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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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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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Asthma, cancer, erectile drugs sent from abroad make up are most confiscations, despite opioid claims | CNN

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For years, the FDA has defended its efforts to intercept prescription drugs coming from abroad by mail as necessary to keep out dangerous opioids, including fentanyl.

The pharmaceutical industry frequently cites such concerns in its battle to stymie numerous proposals in Washington to allow Americans to buy drugs from Canada and other countries where prices are almost always much lower.

But the agency’s own data from recent years on its confiscation of packages containing drugs coming through international mail provides scant evidence that a significant number of opioids enters this way. In the two years for which KHN obtained data from the agency, only a tiny fraction of the drugs inspected contained opioids.

The overwhelming majority were uncontrolled prescription drugs that people had ordered, presumably because they can’t afford the prices at home.

The FDA still stops those drugs, because they lack U.S. labeling and packaging, which federal authorities say ensure they were made under U.S. supervision and tracking.

The FDA said it found 33 packages of opioids and no fentanyl sent by mail in 2022 out of nearly 53,000 drug shipments its inspectors examined at international mail facilities. That’s about 0.06% of examined packages.

According to a detailed breakdown of drugs intercepted in 2020, the lion’s share of what was intercepted — and most often destroyed — was pharmaceuticals. The No. 1 item was cheap erectile dysfunction pills, like generic Viagra. But there were also prescribed medicines to treat asthma, diabetes, cancer, and HIV.

FDA spokesperson Devin Koontz said the figures don’t reflect the full picture because U.S. Customs and Border Protection is the primary screener at the mail facilities.

But data obtained from the customs agency shows it likewise found few opioids: Of more than 30,000 drugs it intercepted in 2022 at the international mail facilities, only 111 were fentanyl and 116 were other opioids.

On average, Americans pay more than twice the price for exactly the same drugs as people in other countries. In polling, 7% of U.S. adults say they do not take their medicines because they can’t afford them. About 8% admit they or someone else in their household has ordered medicines from overseas to save money, though it is technically illegal in most cases. At least four states — Florida, Colorado, New Hampshire, and New Mexico — have proposed programs that would allow residents to import drugs from Canada.

While the FDA has found only a relatively small number of opioids, including fentanyl, in international mail, Congress gave the agency a total of $10 million in 2022 and 2023 to expand efforts to interdict shipments of opioids and other unapproved drugs.

“Additional staffing coupled with improved analytical technology and data analytics techniques will allow us to not only examine more packages but will also increase our targeting abilities to ensure we are examining packages with a high probability of containing violative products,” said Dan Solis, assistant commissioner for import operations at the FDA.

But drug importation proponents worry the increased inspections targeting opioids will result in more uncontrolled substances being blocked in the mail.

“The FDA continues to ask for more and more taxpayer money to stop fentanyl and opioids at international mail facilities, but it appears to be using that money to refuse and destroy an increasing number of regular international prescription drug orders,” said Gabe Levitt, president of PharmacyChecker.com, which accredits foreign online pharmacies that sell medicines to customers in the U.S. and worldwide. “The argument that importing drugs is going to inflame the opioid crisis doesn’t make any sense.”

“The nation’s fentanyl import crisis should not be conflated with safe personal drug importation,” Levitt said.

He was not surprised at the low number of opioids being sent through the mail: In 2022, an organization he heads called Prescription Justice received 2020 FDA data through a Freedom of Information Act request. It showed that FDA inspectors intercepted 214 packages with opioids and no fentanyl out of roughly 50,000 drug shipments. In contrast, they found nearly 12,000 packages containing erectile dysfunction pills. They also blocked thousands of packages containing prescription medicines to treat a host of other conditions.

Over 90% of the drugs found at international mail facilities are destroyed or denied entry into the United States, FDA officials said.

In 2019, an FDA document touted the agency’s efforts to stop fentanyl coming into the United States by mail amid efforts to stop other illegal drugs.

Levitt was pleased that Congress in December added language to a federal spending bill that he said would refocus the FDA mail inspections. It said the “FDA’s efforts at International Mail Facilities must focus on preventing controlled, counterfeit, or otherwise dangerous pharmaceuticals from entering the United States. Further, funds made available in this Act should prioritize cases in which importation poses a significant threat to public health.”

Levitt said the language should shift the FDA from stopping shipments containing drugs for cancer, heart conditions, and erectile dysfunction to blocking controlled substances, including opioids.

But the FDA’s Koontz said the language won’t change the type of drugs FDA inspectors examine, because every drug is potentially dangerous. “Importing drugs from abroad simply for cost savings is not a good enough reason to expose yourself to the additional risks,” he said. “The drug may be fine, but we don’t know, so we assume it is not.”

He said even drugs that are made in the same manufacturing facilities as drugs intended for sale in the United States can be dangerous because they lack U.S. labeling and packaging that ensure they were made properly and handled within the U.S. supply chain.

FDA officials say drugs bought from foreign pharmacies are 10 times as likely to be counterfeit as drugs sold in the United States.

To back up that claim, the FDA cites congressional testimony from a former agency official in 2005 who — while working for a drug industry-funded think tank — said between 8% and 10% of the global medicine supply chain is counterfeit.

The FDA said it doesn’t have data showing which drugs it finds are unsafe counterfeits and which drugs lack proper labeling or packaging. The U.S. Customs and Border Protection data shows that, among the more than 30,000 drugs it inspected in 2022, it found 365 counterfeits.

Pharmaceutical Research and Manufacturers of America, the trade group for the industry, funds a nonprofit advocacy organization called Partnership for Safe Medicines, which has run media campaigns to oppose drug importation efforts with the argument that it would worsen the fentanyl epidemic.

Shabbir Safdar, executive director of the Partnership for Safe Medicines, a group funded by U.S. pharmaceutical manufacturers, said he was surprised the amount of fentanyl and opioids found by customs and FDA inspectors in the mail was so low. He said that historically it has been a problem, but he could not provide proof of that claim.

He said federal agencies are not inspecting enough packages to get the full picture. “With limited resources we may be getting fooled by the smugglers,” he said. “We need to be inspecting the right 50,000 packages each year.”

For decades, millions of Americans seeking to save money have bought drugs from foreign pharmacies, with most sales done online. Although the FDA says people are not allowed to bring prescription drugs into the United States except in rare cases, dozens of cities, county governments, and school districts help their employees buy drugs from abroad.

The Trump administration said in 2020 that drugs could be safely imported and opened the door for states to apply to the FDA to start importation programs. But the Biden administration has yet to approve any.

A federal judge in February threw out a lawsuit filed by PhRMA and the Partnership for Safe Medicines to block the federal drug importation program, saying it’s unclear when, if ever, the federal government would approve any state programs.

Levitt and other importation advocates say the process is often safe largely because the drugs being sold to people with valid prescriptions via international mail are FDA-approved drugs with labeling different from that found at U.S. pharmacies, or foreign versions of FDA-approved drugs made at the same facilities as drugs sold in the U.S. or similarly regulated facilities. Most drugs sold at U.S. pharmacies are already produced abroad.

Because of the sheer volume of mail, even as the FDA has stepped up staffing at the mail facilities in recent years, the agency can physically inspect fewer than 1% of packages presumed to contain drugs, FDA officials said.

Solis said the agency targets its interdiction efforts to packages from countries from which it believes counterfeit or illegal drugs are more likely to come.

Advocates for importation say efforts to block it protect the pharmaceutical industry’s profits and hurt U.S. residents trying to afford their medicines.

“We have never seen a rash of deaths or harm from prescription drugs that people bring across the border from verified pharmacies, because these are the same drugs that people buy in American pharmacies,” said Alex Lawson, executive director of Social Security Works, which advocates for lower drug prices. “The pharmaceutical industry is using the FDA to protect their price monopoly to keep their prices high.”

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Some experts say more women should consider removing fallopian tubes to reduce cancer risk | CNN

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“Knowledge is power,” says Samantha Carlucci, 26. The Ravena, New York, resident recently had a hysterectomy that included removing her fallopian tubes – and believes it saved her life.

The Ovarian Cancer Research Alliance is drawing attention to the role of fallopian tubes in many cases of ovarian cancer and now says more women, including those with average risk, should consider having their tubes removed to cut their cancer risk.

About 20,000 women in the US were diagnosed with ovarian cancer in 2022, according to the National Cancer Institute, and nearly 13,000 died.

Experts have not discovered a reliable screening test to detect the early stages of ovarian cancer, leading them to rely on symptom awareness to diagnose patients, according to OCRA.

Unfortunately, symptoms of ovarian cancer often don’t present themselves until the cancer has advanced, causing the disease to go undetected and undiagnosed until it’s progressed to a later stage.

“If we had a test to detect ovarian cancer at early stages, the outcome of patients would be significantly better,” said Dr. Oliver Dorigo, director of the division of gynecologic oncology in the Department of Obstetrics and Gynecology at Stanford University Medical Center.

Until such a test is widely available, some researchers and advocates suggest a different way to reduce the risk: opportunistic salpingectomy, the surgical removal of both fallopian tubes.

Research has found that nearly 70% of ovarian cancer begins in the fallopian tubes, according to the Ovarian Cancer Research Alliance.

Doctors have already been advising more high-risk women to have a salpingectomy. Several factors can raise risk, including genetic mutations, endometriosis or a family history of ovarian or breast cancer, according to the US Centers for Disease Control and Prevention.

If they accept that they won’t be able to get pregnant afterward and if they are already planning on having pelvic surgery, it can be “opportunistic.”

“We are really talking about instances where a surgeon would already be in the abdomen anyway,” such as during a hysterectomy, said Dr. Karen Lu, professor and chair of the Department of Gynecologic Oncology and Reproductive Medicine at MD Anderson Cancer Center.

Although OCRA shifted its recommendation to include women with even an average risk of ovarian cancer, some experts continue to emphasize fallopian tube removal only for women with a high risk. Some are calling for more research on the procedure’s efficacy in women with an average risk.

Fallopian tubes are generally 4 to 5 inches long and about half an inch thick, according to Dorigo. During an opportunistic salpingectomy, both tubes are separated from the uterus and from a thin layer of tissue that extends along them from the uterus to the ovary.

The procedure can be done laparoscopically, with a thin instrument and a small incision, or through an open surgery, which involves a large incision across the abdomen.

The procedure adds roughly 15 minutes to any pelvic surgery, Dorigo said.

Unlike a total hysterectomy, in which a woman’s uterus, ovaries and fallopian tubes are removed, the removal of the tubes themselves does not affect the menstrual cycle and does not initiate menopause.

The risks associated with an opportunistic salpingectomy are also relatively low.

“Any surgery carries risk … so you do not want to enter any surgery without being thoughtful,” Lu said. “The risk of a salpingectomy to someone that is already undergoing surgery, though, I would say is minimal.”

Many women who have had the procedure say the benefit far outweighs the risk.

Carlucci had her fallopian tubes removed in January during a total hysterectomy, after testing positive for a genetic condition called Lynch syndrome that multiplied her risk of many kinds of cancers, including in the ovaries.

Several members of her family have died of colon and ovarian cancer, she said, and it prompted her to look into the available options.

Knowing that she could choose an opportunistic salpingectomy, which greatly decreased her chances of ovarian cancer, gave her hope.

As part of the total hysterectomy, it eliminated her risk of ovarian cancer.

“You can’t change your DNA, and no amount of dieting and exercise or medication is going to change it, and I felt horrible,” Carlucci said. “When I was given the news that this would 100% prevent me from ever having to deal with any ovarian cancer in my body, it was good to hear.”

Carlucci urges any woman with an average to high risk of ovarian cancer to talk to their doctor about the procedure.

“I know it seems scary, but this is something that you should do, or at the very least consider it,” she said. “It can bring so much relief knowing that you made a choice to keep you here for as long as possible.”

Monica Monfre Scantlebury, 45, of St. Paul, Minnesota, had a salpingectomy in March 2021 after witnessing a death related to breast and ovarian cancer in her family.

In 2018, Scantlebury’s sister was diagnosed with stage IV breast cancer at 27 years old.

“She went on to fight breast cancer,” Scantlebury said. “During the beginning of the pandemic, in March of 2020, she actually lost her battle to breast cancer at 29.”

During this period, Scantlebury herself found out that she was positive for BRCA1, a gene mutation that increases a person’s risk of breast cancer by 45% to 85% and the risk of ovarian cancer by 39% to 46%.

After meeting with her doctor and discussing her options, she decided to have a salpingectomy.

Her doctor told her she would remove the fallopian tubes and anything else of concern that she found during the procedure.

“When I woke up from surgery, she said there was something in my left ovary and that she had removed my left ovary and my fallopian tubes,” Scantlebury said.

Her doctor called about a week later and said there had been cancer cells in her left fallopian tube.

The salpingectomy had saved her life, the doctor said.

“We don’t have an easy way to be diagnosed until it is almost too late,” said Scantlebury, who went on to have a full hysterectomy. “This really saved my life and potentially has given me decades back that I might not have had.”

Audra Moran, president and CEO of the Ovarian Cancer Research Alliance, is sending one message to women: Know your risk.

Moran believes that if more women had the power of knowing their risk of ovarian cancer, more lives would be saved.

“Look at your family history. Have you had a history of ovarian cancer, breast cancer, colorectal or uterine in your family? Either side, male or female, father or mother?” Moran said. “If the answer is yes, then I would recommend talking to a doctor or talking to a genetic counselor.”

The alliance offers genetic testing resources on its website. A genetic counselor assess people’s risks for varying cancers based on inherited conditions, according to the US Bureau of Labor Statistics.

Carlucci and Scantlebury agree that understanding risk is key to preventing deaths among women.

“It’s my story. It’s her story. It’s my sister’s story … It is for all women,” Scantlebury said.

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Report shows ‘troubling’ rise in colorectal cancer among US adults younger than 55 | CNN

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CNN
—

Adults across the United States are being diagnosed with colon and rectal cancers at younger ages, and now 1 in 5 new cases are among those in their early 50s or younger, according to the American Cancer Society’s latest colorectal cancer report.

The report says that the proportion of colorectal cancer cases among adults younger than 55 increased from 11% in 1995 to 20% in 2019. There also appears to be an overall shift to more diagnoses of advanced stages of cancer. In 2019, 60% of all new colorectal cases among all ages were advanced.

“Anecdotally, it’s not rare for us now to hear about a young person with advanced colorectal cancer,” said Dr. William Dahut, chief scientific officer for the American Cancer Society. For example, Broadway actor Quentin Oliver Lee died last year at 34 after being diagnosed with stage IV colon cancer, and in 2020, “Black Panther” star Chadwick Boseman died at 43 of colon cancer.

“It used to be something we never heard or saw this, but it is a high percentage now of colorectal cancers under the age of 55,” Dahut said.

Although it’s difficult to pinpoint a cause for the rise in colorectal cancers among younger adults, he said, some factors might be related to changes in the environment or people’s diets.

“We’re not trying to blame anybody for their cancer diagnosis,” Dahut said. “But when you see something occurring in a short period of time, it’s more likely something external to the patient that’s driving that, and it’s hard not to at least think – when you have something like colorectal cancer – that something diet-related is not impossible.”

The new report also says that more people are surviving colorectal cancer, with the relative survival rate at least five years after diagnosis rising from 50% in the mid-1970s to 65% from 2012 through 2018, partly due to advancements in treatment.

That’s good news, said Dr. Paul Oberstein, a medical oncologist at NYU Langone Perlmutter Cancer Center, who was not involved in the new report. The overall trends suggest that colorectal cancer incidence and death rates have been slowly declining.

“If you look at the overall trends, the incidence of colon cancer in this report has decreased from 66 per 100,000 in 1985 to 35 per 100,000 in 2019 – so almost half,” Oberstein said.

“Changes in the mortality rate are even more impressive,” he said. “In 1970, which was a long time ago, the rate of colorectal cancer death was 29.2 per 100,000 people, and in 2020, it was 12.6 per 100,000. So a dramatic, over 55% decline in deaths per 100,000 people.”

Colorectal cancer is the second most common cause of cancer death in the United States, and it is the leading cause of cancer-related deaths in men younger than 50.

Dahut said the best way to reduce your risk of colorectal cancer is to follow screening guidelines and get a stool-based test or a visual exam such as a colonoscopy when it’s recommended. Any suspicious polyps can be removed during a visual exam, reducing your risk of cancer.

“At the ACS, we recommend if you’re at average risk, you start screening at age 45,” Dahut said. “Usually, then your subsequent screening is based on the results of that screening test.”

For the new report, researchers at the American Cancer Society analyzed data from the National Cancer Institute and the US Centers for Disease Control and Prevention on cancer screenings, cases and deaths.

The researchers found that from 2011 through 2019, colorectal cancer rates increased 1.9% each year in people younger than 55. And while overall colorectal cancer death rates fell 57% between 1970 and 2020, among people younger than 50, death rates continued to climb 1% annually since 2004.

“We know rates are increasing in young people, but it’s alarming to see how rapidly the whole patient population is shifting younger, despite shrinking numbers in the overall population,” Rebecca Siegel, senior scientific director of surveillance research at the American Cancer Society and lead author of the report, said in a news release. “The trend toward more advanced disease in people of all ages is also surprising and should motivate everyone 45 and older to get screened.”

Some regions of the United States appeared to have higher rates of colorectal cancers and deaths than others. These rates were lowest in the West and highest in Appalachia and parts of the South and the Midwest, the data showed. The incidence of colorectal cancer ranged from 27 cases per 100,000 people in Utah to 46.5 per 100,000 in Mississippi. Colorectal cancer death rates ranged from about 10 per 100,000 people in Connecticut to 17.6 per 100,000 in Mississippi.

There were some significant racial disparities, as well. The researchers found that colorectal cancer cases and deaths were highest in the American Indian/Alaska Native and Black communities. Among men specifically, the data showed that colorectal cancer death rates were 46% higher in American Indian/Alaska Native men and 44% higher in Black men compared with White men.

The report also says that more left-sided tumors have been diagnosed, meaning an increasing percentage of tumors are happening closer to the rectum. The proportion of colorectal cancers in that location has steadily climbed from 27% in 1995 to 31% in 2019.

“Historically, we’ve been worried more about the tumors on what we call the right side,” said NYU Langone’s Oberstein.

“But the incidence increasing, especially among young people, seems to be happening not only in those worse tumors but the ones that we think are not as bad,” he said, referring to left-sided tumors. “It’s raising questions about whether something is changing about the risks and the future people who are going to get colon cancer.”

Looking forward, the researchers estimate that there will be 153,020 colorectal cancer cases diagnosed in the US this year and an estimated 52,550 colorectal cancer deaths, with 3,750 of them – or 7% – among people younger than 50.

“These highly concerning data illustrate the urgent need to invest in targeted cancer research studies dedicated to understanding and preventing early-onset colorectal cancer,” Dr. Karen Knudsen, CEO of the American Cancer Society, said in the news release. “The shift to diagnosis of more advanced disease also underscores the importance of screening and early detection, which saves lives.”

The report’s findings, including the rise in colorectal cancer in younger adults, are “troubling,” Dr. Joel Gabre, an expert in gastrointestinal cancers at Columbia University Irving Medical Center, said in an email.

“It reflects other recent published findings demonstrating a rising incidence of colorectal cancer in young people. Most concerning to me, however, is a lack of clear cause and patients being diagnosed late. I think this is an area where more funding for research is needed to understand this really concerning rise,” wrote Gabre, who was not involved in the report.

Gabre says he knows what it’s like to look into his young patients’ eyes and tell them they have colorectal cancer, and “it’s devastating.”

“They have young families and so much of their life ahead of them. That’s why I encourage my patients who are age 45 years and older to get screened,” Gabre said. “I also encourage people to let their doctor know if they have a family history of colon cancer. There is genetic testing we can do to identify some at-risk patients early before they develop cancer.”

The findings highlight the importance of colorectal cancer screening, Dr. Robin Mendelsohn, gastroenterologist and co-director of the Center for Young Onset Colorectal and Gastrointestinal Cancers at Memorial Sloan Kettering Cancer Center, said in an email.

“The age to start screening was recently decreased to 45, which will help in an effort to screen more people, but we still need to understand more why we are seeing this increase which is something we are actively looking into,” wrote Mendelsohn, was not involved in the new report.

Mendelsohn says she has seen an increase in advanced colorectal cancers and diagnoses among her younger patients, and she says to watch for symptoms such as rectal bleeding, abdominal pain and changes in bowel habits.

“Until we understand more, it is important that patients and providers recognize these symptoms so they can be evaluated promptly,” she said. “And, if you are at an age to get screened, please get screened.”

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11 minutes of daily exercise could have a positive impact on your health, large study shows | CNN

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Sign up for CNN’s Fitness, But Better newsletter series. Our seven-part guide up will help you ease into a healthy routine, backed by experts.

CNN
—

When you can’t fit your entire workout into a busy day, do you think there’s no point in doing anything at all? You should rethink that mindset. Just 11 minutes of moderate-to-vigorous intensity aerobic activity per day could lower your risk of cancer, cardiovascular disease or premature death, a large new study has found.

Aerobic activities include walking, dancing, running, jogging, cycling and swimming. You can gauge the intensity level of an activity by your heart rate and how hard you’re breathing as you move. Generally, being able to talk but not sing during an activity would make it moderate intensity. Vigorous intensity is marked by the inability to carry on a conversation.

Higher levels of physical activity have been associated with lower rates of premature death and chronic disease, according to past research. But how the risk levels for these outcomes are affected by the amount of exercise someone gets has been more difficult to determine. To explore this impact, scientists largely from the University of Cambridge in the United Kingdom looked at data from 196 studies, amounting to more than 30 million adult participants who were followed for 10 years on average. The results of this latest study were published Tuesday in the British Journal of Sports Medicine.

The study mainly focused on participants who had done the minimum recommended amount of 150 minutes of exercise per week, or 22 minutes per day. Compared with inactive participants, adults who had done 150 minutes of moderate-to-vigorous aerobic physical activity per week had a 31% lower risk of dying from any cause, a 29% lower risk of dying from cardiovascular disease and a 15% lower risk of dying from cancer.

The same amount of exercise was linked with a 27% lower risk of developing cardiovascular disease and 12% lower risk when it came to cancer.

“This is a compelling systematic review of existing research,” said CNN Medical Analyst Dr. Leana Wen, an emergency physician and public health professor at George Washington University, who wasn’t involved in the research. “We already knew that there was a strong correlation between increased physical activity and reduced risk for cardiovascular disease, cancer and premature death. This research confirms it, and furthermore states that a smaller amount than the 150 minutes of recommended exercise a week can help.”

Even people who got just half the minimum recommended amount of physical activity benefited. Accumulating 75 minutes of moderate-intensity activity per week — about 11 minutes of activity per day — was associated with a 23% lower risk of early death. Getting active for 75 minutes on a weekly basis was also enough to reduce the risk of developing cardiovascular disease by 17% and cancer by 7%.

Beyond 150 minutes per week, any additional benefits were smaller.

“If you are someone who finds the idea of 150 minutes of moderate-intensity physical activity a week a bit daunting, then our findings should be good news,” said study author Dr. Soren Brage, group leader of the Physical Activity Epidemiology group in the Medical Research Council Epidemiology Unit at the University of Cambridge, in a news release. “This is also a good starting position — if you find that 75 minutes a week is manageable, then you could try stepping it up gradually to the full recommended amount.”

The authors’ findings affirm the World Health Organization’s position that doing some physical activity is better than doing none, even if you don’t get the recommended amounts of exercise.

“One in 10 premature deaths could have been prevented if everyone achieved even half the recommended level of physical activity,” the authors wrote in the study. Additionally, “10.9% and 5.2% of all incident cases of CVD (cardiovascular disease) and cancer would have been prevented.”

Important note: If you experience pain while exercising, stop immediately. Check with your doctor before beginning any new exercise program.

The authors didn’t have details on the specific types of physical activity the participants did. But some experts do have thoughts on how physical activity could reduce risk for chronic diseases and premature death.

“There are many potential mechanisms including the improvement and maintenance of body composition, insulin resistance and physical function because of a wide variety of favorable influences of aerobic activity,” said Haruki Momma, an associate professor of medicine and science in sports and exercise at Tohoku University in Japan. Momma wasn’t involved in the research.

Benefits could also include improvement to immune function, lung and heart health, inflammation levels, hypertension, cholesterol, and amount of body fat, said Eleanor Watts, a postdoctoral fellow in the division of cancer epidemiology and genetics at the National Cancer Institute. Watts wasn’t involved in the research.

“These translate into lower risk of getting chronic diseases,” said Peter Katzmarzyk, associate executive director for population and public health sciences at Pennington Biomedical Research Center in Baton Rouge, Louisiana. Katzmarzyk wasn’t involved in the research.

The fact that participants who did only half the minimum recommended amount of exercise still experienced benefits doesn’t mean people shouldn’t aim for more exercise, but rather that “perfect shouldn’t be the enemy of the good,” Wen said. “Some is better than none.”

To get up to 150 minutes of physical activity per week, find activities you enjoy, Wen said. “You are far more likely to engage in something you love doing than something you have to make yourself do.”

And when it comes to how you fit in your exercise, you can think outside the box.

“Moderate activity doesn’t have to involve what we normally think of (as) exercise, such as sports or running,” said study coauthor Leandro Garcia, a lecturer in the school of medicine, dentistry and biomedical sciences at Queen’s University Belfast, in a news release. “Sometimes, replacing some habits is all that is needed.

“For example, try to walk or cycle to your work or study place instead of using a car, or engage in active play with your kids or grand kids. Doing activities that you enjoy and that are easy to include in your weekly routine is an excellent way to become more active.”

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Cancer screenings could be back to normal after millions missed during Covid-19 pandemic | CNN

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CNN
—

Millions of people across the United States missed routine cancer screenings during the second year of the Covid-19 pandemic, with the prevalence of screening for breast, cervical and prostate cancers in the previous year falling anywhere from 6% to 15% between 2019 and 2021, according to a new study from the American Cancer Society.

“We were thinking there would be a rebound in late 2020,” said Dr. William Dahut, chief scientific officer of the American Cancer Society. “We were surprised to see the continued increase in the number of folks not getting their screenings.”

But more recently, it appears that people are starting to return to routine screenings at rates seen before the pandemic, separate research suggests.

Rates of screening for breast, cervical and colon cancers may have returned to normal, according to more recent data published last week in the journal Epic Research, which is owned by the health care software company Epic.

“As screening rates returned to normal from the drop we previously reported, rates of cancer diagnosis returned to normal as well,” Dr. Chris Alban, a clinical informaticist at Epic Research, wrote in an email.

“We haven’t seen evidence that the screenings missed during the pandemic resulted in worsened patient outcomes, though we plan to monitor this trend to see whether it holds over time,” he said. “The recommended intervals between screenings for a given cancer can be several years, so evidence of advanced cancers can take a long time to appear.”

Due to the declines in cancer screenings as well as barriers to accessing treatment in the early days of the pandemic, not only did physicians nationwide worry that screening and treatment delays led to patients arriving at their offices with advanced cancer, some anecdotally reported seeing upticks in advanced cancers at the time.

The prevalence of screening for breast, cervical and prostate cancers did not return to pre-pandemic levels in 2021, the second year of the Covid-19 pandemic, according to the American Cancer Society’s new study, published Thursday in the Journal of Clinical Oncology.

The study included data on more than 60,000 adults in the United States who were eligible for screening for breast, cervical, prostate and colorectal cancers between 2019 and 2021. The data came from the US Centers for Disease Control and Prevention’s National Health Interview Survey.

The researchers found that between 2019 and 2021, the overall prevalence of eligible adults who completed screening in the previous year fell 6% for breast cancer, 15% for cervical cancer and 10% for prostate cancer. That means there were about 1 million fewer people who got screened for breast cancer, 4.4 million fewer screened for cervical cancer and about 700,000 fewer screened for prostate cancer.

“These declines have significant public health implications as they are expected to lead to more advanced stage cancer diagnosis in the future,” the researchers wrote.

The prevalence of screening for colorectal cancer was unchanged, the researchers found.

The growing popularity of at-home colon cancer screening tests probably offset any decline in colorectal cancer screenings, they wrote.

The researchers also found some racial differences, as the Asian community had the largest declines in breast, cervical and prostate cancer screenings.

“These findings are especially concerning as cancer is the leading cause of death in both Asian American men and women,” wrote the researchers, all from the American Cancer Society.

Dahut said that anyone who missed a routine cancer screening during the early days of the pandemic should catch up now.

“Even in the best of times, the number of folks who are screened is far too low,” he said. “Go ahead and follow the guidelines, get screened when appropriate, and the outcomes will be better.”

The Epic Research study involved data on 373,574 cancer diagnoses entered in patients’ charts in the US between January 2018 and December 2022.

The data came from 190 health care organizations that use software from Epic for their electronic health records. Together, these organizations represent 1,123 hospitals and more than 22,500 clinics, and they agreed to contribute to the de-identified data set, meaning no individual patient can be identified within the data.

The data showed a clear decrease in cancer cases early in the pandemic, which correlates with a decline in screening, but screening rates appeared to return to normal last year, as did cancer detection rates. The data also did not appear to show a significant rise in new diagnoses of advanced cancers through the end of last year.

It’s “good news” that the data demonstrate a return to pre-Covid rates of cancer screening, Dr. Arif Kamal, the American Cancer Society’s chief patient officer – who was not involved in the Epic Research study – wrote in an email. He called the new data intriguing but emphasized that more time is needed to determine whether or when rates of advanced cancers may increase due to missed screenings. It could take years.

“Conclusions regarding whether advanced cancer rates have increased due to missed screenings are a bit premature to reach. This is because cancer takes years to develop, and the resulting effect of missed cancers cannot be known after only a few years,” Kamal said.

“We remain hopeful that as cancer screening rates have returned to baseline, that the two years of missed screenings will not have a long-lasting effect on cancer incident or mortality,” he said. “But more time will tell.”

The data from Epic Research’s study is encouraging, as it suggests that more advanced cancers are not being seen, Dr. David Cohn, chief medical officer for the Ohio State University Comprehensive Cancer Center, wrote in an email.

“Whether this holds up over the next few years is yet to be seen,” he added.

Cohn, a practicing gynecologic oncologist who was not involved in either new study, said that he is “always concerned” about a decrease in screening rates and the resulting impact on later cancer diagnoses.

Yet “these data suggest that folks are getting back to the core business of screening,” he said, “such that these data will hopefully hold up over the next few years without seeing an increase in later diagnoses.”

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President Carter is on hospice care, but what is it? Our medical analyst explains | CNN

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CNN
—

On Saturday, the Carter Center announced that former US President Jimmy Carter will be receiving hospice care at his home in Georgia.

“After a series of short hospital stays, former US President Jimmy Carter today decided to spend his remaining time at home with his family and receive hospice care instead of additional medical intervention,” according to the statement. “He has the full support of his family and his medical team.”

The 98-year-old Carter is the oldest living US president in history. He has survived metastatic brain cancer and faced a number of health scares, including brain surgery following a fall in 2019.

As Carter opted for hospice care, CNN Medical Analyst Dr. Leana Wen and I thought that many people might be unfamiliar with hospice care beyond a vague understanding that some people receive it toward the end of life. There can be benefits and blessings for the person receiving the care and their loved ones, but there are also some common misconceptions about what it involves.

I asked Dr. Wen, an emergency physician and professor of health policy and management at the George Washington University Milken Institute School of Public Health, to guide us through some questions.

CNN: What is hospice care and who qualifies for it?

Dr. Leana Wen: Hospice care is a type of specialty medical care for people near the end of their lives that focuses on maximizing comfort for the patient and support for the patient and their family. That includes reducing physical pain and tending to the psychological, emotional and spiritual needs of the patient and the family.

Generally, to qualify for hospice care, the patient must have an incurable medical condition with an anticipated life expectancy of less than six months. The types of medical conditions that patients have include end-stage cancer, advanced dementia, heart failure and chronic obstructive pulmonary disease.

CNN: Where do patients receive hospice care and who provides it?

Wen: Hospice care is an approach to medical care, not a specific place, so it can be provided in a number of different settings. The choice of settings is up to the patient and family. Providers are an interdisciplinary team of physicians, nurses, home health aides, pharmacists and others who will tend to the patient no matter what setting they choose.

Many patients opt to receive hospice care in their homes, where they can be in familiar surroundings. The hospice team helps to provide equipment, supplies and staff to assist the family to care for their loved one. They provide regular home visits and are generally available around the clock for concerns as they come up.

Hospice can also be delivered in a nursing home or at the hospital. In addition, there are specialized hospice centers.

CNN: What are some common misconceptions of hospice care?

Wen: There is a misconception that hospice care is “giving up” on medical care. Actually, hospice care is a specific type of compassionate medical care for patients in the last stages of incurable disease to live as fully and comfortably as they can. A primary aim of hospice care is to manage the patient’s symptoms so that the patient’s last days can be spent with their loved ones, with dignity and the highest quality possible.

A second misconception is that once a patient enters hospice care, they can no longer receive any medical treatment. This is not true. Patients receive medicines to help their symptoms and alleviate their pain. They and their families can also choose to leave hospice at any point and resume, say, active treatment for their cancer.

I’ve also heard people say that hospice care is only for people with a few days to live. This is also not the case. Often, patients don’t begin hospice care soon enough to take full advantage of the help it offers. Beginning it earlier may help provide months — rather than days — of quality time with loved ones.

CNN: What are the benefits and blessings of this type of care?

Wen: In modern medicine, the tendency is to approach diseases as something to be cured. Unfortunately, this is not always possible. The patient may choose not to continue certain treatments that cause severe pain when there is slim chance for a cure. When there is limited time left to live, that patient may wish to minimize suffering and to prioritize spending the remaining time with their loved ones.

I know the benefits and blessings of hospice care firsthand. My mother was diagnosed with metastatic breast cancer in her 40s. She fought her cancer valiantly, undergoing multiple rounds of surgery, radiation and chemotherapy for eight years. Unfortunately, she had multiple recurrences.

During the final recurrence, it became clear that a cure was not possible and that she had limited time — as it turns out, weeks — to live. She opted to enter hospice care, with the aim to spend her final days at home, rather than in the hospital, and with the aim of alleviating her pain and suffering rather going through yet another round of chemotherapy. I understood and supported her decision, and it was important to me and my family to give her what she wanted, which was the highest quality of life with the least amount of suffering.

CNN: Does insurance cover hospice care?

Wen: Most hospice patients are eligible for Medicare, which provides for hospice care through Medicare Hospital Benefit. Medicaid also pays for hospice care in many states, and many private insurers will cover it. For patients who don’t have insurance, there are some community programs that offer sliding scale coverage or free care.

CNN: What’s the difference between hospice and palliative care?

Wen: There are physicians, nurses and other medical professionals who specialize in hospice and palliative medicine; these are very much complementary and related fields of medicine that share a similar philosophy.

Palliative care, like hospice care, also prioritizes easing suffering, improving the quality for the patient, and delivering that care in a way that centers the patient and family. But differently from hospice care, the patient doesn’t have to forgo curative treatment – palliative care can be provided together with curative treatment. Over time, if it becomes apparent that the patient is likely to die within six months, palliative care can transition over to hospice care.

Both hospice and palliative care are important specialty medical services that are underutilized, and can offer much support and comfort to many more patients and families.

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Thousands of people can’t get full treatments of a lifesaving cancer drug | CNN

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CNN
—

Dino Carlone was frightened when he was diagnosed with bladder cancer three years ago, but his spirits were buoyed when he learned that he could get help from a highly effective drug with a great track record.

“You’re telling yourself, ‘OK, I have cancer, and it’s a very aggressive cancer, but I’ve got great therapy. There’s great numbers,’ ” said Carlone, 65.

Carlone was supposed to receive treatment for several years, but he says he only got it for only a few months because his urologist told him there was a shortage of the drug, called Bacillus Calmette-Guérin, or BCG.

Carlone said he was shocked and angry that in a country as wealthy as the United States, there’s a shortage of an important cancer drug.

A new report estimates that more than 8,300 US patients a year are not receiving full BCG treatments for their bladder cancer. BCG is an older drug – it has been around for more than 40 years – and relatively inexpensive. Pharmaceutical companies aren’t clamoring to make it.

“This is a terrible crisis. We should be doing everything we can to give every single one of these patients the best chance of survival,” said Laura Bray, a board member of the End Drug Shortages Alliance, one of the sponsors of the report. “It’s heartbreaking, and we must do better.”

A spokesperson for Merck, the sole maker worldwide of BCG, wrote in an emailed statement that the company increased production of the drug by 200% between 2012 and 2019 and has been producing it “to the full extent of manufacturing capacity over the past several years.”

Merck is building a facility to expand production of BCG. The company expects the facility to be completed sometime between late 2025 and late 2026, which includes time for necessary regulatory approvals, according to the statement.

“Our company will continue to work to complete this project and meet patient needs in as timely a manner as possible. Our commitment to [BCG] is at the core of Merck’s mission to save and improve lives. We continue to recognize the impact supply shortages can have on patients when they cannot receive the medicines they need,” the statement says.

A number of factors are contributing to the shortage, which began in 2019. BCG is a biologic drug – which uses bacteria – and so is more complicated to make than many other types of drugs and especially prone to quality control issues.

Sanofi, the other company that once made BCG, started having production problems in 2012. In 2016, it announced that it would stop making the drug the next year.

Also, while cases of bladder cancer are slowly increasing, it’s still a relatively small market, and making the drug requires a significant investment.

In a written statement, a spokesperson for the US Food and Drug Administration said that “whenever a shortage occurs, FDA actively works with manufacturers and other U.S. federal agencies to try to address supply issues for the drug product in shortage.”

When BCG became available in 1976, it was considered a breakthrough strategy. First used as a tuberculosis vaccine, it contains a weakened bacteria that triggers the immune system to fight the cancer.

“It’s an absolutely fabulous drug,” said Dr. Benjamin Davies, a spokesperson for the American Urological Association.

Bladder cancer patients receive six rounds of BCG after surgery and then more treatments every few months for a year or two, depending on the person, according to Davies. The treatment is done in the doctor’s office, using a catheter that delivers the drug directly to the bladder.

Carlone, of Vero Beach, Florida, said he was supposed to receive BCG doses over a period of about two years. But he said after receiving doses for a few months in early 2020, his urologist told him he wouldn’t be able to get his remaining doses because of the shortage.

“It’s a very, very frightening circumstance to realize that at that point, what they deem to be an aggressive cancer could in fact come right back,” he said.

Bladder cancer has a 30% to 40% recurrence rate, said Davies, a professor of urology at the University of Pittsburgh Medical Center.

“That’s a very high recurrence rate,” he said. “It’s a nasty disease.”

There are about 82,920 new cases of bladder cancer in the US a year and 16,710 deaths, according to the American Cancer Society.

For the new report, 20 health care systems and physician practices responded to a survey from Vizient, a health care performance improvement company.

All of them said they had to use at least one strategy to deal with the BCG shortage, and four of the centers said they couldn’t give BCG at all, according to the report.

Because of the shortage, the American Urological Association recommends prioritizing doses for higher-risk patients.

Some medical centers in the survey said they are splitting doses. A vial is supposed to be used for one dose for one patient, but instead, they use it for more than one patient. That could lead to waste, though, because the entire vial needs to used within six hours of opening, said Erin Fox, an adjunct professor at the University of Utah College of Pharmacy and specialist in drug shortages.

Other drugs can be used instead of BCG, but they are more expensive and don’t work as well, Davies said.

“So not only can’t we give the right drug because of the shortage, but we have to spend more money,” he said.

BCG is just one of many drugs in shortage, including other cancer drugs for adults and for children.

Carlone wonders why the FDA can’t do more to persuade companies to make drugs that aren’t necessarily very lucrative.

“To me, this is a failure,” he said. “As Americans, you rely on [government] institutions, and the institutions are failing as far as I’m concerned.”

According to the FDA statement, the agency “cannot require a pharmaceutical company to make a drug – or make more of a drug – even if it is medically necessary. In addition, we cannot control how much of a drug is distributed – or which purchasers will be given priority.”

Marta Wosińska, a former senior FDA official, said the federal government could offer financial incentives for pharmaceutical companies to make drugs that are in shortage, similar to the way the government has paid them to make Covid-19 vaccines and treatments.

Wosińska, an economist at the Brookings Institution, said it would be “a little bit of a tall order” to expect pharmaceutical companies to make drugs, or increase production of drugs, that aren’t particularly profitable.

“They have a fiduciary responsibility to their shareholders, so you can only ask them to do so much,” said Wosińska, who worked on drug shortages as director of the economics staff at the FDA’s Center for Drug Evaluation and Research before she left the agency in 2016.

Dr. Yoram Unguru, a member of the core faculty at the Johns Hopkins Berman Institute of Bioethics, said that “pharmaceutical companies can continue to generate profits while ensuring access to essential medicines.”

He added that the government has an obligation to fix these shortages.

“The federal government must take a more hands-on approach and maintain a critical stockpile of essential lifesaving medicines and set prices for medications, akin to existing rate-setting bodies that oversee public utilities,” he said.

The BCG shortage is expected to continue for years.

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Cancer is striking more people in their 30s and 40s. Here’s what you need to know | CNN

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—

It’s World Cancer Day, and the outlook for winning the war against this deadly disease is both good and bad.

In the United States, deaths from cancer have dropped 33% since 1991, with an estimated 3.8 million lives saved, mostly due to advances in early detection and treatment. Still, 10 million people worldwide lost their lives to cancer in 2020.

“During the last three years, the No. 1 leading leading cause of death in the world was actually cancer, not Covid-19,” said Dr. Arif Kamal, chief patient officer for the American Cancer Society.

Symptoms of cancer can mimic those of many other illnesses, so it can be difficult to tell them apart, experts say. Signs include unexplained weight loss or gain, swelling or lumps in the groin, neck, stomach or underarms and fever and night sweats, according to the National Cancer Institute.

Bladder, bowel, skin and neurological issues may be signs of cancer, such as changes in hearing and vision, seizures, headaches and bleeding or bruising for no reason, the institute said. But most cancers do not cause pain at first, so you can’t rely on that as a sign.

“We tell patients that if they have symptoms that do not get better after a few weeks, they should visit a doctor,” Kamal said. “It doesn’t mean the diagnosis will be cancer, however.”

Rather than wait for symptoms, the key to keeping cancer at bay is prevention, along with screenings to detect the disease in its early stages. That’s critical, experts say, as new cases of cancer are on the rise globally.

A surprising number of new diagnoses are in people under 50, according to a 2022 review of available research by Harvard University scientists.

Cases of breast, colon, esophagus, gallbladder, kidney, liver, pancreas, prostate, stomach and thyroid cancers have been increasing in 50-, 40- and even 30-year-olds since the 1990s.

That’s unusual for a disease that typically strikes people over 60, Kamal said. “Cancer is generally considered an age-related condition, because you’re giving yourself enough time to have sort of a genetic whoopsie.”

Older cells experience decades of wear and tear from environmental toxins and less than favorable lifestyle choices, making them prime candidates for a cancerous mutation.

“We believed it takes time for that to occur, but if someone is 35 when they develop cancer, the question is ‘What could possibly have happened?’” Kamal asked.

No one knows exactly, but smoking, alcohol consumption, air pollution, obesity, a lack of physical activity and a diet with few fruits and vegetables are key risk factors for cancer, according to the World Health Organization.

Add those up, and you’ve got a potential culprit for the advent of early cancers, the Harvard researchers said.

“The increased consumption of highly processed or westernized foods together with changes in lifestyles, the environment … and other factors might all have contributed to such changes in exposures,” the researchers wrote in their 2022 review.

“You don’t need 65 years of eating crispy, charred or processed meat as a main diet, for example,” Kamal added. “What you need is about 20 years, and then you start to see stomach and colorectal cancers, even at young ages.”

So how do you fight back against the big C? Start in your 20s, Kamal said.

Many of the most common cancers, including breast, bowel, stomach and prostate, are genetically based — meaning that if a close relative has been diagnosed, you may have inherited a predisposition to develop that cancer too.

That’s why it’s critical to know your family’s health history. Kamal suggests young people sit down with their grandparents and other close relatives and ask them about their illnesses — and then write it down.

“The average person doesn’t actually know the level of granularity that is helpful in accessing risk,” he said.

“When I talk to patients, what they’ll say is, ‘Oh, yeah, Grandma had cancer.’ There’s two questions I want to know: At what age was the cancer diagnosed, and what specific type of cancer was it? I need to know if she had cancer in her 30s or 60s, because it determines your level of risk. But they often don’t know.”

The same applies to the type of cancer, Kamal said.

“People often say ‘Grandma had bone cancer.’ Well, multiple myeloma and osteosarcoma are bone cancers, but both of them are relatively rare,” he said. “So I don’t think Grandma had bone cancer. I think Grandma had another cancer that went to the bone, and I need to know that.”

Next, doctors need to know what happened to that relative. Was the cancer aggressive? What was the response to treatment?

“If I hear Mom or Grandma was diagnosed with breast cancer at 40 and passed away at 41, then I know that cancer is very aggressive, and that changes my sense of your risk. I may add additional tests that aren’t in the guidelines for your age.”

Cancer screening guidelines are based on population-level assessments, not individual risk, Kamal said. So, if cancer (or other conditions such as heart disease, diabetes, Alzheimer’s, or even migraines) runs in the family, you become a special case and need a personalized plan.

“And I will tell you the entire scientific community is observing this younger age shift for different cancers and is asking itself: ‘Should guidelines be more deliberate and intentional for younger populations to give them some of this advice?”

closeup of a young caucasian doctor man with a pink ribbon for the breast cancer awareness pinned in the flap of his white coat; Shutterstock ID 724387357; Job: CNN Digital

Report: Black women more likely to die from breast cancer

If your family history is clear of cancer, that lowers your risk — but doesn’t remove it. You can decrease the likelihood of cancer by eating a healthy, plant-based diet, getting the recommended amount of exercise and sleep, limiting alcohol consumption and not smoking or vaping, experts say.

Protecting yourself from the sun and tanning beds is key, too, as harmful ultraviolet rays damage DNA in skin cells and are the prime risk factor for melanoma. However, skin cancer can show up even where the sun doesn’t shine, Kamal said.

“There’s been an increase of melanoma that’s showing up in non-sun-exposed areas such as the underarm, the genital area and between the toes,” he said. “So it’s important to check — or have a partner or dermatologist check — your entire body once a year.”

Skin check: Take off all your clothes and look carefully at all of your skin, including the palms, soles of feet, between toes and buttocks and in the genital area. Use the A, B, C, D, E method to analyze any worrisome spots and then see a specialist if you have concerns, the American Academy of Dermatology advised.

Also see a dermatologist if you have any itching, bleeding or see a mole that looks like an “ugly duckling” and stands out from the rest of the spots on your body.

Get vaccinated if you haven’t: Two vaccinations protect against cervical and liver cancers, and others for cancers such as melanoma are in development.

Hepatitis B is transmitted via blood and sexual fluids and can cause liver cancer and cirrhosis, which is a scarred and damaged liver. A series of three shots, starting at birth, is part of the US recommended childhood vaccines schedule. Unvaccinated adults should check with their doctor to see if they are eligible.

The HPV vaccine protects against several strains of human papillomavirus, the most common sexually transmitted infection, according to the US Centers for Disease Control and Prevention.

Human papillomavirus can cause deadly cervical cancer as well as vaginal, anal and penile cancer. It can also cause cancer in the back of the throat, including the tongue and tonsils.

“These HPV-related head and neck cancers are more aggressive than the non-HPV-related cancers,” Kamal said, “so boys as well as girls should be vaccinated.”

Since the vaccine’s approval in 2006 in the US for adolescents ages 11 to 13, cervical cancer rates have declined by 87%. Today, the vaccine can be given through age 45, the CDC said.

Breast self-exams: Breast cancer is the most common type of cancer diagnosed worldwide, according to the WHO, followed by lung, colorectal, prostate, skin and stomach cancers.

Both men and women can get breast cancer, so men with a family history should be aware of the symptoms as well, experts say. These include pain, redness or irritation, dimpling, thickening or swelling of any part of the breast. New lumps, either in the breast or armpit, any pulling in of the nipple and nipple discharge other than breast milk are also worrisome symptoms, the CDC said.

Women should do a self-exam once a month and see a doctor if there are any warning signs, the National Breast Cancer Association advised. Choose a time when the breasts will be less tender and lumpy, which is about seven to 10 days after the beginning of the menstrual flow.

Screenings and tests: At-home exams and vaccinations can save lives, but many cancers can only be detected through laboratory tests, scans or biopsies. The American Cancer Society has a list of recommended screening by ages.

Getting those done in a timely manner increases the chance for early detection and treatment, but it’s still each person’s responsibility to know their risk factors, Kamal said.

“Remember, guidelines are only for people at average risk,” he said. “The only way someone can know whether the guidelines apply to them is to really understand their family history.”

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