a loss of sensation in the legs and problems controlling the bladder and bowels.

The longer the spinal cord is left exposed, the greater the damage.

Sherrie, 29, and from West Sussex, said the news was a shock, but an abortion was a "definite no". (more…)

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Less chemotherapy better for older or frail patients with advanced stomach and oesophageal cancers

Less chemotherapy is as effective at controlling disease for elderly or frail patients with advanced..

Less chemotherapy is as effective at controlling disease for elderly or frail patients with advanced cancer of the stomach or oesophagus (food pipe), and leads to fewer side effects such as diarrhoea and lethargy. These are the results of a Cancer Research UK funded study, presented prior to the ASCO conference today (Wednesday).

“Increasingly were realising its not just age that affects how well someone can tolerate their treatment and we need to do more work to understand how other conditions or aspects of frailty might play a role.” Dr Peter Hall, Cancer Research UK Edinburgh Centre[contfnewc]

Results from the GO2 trial could change the standard of care for patients who cant have full dose chemotherapy due to their age, frailty or medical fitness.

The study, which ran at hospitals all over the UK, coordinated from the University of Leeds, involved 514 people with stomach or oesophageal cancer. Their average age was 76 and the oldest was 96 years old. All were either frail, elderly or medically unfit, and for those reasons would be unlikely to tolerate full-strength treatment, which involves three chemotherapy drugs.

Patients went through a careful medical assessment, then went onto chemotherapy with just two drugs* and were allocated at random to receive them at either full-strength, medium-dose or low-dose. They were then carefully monitored to see how well the cancer was controlled, whether they had symptoms and side-effects, whether they felt their treatment was worthwhile, and what overall effect it had on their quality of life.

The researchers reported that the medium and lower doses of chemotherapy were as effective as the full-strength dose for controlling the cancer. But when the researchers looked at the overall effect of treatment, including quality of life, they reported that it was the lowest dose treatment that came out best.**

Around 15,800 people in the UK are diagnosed with stomach and oesophageal cancers every year***. Almost half (45%) of these people are 75 and over****. By 2035, this proportion is projected to rise to 55%*****, because of the UKs ageing population. This study, is one of few phase III trials in the country that seek to address how to best care for and treat this increasing population of elderly or frail cancer patients.

These findings also open up the possibility of more older and frail patients being able to take part in clinical trials.

Professor Charles Swanton, Cancer Research UKs chief clinician, said: “These valuable results reduce fears that giving a lower dose chemotherapy regimen is inferior and could make a huge difference for patients with stomach or oesophageal cancer who cant tolerate intensive courses of treatment.

“Older or frail patients are often not considered for new drug trials or standard of care therapy as theyre less able to tolerate combination chemotherapy. These trials are critical to provide much needed evidence on the effectiveness of new therapies and combination approaches, helping us develop new treatments for this growing group of patients.”

The researchers also assessed whether there were differences for the patients in the study who were under 75, or less frail, who might be expected to benefit from stronger treatment; but will be reporting that the lowest dose treatment gave the best results for them as well. (more…)

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