Baby formula shortage stretches into eighth month

 Families across the country are still struggling to find baby formula as the crisis stretches into its eighth month. 

While stocking rates of baby formula have slowly been improving, certain supply is still struggling to rebound. 

The national in-stock rate for baby formula has climbed back to 82.24%, but the supply is still below the 89% supply families were accustomed to before the formula crisis began in February. 

Around 33% of American families were still struggling to find baby formula in September, according to the U.S. Census Bureau’s Household Pulse Survey. Meanwhile, nearly one in five affected households has less than one week of formula accessible, the same survey reveals. 

Mothers in rural areas are having the hardest time accessing formula. 

"In rural parts of my district, there are still empty shelves in key communities," Rep. Elise Stefanik, R-N.Y., told FOX Business. "Working families are having to drive further and further distances to access if they need specialty formula or if they need regular formula and their store is sold out."

Stefanik experienced the empty shelves firsthand after Abbott’s plant shut down in February when a recall compounded ongoing supply-chain hurdles. As a new mother, she scrambled to find formula in her rural district in upstate New York, with stores rationing supply and speciality types of formula unavailable on shelves. 

Lawmakers like Stefanik have been calling on the Food and Drug Administration (FDA) to address why the agency has not acted swiftly enough in response to the shortages and introduced bills that would accept additional formula manufactures to market. Part of the proposed legislation would allow more foreign imports of formula. 

While the FDA eased federal import regulations and the Biden administration airlifted millions of pounds of formula from overseas, some mothers worry that it’s a short-term fix to a market that lacks enough domestic manufacturing. 

Jerri Janelle Rayburg, a mom of two, struggled her entire maternity leave to find formula for her newborn son who was diagnosed with a milk protein allergy. She spent hours driving to five or more stores looking for the hyper-allergenic, sensitive and amino-based product, and found herself relying on imported formula. 

"My formula's being shipped in from Switzerland," Rayburg told FOX Business. "There shouldn't be any reason why you are saying that we can't get formulas from other countries, especially when they are just as good."

Moms like Rayburg are still resorting to Facebook groups, crowd-sourcing platforms and even tracking sites to secure formula. On many occasions, Rayburg meets up with locals to get samples and also ships out formula that she didn’t or couldn’t use to other moms in need. Other times, she relies on text messages from FindMyBabyFormula.com, a free website that helps families track down baby formula. 

She is not the only one who still taps into resources like these to feed her baby.

Ken, founder of FindMyBabyFormula.com, says that the site still sees a large amount of traction today, six months after he built it. 

"I'm still a little shocked by how many users we are seeing every day considering that we don't do any advertisements," Ken told FOX Business. "I would have expected 10 or 20 a day, but we're still receiving, well over 150 a day." 

The tracking website allows users to find specific formulas in their region by signing up with a phone number and ZIP code. Once the product becomes available, the user will receive a text message. 

As a new father and computer programmer, Ken took on the initiative as a side project for friends and family after realizing how many baby formulas exist on the market, with many catering to specific needs. He never anticipated that 500 sign-ups within the first few weeks would surpass 100,000 sign-ups several months later. 

"While we might say the national average is up, that doesn't mean that the formula that you need, that your specific child needs is in stock," Ken said. "That's where the problem still is."

Empirical evidence from his ZIP code data suggests that formula is being shipped in batches by region to stock up stores, which is causing product inventory to dial back in the gaps of time in between. 

In addition, Ken still receives about 10 emails per day from mothers who are looking to re-subscribe to the text messages after opting out earlier on because they need formula again. 

"It’s causing more issues not only for moms, but for people who need it to be able to live every single day," Rayburg said. 

https://www.foxbusiness.com/lifestyle/baby-formula-shortage-stretches-eighth-month

Brussels Terror Attack Victim Euthanized at Age 23

 Performing euthanasia for "mental suffering that cannot be alleviated" is still considered an extraordinary measure. Indeed, fewer than 2% of the requests for euthanasia fall within that category, and few such requests are made by young patients.

There is no doubt that people will talk about the case of Shanti De Corte not only because of the reason stated in her euthanasia request but also because someone so young was able to meet the strict conditions required for the law to be applicable. It's something that Belgian broadcaster RTBF brought up during a recent episode of #Investigation, which reported on the aftermath of the 2016 Brussels attacks.

On May 7, surrounded by her family, Shanti was euthanized. She was 23 years old. Six years earlier, on March 22, 2016, Shanti had been at Brussels Airport when terrorists set off bombs. She was in the departures area with 90 other students from Sint-Rita Campus College, located in the northern town of Kontich. Shanti was only a few meters away from the blast. Although she was not physically injured, the Flemish teen was traumatized by the attack. This was confirmed by the school psychologist who treated the students. "There were some students who reacted worse than others to these traumatic events. And having had two discussions with Shanti, I can tell you that she was one of these students who were more sensitive to the effects. To me, it's quite clear. Even before the attacks, she'd experienced serious psychological issues. Therefore, I referred her for psychiatric care."

Eleven Antidepressants Daily

A few weeks after that March day, Shanti was admitted to a psychiatric hospital in Antwerp. It was a place she knew well, having been an inpatient there several times before the attacks. Shanti was treated with antidepressants. She shared her thoughts about them on numerous occasions. "I get several drugs at breakfast and up to 11 antidepressants a day. I couldn't do without them. With all the drugs I take, I feel like a ghost who doesn't feel anything anymore. Perhaps there were solutions other than the drugs."

It was a brief respite. In 2020, Shanti attempted suicide. Her spirits were at their lowest. She was heavily medicated, and her medication had been increased over time. She turned down therapeutic help that was offered by a therapist who specializes in treating the victims of the Brussels attacks. The student got in touch with the Life End Information Forum, an association that supports the right to die with dignity. In April 2022, Shanti submitted a new euthanasia request, stating that she was in a medically futile condition of mental suffering. Two psychiatrists granted their approval.

A Small Proportion

Last March, the Federal Commission for the Control and Evaluation of Euthanasia reported on data from 2021. "There continues to be a very small number of euthanasia requests that cite mental and behavioral disorders (psychiatric conditions, such as personality disorders, and cognitive issues, like Alzheimer's disease, are included in this group): 1.9% of all cases of euthanasia. Like all euthanasia files, these requests meet the legal conditions (the patient is legally competent, the request is in writing, the condition is medically futile, and the suffering — which is constant, unbearable, and cannot be alleviated — results from a serious and incurable disorder; the request is well-considered and repeated)," the report states.

This article was translated from MediQuality.

https://www.medscape.com/viewarticle/982984

What Is Palliative Sedation, and How Is It Administered?

Recent news stories relating to the "end of life" have brought public attention to palliative sedation (PS), a therapeutic procedure about which unfortunately little is known in the healthcare world and among the public. This lack of knowledge stems from the fact that, thus far, university courses have almost never provided for the systematic teaching of palliative care. This shortcoming leads to a certain resistance to its implementation or, even worse, confusion of PS with medically assisted death (MAD), a term that includes euthanasia and medically assisted suicide. Media debate has often contributed to this confusion, although there has been a higher quality of information and a reduction of semantic and conceptual ambiguity in the most recent news stories. The Italian Palliative Care Society (SICP) has published numerous press releases concering PS. To understand the difference between PS and MAD, it is necessary to know the constituent elements of the two procedures.

Palliative Sedation

In the document titled, "SICP Recommendations on Terminal Sedation/Palliative Sedation," this practice is defined as "the intentional reduction of alertness, up to a loss of consciousness, by pharmacological means to reduce or abolish the perception of a symptom that is otherwise intolerable for the patient, despite the most adequate means having been put in place to control the symptom, which is therefore refractory."

The refractoriness of a symptom means the impossibility of adequately controlling it with traditional treatments (ie, those that do not depress the state of alertness) that are tolerable, effective, and viable in the conditions and in the time available by a healthcare professional expert in palliative care.

Another important defining element is the time frame in which palliative sedation is considered lawful: the phase of imminent death, which can refer to the last 15 days of life. The imminent phase of death is also referred to in the literature as "last hours–last days."

According to the literature, palliative sedation is mainly carried out in the last 2 to 3 days of life.

The percentage of cases in which it is practiced varies significantly (10% to 43% of deceased patients), depending on many factors (case mix of patients, setting, professional skills, cultural attitudes, etc). The average values are 12% to 16%. As regards continuous deep sedation, the incidence reported in the literature is 5% to 15%.

The indications for starting PS include the onset of acute events that involve a situation of impending death and the progressive worsening of the psychophysical symptom that becomes refractory to the best possible treatments.

Acute events with impending risk of death are mainly respiratory distress due to suffocation (eg, massive pulmonary embolism, pulmonary edema, respiratory tract hemorrhage, massive inhalation of gastroenteric material, superior vena cava syndrome, etc); massive bleeding judged to be affecting the digestive and respiratory tracts, the large vessels of the neck or groin, or vegetating tumor masses; and states of epileptic disease.

In these cases, PS can be employed as an emergency treatment, owing to the inevitability of death and the extreme psychophysical suffering of the patient. The settings in which this emergency PS takes place are obviously manifold and include the home environment, the hospice, or other places of hospitalization, such as nursing homes, hospital wards, urgent and emergency care departments, and intensive care units. 

Progressively refractory physical symptoms are represented in both oncologic and chronic-degenerative diseases due to dyspnea (35% to 50% of cases), terminal psychomotor agitation (delirium, 30% to 45% of cases), incoercible nausea and vomiting from intestinal occlusion (25%), and status epilepticus. Pain is rarely reported (5%). Symptoms can become refractory in any oncologic disease, although they occur more frequently in lung, gastrointestinal, head and neck, and breast cancers.

Among nononcologic diseases, the appearance of refractory symptoms is more frequent in association with neurologic pathology (such as amyotrophic lateral sclerosis, muscular dystrophy, Parkinson's disease, multiple sclerosis, dementia, etc) and in chronic respiratory disease, cardiomyopathy, nephropathy, and metabolic pathology. Contrary to what is generally thought, in the final phase of nononcologic pathology, the suffering induced by refractory symptoms (especially dyspnea and delirium) is of similar, if not higher, intensity, compared with that present in a cancer patient.

Psychological symptoms are psychoexistential suffering, which in many cases is directly proportional to the severity of the physical symptoms, but there are rare cases in which psychoexistential distress is present without being associated with physical suffering. In cases in which this distress is refractory to available treatments (pharmacologic or psychotherapeutic treatment, socioeducational and spiritual support), there is an indication for PS.

The types of PS are emergency sedation, relief sedation or temporary sedation, intermittent sedation, and deep continuous sedation.

Emergency sedation is carried out in the immediately preterminal phases in patients suffering from catastrophic events such as asphyxia, massive hemorrhage, epileptic status, and so on.

Respite sedation or transient sedation may be indicated in earlier termination stages to induce temporary relief, pending the benefit of treatments aimed at symptom control or, more frequently, to control psychoexistential suffering when it is predicted that survival will be greater than 2 weeks.

Intermittent sedation is a relief sedation that is repeated several times or cyclically (eg, in nocturnal phases) as agreed upon with the patient to interrupt the phases of deepest and most intolerable distress.

Deep continuous sedation is most frequently applied in palliative care and involves a progressive increase in the level of sedation due to the increase in suffering upon the worsening of the refractory symptom. Indeed, some authors use the term "proportionate palliative sedation" to emphasize this important concept of proportionality.

The drugs used to implement PS are sedatives, especially benzodiazepines (midazolam as a first-choice drug), variously in association with neuroleptics (primarily haloperidol). More rarely, barbiturates or propofol is used in particular conditions. Opiates should not be used for sedative purposes but can be combined for the control of dyspnea and pain.

The types of sedative drugs that can be used are described in the literature.

Since the fundamental objective of PS is to obtain and maintain adequate control of suffering induced by psychophysical symptoms, there are theoretically no maximum doses of sedatives.

Important Distinctions

The empirical and moral distinction between PS and MAD is based on the constituent elements of the procedure: aim (or intention), types of drugs, dosages and route of administration, and final result.

Indeed, the aim of the procedure in PS is the control of suffering and not the induction of death in the patient, as in MAD.

The types of drugs, dosages, and routes of administration used in PS are intended to reduce the perception of suffering (through a proportionate reduction in alertness), not for the rapid induction of death, as is the case in MAD.

The result in PS is the reduction of the perception of suffering through sedative drugs, while in MAD it coincides with the death of the patient. Therefore, it can be concluded that PS is different from MAD, since the latter has the aim of causing the patient's death by using lethal drugs, dosages, and suitable routes of administration.

In recent years, it has become evident that the hypothesized anticipation of death linked to PS is disproved by studies that, starting from the Cochrane review, confirm the absence of respiratory depression and an anticipation of death in sedated patients, compared with those not sedated. Conversely, there are even studies that report a longer survival among sedated patient groups.

Comments

This looks and sounds like medical euthanasia, is it really needed?

William Wilson, BSPharmPharmacist Critical CareFlorida, United States

https://www.medscape.com/viewarticle/983097

Blood Clot Risk Much Higher in Mild COVID Sufferers: Study

 People who got a mild case of COVID-19 in the first year of the pandemic were almost three times as likely to develop blood clots, according to a new British study.

Mild COVID means the patient wasn't hospitalized.

It brought a 2.7 times higher risk of blood clots, the study in Heart says. Those patients were 10 times more likely to die than people who didn't have COVID at all.

Hospitalized patients fared worse – they were almost 28 times more likely to develop blood clots, the research says.

They were also almost 22 times more likely to have heart failure and 17.5 times more likely to suffer a stroke.

Hospitalized COVID-19 patients were more than 100 times more likely to die than people who did not have COVID-19.

Researchers said the risk of cardiovascular disease was highest in the first 30 days after infection.

CNBC reported on the study, saying it followed 18,000 people who got the disease in the pandemic's first year. It compared them with 34,000 people who didn't get it. The study ended in March 2021 and was mostly done before vaccinations began in Britain in December 2020.

"Our findings highlight the increased cardiovascular risk of individuals with past infection, which are likely to be greater in countries with limited access to vaccination and thus greater population exposure to COVID-19," the authors of the study wrote.

Sources

Heart, a journal of the British Medical Journal and British Cardiovascular Society: "Cardiovascular disease and mortality sequelae of COVID-19 in the UK Biobank"

https://www.medscape.com/viewarticle/983129

Beware When Anesthesia in the ICU Runs Afoul of the Law

 Clinicians may be surprised that rules governing deep procedural sedation in intensive care settings forbid certain practices that seem like standard care, according to a discussion at this year's American Society of Anesthesiologists (ASA) annual meeting.

"The way you think is okay, it's how things should work, [is] running afoul of federal regulation and the law. Some things are common sense and might [seem] fine, but the reality is they're running askew of what the federal government wants us to do," warned Grant Lynde, MD, MBA, an operating room anesthesiologist at Emory University School of Medicine in Atlanta.

The problem is that deep procedural sedation in intensive care often amounts to general anesthesia and is potentially unsafe when administered by the wrong person.

Lynde explained that most critical care proceduralists do not want the patient responsive to painful stimulation during procedures. The anesthesia that the proceduralists really want may be deeper than what they're asking for, and then the issue turns into who can administer that deeper sedation or general anesthesia.

In practice, depending on the state, only an anesthesiologist or another physician -- not a trained RN -- can give deep sedation in the ICU. On occasion, it's "less than desirable" but perhaps okay if a patient getting moderate sedation from a nurse gets a little extra and ends up in deep sedation; if this is routinely done for everyone, however, "you're committing Medicare fraud," Lynde said.

He added that it's also not acceptable for anesthesiologists to intubate patients and walk away just before a procedure is performed by someone else.

ASA and federal guidelines say that anyone administering and monitoring deep sedation must be dedicated to that task, meaning that they cannot be the same person performing the diagnostic or therapeutic procedure. Non-anesthesiologists must be qualified and trained to recognize and rescue from general anesthesia.

The regulations may be "difficult to reconcile with contemporary practice in anesthesiology care in the ICU," said session moderator and critical care anesthesiologist Craig Jabaley, MD, also of Emory.

"Deep procedural sedation occurs in a variety of settings whether that's okay or not," said Zackary Chancer, MD, MS, a critical care anesthesiologist at the University of Southern California in Los Angeles, to nervous chuckling from the audience.

He cited intubation, tracheostomy, intracranial monitor placement, and fracture reduction as ICU procedures requiring deep sedation. Other procedures for which deep sedation can also be administered include endoscopy, percutaneous endoscopy gastrostomy, bronchoscopy, cardioversion, wound debridement, and extracorporeal membrane oxygenation cannulation.

To "stay on the side of righteousness," Lynde advised his audience to double-check these rules with local compliance officers, their billing company, and state regulation.

Jabaley noted that there is some institutional variability in how professional guidance is interpreted, and he commiserated with an audience member's complaint that the hospital billers are unhelpful when she has these questions.

Jabaley stressed the importance of a training pathway and robust quality assurance and improvement program that covers both regulatory and clinical aspects of anesthesia in critical care settings.

The important thing is ICU leadership, said Chancer: without the leaders on board, the illegal practices are unlikely to stop.

Disclosures

Chancer, Jabaley, and Lynde disclosed no relevant ties to industry.

Primary Source

American Society of Anesthesiologists

Source Reference: "Point-counterpoint -- Procedural sedation in critical care: treading on thin ice?" ASA 2022; Session PC302.

https://www.medpagetoday.com/meetingcoverage/asa/101440

Giving DHA to Preterm Infants May Improve IQ

 Giving omega-3 fatty acid supplements in the first few months of life to preterm infants born before 29 weeks gestation appeared to modestly boost IQ scores at 5 years of age, researchers reported.

The study involved a subset of children originally enrolled as preterm infants in the randomized N-3 Fatty Acids for Improvement in Respiratory Outcomes (N3RO) trial, which assessed the impact of docosahexaenoic acid (DHA) supplementation on the common preterm birth complication bronchopulmonary dysplasia.

At 5 years of age, children in the DHA supplementation arm of the original trial had full-scale intelligence quotient (FSIQ) scores that were 3.5 points higher than those who did not receive the supplements, Jacqueline Gould, PhD, of the South Australian Health and Medical Research Institute in North Adelaide, and colleagues, reported in the New England Journal of Medicine.

In an email exchange with MedPage Today, Gould characterized the 3.5-point difference as a modest but meaningful difference that could have an impact on educational and vocational outcomes.

"It is difficult to pinpoint the impact [of a 3.5-point IQ difference] for an individual child as there is so much variability from child to child, and IQ is a summary of multiple cognitive abilities that may be differently affected in different children," Gould said, adding that in some children the benefit may be restricted to memory or attention, and in others it may be more global.

In the original N3RO study infants born before 29 weeks gestation were randomized to receive daily doses of 60 mg of DHA per kg of body weight or a control emulsion from the first 3 days of life through week 36 of postmenstrual age or discharge from the neonatal intensive care unit, whichever came first.

Gould explained that infants born this early do not get the DHA from the placenta that full-term babies get. Placental DHA accumulates in the brain during the final trimester of pregnancy, making up approximately 30% of the brain's lipid content.

"Infants born this early miss over 10 weeks of the placental supply of DHA during a key period of development, and are the most at-risk subgroups of preterm infants likely to have a DHA insufficiency as well as cognitive impairment and a lower IQ," Gould said.

The follow-up study included 480 of the 702 children who underwent randomization for the original trial at five Australian centers and who also had FSIQ scores available at 5 years of age (241 in the DHA group and 239 in the control group).

Mean corrected age at IQ assessment was similar in the two treatment groups (roughly 5.3 years in both groups), and other characteristics were also similar.

Mean FSIQ scores at approximately 5 years of age were 95.4±17.3 in the DHA group and 91.9±19.1 in the control group, for a difference of 3.45 points (95% CI 0.38-6.53, P=0.03).

Children who did not get DHA supplementation in the first few months of life were no more likely than those who did to have a diagnosis of autism spectrum disorder, attention deficit-hyperactivity disorder, or other behavioral disorders at age 5 years (below 7.0% in both groups).

The researchers noted that there have been three earlier randomized, controlled trials that have examined the impact of supplemental DHA from birth in preterm infants that "showed mostly null effects on cognition."

And in the original N3NO study and the newly reported follow-up study, the premature birth complication bronchopulmonary dysplasia was slightly more common in the infants given DHA supplements.

Bronchopulmonary dysplasia in preterm infants increases the risk for lower IQ, and Gould and colleagues wrote that the higher IQ scores in the children who received the DHA supplements in the follow-up study suggest "that the possible mechanisms underlying the cognitive effects may be independent of those underlying the effects on the risk of bronchopulmonary dysplasia."

The follow-up study's higher than expected attrition due to the COVID-19 pandemic was cited by the researchers as a study limitation, but they noted that the trial "met the sample size that was calculated to provide 80% power to detect a 4-point difference between groups."

"The effect that we detected (3.5 points) was smaller than the 4-point effect size that has previously been a catalyst for changes to public health policy, yet an effect of 3.5 points may confer a benefit to individual infants," the researchers wrote.

Gould noted that there are currently no set guidelines for DHA supplementation in preterm infants.

"One of our next steps in this research is to work with clinicians to determine recommendations and guidelines," she said. "This DHA intervention is one of the first that clinicians may be able to use while infants born before 29 weeks gestation are still in the hospital to improve their IQ. We suggest clinicians consider and discuss these findings with caregivers of preterm infants."

Disclosures

Funding for the research was provided by the National Heart and Medical Research Council and by Nu-Mega Ingredients.

Gould reported grants from and/or other relationships with Nu-Mega Ingredients, Fonterra Co-operative Group, and Nestle; several co-authors reported grants from Australia's National Health and Medical Council.

Primary Source

New England Journal of Medicine

Source Reference: Gould, JF, et al "Neonatal docosahexaenoic acid in preterm infants and intelligence at 5 years" N Engl J Med 2022; DOI: 10.1056/NEJMoa2206868.

https://www.medpagetoday.com/obgyn/pregnancy/101443

Triple Meeting – Merus drops as competition concerns hit

 Merus looks like it will be first to market in a tiny niche, NRG1-fusion driven cancers, with its lead asset zenocutuzumab. But investors are clearly hoping for bigger things from an earlier project, the EGFR/cMet bispecific MCLA-129; unfortunately, data presented on this asset in a poster at the Triple Meeting sent the group’s shares down 10% yesterday. At issue is whether MCLA-129 can compete with Johnson & Johnson’s similarly acting Rybrevant, which is already approved for NSCLC driven by EGFR exon 20 insertions, and in combo studies for broader EGFR-mutant use. Data from MCLA-129’s phase 1/2 study looked worse than an earlier abstract, and in line with early results with Rybrevant. Across 18 evaluable patients with various cancers and EGFR mutations, there were two confirmed partial responses; a further unconfirmed PR is unlikely to be confirmed, SVB analysts noted. A dose-expansion portion of the trial will focus on, among other things, NSCLC with exon 20 insertions or cMet exon 14 skipping; the former will be tough to break into given Rybrevant’s presence but the latter could be attractive, since J&J has not pursued this use as rapidly, Stifel wrote. The question is whether another such niche could help justify Merus’s almost $1bn valuation.

Selected EGFR x cMet bispecifics in development
Project/product	Company	Status
Rybrevant	J&J	Approved 2021 for NSCLC with EGFR exon 20 insertion mutations; 2L & 1L Mariposa-2 & Mariposa combo trials ongoing
MCLA-129	Merus	Ph1/2 monotherapy data at Triple Meeting Oct 2022; 2/18 PRs (from 2/13 in abstract)
EMB-01	Epimab	Ph1/2 monotherapy data at ELCC 2022; ph1/2 EMB-01 + Tagrisso in EGFR-mutant NSCLC not yet recruiting
CKD-702	Chong Kun Dang Pharma	Ph1/2 monotherapy data in NSCLC at Esmo 2022; 2/24 confirmed PRs
LY3164530	Lilly	Abandoned after tox seen in ph1
Source: Evaluate Pharma, clinicaltrials.gov & Stifel note Oct 12, 2022. https://www.evaluate.com/vantage/articles/events/conferences-snippets/triple-meeting-merus-drops-competition-concerns-hit