UK Junior Doctors on 3-day strike over pay dispute

London: Junior doctors in Britain started a three-day strike in their long-standing dispute with the government over pay and conditions. 

Junior doctors — around half of all doctors in the National Health Service (NHS) — took strike action from 7 a.m. local time on Wednesday until Saturday morning. Further strikes, starting from January 3 next year and lasting six days, have also been announced and would be the longest in the history of the NHS.

The NHS warned on its website that, although other doctors will still be working, “the disruption to staffing will cause a significant reduction in elective activity,” leading to the rescheduling of some appointments and procedures.

Also Read:UK Junior and Senior doctors to go on 4-day joint strike over pay dispute

“On strike days, accident and emergency departments and NHS 111 (digital triage service) are likely to be extremely busy, with longer waiting times than normal,” the NHS added.

Junior doctors’ pay has been cut by more than a quarter since 2008, according to the British Medical Association (BMA). They have been calling for a 35 per cent pay increase amid Britain’s ongoing cost-of-living crisis, Xinhua news agency reported.

In recent talks, doctors were offered an additional three per cent raise on top of the 8.8 per cent pay increase recommended, but the BMA said it would be unevenly spread across doctors’ grades so it would still amount to pay cuts for many doctors this year.

Chancellor of the Exchequer Jeremy Hunt called the strikes “incredibly disappointing” in an interview, adding that Health and Social Care Secretary Victoria Atkins “has said her door is open for constructive discussions”.

Five organisations, including the NHS Confederation and the Patients Association, wrote an open letter, calling on both the government and the BMA to “get back to the negotiating table,” and “find a resolution and bring an end to their dispute”.

Caroline Abrahams from a charity in the UK called Age UK said that the ongoing and upcoming strikes, occurring during “the busiest time of the year in the NHS,” may pose “a much greater potential threat to older people’s health and well-being”.

According to Age UK, more than 1.2 million operations and appointments were cancelled throughout 2023, and waiting lists increased by 510,000 from January to 7.71 million in October.

Widespread strikes in Britain started in the summer of 2022 amid disputes over pay and working conditions. The majority of the strikes were in the health, social work and education sectors.

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USFDA declines to approve Merck chronic cough drug Gefapixant

New Jersey: The U.S. Food and Drug Administration (FDA) declined to approve Merck’s drug for chronic cough, the company said on Wednesday, marking the second rejection in less than two years.

The health regulator concluded the company’s application for the drug, gefapixant, did not meet substantial evidence of effectiveness for treating refractory chronic cough and unexplained chronic cough.

Currently, there are no approved treatments in the United States for coughing bouts that don’t go away despite treatment of underlying conditions or have no identifiable cause.

The condition is estimated to affect up to 13% of the global adult population.

In November, the agency’s advisory committee panel voted 12 to 1 against the late-stage data submitted for gefapixant, on concerns over how well it works.

The FDA’s decision was not related to the drug’s safety, Merck said, adding that it is reviewing the agency’s feedback to determine next steps.

Failing to secure marketing approval the first time, Merck carried out additional efficacy analyses of the drug to address questions raised by the health regulator. The results from the additional analyses were generally consistent with those from the late-stage trial, Merck said.

The FDA’s decision gives some breathing room to rival GSK’s chronic cough treatment camlipixant, which is in late-stage development with anticipated regulatory approval and launch in 2026.

Merck’s gefapixant works by blocking receptors that stimulate the nerves and trigger the urge to cough.

The drug, which was given twice a day, was evaluated across two late-stage trials where a higher dose showed statistically significant reduction in the average number of coughs per hour over a 24-hour period compared to a placebo, according to Merck.

The European Union and Japan have approved Merck’s drug for the condition and it is sold under the brand name Lyfnua.

Read also: Merck bags USFDA nod for Keytruda, Padcev combo for urothelial cancer

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Evergreen Talk Series: Linagliptin and Dapagliflozin combination for T2DM with Cardiovascular risk or established ASCVD

Presenting the Evergreen Talk Series featuring Dr. Brij Mohan
Makkar, a Senior Diabetologist and Obesity Specialist from Delhi, Dr. Sameer I.
Dani, an Interventional Cardiologist from Ahmedabad, and Dr. Tukaram Jamale, a
Nephrologist and Kidney Transplant Physician who serves as the Head of the
Department at KEM Hospital Mumbai. They provide their insights on the use of
Linagliptin, Dapagliflozin, and Metformin for diabetic patients.

Bringing viewpoints from the different specialities of
Diabetology, Cardiology and Nephrology they share the clinical benefits of the
Linagliptin and Dapagliflozin combination for T2DM with Cardiovascular risk or
established ASCVD.

Dr Brij Mohan Makkar: When Linagliptin and Dapagliflozin are combined, Linagliptin
demonstrates cardiovascular safety, hepatic safety, renal safety, no risk of
hypoglycemia, and no weight gain. It acts indirectly on insulin secretion and
suppresses glucagon. SGLT2 inhibitors are useful in reducing mortality in
people with established atherosclerotic cardiovascular disease, heart failure,
and advanced chronic kidney disease. Therefore, using this combination of
molecules in people with established atherosclerotic cardiovascular disease or
those at high risk is the recommended choice according to almost every
guideline now.

Dr Sameer I Dani: Linagliptin and Dapagliflozin both have established evidence or
a record of cardiovascular safety. Both have enough evidence for cardiorenal
safety. These medicines belong to two different classes of drugs and complement
each other. They have different mechanisms of action, different pathways of
metabolism, and that’s how they complement each other without causing drug
interactions. So, the chances of drug-drug interactions are very low. Both
agents have cardiovascular outcome benefits, making the combination use very
logical.

Dr Tukaram Jamale: One of the important reasons that patient discontinues or
decrease the dosages of the drug is cost and the pill burden. Patients at
elevated ASCVD risks stand to benefit the most from these drugs individually.
Therefore, a combination approach serves the purpose of making the treatment
available at a substantially lower cost and reduces the number of pills to be
consumed in a day.

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Assam govt releases budget for eight new medical colleges

Guwahati: In a significant development, the state government has released a budget for eight medical colleges as part of its plan to establish 21 medical colleges in Assam by 2026-2027. 

Currently, Assam boasts a total of 12 medical colleges. However, the government is actively engaged in the development of an additional 9 medical colleges, with plans to complete four more of them by 2026-27. It is important to note that the budget has only been allocated for 8 out of the proposed 12 medical colleges.

The 12 medical colleges, that are still in the pipeline, include Tinsukia Medical College, Biswanath Medical College, Charaideo Medical College, Pragyotishpur Medical College, Morigaon Medical College, Dhemaji Medical College, Bongaigaon Medical College, Golaghat Medical College, Tamulpur Medical College and Hospital, Sibsagar Medical College, Karimganj Medical College and Goalpara Medical College.

Also read- NMC Grants Recognition To 2 Assam Medical Colleges

The budget released for the eight medical colleges- Tinsukia will receive funding of Rs 614.933 crore, Charaideo with Rs 500 crore funding, Biswanath with Rs 500 crore funding, Tamulpur with Rs 666.935 crore funding, Dhemaji with Rs 605.248 crore funding, Bongaigaon with Rs 610.674 crore funding, Morigaon with Rs 647.375 crore funding, and Golaghat with Rs 631.823 crore funding.

Meanwhile, the funding for three proposed medical colleges in Sibsagar, Goalpara, and Karimganj has not yet been finalized. However, the proposed Pragjyotishpur Medical College in Guwahati will be funded through corporate social responsibility.

Earlier, Chief Minister Himanta Biswa Sarma said that the construction of Tinsukia Medical College will be completed this year and medical colleges at Charideo and Biswanath Chariali will be dedicated to the service of the people by next year.

Medical Dialogues team had previously reported where the Minister said that the number of medical colleges in Assam will increase to 21 by 2026-27.

“The inauguration of the first-year courses of Nagaon, Nalbari and Kokrajhar medical colleges has marked the beginning of a new era in medical education in Assam. Prime Minister Narendra Modi inaugurated the medical colleges of Nagaon, Nalbari and Kokrajhar on April 14 this year along with AIIMS in Changsari, which were constructed with an expenditure of Rs. 1,800 crore,” he said.

“Before 2010, there were only three medical colleges in Assam. Jorhat Medical College was inaugurated in 2010 and five medical colleges were established during the last decade. Last year Dhubri Medical College was opened and today academic sessions of Nagaon, Nalbari and Kokrajhar medical colleges have been started,” the Chief Minister added.

The Chief Minister said that in 2014, the number of MBBS seats in Assam was 726. Whereas now it has stood at 1,500 with the increase in the number of medical colleges.

As per the Hitavada news report, there are plans for seven new nursing colleges in Diphu, Lakhimpur, Dhubri, Nagaon, Kokrajhar, Jorhat, and Nalbari. The nursing colleges in Diphu, Lakhimpur, Dhubri, Nagaon, and Kokrajhar will be located within the respective medical colleges. The necessary funds have already been released for these colleges, and the State Public Works Department has prepared detailed project reports. 

The nursing colleges in Jorhat and Nalbari will be constructed at Rs 10 crore under the North Eastern Council. Furthermore, there are proposals for two more dental colleges in Lakhimpur and Morigaon.

Also read- By 2026-27, Assam Will Have 21 Medical Colleges: CM Himanta Biswa Sarma

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Maternal Height Independent Risk of Adverse Outcomes in Women with Gestational Diabetes

A recent retrospective study conducted by Mengkai Du and colleagues from Zhejiang University in Hangzhou, China, shed light on a vital aspect of maternal health: the correlation between maternal height and adverse pregnancy outcomes in women diagnosed with gestational diabetes mellitus (GDM). The investigation delved into how this association varied concerning gestational weight gain (GWG) and pre-pregnancy body mass index (BMI).

The study was published in the journal of Diabetes Therapy by Mengkai Du and colleagues. The study, encompassing 2048 women diagnosed with GDM between July 2017 and June 2018 in Zhejiang Province, China, presented intriguing observations. The researchers discovered that shorter stature in women with GDM was associated with higher rates of low birth weight (LBW) (p = 0.003) and primary cesarean section (primary CS) (p < 0.001). Conversely, taller women with GDM exhibited elevated rates of abnormal neonatal ponderal index (p < 0.001), postpartum hemorrhage (p = 0.044), and macrosomia (p < 0.001).

The investigators highlighted the importance of considering gestational weight gain and pre-pregnancy BMI as independent factors influencing pregnancy outcomes. They noted that shorter women with pre-pregnancy obese BMI faced a substantially higher risk of macrosomia compared to shorter women with normal or overweight pre-pregnancy BMI.

During the study, maternal height was categorized into three groups: shorter (≤158 cm), average (between 158.1 – 162.0 cm), and taller (>162.0 cm). Notably, shorter women experienced higher rates of low birth weight (LBW) (p = 0.003) and primary cesarean section (primary CS) (p < 0.001), while taller women had increased instances of abnormal neonatal ponderal index (p < 0.001), postpartum hemorrhage (p = 0.044), and macrosomia (p < 0.001).

Further analysis revealed intriguing correlations based on gestational weight gain and pre-pregnancy BMI. For instance, shorter women with inadequate gestational weight gain showed a significant association between maternal height and low birth weight (aOR 2.20, 95% CI 1.13–4.29), while taller women with excess weight gain demonstrated a positive link between maternal height and the risk of macrosomia (aOR 1.97, 95% CI 0.95–4.10).

The study’s findings underscore the pivotal role of maternal height in predicting adverse outcomes in women with gestational diabetes mellitus. Importantly, the researchers emphasized the necessity of considering pre-pregnancy BMI and gestational weight gain when assessing the impact of maternal height on pregnancy outcomes. This approach could aid in identifying women at high risk of complications and facilitate personalized prenatal care strategies.

Reference:

Du, M., Muhuza, M. P. U., Tang, Y., Chen, Y., Chen, D., Zhang, L., & Liang, Z. Maternal height is an independent risk of adverse outcomes in women with gestational diabetes mellitus. Diabetes Therapy: Research, Treatment and Education of Diabetes and Related Disorders,2023. https://doi.org/10.1007/s13300-023-01512-3

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First comprehensive medical guideline on management of pouchitis released

The American Gastroenterological Association (AGA) has released the first comprehensive evidence-based guideline on the management of pouchitis, the most common complication people with ulcerative colitis experience following surgery to remove their colon.

Between 150,000 and 300,000 people with ulcerative colitis in the U.S. live with a surgically created internal reservoir or “pouch” created from their small intestine as an alternate way to store and pass stool after their diseased colon is removed. The pouch can become inflamed, a condition called pouchitis, which affects almost half of patients within two years of surgery and up to 80% of patients over time.

“As providers we struggle to get insurance approval for medications to treat pouchitis, because it has not been a well-defined or recognized entity. Our intention with this guideline is to help improve access for patients and providers to use these advanced therapies,” said guideline author Siddharth Singh, MD, MS, University of California, San Diego.

AGA provides the following guidance for physicians caring for patients with ulcerative colitis who undergo proctocolectomy with ileal pouch-anal anastomosis, also known as IPAA or J-pouch.

  • AGA suggests initial treatment of pouchitis with antibiotics.

  • Treatment with multi-strain probiotics following an antibiotic course is suggested for preventing recurrent pouchitis.

  • AGA suggests cyclical or near continuous antibiotic therapy to treat pouchitis that responds to antibiotics but recurs frequently and shortly after antibiotics are discontinued.

  • In patients with recurrent pouchitis that doesn’t respond to antibiotics or Crohn’s-like disease of the pouch, AGA suggests advanced immunosuppressive medications (ie. Infliximab, vedolizumab, ustekinumab, upadacitinib, etc.)

Pouchitis has a significant impact on patients’ quality of life, so there is interest in ways to prevent it from occurring. The AGA guideline suggests against use of antibiotics for primary prevention of pouchitis, and guideline authors did not find enough scientific evidence to recommend for or against the use of probiotics for prevention.

AGA outlines four types of inflammatory pouch disorders

Intermittent pouchitis

  • This happens when a patient experiences infrequent episodes of pouchitis symptoms that get better with treatment.

Chronic antibiotic-dependent pouchitis

  • This occurs when a patient’s pouchitis responds to antibiotics, but symptoms quickly return after antibiotics are stopped (typically within days to weeks).

Chronic antibiotic-refractory pouchitis

  • This occurs when patients experience continuous symptoms of pouchitis that don’t get better with antibiotic therapy. Patients usually require more advanced treatment such as steroids or immunosuppressive medication.

Crohn’s-like disease of the pouch

  • Patients may have issues like fistulas (abnormal passages), strictures (narrowing) and inflammation in the small intestine above the pouch.

Amber Tresca, a patient advocate who has been living with a J-pouch for over 20 years shares that, “it’s important for patients to know how to care for their pouch if they develop pouchitis, especially if they don’t have access to a healthcare provider that is a pouch specialist. This guideline can help patients understand that pouchitis is a real condition, there is treatment for it, and that they don’t have to live with symptoms.”

Reference:

Edward L. Barnes, Manasi Agrawal, Gaurav Syal, Laura E. Raffals, Siddharth Singh, AGA Clinical Practice Guideline on the Management of Pouchitis and Inflammatory Pouch Disorders, DOI:https://doi.org/10.1053/j.gastro.2023.10.015.

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Breastfeeding alters infant gut in ways that boost brain development, may improve test scores

Breastfeeding, even partially alongside formula feeding, changes the chemical makeup-or metabolome-of an infant’s gut in ways that positively influence brain development and may boost test scores years later, suggests new CU Boulder research.

“For those who struggle with exclusively breastfeeding, this study suggests your baby can still get significant benefits if you breastfeed as much as you can,” said senior author Tanya Alderete, an assistant professor of integrative physiology at CU Boulder.

The study, published Dec. 13 in the journal npj Metabolic Health and Disease, also identifies specific metabolites that manufacturers may want to consider adding to infant formula to optimize healthy brain development and concerning compounds they should try to leave out.

“Our research suggests that even at low levels, some contaminants found in formula may have negative neurodevelopmental effects downstream,” said first author Bridget Chalifour, a postdoctoral researcher in Alderete’s lab.

A health report card for the gut

For the study, the research team examined what is known as the “fecal metabolome”-the diverse collection of metabolites found in the gut and shed in poop. Metabolites are small molecules that are churned out by gut bacteria as a byproduct of metabolizing food and make their way into the bloodstream, impacting the brain and other organs.

Breastmilk, formula and solid food also contain metabolites.

While scientists have long studied our resident bacteria, or microbiome, to better understand human health, the emerging field of “metabolomics” goes a step further.

“Looking at the gut microbiome tells us which bacteria are there, while looking at the fecal metabolome can help tell us what they are doing,” said Chalifour. “It’s like a health report card for the gut.”

The team collected fecal samples from 112 infants at 1- and 6-months-old and worked with Donghai Liang, assistant professor of environmental health at Emory University in Atlanta, and other colleagues to chemically analyze which metabolites were present. They grouped infants based on how much they were breastfed vs. formula fed. At age 2, the children took cognitive, motor and language tests.

The study found that the samples from infants in different feeding groups contained significantly different levels of metabolites.

For instance, at 1 month old, 17 metabolites were more abundant the more a baby was breastfed, and 40 were more abundant the more a baby was formula fed.

When looking more closely at specific metabolites, the researchers identified 14 that were also associated with differences in test scores at age 2.

With only one notable exception, caffeine, the more metabolites associated with breast milk a baby had in their stool, the better they did on cognitive tests as toddlers (more on caffeine later.)

The more metabolites associated with formula feeding they had, the worst they did.

“The consistency of these results is striking and supports the benefits of breastfeeding as much as possible in early life,” said Alderete.

Some metabolites associated with formula concerning

One particularly beneficial metabolite was cholesterol: At both 1 and 6 months old, the more a baby was breastfed the more cholesterol they had in their stool. And the more cholesterol babies had in their stool, the better they did on cognitive tests. This makes sense, as the fatty acid is critical for forming healthy circuits between brain cells. As the authors note, 80% to 90% of the brain’s volume grows in the first two years of life.

In contrast, the more a baby was formula fed, the higher their levels of a metabolite called cadaverine, a known contaminant formed via fermentation.

In the study, the more a child was formula fed, the higher their levels of cadaverine and the lower their test scores at age 2. While the compound is considered a toxin at higher levels, the Food and Drug Administration permits low levels in infant formula.

“It may be that formula manufacturers should be more vigilant in getting levels of this compound down to zero,” said Chalifour.

Interestingly, babies who were breastfed had higher levels of caffeine in their stool-perhaps because moms may have been breastfeeding over a cup of coffee.

Not surprisingly, higher levels of caffeine, a stimulant, were associated with poorer cognitive scores. Prenatal caffeine exposure has previously been associated with lower neurodevelopmental scores, and experts recommend no more than 12 ounces, or a cup and a half, of coffee per day for pregnant women.

Not all or nothing

The World Health Organization recommends that infants be exclusively breastfed for the first six months of life, but in the United States, only 63% of infants are exclusively breastfed immediately following birth. By six months, only a quarter of U.S. babies are exclusively breastfed.

Alderete acknowledges that for some parents, breastfeeding isn’t possible. She hopes her research can ultimately help manufacturers improve formula to make it as close to breastmilk as it can be. And she stresses that just because a child was not breastfed does not mean they’ll have neurodevelopmental deficits. Early feeding patterns are just one of many factors that contribute to how a brain develops.

Her takeaway to new parents having trouble breastfeeding exclusively: Don’t give up. It doesn’t have to be all or nothing.

“Just increasing the proportion of breastmilk relative to formula may have a positive impact on your developing child,” she said.

Reference:

Bridget Chalifour, Elizabeth A. Holzhausen, Joseph J. Lim, Emily N. Yeo, Natalie Shen, Dean P. Jones, Bradley S. Peterson, Michael I. Goran, Donghai Liang, Tanya L. Alderete. The potential role of early life feeding patterns in shaping the infant fecal metabolome: implications for neurodevelopmental outcomes. npj Metabolic Health and Disease, 2023; 1 (1) DOI: 10.1038/s44324-023-00001-2.

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Keto diet protects against epileptic seizures; Scientists uncover why

The high-fat, low-carbohydrate ketogenic diet is more than just a trendy weight-loss tactic. It has also been known to help control seizures in children with epilepsy, particularly those who don’t respond to first-line anti-seizure medications.

In a new UCLA study published in the journal Cell Reports, researchers demonstrate that the changes the diet causes in the human gut microbiome-the trillions of bacteria and other microorganisms that live in the digestive tract-can confer protection against seizures in mice.

Understanding how the function of the microbiome is altered by the diet could aid in the development of new therapeutic approaches that incorporate these beneficial changes while avoiding certain drawbacks of the diet, said the study’s lead author, Gregory Lum, a postdoctoral researcher in the laboratory of UCLA professor Elaine Hsiao.

The ketogenic diet is not recommended as a primary anti-seizure option because patients are often averse to drastic changes in their food intake or have trouble staying on the diet due to its strict requirements and potential side effects like, nausea, constipation and fatigue.

In the hope of finding new ways to more effectively treat seizures in the approximately one-third of people with refractory epilepsy who don’t respond to existing anti-seizure medications, Lum sought to understand the underlying molecular mechanisms behind diet’s alteration of the human gut microbiome.

Previous research conducted by Hsiao’s lab had found that in a mouse model bred to mimic epilepsy, mice fed a ketogenic diet had significantly fewer seizures than mice fed a standard diet. Lum took that research step further, studying how the gut microbiome is beneficially altered in children with epilepsy who start ketogenic diet therapy. To that end, he transplanted fecal samples from pediatric epilepsy patients on the diet into mice to gauge whether the diet-associated gut microbiota would protect the mice against seizures.

The fecal samples were collected in collaboration with UCLA’s Ketogenic Diet Therapy Program from 10 pediatric epilepsy patients who did not respond to anti-seizure medication and were subsequently treated with the ketogenic diet. The samples were taken both before they started the diet and after one month on the diet.

The study found that the mice that received fecal transplants from patients collected after a month on the diet were more resistant to seizures than mice that received pre-ketogenic diet fecal transplants.

Importantly, the study also found that in the pediatric patients, the ketogenic diet altered key gut microbiome functions related to fatty acid oxidation and amino acid metabolism-and that these changes were preserved when the fecal matter was transplanted into the mice.

While more research on these changes is needed, Lum said, the study holds promise as a step toward finding new microbiome-based therapies for pediatric epilepsy patients who do not respond to standard anti-seizure medications.

“Narrowing down the functions of the microbes that are beneficial toward seizure protection can potentially lead to new ways to enhance the efficacy of the ketogenic diet or to mimic its beneficial effects,” he said.

Reference:

Gregory R. Lum, Sung Min Ha, Christine A. Olson, Joyce H. Matsumoto, Xia Yang, Elaine Y. Hsiao, Ketogenic diet therapy for pediatric epilepsy is associated with alterations in the human gut microbiome that confer seizure resistance in mice, Cell Reports, DOI:https://doi.org/10.1016/j.celrep.2023.113521.

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FDA Approves First Test to predict Elevated Risk of Developing Opioid Use Disorder

Today, the U.S. Food and Drug Administration approved the first test that uses DNA in assessing whether certain individuals may have an elevated risk of developing opioid use disorder (OUD). As part of a clinical evaluation, the AutoGenomics, Inc. AvertD test is intended to be used prior to first exposure to oral opioid pain medications in patients being considered for a 4-30 day prescription for the treatment of acute pain, such as in patients scheduled to undergo a planned surgical procedure.

The AvertD test, a prescription-use only genetic laboratory test for patients 18 years and older, is to be used only with patients who consent to the test and have no prior use of oral opioid analgesics. The test is administered by a health care provider by swabbing the cheek of a patient to collect a DNA sample that will be used to determine if a patient has a combination of genetic variants that may be associated with an elevated risk of developing OUD. This information should be used as part of a complete clinical evaluation and risk assessment; it should not be used alone to make treatment decisions. The test is not intended to be used in patients being treated for chronic pain. AvertD may help patients who are concerned about being treated with an opioid for acute pain make better informed decisions.

In August 2022, the FDA introduced the FDA Overdose Prevention Framework. Through the Framework, the agency has taken steps to address the drug overdose crisis and substance use disorder, including the approvals of the first nonprescription naloxone nasal spray product and the first generic nonprescription naloxone nasal spray product in March 2023 and July 2023, respectively. The FDA also published draft guidance on Clinical Considerations for Studies of Devices Intended to Treat Opioid Use Disorder in July 2023.

As part of the approval order, AutoGenomic, Inc. must provide training to health care providers to help ensure appropriate use of the test and conduct a large post-market study assessing device performance in patients, regularly reporting progress made toward completion of that study to the FDA.

An earlier version of the AvertD test was the focus of an October 2022 advisory committee meeting, in which a panel discussed data and information related to the test, provided recommendations and voted on the De Novo request for the test. Following the advisory committee meeting, FDA worked with AutoGenomics, Inc. as it modified its test. AutoGenomics subsequently submitted a Premarket Approval application (PMA) for the modified test. The advisory committee’s feedback helped inform the FDA’s evaluation of the test and today’s decision, including the conditions for approval.

The primary risks associated with AvertD, as with any in vitro diagnostic test, are false negative and false positive results. A false negative result could lead to a false sense of security for a patient who is at increased risk of OUD, and/or a health care provider considering prescribing an opioid analgesic which could result in a provider prescribing an opioid analgesic to a patient to whom they would otherwise not do so. The risks of a false positive result (i.e., incorrectly identifying an individual as having a higher risk of OUD) include inadequate pain management due to avoidance of opioids, which may prevent patients from receiving optimal medical care to treat their acute pain. The risks of false negative and false positive results can be mitigated, in part, through accurate, transparent product labeling and a health care provider training program. It is critical that users of the test (health care providers and patients) understand how to interpret the test result and use it not in isolation, but as part of a comprehensive clinical evaluation and risk assessment.

The FDA recognizes that in premarket decision-making for devices, there generally exists some uncertainty around benefits and risks. Given the totality of available evidence and the urgent need for medical devices that can make a positive impact on the overdose crisis, and specifically devices that can help assess the risk of developing OUD, the FDA determined that there is a reasonable assurance of AvertD’s safety and effectiveness, taking into consideration available alternatives, patients’ perspectives, the public health need and the ability to address uncertainty through the collection of post-market data. The PMA incorporates very precise conditions of approval, including mandating a post-approval study and the monitoring of test performance.

The opioid crisis, one of the most profound public health issues facing the United States, calls for innovative measures to prevent, diagnose and treat opioid use disorder, including to assess the risk of developing the disorder. The FDA also has previously granted marketing authorization to several medical devices intended to help individuals reduce the need to use opioid analgesics. The FDA will continue to offer support and expertise to help with the development of medical devices that address the evolving needs of the overdose crisis. This approval represents another step forward in the FDA’s efforts to prevent new cases of OUD, support the treatment of those with the disorder and decrease the misuse of opioid analgesics.

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Modified INFIX combined with sacroiliac joint screws safe and effective for pelvic instable injuries

C-INFIX safe with low complication rates among patients with pelvic unstable injuries suggests a new study published in the BMC Surgery.

The INFIX technique is becoming one of the most commonly performed surgical procedures for anterior pelvic ring instability injuries. The purpose of this article is to compare the clinical outcomes of modified anterior subcutaneous internal fixation (M-INFIX) with conventional anterior subcutaneous internal fixation (C-INFIX) for anterior pelvic ring instability injuries.

A retrospective analysis of 36 cases of unstable pelvic injuries treated operatively at our institution, 20 of which were treated with C-INFIX and 16 with M-INFIX. Data collected included age, gender, ISS score, fracture typing, operative time, operative bleeding, postoperative complications, fracture healing time, Matta score, Majeed score, and follow-up time. Statistical sub-folding of each variable between the two groups was performed.

Results

There was no statistical difference between the C-INFIX and M-INFIX groups in terms of age, gender, ISS (Injury Severity Score), follow-up time, fracture typing, fracture healing time, and Majeed score (P > 0.05). the M-INFIX had a significantly lower incidence of postoperative complications than the C-INFIX group, especially in the incidence of Lateral femoral cutaneous nerve (LFCN) injury (P < 0.05). In contrast, the M-INFIX group had statistically higher operative time, intraoperative bleeding, and Matta score than the C-INFIX group (P < 0.05).

This study was based on a modified application of the surgical experience with C-INFIX and showed better clinical outcomes in terms of complication rates and quality of repositioning than the conventional surgical approach. These findings indicate that further analytical studies of this study would be valuable.

Reference:

Zhao, P., Li, R., Liu, L. et al. Clinical study of modified INFIX combined with sacroiliac joint screws for pelvic instable injuries. BMC Surg 23, 350 (2023). https://doi.org/10.1186/s12893-023-02205-1

Keywords:

C-INFIX, safe, low, complication, rates, among, patients, pelvic, instable, injuries,BMC Surgery, Zhao, P., Li, R., Liu, L.

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