Tag: Shortages

  • Trump’s Tariff Threat for Drug imports Poses Big Political Risks

    Trump’s Tariff Threat for Drug imports Poses Big Political Risks


    President Trump’s decision to move a step closer to imposing tariffs on imported medicines poses considerable political risk, because Americans could face higher prices and more shortages of critical drugs.

    The Trump administration filed a federal notice on Monday saying that it had begun an investigation into whether imports of medicines and pharmaceutical ingredients threaten America’s national security, an effort to lay the groundwork for possible tariffs on foreign-made drugs.

    Mr. Trump has repeatedly said he planned to impose such levies, to shift overseas production of medicines back to the United States. Experts said that tariffs were unlikely to achieve that goal: Moving manufacturing would be hugely expensive and would take years.

    It was not clear how long the investigation would last or when the planned tariffs might go into effect. Mr. Trump started the inquiry under a legal authority known as Section 232 that he has used for other industries like cars and lumber.

    Mr. Trump said in remarks to reporters on Monday that pharmaceutical tariffs would come in the “not too distant future.”

    “We don’t make our own drugs anymore,” Mr. Trump said. “The drug companies are in Ireland, and they’re in lots of other places, China.”

    While some drugs are made at least in part in the United States, America’s reliance on China for medicines has generated alarm for years, with both Republicans and Democrats identifying it as a national security vulnerability.

    Many drugs are not produced without at least one stage of the manufacturing process happening in China. Even India’s giant generic drug sector is deeply dependent on China, because Indian manufacturers typically obtain their raw materials from Chinese plants.

    Imposing disruptive levies on lifesaving medications creates risks for Mr. Trump that were not a major concern with some of his other tariff targets, like steel and aluminum, where Americans generally aren’t directly exposed to increased prices.

    He could face a harsh backlash if pharmaceutical tariffs lead to significant drug price increases or shortages for patients. The number of drug shortages reached a record-level high last year. Americans fill several billion prescriptions a year, on top of purchasing over-the-counter products like cough syrup and Tylenol.

    Mr. Trump has not talked much about lowering drug prices in his second term, nor did he make it a top issue in his 2024 campaign.

    If pharmaceutical tariffs cause an increase in any drug prices, Democrats could jump on the issue for the midterm elections next year and try to undercut Mr. Trump’s popularity among working-class voters.

    Democrats have already seized on the issue. In a letter sent to Trump officials last week, a group of lawmakers led by Representatives Doris Matsui of California and Brad Schneider of Illinois wrote that “reckless tariffs” on medicines threatened to harm Americans.

    “The supply disruptions of critical medical products will unavoidably hurt U.S. patients, force providers to make impossible rationing decisions, and potentially even result in death as treatments are delayed, or more effective medicines and products are swapped for less effective alternatives,” they wrote.

    Kush Desai, a spokesman for the White House, said in a statement on Monday that “President Trump has long been clear about the importance of reshoring manufacturing that is critical to our country’s national and economic security.”

    Targeting pharmaceuticals also risks further inflaming relations with allies like the European Union and India, whose economies are supported by drug exports to the United States. Officials of those countries fear that drug tariffs could prompt companies to renege on investments, resulting in a loss of jobs, factories and tax revenue.

    Along with cars and electronics, pharmaceuticals are one of the categories of goods that the United States imports the most, measured by value.

    Tariffs on drugs would add tens of billions of dollars of import costs for a powerful industry that relies on a complex global supply chain. Production of most medications consumed in the United States happens in more than one part of the world, with plants in different countries handling different stages of the process.

    Expensive patented medications, like the popular weight-loss drug Wegovy, are more likely to be made in Europe or the United States.

    China and India do most of the production of cheaper generic drugs, which account for the vast majority of U.S. prescriptions. For example, plants in those countries make nearly all of the world’s supply of the active ingredients in the painkiller ibuprofen and the antibiotic ciprofloxacin, according to Clarivate, an industry data provider.

    Pharmaceuticals are the latest sector that Mr. Trump has targeted. Tariffs of 25 percent are already in effect for imported steel, aluminum and cars. The Trump administration has also initiated Section 232 investigations, or inquiries into national security concerns, for copper, lumber and computer chips.

    Investigations under the 232 provision must be completed within nine months.

    The drug industry has been lobbying the Trump administration to phase in tariffs gradually or to exempt certain types of products, such as medications at risk of shortages or those deemed essential, like antibiotics.

    John Murphy III, the head of a trade group that represents manufacturers of generic drugs, said in a statement on Monday that tariffs “will only amplify the problems that already exist in the U.S. market for affordable medicines.”

    The tariffs would be paid by drug companies importing products or ingredients into the United States. Many of those manufacturers would most likely try to pass at least some of the added costs to employers and government programs like Medicare and Medicaid that cover most of the tab for Americans’ prescription drugs. That would ultimately affect patients.

    Levies could cause shortages of some cheaper generic drugs, because prices are so close to production costs. Manufacturers with such thin margins may be forced to curtail or end production.

    Industry experts said they were not concerned about shortages for brand-name drugs, which generally have high profit margins that could absorb tariffs.

    Patients whose insurance requires them to pay a deductible or a percentage of a drug’s price could eventually face higher out-of-pocket costs for some drugs. They may also have to pay a higher co-payment if shortages resulting from the tariffs force them to switch to a different, pricier medication. In future years, people could face higher health insurance premiums.

    In some cases, contractual agreements and steep financial penalties may discourage manufacturers from sharply raising prices. With patented products, manufacturers typically have such large margins that their sales would still be highly profitable even if they absorbed the cost of tariffs.

    David Ricks, the chief executive of Eli Lilly, told the BBC earlier this month that his company expected to eat the cost of tariffs. But Lilly could reduce its research spending or cut staffing as a result, he said.

    Mr. Trump has been saying that his tariffs will prompt drugmakers to move their overseas production back to the United States. In recent weeks, several of the industry’s richest companies — Eli Lilly, Johnson & Johnson and Novartis — announced plans to spend billions of dollars to build new plants in the United States.

    But experts say the tariffs aren’t nearly enough to bring most drug production back to the United States. The obstacles are especially steep with crucial generic drugs. Building a new plant takes years. Even shifting production to an existing American plant may be too costly. Labor and other production expenses are much higher in the United States.

    Joaquin Duato, chief executive of Johnson & Johnson, said on a call with analysts on Tuesday that “if what you want is to build manufacturing capacity in the U.S., both in med-tech and in pharmaceuticals, the most effective answer is not tariffs, but tax policy.”

    The Trump administration has been taking aim at Ireland, where nearly all of the largest American drugmakers have a manufacturing presence, in some cases dating back decades. One of Ireland’s biggest appeals for the industry is the tax advantages it offers. Some drugmakers shift their profits there to lower their overall tax bills.

    Last month, Mr. Trump said that Ireland “took our pharmaceutical companies away.” Howard Lutnick, the commerce secretary, said that Ireland was running a “tax scam” that American pharmaceutical companies were exploiting. “That’s got to end,” Mr. Lutnick said.

    Some of the industry’s biggest blockbusters, including the cancer drug Keytruda and the anti-wrinkle injection Botox, are partly produced in Ireland. The United States imports more pharmaceutical products, as measured by their value, from Ireland than any other country.

    Irish officials fear that tariffs could prompt drugmakers to pull back from investments in the country. But experts said that drugmakers may be reluctant to undergo the costly, disruptive process of uprooting their operations there, especially while uncertainty persists about how long Mr. Trump’s tariffs will last.

    Pharmaceuticals have historically been spared from tariffs under a World Trade Organization agreement meant to ensure that patients have access to vital medications.

    Medications were mostly exempted from the round of global tariffs Mr. Trump announced earlier this month and then partly delayed for 90 days. Drugmakers importing from China into the United States have been subject to tariffs, initially 10 percent and later 20 percent, that Mr. Trump had imposed on Chinese imports earlier this year.

    Ana Swanson contributed reporting.



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  • Trump’s Next Tariffs Target Could be Foreign-Made Pharmaceuticals

    Trump’s Next Tariffs Target Could be Foreign-Made Pharmaceuticals


    Newer and more expensive medications are more likely to be made in the United States or Europe. Ireland, in particular, has become a hub because it is a tax haven.

    Many of the industry’s biggest blockbusters are manufactured at least partly in Ireland. Among them are: Keytruda, Merck’s cancer drug; Zepbound, Eli Lilly’s weight-loss drug; and Stelara, Johnson & Johnson’s anti-inflammatory drug used for conditions like arthritis.

    Mr. Trump has taken notice. “This beautiful island of five million people has got the entire U.S. pharmaceutical industry in its grasp,” he said in March at a meeting with Prime Minister Micheal Martin of Ireland.


    U.S. production of pharmaceuticals peaked, by one measure, in 2006.

    That was around the time a wave of top-selling American-made drugs lost patent protection, creating opportunities for generic manufacturers in India and China to ramp up production of generics. Around the same time, U.S. government incentives to manufacture in Puerto Rico were phased out, while new carrots, like tax advantages in Ireland, encouraged manufacturers to move production overseas.

    In 2021, most of America’s top-consumed generic drugs, as well as key antibiotics and antivirals, had no American facility producing their active ingredients, according to Clarivate.

    Mr. Trump said on Wednesday that “the United States can no longer produce enough antibiotics to treat our sick.”

    For example, nearly all the world’s sites producing the active ingredient of amoxicillin, a common antibiotic, are in China, India or Europe, according to Clarivate.

    A Tennessee plant, now owned by a company called USAntibiotics, used to supply nearly all of the amoxicillin consumed in the United States. It now imports the active ingredient from Europe and uses it to formulate pills. The plant now supplies about 5 percent of America’s amoxicillin.

    Medications are usually protected from tariffs under a World Trade Organization agreement aimed at protecting patients’ access to vital drugs. The tariffs that Mr. Trump imposed on certain imports in his first term did not hit pharmaceuticals.

    Starting in February, drugmakers importing active ingredients made in China into the United States have had to pay a tariff that Mr. Trump imposed on Chinese goods. That tariff rose to 20 percent in March. (Wednesday’s levies add a new 34 percent tariff on most Chinese imports, though that does not apply to medicines.)


    For the manufacturers of inexpensive generic drugs with razor-thin profit margins, the added costs of tariffs could be “a tipping point” that prompts them to exit the market, said Erin Fox, an expert at the University of Utah who tracks drug shortages.

    Dr. Fox said she was most worried about drugs for which shortages are already common, such as generic medications given as an injection. These injections are harder to make than pills and are much less profitable than newer medications, discouraging manufacturers from jumping in. An example is lidocaine, used to numb pain during medical procedures. Most production of lidocaine’s active ingredient is in India, according to Clarivate.



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  • Kennedy Called A.D.H.D. Drugs Poison. What Does the Research Say?

    Kennedy Called A.D.H.D. Drugs Poison. What Does the Research Say?


    Health Secretary Robert F. Kennedy Jr. has often criticized prescription stimulants, such as Adderall, that are primarily used to treat attention deficit hyperactivity disorder.

    “We have damaged this entire generation,” he said last year during a podcast, referring to the number of children taking psychiatric medications. “We have poisoned them.”

    In February, the “Make America Healthy Again” commission, led by Mr. Kennedy, announced plans to evaluate the “threat” posed by drugs like prescription stimulants.

    But are they a threat? And if so, to whom?

    Like many medications, prescription stimulants have potential side effects, and there are people who misuse them. Yet these drugs are also considered some of the most effective and well-researched treatments that psychiatry has to offer, said Dr. Jeffrey H. Newcorn, the director of the Division of A.D.H.D. and Learning Disorders at the Icahn School of Medicine at Mount Sinai in New York.

    Here are some answers to common questions and concerns about stimulants.

    Prescription stimulants are drugs that help change the way the brain works by increasing the communication among neurons.

    They are divided into two classes: methylphenidates (like Ritalin, Focalin and Concerta) and amphetamines (like Vyvanse and Adderall).

    The drugs are most often prescribed to treat A.D.H.D., but they’re also used for conditions like narcolepsy or a binge eating disorder. Sometimes they are also used off-label, for treatment-resistant depression, or catatonia, a syndrome that can cause a patient to move in unusual ways, become immobile or stop talking.

    The medications work by amplifying the activity of the neurotransmitters dopamine and norepinephrine in the nerve cells of the brain. Dopamine plays a role in creating the desire for something and the motivation to get it, while norepinephrine can increase alertness and make it easier to focus.

    People with A.D.H.D. may have a deficit of both of these chemicals, so when they use stimulants it essentially helps “even them out,” said Dr. Anthony L. Rostain, chairman of the department of Psychiatry and Behavioral Health at Cooper University Health Care, which is based in Camden, N.J.

    For some users, the effects are profound. “It’s like glasses for poor vision,” Dr. Rostain said.

    No.

    Not everyone who has been diagnosed with A.D.H.D. takes stimulants. There are also non-stimulant medications, like Strattera (atomoxetine). And some people don’t require any medication at all.

    Other interventions, such as behavioral therapy, parent training, school supports, and lifestyle changes to regulate sleep and exercise, are important — regardless of whether someone needs medication or not.

    The use of prescription stimulants has been on the rise since 2012, particularly among adults, and has sharply increased in recent years among women as well as patients ages 20 to 39.

    In 2023, an estimated 6 percent of adults had a current diagnosis of A.D.H.D. and about one-third of those patients reported taking prescription stimulant medication, according to an analysis from the Centers for Disease Control and Prevention.

    In children and adolescents, however, the number of stimulant prescriptions has been more stable in recent decades.

    Overall, it is estimated that about 5 percent of children in the U.S. are currently prescribed medication for A.D.H.D. (Not 15 percent, the number stated by Mr. Kennedy during his confirmation hearing in January.)

    A study published in February found that prescriptions actually declined among children after the pandemic began.

    Government drug use surveys show that in 2022, among people 12 and older, 1.5 percent reported misusing prescription stimulants in the past year — taking the drugs without a doctor telling them to do so, or not in the manner they were prescribed. Sometimes people are aspiring to be more productive or to stay awake, but the drugs are also used recreationally, and can produce a high by swallowing, smoking or snorting the medication — or injecting it into the bloodstream.

    Young adults ages 18 to 25 had the highest rates of misuse: 3.7 percent.

    Among adolescents 12 to 17, the percentage of misuse was much smaller: 0.9 percent.

    This number can vary depending on where they live: In some U.S. schools, as many as 1 in 4 high school students report misusing prescription stimulants, often motivated by their desire to perform better in school. Some schools report no issue with stimulant misuse.

    Taking stimulants can cause elevated blood pressure and heart rate, a reduced appetite, difficulty sleeping, and restlessness or agitation.

    Other common side effects include headaches, an increase in body temperature and abdominal pain.

    Less frequently, stimulants have been known to temporarily slow a child’s growth, Dr. Rostain said, which is why they should have their height and weight monitored by a medical provider while they’re taking the drugs.

    There is also a small risk of developing psychosis that may be tied to dosage. And when stimulants are misused, they can be addictive.

    Patients and their doctors have to weigh the benefits of taking stimulants against these risks. A.D.H.D., particularly when left untreated, is associated with reckless behaviors like careless driving, unsafe sex, substance abuse and aggression. A recent study showed that people with the diagnosis are, on average, dying earlier than their peers — about seven years earlier for men, and about nine for women.

    It depends.

    Studies have shown that A.D.H.D. symptoms can change over time, improving and then worsening again, or vice versa. “It’s not consistent,” Dr. Rostain said. “They wax and wane for many people.”

    As a result, he added, people may end up using A.D.H.D. medications intermittently.

    Still, some people take these drugs longer term, said Dr. Lenard A. Adler, the director of NYU Langone Health’s Adult A.D.H.D. Program.

    “That being said, it’s always appropriate when someone is stable on psychostimulants to attempt to lower the dose,” Dr. Adler added.

    If a patient continues to do well, he said, then it’s worth exploring whether the medication is still needed.

    Yes.

    The stimulant shortage that began in 2022 continues. According to the Food and Drug Administration, as of March, methylphenidate hydrochloride extended release tablets and patches, as well as other types of amphetamine tablets, are either unavailable or in short supply.

    The availability of specific drugs and formulations can vary by region, Dr. Rostain said.

    “It leads to a lot of uncertainty, unpredictability and a lot of anxiety on the part of patients,” he added.



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  • Aviation Chaos Can Quickly Spiral, Despite Contingency Plans

    Aviation Chaos Can Quickly Spiral, Despite Contingency Plans


    Airlines, airports and air traffic controllers prepare for chaos. But that doesn’t make responding to it any less complicated.

    The global aviation system is deeply interconnected and responding to a disruption — especially one as severe as a power outage at a global airport hub — is a delicate balancing act. For airlines, moving even a small number of flights can have cascading effects.

    “They’re thinking not just in terms of a single day, but recovery,” said Dr. Michael McCormick, a professor of air traffic management at Embry‑Riddle Aeronautical University, who managed the federal airspace over New York during the Sept. 11 terrorist attacks. “They have to look at where passengers with bags, aircraft and aircrews need to be tomorrow, the next day, and the next day.”

    When crises occur, airline network operation centers go into overdrive. The centers are the nerve centers of carriers — typically large, quiet, secure rooms with power backups and protections against severe weather and disasters.

    At large airlines, operations centers are staffed around the clock with teams that monitor the weather, manage planes, communicate with air traffic control, schedule crews and much more.

    Small disruptions can be handled surgically — a sick pilot can be replaced or a broken plane swapped out for another. But bigger disruptions like the one at London’s Heathrow Airport can require scrapping and reworking intricate plans while taking into account a wide range of limitations.

    Planes differ in how many people they can carry and how far they can fly, so a small plane used for shorter domestic flights cannot easily be swapped in for a larger one used on longer flights. They also must be fueled adequately and their weight balanced appropriately, needs that must be adjusted if planes are rerouted.

    Regulations require that pilots and flight attendants are not overworked and are allowed to rest after certain number of hours on the clock. If a flight takes too long to depart, a crew can time out. When schedulers do reassign crews, they also have to take into account where those pilots and flight attendants are needed next, or they could risk more disruptions later.

    Airlines, of course, do not operate in isolation. As they change plans, they need to work with airport and air traffic control officials who may have limited resources to accommodate the changes. Airports are limited not just in how many flights they can receive, but also, in some cases, what types of planes they can safely accept. In the United States, for example, many air traffic control towers have long suffered from controller shortages.



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  • Clues From D.C. Plane Crash Suggest Multiple Failures in Aviation Safety

    Clues From D.C. Plane Crash Suggest Multiple Failures in Aviation Safety


    Follow live updates on the deadly plane crash in D.C.

    Clues emerging from the moments before the deadly collision Wednesday night between an Army helicopter and an American Airlines passenger jet suggest that multiple layers of the country’s aviation safety apparatus failed, according to flight recordings, a preliminary internal report from the Federal Aviation Administration, interviews with current and former air traffic controllers and others briefed on the matter.

    The helicopter flew outside its approved flight path. The American Airlines pilots most likely did not see the helicopter close by as they made a turn toward the runway. And the air traffic controller, who was juggling two jobs at the same time, was unable to keep the helicopter and the plane separated.

    An F.A.A. spokesman said the agency could not comment on the ongoing investigation, which is being led by the National Transportation Safety Board. Crash investigators will spend the next several months reviewing flight data, recordings from inside the cockpits, weather patterns, as well as interviewing controllers and others involved to try to figure out what went wrong.

    But the catastrophe already appeared to confirm what pilots, air traffic controllers and safety experts had been warning for years: Growing holes in the aviation system could lead to the kind of crash that left 67 people dead in the Potomac River in Washington.

    Even before an official cause is determined, there were signs Wednesday that pilots and air traffic controllers at Reagan National were not operating under optimal conditions.

    The duties of handling air traffic control for helicopters and for planes at Reagan National on Wednesday night were combined before the deadly crash. That left an air traffic controller handling dual roles, according to a person briefed on the staffing and the report.

    Typically one person handles both helicopter and plane duties after 9:30 p.m., when traffic at Reagan begins to lessen. But the supervisor combined those duties sometime before 9:30, and allowed one air traffic controller to leave, according to the person, who was not authorized to speak publicly about the investigation into the crash. The crash occurred just before 9 p.m.

    While there were no unusual factors causing a distraction for controllers that night, staffing was “not normal for the time of day and volume of traffic,” the preliminary F.A.A. report said.

    On Thursday, five current and former controllers said that the controller in the tower should have more proactively directed the helicopter and the plane to fly away from each other. Instead, the controller asked the helicopter to steer clear of the plane.

    Some of the current and former controllers said the darkness could have made it more difficult for pilots to accurately gauge the distance between themselves and other aircraft. Some wondered whether the helicopter pilots mistook a different plane for the American jet.

    The helicopter was supposed to be flying closer to the bank of the Potomac River and lower to the ground as it traversed the busy Reagan National airspace, four people briefed on the incident said.

    Before a helicopter can enter any busy commercial airspace, it must get the approval of an air traffic controller. In this case, the pilot asked for permission to use a specific, predetermined route that lets helicopters fly at a low altitude along the bank on the east side of the Potomac, a location that would have let it avoid the American Airlines plane.

    The requested route — referred to as Route 4 at Reagan National — followed a specific path known to the air traffic controller and helicopter pilots. The helicopter confirmed visual sight of a regional jet and the air traffic controller instructed the helicopter to follow the route and fly behind the plane.

    But the helicopter did not follow the intended route, the people briefed on the matter said.

    Rather, it was above 300 feet, when it was supposed to be flying below 200 feet, and it was at least a half-mile off the approved route when it collided with the commercial jet.

    A senior Army official urged caution in making any assessments until the helicopter’s black box could be recovered and analyzed, along with other forensic data.

    The official, who spoke on condition of anonymity because of the ongoing inquiry, said the Black Hawk’s pilots had flown this route before, and were well aware of the altitude restrictions and tight air corridor they were permitted to fly in near the airport.

    Safety lapses in aviation have been increasing for years, leading to an alarming pattern of close calls in the skies and at airports involving commercial airlines. They have occurred amid rising congestion at the country’s busiest airports, including Reagan National, where the frequent presence of military flights makes controlling traffic even more complicated.

    At the same time, a chronic shortage of air traffic controllers has forced many to work six-day weeks and 10-hour days — a schedule so fatiguing that multiple federal agencies have warned that it could impede controllers’ abilities to do their jobs properly. Few facilities have enough fully certified air traffic controllers, according to a Times investigation in 2023. Some controllers say little has improved since then.

    The air traffic control tower at Reagan National has been understaffed for years. The tower there was nearly a third below targeted staff levels, with 19 fully certified controllers as of September 2023, according to the most recent Air Traffic Controller Workforce Plan, an annual report to Congress that contains target and actual staffing levels. The targets set by the F.A.A. and the controllers’ union call for 30.

    An F.A.A. spokesman said on Thursday that Reagan National currently employs 25 certified controllers out of their goal of 28.

    The controller who was handling helicopters in the airport’s vicinity Wednesday night was also instructing planes that were landing and departing from its runways. Those jobs are typically assigned to two controllers, rather than one, the internal F.A.A. report said. This increases the workload for the air traffic controller and complicates the job.

    Controllers can also use different radio frequencies to communicate with pilots flying planes and pilots flying helicopters. While the controller is communicating with pilots of the helicopter and the jet, the two sets of pilots may not be able to hear each other.

    As the passenger jet’s pilots were approaching the airport, they were asked by air traffic control to pivot the landing from one runway to another, according to the F.A.A. report, a person briefed on the incident and audio recordings of conversations between an air traffic controller and the pilots. That request may have introduced another complication shortly before the collision.

    The American Airlines flight had originally been cleared by the traffic control tower to land on the airport’s main runway, called Runway 1. The controller then asked the pilot to land on a different, intersecting runway instead — Runway 33 — which the pilot agreed to do.

    That decision, according to the person who was briefed on the incident and four other people who are familiar with the airport’s air traffic, happens routinely when regional jets like the American Airlines aircraft are involved. The decision may also have been made to help keep air traffic moving efficiently by not clogging the main runway, the people said.

    Runway 33 is shorter, requiring intense focus from pilots landing their planes. The last-minute change raised questions within the F.A.A. on Thursday morning about congestion at Reagan National, the person briefed on the event added.

    Robert Isom, American’s chief executive, said at a news conference on Thursday that the pilots of the passenger plane involved in the crash had worked for PSA Airlines, an American subsidiary, for several years. The captain had been employed by the airline for almost six years, while the first officer had worked there for almost two years.

    “These were experienced pilots,” he said.

    Nicholas Bogel-Burroughs contributed reporting.



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