Day: September 17, 2026

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Personalised Testing in Diabetes Shows Benefits in Protecting Kidney Function

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Chronic kidney disease (CKD). Credit: Scientific Animations CC4.0

Type 2 diabetes increases the risk of chronic kidney disease, making prevention of kidney failure a key part of treatment. Newer diabetes medications, including GLP-1s and SGLT2 inhibitors, can reduce the risk of kidney disease, but previous studies have included large proportions of patients who already had signs of kidney damage, making it unclear whether the findings applied to patients without kidney damage.

A new study led by Mass General Brigham researchers found that GLP-1 agonists and SGLT2 inhibitors reduced the risk of kidney deterioration in patients with diabetes who had protein in their urine, a sign of kidney damage, before treatment. However, the researchers found little evidence of kidney benefit among patients without protein in their urine. They also showed that sulfonylureas, an older class of diabetes medication, led to faster declines in kidney function in patients with diabetes who didn’t have protein in their urine. Results are published in the BMJ.

“Our study shows that we need to tailor diabetes treatment to the individual patient instead of using a one-size-fits-all approach,” said corresponding author Alexander Turchin, MD, MS, of the Division of Endocrinology in the Mass General Brigham Department of Medicine. “A simple urine test could help doctors assess whether a patient may receive kidney protection from GLP-1 receptor agonists or SGLT2 inhibitors and whether sulfonylureas could pose additional risk.”

Tracking kidney outcomes

The researchers analysed medical record data from 75 455 patients with type 2 diabetes across the U.S., including 13,872 who presented with protein in their urine. They followed the patients for up to five years and compared the risk of developing chronic kidney disease among patients prescribed GLP-1s and SGLT2 inhibitors with those prescribed sulfonylureas or DPP4i. All patients had moderate cardiovascular risk and were receiving metformin as their primary diabetes medication.

Among patients with protein in their urine, GLP-1s and SGLT2 inhibitors were associated with substantially better kidney outcomes than DPP4i. However, GLP-1s and SGLT2 inhibitors did not appear to provide a significant kidney benefit in patients without protein in their urine. Among patients without protein in their urine at baseline, treatment with sulfonylureas was associated with an increased risk of kidney deterioration compared with DPP4i.

Gap for lower-risk patients

Further research is needed to identify therapies to prevent kidney disease in the large population of patients with type 2 diabetes who don’t present with protein in their urine, the researchers say.

“These findings will allow us to individualise medication choices that maximally benefit the patient in front of us rather than for the hypothetical ‘average person,'” said Turchin. “Patients and their doctors should discuss how to balance these different risks and benefits in their individual circumstances when choosing their type 2 diabetes medications.”

Source: Mass General Brigham

Categories : Ethics and Law Obstetrics & GynaecologyTags : Leave a comment

Women Less Likely than Men to be Offered Active Medical Treatment for the Same Conditions

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Photo by Kindel Media

New research from the University of St Andrews has found that women are less like than men with the same medical condition to be offered active management such as surgery, a stent or a strong painkiller. 

The findings, published in PLOS One, come from a review that sifted 1112 published studies down to those that directly compared the care given to male and female patients. Of the 38 that analysed patient records, 33 reported a significant difference in the treatment men and women received. 

Researchers from the University of St Andrews School of Medicine found that almost none of those studies pointed to any guideline recommending different treatment by sex, leaving open whether this reflects sound clinical judgement or unequal care. 

Dr Andrew O’Malley, who co-led the study, said: “For clinicians, the findings are a prompt to check whether treatment is being offered on clinical grounds rather than assumption. For example, one study found that when the teams deciding who receives advanced heart failure therapy functioned poorly, women were less likely to be selected. Other work shows doctors more often attribute women’s symptoms to anxiety and make more diagnostic errors with female patients, even when test results are positive. 

Dr Miriam Veenhuizen, Honorary Lecturer in the School of Medicine, said: “While the direction of the findings was not a surprise the consistency was. The same pattern appeared in cardiology, surgery, transplant medicine and emergency care, and it survived statistical adjustment in most studies. It’s not entirely clear why this is happening, but it is likely because women were under-represented in clinical trials until recent decades, so many guidelines rest on data from men.” 

Dr Veenhuizen added: “What struck us most was the imbalance in attention. Over the same period, 551 studies examined sex inequality affecting doctors and other health professionals. Only 41 examined what happens to patients.” 

The researchers now intend to test whether the same patterns appear in the outputs of generative AI systems, which are trained on this literature and on clinical records, and which could entrench these differences at scale if left unchecked. 

Source: University of St Andrews

Categories : Neurology Obstetrics & GynaecologyTags : Leave a comment

‘Momnesia’ is Real – A Biological Explanation for Temporary Forgetfulness During Pregnancy

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Photo by SHVETS production

Many women usually say the same thing during pregnancy: they walk into a room and forget why, misplace their keys or struggle to follow a conversation. This phenomenon, often called ‘pregnancy brain’ or ‘momnesia,’ has long lacked a clear biological explanation.

Now, a new study by researchers at Baylor College of Medicine and collaborating institutions and published in Science Bulletin, identifies a specific brain circuit in an animal model that becomes disrupted under the sustained high oestrogen levels present during pregnancy. The findings offer the first biological explanation of how exposure to high-level circulating oestrogen can temporarily impair memory.

A novel brain circuit links high oestrogen levels with memory problems

“We worked with mouse models designed to mimic the sustained, high blood-oestrogen levels of pregnancy. These models showed that elevated oestrogen caused reversible memory impairment without affecting mood or motivation, suggesting a specific cognitive effect rather than a general change in well-being,” said senior author Dr Zheng Sun, associate professor of medicine – endocrinology, diabetes and metabolism and of molecular and cellular biology at Baylor.

Digging into the underlying biology, the team found that oestrogen receptor alpha, the protein that transmits oestrogen’s signals into cells, is the dominant oestrogen receptor in the brain region called the lateral hypothalamus. Furthermore, this region has abundant GABAergic neurons – brain cells that normally send calming, inhibitory signals to other parts of the brain. Using single-nucleus RNA sequencing, the researchers discovered that high oestrogen levels suppress signaling in these neurons, leading them to fire more frequently. “When we genetically removed oestrogen receptors from these hypothalamic neurons, both oestrogen-induced and pregnancy-induced memory problems in mice were reversed,” said Sun, a member of Baylor’s Dan L Duncan Comprehensive Cancer Center.

The team also found that these overactive hypothalamic neurons project directly into a region of the hippocampus that is a hub for memory formation. Using chemogenetics, a technique that allows researchers to turn specific neurons on or off, the team showed that silencing this hypothalamus-to-hippocampus pathway protected mice from estrogen-induced memory problems, whereas artificially activating the same pathway was sufficient to impair memory on its own, even without elevated estrogen.

Reconciling mixed evidence

Oestrogen’s relationship with memory has puzzled researchers for decades. For instance, hormone replacement therapy after menopause has been linked to cognitive benefits in some studies, while high oestrogen during pregnancy or with oral contraceptive use has been linked to memory complaints in others. The new findings suggest a possible explanation – it may not simply be a matter of ‘more oestrogen is better’ or ‘worse,’ but rather where in the brain that oestrogen acts, and at what levels.

“Low-level, cyclical oestrogen exposure appears to support cognitive function, which is part of why hormone therapy can help postmenopausal women,” said senior author Dr Yanlin He, associate professor at Pennington Biomedical Research Center. “But sustained, high-level oestrogen exposure seems to engage a different pathway altogether, one centred in the hypothalamus rather than the hippocampus itself. That distinction may help reconcile a lot of conflicting data in the field.”

Confirming the link in pregnant women

To determine whether these findings translate to humans, the researchers assessed memory performance in women across different stages of pregnancy. They found task-specific memory impairments that emerged during late pregnancy, and that correlated with circulating oestrogen levels, even after accounting for other factors that might influence cognition. This human data supports the idea that the hormone-driven circuit identified in mice may underlie the memory changes many pregnant women experience.

“Momnesia is real, it has a defined biological basis and is temporary,” said senior author Dr Xianghua Zhuang, professor at the Second Qilu Hospital of Shandong University. “We hope this work helps validate what many women have described anecdotally for years, and gives researchers a concrete target for future study.”

“The memory changes observed in both mice and women were temporary and task-specific, not a sign of broader cognitive decline,” said senior author Dr Xinguo Hou, professor at the Qilu Hospital of Shandong University. “Nonetheless, understanding the underlying circuit could eventually inform how clinicians counsel patients about the cognitive side effects of pregnancy or hormonal contraceptives, and could open avenues for therapies targeting this specific pathway without disrupting oestrogen’s broader, beneficial roles in the body.”

Source: Baylor College of Medicine, EurekAlert!

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US Officials Suppressed Warnings over Flawed COVID Vaccine Safety Algorithm

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Investigation reignites questions about what steps were taken to safeguard public health from any unintended consequences of the vaccination rollout

Photo by Mufid Majnun on Unsplash

US health officials knowingly relied on a compromised algorithm to detect signals of harm from mRNA covid-19 vaccines and silenced efforts to fix it, finds an investigation published by The BMJ.

The findings are based on government emails released under the Freedom of Information Act and in response to US Senate investigators, as well as exclusive interviews with public health officials and other scientists by investigative journalist David Willman.

Before rolling out covid-19 vaccines in December 2020, the US Centers for Disease Control and Prevention (CDC) assured healthcare professionals and the public that its Vaccine Adverse Event Reporting System (VAERS) could quickly spot any potentially harmful reactions following vaccination.

The CDC planned to use two “data mining” techniques: “proportional reporting ratios” (PRRs) and an “empirical bayesian” method provided by the Food and Drug Administration (FDA), which operated VAERS jointly with the CDC. The two agencies planned to share and discuss results.

But according to a letter by CDC Director Rochelle Walensky, the agency did not perform PRR analyses until 2022, and both CDC and FDA “chose to rely” entirely on FDA’s bayesian method.

The BMJ can reveal that the FDA’s algorithm failed to signal a potential relationship between mRNA covid vaccination and myocarditis (inflammation of the heart muscle), pericarditis (inflammation of the fluid-filled sac around the heart), Bell’s palsy, tinnitus, and other reported disorders owing to a flaw in the detection methodology.

The problem arose because over 90% of initial VAERS reports were for the new mRNA covid vaccines made by Pfizer and Moderna. If both vaccines elevated the risk of an adverse event like myocarditis in roughly equal amounts, however, the “observed” frequency and “expected” frequency would be similar, resulting in no automated alert.

Internal records show that FDA officials were aware of this limitation before and during the pandemic. Government documents also show that CDC officials were informed during rollout of the vaccines.

In early 2021, FDA medical officer Dr Ana Szarfman, working with statistician William DuMouchel, who had developed the bayesian algorithm, warned top officials about the flaw and proposed an updated algorithm that flagged signals. But Szarfman was asked to “cease and desist.”  Meanwhile, officials continued to cite the lack of system alerts while reassuring clinicians and the public of the vaccines’ safety.

When the CDC finally ran PRR analyses in 2022, CDC director Walensky said results revealed “no additional unexpected safety signals.” Yet the analyses – examined by The BMJ – show hundreds of adverse events that met the agency’s alert criteria, including myocarditis, pericarditis, Bell’s palsy, and tinnitus, which the FDA’s bayesian method had not triggered.

In October 2023, the FDA’s pharmacovigilance chief acknowledged in an email to colleagues that the agency knew – as the vaccines had rolled out more than two years earlier – of the detection deficiency, but did not respond to requests for comment.

Approached by The BMJ, Szarfman insisted that she had not sought to undermine public support for the covid vaccines. Expressing frustration, she noted, “Very few people understand the statistics. That’s the problem.”

DuMouchel said he could not explain officials’ resistance to switch to the updated method, stating, “I think that they were wrong.” He also regretted that FDA officials rejected Szarfman’s proposed fixes for VAERS, adding, “If they had paid attention to Ana, they would have done better.”

Source: The BMJ Group

Categories : Cardiovascular Disease Ethics and LawTags : Leave a comment

Eminent Cardiologist Involved in Treatment Guidelines Received £50m from Drug Research Contracts

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Eminent cardiologist involved in treatment guidelines received £50m from drug research contracts
Case shows what’s at stake in the debate around transparency of doctor-industry relations

Source: CC0

A British cardiologist and former president of the European Society of Cardiology (ESC) has been judged by the ESC to have committed severe misconduct after a Danish TV documentary reported that he had been involved in drawing up guidelines for the use of the heart drug ivabradine (Corlanor, Procoralan) while profiting from lucrative contracts with the drug’s maker.

An investigation published by The BMJ describes how between 2006 and 2015, Kim Fox, emeritus professor of clinical cardiology at the National Heart and Lung Institute, Imperial College London, who reportedly served as cardiologist to the late Queen Elizabeth II, and his wife Karen Summers, a former drug industry executive, received more than £50m as co-directors of the UK based contract research organisation Heart Research.

This company was involved in running at least three clinical trials of ivabradine, made by French drug company Servier, that were published in the same period, reports freelance journalist, Laura Spinney.

In 2006, when Fox became president of the ESC, he chaired an ESC taskforce that published a guideline recommending ivabradine as an alternative treatment for angina in patients who couldn’t tolerate beta blockers. Authors were asked to disclose conflicts of interests, but the guideline did not publicly identify what Fox had disclosed.

As outgoing ESC president in 2008, Fox championed the drug publicly though it had failed to meet the primary endpoint in the first of the three trials Heart Research was involved in.

Ivabradine remains approved for angina and heart failure in Europe, and for heart failure in the US, but persistent doubts have been expressed over its efficacy.

It’s rare for alleged conflicts of interest to involve such large sums of money. The case remains unreported in most of Europe and beyond, even though the ESC’s guidelines are influential worldwide.

The Danish documentary, which aired in September 2024, triggered an internal review by the ESC which found that the 2006 guideline recommendations were “appropriate” and reported “no evidence to suggest a bias towards ivabradine.”

But in March 2025, the ESC ethics committee found that Fox “had failed to meet his ethical obligations and considered his behaviour as a severe misconduct.”

Pulmonologist Irène Frachon, described the sums involved in the case as “monstrous” while Rita Redberg, a cardiologist and former editor in chief of JAMA Internal Medicine, said: “It totally goes against the grain of the profession.”

Fox rejected the ethics committee’s findings and resigned his ESC membership, claiming that he had always declared any conflicts of interest and that “he was not prepared to be judged on the basis of rules and regulations described in 2024 retrospectively for activities in 2006 to 2008.”

The ESC admitted to The BMJ that its declarations process was relatively lax in the early 2000s and said that it had been substantially strengthened since. Meanwhile, Servier said that it “strictly complies” with transparency guidelines established by the European Federation of Pharmaceutical Industries and Associations, a trade body.

The Fox story has emerged at a time when some in Europe are pushing for reforms that would end voluntary declaration of conflicts of interest and enshrine greater transparency in law.

For former ESC vice president John Martin, the ESC has not done enough to restore public trust, and the recent revelations risk damaging the doctor-patient relationship while also leaving the volunteers who run the society feeling betrayed. He urged further action. “The ESC board might be seen as tacitly complicit unless there is a thorough public investigation,” he said. “Many questions remain.”

Source: The BMJ Group