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Wednesday, February 15, 2023

Amgen to raise $24 billion after seeing about $90 billion in demand for mega bond deal

 Deal is one of 10th largest in U.S. corporate bond history

Amgen Inc. plans to borrow $24 billion in the U.S. corporate bond market on Wednesday to help fund its acquisition of Dublin-based Horizon Therapeutics, according to Informa Global Markets.

Amgen (AMGN) and Horizon Therapeutics (HZNP) announced plans for the mashup in December, with Amgen receiving a $28.5 billion bridge credit facility from Citibank and Bank of America to help aid the transaction.

With an initial target size around $20 billion, investor demand for the bonds reached about $90 billion, according to Informa. At $24 billion, it ranks in the Top 10 in terms of largest deals ever financed in the U.S. investment-grade corporate bond market, according to Informa data.

Amgen's mega financing comes despite sharply higher borrowing costs for businesses and households as the Federal Reserve looks to keep pulling U.S. inflation down from a peak of 9.1% last summer.

Yields in the U.S. investment-grade corporate bond market have retreated to around 5.3% from October's peak level of about 6%, in part on hopes that the Fed might be nearing the end of its rate hiking cycle. The pullback in yields underscores the rally in risk assets to kick off 2023, even though recession concerns linger and as companies face some of the highest borrowing costs in more than a decade.

High demand for Agmen's bonds signals a bullish tone on Wall Street, which allowed bankers to narrow the financing costs for the borrower, while also cutting back compensation due to investors.

Amgen's shortest two-year class of bonds was expected to clear at 65 basis points above the risk-free Treasury rate , according to Informa. That's down from earlier price talk of around 90 basis points above the risk-free rate, according to CreditSights.

Its longest 40-year class on bonds was expected to clear at a spread of 200 basis points above the risk-free rate, down from an initial guidance of roughly 230 basis points above the benchmark rate.

The bond financing comes despite a choppy few sessions on Wall Street. January's consumer-price index released on Tuesday pegged CPI at a slower 6.4% annual rate, but still well above the Fed's 2% target. That raised concerns about the potential for the central bank to raise rates higher than earlier anticipated.

https://www.morningstar.com/news/marketwatch/20230215554/amgen-to-raise-24-billion-after-seeing-about-90-billion-in-demand-for-mega-bond-deal

Chinese spy flight flap spurs Congress on nationwide TikTok ban

 The controversy surrounding Chinese surveillance balloons reportedly could act as the catalyst in driving Congress to enact legislation banning TikTok in the United States over national security concerns. 

American lawmakers have been accelerating calls to ban TikTok, owned by Chinese internet company ByteDance, nationwide at the federal level since the U.S. military nearly two weeks ago shot down a suspected Chinese spy balloon off the Carolina coast after it traversed sensitive military sites across North America. 

Last month, Sen. Josh Hawley, R-Mo., and Rep. Ken Buck, R-Colo., introduced legislation dubbed the No TikTok on United States Devices Act, which seeks to prohibit the Chinese-based TikTok app from being downloaded on U.S. devices and ban commercial activity with TikTok’s parent company, ByteDance. 

Though Hawley recognized banning TikTok on government devices was a step in the right direction, he said, "now is the time to ban it nationwide to protect the American people." 

"TikTok poses a threat to all Americans who have the app on their devices. It opens the door for the Chinese Communist Party to access Americans’ personal information, keystrokes, and location through aggressive data harvesting," Hawley said in a statement on Jan. 25 before the spy balloon controversy. 

The No TikTok on United States Devices Act would direct President Biden to use the International Emergency Economic Powers Act (IEEPA) within 30 days to block and prohibit transactions with TikTok’s parent company ByteDance, with stiff penalties for entities that attempt to evade these sanctions. 

Within 120 days of enactment, the legislation would require the Director of National Intelligence to submit a report and brief Congress on the threats to national security posed by TikTok. 

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That would include the ability of the Chinese government to access U.S. user data; the ability of the Chinese government to use U.S. user data for intelligence or military purposes, including surveillance, microtargeting, deepfakes, or blackmail; and ongoing efforts by the Chinese government to monitor or manipulate Americans using data accessed via TikTok.

In an interview last month with "The Marc Cox Morning Show," Hawley said TikTok is accessing users’ email, their photos and their contact lists and is following their keystrokes and the websites they visit. The senator said all that information "can be accessed by the Chinese Communist Party in Beijing." 

spy balloon

The remnants of a large balloon drift above the Atlantic Ocean, just off the coast of South Carolina, with a fighter jet and its contrail seen below it, Feb. 4, 2023. (Chad Fish via AP, File / Getty Images)

But a spokesperson for TikTok, Brooke Oberwetter, told USA Today that the app doesn't access users' emails, follow keystrokes or track websites visited by users through their browsers outside the app. She also claimed TikTok doesn't access users' photos, videos or contacts unless the user allows it. 

Oberwetter also told the outlet that TikTok executives have said the Chinese government has not asked for U.S. user data and if they had, they wouldn’t share that information anyway. The Washington Post reported that app does collect email and IP addresses, phone numbers and users’ approximate location. 

During a House Homeland Security Committee hearing last November, FBI Director Christopher Wray told Congress he was "extremely concerned" about the Chinese government weaponizing data. 

Wray warned that APIs – application programming interfaces – ByteDance embeds in TikTok’s platform are a threat to national security because the Chinese government could "control data collection of millions of users or control the recommendation algorithm, which can be used for influence operations." 

Hawley introduces TikTok ban

Sen. Josh Hawley, seen in a Senate Homeland Security and Governmental Affairs Committee hearing, introduced legislation in January for a federal TikTok ban. (Ting Shen/Bloomberg via Getty Images / Getty Images)

Republican-run states have taken the lead in issuing restrictions on TikTok, mainly banning the platform on state government-issued devices, as critics categorize the app as another Chinese surveillance tool. Universities, meanwhile, have also taken steps to limit access to TikTok at least on campuses. 

Even Democratic Senate Majority Leader Chuck Schumer joined the conversation over the weekend, telling ABC News that a nationwide U.S. ban on TikTok is "something that should be looked at." 

TikTok has been working for years to avert a ban in the U.S. after former President Donald Trump threatened to do so, and it has invested some $1.5 billion in reorganizing its U.S. operations while offering federal regulators more oversight as part of a plan that it says will ensure U.S. user data would not be accessible to its parent company and, therefore, shielded from the CCP.

TikTok CEO Shou Zi Chew is expected to testify before the Energy and Commerce Committee in March. 

https://www.foxbusiness.com/politics/chinese-spy-flight-controversy-acting-catalyst-congress-pass-nationwide-tiktok-ban

U.S. backs Moderna, says government should face COVID-19 vaccine lawsuit

 The U.S. government should face a patent lawsuit over COVID-19 vaccines, not vaccine maker Moderna Inc, the Department of Justice told a Delaware federal court on Tuesday.

The Justice Department's court filing said the United States should be liable for any infringement of Arbutus Biopharma Corp and Genevant Sciences GmbH's patents that took place under Moderna's contract to provide shots for the government's nationwide vaccination effort.

Moderna made the same argument last year in an unsuccessful bid to win an early dismissal of the lawsuit.

Genevant declined to comment on the filing. Representatives for Moderna, the U.S. Food and Drug Administration and the U.S. Department of Health and Human Services did not immediately respond to requests for comment Wednesday.

Warminster Township, Pennsylvania-based Arbutus and Genevant — a joint venture between Arbutus and Roivant Sciences Ltd — sued Cambridge, Massachusetts-based Moderna last year for royalties on its multi-billion-dollar COVID vaccines.

Both Moderna and Pfizer Inc have been the target of multiple patent lawsuits over their COVID vaccines, including a lawsuit brought by Moderna against Pfizer in August.

Moderna asked the Delaware court to dismiss Arbutus and Genevant's case in May, arguing it could only be brought against the government in the U.S. Court of Federal Claims. It cited a law that was previously used to keep patent disputes from interfering with the supply of war materials during World War One.

But U.S. District Judge Mitchell Goldberg said in November that Moderna had not yet shown that the vaccines were made for the government or with its authorization and consent under the law, and that it may have instead been an "incidental beneficiary" of the shots.

The Department of Justice responded Tuesday that Moderna should not be liable based on its contract to provide the vaccines to the government as part of Operation Warp Speed.

It said the government's liability is limited to Moderna's alleged infringing activity that took place under its U.S. contract.

The case is Arbutus Biopharma Corp v. Moderna Inc, U.S. District Court for the District of Delaware, No. 1:22-cv-00252.

https://finance.yahoo.com/news/u-backs-moderna-says-government-170221948.html

No protection against surprise ambulance bills, no aid in sight

 One night in November 2021, 11 weeks into her pregnancy, Carolyn Provine started bleeding — a lot. When she passed out, her wife and mother-in-law called an ambulance and drove 21 miles to the hospital for an emergency surgery. But the hemorrhaging, and miscarriage, no longer were Provine’s only concerns.

“My first thought was, ‘Wait, is there some way for me not to take an ambulance?’” said Provine, 26, a reading specialist in Vermont. “I had had one in college for something that wasn’t life-threatening at all” — a dislocated kneecap, she said — “and my mom had been hit with this pretty big bill.”

Provine had health insurance. But like a vast majority of those who take an ambulance for an emergency, the ride was out of her insurance company’s network. She paid $516.90 — on the low end of the $500 to $750 range for average charges, depending on who owns the ambulance service.

In a cruel twist, ground ambulances were excluded from the federal law that banned most types of surprise medical bills starting in 2022 — even though roughly 85% of all emergency ambulance rides are out-of-network, like Provine’s. And there is no traction in Congress to craft a solution anytime soon. Instead, the federal law known as the No Surprises Act created an ambulance advisory committee, which will study patient billing more and make formal recommendations. But even that committee is off to a shaky start: Its inaugural meeting in January was postponed and is now expected to meet for the first time in March.

“We know that patients continue to get an out-of-network ambulance bill that’s expensive and isn’t covered by their insurance, and they have no recourse and have to pay it. It’s really troubling,” said Patricia Kelmar, a health care director at the consumer advocacy group U.S. PIRG who sits on the federal ambulance advisory committee.

Surprise bills for ambulance trips have been an obvious problem. People don’t shop for most health care services, and that’s most true for patients who are sick, injured, or unconscious while on a gurney in a vehicle. Solving bills in these circumstances has been less obvious, due in part to America’s patchwork system of ambulances.

Local fire departments and municipalities operate a majority of ambulances, according to new research published this year in Health Affairs. Private equity and other publicly traded companies, meanwhile, make up 1 out of 10 ambulances. Some rural ambulances barely see any patients, while those in bigger cities are dispatched at all hours. On top of everything sits differing rules from county and state governments — some of which regulate what ambulances can charge. Federal lawmakers ultimately didn’t want to upend this odd system in the No Surprises Act.

“There was a natural nervousness that this might mess with the applecart a little bit,” said Loren Adler, an associate director of the USC-Brookings Schaeffer Initiative for Health Policy, who also sits on the ambulance billing advisory committee.

Some states have taken matters into their own hands, to the extent they can. Ten states have outlawed surprise bills for ground ambulances, according to a recent report authored by Kelmar of U.S. PIRG. But those protections only apply to people who are insured in a plan regulated by that state. Most people who get health insurance through their jobs are enrolled in self-insured plans, which are exempt from state insurance laws.

James Safin found this out the hard way this past November while working at his employer in Illinois, which is one of the 10 states that bans or limits surprise ambulance bills. The 34-year-old felt extremely dizzy and disoriented and called for an ambulance, which was operated by the village of Westchester. After clearing a checkup and tests at a nearby hospital, he went home.

In December, Safin wanted to know how much he owed for the ambulance. He gets insurance through a self-insured employer. The employer’s third-party administrator, Aetna’s Meritain Health, originally said insurance would pay almost $500 for the ambulance, and Safin would owe a separate $122.89, according to documents shared with STAT. But a few weeks later, he received a bill in the mail from Westchester for almost $2,300.

“I was taken aback,” Safin said. “It was very surprising and alarming. It contradicted what I had been told.”

After several weeks of inquiries from STAT, Westchester’s fire department, which runs the ambulance service that took Safin, and a Westchester attorney did not formally respond. A spokesperson for CVS Health, which owns Aetna and Meritain Health, sent a statement: “The claim for the ambulance service that Mr. Safin needed was administered correctly.” Neither side would even confirm whether they had negotiated with each other. Safin ultimately contacted his company’s human resources department, which has since told him he would not owe the $2,300 and is working to settle the bill.

More than 100 million other Americans in self-insured health plans face the same situation if they take an ambulance today.

“You need a federal solution here,” Adler said. “It’s pretty unfair to just leave people in the lurch.”

There’s no consensus on what that solution should be. The arbitration process created by the No Surprises Act for other medical bills has been a mess so far — doctors, other provider groups, and insurers have been entangled in a Gordian knot of unsettled claims, and a flurry of lawsuits led by doctors is muddying how arbiters should make final judgments. Experts agree jamming ambulance claims into the same process isn’t feasible.

“The fundamental policy question is, how do you design an arbitration system that encourages [the two sides] to settle?” said Ben Chartock, a health economist at Bentley University who has studied surprise bills for roughly a decade.

Policy experts have also floated a simpler approach: paying all out-of-network ambulance bills based on percentages of what Medicare would pay. For 2023, Medicare pays a base rate of $266 per ambulance ride, and that base rate could fluctuate higher based on the level of care someone needs, geography, and other add-on payments. Medicare also pays $8.54 per mile traveled. All in, Medicare pays around $500 for the average ambulance ride.

Ambulances, like other providers, argue Medicare underpays them. Previous government studies have suggested that’s not true in all cases. To that end, Medicare is in the middle of a multi-year project to collect cost and revenue data from ambulance providers.

The foundational, intractable problem ultimately is the same one that has defined all surprise billing disputes: The two negotiating parties don’t like each other very much.

“We want to take the patient out of the middle,” said Maria Bianchi, CEO of the American Ambulance Association. “The problem comes down to inadequate reimbursement by a lot of the insurers.” Bianchi added that insurers often pay little to no attention to smaller ambulance companies that have a relatively low amount of claims. America’s Health Insurance Plans, which represents insurers in Washington, did not provide a formal position on ground ambulance surprise bills.

James Gelfand, president of the ERISA Industry Committee, which lobbies on behalf of large self-insured employers, believes ambulances are using their complicated structure as an excuse to get off the hook for deliberate business decisions. He testified twice in front of Congress in 2019, demanding lawmakers include ground ambulances, to no avail. He said the problems have only gotten worse, and employers often aren’t notified when out-of-network bills are sent to their workers.

“Because the balance bill can be so devastating for patients, many times a group health plan will simply pay it even though they’re not under any obligation to do so,” Gelfand told STAT. “It’s great for an individual patient, but it’s bad for the plan. And it’s also bad for the markets because it encourages this behavior.”

“It doesn’t make sense to protect someone at the hospital, but not on the way there,” he added.

For now, patients’ fate rests with the federal advisory committee. The federal government did not respond to questions about the panel’s agenda. The committee has six months after the first meeting to write a report with recommendations — meaning the earliest anything will come out is later this fall. In the meantime, Congress has no plans of acting, either.

“I don’t think there’s going to be surprise [billing] legislation this year, because, frankly, my office and a few others drove it last time,” Sen. Bill Cassidy (R-La.), the new ranking member of a key Senate health committee, told STAT earlier this month. “We’re not currently engaged in that issue, so I don’t see others picking up the mantle.”

Patients who get an unexpected ambulance bill don’t have many protections, but they can still fight back, consumer advocates say. They should start by appealing with the insurance company and ambulance provider. The appeals process is often intimidating and time-intensive — creating an extra burden for people who are recovering from a traumatic health episode — but persistence can often force the two sides to come to an agreement.

“It’s worth doing for patients, if there’s no other option,” said Caitlin Donovan, a senior director at the National Patient Advocate Foundation. If appealing hits a stalemate, patients should rope in their HR and benefits managers. Donovan said she’s also heard of people paying for ambulance memberships to avoid any billing hassles.

Provine is fully recovered. Even though she and her wife didn’t go into debt paying the ambulance bill, the experience made a bad impression. It’s the type of thing that could make patients second-guess whether they call an ambulance at all, and one she believes adds more stress to an already stressful situation.

“Nobody is in a position to turn down an ambulance by the time they arrive,” Provine said. “When you’re in an emergency, you may not even be sharp enough. It’s not like, ‘Let me come out of my anemia haze for a second to Google ambulance companies.’ That’s not how it works.”

https://www.statnews.com/2023/02/13/surprise-ambulance-bills-no-fix-in-sight/

Potential Role of Spike Protein in Neurodegenerative Diseases

 Stephanie Seneff • Anthony M. Kyriakopoulos • Greg Nigh • Peter A. McCullough

DOI: 10.7759/cureus.34872

Abstract

Human prion protein and prion-like protein misfolding are widely recognized as playing a causal role in many neurodegenerative diseases. Based on in vitro and in vivo experimental evidence relating to prion and prion-like disease, we extrapolate from the compelling evidence that the spike glycoprotein of SARS-CoV-2 contains extended amino acid sequences characteristic of a prion-like protein to infer its potential to cause neurodegenerative disease. We propose that vaccine-induced spike protein synthesis can facilitate the accumulation of toxic prion-like fibrils in neurons. We outline various pathways through which these proteins could be expected to distribute throughout the body. We review both cellular pathologies and the expression of disease that could become more frequent in those who have undergone mRNA vaccination. Specifically, we describe the spike protein’s contributions, via its prion-like properties, to neuroinflammation and neurodegenerative diseases; to clotting disorders within the vasculature; to further disease risk due to suppressed prion protein regulation in the context of widely prevalent insulin resistance; and to other health complications. We explain why these prion-like characteristics are more relevant to vaccine-related mRNA-induced spike proteins than natural infection with SARS-CoV-2. We note with an optimism an apparent loss of prion-like properties among the current Omicron variants. We acknowledge that the chain of pathological events described throughout this paper is only hypothetical and not yet verified. We also acknowledge that the evidence we usher in, while grounded in the research literature, is currently largely circumstantial, not direct. Finally, we describe the implications of our findings for the general public, and we briefly discuss public health recommendations we feel need urgent consideration.

https://www.cureus.com/articles/129846-a-potential-role-of-the-spike-protein-in-neurodegenerative-diseases-a-narrative-review#!/

Lawmakers Hash Out Ways to Protect Kids From Internet Bullies, Predators

 Lawmakers questioned experts and advocates about the best ways to keep children safe from the dangers lurking on the internet during a hearing

opens in a new tab or window of the Senate Committee on the Judiciary on Tuesday.

"Child safety is a top priority. We lock the door and teach our kids not to talk to strangers," said Committee Chair Dick Durbin (D-Ill.). "But in the virtual world, criminals and bullies don't need to pick a lock or wait outside the playground to hurt our kids. They only have to lurk in the shadows online of Facebook and Snapchat. In those shadows, they can bully, intimidate, addict, or sexually exploit our kids. Right in our own homes."

During the hearing, witnesses shared horror stories recounting the dangers of social media and called on lawmakers to take action.

Kristin Bride, a social media reform advocate and "parent survivor" from Portland, Oregon, lost her son, Carson, to suicide in June 2020. After his first night of training for a summer job at a pizza restaurant, he wrote his work schedule on the kitchen calendar. That night, while his parents slept, he took his life.

"After his death, we discovered that Carson had received nearly 100 negative, harassing, sexually explicit, and humiliating messages, including 40 in just 1 day," she said.

The bullies were "Snapchat friends" -- high school classmates of Carson's who used the anonymous apps YOLO and LMK to mask their identities, Bride explained. "Anonymous apps like Whisper, Sarahah, and Yik Yak have a long history of enabling cyberbullying and leading to teen suicides."

In its user policies, YOLO stated that it would monitor for cyberbullying and share the identities of anyone engaging in such behavior. But Bride sent four requests to the company asking them to unmask her son's bullies. All were ignored.

She filed a class action lawsuit against YOLO and LMK for "product liability design defects and fraudulent product misrepresentation," but it was dismissed in a California court last month due to Section 230 of the Communications Decency Act, which "provides that companies will not be treated as publisher or speaker of any information provided by another person," as noted by Durbin.

Another witness, Mitch Prinstein, PhD, chief science officer for the American Psychological Association, highlighted other online dangers, including "numerous online communities and opportunities to engage with content that actually teaches kids how to cut themselves, how to engage in behaviors that are consistent with an eating disorder, [and] how to conceal these behaviors from their parents and adults."

These forums and online chat rooms even "sanction young people when they discuss the possibility of engaging in adaptive rather than maladaptive behaviors," he added.

These same types of spaces also train predators.

"The dark net, including Tor, has become the newest online haven for child exploitation," said John Pizzuro, a former law enforcement officer in New Jersey and CEO of Raven, an initiative built to raise funding for law enforcement to stop such exploitation.

There are forums where offenders share "best practices on how to groom and abuse children effectively," he explained. "There's a post even named the 'Art of Seduction,' that explains how to seduce children, that has been read more than 54,000 times."

According to Pizzuro, virtually all social media and gaming platforms have vulnerabilities that make it easy for offenders to target children.

"If the platform allows individuals to chat, or a way to share photographs and videos, I assure you there's a very real danger that offenders are using that access to groom or sexually exploit minors," he said.

Finding Solutions

Senators proposed a number of strategies to address the harmful and criminal acts either being willingly perpetrated online by social media companies or allowed to continue because of their negligence.

The business model in Big Tech is to compel people to watch or read their content as much as possible, "whether or not those things are good for you," said Sen. Lindsey Graham (R-S.C.), citing a 2021 report

opens in a new tab or window from the Surgeon General that details their operations.

"They make money based on eyeballs and advertising," he noted, and American consumers remain "virtually unprotected" from their behavior.

"There were 21 million episodes last year of sexual exploitation against children ... And we have no system in place to empower parents and empower consumers to seek justice to fight back and protect themselves," Graham said. "There is no regulatory agency in America with any meaningful power to control this."

To that end, he is working with Sen. Elizabeth Warren (D-Mass.) on a bill to develop a "digital regulatory commission" with the authority to shut down any website that doesn't follow "best business practices" for protecting children from sexual exploitation.

Along with Sen. Richard Blumenthal (D-Conn.), Graham also lobbied to pass the EARN IT Act

opens in a new tab or window, which "removes blanket immunity for violations of laws related to online child sexual abuse material (CSAM)" from Section 230, as noted in a press releaseopens in a new tab or window.

This legislation would hold tech companies responsible for "complicity" in the sexual abuse and exploitation of children if they refuse to report or remove images of such abuse on their platforms, and it would allow survivors -- people like Bride -- recourse to civil litigation.

"It's a step, not a stride," said Blumenthal, "but it will mark major progress if we are able to pass this measure."

Bride also urged Congress to pass the Kids Online Safety Act,opens in a new tab or window which she said "requires social media companies to have a 'duty of care' when designing their products for America's children." She called the bill "long overdue."

Durbin noted that he also had been working on "a comprehensive bill to close the gaps in the law and crack down on the proliferation of child sex abuse material online," known as the STOP CSAM Actopens in a new tab or window. He plans to release a discussion draft on Monday.

In addition, Sen. Josh Hawley (R-Mo.) and Sen. John Kennedy (R-La.) called for passing legislation to ban children from social media until age 16.

Asked whether this would be an effective strategy, Emma Lembke, founder of the LOG OFF Movement and a sophomore at Washington University in St. Louis, said, "I think the question we really have to ask is when children, who know more than most parents, enter these online spaces, how are they protected? Because we have seen time and time again that no matter the bans, kids find a way."

At the closing of the hearing, Durbin promised the witnesses that he would hold a legislative mark-up to determine the "common goals" of the committee and "common efforts to reach those goals."

The final result will probably not include everything that he wants or that the witnesses themselves would have written, "but if it is a step forward to protect children, we're going to do it," he said.

https://www.medpagetoday.com/washington-watch/washington-watch/103116

Primary Care COPD Screening Tool Shows Mixed Results

 The five-question CAPTURE

opens in a new tab or window screening tool showed high specificity but low sensitivity in detecting undiagnosed chronic obstructive pulmonary disease (COPD) in primary care.

Of 110 patients with undiagnosed but clinically significant COPD, 53 had a positive result on CAPTURE with a specificity of 88.6% (95% CI 87.6%-89.6%) and a sensitivity of 48.2% (95% CI 38.6%-57.9%), reported Fernando J. Martinez, MD, MS, of Weill Cornell Medicine in New York City, and colleagues, in JAMAopens in a new tab or window.

The area under the receiving operator curve (AUC) was 0.81 (95% CI 0.77-0.85) for various positive screening thresholds.

"The goal with trying to find COPD is to treat it earlier, which will help make patients feel better and hopefully prevent their disease from progressing," Martinez said in a statement.

COPD is underdiagnosed in primary care and is the leading cause of death and morbidity, the researchers noted. "Undiagnosed patients experience impaired health status and greater risk of acute respiratory events, health care use, and all-cause mortality," they wrote. "Although there is insufficient evidence to support COPD screening in asymptomatic individuals, identifying patients with respiratory symptoms has been suggested."

Whether the CAPTURE (COPD Assessment in Primary Care To Identify Undiagnosed Respiratory Disease and Exacerbation Risk) screening tool is up to that task remains to be seen. "Sensitivity was influenced by the high proportion of individuals with airflow obstruction, but limited respiratory symptoms; specificity was influenced by high prevalence of respiratory symptoms among those with a normal spirometry result," Martinez and co-authors noted. "Overall, this study demonstrates the challenge of identifying undiagnosed patients with COPD in primary care."

For the cross-sectional study, 4,679 primary care patients (mean age 61.6; 63% female; predominantly white) without a prior COPD diagnosis were enrolled at seven U.S. primary care-based research networks from October 2018 to April 2022.

A total of 4,325 people had data adequate for analysis. Of these, 44.6% had ever smoked cigarettes, 18.3% had a prior asthma diagnosis or used inhaled respiratory medications, 13.2% currently smoked cigarettes, and 10% reported at least one cardiovascular comorbidity.

CAPTURE included questions on a patient's ability to breathe during physical activity; exposure to forms of smoke, dust, or pollution; change in breathing as a result of seasons, air quality, or weather; ease of fatigue versus peers; and lapses in work, school, or other activities due to colds, bronchitis, or pneumonia. Questionnaire scores can range from 0-6 with larger scores indicating symptoms, acute respiratory illness, or greater respiratory exposure.

Positive results were defined as scores at ≥5, or scores 2, 3, or 4 that were accompanied by further spirometry and a peak expiratory flow rate (PEFR) below 350 L/min for males or below 250 L/min for females.

Clinically significant COPD was defined as spirometry-defined COPD combined with either forced expiratory volume in the first second of expiration (FEV1), less than 60% of the predicted value, or a self-reported history of acute respiratory illness in the past year. Martinez's group noted this definition "was based on older criteria that focused on the severity of airflow obstruction and prior respiratory illnesses," whereas more up-to-date Global Initiative for Chronic Obstructive Lung Disease

opens in a new tab or window (GOLD) therapeutic strategies are dependent on symptoms and respiratory illness.

Overall, 12.3% of all patients received a positive result for clinically significant for COPD via CAPTURE; of those, 43.8% obtained a result based solely on the questionnaire, while 56.2% received a positive result from CAPTURE plus PEFR. Among patients with a positive screening result, 88.7% had either COPD, a preserved ratio impaired spirometry result, or were symptomatic but with a normal spirometry result compared with 43.4% of patients with a negative screening result.

One benefit of CAPTURE is that it can push physicians to escalate assessment of patients with respiratory symptoms, particularly if spirometry is too difficult to integrate into a brief primary care office visit, the researchers noted.

"CAPTURE was designed to be easy for physicians to use," said Antonello Punturieri, MD, PhD, of the National Heart, Lung, and Blood Institute, which helped develop the tool. "The screening is simple, takes less than a minute, and helps identify adults with trouble breathing who should be evaluated further," he said in a statement.

The sensitivity of CAPTURE needs improvement, Martinez and colleagues acknowledged. One possible strategy for boosting results "would be to consider using an alternate definition of clinically significant COPD that would be congruent with the current GOLD recommendations for treatment initiation," they wrote. "Evaluation is ongoing to optimize the approach and composition of the CAPTURE screening tool's questions."

Disclosures

The study was funded by NHLBI, and through the COPD Foundation-led Industry Advisory Committee, supported by AstraZeneca, Boehringer Ingelheim, GSK, Sunovion, Teva Pharmaceuticals, and Viatris. Albuterol was supplied by GSK. The AeroChamber Plus Flow-Vu Spacers were supplied by Trudell Medical/Monaghan Medical AbbVie.

Martinez disclosed relationships with Chiesi Farmaceutici, CSL Behring, GSK, Medtronic, Novartis, Polarean, Sanofi, and Regeneron, AstraZeneca, Boehringer Ingelheim, Pulmatrix, Theravance Biopharma, and Viatris, as well as holding a patent for a CAPTURE screening tool licensed to Weill Cornell Medicine. Co-authors disclosed relationships with multiple entities.

Primary Source

JAMA

Source Reference: opens in a new tab or windowMartinez FJ, et al "Discriminative accuracy of the CAPTURE tool for identifying chronic obstructive pulmonary disease in US primary care settings" JAMA 2023; DOI: 10.1001/jama.2023.0128.


https://www.medpagetoday.com/pulmonology/smokingcopd/103117