He Regulated Medical Devices. She Represented Their Makers.

For 15 years, Dr. Jeffrey E. Shuren was the federal official charged with ensuring the safety of a vast array of medical devices including artificial knees, breast implants and Covid tests.When he announced in July that he would be retiring from the Food and Drug Administration later this year, Dr. Robert Califf, the agency’s commissioner, praised him for overseeing the approval of more novel devices last year than ever before in the nearly half-century history of the device division.But the admiration for Dr. Shuren is far from universal. Consumer advocates see his tenure as marred by the approval of too many devices that harmed patients and by his own close ties to the $500 billion global device industry.One connection stood out: While Dr. Shuren regulated the booming medical device industry, his wife, Allison W. Shuren, represented the interests of device makers as the co-leader of a team of lawyers at Arnold & Porter, one of Washington’s most powerful law firms.Dr. Shuren signed ethics agreements obtained by The Times that were meant to wall him off from matters involving Arnold & Porter’s business. But it’s not clear how rigorously the ethics agreements were actually enforced. His wife’s law firm refused to provide a list of clients — and the agency had no legal authority to require it, said Michael Felberbaum, a spokesman for the F.D.A.In a review of thousands of pages of court documents and F.D.A. records and dozens of interviews with current and former agency staff members and advocates, The Times identified some clients and several instances in which the Shurens’ roles intersected.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.

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Philippines Reports First Mpox Case Since W.H.O. Declared Global Emergency

It was not clear if the patient had contracted the new, potentially more deadly strain of the disease, which first appeared outside of Africa last week, in Sweden.The Philippines reported its first case this year of mpox, previously known as monkeypox, on Monday, just days after the World Health Organization declared the disease a global health emergency.The Philippines Department of Health, in a statement announcing the case, did not say whether the patient was infected with Clade Ib, the newer and potentially more deadly version of the mpox virus that is dominant now in the Democratic Republic of Congo, driving a rise in cases there.It was an older strain, Clade IIb, that caused a worldwide outbreak of mpox in 2022.Last Thursday — a day after the W.H.O. declaration of a global emergency — officials in Sweden revealed that a patient there was the first person outside of Africa to be diagnosed with the new strain, setting off fears of a much wider spread. Also on Thursday, Pakistan announced a case of mpox but said it was not yet clear which strain of the disease was involved.Here is what we know.The case in the PhilippinesThe patient is a 33-year-old Filipino man with no travel history outside of the country, whose mpox infection was confirmed and reported on Sunday to the Department of Health, the department said.The man became sick more than a week ago, first with a fever, “followed four days later by findings of a distinct rash on the face, back, nape, trunk, groin, as well as palms and soles,” the department said. The patient was seen in a government hospital, where samples of his skin lesions were taken to test for genetic evidence of the virus.The Philippines’ secretary of health, Dr. Teodoro J. Herbosa, discouraged public panic by emphasizing that officials were working to make testing convenient. “Our health system is working,” he said in a statement, “we can handle the situation and will keep the public well-informed.”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.

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A New Treatment for Severe Allergic Reactions — Without the Needle

Dr. Michael Blaiss, an allergist at the Medical College of Georgia, was often surprised by how hesitant his patients were to use their auto-injectors, syringe-like devices like the EpiPen that deliver a drug needed to head off potentially fatal allergic reactions.Some patients called his office, on the verge of shock, to double-check that it was necessary to give themselves the shot. Others told him they would rather wait in the emergency room parking lot to “see what happens.”Children suffering dangerous reactions sometimes ran away from their parents, terrified of the needle. One Tom-and-Jerry-like chase ended with a father getting mistakenly injected, Dr. Blaiss recalled.A new device recently approved by the Food and Drug Administration may help quell some of the anxiety. The device, Neffy, administers epinephrine, the drug in the EpiPen, through a nasal spray rather than a needle.“We have needed this for so long,” Dr. Blaiss said. “I truly believe it will save lives.”Patient advocates and allergists, who regularly see the consequences of needle aversion, have been awaiting an auto-injector alternative for years. Among the general population, this fear is relatively common — most children and up to 30 percent of young adults are afraid of needles, according to one systematic review.Ilana Golant, founder and chief executive of the Food Allergy Fund, said she knew parents who had been so nervous to give the shot that they had missed the window to stave off a serious reaction, landing their child in the hospital.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.

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A Personalized Brain Pacemaker for Parkinson’s

When Shawn Connolly was diagnosed with Parkinson’s disease nine years ago, he was a 39-year-old daredevil on a skateboard, flipping and leaping from walls, benches and dumpsters through the streets of San Francisco. He appeared in videos and magazines, and had sponsorships from skateboard makers and shops.But gradually, he began to notice that “things weren’t really working right” with his body. He found that his right hand was cupping, and he began cradling his arm to hold it in place. His balance and alignment started to seem off.Over time, he developed a common Parkinson’s pattern, fluctuating between periods of rapid involuntary movements like “I’ve got ants in my pants” and periods of calcified slowness when, he said, “I could barely move.”A couple of years ago, Mr. Connolly volunteered for an experiment that summoned his daring and determination in a different way. He became a participant in a study exploring an innovative approach to deep brain stimulation.In the study, which was published Monday in the journal Nature Medicine, researchers transformed deep brain stimulation — an established treatment for Parkinson’s — into a personalized therapy that tailored the amount of electrical stimulation to each patient’s individual symptoms.The researchers found that for Mr. Connolly and the three other participants, the individualized approach, called adaptive deep brain stimulation, cut in half the time they experienced their most bothersome symptom.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.

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