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Friday, January 27, 2023

Dangerous loophole for drug ads needs to be closed

 loophole in prescription drug regulation exposes American consumers to false and misleading claims of drug ads via on-line businesses promoting potent drugs without accurate information about their risks and benefits.

Many countries prohibit direct-to-consumer advertising of prescription drugs. The United States allows it, but only if pharmaceutical companies comply with standards for accuracy and balance established and enforced by the Food and Drug Administration.

Almost everyone who watches television has seen drug ads, but most may not be aware of some of the requirements for them. Pharmaceutical companies can claim only benefits that have been approved by the FDA after an independent evaluation of supporting scientific evidence. Ads must balance accurate claims about benefits with descriptions of common and serious risks.

Some companies that violate these regulations are required to publish corrective advertising or have been ordered to remove false and misleading claims.

It’s a different story on websites and social media platforms, where ads for prescription drugs can target consumers with exaggerated or misleading claims of benefits. They may also omit essential risk information. Some examples:

    • Clinics offer infusions of the anesthetic ketamine for psychiatric disorders claiming they will “transform your life,” even though the FDA has never approved these hallucinogenic treatments for this purpose.
  • Clinics tout injections of testosterone, saying it will make men “feel young and energetic again.”
  • Sites offer an online evaluation for attention-deficit/hyperactivity disorder (ADHD) and continuing prescriptions for amphetamine stimulants to treat it but fail to include the FDA-mandated warning that these controlled substances have a high potential for abuse and addiction.

How did the online universe become a cauldron of medical misinformation about prescription drugs? Blame it on the loophole in law and regulation.

False and misleading ads about almost any marketed product are prohibited by law and subject to enforcement by the Federal Trade Commission. Prescription drug advertising is an exception — it is directly regulated by the FDA. But in the 1980s, when the FDA first opened the door to direct-to-consumer advertising, the only significant business entities promoting prescription drugs were pharmaceutical companies, and the primary outlets for drug ads were television, radio, and print media such as newspapers and magazines. As a result, advertising regulations for prescription drugs were focused on entities “that manufacture, distribute, or pack” prescription drugs.

Today, though, there are other kinds of businesses advertising or promoting prescription drugs. As part of a two-year investigation into the emerging use of ketamine for scores of psychiatric disorders, we identified hundreds of clinics that offer ketamine infusions at doses that induce a hallucinogenic experience. But the risks of ketamine are substantial and the benefits open to question, as we described in a review in the journal Pharmacotherapy.

Some telehealth startups are also taking advantage of loosely regulated prescription drug marketing. According to investigative reports in the Wall Street Journal and Bloomberg, one company recruited thousands of people with aggressive advertising to provide them with amphetamine stimulants, rated as among the most potentially addictive drugs, to treat ADHD and other problems. According to those investigations, one startup recruited so many people that several major pharmacy chains started refusing to fill their prescriptions.

A network of more than 50 centers is currently advertising testosterone replacement therapy to men. New startups are offering telemedicine prescriptions for antidepressant drugs after an on-line evaluation. Unapproved and not-fully-tested drug formulations created by compounding pharmacies are also being advertised nationwide.

There are good reasons for the extensive regulation of prescription drug advertising. People with disorders that impair their quality of life or threaten death are vulnerable to false and misleading claims that appear to offer hope. Fueling such yearnings with exaggerated — or simply erroneous — claims of possible benefits also increases the likelihood of inappropriate or dangerous use.

The U.S.’s now-obsolete system to regulate the promotion of prescription drugs needs to be updated to deal with the many new avenues through which prescription drugs are advertised, prescribed, and dispensed. Current prescription drug advertising regulations and enforcement should apply to all business entities — not just the companies that make drugs — that are advertising and providing people with prescription drugs. The FDA needs to provide clear guidance to emerging business entities that explains what is expected from drug ads on websites and social media that aims to recruit people to supply them with prescription drugs.

Regulatory loopholes mean that millions of consumers are being persuaded to take potent prescription drugs based on exaggerated claims of benefits that may not exist and assurances of safety that are simply false.

Thomas J. Moore is a faculty associate at the Johns Hopkins Bloomberg School of Public Health and a professorial lecturer in the Department of Epidemiology at the George Washington University Milken Institute School of Public Health. G. Caleb Alexander is an internist and professor of epidemiology at the Johns Hopkins Bloomberg School of Public Health.

https://www.statnews.com/2023/01/26/drug-ads-dangerous-drug-advertising-loophole/

It’s easy to buy flavored vapes in California, even in cities with longtime bans

 California cities are supposed to be cracking down on sales of flavored vapes, which are now illegal across the state. But even cities that have banned such vapes for years are unwilling — or unable — to police the sellers.

STAT visited 24 vape shops earlier this month in Oxnard, Ventura, Pasadena, El Monte, Carson and West Hollywood — all of which have had bans on flavored vapes on the books for at least a year; most for two or more years. Seventeen of the shops, or 70%, were selling the products anyway. One city is doing much better than the others: In Oxnard, where we hit five shops, none of the stores sold flavored vapes.

Many of the sellers of these products appeared to be openly flouting the law with impunity. In the city of Ventura, which banned flavored vapes in December 2019, five of the six shops STAT visited were selling illegal products. Two shops selling vapes were located on the city’s bustling main street, less than a block from city hall.

thers are making a minimal effort to appear to comply. One smoke shop in El Monte, which banned flavored products in January 2021, kept a handmade sign that read “not for sale” above its vape display. An employee there sold STAT an “energy” flavored vape when asked, with no protest. (Buying a flavored vape is not illegal in California; only selling the products is.)

The open defiance of those local laws portends badly for the state’s newly enacted flavor ban. Voters in California enacted a statewide ban on flavored vapes in November, which took effect in December. Enforcement of the new law will primarily be handled by the same local jurisdictions that have failed to enforce their own policies, not the more powerful state attorney general. The newly enacted state law is also strikingly weak: Retailers can be fined $250 for each violation, but the law does not include increased penalties for repeat offenders. Retailers also cannot lose their license for repeatedly flouting the law, like they can if they’re caught repeatedly selling products to kids — though cities and counties with stronger laws can continue to apply them.

Former state Sen. Jerry Hill, a Democrat and the chief sponsor of the statewide ban, said he was “shocked” and “outraged” by STAT’s reporting. Hill, who had to step down at the end of 2020 because of term limits, was optimistic more and more retailers would stop selling these products, but acknowledged the law may eventually have to be amended to strengthen the state’s enforcement powers.

“It would have been better to have a stronger penalty … but politics is the art of compromise,” said Hill, who admitted he “did not think that businesses would completely ignore [the law].”\

“If it’s not working … then something else will follow,” he added.

At the federal level, Rep. Nanette Barrag​​án, a Democrat who represents Carson, where STAT found four shops illegally selling flavored vapes, expressed similar dismay.

“I’m very concerned that shops appear to be selling flavored tobacco products when a ban is in place,” she said when told of STAT’s reporting. “The ban needs to be enforced so we can ensure that these dangerous products stay out of the hands of young people.”

California’s enactment of the statewide flavor ban could also have national implications. The state — the largest in the nation and the fifth state to completely ban all flavored vape products — is seen as a model for other states to follow. Eight states have introduced similar legislation so far this year.

“The nation’s eyes are on what California does,” said Matt Myers, the president of the Campaign for Tobacco-Free Kids, which supports the flavor ban. (The Campaign, like STAT, receives funding from Bloomberg Philanthropies.) “If California succeeds, it will demonstrate clearly the potential of flavor bans to reduce both youth use and minority use [of tobacco]. If California fails, it will give the industry an argument that these laws aren’t effective.”

The continued prevalence of flavored products is at least partially due to cities’ lack of oversight efforts. When STAT requested the number of inspections and violations issued by each city it investigated, only Pasadena and Carson provided that data. Pasadena said it has fined one business since it started actively enforcing its ban last July. Carson hasn’t issued a single fine, and has only completed two inspections since it began enforcing the ban in 2021.

At many of the vape shops STAT visited, you wouldn’t know the products were illegal. Their shelves were overflowing with the types of cheap, disposable flavored products increasingly being used by young people.

One store in West Hollywood, for example, displayed roughly thirty flavors of Elf Bars and at least twenty flavors of Flum, two of the most prevalent vape brands. They make products in flavors like bubble gum, gummy drop, and rainbow skittles.

Often shops openly advertised the sale of these products. One store in Ventura displayed a window decal advertising it was an authorized Flum retailer, for example, and had 27 flavors of the product — the shopkeeper even volunteered that he had the newest flavor, Rums Freeze.

Some shops were more clandestine about their sales. Ten of the stores STAT visited only pulled out flavored products when asked. An employee at a vape shop in Ventura admitted that the products were sold “on the low” after she pulled a cart of vapes out from behind a curtain.

One shop in Pasadena, which displayed a window decal opposing the flavor ban, told STAT that disposables — and disposables only — had to be bought with cash.

Another shop had a sign on its counter warning, “effectively immediately, California law prohibits the sale of flavored tobacco products,” but then sold STAT a Pear Ice Hyppe Bar without question.

The only city where STAT could not find a wide assortment of flavored vapes was Oxnard, which was one of the earliest cities to ban these products, in 2019. There, STAT could only find tobacco and “clear” flavored vapes, largely unflavored products that are advertised online as having a “light menthol” flavor.

Already, there’s debate on whether these “clear” products are legal under the California law. Tobacco control advocates insist they should be illegal, though some vape shops have been reportedly told by regulators they can sell these products, according to the industry publication Filter.

Even with Oxnard’s flavor ban working largely as intended, it was easy to find flavored vapes close by.

One shop employee in Oxnard suggested STAT visit Port Hueneme, a neighboring town that had not implemented its own flavor ban ahead of the state law. There, STAT found three vape shops selling flavored products all within a two-mile radius, including one with signage outside that read “We carry all your flavored goods.”

The stores STAT visited in Port Hueneme were not included in its tally of 24 stores because the city only enacted its flavor ban when the state law was enacted.

It remains unclear how California will fix the enforcement issues. Some are hopeful that the situation will begin to resolve on its own.

Shopkeepers in a few stores STAT visited did volunteer that they were selling off their leftover inventory in the wake of the November referendum. While that is illegal, it remains to be seen if those businesses will begin to follow the law after they recoup their investment.

One city, El Monte, also told STAT that it was planning to launch a “full enforcement campaign” on March 1, after it had “paused some of our enforcement activities during COVID.”

Former state Sen. Richard Pan, a Democrat and a vocal proponent and co-sponsor of the ban, said he hoped the situation would improve as retailers get educated about the policy. He argued that an effort financed by tobacco companies to put the law, which was first signed by the governor in 2020, to a statewide ballot could have led some retailers to be confused about what they currently can sell.

“There’s a lot of confusing messages out there. Now that everything is settled, it’s time for everyone to get on the same page,” said Pan, who acknowledged he was assuming most store owners want to follow the law.

When STAT described certain shops’ open defiance of the law, however, even Pan argued that there may need to be additional “enforcement efforts.”

“They need to understand there’s consequences for that,” Pan said.

In California, different jurisdictions place the responsibility of regulating vape shops on different agencies with wildly different missions.

In El Monte, enforcement of the ban is handled by the police department and code enforcement. However, in Carson it’s handled by the city’s finance department. In Pasadena, it’s the public health department.

It’s also unclear how long it’ll take municipalities without longstanding flavor bans to set up their own enforcement program. The state law does not specify what local agencies should be tasked with enforcing the law, nor does it set timelines for each localities’ enforcement program to be established. The law also doesn’t provide funding for local agencies to do this enforcement.

Bill Lockyer, a former California attorney general and state senator, argued the state needed to send a strong message that it would enforce the law. But he struggled to articulate how that could happen.

“I would think some enforcement that would put people on notice, ‘We are coming,’ might be useful,” Lockyer said. “I don’t know who is going to do that.”

Supporters of the law acknowledge that it may need to be amended to give the state more power to go after retailers that ignore the law.

Eric Lindblom, a senior scholar at Georgetown University, pitched a number of ways the law could be strengthened, including giving regulators the ability to shut down stores that repeatedly violate it, and giving inspectors the ability to seize and destroy illegal products they find on the shelves.

“It’s terrific that it’s in place. It’s a very, very clear statement that flavored tobacco products should not be on the market. [But] it looks like we’ve got some procedural, enforcement, and administrative problems,” said Lindblom, who has helped states and cities craft similar policies.

Some advocates are also calling for the attorney general to test its legal authority by going after manufacturers and distributors of vapes that are banned in the state.

“If California doesn’t enforce this law against the manufacturers and distributors quickly, then trying to do it store by store [will be] an enforcement nightmare,” said Myers, of the Campaign for Tobacco-Free Kids. “They have a strong law that will not be effective unless they take statewide action against the stakeholders who make and distribute these products across the state.”

Myers was adamant that the state has the power to go after these industries, despite the fact that the law does not mention fines or other sanctions against these industries. Other legal experts were less certain California has that power because, they said, it might be considered unlawfully regulating interstate commerce, which only the federal government can regulate.

“There is a chance that somebody might raise an alarm about affecting a national player,” said Andrew Twinamatsiko, an attorney who previously advised California on tobacco control laws and is now associate director of the Health Policy and the Law Initiative at Georgetown University’s O’Neill Institute. “There could be a fine line to walk there.”

The decision on whether to take such action will likely fall to Rob Bonta, California’s attorney general. Bonta declined an interview with STAT and declined through a spokesperson to say whether he would take a more active role in prosecuting violators of the law.

In a written statement, the AG’s office said that “prosecution and enforcement of retail flavor bans, like Ventura’s ordinance or SB 793, is typically handled at the local level.” The AG did not directly answer STAT’s question on whether the office has the power to go after manufacturers and retailers directly, but did note that the agency can “[crack] down on the trafficking and distribution of illegal products.”

The office also highlighted millions of dollars in grant funding the office has supplied to local jurisdictions to help with enforcing the law, and several speaking engagements the office has done with local health and law enforcement agencies.

STAT’s coverage of the commercial determinants of health is supported by a grant from Bloomberg Philanthropies. Our financial supporters are not involved in any decisions about our journalism.

https://www.statnews.com/2023/01/27/california-flavored-vape-ban/

Amazon selling Bay area offices to unwind COVID expansion

 E-commerce giant Amazon is reportedly going to offload an office complex it has in the Bay Area of Northern California. 

The nearly 29-acre site is located in Milpitas, a city between Fremont and San Jose

Amazon bought the property for over $120 million in 2021 during the second year of the COVID-19 pandemic, according to Bloomberg, which first reported the news Thursday.

Amazon spokesperson Steve Kelly told FOX Business Friday the company is "always evaluating our network to make sure it fits our business needs."

"As part of this effort, we’ve made the decision to explore selling the Metro Corporate Center site," he said. "We’re happy to remain part of the local community and will continue to deliver for customers from our two delivery stations in Milpitas."

Bloomberg reported the buyer of the empty complex will be developer Dermody Properties, which plans to make it a warehouse. 

George Condon, the West Region partner for Dermody Properties, told FOX Business the property was under contract with an anticipated close date in April. 

He said the building "will be one of only eight modern, Class-A warehouses larger than 400,000 square feet serving the Bay Area." 

Amazon has also opened new sites in January in Sioux Falls, South Dakota, and another in Papillion, Nebraska, according to local reports.

Amazon

An Amazon building (AP Photo/Bebeto Matthews, File / AP Newsroom)

In November, a same-day shipping facility for Amazon also reportedly opened in Northern California.

In late October, Amazon said it generated $127.1 billion in net sales for the third quarter, a 15% increase from the same three-month period the prior year. The company’s quarterly net income was $2.9 billion, dropping nearly 9% year-over-year.

TickerSecurityLastChangeChange %
AMZNAMAZON.COM INC.102.24+3.02+3.04%

Amazon shares were trading at roughly $102 Friday afternoon, up over 19% from the start of 2023 but down nearly 29% over the past year.

https://www.foxbusiness.com/markets/amazon-selling-bay-area-offices-to-unwind-covid-expansion

CFPB has a data privacy blind spot

 The safety and security of your personal financial data is a top priority for America’s leading banks, and it should be for the Consumer Financial Protection Bureau (CFPB) too. Unfortunately, the CFPB tasked with protecting consumers and promoting fair competition may be missing the mark with its implementation of “Section 1033” – a little-known provision of the Dodd-Frank Act that could have sweeping implications for the financial services marketplace and consumers alike.

Passed into law more than a decade ago, Section 1033 was intended to ensure consumers were able to access their own personal information held by their financial services provider. But this language was written well before the fintech boom or rise in cyber security scares and has since raised many questions about who can access a consumer’s data, how that data is being protected and shared, what consent is needed, and which party is liable for a potential data breach.

Through this rulemaking, the CFPB could answer these pressing questions in a manner that promotes competition and innovation while still protecting consumers. Instead, the proposal as outlined would dramatically hinder competition and put the safety of consumers and the security of their sensitive financial data at risk. 

Over the past decade, the financial services ecosystem has rapidly evolved. Since the Dodd-Frank Act was passed in 2010, there has been a dramatic increase of non-bank third parties and data aggregators that increasingly utilize consumers’ personal financial information to conduct business. In fact, according to the New York Federal Reserve, non-bank lenders now issue nearly three-quarters of all personal loans — double their share from just five years ago and pushing balances to all-time highs. Unlike well-regulated financial institutions, these entities do not have any federal oversight and lack the same stringent federal standards as banks, depriving users of these providers the protections they expect and deserve.

Although consumers often consent to sharing their financial data as part of the terms of service they must agree to when using certain non-bank services, consumers are generally unaware of how that data may be used or shared. To access data, many aggregators rely on screen scraping, to obtain a consumer’s personal financial information. This process, which typically uses a consumer’s access credentials to pull sensitive user information from a bank’s online financial account management portal, is fundamentally unsafe and puts consumer data at risk.  

Because many consumers commonly mistake deleting a mobile phone or computer application with revoking consent, many non-bank third parties maintain continued, unfettered access to consumers’ personal information even after the relationship has seemingly been severed. In fact, a December 2021 consumer survey report on data privacy and financial app usage found that 80 percent of consumers were largely unaware that apps use third-party providers to gather users’ financial data, and only 24 percent knew data aggregators may sell their personal data to other parties for marketing, research, and other purposes. Despite these concerns, the CFPB has yet to indicate how the agency will supervise these entities for compliance with the final Section 1033 rule.

CFPB Director Rohit Chopra has stated this rule is intended to “empower people to break up with banks that provide bad service and unleash more market competition.” Not only does this sentiment stray from the plain language of Section 1033, it fails to account for the fact that the financial services ecosystem is among the most competitive and innovative in the world. 

The CFPB also indicated that the proposal will only allow consumers to access their information from banks and credit card companies, and not from other financial services providers that may also hold their data, including non-bank mortgage originators, captive auto lenders, fintech Buy Now Pay Later lenders, and other nonbank financial services providers. This approach to implementation would ironically hinder competition by creating an unlevel playing field between well-regulated financial institutions and non-banks, leaving millions of consumers without adequate protections. As the Consumer Bankers Association conveyed in a comment letter this week, by limiting new data-sharing requirements to only certain segments of the marketplace, the Bureau is failing to comply with the basic premise of this important law — to empower consumers with access to all their data.

In light of the growth and challenges that have arisen from the lack of data and consumer protection rules for non-bank third parties, the importance of delivering a final Section 1033 rule that promotes a safe, fair, and competitive financial services marketplace could not be greater. As it stands, the CFPB’s intended proposal implementing Section 1033 will expose the sensitive financial information of millions of consumers to unnecessary risks and fail to provide them with access required by Congress. To meaningfully deliver on their mission, policymakers must shift course before it is too late.

Dan Smith is Executive Vice President and Head of Regulatory Affairs at the Consumer Bankers Association.

https://thehill.com/opinion/congress-blog/3833748-the-cfpb-has-a-data-privacy-blind-spot/

White House officials speak with mayors before possible protests of Tyre Nichols footage

 White House officials on Friday held a call with roughly 15 mayors to brief them on preparations to give federal support in response to demonstrations that may stem from the release of footage of police beating of Tyre Nichols, a 29-year-old Black man who died after a traffic stop earlier this month.

White House homeland security adviser Liz Sherwood-Randall and senior adviser to the president Julie Rodriguez spoke with the mayors, urging them to remain in regular contact and emphasizing the need for protests to remain peaceful.

“Participating mayors shared their perspectives on how important it is to recognize the pain felt by communities across this country, be prepared in advance with a game plan to provide adequate community support, and to reinforce the importance of peace and calm during these difficult moments,” the White House said in a readout of the call.

Participants included mayors from Atlanta, Boston, Chicago, New York City, Seattle, Los Angeles, Cleveland, St. Louis and Baltimore. Sixteen mayors joined the call, the White House said.

President Biden is spending the weekend at Camp David in Maryland. Before departing the White House, he told reporters it was important that any demonstrations in response to the footage remain peaceful. He noted that Nichols’s mother has asked that demonstrations stay nonviolent.

“I’m obviously very concerned about it. But I think she has made a very strong plea. She’s obviously in enormous pain,” Biden said.

Biden earlier Friday spoke with Nichols’s mother and stepfather and praised their courage while offering his condolences on the loss of their son.

Footage of Nichols’s beating is expected to be released on Friday night, and state, federal and local officials in Memphis, Tenn., have expressed concern about public reactions to the video.

The five now-former Memphis Police officers involved in the incident were charged with second-degree murder and other offenses on Thursday. All five men, who are all Black, were fired from the department.

Several officials at the federal, state and local level have described the video footage as horrific and appalling, with some officials comparing it to the Rodney King video from 1991, when grainy footage showed the man being beaten by Los Angeles Police Department officers.

https://thehill.com/homenews/administration/3833872-white-house-officials-speak-with-mayors-ahead-of-possible-protests-over-tyre-nichols-footage/

Student debt relief challengers make case to Supreme Court

 Challengers to the Biden administration’s student debt relief plan submitted their written arguments to the Supreme Court on Friday, contending the administration overstepped its authority.

In their separate briefs, six Republican-led states and two individual loan borrowers who did not qualify for the relief argued the administration should not be allowed to forgive up to $20,000 for qualifying individuals.

The justices will hear oral argument in the cases on Feb. 28, two of the most high-profile challenges to Biden administration policies at the Supreme Court this term. 

The challenges have put millions of borrowers — and Biden’s campaign promise — in limbo as the program remains on pause until the court’s ruling, expected by the summer.

The administration previously argued to the justices that they shouldn’t consider the merits of the two lawsuits because neither group of challengers have standing, meaning the legal capacity to sue.

The six states — Arkansas, Iowa, Kansas, Missouri, Nebraska and South Carolina — pushed back in Friday’s brief by asserting they will each suffer financially due to the plan for differing reasons.

Missouri argued the plan will harm its student loan service, three states cited impacts from how some borrowers are now consolidating their loans and four said their tax revenues will take a hit.

Meanwhile, the individual challengers argued they have standing because they were denied a procedural right to express their views through a formal comment period.

“Respondents have federal student loans that are not being forgiven under the Program but could be if the Secretary followed the proper procedures,” wrote attorneys for Myra Brown and Alexander Taylor, the two individual challengers.

If the court does reach the merits, the administration cites the 2003 Higher Education Relief Opportunities for Students (HEROES) Act as Cardona’s authority to forgive the loans.

Both the six states and the two individuals contended that the law “does not authorize the Program” because the court’s precedents require Congress to give clearer authority for such an important decision.

“Canceling hundreds of billions of dollars in student loans—through a decree that extends to nearly all borrowers—is a breathtaking assertion of power and a matter of great economic and political significance,” the states wrote in their brief.

The law allows the secretary to modify federal financial aid programs when necessary in connection with a national emergency, and Cardona has tied the plan to the emergency the Trump administration first established for the pandemic that still remains in effect.

“While President Biden declares the pandemic over, his Secretary of Education and Department of Education cite COVID-19 to justify the Loan Cancellation Program—an unlawful attempt to eliminate $430 billion of federal student-loan debt,” the states argued.

https://thehill.com/regulation/court-battles/3833910-student-debt-relief-challengers-make-case-to-supreme-court/

Gum infection may be a risk factor for heart arrhythmia

 Periodontitis, a gum disease, can lead to a litany of dental issues from bad breath to bleeding and lost teeth. Now, researchers at Hiroshima University have found that it could be connected to even more severe problems elsewhere in the body—the heart.

In a study published in JACC: Clinical Electrophysiology, the team found a significant correlation between  and fibrosis (which is scarring to an appendage of the heart's  that can lead to an  called atrial fibrillation) in a sample of 76 patients with cardiac disease.

"Periodontitis is associated with a long-standing inflammation, and inflammation plays a key role in atrial fibrosis progression and atrial fibrillation pathogenesis," said first author Shunsuke Miyauchi, assistant professor with the Hiroshima University's Health Service Center. He is also affiliated with the university's Graduate School of Biomedical and Health Sciences. "We hypothesized that periodontitis exacerbates atrial fibrosis. This histological study of left atrial appendages aimed to clarify the relationship between clinical periodontitis status and degree of atrial fibrosis."

The left atrial appendages were surgically removed from the patients, and the researchers analyzed the tissue to establish the correlation between severity of the atrial fibrosis and severity of the . They found that the worse the periodontitis, the worse the fibrosis, suggesting that the inflammation of gums may intensify inflammation and disease in the heart.

"This study provides basic evidence that periodontitis can aggravate atrial fibrosis and can be a novel modifiable risk factor for atrial fibrillation," said corresponding author Yukiko Nakano, professor of cardiovascular medicine in Hiroshima University's Graduate School of Biomedical and Health Sciences.

According to Nakano, in addition to improving other risk factors such as weight, activity levels, tobacco and alcohol use, periodontal care could aid in comprehensive atrial fibrillation management. However, she cautioned that this study did not establish a , meaning that while gum disease and atrial fibrosis degrees of severity appear connected, researchers have not found that one definitively leads to the other.

"Further evidence is required for establishing that periodontitis contributes to the atrial fibrosis in a causal manner and that periodontal care can alter ," Nakano said. "One of our goals is to confirm that periodontitis is a modifiable risk factor for atrial fibrillation and to promote dental specialists' participation in comprehensive atrial fibrillation management. Periodontitis is an easy modifiable target with lower cost among known atrial fibrillation . Thus, the achievement of this study series may bring benefits for many people worldwide."

Next, the researchers said they hope to conduct future clinical trials to clarify if periodontal intervention reduces  occurrence and improves patient outcomes.

More information: Shunsuke Miyauchi et al, Relationship Between Periodontitis and Atrial Fibrosis in Atrial Fibrillation, JACC: Clinical Electrophysiology (2022). DOI: 10.1016/j.jacep.2022.08.018


https://medicalxpress.com/news/2023-01-gum-infection-factor-heart-arrhythmia.html