FDA Approves Journavx Drug to Treat Pain Without Addiction Risk

The drug, Journavx by Vertex Pharmaceuticals, blocks pain signals to the brain, making it nonaddictive.The Food and Drug Administration approved a new medication Thursday to treat pain from an injury or surgery. It is expensive, with a list price of $15.50 per pill. But unlike opioid pain medicines, it cannot become addictive.That is because the drug, suzetrigine, made by Vertex Pharmaceuticals and to be sold as Journavx, works only on nerves outside the brain, blocking pain signals. It cannot get into the brain.Researchers say they expect it to be the first of a new generation of more powerful nonaddictive drugs to relieve pain.To test the drug, Vertex, which is based in Boston, conducted two large clinical trials, each with approximately 1,000 patients who had pain from surgery. They were randomly assigned to get a placebo; to get the opioid sold as Vicodin, a widely used combination pain medicine of acetaminophen (Tylenol) and hydrocodone; or to get suzetrigine.In one trial, patients had an abdominoplasty, or tummy tuck. In the other, they had a bunionectomy. Side effects of suzetrigine reported by patients were similar to the ones reported by those taking the placebo.The company also submitted data from a 250-person study that assessed the drug’s safety and tolerability in patients with pain from surgery, trauma or accidents.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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RFK Jr. Says He Won’t Keep Financial Stake in HPV Vaccine Lawsuits

During intense questioning Thursday by members of the Senate health committee about his plan to keep a financial stake in major vaccine litigation, Robert F. Kennedy said that he would give away his rights to fees that might flow from it.It appears to be a reversal from the details of the government ethics agreement that he filed for his Senate confirmation hearings to become the nation’s health secretary.Just last week, the ethics agreement he provided to senators stated that he would retain a stake in the continuing litigation, meaning that if confirmed, he could receive payments while overseeing the vast U.S. health bureaucracy that includes regulating drug companies. The financial disclosure specified that Mr. Kennedy would collect fees from Wisner Baum, a personal injury law firm based in Los Angeles.Mr. Kennedy said that he had sent hundreds of clients to the firm, which is suing the drug maker Merck over claims that young people were injured by the company’s Gardasil vaccine, aimed at preventing cervical cancer caused by the human papillomavirus, or HPV. In the ethics statement, he reported: “I am entitled to 10 percent of fees awarded” in cases that he referred to Wisner Baum.Lawmakers considering his confirmation on Wednesday and Thursday denounced the financial arrangement, with many Democrats suggesting that it posed an inherent conflict because he would stand to gain financially from decisions he made as health secretary that involved drug companies.“I have given away all of my rights to any fees in that lawsuit,” Mr. Kennedy told senators on Thursday. Asked to elaborate, Katie Miller, a spokeswoman for Mr. Kennedy, said that he “isn’t personally retaining the fees.”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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Loretta Ford, ‘Mother’ of the Nurse Practitioner Field, Dies at 104

She transformed nursing by making it an area of clinical practice and research and recasting nurses as colleagues of doctors, not assistants.Loretta Ford, who co-founded the first academic program for nurse practitioners in 1965, then spent decades transforming the field of nursing into an area of serious clinical practice, education and research, died on Jan. 22 at her home in Wildwood, Fla. She was 104.Her daughter, Valerie Monrad, confirmed the death.Today there are more than 350,000 nurse practitioners in America; it is one of the fastest growing fields, and last year U.S. News and World Report ranked it the top job in the country, a reflection of salary potential, job satisfaction and career opportunities.That success is in large part the result of a single person, Dr. Ford, who in 1965 co-founded the first graduate program for nurse practitioners, at the University of Colorado, and subsequently mapped the outlines of what the field entailed.At the time, nurses were important figures in the medical field, providing not just administrative support but also vital services where and when doctors were unavailable. But the training and career framework for nurses was almost completely absent.“In nurses’ training, the focus is too much on teaching and administration,” Dr. Ford said in a speech at Duke University in 1970. “We want to make the nurse into a clinician.”She went further in 1972, when she was hired as the first dean of the school of nursing at the University of Rochester. There she implemented the “unification” model of nursing, in which education, practice and research are fully integrated.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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Is the HPV Vaccine Safe? Yes, Despite What R.F.K. Jr. Has Said.

Amid a tense line of questioning during the first day of confirmation hearings, Robert F. Kennedy Jr. said he would keep his financial stake in pending litigation centered on Gardasil, a vaccine meant to prevent cervical cancer, which can be caused by the human papillomavirus, or HPV.On Thursday, under questioning by Senator Patty Murray, Democrat of Washington, Mr. Kennedy declined to disavow comments he had made disparaging the vaccine as unsafe and as something that no parent should give to a child. (Unexpectedly, he also seemed to assert that he had surrendered his financial stake in the litigation.)Mr. Kennedy has often singled out Gardasil in his critiques of vaccines, suggesting that its ingredients increase the risk of cancer, lead to autoimmune conditions and may be responsible for a rise in mental illness.The Children’s Health Defense, a nonprofit co-founded by Mr. Kennedy, called the vaccine “one of the most dangerous vaccines ever approved.”The Centers for Disease Control and Prevention, which monitors the side effects and ongoing safety of vaccines like Gardasil, disagrees with that characterization, noting that the body of scientific evidence “overwhelmingly supports their safety.”Before the Gardasil vaccine was approved by federal regulators in 2014, it underwent lengthy clinical trials with more than 15,000 participants.C.D.C. monitoring has revealed some minor side effects, most commonly dizziness, nausea, headache and fever. And in extremely rare cases, there have been more serious side effects documented, like Guillain-Barré syndrome.But the vaccine is also remarkably effective at preventing cancer — roughly 97 percent effective in preventing cervical cancer, and nearly 100 percent effective in preventing external genital warts.The C.D.C. is currently conducting research into the relationship between all vaccinations and certain conditions like postural orthostatic tachycardia syndrome (POTS) and chronic fatigue syndrome.But current studies show that HPV vaccines cause “no increased risk” of chronic fatigue syndrome and do “not support a causal link” between Gardasil and POTS.

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Pause on U.S. Funding Spreads Fear of H.I.V. Spike Across Africa

Patients and health care advocates said the abrupt decision to halt U.S. funding for a lifesaving H.I.V. program led to widespread confusion. The backtracking didn’t help.As he does every three months, Sibusiso traveled on Wednesday morning to a clinic in the capital of Eswatini, a tiny southern African nation, to get a refill of the H.I.V. medication he needs to save his life. When he arrived, the door was locked and about 20 other patients stood outside, baffled that the clinic was closed.Sibusiso, 39 and unemployed, had heard rumors that President Trump was pulling funding for the program that supported his treatment. Now, though, he learned the reality: The Trump administration had ordered a halt to the President’s Emergency Plan for AIDS Relief, or PEPFAR, one of America’s most consequential aid programs in Africa.The abrupt pause of a $6.5 billion program established by former President George W. Bush and credited with saving the lives of tens of millions people, sent patients, clinicians and public health activists across Africa into a panic. Many feared a return to some of the darkest days on the continent, when H.I.V. spread rapidly and a diagnosis was akin to a death sentence.As Sibusiso stood outside the clinic, he feared he could be next. He had taken the last of his antiretroviral medication that morning. And even though the Trump administration had backtracked, suddenly announcing on Tuesday that lifesaving medications and treatments could continue to be distributed, the clinic remained shuttered in the confusion.Sibusiso, standing outside, had no idea where or when he could get more medicine.“I’m now thinking of dying,” said Sibusiso, who requested that only his first name be used to protect his privacy. “What am I going to do without this treatment?”The Trump administration has said that foreign assistance programs will be paused for three months as it reviews how money is being spent. If the administration decides to end PEPFAR, it could lead to 600,000 deaths over the next decade in South Africa alone, where the program has its largest number of beneficiaries, according to a study.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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How to Travel With Babies and Toddlers

Traveling with a baby or a toddler can be fun, frustrating, even revelatory. Planning is key, and so is your willingness to tailor the trip to the youngest traveler. As Dr. Elizabeth Barnett, the director of the pediatric travel program at Boston Medical Center, advises, “If you take a young child, it’s all about the child.”Choose one (or two) destinationsThis is not the time for a “nine European capitals in seven days” trip. Think about picking one place or splitting your trip between two destinations. That will allow you to settle in and get the sleep schedule sorted out. Most small children thrive on routines. If you find the right playground or bakery, your child will enjoy returning.Getting there: It’s all about strategy — and luckAirports, airplanes, long drives, train rides: They all loom large, depending on your child’s disposition. Get ready to distract, soothe, sing, nurse — whatever helps. For toddlers, pediatricians agree that travel is the perfect occasion to forget screen time rules and embrace devices and programming that will help pass the time.For babies, sucking something aboard an airplane can help with painful air pressure changes in the ears, so pack a pacifier and a bottle, and if you’re breastfeeding, dress for comfortable semipublic nursing. Don’t give your baby medication to promote sleep unless you’ve discussed it with your pediatrician — and if you get clearance, try it at home first in case there are negative reactions. Healthychildren.org, from the American Academy of Pediatrics, is a good source for tips on air travel with babies.Keep in mind that if an infant car seat is going to be used on an airplane, it should say on the label that it is certified for use on aircraft.Some children behave perfectly on long flights, while others lose it completely. But every child is capable of both. It’s up to you to bring along equipment and diversions, snacks, changes of clothing and a friendly, apologetic smile in case your child interferes with other passengers’ comfort.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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