Nutrition and breastfeeding
Breastfeeding mothers are advised to include a variety of foods in their daily diets, and increase their fluid intake or drink the recommended daily intake of water to stay hydrated
View the full post Nutrition and breastfeeding on NOW Grenada.
Breastfeeding mothers are advised to include a variety of foods in their daily diets, and increase their fluid intake or drink the recommended daily intake of water to stay hydrated
View the full post Nutrition and breastfeeding on NOW Grenada.
1 year 5 months ago
Health, PRESS RELEASE, breastfeeding, breastmilk, CDC, gfnc, grenada food and nutrition council, us centres for disease control
Health Archives - Barbados Today
Surveillance systems in place ahead of thousands arriving for World Cup
Health authorities have implemented robust measures to safeguard the island against potential disease outbreaks ahead of the T20 Cricket World Cup, which is set to welcome thousands of visitors in the coming weeks, the country’s chief medical officer has assured.
And the island’s top doctor has declared the COVID-19 pandemic that killed 650 Barbadians from more 100 000 cases is effectively over and the Ministry of Health has stopped vaccinating citizens.
In an exclusive interview with Barbados TODAY on Monday, Dr Kenneth George said: “We have put surveillance systems in place. We have trained several persons not particularly in public health with respect to managing unusual outbreaks.”
With tourists expected from both traditional and non-traditional markets, Dr George highlighted the government’s concerns regarding certain non-COVID diseases.
“There are other diseases of public health concern which we are monitoring,” he said. “We have made sure that our Barbados Drug Service has the appropriate drugs
available for the treatment of any cases of tuberculosis, malaria…because, when people travel, they travel sometimes with the disease.”
Despite the anticipated influx of foreign visitors during the prestigious tournament, the chief medical advisor expressed optimism about the public health situation.
He said the outlook for the World Cup “is good”.
“I don’t expect any major outbreak of any serious disease,” he said, emphasising the importance of proper food handling practices “to protect the food source for Barbadians and visitors alike”.
In a new development, Dr George reported that while “a few” COVID-19 cases emerge occasionally, there is currently “no active” vaccine programme related to the virus.
“We haven’t given AstraZeneca vaccine for about 18 months. There has been no AstraZeneca vaccine on the market in Barbados for a while. The COVID pandemic is over…we still get a few cases, and there is no active vaccine in Barbados for COVID at the moment.”
This revelation comes after AstraZeneca’s decision to withdraw its COVID-19 vaccine from further production, citing a shift in demand towards newer, updated vaccines due to the emergence of new variants.
While the vaccine was estimated to have saved millions of lives from more than three billion doses, it has also been liked to rare, and sometimes fatal, blood clots.
Addressing the unavailability of COVID-19 vaccines in Barbados, Dr George explained: “We are not vaccinating people. The reason is that vaccines are very expensive, and the smaller markets were traditionally shut out. We had gotten a few offers of vaccine, but the vaccines were too close to the expiratory date; and we took a decision that we are not going to take vaccines from countries that wanted to offer vaccines to Barbados.”
The chief medical officer reiterated the ministry’s stance on administering only efficacious vaccines to Barbadians, considering factors such as expiry dates.
“There are no [COVID] vaccines available in Barbados, period,” he declared.
emmanueljoseph@barbadostoday.bb
The post Surveillance systems in place ahead of thousands arriving for World Cup appeared first on Barbados Today.
1 year 5 months ago
Health, Local News
PAHO/WHO | Pan American Health Organization
GAFFI and PAHO Join Forces to Combat Fungal Disease in Latin America and the Caribbean
GAFFI and PAHO Join Forces to Combat Fungal Disease in Latin America and the Caribbean
Cristina Mitchell
14 May 2024
GAFFI and PAHO Join Forces to Combat Fungal Disease in Latin America and the Caribbean
Cristina Mitchell
14 May 2024
1 year 5 months ago
Nursing Homes Wield Pandemic Immunity Laws To Duck Wrongful Death Suits
In early 2020, with reports of covid-19 outbreaks making dire headlines, Trever Schapers worried about her father’s safety in a nursing home in Queens.
She had delighted in watching her dad, John Schapers, blow out the candles on his 90th birthday cake that February at the West Lawrence Care Center in the New York City borough. Then the home went into lockdown.
In early 2020, with reports of covid-19 outbreaks making dire headlines, Trever Schapers worried about her father’s safety in a nursing home in Queens.
She had delighted in watching her dad, John Schapers, blow out the candles on his 90th birthday cake that February at the West Lawrence Care Center in the New York City borough. Then the home went into lockdown.
Soon her father was dead. The former union painter spiked a fever and was transferred to a hospital, where he tested positive for covid, his daughter said, and after two weeks on a ventilator, he died in May 2020.
But when Trever Schapers sued the nursing home for negligence and wrongful death in 2022, a judge dismissed the case, citing a New York state law hastily passed early in the pandemic. It granted immunity to medical providers for “harm or damages” from an “act or omission” in treating or arranging care for covid. She is appealing the decision.
“I feel that families are being ignored by judges and courts not recognizing that something needs to be done and changed,” said Schapers, 48, who works in the medical field. “There needs to be accountability.”
The nursing home did not return calls seeking comment. In a court filing, the home argued that Schapers offered no evidence that the home was “grossly negligent” in treating her father.
More than four years after covid first raged through many U.S. nursing homes, hundreds of lawsuits blaming patient deaths on negligent care have been tossed out or languished in the courts amid contentious legal battles.
Even some nursing homes that were shut down by health officials for violating safety standards have claimed immunity against such suits, court records show. And some families that allege homes kept them in the dark about the health of their loved ones, even denying there were cases of covid in the building, have had their cases dismissed.
Schapers alleged in a complaint to state health officials that the nursing home failed to advise her that it had admitted covid-positive patients from a nearby hospital in March 2020. In early April, she received a call telling her the facility had some covid-positive residents.
“The call I received was very alarming, and they refused to answer any of my questions,” she said.
About two weeks later, a social worker called to say that her father had a fever, but the staff did not test him to confirm covid, according to Schapers’ complaint.
The industry says federal health officials and lawmakers in most states granted medical providers broad protection from lawsuits for good faith actions during the health emergency. Rachel Reeves, a senior vice president with the American Health Care Association, an industry trade group, called covid “an unprecedented public health crisis brought on by a vicious virus that uniquely targeted our population.”
In scores of lawsuits, however, family members allege that nursing homes failed to secure enough protective gear or tests for staffers or residents, haphazardly mixed covid-positive patients with other residents, failed to follow strict infection control protocols, and brazenly misled frightened families about the severity of covid outbreaks among patients and staff.
“They trusted these facilities to take care of loved ones, and that trust was betrayed,” said Florida attorney Lindsey Gale, who has represented several families suing over covid-related deaths.
“The grieving process people had to go through was horrible,” Gale said.
A Deadly Toll
KFF Health News found that more than 1,100 covid-related lawsuits, most alleging wrongful death or other negligent care, were filed against nursing homes from March 2020 through March of this year.
While there’s no full accounting of the outcomes, court filings show that judges have dismissed some suits outright, citing state or federal immunity provisions, while other cases have been settled under confidential terms. And many cases have stalled due to lengthy and costly arguments and appeals to hash out limits, if any, of immunity protection.
In their defense, nursing homes initially cited the federal Public Readiness and Emergency Preparedness Act, which Congress passed in December 2005. The law grants liability protection from claims for deaths or injuries tied to vaccines or “medical countermeasures” taken to prevent or treat a disease during national emergencies.
The PREP Act steps in once the secretary of Health and Human Services declares a “public health emergency,” which happened with covid on March 17, 2020. The emergency order expired on May 11, 2023.
The law carved out an exception for “willful misconduct,” but proving it occurred can be daunting for families — even when nursing homes have long histories of violating safety standards, including infection controls.
Governors of at least 38 states issued covid executive orders, or their legislatures passed laws, granting medical providers at least some degree of immunity, according to one consumer group’s tally. Just how much legal protection was intended is at the crux of the skirmishes.
Nursing homes answered many negligence lawsuits by getting them removed from state courts into the federal judicial system and asking for dismissal under the PREP Act.
For the most part, that didn’t work because federal judges declined to hear the cases. Some judges ruled that the PREP Act was not intended to shield medical providers from negligence caused by inaction, such as failing to protect patients from the coronavirus. These rulings and appeals sent cases back to state courts, often after long delays that left families in legal limbo.
“These delays have been devastating,” said Jeffrey Guzman, a New York City attorney who represents Schapers and other families. He said the industry has fought “tooth and nail” trying to “fight these people getting their day in court.”
Empire State Epicenter
New York, where covid hit early and hard, is ground zero for court battles over nursing home immunity.
Relatives of residents have filed more than 750 negligence or wrongful death cases in New York counties since the start of the pandemic, according to court data KFF Health News compiled using the judicial reporting service Courthouse News Service. No other area comes close. Chicago’s Cook County, a jurisdiction where private lawyers for years have aggressively sued nursing homes alleging poor infection control, recorded 121 covid-related cases.
Plaintiffs in hundreds of New York cases argue that nursing homes knew early in 2020 that covid would pose a deadly threat but largely failed to gird for its impact. Many suits cite inspection reports detailing chronic violations of infection control standards in the years preceding the pandemic, court records show. Responses to this strategy vary.
“Different judges take different views,” said Joseph Ciaccio, a New York lawyer who has filed hundreds of such cases. “It’s been very mixed.”
Lawyers for nursing homes counter that most lawsuits rely on vague allegations of wrongdoing and “boilerplate” claims that, even if true, don’t demonstrate the kind of gross negligence that would override an immunity claim.
New York lawmakers added another wrinkle by repealing the immunity statute in April 2021 after Attorney General Letitia James noted the law could give nursing homes a free pass to make “financially motivated decisions” to cut costs and put patients at risk.
So far, appeals courts have ruled lawmakers didn’t specify that the repeal should be made retroactive, thus stymying many negligence cases.
“So these cases are all wasting the courts’ time and preventing cases that aren’t barred by immunity statutes from being resolved sooner and clogging up the court system that was already backlogged from COVID,” said attorney Anna Borea, who represents nursing homes.
Troubled Homes Deflect Suits
Some nursing homes that paid hefty fines or were ordered by health officials to shut down at least temporarily because of their inadequate response to covid have claimed immunity against suits, court records show.
Among them is Andover Subacute and Rehabilitation nursing home in New Jersey, which made national headlines when authorities found 17 bodies stacked in a makeshift morgue in April 2020.
Federal health officials fined the facility $220,235 after issuing a critical 36-page report on covid violations and other deficiencies, and the state halted admissions in February 2022.
Yet the home has won court pauses in at least three negligence lawsuits as it appeals lower court rulings denying immunity under the federal PREP Act, court records show. The operators of the home could not be reached for comment. In court filings, they denied any wrongdoing.
In Oregon, health officials suspended operations at Healthcare at Foster Creek, calling the Portland nursing home “a serious danger to the public health and safety.” The May 2020 order cited the home’s “consistent inability to adhere to basic infection control standards.”
Bonnie Richardson, a Portland lawyer, sued the facility on behalf of the family of Judith Jones, 75, who had dementia and died in April 2020. Jones’ was among dozens of covid-related deaths at that home.
“It was a very hard-fought battle,” said Richardson, who has since settled the case under confidential terms. Although the nursing home claimed immunity, her clients “wanted to know what happened and to understand why.” The owners of the nursing home provided no comment.
No Covid Here
Many families believe nursing homes misled them about covid’s relentless spread. They often had to settle for window visits to connect with their loved ones.
Relatives of five patients who died in 2020 at the Sapphire Center for Rehabilitation and Nursing in the Flushing neighborhood in Queens filed lawsuits accusing the home’s operators of keeping them in the dark.
When they phoned to check on elderly parents, they either couldn’t get through or were told there was “no COVID-19 in the building,” according to one court affidavit.
One woman grew alarmed after visiting in February 2020 and seeing nurses wearing masks “below their noses or under their chin,” according to a court affidavit.
The woman was shocked when the home relayed that her mother had died in April 2020 from unknown causes, perhaps “from depression and not eating,” according to her affidavit.
A short time later, news media reported that dozens of Sapphire Center residents had died from the virus — her 85-year-old mother among them, she argued in a lawsuit.
The nursing home denied liability and won dismissal of all five lawsuits after citing the New York immunity law. Several families are appealing. The nursing home’s administrator declined to comment.
Broadening Immunity
Nursing home operators also have cited immunity to foil negligence lawsuits based on falls or other allegations of substandard care, such as bedsores, with little obvious connection to the pandemic, court records show.
The family of Marilyn Kearney, an 89-year-old with a “history of dementia and falls,” sued the Watrous Nursing Center in Madison, Connecticut, for negligence. Days after she was admitted in June 2020, she fell in her room, fracturing her right hip and requiring surgery, according to court filings.
She died at a local hospital on Sept. 16, 2020, from sepsis attributed to dehydration and malnutrition, according to the suit.
Her family argued that the 45-bed nursing home failed to assess her risk of falling and develop a plan to prevent that. But Watrous fired back by citing an April 2020 declaration by Connecticut Gov. Ned Lamont, a Democrat, granting health care professionals or facilities immunity from “any injury or death alleged to have been sustained because of the individual’s or health care facility’s acts or omissions undertaken in good faith while providing health care services in support of the state’s COVID-19 response.”
Watrous denied liability and, in a motion to dismiss the case, cited Lamont’s executive order and affidavits that argued the home did its best in the throes of a “public health crisis, the likes of which had never been seen before.” The operators of the nursing home, which closed in July 2021 because of covid, did not respond to a request for comment. The case is pending.
Attorney Wendi Kowarik, who represents Kearney’s family, said courts are wrestling with how much protection to afford nursing homes.
“We’re just beginning to get some guidelines,” she said.
One pending Connecticut case alleges that an 88-year-old man died in October 2020 after experiencing multiple falls, sustaining bedsores, and dropping more than 30 pounds in the two months he lived at a nursing home, court records state. The nursing home denied liability and contends it is entitled to immunity.
So do the owners of a Connecticut facility that cared for a 75-year-old woman with obesity who required a lift to get out of bed. She fell on April 26, 2020, smashing several teeth and fracturing bones. She later died from her injuries, according to the suit, which is pending.
“I think it is really repugnant that providers are arguing that they should not be held accountable for falls, pressure sores, and other outcomes of gross neglect,” said Richard Mollot, executive director of the Long Term Care Community Coalition, which advocates for patients.
“The government did not declare open season on nursing home residents when it implemented COVID policies,” he said.
Protecting the Vulnerable
Since early 2020, U.S. nursing homes have reported more than 172,000 residents’ deaths, according to Centers for Medicare & Medicaid Services data. That’s about 1 in 7 of all recorded U.S. covid deaths.
As it battles covid lawsuits, the nursing home industry says it is “struggling to recover due to ongoing labor shortages, inflation, and chronic government underfunding,” according to Reeves, the trade association executive.
She said the American Health Care Association has advocated for “reasonable, limited liability protections that defend staff and providers for their good faith efforts” during the pandemic.
“Caregivers were doing everything they could,” Reeves said, “often with limited resources and ever-changing information, in an effort to protect and care for residents.”
But patients’ advocates remain wary of policies that might bar the courthouse door against grieving families.
“I don’t think we want to continue to enact laws that reward nursing homes for bad care,” said Sam Brooks, of the Coalition for the Protection of Residents of Long-Term Care Facilities, a patient advocacy group.
“We need to keep that in mind if, God forbid, we have another pandemic,” Brooks said.
Bill Hammond, a senior fellow at the Empire Center for Public Policy, a nonpartisan New York think tank, said policymakers should focus on better strategies to protect patients from infectious outbreaks, rather than leaving it up to the courts to sort out liability years later.
“There is no serious effort to have that conversation,” Hammond said. “I think that’s crazy.”
KFF Health News is a national newsroom that produces in-depth journalism about health issues and is one of the core operating programs at KFF—an independent source of health policy research, polling, and journalism. Learn more about KFF.
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1 year 5 months ago
Aging, Courts, COVID-19, Public Health, Connecticut, Dementia, Illinois, New Jersey, New York, Nursing Homes, Oregon
Minister Williams responsible for 3 ministerial portfolios
In addition to his ministerial portfolio of Mobilisation, Implementation and Transformation, Hon. Andy Williams is currently Acting Prime Minister and Minister for Health
View the full post Minister Williams responsible for 3 ministerial portfolios on NOW Grenada.
1 year 5 months ago
Business, Health, Politics, 3i africa summit, andy williams, dickon mitchell, gis, government information service, joseph andall, linda straker, philip telesford
Residents protest thermoelectric vessels in Azua
Azua, DR.- Residents in the Azua province voiced their opposition to the installation of thermoelectric vessels aimed at boosting energy production, citing concerns over polluting emissions.
Azua, DR.- Residents in the Azua province voiced their opposition to the installation of thermoelectric vessels aimed at boosting energy production, citing concerns over polluting emissions.
Protesters gathered near Los Negros beach in Azua province, chanting slogans and holding candlelight vigils to mourn the environmental impact. They expressed their dissatisfaction with the presence of the vessels, denouncing them as harmful to the environment.
“Those who want the vessels can take them away,” and “The criminal vessels must be removed,” they exclaimed. The demonstrators marched to the beach, where the vessels are visible a few meters offshore, donning caps and shirts emblazoned with the slogan “No vessels in Los Negros.”
Environmental authorities granted permits in 2022 for the anchoring of two vessels, with the aim of increasing thermoelectric generation in the area from 180 MW to 400 MW. The permits were issued following an evaluation process, as stated by the firm in a statement released in March 2023.
Local residents have reported emissions of smoke and wastewater discharge from the vessels operated by the Turkish company Karadeniz Holding. “Human health is being compromised here. The ecology, mangroves, and marine species are all being affected,” remarked one protester.
1 year 5 months ago
Health
VIDEO: RGX-314 shows positive results for diabetic retinopathy at 1 year
FORT LAUDERDALE, Fla.
— In this Healio Video Perspective from the Retina World Congress, Dilsher Dhoot, MD, shares 1 year results from the phase 2 ALTITUDE trial investigating RGX-314 gene therapy for the treatment of diabetic retinopathy.According to Dhoot, the two dose levels of RGX-314 (Regenxbio, AbbVie) that were studied were well tolerated and demonstrated improvement in patient Diabetic Retinopathy Severity Scale score compared to a control group..“I think the results of this trial are compelling,” he said. “Potentially having a one-time gene therapy in-office
1 year 5 months ago
Ministry alerts public to Saharan dust arrival and health risks
Santo Domingo.- The Ministry of Public Health issued a warning urging the public to take precautions against respiratory issues as Saharan dust is expected to reach the area starting this weekend.
Santo Domingo.- The Ministry of Public Health issued a warning urging the public to take precautions against respiratory issues as Saharan dust is expected to reach the area starting this weekend.
Emphasizing the importance of preventive measures, particularly for individuals with asthma, allergies, COPD, pulmonary fibrosis, pneumonia, and other respiratory conditions, the ministry explained that the phenomenon of Saharan dust is a regular occurrence preceding the cyclone season. This event leads to the formation of dust clouds, creating a simultaneously dry and humid atmosphere that heightens the risk of respiratory ailments, allergic reactions, and other health concerns.
Annually, typically between May and August, the dense cloud of Saharan dust descends upon the region, prompting heightened vigilance among those already susceptible to respiratory issues. Special attention is advised for vulnerable groups such as the elderly, infants, pregnant and postpartum women, immunocompromised individuals, and other at-risk populations, as outlined in a press release by the Ministry of Public Health. Moreover, the ministry cautioned that the particles carried by the dust may cause temporary eye irritation.
Furthermore, the Ministry of Health highlighted the concurrent occurrence of Saharan dust and recent rainfall across the national territory, posing an additional risk for outbreaks of diseases like dengue, leptospirosis, and acute diarrheal illnesses. To mitigate these risks, the ministry recommended staying hydrated, wearing lightweight, light-colored clothing, using damp cloths to clean surfaces, and minimizing exposure to sunlight between 10 a.m. and 4 p.m.
1 year 5 months ago
Health
FDA Said It Never Inspected Dental Lab That Made Controversial AGGA Device
The FDA never inspected Johns Dental Laboratories during more than a decade in which it made the Anterior Growth Guidance Appliance, or “AGGA,” a dental device that has allegedly harmed patients and is now the subject of a criminal investigation.
According to FDA documents obtained through the Freedom of Information Act, the agency “became aware” of the AGGA from a joint investigation by KFF Health News and CBS News in March 2023, then responded with its first-ever inspection of Johns Dental months later.
That inspection found that the Indiana dental device manufacturer didn’t require all customer complaints to be investigated and the company did not investigate some complaints about people being hurt by products, including the AGGA, the FDA documents state. The FDA requires device companies to investigate complaints and forward them to the agency. Johns Dental had “never” alerted the FDA to any such complaints, according to the documents.
The AGGA, which its inventor testified has been used on more than 10,000 patients, was promoted by dentists nationwide, some of whom said it could “grow” or “expand” an adult’s jaw without surgery and treat common ailments like sleep apnea. But these claims were not backed by peer-reviewed research, and Johns Dental has settled lawsuits from 20 patients who alleged the AGGA caused them grievous harm. The company has not admitted liability.
Two former FDA officials said the AGGA was likely able to stay on the market — and off the FDA’s radar — for so long because of the lack of inspections and investigations at Johns Dental. Madris Kinard, a former FDA manager who founded Device Events, which analyzes FDA data, said it defies belief that Johns Dental never received a complaint worthy of relaying to the FDA.
“That’s a red flag for me. If I don’t see a single report to the FDA, I typically think there is something going on,” Kinard said. “When they don’t report, what you have is devices that stay on the market much longer than they should. And patients get harmed.”
Johns Dental Laboratories declined to comment when reached by phone and its lawyers did not respond to requests for an interview. The family-owned company, which has operated since 1939 in the western Indiana city of Terre Haute, sells dozens of products to dentists and makes hundreds of retainers and sleep apnea appliances each month, according to its website.
Twelve of Johns Dental’s products are registered with the FDA as Class II medical devices, meaning they carry at least a moderate risk, and some have been featured on the company website for at least two decades, according to screen captures preserved by the Internet Archive.
The AGGA, which was invented by Tennessee dentist Steve Galella in the 1990s, was not registered with the FDA like Johns Dental’s other devices. Company owner Jerry Neuenschwander has said in sworn court depositions that Johns Dental started making the AGGA in 2012 and became Galella’s exclusive manufacturer in 2015 and that at one point the AGGA was responsible for about one-sixth of Johns Dental’s total sales revenue.
In another deposition, Johns Dental CEO Lisa Bendixen said the company made about 3,000 to 4,000 AGGAs a year and paid Galella’s company a “royalty” of $50 to $65 for every sale.
“We are not dentists. We do not know how these appliances work. All we do is manufacture to Dr. Galella’s specifications,” she said, according to a deposition transcript.
The FDA’s lack of knowledge about the AGGA likely contributed to its loose oversight of Johns Dental. When asked to explain the lack of inspection, the FDA said that, based on what it knew at the time, it was not required to inspect Johns Dental until 2018 when the company registered as a “contract manufacturer” of other medical devices. Prior to 2018, the FDA was only aware of Johns Dental operating as a “dental laboratory,” which normally do not manufacture their own products and only modify devices made by other companies to fit dentists’ specifications. The FDA does not regularly inspect dental labs, although it can if it has concerns or gets complaints, the agency said.
Kinard said that based on her experience at the FDA she believes the agency prioritizes medical devices over dental devices, which may have contributed to the lack of inspections at Johns Dental.
“There hasn’t been much attention to dental devices in the past,” Kinard said. “Hopefully that’s going to change because of dental implant failures, as well as this device, which has quite obviously had serious issues.”
The AGGA resembles a retainer and uses springs to apply pressure to the front teeth and upper palate, according to a patent application. Last year, the KFF Health News-CBS News investigation revealed the AGGA was not backed by any peer-reviewed research and had never been submitted to the FDA for review. At the time, at least 20 patients had alleged in lawsuits that the AGGA had caused grievous harm to their teeth, gums, and bone — and some said they’d lost teeth. Multiple dental specialists said in interviews that they had examined AGGA patients whose teeth had been shoved out of position by the device, sometimes causing tens of thousands of dollars in damage.
“The entire concept of this device, of this treatment, makes zero sense,” said Kasey Li, a maxillofacial surgeon who published research on AGGA patients that appeared on a National Institutes of Health website. “It doesn’t grow the jaw. It doesn’t widen the jaw. It just pushes the teeth out of their original position.
Johns Dental and Galella have negotiated out-of-court settlements with the original 20 AGGA plaintiffs without publicly admitting fault. At least 13 more AGGA patients have filed similar lawsuits since the KFF Health News-CBS News investigation. Johns Dental and Galella denied wrongdoing or have not yet responded to the allegations in the newer lawsuits.
Galella declined to be interviewed in 2023 and neither he nor his attorneys responded to recent requests for comment. One of his attorneys, Alan Fumuso, said in a 2023 statement that the AGGA “is safe and can achieve beneficial results” when used properly.
In the wake of the KFF Health News-CBS News report, Johns Dental abruptly stopped making the AGGA, according to the newly released FDA documents. The Department of Justice soon after opened a criminal investigation into the AGGA that was ongoing as of December, according to court filings. No charges have been filed. A DOJ spokesperson declined comment.
Spurred by the March 2023 news report, the FDA inspected Johns Dental in July. The FDA’s website shows that Johns Dental was issued seven citations, but the substance of the agency’s findings was not known until the inspection report was obtained this year.
FDA investigator David Gasparovich wrote in that report that he arrived unannounced at Johns Dental last July and was met by five attorneys who instructed employees not to answer any questions about the AGGA or the company’s complaint policies. Neuenschwander was told by his attorney not to talk to the inspector, the report states.
“He asked if he could photograph my credentials,” Gasparovich wrote in his report. “This was the last conversation I would have with Mr. Neuenschwander at the request of his attorney.”
The FDA requires device companies to investigate product complaints and submit a “medical device report” to the agency within 30 days if the products may have contributed to serious injury or death. Gasparovich’s inspection report states that Johns Dental had “not adequately investigated customer complaints,” and its complaint policies were “not adequately established,” allowing employees to not investigate if the product was not first returned to the company.
Johns Dental received four complaints about the AGGA after the KFF Health News-CBS News report, including one that came after the FDA announced “safety concerns” about the device, according to the inspection report.
“Zero (0) out of the four (4) complaints were investigated,” Gasparovich wrote in the report. “Each complaint was closed on the same day it was received.”
In the months after Gasparovich’s inspection, Johns Dental sent letters to the FDA saying it revised its complaint policies to require more investigations and hired a consultant and an auditor to address other FDA concerns, according to the documents obtained through FOIA.
Former FDA analyst M. Jason Brooke, now an attorney who advises medical device companies, said the FDA uses an internal risk-based algorithm to determine when to inspect manufacturers and he advises his clients to expect inspections every three to five years.
Brooke said the AGGA is an example of how the FDA’s oversight can be hamstrung by its reliance on device manufacturers to be transparent. If device companies don’t report to the agency, it can be left unaware of patient complaints, malfunctions, or even entire products, he said.
When a company “doesn’t follow the law,” Brooke said, “the FDA is in the dark.”
“If there aren’t complaints coming from patients, doctors, competitors, or the company itself, then in a lot of ways, there’s just a dearth of information for the FDA to consume to trigger an inspection,” Brooke said.
CBS News producer Nicole Keller contributed to this article.
KFF Health News is a national newsroom that produces in-depth journalism about health issues and is one of the core operating programs at KFF—an independent source of health policy research, polling, and journalism. Learn more about KFF.
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1 year 5 months ago
Health Industry, Dental Health, FDA, Indiana, Investigation, Tennessee, When Medical Devices Malfunction
Ozempic warning for weight loss - Trinidad & Tobago Express Newspapers
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- Everything you need to know about semaglutide weight loss drugs New Scientist
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1 year 5 months ago
Health Archives - Barbados Today
Rotary Club of Barbados hosts successful Health Fair
Scores of Barbadians and visitors turned out to the Golden Square Freedom Park early Saturday morning to await their turn for vital health screenings. It was a culmination of a nine-month-long endeavour by the Rotary Club of Barbados, dedicated to combating non-communicable diseases (NCDs) within the community.
The event, held under the banner of the Rotary Club’s Health and Wellness Initiative, was spearheaded by the club’s president, Ermine Darroux-Francis. Rotary Club is one of the oldest in Barbados, boasting a proud 61-year history and a membership exceeding 110.
“We started at 9 a.m. and people were waiting to get tested. So, this in itself is a success for us,” Darroux-Francis told Barbados TODAY, adding that from early in the morning, Barbadians were lining up to take part in the event.
She expressed her satisfaction with the turnout, emphasising the importance of early detection in the fight against NCDs.
“Barbadians are responding, and this is good because we believe early detection and knowing your status is the first step to help fight NCDs,” she added.
The initiative, which started in September last year, saw Rotarians traversing all 11 parishes to conduct early screenings. The Rotary Club President explained that the decision to embark on this project stemmed from the alarming rates of NCDs reported by health authorities in the region. With a focus on early screening and raising awareness, the Rotary Club aimed to make a tangible difference in combating these diseases.
Reflecting on the broader spectrum of Rotary’s endeavours, Darroux-Francis highlighted their commitment to seven key areas of focus, including disease prevention and youth empowerment. “For us, the economic value of this particular project is more than $600,000,” she revealed, underscoring the club’s substantial investment in community health.
Acknowledging Rotary’s ongoing initiatives, particularly in youth development, Darroux-Francis outlined their Youth Elevation Scheme, conducted in collaboration with the Juvenile Liaison Scheme. “Our aim is to boost their confidence, enhance their communication and listening skills, and help them to think before they act,” she stated.
The event was a culmination of a nine-month-long endeavour by the Rotary Club of Barbados, dedicated to combating non-communicable diseases (NCDs) within the community. (Photo by Ryan Gilkes)
In addition to youth-focused endeavours, the Rotary Club of Barbados extends its support to various community projects, ranging from disaster management to medical assistance. Their partnership with organisations such as the Child Care Board exemplifies their commitment to holistic community welfare.
Addressing concerns about the sustainability of their health initiatives, Darroux-Francis emphasised collaboration with key stakeholders, including the Ministry of Health and Wellness and surgical and educational institutions. “We expect the project to continue and to provide support to the community,” she affirmed while highlighting the collaborative effort that underpinned the event’s success.
Among the organisations taking part were Sagicor Life Inc, Ross University, the Blood Collection Centre of the Ministry of Health and Wellness, Bayview Hospital and Laboratory, the Barbados Cancer Society, the Barbados Heart and Stroke Foundation, the Maria Holder Diabetes Center for the Caribbean, and the Diabetes and Hypertension Association, Wibisco and Pelican Produce. (RG)
The post Rotary Club of Barbados hosts successful Health Fair appeared first on Barbados Today.
1 year 5 months ago
Health, Local News
Obesity linked to several cancer types - The News International
- Obesity linked to several cancer types The News International
- Nearly 40% of the cancer cases are due to obesity, finds new study The Times of India
- 4 in 10 cancer cases related to obesity: New study Hindustan Times
- Fat-nurtured microbes in gut promote cancer progression: study CGTN
- High-fat diet linked to aggravating breast cancer: Study | Daily Sabah Daily Sabah
1 year 5 months ago
News Archives - Healthy Caribbean Coalition
Call for Consultants
The HCC is seeking to expand our database of consultants with expertise in the area of NCD prevention and control. The HCC relies on consultants to support the implementation of our projects in the short, medium and long-term. To this end we are inviting individual consultants and consulting firms to submit CVs to the HCC.
Submitted CVs will be reviewed to ensure they meet the selection criteria and if successful they will be placed in our consultant database. Please note that consultants do not need to be based in the Caribbean but must meet the selection criteria outlined below. The database will be the first resource we turn to when consultancy opportunities arise.
Please see below selection criteria.
1. NCD Prevention and Control Expertise including any or all of the 5*5
a. 5 NCDs: cardiovascular diseases, cancer, diabetes, chronic respiratory diseases and mental health and neurological disorders; as well as the 5 main NCD risk factors: tobacco use, harmful use of alcohol, unhealthy diet, insufficient physical activity, and air pollution.
2. CARICOM/Caribbean Expertise
3. Area of Expertise
a. Healthy Food Policy*
b. Tobacco Control
c. Alcohol Control
d. Physical Activity
e. Mental Health
f. Cervical Cancer control
g. Multisectoral/ multi stakeholder responses/mechanisms for NCDs*
h. Commercial Determinants of Health (Good governance, conflict of interest management, countering policy interference)*
4. Special Skills within the context of NCDs
a. Communications*
b. Public Relations (PR)*#
c. Public health writing (Op Eds etc.)*
d. Law and NCDs (including human-rights based approaches)
e. Meaningful Engagement of People Living with NCDs*
f. Meaningful Engagement of Young People*
g. Strategic Planning*
h. Monitoring and Evaluation*
If you are interested, kindly submit your CV to HCC at hcc@healthycaribbean.org with the subject: HCC CALL FOR CONSULTANTS. In the body of the email please indicate your area of expertise, any special skills and your location. Please submit your CV by 31 May 2024. If you miss this call, we will be sending out further calls in the 3rd quarter of 2024.
*Current priority needs.
The post Call for Consultants appeared first on Healthy Caribbean Coalition.
1 year 5 months ago
News
Bioanalysts union appeals to President Abinader for improved conditions
Santo Domingo.- The president of the Dominican College of Bioanalysts (CODOBIO) has called upon the intervention of the President of the Republic to address a series of grievances aimed at enhancing the conditions of her union.
Santo Domingo.- The president of the Dominican College of Bioanalysts (CODOBIO) has called upon the intervention of the President of the Republic to address a series of grievances aimed at enhancing the conditions of her union.
María Esther Santos made her plea, stating, “We once again urge President Luis Rodolfo Abinader Corona to receive us and consider the legitimate demands we have put forth. We seek solutions that will benefit our professional community.” This appeal was made during a meeting at the organization’s headquarters, attended by its Board of Directors.
Santos emphasized several critical demands on behalf of bioanalysts. These included a call for a 100% salary increase for those in the public sector and the provision of health insurance for retirees. Furthermore, she stressed the importance of ensuring adequate pensions with incentives and salary adjustments in the private sector.
Additional measures advocated by Santos encompassed the automatic implementation of incentives, the creation of new positions, and the reclassification of existing roles. Furthermore, she pushed for the application of a 14th salary, acknowledgment of master’s degrees and specialties, and access to suitable housing for professionals in the field.
Highlighting the significance of the role played by clinical laboratory professionals in both public and private settings, Santos expressed confidence that their demands would be given the due attention and diligence they merit.
The comprehensive list of demands presented to President Luis Abinader includes:
- A 100% salary increase for bioanalysts employed in the public sector, decentralized bodies, boards of trustees, and NGOs.
- Salary adjustments and review of retirement benefits for retired bioanalysts, particularly those with monthly incomes ranging between 8,000 and 15,000 pesos, alongside comprehensive medical insurance coverage.
- Ensuring 100% decent pensions with incentives for tenure and the unification of job categories.
- Implementation of salary increases and adjustments for bioanalysts in the private sector.
- Automation of incentive applications for service time, distance, and border postings, ensuring acquired rights are implemented automatically.
- Facilitation of new appointments for bioanalysts.
- Continuation of position reclassification processes and designation changes.
- Implementation of a 14th salary.
- Recognition of master’s degrees and specialties for bioanalysts.
- Inclusion of bioanalysts in housing projects.
1 year 5 months ago
Health
PAHO/WHO | Pan American Health Organization
OPS pide a países del hemisferio sur prepararse para posible aumento de enfermedades respiratorias y el dengue
PAHO urges countries in the Southern Hemisphere to prepare for possible increase in respiratory diseases and dengue
Cristina Mitchell
10 May 2024
PAHO urges countries in the Southern Hemisphere to prepare for possible increase in respiratory diseases and dengue
Cristina Mitchell
10 May 2024
1 year 5 months ago
Ministry of Public Health issues alert for flood-related diseases
Santo Domingo.- The Ministry of Public Health (MSP), through its Directorate of Epidemiology (Diepi), has issued an epidemiological alert regarding floods, citing the heightened risk of diseases within affected populations.
Public Health authorities are urging the population to implement response and control measures to mitigate the risk of epidemic outbreaks.
Santo Domingo.- The Ministry of Public Health (MSP), through its Directorate of Epidemiology (Diepi), has issued an epidemiological alert regarding floods, citing the heightened risk of diseases within affected populations.
Public Health authorities are urging the population to implement response and control measures to mitigate the risk of epidemic outbreaks.
The advisory emphasizes the importance of avoiding exposure to contaminated waters and environments during and after heavy rainfall to prevent diseases such as leptospirosis, respiratory infections, cholera, and others that are exacerbated by flooding.
Individuals are encouraged to utilize personal protective measures such as plastic boots and gloves if contact with contaminated environments is unavoidable.
Furthermore, citizens are advised against accumulating garbage and urged to eliminate mosquito breeding sites in homes and surrounding areas to prevent the proliferation of vectors such as rats and mosquitoes.
Additional recommendations include consuming only safe drinking water, either by boiling it for 15 minutes or by adding five drops of 5% bleach to each gallon of water before consumption. It is also advised to consume well-cooked foods and to properly wash fruits and vegetables.
The alert stresses the importance of hand hygiene, particularly after using the bathroom and before meals. Individuals exhibiting symptoms such as fever, nausea, vomiting, general malaise, pain behind the eyes, muscle or joint pain, or bone pain are advised to seek immediate medical attention at the nearest health center and refrain from self-medication.
Health personnel are instructed to promptly report any health events related to increased rainfall, and Provincial Directorates and Health Areas are tasked with disseminating the epidemiological alert within the local surveillance network, health centers, and other relevant sectors.
1 year 5 months ago
Health
Health Archives - Barbados Today
‘More men seeking cancer tests’
More Barbadian men are coming forward to get tested for prostate cancer, according to officials of a cancer-fighting charity.
After several years of pleading with men to come forward and have their prostates tested, the signs point to a drastic change in behaviour, said Cancer Support Services’ spokesman Antoine Williams as he spoke to reporters at the end of a two-day nurses’ training workshop at Coconut Court Beach Hotel.
“When we do our prostate testing sessions, we are seeing the increases,” he said. “We try to measure it based on the numbers. So, for example, we’ve had 100, 120, 140 [men coming forward]. The numbers are increasing, which is good, and again the age groups are also increasing, so there is that awareness. We are seeing men who are even coming in as groups, whether it’s with the church (or) community groups, so there is that definite increase.”
Williams added that more people are seeking the charity’s financial support, care and counselling services: “I would say that there is definitely an uptake.”
Reverend Anderson Kellman, one of the facilitators of the programme. (SB)
Reverend Anderson Kellman, one of the facilitators of the nurse enrichment programme, said more men are also coming forward to seek counselling to help them cope with their cancer diagnosis.
“There are still more women coming for counselling than men, but I’ve seen a significant number of men come for therapy, and that is a very heartwarming reality,” he said. “We as men sometimes… grin and bear to our own destruction, but yes, we are seeing a lot more men coming now seeking counselling…. I think that is a very good sign.”
Despite the encouraging signs, the lack of human resources available to deal effectively with the demand for services is still a concern, the officials said.
“I think people have said in the sessions that the issue of not having enough manpower that they desire is a major concern. Of course, people are more demanding now in terms of service. Once upon a time, there was a mystique in terms of doctors, the nurses and the medical people, but now people can go online and read stuff and therefore have different kinds of expectations. That also puts pressure in terms of the scarce resources that they have at the QEH.
“We are not going to push a panic button, but all we are simply saying is that the (patients) are more demanding now, therefore the idea of service becomes even more important,” Reverend Kellman said.
Seventeen nurses participated in this year’s enrichment programme which drew nursing officers, registered nurses and nursing assistants from all areas of the Queen Elizabeth Hospital, from the Accident and Emergency Department to the antenatal clinic. The nurses were trained in teamwork, emotional intelligence and palliative care. (SB)
The post ‘More men seeking cancer tests’ appeared first on Barbados Today.
1 year 5 months ago
Health, Local News
PAHO/WHO | Pan American Health Organization
Caribbean Mosquito Awareness Week 2024: PAHO calls to unite against dengue
Caribbean Mosquito Awareness Week 2024: PAHO calls to unite against dengue
Cristina Mitchell
10 May 2024
Caribbean Mosquito Awareness Week 2024: PAHO calls to unite against dengue
Cristina Mitchell
10 May 2024
1 year 5 months ago
Government hospitals receive bed linen donation
Yoland Clyne-Greenidge donated over 400 pieces of bed linen to hospital officials on Thursday, 2 April to benefit The General Hospital in St George’s and the Mirabeau Hospital in St Andrew
View the full post Government hospitals receive bed linen donation on NOW Grenada.
1 year 5 months ago
Health, PRESS RELEASE, diaspora, dr tyhiesia donald, gis, grace james, hospital, office of diaspora affairs, sherrien bhagwan, terrance forrester, yoland clyne-greenidge
Medical News, Health News Latest, Medical News Today - Medical Dialogues |
Medical Bulletin 10/ May/ 2024
Here are the top medical news for the day:
Study finds excessive salt consumption may raise stomach cancer riskA long-term study by MedUni Vienna, published in the journal Gastric Cancer, revealed a link between high salt consumption and stomach cancer.In the list of the most common types of cancer worldwide, stomach cancer is in fifth place. The risk of this tumour disease increases with age, but the latest statistics paint a worrying picture of an increase in adults under the age of 50. Risk factors include tobacco and alcohol consumption, overweight and obesity. The fact that a very salty diet increases the risk of stomach cancer has previously been proven in studies with Asian population groups, who frequently eat food preserved in salt, heavily salted fish or extremely salty marinades and sauces.Excessive salt intake can have several adverse effects on overall health. It can lead to high blood pressure, a major risk factor for heart disease and stroke. Additionally, too much salt can contribute to the development of kidney disease by putting strain on the kidneys and increasing the risk of kidney stones. Excess salt intake has also been linked to stomach cancer, osteoporosis, and cognitive decline."Our research shows the connection between the frequency of added salt and stomach cancer. With our study, we want to raise awareness of the negative effects of extremely high salt consumption and provide a basis for measures to prevent stomach cancer," summarises study leader Tilman Kühn.In the study, researchers analyzed data from over 470,000 adults enrolled in the UK Biobank study, which included responses to questions about salt consumption frequency collected via questionnaire between 2006 and 2010. They compared these self-reported salt intake levels with actual salt excretion measured in urine samples and data from national cancer registries.The study found that individuals who reported always or frequently adding salt to their food had a 39% higher risk of developing stomach cancer over an 11-year observation period compared to those who seldom or never added salt."Our results also stood up to the consideration of demographic, socioeconomic and lifestyle factors and were just as valid for prevailing comorbidities," says first author Selma Gicevic, emphasising the significance of the results.Reference: Kronsteiner-Gicevic, S., Thompson, A.S., Gaggl, M. et al. Adding salt to food at table as an indicator of gastric cancer risk among adults: a prospective study. Gastric Cancer (2024). https://doi.org/10.1007/s10120-024-01502-9Eating disorders common in people with insulin-dependent diabetes, finds studyAccording to a study published in the journal Eating Behaviors, researchers at the University of Eastern Finland found that one in four patients with insulin-dependent diabetes aged 16 years and older also exhibit some kind of eating disorder symptoms.Eating disorders are more prevalent in people with diabetes than in the general population and they are also more deadly. Many diabetes-related factors increase the risk of eating disorders, such as concerns over shape and weight, a focus on diet and carbohydrates, and difficulties coping with a long-term condition. Certain risk factors, such as high body mass index (BMI), body dissatisfaction, deficient coping strategies, and symptoms of depression, are associated with eating disorders of both type 1 and type 2 diabetes.Patients with insulin-dependent diabetes have a unique form of disordered eating known as insulin omission. Insulin omission refers to intentionally skipping insulin doses to lose glucose calories through the glucose excretion in the urine, leading to weight loss“Intentional skipping or restriction of insulin doses will lead to weight loss, but this also maintains high blood glucose, throwing the management of diabetes off balance,” said Doctoral Researcher Pia Niemelä of the University of Eastern Finland.In the study, researchers conducted a meta-analysis by compiling findings from 45 previous studies. The data included a total of 11,592 individuals with insulin-dependent diabetes, of whom 2,521 exhibited eating disorder symptoms.The result revealed that eating disorder symptoms were more common in women than in men, which is an observation that has previously been made in young people as well. Age, however, was not a significant factor, as eating disorders occurred regardless of age group.“Eating disorder symptoms are often thought to affect adolescents and young adults. However, our meta-analysis shows that adults, too, suffer from eating disorder symptoms, which is why it is important to learn to identify patients with eating disorders. Understanding the clinical picture and its prevalence is the first step in developing treatment and care pathways,” said Niemelä.Reference: Pia E. Niemelä, Hanna A. Leppänen, Ari Voutilainen, Essi M. Möykkynen, Kirsi A. Virtanen, Anu A. Ruusunen, Reeta M. Rintamäki; Prevalence of eating disorder symptoms in people with insulin-dependent-diabetes: A systematic review and meta-analysis; Eating Behaviors; Volume 53 2024; https://doi.org/10.1016/j.eatbeh.2024.101863.High testosterone linked to risk of atrial fibrillation: Study In a study published in the journal eClinicalMedicine, part of The Lancet discovery science, researchers examined the association between testosterone levels and the risk of atrial fibrillation in men.Atrial fibrillation occurs when the heart’s upper chambers beat irregularly. AFib is the most common type of heart arrhythmia, according to the Centers for Disease Control and Prevention (CDC). The CDC also estimates that by 2030, 12.1 million people will have AFib.High testosterone levels have been associated with an increased risk of atrial fibrillation. Testosterone may influence the cardiovascular system through various mechanisms, including its effects on inflammation and blood pressure regulation. Elevated testosterone levels have been linked to changes in cardiac ion channels and electrical activity, which can predispose individuals to abnormal heart rhythms. Additionally, testosterone has been implicated in promoting cardiac fibrosis which may contribute to the development and progression of atrial fibrillation. In the ASPirin in Reducing Events in the Elderly (ASPREE) study, researchers analyzed data from 4,570 healthy male participants aged over 70 with no history of cardiovascular disease or thyroid cancer. Over an average follow-up period of 4.4 years, 286 men (6.2%) developed atrial fibrillation (AFib). Researchers divided serum testosterone levels into quintiles to examine the relationship between testosterone levels and AFib incidence.The study revealed a nonlinear association between testosterone levels and AFib incidence. Men with testosterone levels in the highest quintiles had a greater risk of AFib compared to those with average levels. This association persisted even after excluding participants with heart failure or other major cardiovascular events during follow-up. It was independent of factors like body mass index, alcohol consumption, diabetes, and high blood pressure.“As patients age, testosterone levels drop . Starting at age 30 there’s a one percent reduction in testosterone levels annually. Some patients who start off with relatively high numbers may never notice any change in their energy, their mood, or their sexual performance. However, patients generally complain of symptoms starting around the age of 40 and it’s appropriate to test their levels. It’s important to not just treat a number but actually treat symptoms that patients may be experiencing,” said Mehran Movassaghi, a board certified urologist and director of Men’s Health at Providence Saint John’s Health Center.Reference: Cammie Tran k, Bu B. Yeap k, Jocasta Ball, Daniel Clayton-Chubb, Sultana Monira Hussain, Amy Brodtmann, et al.; Testosterone and the risk of incident atrial fibrillation in older men: further analysis of the ASPREE study; eClinicalMedicine, part of The Lancet discovery science; 2024; DOI:https://doi.org/10.1016/j.eclinm.2024.102611
1 year 5 months ago
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