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Congenital diaphragmatic hernia (CDH) is a common condition, affecting one in every 2500 births. Up to 30 per cent of affected babies die from it. The main problem is the underdeveloped lung. The condition also involves a hole in the diaphragm, which paediatric surgeons correct by closing it in the first week of life. Until now, there has been little medical knowledge about how CDH develops — what exactly goes wrong during embryonic development. Dr Richard Wagner, a paediatric surgeon and scientist at Leipzig University Hospital, teamed up with researchers from Massachusetts General Hospital in Boston to establish a new patient-specific cell model at Harvard Medical School. Using their model, the researchers investigated possible ways of treating this condition.
Babies with CDH are placed on a ventilator immediately after birth. “We were able to isolate stem cells from the fluid that is sucked out of the children’s lungs and otherwise disposed of, and grow them in the laboratory,” explains Dr Wagner, first author of the study. While working as a postdoctoral researcher in the US, the doctor from Leipzig examined the stem cells in the laboratory together with the American researchers, designing cell models of the airways of the tiny patients. This gave them access for the first time to “living” human lung tissue from patients with CDH. They then compared the stem cells from healthy and underdeveloped lungs.
Goal of treatment during pregnancy
When the researchers looked at the molecular properties of the stem cells, they found that they had been altered due to inflammation. However, drug therapy in the cell model was able to restore functionality. “We also tested this process in animal models and showed that the treatment contributed to better lung development there, too. With the same drug therapy, we were therefore able to achieve positive effects both in human cells in the Petri dish and in the living organism in the established animal model,” explains Dr Wagner.
The treatment was performed with the steroid dexamethasone. This drug is already used in clinical practice to induce lung maturity in the fetus when there is a risk of premature birth during pregnancy. “What is most appealing is the fact that we already know that this drug is not harmful in pregnancy. If we were to collect more data in laboratory research, it would be possible to investigate later in clinical trials whether there are advantages to administering the drug during pregnancy in order to slow down the possible inflammation in the organism and help the lungs grow,” says Dr Wagner, adding that the aim in future is to be able to intervene with a drug directly after the diagnosis of a diaphragmatic hernia, which happens at around the 20th week of pregnancy.

When our bodies become infected, various immune responses are triggered, starting with a release of granulocytes, white blood cells containing special enzymes that make up about half or more of all human white blood cells.
Neutrophils are also granulocytes that fight off invasive bacteria and fungi, often with zero tolerance for such invaders. Sometimes, however, a balanced and less aggressive approach goes even further in providing a cure.
Now, a team of researchers at Kyoto University has determined that neutrophils induce anti-inflammatory — or M2 — macrophages deep in the core of these granulocytes.
In previous studies, chronic inflammatory macrophages were found to have the potential to polarize or differentiate into two opposite versions: pro-inflammatory, or M1, and anti-inflammatory, or M2 types. These constitute an M1-M2 equilibrium which regulates the severity of inflammation and tissue health — or homeostasis.
This dual nature or polarization describes how M2 can revert to M1 or even M0 — the non-inflammatory or steady state — in the deep granuloma zone where a bacteria-permissive microenvironment is formed. The team has examined the dense globular structures of granulomas in animals, particularly in the lungs.
“Microbes and cancer cells may manipulate this permissive microenvironment to favor their survival,” says Tatsuaki Mizutani.
Human granuloma-related disorders including tuberculosis are a hallmark of chronic inflammatory diseases. Mizutani posits that the results his team obtained from tuberculosis may also be applied to tumors.
Previous studies have revealed that intercellular interactions within granulomas drive effective inflammatory responses against pathogens or contaminants, but chronic inflammation — as in tuberculosis and tumors — persists over prolonged periods of time.
To test how to predict tumor development, Mizutani’s team previously established a lung granuloma model in guinea pigs, which demonstrated the specific accumulation of Neutrophil S100A9 — or A9 — deep in the cores of granulomas. A9 is expressed in monocytes and macrophages at low levels but at high levels within neutrophils.
“What is interesting is that both the inflammatory and anti-inflammatory effects of A9 have been reported in A9-deficient mice,” notes Mizutani, whose team is now considering whether to make A9’s multifunctional nature anti-tumorigenic in the tumor microenvironment.
“Our understanding of how a permissive microenvironment in tumors is formed may be applied to effective cancer drug development,” reflects Mizutani.

Modern living seems to have exacerbated the conditions of our gut. There is an escalating prevalence of irritable bowel syndrome and overactive bladder syndrome among individuals who do not exhibit signs of infectious maladies or other established ailments, but rather report experiencing sudden symptoms. Recently, a team of researchers from POSTECH and Korea Advanced Institute of Science and Technology (KAIST) have proposed a sensor to monitor overactive bladders.
The research team consisting of Professor Sung-Min Park and Young-Soo Lim at POSTECH’s Department of Convergence IT Engineering and Professor Steve Park and Byungkook Oh at KAIST’s Department of Materials Science has developed an ultra-soft and highly stretchable tissue-adhesive hydrogel-based multifunctional implantable sensor for monitoring overactive bladders. The research findings were published in Biosensors and Bioelectronics.
Overactive bladder syndrome is a medical condition characterized by an uncontrollable, frequent urge to urinate. People with the syndrome may even wake up during the night to urinate, without any underlying illness. The condition is not life-threatening, but it can disrupt the patients’ daily activities, reducing their quality of life.
People with overactive bladder syndrome have traditionally relied on medication for treatment, which has proven to be ineffective for some. A relatively new treatment involves giving electrical stimulation directly or indirectly to nerves linked to the bladder in order to reduce excessive bladder activity. However, this treatment is not without its challenges, as it can be difficult to deliver the right amount of stimulation to the nerves without monitoring bladder activities. Overstimulation can lead to side effects or render the treatment ineffective.
Hence, the researchers focused on developing a monitoring device to observe bladder activity in real-time. Since detrusor muscle is controlled by neural activity, they hypothesized that a full electromechanical measurement was required to accurately monitor overactive bladder symptoms. From that perspective, the team designed a USH-SI sensor that can monitor both mechanical (strain sensor to measure contraction and relaxation) and bioelectrical (EMG sensor to measure neural signal) activities of the bladder in one platform.
In a test where the team surgically inserted the USH-SI sensor into an anesthetized pig, it was demonstrated that the sensor is capable of measuring in-vivo strain and EMG signals of the bladder, allowing monitoring of detrusor muscle locomotion and neural activity. In particular, the strong adhesiveness of the hydrogel (adhesive strength: 260.86 N/m) enabled firmer attachment onto the bladder compared to conventional silicone sensors. Sensor insertion can be performed using surgical-robot-assisted laparoscopic surgery.
“The new sensor shows that sensors can be made small enough to be inserted by surgical-robot-assisted laparoscopic surgery,” explained Professor Steve Park from KAIST. He added, “This has the potential to minimize the time taken for a patient to recover and reduce side effects.”
“We combined the USH-SI sensor with a neural stimulator targeted to treat overactive bladders, a chronic condition,” remarked Professor Sung-Min Park who led the study. He further explained, “This allows for monitoring and neural stimulation simultaneously. We expect it to be a platform that can be applied to other internal organs.”
The study was conducted with the support from the Nano · Material Technology Development Program through the National Research Foundation of Korea.

Incidence of illnesses such as diabetes and hypertension are climbing quickly in most sub-Saharan countries, but the conditions are rarely diagnosed or treated.NAIROBI, Kenya — Hannah Wanjiru was plagued by dizzy spells and headaches for years. After a half-dozen costly trips to the doctor, she was finally diagnosed with high blood pressure. It took two more years — and some fainting spells — before she finally started to take medication. By then, her husband, David Kimani, had been shuttling between doctors himself and ended up with a diagnosis of diabetes, another condition the couple knew nothing about.They might have wished for different diseases. Not far from their small apartment in the Kenyan capital, there is a public hospital where treatments for H.I.V. and tuberculosis are provided for free. Posters for free H.I.V. prevention services paper the streets in their low-income neighborhood.There is no such program for high blood pressure or diabetes, or for cancer or chronic respiratory conditions. The health systems in Kenya and much of sub-Saharan Africa — and the international donations that support them — are heavily weighted to the treatment of infectious diseases such as H.I.V. and malaria.“Sometimes I go to have my sugars tested and I wait all day and I am almost fainting right there in the lineup,” said Mr. Kimani.Success in fighting H.I.V., malaria and other deadly infectious diseases, plus an expansion of essential services, have helped countries in sub-Saharan Africa achieve extraordinary gains in healthy life expectancy over the past two decades — 10 additional years, the largest improvement in the world, the World Health Organization reported recently.“But this was offset by the dramatic rise in hypertension, diabetes and other noncommunicable diseases and the lack of health services targeting these diseases,” the agency said, launching a report on health care in Africa. It warned that the rise in life expectancy could be erased before the next decade is out.Noncommunicable diseases now account for half of hospital bed occupancy in Kenya and more than a third of deaths. The rates are similar across the rest of sub-Saharan Africa, and people in this region are being affected at younger ages than those in other parts of the world.Mr. Kimani and Hannah Wanjiru on the roof of their home. There is a clinic nearby that offers free treatment for H.I.V. and tuberculosis, but there is no such program for conditions like diabetes or cancer.Malin Fezehai for The New York Times“Vaccination programs are running very well, H.I.V. programs are running very well — but these same people will die of noncommunicable diseases while they are young,” said Dr. Gershim Asiki, a research scientist focused on management and prevention of these conditions at the African Population and Health Research Center, an independent organization in Nairobi.The medications and supplies Ms. Wanjiru, 44, and Mr. Kimani, 49, need to control their conditions cost $60 each month, a huge portion of the income from their small convenience store, Ms. Wanjiru said over tea in their sitting room. Both skip their medication on months when school fees are due for their four children.“I get headaches and I feel weak, and then I feel stressed knowing I need to buy medication instead of food for my family,” Mr. Kimani said.Routine screening for conditions such as high blood pressure is rare here, diagnosis rates are low and care is often available only at specialized centers in urban areas. The public is not aware of the ailments — everyone can recognize malaria, but few connect blurry vision or exhaustion with hypertension — and primary care health workers often don’t know what to check for either.When Dr. Asiki’s organization set up random screenings in a low-income community in Nairobi a couple of years ago, researchers found that a quarter of adults had hypertension. But 80 percent of them did not know they had it. Of those who did, fewer than 3 percent were controlling their blood pressure with medication.A fraction of Kenya’s health budget goes to noncommunicable disease — it was 11 percent in 2017-18, the latest figures in the government’s strategic plan — and those funds are mostly earmarked for expensive curative services such as radiation machines at cancer clinics and kidney dialysis centers. “But people come with cancers that are already Stage 4, with very little chance of survival, because they cannot get diagnosed,” Dr. Asiki said.Government ministers like to cut the ribbon on new cancer centers, but there is no perceived political value in investing in a long-term screening program, said Catherine Karekezi, executive director of the Kenyan chapter of an international patient advocacy organization called the Noncommunicable Disease Alliance.“Eighty percent of deaths from noncommunicable disease in this country are from preventable causes,” Dr. Karekezi said. “We can prevent the causes, and if you do have the condition, we could prevent you from progressing to complications.”Azibeta Kamonga, 70, lives in the sprawling low-income community of Kibera, in the Kenyan capital. She was diagnosed with diabetes 17 years ago, but can rarely afford to buy medication, and often feels weak and dizzy.Malin Fezehai for The New York TimesInstead, she said, younger people are falling ill and developing serious complications, and are sometimes unable to work. “It’s the economically active segment of the population that is affected,” she said.People die of undiagnosed heart disease or complications from diabetes in their 50s and that’s chalked up to “old age.” The systems to accurately track causes of death are weak, which means that neither the public nor policymakers understand the true scale of the problem, Dr. Asiki said.Unlike H.I.V. medication and care, which is usually free and subsidized by international donors, treatment for diabetes or blood pressure are usually out-of-pocket expenses for families, and often cripplingly expensive, said Dr. Jean-Marie Dangou, who coordinates the noncommunicable disease program of the W.H.O.’s Africa regional office.“In the Democratic Republic of Congo, hypertension treatment is two-thirds of the typical household income each month,” he said. “That’s absurd, for that family. But it is not unusual.”Annah Mutindi, 42, used up all her savings from her job as a clerk in a Nairobi dress shop on doctor visits and tests before a painful lump in her breast was diagnosed as cancer in January 2021. She was prescribed a course of 12 biweekly sessions of chemotherapy. She could have had them for a minimal cost, in theory, at a large public hospital in the center of the city, but the treatment was continuously out of stock.Instead she had to wait until her family and friends scraped together $360 every few weeks so she could pay for the treatments one by one, stretched over the next nine months.“I was in shock when they told me it was cancer, because I never touch alcohol and I eat healthy,” Ms. Mutindi said, recalling her diagnosis. “They said maybe it was environmental factors.”The share of deaths caused by noncommunicable disease is increasing across the region, most rapidly in the continent’s most populous states, Dr. Dangou said. In Ethiopia, for example, mortality caused by these conditions climbed to 43 percent of deaths last year from 30 percent in 2015, and made a similar jump in the D.R.C. It is clear that rapid urbanization and an increase in sedentary lifestyles is driving some of the increase in these conditions. So is growing use of tobacco and alcohol, and consumption of processed foods. Kenya’s government has been slow to update policies to discourage these. And all three industries have powerful lobbying organizations that are focused on stalling legislation such as a tax on sugar-sweetened beverages. Kenya is a major producer of tobacco and the industry reminds the government of the jobs it creates, Dr. Asiki saidThere’s also the simple fact that people are living longer because of the progress fighting infectious diseases. But others causes, such as possible genetic factors and a correlation with exposure to infectious disease, are less understood.Annah Mutindi with her son, Joel, at the entrance to their apartment in Nairobi. Ms. Mutindi used up all her savings on doctor visits and tests to learn that a painful lump in her breast was cancer in January 2021.Malin Fezehai for The New York TimesThere is little public investment in researching the mystery of why noncommunicable disease rates are rising so quickly, and in comparatively younger people, in this region. The experience of high-income countries is of limited relevance to the situation in a country such as Kenya, Dr. Asiki said. Scarcity of nutritious food in childhood appears to prime people metabolically for obesity in adulthood. There is some evidence that malaria infections predispose people to cardiovascular disease; hepatitis infections put them at risk for cancer.Taking the antiretroviral drugs that control H.I.V. for years can lead to a higher risk of heart disease. Urban dwellers are also exposed to increased rates of air pollution and environmental toxins, and some to the stress of living in areas with high rates of violence and insecurity. All of these are contributing factors, Dr. Asiki said, but their combined effect is not yet well understood.Dr. Andrew Mulwa, who directs preventive and health promotion programs for the Kenyan Ministry of Health, said the government was concerned about the soaring rates of noncommunicable conditions, but that it was slow work rolling out diagnostics and treatment to the primary care level in rural areas.“When I worked as a clinician in a rural area 10 years ago, you would see 50 patients a day with these conditions, and now it is 500 to 1,000 at the same facility,” he said.Poor nutrition is influencing the rise of noncommunicable diseases in multiple ways — what Dr. Asiki calls “a double burden of under-nutrition.” This region is home to both the largest number of stunted children in the world and the fastest-rising rate of obesity.It is common in low-income households to find both malnourished children, who lack the protein and nutrients essential for growth, and adults who are obese, because they are reliant on cheap, fatty and energy-dense street foods — often a more affordable option than paying for vegetables and cooking gas to make food at home.“You can have enough of the bad food but scarcity of the needed foods,” Dr. Asiki said. “The body stores excess energy as fat — but at the end it’s still scarcity.”He speculated that the government had been slow to roll out screening programs because there was no way it could respond to the extent of the problem.“That’s when you suddenly realize, I don’t have enough medications for hypertension, I don’t have enough medications to treat people with cancer,” Dr. Asiki said. “If you screen, you will pick cases that are treatable. But do we have the resources to treat them?”

His vital signs were normal. He didn’t have a fever. A slew of tests couldn’t find the cause. Then a locker-room conversation between doctors led to the diagnosis.“It’s happening,” the 58-year-old man said quietly. Dr. Mark Chelmowski looked over to observe his patient. He was leaning forward, elbows on table, head propped up on his hands. Beads of sweat suddenly appeared on the man’s brow. More popped up on his cheeks, then his jaw. Rivulets ran down the contours of his face, then dripped off his chin onto the table. The man’s eyes were closed. He almost seemed asleep. Chelmowski said his name. “Yes, doctor” was the only response the normally chatty man gave. It was as if he were somehow distracted by the profound sweating. The patient’s vital signs were normal. He didn’t have a fever. His blood pressure and heart rate were normal. Throughout the exam, the patient sat quietly sweating. The collar, front and back of his shirt darkened. Then, as abruptly as it started, it was over. He opened his eyes and looked at Chelmowski. The patient could see the surprise in his doctor’s face. Chelmowski knew about his episodes of sweating — the two of them had been trying to figure them out for the past five months — but he had not yet witnessed one. The first time it happened, the patient was in his car on the way to the gym when suddenly he felt intensely hot. It was a bright July day in the Milwaukee area and seasonably warm. But this heat felt as if it came from inside his body. A vague prickling sensation spread down his face and neck to his chest and back. His heart seemed to speed up and then — pow — he was drenched in sweat. He turned the car around and headed home. He was describing the strange event to his partner when it happened again. And again. Each episode lasted only a couple of minutes, but it was strange. The sweating was so excessive. After a fourth episode, the patient’s partner insisted they go to the emergency room. He had another bout in front of the E.R. doctor, who immediately admitted him to the hospital. He was worried the patient might be having a heart attack. Profuse sweating often accompanies myocardial infarctions, the doctor told him. But it wasn’t his heart. He was discharged the next day and encouraged to follow up with his primary-care doctor. Chelmowski had been trying to figure out these strange episodes ever since. He had never seen anything like it, he told the patient after finally witnessing the strange sweating event. And he really wasn’t sure where else to look. When he saw the patient a week after that first episode, his exam was completely unremarkable. So were the tests that the doctor ordered. His thyroid hormones were normal. He didn’t have an infection. His inflammatory markers were not elevated. And he seemed fine. Whatever it was, the doctor figured, it was over. Then, a month later, it happened again: a half day of intense episodes of drenching sweats and strange distraction, one after the other, each lasting only a few minutes. From that point, the episodes recurred every three to five weeks. A Trip to the TropicsThe pattern made the strange symptom seem even stranger. The patient was in good shape. He ate a healthy diet and exercised regularly. The only medication he took was an acid reducer for his heartburn. He was almost never sick.Chelmowski spent hours trying to figure out what was going on. The patient had traveled to the tropics earlier that year. Repeated tests for malaria were negative. It wasn’t H.I.V. The doctor referred him to an endocrinologist. Could this be a pheochromocytoma — a usually benign tumor that causes the adrenal glands to produce too much of the fight-or-flight hormones? Carcinoid tumors live in the gut and produce a variety of hormones. One key symptom of this tumor is flushing and sweating. He was tested for these abnormalities along with other hormonal disorders. Nothing. The infectious-disease doctors who saw him couldn’t find an infection. A cardiologist ordered echocardiograms and EKGs. Normal. A portable monitor found no abnormal heart rhythms over the course of 30 days. Chelmowski looked for cancers. They can often cause odd symptoms like this. But he found nothing. The patient saw a rheumatologist and a neurologist. They didn’t find anything, either. Chelmowski searched the medical literature for possibilities. He did his own version of crowdsourcing — asking every doctor he ran across if they had any patients with these symptoms. No one had any answers. Chelmowski was stumped and frustrated. What was he missing? He referred the patient to the Mayo Clinic in Rochester, Minn. Maybe they could figure this out. The patient spent two full days in Rochester. He was poked, prodded, imaged, stuck and questioned. Finally, they came up with an answer: Although his testosterone level was in the normal range, perhaps it was less than he was used to. Maybe this was a relative hormonal deficiency akin to a woman’s menopause, a reaction to the natural reduction of sex hormones because of aging. They recommended testosterone-replacement therapy. The patient was skeptical but applied the testosterone gel as directed. He used it for months. It didn’t help. Photo illustration by Ina JangLocker-Room Consultation Chelmowski was beginning to worry that he was never going to figure it out. Early one morning, at his usual spin class, he found himself on a bike next to an old friend, George Morris, who was a neurologist specializing in seizure disorders. Could these weird episodes be seizures? They weren’t like any seizures Chelmowski had ever heard of, but who knows? In the locker room, he approached Morris. “Have you ever heard of seizures characterized by profuse sweating?” he asked. He outlined the patient’s story. Morris nodded his head as he listened. Yes, he had several patients who sweated like this. Chelmowski should send the patient to his clinic to be tested. A few weeks later the patient went to the epilepsy center at Aurora St. Luke’s Medical Center, where Morris was medical director. A 20-minute electroencephalogram was normal. If these were seizures, Morris told him, there was a good chance that they would show up on the EEG only when he was having one. They arranged for the patient to return before his next expected day of sweating. It took about an hour for the electrodes to be placed onto his head for the EEG. He could almost cover the whole array with a baseball cap. He didn’t usually wear one, but it was better than walking around with a head full of wires for all to see. Every morning a technician would come to his house to download the data. He was supposed to be hooked up for seven days, but when no sweating episodes happened, they gave him another weekend. And finally, his long-awaited day of sweating occurred. A couple of days later he got a call. These were seizures. They originated on the left side of his brain, just behind the ear, in what is known as the temporal lobe. A seizure is an episode of abnormal brain activity, and the temporal lobe is in close communication with the autonomic nervous system, which can trigger sweating. Days later, he went back to the center to see Morris and start medications to stop the seizures. He asked the doctor why the episodes came every month. Morris just shook his head. Some seizures have this kind of rhythm. They can be any number of days apart, but a 20-to-30-day cycle is the most common. No one is sure why. It took a while for the patient to get on the right medications at the right dose, but once on it, his seizures stopped. He hasn’t had one in nearly five years. The patient doesn’t know why he started getting seizures at age 58, although he wonders whether it’s linked to a car accident he was in when he was 10 or 11. He was riding in the front seat in the days before seatbelts and smashed his head on the steering wheel. Maybe, Morris told me. That kind of injury can cause seizures many years later. The injured neurons cause abnormalities in surrounding brain cells, which may, eventually, trigger the abnormal activity that results in a seizure. But epilepsy, as recurring seizures are called, often starts in late middle age. Morris attributes it to cerebrovascular disease — what others call ministrokes.This patient isn’t buying it. He still traces it all back to a head-on collision resulting in a close encounter with a hard plastic steering wheel.Lisa Sanders, M.D., is a contributing writer for the magazine. Her latest book is “Diagnosis: Solving the Most Baffling Medical Mysteries.” If you have a solved case to share, write her at Lisa.Sandersmdnyt@gmail.com.

The F.D.A. seemed poised to rescind approval of Makena, after studies over time indicated the treatment did not halt early childbirth for many women.The company that makes Makena, the only drug aimed at preventing preterm birth, announced on Tuesday that it was voluntarily pulling the medication off the market after advisers for the Food and Drug Administration concluded that the treatment did not help pregnant women at all.Makena’s drugmaker, the Covis Pharma Group, said its decision had been made in deference to an F.D.A. advisory committee that agreed unanimously in October that a large study had showed that the drug offered no benefit to newborns.Makena had been cited by critics as a flawed example of the F.D.A.’s accelerated drug approval program because the agency’s original green light for sale was based on indications that the drug would be effective. But a succession of manufacturers could not provide convincing proof after years of study that the drug halted sometimes dangerous preterm births.Makena is now owned by Covis Pharma Group, a private-equity-backed company based in Switzerland.“While we stand by Makena’s favorable benefit-risk profile, including its efficacy in women at highest risk of preterm birth, we are seeking to voluntarily withdraw the product and work with the F.D.A. to effectuate an orderly wind-down,” Raghav Chari, chief innovation officer at Covis, said.The drug’s removal means that many women who have had an early birth will have no evidence-backed therapy to use during another pregnancy. While the drug was criticized for giving women false hope, patients and doctors who favored further study in the highest-risk populations spoke up in its defense at recent agency meetings.Despite dismal study results of late, Makena was the only resort for a health risk that disproportionately affects Black women and children who have higher risks of disability or death with premature birth. The initial study of the drug that led to its accelerated approval in 2011 showed signs of promise, but a far larger trial that concluded in 2019 showed no benefit for mothers or babies.The road to removing the drug from the market has been lengthy. The F.D.A. first proposed taking the drug off the market in October 2020. The drug’s sponsor appealed the decision, setting up a lengthy process leading to a hearing last fall.By October of last year, 15 F.D.A. advisers voted unanimously that the lengthy so-called confirmatory study had showed no benefit to babies. All but one agreed that the drug should be withdrawn from the market.Covis’s decision on Tuesday followed the recommendation made this past January by Dr. Celia Witten, an agency official and the presiding officer at the October hearing, that the drug be removed from the market. Still, Dr. Witten said she agreed with an advisory panel member who had acknowledged that officials could feel an imperative to “do something” when faced with a patient in need.“I think that when we leave something on the market that hasn’t been shown to be effective, we lose out on other investigations that might be pursued,” Dr. Anjali Kaimal, an obstetrician and administrator at the University of South Florida, said during the October hearing. “And the last thing I would say is that, again, faced with that powerless feeling: Is false hope really any hope at all?”In its news release on Tuesday, Covis said it had outlined a plan for voluntary withdrawal that included a wind-down period allowing patients using the medication to complete their courses and for the company to use its remaining inventory.But the F.D.A. “was not in agreement with the proposal,” Covis said, and let the process advance to Dr. Witten’s recommendation.The F.D.A.’s “accelerated approval” program is intended to grant rapid approval to a drug targeted at a serious, unmet medical need if it shows promise in delivering a benefit to patients. The program has sped about 300 drugs to the market in 30 years. It drew fierce criticism over the approval of the Alzheimer’s drug Aduhelm, an expensive drug that many experts criticized as risky and ineffective.Congressional efforts to alter the accelerated approval process culminated last year with minor changes, including the speeding up of follow-up studies to confirm whether a drug benefits patients.The F.D.A. should seek even more authority to improve the program, said Dr. Michael Carome, director of health research at Public Citizen, a consumer advocacy group. He said the agency advisers should be reviewing a drug seeking fast-tracked approval before an initial OK is granted. The F.D.A. should also seek authority to pull a drug from the market rapidly when the follow-up study shows no benefit, Dr. Carome said.“Makena is a classic example,” he said, “where the clock has dragged out too long.”

Published7 hours agoShareclose panelShare pageCopy linkAbout sharingImage source, Getty ImagesPeople’s general mental health and anxiety symptoms hardly deteriorated at all during the pandemic, research suggests.The BMJ review analysed 137 studies, most from high-income European and Asian countries.Most people are resilient and made the best of a difficult situation, it says.But depression became a little worse overall and among women, older people, university students and those belonging to sexual or gender minorities.Other studies have found women felt the impact of the pandemic more because of the jobs they do and the role they play in family life.”At a population level, there has been a high level of resilience during Covid-19,” the Canadian researchers, from institutions including McGill, Ottawa and Toronto universities, say. “And changes in general mental health, anxiety symptoms, and depression symptoms have been minimal to small.”Huge leap in children in mental health crisisMedical body backs online mental health treatmentsThe raw honesty of blogger Beth Matthews, and how she saved livesBut the pandemic continues to affect societies around the world.”The pandemic has affected the lives of many people – and some are now experiencing mental-health difficulties for the first time,” the researchers say. “Governments should continue to ensure that mental-health supports are available and respond to population needs.”The review did not focus on lower-income countries, or children, young people and those with existing problems, the groups most likely affected, experts say, and risks hiding important effects among disadvantaged groups.”There is evidence from other studies of considerable variation – with some people’s mental health improving and others’ deteriorating,” Dr Gemma Knowles, from King’s College London, said.”This may mean no overall increase – but this shouldn’t be interpreted as suggesting the pandemic didn’t have major negative effects among some groups.”Other studies suggest the pandemic increased mental distress for particular groups, such as children, young people and parents in poverty.’Soaring demand’As many as one in six seven-16-year-olds and one in four 17-19-year-olds in England had a probable mental disorder in 2022, an online NHS survey found, up on previous years.Separate NHS figures show the number of children in contact with mental-health services rose by nearly 30% between 2020-21 and 2021-22, to nearly a million.And in a survey by mental-health charity Mind, in 2021, about a third of adults and young people said their mental health had become much worse since March 2020.Those most affected by the pandemic were people who struggled with their mental health before Covid.Dr Roman Raczka, who chairs the British Psychological Society’s division of clinical psychology, said the full picture remained unclear and more studies among people with health problems in deprived areas were needed.”We do know that overstretched and underfunded mental-health services have been unable to meet soaring demand in recent years,” he said.”With more people reaching out for support, it is vital that the government adequately funds services to deliver the support that is needed.” More on this storyHuge leap in children in mental health crisis4 February 2022Medical body backs online mental health treatments1 MarchQuarter of 17-19-year-olds may have mental disorder29 November 2022Child mental health not improved since lockdown30 September 2021Related Internet LinksMind mental health charityYoungMinds – Mental Health Charity For Children And Young People – YoungMindsWhat has the impact of the pandemic been on mental health? Mind charityThe BBC is not responsible for the content of external sites.