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UK asks drug companies to sign no-deal Brexit gag clause

LONDON — Drug companies advising the U.K. government on how to maintain medicine supplies after a no..

LONDON — Drug companies advising the U.K. government on how to maintain medicine supplies after a no-deal Brexit have signed strict non-disclosure agreements (NDAs) barring them from revealing information on planned border arrangements and supply routes.

The government is being so secretive that information is only being provided to firms orally, or via hard copies of documents that must be returned at the end of meetings, according to a draft NDA document published by Department of Health and Social Care.

Firms consulted on no-deal arrangements are threatened with injunction if they breach the terms of the agreements.

The government has been in close contact with the pharmaceutical industry, which is stockpiling drugs to ensure British citizens still have access to vital medicines if supply routes are disrupted by delays at the border.

The template NDA, published by the department in response to a written parliamentary question from the opposition Labour party, states that the government “will need to share confidential and sensitive information about customs and border arrangements and supply routes.”

Attendees at meetings are required not to divulge what they have heard, “not to take or make a copy of any papers provided for a meeting,” and “to return at the end of each meeting where requested any papers or material provided by the Department.”

Mike Thompson, CEO of industry body the Association of the British Pharmaceutical Industry (ABPI), told POLITICO: “Given the complexity of planning — including commercially sensitive information shared between government and industry — an NDA was agreed to support effective planning for continued medicines supply in a no deal Brexit.

“The ABPI is clear and continues to advise government that no deal is not in the interest of patients in the U.K. or the EU.”

Health and Social Care Secretary Matt Hancock told the House of Commons health committee last week that he was “confident … so long as everybody does what they need to do” that the U.K. would have an “unhindered supply of medicines,” even if there is no deal.

“We are getting on with making sure that we have the plans in place, and we are taking the actions that we need to take now in order to have the mitigations in place,” he said.

The Department of Health and Social Care had not responded to a request for comment at the time of publication.

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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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