Lead Poisoning Risk From Ceramics Shouldn't Be Glazed Over

 A family of five in New York City, including a young child, developed lead poisoning that was determined to be from use of ceramic cookware from Mexico, researchers said.

Elevated blood lead levels were discovered in the 3-year-old child during routine health screenings over several years, and subsequent testing of the child's two adult siblings, as well as the two parents, all revealed elevated lead levels, reported Paromita Hore, PhD, of the New York City Department of Health and Mental Hygiene, and colleagues.

Lead was detected in the glazed interior of ceramic ware that the family purchased in Mexico, which they were using to cook, store meals, and make coffee, the authors noted in the Morbidity and Mortality Weekly Report.

Hore and team cautioned that lead levels in traditional ceramic ware around the world can be "thousands of times higher" than U.S. limits, and that glaze or paint can transfer to food or drinks prepared or stored in these products. In fact, the New York Department of Health has linked ceramic ware from Ecuador, Mexico, Morocco, Turkey, the U.S., and Uzbekistan to cases of lead poisoning in children and adults.

This case was first discovered in September 2017, when the 3-year-old child had a blood lead level of 7 μg/dL, above the CDC reference value of 5 μg/dL, but below the Department of Health threshold of 10 μg/dL required for a home inspection. When the child had lead levels of 5 μg/dL in 2018, the Department of Health sent a letter to the family, recommending testing all family members and "avoiding the use of clay pots and dishes from other countries." The family declined a home inspection.

In November 2020, the child's entire family was screened for lead and all had blood lead levels ranging from 5 μg/dL to 53 μg/dL. During the follow-up risk assessment, the Department of Health learned that the family was using ceramic cookware from Mexico. The mother said she used Mexican spices for cooking and the father said he engaged in "household renovation activities," but the Department of Health was unable to collect samples, as the family again declined a home inspection.

After they stopped using the ceramic cookware, the family's blood lead levels declined to 2-21 μg/dL within 4 months, and 1-6 μg/dL after 14 to 16 months, Hore and colleagues noted.

The authors said that the Department of Health issued press releases in May 2017 and September 2021 about the risks of lead exposure in ceramic ware, and also issued a health advisory in 2021. However, they concluded that "ultimately, source control ... requires the engagement of global stakeholders."

Disclosures

Hore and co-authors disclosed support from the New York State Department of Health and support for attending CDC's 2019 National Healthy Homes and Lead Poisoning Prevention Training Center conference in Ohio and the Grantee Meeting in Atlanta.

One co-author disclosed support for traveling to CDC's National Healthy Homes and Lead Poisoning Prevention Training Center conferences in 2019 and 2020.

Primary Source

Morbidity and Mortality Weekly Report

Source Reference: Hore P, et al "Lead poisoning of a family of five resulting from use of traditional glazed ceramic ware -- New York City, 2017-2022" MMWR 2022; DOI: 10.15585/mmwr.mm7122a3.

https://www.medpagetoday.com/publichealthpolicy/publichealth/99019

Health Groups Critique Medicare Trustees Report

 Healthcare and economic groups were generally pleased with the results of the 2022 Medicare Trustees report, which predicted that the Medicare Hospital Insurance trust fund will likely be adequately funded until 2028 -- 2 years longer than last year's report predicted. However, concerns remained about Medicare's long-term financial outlook.

"We are encouraged that this report shows an improved outlook compared to last year's forecast," said Mary Beth Donahue, president and CEO of the Better Medicare Alliance, a lobbying group for Medicare Advantage plans, in a statement. But "as policymakers consider this report's findings and actions to secure Medicare in the years ahead, there are critical lessons to be drawn from Medicare Advantage," she added.

The AARP, a lobbying group for those ages 50 and older, was more circumspect.

The report "send[s] a clear message to Congress: despite the short-term improvement, you must act to protect the benefits people have earned and paid into both now and for the long term," AARP CEO Jo Ann Jenkins said in a statement. "The stakes are too high for the millions of Americans who rely on Medicare and Social Security for their health and financial well-being."

Medicare has two separate trust funds, the Hospital Insurance (HI) trust fund and the Supplementary Medical Insurance (SMI) trust fund. The HI trust fund pays for Medicare Part A, which covers inpatient hospital services, hospice care, and skilled nursing facility and home health services following hospital stays; SMI pays for Medicare Part B -- which covers visits to doctor's offices and other outpatient facilities -- and Part D, which covers prescription drugs. The HI trust fund is financed through a payroll tax, while SMI is financed roughly 25% by beneficiary premiums and 75% by general revenues.

The six trustees of those funds, as well as of the two Social Security trust funds, include the secretaries of Labor, Treasury, and Health and Human Services, as well as the Social Security commissioner. The other two trustee positions -- which are reserved for members of the public -- have been vacant since 2015.

Last year's trustees report predicted that the HI trust fund would stop being fully funded in 2026. This year's report, released on Thursday, predicted that point would come 2 years later -- in 2028. First, "HI income is projected to be higher than last year's estimates because both the number of covered workers and average wages are projected to be higher," they wrote. In addition, "HI expenditures are projected to be lower than last year's estimates in the beginning of the short-range period mainly due to the pandemic, but are projected to become larger after 2023 due to higher projected provider payment updates."

Over the longer term, "policymakers should determine effective solutions to the long-range HI financial imbalance," according to the report. "Even assuming that the provider payment rates will be adequate, the HI program does not meet either the trustees' short-range test of financial adequacy or long-range test of close actuarial balance. HI revenues would cover only 90% of estimated expenditures in 2028 and 80% in 2046."

The American Medical Association (AMA) remained concerned about Medicare's future, even with the 2-year delay in the HI insolvency date.

"Medicare trustees acknowledged that patients will face limited access to Medicare-participating physicians because of the long-term growing financial instability of the Medicare physician payment system," AMA President Gerald Harmon, MD, said in a statement. "The AMA welcomes this recognition and urges Congress to work with physician stakeholders to put the payment system on a sustainable path."

"Fiscal uncertainty is the only sure thing given the pandemic, statutory payment cuts, growing practice costs, and administrative burdens," he added. "This report is a wake-up call. We should not hit the snooze button."

In particular, the AMA highlighted a section on p. 190 of the report that reads in part, "Additional updates totaling $500 million per year and 5% annual bonuses are scheduled to expire in 2025, resulting in a payment reduction for most physicians. In addition, the law specifies the physician payment updates for all years in the future, and these updates do not vary based on underlying economic conditions, nor are they expected to keep pace with the average rate of physician cost increases ... Absent a change in the delivery system or level of update by subsequent legislation, the trustees expect access to Medicare-participating physicians to become a significant issue in the long term."

The outlook for the SMI trust fund looks much rosier because it's financed differently than the HI trust fund, according to the trustees.

"The trustees project that both the Part B and Part D accounts of the SMI trust fund will remain in financial balance for all future years because beneficiary premiums and general revenue transfers are assumed to be set at a level to meet expected costs each year," they said. However, they added, "SMI costs are projected to increase significantly as a share of GDP over the next 75 years, from 2.4% to 4.5% under current law."

https://www.medpagetoday.com/publichealthpolicy/medicare/99048

Genetic data indicate at least 2 separate monkeypox outbreaks underway, suggest wider spread

 The Centers for Disease Control and Prevention said Friday that new genetic sequencing data indicate there are at least two distinct monkeypox outbreaks underway outside Africa — a surprise finding that one official said suggests international spread is wider, and has been occurring for longer than has been previously realized.

Three of 10 viruses the CDC has sequenced from recent U.S. monkeypox cases — two from 2021 and eight from 2022 — are different from the viruses that have been sequenced by several countries involved in the large outbreak that is spreading in and from Europe. That outbreak is currently being driven by infections in gay, bisexual, and other men who have sex with men.

While the three divergent viruses are clearly linked to one another and have a common ancestor, they also differ more from one another than do the other viruses, Inger Damon, director of CDC’s division of high-consequence pathogens and pathology, told STAT in an interview.

The people infected in these three cases contracted the virus over a surprising geographic range of places — one in Nigeria, one elsewhere in West Africa, and the third in either the Middle East or East Africa. This apparent wide dissemination of a related virus — one that differs from the European outbreak strain — suggests monkeypox outbreaks outside of the countries where the virus is considered endemic may have been smoldering for longer than has been appreciated, Damon acknowledged.

“I think that is one very plausible explanation,” she said.

“What we think that this indicates is that there are likely multiple introductions out of Nigeria at points in the recent past, and there are likely additional transmission events occurring globally,” Damon said.

“It does raise the question … are there reservoirs and human infections occurring in a wider area? And I think it’s really a further understanding of the Middle East and East Africa as potential areas where the virus was introduced.”

Damon said it is unlikely that the three divergent sequences indicate that there was undetected domestic transmission in the U.S. after the Texas case last July. “We don’t have any evidence to support that at this point in time. The illness onset of these individuals was really associated with [their] travel event.”

Public health authorities have already raised concerns about whether monkeypox spread can be stopped, with Hans Kluge, the director of the European office of the World Health Organization, acknowledging earlier this week that it is currently unclear whether the outbreak will be contained.

When asked if she thought the spread of monkeypox could be stopped, Damon sidestepped the question.

“Everybody is working really hard to try to understand what’s happening and … to think about what public health tools can be used to prevent additional spread, including sort of looking at the use of vaccines and the use of therapeutics, which are not unlimited in supply,” she said. “I think it is only with the tight surveillance and looking at what is happening will we understand whether this is something that can be contained.”

The CDC had previously uploaded four genetic sequences of U.S. cases from 2022 to an internationally shared database. As of Thursday, 21 cases had been reported from 11 states since the current outbreak came to light.

On Friday, the CDC uploaded four more sequences from this year, plus two from independent introductions that occurred in 2021. Those 2021 cases, detected in July and November, were people who had traveled to Nigeria and returned to Texas and Maryland, respectively.

All of the recent U.S. cases were infected with the West African clade of monkeypox, which is also the clade responsible for the European outbreak. The West African clade causes milder disease than the Congo Basin clade, which has been seen to kill as many as one in 10 infected people in the Central African countries where it is found. The West African clade has a lower fatality rate, estimated to be around 1%. There have been no deaths reported yet among cases outside of Africa this year.

Since mid-May, when health authorities in the United Kingdom alerted the world to the fact that monkeypox was transmitting in that country, roughly 40 countries in Europe, the Americas, the Middle East as well as Australia have reported nearly 800 confirmed cases.

Damon said the six other viruses from 2022 that the CDC has sequenced are very similar to the viruses scientists in Europe have posted. “Those really cluster so closely that we really believe that they are all linked to the same outbreak,” she said, noting that the Maryland case from November was related to those viruses.

Damon said the new findings suggest that medical professionals should think monkeypox when faced with patients who have unusual sores or what could appear to be a sexually transmitted infection.

“If you see an unusual rash illness or you see something that looks to you like a sexually transmitted disease in terms of it, looks like syphilis, looks like herpes, we probably need to be thinking about testing for monkeypox,” she said.

https://www.statnews.com/2022/06/03/genetic-data-indicate-at-least-two-separate-monkeypox-outbreaks-underway-suggesting-wider-spread/

Weight loss from bariatric surgery associated with reduced risk of cancer

 Undergoing bariatric surgery in order to lose weight may substantially reduce some patients’ risk of cancer, according to a new study.

The finding, which mirrored the results of some previous studies, relied on observational data and not a randomized controlled trial, the gold standard of scientific research. Still, Ali Aminian, lead author of the study and director of Cleveland Clinic’s Bariatric & Metabolic Institute, described the data as “striking.”

The new study, conducted at the Cleveland Clinic, included 5,053 adult patients with obesity who had bariatric surgery and 25,265 who did not but were matched to the first group by characteristics such as sex, age, body mass index, smoking status, state of residence, and presence of type 2 diabetes.

Between 2004 and 2017, 96 patients in the surgery group and 780 in the control group developed cancer. That translates to a rate of 2.9% in the bariatric surgery group and 4.9% in the control group – meaning that patients who received surgery appear to have developed cancer 32% less often. Over 10 years, 0.8% of the patients in the bariatric surgery group and 1.4% of those in the control group died from cancer, a 48% difference in the rate of death. The results were published Friday in the Journal of the American Medical Association.

“Patients in this study were very obese,” wrote Joanne Elmore, a professor of medicine at the David Geffen School of Medicine, in an email. She noted that a BMI of 45, the median level for a patient, equates to a person who is 5’8” and weighs 300 pounds. She also pointed out that patients who choose to undergo bariatric surgery could be very different from those who don’t, which could bias the results. For instance, perhaps patients who undergo the surgery are trying to be healthier in other ways. Still, she said: “This study provides yet another reason to increase our efforts to maintain a healthier weight.”

Otis Brawley, a Bloomberg distinguished professor at Johns Hopkins University, said the results, when combined with previous research, mean that at least for people who have a high body mass index, bariatric surgery has a clear benefit.

“I’m pretty certain that the weight reduction in people with a high BMI prevents some cancers and some cardiovascular disease,” Brawley said.

However, Brawley noted, the data are weaker for people who are obese but have lower BMIs. He noted that most obese Americans have a BMI in the high 30s, significantly lower than the median BMI of 45 seen in the study.

Most of the patients enrolled in the study were women, who are more likely to undergo bariatric surgery. The most pronounced effect, Brawley noted, was in uterine cancers, which are more closely linked to obesity. Obese women have a 12-fold higher risk of uterine cancer. However, the study also saw substantially lower rates of colorectal, prostate, and breast cancers.

Steven Nissen, the study’s senior author and the chief academic officer of the Cleveland Clinic’s Heart, Vascular, and Thoracic Institute, said in a statement that the study provides “the best possible evidence on the value of intentional weight loss to reduce cancer risk and mortality.”

The results could play a role in an ongoing discussion over whether obesity should be treated medically. That could influence how often and when insurance companies cover bariatric weight loss surgery. It could also influence how insurance companies cover new classes of drugs that can be used for weight loss. These medicines, originally developed to treat diabetes, are gaining traction as weight loss treatments. They include Wegovy, from Novo Nordisk, and terzepitide, a new medicine being developed by Eli Lilly. Nissen is working with Lilly on the obesity medicine.

https://www.statnews.com/2022/06/03/weight-loss-from-bariatric-surgery-is-associated-with-a-reduced-risk-of-cancer-in-study/

CDC: 20 monkeypox cases detected in 11 states, viral strain IDd

 The number of monkeypox cases identified in the U.S. have doubled in the past week to 20, but the Centers for Disease Control and Prevention (CDC) says the risk to the public remains low and the strain causing these cases is believed to be a less severe version of the disease.

During a press briefing Thursday, officials from the CDC and the White House confirmed that 20 cases had been identified across 11 states.

“The strain of the monkeypox virus affecting patients in this outbreak is the West African clade, and that is less severe than other known clades [such as] the Congo Basin clade, meaning that in historical outbreaks in Africa it has led to fewer deaths,” said Jennifer McQuiston, deputy director for the CDC’s Division of High Consequence Pathogens and Pathology.

While the strain is believed to be a less severe one, McQuiston stressed that it should not be minimized since the virus can still result in pain due to its characteristic rash as well as severe scarring once the lesions have healed.

Most monkeypox cases in the U.S. have been found among men who have sex with men, but the CDC confirmed that one case had been found in a woman who had traveled to West Africa and reported having a heterosexual sex life.

The CDC provided a rough timeline of the monkeypox outbreak in the U.S., sharing that the first two cases were detected in men — one in Massachusetts and one in New York — who had traveled internationally.

The U.S. is currently following a strategy of containment to limit the spread of monkeypox by isolating cases, identifying people who have possibly been exposed and making sure that vaccines are offered to them. No monkeypox-related deaths have yet been reported.

So far, the federal government has delivered about 1,200 doses of smallpox vaccines believed to be effective against monkeypox as well as 100 courses of treatments to eight jurisdictions. The two smallpox vaccines that are being mobilized are Jynneos and the older ACAM2000.

CDC officials stressed that the agency currently has “more than enough vaccines” to handle the current infections, though they declined to specify how many vaccines doses are currently available in the U.S.

This week, jurisdictions including Chicago, Philadelphia, Los Angeles County and Georgia all reported their first cases of monkeypox for this year.

https://thehill.com/policy/healthcare/3510918-cdc-20-monkeypox-cases-detected-in-11-states-viral-strain-identified/

New Biogen/Ionis Data Suggests ALS Drug Effective Upon Earlier Initiation

 Biogen and Ionis Pharmaceuticals have announced results from the Phase III VALOR trial and an open-label extension (OLE) trial of amyotrophic lateral sclerosis (ALS) hopeful tofersen. This data suggests that earlier initiation of the drug compared to delayed initiation decreased declines in clinical function, respiratory function, muscle strength and quality of life.

Because the majority of patients in the trial survived without permanent ventilation (PV), neither PV nor median time to death could be estimated. But they argue early survival data hints at a lower risk of death or PV with earlier initiation of the drug.

In October 2021, Biogen put a positive spin on the failure of the VALOR trial. Although the drug missed the primary endpoint, the company emphasized favorable trends in multiple secondary and exploratory markers. Biogen is partnered with Ionis on the drug.

At the time, many analysts and skeptics wondered if Biogen was re-visiting its strategy for the controversial Alzheimer’s drug Aduhelm (aducanumab). When that drug failed clinical trials, the company revived it after an analysis of subgroups of the studies and evidence that it cleared amyloid plaque in the brain of Alzheimer’s patients, even if the clinical improvements weren’t as convincing. Aduhelm was approved under an accelerated approval pathway that depends upon surrogate biomarkers instead of clinical improvement.

Biogen’s announcement seemed to suggest that tofersen had positive effects on superoxide dismutase 1 (SOD1) levels in SOD1 ALS, even though it failed to hit the primary endpoint.

SOD1-ALS is a rare, progressive and fatal genetic form of ALS and affects about 2% of ALS patients. ALS, also known as Lou Gehrig's disease, is a fatal, progressive neurodegenerative disease with an average survival of three to five years, typically ending in respiratory failure.

Toferson is an antisense drug that binds to SOD1 messenger RNA (mRNA), helping it degrade by RNase-H, which decreases the synthesis of SOD1 protein production.

Biogen and Ionis presented their latest findings at the European Network to Cure ALS (ENCALS) meeting held in Edinburgh, Scotland.

“We are very pleased with these new 12-month data, which show that tofersen slowed disease progression and lowered neurofilament levels,” C. Frank Bennett, Ph.D., executive vice president, chief scientific officer and franchise leader for neurological programs at Ionis said. “Together, these results offer compelling evidence of tofersen’s potential to provide meaningful clinical benefit to people living with SOD1-ALS.”

The 12-month data compared initiation of tofersen at the start of VALOR to delayed initiation of the drug six months later in the OLE part of the study. Clinical function as measured by ALSFRS-R had a difference of 3.5 points; respiratory function measured by slow vital capacity had a difference of 9.2%-predicted; muscle strength as measured by the handheld dynamometry megascore had a difference of 0.28 and quality of life as measured by the 5-item ALS assessment questionnaire (ALSAQ-5) demonstrated a difference of 10.3 points.

For biomarkers, tofersen decreased CSF SOD1 protein levels by 33% in the early-start and 21% in the delayed-start group. The drug decreased plasma neurofilament levels, a marker of neuron injury, by 51% in the early-start cohort and 41% in the delayed-start cohort.

The most common side effects were headache, procedural pain, fall, back pain and pain in the extremities. Usually, they were mild to moderate. However, 36.5% reported serious adverse events in VALOR and/or the OLE and 17.3% of participants discontinued treatment because of them. Serious neurologic events included myelitis, radiculitis, aseptic meningitis and papilledema, which were reported in 6.7% of patients receiving toferson in VALOR and its OLE. There were also 14 reported deaths in patients receiving the drug in the studies, although none have been determined to be related to the drug.

ALS is a tough nut to crack and is a serious unmet medical need. In March, Biogen and Ionis reported another of their drugs for ALS, BIIB078, failed a Phase I trial in C9orf72-associated ALS. The drug was generally well tolerated but did not meet any secondary endpoints and didn’t show any clinical benefit. They discontinued that program.

It’s not all bad news, though. Just this week, Eledon Pharmaceuticals announced positive topline data from its Phase IIa trial of tegoprubart for ALS. The drug is a humanized monoclonal antibody that inhibits CD40 Ligand (CD40L). It hit the primary endpoints of safety and tolerability. Target engagement was seen at the 4 and 8 mg/kg dosing levels using CD40L and CXCL13 biomarkers related to T cell and B cell function, respectively, and a pro-inflammatory ALS signature was identified. Again, this is promising biomarker data, but not necessarily a definitive indication of clinical benefit, although Eledon hopes it is.

https://www.biospace.com/article/biogen-and-ionis-still-trying-to-support-als-drug-tofersen/

Novavax: 'Insufficient evidence' typing vaccine to heart inflammation

 Novavax Inc. NVAX, -19.39% said Friday that the company believes "there is insufficient evidence to establish a causal relationship" between its COVID-19 vaccine candidate and instances of myocarditis and pericarditis. Novavax's stock tumbled about 22% in trading on Friday after the Food and Drug Administration said the company's experimental two-dose vaccine could have a higher risk for myocarditis than what has been reported for the mRNA vaccines since they were authorized. (Both the Moderna Inc. and BioNTech SE BNTX, -0.85% /Pfizer Inc. PFE, +1.33% vaccines have since been fully approved by the FDA.) The regulator's report was released ahead of Tuesday's advisory committee meeting, where the group of advisors is set to vote on whether the benefits of Novavax's vaccine outweigh the risks. Novavax's stock is down 69.7% so far this year, while the broader S&P 500 SPX, -1.51% has declined 12.3%.

https://www.marketwatch.com/story/novavax-there-is-insufficient-evidence-tying-its-covid-19-vaccine-to-heart-inflammation-2022-06-03