STAT

STAT+: Pharmalittle: We’re reading about fake studies, AbbVie investing in psychiatric meds, and more

Good morning, everyone, and welcome to the middle of the week. Congratulations on making it this far, and remember there are only a few more days until the weekend arrives. So keep plugging away. After all, what are the alternatives?

While you ponder the sobering possibilities, we invite you to join us for a delightful cup of stimulation. Our choice today is maple bourbon. Remember that no prescription is required and so rebates do not have to be calculated. Meanwhile, here is the latest menu of tidbits to help you on your way. Have a wonderful day, and please do stay in touch. …

Fake studies have flooded publishers of top scientific journals, leading to thousands of retractions and millions of dollars in lost revenue, The Wall Street Journal says. The biggest hit has come to Wiley, which is closing 19 journals, some of which were infected by large-scale research fraud. The sources of the fake science are “paper mills” — businesses or individuals that, for a price, will list a scientist as an author of a wholly or partially fabricated paper. The mill submits the work, generally avoiding the most prestigious journals in favor of publications such as one-off special editions that might not undergo as thorough a review and where there is a better chance of getting bogus work published.

A U.S. lawmaker is accusing Amgen of “putting profits before patients” over its decision to continue marketing a high dose of a pricey cancer treatment instead of a lower dose that is less expensive and not as toxic to patients, STAT reports. At issue is a medication called Lumakras, which is used to treat non-small cell lung cancer and which won conditional regulatory approval three years ago. At the time, the Food and Drug Administration required Amgen to run a trial confirming earlier test results, as well as a so-called post-marketing study to examine safety and effectiveness at different dosages, in order to gain full approval.

Continue to STAT+ to read the full story…

1 year 1 month ago

Pharma, Pharmalot, pharmalittle, STAT+

Health | NOW Grenada

Increase in acute gastroenteritis cases

“Children in childcare centres are particularly vulnerable due to their close physical interactions and limited understanding of proper hygiene practices”

View the full post Increase in acute gastroenteritis cases on NOW Grenada.

“Children in childcare centres are particularly vulnerable due to their close physical interactions and limited understanding of proper hygiene practices”

View the full post Increase in acute gastroenteritis cases on NOW Grenada.

1 year 1 month ago

Community, Health, PRESS RELEASE, Youth, gastro, gastroenteritis, gis, Ministry of Health

Health | NOW Grenada

Minimal service interruptions in 2 ministries

There is likely to be minimal interruptions in some service areas, as management and staff from the 2 ministries will be engaged in professional development activities

View the full post Minimal service interruptions in 2 ministries on NOW Grenada.

There is likely to be minimal interruptions in some service areas, as management and staff from the 2 ministries will be engaged in professional development activities

View the full post Minimal service interruptions in 2 ministries on NOW Grenada.

1 year 1 month ago

Health, Notice, PRESS RELEASE, gis, Ministry of Health, ministry of mental health wellness and religious affairs, tony blair institute

Health

Establish the potential usefulness of the ackee seed

ACKEE IS the national fruit of Jamaica and is a major source of food. In other regions, components of the plant have traditionally been used for a variety of conditions. It is widely found throughout the West Indies and has been naturalised to...

ACKEE IS the national fruit of Jamaica and is a major source of food. In other regions, components of the plant have traditionally been used for a variety of conditions. It is widely found throughout the West Indies and has been naturalised to...

1 year 1 month ago

Health

Lifestyle management for diabetes

ADOPTING A healthy lifestyle can help you manage your diabetes. It may also improve your critical health numbers, including weight, blood sugar, blood pressure and blood cholesterol. When it comes to food and eating, we are all different. Some of...

ADOPTING A healthy lifestyle can help you manage your diabetes. It may also improve your critical health numbers, including weight, blood sugar, blood pressure and blood cholesterol. When it comes to food and eating, we are all different. Some of...

1 year 1 month ago

MedCity News

AbbVie Expands Psychiatric Drug Prospects, Inking R&D Pact With Neuroscience Startup

AbbVie’s alliance with Gilgamesh Pharmaceuticals is pursuing next-generation psychiatric medications. The companies aim to bring patients drugs that offer the benefit of psychedelics but with a better side effect profile.

AbbVie’s alliance with Gilgamesh Pharmaceuticals is pursuing next-generation psychiatric medications. The companies aim to bring patients drugs that offer the benefit of psychedelics but with a better side effect profile.

The post AbbVie Expands Psychiatric Drug Prospects, Inking R&D Pact With Neuroscience Startup appeared first on MedCity News.

1 year 1 month ago

BioPharma, Daily, Pharma, AbbVie, biopharma nl, Gilgamesh Pharmaceuticals, neuroscience, New York, North Chicago, psychedelics, Startups

Health – Dominican Today

Médico Express and Caribbean Health TPA foster medical tourism

Santo Domingo.- Dominican health tourism continues to solidify its position within our national brand and export portfolio. The combination of skilled medical professionals, cutting-edge technologies, and modern infrastructure paves the way for sustained growth.

Santo Domingo.- Dominican health tourism continues to solidify its position within our national brand and export portfolio. The combination of skilled medical professionals, cutting-edge technologies, and modern infrastructure paves the way for sustained growth. A recent example of collaboration in this endeavor is the inter-institutional agreement signed between Médico Express and Caribbean Health TPA to promote medical tourism and telemedicine.

Alejandro Cambiaso, executive president of Médico Express, and Rodolfo Núñez-Musa, medical director of Caribbean Health, disclosed that the agreement encompasses a range of services such as diagnostics, emergency care, specialized consultations, outpatient surgeries, ophthalmology, dentistry, orthopedics, pediatrics, and endoscopy, all accessible through Médico Express San Isidro’s international department.

Médico Express San Isidro stands out as an innovative outpatient health center, adhering to international standards, delivering high-quality medical services to both local residents and tourists.

Caribbean Health specializes in attracting patients from Caribbean islands to seek specialized medical care in the Dominican Republic. Dr. Núñez-Musa noted that over the past year, the company facilitated treatment for approximately one thousand patients from Turks and Caicos, Saint Martin, Bahamas, and other Caribbean nations.

Furthermore, as part of their strategy for remote patient care, recruitment, and monitoring, they have established Collaborative Telemedicine Centers (CTCs) across the Caribbean, providing assistance and second medical opinions, with collaboration from Médico Express.

The experts and signatories of the agreement emphasized that medical tourism in the Dominican Republic has seen steady growth year after year. This is attributed to the quality of services and the commitment to local training and international accreditation processes within member centers of the Dominican Tourism Association of Health (ADTS).

1 year 1 month ago

Health, tourism

Health Archives - Barbados Today

Student nurses awarded scholarships

In celebration of International Nurses’ Day, CIBC Caribbean on Monday awarded three student nurses with scholarships in the name of Ramona Mascoll, the first medical worker in Barbados to succumb to COVID-19 in 2021.

During the presentation of the awards at the Barbados Community College (BCC), Director of Corporate Banking, Barbados & OECS,CIBC Caribbean, Jeffrey Newton commended first-year student Rashawn Gibson, second-year student Kayli Jordan and third-year student Shannon Yarde for pursuing a career in nursing.

“It has to be a calling and a commitment to want to care for others the way nurses are called upon to do, and I commend the three of you, because in this fast-paced, technologically driven world today, it’s easy for young people to get caught up in the glitz and want to get in professions that are considered glamorous, and shun those that are not. That’s what we call nursing a calling… – you are there for people at their most vulnerable,” he said.

“Few people would see you on those nights when you are on duty and can’t sleep like the rest of us because you are taking care of sick people in your care, or dealing sometimes with an unpleasant side effect of people being ill, and worried. By enrolling in the Barbados Community College, you are giving a commitment to help others when they cannot help themselves, and that is a noble commitment.”

Director of Corporate Banking, Barbados & OECS, CIBC Caribbean, Jeffrey Newton. (HG)

The scholarships are each worth $2 000, and cover registration fees, books, and uniforms.

Newton said: “We are pleased to hear that all of the students that have been awarded to date, continue to maintain good GPAs and excellent overall performances, with the first group awarded in 2021 due to graduate this year. This is pleasing news for a sponsor.”

“This year, on advice from the college, the scholarships are distributed across the years of the programme. So we have a first-year, second-year, and third-year student; whereas in previous years they were awarded to all first-year students.”

Meanwhile, Head of the Nursing Department at BCC Dr Sonia Watson-Miller said she was pleased to see the scholarships continue.

“I am proud that this opportunity has continued since 2021. Our selection of the students was based on three categories, not only the academic performance but also their personality and any financial [assistance] that was needed. Our pass rate has been improving for the last five years, and last year we had the highest of 91 per cent. So our pass rate has been improving,” she said.

Gibson expressed gratitude that she was selected.

“I am truly honoured and never thought that I would be given this opportunity. It truly shows that hard work and dedication pays off, and it motivates me to continue to work harder and to make a difference in the field of nursing,” she said. 

“This scholarship will not only help to ease the financial burden, allowing students to focus mainly on their studies but also not to worry about the cost. I want to end my speech by encouraging more young persons, especially males, to get involved in the profession, as we need more persons in the field.” (SB)

The post Student nurses awarded scholarships appeared first on Barbados Today.

1 year 1 month ago

Education, Health, Local News

Health | NOW Grenada

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 1 month 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 1 month 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 1 month ago

KFF Health News

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 1 month ago

Aging, Courts, COVID-19, Public Health, Connecticut, Dementia, Illinois, New Jersey, New York, Nursing Homes, Oregon

Health | NOW Grenada

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

1 year 1 month ago

Business, Health, Politics, 3i africa summit, andy williams, dickon mitchell, gis, government information service, joseph andall, linda straker, philip telesford

Health – Dominican Today

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 1 month ago

Health

Healio News

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 1 month ago

Health – Dominican Today

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 1 month ago

Health

KFF Health News

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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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)

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