Elon Musk’s first human experiment with a computerized brain device developed significant flaws, but the subject, who is paralyzed, has few regrets.Just four months ago, Noland Arbaugh had a circle of bone removed from his skull and hair-thin sensor tentacles slipped into his brain. A computer about the size of a small stack of quarters was placed on top and the hole was sealed.Paralyzed below the neck, Mr. Arbaugh is the first patient to take part in the clinical trial of humans testing Elon Musk’s Neuralink device, and his early progress was greeted with excitement.Working with engineers, Mr. Arbaugh, 30, trained computer programs to translate the firing of neurons in his brain into the act of moving a cursor up, down and around. His command of the cursor was soon so agile that he could challenge his stepfather at Mario Kart and play an empire-building video game late into the night.But as weeks passed, about 85 percent of the device’s tendrils slipped out of his brain. Neuralink’s staff had to retool the system to allow him to regain command of the cursor. Though he needed to learn a new method to click on something, he can still skate the cursor across the screen.Neuralink advised him against a surgery to replace the threads, he said, adding that the situation had stabilized.The setback became public earlier this month. And although the diminished activity was initially difficult and disappointing, Mr. Arbaugh said it had been worth it for Neuralink to move forward in a tech-medical field aimed at helping people regain their speech, sight or movement.We are having trouble retrieving the article content.Please enable JavaScript in your browser settings.Thank you for your patience while we verify access. If you are in Reader mode please exit and log into your Times account, or subscribe for all of The Times.Thank you for your patience while we verify access.Already a subscriber? Log in.Want all of The Times? Subscribe.

Thousands of people with sleep apnea and other illnesses had sued the company, claiming flawed devices were harming them. Philips Respironics has reached a $1.1 billion settlement over claims that people who used their CPAP and other breathing devices were harmed by noxious gasses and flecks of foam that lodged in their airways, sometimes for years.Thousands of people contended in lawsuits that they had been injured by popular Philips DreamStation machines. The settlement affects CPAP, or continuous positive airway pressure, machines that people with sleep apnea or other respiratory difficulties use at night to improve their breathing, as well as other types of machines used at home and in hospitals.Philips did not admit any fault in the settlement, including whether the devices caused the injuries, according to a financial report issued Monday.The personal injury settlement follows a $479 million settlement reached in September over economic losses to the patients and medical equipment sales companies that financed replacement devices. Philips also agreed to a consent decree earlier this year that forced the company to halt U.S. sales of new devices until certain conditions are met.Monday’s agreement largely settles years of litigation over a problem that was deeply upsetting to patients and doctors, who had to weigh the risk of letting patients’ interrupted breathing go untreated against the use of a machine that might cause harm. Patients flooded lawmakers and the Food and Drug Administration with complaints about a chaotic recall and replacement effort that left many waiting for months or more than a year for an updated device.In a letter to Philips in May 2022, the F.D.A. noted that the company had received reports about the problem as early as 2015, but failed to evaluate the information and address the device’s problems.The recall started in the summer of 2021 amid concerns that the machines blew out potentially cancer-causing gases. The initial recall affected about 15 million breathing machines produced since 2006, though roughly five million were still in circulation in mid-2021.The F.D.A. reported earlier this year that since Philips first warned of the problems, officials had received 116,000 complaints, including 561 reports of deaths, that people or lawyers said were linked to the faulty foam in the device.The company has since tempered its warnings, saying that further testing showed that the gasses were not as toxic as initially believed.Investors recognized the resolution, as the company stock surged by about 33 percent Monday morning, to about $28 per share. The company said that part of the settlement would be covered by insurance.Plaintiffs’ lawyers welcomed the settlement.“Ultimately, these combined agreements accomplish what we sought to achieve when this litigation began — holding Philips accountable by obtaining care for those with physical injuries and compensation for those needing new respiratory devices,” Sandra L. Duggan, Kelly K. Iverson and Christopher A. Seeger, lawyers representing the plaintiffs, said in a statement.

A Chinese company targeted by members of Congress over potential ties to the Chinese government makes blockbuster drugs for the American market that have been hailed as advances in the treatment of cancers, obesity and debilitating illnesses like cystic fibrosis.WuXi AppTec is one of several companies that lawmakers have identified as potential threats to the security of individual Americans’ genetic information and U.S. intellectual property. A Senate committee approved a bill in March that aides say is intended to push U.S. companies away from doing business with them.But lawmakers discussing the bill in the Senate and the House have said almost nothing in hearings about the vast scope work WuXi does for the U.S. biotech and pharmaceutical industries — and patients. A New York Times review of hundreds of pages of records worldwide shows that WuXi is heavily embedded in the U.S. medicine chest, making some or all of the main ingredients for multibillion-dollar therapies that are highly sought to treat cancers like some types of leukemia and lymphoma as well as obesity and H.I.V.The Congressional spotlight on the company has rattled the pharmaceutical industry, which is already struggling with widespread drug shortages now at a 20-year high. Some biotech executives have pushed back, trying to impress on Congress that a sudden decoupling could take some drugs out of the pipeline for years.WuXi AppTec and an affiliated company, WuXi Biologics grew rapidly, offering services to major U.S. drugmakers that were seeking to shed costs and had shifted most manufacturing overseas in the last several decades.WuXi companies developed a reputation for low-cost and reliable work by thousands of chemists who could create new molecules and operate complex equipment to make them in bulk. By one estimate, WuXi has been involved in developing one-fourth of the drugs used in the United States. WuXi AppTec reported earning about $3.6 billion in revenue for its U.S. work.We are having trouble retrieving the article content.Please enable JavaScript in your browser settings.Thank you for your patience while we verify access. If you are in Reader mode please exit and log into your Times account, or subscribe for all of The Times.Thank you for your patience while we verify access.Already a subscriber? Log in.Want all of The Times? Subscribe.

Millions in Sackler donations sat dormant, rising in value as the opioid epidemic raged and as other institutions distanced themselves from the makers of a notorious painkiller.The National Academy of Sciences is asking a court to allow it to repurpose about $30 million in donations from the wealthy Sackler family, who controlled the company at the center of the opioid epidemic, and to remove the family name from the endowment funds.The petition filed by the Academy in Superior Court in Washington, D.C., Thursday aims to modify the terms of the donations so the institution can use them for scientific studies, projects and educational activities.The move follows a report in The New York Times last year that examined donations from several Sackler members, including an executive of Purdue Pharma, which produced the painkiller OxyContin that has long been blamed for fueling the opioid crisis that has claimed thousands of lives.“The notoriety of the Sackler name has made it impossible for the Academy to carry out the purposes for which it originally accepted the funds,” Marcia McNutt, president of the National Academy of Sciences, said in a statement released on Thursday.Daniel S. Connolly, a spokesman for the Raymond Sackler family, said it supported the National Academies in “using the funds as they see fit” and would have supported the change.“We would have said yes if we’d been asked, just as we will still say yes despite this unnecessary court filing and false assertions about us,” Mr. Connolly said in a statement.We are having trouble retrieving the article content.Please enable JavaScript in your browser settings.Thank you for your patience while we verify access. If you are in Reader mode please exit and log into your Times account, or subscribe for all of The Times.Thank you for your patience while we verify access.Already a subscriber? Log in.Want all of The Times? Subscribe.

The agency faulted the device maker for delayed notice of mounting complications, citing increasing reports of how use of the device perforated the walls of the heart.A troubled heart pump that has now been linked to 49 deaths and dozens of injuries worldwide will be allowed to remain in use, despite the Food and Drug Administration’s decision to issue an alert about the risk that it could puncture a wall of the heart.The tiny Impella pumps, about the width of a candy cane, are threaded through blood vessels to take over the work of the heart in patients who are undergoing complex procedures or have life-threatening conditions.The F.D.A. said the manufacturer of the device, Abiomed, should have notified the agency more than two years ago, when the company first posted an update on its website about the perforation risk. Such a notice, the F.D.A. added, would have led to a much broader official agency warning to hospitals and doctors.The alert is the latest of concerns raised in recent years about the deadly side effects of cardiac devices, especially those that take over the heart’s role in circulating blood. It is the third major F.D.A. action for an Impella device in a year.A series of studies suggested that the Impella heart devices heighten the risk of death in patients with unstable medical conditions. Meanwhile, the device maker has spent millions of dollars promoting the device and awarding consulting payments to cardiologists and grants to hospitals.Since Abiomed’s first notice about the Impella’s complications in October 2021, the F.D.A. received 21 additional reports of heart-wall tears linked to patient deaths, according to Audra Harrison, a spokeswoman for the agency.We are having trouble retrieving the article content.Please enable JavaScript in your browser settings.Thank you for your patience while we verify access. If you are in Reader mode please exit and log into your Times account, or subscribe for all of The Times.Thank you for your patience while we verify access.Already a subscriber? Log in.Want all of The Times? Subscribe.

The agency tested 75 types of cinnamon after hundreds of children were poisoned by the spice in applesauce. It found some lead in cinnamon brands sold at some dollar stores and other markets.The Food and Drug Administration is telling consumers to throw out certain brands of cinnamon that were found to have elevated levels of lead, and it urged companies to recall the products from store shelves.The agency conducted tests across the country after at least 460 children were sickened last year by illnesses linked to applesauce pouches. Those products had been contaminated with very high levels of lead from cinnamon processed in Ecuador.The F.D.A.’s latest tests, however, detected far lower levels, 2 to 3 parts per million, in the cinnamon. In contrast, the cinnamon from Ecuador that sickened children last year had 2,200 to 5,100 parts per million.“Although we have concern about these products in the safety alert, they do not present the same level of risk to human health as the cinnamon in the apple purée and applesauce products,” Conrad Choiniere, an F.D.A. food official, said in a release on Wednesday.Lead is a potent toxin that is particularly hazardous to young children and has been tied to learning and behavior challenges as well as developmental delays. The agency said no illnesses were reported in relation to the latest batches of cinnamon, which were singled out over elevated lead levels after tests of 75 samples from retail stores.The latest batches of cinnamon and the applesauce pouches were both sold at Dollar Tree stores. The company has said it is committed to the safety of the products it sells. Brands that the F.D.A. has urged companies to recall include Supreme Tradition cinnamon, sold exclusively at Dollar Tree and Family Dollar stores. Other cinnamon with elevated lead levels in the recent tests included the La Fiesta brand sold at La Superior SuperMercados and the Marcum brand sold at Save A Lot.We are having trouble retrieving the article content.Please enable JavaScript in your browser settings.Thank you for your patience while we verify access. If you are in Reader mode please exit and log into your Times account, or subscribe for all of The Times.Thank you for your patience while we verify access.Already a subscriber? Log in.Want all of The Times? Subscribe.

Lawmakers want shopkeepers to remove e-cigarettes that were not authorized by the F.D.A. Retailers say it is not that simple.The chairmen of five key Senate committees on Thursday warned the chief executives of major convenience stores and wholesalers to stop sales of illicit flavored vaping products that they called “widespread violations of federal law.”The senators voiced their concerns in letters to the companies, amplifying the frustration among some lawmakers in Congress over the continued availability of e-cigarettes in vivid colors and candy flavors that attract young people who could become addicted to nicotine. The unchecked sales, they wrote, “pose a tremendous public health threat.”“F.D.A. and the industry must do more to address the youth vaping epidemic and remove unauthorized vaping products from their shelves immediately,” Senator Dick Durbin of Illinois, the Democratic whip, said.The letters were addressed to retailers including 7-Eleven, Circle K, bp America, Pilot, Kwik Trip and others. The Food and Drug Administration had earlier issued warnings about sales of unauthorized brands like Elf Bar, E.B. Design and Funky Republic.The senators’ letters reminded the companies that Congress gave the F.D.A. authority over tobacco products in a landmark 2009 law. Selling unapproved items can result in fines or an order to stop selling any tobacco products, the letter notes.“Today, millions of children use unauthorized e-cigarettes, risking nicotine addiction, respiratory illness, exacerbation of depression and anxiety, and many other harms,” read the letter to Joseph DePinto, the chief executive of 7-Eleven. The company did not respond to a request for comment.We are having trouble retrieving the article content.Please enable JavaScript in your browser settings.Thank you for your patience while we verify access. If you are in Reader mode please exit and log into your Times account, or subscribe for all of The Times.Thank you for your patience while we verify access.Already a subscriber? Log in.Want all of The Times? Subscribe.

Hundreds of children sickened from high levels of lead in applesauce pouches last year put a spotlight on lapses in the food-safety system.A recent outbreak of lead poisoning from cinnamon in applesauce has drawn attention to the toxic effect the heavy metal can have on children. The cinnamon in the applesauce was believed to have been intentionally contaminated, possibly to add to its value as a commodity sold by weight. It had unusually high levels of lead.The Centers for Disease Control and Prevention estimates that more than 400 children were poisoned in the applesauce outbreak. Their median blood lead levels were six times higher than the average seen during the height of the Flint water crisis, the C.D.C. said.While such poisoning cases are rare, lead is a widespread contaminant and has been under increasing scrutiny. Here’s what you need to know.How do children get exposed to lead?Paint is one of the most common and well-known sources of lead. Children can also be exposed by drinking water that flows through old lead pipes.Lead poisoning through food is less common but does occur. Lead can get into food at low levels when plants draw it up from the soil. For instance, a study about baby foods found that sweet potatoes had some of the highest levels of lead among the products tested.A lead-based pigment is sometimes illegally added to spices to bulk them up or make their color pop. The Food and Drug Administration suspects that the additive caused the applesauce contamination last year.We are having trouble retrieving the article content.Please enable JavaScript in your browser settings.Thank you for your patience while we verify access. If you are in Reader mode please exit and log into your Times account, or subscribe for all of The Times.Thank you for your patience while we verify access.Already a subscriber? Log in.Want all of The Times? Subscribe.

As public health groups pressure the Biden administration to impose a ban on menthol cigarettes, research suggests similar moves in other countries have led to lower smoking rates.Nearly a quarter of menthol cigarette smokers quit in the year or two after a ban on menthol went into effect, according to a study published on Wednesday.Researchers found that about half of the menthol smokers switched to other cigarettes and another quarter managed to keep smoking menthols. The rate of menthol smokers who quit was higher in nations that imposed bans, in contrast with cities or states, since it was harder for people to drive a few miles to keep buying menthol cigarettes, according to the study.The Food and Drug Administration has been urging the Biden administration to impose a ban on menthol cigarettes, a goal that has generated intense opposition from retailers and tobacco companies alongside concerns in a presidential election year that it could alienate Black voters.Black smokers, who heavily favor menthol cigarettes, also stand to gain the most from such a ban, public health researchers say, noting that premature deaths from cancer, heart and lung disease could be avoided after a sharp decline in smoking rates.The study analyzed the effects of bans in other countries, including Canada and some in the European Union, as well as bans in force in states, including Massachusetts. The researchers reviewed studies, smoking rates and cigarette sales as part of their analysis.“Our review found that a menthol ban will have a pro-equity impact, meaning that we expect smoking to reduce the most among Black individuals who smoke as compared to other racial or ethnic groups,” said Sarah Mills, lead author of the study and an assistant professor at the University of North Carolina school of public health.We are having trouble retrieving the article content.Please enable JavaScript in your browser settings.Thank you for your patience while we verify access. If you are in Reader mode please exit and log into your Times account, or subscribe for all of The Times.Thank you for your patience while we verify access.Already a subscriber? Log in.Want all of The Times? Subscribe.

The F.T.C. and H.H.S. are examining the tactics of group purchasing organizations that generic industry executives say have led to scarce supplies of treatments like chemotherapy.The Federal Trade Commission and the Department of Health and Human Services said on Wednesday that they would examine the causes of generic drug shortages and the practices of “powerful middlemen” that are involved in the supply chain.The federal agencies’ inquiry is aimed at the group purchasing organizations and drug distributors that have been in the spotlight in recent months as drug shortages reached a 10-year peak. The agencies want to examine the companies’ influence on how the drugs are sold to hospitals and other health facilities, assessing whether the middlemen put pressure on pricing and manufacturing that led to breakdowns.During Congressional hearings in the last year, oncology experts have testified about the effects of the shortages, describing difficult decisions that forced them to ration key chemotherapy drugs. They detailed month-to-month, sometimes week-to-week, gaps in supplies that were posing deadly risks for some patients.“For years Americans have faced acute shortages of critical drugs, from chemotherapy to antibiotics, endangering patients,” Lina Khan, the F.T.C. chairwoman, said in a statement. “Our inquiry requests information on the factors driving these shortages and scrutinizes the practices of opaque drug middlemen.”In earlier interviews with The Times, generic drug industry executives had expressed deepening concerns about their reliance on three major group purchasing organizations for contracts to sell medicines to hospitals and health center customers. The generic executives complained that their companies sometimes offered below-market prices to get big contracts, a strategy that had eroded stability in the industry, especially among makers of sterile injectable products often used in surgical and cancer care.Lawmakers have echoed the concerns. Late last year, Senator Ron Wyden, a Democrat of Oregon and chairman of the Senate Finance Committee, criticized “very powerful health care middlemen” in the generic drug industry. Last month, he and Senator Mike Crapo, a Republican of Idaho, outlined ways to limit drug shortages, focusing in part on proposed changes to Medicare payments for sterile injectable drugs.We are having trouble retrieving the article content.Please enable JavaScript in your browser settings.Thank you for your patience while we verify access. If you are in Reader mode please exit and log into your Times account, or subscribe for all of The Times.Thank you for your patience while we verify access.Already a subscriber? Log in.Want all of The Times? Subscribe.