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Colorectal cancer is rising among younger adults and scientists are racing to uncover why | CNN

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CNN
—

Nikki Lawson received the shock of her life at age 35.

A couple of years ago, she noticed that her stomach often felt irritable, and she would get sudden urges to use the restroom, sometimes with blood in her stool. She even went to the hospital one day when her symptoms were severe, she said, and she was told it might be a stomach ulcer before being sent home.

“That was around the time when Chadwick Boseman, the actor, passed away. I remember watching him on the news and having the same symptoms,” Lawson said of the “Black Panther” star who died of colon cancer at age 43 in August 2020.

“But at that time, I was not thinking ‘this is something that I’m going through,’ ” she said.

Instead, Lawson thought changing her diet would help. She stopped eating certain red meats and ate more fruits and vegetables. She began losing a lot of weight, which she thought was the result of her new diet.

“But then I went for a physical,” Lawson said.

Her primary care physician recommended that she see a gastroenterologist immediately because she had low iron levels.

“When I went and I saw my gastro, she said, ‘I’m sorry, I have bad news. We see something. We sent it off to get testing. It looks like it is cancer.’ My whole world just kind of blanked out,” Lawson said. “I was 35, healthy, going about my day, raising my daughter, and to get a diagnosis like this, I was just so shocked.”

Lawson, who was diagnosed with stage III rectal cancer, is among a growing group of colon and rectal cancer patients in the United States who are diagnosed at a young age.

The share of colorectal cancer diagnoses among adults younger than 55 in the US has been rising since the 1990s, and no one knows why.

Researchers at Dana-Farber Cancer Institute are calling for more work to be done to understand, prevent and treat colorectal cancer at younger ages.

In a paper published last week in the journal Science, the researchers, Dr. Marios Giannakis and Dr. Kimmie Ng, outlined a way for scientists to accelerate their investigations into the puzzling rise of colorectal cancer among younger ages, calling for more specialized research centers to focus on younger patients with the disease and for diverse populations to be included in studies on early-onset colorectal cancer.

Their hope is that this work will help improve outcomes for young colorectal cancer patients like Lawson.

Among younger adults, ages 20 to 49, colorectal cancer is estimated to become the leading cause of cancer-related deaths in the United States by 2030.

Lawson, now 36 and living in Palm Bay, Florida, with her 5-year-old daughter, is in remission and cancer-free.

The former middle school teacher had several surgeries and received radiation therapy and chemotherapy to treat her cancer. She is now being monitored closely by her doctors.

For other young people with colorectal cancer, “my words of hope would be to just stay strong. Just find that courage within yourself to say, ‘You know what, I’m going to fight this.’ And I just looked within myself,” Lawson said.

“I also have a very supportive family system, so they were definitely there for me. But it was very emotional,” she said of her cancer treatments.

“I remember crying through chemotherapy sessions and the medicine making you so weak, and my daughter was 4, and having to be strong for her,” she said. “My advice to any young person: If you see symptoms or you see something’s not right and you’re losing a lot of weight and not really trying to, go to see a doctor.”

Signs and symptoms of colorectal cancer include changes in bowel habits, rectal bleeding or blood in the stool, cramping or abdominal pain, weakness and fatigue, and weight loss.

A report released this month by the American Cancer Society shows that the proportion of colorectal cancer cases among adults younger than 55 increased from 11% in 1995 to 20% in 2019. Yet the factors driving that rise remain a mystery.

There’s probably more than just one cause, said Lawson’s surgeon, Dr. Steven Lee-Kong, chief of colorectal surgery at Hackensack University Medical Center in New Jersey.

He has noticed an increase in colorectal cancer patients in their 40s and 30s within his own practice. His youngest patient was 21 when she was diagnosed with rectal cancer.

“There is a phenomenon of decreasing overall colorectal cancer rates in the population in general, we think because of the increase in screening for particularly for older adults,” Lee-Kong said. “But that doesn’t really account for the overall increase in the number of patients younger than, say, 50 and 45 that are developing cancer.”

Some of the factors known to raise anyone’s risk of colorectal cancer are having a family history of the disease, having a certain genetic mutation, drinking too much alcohol, smoking cigarettes or being obese.

“They were established as risk factors in older cohorts of patients, but they do seem to be also associated with early-onset disease, and those are things like excess body weight, lack of physical activity, high consumption of processed meat and red meat, very high alcohol consumption,” said Rebecca Siegel, a cancer epidemiologist and senior scientific director of surveillance research at the American Cancer Society, who was lead author of this month’s report.

“But the data don’t support these specific factors as solely driving the trend,” she said. “So if you have excess body weight, you are at a higher risk of colorectal cancer in your 40s than someone who is average weight. That is true. But the excess risk is pretty small. So again, that is probably not what’s driving this increase, and it’s another reason to think that there’s something else going on.”

Many people who are being diagnosed at a younger age were not obese, including some high-profile cases, such as Broadway actor Quentin Oliver Lee, who died last year at 34 after being diagnosed with stage IV colon cancer.

“Anecdotally, in conferences that I’ve attended, that is the word on the street: that most of these patients are very healthy. They’re not obese; they’re very active,” Siegel said, which adds to the mystery.

“We know that excess weight increases your risk, and we know that we’ve had a big increase in body weight in this country,” she said. “And that is contributing to more cancer for a lot of cancers and also for colorectal cancer. But does it explain this trend that we’re seeing, this steep increase? No, it doesn’t.”

Yet scientists remain divided when it comes to just how much of a role those known risk factors – especially obesity – play in the rise of colorectal cancer among adults younger than 55.

Even though the cause of the rise of colorectal cancer in younger adults is “still not very well understood,” Dr. Subhankar Chakraborty argues that dietary and lifestyle factors could be playing larger roles than some would think.

“We know that smoking, alcohol, lack of physical activity, being overweight or obese, increased consumption of red meat – so basically, dietary factors and environmental and lifestyle factors – are likely playing a big role,” said Chakraborty, a gastroenterologist with The Ohio State University Comprehensive Cancer Center.

“There are also some other factors, such as the growing incidence of inflammatory bowel disease, that may also be playing a role, and I think the biggest factors is most likely the diet, the lifestyle and the environmental factors,” he said.

It has been difficult to pinpoint causes of the rise of cases in younger ages because, if someone has a polyp in their colon for example, it can take 10 to 15 years to develop into cancer, he says.

“During that, all the way from a polyp to the cancer stage, the person is exposed to a variety of things in their life. And to really pinpoint what is going on, we would need to follow specific individuals over time to really understand their dietary patterns, medications and weight changes,” Chakraborty said. “So that makes it really hard, because of the time that cancer actually takes to develop.”

Some researchers have been investigating ways in which the rise in colorectal cancer among younger adults may be connected to increases in childhood obesity in the US.

“The rise in young-onset colorectal cancer correlates with a doubling of the prevalence of childhood obesity over the last 30 years, now affecting 20% of those under age 20,” Dr. William Karnes, a gastroenterologist and director of high-risk colorectal cancer services at the UCI Health Digestive Health Institute in California, said in an email.

“However, other factors may exist,” he said, adding that he has noticed “an increasing frequency of being shocked” by discoveries of colorectal cancer in his younger patients.

There could be correlations between obesity in younger adults, the foods they eat and the increase in colorectal cancers for the young adult population, said Dr. Shane Dormady, a medical oncologist from El Camino Health in California who treats colorectal cancer patients.

“I think younger people are on average consuming less healthy food – fast food, processed snacks, processed sugars – and I think that those foods also contain higher concentrations of carcinogens and mutagens, in addition to the fact that they are very fattening,” Dormady said.

“It’s well-publicized that child, adolescent, young adult obesity is rampant, if not epidemic, in our country,” he said. “And whenever a person is at an unhealthy weight, especially at a young age, which is when the cells are most susceptible to DNA damage, it really starts the ball rolling in the wrong direction.”

Yet at the Center for Young Onset Colorectal and Gastrointestinal Cancers at Memorial Sloan Kettering Cancer Center, researchers and physicians are not seeing a definite correlation between the rise in colorectal cancer among their younger adult patients and a rise in obesity, according to Dr. Robin Mendelsohn, gastroenterologist and co-director of the center, where scientists and doctors continue to work around the clock to solve this mystery.

“When we looked at our patients, the majority were more likely to be overweight and obese, but when we compare them to a national cohort without cancer, they’re actually less likely to be overweight and obese,” she said. “And anecdotally, a lot of the patients that we see are young and fit and don’t really fit the obesity profile.”

That leaves many oncologists scratching their heads.

Some scientists are also exploring whether genetic mutations that can raise someone’s risk for colorectal cancer have played a role in the rise of cases among younger adults – but the majority of these patients do not have them.

Karnes, of UCI Health, said “it is unlikely” that there has been an increase in the genetic mutations that raise the risk of colorectal cancer, “although, as expected, the percentage of colorectal cancers caused by such mutations, e.g., Lynch syndrome, is more common in people with young-onset colorectal cancer.”

Lynch syndrome is the most common cause of hereditary colorectal cancer, causing about 4,200 cases in the US per year. People with Lynch syndrome are more likely to get cancers at a younger age, before 50.

“In my practice and in the medical community, the oncologic community, I don’t think there’s any proof that genetic syndromes and gene mutations that patients are born with are becoming more frequent,” El Camino Health’s Dormady said. “I don’t think the inherent frequency of those mutations is going up.”

The tumors of younger colorectal cancer patients are very similar to those of older ones, said Mendelsohn at Memorial Sloan Kettering Cancer Center.

“So then, the question is, if they’re biologically the same, why are we seeing this increasingly in younger people?” she said. “About 20% may have a genetic mutation, so the majority of patients do not have a family history or genetic predisposition.”

Therefore, Mendelsohn added, “it’s likely some kind of exposure, whether it be diet, medication, changing microbiome,” that is driving the rise in colorectal cancers in younger adults.

That rise “has been something that’s been on our radar, and it has been increasing since the 1990s,” Mendelsohn said. “And even though it is increasing, the numbers are still small. So it’s still a small population.”

Dormady, at El Camino Health, said he now sees more colorectal cancer patients in their early to mid-50s than he did 20 years ago, and he wonders whether it might be a result of colorectal cancer screening being easier to access and better at detecting cancers.

“The first thing to consider is that some of our diagnostic modalities are becoming better,” he said, especially because there are now many at-home colorectal cancer testing kits. Also, in 2021, the US Preventive Services Task Force lowered the recommended age to start screening for colon and rectal cancers from 50 to 45.

“I think you have a subset of patients who are being screened earlier with colonoscopies; you have advancing technology where we can potentially detect tumor cell DNA in the stool sample, which is leading to earlier diagnosis. And sometimes that effect will skew statistics and make it look like the incidence is really on the rise, but deeper analysis shows you that part of that is due to earlier detection and more screening,” he said. “So that could be one facet of the equation.”

Overall, pinpointing what could be driving this surge in colorectal cancer diagnoses among younger ages will not only help scientists better understand cancer as a disease, it will help doctors develop personalized risk assessments for their younger patients, Ohio State University’s Chakraborty said.

“Because most of the people who go on to develop colorectal cancer really have no family history – no known family history of colon cancer – so they would really not be aware of their risk until they begin to develop symptoms,” he said.

“Having a personalized risk assessment tool that will take into account their lifestyle, their environmental factors, genetic factors – I think if we have that, then it would allow us hopefully, in the future, to provide some personalized recommendations on when a person should be screened for colorectal cancer and what should be the modality of screening based on their risk,” he said. “Younger adults tend to develop colon cancer mostly in the left side, whereas, as we get older, colon cancer tends to develop more on the right side. So there’s a little difference in how we could screen younger adults versus older adults.”

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Many firefighters who responded to Ohio train derailment didn’t have the needed training, equipment | CNN

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CNN
—

Many of the first responders who helped fight the fire that erupted after the train derailment in East Palestine, Ohio, last month were ill-equipped and untrained to fight the massive chemical blaze that some now call “the hell fire.”

In testimony Wednesday before the US Senate’s Commerce, Science and Transportation Committee, lawmakers heard about myriad issues that snarled the response and that put firefighters who rushed to the scene at greater immediate risk – and may raise risks to their health throughout their lives.

About 300 firefighters from 50 departments dashed to the scene of the derailment in East Palestine on the night of February 3. Many of them were volunteers without hazmat training or specialized equipment.

Officials investigating the derailment testified that these first responders weren’t able to access information about the chemicals that were in 11 overturned cars carrying hazardous materials.

Jennifer Homendy, chair of the National Transportation Safety Board, the agency investigating the crash, urged senators to consider meaningful changes to help inform exposed communities and first responders.

“People deserve to know what chemicals are moving through their communities and how to stay safe in an emergency, That includes responders who risk their lives for each of us every single day. They deserve to be prepared,” Homendy said.

Studies have shown that firefighters have a higher rates of cancer compared with members of the general population because of toxic chemicals they’re exposed to on the job. These cancers include digestive, oral, lung and bladder cancers. A rare type of cancer called malignant mesothelioma is about twice as common in firefighters than in the general population, probably due to exposure to asbestos in burning buildings, for example.

Cancer is now the leading cause of death for working firefighters, according to the International Association of Fire Fighters.

Ohio Gov. Mike DeWine said Wednesday that he is very concerned about the long-term health of the firefighters who responded to the derailment.

“They all need to be assessed,” he said. “There needs to be established a baseline, and they need to be assured that in five years or 10 years, there’s still a place where they could go.”

“We look to the railroad to establish that fund,” DeWine said in testimony before the committee.

The derailment occurred about 9 p.m. February 3, and the night air quickly filled with smoke. Visibility was poor, and some of the placards on overturned railcars had burned away, leaving responders clueless about what chemicals were spilling and catching fire around them.

There’s an app, AskRail, meant to give users more information about the what’s on trains involved in accidents, but none of the first responders to the derailment in East Palestine had access to it, Homendy said.

Even if they had been able to use it, the app lists what is in cars by their order on the train, and its information may have been of limited help to firefighters on the scene who were looking at cars that were “bunched up” and not in their normal order, said David Comstock, chief of the Ohio Western Reserve Fire District.

There are better ways of getting urgent information to first responders, he told the senators.

After auto accidents, for example, some telematic systems in cars transmit information about the crash to emergency dispatchers who can then send it to crews responding to the scene.

“So en route to a motor vehicle accident, I know the car has flipped three times, airbags gone out, and it has information about that car – whether it’s an electric car, things I have to worry about,” Comstock said.

No information like that was available to crews responding to the derailed train.

“They didn’t have the information for quite a long time on what was on the train,” Homendy said.

Facing criticism over its role in the response, the company that owns and operates the train, Norfolk Southern, has announced that it will create a new regional training center for first responders. CEO Alan Shaw repeated that pledge in his testimony Wednesday before the committee.

The company also intends to expand its Operation Awareness & Response program, which travels its 22-state network to teach first responders how to stay safe after train accidents.

Comstock testified that more training is important, but so is more gear. He said most fire stations in the area are lucky if they can supply each member of their crew with a single set of turnout gear: the protective coat, pants, boots, gloves and helmets firefighters wear.

“When I have to wash that, I’m out of service,” he said. “In response to the derailment, I had three firefighters who were exposed. Their gear is contaminated. I can’t use it.”

It takes six months to order replacement gear, he said.

“That means I have three firefighters who are out of service for six months who can’t respond to auto accidents or structure fires,” he said.

Even then, that basic gear isn’t designed to stand up to hazardous materials like the chemicals on the Norfolk Southern train.

For that kind of incident, firefighters need hazmat suits, which can cost $15,000 each, Comstock testified, along with specialized monitoring equipment.

“It’s unrealistic for the federal government to provide that to every department, but we do need to look at a regional approach so we can call in those teams that can supplement what we’re trying to do,” he said.

Comstock said he hopes the committee will consider the needs of firefighters as it drafts legislation to right the wrongs of the East Palestine incident.

“This incident has emphasized the need to better train and equip firefighters to respond to hazardous material incidents, specifically to derailments in rural areas, which are mostly served by volunteer fire departments that often lack sufficient resources, tax base and manpower,” he said.

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New drug shortages in the US increased nearly 30% in 2022, Senate report finds | CNN

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CNN
—

When a pharmaceutical plant in Shanghai that made contrast material for radiological scans shut down last year, half the United States’ supply of the radioactive substance immediately became unavailable. Health care providers had to make difficult choices about who got potentially lifesaving tests.

“I work in the VA system. This impacted veterans literally overnight, where we needed to make decisions about whether we were going to allow some scans to be done to evaluate someone’s cancer or treat someone’s heart disease,” said Dr. Andrew Shuman, a head and neck surgeon who works at the US Department of Veterans Affairs and is an associate professor at University of Michigan Health. “Veterans deserve better and we should not be reliant on a supply chain that’s that tenuous.”

Shuman was one of several experts who testified Wednesday in front of the US Senate’s Homeland Security and Governmental Affairs Committee that shortages like these make the US drug and medical supply far too vulnerable and put national security at risk.

New drug shortages in the US increased nearly 30% between 2021 and 2022, according to a report commissioned by the Senate that was published Wednesday. At the end of 2022, drug shortages experienced a record five-year high of 295 active drug shortages, according to the report. It also found that while the average drug shortage lasts about 1.5 years, more than 15 critical drug products have been in shortage for over a decade.

Many Americans became aware of national shortages during the Covid-19 pandemic. In one of the most notable examples last year, anxious parents reported going from store to store in search of common pain relievers and antibiotics during an especially rough RSV season.

Increased demand can cause shortages, but the way drugs are made and sold for the US market is also a large part of the problem, the experts said Wednesday.

Shortages of common and specialized drugs have been a constant for decades, the report says.

“Since 2007, the FDA identified an average of over 100 separate drug shortages per year. In 2011, the FDA identified a whopping 267 drugs in short supply and despite possessing the most innovative medical industry in the world, the US is unable to maintain a consistent supply of the most crucial medicines,” ranking committee member Sen. Rand Paul, R-Kentucky, said at the hearing.

Under the current regulatory system, the problem won’t probably get better any time soon, the experts said.

“Even drugs needed to treat childhood and adult cancers, including some that have simply no alternative treatment, are regularly in shortage. And while some shortages may only be an inconvenience, others have had devastating impacts on patient care,” said Sen. Gary Peters, D-Michigan, who commissioned the new report.

At its peak last year, there were 295 drugs in shortage, Peters said. In years past, the number has been even higher. The US Food and Drug Administration currently lists 130 drugs in shortage.

Some common medications like Adderall have been on the list for months. Many others like albuterol sulfate, which doctors use to treat breathing problems, are a staple in hospitals.

Albuterol has been in short supply since last summer, according to the American Society of Health-System Pharmacists, and it’s been on the FDA shortage list since October. That particular shortage is expected to get even worse because a major supplier to US hospitals shut down at the beginning of March.

The albuterol shortage shows how consolidation in the market has been a real problem for a number of drugs, experts say. In a consolidated market, labor issues and manufacturing disruptions can make drugs particularly hard to find.

Only one company made certain albuterol products used for continuous nebulizer treatment. The manufacturer that shut down, Akorn Operating Co., filed for Chapter 11 bankruptcy in May 2020.

Lower-priced drugs, generics like albuterol and certain antibiotics like amoxicillin tend to have a higher likelihood of being in shortage, according to an analysis presented at the hearing by US Pharmacopeia, a nonprofit that works to strengthen the global supply chain of medicines and publishes a set of guidelines for medicines. Economics is largely to blame.

“Manufacturers only receive pennies per dose for some of these drugs,” testified Dr. Vimala Raghavendran, senior director of the pharmaceutical supply chain center at US Pharmacopeia. That means there is little financial incentive for multiple manufacturers to make a generic medicine.

Another problem is with the suppliers of the ingredients that make the drugs. Nearly 80% of the manufacturing facilities that produce these active pharmaceutical ingredients are outside the US, the Senate report says. And there is no one agency that keeps track of all these manufacturers, so it is difficult to get a big picture of where the next problem will come from, Raghavendran said.

“Policymakers are flying blind in our understanding of US reliance on other countries for critical ingredients used in the manufacture of medicines,” she said.

Many ingredient makers are based in China or India. If there are work stoppages there, as during the pandemic, it can affect thousands of products.

Consolidation in ingredient manufacturing was a problem even before the pandemic. In 2018, regulators discovered that material created by a Chinese-based company, Zhejiang Huahai Pharmaceutical Co., that went into certain heart drugs was contaminated with a potential cancer-causing impurity. Thousands of drugs had to be recalled in dozens of countries, causing shortages around the world.

In too many cases, the experts said Wednesday, it is not clear why drugs wind up in such short supply. Part of the problem is a lack of transparency about quality results and inspections information. The cause of a specific shortage may be known to regulators, but the information is rarely publicly available.

“FDA sees really clear quality differences between products and manufacturing sites, but this information is confidential, and it’s not available to people making the purchases. Buyers can’t easily see the reliability of manufacturing operations,” Erin Fox, associate chief pharmacy officer at the University of Utah, said at the hearing.

Fox urged the government to develop a rating system for pharmaceutical manufacturing reliability. The FDA has been working on quality metrics ratings, but it doesn’t intend to make the scores publicly available, she said.

Without knowing whether a company is reliable, a health care system can’t always anticipate that a facility is likely to be shut down and create a shortage. A government rating system could help health systems pick more reliable suppliers, Fox said. Because it is so difficult to anticipate what drugs will be in short supply, most health systems must employ someone full-time to exclusively deal with shortage management.

At Michigan, Shuman said, there are multiple pharmacists whose full-time jobs are to manage drug shortages.

“Not every hospital has that resource. Patients should not have better access to scarce drugs based on the hospital they go to,” he said.

Shortages have a direct negative impact on patients and on their providers. Studies show that people often have worse health outcomes when they can’t be treated with the appropriate medication and even, in some cases, when alternative drugs are used.

“One of the challenges of drug shortages is that it requires hospitals to essentially MacGyver different treatment opportunities and regimens, which is not necessarily evidence for data based,” Shuman said.

People with sepsis, for instance, had a higher mortality rate when there was a shortage of the drug norepinephrine.

With shortages of cancer drugs, Shuman described “a tragedy that’s happening in slow motion.”

He cited etoposide, a medicine used to manage a wide variety of cancers, including those of the prostate, bladder, stomach and lung. It’s a low-cost drug at $50 a vial and has been on the market for more than 40 years.

In 2018, when a manufacturing delay caused a national shortage, some doctors had to make terrible choices.

“Which of our patients with cancer should get it? How can we prioritize between American lives? Should our limited vials go to an older woman who was just diagnosed with lung cancer, a young man who’s already been successfully taking it for testicular cancer, or a baby with neuroblastoma and aggressive cancer for which this drug is recommended but others might substitute?” Shuman said. “As a doctor who’s devoted my life to fighting cancer, it’s hard to express how horrible that is.”

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Men with advanced prostate cancer going without life-prolonging medication amid shortage | CNN

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CNN
—

Doctors across the United States who treat people with advanced prostate cancer can’t find supplies of a medicine that may help them live longer.

Pluvicto, a drug to treat metastatic castration-resistant prostate cancer, also known as mCRPC, is in such short supply that its maker, Novartis, said it cannot allow further supply to new patients until it can produce more of the drug. The company said it is working to produce enough doses to treat existing patients.

“We recognize that this situation is distressing for patients whether they are currently in the treatment process and being rescheduled, or waiting for their first dose of Pluvicto,” Novartis said in a statement to CNN. “Any interruption in the process, from unplanned manufacturing events to doses not arriving in time, may result in patient doses being rescheduled and can have a cascading effect on patients scheduled for future treatment.”

The Swiss company said it has been in touch with treatment centers and providers in the US and is “actively engaging with them to manage rescheduling of patient doses.”

The problem is that Novartis’ manufacturing facility in Ivrea, Italy, can’t keep up with demand for the drug. In May, it had to suspend production at the facility due to what it said was “an abundance of caution” related to potential quality issues. It also paused production at a New Jersey plant that makes the drug for the Canadian market.

Novartis resumed production at both plants in June.

The company hopes to get the New Jersey plant authorized to produce the drug for the US market, but it’s not clear when that might happen. Novartis said in early March that it had completed its filing for approval from the US Food and Drug Administration.

Someone who has a late-stage cancer that has spread to other parts of the body doesn’t have a lot of time to wait for the company to make more, doctors say, nor do they have many other treatment options. So even if Novartis got approval for the New Jersey plant quickly, the help will come too late for many people, according to Dr. Daniel Spratt, chair of the Department of Radiation Oncology at University Hospitals Seidman Cancer Center in Cleveland.

Novartis said it is prioritizing people who are currently being treated with Pluvicto, which is given in six cycles. But Spratt said the supply has recently been too low even for some of these patients.

“Many patients are missing months of therapy,” he said. “The real tragedy is the patients partially under treatment who have had great responses and we can’t get them the rest of their therapy in a timely fashion.”

Next to skin cancer, prostate cancer is the most common cancer in American men, according to the American Cancer Society. Most men do not die from prostate cancer, but about 34,700 people are expected to die from it this year. It’s the second leading cause of cancer death for American men, behind only lung cancer.

Pluvicto is a targeted radioligand therapy, meaning it uses radioactive atoms to deliver radiation to targeted cells, fighting cancer while limiting damage to the surrounding tissues.

There is no cure for this advanced stage of cancer, but Pluvicto can help people live longer. When the drug got FDA approval in March 2022, Spratt said, there was a lot of excitement about its potential. His patients who had heard about the trials have been asking about it for years.

One study from Novartis’ trials found that people who got the drug lived a median of about 15 months after diagnosis, four months longer than the median for people who didn’t get the treatment. For a handful of people, the recovery is even more dramatic.

“There are some patients that really do have those sort of miraculous responses, so it does occasionally give us one of those ‘wow’ moments,” said Dr. William Dahut, chief scientific officer at the American Cancer Society.

Dahut said doctors also like Pluvicto because, compared with other cancer treatments, it’s easy to administer and has relatively few side effects, other than dry mouth.

Another side effect of the shortage is that it’s slowing the progression of research. There is some indication that the drug could help people before their cancer reaches such a late stage.

“We’re anxious to have greater supply to study it in broader populations,” Dahut said.

Spratt said he is working closely with the medical oncologists in his health care system to try to find alternative treatment options, and he’s been looking to get people into clinical trials so they can get access to the therapy.

“But there’s really very few options available,” he said.

Novartis said that if the FDA approves its plant in Milburn, New Jersey, it could supply more Pluvicto as early as this summer.

The agency told CNN that it “is not able to discuss details regarding any possible communications or actions with companies due to commercial confidential information.”

“To be clear, FDA does not manufacture, produce, bottle, or ship drugs and cannot force companies to do so or make more of a drug. However, in general, the FDA works with firms making drugs in shortage to help them ramp up production if they are willing to do so. Often, they need new production lines approved or need new raw material sources approved to help increase supplies. FDA can and does expedite review of these to help resolve shortages of medically necessary drugs.”

Novartis is also building a plant in Indianapolis where the drug will be produced, but that won’t be up and running until the end of the year, the company said.

In the meantime, doctors will often have to tell their patients that they probably won’t be able to help get them this life-extending drug for some time.

“Some men and their physicians will feel that some hope was taken from them,” Spratt siad. “Cancer is the enemy here, not the company, but it’s unfortunate to have that excitement that your physician will be able to prescribe it to you and just not be able to give it to them.”

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

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—

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

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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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CNN
—

“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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