Major HRT supplier sanctioned after whistleblowers raise concerns over patient safety
A group of employees from Theramex, which supplies HRT treatments to millions of patients in the UK, wrote a letter to the pharmaceutical regulator Association of the British Pharmaceutical Industry over allegations the company was not following regulatory standards and may 'jeopardise' patient safety.
The whistleblowers claimed some products featured inaccurate prescribing information and failed to highlight common side effects. They claimed they had been forced to contact the regulator after their attempts to raise issues internally were brushed off.
The company has now admitted it breached regulatory codes, amounting to 'bringing discredit upon, and reducing confidence in the pharmaceutical industry', according to an interim case report from the ABPI. It also failed to maintain high standards and provide accurate and up-to-date prescribing information, the report said.
Theramex is a global pharmaceutical company specialising in women's health products, such as hormone replacement therapy (HRT) and fertility treatments. Theramex UK is its London-based arm.
It supplies common HRT therapies including Evorel, Bijuve and Intrarosa. From April to June 2025, there were 760,000 prescriptions of Evorel and 2,748 prescriptions of Bijuve, according to data from the NHS Business Services Authority. In 2023-24, there were 2.8 million prescriptions of Evorel.
One employee wrote the complaint on behalf of a group, according to the complaint published by the Prescription Medicines Code of Practice Authority, which is part of the ABPI.
The complaint, filed in October 2024, said: 'We are a group of employees from various cross-functional teams at Theramex, and we are writing to express our growing concerns regarding the company's adherence to regulatory standards and the accountability of its leadership.
'While we have attempted to escalate these issues internally on numerous occasions, there has been a consistent lack of action or meaningful response, which leaves us with no choice but to seek external guidance and support.'
The complaint alleged that some of Theramex's products, such as Intrarosa and Evorel, had not had their prescribing information updated. In the case of Evorel, information for health professionals was 'incomplete' and did not include information on common side effects such as uterine spasms and vaginal infection, the letter claimed.
For another drug, the letter alleged that prescribing information had not been updated for five years.
The complaint warned: 'This oversight can lead to healthcare professionals (HCPs) not being fully informed of potential risks, which could jeopardise patient safety.'
The PMCPA panel found Theramix's 'failure to provide accurate and complete prescribing information was unacceptable'.
The employees also alleged the company failed to comply with regulators for clinical trial compliance warning. 'The lack of resources within Theramex's global headquarters to ensure compliance with these standards is alarming,' it said.
Finally, the letter alleged the company has a 'blame culture' that was 'deeply concerning.'
In response to the complaint, Theramex UK said it took its obligations under the ABPI code of practice 'very seriously' and launched an internal investigation.
It said that, although it had a process to update prescribing information, this was not sufficiently robust to ensure prescribing information was immediately updated.
The pharma company acknowledged it did not meet standards concerning this allegation and admitted that, at the time of the complaint, it did not have a process in place for clinical studies.
The employees' letter claimed it had tried to escalate matters to senior leaders within Theramex. The company claimed it was not aware of any of the matters having been escalated internally prior to them being reported to the regulator.
As part of the sanction, Theramex must provide written confirmation that it will cease practices that breach codes, pay a charge and advertise details of the case.
Theramex UK said it 'absolutely acknowledges' the recent ruling and 'respects the [regulator's] decision'. 'Of course, we remain fully committed to ensuring our practices align with the highest ethical standards and necessary steps and corrective measures have been taken,' it said.
Try Our AI Features
Explore what Daily8 AI can do for you:
Comments
No comments yet...
Related Articles
Yahoo
42 minutes ago
- Yahoo
Menopause increases your risk of STIs due to how aging changes your body
Diagnoses for sexually transmitted infections, or STIs, are increasing in older adults. The Centers for Disease Control and Prevention reports the number of people older than 65 diagnosed with chlamydia, gonorrhea or syphilis in the U.S. increased about three-, five- and sevenfold, respectively, from 2010 to 2023. Data also suggests that women older than 50 are at greater risk for HIV than younger women. Explanations for why these infections are so common in older adults include limited understanding of STIs in this age group, infrequent condom use and increased availability of medications for conditions that typically limit sexual activity in older adults, such as like Viagra and Cialis for erectile dysfunction and estrogen creams and tablets for vaginal dryness. Many older adults are reluctant to discuss their sexual history with their partners and health care providers, which contributes to misconceptions that they are monogamous or sexually inactive. In my work as an infectious disease scientist, I examine the largely unexplored biological reasons for why postmenopausal women have increased susceptibility to STIs. My recently published research shows that menopause is associated with loss of the genital tract's protective barrier, an essential defense against the microbial pathogens that cause STIs. Menopause: A natural part of aging Menopause is the stage in a woman's life marked by no menstrual periods for 12 consecutive months. In the U.S., menopause begins on average between ages 45 and 55. It is estimated that by the year 2030, 1.2 billion women worldwide will be menopausal or postmenopausal. Menopause results from a loss of estrogen production from the ovaries, which can diminish vaginal lubrication and vaginal tissue elasticity. This can cause a condition called genitourinary syndrome of menopause, or GSM, which involves symptoms such as vaginal dryness and irritation, painful sex and frequent urinary tract infections. Roughly half of postmenopausal women experience GSM. In addition to these negative effects on vaginal health, research from my lab has found that menopause also compromises the structural integrity of the tissue lining the vagina. The surface of the vagina is composed of multiple layers of epithelial cells that are held together by numerous adhesion molecules, including the proteins desmoglein-1, or DSG1, and desmocollin-1, or DSC1. These proteins strengthen the vaginal lining and restrict pathogen access to deeper tissue, reducing the risk of infection. To explore how menopause affects the vaginal lining, we compared the DSG1 and DSC1 levels in vaginal tissue from postmenopausal and premenopausal women. We found significantly lower DSG1 and DSC1 levels in postmenopausal women. We then surgically removed the ovaries of mice to model the loss of ovarian estrogen production in postmenopausal women. We also detected significantly less DSG1 and DSC1 proteins in vaginal tissue from mice without ovaries compared with mice with intact ovaries. Mice without ovaries also had greater susceptibility to infection with herpes simplex virus type 2, or HSV-2, and were less able to clear chlamydia infection from their lower genital tract. On the other hand, applying estrogen cream to mice without ovaries restored the integrity of their vaginal lining and fully protected these mice from HSV-2 infection. Too important to ignore Fully understanding the behavioral and biological risk factors that contribute to STI susceptibility can help clinicians and public health officials tackle the startling increases in STIs among older adults. Together, our studies show there is a loss of integrity in the vaginal lining after menopause. While additional research is needed, findings from our lab suggest that estrogen-containing compounds used to relieve vaginal irritation and other symptoms of genitourinary syndrome of menopause can also reduce susceptibility to STIs among older adults. In the meantime, health care providers can help reduce the risk of STIs among older adults by consistently counseling them about safe sex practices and offering routine STI screening. This article is republished from The Conversation, a nonprofit, independent news organization bringing you facts and trustworthy analysis to help you make sense of our complex world. It was written by: Thomas L. Cherpes, The Ohio State University Read more: Millions of women are working during menopause, but US law isn't clear on employees' rights or employers' obligations Iceland's recent volcanic eruptions driven by pooling magma are set to last centuries into the future The sex of your cells matters when it comes to heart disease Thomas L Cherpes receives funding from the National Institute on Aging and the National Institute of Child Health and Human Development
Yahoo
2 hours ago
- Yahoo
Why does your mind goes 'blank'? New brain scans reveal the surprising answer
When you buy through links on our articles, Future and its syndication partners may earn a commission. You look up from your phone screen and suddenly realize you weren't thinking about anything. It's not a lapse in memory or a daydream; it's literally a moment when you're not thinking of anything at all. Neuroscientists have a term for it — mind blanking — which they define as a brief, waking state when conscious thought simply stops. Scientists used to think our waking minds were always generating thoughts, but recent research shows that's not the case. Mind blanking is now recognized as a distinct conscious state associated with changes in arousal, which in neuroscience refers to alertness and responsiveness to stimuli. Studying this curious state could shed light on how consciousness works, some researchers think. "For some, it's kind of a blip in the mind, and suddenly there's nothing," Thomas Andrillon, a neuroscience researcher at the French National Institute of Health and Medical Research and the Paris Brain Institute, told Live Science. "But not with that feeling, 'There was something that I forgot.'" Often, people are unaware of the lapse until they are prompted to answer "What were you just thinking about?" "When we interrupt them randomly," Andrillon continued, "it's clear it's more frequent than what people realize." Although the frequency of this phenomenon varies among individuals, various studies suggest about 5% to 20% of a person's waking hours may be spent in this state. Related: Super-detailed map of brain cells that keep us awake could improve our understanding of consciousness An investigation of 'mind blanking' In a study published in the July issue of the journal Trends in Cognitive Sciences, Andrillon and his team used electroencephalography (EEG) — which involves placing electrodes on participants' heads — to measure brain activity while people experienced lapses in attention, such as mind wandering or mind blanking. Mind wandering occurs when people's thoughts drift to tasks or ideas unrelated to the one at hand, while mind blanking involves the absence of all thought. While wearing EEG caps, participants watched numbers flash rapidly on a display screen. They were instructed to press a button every time a number appeared except for 3, which they were told to skip. This task tests how quickly people react when a response is required and how well they can inhibit that response, when necessary. Because most of the presented numbers required a response, people often pressed the button by mistake when they saw a 3 onscreen. The researchers paused the task once a minute to ask what the participants were thinking, finding that they were either focused on the task, their mind was wandering, or they were experiencing a "mind blank." Participants pressed the button more quickly when their minds were wandering, whereas their responses slowed noticeably during mind blanking, suggesting these two mental states are distinct. Brain activity told a similar story. The EEG data showed that the participants' brain activity tended to slow down slightly more when their minds were blank than when they were wandering, compared to the baseline of their paying attention. 'The connectivity changes as if the inner workings of the brain were specific, in a way, to that state," Andrillion said. EEG data is great for tracking rapid changes in brain activity, but it can't pinpoint exactly which brain regions are involved. That's in part because it records brain waves through the skull, and the signals blur as they make their way through the brain tissue, fluid and bone. Andrillon explained it's like listening through a wall. You can tell if a group inside is noisy or quiet, but you can't tell who is talking. The EEG results from the study suggest that during mind blanking, the brain's activity slows down globally, but the technique couldn't identify specific areas. That's where functional MRI (fMRI) came in. Related: 'Hyper-synchronized' brain waves may explain why different psychedelics have similar effects, rat study reveals Hypersynchronization fMRI provides a clearer view of which regions are active and how they interact, but its tracking speed is slower because the technique tracks bloodflow, rather than directly following brain signals. fMRI is more like peeking into the room and seeing who's talking to whom, but not knowing precisely when, Andrillion said. Study co-author Athena Demertzi, a neuroscience researcher at the GIGA Institute-CRC Human Imaging Center at the University of Liège in Belgium, led the fMRI portion of the study. As people rested in an fMRI scanner with no particular task at hand, Demertzi and her team periodically asked what they were thinking. The results were surprising: when people reported mind blanking, their brains showed hyperconnectivity — a global, synchronized activity pattern similar to that seen in deep sleep. Typically, when we are awake and conscious, our brain regions are connected and communicating but not synchronized, as they appear to be during mind blanks. "What we think happens in the case of mind blanking is that the brain is pushed a little bit toward the side of synchronization," Andrillon said. "That might be enough to disrupt these sweet spots of consciousness, sending our mind to blank." Research into mind blanking is still in its early stages, but Andrillon and Demertzi noted that its similarity to brain patterns seen during deep sleep may offer an important clue as to its function. Deep sleep, also known as slow-wave sleep, coincides with important cleanup work for the brain. It clears away accumulated waste, cools the brain, conserves energy and helps reset the system after a full day of mental activity. RELATED STORIES —Why do we forget things we were just thinking about? —Electronic' scalp tattoos could be next big thing in brain monitoring —'Hyper-synchronized' brain waves may explain why different psychedelics have similar effects, rat study reveals Andrillon and Demertzi suggested mind blanking may act as a mini-reset while we're awake. Demertzi said it's like "taking five to steam off" or "to cool your head." Early studies in Demertzi's lab suggest sleep-deprived people report more mind blanks, adding support to this idea. Both researchers stressed that this state is likely a way for the brain to maintain itself, though "it's not ideal for performance," Andrillon said. Andrillon believes it's possible but unlikely that there are people who have never experienced mind blanking. Detecting a mind blank can be a challenge. "It can require being interrupted," Andrillon said, "to realize, 'OK, actually, there was no content.'"
Yahoo
3 hours ago
- Yahoo
🚨Forza, captain: Franco Baresi undergoes surgery for lung nodule
AC Milan has issued an official statement informing that Franco Baresi, a club legend and current honorary vice-president, was successfully operated on to remove a lung nodule. After surgery, the 65-year-old Italian football legend will undergo oncological recovery therapy with immunotherapy. The club dedicated a message of encouragement through its official channels. "Come on Captain, we're all with you!", reflecting the affection and support of all Milan fans and the football world. This article was translated into English by Artificial Intelligence. You can read the original version in 🇪🇸 here. 📸 Marco Luzzani - 2024 Getty Images
