Biden Promised to Follow the Science. But Sometimes, He Gets Ahead of the Experts.

White House officials dismiss criticism that President Biden’s comments on booster shots amount to undue pressure on public health experts.WASHINGTON — As he announced on Friday that booster shots would be available to some Americans, President Biden made a prediction: His administration was likely to soon provide third doses of the vaccine “across the board” to anyone who wanted one.“In the near term, we’re probably going to open this up,” he told reporters in remarks from the State Dining Room at the White House.But that assessment — a politically popular one in a country where most people vaccinated against the coronavirus say they are eager for a booster — was the latest example of how Mr. Biden and some of his team have been ahead of the nation’s top public health scientists, who have emphatically said in recent days that there is simply not enough evidence to suggest that boosters are necessary for the entire American population.In fact, two panels of scientists — one for the Food and Drug Administration and the other for the Centers for Disease Control and Prevention — voted in recent days against recommending boosters for everyone after fierce public debates streamed online.The president’s Friday remarks were the second time in two months that he had suggested boosters would be available to everyone. And they were issued on the same day that Dr. Rochelle P. Walensky, the C.D.C. director and one of the president’s political appointees, came under fire for allowing boosters for a broader group of people than her agency’s own immunization panel recommended.Taken together, the announcements by Mr. Biden and Dr. Walensky did not sit well with all of the scientists who advise them, raising questions about the president’s pledge to always “follow the science” as he fought the pandemic. While some of them credited the C.D.C. director for charting a course through uncertain waters, others warned that politics had intruded on scientific decisions — something that Mr. Biden had promised to avoid after the blatant pressures seen during the Trump administration.“Everybody uses this statement ‘follow the science’ very glibly, and I think that the science here did not warrant picking out a group of people and saying that you may be at more risk for acquiring an infection,” said Dr. Sarah S. Long, a member of the C.D.C.’s advisory committee, referring to the groups of workers who were made eligible for booster shots.Dr. Long, who is a professor of pediatrics at Drexel University College of Medicine, said that a president telegraphing his opinion before the formal public health process undermined the expert advisers, calling it a violation of the “checks and balances” built into the system. She also criticized Dr. Walensky for expanding the number of people eligible for the boosters.If that pattern of reversals were to extend beyond boosters, she said, that “would be the end of the vaccine program as you know it.”But a number of other committee members — including some who also resisted a broad expansion of the booster program — defended Dr. Walensky’s ruling, adding that federal regulators authorized additional shots less than 24 hours before the C.D.C.’s advisers were asked to give guidance. That left them little time to hammer out the language of their recommendations, much less to debate the type of issues that were weighing on Dr. Walensky, like staffing needs at hospitals or schools.“During a time when we have over 2,000 Americans dying per day, we’re not in a position to sit on our hands and wait,” said Dr. Camille Kotton, the clinical director of transplant and immunocompromised host infectious diseases at Massachusetts General Hospital. “We need to act as quickly and thoughtfully as we can.”Still, the C.D.C.’s medical advisers largely said on Friday that fresh attempts from the White House to get ahead of parts of the booster campaign undercut the sort of clarity that the public desperately needed.“I hope, despite the pandemic being a public health emergency, that we would have the space and the grace to be able to continue to use our process,” said Dr. Grace Lee, the immunization committee’s chairwoman and a professor of pediatrics at Stanford University School of Medicine.For the president to be subject to that kind of criticism is exactly where he promised he would never be.As a candidate, Mr. Biden repeatedly denounced President Donald J. Trump for pressuring scientists at the C.D.C. and the F.D.A. In March, after becoming president, Mr. Biden repeated what officials have said is his North Star on the pandemic during a visit to the C.D.C.’s headquarters in Atlanta.Dr. Rochelle Walensky, the C.D.C. director, overruled a panel of advisers and expanded the number of people eligible for booster shots.Scott Olson/Getty Images“There’s an entire generation coming up that is learning from what you’ve done,” he told employees there that day. “I don’t just mean learning about how to deal with a virus. Learning about it makes a difference to tell the truth, to follow the science, and just wherever it takes you, and just be honest about it.”White House officials insist that the president is doing just that, and they dismiss criticism that his comments about the additional doses amount to undue pressure on the government’s public health experts. They say that the discussion about boosters was initiated by the government’s top doctors and that he made it clear from the beginning that any decision by the administration would be subject to independent review and approval.And Mr. Biden has deferred far more to the public health experts than did Mr. Trump, who publicly and privately pushed F.D.A. and C.D.C. officials to act more quickly to approve vaccines and actively promoted unproven treatments for the coronavirus like hydroxychloroquine. The former president also clashed repeatedly with scientists about wearing masks and decisions about when to reopen schools, churches and other activities.But Mr. Biden’s public embrace of booster shots has rankled many in the public health sector, including those working inside the government, who say it could have the effect of putting undue pressure on scientists to make a recommendation they do not believe is supported by the evidence.Some public health officials and doctors say they fear Mr. Biden — who has staked his presidency on successfully managing the pandemic — is pushing for boosters because they are politically popular. A Reuters/Ipsos national survey conducted Aug. 27-30 found that 76 percent of Americans who have received at least one shot of a vaccine want a booster. Only 6 percent do not, the poll found..css-1xzcza9{list-style-type:disc;padding-inline-start:1em;}.css-3btd0c{font-family:nyt-franklin,helvetica,arial,sans-serif;font-size:1rem;line-height:1.375rem;color:#333;margin-bottom:0.78125rem;}@media (min-width:740px){.css-3btd0c{font-size:1.0625rem;line-height:1.5rem;margin-bottom:0.9375rem;}}.css-3btd0c strong{font-weight:600;}.css-3btd0c em{font-style:italic;}.css-w739ur{margin:0 auto 5px;font-family:nyt-franklin,helvetica,arial,sans-serif;font-weight:700;font-size:1.125rem;line-height:1.3125rem;color:#121212;}#NYT_BELOW_MAIN_CONTENT_REGION .css-w739ur{font-family:nyt-cheltenham,georgia,’times new roman’,times,serif;font-weight:700;font-size:1.375rem;line-height:1.625rem;}@media (min-width:740px){#NYT_BELOW_MAIN_CONTENT_REGION .css-w739ur{font-size:1.6875rem;line-height:1.875rem;}}@media (min-width:740px){.css-w739ur{font-size:1.25rem;line-height:1.4375rem;}}.css-9s9ecg{margin-bottom:15px;}.css-16ed7iq{width:100%;display:-webkit-box;display:-webkit-flex;display:-ms-flexbox;display:flex;-webkit-align-items:center;-webkit-box-align:center;-ms-flex-align:center;align-items:center;-webkit-box-pack:center;-webkit-justify-content:center;-ms-flex-pack:center;justify-content:center;padding:10px 0;background-color:white;}.css-pmm6ed{display:-webkit-box;display:-webkit-flex;display:-ms-flexbox;display:flex;-webkit-align-items:center;-webkit-box-align:center;-ms-flex-align:center;align-items:center;}.css-pmm6ed > :not(:first-child){margin-left:5px;}.css-5gimkt{font-family:nyt-franklin,helvetica,arial,sans-serif;font-size:0.8125rem;font-weight:700;-webkit-letter-spacing:0.03em;-moz-letter-spacing:0.03em;-ms-letter-spacing:0.03em;letter-spacing:0.03em;text-transform:uppercase;color:#333;}.css-5gimkt:after{content:’Collapse’;}.css-rdoyk0{-webkit-transition:all 0.5s ease;transition:all 0.5s ease;-webkit-transform:rotate(180deg);-ms-transform:rotate(180deg);transform:rotate(180deg);}.css-eb027h{max-height:5000px;-webkit-transition:max-height 0.5s ease;transition:max-height 0.5s ease;}.css-6mllg9{-webkit-transition:all 0.5s ease;transition:all 0.5s ease;position:relative;opacity:0;}.css-6mllg9:before{content:”;background-image:linear-gradient(180deg,transparent,#ffffff);background-image:-webkit-linear-gradient(270deg,rgba(255,255,255,0),#ffffff);height:80px;width:100%;position:absolute;bottom:0px;pointer-events:none;}.css-uf1ume{display:-webkit-box;display:-webkit-flex;display:-ms-flexbox;display:flex;-webkit-box-pack:justify;-webkit-justify-content:space-between;-ms-flex-pack:justify;justify-content:space-between;}.css-wxi1cx{display:-webkit-box;display:-webkit-flex;display:-ms-flexbox;display:flex;-webkit-flex-direction:column;-ms-flex-direction:column;flex-direction:column;-webkit-align-self:flex-end;-ms-flex-item-align:end;align-self:flex-end;}.css-12vbvwq{background-color:white;border:1px solid #e2e2e2;width:calc(100% – 40px);max-width:600px;margin:1.5rem auto 1.9rem;padding:15px;box-sizing:border-box;}@media (min-width:740px){.css-12vbvwq{padding:20px;width:100%;}}.css-12vbvwq:focus{outline:1px solid #e2e2e2;}#NYT_BELOW_MAIN_CONTENT_REGION .css-12vbvwq{border:none;padding:10px 0 0;border-top:2px solid #121212;}.css-12vbvwq[data-truncated] .css-rdoyk0{-webkit-transform:rotate(0deg);-ms-transform:rotate(0deg);transform:rotate(0deg);}.css-12vbvwq[data-truncated] .css-eb027h{max-height:300px;overflow:hidden;-webkit-transition:none;transition:none;}.css-12vbvwq[data-truncated] .css-5gimkt:after{content:’See more’;}.css-12vbvwq[data-truncated] .css-6mllg9{opacity:1;}.css-qjk116{margin:0 auto;overflow:hidden;}.css-qjk116 strong{font-weight:700;}.css-qjk116 em{font-style:italic;}.css-qjk116 a{color:#326891;-webkit-text-decoration:underline;text-decoration:underline;text-underline-offset:1px;-webkit-text-decoration-thickness:1px;text-decoration-thickness:1px;-webkit-text-decoration-color:#326891;text-decoration-color:#326891;}.css-qjk116 a:visited{color:#326891;-webkit-text-decoration-color:#326891;text-decoration-color:#326891;}.css-qjk116 a:hover{-webkit-text-decoration:none;text-decoration:none;}In mid-August, the president told the nation that his administration planned to deliver booster shots to everyone starting the week of Sept. 20, pending decisions by the F.D.A. and the C.D.C.“Just remember as a simple rule, eight months after your second shot, get a booster shot,” he said during remarks at the White House.That turned out to be premature. Only Pfizer, one vaccine maker, has won authorization to administer additional doses, and for just some of its recipients. On Wednesday, the F.D.A. authorized boosters, but only for older adults, people with underlying health conditions and some frontline workers who are frequently exposed to the virus.The agency’s decision stood in direct contrast to Mr. Biden’s earlier comments.Doctors were also split on Friday over the decision by Dr. Walensky to overrule her own panel of immunization experts.On Thursday, the panel voted to recommend boosters for older adults and those with underlying health issues. But it advised against allowing frontline workers like teachers and nurses who have already been vaccinated to get a booster shot.In a decision announced early Friday morning, Dr. Walensky rejected that last recommendation and said that the C.D.C. would allow the frontline workers to receive boosters. In a briefing for reporters later on Friday, she defended the move, noting that the panel was sharply divided on the issue.“Our teachers are facing uncertainty as they walk into the classroom, and I must do what I can to preserve the health across our nation,” Dr. Walensky said, calling it “a first step” and saying that “we will continue to review new data on effectiveness and experience with the third shot, as it becomes available.”Dr. Steven Joffe, a professor of medical ethics and health policy at the University of Pennsylvania, said that with such a close vote at the C.D.C.’s meeting, it was reasonable for Dr. Walensky to rule a different way. But he suggested that she could have been influenced by the support she and the administration had earlier shown for a broader distribution of the booster.“To what extent did she feel like she was bound to follow that line of decision-making?” he said. “I can’t get inside her head and answer that question. The fact that the final decision makers had already staked out their final positions had put the advisory committees in a very difficult position.”Jason L. Schwartz, an associate professor of health policy at the Yale School of Public Health, said that Dr. Walensky’s intervention “reflects just how closely and directly engaged the senior political appointees are in shaping this booster program.”He predicted her involvement was “going to color” the expert committee’s future work.Michael D. Shear

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A 3D-printed vaccine patch offers vaccination without a shot

Scientists at Stanford University and the University of North Carolina at Chapel Hill have created a 3D-printed vaccine patch that provides greater protection than a typical vaccine shot.
The trick is applying the vaccine patch directly to the skin, which is full of immune cells that vaccines target.
The resulting immune response from the vaccine patch was 10 times greater than vaccine delivered into an arm muscle with a needle jab, according to a study conducted in animals and published by the team of scientists in the Proceedings of the National Academy of Sciences.
Considered a breakthrough are the 3D-printed microneedles lined up on a polymer patch and barely long enough to reach the skin to deliver vaccine.
“In developing this technology, we hope to set the foundation for even more rapid global development of vaccines, at lower doses, in a pain- and anxiety-free manner,” said lead study author and entrepreneur in 3D print technology Joseph M. DeSimone, professor of translational medicine and chemical engineering at Stanford University and professor emeritus at UNC-Chapel Hill.
The ease and effectiveness of a vaccine patch sets the course for a new way to deliver vaccines that’s painless, less invasive than a shot with a needle and can be self-administered.

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Shrinking waveforms on electrocardiograms predict worsening health and death of hospitalized COVID-19 and influenza patients

Specific and dynamic changes on electrocardiograms (EKGs) of hospitalized patients with COVID-19 or influenza can help predict a timeframe for worsening health and death, according to a new Mount Sinai study. The work, published in the September 24 online issue of the American Journal of Cardiology, shows that shrinking waveforms on these tests can be used to help better identify high-risk patients and provide them more aggressive monitoring and treatment.
“Our study shows diminished waveforms on EKGs over the course of COVID-19 illness can be an important tool for health care workers caring for these patients, allowing them to catch rapid clinical changes over their hospital stay and intervene more quickly. With COVID-19 cases and hospitalizations continuing to rise again, EKGs may be helpful for hospitals to use when caring for these patients before their condition gets dramatically worse,” says senior author Joshua Lampert, MD, Cardiac Electrophysiology fellow at The Mount Sinai Hospital. “This is particularly useful in overwhelmed systems, as there is no wait for blood work to return and this test can be performed by the majority of health care personnel. Additionally, the EKG can be done at the time of other bedside patient care, eliminating the potential exposure of another health care worker to COVID-19.”
An EKG is a noninvasive test that records the electrical activity of the heart. It is widely used for diagnosing cardiovascular disease and arrhythmia, or abnormal heart rhythm. Small patches called electrodes are placed on the arms, legs, and chest, and connected by wires to a machine that turns the heart’s electrical signals into wavy lines.
Researchers did a retrospective analysis of EKGs on 140 patients hospitalized with COVID-19 across the Mount Sinai Health System in New York City between March 7 and April 12, 2020, and compared them with 281 EKGs from patients with laboratory-confirmed influenza A or influenza B admitted to The Mount Sinai Hospital between January 2, 2017, and January 5, 2020.
The researchers looked at three EKG time points for each patient: a baseline scan done within a year prior to COVID-19 or influenza hospitalization (and available in Mount Sinai’s records), a scan taken at hospital admission, and follow-up EKGs performed during hospitalization.
They manually measured QRS waveform height — a measure of the electrical activity of the ventricles, the major chambers of the heart — on all electrocardiograms; changes in this electrical activity could be a sign that the ventricles are failing. The researchers analyzed follow-up EKGs after hospital admission and analyzed changes in the waveforms according to a set of criteria they developed called LoQRS amplitude (LoQRS) to identify a shrinkage of the electrical signal on the EKG. LoQRS was defined by QRS amplitude measuring less than 5mm measured from the arms and legs or less than 10mm when measured on the chest wall as well as a relative reduction in waveform height in either location by at least 50 percent.
Fifty-two COVID-19 patients in the study did not survive, and the analysis shows 74 percent of those patients had LoQRS. Their EKG QRS waveforms became smaller roughly 5.3 days into their hospital admission and they died approximately two days after the first abnormal EKG was found.
Out of the 281 influenza patients studied, LoQRS was identified in 11 percent of them. Seventeen influenza patients died, and LoQRS was present in 39 percent of these cases. Influenza patients met LoQRS criteria a median of 55 days into their hospital admission, and the median time to death was six days from when LoQRS was identified. Overall, these results show influenza patients followed a less virulent course of illness when compared to COVID-19 patients.
“When it comes to caring for COVID-19 patients, our findings suggest it may be beneficial not only for health care providers to check an EKG when the patient first arrives at the hospital, but also follow-up EKGs during their hospital stay to assess for LoQRS, particularly if the patient has not made profound clinical progress. If LoQRS is present, the team may want to consider escalating medical therapy or transferring the patient to a highly monitored setting such as an intensive care unit (ICU) in anticipation of declining health,” adds Dr. Lampert.

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Unusual visual examination of objects may indicate later autism diagnosis in infants

Unusual visual inspection of objects by infants 9 months of age and older is predictive of a later diagnosis of autism spectrum disorder (ASD), a new UC Davis Health study has found.
Unusual visual inspection is defined as: looking out of the corners of the eyes, holding an object up very close to the face, looking at something with one eye closed, or staring at an object uninterrupted for more than 10 seconds.”Unusual visual inspection behavior has long been associated with autism but never yet as early as 9 months of age,” said Meghan Miller, associate professor in the Department of Psychiatry and Behavioral Sciences and UC Davis MIND Institute and the first author on the study.
The study, published in the Journal of Abnormal Psychology, also found that this behavior at 9 months predicted 12-month social behavior, but not vice versa.
“The findings support major theories of autism which hypothesize that infants’ over-focus on objects might be at the expense of their interest in people. Ultimately, this study suggests that unusual visual inspection of objects may precede development of the social symptoms characteristic of ASD,” Miller said.
Visual inspection, repetitive behavior and social engagement in children with autism
About 1 in 54 children in the U.S. has been identified with ASD. Younger siblings of children with autism are at an elevated risk of being diagnosed with autism, at a rate of approximately one in five.

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In a gene tied to growth, scientists see glimmers of human history

A new study delves into the evolution and function of the human growth hormone receptor gene, and asks what forces in humanity’s past may have driven changes to this vital piece of DNA.
The research shows, through multiple avenues, that a shortened version of the gene — a variant known as GHRd3 — may help people survive in situations where resources are scarce or unpredictable.
Findings will be published on Sept. 24 in Science Advances.
Here’s the story the study tells: GHRd3 emerged about 1-2 million years ago, and was likely the overwhelmingly predominant version of the gene in the ancestors of modern humans, as well as in Neanderthals and Denisovans.
Then, “In the last 50,000 years or so, this variant becomes less prevalent, and you have a massive decrease in the frequency of this variant among East Asian populations we studied, where we see the estimated allele frequency drop from 85% to 15% during the last 30,000 years,” says University at Buffalo evolutionary biologist Omer Gokcumen. “So the question becomes: Why? Was this variant favored in the past, and it fell out of evolutionary favor recently? Or is what we are observing just a blip among the complexity of genomes?”
The research provides new insights into the function of GHRd3 that may help explain why these evolutionary changes occurred, demonstrating that the variant may be useful in coping with nutritional stress.

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Schools With Mask Mandates Saw Fewer Outbreaks, C.D.C. Finds

School mask mandates have generated controversy in many parts of the country. Now, two studies, published on Friday by the Centers for Disease Control and Prevention, provide additional evidence that masks protect children from the coronavirus, even when community rates are high and the contagious Delta variant is circulating.One study, conducted in Arizona, where children returned to school in July, found that schools that did not require staff and students to wear masks were 3.5 times as likely to have a virus outbreak as schools that required universal masking.A second study looked at infections among all children in 520 different counties across the United States, and found that once the public school year started, pediatric cases increased at a far higher rate in counties where schools did not require masks.The first study analyzed data on about 1,000 public schools in Maricopa and Pima counties, which include the metropolitan areas of Phoenix and Tucson, and account for most of the state’s population.Only 21 percent of the schools implemented a universal mask mandate upon opening, and nearly half had no mask requirement at all. Another roughly 30 percent enacted a mask requirement about 15 days after school started.Between July 15 and Aug. 31, there were 191 school-associated virus outbreaks that occurred about a week after school started. The majority of them — 113 outbreaks, or nearly 60 percent of the total — occurred in schools with no mask requirement.Only 16 outbreaks, or 8 percent of the total, took place in schools that implemented mask requirements regardless of vaccination status from the start. There were 62 outbreaks, or about one-third of the total amount, in schools that implemented a mask requirement after the school year had already started.The study defined an outbreak as two or more positive confirmed cases of infection among staff or students within a 14-day period.“The school year starts very early in Arizona, in mid-July, so we had the advantage of being able to get an early look at data for the new school year a bit sooner than was possible for the rest of the country, which was important, because of the transmission of the Delta variant,” said J. Mac McCullough, associate professor at Arizona State University and a co-author of the study.The C.D.C. recommends a layered approach to preventing coronavirus outbreaks in schools — masking, distancing, staying home when sick and vaccination for those eligible. “This study really shines a lens on the masking part of that,” Dr. McCullough said.The second study looked at the association between school mask policies in a given county and communitywide infections among children, finding that counties with no school mask requirement experienced a larger uptick in pediatric case rates after the start of school than counties with school mask requirements.Between the week before school started and the second week of school, the number of pediatric infections increased by 35 cases per 100,000 in counties without mask requirements, while the number increased by 16 cases per 100,000 population in counties with school mask requirements.

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CBD trial to treat hallucinations in Parkinson’s disease

Researchers across the UK are trialling a range of cannabis extracts to treat conditions from pain and asthma to brain cancer.Charles Ogilvie-Forbes is taking part in a study at King’s College Hospital, London, using CBD to treat the hallucinations he experiences due to his Parkinson’s disease.Filming and graphics: Julius PeacockEdited: Rachael Buchanan

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Linda Evangelista Says Body-Sculpting Procedure Left Her ‘Disfigured’

The ’90s-era supermodel said side effects from a fat-freezing procedure caused her to become depressed and turned her into a recluse after “not looking like myself any longer.”Linda Evangelista, the supermodel made famous in the 1990s, said she had become “brutally disfigured” and “unrecognizable” after a cosmetic body-sculpting procedure that had turned her into a recluse.In an Instagram post on Wednesday, she referred to filing a lawsuit, saying that she was taking “a big step towards righting a wrong that I have suffered and have kept to myself for over five years.”She added: “To my followers who have wondered why I have not been working while my peers’ careers have been thriving, the reason is that I was brutally disfigured by Zeltiq’s CoolSculpting procedure which did the opposite of what it promised.”Ms. Evangelista, 56, said that after the fat-freezing procedure she developed paradoxical adipose hyperplasia, a side effect in which patients develop firm tissue masses in the treatment areas.She said the cosmetic procedure left her “permanently deformed even after undergoing two painful, unsuccessful, corrective surgeries.” She said she had not been told of the risk.“PAH has not only destroyed my livelihood, it has sent me into a cycle of deep depression, profound sadness, and the lowest depths of self-loathing,” she wrote. “In the process, I have become a recluse.”Ms. Evangelista, who was known as one of the five top supermodels in the 1990s, detailed her story on Instagram, where she has 912,000 followers and where thousands of people commented or expressed support. Her story was also widely covered in international and national media outlets.Ms. Evangelista filed a lawsuit on Tuesday against Zeltiq Aesthetics Inc., in the U.S. District Court for the Southern District of New York. The suit said she was seeking compensatory damages of $50 million for her distress and loss of work, promotions and public appearances.Representatives for the company did not immediately respond to requests for comment on Thursday. A lawyer for Ms. Evangelista was not immediately available for comment.The lawsuit said Ms. Evangelista had seven treatments from August 2015 through February 2016 to break down fat cells in her abdomen, flanks, back and bra area, inner thighs, and chin. Within a few months, she developed “hard, bulging, painful masses under her skin in those areas,” it said, and was given a diagnosis of PAH in June 2016.The filing said her quality of life, her career and her body “were all ruined in 2016 after she was permanently disfigured” by the procedure and the multiple attempts at corrective surgery that followed.“Ms. Evangelista enjoyed a wildly successful and lucrative modeling career from 1984 through 2016, until she was permanently injured and disfigured by Zeltiq’s CoolSculpting System,” the lawsuit said.The suit accused the company of having “intentionally concealed” the risks or “failed to adequately warn” about them, and said Ms. Evangelista developed depression and a fear of going outside.Ms. Evangelista had full body liposuctions after the diagnosis by a doctor referred to her by Zeltiq in 2016 and 2017, but the procedures were unsuccessful and resulted in scarring, the lawsuit said.“Ms. Evangelista was promised a more contoured appearance; instead, the target fat cells actually increased in number and size and formed hard, bulging masses under her skin,” it said.According to CoolSculpting, its procedure has been cleared by the Food and Drug Administration for the treatment of visible fat bulges.In response to questions, the F.D.A. said in an email that it could not comment on litigation, but that it was “committed to ensuring medical devices are safe and effective and that patients can be fully informed when making personal health decisions.” It said that it monitors reports from consumers of adverse events after a device reaches the market and would “take action where appropriate.”Cryolipolysis, the name of the nonsurgical fat-freezing procedure, uses cold temperature to break down fat cells, according to the American Society of Plastic Surgeons.It is mostly used by patients who want to reduce a specific fat bulge that they have been unable to diminish through other means. Generally, the area of concern is “vacuumed” into the hollow of an applicator, where it is subjected to cold temperature.The surgeons’ society said the complication rate was low, with less than 1 percent of patients who may develop paradoxical fat hyperplasia, which is an unexpected increase in the number of fat cells. The side effect is more common in men than in women, the society said.Ms. Evangelista also said that the public scrutiny of her appearance had harmed her emotionally. “I have been left, as the media has described, ‘unrecognizable,’” she said.Jonah E. Bromwich

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Comedians Turn Their Attention to Abortion

Alison Leiby has an hourlong set looking at the experience of an unwanted pregnancy. She’s among a spate of female artists finding humor in the issue.A stand-up show about abortion sounds like a bad idea. The comic Alison Leiby knows that. Just look at her title: “Oh God, an Hour About Abortion.”Leiby doesn’t just anticipate your expectations. She subverts them. As states like Texas pass laws dramatically restricting abortion rights, and the Supreme Court prepares to hear a case in December that could overturn Roe v. Wade, her deftly funny, jarringly understated show doesn’t respond to the news so much as clarify it.Abortion is not new territory in comedy, and there’s a long history of male comics doing against-the-grain bits staking out an abortion-rights position while also poking fun at the idea that a fetus isn’t a person. I saw this done decades ago by George Carlin, and again this month by Bill Burr. Neal Brennan also has a quick joke in his current show, “Unacceptable,” about how liberals show empathy for everyone — but fetuses. Leiby is part of a recent spate of female artists making comedy about reproductive rights that digs into the realities of abortion today more than abstract arguments about it.Leiby, who has been performing her show around New York City (next up: Caveat on Tuesday), employs none of the debating-society smirk of those jokes about the life of the fetus. Without a trace of didacticism, she finds humor in the messy, confusing, sometimes banal experience of an unwanted pregnancy and an abortion. This is comedy about the heartbeat of the mother — and to the extent it engages with the abstract question of life, it’s when Leiby mentions her friends’ first Instagram post of their newborn, which, she says, “I think we can all agree is when life really begins.”Her offhandedness is part of her charm, but it has a purpose. Leiby wants to give us a portrait of abortion not as a crisis or a moral question, but as a common and confusing medical procedure. The broader context of this show, as she reminds the audience, is a culture of silence surrounding women. From sex education to birth control, she explains how much is unspoken, rushed through or hidden from view. Leiby even shocked herself when she called Planned Parenthood, she says, and in asking about an abortion, whispered the word. She mocks the vague ads for birth control and imagines an honest one in which a 37-year-old woman wakes up in a cold sweat screaming next to a mediocre white man, which leads to a scene of him eating Cheetos in a hospital room as she gives birth.Leiby doesn’t move much onstage, and her gestures are limited. Her comedy leans on her nimble writing, which displays a range and density of spiky jokes — puns, metaphors, misdirection. She knows how to set a scene and is alert to the details of nightmares. She is terrified of scary movies and has a ticklishly amusing podcast, “Ruined,” in which a friend, Halle Kiefer, explains the plots of horror films to her. It’s like listening to a play-by-play announcer and color commentator of a game on the radio, except instead of balls or strikes, it’s about beheadings and exorcisms.What comes across on the podcast and in this show is a sensitivity to anxiety and fear mitigated by curiosity. Leiby understands that whether to have a child is a subject fraught with confusion for many, and she acknowledges it, but that’s not her issue. She presents herself as a wry if bumbling protagonist of her own story, describing her attitude toward the prospect of children like this: “I acted like my eggs were Fabergé: feminine but decorative.”In 2004, The New York Times published an article about culture and abortion titled “Television’s Most Persistent Taboo.” That has changed. In a short set on “The Comedy Lineup,” on Netflix, the comic Kate Willett has a sharp joke about how men looking to hook up should care about abortion rights. “I don’t even know if the men that I know understand that sex can make a kid,” she said. “They are super worried that sex can make someone your girlfriend.”In the past year, streaming services have put out two comedies, “Plan B” (directed by Natalie Morales) and “Unpregnant” (directed by Rachel Lee Goldenberg), about girls who go on the road with a friend to get reproductive help. These knockabout buddy films aren’t explicitly about the recent state-level pushes for anti-abortion legislation, but they certainly haunt the action, with closed clinics and ideologues providing key plot points.Like Leiby’s show, these movies present getting an abortion or taking the morning-after pill, often called Plan B, as ordinary decisions made relatively easily, but because of the dictates of a commercial comedy, their plots are full of incident and action, romantic and villainous turns. They make the process of getting an abortion into a high-stakes adventure.Haley Lu Richardson, left, and Barbie Ferreira in “Unpregnant.”Ursula Coyote/HBO MaxVictoria Moroles, left, and Kuhoo Verma in “Plan B.”Brett Roedel/HuluIn observational comedy, Leiby has found a form better suited to what she wants to say. “Oh God” is about details, and by zeroing in on them, it navigates the difficult terrain of making a funny hour about a difficult, polarizing subject. Even so, this isn’t one of those comedy shows interrupted by grave talk or political speeches. It’s one where the response to the person at the clinic asking if she wants “pills or procedure” is: “That’s a real fries or salad.”There’s a power in the relatable details of storytelling. Before Leiby gets the procedure, she’s asked a series of questions: Does she want to know if there’s a heartbeat? Does she want to know if it’s twins? In her telling, these are poignant, even painful moments leavened by quips. To the question about twins, she wonders: “Does it cost more?”Leiby proves that light comedy can be as pointed and meaningful as that which advertises its own weightiness. For while she tells a story about a safe, legal and quick abortion, she doesn’t ignore other more fraught situations, either today or in a potential post-Roe future. She explores this indirectly through her relationship with her mother, which gives her an opportunity to dig into the issue before abortion was legal. Through this historical perspective, she frames the stakes of the next year, when abortion could grow even more prominent in the American discourse.Political stand-up typically lends itself to argumentative point-making, but it can use other tools. In repositioning abortion not as a political battle of ideas but as the real-world choices in the lives of flawed human beings, she brings this charged issue down to earth.

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