FDA Accused of Going "Rogue" Over New COVID-19 Boosters
Fort Myers Beach Mayor Dan Allers Delivers Message of Hope and Progress Ahead of Hurricane Ian Anniversary
BE SURE YOU ARE THOROUGH WHEN BOAT SHOPPING!
Poor St. Clare Nuns Thank FMB Community
Hunter’s Gun Woes and the Biden Family Drama
Will House Democrats Exploit Speaker McCarthy's Precarious Position?
The ‘Big Guy’ Enigma: Decoding Emails and Biden's Mysterious Mentions
Boating: Stay Prepared, Stay Safe!
Rise in Early Onset Cancers Puzzles Experts
Fort Myers Beach Business Round-Up
Ripples in the Georgia Indictment: MAGA Attorney Sidney Powell's Legal Dance
BREAKING: McCarthy Launches Biden Impeachment Inquiry Based on “Pseudonymous” Biden Emails in National Archives
Hurricane Ian left San Damiano Monastery and Ascension Parish Church on Fort Myers Beach in ruins. The Poor Clares order lives a cloistered and secluded life to foster intense prayer. The nuns do not minister outside their residence but dedicate their lives to contemplation and prayer for others.
Since Ian, the Poor Clares have been displaced. We were able to reach Sister Mary Frances of Jesus Fortin, the Abess of the monastery, who provided this message:
“We are grateful to all those who have helped us through this ordeal. We have moved four times since Hurricane Ian. We are finally at our own address, although it is temporary until we can build a new monastery. Unfortunately, we cannot go back to the beach. We love our friends and neighbors there, but since the chapel is going to be torn down and it would take at least four years to rebuild a chapel, we have decided to relocate. You are all in our prayers, and our memories of life on the beach are precious to us. We do not forget you in our prayers, especially with the challenges you all face. God bless you each and every one!”
The Poor Clares can be reached at their new address:
San Damiano Monastery of St. Clare
593 39th Avenue N.W.
Naples, FL 34120
Phone: 239-328-1274
Virologist Dr. Robert Malone has criticized the Food and Drug Administration (FDA), accusing the agency of deviating from its own rules and regulations by recommending new COVID-19 boosters with limited clinical trial data regarding their efficacy and safety. In a recent interview, Dr. Malone described the FDA's actions as going "rogue."
Dr. Malone's comments came on the same day the FDA cleared new COVID-19 vaccines to address waning vaccine effectiveness. He argued that the absence of human clinical trial data demonstrating the effectiveness and safety of these updated vaccines should have prevented their approval.
According to Dr. Malone, the FDA authorized the new vaccines based on the premise that "neutralizing antibodies as detected in mice and their cross-reactivity are correlative protection," which he labeled as a falsehood since there are no established correlates of protection for SARS-CoV-2.
The FDA approved Moderna's and Pfizer's new mRNA vaccines on September 11 without analyzing data from human trials. The agency stated that its decision was supported by its assessment of "manufacturing data" from vaccine producers and "non-clinical immune response data on the updated formulations." It argued that the benefit-risk profile of earlier vaccine versions is well understood and that the new vaccines are a good match for current COVID-19 variants.
The Centers for Disease Control and Prevention (CDC) recommended these new vaccines on September 12, urging almost all Americans to get them, including children as young as six months old.
The new vaccines target the XBB.1.5 sub-type of the Omicron variant, although this subvariant has largely been replaced by newer strains of the virus.
Dr. Joseph Ladapo, Florida's Surgeon General, expressed concern about the limited data and suggested people might be better off without the new shots. He pointed to studies showing the waning effectiveness of previous vaccines over time and raised questions about their safety.
CDC Director Mandy Cohen defended the vaccines as effective tools against the virus and stated that they had undergone extensive clinical trials and monitoring for safety. However, critics, including some doctors, have questioned the need for these boosters in younger, healthy individuals.
Dr. Ladapo encouraged people to make decisions based on their own judgment and truth, emphasizing the importance of listening to their intuition. A study from January to July 2023 found that individuals who received new COVID-19 booster shots in California state prisons were more likely to contract COVID-19 compared to those who did not receive the boosters. The infection rate among the booster-receiving group was 3.2%, higher than the 2.7% among the unvaccinated.
The CDC also recently conceded that the new BA.2.86 strain could cause infections even in individuals previously vaccinated against COVID-19. The agency expressed concerns about the variant's mutations potentially enabling greater evasion of existing immunity from vaccines and prior infections compared to previous variants.
An alarming increase in early-onset cancers has medical professionals, including Yale epidemiologist Dr. Harvey Risch, searching for explanations. Risch has noted the surprising emergence of long-latency cancers in young individuals, such as 25-year-olds with colon cancer absent of family history.
“Some cancers are so aggressive, their progression within weeks is unlike what we’d expect," commented Risch, who's affiliated with Yale’s Departments of Epidemiology, Public Health, and Medicine.
The Harvard Gazette highlighted a surge in cancer diagnoses among individuals under 50. Factors like altered microbiomes, sleep deprivation, and increased alcohol consumption are under scrutiny in this three-decade-long global trend.
Research from Brigham and Women’s Hospital indicates that since 1990, there’s been a noticeable uptick in early-onset cancers worldwide, including those of the breast, colon, and liver. Their findings were recently published in Nature Reviews Clinical Oncology.
Shuji Ogino, a professor at Harvard Chan School and Harvard Medical School, detailed a "birth cohort effect." He said, "Each successive generation, born a decade apart, has an escalating risk of developing cancer before 50." This trend, Ogino believes, is linked to risk exposures during youth and is expected to persist in upcoming generations.
Ogino, in collaboration with lead author Tomotaka Ugai, spent over a decade analyzing global data on 14 cancer types that showed increased incidence in adults before age 50.
Their comprehensive review linked early life "exposomes"— diet, lifestyle, and environmental factors — to this trend. Although some of the rise can be credited to enhanced early detection via screening programs, the team is convinced that not all can be chalked up to better detection methods.
Among risk factors identified, alcohol consumption, smoking, sleep deprivation, and unhealthy diets stood out. Notably, while adult sleep patterns remain consistent, today’s children sleep substantially less than previous generations.
"Eight of the 14 cancers on the rise are tied to the digestive system. The food we consume directly impacts our gut's microorganisms," Ugai shared.
The study acknowledges its limitation: the scarcity of data from low- and middle-income countries. Ogino and Ugai are keen on expanding research collaborations globally and emphasize the need for longitudinal cohort studies, which can provide a more holistic view of cancer risk factors spanning a lifetime.
Renowned for building single-family homes in Southwest Florida for 17 years, Tri-Town Construction is pivoting towards rejuvenating Fort Myers Beach. The company's strategic move includes a forthcoming sales center, prominently located on Estero Boulevard.
Company owner, Marc Devisse, specializes in custom home constructions. To streamline developments along the beach, Devisse introduces two model homes, spanning 1,360 and 1,853 square feet. Prospective homebuyers can anticipate the grand opening of the sales center by the end of September, showcasing these stellar designs.
Devisse credits a “team approach” is responsible for the company’s growth and its many happy customers, on the company’s website at www.tri-townconstruction.com.
“They make a difference in the community physically with their excellent work, and because of that, they allow us to contribute to the community financially through our charitable programs.”
The Cape Coral Museum of History buzzed with enthusiasm at this month's Fort Myers Beach Chamber of Commerce Coffee Connection. Nearly two dozen FMB Chambers members took the trek across the Caloosahatchee during the morning rush and were rewarded with a first-class exposition of the facilities.
In a private tour, Executive Director Janel Trull explained enlightening details about the museum and the history of Cape Coral. FMB Chamber members were also given a sneak peek into the highly anticipated Festa Italiana scheduled for September 30th.
The Museum is the official repository for the history of Cape Coral and serves as a public resource for all sectors of the local community, as well as international and U.S. tourists, according to its website at www.capecoralmuseum.org.
For more information on the FMB Chamber visit www.fortmyersbeach.org.
Homebound marked a significant step forward with its inaugural groundbreaking on a residential property located on Hibiscus Drive this past Friday.
Samir Malviya, Vice President of Homebound, praised the resilience and collaboration of Fort Myers Beach. "The determination to rebuild and emerge even mightier is evident," said Malviya.
US House Speaker Kevin McCarthy (R-Calif.) announced on Monday the initiation of an impeachment inquiry into President Joe Biden concerning alleged involvement in his son Hunter Biden's business activities.
McCarthy stated, "We've found serious and credible allegations regarding President Biden's conduct, indicating a potential culture of corruption." He has directed the House committee to begin the formal impeachment inquiry, asserting that it's imperative to "gather all the facts and answers for the American public."
This significant announcement comes as the House resumes after a seven-week summer hiatus, with a government shutdown looming in 19 days if funding measures aren't settled.
Central to the contention is an ongoing House Oversight Committee investigation into the Biden family's alleged foreign business ventures. Chairman James Comer (R-Ky.) recently pointed to National Archives emails as pivotal evidence. These correspondences allegedly link President Biden to pseudonymous email accounts utilized during his vice-presidential tenure.
The controversy heightened when Southeastern Legal Foundation, a conservative advocacy group, disclosed that NARA was in possession of approximately 5,400 emails possibly connected to pseudonymous accounts. NARA representatives, however, refrained from commenting on these findings.
Furthermore, McCarthy alleges President Biden misled the public about his cognizance of his family's overseas transactions. Testimonies and bank records supposedly implicate President Biden in several interactions leading to substantial financial gains for Hunter Biden.
"These allegations suggest abuse of power, obstruction, and corruption that merit further House investigation," McCarthy emphasized.
The White House condemned the move, with spokesman Ian Sims labeling it "extreme politics." Meanwhile, Sen. Elizabeth Warren (D-Mass.) termed the initiative "politics on steroids." In contrast, Sen. Chuck Grassley (R-Iowa) highlighted the inquiry's potential to unveil information otherwise inaccessible to Senate Republicans.
President Biden has not yet publicly responded to these developments.
WILMINGTON, Del. – President Joe Biden's son, Hunter Biden, 50, could soon be indicted on felony gun charges, according to a recent federal court filing in Delaware.
In a document filed on Sept. 6, Special Counsel David Weiss's team revealed plans to approach a grand jury for an indictment against the younger Biden. The Speedy Trial Act mandates the government to pursue a grand jury indictment by September 29, 2023. Weiss's team intends to act before this deadline.
The prosecution alleges that in October 2018, Hunter Biden unlawfully possessed a firearm while being addicted to an illegal substance, a direct violation of federal law. Initially, prosecutors were open to a pretrial diversion agreement. However, recent developments have seen the deal dissolve.
If convicted, Hunter Biden could serve up to a decade behind bars.
While the White House remains silent on the matter, Mr. Biden's attorneys insist he is adhering to the original diversion agreement's terms. Yet, complications have arisen regarding the validity of the agreement. Prosecutors maintain that since the U.S. probation officer for Delaware, Margaret Bray, did not sign it, the deal is not binding for either party.
Hunter Biden's defense, however, contradicts this. In prior filings, they provided evidence of a signed agreement between Special Assistant U.S. Attorney Leo Wise, Hunter Biden, and former attorney Christopher Clark.
Interestingly, David Weiss, originally appointed as a U.S. attorney during the Trump administration, was later named special counsel by Attorney General Merrick Garland, an appointee of President Biden.
The agreement in question necessitated Hunter Biden to refrain from purchasing or possessing any firearm for two years. Alongside the agreement, he publicly confessed to a history of drug use, starting with crack and powder cocaine in 2016 and escalating to habitual usage by 2017.
President Biden, when pressed on his son's legal entanglements, declined to comment, emphasizing the Justice Department's autonomy in the matter.
Separately, tax charges against Hunter Biden, which pertained to unpaid taxes on more than $3 million of earnings from 2017 and 2018, were dropped in August. Prosecutors are considering refiling these charges in a different district.
BRUSSELS — In a new report released on Sept. 4, the European Union Agency for Asylum (EUAA) unveiled that the European Union and associated nations, including Switzerland and Norway, witnessed a nearly 30% spike in asylum applications in the first half of 2023. The total number of applications registered reached 519,000, reflecting a significant 28% rise compared to the same period in 2022.
This trend follows a considerable 53% year-on-year surge observed in 2022. If the current trajectory persists, EUAA predicts the numbers might cross the 1 million mark by the year's end. Notably, these figures exclude around 4 million Ukrainians who sought refuge due to the Russian invasion and are presently under temporary protection.
The surge has inevitably burdened many EU+ nations. "The escalation has placed tremendous strain on EU+ nations, both in processing applications and safeguarding those in genuine need," stated the agency. Consequently, pending asylum cases have also risen by 34% from last year. By June, the EUAA stepped in to provide operational aid to 13 member states grappling with the influx.
Syrians continued to lead in asylum applications, accounting for 67,000 requests between January and June 2023 — a staggering 50% hike compared to the first half of 2022. Germany remains the primary recipient of these applications, processing about 62% in the mentioned period.
Other significant contributors to the application tally were Afghans, Venezuelans, Turks, and Colombians, jointly making up 44% of all applications. Venezuelans and Colombians, in particular, registered a remarkable increase in their numbers, with application rises of 41% and 73% respectively, compared to the first half of 2022.
Russians and Iranians have also seen a surge in granted protections. For Russians, the approval rates jumped from 20% in 2021 to 35% currently. Iranians witnessed an increment from 31% in 2020 to 47% at present.
Increasing political tensions in the Ivory Coast resulted in about 9,300 asylum applications, while Guinea, a West African nation, accounted for approximately 8,700 applications.
EU nations are grappling with the sustained inflow of asylum seekers and migrants. Belgium recently decided to limit shelter provisions only to families, women, and children, drawing criticism from human rights bodies. The Netherlands faced political upheaval with Prime Minister Mark Rutte resigning over migration policy disagreements in July.
Outside the EU, the UK's asylum-related expenses have surged. With the asylum budget escalating from £2.12 billion ($2.66 billion) in 2021/22 to £3.97 billion ($4.98 billion) in 2022/23, UK Prime Minister Rishi Sunak labeled the trend "unacceptable."
The EU, in June, adopted a common asylum reform package. The policy proposes a hefty 20,000 euro ($21,493) fine on countries declining to accept refugees. Notably, Hungary and Poland rejected the agreement, while Bulgaria, Lithuania, Malta, and Slovakia abstained from voting.
FORT MYERS BEACH, Fla. — The music world mourned the passing of singer-songwriter Jimmy Buffett, affectionately known as the "King of Escapism," on September 1, 2023. The legend, who serenaded generations with his breezy, paradise-inspired tracks, was 76.
Cruisin' Tikis Fort Myers Beach, along with various tiki boat bars, orchestrated a vibrant waterfront parade titled '5 O'clock Somewhere' to pay homage to Buffett. Scores of fans from across Southwest Florida congregated, margaritas in tow, echoing the tunes that once defined their sun-soaked escapades.
Mary Dahl, a Fort Myers resident and ardent Buffett admirer, remarked, "We're here with margaritas, just hoping to celebrate Jimmy's legacy."
The event provided an apt platform for fans to bid farewell. Nick Becker from Cruisin' Tikis Fort Myers Beach noted the profound influence Buffett had in the region. "His passing was a shock to all of us," Becker stated.
Cruisin' Tikis has deep-rooted ties with the artist. Originating in Key West under the aegis of Greg Darby, a staunch Buffett supporter, the tiki boats owe their existence to the combined vision of Darby and Buffett.
Becker estimates that over 100 individuals participated in the tribute. "What better way to honor his memory than being out on the water, sipping margaritas?" he mused.
While the main festivities unfolded on the waves, shoreline spectators also partook in the tribute. Dahl reflected on Buffett's untimely passing: "He lived life to the fullest. It just seemed too soon."
In the coming months, Fort Myers Beach will witness the launch of the Margaritaville Resort, inspired by Buffett himself. The resort is slated to begin operations on February 1, 2024, and has started accepting reservations, according to its official website.
Ralph Kertz, who attended the parade, expressed optimism about the resort's launch, anticipating it to usher in a new wave of attractions to the locale.
This story was first reported by FOX 4 News Southwest Florida.
In Florida, residents are feeling the effects of hurricanes everywhere – especially in their wallets.
A diminishing pool of insurance carriers poses significant implications for homeowners and multifamily property owners, as these firms become increasingly selective in extending coverage. Robert Norberg, President of Arden Insurance Associates in Lantana, commented on the shift, emphasizing the preference insurers show towards newer properties and those with minimal claim histories.
"Insurers have grown stringent. Most now require properties to have been constructed post-2022, and a new roof has become almost a mandate for consideration," says Mr. Norberg, a seasoned player in the South Palm Beach insurance arena. This conservative approach, coupled with Travelers Insurance's recent cessation of auto insurance offerings and Farmers Insurance's complete withdrawal from Florida, illustrates a concerning trend.
Insight from Insurance Information Institute (Triple I) underscores the mounting strain, placing the average annual home insurance cost in Florida at $6,000 — significantly higher than the national average of $1,700. Furthermore, Florida's rates have surged by 42% over the previous year, doubling in the past three years.
State officials had anticipated that recent legislative reforms in the insurance domain, combined with a hiatus from severe climatic events, might stabilize the industry, facilitating more favorable terms for policyholders.
While the state's insurance scenario has drawn attention on a national scale — with former President Donald Trump pointing fingers at Governor Ron DeSantis for the soaring costs — the backdrop paints a more complex picture. Trump's remarks came in the wake of key players like Farmers, Bankers, and Lexington Insurance, an AIG affiliate, retreating from Florida. Only a handful, including state-backed Citizens Insurance, remain.
Mr. Michael Peltier, a spokesperson for Citizens, remarked on the company's relative respite from the recent Hurricane Idalia, which spared their key client locales. Damage, he noted, is estimated between $2.2 billion and $3 billion, considerably lower than some media projections.
Brant Brown, COO of Westmount Realty Capital in Dallas, observes the broader landscape of insurance in the U.S., suggesting that recent weather disturbances are just a part of the narrative. "The underlying turmoil in the insurance sector isn't merely a result of recent climate events. The accumulation of minor claims over years has compounded, putting a strain on the industry's financials," he stated.
Mr. Brown further articulated the dearth of carriers in areas recurrently hit by adverse weather, such as Florida and parts of Texas. The limited market capacity, he opines, has armed agencies with the leverage to set stringent terms, reflecting a longer-term trend in the industry.