Month: July 2021

Categories : Medical IndustryTags :

Over 100 Fast-tracked Drugs Not Confirmed Effective

On By ModernMedia

Of 253 drugs approved via the FDA’s accelerated approval pathway, clinical effectiveness has been confirmed in 112, according to a new investigation by The BMJ.

Clinical reporter Elisabeth Mahase found that, as of the end of last year, 24 of those 112 drugs have been on the market for more than 5 years, and some have been on the market for more than 2 decades — often with a high price tag, according to.

Though the accelerated approval pathway allows drugs onto the market before efficacy has been established, the manufacturer has to perform confirmatory trials or else the approval will be rescinded.

However, Mahase noted that only 16 drugs authorised through the accelerated approval pathway have been withdrawn since its creation in 1992 . Most of those were shown to lack efficacy, but in some cases, confirmatory trials were simply never done. Celecoxib (Celebrex), for example, was given accelerated approval in 1999 for the treatment of familial adenomatous polyposis, a genetic disorder that carries a high risk of bowel cancer if untreated, remained on the market for about 12 years before the FDA asked Pfizer to voluntarily withdraw it for this specific indication because efficacy trials were never completed.

The BMJ asked the manufacturers of 24 drugs that have been on the market for more than 5 years if they had conducted phase IV trials. Six drugs had been withdrawn, approved, or postponed. Of the remaining 18 drugs, relevant trial information was provided for a third. Four manufacturers of those six drugs were recruiting participants, and two reported talking to the FDA about final trial design. Eleven companies representing 12 drugs did not respond.

FDA response

“We are committed to ensuring the integrity of the accelerated approval program, which is designed to bring safe and effective drugs to patients with unmet medical needs as quickly as possible,” an FDA spokesperson said in a statement provided to MedPage Today. “The program allows the FDA to approve a drug or biologic product intended to treat a serious or life-threatening condition based on an outcome that can be measured earlier than survival that demonstrates a meaningful advantage over available therapies.”

The FDA could choose to initiate proceedings to withdraw a drug’s approval should post-marketing trials show no benefit or not be performed in time, added the spokesperson.

“Because the FDA continues to use this pathway to accelerate access to drugs for serious and life-threatening diseases for which there is an unmet medical need, at any point in time there will be drugs that are not converted because the confirmatory trials are ongoing,” the spokesperson said.

“Despite the pathway’s good intentions to accelerate ‘the availability of drugs that treat serious diseases,’ experts are concerned that it is now being exploited, to the detriment of patients — who may be given a drug that offers little benefit and possible harm — and of taxpayers,” she continued.

Fixing the accelerated approval pathway

Concerns about the accelerated approval pathway include a lack of threats from the FDA to withdraw a drug should confirmatory trials not be done, the agency’s use of indirect (or surrogate) measures of clinical benefit in some cases, and the potential for drug manufacturers to take advantage of the pathway when it comes to actual measures of safety and effectiveness, Mahase wrote.

Nevertheless, experts still agree that the accelerated approval pathway is of benefit, she noted. Suggested changes to the pathway include planning or starting confirmatory trials as part of the approval as well as closer examination of surrogate measures.

A recent example is Biogen’s controversial Alzheimer’s disease treatment aducanumab (Aduhelm) received FDA approval via the process last month, which was based on the surrogate endpoint of reduction of amyloid-beta plaque in the brain.

The drug has attracted criticism since its recent fast-track approval, with critics pointing out that the drug has not been proven effective and its $56 000 annual price is unreasonable.

Source: MedPage Today

Journal information: Mahase E “FDA allows drugs without proven clinical benefit to languish for years on accelerated pathway” BMJ 2021; DOI: 10.1136/bmj.n1898.

Categories : Cardiovascular Disease Immune SystemTags :

ACE Inhibitors Reduce Immune Defence against Bacteria

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Neutrophil interacting with two pink-colored, rod shaped, multidrug-resistant (MDR), Klebsiella pneumoniae
Neutrophil interacting with two pink-colored, rod shaped, multidrug-resistant (MDR), Klebsiella pneumoniae. Photo by CDC on Unsplash

Scientists have found evidence suggesting that giving patients ACE inhibitors reduces the ability of their immune system to resist bacterial infections.  the group describes testing of multiple ACE inhibitors in mice and human cells.

ACE inhibitors are typically given to patients with hypertension, and some instances to people with heart failure, kidney disease or diabetes. The drugs relaxes the walls of arteries, veins and capillaries, reducing blood pressure. Some prior studies had shown that the drugs also help the immune system by boosting neutrophils, which are produced to fight bacteria. In this new study, published in the journal Science Translational Medicine, the researchers have found the opposite to be true.

In order to see the effects of ACE inhibitors on the immune system, researchers at Cedars-Sinai Medical Center administered different brands of ACE inhibitor such as Zestril and Altace, to mice and then tested their ability to resist bacterial infections. Compared to untreated mice, those with the ACE inhibitors had greater difficulty in recovering from bacterial infections such as staph.

Seven human patients who were taking an ACE inhibitor volunteered blood samples to measure their immune response. The researchers found that the neutrophils were unable to produce the molecules needed to fight off bacteria. They were also found to be in vitro ineffective against bacteria.

The researchers also tested another drug used to treat hypertension, an angiotensin II receptor drug, Cozaar. These drugs work by preventing arterial walls from constricting, which reduces blood pressure. They found no evidence of a negative impact on immunity. They did not test beta-blockers, which work by preventing adrenergic receptors from being stimulated, reducing cardiac action.

The researchers concluded that administering ACE inhibitors to patients puts them at an increased risk of bacterial infections, noting that doctors may want to try alternative drugs to treat their patients.

Source: MedicalXpress

Journal information: Duo-Yao Cao et al, An ACE inhibitor reduces bactericidal activity of human neutrophils in vitro and impairs mouse neutrophil activity in vivo, Science Translational Medicine (2021). DOI: 10.1126/scitranslmed.abj2138

Categories : COVIDTags :

Lambda Variant Might Be The Most Dangerous Yet

On By ModernMedia
Source: CDC

The evolutionary traits of the Lambda variant, giving it both greater transmissibility and immune escape abilities make it possibly the most dangerous variant so far, according to a new study published on the bioRxiv preprint server.

Mutations present in the Spike (S) protein seen in many variants of concern (VOCs) and variants of interest (VOI) allow them to be resistant to the neutralising antibodies (NAbs) from COVID vaccination or infection.

The Lambda variant is predominantly spreading in South American countries. According to the Global Initiative on Sharing All Influenza Data (GISAID) database, the Lambda variant has been reported in 26 countries worldwide. Chile, despite its vaccination rate of 60% saw a surge in COVID cases due to the Lambda variant, due to its immune escape capability.

Lambda variant’s evolutionary traits

In this study, which is awaiting peer review as a preprint, the researchers reported that insertion of the N246-253RSYLTPGD mutation in the NTD of the Lambda S protein is associated with the increased virulence. This mutation is responsible for the rapid spread of the Lambda variant in the Southern American countries.

The authors of this study have indicated two of the critical virological features of the Lambda variant, namely, a) resistance to viral-induced immune responses due to the RSYLTPGD246- 253N, L452Q, and F490S mutations and b) enhancement in transmissibility due to the T76I and L452Q mutations.

This study found that the Lambda S is more resistant to the vaccine-induced antisera compared to the Lambda+N246-253RSYLTPGD S derivative. Another key finding is that RSYLTPGD246-253N mutation overlaps with a component of the NTD “supersite” indicating that it is the immunodominant site. Mutation of this site has therefore enabled the Lambda variant to escape immunity conferred by COVID vaccination.

The comparative study between the parental D614G S strain and the Lambda variant has shown significantly higher infectivity in the latter viral strain.

This study confirms other studies’ finding of increased infectivity of the Lambda, Delta and Epsilon variants is due to the L452Q/R mutation. However, higher infectivity does not guarantee a rapid spread, as seen with the Epsilon variant which failed to spread in the human population despite high infectivity.

This caused the to WHO drop it from the VOC/VOI classification on July 6, 2021. In order to understand if a variant would infect a large number of people, it is essential to determine if it has increased viral infectivity and evasion from the immune response. This study revealed that the Lambda variant possesses both these virological features.

Source: News-Medical.Net

Journal information: “SARS-CoV-2 Lambda variant exhibits higher infectivity and immune resistance,” Izumi Kimura, et al., bioRxiv, 2021.07.28.454085; doi: https://doi.org/10.1101/2021.07.28.454085

Categories : NeurologyTags :

Foetal Brain Development Mapped in Great Detail

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Image source: Pixabay

Researchers at Karolinska Institute have charted a highly detailed molecular atlas of the foetal development of the brain.

The study, published in Nature, made use of single-cell technology which was performed on mice. In this way, researchers have identified almost 800 different cells that are active during foetal development – far more than previously known.

“Brain development is well described and the main cell types are known. What is new about our atlas is the high resolution and detail,” said Sten Linnarsson, head of research and professor at the Department of Medical Biochemistry and Biophysics, Karolinska Institutet.

In their work, the researchers followed the brain development of the mice from day seven, when the brain is just forming, to the end of pregnancy on day 18.

Using single-cell technology, they were able to identify the detailed composition of the brain during foetal development: what cell types exist, how many cells of each type, and how this changes at the various stages of development.

The researchers also studied gene activity in each individual cell, classifying cells according to these activity patterns.

Creating a molecular atlas

The result is a molecular atlas that accurately illustrates how all cells in the brain develop from the early embryo. The atlas shows, for example, the way early neural stem cells first increase and then decrease in number, being replaced by transitional forms in several waves that eventually mature into ready-made neurons.

The researchers also demonstrated how early stem cell lines branch much like a family tree, giving rise to several different types of mature cells. The next step is mapping out atlases of the human brain, both in adults and during foetal development.

“Atlases like this are of great importance for research into the brain, both to understand brain function and its diseases. Cells are the body’s basic building blocks and the body’s diseases are always expressed in specific cells. Genes that cause serious diseases are found in all of the body’s cells, but they cause disease only in specific cells in the brain,” said Prof Linnarsson.

Source: Karolinska Institute

Journal information: “Molecular Architecture of the Developing Mouse Brain”, Gioele La Manno, et al. Nature, online 28 July 2021, doi:10.1038/s41586-021-03775-x.

Categories : General Interest Medical Research & TechnologyTags :

Boy Walks With Help of A Robotic Exoskeleton his Father Designed

On By ModernMedia
Photo by Rachel Kuo on Unsplash

Though it’s not quite as fantastic as Iron Man’s super-powered exoskeleton, a robotic exoskeleton designed by his father’s company helps 16 year old Oscar Constanza to walk. Oscar has a genetic neurological condition that means his nerves do not send enough signals to his legs.

Fastened to his shoulders, chest, waist, knees and feet, the exoskeleton enables Oscar to walk across the room and turn around. The exoskeleton is a voice-operated robot, responding to the user’s verbal commands, rather than other designs which respond to user movements or nerve signals.

“Before, I needed someone to help me walk … this makes me feel independent,” said Oscar.

His father Jean-Louis Constanza is one of the co-founders of the company that makes the exoskeleton, which is called Atalante.

“One day Oscar said to me: ‘dad, you’re a robotic engineer, why don’t you make a robot that would allow us to walk?’” his father recounted
“Ten years from now, there will be no, or far fewer, wheelchairs,” he said.

Exoskeletons are being produced around the world, with a wide variety of applications including, the military, industrial work and in healthcare to help nurses move and position patients. During the COVID pandemic, they have even been evaluated for use in the physically taxing task of prone positioning of COVID patients in ICU wards. Some, like Wandercraft’s model, are designed to help people with mobility problems to walk.

Since most are still quite heavy, manufacturers are competing to make them as light and usable as possible.

Wandercraft’s Atalante exoskeleton, which is an outer frame that supports but also simulates the movement of the wearer’s body, has been sold to dozens of hospitals in France, Luxembourg and the United States, with a unit price of about $176 000, said Constanza. The Atalante exoskeleton is currently aimed at use in physical rehabilitation in stroke and spinal cord injury patients.

At the moment, it cannot be bought by private individuals for everyday use – but the Wandercraft engineers are working on this as the design would need to be much lighter.

Source: New York Post

Categories : COVIDTags :

A Fourth Wave in the Festive Season?

On By ModernMedia
Image by Quicknews

Health experts are warning that even while the COVID vaccination programme is speeding up, with vaccinations passing the 7 million mark, a fourth wave of infections could still be possible before the Christmas holidays.

The government’s vaccine rollout has been long delayed, including a false start where one million doses of AstraZeneca vaccine were sold on due its inefficacy against the then-dominant Beta variant. Compounded with vaccine hesitancy, it is only now that the vaccination programme is starting to gain ground. Still, many of these in the most vulnerable group are still awaiting their vaccinations.

Back in January, experts were already warning vaccination delays would result in a deadly third wave – a warning that proved all too true.

“It’s a concern to us and we have to get the herd immunity up as fast as possible, and we also have to protect the most vulnerable people in the community. And that’s why we started with the roll out to older people, and not enough have come forward and that’s why we are now messaging the younger population, please bring the elderly amongst your family and your friends, your community, for vaccination,” said Dr Nicholas Crisp of the Department of Health.

Last month, at the Moseneke inquiry into whether elections could be held under lockdown, Wits University vaccinologist Prof Shabir Madhi and the head of the SA National Aids Council, Dr Fareed Abdullah, also expected a fourth wave to arrive later in the year – putting paid to any election plans. The two experts both predicted a fourth wave in later October.

“The peaks are almost six months apart. We don’t know when exactly the third wave will peak, probably over the next few weeks, and we’ll see that six months regularity and if that continues, then we can expect a fourth wave a bit sooner than earlier suggested,” said Prof Madhi.

Professor Francois Venter, director of Ezintsha at Wits health sciences meanwhile, said he expected a fourth outbreak of the coronavirus could hit South Africa around November. Future COVID waves in South Africa hinge on the vaccine rollout – and who is being vaccinated is important, not just how many.

Meanwhile, the Western Cape is experiencing vaccine shortages as cases spike there. The province’s premier David Winde said in a statement: “The fact that there is such enthusiasm to get vaccinated is great news, but we understand it is also very frustrating when it is not possible to be vaccinated as soon as possible.

“The fact that the demand is far outstripping our current supplies means that we are experiencing pressures at some of our sites. We please ask for your patience and understanding.”

Source: Eyewitness News

Categories : Gender GeneticsTags :

Study Finds Testosterone’s Importance for Success Overrated

On By ModernMedia
Ball-and-stick model of the testosterone molecule, C19H28O2, as found in the crystal structure of testosterone monohydrate. Credit: Ben Mills, Wikimedia Commons.

With the Olympics underway, testosterone is again in the spotlight over its role in enhancing physical performance, with rules about its natural level being once again debated. It has also been popularly thought to be involved in success in other endeavours – but its importance in this regard may be overrated.

New research has found little evidence that testosterone exerts a meaningful influence on successes in life for men or women. The study in fact suggests that testosterone’s importance outside of physical endeavours could be even less important than previously believed.

In men, it is known that testosterone is linked to socioeconomic position, such as income or educational qualifications.  Researchers from the University of Bristol’s Population Health Sciences (PHS) and MRC Integrated Epidemiology Unit (IEU) set out to determine whether this is because testosterone has an influence on socioeconomic position, as opposed to socioeconomic circumstances affecting testosterone levels, or if it was a case of health affecting both. The findings are published in Science Advances.

To isolate effects of testosterone itself, the investigators used Mendelian randomisation in a sample of 306,248 UK adults from UK Biobank. They explored testosterone’s influence on socioeconomic position, including income, employment status, neighborhood-level deprivation, and educational qualifications; on health, including self-rated health and BMI, and on risk-taking behaviour.  

Dr Amanda Hughes, Senior Research Associate in Epidemiology in Bristol Medical School: Population Health Sciences (PHS), said: “There’s a widespread belief that a person’s testosterone can affect where they end up in life. Our results suggest that, despite a lot of mythology surrounding testosterone, its social implications may have been over-stated.”

First, the team identified genetic variants linked to higher testosterone levels, and explored their links to outcomes. Since genetic variations are essentially fixed throughout a lifetime, it is highly unlikely that they are affected by socioeconomic circumstances, health, or other environmental factors.

In common with prior studies, multivariate analysis showed men with higher testosterone had higher household income, lived in less deprived areas, and were more likely to have a university degree and a skilled job. Higher testosterone in women was linked to lower socioeconomic position, including lower household income, living in a more deprived area, and lower chance of having a university degree. Consistent with previous evidence, higher testosterone was associated with better health for men and poorer health for women, and greater risk-taking behaviour for men.

In contrast, the Mendelian randomisation method showed there was little evidence that the testosterone-linked genetic variants were associated with any outcome for men or women. The research team concluded that there is little evidence that testosterone meaningfully affected socioeconomic position, health, or risk-taking in men or women. The study suggests that – despite the mythology surrounding testosterone – its importance is much less than previously held.

Since the results for women were less precise than the men’s, the influence of testosterone in women could be further explored with larger sample sizes.  

Dr Hughes added: “Higher testosterone in men has previously been linked to various kinds of social success. A study of male executives found that testosterone was higher for those who had more subordinates. A study of male financial traders found that higher testosterone correlated with greater daily profits. Other studies have reported that testosterone is higher for more highly educated men, and among self-employed men, suggesting a link with entrepreneurship.

“Such research has supported the widespread idea that testosterone can influence success by affecting behaviour. There is evidence from experiments that testosterone can make a person more assertive or more likely to take risks – traits which can be rewarded in the labor market, for instance during wage negotiations. But there are other explanations. For example, a link between higher testosterone and success might simply reflect an influence of good health on both. Alternatively, socioeconomic circumstances could affect testosterone levels. A person’s perception of their own success could influence testosterone: in studies of sports matches, testosterone has been found to rise in the winner compared to the loser.”

Source: University of Bristol

Journal information: Testosterone and socioeconomic position: Mendelian Randomization in 306,248 men and women in UK Biobank’, Science Advances (2021).

Categories : Injury & TraumaTags :

New Insights into First Stages of Wound Healing

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Photo by cottonbro from Pexels
Photo by cottonbro from Pexels

A new study from Vanderbilt University researchers has revealed how cells detect and react to wounds.

The epithelial cells which cover the body and its organs, must be able to heal wounds, as they are constantly exposed to insults and abrasion. “When these cells detect a wound nearby, they change their behaviours,” said study co-leader Professor Andrea Page-McCaw in the Department of Cell and Developmental Biology. “They transition from stationary, nondividing, noninvasive cells to cells that migrate, divide and invade.” This also describes the behaviors of cancer cells, which adopt wound-healing behaviours without any wound.

The researchers began with focusing on epithelial cells’ first known reaction of to a nearby wound: an increase in calcium levels, which typically occurs within a minute of wounding.

“We were able to connect the response of these cells directly to the cellular damage inherent in wounding,” Prof Page-McCaw said. “We found that wounds destroy cells, causing them to leak or even burst, and some of their contents get out. Outside of cells, tissues have a detector molecule ready to sense these cellular contents. When they do, proteases in the cellular contents chop up the detector molecule into smaller pieces, which spread to nearby cells. This activates receptors on the cells’ surfaces, giving them the information that a wound is nearby.”

Successful and efficient wound healing is key for recovery from trauma or surgery, and this study improves the understanding of how wounds are recognised by epithelial cells and how this leads to wound healing. This will help develop therapeutics that can address this health issue.

Slow wound healing time can be caused by a number of factors, such as diabetes, and can lead to infection and declining health. By figuring out how to downregulate these wound-healing behaviours in combination with other cancer interventions, this work offers insights that could help combat cancer’s adoption of this mechanism.

The researchers will next focus on how cells use the information they receive about the presence of a wound, specifically how the information is encoded in the calcium signal dynamics and then converted into migration, proliferation and changes in cell- and tissue-level mechanics. “Now that we have a solid understanding of how the presence of a wound is first signaled to nearby cells, we can ask a lot of interesting follow-up questions,” said study co-leader Shane Hutson, chair of the Department of Physics and Astronomy and professor of physics and biological sciences. “How much information is present in those signals? Can cells interpret the signals to know how large the wound is or how far they are from the wound? Do they use the way the dynamic signals change with time to make that measurement? What are the detailed mechanisms by which the signals then get turned into cellular actions?”

Source: Vanderbilt University

Journal information: James T. O’Connor et al, Proteolytic activation of Growth-blocking peptides triggers calcium responses through the GPCR Mthl10 during epithelial wound detection, Developmental Cell (2021). DOI: 10.1016/j.devcel.2021.06.020

Categories : Hospitals Implants and ProsthesesTags :

Deaths From Medical Devices Are Underreported in the US

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Photo by Vidal Balielo Jr. from Pexels
Photo by Vidal Balielo Jr. from Pexels

Researchers have found that a number of deaths related to medical device adverse events were improperly categorised in the FDA’s Manufacturer and User Facility Device Experience (MAUDE) database, according to a new study.

Flagging terms commonly associated with death, the study investigators used a natural language processing algorithm to identify 290 141 reports where serious injury or death was reported; 52.1% of these events were reported as deaths, and 47.9% were classified as either malfunction, injury, or missing (report was uncategorised), reported Christina Lalani, MD, of the University of California San Francisco, and colleagues, in JAMA Internal Medicine.

Overall, 23% of reports with a death were not placed in the death category, amounting to some 31 552 reports filed from December 31, 1991, to April 30, 2020.

Whether to classify the event as a malfunction, injury, death, or ‘other’ is up to the physician or manufacturer. According to the FDA, the reporter is required to categorise an adverse event as an official death if the cause of death is unknown, or if the device “may have caused or contributed to a death.”

The three most common product codes among the adverse event reports were for ventricular assist bypass devices (38 708 reports), dialysate concentrate for haemodialysis (25 261 reports), and transcervical contraceptive tubal occlusion devices (14 387 reports).

The natural language processing algorithm scanned through reports, identifying terms such as “patient died,” “patient expired,” “could not be resuscitated,” and “time of death.” Of the 70 terms that were associated with a death, 62 (88.6%) were found among miscategorised adverse event reports involving a patient death. And, out of all 62, there were 17 terms that had an estimated percentage of 100%, meaning that “every time that term was used, the patient had died, even though the reporter had not classified the report as death,” the team wrote.

Only 18 terms had sample sizes large enough for researchers to calculate confidence intervals; among them, the words “death” or “deaths” were linked to 12% of adverse event reports in which a patient died, but were classified as malfunction, other, or missing — the highest rate of all the analysed terms.

The researchers acknowledged a major limitation in that only reports with at least one death-associated term were included, in contrast to all the reports from the MAUDE database. Improperly categorised deaths likely contribute to an underestimate.

“The classification chosen by the reporter is vital, as the FDA must review all adverse events reported as deaths, which is not the case for other reporting categories,” the authors wrote. Improving the reports’ accuracy is crucial, since patient death frequency can prompt the FDA to pursue investigations into the device’s safety, they added.

The researchers pointed out an inherent conflict of interest as 95.9% of the reports evaluated in the study were submitted by manufacturers.

“It may not be in their interest to facilitate identification of serious problems with their own devices in a timely manner,” they wrote. “There have been multiple instances of delays by manufacturers in reporting serious malfunctions and deaths that were associated with medical devices, as well as complete failures to report.”

Therefore, it’s likely that a significant number of patients have been unknowingly treated with devices that were later revealed to be dangerous, Dr Lalani and colleagues noted. For example, they referenced the reporting failures that occurred from 2002 to 2013, when 32 000 women reported adverse events associated with the permanent birth control device Essure while the FDA only received 1023 adverse event reports from the manufacturer.

They concluded that patients and care providers should submit reports directly to the FDA as well as or instead of the manufacturer.

Source: MedPage Today

Journal information: Lalani C, et al “Reporting of death in US Food and Drug Administration medical device adverse event reports in categories other than death” JAMA Intern Med 2021; DOI: 10.1001/jamainternmed.2021.3942.

Categories : Hospitals Obstetrics & GynaecologyTags :

Nearly Half of Female Surgeons Experience Pregnancy Complications

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Photo by JESHOOTS.COM on Unsplash
Long hours and delaying pregnancy to after 35 increase complication risk for female surgeons’ pregnancies. Photo by JESHOOTS.COM on Unsplash

A survey of female surgeons found that 48 percent had experienced major pregnancy complications, with even higher risks for those with more operation hours per week in the last trimester of pregnancy.

Women are entering the surgical field in increasing numbers but they continue to face well-known challenges related to childbearing. Surveys have documented pregnancy-related stigma, unmodified work schedules, brief maternity leave options, and little support for childcare and lactation needs after delivery. Due to a lack of childcare options in developed countries, many female trainees delay pregnancy until after 35, already a risk factor for pregnancy complications, researchers from Brigham and Women’s Hospital and elsewhere surveyed 1175 surgeons and surgical trainees from across the US to study their or their partner’s pregnancy experiences. They found that 48 percent of surveyed female surgeons experienced major pregnancy complications, with those who operated 12-or-more hours per week during the last trimester of pregnancy at a higher risk compared to those who did not. Their findings are published in JAMA Surgery.

“The way female surgeons are having children today makes them inherently a high-risk pregnancy group,” said corresponding author Erika Rangel, MD, MS, of the Division of General and Gastrointestinal Surgery. “In addition to long working hours, giving birth after age 35 and multiple gestation which is associated with increased use of assisted reproductive technologies – is a risk factor for having major pregnancy complications, including preterm birth and conditions related to placental dysfunction.”

The researchers found that over half (57 percent) of female surgeons worked more than 60 hours per week during pregnancy. Over a third (37 percent) took more than six overnight calls. Of the 42 percent of women who experienced a miscarriage (a rate twice that of the general population) three-quarters took no leave afterwards.

“As a woman reaches her third trimester, she should not be in the operating room for more than 12 hours a week,” Dr Rangel said. “That workload should be offset by colleagues in a fair way so that it does not add to the already-existing stigma that people face in asking for help, which is unfortunately not a part of our surgical culture.”

Male and female surgeons were asked to respond to the survey, which had been developed with obstetricians and gynaecologists. Nonchildbearing surgeons answered questions regarding their partners’ pregnancies. The investigators found that, compared to female nonsurgeons, female surgeons were 1.7 times more likely to experience major pregnancy complications, along with greater risk of musculoskeletal disorders, non-elective caesarean delivery, and postpartum depression, which was reported by 11 percent of female surgeons.

“The data we have accumulated is useful because it helps institutions understand the need to invest in a top-down campaign to support pregnant surgeons and change the culture surrounding childbearing,” Dr Rangel said. “We need to start with policy changes at the level of residency programs, to make it easier and more acceptable for women to have children when it’s healthier, while also changing policies within surgical departments. It is a brief period of time that a woman is pregnant, but supporting them is an investment in a surgeon who will continue to practice for another 25 or 30 years.”

Source: Brigham and Women’s Hospital

Journal information: Rangel EL et al. “Incidence of Infertility and Pregnancy Complications in US Female Surgeons” JAMA Surgery DOI: 10.1001/jamasurg.2021.3301