Kent man with depression calls for ketamine prescriptions

Published3 hours agoShareclose panelShare pageCopy linkAbout sharingBy Mark Norman & Christian FullerBBC NewsA man with depression is calling for ketamine treatment to be made available on prescription. Ketamine is licensed to be used as an anaesthetic but has a reputation as an illegal party drug.But Simon Bottle, from Hawkhurst, Kent, has lived with depression for 30 years and says taking the drug has been “game changing”. The Royal College of Psychiatrists said more research on its effectiveness in clinical settings was needed. Mr Bottle said depression had impacted his education, career and personal life, until he paid for a private prescription of ketamine. “I’ve had what people would call breakdowns probably three or four times where I’ve gone from being just about functional and dealing with it and then becoming completely incapacitated by it,” he said. The businessman is campaigning for the NHS to prescribe ketamine for patients who have not responded to other forms of antidepressants.”It introduced hope to an illness in which by definition you lose all hope,” he said. “One of the things that happened for me almost instantaneously was a feeling of a huge weight starting to be lifted off your shoulders, which I hadn’t felt in decades. “It gave me a toehold initially, which turned into a springboard. That has been game changing.”After trials in the US, Australia and at an NHS hospital in Oxford, Prof Rupert McShane, of Oxford Health NHS Foundation Trust, backed the calls for the NHS to use ketamine to treat drug resistant depression, rather than electroconvulsive therapy (ECT), which he says many patients are “too frightened” to have. He said 30% of depression patients who took ketamine remained well after one year without it, compared to 5% of those on other antidepressants. “I think if we were to get a license for intravenous ketamine as an alternative for people who have been considered for ECT, it would without doubt be a game changer,” he said. “Ketamine in low doses works in a different way to conventional antidepressants. “And what is really exciting is that there is new data which suggests that it is as good as the best treatment for depression that we’ve got, which is ECT.”A Royal College of Psychiatrists spokesperson said early research indicated that ketamine may be effective in treating some people with severe mental illnesses, who have not responded to other forms of treatment.”However, we still need more research on its potential effectiveness in clinical settings and also what safeguards might need to be put in place should it be deemed appropriate for use in this group of patients,” they said. If you’re affected by the issues in this piece, you can find support from BBC Action Line.Follow BBC South East on Facebook, on Twitter, and on Instagram. Send your story ideas to southeasttoday@bbc.co.ukMore on this storyKetamine for alcoholics trial goes to next stagePublished13 December 2022Ketamine’s ‘rapid help’ for depressionPublished16 April 2018Ketamine’s depression treatment hopesPublished6 April 2017Related Internet LinksThe Royal College of PsychiatristsOxford Health NHS Foundation TrustThe BBC is not responsible for the content of external sites.

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Cheri Pies, Author of “Considering Parenthood,” Dies at 73

She made her name with a watershed book for same-sex parents and later studied the impact of racial and economic inequality on health.Cheri Pies, a professor of public health who broke barriers with her landmark 1985 book, “Considering Parenthood: A Workbook for Lesbians,” a bible of the “gayby boom” of the 1980s and beyond, died on July 4 at her home in Berkeley, Calif. She was 73.The cause was cancer, said her wife, Melina Linder.Later in life, Dr. Pies (her first name was pronounced “Sherry”) became a pioneering researcher and professor at the University of California, Berkeley School of Public Health, investigating the effects of economic and racial inequality in matters like infant mortality and health over generations.But she made her name decades before her turn toward academia with her groundbreaking book. That journey began in the 1970s, when Dr. Pies was working as a health educator for Planned Parenthood, counseling straight women considering motherhood.Her focus began to shift in 1978, after her female partner adopted a daughter. At that time, the concept of openly gay parents was still mostly unheard-of in the culture at large.Just that year, New York became the first state to say it would not reject applications for adoption solely on the basis of homosexuality. A year later, a gay couple in California broke barriers as the first known to jointly adopt a child.Dr. Pies was struck by the lack of support available to same-sex parents, as well as the lack of basic information about the unique challenges they face. She began running workshops in her home in Oakland, Calif., advertising them with fliers in women’s bookshops and other places where lesbians gathered.By the early 1980s, word of her work had spread beyond the Bay Area, and she was bombarded with letters and phone calls from lesbians around the country. In response, Dr. Pies compiled her teachings and experiences into a book. “Considering Parenthood: A Workbook for Lesbians,” published by the lesbian feminist press Spinsters Ink, provided practical advice on a wide range of topics, including the use of sperm donors, legal issues surrounding adoption, and ways to build a support network.The book, which appeared 30 years before same-sex marriage was legalized nationally, opened the floodgates for countless other books about L.G.B.T.Q. parenthood.“She was absolutely a pioneer, and those of us who came later built on her work,” G. Dorsey Green, a psychologist and author of “The Lesbian Parenting Book” (with D. Merilee Clunis, 2003), was quoted as saying in an obituary about Dr. Pies on Mombian, a website for lesbian parents. “I would recommend her book to clients. That was when lesbian couples were just starting to think about having children as out lesbians. Cheri started that conversation.”Dr. Pies, who earned a master’s degree in social work from Boston University in 1976, would eventually turn to academia, receiving another master’s degree, in maternal and child health, from Berkeley in 1985 and a doctorate in health education there in 1993.She was serving as the director of family, maternal and child health programs for Contra Costa County, which borders Berkeley and Oakland, when she heard a lecture in 2003 by Dr. Michael C. Lu, who would go on to become the dean of the Berkeley School of Public Health.Dr. Lu spoke about a concept called life course theory, which centers on the idea that the social and economic conditions at each stage in life, starting with infancy, can have powerful, lasting effects over generations. “What surrounds us shapes us,” Dr. Pies explained in a 2014 lecture at the University of Alabama at Birmingham. “Some people would say your ZIP code is more important than your genetic code.”At Berkeley, Dr. Pies would eventually collaborate with Dr. Lu and others to create the Best Babies Zone initiative, a groundbreaking program that would study — and, ideally, improve — health conditions in economically challenged neighborhoods around the country.In 2012, she became the program’s principal investigator, after Dr. Lu took a post in the Obama administration. The initiative included home health visits and work with community leaders to create parent-child play groups, improve park safety and enhance job-skills training. It began in Oakland, New Orleans and Cincinnati and had spread to six other cities by 2017, the year Dr. Pies retired from Berkeley. The program is still active today.“There are people doing large-scale policy work around structural racism, trying to change policy and practice,” Dr. Pies said in an interview published on the Berkeley School of Public Health website in April. “Best Babies Zone is at the other end of the spectrum, going small-scale to make change for people who can’t wait for policy change to happen.”The high incidence of low birth weight and sudden infant death syndrome in such communities was a focus of the program. “Babies are the canary in the mine,” Dr. Pies said in her University of Alabama speech. “If babies aren’t born healthy, you know that something isn’t right in the community.”Cheramy Anne Pies was born on Nov. 26, 1949, in Los Angeles, the second of three daughters of Morris Pies, a physician, and Doris (Naboshek) Pies, a nurse. (She later changed her name to Cheri.)“Considering Parenthood” paved the way for countless other books about L.G.B.T.Q. parenthood.Spinsters InkGrowing up in Encino, in the San Fernando Valley, the outgoing, ebullient Cheri was a fan of movies, particularly musicals like “My Fair Lady,” and got an early taste of the medical profession working as a receptionist in her father’s office.After graduating from nearby Birmingham High School, she enrolled at Berkeley in 1967, where she earned a bachelor’s degree in social science in 1971.Berkeley at the time was a cauldron of Vietnam War-era political passions, after the Free Speech Movement protests that rocked the campus starting in 1964. “Even though I was not actively engaged in it, I was certainly exposed to the politics of it,” she later said of the movement.In addition to her wife, Dr. Pies is survived by her sisters, Lois Goldberg and Stacy Pies.She would eventually channel Berkeley’s 1960s spirit of activism as an author and professor, working to improve the lives of openly lesbian parents of the 1980s and beyond — whose numbers swelled so quickly that by 1996, Newsweek magazine would report that an estimated six million to 14 million children in the United States had at least one gay parent.“Adoption agencies report more and more inquiries from prospective parents — especially men — who identify themselves as gay,” the article read, “and sperm banks say they’re in the midst of what some call a ‘gayby boom’ propelled by lesbians.”Many of that generation would acknowledge their debt to Dr. Pies for the rest of her life, Ms. Linder said in a phone interview: “Cheri and I could be anywhere in the world — on a hike in New Zealand or just walking in the Berkeley Hills — and people would see her and stop to thank her, saying how Ben or Alice or whoever would not be in their life were it not for Cheri.”

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A Number That Should Guide Your Health Choices (It’s Not Your Age)

Life expectancy increasingly figures into calculations about whether screenings and treatments are appropriate. Here’s how to find out yours. At her annual visit, the patient’s doctor asks if she plans to continue having regular mammograms to screen for breast cancer, and then reminds her that it’s been almost 10 years since her last colonoscopy.She’s 76. Hmmm.The patient’s age alone may be an argument against further mammogram appointments. The independent and influential U.S. Preventive Services Task Force, in its latest draft guidelines, recommends screening mammograms for women 40 to 74, but says “the current evidence is insufficient to assess the balance of benefits and harms of screening mammography in women age 75 years or older.”Screening for colorectal cancer, with a colonoscopy or with a less invasive test, becomes similarly questionable at advanced ages. The task force gives it a C grade for those 76 to 85, meaning there’s “at least moderate certainty that the net benefit is small.” It should only be offered selectively, the guidelines say.But what else is true about this hypothetical woman? Is she playing tennis twice a week? Does she have heart disease? Did her parents live well into their 90s? Does she smoke?Any or all such factors affect her life expectancy, which in turn could make future cancer screenings either useful, pointless or actually harmful. The same considerations apply to an array of health decisions at older ages, including those involving drug regimens, surgeries, other treatments and screenings.“It doesn’t make sense to draw these lines by age,” said Dr. Steven Woloshin, an internist and director of the Center for Medicine and Media at the Dartmouth Institute. “It’s age plus other factors that limit your life.”Slowly, therefore, some medical associations and health advocacy groups have begun to shift their approaches, basing recommendations about tests and treatments on life expectancy rather than simply age.“Life expectancy gives us more information than age alone,” said Dr. Sei Lee, a geriatrician at the University of California, San Francisco. “It leads to better decision making more often.”Some recent task force recommendations already reflect this broader view. For older people undergoing lung cancer tests, for instance, the guidelines advise considering factors like smoking history and “a health problem that substantially limits life expectancy” in deciding when to discontinue screening.The task force’s colorectal screening guidelines call for considering an older patient’s “health status (e.g., life expectancy, co-morbid conditions), prior screening status and individual preferences.”The American College of Physicians similarly incorporates life expectancy into its prostate cancer screening guidelines; so does the American Cancer Society, in its guidelines for breast cancer screening for women over 55.But how does that 76-year-old woman know how long she will live? How does anybody know?A 75-year-old has an average life expectancy of 12 years. But when Dr. Eric Widera, a geriatrician at the University of California, San Francisco, analyzed census data from 2019, he found enormous variation.The data shows that the least healthy 75-year-olds, those in the lowest 10 percent, were likely to die in about three years. Those in the top 10 percent would probably live for another 20 or so.All these predictions are based on averages and can’t pinpoint life expectancy for individuals. But just as doctors constantly use risk calculators to decide, say, whether to prescribe drugs to prevent osteoporosis or heart disease, consumers can use online tools to get ballpark estimates.For instance, Dr. Woloshin and his late wife and research partner, Dr. Lisa Schwartz, helped the National Cancer Institute develop the Know Your Chances calculator, which went online in 2015. Initially, it used age, sex and race (but only two, Black or white, because of limited data) to predict the odds of dying from specific common diseases and the odds of mortality overall over a span of five to 20 years.The institute recently revised the calculator to add smoking status, a critical factor in life expectancy and one that, unlike the other criteria, users have some control over.“Personal choices are driven by priorities and fears, but objective information can help inform those decisions,” said Dr. Barnett Kramer, an oncologist who directed the institute’s Division of Cancer Prevention when it published the calculator.He called it “an antidote to some of the fear-mongering campaigns that patients see all the time on television,” courtesy of drug manufacturers, medical organizations, advocacy groups and alarmist media reports. “The more information they can glean from these tables, the more they can arm themselves against health care choices that don’t help them,” Dr. Kramer said. Unnecessary testing, he pointed out, can lead to overdiagnosis and overtreatment.A number of health institutions and groups provide disease-specific online calculators. The American College of Cardiology offers a “risk estimator” for cardiovascular disease. A National Cancer Institute calculator assesses breast cancer risk, and Memorial Sloan Kettering Cancer Center provides one for lung cancer.Calculators that look at single diseases, however, don’t usually compare the risks to those of mortality from other causes. “They don’t give you the context,” Dr. Woloshin said.Probably the broadest online tool for estimating life expectancy in older adults is ePrognosis, developed in 2011 by Dr. Widera, Dr. Lee and several other geriatricians and researchers. Intended for use by health care professionals but also available to consumers, it offers about two dozen validated geriatric scales that estimate mortality and disability.The calculators, some for patients living on their own and others for those in nursing homes or hospitals, incorporate considerable information about health history and current functional ability. Helpfully, there’s a “time to benefit” instrument that illustrates which screenings and interventions may remain useful at specific life expectancies.Consider our hypothetical 76-year-old. If sh e’s a healthy never-smoker who is experiencing no problems with daily activities and is able, among other things, to walk a quarter mile without difficulty, a mortality scale on ePrognosis shows that her extended life expectancy makes mammography a reasonable choice, regardless of what age guidelines say.“The risk of just using age as a cutoff means we’re sometimes undertreating” very healthy seniors, Dr. Widera said.If she’s a former smoker with lung disease, diabetes and limited mobility, on the other hand, the calculator indicates that while she probably should continue taking a statin, she can end breast cancer screening.“Competing mortality” — the chance that another illness will cause her death before the one being screened for — means that she will probably not live long enough to see a benefit.Of course, patients will continue to make decisions of their own. Life expectancy is a guide, not a limit on medical care. Some older people don’t ever want to stop screenings, even when the data shows they’re no longer helpful.And some have exactly zero interest in discussing their life expectancy; so do some of their doctors. Either party can over- or underestimate risks and benefits.“Patients simply will say, ‘I had a great-uncle who lived to 103,’” Dr. Kramer recalled. “Or if you tell someone, ‘Your chances of long-term survival are one in 1,000,’ a strong psychological mechanism leads people to say, ‘Oh thank God, I thought it was hopeless.’ I saw it all the time.”But for those seeking to make health decisions on evidence-based calculations, the online tools provide valuable context beyond age alone. Considering projected life expectancy, “You’ll know what to focus on, as opposed to being frightened by whatever’s in the news that day,” Dr. Woloshin said. “It anchors you.”The developers want patients to discuss these predictions with their medical providers, however, and caution against making decisions without their involvement.“This is meant to be a jumping-off point” for conversations, Dr. Woloshin said. “It’s possible to make much more informed decisions — but you need some help.”

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Drugmakers Throw ‘Kitchen Sink’ to Halt Medicare Price Negotiations

The government will soon announce the first 10 medications that will be subject to price negotiations with Medicare under a new law. Drugmakers are fighting the measure in court.The pharmaceutical industry, which suffered a stinging defeat last year when President Biden signed a law authorizing Medicare to negotiate the price of some prescription medicines, is now waging a broad-based assault on the measure — just as the negotiations are about to begin.The law, the Inflation Reduction Act, is a signature legislative achievement for Mr. Biden, who has boasted that he took on the drug industry and won. Medicare is the federal health insurance program for older and disabled people; the provisions allowing it to negotiate prices are expected to save the government an estimated $98.5 billion over a decade while lowering insurance premiums and out-of-pocket costs for many older Americans.On Tuesday, Johnson & Johnson became the latest drugmaker to take the Biden administration to federal court in an attempt to put a halt to the drug pricing program. Three other drug companies — Merck, Bristol Myers Squibb and Astellas Pharma — have filed their own lawsuits, as have the industry’s main trade group and the U.S. Chamber of Commerce.The suits make similar and overlapping claims that the drug pricing provisions are unconstitutional. They are scattered in federal courts around the country — a tactic that experts say gives the industry a better chance of obtaining conflicting rulings that will put the legal challenges on a fast track to a business-friendly Supreme Court.The legal push comes just weeks before the Centers for Medicare & Medicaid Services is scheduled to publish a long-awaited list of the first 10 drugs that will be subject to negotiations. The list is due out by Sept. 1; the makers of the selected drugs have until Oct. 1 to declare whether they will participate in negotiations — or face steep financial penalties for not doing so. The lower prices will not take effect until 2026.Earlier this month, the chamber asked a federal judge in Ohio to issue an injunction that would block any negotiations while its case is being heard.Lawrence O. Gostin, an expert in public health law at Georgetown University, said the Supreme Court might be sympathetic to some of the industry’s arguments. In particular, he pointed to a claim by drugmakers that by requiring them to negotiate or pay a fine, the law violates the Fifth Amendment’s prohibition on the taking of private property for public use without just compensation.“The Supreme Court is openly hostile to any perceived violation of the Fifth Amendment,” Mr. Gostin said, adding, “It would not surprise me at all to see these cases go up to the Supreme Court and have them strike it down.”For Mr. Biden and his fellow Democrats, that would be a painful blow. The president and Democrats have long campaigned on reducing drug prices and plan to make it a central theme of their 2024 campaigns. The White House press secretary, Karine Jean-Pierre, said in a statement that Mr. Biden was confident the administration would win in court.“For decades, the pharma lobby has blocked efforts to let Medicare negotiate lower drug costs,” she said. “President Biden is proud to be the first president who beat them.”Republicans opposed the drug pricing provisions, which they regard as a form of government price control. But the politics of the issue are treacherous for them. Because so many Americans are concerned about high drug prices, it is hard for Republicans to come to the industry’s defense, said Joel White, a Republican strategist with expertise in health policy.Instead, Republicans are focused on another priority of the drug industry: scrutinizing the practices of pharmacy benefit managers, which negotiate prices with drug companies on behalf of health plans. The drug companies say that by taking a middleman’s cut, the pharmacy benefit managers are contributing to the high cost of prescription medicines.For drugmakers, the stakes of the legal challenges are bigger than just their business with Medicare, their biggest customer. The industry fears that Medicare will, in effect, set the bar for all payers, and that once the government’s lower prices are made public, pharmacy benefit managers negotiating on behalf of the privately insured will have more leverage to demand deeper discounts.In conjunction with its legal campaign, the pharmaceutical industry is waging a public relations offensive. The industry trade group that filed one of the lawsuits, the Pharmaceutical Research and Manufacturers of America, known as PhRMA, is running advertisements targeting pharmacy benefit managers, and industry executives are publicly arguing that the drug pricing provisions will lead to fewer cures. The implication is clear: Lower prices will mean a dent in revenues, which will discourage companies from developing certain drugs.“You can’t take hundreds of billions of dollars out of the pharmaceutical industry and not expect that it’s going to have a real impact on the industry’s ability to develop new treatments and cures for patients,” said Robert Zirkelbach, an executive vice president at PhRMA. He cited an analysis funded by the drugmaker Gilead Sciences that asserted the industry would lose $455 billion over seven years if companies negotiated with Medicare.A study released last month that was funded by the Biotechnology Innovation Organization, another trade group, warned that the pricing provisions would discourage innovation, resulting in as many as 139 fewer drug approvals over the next 10 years.But that assessment is at odds with an analysis by the Congressional Budget Office, which estimated that the law would result in only one fewer drug approval over a decade and about 13 fewer drugs over the next 30 years.President Biden and Democrats have long campaigned on lowering drug prices and plan to make it a central theme of their 2024 campaigns.Haiyun Jiang/The New York TimesIn addition, many new drugs “are not offering clinically meaningful benefit over existing drugs,” said Ameet Sarpatwari, an expert in pharmaceutical policy at Harvard Medical School. The Inflation Reduction Act, he said, might incentivize companies to focus more heavily on breakthrough therapies, instead of so-called me-too drugs, because the law requires the government to consider the clinical benefit of medications in determining the price Medicare will pay for them.Until now, Medicare has been explicitly barred from negotiating prices directly with drugmakers — a condition the industry demanded in exchange for supporting the creation of Part D, the Medicare prescription drug program, which was signed into law 20 years ago by President George W. Bush.Under the Inflation Reduction Act, the government will select an initial set of 10 drugs for price negotiations based on how much the Part D program spends on them. More drugs will be added in the coming years.Experts expect the initial list of drugs to include oft-prescribed medicines like the blood thinners Eliquis and Xarelto; cancer drugs like Imbruvica and Xtandi; Symbicort, which treats asthma and chronic obstructive disorder; and Enbrel, for rheumatoid arthritis and other autoimmune disorders.Medicare already pays discounted prices for those drugs. In 2021, the most recent year for which data is available, Medicare spent about $4,000 per patient for Eliquis and Xarelto, which at the time had sticker prices of $6,000 per year. The lower price reflects discounts extracted from drugmakers by pharmacy benefit managers negotiating on behalf of the private companies that contract with the government to manage Part D plans.But those negotiations are opaque and only modestly reduce Medicare’s spending. The rationale behind the Inflation Reduction Act’s drug pricing provisions is that because Medicare covers so many people, it can use its leverage to extract even deeper discounts.Merck sued the government in June over the drug pricing provisions. Three other drugmakers have also filed lawsuits: Bristol Myers Squibb, Astellas Pharma and Johnson & Johnson.Matt Rourke/Associated PressThe United States spends more per person on drugs than comparable nations, in part because other countries proactively control drug pricing. Surveys show that many Americans forego taking their medicines because they cannot afford them.Experts say the Medicare negotiation program is likely to translate into direct savings for seniors, initially in the form of reduced premiums made possible by reduced drug spending. And when lower prices take effect in 2028 for drugs administered in clinics and hospitals under another Medicare program, known as Part B, that could mean lower out-of-pocket costs for seniors covered by traditional Medicare who do not have supplemental insurance.Backers of the Inflation Reduction Act say that in addition to saving money for the government and patients, the negotiations will inject much-needed transparency into the complicated process of determining drug prices. If a company declines to negotiate, it must either pay a hefty excise tax or withdraw all of its drugs from both Medicare and Medicaid.“This is not a ‘negotiation,’” Merck said in its complaint. “It is tantamount to extortion.”Taken together, the lawsuits make a variety of constitutional arguments. In addition to the assertion that the government is violating the Fifth Amendment by unjustly taking property, they include claims that the law violates the First Amendment by compelling drug companies to agree in writing that they are negotiating a “fair price.” Another argument is that the excise tax amounts to an excessive fine that is prohibited by the Eighth Amendment.“If the government can impose price controls in this fashion on drug companies,” said Jennifer Dickey, a deputy chief counsel at the chamber’s legal arm, “it could do the same thing to any sector of our economy.”Biden administration officials say there is nothing compulsory about the law. They argue that the companies are free not to negotiate and that they can issue news releases or make other public statements disagreeing with the negotiated price. And they note that the government routinely negotiates for the purchase of other products and that the Department of Veterans Affairs already negotiates drug prices with pharmaceutical companies.“To me, Medicare is doing what it should do,” said Mr. Gostin, the Georgetown professor. “It’s a huge buyer of a product, and it’s basically using that clout, that bargaining power, to get the best price.”The drug industry “is throwing the kitchen sink at the government,” he added. “They’re looking for what sticks, and their arguments are directly targeted at the Supreme Court.”

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3 Dead After Listeria Outbreak in Washington State

Health officials said five cases of listeriosis in Puget Sound were probably caused by the same unidentified food source. All of those infected were older than 60.Health officials in Washington State said on Friday that three people had died and two had been hospitalized in the Puget Sound area after contracting food-borne listeria infections in what appeared to be an outbreak.Testing indicated that all five patients, three men and two women, became ill between Feb. 27 and June 30 and probably had the same source of infection, officials said, though an investigation had not yet identified a common food source.Each infected person was in their 60s or 70s and had a compromised immune system, officials said.Four of the cases were in Pierce County, and one was in Thurston County.The Washington State Department of Health said it was working with “local health jurisdictions to gather information from interviews with patients and their families to help identify any common exposures.”While it was still unclear where the cases originated, officials said the bacteria were commonly found in unheated cheeses and deli meats, unpasteurized dairy products, and premade deli salads, such as potato or tuna salads.Officials added that the microorganism would die at temperatures above 165 degrees Fahrenheit.Last year, a multistate listeria outbreak was linked to contaminated deli meat and cheeses. Other recent outbreaks have been caused by contaminated store-bought ice cream and leafy greens.The illness listeriosis, caused by the bacteria listeria, is of greatest threat to older adults, people with weakened immune systems and those who are pregnant.Listeriosis typically manifests within two weeks of consuming contaminated food and can cause flulike symptoms, according to the Centers for Disease Control and Prevention. In pregnant people, severe cases can lead to miscarriage and other complications.Washington State records 10 to 25 cases of the infection each year, according to the Tacoma-Pierce County Health Department.From 2009 to 2021, the latest year for which data is available, the state logged 18 listeria outbreaks that resulted in 238 hospitalizations and 47 deaths, according to the C.D.C.

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A Mystery in the E.R.? Ask Dr. Chatbot for a Diagnosis.

At a medical school in Boston, instructors are using ChatGPT in training exercises to help teach students how to think like doctors.The patient was a 39-year-old woman who had come to the emergency department at Beth Israel Deaconess Medical Center in Boston. Her left knee had been hurting for several days. The day before, she had a fever of 102 degrees. It was gone now, but she still had chills. And her knee was red and swollen.What was the diagnosis?On a recent steamy Friday, Dr. Megan Landon, a medical resident, posed this real case to a room full of medical students and residents. They were gathered to learn a skill that can be devilishly tricky to teach — how to think like a doctor.“Doctors are terrible at teaching other doctors how we think,” said Dr. Adam Rodman, an internist, a medical historian and an organizer of the event at Beth Israel Deaconess.But this time, they could call on an expert for help in reaching a diagnosis — GPT-4, the latest version of a chatbot released by the company OpenAI.Artificial intelligence is transforming many aspects of the practice of medicine, and some medical professionals are using these tools to help them with diagnosis. Doctors at Beth Israel Deaconess, a teaching hospital affiliated with Harvard Medical School, decided to explore how chatbots could be used — and misused — in training future doctors.Instructors like Dr. Rodman hope that medical students can turn to GPT-4 and other chatbots for something similar to what doctors call a curbside consult — when they pull a colleague aside and ask for an opinion about a difficult case. The idea is to use a chatbot in the same way that doctors turn to each other for suggestions and insights.For more than a century, doctor have been portrayed like detectives who gathers clues and use them to find the culprit. But experienced doctors actually use a different method — pattern recognition — to figure out what is wrong. In medicine, it’s called an illness script: signs, symptoms and test results that doctors put together to tell a coherent story based on similar cases they know about or have seen themselves.If the illness script doesn’t help, Dr. Rodman said, doctors turn to other strategies, like assigning probabilities to various diagnoses that might fit.Researchers have tried for more than half a century to design computer programs to make medical diagnoses, but nothing has really succeeded.Physicians say that GPT-4 is different. “It will create something that is remarkably similar to an illness script,” Dr. Rodman said. In that way, he added, “it is fundamentally different than a search engine.”Dr. Rodman and other doctors at Beth Israel Deaconess have asked GPT-4 for possible diagnoses in difficult cases. In a study released last month in the medical journal JAMA, they found that it did better than most doctors on weekly diagnostic challenges published in the New England Journal of Medicine.But, they learned, there is an art to using the program, and there are pitfalls.Dr. Christopher Smith, the director of the internal medicine residency program at the medical center, said that medical students and residents “are definitely using it.” But, he added, “whether they are learning anything is an open question.”The concern is that they might rely on A.I. to make diagnoses in the same way they would rely on a calculator on their phones to do a math problem. That, Dr. Smith said, is dangerous.Learning, he said, involves trying to figure things out: “That’s how we retain stuff. Part of learning is the struggle. If you outsource learning to GPT, that struggle is gone.”At the meeting, students and residents broke up into groups and tried to figure out what was wrong with the patient with the swollen knee. They then turned to GPT-4.The groups tried different approaches.One used GPT-4 to do an internet search, similar to the way one would use Google. The chatbot spat out a list of possible diagnoses, including trauma. But when the group members asked it to explain its reasoning, the bot was disappointing, explaining its choice by stating, “Trauma is a common cause of knee injury.”Another group thought of possible hypotheses and asked GPT-4 to check on them. The chatbot’s list lined up with that of the group: infections, including Lyme disease; arthritis, including gout, a type of arthritis that involves crystals in joints; and trauma.GPT-4 added rheumatoid arthritis to the top possibilities, though it was not high on the group’s list. Gout, instructors later told the group, was improbable for this patient because she was young and female. And rheumatoid arthritis could probably be ruled out because only one joint was inflamed, and for only a couple of days.As a curbside consult, GPT-4 seemed to pass the test or, at least, to agree with the students and residents. But in this exercise, it offered no insights, and no illness script.One reason might be that the students and residents used the bot more like a search engine than a curbside consult.To use the bot correctly, the instructors said, they would need to start by telling GPT-4 something like, “You are a doctor seeing a 39-year-old woman with knee pain.” Then, they would need to list her symptoms before asking for a diagnosis and following up with questions about the bot’s reasoning, the way they would with a medical colleague.That, the instructors said, is a way to exploit the power of GPT-4. But it is also crucial to recognize that chatbots can make mistakes and “hallucinate” — provide answers with no basis in fact. Using it requires knowing when it is incorrect.“It’s not wrong to use these tools,” said Dr. Byron Crowe, an internal medicine physician at the hospital. “You just have to use them in the right way.”He gave the group an analogy.“Pilots use GPS,” Dr. Crowe said. But, he added, airlines “have a very high standard for reliability.” In medicine, he said, using chatbots “is very tempting,” but the same high standards should apply.“It’s a great thought partner, but it doesn’t replace deep mental expertise,” he said.As the session ended, the instructors revealed the true reason for the patient’s swollen knee.It turned out to be a possibility that every group had considered, and that GPT-4 had proposed.She had Lyme disease.Olivia Allison contributed reporting.

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How Gilead Profited by Slow-Walking a Promising H.I.V. Therapy

Gilead delayed a new version of a drug, allowing it to extend the patent life of a blockbuster line of medications, internal documents show.In 2004, Gilead Sciences decided to stop pursuing a new H.I.V. drug. The public explanation was that it wasn’t sufficiently different from an existing treatment to warrant further development.In private, though, something else was at play. Gilead had devised a plan to delay the new drug’s release to maximize profits, even though executives had reason to believe it might turn out to be safer for patients, according to a trove of internal documents made public in litigation against the company.Gilead, one of the world’s largest drugmakers, appeared to be embracing a well-worn industry tactic: gaming the U.S. patent system to protect lucrative monopolies on best-selling drugs.At the time, Gilead already had a pair of blockbuster H.I.V. treatments, both of which were underpinned by a version of a drug called tenofovir. The first of those treatments was set to lose patent protection in 2017, at which point competitors would be free to introduce cheaper alternatives.The promising drug, then in the early stages of testing, was an updated version of tenofovir. Gilead executives knew it had the potential to be less toxic to patients’ kidneys and bones than the earlier iteration, according to internal memos unearthed by lawyers who are suing Gilead on behalf of patients.Despite those possible benefits, executives concluded that the new version risked competing with the company’s existing, patent-protected formulation. If they delayed the new product’s release until shortly before the existing patents expired, the company could substantially increase the period of time in which at least one of its H.I.V. treatments remained protected by patents.The “patent extension strategy,” as the Gilead documents repeatedly called it, would allow the company to keep prices high for its tenofovir-based drugs. Gilead could switch patients to its new drug just before cheap generics hit the market. By putting tenofovir on a path to remain a moneymaking juggernaut for decades, the strategy was potentially worth billions of dollars.Gilead ended up introducing a version of the new treatment in 2015, nearly a decade after it might have become available if the company had not paused development in 2004. Its patents now extend until at least 2031.The delayed release of the new treatment is now the subject of state and federal lawsuits in which some 26,000 patients who took Gilead’s older H.I.V. drugs claim that the company unnecessarily exposed them to kidney and bone problems.In court filings, Gilead’s lawyers said that the allegations were meritless. They denied that the company halted the drug’s development to increase profits. They cited a 2004 internal memo that estimated Gilead could increase its revenue by $1 billion over six years if it released the new version in 2008.“Had Gilead been motivated by profit alone, as plaintiffs contend, the logical decision would have been to expedite” the new version’s development, the lawyers wrote.Gilead’s top lawyer, Deborah Telman said in a statement that the company’s “research and development decisions have always been, and continue to be, guided by our focus on delivering safe and effective medicines for the people who prescribe and use them.”Descovy, one of Gilead’s newer H.I.V. products, has a sticker price of $26,000 annually.Rich Pedroncelli/Associated PressToday, a generation of expensive Gilead drugs containing the new iteration of tenofovir account for half of the market for H.I.V. treatment and prevention, according to IQVIA, an industry data provider. One widely used product, Descovy, has a sticker price of $26,000 annually. Generic versions of its predecessor, Truvada, whose patents have expired, now cost less than $400 a year.If Gilead had moved ahead with its development of the updated iteration of the drug back in 2004, its patents either would have expired by now or would soon do so.“We should all take a step back and ask: How did we allow this to happen?” said James Krellenstein, a longtime AIDS activist who has advised lawyers suing Gilead. He added, “This is what happens when a company intentionally delays the development of an H.I.V. drug for monopolistic purposes.”Gilead’s apparent maneuver with tenofovir is so common in the pharmaceutical industry that it has a name: product hopping. Companies ride out their monopoly on a medication and then, shortly before the arrival of generic competition, they switch — or “hop” — patients over to a more recently patented version of the drug to prolong the monopoly.The drug maker Merck, for example, is developing a version of its blockbuster cancer drug Keytruda that can be injected under the skin and is likely to extend the company’s revenue streams for years after the infused version of the drug faces its first competition from other companies in 2028. (Julie Cunningham, a spokeswoman for Merck, denied that it is engaged in product hopping and said the new version is “a novel innovation aimed at providing a greater level of convenience for patients and their families.”)Christopher Morten, an expert in pharmaceutical patent law at Columbia University, said the Gilead case shows how the U.S. patent system creates incentives for companies to decelerate innovation.“There’s something profoundly wrong that happened here,” said Mr. Morten, who provides pro bono legal services to an H.I.V. advocacy group that in 2019 unsuccessfully challenged Gilead’s efforts to extend the life of its patents. “The patent system actually encouraged Gilead to delay the development and launch of a new product.”David Swisher, who lives in Central Florida, is one of the plaintiffs suing Gilead in federal court. He took Truvada for 12 years, starting in 2004, and developed kidney disease and osteoporosis. Four years ago, when he was 62, he said, his doctor told him he had “the bones of a 90-year-old woman.”It was not until 2016, when Descovy was finally on the market, that Mr. Swisher switched off Truvada, which he believed was harming him. By that time, he said, he had grown too sick to work and had retired from his job as an airline operations manager.“I feel like that whole time was taken away from me,” he said.Gilead, one of the world’s largest drugmakers, faces state and federal lawsuits from some 26,000 patients who took the company’s older H.I.V. drugs.Mike Blake/ReutersFirst synthesized in the 1980s by researchers in what was then Czechoslovakia, tenofovir was the springboard for Gilead’s dominance in the market for treating and preventing H.I.V.In 2001, the Food and Drug Administration for the first time approved a product containing Gilead’s first iteration of tenofovir. Four more would follow. The drugs prevent the replication of H.I.V., the virus that causes AIDS.Those became game-changers in the fight against AIDS, credited with saving millions of lives worldwide. The drugs came to be used not only as a treatment but also as a prophylactic for those at risk of getting infected.But a small percentage of patients who were taking the drug to treat H.I.V. developed kidney and bone problems. It proved especially risky when combined with booster drugs to enhance its effectiveness — a practice that was once common but has since fallen out of favor. The World Health Organization and the U.S. National Institutes of Health discourage the use of the original version of tenofovir in people with brittle bones or kidney disease.The newer version doesn’t cause those problems, but it can cause weight gain and elevated cholesterol levels. For most people, experts say, the two tenofovir-based drugs — the first known as T.D.F., the second called T.A.F. — offer roughly equal risks and benefits.The internal company records from the early 2000s show that Gilead executives at times wrestled with whether to rush the new formulation to market. At some points, the documents cast the two iterations of tenofovir as similar from a safety standpoint.But other memos indicate that the company believed the updated formula was less toxic, based on studies in laboratories and on animals. Those studies showed that the newer formulation had two advantages that could reduce side effects. It was much better than the original at delivering tenofovir to its target cells, meaning that much less of it leaked into the bloodstream, where it could travel to kidneys and bones. And it could be given at a lower dose.The new version “may translate into a better side effect profile and less drug-related toxicity,” read an internal memo in 2002.That same year, the first human clinical trial of the newer version got underway. A Gilead employee mapped out a development timeline that would have brought the newer formulation to market in 2006.But in 2003, Gilead executives began to sour on rushing it forward. They worried that doing so would “ultimately cannibalize” the growing market for the older version of tenofovir, according to minutes from an internal meeting. Gilead’s head of research at the time, Norbert Bischofberger, instructed company analysts to explore the new formulation’s potential as an intellectual property “extension strategy,” according to a colleague’s email.That analysis resulted in a September 2003 memo that described how Gilead would develop the newer formulation to “replace” the original, with development “timed such that it is launched in 2015.” In a best-case scenario, company analysts calculated, their strategy would generate more than $1 billion in annual profits between 2018 and 2020.Gilead moved to resurrect the newer formulation in 2010, putting it on track for its 2015 release. John Milligan, Gilead’s president and future chief executive, told investors that it would be a “kinder, gentler version” of tenofovir.After winning regulatory approvals, the company embarked on a successful marketing campaign, aimed at doctors, that promoted its new iteration as safer for kidneys and bones than the original.By 2021, according to Ipsos, a market research firm, nearly half a million H.I.V. patients in the United States were taking Gilead products containing the new version of tenofovir.Susan C. Beachy

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Women losing babies in pregnancy promised better care in UK

Published17 minutes agoShareclose panelShare pageCopy linkAbout sharingImage source, Getty ImagesBy Smitha Mundasad & Tulip MazumdarHealth reporters Women who lose babies during pregnancy have been promised improved care, including better ways for remains to be collected and stored with dignity.The government will also introduce a voluntary certificate for parents who lose their baby before 24 weeks. The commitments come in response to an independent review of care in England.In the past, women have been told to retrieve baby-loss remains from toilets and store them in home fridges.As part of new measures focusing on women’s health, the NHS website will also be updated to include more content on hormone replacement therapy and to allow people to search for the local availability of in vitro fertilisation treatment (IVF).Officials acknowledged the work of BBC presenter Naga Munchetty and patient groups to raise awareness of the painful womb condition adenomyosis and said they would provide more information online.The separate independent Pregnancy Loss Review made 73 recommendations for improving care for people who experience baby loss before 24 weeks.There are around 500 miscarriages a day in the UK – defined as a loss of a pregnancy before 24 weeks. For many women this happens at home, with little support or pain relief. Image source, JessicaJessica Wharton, 28, an English tutor from Wythenshawe, had two early pregnancy losses last year.She says the lack of acknowledgement of her losses left her feeling heartbroken. She said: “Apart from us as a couple and our friends and family, no-one really acknowledged our loss. “When I asked the hospital for something to acknowledge them they said they couldn’t do that.”We felt the baby was part of us and we had tried for a long time. This was still our child.”She said her experiences would have been improved by staff being more empathetic, more available to listen to her and to tell her what to expect.”A year later it is still very raw. We are trying to take each day as it comes and hold them in our hearts.” While babies born after 24 weeks gestation are official recorded as stillbirths, there is currently no formal way to mark losses before this time.The government says a voluntary certificate would be made available from October, and while not a legal document, would help “provide comfort and help parents validate their loss”. Commitments include:Beginning to explore how women who have experienced baby loss can get 24/7 access to care and how those experiencing multiple miscarriages receive treatment and testing Developing and creating “a bespoke holder” to allow remains to be collected and stored with due dignity This video can not be playedTo play this video you need to enable JavaScript in your browser.The independent review said early loss was commonly viewed as a “clinical episode” with some healthcare professionals not taking individuals’ emotional and physical care seriously.Co-lead of the review, and baby loss charity founder, Zoe Clark-Coates, said: “I want to see people stopping having to hit Google to find out ‘what care should I be receiving, where should I be going for support’ – this support should be easily available to every single person.”Other recommendations in the review include:Education in schools on the symptoms of all types of baby loss and where to seek helpRoutine offers of mental health support for women and partnersSupport to understand why the loss occurred with appointments and advice for future pregnancies Private spaces in hospitals for patients experiencing baby lossFurther research on the increased risk for women from Black, Asian and ethnic minority backgrounds and people from more deprived areasMaria Caulfield, minister for women’s health, said: “We will keep working and investing so girls and women across the country can benefit from the world-class healthcare they deserve.” The BBC Action line has more details of organisations offering advice and support.More on this story’We had to put our baby’s remains in the fridge’Published30 May 2022Miscarriage: ‘I was in pain – they did not listen’Published8 February 2022Naga reveals womb disorder makes her scream in painPublished22 MayWoman who had eight miscarriages felt ignored at times. Video, 00:01:53Woman who had eight miscarriages felt ignored at timesPublished8 February 20221:53Related Internet LinksMiscarriage – NHS.websiteThe BBC is not responsible for the content of external sites.

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Revealing HIV drug-resistance mechanisms through protein structures

Salk Institute researchers, in collaboration with the National Institutes of Health, have discovered the molecular mechanisms by which the human immunodeficiency virus (HIV) becomes resistant to Dolutegravir, one of the most effective, clinically used antiviral drugs for treating HIV.
The new study, published July 21, 2023 in Science Advances, reveals how changes to the 3D structures of integrase, an HIV protein, can lead to Dolutegravir resistance and how other compounds may be able to overcome this resistance.
“With HIV, one must think two steps ahead of the virus,” says Salk Associate Professor Dmitry Lyumkis, co-senior author and the Hearst Foundation Developmental Chair. “We’ve now determined how the virus could continue evolving against drugs like Dolutegravir, which is important to consider for the development of future therapeutics.”
HIV infection depends on the ability of the virus to paste its own genetic material into the genomes of human cells, essentially hijacking the cells to become virus-producing factories. Dolutegravir and related drugs work by blocking integrase, a protein critical to the ability of the virus to integrate its own DNA into the host genome. Without functioning integrase, HIV can’t effectively infect human cells. However, HIV is a rapidly mutating virus, and an increasing number of HIV strains are resistant to Dolutegravir.
In the past, Lyumkis’ lab discovered the 3D structure of the integrase protein while attached to DNA as well as exactly how drugs like Dolutegravir bind to and block integrase. But researchers weren’t sure how the integrase structure changed when the virus stopped responding to Dolutegravir.
In the new study, Lyumkis and collaborators from the National Institutes of Health created versions of the integrase protein with mutations known to make HIV resistant to Dolutegravir. Then they determined the structure of each mutant integrase, revealing why Dolutegravir could no longer bind to and block each version of the protein. The scientists also evaluated the “fitness” of the virus (its capacity to produce infectious descendants) and the activity of the enzyme to better understand what leads to drug resistance in patients.
“We were quite surprised by the magnitude of resistance that these integrase variants had,” says Lyumkis. “The ability of Dolutegravir to function was completely compromised.”
The researchers also tested the efficacy of an experimental HIV drug, 4d, to block the function of Dolutegravir-resistant integrase proteins. 4d was developed by Lyumkis’ collaborators at the NIH as a next-generation integrase-targeting drug and is currently in pre-clinical animal trials. In all the variants, they discovered that 4d still potently blocked the ability of HIV to integrate its genes into human cells. This suggests that 4d or variants of this compound may be effectively used to treat the virus in patients who have developed resistance to Dolutegravir.

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How mother and infant sleep patterns interact during the first two years of life

New mothers can expect sleep deprivation in the first few years of baby’s life. But too little sleep can take a toll on the health of both mother and child. A new study from the University of Illinois Urbana-Champaign looks at maternal and infant sleep patterns, identifying predictors and providing recommendations for instilling healthy habits.
“The first two years is a really critical period where a lot of development is going on, and sleep is important for health. We wanted to look at the association of mother and infant sleep and whether it changes over time,” said Tianying Cai, now a postdoctoral researcher at Northwestern University. She worked on the research as a doctoral student in the Department of Human Development and Family Studies (HDFS), part of the College of Agricultural, Consumer and Environmental Sciences (ACES) at the U. of I.
“We identified two distinct groups, a low maternal sleep group where the mothers get 5 to 6 hours of sleep per night, and an average maternal sleep group, which meets the national recommended sleep guidelines with 7 to 8 hours per night. Children in the low maternal sleep group also slept less, although the difference wasn’t as large as for the mothers,” Cai stated.
The research team followed parents of 464 infants in the first two years of life. Mothers completed surveys about bedtime routines, their child’s sleep duration, nighttime waking, and sleep problems at 3, 12, 18, and 24 months of age.
The families were part of STRONG Kids 2, a program at the U. of I. that promotes nutrition and healthy habits in families with young children. STRONG Kids 2 co-directors Barbara Fiese, professor emerita of HDFS, and Sharon Donovan, professor of food science and human nutrition, also contributed to the study.
Mothers who fit the low maternal sleep profile got an average of 5.74 hours of sleep per night at 3 months and 5.9 hours at 12 to 24 months, while their children got 9.6 and 10.52 hours, respectively. In the average sleep profile, mothers got 7.31 hours at 3 months and 7.28 hours at 12 to 24 months, while child sleep averaged 9.99 hours at 3 months and 11 hours at 12 to 24 months.
The research team also identified factors that influence the amount of sleep a mother gets. Not surprisingly, one of the strongest predictors is infant-signaled nighttime waking, which means the infant is more likely to alert the parent at night. This could be either because these infants woke more frequently, or because the mothers were more likely to wake up when infants stirred, Cai noted.

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