Pharmacists affiliated with the University of Florida have spent decades nudging the agency to pull a decongestant from over-the-counter medicines.Dr. Leslie Hendeles began prodding the Food and Drug Administration to reject a decongestant in cold medicines when he had a mop of curly red hair and Bill Clinton had just become president.By the time opposition to the drug had coalesced, Dr. Hendeles was appearing, at age 80, as an expert to testify before the agency’s advisers, his hair white and his overview of the ingredient spanning 50 years.His advocacy culminated in the advisory panel’s unanimous vote on Tuesday, when it concluded that the decongestant, a common ingredient in cold and flu remedies, is ineffective.Prompted by the news, consumers threw open their medicine cabinets upon learning that the decongestant, phenylephrine, was listed in more than 250 of their go-to drugs for congestion like some versions of DayQuil, Sudafed, Tylenol and Theraflu. And the decision has caused some confusion — experts say the ingredient still works in nasal sprays, just not when taken orally in pill or liquid form.Given that the drug is considered safe, experts say there is no need to throw away the products, which contain other ingredients that do work.Nothing will change immediately. F.D.A. officials have to review the panel’s decision, solicit public comments and most likely will give drug makers some time to adjust or swap out ingredients rather than face a decision to strip store shelves of so many consumer staples. Other delays could occur if the companies contest the actions in court. And some experts, notably Dr. Scott Gottlieb, a former F.D.A. commissioner, have long maintained that phenylephrine does work, to some extent. Some defenders of the drug may try to oppose any action that banishes the decongestant altogether.But how phenylephrine stayed on the market this long despite decades of studies and questions is a tangled story involving old drug standards dating back to a law signed by President Kennedy, the proliferation of meth labs using everyday cold remedies in the 1990s, and even the pandemic.Like other federal agencies, the F.D.A. can move glacially, at times hampered by antiquated rules and a morass of regulatory procedures.“There is no question that regulation of over-the-counter medications was broken for many years,” said Dr. Joshua Sharfstein, a former agency official and vice dean at the Bloomberg School of Public Health at Johns Hopkins. The latest moves, he said, indicate that the “agency is only now getting its handcuffs off.”One could argue the process of dissecting phenylephrine — a drug used for dilating eyes and calming hemorrhoids — took roughly six decades. The Kennedy era had ushered in a new law that required the F.D.A. to evaluate a drug’s effectiveness in addition to existing safety standards.President Kennedy gave a pen to Frances Oldham Kelsey of the F.D.A. after signing the Drug Industry Act of 1962, which required companies to demonstrate a drug’s safety and effectiveness before marketing it.Abbie Rowe/White House Photographs, John F. Kennedy Presidential Library and Museum, BostonIt wasn’t until 1976 that the F.D.A. began reviews of over-the-counter cold medicines, like phenylephrine, as a class of drugs.But by the early 1990s, the decongestant still hadn’t received a full approval, and the lengthy delays had attracted the attention of Dr. Hendeles and a group of pharmacy professors at the University of Florida.They would become the one constant in the last 30 years of phenylephrine’s history by putting pressure on the F.D.A. to do something.Dr. Hendeles published his first critique of the drug in 1993, noting that the agency had oversight of two more popular decongestants that were effective and a third that was not: phenylephrine. The medication was meant to constrict blood vessels and clear congestion in the nose. But it was destroyed in the stomach, he wrote in a medical journal. That meant most of the medication didn’t make it to the bloodstream — much less to the nose.By the 2000s, what would seem like an unrelated problem was surging: Illegal methamphetamine labs in rural areas on the West Coast were exploding, as was abuse of the illicit drug.Meth cooks’ ingredient of choice was one of the most common decongestants on the market at the time, pseudoephedrine, which could be found at any drugstore.By then, it was one of two decongestants available for congestion relief; a third had been pulled in 2000 after studies tied it to strokes.The meth crisis prompted the passage of state and federal laws to restrict sales of products containing pseudoephedrine, and consumers had to show identification and sign a ledger to buy it from behind the counter or a locked cabinet of a pharmacy.Concerned about losing sales, companies with medicines containing the popular meth additive turned to the last option authorized by the F.D.A.: phenylephrine.Dr. Hendeles said he was dismayed to see the ingredient in medicines lining pharmacy shelves, knowing patients were complaining that the replacement didn’t help them at all.He teamed up with a colleague, Dr. Randall Hatton, and they dug deeper, plumbing the data used in the 1970s for the drug’s initial approval.Dr. Hatton unearthed memos to the F.D.A. from the 1960s and 1970s that had not been peer-reviewed. He and colleagues ran the data in modern analysis software and concluded that the drug was no better than a placebo.As their research progressed, Dr. Hendeles tried to reach the F.D.A., where he had once been a visiting scientist. He was not breaking through, he said. So he turned to the office of U.S. Representative Henry Waxman, a crusading California lawmaker, for help.Dr. Leslie Hendeles, left, and Dr. Randall Hatton worked together to urge the F.D.A. to review the effectiveness of phenylephrine.UF News ServiceMr. Waxman fired off four letters, citing the professors’ findings and imploring the agency to act. “F.D.A. has a duty to arm Americans with the information they need so that they don’t waste their hard-earned money on medicines that do not work,” he wrote in a letter in 2006.The F.D.A. replied that same year, restating the findings of its 1976 decision. The letter suggested that if a consumer did not get relief from phenylephrine, “they have the option of not purchasing it.”Dr. Hendeles, the letter said, was free to petition the agency.And he did. Dr. Hendeles requested a dosing review and examination of use of the drug for children. That led to a public F.D.A. advisory hearing in 2007. There, the Consumer Healthcare Products Association, the business trade group that represents the makers of over-the-counter medicine, maintained that the drug worked.Dr. Hendeles recalled what he considered show-stopper testimony. Representatives for Schering Plough, at the time the maker of Claritin-D, which contained the restricted decongestant pseuodoephedrine, told advisers that they had studied its rival, phenylephrine, and found it had no effect. The company’s newspaper ads touted its “bold move” to keep the “powerful formula” for Claritin-D, a letter by Mr. Waxman noted.Still, the advisory committee voted 11 to 1 that “evidence is supportive” that phenylephrine “may be effective,” and called for more research.Eight years passed.Then Dr. Hendeles and colleagues pounced on a study that emerged from Merck, which had acquired Schering Plough. The company examined the drug at the authorized dose and at a dose four times as high, and again found it did not relieve symptoms. Merck also funded a study on a slow-release formula.But that stubborn head complaint — congestion — did not budge.(In 2014, Merck sold Claritin-D, which still contains pseudoephedrine, to Bayer.)The Florida pharmacists petitioned the agency for a ban, using the latest study as ammunition. But their efforts were stymied by what many former agency officials described as a beleaguered over-the-counter division, which had 31 staff members in 2018.The staff had to follow “an arcane process that handcuffed the agency and provided insufficient resources to clear a backlog,” said Dr. Peter Lurie, who was an associate commissioner at the agency through 2017.Dr. Scott Gottlieb called the advisory panel’s decision “a shame.”Eric Thayer for The New York TimesThe Florida team ran into other hurdles throughout the years.After this week’s vote, in posts on X, formerly known as Twitter, Dr. Gottlieb, who was the agency’s commissioner from 2017 to early 2019, called the panel’s decision “a shame.” He recalled that phenylephrine “was believed to be weakly active when we looked at this question around 2005/06. Now there may be no good, cheap, accessible options for consumers to get incremental relief.”In an interview on Friday, Dr. Gottlieb said he thought more study of the ingredient was needed. “I think it’s premature to say that it doesn’t work,” he said.Interest in the decongestant was renewed after pandemic legislation expanded agency staffing and overhauled the F.D.A.’s procedures for over-the-counter drugs so that decisions would be more aligned with those in its prescription drug division.Soon after, the F.D.A. team took up the longstanding issues with the decongestant, producing a painstaking, 89-page review of phenylephrine that the advisory panel combed as the basis for its decision. (The agency’s report confirmed the findings of Dr. Hendeles and his colleagues, and also noted apparent bias in some of the 1970s data that led to the drug’s initial acceptance.)“It was a joy to read,” Dr. Hendeles said.When he testified before the panel earlier this week, Dr. Hendeles talked about a study from 1971 involving modified scuba masks to measure nasal congestion — the first finding phenylephrine to be a dud.Other organizations including Public Citizen, the American College of Clinical Pharmacy and the National Center for Health Research also urged the panel to dispense with the ingredient. The industry association argued that the ingredient was effective and that low levels in the blood did not negate its effect. A statement from Kenvue, a spinoff of Johnson & Johnson, said products with phenylephrine are a small part of its business and it sells cold products without it.When agency advisers cast their 16-to-0 vote, Dr. Hendeles was thrilled. “Nothing was as exciting and exhilarating as the vote,” he said.Lawyers representing people who purchased cold and flu medicines containing phenylephrine are already announcing lawsuits against the drug makers, claiming the companies knew the decongestant was useless.For now, the products remain on the shelves. “We feel vindicated for something that we worked on for a long time,” Dr. Hatton said. “But it’s not over.”

The F.D.A. is expected to approve a new round of shots by Pfizer and Moderna as early as Monday to prepare Americans for the fall and winter season when infections usually tick upward.The latest Covid boosters are expected to be approved by the Food and Drug Administration as early as Monday, arriving alongside the seasonal flu vaccine and shots to protect infants and older adults from R.S.V., a potentially lethal respiratory virus.The Centers for Disease Control and Prevention is expected to follow up on Tuesday with an advisory meeting to discuss who should get the new shots, by Pfizer-BioNTech and Moderna. After a final decision by the C.D.C.’s director, millions of doses will be shipped to pharmacies, clinics and health systems nationwide within days.As Covid cases creep up, the prevention measures could portend the first winter of the decade without a crush of patients pushing hospitals beyond capacity. But a healthy winter is far from a lock: Last year, the updated Covid vaccine made it into the arms of only 20 percent of adults in the United States.Some experts view that statistic with little alarm because the number of Covid deaths slowed over the last year, thanks to an increasingly immune population and higher vaccine rates among older Americans. Others see this year as an opportunity to protect more vulnerable people from severe illness or death.“We now have some really good tools,” said Dr. Marcus Plescia, chief medical officer of the Association of State and Territorial Health Officials, a public health group. “It’s just — what is it going to take to get people comfortable with using them?”Federal officials have been retreating from labeling the new formulation as boosters to previous shots, preferring to recast them as an annual immunization effort akin to the flu vaccine. That shift may reflect concern over the fatigue that some Americans have expressed about yet another round of shots against the virus.The vaccine campaign will also be the first since the end of the public health emergency, which expired in May. In previous years, the U.S. government bought hundreds of millions of vaccine doses and distributed them for free. This year, private insurance and government payers like Medicare that cover the vast majority of Americans are expected to provide the vaccines to people for no fee.But the question remains whether the private market of hospitals, clinics and pharmacies will be able to calibrate their vaccine orders to stock a realistic supply. Experts are uncertain how much demand there will be for the latest shots.“There could be a period in here where things are a little bit chaotic, and that’s never a good situation,” Dr. Plescia said.Packing the Moderna vaccine at a distribution center in Mississippi in 2020. This year, vaccine makers are expected to donate doses for the uninsured.Paul Sancya/Agence France-Presse — Getty ImagesAlso of concern in the handoff to the private market: the nation’s 23 million adults with no health insurance. The Biden administration has made plans to cover costs and offer the Covid vaccine through local clinics and major pharmacies, but some experts are worried about whether people who lack insurance will be aware of the new shots — or where to get them.“They don’t have an insurer sending them leaflets — they may not have a usual source of care,” said Anthony Wright, executive director of Health Access, a California advocacy group. “And so the trusted messenger of their health plan, their doctor, their clinic, is not there saying, ‘It’s no cost. It’s really easy.’”Vaccine manufacturers are expected to donate doses for the uninsured. Kelly Cunningham, a spokeswoman for Moderna, said the company had no cap on the number of Covid vaccine doses it planned to donate.The latest shots are becoming available as Covid hospitalizations and deaths are rising slightly, albeit not to the levels of past years. In the week ending Aug. 26, there were 17,400 people admitted to the hospital — more than about 6,000 at a low point this summer. Deaths were also up to about 600 a week last month, though far lower than the weekly average of 14,000 deaths of 2021.Once the vaccines are approved and the C.D.C. signs off, the Biden administration plans to urge the public to get their Covid and flu shots at the same time, a practice that has been studied and deemed safe, an administration official said. It’s a messaging effort they expect to share with major vaccine makers, which will be marketing the Covid doses commercially for the first time.Walgreens and CVS said they both already have the updated flu and R.S.V. shots available in stores. Once Covid vaccine approvals are in place, Dr. Kevin Ban, Walgreens’ chief medical officer, said the chain would have the new shots on hand “as soon as possible.” A CVS spokesperson said doses could be arriving later this week. Representatives of both chains said the Covid shot would be available at no cost to all who are eligible under the C.D.C. guidelines expected Tuesday.Targeted populations most certainly will include people 65 and older as well as those who are immunocompromised or have serious underlying medical conditions that leave them more susceptible to severe illness from the virus.Nursing homes, some of which were host to inoculation teams from the major drugstore chains when vaccines first became available, are now relying on their usual long-term-care pharmacies to supply most vaccines. But many homes have fallen behind on booster rates: Recent Medicare data show that about 62 percent of residents are up-to-date on their shots even though older adults are among the most vulnerable to severe disease and death from the virus.The new Covid vaccines target the XBB.1.5 variant, which was dominant when vaccine makers began to formulate and test a new version. Though the virus has had a rotating cast of variants, experts say the new Covid jab should fortify protections against severe infection.Recent fears that one newer, highly mutated variant would escape the vaccine proved unfounded by reputable independent labs, said Fikadu Tafesse, an associate professor of molecular microbiology and immunology at Oregon Health & Science University. The C.D.C. also reviewed studies on the matter and confirmed Friday that the vaccine was holding strong.“We were really getting ready for no response at all, but the data is very, very promising,” Dr. Tafesse said.A production line of Pfizer’s Covid vaccine in Michigan. As with previous shots, the latest vaccine won’t eliminate the chances of getting the disease, but is expected to reduce the chances of severe illness, hospitalization or death.Pfizer, via Associated PressAs with earlier shots, the updated ones are not expected to eliminate the chances of contracting a mild case of Covid. Instead, they are expected to reduce the chances of severe illness, hospitalization or death. The first Covid vaccines, given in early 2021 and targeting the initial form of the virus that emerged in Wuhan, had an efficacy rate of about 95 percent, meaning that far fewer vaccinated people became sick than those who were not immunized.As the first vaccine’s potency waned with newer Omicron variants, a bivalent booster was approved in August 2022 that targeted the initial virus and BA.5, which was dominant at the time. That shot led to fewer people with Covid being hospitalized, dropping over several months to 25 percent from 60 percent..The latest mRNA vaccines by Pfizer and Moderna is called a monovalent because it was aimed at one variant of Omicron, XBB.1.5., and unlike earlier boosters does not include protection against the original virus that caused widespread infections in China more than three years ago. But experts and researchers say that it should provide protection against many of Omicron’s variants.Pfizer and Moderna reported that their vaccines had a potent response to the newest circulating variants, though only Moderna posted its initial data on Thursday. But researchers continue to discuss how well it will stand up to new variants. The F.D.A. has mainly reviewed results submitted by the companies of animal or smaller human studies of immune response.Jerica Pitts, a spokeswoman for Pfizer, said the data submitted by the company to the F.D.A. in June involved tests in animals. Trials following people who received the shot are continuing, she said.Moderna submitted data to the F.D.A. on the immune response of 100 people to the new shots, which the company said in June “robustly elicit neutralizing antibodies” against XBB variants.John Moore, a professor of virology and immunology at Weill Cornell Medicine, said he was not impressed with the latest results. He said the new shot showed an immune response similar to last fall’s booster. That means that although the new shot will be worth getting, “it’s nothing remotely like a game changer.”Regulators are also considering whether to authorize a booster dose from Novavax, which employs a different but widely used technology for its coronavirus vaccine. That shot could be authorized in the coming weeks, giving some Americans who may prefer Novavax’s formulation as an alternative to the vaccines offered by Moderna and Pfizer-BioNTech.Dr. Daniel Griffin, an infectious disease physician at Columbia University in New York, said getting the Covid shot in late October would provide robust protection at a time when people gather for holidays, and would help stop the virus’s spread to the most vulnerable, including older adults, pregnant people and those with compromised immune systems.And while many might be weary of the social-protection argument, he said they could lessen their own odds of a more serious outcome.“So a younger individual may say, ‘I’m not going to get a booster for the public health,’” Dr. Griffin said, “‘but I am going to get a booster because if I can reduce my chance of getting Covid, I can reduce my chance of long Covid.’”Noah Weiland and Carl Zimmer contributed to this report.

The manufacturer, Philips Respironics, said it would compensate users of CPAP machines and other flawed devices that were recalled after they blew bits of foam into consumers’ mouths and lungs.Philips Respironics has agreed to a $479 million partial settlement on claims over flaws in the company’s breathing machines that spewed gases and flecks of foam into the airways of consumers and that spawned recalls involving millions of the devices, lawyers for plaintiffs in the lawsuit announced on Thursday.As one segment of continuing class-action lawsuits over the devices, the agreement covers only monetary reimbursements to users of the devices and vendors who might have financed replacements for consumers, according to the lawyers. The economic claims amount is uncapped, which will permit other device users to apply for compensation.This tentative settlement, which is subject to federal court approval, does not address other significant claims in the plaintiffs’ cases involving personal injury or the cost of medical care related to use of the breathing machines. Philips did not admit wrongdoing or liability as part of the proposed deal.The company has faced a multiyear setback, after beginning recalls in the United States of about five million of its breathing machines, which are intended for people with sleep apnea and other maladies. The lawsuits have claimed that flaking foam and gasses emitted from the machines were linked to health issues including respiratory illnesses, lung cancer and death. The foam was used in the machines to reduce noise and vibration.In June 2021, the Food and Drug Administration announced a recall of Philips machines that also included BiPAP devices and ventilators made since 2009, warning that foam deterioration in the products could cause “serious injury” to users. Philips initially released a memo to doctors saying the foam breakdown posed risks of “toxic carcinogenic effects,” but the company has since released updates reporting a far lower level of concern.“We are confident in these claims and we look forward to holding Philips accountable for the physical harms they caused patients,” the plaintiffs’ lawyers said in a statement.Millions of people suffer from sleep apnea, a condition associated with interrupted breathing that carries a number of risks, including strokes, heart attacks and possible cognitive decline from decreased oxygen supply.The spate of recalls in the last few years frustrated doctors and device users, who anguished over whether to continue using the machines and face potential health hazards, or forgo any treatment. Rival companies were hard-pressed to fill orders from those seeking replacements, leaving many consumers with no options.The agreement announced on Thursday would provide compensation ranging from about $50 to $1,500 to each consumer, in addition to $100 for each device returned to Philips. The company said it replaced and delivered nearly 2.5 million devices for U.S. consumers and suppliers.“Patient safety and quality are our top priorities, and we want patients to feel confident when using their Philips Respironics devices,” the company said in a statement.The F.D.A. and some experts have criticized Philips for not notifying consumers when it first learned of potential flaws with some of its devices. Agency and court records show that concerns at Philips emerged in 2015. More than 105,000 injuries and 385 reports of deaths that were possibly related to the foam breakdown in Philips machines have been reported to the F.D.A.The U.S. Department of Justice has been in touch with Philips about a possible consent decree to address problems related with the recall process, the company said in an earnings disclosure in July. Under a subpoena issued in April 2022 as part of another investigation into the events leading up to the recall, Philips continued to supply information, the July report said.

The NewsPulse oximeters routinely overestimated levels of oxygen in the blood in darker-skinned Covid patients, leading to delays in treatment and hospital readmissions, according to a research article published on Thursday.The research focused on the first years of the coronavirus pandemic, when patients overwhelmed hospitals. At the time,blood-oxygen levels were a key factor in deciding which patients wound up in limited hospital beds and received treatment.Researchers from Baylor College, Johns Hopkins University and HCA Healthcare reviewed the cases of about 24,500 patients whose blood-oxygen levels were first measured with a pulse oximeter via a fingertip and whose blood was then drawn and tested to further examine those levels.These researchers and other experts have raised concerns that the pulse oximeter readings via fingertip of people with darker skin pigment often show flawed results. The issue has already led to reviews by federal regulators, with some efforts underway to determine how to produce more accurate readings.iStock/GettyWhy It Matters: The readings influence patient care.Pulse oximeter readings are used routinely and help inform doctors in shaping medical care for any number of illnesses, including heart failure, sleep apnea and respiratory conditions. A normal reading for a patient in good health should be an oxygen saturation level in the blood of about 95 percent or higher. If the readings are falsely high, patients may look fine on paper — but they may not get the level of care they need.The patients in the study released Thursday in JAMA Network Open were the ones researchers would have expected to have fared the best: Their doctors saw the need to take a more precise measure of their blood-oxygen levels. (Most patients’ fingertip reading is never double-checked with a blood draw.)Patients with a fingertip pulse-oximeter reading of 94 percent or more but whose blood tests showed lower levels were deemed to have an unrecognized need for Covid therapy. Black patients were found to be nearly 50 percent more likely than white patients to have their condition go undetected. Hispanic patients were 18 percent more likely than white patients to have an unrecognized need.Patients with unrecognized needs, regardless of race, experienced delays of roughly an hour that translated into a 10 percent higher risk of delayed Covid treatment. They were also more than twice as likely to be readmitted to the hospital.The new study did not include patients whose oxygen levels might have mistakenly appeared normal via the pulse oximeter but had no follow-up blood test, and perhaps were sent home even though they may have been seriously ill.“That’s the patient population that we’re really truly concerned about,” said Dr. Ashraf Fawzy, a study author who is a Johns Hopkins assistant professor and intensive care physician.Background: Flaws could lead to great health disparities.The Food and Drug Administration approves the type of fingertip pulse oximeter used in hospitals and sold by prescription. The agency issued a safety communication about the flaws in early 2021. And it held a hearing in the fall before an expert panel, with researchers outlining studies pointing to the role the device might have in deepening health disparities for patients with darker skin tone.The agency approved those devices through its so-called 510(k) program, which clears devices that are similar to existing ones — with some additional scrutiny. The program has been criticized over the years because the standards for clearing devices are typically lower than those for the agency’s approval of new drugs.During the hearing in November, the F.D.A. noted that the pulse oximeters sold over the counter are subject to even less oversight, prompting agency advisers to call for warnings to consumers who use the devices to gauge their own respiratory health.What’s Next: The F.D.A. promises further review.The F.D.A. has not announced a major change in how it oversees pulse oximeters, but it said on Thursday that it planned to publish a discussion paper to get feedback on the issue and convene another meeting with experts to discuss potential approaches.“It is a high priority for the agency to ensure that oximetry device performance is equitable and accurate for all U.S. patients,” the agency said in a statement.Some work has also begun to design a better pulse oximeter.For now, though, Dr. Fawzy said doctors should trust their overall impression of a patient’s condition when taking a pulse-oximeter reading into account.“It’s important for us to recognize that this device may lead to clinical decisions that are inaccurate,” he said, “or that we may be under-treating certain people or under-recognizing their needs.”

The LatestA tornado that ripped apart a vast Pfizer drug warehouse in North Carolina last week will probably lead to disrupted supplies of crucial drugs used in surgery and critical care, according to estimates made by an independent nonprofit.The tornado, which reached wind speeds of 150 miles per hour and snapped trees at the base, primarily hit a storage center where Pfizer kept raw materials, packing supplies and finished medications. The production plant at the site did not have “major damage,” the company said, noting that it’s working to restart operations soon.Pfizer released a list of drugs that could go into shortage — or in some cases, a deeper state of shortage. They include common I.V. pain relievers like fentanyl and morphine, as well as lidocaine, used in local anesthesia, and heparin, used to treat or prevent blood clots.The tornado-damaged Pfizer pharmaceutical factory in Rocky Mount, N.C.Sean Rayford/Getty ImagesWhy It Matters: Some of these medicine are not widely produced.The U.S. Pharmacopeia, a nonprofit that examines the drug supply chain, took a close look at the likely effect of the tornado damage. The nonprofit assigns “vulnerability scores” to medications, accounting for factors linked to shortages, like low prices, quality problems at production sites and the number of companies that make the drug.The painkiller infusions had a high vulnerability score, as did I.V. electrolytes like potassium chloride and magnesium sulfate that are made at the plant and listed by Pfizer as potentially affected by the tornado. These medications help patients with severe dehydration or diabetes complications, among other conditions.One unexpected upside to the deepening shortages of some medications is that, under federal rules, specialized pharmacies are allowed to make the drugs on an emergency basis. That policy “will come in handy at a time like this when you have an unexpected shock to the system,” said Vimala Raghavendran, a shortage expert at the U.S. Pharmacopeia.Last Time This Happened: Cancer drug shortage threatened patient care.This disaster struck as the last drug shortage crisis began to ease. For weeks this spring and summer, doctors were running out of two inexpensive, generic chemotherapy drugs that are the best shot at a cure for patients with testicular, ovarian and other cancers.Doctors predicted heightened death rates as patients arrived for treatment only to discover they would not be getting the most potent drug in the combination used to treat them. The Food and Drug Administration has since begun to allow shipments of the drugs from China that were not expressly approved for the United States market.Now, “it seems better,” Dr. Lucio Gordan, president of Florida Cancer Specialists, said in an email on Tuesday, noting that his centers have a month’s supply of the drugs, which are called cisplatin and carboplatin.What We Don’t Know: Will Congress or the White House act?Medication shortages are not new. But the cancer drug crisis started a widespread conversation about its root causes and solutions. Some proposals have come from Medicare, which unveiled a plan to incentivize hospitals to stockpile essential drugs. A key Senate health committee advanced a pandemic-funding bill that would give the F.D.A. more data to head off shortages.Leaders in the generic drug industry and other experts cite the pressure from intermediary companies that award the lowest-price bidder with access to millions of customers. The “race to the bottom” in prices, they say, destabilizes the industry and rewards those who might cut corners or operate overseas, often in India, where labor costs are lowest. House Republicans have been examining some of those dynamics but have not issued proposals.

Extensive damage occurred at the company’s property in Rocky Mount, and many products used by hospitals appeared to have been affected. This could further exacerbate shortages.A Pfizer facility and several homes sustained major damage when a tornado ripped through a 16-mile strip of Rocky Mount, N.C.By The Associated PressA tornado caused extensive damage to a Pfizer drug manufacturing site in Rocky Mount, N.C., on Wednesday, threatening critical supplies for hospitals across the country.The company estimated that one-fourth of the injectable medications it supplies to U.S. hospitals were made at the Rocky Mount property, including drugs used during surgeries and other procedures to help block pain, keep patients sedated and fight infections.Though the company has yet to disclose the extent of the storm’s impact, video footage of the site and interviews with the Nash County sheriff and with people briefed on the damage indicated that the tornado caused the worst damage at the company’s warehouse.On Thursday, Pfizer declined to comment on the drugs affected or the proportion of its supply destroyed in the tornado, which could be considerable given that a lot of these medications required careful production and handling to ensure sterility.It was also unclear how deeply the destruction would exacerbate existing national drug shortages, which have reached a 10-year high in recent months. Hospitals are on high alert because low-cost generic products manufactured at the site, are already among the most shortage-prone on the market.“From a health care practitioner point of view, I’m just holding my breath,” said Michael Ganio, a senior director at the American Society of Health-System Pharmacists.The tornado ripped through a 16-mile strip of the Rocky Mount area, about 50 miles east of Raleigh, at about 12:30 p.m. on Wednesday. It snapped trees at the base and tossed homes 20 yards from their foundations, according to a summary by the National Weather Service. The tornado reached wind speeds up to 150 miles per hour before it ripped off large pieces of the metal roof of a Pfizer building and flipped big-rig trucks in the parking lot. Sixteen people were injured, but no deaths were reported.Several people said the tornado caused the most damage to a company warehouse; the impact to the manufacturing plant — and its ability to continue producing medicines — is not yet clear, according to Mittal Sutaria, a senior vice president of pharmacy contracts at Vizient, which provides contracting for medications to hospitals.She said Pfizer had teams on-site to assess the damage.Dr. Sutaria, who said Vizient had been in touch with Pfizer, added that the Rocky Mount site made anesthesia products, as well as fentanyl and morphine, which are used in IVs for pain management. It also makes antibiotics administered to fight severe infections, and muscle blockers including succinylcholine, also used in surgery.Keith Stone, the sheriff of Nash County, where Rocky Mount is situated, told local news reporters on Wednesday that much of the Pfizer building was splintered, the roof was crushed and as many as 50,000 pallets of medicine were destroyed.About 100 vehicles were also damaged, including forklift trucks that were strewn across nearby railroad tracks, Sheriff Stone said in an interview on Thursday. “It’s just amazing what can come up so quick and have so much damage and be gone so fast,” he said.Steve Danehy, a spokesman for Pfizer, said on Thursday that the company’s Rocky Mount team was “working very hard to address and assess the situation,” but did not provide any details. The company said its staff survived the tornado without serious injuries.Pfizer is expected to report its findings to the Food and Drug Administration, which tracks shortages.“We are following the situation closely as it evolves and are working with the company to understand the extent of the damage and any potential impact to the nation’s drug supply,” said Chanapa Tantibanchachai, a spokeswoman for the agency.The Rocky Mount facility, established in 1968, employs 4,500 people and has 24 filling lines and 22 packing lines. Though not as large as Pfizer’s manufacturing complex in Kalamazoo, Mich., the North Carolina site spans 1.4 million square feet of manufacturing space. The medicines made at the site are also shipped to Japan, Canada, Brazil and other countries.The specific products made at the Pfizer plant — and the share of the market they comprise — is not typically public information. However, the company sells dozens of injectable items, including I.V. antibiotics, anti-seizure drugs used in brain surgery and even an antidote to coral snake venom.Many Pfizer medicines were already in short supply before the tornado: About 130 products marketed to hospitals were listed as “depleted” and about 100 more were in “limited supply,” according to the company’s list of 660 products.Pfizer has other manufacturing plants in Kansas, New York, Massachusetts and Wisconsin where the company could possibly shift some production to ease any shortages resulting from the Rocky Mount destruction.Soumi Saha, a senior vice president with Premier, a company that provides contracting services for medications to hospitals, said that Pfizer had a strong track record for building in some redundancy so that products were manufactured at more than one site.If the storm damage is limited to the warehouse and does not affect production schedules at the manufacturing plants, that could mitigate potential shortages, she said.Dr. Ganio recalled other drug shortages caused by disasters in production zones.Hurricane Maria struck Puerto Rico in 2017, leaving hospitals scrambling for IV bags. Another occurred last year when a region of China that was hard-hit by Covid had a lapse in producing contrast dye for CT scans and other medical images. And in recent months, doctors have warned that survival rates for some cancer patients are in jeopardy because of a halt in production at a manufacturing plant in India after the F.D.A. cited major quality lapses.Given the worrisome shortages that affect so many lives — and that have resulted in hoarding of certain drugs and bartering among advocates who trade and find scarce drugs for the most desperate — policy experts, lawmakers and federal officials have been discussing solutions in recent weeks.On Thursday, Senate lawmakers passed a pandemic preparedness bill out of a key health committee. It had provisions aimed at stemming shortages and increasing reports by drugmakers to alert the F.D.A. to circumstances that might lead to shortages so the agency could help head them off. The bill would also require a report from the F.D.A. within 90 days of the legislation’s passage on the agency’s ability to deal with shortages and whether it needs more help from lawmakers.Still, the natural occurrence of a tornado provided a stark reminder of the need to better manage shortages.“This reinforces the need for resiliency in our supply chain and a true focus on preparedness, not only for the next pandemic,” Dr. Saha said, “but for any unforeseen circumstance that creates shocks in our supply chain.”

The respiratory virus is a global killer of babies and young children.The Food and Drug Administration on Monday approved a shot to protect infants and vulnerable toddlers against respiratory syncytial virus, or R.S.V., offering one of the first protections for an illness that fills children’s hospitals year after year.The monoclonal antibody shot is expected to be available at the start of the fall R.S.V. season. The F.D.A. is also considering approval of an R.S.V. vaccine by Pfizer for pregnant women that is meant to protect infants from the virus.The treatment approved on Monday, called Beyfortus by its developers Sanofi and AstraZeneca, addresses an illness that can be severe in older adults and young infants. About 80,000 children ages 5 and younger are hospitalized with the virus each year, according to the Centers for Disease Control and Prevention.“R.S.V. can cause serious disease in infants and some children and results in a large number of emergency department and physician office visits each year,” Dr. John Farley, an official in the F.D.A. Center for Drug Evaluation and Research, said. “Today’s approval addresses the great need for products to help reduce the impact of R.S.V. disease on children, families and the health care system.”The potential to blunt the effects of R.S.V. will extend to older adults: In recent months, the F.D.A. has approved two vaccines against the virus for adults 60 and older. The virus is linked to 60,000 hospitalizations and up to 10,000 deaths each year in people 65 and older, according to the C.D.C. The agency estimated that more than 21,000 people in that age group would need to take the GSK vaccine to prevent one R.S.V. death in one year; the number was nearly 25,000 for the Pfizer shot.Agency advisers considering the antibody shot for infants cast a unanimous vote in June in favor of approving the treatment for infants. More than 3,200 infants were given the shot in studies that Sanofi and AstraZeneca submitted to the F.D.A. One six-month study found that efficacy against very severe R.S.V. that required medical attention was 79 percent.F.D.A. advisers were more cautious about an R.S.V. shot by Pfizer intended for pregnant women. In May, a panel voted 10 to 4 that the vaccine was safe, a reflection of concerns about slightly elevated rates of preterm births among mothers who received the vaccine, compared with those who received a placebo.Studies of a similar vaccine by GSK were halted after researchers detected an increase in preterm births. The agency has yet to make a decision on that maternal Pfizer vaccine, called Abrysvo, though a company spokeswoman said that approval was anticipated in the coming weeks.

The F.D.A. and the powerful beverage industry protested the new findings, and a second W.H.O. group stood by its standard that the sweetener is generally safe.A World Health Organization agency declared on Thursday that aspartame, an artificial sweetener widely used in diet drinks and low-sugar foods, could possibly cause cancer.A second W.H.O. committee, though, held steady on its assessment of a safe level of aspartame consumption. By some calculations using the panel’s standard, a person weighing 150 pounds could avoid a risk of cancer but still drink about a dozen cans of diet soda a day.The declaration by a W.H.O. agency of a cancer risk associated with aspartame reflects the first time the prominent international body has weighed in publicly on the effects of the nearly ubiquitous artificial sweetener. Aspartame has been a contentious ingredient for decades.The International Agency for Research on Cancer, or I.A.R.C., said it based its conclusion that aspartame was a possible carcinogen on limited evidence from three observational studies of humans that the agency said linked consumption of artificially sweetened beverages to an increase in cases of liver cancer — at levels far below a dozen cans a day. It cautioned that the results could potentially be skewed toward the profile of people who drink higher amounts of diet drinks and called for further study.Still, people who consume high amounts of aspartame should consider switching to water or other unsweetened drinks, said Dr. Francesco Branca, director of the W.H.O. Department of Nutrition and Food Safety.But, he added: “Our results do not indicate that occasional consumption should pose a risk to most.”Concerns about rising global rates of obesity and diabetes as well as changing consumer preferences have resulted in an explosion of no- and low-sugar food and beverages. Aspartame, one of six sweeteners approved by U.S. regulators, is found in thousands of products, from packets of Equal to sugar-free gum, diet sodas, teas, energy drinks and even yogurts. It is also used to sweeten various pharmaceutical products.The U.S. Food and Drug Administration, which approved aspartame decades ago, on Thursday issued an unusual criticism of the global agency’s findings and reiterated its longstanding position that the sweetener is safe. In a statement, the F.D.A. said it “disagrees with I.A.R.C.’s conclusion that these studies support classifying aspartame as a possible carcinogen to humans.”The F.D.A. also said that “aspartame being labeled by the W.H.O. as ‘possibly carcinogenic to humans’ does not mean that aspartame is actually linked to cancer.” The F.D.A. declined to make any of its experts available for interviews to discuss the agency’s specific concerns.But its salvo against the international organization was sure to ignite further debate in Europe — where the sweetener is still deemed safe — and renew review in the United States. And the dueling global agencies’ pronouncements are likely to fuel confusion among consumers.The W.HO. has occasionally been out of step with other authorities on potential cancer risks, like glyphosate, and later led the way toward establishing that it was dangerous to human health. The international body’s designation of a cancer link to that ingredient in Roundup, a weed killer, became the stepping stone for lawsuits against the makers of the herbicide.Around the world, the powerful beverage industry has fought long and hard against any regulatory or scientific finding that tied artificial sweetener use to risks of cancer or other health problems. Aspartame is only the latest battleground for multinational companies to push back against new studies or potential links to health risks.Researchers in the Cesare Maltoni Cancer Research Center in Bologna, Italy, in 2006. Italian researchers conducting rodent studies from 2005 to 2010 rekindled the debate over aspartame.Pigi Cipelli for The New York Times“Aspartame is safe,” Kevin Keane, interim president of the American Beverage Association, said in a statement. He cited the dueling W.H.O. announcements, singling out the second panel, the Joint Expert Committee on Food Additives, that performed a concurrent review and left its recommended daily intake amount unchanged. It also deemed the evidence for cancer in humans “not convincing,” a W.H.O. summary shows.“After a rigorous review, the World Health Organization finds aspartame is safe and ‘no sufficient reason to change the previously established acceptable daily intake,’” Mr. Keane said. “This strong conclusion reinforces the position of the F.D.A. and food safety agencies from more than 90 countries.”Coca-Cola referred questions to the American Beverage Association and PepsiCo did not respond to requests for comment.The safety of sugar replacements, including the decades-old science dispute over the use of saccharin in the diet drink Tab, has been heavily scrutinized. Once linked to bladder cancer in rats, Congress mandated further study of saccharin. Since then, according to the F.D.A., 30 studies showed the rodent results did not apply to humans; U.S. officials removed saccharin from a list of potential carcinogens. More recently, other sweeteners have come under scrutiny for their ties to possible health risks.At the center of the dispute over aspartame are rodent studies from 2005-2010 by Italy-based researchers that showed a link to cancer. The F.D.A. has dismissed the long-debated studies as “compromised.”Dr. William Dahut, chief scientific officer of the American Cancer Society, which led one of the key studies the W.H.O. relied on, said the findings should be considered alongside the W.H.O.’s report earlier this year that indicated artificial sweeteners offered no help in achieving weight loss or protection from other chronic conditions.He said there was little evidence now to suggest a daily Diet Coke would elevate the risk of cancer, adding that “more research is needed.” Overall, he said, the science was more definitive on reducing cancer risk by avoiding tobacco, alcohol, processed meat and excess body weight.The I.A.R.C. said it could not rule out the possibility that the studies linking aspartame to liver cancer were a result of chance or other factors associated with drinking diet soda.The W.H.O.’s cancer agency has four categories: carcinogenic, probably carcinogenic, possibly carcinogenic and no classification. Those levels reflect the strength of the science rather than how likely the substance is to cause cancer.The other W.H.O. group on food additives recommended that daily consumption should be below 40 milligrams of aspartame per kilogram of a person’s weight — slightly lower than the suggested U.S. level of 50 milligrams.The F.D.A. said it estimated that a person weighing 132 pounds would need to consume 75 packets of aspartame sweetener to reach the threshold of exposure to a potential risk.For its review of aspartame, the I.A.R.C. convened 25 cancer experts from 12 nations in Lyon, France, to conduct the review of existing studies. It concluded that there was limited evidence for cancer in humans based on three studies linking artificially sweetened drinks to increases in hepatocellular carcinoma, the most common type of liver cancer.One study in 2016 was led by W.H.O. officials, who looked at nearly 500,000 people in Europe who were followed for about 11 years. The study tracked participants’ juice and soft drink intake and the relationship to liver and bile duct cancers. It examined those who drank artificially sweetened soft drinks and found that each additional serving of diet soft drink a week was associated with a 6 percent increased risk of liver cancer.A U.S. study published last year by researchers from Harvard, Boston University and the National Cancer Institute examined sweetened beverage consumption reported by people on questionnaires and cancer case registries. Researchers found an elevated risk of liver cancer in people with diabetes who said they consumed two or more artificially sweetened sodas a day. That study found no increase in liver cancer among diet soda drinkers who did not have diabetes.The F.D.A., which approved aspartame decades ago, responded strongly to the I.A.R.C.’s conclusions.Andrew Harnik/Associated PressA third study, led by the American Cancer Society, examined the use of beverages sweetened by sugar and artificial sweeteners and cancer death data. It found a 44 percent increase in liver cancer among men who never smoked and drank two or more artificially sweetened drinks a day. Even adjusting for high body mass — in itself a cancer risk factor — the men had a 22 percent increase in risk, data in a supplement to the study shows.The American Beverage Association, which represents Coca-Cola and PepsiCo, has been vocal in saying that the W.H.O.’s food additive panel — not the cancer experts — should be the lead authority evaluating aspartame.In recent weeks, the beverage industry trade group has financed a new coalition led by Alex Azar, an appointee of former President Donald J. Trump, and Donna Shalala, an appointee of former President Bill Clinton. Both Mr. Azar and Ms. Shalala were former secretaries of the Department of Health and Human Services. In an opinion article in Newsweek earlier this month, the two embraced the F.D.A.’s position on the safety of aspartame, and called the agency “the world’s gold standard for independent regulatory bodies.”The trade group had previously contested another review of aspartame’s potential links to cancer in California. In 2016, a state committee discussed reviewing aspartame, but it went no further.California officials said this week that the state could review the latest W.H.O. decision.Besides aspartame, the W.H.O.’s cancer agency has deemed other possible carcinogens to range from the seemingly benign, like Ginkgo biloba extract and aloe vera leaf extract, to the more concerning, like gasoline exhaust and perfluorooctanoic acid, the most common of the industrial chemicals known as per- and polyfluoroalkyl substances, or PFAS, that has recently been subject to billion-dollar settlements over drinking water contamination.In deeming aspartame a possible carcinogen, the I.A.R.C. also dipped into one of the central controversies of aspartame research. It concluded that there was some evidence for cancer in lab animals based on studies performed by the Ramazzini Institute in Italy, citing the group’s finding of increased tumors in aspartame studies from the mid-2000s. Based on concerns over the group’s methods and interpretations, though, the findings were deemed limited.For its part, the Ramazzini Institute said in 2021 that its work on aspartame was validated and that its earlier findings were “savagely attacked by the chemical manufacturing and processed food industries and by their allies in regulatory agencies.”Dr. Branca of the W.H.O. responded to questions about the need for an I.A.R.C. review during a news conference on Wednesday, saying that 10 million people die of cancer each year. “So there’s a societal concern that our organization needed to respond to,” he said.He said the results demonstrated a clear need for further high-quality research.“We’ve in a sense raised a flag here, indicating that we need to clarify much more in the situation,” Dr. Branca said. “It is not something which we can dismiss at this moment.”Julie Creswell contributed reporting to this article.

Tony Shepard learned he had vocal cord cancer this spring, but he was encouraged when his doctor said he had an 88 percent chance at a cure with chemotherapy and radiation.That outlook began to dim in recent weeks, though, after the oncology practice he goes to in Central California began to sporadically run out of the critical medication he needs.Since Mr. Shepard’s doctor informed him of the shortage, each treatment session has felt like a game of “Russian roulette,” he said, knowing that failure would mean the removal of his vocal cords and the disappearing of his voice.“I try not to even think about it,” said Mr. Shepard, 62, a manager of a gas station in Madera, a town in California’s Central Valley. “It’s something scary that you don’t really want to think about — but you know it’s a reality.”The nation’s monthslong shortage of highly potent cancer drugs is grinding on, forcing patients and their doctors to face even grimmer realities than those cancer typically presents. Thousands of patients like Mr. Shepard have been confronting gut-wrenching options, delays in treatment and potentially bleaker futures.Oncologists are concerned that the alternatives to two crucial chemotherapy drugs are far less effective in treating certain cancers, and are sometimes more toxic. The backup therapies or lack thereof, they say, pose particularly troubling prospects for patients with ovarian, testicular, breast, lung and head and neck cancers.There are few, if any, signs that the shortage will ease anytime soon. A plant that was a main producer of the more popular drugs shut down late last year and has not reopened, depleting its stock. The easing of restrictions on imported drugs from China this month has provided some relief, but doctors said the influx has yet to make much of a dent. Some companies that sell the medications are projecting that the shortage will last through the fall or later.So far, neither a group of experts organized by the Biden administration nor prominent medical organizations have found a way to avoid rationing the crucial chemo drugs.To bridge the gaps, some doctors are extending care intervals and skimming precious milliliters to stretch doses. Others are turning to a strategy of surgery first and chemo later, banking on a resumption of supplies.One of the nation’s top cancer care groups, the American Society of Clinical Oncology, is now advising doctors with low quantities of the medications to administer them to patients with a shot at a cure — and to deny them to patients with recurrent or widely spread disease.​​ “We’re in a situation where patients are being left behind, and we’re really worried survival could be affected by the chemotherapy shortage,” said Dr. Angeles Alvarez Secord, president of the Society of Gynecologic Oncology and a professor at Duke University School of Medicine.Two main chemotherapy drugs, cisplatin and carboplatin, are deployed as frontline medicines in cocktails used to shrink or eliminate tumors. More than a dozen cancer drugs are also officially in short supply, as well as hundreds of other medications, including antibiotics and sterile injectable fluids. Still, doctors predict that the absence of the powerful chemotherapies may hurt patients most.Cisplatin and carboplatin are inexpensive: They cost $15 and $23 per vial, according to the U.S. Pharmacopeia, a nonprofit aimed at medication safety and supply. But manufacturing the drugs requires a reliable supply of platinum, a metal used, as well as a sterile plant and special controls to protect workers from the drugs’ toxic effects. As a result, few companies make them.A cisplatin injection box in the pharmaceutical storage room at the Center for Cancer and Blood Disorders in Fort Worth, Texas.Emil Lippe for The New York TimesThe most recent shortages of these widely used drugs occurred when a leading manufacturer, Intas Pharmaceuticals, shut down production in December after the Food and Drug Administration had performed a surprise inspection at its plant in Ahmedabad, India. The U.S. agency issued a report that said employees were shredding, tearing and pouring acid on quality control records and noted a “cascade of failure” at the site.The company’s subsidiary, Accord Healthcare, in Durham, North Carolina, said recently that it was still making improvements at the plant that were needed to restart production.By this spring, the effects of the Intas shutdown were deeply felt. A survey by the National Comprehensive Cancer Network of academic treatment centers released earlier this month found that 93 percent of the 27 centers that responded were experiencing a carboplatin shortage. As a result, 36 percent of them reported altering treatments for their patients, resorting to lower doses and longer intervals between therapies.At cCare Cancer Center in Fresno, Calif., where Mr. Shepard receives care for his vocal cord cancer, efforts to stretch supply have given way to sporadic availability. For the last six weeks, vials of the platinum drugs have been unavailable roughly half of the time, an oncologist, Dr. Ravi Rao, said.He said Mr. Shepard’s odds of a cure without the drugs would fall from roughly 90 percent to about 45 percent. Fortunately, Mr. Shepard said, the drugs have been available for the first two of seven treatments.Patients with ovarian cancer are facing the worst outlook, Dr. Rao said, because of how common the disease is and how central the platinum drugs have been in tackling it for decades. Without those drugs, one patient with extensive ovarian cancer has odds of survival that fall to the single digits from about 30 percent, he said.“This shortage will lead to people dying,” said Dr. Rao, who is also a board member of the Community Oncology Alliance. “There’s just no way around it. You cannot remove these lifesaving drugs and not have bad outcomes.”Others who face heightened threats are patients with testicular cancer, because cisplatin has a known record of curing even advanced cases, said Dr. Julie Gralow, the ASCO chief medical officer, in her testimony to a House subcommittee earlier this month.“This is critical, impacting maybe as many as half a million Americans with just these two drugs,” Dr. Gralow said.Arias Pitts, a single mother living in Tampa, Fla., was diagnosed with an aggressive breast cancer in April and encountered the shortage at her first treatment last month.Octavio Jones for The New York TimesFor Florida Cancer Specialists, with more than 90 sites, the shortage initially meant conserving 10 to 15 percent of a patient’s dose to stretch stock, said Dr. Lucio Gordan, president of the practice.That was not enough, so doctors began to only give the drugs to patients with a chance at a cure or those enrolled in clinical trials. The practice found some products at vastly inflated prices — apparent price gouging — but bought them anyway.Still, by May, the practice was without carboplatin for 12 days and cisplatin for eight days, Dr. Gordan said.Arias Pitts, 33, who was diagnosed with an aggressive breast cancer in April, encountered the shortage when she arrived to begin treatment on May 16. The carboplatin her doctor had ordered for the first of six rounds of chemotherapy was not available.“Of course I had questions and concerns,” said Ms. Pitts, an academic adviser at the University of South Florida and a single mother of a 4-year-old. She added: “It’s stressful.”The F.D.A. has taken steps to ease the shortage. It oversaw the testing and release of batches of the platinum drugs manufactured by Intas in India that were made before the shutdown, but that stock has now been exhausted.It is also temporarily allowing Qilu Pharmaceuticals, based in China, to ship its cisplatin to the United States.Jordan Berman, a vice president of Apotex Pharmaceuticals, a Toronto company importing the Qilu drugs, said it received shipments of cisplatin on June 6 and began routing them through major U.S. distributors.Oncologists and supply chain experts said there was little data so far to gauge the effect the imports would have. About 600 vials of cisplatin from China arrived at Florida Cancer Specialists earlier this month, Dr. Gordan said. But that was not enough for the practice to resume offering the drugs to patients with advanced or recurrent cancers.“It’s about six days of treatment for us,” Dr. Gordan said. “We’re scrambling.”Studies in the 1980s and 90s showed that the platinum drugs were a vast improvement over existing treatments, performing best in combination with other drugs and doubling the response rates for ovarian and head and neck cancer. The platinum drugs pushed the five-year survival rate for testicular cancer to 95 percent from roughly 10 percent.While newer immunotherapy treatments have improved the outcome for patients with certain types of cancer, like melanoma, oncologists also include them in cocktails with the platinum drugs to extend their lives and enhance the potential for survival.“In general, we haven’t seen these home runs in cancer” in recent years, said Dr. Mikkael Sekeres, a University of Miami oncologist and former F.D.A. oncology adviser.Oncologists advising the field amid the current shortages have urged those treating early-stage lung cancer patients to send them to a center that has the drugs, noting, “there are no equally effective alternatives.”Dr. Evan Myers, a Duke University researcher in the obstetrics and gynecology department, said he was planning to measure the effects of the shortages. One study of a different medication shortage affecting children and adolescents with Hodgkin’s lymphoma found that the substitute drug was “significantly less effective,” and reduced the survival rate for the young people who received the backup treatment.Dr. Myers said this year’s shortages would, at a minimum, likely have an effect on the quality of life for people undergoing treatment. “They’re going to be waiting for the other shoe to drop,” he said.Dr. Prasanthi Ganesa at the infusion center of the Center for Cancer and Blood Disorders in Fort Worth. “We feel really helpless,” she said.Emil Lippe for The New York TimesDoctors are also struggling with how to convey such devastating news, said Dr. Prasanthi Ganesa, medical director of The Center for Cancer and Blood Disorders in Fort Worth. Her practice is looking at each case individually, but is also prioritizing crucial doses for patients who could potentially be cured.“I can imagine a patient listening to this and saying, ‘You know, I am trying to live longer, that is my priority. So I need that drug, doc,’” she said. “We feel really helpless.”The situation demands action, said Dr. Karen Knudsen, chief executive of the American Cancer Society. The White House and Congress, which have discussed the problem, have advanced few concrete solutions.“The necessity for a durable solution is growing greater by the day,” Dr. Knudsen said, adding, “Patients are left hanging.”

The NewsSales of e-cigarettes rose by nearly 47 percent from January 2020, just before the pandemic hit the United States, to December 2022, according to an analysis released on Thursday by the Centers for Disease Control and Prevention.The increase over that period occurred while teenagers and young adults reported in surveys that they had recently tried e-cigarettes at much higher rates than older adults did.According to the C.D.C., about 4.5 percent of all adults said they used e-cigarettes. But the rates went up as the age dropped. About 14 percent of high school students and 11 percent of young adults reported using the devices within the last 30 days of the survey, the C.D.C. data showed.Sales were still growing through May of last year, but then dropped by 12 percent through December. Researchers attributed the decline to several possible factors, including state or local bans on flavored products; government enforcement; and the introduction of devices that offered thousands of “puffs” in a single device.Overall, four-week sales of e-cigarettes climbed to 25.9 million units late last year, from 15.5 million units in early 2020.A health warning accompanies the display of Vuse e-cigarettes.Michael M. Santiago/Getty ImagesWhy It Matters: Effects of vaping are still unknownThe Food and Drug Administration has embraced the use of e-cigarettes, regulating their sale on the market as an aid for adult smokers to make the transition to a less harmful product.But tobacco opponents and public health experts warn that the popular devices have lured teenagers and young people — who would be unlikely to smoke traditional cigarettes — into an addictive habit amid growing concerns about vaping nicotine.The C.D.C.’s analysis reinforces data indicating that fruit and candy flavors have surged in popularity. The vaping devices often contain high levels of nicotine and are sold in appealing colors and flavors, like strawberry ice cream and mango ice.The American Heart Association has called for more action to reduce youth vaping and issued a scientific statement last year saying that e-cigarettes appeared to lead to increased risk of heart and lung disease. The American Lung Association has also aired concerns, saying it was “very troubled by the evolving evidence about the impact of e-cigarettes on the lungs” and citing the known and unknown toxic effects of chemicals used in vapes.Background: Youth vaping was on the riseThe C.D.C. study does not include sales from vaping and tobacco shops or internet sales, so the findings are limited.Still, trends have shifted in the last few years. Vaping of e-cigarettes among minors has declined from a record high in 2019, when nearly 28 percent of high school students reported vaping within the last 30 days. At the time, products that were sleek and produced by Juul Labs were the most popular, and the company was largely blamed for the soaring rate of teenage vaping. Juul has since resolved myriad lawsuits brought by many states and individuals, resulting in settlements adding up to nearly $3 billion.The F.D.A. has rejected applications for millions of products to get on the market, approving only about two dozen tobacco-flavored vaping devices. Yet the agency has struggled with enforcement; flavored vapes have flooded gas stations, convenience stores and vape shops nationwide.The agency prevailed in court in recent weeks against the makers of Hyde vapes, which were a favorite among high school students in a recent youth tobacco survey. The latest report from the C.D.C. shows Elf Bar Vapes rising in popularity. The F.D.A. has issued an import alert for them to be seized at the border and on Thursday announced enforcement against nearly 200 retailers selling those vapes and Esco Bar products.What’s Next: Regulation and enforcementThe F.D.A. has said it will issue final decisions by the end of this year on the remaining applications for selling vaping products to address the top sellers by Vuse, Juul and others.Tobacco control advocates are pressuring the F.D.A. to step up its enforcement of unauthorized e-cigarettes and to also move forward with a proposed ban on menthol cigarettes.Many interested parties are also watching the effects of a statewide flavor ban unfolding in California — one similar to those in six other states and more than 300 jurisdictions. Since Dec. 21, when the ban took effect, vape product sales fell 35 percent through late March, according to data from the C.D.C. Foundation.