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Chronic pain patients struggle to get opioid prescriptions filled, even as CDC eases guidelines | CNN

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KHN
—

Jessica Layman estimates she has called more than 150 doctors in the past few years in her search for someone to prescribe opioids for her chronic pain.

“A lot of them are straight-up insulting,” said the 40-year-old, who lives in Dallas. “They say things like ‘We don’t treat drug addicts.’”

Layman has tried a host of non-opioid treatments to help with the intense daily pain caused by double scoliosis, a collapsed spinal disc, and facet joint arthritis. But she said nothing worked as well as methadone, an opioid she has taken since 2013.

The latest phone calls came late last year, after her previous doctor shuttered his pain medicine practice, she said. She hopes her current doctor won’t do the same. “If something should happen to him, there’s nowhere for me to go,” she said.

Layman is one of the millions in the U.S. living with chronic pain. Many have struggled to get opioid prescriptions written and filled since 2016 guidelines from the Centers for Disease Control and Prevention inspired laws cracking down on doctor and pharmacy practices. The CDC recently updated those recommendations to try to ease their impact, but doctors, patients, researchers, and advocates say the damage is done.

“We had a massive opioid problem that needed to be rectified,” said Antonio Ciaccia, president of 3 Axis Advisors, a consulting firm that analyzes prescription drug pricing. “But the federal crackdowns and guidelines have created collateral damage: patients left high and dry.”

Born of an effort to fight the nation’s overdose crisis, the guidance led to legal restrictions on doctors’ ability to prescribe painkillers. The recommendations left many patients grappling with the mental and physical health consequences of rapid dose tapering or abruptly stopping medication they’d been taking for years, which carries risks of withdrawal, depression, anxiety, and even suicide.

In November, the agency released new guidelines, encouraging physicians to focus on the individual needs of patients. While the guidelines still say opioids should not be the go-to option for pain, they ease recommendations about dose limits, which were widely viewed as hard rules in the CDC’s 2016 guidance. The new standards also warn doctors about risks associated with rapid dose changes after long-term use.

But some doctors worry the new recommendations will take a long time to make a meaningful change — and may be too little, too late for some patients. The reasons include a lack of coordination from other federal agencies, fear of legal consequences among providers, state policymakers hesitant to tweak laws, and widespread stigma surrounding opioid medication.

The 2016 guidelines for prescribing opioids to people with chronic pain filled a vacuum for state officials searching for solutions to the overdose crisis, said Dr. Pooja Lagisetty, an assistant professor of medicine at the University of Michigan Medical School.

The dozens of laws that states passed limiting how providers prescribe or dispense those medications, she said, had an effect: a decline in opioid prescriptions even as overdoses continued to climb.

The first CDC guidelines “put everybody on notice,” said Dr. Bobby Mukkamala, chair of the American Medical Association’s Substance Use and Pain Care Task Force. Physicians reduced the number of opioid pills they prescribe after surgeries, he said. The 2022 revisions are “a dramatic change,” he said.

The human toll of the opioid crisis is hard to overstate. Opioid overdose deaths have risen steadily in the U.S. in the past two decades, with a spike early in the covid-19 pandemic. The CDC says illicit fentanyl has fueled a recent surge in overdose deaths.

Taking into account the perspective of chronic pain patients, the latest recommendations try to scale back some of the harms to people who had benefited from opioids but were cut off, said Dr. Jeanmarie Perrone, director of the Penn Medicine Center for Addiction Medicine and Policy.

“I hope we just continue to spread caution without spreading too much fear about never using opioids,” said Perrone, who helped craft the CDC’s latest recommendations.

Christopher Jones, director of the CDC’s National Center for Injury Prevention and Control, said the updated recommendations are not a regulatory mandate but only a tool to help doctors “make informed, person-centered decisions related to pain care.”

Multiple studies question whether opioids are the most effective way to treat chronic pain in the long term. But drug tapering is associated with deaths from overdose and suicide, with risk increasing the longer a person had been taking opioids, according to research by Dr. Stefan Kertesz, a professor of medicine at the University of Alabama-Birmingham.

He said the new CDC guidance reflects “an extraordinary amount of input” from chronic pain patients and their doctors but doubts it will have much of an impact if the FDA and the Drug Enforcement Administration don’t change how they enforce federal laws.

The FDA approves new drugs and their reformulations, but the guidance it provides for how to start or wean patients could urge clinicians to do so with caution, Kertesz said. The DEA, which investigates physicians suspected of illegally prescribing opioids, declined to comment.

The DEA’s pursuit of doctors put Danny Elliott of Warner Robins, Georgia, in a horrible predicament, said his brother, Jim.

In 1991, Danny, a pharmaceutical company rep, suffered an electric shock. He took pain medicine for the resulting brain injury for years until his doctor faced federal charges of illegally dispensing prescription opioids, Jim said.

Danny turned to doctors out of state — first in Texas and then in California. But Danny’s latest physician had his license suspended by the DEA last year, and he couldn’t find a new doctor who would prescribe those medications, Jim said.

Danny, 61, and his wife, Gretchen, 59, died by suicide in November. “I’m really frustrated and angry about pain patients being cut off,” Jim said.

Danny became an advocate against forced drug tapering before he died. Chronic pain patients who spoke with KHN pointed to his plight in calling for more access to opioid medications.

Even for people with prescriptions, it’s not always easy to get the drugs they need.

Pharmacy chains and drug wholesalers have settled lawsuits for billions of dollars over their alleged role in the opioid crisis. Some pharmacies have seen their opioid allocations limited or cut off, noted Ciaccia, with 3 Axis Advisors.

Rheba Smith, 61, of Atlanta, said that in December her pharmacy stopped filling her prescriptions for Percocet and MS Contin. She had taken those opioid medications for years to manage chronic pain after her iliac nerve was mistakenly cut during surgery, she said.

Smith said she visited nearly two dozen pharmacies in early January but could not find one that would fill her prescriptions. She finally found a local mail-order pharmacy that filled a one-month supply of Percocet. But now that drug and MS Contin are not available, the pharmacy told her.

“It has been a horrible three months. I have been in terrible pain,” Smith said.

Many patients fear a future of constant pain. Layman thinks about the lengths she’d go to in order to get medication.

“Would you be willing to buy drugs off the street? Would you be willing to go to an addiction clinic and try to get pain treatment there? What are you willing to do to stay alive?” she said. “That is what it comes down to.”

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US maternal death rate rose sharply in 2021, CDC data shows, and experts worry the problem is getting worse | CNN

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CNN
—

As women continue to die due to pregnancy or childbirth each year in the United States, new federal data shows that the nation’s maternal death rate rose significantly yet again in 2021, with the rates among Black women more than twice as high as those of White women.

Experts said the United States’ ongoing maternal mortality crisis was compounded by Covid-19, which led to a “dramatic” increase in deaths.

The number of women who died of maternal causes in the United States rose to 1,205 in 2021, according to a report from the National Center for Health Statistics, released Thursday by the US Centers for Disease Control and Prevention. That’s a sharp increase from years earlier: 658 in 2018, 754 in 2019 and 861 in 2020.

That means the US maternal death rate for 2021 – the year for which the most recent data is available – was 32.9 deaths per 100,000 live births, compared with rates of 20.1 in 2019 and 23.8 in 2020.

The new report also notes significant racial disparities in the nation’s maternal death rate. In 2021, the rate for Black women was 69.9 deaths per 100,000 live births, which is 2.6 times the rate for White women, at 26.6 per 100,000.

The data showed that rates increased with the mother’s age. In 2021, the maternal death rate was 20.4 deaths per 100,000 live births for women under 25 and 31.3 for those 25 to 39, but it was 138.5 for those 40 and older. That means the rate for women 40 and older was 6.8 times higher than the rate for women under age 25, according to the report.

The maternal death rate in the United States has been steadily climbing over the past three decades, and these increases continued through the Covid-19 pandemic.

Questions remain about how the pandemic may have affected maternal mortality in the United States, according to Dr. Elizabeth Cherot, chief medical and health officer for the infant and maternal health nonprofit March of Dimes, who was not involved in the new report.

“What happened in 2020 and 2021 compared with 2019 is Covid,” Cherot said. “This is sort of my reflection on this time period, Covid-19 and pregnancy. Women were at increased risk for morbidity and mortality from Covid. And that actually has been well-proven in some studies, showing increased risks of death, but also being ventilated in the intensive care unit, preeclampsia and blood clots, all of those things increasing a risk of morbidity and mortality.”

The American College of Obstetricians and Gynecologists previously expressed “great concern” that the pandemic would worsen the US maternal mortality crisis, ACOG President Dr. Iffath Abbasi Hoskins said in a statement Thursday.

“Provisional data released in late 2022 in a U.S. Government Accountability Office report indicated that maternal death rates in 2021 had spiked—in large part due to COVID-19. Still, confirmation of a roughly 40% increase in preventable deaths compared to a year prior is stunning new,” Hoskins said.

“The new data from the NCHS also show a nearly 60% percent increase in maternal mortality rates in 2021 from 2019, just before the start of the pandemic. The COVID-19 pandemic had a dramatic and tragic effect on maternal death rates, but we cannot let that fact obscure that there was—and still is—already a maternal mortality crisis to compound.”

Health officials stress that people who are pregnant should get vaccinated against Covid-19 and that doing so offers protection for both the mother and the baby.

During the early days of the pandemic, in 2020, there was limited information about the vaccine’s risks and benefits during pregnancy, prompting some women to hold off on getting vaccinated. But now, there is mounting evidence of the importance of getting vaccinated for protection against serious illness and the risks of Covid-19 during pregnancy.

The Covid-19 pandemic also may have exacerbated existing racial disparities in the maternal death rate among Black women compared with White women, said Dr. Chasity Jennings-Nuñez, a California-based site director with Ob Hospitalist Group and chair of the perinatal/gynecology department at Adventist Health-Glendale, who was not involved in the new report.

“In terms of maternal mortality, it continues to highlight those structural and systemic problems that we saw so clearly during the Covid-19 pandemic,” Jennings-Nuñez said.

“So in terms of issues of racial health inequities, of structural racism and bias, of access to health care, all of those factors that we know have played a role in terms of maternal mortality in the past continue to play a role in maternal mortality,” she said. “Until we begin to address those issues, even without a pandemic, we’re going to continue to see numbers go in the wrong direction.”

Some policies have been introduced to tackle the United States’ maternal health crisis, including the Black Maternal “Momnibus” Act of 2021, a sweeping bipartisan package of bills that aim to provide pre- and post-natal support for Black mothers, including extending eligibility for certain benefits postpartum.

As part of the Momnibus, President Biden signed the bipartisan Protecting Moms Who Served Act in 2021, and other provisions have passed in the House.

In the United States, about 6.9 million women have little or no access to maternal health care, according to March of Dimes, which has been advocating in support of the Momnibus.

The US has the highest maternal death rate of any developed nation, according to the Commonwealth Fund and the latest data from the World Health Organization. While maternal death rates have been either stable or rising across the United States, they are declining in most countries.

“A high rate of cesarean sections, inadequate prenatal care, and elevated rates of chronic illnesses like obesity, diabetes, and heart disease may be factors contributing to the high U.S. maternal mortality rate. Many maternal deaths result from missed or delayed opportunities for treatment,” researchers from the Commonwealth Fund wrote in a report last year.

The ongoing rise in maternal deaths in the United States is “disappointing,” said Dr. Elizabeth Langen, a high-risk maternal-fetal medicine physician at the University of Michigan Health Von Voigtlander Women’s Hospital. She was not involved in the latest report but cares for people who have had serious complications during pregnancy or childbirth.

“Those of us who work in the maternity care space have known that this is a problem in our country for quite a long time. And each time the new statistics come out, we’re hopeful that some of the efforts that have been going on are going to shift the direction of this trend. It’s really disappointing to see that the trend is not going in the right direction but, at some level, is going in the worst direction and at a little bit of a faster rate,” Langen said.

“In the health care system, we need to accept ultimate responsibility for the women who die in our care,” she added. “But as a nation, we also need to accept some responsibility. We need to think about: How do we provide appropriate maternity care for people? How do we let people have time off of work to see their midwife or physician so that they get the care that they need? How do all of us make it possible to live a healthy life while you’re pregnant so that you have the opportunity to have the best possible outcome?”

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How to reduce PFAS in your drinking water, according to experts | CNN

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CNN
—

In the next three years, drinking water in the United States may be a bit safer from potentially toxic chemicals that have been detected in the blood of 98% of Americans.

Perfluoroalkyl and polyfluoroalkyl substances or PFAS are a family of thousands of man-made chemicals that do not break down easily in the environment. A number of PFAS have been linked to serious health problems, including cancer, fertility issues, high cholesterol, hormone disruption, liver damage, obesity and thyroid disease.

The US Environmental Protection Agency proposed on Tuesday stringent new limits on levels of six PFAS chemicals in public water systems. Under the proposed rule, public systems that provide water to at least 15 service connections or 25 people will have three years to implement testing procedures, begin notifying the public about PFAS levels, and reduce levels if above the new standard, the EPA said.

Two of the most well-studied and potentially toxic chemicals, PFOA and PFOS, cannot exceed 4 parts per trillion in drinking water, compared with a previous health advisory of 70 parts per trillion, the EPA said.

Another four chemicals — PFNA, PFHxS, PFBS and GenX — will be subject to a hazard index calculation to determine whether the levels of these PFAS pose a potential risk. The calculation is “a tool the EPA uses to address the cumulative risks from all four of those chemicals,” said Melanie Benesh, vice president of government affairs for the Environmental Working Group, a consumer organization that monitors exposure to PFAS and other chemicals.

“The EPA action is a really important and historic step forward,” Benesh said. “While the proposed regulations only address a few PFAS, they are important marker chemicals. I think requiring water systems to test and treat for these six will actually do a lot to address other PFAS that are in the water as well.”

For people who are concerned about PFAS exposure, three years or so is a long time. What can consumers do now to limit the levels of PFAS in their drinking water?

First, look up levels of PFAS in your local public water system, suggested David Andrews, a senior scientist at the Environmental Working Group. The advocacy nonprofit has created a national tap water database searchable by zip code that lists PFAS and other concerning chemicals, as well as a national map that illustrates where PFAS has been detected in the US.

However, not all water utilities currently test for pollutants, and many rural residents rely on wells for water. Anyone who wants to personally test their water can purchase a test online or from a certified lab, Andrews said.

“The most important thing is to ensure the testing method can detect down to at least four parts per trillion or lower of PFAS,” he said. “There are a large number of labs across the country certified to test to that level, so there are a lot of options available.”

If levels are concerning, consumers can purchase a water filter for their tap. NSF, formerly the National Sanitation Foundation, has a list of recommended filters.

“The water filters that are most effective for PFAS are reverse osmosis filters, which are more expensive, about in the $200 range,” Andrews said. Reverse osmosis filters can remove a wide range of contaminants, including dissolved solids, by forcing water through various filters.

“Granular activated carbon filters are more common and less expensive but not quite as effective or consistent for PFAS,” he said, “although they too can remove a large number of other contaminants.”

Reverse osmosis systems use both carbon-based filters and reverse osmosis membranes, Andrews explained. Water passes through the carbon filter before entering the membrane.

“The important part is that you have to keep changing those filters,” he said. “If you don’t change that filter, and it becomes saturated, the levels of PFAS in the filtered water can actually be above the levels in the tap water.”

Carbon filters are typically replaced every six months, “while the reverse osmosis filter is replaced on a five-year time frame,” he added. “The cost is relatively comparable over their lifetime.”

Another positive: Many of the filters that work for PFAS also filter other contaminants in water, Andrews said.

Drinking water is not the only way PFAS enters the bloodstream. Thousands of varieties of PFAS are used in many of the products we purchase, including nonstick cookware, infection-resistant surgical gowns and drapes, mobile phones, semiconductors, commercial aircraft, and low-emissions vehicles.

The chemicals are also used to make carpeting, clothing, furniture, and food packaging resistant to stains, water and grease damage. Once treated, the report said, textiles emit PFAS over the course of their lifetimes, escaping into the air and groundwater in homes and communities.

Made from a chain of linked carbon and fluorine atoms that do not readily degrade in the environment, PFAS are known as “forever chemicals.” Due to their long half life in the human body, it can take some PFAS years to completely leave the body, according to a 2022 report by the prestigious National Academies of Sciences, Engineering, and Medicine.

“Some of these chemicals have half-lives in the range of five years,” National Academies committee member Jane Hoppin, an environmental epidemiologist and director of the Center for Human Health and the Environment at North Carolina State University in Raleigh, told CNN previously.

“Let’s say you have 10 nanograms of PFAS in your body right now. Even with no additional exposure, five years from now you would still have 5 nanograms.

“Five years later, you would have 2.5 and then five years after that, you’d have one 1.25 nanograms,” she continued. “It would be about 25 years before all the PFAS leave your body.”

The 2022 National Academies report set “nanogram” levels of concern and encouraged clinicians to conduct blood tests on patients who are worried about exposure or who are at high risk. (A nanogram is equivalent to one-billionth of a gram.)

People in “vulnerable life stages” — such as during fetal development in pregnancy, early childhood and old age — are at high risk, the report said. So are firefighters, workers in fluorochemical manufacturing plants, and those who live near commercial airports, military bases, landfills, incinerators, wastewater treatment plants and farms where contaminated sewage sludge is used.

The PFAS-REACH (Research, Education, and Action for Community Health) project, funded by the National Institute of Environmental Health Sciences, gives the following advice on how to avoid PFAS at home and in products:

Stay away from stain-resistant carpets and upholstery, and don’t use waterproofing sprays.
Look for the ingredient polytetrafluoroethylene, or PTFE, or other “fluoro” ingredients on product labels.
Avoid nonstick cookware. Instead use cast-iron, stainless steel, glass or enamel products.
Boycott takeout containers and other food packaging. Instead cook at home and eat more fresh foods.
Don’t eat microwave popcorn or greasy foods wrapped in paper.
Choose uncoated nylon or silk dental floss or one that is coated in natural wax.

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‘Am I dreaming?’: Double lung transplants save two people with late-stage cancer | CNN

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CNN
—

Two people with stage IV lung cancer who had been told that they had only weeks or months to live are breathing freely after receiving double lung transplants, Northwestern Medicine in Chicago said Wednesday.

Lung cancer is the leading cause of cancer-related deaths in the United States. The American Cancer Society estimates that over 127,000 Americans will die from the disease this year.

It is considered stage IV once additional tumors have developed in the lungs, aside from the primary tumor, or the cancer has spread to more organs.

Someone diagnosed with stage IV lung cancer has limited treatment options, Northwestern Medicine says. A double lung transplantation offers a potentially lifesaving option for some people with a poor prognosis, but doctors say there are specific criteria a lung cancer patient must meet, including that the cancer is contained within the lungs and the person has tried all other treatment options.

In 2020, 54-year-old Albert Khoury of Chicago received a devastating lung cancer diagnosis.

Khoury, a cement finisher for the Chicago Department of Transportation, began to have back pain, sneezing and chills, along with coughing up blood, according to Northwestern Medicine. It was near the start of the Covid-19 pandemic, so at first, he thought he had coronavirus-related symptoms.

He was diagnosed with stage I lung cancer soon after.

Because of the pandemic, Khoury did not begin treatment until July 2020. At that point, the cancer had progressed to stage II and was continuing to grow, eventually reaching stage IV. He was told to consider hospice, special care for people near the end of their lives that focuses on comfort and support.

“I had a couple weeks to live,” Khoury said in a video released by the hospital. “Not that much time.”

His sister suggested that he reach out to Northwestern Medicine about the possibility of a double lung transplant.

“I need new lungs. That is the only hope to live,” Khoury said he told his doctor.

He met with an oncologist at Northwestern Medicine, who told him he should try additional treatments first. But not too long after, he was admitted to the intensive care unit with pneumonia and sepsis.

As his health declined, the oncologists began considering the rarely used procedure.

“His lungs were filled with cancer cells, and day by day, his oxygen was dropping,” said Dr. Young Chae, a medical oncologist at Northwestern Medicine who helped treat Khoury.

Transplant is typically considered for people with some form of lung cancer that has not spread to other parts of the body and for those who have tried all other treatment options and have limited time to live, according to Dr. Ankit Bharat, chief of thoracic surgery at the Northwestern Medicine Canning Thoracic Institute, who helped treat Khoury.

William Dahut, chief scientific officer at the American Cancer Society, also noted the importance of ensuring that cancer has not spread to other parts of the body before doing a transplant.

“There would need to be as much certainty as possible that the cancer is limited to the lungs, so whatever sort of extensive screening tests should be done … to ensure that there are no cancer cells outside of the lungs,” said Dahut, who was not involved in the care of either Northwestern patient.

The oncologists decided Khoury was eligible for the procedure. In September 2021, he spent about seven hours in surgery.

“Surgeons had to be extremely meticulous to not let trillions of cancer cells from the old lungs spill out into Khoury’s chest cavity or into his blood stream,” Northwestern Medicine noted in a news release.

The surgery is not without risk, Bharat said. In people with late-stage cancers, there is always a chance of it returning after the procedure.

“There is certainly the risk of potentially being in a worse off situation than they were,” he said. “So you go through a big surgery, and then you could very quickly have the cancer come back.”

Another risk is the treatment needed after a transplant, Dahut said.

All lung transplant recipients have to take medications to weaken their immune systems, which helps reduce the possibility of their body rejecting the organ – but also decreases its ability to fight off infection, according to the National Cancer Institute.

“Drugs that actually suppress your immune system put you at risk for infection afterwards but could even potentially put you at risk for second cancers afterwards,” Dahut said.

However, 18 months later, Khoury has not had any complications and is back to work.

His doctor showed him an X-ray of his chest with no signs of cancer. “When I saw that X-ray, I believed him,” Khoury said. “My body is in my hands now.”

The procedure was put to the test again last year, this time in a 64-year-old Minnesota woman.

Tannaz Ameli, a retired nurse from Minneapolis, had a persistent cough for several months. Her doctors did a chest X-ray and diagnosed her with pneumonia.

The illness lingered until she was told she had stage IV lung cancer in January 2022.

“There was no hope for my life at that point. They gave me … three months,” Ameli said in a video released by Northwestern Medicine.

She went through unsuccessful chemotherapy treatments and was told to consider hospice.

“I had no hope. I was ready for my life to end,” she said.

But her husband reached out to Northwestern Medicine about the option of a transplant. The oncologists found that Ameli fit their criteria, and she received a double lung transplant in July.

When she was told the procedure had made her cancer-free, she wondered, ” ‘Am I dreaming, sitting here? Can it happen?’ And it did happen.”

Ameli hasn’t had any complications, and she said the procedure has given her a new perspective on life.

“Every morning when I open my eyes, I just can’t believe it,” Ameli said. “Life has a different meaning now.”

Double lung transplants for cancer are rare due to the concern that the cancer may come back, Bharat said.

Historically, the surgery required sequential transplantations, but they are looking to alter the approach to lower the risk of recurrence, he said.

“Typically, what happens in a double lung transplant procedure is, we take one lung out, put the new one in, then take the second lung out and put the second lung in,” he said. “The concern is that when you take one lung out and put a new lung, the other lung is still attached, and they could cross-contaminate. … You could inadvertently have the cancer cells spread into the bloodstream.”

If cancer cells cross-contaminate or enter the bloodstream, there is a higher risk of cancer coming back.

Bharat and his team took a different approach with Khoury and Ameli: They opened the chest cavity and did a full heart and lung bypass.

“Essentially, what that means is, we don’t let any blood go through the heart and the lungs and bypass all of that,” Bharat said. “That allows us to then stop the blood flow to the lungs, which will prevent any cancer cells from going from the lung into the bloodstream.”

The surgeons gave Khoury and Ameli lung-shaped friendship necklaces Wednesday to mark their success.

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Most men with prostate cancer can avoid or delay harsh treatments, long-term study confirms | CNN

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CNN
—

Most men who are diagnosed with prostate cancer can delay or avoid harsh treatments without harming their chances of survival, according to new results from a long-running study in the United Kingdom.

Men in the study who partnered with their doctors to keep a close eye on their low- to intermediate-risk prostate tumors – a strategy called surveillance or active monitoring – slashed their risk of the life-altering complications such as incontinence and erectile dysfunction that can follow aggressive treatment for the disease, but they were no more likely to die of their cancers than men who had surgery to remove their prostate or who were treated with hormone blockers and radiation.

“The good news is that if you’re diagnosed with prostate cancer, don’t panic, and take your time to make a decision” about how to proceed, said lead study author Dr. Freddie Hamdy, professor of surgery and urology at the University of Oxford.

Other experts who were not involved in the research agreed that the study was reassuring for men who are diagnosed with prostate cancer and their doctors.

“When men are carefully evaluated and their risk assessed, you can delay or avoid treatment without missing the chance to cure in a large fraction of patients,” said Dr. Bruce Trock, a professor of urology, epidemiology and oncology at Johns Hopkins University.

The findings do not apply to men who have prostate cancers that are scored through testing to be high-risk and high-grade. These aggressive cancers, which account for about 15% of all prostate cancer diagnoses, still need prompt treatment, Hamdy said.

For others, however, the study adds to a growing body of evidence showing that surveillance of prostate cancers is often the right thing to do.

“What I take away from this is the safety of doing active monitoring in patients,” said Dr. Samuel Haywood, a urologic oncologist at the Cleveland Clinic in Ohio, who reviewed the study, but was not involved in the research.

Results from the study were presented on Saturday at the European Association of Urology annual conference in Milan, Italy. Two studies on the data were also published in the New England Journal of Medicine and a companion journal, NEJM Evidence.

Prostate cancer is the second most common cancer in men in the United States, behind non-melanoma skin cancers. About 11% – or 1 in 9 – American men will be diagnosed with prostate cancer in their lifetime, and overall, about 2.5% – or 1 in 41 – will die from it, according to the National Cancer Institute. About $10 billion is spent treating prostate cancer in the US each year.

Most prostate cancers grow very slowly. It typically takes at least 10 years for a tumor confined to the prostate to cause significant symptoms.

The study, which has been running for more than two decades, confirms what many doctors and researchers have come to realize in the interim: The majority of prostate cancers picked up by blood tests that measure levels of a protein called prostate-specific antigen, or PSA, will not harm men during their lifetimes and don’t require treatment.

Dr. Oliver Sartor, medical director of the Tulane Cancer Center, said men should understand that a lot has changed over time, and doctors have refined their approach to diagnosis since the study began in 1999.

“I wanted to make clear that the way these patients are screened and biopsied and randomized is very, very different than how these same patients might be screened, biopsied and randomized today,” said Sartor, who wrote an editorial on the study but was not involved in the research.

He says the men included in the study were in the earliest stages of their cancer and were mostly low-risk.

Now, he says, doctors have more tools, including MRI imaging and genetic tests that can help guide treatment and minimize overdiagnosis.

The study authors say that to assuage concerns that their results might not be relevant to people today, they re-evaluated their patients using modern methods for grading prostate cancers. By those standards, about one-third of their patients would have intermediate or high-risk disease, something that didn’t change the conclusions.

When the study began in 1999, routine PSA screening for men was the norm. Many doctors encouraged annual PSA tests for their male patients over age 50.

PSA tests are sensitive but not specific. Cancer can raise PSA levels, but so can things like infections, sexual activity and even riding a bicycle. Elevated PSA tests require more evaluation, which can include imaging and biopsies to determine the cause. Most of the time, all that followup just isn’t worth it.

“It is generally thought that only about 30% of the individuals with an elevated PSA will actually have cancer, and of those that do have cancer, the majority don’t need to be treated,” Sartor said.

Over the years, studies and modeling have shown that using regular PSA tests to screen for prostate cancer can do more harm than good.

By some estimates, as many as 84% of men with prostate cancer identified through routine screening do not benefit from having their cancers detected because their cancer would not be fatal before they died of other causes.

Other studies have estimated about 1 to 2 in every five men diagnosed with prostate cancer is overtreated. The harms of overtreatment for prostate cancer are well-documented and include incontinence, erectile dysfunction and loss of sexual potency, as well as anxiety and depression.

In 2012, the influential US Preventive Services Task Force advised healthy men not to get PSA tests as part of their regular checkups, saying the harms of screening outweighed its benefits.

Now, the task force opts for a more individualized approach, saying men between the ages of 55 and 69 should make the decision to undergo periodic PSA testing after carefully weighing the risks and benefits with their doctor. They recommend against PSA-based screening for men over the age of 70.

The American Cancer Society endorses much the same approach, recommending that men at average risk have a conversation with their doctor about the risks and benefits beginning at age 50.

The trial has been following more than 1,600 men who were diagnosed with prostate cancer in the UK between 1999 and 2009. All the men had cancers that had not metastasized, or spread to other parts of their bodies.

When they joined, the men were randomly assigned to one of three groups: active monitoring or using regular blood tests to keep an eye on their PSA levels; radiotherapy, which used hormone-blockers and radiation to shrink tumors; and prostatectomy, or surgery to remove the prostate.

Men who were assigned monitoring could change groups during the study if their cancers progressed to the point that they needed more aggressive treatment.

Most of the men have been followed for around 15 years now, and for the most recent data analysis, researchers were able get follow-up information on 98% of the participants.

By 2020, 45 men – about 3% of the participants – had died of prostate cancer. There were no significant differences in prostate cancer deaths between the three groups.

Men in the active monitoring group were more likely to have their cancer progress and more likely to have it spread compared with the other groups. About 9% of men in the active monitoring group saw their cancer metastasize, compared with 5% in the two other groups.

Trock points out that even though it didn’t affect their overall survival, a spreading cancer isn’t an insignificant outcome. It can be painful and may require aggressive treatments to manage at that stage.

Active surveillance did have important benefits over surgery or radiation.

As they followed the men over 12 years, the researchers found that 1 in 4 to 1 in 5 of those who had prostate surgery needed to wear at least one pad a day to guard against urine leaks. That rate was twice as high as the other groups, said Dr. Jenny Donovan of the University of Bristol, who led the study on patient-reported outcomes after treatment.

Sexual function was affected, too. It’s natural for sexual function to decline in men with age, so by the end of the study, nearly all the men reported low sexual function, but their patterns of decline were different depending on their prostate cancer treatment, she said.

“The men who have surgery have low sexual function early on, and that continues. The men in the radiotherapy group see their sexual function drop, then have some recovery, but then their sexual function declines, and the active monitoring group declines slowly over time,” Donovan said.

Donovan said that when she presents her data to doctors, they point out how much has changed since the study started.

“Some people would say, ‘OK, yeah, but we’ve got all these new technologies now, new treatments,’ ” she said, such as intensity-modulated radiation therapy, brachytherapy and robot-assisted prostate surgeries, “but actually, other studies have shown that the effects on these functional outcomes are very similar to the effects that we see our study,” she said.

Both Donovan and Hamby feel the study’s conclusions still merit careful consideration by men and their doctors as they weigh treatment decisions.

“What we hope that clinicians will do is use these figures that we’ve produced in these papers and share them with the men so that newly diagnosed men with localized prostate cancer can really assess those tradeoffs,” Donovan said.

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Insurance requirements for prior authorization may prompt ‘devastating’ delays | CNN

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When Paula Chestnut needed hip replacement surgery last year, a pre-operative X-ray found irregularities in her chest.

As a smoker for 40 years, Chestnut was at high risk for lung cancer. A specialist in Los Angeles recommended the 67-year-old undergo an MRI, a high-resolution image that could help spot the disease.

But her MRI appointment kept getting canceled, Chestnut’s son, Jaron Roux, told KHN. First, it was scheduled at the wrong hospital. Next, the provider wasn’t available. The ultimate roadblock she faced, Roux said, arrived when Chestnut’s health insurer deemed the MRI medically unnecessary and would not authorize the visit.

“On at least four or five occasions, she called me up, hysterical,” Roux said.

Months later, Chestnut, struggling to breathe, was rushed to the emergency room. A tumor in her chest had become so large that it was pressing against her windpipe. Doctors started a regimen of chemotherapy, but it was too late. Despite treatment, she died in the hospital within six weeks of being admitted.

Though Roux doesn’t fully blame the health insurer for his mother’s death, “it was a contributing factor,” he said. “It limited her options.”

Few things about the American health care system infuriate patients and doctors more than prior authorization, a common tool whose use by insurers has exploded in recent years.

Prior authorization, or pre-certification, was designed decades ago to prevent doctors from ordering expensive tests or procedures that are not indicated or needed, with the aim of delivering cost-effective care.

Originally focused on the costliest types of care, such as cancer treatment, insurers now commonly require prior authorization for many mundane medical encounters, including basic imaging and prescription refills. In a 2021 survey conducted by the American Medical Association, 40% of physicians said they have staffers who work exclusively on prior authorization.

So today, instead of providing a guardrail against useless, expensive treatment, pre-authorization prevents patients from getting the vital care they need, researchers and doctors say.

“The prior authorization system should be completely done away with in physicians’ offices,” said Dr. Shikha Jain, a Chicago hematologist-oncologist. “It’s really devastating, these unnecessary delays.”

In December, the federal government proposed several changes that would force health plans, including Medicaid, Medicare Advantage, and federal Affordable Care Act marketplace plans, to speed up prior authorization decisions and provide more information about the reasons for denials. Starting in 2026, it would require plans to respond to a standard prior authorization request within seven days, typically, instead of the current 14, and within 72 hours for urgent requests. The proposed rule was scheduled to be open for public comment through March 13.

Although groups like AHIP, an industry trade group formerly called America’s Health Insurance Plans, and the American Medical Association, which represents more than 250,000 physicians in the United States, have expressed support for the proposed changes, some doctors feel they don’t go far enough.

“Seven days is still way too long,” said Dr. Julie Kanter, a hematologist in Birmingham, Alabama, whose sickle cell patients can’t delay care when they arrive at the hospital showing signs of stroke. “We need to move very quickly. We have to make decisions.”

Meanwhile, some states have passed their own laws governing the process. In Oregon, for example, health insurers must respond to nonemergency prior authorization requests within two business days. In Michigan, insurers must report annual prior authorization data, including the number of requests denied and appeals received. Other states have adopted or are considering similar legislation, while in many places insurers regularly take four to six weeks for non-urgent appeals.

Waiting for health insurers to authorize care comes with consequences for patients, various studies show. It has led to delays in cancer care in Pennsylvania, meant sick children in Colorado were more likely to be hospitalized, and blocked low-income patients across the country from getting treatment for opioid addiction.

In some cases, care has been denied and never obtained. In others, prior authorization proved a potent but indirect deterrent, as few patients have the fortitude, time, or resources to navigate what can be a labyrinthine process of denials and appeals. They simply gave up, because fighting denials often requires patients to spend hours on the phone and computer to submit multiple forms.

Erin Conlisk, a social science researcher for the University of California-Riverside, estimated she spent dozens of hours last summer trying to obtain prior authorization for a 6-mile round-trip ambulance ride to get her mother to a clinic in San Diego.

Her 81-year-old mother has rheumatoid arthritis and has had trouble sitting up, walking, or standing without help after she damaged a tendon in her pelvis last year.

Conlisk thought her mom’s case was clear-cut, especially since they had successfully scheduled an ambulance transport a few weeks earlier to the same clinic. But the ambulance didn’t show on the day Conlisk was told it would. No one notified them the ride hadn’t been pre-authorized.

The time it takes to juggle a prior authorization request can also perpetuate racial disparities and disproportionately affect those with lower-paying, hourly jobs, said Dr. Kathleen McManus, a physician-scientist at the University of Virginia.

“When people ask for an example of structural racism in medicine, this is one that I give them,” McManus said. “It’s baked into the system.”

Research that McManus and her colleagues published in 2020 found that federal Affordable Care Act marketplace insurance plans in the South were 16 times more likely to require prior authorization for HIV prevention drugs than those in the Northeast. The reason for these regional disparities is unknown. But she said that because more than half the nation’s Black population lives in the South, they’d be the patients more likely to face this barrier.

Many of the denied claims are reversed if a patient appeals, according to the federal government. New data specific to Medicare Advantage plans found 82% of appeals resulted in fully or partially overturning the initial prior authorization denial, according to KFF.

It’s not just patients who are confused and frustrated by the process. Doctors said they find the system convoluted and time-consuming, and feel as if their expertise is being challenged.

“I lose hours of time that I really don’t have to argue … with someone who doesn’t even really know what I’m talking about,” said Kanter, the hematologist in Birmingham. “The people who are making these decisions are rarely in your field of medicine.”

Occasionally, she said, it’s more efficient to send patients to the emergency room than it is to negotiate with their insurance plan to pre-authorize imaging or tests. But emergency care costs both the insurer and the patient more.

“It’s a terrible system,” she said.

A KFF analysis of 2021 claims data found that 9% of all in-network denials by Affordable Care Act plans on the federal exchange, healthcare.gov, were attributed to lack of prior authorization or referrals, but some companies are more likely to deny a claim for these reasons than others. In Texas, for example, the analysis found 22% of all denials made by Blue Cross and Blue Shield of Texas and 24% of all denials made by Celtic Insurance Co. were based on lack of prior authorization.

Facing scrutiny, some insurers are revising their prior authorization policies. UnitedHealthcare has cut the number of prior authorizations in half in recent years by eliminating the need for patients to obtain permission for some diagnostic procedures, like MRIs and CT scans, said company spokesperson Heather Soules. Health insurers have also adopted artificial intelligence technology to speed up prior authorization decisions.

Meanwhile, most patients have no means of avoiding the burdensome process that has become a defining feature of American health care. But even those who have the time and energy to fight back may not get the outcome they hoped for.

When the ambulance never showed in July, Conlisk and her mother’s caregiver decided to drive the patient to the clinic in the caregiver’s car.

“She almost fell outside the office,” said Conlisk, who needed the assistance of five bystanders to move her mother safely into the clinic.

When her mother needed an ambulance for another appointment in September, Conlisk vowed to spend only one hour a day, for two weeks leading up to the clinic visit, working to get prior authorization. Her efforts were unsuccessful. Once again, her mother’s caregiver drove her to the clinic himself.

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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When we’ll be able to 3D-print organs and who will be able to afford them | CNN

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What if doctors could just print a kidney, using cells from the patient, instead of having to find a donor match and hope the patient’s body doesn’t reject the transplanted kidney?

The soonest that could happen is in a decade, thanks to 3D organ bioprinting, said Jennifer Lewis, a professor at Harvard University’s Wyss Institute for Biologically Inspired Engineering. Organ bioprinting is the use of 3D-printing technologies to assemble multiple cell types, growth factors and biomaterials in a layer-by-layer fashion to produce bioartificial organs that ideally imitate their natural counterparts, according to a 2019 study.

This type of regenerative medicine is in the development stage, and the driving force behind this innovation is “real human need,” Lewis said.

In the United States, there are 106,800 men, women and children on the national organ transplant waiting list as of March 8, 2023, according to the Health Resources & Services Administration. However, living donors provide only around 6,000 organs per year on average, and there are about 8,000 deceased donors annually who each provide 3.5 organs on average.

The cause of this discrepancy is “a combination of people who undergo catastrophic health events, but their organs aren’t high enough quality to donate, or they’re not on the organ donor list to begin with, and the fact that it’s actually very difficult to find a good match” so the patient’s body doesn’t reject the transplanted organ, Lewis said.

And even though living donors are an option, “to do surgery on someone who doesn’t need it” is a big risk, said Dr. Anthony Atala, director of the Wake Forest Institute for Regenerative Medicine. “So, living related donors are usually not the preferred way to go because then you’re taking an organ away from somebody else who may need it, especially now as we age longer.”

Atala and his colleagues were responsible for growing human bladders in a lab by hand in 2006, and implanting a complicated internal organ into people for the first time — saving the lives of three children in whom they implanted the bladders.

Every day, 17 people die waiting for an organ transplant, according to the Health Resources & Services Administration. And every 10 minutes, another person is added to the waitlist, the agency says. More than 90% of the people on the transplant list in 2021 needed a kidney.

“About a million people worldwide are in need of a kidney. So they have end-stage renal failure, and they have to go on dialysis,” Lewis said. “Once you go on dialysis, you have essentially five years to live, and every year, your mortality rate increases by 15%. Dialysis is very hard on your body. So this is really motivating to take on this grand challenge of printing organs.”

“Anti-hypertensive pills are not scarce. Everybody who needs them can get them,” Martine Rothblatt, CEO and chairman of United Therapeutics, said in June 2022 at the Life Itself conference, a health and wellness event presented in partnership with CNN. United Therapeutics was one of the conference sponsors.

“There is no practical reason why anybody who needs a kidney — or a lung, a heart, a liver — should not be able to get one,” she added. “We’re using technology to solve this problem.”

To begin the process of bioprinting an organ, doctors typically start with a patient’s own cells. They take a small needle biopsy of an organ or do a minimally invasive surgical procedure that removes a small piece of tissue, “less than half the size of a postage stamp,” Atala said. “By taking this small piece of tissue, we are able to tease cells apart (and) we grow and expand the cells outside the body.”

This growth happens inside a sterile incubator or bioreactor, a pressurized stainless steel vessel that helps the cells stay fed with nutrients — called “media” — the doctors feed them every 24 hours, since cells have their own metabolism, Lewis said. Each cell type has a different media, and the incubator or bioreactor acts as an oven-like device mimicking the internal temperature and oxygenation of the human body, Atala said.

“Then we mix it with this gel, which is like a glue,” Atala said. “Every organ in your body has the cells and the glue that holds it together. Basically, that’s also called ‘extracellular matrix.’”

This glue is Atala’s nickname for bioink, a printable mixture of living cells, water-rich molecules called hydrogels, and the media and growth factors that help the cells continue to proliferate and differentiate, Lewis said. The hydrogels mimic the human body’s extracellular matrix, which contains substances including proteins, collagen and hyaluronic acid.

The non-cell sample portion of the glue can be made in a lab, and “is going to have the same properties of the tissue you’re trying to replace,” Atala said.

The biomaterials used typically have to be nontoxic, biodegradable and biocompatible to avoid a negative immune response, Lewis said. Collagen and gelatin are two of the most common biomaterials used for bioprinting tissues or organs.

From there, doctors load each bioink — depending on how many cell types they’re wanting to print — into a printing chamber, “using a printhead and nozzle to extrude an ink and build the material up layer by layer,” Lewis said. Creating tissue with personalized properties is enabled by printers being programmed with a patient’s imaging data from X-rays or scans, Atala said.

“With a color printer you have several different cartridges, and each cartridge is printing a different color, and you come up with your (final) color,” Atala added. Bioprinting is the same; you’re just using cells instead of traditional inks.

How long the printing process takes depends on several factors, including the organ or tissue being printed, the fineness of the resolution and the number of printheads needed, Lewis said. But it typically lasts a few to several hours. The time from the biopsy to the implantation is about four to six weeks, Atala said.

A 3D printer seeds different types of cells onto a kidney scaffold at the Wake Forest Institute for Regenerative Medicine.

The ultimate challenge is “getting the organs to actually function as they should,” so accomplishing that “is the holy grail,” Lewis said.

“Just like if you were to harvest an organ from a donor, you have to immediately get that organ into a bioreactor and start perfusing it or the cells die,” she added. To perfuse an organ is to supply it with fluid, usually blood or a blood substitute, by circulating it through blood vessels or other channels.

Depending on the organ’s complexity, there is sometimes a need to mature the tissue further in a bioreactor or further drive connections, Lewis said. “There’s just a number of plumbing issues and challenges that have to be done in order to make that printed organ actually function like a human organ would in vivo (meaning in the body). And honestly, this has not been fully solved yet.”

Once a bioprinted organ is implanted into a patient, it will naturally degrade over time — which is OK since that’s how it’s designed to work.

“You’re probably wondering, ‘Well, then what happens to the tissue? Will it fall apart?’ Actually, no,” Atala said. “These glues dissolve, and the cells sense that the bridge is giving way; they sense that they don’t have a firm footing anymore. So cells do what they do in your very own body, which is to create their own bridge and create their own glue.”

Atala and Lewis are conservative in their estimates about the number of years remaining before fully functioning bioprinted organs can be implanted into humans.

“The field’s moving fast, but I mean, I think we’re talking about a decade plus, even with all of the tremendous progress that’s been made,” Lewis said.

“I learned so many years ago never to predict because you’ll always be wrong,” Atala said. “There’s so many factors in terms of manufacturing and the (US Food and Drug Administration regulation). At the end of the day, our interest, of course, is to make sure the technologies are safe for the patient above all.”

Whenever bioprinting organs becomes an available option, affordability for patients and their caregivers shouldn’t be an issue.

They’ll be “accessible for sure,” Atala said. “The costs associated with organ failures are very high. Just to keep a patient on dialysis is over a quarter of a million dollars per year, just to keep one patient on dialysis. So, it’s a lot cheaper to create an organ that you can implant into the patient.”

The average kidney transplant cost was $442,500 in 2020, according to research published by the American Society of Nephrology — while 3D printers retail for around a few thousand dollars to upward of $100,000, depending on their complexity. But even though low-cost printers are available, pricey parts of bioprinting can include maintaining cell banks for patients, culturing cells and safely handling biological materials, Lewis said.

Some of the major costs of current organ transplantation are “harvesting the organ from the donor, the transport costs and then, of course, the surgery that the recipient goes through, and then all the care and monitoring,” Lewis said. “Some of that cost would still be in play, even if it was bioprinted.”

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What is the painful condition called shingles? | CNN

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Sen. Dianne Feinstein, the 89-year-old California Democrat, recently announced she is out of the hospital and recovering at home from shingles, a painful viral inflammation in the skin’s nerves that causes a blistering rash lasting for two to four weeks. Feinstein was diagnosed in February and hospitalized in San Francisco last week.

Shingles, also called herpes zoster, is caused by the varicella-zoster virus — which is the same virus responsible for chickenpox. Varicella zoster is also responsible for a rare condition called Ramsay Hunt syndrome that caused pop star Justin Bieber’s face to become partially paralyzed in June 2022.

“As you can see, this eye is not blinking. I can’t smile on this side of my face. This nostril will not move,” Bieber said at the time in answer to fans who wondered why he had canceled performances.

Painful skin is one of first signs of shingles, and for some people, the pain is intense. It can create a burning sensation, or the skin can tingle or be sensitive to touch, according to the Mayo Clinic. Shingles can occur at other places on the body, such as the face and scalp, but the most common presentation is on the torso on one side of the body.

A red rash will begin to develop at the site of the pain within a few days. The rash often begins as a small, painful patch, which then spreads like “a stripe of blisters that wraps around either the left or right side of the torso,” the Mayo Clinic said.

In rare cases, the rash may become more widespread and look similar to a chickenpox rash, typically in people with weakened immune systems, according to the US Centers of Disease Control and Prevention.

In addition to pain, some people may develop chills, fatigue, fever, headache, upset stomach and sensitivity to light. See a doctor if you are over 50, have a weakened immune system, the rash is widespread and painful, or the pain and rash occur near an eye.

“If left untreated, this infection may lead to permanent eye damage,” according to the Mayo Clinic.

The varicella-zoster virus is highly contagious when in the blister stage, spreading through direct contact with the fluid from blisters and via viral particles in the air.

However, you cannot get shingles from someone who has shingles. If you aren’t vaccinated for chickenpox or haven’t previously had it and are infected by that person, you will develop chickenpox, which then puts you at risk for shingles later in life, the CDC said.

If you have shingles, you can prevent the spread of the virus by covering the rash and not touching or scratching the raised vesicles that form the rash, the CDC stated. Wash your hands often.

“People with shingles cannot spread the virus before their rash blisters appear or after the rash crusts,” the CDC said.

If the rash is covered, the risk of transmission “is low,” the CDC said. “People with chickenpox are more likely to spread (the virus) than people with shingles.”

If you think you have shingles, call a doctor as soon as you can, the CDC recommended. If caught early, there are antiviral medications, including acyclovir, valacyclovir and famciclovir, that can shorten the length and severity of the illness.

“These medicines are most effective if you start taking them as soon as possible after the rash appears,” the CDC said.

Doctors may also suggest over-the-counter or prescription pain medication for the burning and pain, while calamine lotion, wet compresses and oatmeal baths may ease itching.

For older adults, the population most likely to develop shingles, the best treatment is prevention. The US Food and Drug Administration approved a two-dose vaccine called Shingrix in 2017 for people 50 and older.

“Shingrix is also recommended for adults 19 years and older who have weakened immune systems because of disease or therapy,” the CDC said.

Shingrix, which is not based on a live virus, is more than 90% effective in encouraging the aging immune system to recognize and be ready to fight the virus, according to its manufacturer, GlaxoSmithKline.

Anyone who has had a severe allergic reaction to a dose of Shingrix or is allergic to any of the components of the vaccine should avoid it, the CDC said.

“People who currently have shingles, and women who are pregnant or breastfeeding, should wait to get Shingrix,” the CDC said.

Another vaccine called Zostavax, which the FDA approved for people over 50 in 2006, is 51% effective in preventing shingles, according to the CDC. Zostavax is based on a live virus, the same approach used for the chickenpox vaccine recommended in childhood. It has not been sold in the United States since November 2020.

If you have never had chickenpox, you can’t get shingles. However, once you’ve had chickenpox, the virus remains inactive in the spine’s sensory neurons, possibly erupting years later as shingles.

Two doses of a chickenpox vaccine for children, teens and adults, introduced in 1995, is 100% effective at preventing a severe case of chickenpox, according to the CDC. Immunity lasts 10 to 20 years, the CDC noted.

In the small number of people who still get chickenpox after vaccination, the illness is typically milder, with few or no blisters.

The CDC recommends the vaccine be given to children in two doses, the first between 12 and 15 months and a second one between 4 and 6 years. Anyone 13 years old and older who has no evidence of immunity can get two doses four to eight weeks apart, the CDC said.

Some people should not get the vaccine, including pregnant women, people with certain blood disorders or those on prolonged immunosuppressive therapy, and those with a moderate or severe illness, among others.

About 1 in 10 people will develop a painful and possibly debilitating condition called postherpetic neuralgia, or long-term nerve pain. All other signs of the rash can be gone, but the area is extremely painful to touch. Less often, itching or numbness can occur.

The condition rarely affects people under 40, the CDC said. Older adults are most likely to have more severe pain that lasts longer than a younger person with shingles. For some, the nerve pain can be devastating.

“Five years later, I still take prescription medication for pain,” said a 63-year-old harpist who shared his story on the CDC website. “My shingles rash quickly developed into open, oozing sores that in only a few days required me to be hospitalized.

“I could not eat, sleep, or perform even the most minor tasks. It was totally debilitating. The pain still limits my activity levels to this day,” said the musician, who has been unable to continue playing the harp due to pain.

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How human gene editing is moving on after the CRISPR baby scandal | CNN

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For most of her life, Victoria Gray, a 37-year-old mother of four from Mississippi, had experienced excruciating bouts of pain.

Born with the blood disorder sickle cell disease, lengthy hospital stays and debilitating fatigue disrupted her childhood, forcing her to quit pursuing a college nursing degree and take potent and addictive painkillers.

“The pain I would feel in my body was like being struck by lightning and hit by a freight train all at once,” she said this week at the Third International Summit on Human Genome Editing in London.

In 2019, she received an experimental treatment for the inherited disease that used the gene-editing technique CRISPR-Cas9, which allowed doctors to make very precise changes to her DNA. While the procedure itself was grueling and took seven to eight months to fully recover from, she said it has transformed her life.

“The feeling is amazing. I really feel that I’m cured now,” Gray said. “Because I no longer have to face the battles that I faced on a day-to-day (basis). I came from having to have an in-home caregiver to help me take baths, clean my house and care for my children. Now I do all those things on my own.”

She’s now able to enjoy a life she once felt was passing her by. She holds down a full-time job as a Walmart cashier, and she’s able to attend her children’s football games and cheerleading events and enjoy family outings. “The life I felt I was just existing in I’m now thriving in,” she said.

Gray shared her experience with doctors, scientists, patient advocates and bioethicists who gathered in London for the human genome editing summit, at which participants reported on advances made in the field and debated the thorny ethical issues posed by the cutting-edge technology.

“I’m here really to be a light because there’s mixed feelings about gene editing. And I think people can see the positive result of it. You know that a person who was once suffering in life, was miserable, now is able to be a part of life and enjoy it,” Gray told CNN.

Gray’s uplifting story, which received a standing ovation from the audience, stood in contrast to a presentation made the last time the conference was held, in Hong Kong in 2018, when Chinese doctor He Jiankui stunned his peers and the world with the revelation that he had created the world’s first gene-edited babies.

The two girls grew from embryos He had modified using CRISPR-Cas9, which he said would make them resistant to HIV. His work was widely condemned by the scientific community, which decried the experiment as medically unnecessary and ethically irresponsible. He received a three-year jail sentence in 2019.

Questions about the baby scandal still linger more than four years later, and after being recently released from prison, He is reportedly seeking to continue his work. China has tightened its regulation of experimental biomedical research since 2018, but it hasn’t gone far enough, said Joy Zhang, a medical sociologist at the University of Kent in the United Kingdom.

“Ethical governance in practice is still confined to traditional medical, scientific, as well as educational, establishments. The new measures fail to directly address how privately funded research and other … ventures will be monitored,” Zhang said at the conference.

Ethically questionable experimental research isn’t an issue confined to China, said Robin Lovell-Badge, head of the Laboratory of Stem Cell Biology and Developmental Genetics at the Francis Crick Institute in London, who chaired the 2018 Hong Kong conference session in which He attempted to defend his work.

“(He Jiankui) is not the only concern in this area. One of our big concerns I always have is the possibility that there will be rogue companies, rogue scientists setting up to do genome editing in an inappropriate way,” Lovell-Badge said on Monday at the conference.

Gray shared her story at Monday's conference.

While the CRISPR baby scandal tarnished the technology’s reputation, CRISPR-Cas9 and related techniques have made a major impact on biomedical research, and two scientists behind the tool — Emmanuelle Charpentier and Jennifer A. Doudna — won a Nobel prize for their work in 2020.

“Clinical trial results demonstrate that CRISPR is safe, and it’s effective for treating and curing human disease — an extraordinary advance given the technology is only 10 years old,” Doudna said at the conference in a video address. “It’s important with a powerful technology like this to grapple with the challenges of responsible use.”

In addition to the sickle cell trial that includes Gray, clinical trials are also underway to test the safety of gene editing in treating several other conditions, including a related blood disorder called beta thalassemia; leber congenital amaurosis, which is a form of inherited childhood blindness; blood cancers such as leukemia and lymphoma; type 1 diabetes; and HIV/AIDS.

DNA acts as a instruction manual for life on our planet, and CRISPR-Cas9 can target sites in plant and animal cells using guide RNA to get the Cas-9 enzyme to a more precise spot on a strand of DNA. This allows scientists to change DNA by knocking out a particular gene or inserting new genetic material at a predetermined site in the strand.

People with sickle cell disease have abnormal hemoglobin in red blood cells that can cause them to get hard and sticky, clogging blood flow in small vessels.

In the trial that Gray was part of, doctors increased the production of a different kind of hemoglobin, known as fetal hemoglobin, which makes it harder for cells to sickle and stick together. The process is invasive and involves removing premature cells from the bone marrow and modifying them — by using CRISPR-Cas9 in the lab — to eventually produce fetal hemoglobin. The patient has to undergo a round of chemotherapy before receiving the gene-edited cells to ensure the body doesn’t reject them.

The conference also shed light on new, more sophisticated gene-editing techniques, such as prime editing and base editing, which recently was used to modify immune cells and successfully treat a teen with treatment-resistant leukemia.

These next generation techniques will allow humans “to have some say in the sequence of our genomes so we are no longer so beholden to the misspellings in our DNA,” said David Liu, the Richard Merkin professor and director of the Merkin Institute of Transformative Technologies in Healthcare at the Broad Institute of MIT and Harvard University.

The gene therapy trials currently underway involve treating people who were born with a certain disease or condition by altering non-reproductive cells in what’s known as somatic gene editing.

The next frontier — many would say red line — is heritable gene editing: altering the genetic material in human sperm, eggs or embryos so that it can be safely passed onto the next generation. The goal would be to prevent babies from inheriting genetic diseases.

A researcher handles a petri dish while observing a CRISPR/Cas9 process through a stereomicroscope at the Max-Delbrueck-Centre for Molecular Medicine in 2018.

“It’s a very different set of ethical trade-offs when you’re not a treating disease in an existing individual but you’re in fact preventing an individual yet to be born from suffering from a disease. That’s a very different set of considerations,” said George Daley, Caroline Shields Walker Professor of Medicine and dean of the faculty of medicine at Harvard Medical School.

In a statement released at the end of the conference, the organizers said “heritable human genome editing remains unacceptable at this time.”

They added that public discussion and policy debates should continue and were important for resolving whether this technology should be used.

The hope offered by gene therapy is creating fresh ethical storms — primarily over who gets access to such treatments. The therapy Gray received, which is expected to soon receive regulatory approval, is likely to cost more than $2 million per person, putting it out of reach for many who need it in the United States and in low-income countries.

“If we want to be serious about equitable access to these kinds of therapies, we have to start talking early on about ways to develop them and make them available and make them cost effective and sustainable,” said Alta Charo, the Warren P. Knowles Professor Emerita of Law and Bioethics at the University of Wisconsin at Madison.

Researchers want to develop CRISPR therapies that can be delivered though an injection rather than the chemotherapy and invasive bone marrow transplant Gray went through.

Worldwide, more than 300,000 children are born with sickle cell disease every year, over 75% of whom live in sub-Saharan Africa, where screening programs and treatment options are limited.

Even relatively affordable drugs to treat sickle cell disease, such as hydroxyurea, don’t reach everyone who needs them in India, said Gautam Dongre, the secretary of the National Alliance of Sickle Cell Organizations in India and father of two children with sickle cell disease.

“After 40 years if these drugs aren’t reachable for the common people, then what about gene therapy?” Dongre asked at the conference.

Julie Makani, an associate professor in the department of haematology and blood transfusion at Muhimbili University of Health and Allied Sciences in Tanzania, said more genomic research should take place in Africa.

“The ultimate thing for me, particularly as a physician scientist, is not just discovery, but also seeing the application of knowledge…into (an) improvement in health,” Makani said.

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Canadian siblings born four months early set record as the world’s most premature twins | CNN

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—

For expectant parents Shakina Rajendram and Kevin Nadarajah, the doctor’s words were both definitive and devastating: Their twins were not “viable.”

“Even in that moment, as I was hearing those words come out of the doctor’s mouth, I could still feel the babies very much alive within me. And so for me, I just wasn’t able to comprehend how babies who felt very much alive within me could not be viable,” Rajendram recalled.

Still, she knew that there was no way she would be able to carry to term. She had begun bleeding, and the doctor said she would give birth soon. The parents-to-be were told that they would be able to hold their babies but that they would not be resuscitated, as they were too premature.

Rajendram, 35, and Nadarajah, 37, had married and settled in Ajax, Ontario, about 35 miles east of Toronto, to start a family. They had conceived once before, but the pregnancy was ectopic – outside the uterus – and ended after a few months.

As crushing as the doctor’s news was, Nadarajah said, they both refused to believe their babies would not make it. And so they scoured the Internet, finding information that both alarmed and encouraged them. The babies were at just 21 weeks and five days gestation; to have a chance, they would need to stay in the womb a day and a half longer, and Rajendram would have to go to a specialized hospital that could treat “micropreemies.”

The earlier a baby is born, the higher the risk of death or serious disability, the US Centers for Disease Control and Prevention says. Babies born preterm, before 37 weeks gestation, can have breathing issues, digestive problems and brain bleeds. Development challenges and delays can also last a lifetime.

The problems can be especially severe for micropreemies, those born before 26 weeks gestation who weigh less than 26 ounces.

Research has found that infants born at 22 weeks who get active medical treatment have survival rates of 25% to 50%, according to a 2019 study.

Adrial was born weighing less than 15 ounces.

Rajendram and Nadarajah requested a transfer to Mount Sinai Hospital in Toronto, one of a limited number of medical centers in North America that provides resuscitation and active care at 22 weeks gestation.

Then, they say, they “prayed hard,” with Rajendram determined to keep the babies inside her just a few hours longer.

Just one hour after midnight on March 4, 2022, at 22 weeks gestation, Adiah Laelynn Nadarajah was born weighing under 12 ounces. Her brother, Adrial Luka Nadarajah, joined her 23 minutes later, weighing not quite 15 ounces.

According to Guinness World Records, the pair are both the most premature and lightest twins ever born. The previous record holders for premature twins were the Ewoldt twins, born in Iowa at the gestational age of 22 weeks, 1 day.

It is a record these parents say they want broken as soon as possible so more babies are given the opportunity to survive.

“They were perfect in every sense to us,” Rajendram said. “They were born smaller than the palm of our hands. People still don’t believe us when we tell them.”

The babies were born at just the right time to be eligible to receive proactive care, resuscitation, nutrition and vital organ support, according to Mount Sinai Hospital. Even an hour earlier, the care team may not have been able to intervene medically.

“We just didn’t really understand why that strict cut off at 22, but we know that the hospital had their reasons. They were in uncharted territory, and I know that they had to possibly create some parameters around what they could do,” Rajendram said.

“They’re definitely miracles,” Nadarajah said as he described seeing the twins in the neonatal intensive care unit for the first time and trying to come to terms with what they would go through in their fight to survive.

“I had challenging feelings, conflicting feelings, seeing how tiny they were on one hand, feeling the joy of seeing two babies on the second hand. I was thinking, ‘how much pain they are in?’ It was so conflicting. They were so tiny,” he said.

These risks and setbacks are common in the lives of micropreemies.

Dr. Prakesh Shah, the pediatrician-in-chief at Mount Sinai Hospital, said he was straightforward with the couple about the challenges ahead for their twins.

He warned of a struggle just to keep Adiah and Adrial breathing, let alone feed them.

The babies weighed little more than a can of soda, with their organs visible through translucent skin. The needle used to give them nutrition was less than 2 millimeters in diameter, about the size of a thin knitting needle.

“At some stage, many of us would have felt that, ‘is this the right thing to do for these babies?’ These babies were in significant pain, distress, and their skin was peeling off. Even removing surgical tape would mean that their skin would peel off,” Shah told CNN.

But what their parents saw gave them hope.

“We could see through their skin. We could see their hearts beating,” Rajendram said.

They had to weigh all the risks of going forward and agreeing to more and more medical intervention. There could be months or even years of painful, difficult treatment ahead, along with the long-term risks of things like muscle development problems, cerebral palsy, language delays, cognitive delays, blindness and deafness.

Rajendram and Nadarajah did not dare hope for another miracle, but they say they knew their babies were fighters, and they resolved to give them a chance at life.

“The strength that Kevin and I had as parents, we had to believe that our babies had that same strength, that they have that same resilience. And so yes, they would have to go through pain, and they’re going to continue going through difficult moments, even through their adult life, not only as premature babies. But we believed that they would have a stronger resolve, a resilience that would enable them to get through those painful moments in the NICU,” Rajendram said.

There were painful setbacks over nearly half a year of treatment in the hospital, especially in the first few weeks.

“There were several instances in the early days where we were asked about withdrawing care, that’s just a fact, and so those were the moments where we just rallied in prayer, and we saw a turnaround,” Nadarajah said.

Adiah spent 161 days in the hospital and went home on August 11, six days before her brother, Adrial, joined her there.

Adrial’s road has been a bit more difficult. He has been hospitalized three more times with various infections, sometimes spending weeks in the hospital.

Both siblings continue with specialist checkups and various types of therapy several times a month.

But the new parents are finally more at ease, celebrating their babies’ homecoming and learning all they can about their personalities.

The twins are now meeting many of the milestones of babies for their “corrected age,” where they would be if they were born at full-term.

“The one thing that really surprised me, when both of them were ready to go home, both of them went home without oxygen, no feeding tube, nothing, they just went home. They were feeding on their own and maintaining their oxygen,” Shah said.

Adiah is now very social and has long conversations with everyone she meets. Their parents describe Adrial as wise for his years, curious and intelligent, with a love of music.

“We feel it’s very important to highlight that contrary to what was expected of them, our babies are happy, healthy, active babies who are breathing and feeding on their own, rolling over, babbling all the time, growing well, playing, and enjoying life as babies,” Rajendram said.

These parents hope their story will inspire other families and health professionals to reassess the issue of viability before 22 weeks gestation, even when confronted with sobering survival rates and risks of long-term disability.

“Even five years ago, we would not have gone for it, if it was not for the better help we can now provide,” Shah said, adding that medical teams are using life-sustaining technology in a better way than in previous years. “It’s allowing us to sustain these babies, helping keep oxygen in their bodies, the role of carbon dioxide, without causing lung injury.”

Adiah and Adrial’s parents say they’re not expecting perfect children with perfect health but are striving to provide the best possible life for them.

“This journey has empowered us to advocate for the lives of other preterm infants like Adiah and Adrial, who would not be alive today if the boundaries of viability had not been challenged by their health care team,” Rajendram said.

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