Tag: urogenital disorders and injuries

Urinary tract infections in men: Here are 10 things to know | CNN

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Editor’s Note: Dr. Jamin Brahmbhatt is a urologist and robotic surgeon with Orlando Health and president of the Florida Urological Society.



CNN
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While urinary tract infections are more common in women, men can still get what’s commonly known as a UTI. Here are 10 things I’d like you to know about urinary tract infections, including who’s more at risk and how to get treatment.

UTI is short for urinary tract infection. It’s an infection of the organs in your body – I call them pipes – that are meant to funnel your urine out of your system and into the urinal. Most UTIs are caused by bacteria that work their way into the urethra, prostate, bladder or kidneys.

Way more women than men are diagnosed with UTIs. Anatomically, we feel this happens because women have a shorter urethra – the tube that connects the bladder to the outside world. The shorter length makes it easier for bacteria to travel to the urinary system. Men have longer urethras and therefore can be protected against urinary infections.

But the length of the urethra alone cannot protect men against UTIs – over their lifetimes, 12% of men will get urinary symptoms linked to a UTI. This by no means implies a urethra or penis are short or small. In men, there is usually a more clear pathologic cause to the infection beyond just the length of the urethra.

There are many reasons why a guy may get a UTI – all of them we take seriously and should not be ignored.

Men older than 50 tend to get more infections than younger men. As a urologist, I see men get recurrent infections when they do not properly empty their bladder because of an enlarged prostate. Beyond the prostate, men may not empty their bladder if they have nerve damage from stroke, uncontrolled diabetes or injury to the spine.

Men can also get infections that start from the prostate or testicles that seed up into the bladder, or the opposite can happen where the infection goes from the bladder to the other organs. Kidney stones can also be a cause of infection. (I know this from personal experience – I’ve had a kidney stone myself!)

Younger men may also present with urinary infections because of sexually transmitted diseases. Men can also get an infection if they have a recent procedure done in the urinary system.

4. What are the signs and symptoms of a UTI?

Burning with urination (dysuria), increased urinary frequency, urgency, incontinence, foul smell, blood in the urine, fevers, chills, pain in the abdomen near the bladder. Believe it or not, some men may have zero symptoms and still get diagnosed with a UTI based on urine cultures done for other purposes.

UTI is diagnosed by sending your urine off for a culture. This is when a sample of your urine is processed and evaluated for various strains of bacteria. The most common bacteria identified in urinary tract infections is E.coli. Once the culture is done, the results can guide treatment, which is usually oral antibiotics. There is a test called a urine analysis which can be done quickly in our office which can suggest an infection. However, the best test is an actual culture.

Doctors do not wait for the culture results – which can take one to three days – to start treatment. If an infection is suspected, an antibiotic will be started immediately and then adjusted based on the culture results.

UTIs generally are treated with oral or IV antibiotics. Most infections can be treated with oral antibiotics. However there are superbugs that may be resistant to what we can give you by mouth that may require the use of stronger antibiotics through an IV. Most treatments last seven to 10 days, but can be longer.

In severe cases of infection that has spread to the bloodstream, strong IV antibiotics are started immediately to control the infection. Patients are placed in the hospital to start these strong treatments. You do not have to stay in the hospital for weeks if you have infection in your bloodstream. As long as you are doing well – no fever, normal labs, heart and pulse OK – then you may continue these IV treatments from home. Each treatment is tailored to your condition.

As a doctor, my answer is: No. Men should not try to treat infections on their own. If you have symptoms, get yourself to a doctor or emergency room.

The best prevention is making sure first there is nothing anatomical that needs to be corrected, such as an enlarged prostate, kidney stone or blockage.

Proper hygiene can help prevent infections. Men with uncircumcised penises should make sure they can retract the foreskin and clean under the foreskin and the glans properly. Cranberry supplements have been shown to help prevent infections. Staying hydrated by drinking enough fluids/water during the day can also help. Making sure you don’t hold your urine can help, too. Staying in good health to avoid chronic medical conditions such as diabetes and heart disease will also protect against infections.

9. My infection is gone. Are there any long-term effects on my body?

Recurrent, untreated infections could cause strictures, or tight scars, in your urethra that would slow your stream and make it difficult to empty your bladder. Infections could also cause the bladder to lose its ability to fill and empty properly. In the long run, if you are getting constantly treated with antibiotics, we may run out of antibiotics to give you due to resistance.

The first priority is to clear the infection with antibiotics.

From there, we do a full workup with a detailed history, evaluation of chronic medical problems and exam of the genitals to look for anatomic issues such as a foreskin that won’t retract back. Imaging may include a CT scan of the abdomen and pelvis to look for kidney stones, blocked tubes and other abnormalities.

If you see a urologist, you will likely get a cystoscopy, where we place a camera inside of a small tube into the urethra to look at the inside of your urine channel. The cystoscopy helps look for strictures, large obstructing prostates and changes to the bladder walls. Once a cause is found, it’s aggressively treated with either medication or surgery.

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Black or ‘Other’? Doctors may be relying on race to make decisions about your health | CNN

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Editor’s Note: CNN’s “History Refocused” series features surprising and personal stories from America’s past to bring depth to conflicts still raging today.



CNN
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When she first learned about race correction, Naomi Nkinsi was one of five Black medical students in her class at the University of Washington.

Nkinsi remembers the professor talking about an equation doctors use to measure kidney function. The professor said eGFR equations adjust for several variables, including the patient’s age, sex and race. When it comes to race, doctors have only two options: Black or “Other.”

Nkinsi was dumbfounded.

“It was really shocking to me,” says Nkinsi, now a third-year medical and masters of public health student, “to come into school and see that not only is there interpersonal racism between patients and physicians … there’s actually racism built into the very algorithms that we use.”

At the heart of a controversy brewing in America’s hospitals is a simple belief, medical students say: Math shouldn’t be racist.

The argument over race correction has raised questions about the scientific data doctors rely on to treat people of color. It’s attracted the attention of Congress and led to a big lawsuit against the NFL.

What happens next could affect how millions of Americans are treated.

Carolyn Roberts, a historian of medicine and science at Yale University, says slavery and the American medical system were in a codependent relationship for much of the 19th century and well into the 20th.

“They relied on one another to thrive,” Roberts says.

It was common to test experimental treatments first on Black people so they could be given to White people once proven safe. But when the goal was justifying slavery, doctors published articles alleging substantive physical differences between White and Black bodies — like Dr. Samuel Cartwright’s claim in 1851 that Black people have weaker lungs, which is why grueling work in the fields was essential (his words) to their progress.

The effects of Cartwright’s falsehood, and others like it, linger today.

In 2016, researchers asked White medical students and residents about 15 alleged differences between Black and White bodies. Forty percent of first-year medical students and 25% of residents said they believed Black people have thicker skin, and 7% of all students and residents surveyed said Black people have less sensitive nerve endings. The doctors-in-training who believed these myths — and they are myths — were less likely to prescribe adequate pain medication to Black patients.

To fight this kind of bias, hospitals urge doctors to rely on objective measures of health. Scientific equations tell physicians everything from how well your kidneys are working to whether or not you should have a natural birth after a C-section. They predict your risk of dying during heart surgery, evaluate brain damage and measure your lung capacity.

But what if these equations are also racially biased?

Race correction is the use of a patient’s race in a scientific equation that can influence how they are treated. In other words, some diagnostic algorithms and risk predictor tools adjust or “correct” their results based on a person’s race.

The New England Journal of Medicine article “Hidden in Plain Sight” includes a partial list of 13 medical equations that use race correction. Take the Vaginal Birth After Cesarean calculator, for example. Doctors use this calculator to predict the likelihood of a successful vaginal delivery after a prior C-section. If you are Black or Hispanic, your score is adjusted to show a lower chance of success. That means your doctor is more likely to encourage another C-section, which could put you at risk for blood loss, infection and a longer recovery period.

Cartwright, the racist doctor from the 1800s, also developed his own version of a tool called the spirometer to measure lung capacity. Doctors still use spirometers today, and most include a race correction for Black patients to account for their supposedly shallower breaths.

Turns out, second-year medical student Carina Seah wryly told CNN, math is as racist as the people who make it.

The biggest problem with using race in medicine? Race isn’t a biological category. It’s a social one.

“It’s based on this idea that human beings are naturally divided into these big groups called races,” says Dorothy Roberts, a professor of law and sociology at the University of Pennsylvania, who has made challenging race correction in medicine her life’s work. “But that’s not what race is. Race is a completely invented social category. The very idea that human beings are divided into races is a made-up idea.”

Ancestry is biological. Where we come from — or more accurately, who we come from — impacts our DNA. But a patient’s skin color isn’t always an accurate reflection of their ancestry.

Look at Tiger Woods, Roberts says. Woods coined the term “Cablinasian” to describe his mix of Caucasian, Black, American Indian and Asian ancestries. But to many Americans, he’s Black.

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“You can be half Black and half White in this country and you are Black,” says Seah, who is getting her medical degree and a PhD in genetics and genomics at the Icahn School of Medicine at Mount Sinai in New York. “You can be a quarter Black in this country — if you have dark skin, you are Black.”

So it can be misleading, Seah says, even dangerous, for doctors to judge a patient’s ancestry by glancing at their skin. A patient with a White mother and Black father could have a genetic mutation that typically presents in patients of European ancestry, Seah says, but a doctor may not think to test for it if they only see Black skin.

“You have to ask, how Black is Black enough?” Nkinsi asks. And there’s another problem, she says, with using a social construct like race in medicine. “It also puts the blame on the patient, and it puts the blame on the race itself. Like being Black is inherently the cause of these diseases.”

Naomi Nkinsi is a third-year medical and masters of public health student at the University of Washington in Seattle. She has been advocating for the removal of race correction in medicine.

After she learned about the eGFR equation in 2018, Nkinsi began asking questions about race correction. She wasn’t alone — on social media she found other students struggling with the use of race in medicine. In the spring of 2020, following a first-year physiology lecture, Seah joined the conversation. But the medical profession is nothing if not hierarchical; Nkinsi and Seah say students are encouraged to defer to doctors who have been practicing for decades.

Then on May 25, 2020, George Floyd was killed by police in Minneapolis.

His death and the growing momentum around Black Lives Matter helped ignite what Dr. Darshali A. Vyas calls an “overdue reckoning” in the medical community around race and race correction. A few institutions had already taken steps to remove race from the eGFR equation. Students across the country demanded more, and hospitals began to listen.

History Refocused BLM White Coats

Four days after Floyd’s death, the University of Washington announced it was removing race correction from the eGFR equation. In June, the Boston-based hospital system Mass General Brigham where Vyas is a second-year Internal Medicine resident followed suit. Seah and a fellow student at Mount Sinai, Paloma Orozco Scott, started an online petition and collected over 1600 signatures asking their hospital to do the same.

Studies show removing race from the eGFR equation will change how patients at those hospitals are treated. Researchers from Brigham and Women’s Hospital and Penn Medicine estimated up to one in every three Black patients with kidney disease would have been reclassified if the race multiplier wasn’t applied in earlier calculations, with a quarter going from stage 3 to stage 4 CKD (Chronic Kidney Disease).

That reclassification is good and bad, says Dr. Neil Powe, chief of medicine at Zuckerberg San Francisco General Hospital. Black patients newly diagnosed with kidney disease will be able to see specialists who can devise better treatment plans. And more patients will be placed on kidney transplant lists.

On the flip side, Powe says, more African Americans diagnosed with kidney disease means fewer who are eligible to donate kidneys, when there’s already a shortage. And a kidney disease diagnosis can change everything from a patient’s diabetes medication to their life insurance costs.

Dr. Neil Powe says by simply removing race from the eGFR equations,

Powe worries simply eliminating race from these equations is a knee-jerk response — one that may exacerbate health disparities instead of solve them. For too long, Powe says, doctors had to fight for diversity in medical studies.

The most recent eGFR equation, known as the CKD-EPI equation, was developed using data pooled from 26 studies, which included almost 3,000 patients who self-identified as Black. Researchers found the equation they were developing was more accurate for Black patients when it was adjusted by a factor of about 1.2. They didn’t determine exactly what was causing the difference in Black patients, but their conclusion is supported by other research that links Black race and African ancestry with higher levels of creatinine, a waste product filtered by the kidneys.

Put simply: In the eGFR equation, researchers used race as a substitute for an unknown factor because they think that factor is more common in people of African descent.

Last August, Vyas co-authored the “Hidden in Plain Sight” article about race correction. Vyas says most of the equations she wrote about were developed in a similar way to the eGFR formula: Researchers found Black people were more or less likely to have certain outcomes and decided race was worth including in the final equation, often without knowing the real cause of the link.

“When you go back to the original studies that validated (these equations), a lot of them did not provide any sort of rationale for why they include race, which I think is appalling.” That’s what’s most concerning, Vyas says – “how willing we are to believe that race is relevant in these ways.”

Vyas is clear she isn’t calling for race-blind medicine. Physicians cannot ignore structural racism, she says, and the impact it has on patients’ health.

Powe has been studying the racial disparities in kidney disease for more than 30 years. He can spout the statistics easily: Black people are three times more likely to suffer from kidney failure, and make up more than 35% of patients on dialysis in the US. The eGFR equation, he says, did not cause these disparities — they existed long before the formula.

“We want to cure disparities, let’s go after the things that really matter, some of which may be racist,” he says. “But to put all our stock and think that the equation is causing this is just wrong because it didn’t create those.”

In discussions about removing race correction, Powe likes to pose a question: Instead of normalizing to the “Other” group in the eGFR equation, as many of these hospitals are doing, why don’t we give everyone the value assigned to Black people? By ignoring the differences researchers saw, he says, “You’re taking the data on African Americans, and you’re throwing it in the trash.”

Powe is co-chair of a joint task force set up by the National Kidney Foundation and the American Society of Nephrology to look at the use of race in eGFR equations. The leaders of both organizations have publicly stated race should not be included in equations used to estimate kidney function. On April 9, the task force released an interim report that outlined the challenges in identifying and implementing a new equation that’s representative of all groups. The group is expected to issue its final recommendations for hospitals this summer.

Race correction is used to assess the kidneys and the lungs. What about the brain?

In 2013, the NFL settled a class-action lawsuit brought by thousands of former players and their families that accused the league of concealing what it knew about the dangers of concussions. The NFL agreed to pay $765 million, without admitting fault, to fund medical exams and compensate players for concussion-related health issues, among other things. Then in 2020, two retired players sued the NFL for allegedly discriminating against Black players who submitted claims in that settlement.

01 race correction Kevin Henry Najeh Davenport SPLIT

The players, Najeh Davenport and Kevin Henry, said the NFL race-corrected their neurological exams, which prevented them from being compensated.

According to court documents, former NFL players being evaluated for neurocognitive impairment were assumed to have started with worse cognitive function if they were Black. So if a Black player and a White player received the exact same scores on a battery of thinking and memory tests, the Black player would appear to have suffered less impairment. And therefore, the lawsuit stated, would be less likely to qualify for a payout.

Race correction is common in neuropsychology using something called Heaton norms, says Katherine Possin, an associate professor at the University of California San Francisco. Heaton norms are essentially benchmark average scores on cognitive tests.

Here’s how it works: To measure the impact of a concussion (or multiple concussions over time), doctors compare how well the patient’s brain works now to how well it worked before.

“The best way to get that baseline was to test you 10 years ago, but that’s not something we obviously have for many people,” Possin says. So doctors estimate your “before” abilities using an average score from a group of healthy individuals, and adjust that score for demographic factors known to affect brain function, like your age.

Heaton norms adjust for race, Possin says, because race has been linked in studies to lower cognitive scores. To be clear, that’s not because of any biological differences in Black and White brains, she says; it’s because of social factors like education and poverty that can impact cognitive development. And this is where the big problem lies.

In early March, a judge in Pennsylvania dismissed the players’ lawsuit and ordered a mediator to address concerns about how race correction was being used. In a statement to CNN, the NFL said there is no merit to the players’ claim of discrimination, but it is committed to helping find alternative testing techniques that do not employ race-based norms.

The NFL case, Possin wrote in JAMA, has “exposed a major weakness in the field of neuropsychology: the use of race-adjusted norms as a crude proxy for lifelong social experience.”

This happens in nearly every field of medicine. Race is not only used as a poor substitute for genetics and ancestry, it’s used as a substitute for access to health care, or lifestyle factors like diet and exercise, socioeconomic status and education. It’s no secret that racial disparities exist in all of these. But there’s a danger in using race to talk about them, Yale historian Carolyn Roberts says.

We know, for example, that Black Americans have been disproportionally affected by Covid-19. But it’s not because Black bodies respond differently to the virus. It’s because, as Dr. Anthony Fauci has noted, a disproportionate number of Black people have jobs that put them at higher risk and have less access to quality health care. “What are we making scientific and biological when it actually isn’t?” Roberts asks.

Vyas says using race as a proxy for these disparities in clinical algorithms can also create a vicious cycle.

“There’s a risk there, we argue, of simply building these into the system and almost accepting them as fact instead of focusing on really addressing the root causes,” Vyas says. “If we systematize these existing disparities … we risk ensuring that these trends will simply continue.”

Nearly everyone on both sides of the race correction controversy agrees that race isn’t an accurate, biological measure. Yet doctors and researchers continue to use it as a substitute. Math shouldn’t be racist, Nkinsi says, and it shouldn’t be lazy.

“We’re saying that we know that this race-based medicine is wrong, but we’re going to keep doing it because we simply don’t have the will or the imagination or the creativity to think of something better,” Nkinsi says. “That is a slap in the face.”

Shortly after Vyas’ article published in The New England Journal of Medicine, the House Ways and Means Committee sent letters to several professional medical societies requesting information on the misuse of race in clinical algorithms. In response to the lawmakers’ request, the Agency for Healthcare Research and Quality is also gathering information on the use of race-based algorithms in medicine. Recently, a note appeared on the Maternal Fetal Medicine Units Network’s website for the Vaginal Birth After Cesarean equation — a new calculator that doesn’t include race and ethnicity is being developed.

Dorothy Roberts is excited to see change on the horizon. But she’s also a bit frustrated. The harm caused by race correction is something she’s been trying to tell doctors about for years.

“I’ve taught so many audiences about the meaning of race and the history of racism in America and the audiences I get the most resistance from are doctors,” Roberts says. “They’re offended that there would be any suggestion that what they do is racist.”

Nkinsi and Seah both encountered opposition from colleagues in their fight to change the eGFR equation. Several doctors interviewed for this story argued the change in a race-corrected scores is so small, it wouldn’t change clinical decisions.

If that’s the case, Vyas wonders, why include race at all?

“It all comes from the desire for one to dominate another group and justify it,” says Roberts. “In the past, it was slavery, but the same kinds of justifications work today to explain away all the continued racial inequality that we see in America… It is mass incarceration. It’s huge gaps in health. It’s huge differences in income and wealth.”

It’s easier, she says, to believe these are innate biological differences than to address the structural racism that caused them.



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

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

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

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CNN
 — 

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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CNN
 — 

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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CNN
 — 

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

The BCG shortage is expected to continue for years.

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