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2022 news preview: Expect a row over controversial Alzheimer’s drug

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A participant in a clinical trial for aducanumab

Kayana Szymczak/New York Times/Redux/eyevine

EXPECT to see debate over a new medicine to treat Alzheimer’s disease, called aducanumab, continue into 2022. Approved in the US last June, it is the first drug designed to treat a possible cause of this form of dementia, rather than the symptoms.

Aducanumab targets beta-amyloid, a protein that makes up plaques in the brain often seen in people with Alzheimer’s disease. But the drug has its critics as well as its cheerleaders. It hasn’t so far been proven to reduce memory loss and confusion, the chief symptoms of Alzheimer’s disease. Other commonly used medicines slightly alleviate these symptoms, but they don’t work for everyone and their effects wear off.

The US drug regulatory body, the Food and Drug Administration (FDA), approved aducanumab for use to combat early Alzheimer’s on the basis that it reduces the extent of amyloid plaques. These have long been seen as a “biomarker” of Alzheimer’s – in other words, a biological indicator of disease progression or severity.

Other medicines have been approved on the basis of biomarkers – for instance, levels of “bad cholesterol” are seen as a biomarker for heart disease. But for Alzheimer’s, it is still being debated if plaques are a valid biomarker.

There is growing concern that they may not be a cause but something more like a side effect of the disease process. Targeting the plaques is “reasonably likely to have a clinical effect”, says Susan Kohlhaas at Alzheimer’s Research UK. “But that’s still to be tested.”

When the FDA approved aducanumab, it went against the recommendations of its scientific advisory panel, which it usually follows – none of the 11 members considered it ready for approval and three members resigned in protest. The agency’s acting commissioner has since asked for an investigation to take place into the approval process.

The drug’s maker, Biogen, told New Scientist: “The approval of aducanumab by the FDA came after an extensive development, clinical testing and regulatory review process, supported by data of more than 3000 patients who participated in our trials.”

“We have to leave no stone unturned in our search for treatments”

One clinical trial showed that about 40 per cent of people on the drug experienced brain swelling or bleeding visible on a scan.

The FDA has said aducanumab should now be tested in a larger clinical trial, but in practice these can take many years to produce results. Few people may want to be in a placebo-controlled trial and risk taking dummy pills after the drug has been approved.

On 17 December, the European Medicines Agency decided not to approve aducanumab. It is also under review by the UK’s Medicines and Healthcare products Regulatory Agency.

If the drug is approved in the UK, it would need to be assessed to decide whether it is cost-effective for use by the national health services. In the US, it is priced at $56,000 a year.

“We have to make sure that we leave no stone unturned in our search for life-changing treatments,” says Kohlhaas. “It’s important to respect the regulatory process that happens in the UK and elsewhere. We also need to make sure that our treatments are evaluated for safety and effectiveness.”

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Solar storms may cause up to 5500 heart-related deaths in a given year

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In an approximate 11-year cycle, the sun blasts out charged particles and magnetised plasma that can distort Earth’s magnetic field, which may disrupt our body clock and ultimately affect our heart



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17 June 2022

A solar storm

Jurik Peter/Shutterstock

Solar storms that disrupt Earth’s magnetic field may cause up to 5500 heart-related deaths in the US in a given year.

The sun goes through cycles of high and low activity that repeat approximately every 11 years. During periods of high activity, it blasts out charged particles and magnetised plasma that can distort Earth’s magnetic field.

These so-called solar storms can cause glitches in our power grids and bring down Earth-orbiting satellites. A handful of studies have also hinted that they increase the risk of …

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UK Covid infection rate rising, with more than a million cases in England | Coronavirus

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Coronavirus infections are rising in the UK, figures have revealed, with experts noting the increase is probably down to the more transmissible BA.4 and BA.5 Omicron variants.

The figures from the Office for National Statistics (ONS), based on swabs collected from randomly selected households, reveal that in the week ending 11 June an estimated one in 50 people in the community in England are thought to have had Covid – around 1.13 million people.

The figure is even higher, at one in 45, in both Wales and Northern Ireland, while it was highest in Scotland where, in the week ending 10 June, one in 30 people are thought to have been infected.

While the figures remain below the peak levels of infection seen earlier this year, when around one in 13 people in England had Covid, the findings are a rise on the previous week where one in 70 people in England were thought to be infected. Furthermore, the data reveals increases in all regions of England, except the north-east, and across all age groups.

Experts say that a key factor in the increase is probably the rise of the Covid variants of concern BA.4 and BA.5.

“Infections have increased across all four UK nations, driven by rising numbers of people infected with the BA.4 and BA.5 Omicron variants,” said Kara Steel, senior statistician for the Covid-19 Infection Survey.

While Steel said it remained too early to say if this was the start of another wave, others have warned it may already have begun, with increased mixing and travelling among other factors fuelling a rise in cases.

Among concerns scientists have raised are that BA.4, BA.5 and another variant on the rise, BA.2.12.1, replicate more efficiently in human lung cells than BA.2.

Prof Azra Ghani, an epidemiologist at Imperial College London, said the latest figures were not surprising, and might rise further.

“This increase in infection prevalence is likely due to the growth of the BA.4 and BA.5 Omicron subvariants, which as we have seen elsewhere in Europe, appear to be able to escape immunity generated from previous Omicron subvariants,” she said.

“It is therefore possible that we will continue to see some growth in infection prevalence in the coming weeks and consequently an increase in hospitalisations, although these subvariants do not currently appear to result in any significantly changed severity profile. This does however serve as a reminder that the Covid-19 pandemic is not over.”

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NHS to offer women in England drug that cuts recurrence of breast cancer | Breast cancer

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Thousands of women in England with breast cancer are to benefit from a new pill on the NHS which reduces the risk of the disease coming back.

The National Institute for Health and Care Excellence (Nice) has given the green light to abemaciclib, which cuts the chance of breast cancer returning after a patient has had surgery to remove a tumour.

Trials showed that patients who had the drug with hormone therapy had a more than 30% improved chance of their cancer not coming back after surgery, compared with hormone therapy alone.

“It’s fantastic thousands of women with this type of primary breast cancer will now have an additional treatment option available on the NHS to help further reduce the risk of the disease coming back,” said Delyth Morgan, the chief executive of charity Breast Cancer Now.

“The fear of breast cancer returning or spreading to other parts of their body and becoming incurable can cause considerable anxiety for so many women and their loved ones.

“New effective treatments such as abemaciclib, which can offer more women the chance to further reduce the risk of the disease recurring, are therefore extremely welcome and this is an important step change in the drug options available for this group of patients.”

The twice-a-day pill is suitable for women with hormone receptor-positive, HER2-negative, node-positive early breast cancer at high risk of recurrence who have had surgery. About 4,000 women will benefit initially, Nice said.

Helen Knight, the interim director of medicines evaluation at Nice, said the draft recommendation came less than a month after abemaciclib received its licence.

“The fact that we have been able to produce draft recommendations so quickly is testament to the success of our ambition to support patient access to clinically and cost effective treatments as early as possible,” said Knight. “Until now there have been no targeted treatments for people with this type of breast cancer.

“Abemaciclib with hormone therapy represents a significant improvement in how it is treated because being able to have a targeted treatment earlier after surgery will increase the chance of curing the disease and reduce the likelihood of developing incurable advanced disease.”

Abemaciclib works by targeting and inhibiting proteins in cancer cells which allow the cancer to divide and grow. It normally costs £2,950 for a packet of 56 150mg-tablets, but the manufacturer, Eli Lilly, has agreed an undisclosed discounted price for NHS England.

“Thanks in part to this latest deal struck by NHS England, NHS patients will be able to access another new targeted drug for a common and aggressive form of breast cancer,” said Prof Peter Johnson, the cancer director of NHS England.

“Abemaciclib, when used alongside a hormone therapy, offers a new, doubly targeted, treatment option, helping to increase the chances of beating the cancer for good, as well as meeting the NHS’s commitment to delivering improved cancer care under our long-term plan.”

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