Tag: government bodies and offices

Concerned about the courts, some states and universities are stockpiling abortion drugs | CNN

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CNN
 — 

With an eye on the courts, a growing number of Democratic-led states are stockpiling the pills that can be used for a medication abortion, the most common form of the procedure in the US.

The officials want to be prepared, in case US District Judge Matthew Kacsmaryk’s decision to suspend the US Food and Drug Administration’s approval of mifepristone goes through, so medication abortions would still be available in their states for some period of time. But they’re taking different approaches to the idea.

New York Gov. Kathy Hochul announced Tuesday that her state’s Department of Health would buy 150,000 doses of misoprostol, the other of the two drugs typically used in a medication abortion.

Misoprostol can be used off-label for an abortion, without mifepristone, but patients often have to use more of it. It would not be covered by the court case, and if Kacsmaryk’s decision stands, the New York City’s Health Department tweeted, it will change to using this medication only.

“Medication abortion continues to be available at our Sexual Health Clinics and NYC Health + Hospitals locations. Should mifepristone become unavailable, we will continue to make medication abortion accessible to all in NYC by shifting to a misoprostol-only treatment regimen,” the tweet said.

The state says the 150,000 doses should represent a five-year supply of pills.

“Anti-choice extremists have shown that they are not stopping at overturning Roe, and they are working to entirely dismantle our country’s reproductive health care system, including medication abortion and contraception,” Hochul said. “New York will always be a safe harbor for abortion care, and I am taking action to protect abortion access in our State and continue to lead the nation in defending the right to reproductive autonomy.”

California is also stocking up on misoprostol.

“While California still believes Mifepristone is central to the preferred regimen for medication abortion, the State negotiated and purchased an emergency stockpile of Misoprostol in anticipation of Friday’s ruling by far-right federal judge Matthew Kacsmaryk to ensure that California remains a safe haven for safe, affordable, and accessible reproductive care,” Gov. Gavin Newsom’s office said in a release Monday.

California plans to purchase up to 2 million pills through CalRx, a state initiative set up to make drugs more affordable.

The governor’s office said the state now has more than 250,000 pills on hand, which it purchased for about $100,000.

California said it shared the terms of its purchase agreement with other members of the Reproductive Freedom Alliance, a nonpartisan coalition of 21 governors who are committed to protecting reproductive rights, and who might also be interested in taking such action.

Another member of that alliance, Washington Gov. Jay Inslee, announced last week that his state bought a three year-supply of mifepristone, the drug at the center of Kacsmaryk’s ruling.

Inslee directed the state Department of Corrections – which has a pharmacy license and is legally able to buy medications – to buy the drug last month, he said, and the shipment was delivered March 31. The University of Washington also purchased 10,000 doses.

Lawmakers are introducing a bill to authorize officials to distribute or sell the medication to licensed providers throughout the state.

“This Texas lawsuit is a clear and present danger to patients and providers all across the country. Washington will not sit by idly and risk the devastating consequences of inaction,” Inslee said. “Washington is a pro-choice state, and no Texas judge will order us otherwise.”

In the meantime, its attorney general, Bob Ferguson, is helping lead a multistate lawsuit to protect access to mifepristone.

On Friday, the same day Kacsmaryk’s ruling came down, a federal judge in Washington ordered the US not to make any changes that would restrict access to mifepristone in the territories that brought the lawsuit: 17 states and the District of Columbia.

On Monday, Massachusetts Gov. Maura T. Healey announced that at her request, the University of Massachusetts and health care providers have also taken action to stockpile doses of mifepristone.

The governor’s office said last week that the university bought about 15,000 doses of mifepristone, enough to cover the commonwealth for about a year, and the pills are expected to arrive this week. Local health care providers have agreed to buy more, and the government agreed to set aside $1 million to pay for those doses.

The Massachusetts governor also signed an executive order confirming protections for medication abortion under existing law.

“Here in Massachusetts, we are not going to let one extremist judge in Texas turn back the clock on this proven medication and restrict access to care in our state,” Healey said. “The action we are taking today protects access to mifepristone in Massachusetts and protects patients and providers from liability. In Massachusetts, we stand for civil rights and freedom. We will always protect access to reproductive health care, including medication abortion.”

Danco Laboratories, the manufacturer of the brand-name version of mifepristone, says that orders for the drug have increased substantially in recent months and are significantly higher than they were at this time last year.

Demand for mifepristone is up across all types of customers, including clinics, pharmacies and individual providers, said Abby Long, Danco’s director of public affairs. But Massachusetts is the only state that has requested an especially large number of pills from the company.

Maine Gov. Janet Mills, who called the Texas decision “reckless” and a “fundamental assault on women’s rights,” said Monday that her administration is evaluating its options, “including procuring mifepristone if needed, to protect access to medication abortion for Maine women.”

The Connecticut governor’s office said Wednesday that it is also monitoring the situation.

Oregon Gov. Tina Kotek’s office said in an email Wednesday that she has directed the Oregon Health Authority to “explore all available avenues for ensuring Oregon is prepared should Mifepristone become less available. That includes evaluating the supply of Mifepristone and Misoprostol and consulting with providers to better understand the potential impact on the provision of abortion and reproductive health care and what additional support might be necessary.”



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Up to 20,000 people who attended a religious gathering may have been exposed to measles. What should they do next? | CNN

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CNN
 — 

Up to 20,000 people who attended a religious gathering at a college in Wilmore, Kentucky, in February could have been exposed to a person later diagnosed with measles.

On Friday, the US Centers for Disease Control and Prevention issued an alert to clinicians and public health officials about the confirmed case of measles in an individual present at the gathering who had not been vaccinated against the disease.

“If you attended the Asbury University gathering on February 17 or 18 and you are unvaccinated or not fully vaccinated against measles, you should quarantine for 21 days after your last exposure and monitor yourself for symptoms of measles so that you do not spread measles to others,” according to the CDC advisory.

The CDC also recommended that people who are unvaccinated receive the measles, mumps, and rubella (MMR) vaccine.

Reading this news, people may have questions about measles, including its symptoms, infection outcomes and who is most at risk. They may also want to know what makes measles so contagious, what has been the cause of recent outbreaks and how effective the MMR vaccine is.

To help answer these questions, I spoke with CNN Medical Analyst Dr. Leana Wen, an emergency physician and professor of health policy and management at the George Washington University Milken Institute School of Public Health. Previously, she served as Baltimore’s health commissioner, where her duties included overseeing the city’s immunization and infectious disease investigations.

CNN: What is measles, and what are the symptoms?

Dr. Leana Wen: Measles is an extremely contagious illness that’s caused by the measles virus. Despite many public health advances, including the development of the MMR vaccine, it remains a major cause of death among children globally.

The measles virus is transmitted via droplets from the nose, mouth or throat of infected individuals. If someone is infected and coughs or sneezes, droplets can land on you and infect you. These droplets can land on surfaces, and if you touch the surface and then touch your nose or mouth, that could infect you, too.

Symptoms usually appear 10 to 12 days after infection. They include a high fever, runny nose, conjunctivitis (pink eye) and small, painless white spots on the inside of the mouth. A few days after these symptoms begin, many individuals develop a characteristic rash — flat red spots that generally start on the face and then spread downward over the neck, trunk, arms, legs and feet. The spots can become joined together as they spread and can be accompanied by a high fever.

A nurse gives a woman a measles, mumps and rubella virus vaccin at the Utah County Health Department on April 29, 2019 in Provo, Utah.

CNN: What are outcomes of measles infections? Who is most at risk?

Wen: Many individuals recover without incident. Others, however, can develop severe complications.

One in five unvaccinated people with measles are hospitalized, according to the CDC. As many as 1 out of every 20 children with measles will get pneumonia; about 1 in 1,000 who get measles can develop encephalitis, a swelling of the brain that can lead to seizures and leave the child with lasting disabilities. And nearly 1 to 3 out of every 1,000 children who are infected with measles will die.

Measles is not only a concern for children. It can also cause premature births in pregnant women who contract it. Immunocompromised people, such as cancer patients and those infected with HIV, are also at increased risk.

CNN: What makes measles so contagious?

Wen: Measles is one of the most contagious diseases in the world — up to 90% of the unvaccinated people who come into contact with a contagious individual will also become infected. The measles virus can remain in the air for up to two hours after an infected person leaves an area.

Another reason why measles spreads so easily is its long incubation period. In infected people, the time from exposure to fever is an average of about 10 days, and from exposure to rash onset is about 14 days — but could be up to 21 days. In addition, infected people are contagious from four days before rash starts through four days after. That’s a long period of time where they could unknowingly infect others.

CNN: What has been the cause of recent measles outbreaks?

Wen: It’s important to note that this incident in Kentucky is not yet considered an outbreak. Only one person has been diagnosed with measles. That person was possibly exposed to many others given the number of people in attendance at this gathering, but we don’t know yet if any of those people were infected.

But let’s look at a recent example of a confirmed outbreak in the US: In November 2022, health officials in central Ohio raised alarm over young children being diagnosed with measles. In all, 85 children got sick. None of the children died, but 36 needed to be hospitalized. All those infected were either unvaccinated or not yet fully vaccinated.

Health officials were able to contain the outbreak through contact tracing, vaccination and other public health measures in early February, and it was declared over. But there is concern it won’t be the last of its kind. A study from the CDC reported the rate of immunizations for required vaccines among kindergarten students nationwide dropped from 95% in the 2019-20 school year to 93% in the 2021-22 school year. Some communities have far lower rates than this national average, however, which can lead to outbreaks — not only of measles but also diseases like polio that can also have severe consequences.

CNN: How effective is the MMR vaccine?

Wen: The MMR vaccine is a two-dose vaccine. The recommendation is for children to receive the first dose at age 12-15 months and the second dose at age 4-6 years. One dose of the MMR vaccine 93% effective at preventing measles infection. Two doses are 97% effective.

CNN: What is the best way to protect against measles?

Wen: The MMR vaccine is an extremely safe and very effective vaccine and is recognized as a significant public health advance for preventing an otherwise extremely contagious disease from spreading and causing potentially very severe — even fatal — outcomes.

Consider that the vaccine was licensed in the US in 1963. In the four years before that, there were an average of more than 500,000 cases of measles every year and over 430 measles-associated deaths. By 1998, there were just 89 cases and no measles-associated deaths. That’s a huge public health triumph.

Young children should receive the vaccine according to the recommended schedule. Older kids and adults who never received it should also discuss getting it with their health care provider. And clinicians and public health officials in the US and around the world should redouble efforts to increase routine childhood immunizations so as to stop preventable diseases from making a comeback.

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Ohio, Pennsylvania offer health services following train derailment, but some residents feel skeptical | CNN

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Darlington Township, Pennsylvania
CNN
 — 

The municipal building in tiny Darlington Township, Pennsylvania, was buzzing with activity on Wednesday afternoon as a stream of locals arrived seeking information on health screenings, chemical exposures and well testing.

Darlington, home to about 1,800 people, sits just over the border from East Palestine, Ohio, the site of a catastrophic train derailment and controlled burn of toxic chemicals that sent black smoke billowing over the area for days in early February. Residents here say the wind blew acrid smoke into their homes and coated their cars with a fine ash. State and federal officials gave East Palestine residents the all-clear to return to their homes days later.

But residents in both places are now wondering whether their water is safe to drink and their air safe to breathe. The characteristic floral, fruity odor of butyl acrylate still permeates some homes and wafts up from some of the impacted streams that run through the town. Some say they’re experiencing symptoms – cough, headaches, rashes, watering eyes and dripping noses – that might be related to a chemical exposure.

Government-run community resource centers and health clinics have opened in East Palestine and Darlington to answer residents’ questions and connect them to any care they might need. More than 140 people have come to the clinic in East Palestine since it first opened on February 21, according to the Ohio Department of Health. The Darlington center opened February 28, and more than 200 people visited in its first two days, according to the Pennsylvania Department of Health.

Still, some residents are skeptical of the clinics, and the response overall. While many residents who live near the derailment site are following the testing for chemicals in the air and water, what they really want to know is whether they’ve had chemicals from the accident in their bodies, and whether those chemicals have impacted their health.

They’re swapping information online, and seeking out blood tests they hope will identify potential problems. Some are seeking out medical care so there’s a record of their symptoms.

On the advice of a lawyer, Ron Book and his wife came to the East Palestine Health Assessment Clinic on Wednesday afternoon to have their illnesses documented. Book says since the derailment, his nose has been running constantly. He has a sore throat, and he feels stuffy.

“It’s like I have a cold, but I don’t have a cold,” he said.

Book said he saw a doctor who took his vitals and advised him to keep up with the regular blood work that he needs for his ongoing treatment for prostate cancer. He was inside for about 45 minutes, and said the experience was helpful, and about what he expected.

“They can’t heal you,” Book says, “because nobody knows about this chemical.”

At the Darlington center, tables were staffed with experts to answer questions about the chemicals involved in the train derailment, free well and air testing for residents, and potential impacts to area farms.

There were pamphlets on how to manage stress following a disaster and mental health counselors, as well as Zuko, a 3-year-old Great Dane therapy dog.

Residents are also invited to take a nine-page questionnaire to contribute data to a newly launched Assessment of Chemical Exposure, or ACE, study, which is being conducted by the federal Agency for Toxic Substances and Disease Registry. Health investigators can use their data to inform a study into the health effects associated with the chemical exposures after the derailment.

People could see a doctor, or get referrals for a primary care physician.

“I think approximately 40% of people sought some sort of clinical evaluation,” said Nate Wardle, who is the special response project manager for the Pennsylvania Department of Health.

Wardle said when they opened the clinic, they weren’t sure what to expect – whether residents would be angry that it took more than three weeks to get them these services. So far, he said, people have been grateful and eager to get the help.

Jim Denes, who is 71, came to the health clinic in Darlington Township on Wednesday. He said he lives less than 2 miles from the accident site. On Friday of last week, Denes said he felt awful.

“I was just miserable. I was trying to cough up stuff, I couldn’t,” Denes said. “My eyes were all runny and watery.”

He said he took a Covid-19 test, but it was negative.

Denes said he’s extremely tired and had to drag himself to the clinic, but he’s glad he did. The doctor he saw diagnosed him with bronchitis and prescribed an antibiotic. The clinic was a lot closer than his regular doctor in Ellwood City, and he was able to walk in and be seen without a wait.

Denes said the doctor told him he couldn’t say whether it was related to the chemicals that were spilled or not.

Some residents said they have no interest in going to government-run health clinics.

“I honestly, at this point, don’t know who’s working with who and I really just don’t trust anything that has to do with the government right now,” said Giovanni Irizarry, whose family lives within a mile of the train derailment site.

In the evening hours of February 3, his wife Ashley Irizarry was driving to work when she noticed she could see thick black smoke hanging in the air, even though it was dark. Eventually, she saw the raging fire along the railroad tracks.

That night, Ashley had a red rash on her cheeks, her eyes were burning and red and a metallic chemical smell had burned her nose and throat. On Saturday, Giovanni said, his lips burned like he’d had scalding hot soup. Giovanni’s mother, who was living with them, developed a cough so severe she couldn’t catch her breath. The Irizarrys evacuated on Sunday to Boardman, Ohio, about 15 miles away.

They returned home on Saturday, February 11, in anticipation of school restarting on Monday.

As soon as they got close to town, Giovanni said, “I immediately felt my lips like start that burning sensation.”

He and his mom started coughing. His wife and kids developed debilitating and unrelenting headaches. After the kids came home from school on Monday, both started vomiting.

Ashley says she has taken the family to their primary care doctor, an urgent care and the hospital.

“It was not getting better,” she said.

Medical records reviewed by CNN show Ashley was prescribed a steroid and given a chest X-ray due to “toxic effects of gas exposure.” Her son was also diagnosed with chemical exposure.

When the doctors looked into her nose and throat they told her ” ‘Your mucous membranes are all pale. Like they were burned,’ but they didn’t know what to do at this time,” Ashley said in an interview with CNN on Wednesday.

On public Facebook groups, residents are sharing names of providers who will order blood testing for chemical exposures, which isn’t something either of the government-run clinics is doing currently. Some have even tried to do their own research to try to identify the medical codes needed to order tests for specific chemicals in the blood from large labs.

Instead of going to the government health clinic, on Wednesday, Ashley went to see their chiropractor, Richard Tsai, who has been ordering certain blood tests for existing patients who think they have having health problems connected to chemical exposures from the derailment.

Tsai’s practice, Blackhawk Chiropractic, is right next door to the Darlington Township community resource center and clinic that was opened by the Pennsylvania Department of Health and other state agencies this week.

The tests Tsai orders are general and standard in medical care – a test called a complete blood count, which measures levels of red cells, white cells, and clotting factors in the blood; and a test called a basic metabolic panel, which measures blood sugar, electrolytes, and kidney function. If his patients ask for it, he also orders a more specialized test that measure exposure to the chemical benzene. In the past two days, he estimates about 15 patients have asked him for blood testing.

Tsai, who lives in East Palestine, says he’s been frustrated by the government’s response.

“We shouldn’t be having to do this,” Tsai said, in an interview with CNN on Wednesday.

“Why are people having to figure this out on Facebook? These people need to know where to go and what’s available.”

Dr. Bruce Vanderhoff, director of the Ohio Department of Health, pushed back against the idea that the government wasn’t giving people enough information. He said that during the course of the medical assessment at the health clinic, the clinic physician might make recommendations for further testing, but that would be done by the person’s regular doctor.

If people don’t have a doctor that they see regularly, Vanderhoff said they are trying to help residents find one.

Vanderhoff said it would be important for the primary care providers to continue to monitor changes in a patient’s overall health.

“Because when we look at the chemicals involved, especially the primary chemical vinyl chloride, there is simply not a blood test that we can do or a urine test that we can do that would say ‘Aha! You had an exposure,’ ” Vanderhoff said. “That would be great, but that’s just not the case.”

Tsai, who lives in East Palestine, said that he’s legally able to order medical tests, so he does, within limits. “Why wouldn’t you do that?” he said.

Dr. Erin Haynes, the chairperson of the department of epidemiology and environmental health at the University of Kentucky, says she thinks it’s sound for residents to seek out common blood tests.

In an email to CNN, Haynes said in addition to a complete blood count and basic metabolic panel she would add a liver function test, since vinyl chloride, one chemical that was on the train, can damage the liver.

But Haynes says trying to test for specific chemicals may be a step too far.

“Testing for chemical exposure at this point is a difficult,” says Haynes, who has helped impacted communities investigate environmental exposures. “The high levels are now gone, and we aren’t exactly sure what to measure in blood or urine since we don’t know what chemicals formed during the fire. There are suspects, but not clear answers yet.”

Haynes said it would be ideal to collect blood and urine samples now, but store them for later testing, but this would be difficult for a local clinic to do.

Overall, Haynes says the government’s response to chemical spills like this one leaves something to be desired.

“The community is in dire need of an organized and coordinated health monitoring study that includes exposure assessment,” said Haynes, who hopes to bring such a study to the area soon.

Down the road, she says, there’s still a lot to learn about the health impacts of environmental exposures to toxins.

“We also need more research on what these chemicals do and methods for rapid testing,” Haynes said. “Communities with railroad must know what is moving through their community, when and how much. They also must receive training on how to safely respond when a disaster occurs.”

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Beware the budget butt lift, regulators warn amid social media-inspired boom | CNN

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In hindsight, Nikki Ruston said, she should have recognized the red flags.

The office in Miami where she scheduled what’s known as a Brazilian butt lift had closed and transferred her records to a different facility, she said. The price she was quoted – and paid upfront – increased the day of the procedure, and she said she did not meet her surgeon until she was about to be placed under general anesthesia.

“I was ready to walk out,” said Ruston, 44, of Lake Alfred in Central Florida. “But I had paid everything.”

A few days after the July procedure, Ruston was hospitalized due to infection, blood loss, and nausea, her medical records show.

“I went cheap. That’s what I did,” Ruston recalled recently. “I looked for the lowest price, and I found him on Instagram.”

People like Ruston are commonly lured to office-based surgery centers in South Florida through social media marketing that makes Brazilian butt lifts and other cosmetic surgery look deceptively painless, safe, and affordable, say researchers, patient advocates, and surgeon groups.

Unlike ambulatory surgery centers and hospitals, where a patient might stay overnight for observation after treatment, office-based surgery centers offer procedures that don’t typically require an inpatient stay and are regulated as an extension of a doctor’s private practice.

But such surgical offices are often owned by corporations that can offer discount prices by contracting with surgeons who are incentivized to work on as many patients per day as possible, in as little time as possible, according to state regulators and physicians critical of the facilities.

Ruston said she now lives with constant pain, but for other patients a Brazilian butt lift cost them their lives. After a rash of deaths, and in the absence of national standards, Florida regulators were the first in the nation to enact rules in 2019 meant to make the procedures safer. More than three years later, data shows deaths still occur.

Patient advocates and some surgeons – including those who perform the procedure themselves – anticipate the problem will only get worse. Emergency restrictions imposed by the state’s medical board in June expired in September, and the corporate business model popularized in Miami is spreading to other cities.

“We’re seeing entities that have a strong footprint in low-cost, high-volume cosmetic surgery, based in South Florida, manifesting in other parts of the country,” said Dr. Bob Basu, a vice president of the American Society of Plastic Surgeons and a practicing physician in Houston.

During a Brazilian butt lift, fat is taken via liposuction from other areas of the body – such as the torso, back, or thighs – and injected into the buttocks. More than 61,000 buttock augmentation procedures, both butt lifts and implants, were performed nationwide in 2021, a 37% increase from the previous year, according to data from the Aesthetic Society, a trade group of plastic surgeons.

As with all surgery, complications can occur. Miami-Dade County’s medical examiner has documented nearly three dozen cosmetic surgery patient deaths since 2009, of which 26 resulted from a Brazilian butt lift. In each case, the person died from a pulmonary fat embolism, when fat entered the bloodstream through veins in the gluteal muscles and stopped blood from flowing to the lungs.

No national reporting system nor insurance code tracks outcomes and patient demographics for a Brazilian butt lift. About 3% of surgeons worldwide had a patient die as a result of the procedure, according to a 2017 report from an Aesthetic Surgery Education and Research Foundation task force.

Medical experts said the problem is driven, in part, by having medical professionals like physician assistants and nurse practitioners perform key parts of the butt lift instead of doctors. It’s also driven by a business model that is motivated by profit, not safety, and incentivizes surgeons to exceed the number of surgeries outlined in their contracts.

In May, after a fifth patient in as many months died of complications in Miami-Dade County, Dr. Kevin Cairns proposed the state’s emergency rule to limit the number of butt lifts a surgeon could perform each day.

“I was getting sick of reading about women dying and seeing cases come before the board,” said Cairns, a physician and former member of the Florida Board of Medicine.

Some doctors performed as many as seven, according to disciplinary cases against surgeons prosecuted by the Florida Department of Health. The emergency rule limited them to no more than three, and required the use of an ultrasound to help surgeons lower the risk of a pulmonary fat clot.

But a group of physicians who perform Brazilian butt lifts in South Florida clapped back and formed Surgeons for Safety. They argued the new requirements would make the situation worse. Qualified doctors would have to do fewer procedures, they said, thus driving patients to dangerous medical professionals who don’t follow rules.

The group has since donated more than $350,000 to the state’s Republican Party, Republican candidates, and Republican political action committees, according to campaign contribution data from the Florida Department of State.

Surgeons for Safety declined KHN’s repeated interview requests. Although the group’s president, Dr. Constantino Mendieta, wrote in an August editorial that he agreed not all surgeons have followed the standard of care, he called the limits put on surgeons “arbitrary.” The rule sets “a historic precedent of controlling surgeons,” he said during a meeting with Florida’s medical board.

In January, Florida state Sen. Ileana Garcia, a Republican, filed a draft bill with the state legislature that proposes no limit on the number of Brazilian butt lifts a surgeon can perform in a day. Instead, it requires office surgery centers where the procedures are performed to staff one physician per patient and prohibits surgeons from working on more than one person at a time.

The bill would also allow surgeons to delegate some parts of the procedure to other clinicians under their direct supervision, and the surgeon must use an ultrasound.

Florida’s legislature convenes on March 7.

Consumers considering cosmetic procedures are urged to be cautious. Like Ruston, many people base their expectations on before-and-after photos and marketing videos posted on social media platforms such as Facebook, Snapchat, and Instagram.

“That’s very dangerous,” said Basu, of the American Society of Plastic Surgeons. “They’re excited about a low price and they forget about doing their homework,” he said.

The average price of a buttocks augmentation in 2021 was $4,000, according to data from the Aesthetic Society. But that’s only for the physician’s fee and does not cover anesthesia, operating room fees, prescriptions, or other expenses. A “safe” Brazilian butt lift, performed in an accredited facility and with proper aftercare, costs between $12,000 and $18,000, according to a recent article on the American Society of Plastic Surgeons’ website.

Although Florida requires a physician’s license to perform liposuction on patients who are under general anesthesia, it’s common in the medical field for midlevel medical practitioners, such as physician assistants and nurse practitioners, to do the procedure in office settings, according to Dr. Mark Mofid, who co-authored the 2017 Aesthetic Surgery Education and Research Foundation task force study.

By relying on staffers who don’t have the same specialty training and get paid less, office-based surgeons can complete more butt lifts per day and charge a lower price.

“They’re doing all of them simultaneously in three or four different rooms, and it’s being staffed by one surgeon,” said Mofid, a plastic surgeon in San Diego, who added that he does not perform more than one Brazilian butt lift in a day. “The surgeon isn’t doing the actual case. It’s assistants.”

Basu said patients should ask whether their doctor holds privileges to perform the same procedure at a hospital or ambulatory surgery center, which have stricter rules than office surgery centers in terms of who can perform butt lifts and how they should be done.

People in search of bargains are reminded that cosmetic surgery can have other serious risks beyond the deadly fat clots, such as infection and organ puncture, plus problems with the kidneys, heart, and lungs.

Ruston’s surgery was performed by a board-certified plastic surgeon she said she found on Instagram. She was originally quoted $4,995, which she said she paid in full before surgery. But when she arrived in Miami, she said, the clinic tacked on fees for liposuction and for post-surgical garments and devices.

“I ended up having to pay, like, $8,000,” Ruston said. A few days after Ruston returned home to Lake Alfred, she said, she started to feel dizzy and weak and called 911.

Paramedics took her to an emergency room, where doctors diagnosed her with anemia due to blood loss, and blood and abdominal infections, her medical records show.

“If I could go back in time,” she said, “I wouldn’t have had it done.”

KHN (Kaiser Health News) is a national newsroom that produces in-depth journalism about health issues. Together with Policy Analysis and Polling, KHN is one of the three major operating programs at KFF (Kaiser Family Foundation). KFF is an endowed nonprofit organization providing information on health issues to the nation.

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First on CNN: HHS secretary sends letter to state governors on what’s to come when Covid-19 public health emergency ends | CNN

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CNN
 — 

Plans are moving forward at the US Department of Health and Human Services to prepare for the end of the nation’s Covid-19 public health emergency declaration in May.

On Thursday, HHS Secretary Xavier Becerra sent a letter and fact sheet to state governors detailing what exactly the end of the emergency declaration will mean for jurisdictions and their residents.

“Addressing COVID-19 remains a significant public health priority for the Administration, and over the next few months, we will transition our COVID-19 policies, as well as the current flexibilities enabled by the COVID-19 emergency declarations, into improving standards of care for patients. We will work closely with partners including state, local, Tribal, and territorial agencies, industry, and advocates, to ensure an orderly transition,” Becerra wrote in a draft of the letter obtained by CNN.

“In the coming days, the Centers for Medicare & Medicaid Services (CMS) will also provide additional information, including about the waivers many states and health systems have adopted and how they will be impacted by the end of the COVID-19 PHE,” he wrote. “I will share that resource with your team when available.”

Declaring a public health emergency in the United States means that certain actions, access to funds, grants, waivers and data – among other steps – can happen more quickly in response to the crisis for the duration of the emergency. A declaration lasts 90 days – unless HHS ends it – and may be renewed.

On January 30, the White House announced its intention to end the Covid-19 national and public health emergencies on May 11, signaling that the administration considers the nation to have moved out of the emergency response phase.

Becerra had agreed to give governors a 60-day notice to prepare for the end of the emergency. Thursday’s letter was sent 90 days ahead of the emergency’s planned end.

“We are having ongoing conversations about what else we need to do in the next 90 days to ensure a smooth transition. I can tell you that every one of our agencies has been working hard on this plan,” an HHS official told CNN. “We’re going to have a series of additional materials that will go out, as well as a series of conversations over the coming days and weeks.”

The end of the public health emergency will affect some Medicare and state Medicaid flexibilities provided for the duration of the emergency. This includes waivers like the requirement for a three-day hospital stay before Medicare will cover care at a skilled nursing facility.

“We’ve been working closely with the governors on the public health emergency. This is a combination of both federal flexibilities that we allow, and the states are often the ones who are using those flexibilities,” the HHS official said.

“Just about every aspect of the pandemic response, I would say, has been in partnership with our state partners. And so, I think they have been, frankly for months now, the ones that we have been going to and the ones that we publicly committed to notifying in advance of changes to the public health emergency declaration.”

But the emergency’s end will not impact the authorizations of Covid-19 devices, including tests, vaccines and treatments that have been authorized for emergency use by the US Food and Drug Administration.

During the Covid-19 pandemic, the FDA has issued about 15 times as many emergency use authorizations as it did for all other previous public health emergencies, Commissioner Dr. Robert Califf said Wednesday in a joint hearing of the House Oversight and Investigations and Health subcommittees.

“Today, we’ve issued EUAs or provided traditional marketing authorizations to over 2,800 medical devices for Covid-19, which is 15 times more EUAs than all other previous emergencies combined,” Califf said. He added that the effects of the end of the emergency declaration will be “modest” because the “EUAs are independent of the public health emergency, so we can keep them going as long as we need to.”

The emergency is slated to end May 11. “What happens on May 12? On May 12, you can still walk into a pharmacy and get your bivalent vaccine,” Dr. Ashish Jha, the White House’s coronavirus response coordinator, wrote on Twitter last week.

He said that at some point, probably in the summer or early fall, the Biden administration will transition from federal distribution of Covid-19 vaccines and treatments to purchases through the regular health care system – but that’s not happening quite yet.

Overall, there are additional Medicaid waivers and other flexibilities that states and territories have received under the public health emergency. Some of those will be terminated. But state Medicaid programs will have to continue covering Covid-19 testing, treatments, and vaccinations without cost-sharing through September 30, 2024.

The end of the public health emergency declaration means Medicare beneficiaries will face out-of-pocket costs for over-the-counter home Covid-19 tests and treatment. However, people with Medicare will continue to have no cost for medically necessary lab-conducted Covid-19 tests ordered by their health care providers.

Covid-19 vaccinations will continue to be covered at no cost for all Medicare beneficiaries.

Those with private insurance could face charges for lab tests, even if they are ordered by a provider, according to the Kaiser Family Foundation. Vaccinations will continue to be free for those with private insurance who go to in-network providers, but going to an out-of-network providers could incur charges once federal supplies run out.

And the privately insured will not be able to get free at-home tests from pharmacies and retailers anymore unless their insurers choose to cover them.

Americans with private insurance have not been charged for monoclonal antibody treatment since they were prepaid by the federal government, though patients may be charged for the office visit or administration of the treatment, according to Kaiser. But that is not tied to the public health emergency, and the free treatments will be available until the federal supply is exhausted. The government has already run out of some of the treatments so those with private insurance may already be picking up some of the cost.

The uninsured had been able to access no-cost testing, treatments and vaccines through a different pandemic relief program. However, the federal funding ran out in the spring of 2022, making it more difficult for those without coverage to obtain free services.

Also, the “ability of health care providers to safely dispense controlled substances via telemedicine without an in-person interaction is affected; however, there will be rulemaking that will propose to extend these flexibilities,” according to the letter’s fact sheet.

One of the most meaningful pandemic enhancements for states is no longer tied to the public health emergency. Congress severed the connection in December as part of its fiscal year 2023 government funding package, which state Medicaid officials had urged lawmakers to do.

States will now be able to start processing Medicaid redeterminations and disenrolling residents who no longer qualify, starting April 1. They have 14 months to review the eligibility of their beneficiaries.

As part of a Covid-19 relief package passed in March 2020, states were barred from kicking people off Medicaid during the public health emergency in exchange for additional federal matching funds. Medicaid enrollment has skyrocketed to a record 91 million people since then.

A total of roughly 15 million people could be dropped from Medicaid when the continuous enrollment requirement ends, according to an analysis the Department of Health and Human Services released in August. About 8.2 million folks would no longer qualify, but 6.8 million people would be terminated even though they are still eligible, the department estimated.

Many who are disenrolled from Medicaid, however, could qualify for other coverage.



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Recently identified inflammatory disease VEXAS syndrome may be more common than thought, study suggests | CNN

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CNN
 — 

David Adams spent half a decade fighting an illness he couldn’t name. He was in and out of the hospital several times per year. His inflamed joints made his hands feel like they had been squeezed into gloves – and he could no longer play his beloved classical and jazz guitars.

He had constant fevers and fatigue. He even developed pain and swelling in his genitalia, which was his first sign that something was really wrong.

“At the turn of the year 2016, I started with some really painful effects in the male anatomy,” said Adams, now 70. “After that, again, a lot of fatigue – my primary care physician at that point had blood tests done, and my white blood cell count was very, very low.”

Next, Adams, who lives in Alexandria, Virginia, saw a hematologist, a pulmonologist, a urologist, a rheumatologist and then a dermatologist. Some of them thought he might have cancer.

Adams’ symptoms continued, with even more fatigue, pneumonia and a large rash below his waist. He tried at least a dozen medications, saw about two dozen doctors, and nothing helped.

In 2019, worsening symptoms forced him to retire early from his decades-long career in clinical data systems. But he remained in the dark about what was causing the problems.

Finally, in 2020, scientists at the National Institutes of Health discovered and named a rare genetic disorder: VEXAS syndrome, which wreaks havoc on the body through inflammation and blood problems.

Adams had an appointment with his rheumatologist at the time, and when he walked into the office, he saw that his physician “was giddy like a little kid.”

In his doctor’s hands was a copy of a paper in the New England Journal of Medicine detailing the discovery of VEXAS syndrome.

Adams had his answer.

“For the first time, there was a one-to-one correlation of symptoms,” he said. “It was quite a shock.”

An estimated 1 in about 13,500 people in the United States may have VEXAS syndrome, a new study suggests, which means the mysterious and sometimes deadly inflammatory disorder may be more common than previously thought.

In comparison, the genetic disorder spinal muscular atrophy affects about 1 in 10,000 people and Huntington’s disease occurs in about 1 in every 10,000 to 20,000 people.

Since its discovery, occasional VEXAS cases have been reported in medical research, but the study reveals new estimates of its prevalence.

The research, published Tuesday in the journal JAMA, suggests that about 1 in 13,591 people in the US have mutations in the UBA1 gene, which develop later in life and cause VEXAS syndrome.

“This study is demonstrating that there’s likely tens of thousands of patients in the US that have this disease, and the vast majority of them are probably not being recognized because physicians aren’t really considering this as a diagnosis more broadly,” said Dr. David Beck, an assistant professor in the Department of Medicine at NYU Langone Health and a lead author of the study.

VEXAS syndrome is not inherited, so people who have it don’t pass the disease to their children. But the UBA1 gene is on the X chromosome, so the syndrome is an X-linked disease. It predominantly affects men, who carry only one X chromosome. Women have two X chromosomes, so if they have a mutation in a gene on one X chromosome but not the other, they are generally unaffected.

“It’s present in 1 in 4,000 men over the age of 50. So we think it’s a disease that should be thought about in terms of testing for individuals that have the symptoms,” said Beck, who also led the federal research team that identified the shared UBA1 mutation among VEXAS patients in 2020.

“The benefit of VEXAS syndrome is that we have a test. We have a genetic test that can help directly provide the diagnosis,” he said. “It’s just a question of patients who meet the criteria – who are older individuals with systemic inflammation, low blood counts, who really aren’t responding to anything but steroids – then advocating to their doctors to get genetic testing to get a diagnosis.”

Adams, who became a patient of Beck’s, said that finally getting a diagnosis – and understanding the cause of his symptoms – was life-changing.

“It really was incredibly freeing to have the diagnosis,” he said.

“You can’t fight your enemy unless your enemy has a name,” he added. “We finally had something where we could point to and say, ‘OK, we understand what’s going on. This is VEXAS.’ “

For the new study, Beck and his colleagues at the NIH, New York University, Geisinger Research and other institutions analyzed data on 163,096 patients in a health system in central and northeastern Pennsylvania, from January 1996 to January 2022, including electronic health records and blood samples.

Eleven of the patients had a disease-causing UBA1 variant, and a 12th person had a “highly suspicious” variant.

Only three of the 12 are still alive. A five-year survival rate of 63% has been previously reported with VEXAS.

Among the 11 patients in the new study who had pathogenic variants in UBA1, only two were women. Seven had arthritis as a symptom, and four had been diagnosed with rheumatologic diseases, such as psoriasis of the skin or sarcoidosis, which causes swollen lumps in the body. All had anemia or low blood cell counts.

“None had been previously clinically diagnosed with VEXAS syndrome,” Beck said.

The finding “is emphasizing how it’s important to be able to pick these patients out, give them the diagnosis and start the aggressive therapies or aggressive treatments to keep their inflammation in check,” he said.

VEXAS – an acronym for five clinical characteristics of the disease – has no standardized treatment or cure, but Beck said symptoms can be managed with medications like the steroid prednisone or other immunosuppressants.

“But the toxicities of prednisone over years is challenging. There are other anti-inflammatory medications that we use, but they’re only partially effective at the moment,” he said. “One treatment for individuals that we’ve seen that’s very effective is bone marrow transplantation. That comes with its own risks, but that’s just underscoring the severe nature of the disease.”

Although the new study helps provide estimates of the prevalence and symptoms of VEXAS syndrome, the data is not representative of the entire United States, and Beck said that more research needs to be done on a larger, more diverse group of people.

Some men might be hesitant to seek medical care for VEXAS symptoms, but Adams said that doing so could save their life.

“Eventually, it’s going to get so bad that you’ll end up like my first hospitalization, where you’re on death’s door,” Adams said. “You don’t want to be in that situation.”

Adams has been taking prednisone to ease his symptoms, and it’s helped. But because steroid use can have side effects such as cataracts and weight gain, he has been working with his doctors to find other therapies so he can reduce his intake of the medication.

Beck and his colleagues are studying targeted therapies for VEXAS syndrome, as well as conducting stem cell bone marrow transplant trials at the NIH.

“There are many different facets of the disease,” Dr. Bhavisha Patel, a hematologist and researcher in the National Heart, Lung and Blood Institute’s Hematopoiesis and Bone Marrow Failure Laboratory, said in an NIH news release last month.

“I believe that is what is challenging when we think about treatment, because it’s so heterogeneous,” said Patel, who was not involved in the new study.

“Both at NIH and worldwide, the groups that have dedicated themselves to VEXAS are looking for medical therapies to offer to other patients who don’t qualify for a bone marrow transplant,” she said. “We continue to collaborate on many projects in order to categorize this disease further and ultimately come up with the best treatment options.”

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Study shows convalescent plasma works for immune-compromised Covid-19 patients, but it can be hard to find | CNN

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CNN
 — 

Convalescent plasma – a once-celebrated treatment for Covid-19 that has largely fallen out of favor – does work well for people who are immune-compromised, according to a study published Thursday.

The report in the journal JAMA Network Open analyzed the results of nine studies and found that immune-compromised Covid-19 patients were 37% less likely to die if they got convalescent plasma, an antibody-rich blood product from people who’d recovered from the virus.

Although it’s legal to use convalescent plasma to treat Covid patients who are immune-compromised, as inpatients or outpatients, government guidelines are neutral about whether the treatment works, so some hospitals offer it but others do not.

“Our concern is that many patients who need [convalescent plasma] are not getting it,” said Dr. Arturo Casadevall, an infectious disease expert at Johns Hopkins University and a co-author of the new study. “This is really important because these people can be treated, and they could have better outcomes with this material if we can just get the word out.”

He said it’s to everyone’s advantage to treat immune-compromised patients quickly.

Immune-compromised people sometimes have “smoldering Covid” for months because they lack the antibodies to fight it off, which gives the virus plenty of opportunities to mutate in the person’s body.

“These immune-compromised patients are essentially variant factories,” said Dr. Michael Joyner, an anesthesiologist at the Mayo Clinic and another study co-author. “And you do not want a bunch of people running around out there making weird variants.”

There are about 7 million immune-compromised people in the US, and treating them if they contract Covid-19 has proved challenging.

Many of them can’t take the antiviral drug Paxlovid because it interferes with other medicines they take.

Monoclonal antibodies, once popular for prevention and treatment for this group, aren’t used anymore because coronavirus variants have changed over time. One of the advantages of convalescent plasma is that as long as it’s been donated recently, there’s a high likelihood it will have antibodies to currently circulating variants, according to advocates for the treatment.

But the National Institutes of Health’s Covid-19 treatment guidelines say there’s not enough evidence to recommend either for or against the use of convalescent plasma in people with compromised immune systems.

Three times last year – in May, August and December – Casadevall, Joyner and dozens of other doctors from Harvard, Stanford, Mayo, Columbia and other academic medical centers wrote emails to scientists at the National Institutes of Health, sending them research materials and urging them to revise the guidelines. They say they have not received a response.

Joyner said he’s “frustrated” with the NIH’s “bureaucratic rope-a-dope,” calling the agency’s guidelines a “wet blanket” that discourages doctors from trying convalescent plasma on these people.

Some patient advocates say they’re angry.

“This lack of response to the researchers is infuriating,” said Janet Handal, co-founder of the Transplant Recipient and Immunocompromised Patient Advocacy Group.

Several large randomized clinical trials on the general population, including one in India and one in the UK, have found that convalescent plasma did not reduce Covid-19 deaths or prevent severe illness, and the treatment is no longer authorized in the US for people who have healthy immune systems.

The nine studies analyzed in the new report are much smaller and looked only at immune-compromised patients.

Dr. Peter Horby, a professor at the University of Oxford and the co-principal investigator of the large UK study, said that a large randomized clinical trial should be done on immune-compromised patients before clinical practice guidelines for this group are changed.

He said that support for convalescent plasma to treat Covid-19 has been based on “an emotional feeling that something had to be done.”

“We’ve seen time and again that people’s beliefs and emotions about what works can be wildly wrong, and so the best thing to do is to evaluate these things properly in trials,” he said.

At the beginning of the pandemic, there was great enthusiasm for convalescent plasma as Covid-19 survivors sought to save lives, donating antibodies against the virus to people who were sometimes at death’s door.

In August 2020, the US Food and Drug Administration granted emergency use authorization for the treatment, but some questioned whether it was politically motivated and whether the data really showed that it worked.

Then, the large clinical trials suggested convalescent plasma didn’t work.

“We didn’t see a benefit,” said Horby, director of Oxford’s Pandemic Sciences Institute.

But there was one exception.

Horby said his study did find “some evidence of some benefit” in Covid-19 patients who had not developed antibodies against the virus. This would most likely include immune-compromised patients because their faulty immune systems don’t always generate antibodies the way they should, even after infection.

When this group of patients received convalescent plasma, Horby said, they had a slightly shortened hospital stay and a slightly lower risk of ending up on a ventilator compared with similar patients who did not receive convalescent plasma.

Joyner and Casadevall, the Mayo and Hopkins doctors, point to that finding – and a similar one in a large trial in Australia, Canada, the UK and the US, as well as results of smaller studies – as an indication that convalescent plasma is worth trying in immune-compromised patients.

Immune-compromised patients who catch Covid-19 can get convalescent plasma relatively easily if they’re patients at Hopkins, Mayo or several other medical centers.

But many other people might have a difficult time accessing it.

It took Bernadette Kay of Manhattan Beach, California, months to get it, and she had to be “relentless” and call in the help of several “angels” in New York, Maryland, Minnesota and California to finally make it work.

Kay, 64, who has a compromised immune system because of a drug she takes for rheumatoid arthritis, got Covid-19 in July. She took two monoclonal antibodies, as well as remdesivir and Paxlovid – twice. But she still tested positive on and off for months and had fatigue, congestion and headaches.

“I felt like half a person,” she said. “I was not an able-bodied person. I was disabled because of lack of energy. It feels dark – a heavy feeling in your forehead and your face.”

Kay said she saw several doctors and none of them suggested convalescent plasma. That’s where her first angel came in: her daughter, who had signed her up for the Transplant Recipient and Immunocompromised Patient Advocacy Group.

That group, as well as the CLL Society, an advocacy organization for cancer patients, have been helping immune-compromised people when they get infected with Covid-19, connecting them with experts and offering guidance on how to arrange to have the plasma ordered.

Kay says Handal, the co-founder of the immune-compromised patients’ group, was her second angel, because she pointed her to angels No. 3 and 4: Joyner, the Mayo doctor, and Dr. Shmuel Shoham, an infectious disease expert at Hopkins.

Joyner and Shoham pointed Kay to her fifth angel: Chaim Lebovits, a businessman, leader in the New York’s Hasidic Jewish community and co-founder of the Covid Plasma Initiative.

Lebovits reached out to a hospital and blood bank near Kay that could procure the plasma once a doctor ordered it. Kay then reached out to six local doctors, most of them infectious disease experts, inquiring about convalescent plasma, but she didn’t make any progress.

“I think they thought it was quack medicine,” she said.

By this time, it was November, four months after she initially tested positive for Covid. She sought out a seventh doctor, sending him information from plasma experts, including a slide presentation by Joyner and Casdevall. She said that doctor, after conferring with someone at the blood bank that Libovits had suggested, agreed to order the plasma.

That’s where her sixth angel came in: Robert Simpson, vice president for hospital services at the San Diego Blood Bank, who arranged to have the blood flown in from Stanford University Medical Center.

“Robert watched the flight on Flight Tracker and had a courier waiting to bring it to the hospital,” Kay said, adding that she calls her angels collectively her “circle of love.”

Two to three weeks after her infusion, she began to feel better. She tested negative on January 4 and has continued to feel well and test negative since then.

“My energy level is back to normal. I don’t feel like half a person,” she said.

She said she’ll never know for sure exactly what spurred her recovery, but “I think it was plasma that made the difference, because in six months, nothing else made a difference.”

Kay, who works in health care, said most other people wouldn’t have known how to navigate the system like she did or might have given up in frustration.

“With the help of Janet [Handal] and her team of scientists, I’ve been able to get where I am today,” she said. “But it was not easy. This was driven by my bullheaded advocacy, because that’s who I am. I think I’m a total anomaly. No one has the persistence that I have.”

Joyner said that while he and his colleagues wait for a response from their emails to the NIH, they’ve formed the National Covid-19 Convalescent Plasma Project, and they have a phone meeting every Thursday night to discuss their progress.

“We’ve encountered many roadblocks,” said Dr. Liise-anne Pirofski, chief of the Division of Infectious Diseases at the Albert Einstein College of Medicine. “It’s just not viewed as part of the Covid-19 treatment armamentarium, and it should be.”

Pirofski, Joyner and Casadevall say they receive no financial benefit from convalescent plasma. They think one reason convalescent plasma isn’t more widely used is that there isn’t a pharmaceutical company spending money to advocate for it.

Handal, who runs the Facebook group for people who are immune-compromised, said that after she sent several emails to the NIH, agency scientists wrote back, inviting her and other leaders of her group to a meeting next week.

She plans to tell them that they need to review their Covid-19 plasma guidelines and fund more research on the coronavirus and the immune-compromised, as they have few treatment options and so often isolate at home with their families to avoid the virus.

“It is unconscionable that the NIH has let stand for months its guideline on Covid convalescent plasma, which says there is not enough information to make a recommendation, while we who are immune-compromised see our treatments dwindle,” she said. “The NIH needs to speak to the clinician researchers who are experts, prioritize the immune-compromised and fund the research needed to keep us safe.”

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