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Breast density changes over time could be linked to breast cancer risk, study finds | CNN

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CNN
—

Breast density is known to naturally decrease as a woman ages, and now a study suggests that the more time it takes for breast density to decline, the more likely it is that the woman could develop breast cancer.

Researchers have long known that women with dense breasts have a higher risk of breast cancer. But according to the study, published last week in the journal JAMA Oncology, the rate of breast density changes over time also appears to be associated with the risk of cancer being diagnosed in that breast.

“We know that invasive breast cancer is rarely diagnosed simultaneously in both breasts, thus it is not a surprise that we have observed a much slower decline in the breast that eventually developed breast cancer compared to the natural decline in density with age,” Shu Jiang, an associate professor of surgery at Washington University School of Medicine in St. Louis and first author of the new study, wrote in an email.

Breast density refers to the amount of fibrous and glandular tissue in a person’s breasts compared with the amount of fatty tissue in the breasts – and breast density can be seen on a mammogram.

“Because women have their mammograms taken annually or biennially, the change of breast density over time is naturally available,” Jiang said in the email. “We should make full use of this dynamic information to better inform risk stratification and guide more individualized screening and prevention approaches.”

The researchers, from Washington University School of Medicine in St. Louis and Brigham and Women’s Hospital in Boston, analyzed health data over the course of 10 years among 947 women in the St. Louis region who completed routine mammograms. A mammogram is an X-ray picture of the breast that doctors use to look for early signs of breast cancer.

The women in the study were recruited from November 2008 to April 2012, and they had gotten mammograms through October 2020. The average age of the participants was around 57.

Among the women, there were 289 cases of breast cancer diagnosed, and the researchers found that breast density was higher at the start of the study for the women who later developed breast cancer compared with those who remained cancer-free.

The researchers also found that there was a significant decrease in breast density among all the women over the course of 10 years, regardless of whether they later developed breast cancer, but the rate of density decreasing over time was significantly slower among breasts in which cancer was later diagnosed.

“This study found that evaluating longitudinal changes in breast density from digital mammograms may offer an additional tool for assessing risk of breast cancer and subsequent risk reduction strategies,” the researchers wrote.

Not only is breast density a known risk factor for breast cancer, dense breast tissue can make mammograms more difficult to read.

“There are two issues here. First, breast density can make it more difficult to fully ‘see through’ the breast on a mammogram, like looking through a frosted glass. Thus, it can be harder to detect a breast cancer,” Dr. Hal Burstein, clinical investigator in the Breast Oncology Center at Dana-Farber Cancer Institute, who was not involved in the new study, said in an email. “Secondly, breast density is often thought to reflect the estrogen exposure or estrogen levels in women, and the greater the estrogen exposure, the greater the risk of developing breast cancer.”

In March, the US Food and Drug Administration published updates to its mammography regulations, requiring mammography facilities to notify patients about the density of their breasts.

“Breast density can have a masking effect on mammography, where it can be more difficult to find a breast cancer within an area of dense breast tissue,” Jiang wrote in her email.

“Even when you take away the issue of finding it, breast density is an independent risk factor for developing breast cancer. Although there is lots of data that tell us dense breast tissue is a risk factor, the reason for this is not clear,” she said. “It may be that development of dense tissue and cancer are related to the same biological processes or hormonal influences.”

The findings of the new study demonstrate that breast density serves as a risk factor for breast cancer – but women should be aware of their other risk factors too, said Dr. Maxine Jochelson, chief of the breast imaging service at Memorial Sloan Kettering Cancer Center in New York, who was not involved in the study.

“It makes sense to some extent that the longer your breast stays dense, theoretically, the more likely it is to develop cancer. And so basically, it expands on the data that dense breasts are a risk,” Jochelson said, adding that women with dense breasts should ask for supplemental imaging when they get mammograms.

But other factors that can raise the risk of breast cancer include having a family history of cancer, drinking too much alcohol, having a high-risk lesion biopsied from the breast or having a certain genetic mutation.

For instance, women should know that “density may not affect their risk so much if they have the breast cancer BRCA 1 or 2 mutation because their risk is so high that it may not make it much higher,” Jochelson said.

Some ways to reduce the risk of breast cancer include keeping a healthy weight, being physically active, drinking alcohol in moderation or not at all and, for some people, taking medications such as tamoxifen and breastfeeding your children, if possible.

“Breast density is a modest risk factor. The ‘average’ woman in the US has a 1 in 8 lifetime chance of developing breast cancer. Women with dense breasts have a slightly greater risk, about 1 in 6, or 1 in 7. So the lifetime risk goes up from 12% to 15%. That still means that most women with dense breasts will not develop breast cancer,” Burstein said in his email.

“Sometimes radiologists will recommend additional breast imaging to women with dense breast tissue on mammograms,” he added.

The US Preventive Services Task Force – a group of independent medical experts whose recommendations help guide doctors’ decisions – recommends biennial screening for women starting at age 50. The task force says that a decision to start screening earlier “should be an individual one.” Many medical groups, including the American Cancer Society and Mayo Clinic, emphasize that women have the option to start screening with a mammogram every year starting at age 40.

“It’s also very clear that breast density tends to be highest in younger women, premenopausal women, and for almost all women, it tends to go down with age. However, the risk of breast cancer goes up with age. So these two things are a little bit at odds with each other,” said Dr. Freya Schnabel, director of breast surgery at NYU Langone’s Perlmutter Cancer Center and professor of surgery at NYU Grossman School of Medicine in New York, who was not involved in the new study.

“So if you’re a 40-year-old woman and your breasts are dense, you could think about that as just being really kind of age-appropriate,” she said. “The take-home message that’s very, very practical and pragmatic right now is that if you have dense breasts, whatever your age is, even if you’re postmenopausal – maybe even specifically, if you are postmenopausal – and your breasts are not getting less dense the way the average woman’s does, that it really is a reason to seek out adjunctive imaging in addition to just mammography, to use additional diagnostic tools, like ultrasound or maybe even MRI, if there are other risk factors.”

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US cigarette smoking rate falls to historic low, but e-cigarette use keeps climbing | CNN

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CNN
—

The percentage of adults who smoked cigarettes in the United States fell to a historic low last year, the US Centers for Disease Control and Prevention found. However, e-cigarettes are becoming even more popular.

About 11% of adults told the CDC last year that they were current cigarette smokers, according to the latest preliminary data from the National Health Interview Survey, a biannual survey that provides general information about health-related topics. The survey includes responses from 27,000 people age 18 and older. In 2020 and 2021, about 12.5% of adults said they smoked cigarettes.

This is a significant drop from when surveys like these started. Surveys of Americans in the 1940s found that about half of all adults said they smoked cigarettes. Rates began to decline in the 1960s, and more recently, in 2016, 15.5% of adults said they smoked cigarettes.

Recent studies have shown some groups are still at higher risk. While the latest CDC survey doesn’t capture this level of detail, cigarette smoking rates among some communities – including Native Americans, Alaska Natives and members of the LGBTQ community remain “alarmingly high” according to the 2023 State of Tobacco Control report from the American Lung Association.

The general drop in cigarette smoking among adults should have a positive impact on public health.

Cigarette smoking is still the leading cause of preventable death and disability in the US. So many people have died from smoking, the CDC finds, that more than 10 times as many US citizens have died prematurely from cigarette smoking than have died in all the wars fought by the US.

Smokers are 90% of the lung cancer cases in the United States, but smoking can also cause someone to have a stroke, coronary heart disease, and COPD, as well as other cancers including bladder, colon, kidney, liver, stomach and other cancers. People who live with smokers also are at a greater risk of death, because of secondhand smoke.

This latest survey does not capture why fewer people smoked cigarettes, but the number has been on the decline since the 1960s, after the US surgeon general released the first report on smoking and health that concluded that smoking causes serious health problems.

Experts credit a variety of efforts for the decline in cigarette smoking – anti-smoking campaigns, programs that educate children about the danger of smoking, laws that severely restrict where people could smoke and where cigarette companies could advertise, as well as better access to smoking cessation programs and higher taxes that make cigarettes expensive.

However, Congress hasn’t raised federal tobacco taxes in 14 years. The federal cigarette tax remains $1.01 per pack, and taxes vary for other tobacco products. No state increased its cigarette taxes in 2022.

The pandemic may also have had an influence. Smokers were much more vulnerable to the severe consequences of Covid-19 and that gave some people the extra motivation they needed to quit – and may have given doctors the extra motivation they needed to help them too, according to Dr. Panagis Galiatsatos, a volunteer medical spokesperson with the American Lung Association. At some level, the pandemic also made the medical establishment easier to access.

“The pandemic, I think, really allowed physicians time they never probably had in the past to conduct these telemedicine visits that were appropriate just for smoking cessation strategies, helping them help patients quit and stay quit,” said Galiatsatos, who is a pulmonary and critical care medicine physician and is director of the Tobacco Treatment Clinic with Johns Hopkins Medicine.

Galiatsatos points to the US Surgeon General report released during the Trump administration, just prior to the start of the pandemic. The report detailed that of the patients they have now that smoke, the few that are left are going to be the most resistant to quitting. Then-Surgeon General Jerome Adams’ report encouraged more doctors to help their patients quit. The report found that 40% of smokers are not routinely told by their doctors to stop.

Still, the culture has changed. Smoking is much less socially acceptable in some cultures in the US.

E-cigarette use, though, seems to be more socially acceptable, especially among younger people studies show, and that may explain why those numbers are up.

The current survey found that e-cigarette use rose to nearly 6% last year, that’s up from about 4.9% the year before.

Some argue that e-cigarettes are a good substitute for regular cigarettes, and in some countries they are even promoted as a smoking cessation devices, but the CDC says that “e-cigarettes are not safe for youth, young adults, and pregnant women, as well as adults who do not currently use tobacco products.”

A BMJ study published in February found that people who used e-cigarettes to quit smoking found them to be less helpful than more traditional smoking cessation aids.

The US Food and Drug Administration says there is not enough evidence to support claims that these products are effective tools to help people quit smoking. None are approved for this purpose. The FDA says there are no safe tobacco products, including e-cigarettes, vapes, and other electronic nicotine delivery systems.

“I always hold no stigma or judgment when anyone wants to smoke a traditional cigarette or use electronic cigarettes, but as a lung doctor, I will always promote only air to come into the lungs,” said Galiatsatos. “From my standpoint, I think we should still have a public health mindset around e-cigarette usage because for some individuals, they’re going to have health consequences from this product.”

He said people may choose to vape instead of smoke cigarettes, but clinicians should be prepared to help this population if they do want to quit.

E-cigarettes can, though, produce a number of chemicals that are not good for human health, including acrolein, acetaldehyde, and formaldehyde. Studies show these chemicals are known as aldehydes and can cause lung and heart disease, according to the American Lung Association.

Among teens, nicotine exposure can harm the developing brain, according to the US surgeon general.

E-cigarettes are much more popular than cigarettes among teens, so the adult e-cigarette user numbers will likely continue to grow.

About 14% of high school students said they used e-cigarettes, and 2% of high school students smoked cigarettes last year, according to separate CDC data.

The rate of kids that use e-cigarettesis high, the American Academy of Pediatrics says.

Specifically, in 2022, nearly 5% of middle school and about 17% of high school students reported some form of current tobacco use, according to CDC data from an earlier survey. In 2021, about 11% of middle schoolers and 34% of high schoolers said they had ever tried tobacco.

These “try rates” are important because most adult smokers started at young ages, according to the CDC.

The AAP continues to encourage pediatricians to screen for tobacco use as part of a child’s regular checkup. A talk about tobacco should start no later than age 11 or 12, the report says.

For adult smokers, the CDC encourages encourages people to call 1-800-QUIT-NOW where people can get free confidential coaching. The government also offers free online resources and even text programs that can help people quit.

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New study suggests Black women should be screened earlier for breast cancer | CNN

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CNN
—

A new study on breast cancer deaths raises questions around whether Black women should screen at earlier ages.

An international team of researchers wrote in the study, published Wednesday in the journal JAMA Network Open, that clinical trials may be warranted to investigate whether screening guidelines should recommend Black women start screening at younger ages, around 42 instead of 50.

The US Preventive Services Task Force – a group of independent medical experts whose recommendations help guide doctors’ decisions – recommends biennial screening for women starting at age 50. The Task Force says that a decision to start screening prior to 50 “should be an individual one.” Many medical groups, including the American Cancer Society and Mayo Clinic, already emphasize that women have the option to start screening with a mammogram every year starting at age 40.

Even though Black women have a 4% lower incidence rate of breast cancer than White women, they have a 40% higher breast cancer death rate.

“The take-home message for US clinicians and health policy makers is simple. Clinicians and radiologists should consider race and ethnicity when determining the age at which breast cancer screening should begin,” Dr. Mahdi Fallah, an author of the new study and leader of Risk Adapted Cancer Prevention Group at the German Cancer Research Center in Heidelberg, Germany, said in an email.

“Also, health policy makers can consider a risk-adapted approach to breast cancer screening to address racial disparities in breast cancer mortality, especially the mortality before the recommended age of population screening,” said Fallah, who is also a visiting professor at Lund University in Sweden and an adjunct professor at the University of Bern in Switzerland.

Breast cancer screenings are typically performed using a mammogram, which is an X-ray picture taken of the breast that doctors examine to look for early signs of breast cancer developing.

“Guidelines for screening actually already do recommend basing a woman’s time to initiate screening on the risk of developing cancer, though race and ethnicity have not been traditional factors that go into these decisions,” Dr. Rachel Freedman, a breast oncologist at Dana-Farber Cancer Institute, who was not involved in the new study, said in an email.

The American Cancer Society currently recommends that all women consider mammogram screenings for breast cancer risk starting at the age of 40 – and for women 45 to 54, it’s recommended to get mammograms every year. Those 55 and older can switch to screening every other year if they choose.

But “we are in the process of updating our breast cancer screening guidelines, and we are examining the scientific literature for how screening guidelines could differ for women in different racial and ethnic groups, and by other risk factors, in a way that would reduce disparities based on risk and disparities in outcome,” Robert Smith, senior vice president for cancer screening at the American Cancer Society, who was not involved in the new study, said in an email. “We are examining these issues closely.”

The American Cancer Society’s recommendations appear to align with the findings in the new study, as the research highlights how screening guidelines should not be a “one-size-fits-all policy,” but rather help guide conversations that patients and their doctors have together.

“We, here at the American Cancer Society, strongly recommend that all women consider a screening mammogram from the age of 40 onwards, and that means having a discussion with their doctor,” said Dr. Arif Kamal, the American Cancer Society’s chief patient officer, who was not involved in the new study.

“The authors highlight that age 50 can be a little late,” Kamal said about the study’s findings on when to begin breast cancer screening. “We are in agreement with that, particularly for women who may be at slightly higher risk.”

The researchers – from China, Germany, Sweden, Switzerland and Norway – analyzed data on 415,277 women in the United States who died of breast cancer in 2011 to 2020. That data on invasive breast cancer mortality rates came from the National Center for Health Statistics and was analyzed with the National Cancer Institute’s SEER statistical software.

When the researchers examined the data by race, ethnicity and age, they found that the rate of breast cancer deaths among women in their 40s was 27 deaths per 100,000 person-years for Black women compared with 15 deaths per 100,000 in White women and 11 deaths per 100,000 in American Indian, Alaska Native, Hispanic and Asian or Pacific Islander women.

“When the breast cancer mortality rate for Black women in their 40s is 27 deaths per 100,000 person-years, this means 27 out of every 100,000 Black women aged 40-49 in the US die of breast cancer during one year of follow-up. In other words, 0.027% of Black women aged 40-49 die of breast cancer each year,” Fallah said in the email.

In general, for women in the United States, their average risk of dying from breast cancer in the decade after they turn 50, from age 50 to 59, is 0.329%, according to the study.

“However, this risk level is reached at different ages for women from different racial/ethnic groups,” Fallah said. “Black women tend to reach this risk level of 0.329% earlier, at age 42. White women tend to reach it at age 51, American Indian or Alaska Native and Hispanic women at age 57 years, and Asian or Pacific Islander women later, at age 61.”

So, the researchers determined that when recommending breast cancer screening at age 50 for women, Black women should start at age 42.

Yet “the authors didn’t have any information on whether the women included in this study actually had mammographic screening and at what age. For example, it is possible that many women in this study actually had screening during ages 40-49,” Freedman, of the Dana-Farber Cancer Institute, said in her email.

“This study confirms that the age of breast cancer-mortality is younger for Black women, but it doesn’t confirm why and if screening is even the main reason. We have no information about the types of cancers women developed and what treatment they had either, both of which impact mortality from breast cancer,” she said.

The harm of starting mammograms at a younger age is that it raises the risk of a false positive screening result – leading to unnecessary subsequent tests and emotional stress.

But the researchers wrote in their study that “the added risk of false positives from earlier screenings may be balanced by the benefits” linked with earlier breast cancer detection.

They also wrote that health policy makers should pursue equity, not just equality, when it comes to breast cancer screening as a tool to help reduce breast cancer death rates.

Equality in the context of breast cancer screening “means that everyone is screened from the same age regardless of risk level. On the other hand, equity or risk-adapted screening means that everyone is provided screening according to their individual risk level,” the researchers wrote. “We believe that a fair and risk-adapted screening program may also be associated with optimized resource allocation.”

The new study is “timely and relevant,” given the overall higher mortality rate for breast cancer in Black women and that Black women are more likely to be diagnosed at a younger age compared with other ethnic groups, Dr. Kathie-Ann Joseph, surgical oncologist at NYU Langone’s Perlmutter Cancer Center and professor of surgery and population health at the NYU Grossman School of Medicine, said in an email.

“While some may argue that earlier screening may lead to increased recalls and unnecessary biopsies, women get recalled for additional imaging about 10% of the time and biopsies are needed in 1-2% of cases, which is quite low,” said Joseph, who was not involved in the new study.

“This has to be compared to the lives saved from earlier screening mammography,” she said. “I would also like to point out that while we certainly want to prevent deaths, earlier screening can have other benefits by allowing women of all racial and ethnic groups to have less extensive surgery and less chemotherapy which impacts quality of life.”

Breast cancer is the most common cancer among women in the United States, except for skin cancers. This year, it is estimated that about 43,700 women will die from the disease, according to the American Cancer Society, and Black women have the highest death rate from breast cancer.

Even though Black women are 40% more likely than White women to die from the disease, Kamal of the American Cancer Society said that the disparity in deaths is not a result of Black women not following the current mammogram guidelines.

Rather, implicit bias in medicine plays a role.

“In the United States, across the country, there are not differences in mammogram screening rates among Black women and White women. In fact, across the entire country, the number is about 75%. We see about 3 in 4 women – Black, White, Hispanic, and Asian – are on time with their mammograms,” Kamal said.

Yet there are multiple timepoints after a patient is diagnosed with breast cancer where they may not receive the same quality of care or access to care as their peers.

“For example, Black women are less likely to be offered enrollment in a clinical trial. That is not because of a stated difference in interest. In fact, the enrollment rate in clinical trials is equal among Black women and White women, if they’re asked,” Kamal said.

“What we have to understand is where the implicit and systemic biases held by patients and their caregivers and their families may exist – those that are held within health systems and even policies and practices that impede everyone having fair and just access to high quality health care,” he said.

Additionally, Black women have nearly a three-fold increased risk of triple-negative breast cancers. Those particular type of cancers tend to be more common in women younger than 40, grow faster than other types of invasive breast cancer and have fewer treatment options.

Black women also tend to have denser breast tissue than White women. Having dense tissue in the breast can make it more difficult for radiologists to identify breast cancer on a mammogram, and women with dense breast tissue have a higher risk of breast cancer.

But such biological differences among women represent just a small part of a much larger discussion around racial disparities in breast cancer, Kamal said.

“There are systemic issues, access to care issues that really go beyond biology,” he said. “The reality is cancer affects everybody and it does not discriminate. Where the discrimination sometimes occurs is after the diagnosis, and that’s really what we need to focus on.”

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EPA proposes new regulations on toxic gas used to sterilize spices and medical equipment | CNN

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CNN
—

The US Environmental Protection Agency on Tuesday proposed a set of new restrictions on facilities that use the cancer-causing chemical ethylene oxide, a colorless, odorless gas that is used to sterilize medical devices and spices.

The agency said the new rules, which have not been finalized, would help to reduce ethylene oxide gas that these facilities release by 80%, bringing emissions below a Clean Air Act standard for elevated cancer risk.

Communities exposed to ethylene oxide gas have been pushing the EPA to put tighter controls on plants that use ethylene oxide gas.

In 2018, an EPA report found that dozens of communities across the nation faced elevated cancer risks because of trace of amounts of ethylene oxide released into air as part of the sterilization process.

The EPA issued the report on the new risks without issuing a news release, as it had done for the same report in years past. Some affected communities learned of the risk through a health assessment conducted by the Agency for Toxic Substances and Disease Registry, a division of the US Centers for Disease Control and Prevention, and media reports. A report from the EPA’s Office of the Inspector General found that some communities weren’t alerted to their risk by EPA at all.

The elevated risk became apparent after a two-decade long review of the toxicity of ethylene oxide by scientists in EPA’s Integrated Risk Information System (IRIS) program.

While the EPA acknowledged that ethylene oxide was more dangerous that had been previously understood, it continued to use an older set of rules to regulate facilities that released ethylene oxide as well as companies that manufacture it.

The proposed rules aim to better align regulations on the producers and users of ethylene oxide with the cancer risk posed by the chemical. They follow a set of proposed rules issued by EPA last week that would put new controls on facilities that manufacture ethylene oxide.

Taken together, the two sets of rules would remove 77 tons of ethylene oxide emissions a year, an 84% reduction compared with 2020 levels, EPA Deputy Administrator Janet McCabe said in a call with reporters on Tuesday.

Environmental watchdog groups applauded the proposed restrictions, but noted that they don’t go far enough to protect vulnerable communities, where residents are often low-income and disproportionately people of color.

“These regulations are long overdue, by almost a decade. I’m relieved and pleased that the EPA has finally issued proposed standards that are based on their own scientists’ recommendations on an updated, higher cancer risk value. If enacted, these updated regulations would reduce emissions in fenceline communities,” said Darya Minovi, a senior researcher scientist at the Union of Concerned Scientists.

“When the EPA issues the final rule, they should throw the net wider. The standard should cover a larger range of facilities to include off-site warehouses that often store recently sterilized equipment that continue to release ethylene oxide, but aren’t regulated for their air emissions.”

Minovi also said the EPA should require fenceline monitors – devices that constantly read the air outside of facilities to make sure that toxic gas isn’t drifting into neighborhoods.

Jaime Rukstales, a member of the Illinois grassroots advocacy group Stop EtO in Lake County – one of the communities impacted by ethylene oxide pollution – says the EPA needs to impose tougher restrictions on “all types of facilities that impact the health of our communities … including sterilizers, manufacturers and warehouses near our homes, schools and businesses.”

Some off-site warehouses used to store newly sterilized products have registered high levels of ethylene oxide due to off-gassing of the products.

Meanwhile, chemical manufacturers sued the EPA in February over its updated hazard assessment for ethylene oxide. The industry wants the agency to use a less protective standard developed by the Texas Commission on Environmental Quality.

AdvaMed, a group that lobbies for the interests of medical device manufacturers, warned that more regulations could pose problems for patients.

“If new EPA regulations force sterilization facilities to close, patients could face treatment delays as sterile technology supplies, such as pacemakers and surgical equipment, fall short,” Scott Whitaker, president and CEO of AdvaMed, said in a comment posted on the group’s website.

The EPA said some commercial sterilizers have already made the planned changes.

“Many sterilization and health care facilities are already taking the steps outlined in the proposal and have seen emissions drop significantly,” McCabe said.

Most facilities have taken action to control ethylene oxide blown out of sterilization chambers through exhaust vents known as “back vents” but only 25% to 33% of sterilizers are controlling so-called fugitive emissions, ethylene oxide that escapes or leaks into room air, said Jonathan Witt, an environmental engineer and technical lead on EPA’s review of the National Emissions Standards for Hazardous Air Pollutants.

“So we think it’s a good sizable chunk of the industry, but still a little ways to go,” Witt said on a call with reporters.

If the rules go into effect, sterilizers would have 18 months to make the changes, which the EPA said is an accelerated time frame under the Clean Air Act.

AdvaMed’s Whitaker says that’s not enough time.

“It could take many months for abatement equipment to arrive. Supply chains and manufacturing are still recovering from the pandemic,” he noted in the statement.

In issuing the proposed rules, the EPA said it aimed to strike a balance between lowing cancer risks for impacted communities and workers who use ethylene oxide while preserving “critical sterilization capabilities.”

The proposed rules would apply to 86 commercial sterilization facilities in the United States that use ethylene oxide gas to fumigate spices and medical devices.

The EPA says 20 billion medical devices – mostly single-use, disposable items used in health care such as catheters, gloves and surgical gowns – are sterilized using ethylene oxide.

The US Food and Drug Administration is actively exploring alternatives to the use of the gas, the EPA said on Tuesday, but some devices still can’t be sterilized any other way.

In proposing the new rules, EPA said its new analysis found that exposure to ethylene oxide, or EtO, on the job significantly increased cancer risks for workers in sterilization facilities and those who apply ethylene oxide in health care facilities.

“Now, a new EPA analysis shows that there may also be significant risks to workers who handle [ethylene oxide] and people who live, work or go to school near places where EtO is used in sterilization. And failing to take action to address these risks is simply unacceptable,” EPA Administrator Janet McCabe said on a call with reporters.

The additional lifetime cancer risk for a worker exposed to ethylene oxide for eight hours a day, 240 days a year for 35 years was between 1 in 10 and 1 in 36 for workers in sterilization facilities; and between 1 in 12 and 1 in 25 for workers exposed to ethylene oxide in health care facilities.

To help lower those risks, the proposed rules require greater use of personal protective equipment for workers and new controls to decrease the amount of ethylene oxide in indoor air.

Whitaker from AdvaMed, the medical device industry group, said the cancer risk for employees exposed to ethylene oxide on the job is overstated and disregards “the strong employee protections already in practice.”

Companies will also be required to use new real-time monitoring methods to confirm that these pollution controls are working inside facilities. These controls can measure ethylene oxide in indoor air down to 10 parts per billion. If ethylene oxide levels climb above this threshold, everyone in the workplace would be required to wear protective equipment.

They will also lower the amount of ethylene oxide that can be used for each sterilization cycle. The EPA is proposing to limit the application rate for ethylene oxide to no more than 500 milligrams per liter of air.

The rules would eliminate some niche uses of ethylene oxide where alternatives exist, including its use in museums, archival settings, beekeeping, some cosmetics, and in musical instruments.

The EPA will take public comment on the new rules for 60 days. The agency will also host a virtual public webinar on May 1 to discuss its proposed rules and new risk assessment.

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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

Post By Health 2023 ohio train disaster, Accidents, brand safety-nsf accidents and disasters, brand safety-nsf automotive negative, brand safety-nsf health issues, brand safety-nsf sensitive, business, business and industry sectors, Cancer, chemical industry and chemicals, chemicals and environment, disasters and safety, diseases and disorders, domestic alerts, domestic-health and science, economy and trade, environment and natural resources, firefighters and firefighting, fires, health and medical, iab-cancer, iab-disasters, iab-diseases and conditions, iab-environment, iab-medical health, iab-politics, iab-science, international alerts, international-health and science, labor and employment, public safety workers, rail transportation, toxic and hazardous substances, traffic accidents, train accidents, transportation and warehousing, workers and professionals

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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CNN
—

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

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

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

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

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

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

He was diagnosed with stage I lung cancer soon after.

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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CNN
—

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

Active surveillance did have important benefits over surgery or radiation.

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

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

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

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

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

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

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

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