AVAHO

Many states have restored restrictions on telehealth use that they suspended earlier in the COVID-19 pandemic, according to a new report jointly prepared by the Reason Institute, the Pioneer Institute, and the Cicero Institute.

Among the most important restrictions that have been reinstated in some states are those barring requirements for insurers to cover telehealth and regulations that prohibit telehealth visits across state lines, unless the physician is licensed in both states.

“Only three states – Arizona, Florida, and Indiana – allow all health care providers to easily practice telehealth across state lines,” says a news release on the think tanks’ report. “Forty-seven others have arbitrary barriers in place that limit patients’ access to specialists and available appointments based purely on residency.”

“Once the [state-based] public health emergency declarations started to end or executive orders were withdrawn, many of the new flexibilities for providers, insurers, and patients were lost overnight,” Vittorio Nastasi, a policy analyst at Reason Foundation and a co-author of the report, says in the news release. “States need to adopt a number of telehealth reforms to provide their residents better access to this safe and effective virtual care.”

On a positive note, the report says, most states have removed the requirement that a patient must first see a provider in person before they can use telehealth services. The exceptions are Tennessee, Alaska, and West Virginia, which require an in-person visit before certain telehealth services can be provided.

In addition, 20 states allow nurse practitioners to conduct telehealth visits without being under the supervision of a physician. Prior to the pandemic, some states allowed only doctors to use telehealth, the report says, but, during the COVID crisis, “the acute shortage of providers in many counties adds to the need for more kinds of providers to be able to use it.”

A number of states place restrictions on the telehealth modalities that can be utilized. Under the definition by the American Telemedicine Association, telehealth includes audio-video visits, remote patient monitoring, and “store and forward” telemedicine, which entails collecting clinical information and sending it to another site for evaluation. The latter method is particularly useful for consultations with specialists, the report notes.
 

Coverage mandates and payment parity

The report also examines other parameters of telehealth regulations in each state, including whether they have telehealth coverage mandates and whether they require physicians to be paid the same amount for similar types of in-person and telehealth visits.

The report views insurance mandates as beneficial, but not if they require coverage of all virtual services. While telehealth can be a game changer for post-stroke care and for other “treatment-intensive conditions,” the report says, the evidence of better outcomes for other conditions treated through telehealth is far less certain. Therefore, it advises states to “protect flexibility so that new innovative models can emerge.”

Ateev Mehrotra, MD, a professor at Harvard Medical School who studies telehealth, agrees that it offers more value in some clinical situations than in others. “High value is improving quality or outcomes at a reasonable cost,” he told this news organization. “If a telemedicine visit for stroke can save a person’s life and prevent disability, let’s pay for it. A telemedicine visit for a cold may not be necessary. Mom’s chicken soup is fine.”

A little over half of the states still require payment parity, according to the report. While these regulations are intended to promote the use of telehealth, the authors note, they can increase the growth of health care costs. Moreover, they argue, it’s hard to defend equal payments for virtual visits when the overhead required to deliver them – such as office rental, utility, and labor costs – is much lower than that for in-person visits. Also, it makes no sense for health systems to charge facility fees for telehealth visits when these visits can be initiated from anywhere, they say.

Dr. Mehrotra concurs with this view. “If you see someone in your office, your fee includes all the overhead for your office, and it’s a substantial cost,” he says. “For many procedures, it’s more than half of the cost. If you have a telemedicine visit and you’re at home, why would you pay the same amount? The visit may take the same amount of time, but all the money that goes for overhead is not accounted for.”
 

Telemedicine across state lines

The report’s contention about the difficulty of conducting telehealth encounters across most state lines seems to be at odds with the growth in the Interstate Medical Licensure Compact, which makes it easier for physicians in one compact member state to get licensed in others. Currently, 35 states belong to the compact, Joe Knickrehm, vice president of communications for the Federation of State Medical Boards, told this news organization.

In addition, he says, “12 state boards issue a special purpose license, telemedicine license or certificate, or license to practice medicine across state lines to allow for the practice of telemedicine.”

The catch, Dr. Mehrotra says, is that, despite the streamlining of license applications in compact member states, the fees charged by the state boards are still very high – a point that the report also makes. “If I want to have broad scope of practice, I’d have to pay thousands of dollars to many states. The license fees start to add up. Also, I have to keep track of each state’s CME requirements, which are all different. Keeping up with all of that is an administration burden, and it’s a pain.”

Mr. Knickrehm contends that obtaining multiple licenses via the compact “is generally less expensive for physicians than the cost of requesting transcripts, fingerprints, and other necessary paperwork each time they apply for licensure in a new state. Physicians are seeing the benefits of an expedited process that allows them to begin practicing more quickly [in other states].”

Dr. Mehrotra says he has seen the same retrenchment in state telehealth regulations that the report references. However, he says, “CMS [the Centers for Medicare & Medicaid Services] has signaled that at least through 2022 and maybe into 2023, they’ll continue their extensions of telemedicine [pandemic regulations].” After that, Congress would have to decide whether to make the changes permanent.

“Right now, it’s hard for me to see how a payer is going to pull back on telehealth, unless there’s ample evidence of overuse of telehealth,” he argues. “With the public and providers liking telehealth, it’s hard to say on theoretical grounds that we should stop using it. That’s why Medicare and others have extended it and why Congress will too.”

A version of this article first appeared on Medscape.com.

Many states have restored restrictions on telehealth use that they suspended earlier in the COVID-19 pandemic, according to a new report jointly prepared by the Reason Institute, the Pioneer Institute, and the Cicero Institute.

Among the most important restrictions that have been reinstated in some states are those barring requirements for insurers to cover telehealth and regulations that prohibit telehealth visits across state lines, unless the physician is licensed in both states.

“Only three states – Arizona, Florida, and Indiana – allow all health care providers to easily practice telehealth across state lines,” says a news release on the think tanks’ report. “Forty-seven others have arbitrary barriers in place that limit patients’ access to specialists and available appointments based purely on residency.”

“Once the [state-based] public health emergency declarations started to end or executive orders were withdrawn, many of the new flexibilities for providers, insurers, and patients were lost overnight,” Vittorio Nastasi, a policy analyst at Reason Foundation and a co-author of the report, says in the news release. “States need to adopt a number of telehealth reforms to provide their residents better access to this safe and effective virtual care.”

On a positive note, the report says, most states have removed the requirement that a patient must first see a provider in person before they can use telehealth services. The exceptions are Tennessee, Alaska, and West Virginia, which require an in-person visit before certain telehealth services can be provided.

In addition, 20 states allow nurse practitioners to conduct telehealth visits without being under the supervision of a physician. Prior to the pandemic, some states allowed only doctors to use telehealth, the report says, but, during the COVID crisis, “the acute shortage of providers in many counties adds to the need for more kinds of providers to be able to use it.”

A number of states place restrictions on the telehealth modalities that can be utilized. Under the definition by the American Telemedicine Association, telehealth includes audio-video visits, remote patient monitoring, and “store and forward” telemedicine, which entails collecting clinical information and sending it to another site for evaluation. The latter method is particularly useful for consultations with specialists, the report notes.
 

Coverage mandates and payment parity

The report also examines other parameters of telehealth regulations in each state, including whether they have telehealth coverage mandates and whether they require physicians to be paid the same amount for similar types of in-person and telehealth visits.

The report views insurance mandates as beneficial, but not if they require coverage of all virtual services. While telehealth can be a game changer for post-stroke care and for other “treatment-intensive conditions,” the report says, the evidence of better outcomes for other conditions treated through telehealth is far less certain. Therefore, it advises states to “protect flexibility so that new innovative models can emerge.”

Ateev Mehrotra, MD, a professor at Harvard Medical School who studies telehealth, agrees that it offers more value in some clinical situations than in others. “High value is improving quality or outcomes at a reasonable cost,” he told this news organization. “If a telemedicine visit for stroke can save a person’s life and prevent disability, let’s pay for it. A telemedicine visit for a cold may not be necessary. Mom’s chicken soup is fine.”

A little over half of the states still require payment parity, according to the report. While these regulations are intended to promote the use of telehealth, the authors note, they can increase the growth of health care costs. Moreover, they argue, it’s hard to defend equal payments for virtual visits when the overhead required to deliver them – such as office rental, utility, and labor costs – is much lower than that for in-person visits. Also, it makes no sense for health systems to charge facility fees for telehealth visits when these visits can be initiated from anywhere, they say.

Dr. Mehrotra concurs with this view. “If you see someone in your office, your fee includes all the overhead for your office, and it’s a substantial cost,” he says. “For many procedures, it’s more than half of the cost. If you have a telemedicine visit and you’re at home, why would you pay the same amount? The visit may take the same amount of time, but all the money that goes for overhead is not accounted for.”
 

Telemedicine across state lines

The report’s contention about the difficulty of conducting telehealth encounters across most state lines seems to be at odds with the growth in the Interstate Medical Licensure Compact, which makes it easier for physicians in one compact member state to get licensed in others. Currently, 35 states belong to the compact, Joe Knickrehm, vice president of communications for the Federation of State Medical Boards, told this news organization.

In addition, he says, “12 state boards issue a special purpose license, telemedicine license or certificate, or license to practice medicine across state lines to allow for the practice of telemedicine.”

The catch, Dr. Mehrotra says, is that, despite the streamlining of license applications in compact member states, the fees charged by the state boards are still very high – a point that the report also makes. “If I want to have broad scope of practice, I’d have to pay thousands of dollars to many states. The license fees start to add up. Also, I have to keep track of each state’s CME requirements, which are all different. Keeping up with all of that is an administration burden, and it’s a pain.”

Mr. Knickrehm contends that obtaining multiple licenses via the compact “is generally less expensive for physicians than the cost of requesting transcripts, fingerprints, and other necessary paperwork each time they apply for licensure in a new state. Physicians are seeing the benefits of an expedited process that allows them to begin practicing more quickly [in other states].”

Dr. Mehrotra says he has seen the same retrenchment in state telehealth regulations that the report references. However, he says, “CMS [the Centers for Medicare & Medicaid Services] has signaled that at least through 2022 and maybe into 2023, they’ll continue their extensions of telemedicine [pandemic regulations].” After that, Congress would have to decide whether to make the changes permanent.

“Right now, it’s hard for me to see how a payer is going to pull back on telehealth, unless there’s ample evidence of overuse of telehealth,” he argues. “With the public and providers liking telehealth, it’s hard to say on theoretical grounds that we should stop using it. That’s why Medicare and others have extended it and why Congress will too.”

A version of this article first appeared on Medscape.com.

Many states have restored restrictions on telehealth use that they suspended earlier in the COVID-19 pandemic, according to a new report jointly prepared by the Reason Institute, the Pioneer Institute, and the Cicero Institute.

Among the most important restrictions that have been reinstated in some states are those barring requirements for insurers to cover telehealth and regulations that prohibit telehealth visits across state lines, unless the physician is licensed in both states.

“Only three states – Arizona, Florida, and Indiana – allow all health care providers to easily practice telehealth across state lines,” says a news release on the think tanks’ report. “Forty-seven others have arbitrary barriers in place that limit patients’ access to specialists and available appointments based purely on residency.”

“Once the [state-based] public health emergency declarations started to end or executive orders were withdrawn, many of the new flexibilities for providers, insurers, and patients were lost overnight,” Vittorio Nastasi, a policy analyst at Reason Foundation and a co-author of the report, says in the news release. “States need to adopt a number of telehealth reforms to provide their residents better access to this safe and effective virtual care.”

On a positive note, the report says, most states have removed the requirement that a patient must first see a provider in person before they can use telehealth services. The exceptions are Tennessee, Alaska, and West Virginia, which require an in-person visit before certain telehealth services can be provided.

In addition, 20 states allow nurse practitioners to conduct telehealth visits without being under the supervision of a physician. Prior to the pandemic, some states allowed only doctors to use telehealth, the report says, but, during the COVID crisis, “the acute shortage of providers in many counties adds to the need for more kinds of providers to be able to use it.”

A number of states place restrictions on the telehealth modalities that can be utilized. Under the definition by the American Telemedicine Association, telehealth includes audio-video visits, remote patient monitoring, and “store and forward” telemedicine, which entails collecting clinical information and sending it to another site for evaluation. The latter method is particularly useful for consultations with specialists, the report notes.
 

Coverage mandates and payment parity

The report also examines other parameters of telehealth regulations in each state, including whether they have telehealth coverage mandates and whether they require physicians to be paid the same amount for similar types of in-person and telehealth visits.

The report views insurance mandates as beneficial, but not if they require coverage of all virtual services. While telehealth can be a game changer for post-stroke care and for other “treatment-intensive conditions,” the report says, the evidence of better outcomes for other conditions treated through telehealth is far less certain. Therefore, it advises states to “protect flexibility so that new innovative models can emerge.”

Ateev Mehrotra, MD, a professor at Harvard Medical School who studies telehealth, agrees that it offers more value in some clinical situations than in others. “High value is improving quality or outcomes at a reasonable cost,” he told this news organization. “If a telemedicine visit for stroke can save a person’s life and prevent disability, let’s pay for it. A telemedicine visit for a cold may not be necessary. Mom’s chicken soup is fine.”

A little over half of the states still require payment parity, according to the report. While these regulations are intended to promote the use of telehealth, the authors note, they can increase the growth of health care costs. Moreover, they argue, it’s hard to defend equal payments for virtual visits when the overhead required to deliver them – such as office rental, utility, and labor costs – is much lower than that for in-person visits. Also, it makes no sense for health systems to charge facility fees for telehealth visits when these visits can be initiated from anywhere, they say.

Dr. Mehrotra concurs with this view. “If you see someone in your office, your fee includes all the overhead for your office, and it’s a substantial cost,” he says. “For many procedures, it’s more than half of the cost. If you have a telemedicine visit and you’re at home, why would you pay the same amount? The visit may take the same amount of time, but all the money that goes for overhead is not accounted for.”
 

Telemedicine across state lines

The report’s contention about the difficulty of conducting telehealth encounters across most state lines seems to be at odds with the growth in the Interstate Medical Licensure Compact, which makes it easier for physicians in one compact member state to get licensed in others. Currently, 35 states belong to the compact, Joe Knickrehm, vice president of communications for the Federation of State Medical Boards, told this news organization.

In addition, he says, “12 state boards issue a special purpose license, telemedicine license or certificate, or license to practice medicine across state lines to allow for the practice of telemedicine.”

The catch, Dr. Mehrotra says, is that, despite the streamlining of license applications in compact member states, the fees charged by the state boards are still very high – a point that the report also makes. “If I want to have broad scope of practice, I’d have to pay thousands of dollars to many states. The license fees start to add up. Also, I have to keep track of each state’s CME requirements, which are all different. Keeping up with all of that is an administration burden, and it’s a pain.”

Mr. Knickrehm contends that obtaining multiple licenses via the compact “is generally less expensive for physicians than the cost of requesting transcripts, fingerprints, and other necessary paperwork each time they apply for licensure in a new state. Physicians are seeing the benefits of an expedited process that allows them to begin practicing more quickly [in other states].”

Dr. Mehrotra says he has seen the same retrenchment in state telehealth regulations that the report references. However, he says, “CMS [the Centers for Medicare & Medicaid Services] has signaled that at least through 2022 and maybe into 2023, they’ll continue their extensions of telemedicine [pandemic regulations].” After that, Congress would have to decide whether to make the changes permanent.

“Right now, it’s hard for me to see how a payer is going to pull back on telehealth, unless there’s ample evidence of overuse of telehealth,” he argues. “With the public and providers liking telehealth, it’s hard to say on theoretical grounds that we should stop using it. That’s why Medicare and others have extended it and why Congress will too.”

A version of this article first appeared on Medscape.com.

Pradeep Bansal considered the five capsules he was about to swallow. Together they made up a 25-mg dose of a substance that, in another setting, could have landed him in federal prison.

The substance was psilocybin, the active ingredient in magic mushrooms. To be more exact, it was a synthetic form of psilocybin called COMP360, made to pharmaceutical standards by a company called COMPASS Pathways. He was taking it as part of an Food and Drug Administration–approved clinical study on mental health therapy for people with cancer.

Dr. Bansal, a New York gastroenterologist, was far more comfortable giving medical treatment than receiving it. But he was getting used to it.

He had already been through surgery and a number of other treatments to address the physical aspects of his cancer. The psilocybin was to address the mental aspects – the crushing anxiety and depression that had stuck with him after his diagnosis.

Dr. Bansal did not arrive at this moment lightly.

“I was extremely skeptical going into this process,” said Dr. Bansal, who during a long medical career had looked with distrust and even disdain at alternative therapies.

“I don’t have much patience for holistic medicine, homeopathy, acupuncture, or alternative medicines with claims of spiritual upliftment or altered states of mind.”

But Bansal had done his homework on psilocybin and was impressed.

People with late-stage cancer and other serious health conditions who got psilocybin-assisted psychotherapy had “significant decreases” in anxiety and depression as long as 12 months after the treatment, according to studies published in 2011, 2014, and 2016.

One study from Johns Hopkins University tracked the effects of a single guided dose of psilocybin in terminal cancer patients with anxiety and depression. More than 80% had a “significant decrease” in symptoms – even 6 months after treatment – with more than 60% of the group remaining in the normal mood range.

For the study Dr. Bansal joined, there had been weeks of screening and consultation and preparation in a strictly controlled scientific trial.

And yet, even with all that he had learned, even with his psychiatrist-guide by his side, he was afraid. Afraid of what he might experience under the powerful effects of psilocybin. And afraid that this was all a misguided waste of time – that his mental angst would still be there when it was all over.

He knew that psilocybin, like other psychedelic substances, could take you on a “trip” – could remove you, at least for a time, from normal conscious experience.

Maybe he would feel “funny,” he thought. Maybe he would have some hallucinations. But how would that change the reality of his cancer? How would it lift the black dread and anxiety he felt about his future?
 

Stuck in a dark place

Dr. Bansal had first noticed blood in his urine – a lot of it – in September 2019. 

Two months later, doctors diagnosed cancer in his right kidney. He would need surgery to remove the kidney and surrounding lymph nodes (an operation called radical nephrectomy).

It was a shock, said Dr. Bansal. But the diagnosis and the surgery happened so quickly that he hardly had time to think. And treatment results seemed good. The cancer was only in stage I and the CT scans showed no signs of cancer after surgery.

“We were so relieved. Everyone was so happy,” Dr. Bansal said. “They didn’t even give me chemotherapy after surgery because it seemed so early.”

But a routine scan in June 2020 revealed more cancer in his lung. Within a couple of months, it was in his bladder too.

“It was devastating,” Dr. Bansal said. “I went from thinking I was healthy again to stage IV cancer.”

As doctors scheduled surgery to remove part of his lung, Dr. Bansal started on painful immunotherapy (BCG therapy) for his bladder.

At this point, from a psychological standpoint, Dr. Bansal was reeling. As a doctor, he knew all too well the meaning of stage IV cancer.

With two adult children and a grandchild on the way, Dr. Bansal had been looking forward to retirement with his wife of almost 40 years. “Suddenly, I wasn’t sure I was going to last that long,” Bansal recalled. “I was in a very dark place. I was very anxious, very depressed from lack of sleep.”

He saw a therapist about his cancer diagnosis and maintained his regular meditation practice at home. He hired a personal trainer and tried to focus on any good news that he got about his treatment.

Those things helped, but not enough.

The basic facts were inescapable. His cancer might end everything. He couldn’t stop thinking about it. And then he couldn’t stop thinking about how he couldn’t stop thinking about it.

If the worst happened, he didn’t want to spend his last days in a state of such relentless existential angst. And it wasn’t just for himself. He wanted to be strong and mentally present for his family and his loved ones and his patients.

As he searched for something to ease his mental anguish, Dr. Bansal recalled some psychedelic research on end-of-life anxiety and depression that he’d read about in Michael Pollan’s book on psychedelics, “How to Change Your Mind” (New York, Penguin Press, 2018).

The studies were small and the research was new, but Dr. Bansal was impressed enough with the results to take a chance. He called a lead researcher of one of the studies, a fellow New York doctor, and eventually found himself accepted into a new study.
 

Starting the journey

By the time Dr. Bansal arrived at the Bill Richards Center for Healing at the Aquilino Cancer Center in Rockville, Md., he had already been through weeks of screening.

The main requirements for the study were a cancer diagnosis and a measurable level of depression. But study participants also had to be physically fit enough to handle the medication, and psychologically free from a personal or family history of psychosis or schizophrenia. (The study also required participants to slowly wean themselves from medications like SSRIs for depression or antianxiety medications under the strict supervision of a qualified doctor.)

Dr. Bansal’s week of treatment began almost immediately on arrival at Aquilino. Everything was carefully choreographed but not rushed. From Monday to Wednesday, doctors followed his physical health with exams, ECGs, and blood work. And most importantly, they began to prepare him for the “dosing session” on Thursday when he would take the psilocybin.

This is the careful crafting of “set and setting” stressed in so many psychedelic therapies. “Set” refers to your mindset going into the drug experience. “Setting” is the space and people around you when the drug sends you into an altered state of consciousness.

Dr. Bansal met several times with at least three therapists in the days leading up to his dosing. He attended 4-plus hours of therapist-led group sessions with other people who would get a dosing on the same day. Together, they talked about what to expect during the experience and what to do in the face of fear or panic. 

He connected with a therapist who would be his personal guide. Dr. Bansal’s therapist was a military psychiatrist with over 30 years’ experience.

“He was there with me from day 1, and so we established a relationship,” Dr. Bansal said.

“He asked me a lot of personal background history – you know, my religious convictions, aspirations, all those things.”

“Trust and let go,” was a kind of mantra for the treatment repeated by his guide and other doctors.

For Dr. Bansal, a doctor and scientist accustomed to using hard facts rather than touchy-feely slogans to navigate the care of patients, it was an adjustment, to say the least.

But he did his best to set aside his doubts and embrace the journey he was about to take.
 

The day of the trip

Thursday morning finally arrived. The setting of the dosing room was warm and welcoming, more like a cozy home study than a hospital room.

This matters more than you might think. First, because it’s important that you feel safe, open, and comfortable enough to let go and enter into a therapeutic process. But also because though rare, it’s possible – especially with psilocybin – for people to lose track of where they are and what they’re doing and put themselves or others in danger.

The dose, 25 mg, had been carefully calibrated to induce a psychedelic experience sufficient for therapy. Much less than that, say 10 mg, isn’t enough for most people to enter this state. A double dose, 50 mg, though not physically unsafe, may leave you too incoherent to have the useful insights key to therapeutic value.

A doctor, the lead investigator of the study, brought the five capsules into the room in an intricately carved crucible with a small ceremonial cup that held the water with which to take it.

“It was very solemn,” Dr. Bansal said. “He sat down with me in a very calming way.”

The doctor said: “Don’t worry about it. Just trust and let go.”

And that’s just what he did.

Dr. Bansal swallowed the capsules and lay down. The doctor quietly left the room so that Dr. Bansal and his psychiatrist guide could begin their session together.

Special eye shades kept him in the pitch dark whether his eyes were open or closed. Headphones streamed a curated musical playlist – much of it Western classical like Strauss, Bach, Mozart, and Beethoven – but also modern electronica and other music from cultures around the globe.

Dr. Bansal would remain here, with his therapist-guide by his side, in largely this same position, for the next 7-and-a-half hours.

It took about 45 minutes for the medication to kick in.
 

The investigator

The doctor who brought the capsules into the dosing room was Manish Agrawal, MD, codirector of clinical research at the Aquilino Cancer Center and lead investigator of the study.

Dr. Agrawal trained at the National Cancer Institute and practiced for many years as an oncologist before developing an interest in psychedelic therapies. It was his work with cancer patients that drew him to psychedelics in the first place.

He had seen too many of his patients mentally wrecked by a cancer diagnosis, and he often felt helpless to comfort them.

“You take care of the physical aspects of the cancer, right? You talk about side effects and recommend another scan to look for recurrence.”

“But what about the psychological effects?”

They can be very serious and too often go ignored, said Dr. Agrawal. Your plans for the future suddenly become moot. You may be concerned about your ability to work or worried about the pain and suffering and financial strain that might be ahead for both you and your family. And to top it all off, you’re staring into the face of your own mortality.

So it’s no wonder, said Dr. Agrawal, that many people develop clinical levels of anxiety and depression after a cancer diagnosis.

Like Dr. Bansal, Dr. Agrawal had been impressed by early studies on psilocybin-assisted therapies for end-of-life anxiety and depression. He had tried other approaches – support groups, one-on-one therapy, religious counselors, psychiatrist-prescribed medication – but he was never really happy with the results.

To Dr. Agrawal, psilocybin-assisted therapy was the first thing that looked like it could really make a difference.

And so after his psychedelic certification at the California Institute of Integral Studies, Dr. Agrawal was determined to change his approach.

The result was the Bill Richards Center for Healing at Aquilino Cancer Center, built specifically to study psychedelic-assisted therapies for psychological distress in people with cancer. The mission of the center is to help develop safe, FDA-approved psychedelic therapies for the mental health of cancer patients, and, once approved, provide a state-of-the-art facility and staff to administer those treatments.
 

A trip into the unknown

Back in the dosing room, Dr. Bansal was starting to feel the effects of the medication. As the psilocybin kicked in, spectacular images swirled.

“It was as if a million stained glass windows had suddenly come to life and were dancing in front of my vision,” Dr. Bansal said.

There were moving landscapes and intricate swirling patterns and massive stages in the sky where he saw orchestras playing the music he was hearing.

Dr. Bansal saw himself being crushed by a huge machine and buried, dead, in the Earth. He died and returned to life several times, glided over the top of New York City with the skyscrapers just below him, and took in the vision of the entire universe.

“I saw this expanse of the sky that was limitless. And there was this prehistoric reptile creature that spanned galaxies in the sky ahead of me who was dying. I said: ‘My God, the universe is dying,’ but then after a few moments, the universe came to life again in a burst of stars exploding.”

All the while, Dr. Bansal said, he was well aware that it was simply his mind creating these images, thoughts, and ideas. He knew he was in a safe room wearing eyeshades and headphones.

And yet, he says, it felt true. “The images and feelings are so powerful that you cannot help but believe they are in some way a part of reality.”

“At one point, I saw this giant Ferris wheel coming towards me and it was full of giant crabs, clicking and clacking their pincers. And my brain told me: ‘That’s my cancer!’ ”

Dr. Bansal was terrified. But he and his therapist had arranged a system of signals before the session. “If I was feeling afraid, I would hold his hand and if I had other issues, I would raise my hand. If I was feeling good, I would give him a thumbs up.”

Dr. Bansal reached out to his therapist and grasped his hand. “I said, ‘My cancer is coming at me!’ ”

His therapist was clear about what to do: Stand firm and walk toward it.

“That’s what they tell you: If you see anything frightening, you face it. And that’s the whole point of this exercise. And so, I stood and walked forward, and it just blew off in a puff of smoke.”
 

A state of peace

Around 3 hours into the experience, Dr. Bansal started to feel an immense sense of peace, happiness, and even comfort.

“I felt like I was watching a movie or a multidimensional slideshow. I was also a part of the movie. I felt like I could tell my mind what I wanted to see, and it would show it to me. It’s almost like you can mold your own visions. It was mystical.”

After about 8 hours, as the effects of the drug wore off, Dr. Bansal removed his eyeshades and headphones. He was completely drained.

“Even though I was lying down on my back for 7 hours, I felt like I had been run over by a truck. I was exhausted beyond belief physically and mentally.”

This was partly because of the fact that he hadn’t eaten much during the session. But mostly, said Dr. Bansal, it was because of the searing emotional intensity of the experience.
 

After the journey

It’s hard to put into words, said Dr. Bansal, what this treatment has done for his life. He feels as if he has stumbled onto something very precious that had been right in front of him all along. He wrote of his change in perspective almost obsessively in his journal in the days and weeks after treatment. One passage reads:

“It seems that, as time is passing on, I’m becoming more relaxed and hopeful, more calm, and at peace. Family has become even more important to me now. Money, politics, material gains, alcohol, seem less important.”

And yet there was nothing “easy” about the experience. In fact, in some ways the experience demanded more from him. “I feel I need to be more compassionate and considerate – less irritable and angry, more understanding of others’ needs. I feel I need to be a better human being, a better patient, a better father, and a better doctor for my patients.”

The experience, he said, gave him something far more important than mere ease. It gave him a sense of meaning.

From his journal:

“I died, and I was reborn. If I survived this, then I can face anything and anybody in the cosmic scheme. I can become part of it.

“How many sorrows in the universe? My cancer is nothing. Life does not end with the end of life. What was will be again. Eternally.”

That’s not an unusual response, according to the namesake of the Bill Richards Center for Healing. Bill Richards, PhD, has worked in the world of psychedelic-assisted psychotherapy since 1963.

A psychologist with decades of experience, Dr. Richards and colleagues figure that, with few possible exceptions, he has helped treat more people with psychedelic therapies than anyone alive in Western medicine today. At Aquilino, he works directly with patients and oversees the therapy protocol that goes along with the psilocybin dosing sessions.

“It’s inspiring,” Dr. Richards said.

“You meet someone who’s very depressed and scared and isolating from family and having all kinds of physical complaints. And a few days later, you talk to the same person and they have a whole new lease on life.”

And the positive effects can extend deep into the family system, he said.

After psilocybin treatment, said Dr. Richards, the person with cancer can become a kind of social worker for the family. They’re often far better able to talk about death and loss and even money and family issues than their loved ones. It’s not uncommon after treatment to see the resolution of years-old resentments or grievances that have dogged a family for many years.

Plus, said Dr. Richards, the cancer patient often ends up as a kind model to other family members for how to approach death. “They can demonstrate how to live fully – right to the last breath – which is a real gift because those relatives and loved ones have to die someday too, you know.”

At 80 years old, Dr. Richards is still in active practice and hopes to spend the rest of his days working with people in end-of-life care.
 

After the experience

Psychedelic-assisted therapy does not end with the dosing session. Integration sessions, where you discuss what happened during the dosing session, are a key part of most treatments.

The goal is to help participants absorb and “integrate” their experience. It typically happens over two or more sessions of 60-90 minutes with a therapist. In some cases, the therapist may invite a significant other to join in the integration process.

Dr. Agrawal’s trial at the Bill Richards center added something new: group therapy. Not only did Dr. Bansal meet with his therapist, he also met with a group of three other people in the trial who had their dosing the same day.

The point, said Dr. Agrawal, is to try and determine the effect of the group on the therapy. After their private dosing sessions, they come back together to discuss their experiences.

“After the psilocybin, they feel like they’ve been to war together,” Dr. Agrawal said. “There is this profound openness and connection. They feel able to share things with each other that they wouldn’t with other people.”

It will take some time to figure out how the group affects the overall outcome, but Dr. Bansal thinks it was integral to the success of his treatment.

In fact, he continues to meet regularly with his therapy group, even though it’s long since past the requirements of the study.
 

Pradeep 2.0

Dr. Bansal still has tough days with his cancer. Recently, immunotherapy treatment for his bladder caused side effects – pain, bleeding, fever, and chills – for most of the night. He felt like he was “passing razor blades” when he peed.

“And yet it was somehow okay,” he said. “It was only pain.”

“It’s as if there is a part of me that is watching myself objectively, going through the painful process of treatments saying: ‘It’s all right. I will be with you through this journey, through this experience. Don’t worry.’”

Months after taking that one dose, Dr. Bansal still calls it as “the single most powerful experience of my life.”

The change in his mental outlook, Dr. Bansal said, was profound, particularly in regard to his cancer.

“I understood that I still had cancer and that it could kill me in a few weeks, or months, or years. But my perspective had shifted.”

Dr. Bansal was as surprised as anyone. “Had somebody told me going into this that I would come out a transformed being or a person with a completely different perspective on life, I would never have believed it.”

He even named his new outlook. “I call it Pradeep 2.0.”

A version of this article first appeared on WebMD.com.

Pradeep Bansal considered the five capsules he was about to swallow. Together they made up a 25-mg dose of a substance that, in another setting, could have landed him in federal prison.

The substance was psilocybin, the active ingredient in magic mushrooms. To be more exact, it was a synthetic form of psilocybin called COMP360, made to pharmaceutical standards by a company called COMPASS Pathways. He was taking it as part of an Food and Drug Administration–approved clinical study on mental health therapy for people with cancer.

Dr. Bansal, a New York gastroenterologist, was far more comfortable giving medical treatment than receiving it. But he was getting used to it.

He had already been through surgery and a number of other treatments to address the physical aspects of his cancer. The psilocybin was to address the mental aspects – the crushing anxiety and depression that had stuck with him after his diagnosis.

Dr. Bansal did not arrive at this moment lightly.

“I was extremely skeptical going into this process,” said Dr. Bansal, who during a long medical career had looked with distrust and even disdain at alternative therapies.

“I don’t have much patience for holistic medicine, homeopathy, acupuncture, or alternative medicines with claims of spiritual upliftment or altered states of mind.”

But Bansal had done his homework on psilocybin and was impressed.

People with late-stage cancer and other serious health conditions who got psilocybin-assisted psychotherapy had “significant decreases” in anxiety and depression as long as 12 months after the treatment, according to studies published in 2011, 2014, and 2016.

One study from Johns Hopkins University tracked the effects of a single guided dose of psilocybin in terminal cancer patients with anxiety and depression. More than 80% had a “significant decrease” in symptoms – even 6 months after treatment – with more than 60% of the group remaining in the normal mood range.

For the study Dr. Bansal joined, there had been weeks of screening and consultation and preparation in a strictly controlled scientific trial.

And yet, even with all that he had learned, even with his psychiatrist-guide by his side, he was afraid. Afraid of what he might experience under the powerful effects of psilocybin. And afraid that this was all a misguided waste of time – that his mental angst would still be there when it was all over.

He knew that psilocybin, like other psychedelic substances, could take you on a “trip” – could remove you, at least for a time, from normal conscious experience.

Maybe he would feel “funny,” he thought. Maybe he would have some hallucinations. But how would that change the reality of his cancer? How would it lift the black dread and anxiety he felt about his future?
 

Stuck in a dark place

Dr. Bansal had first noticed blood in his urine – a lot of it – in September 2019. 

Two months later, doctors diagnosed cancer in his right kidney. He would need surgery to remove the kidney and surrounding lymph nodes (an operation called radical nephrectomy).

It was a shock, said Dr. Bansal. But the diagnosis and the surgery happened so quickly that he hardly had time to think. And treatment results seemed good. The cancer was only in stage I and the CT scans showed no signs of cancer after surgery.

“We were so relieved. Everyone was so happy,” Dr. Bansal said. “They didn’t even give me chemotherapy after surgery because it seemed so early.”

But a routine scan in June 2020 revealed more cancer in his lung. Within a couple of months, it was in his bladder too.

“It was devastating,” Dr. Bansal said. “I went from thinking I was healthy again to stage IV cancer.”

As doctors scheduled surgery to remove part of his lung, Dr. Bansal started on painful immunotherapy (BCG therapy) for his bladder.

At this point, from a psychological standpoint, Dr. Bansal was reeling. As a doctor, he knew all too well the meaning of stage IV cancer.

With two adult children and a grandchild on the way, Dr. Bansal had been looking forward to retirement with his wife of almost 40 years. “Suddenly, I wasn’t sure I was going to last that long,” Bansal recalled. “I was in a very dark place. I was very anxious, very depressed from lack of sleep.”

He saw a therapist about his cancer diagnosis and maintained his regular meditation practice at home. He hired a personal trainer and tried to focus on any good news that he got about his treatment.

Those things helped, but not enough.

The basic facts were inescapable. His cancer might end everything. He couldn’t stop thinking about it. And then he couldn’t stop thinking about how he couldn’t stop thinking about it.

If the worst happened, he didn’t want to spend his last days in a state of such relentless existential angst. And it wasn’t just for himself. He wanted to be strong and mentally present for his family and his loved ones and his patients.

As he searched for something to ease his mental anguish, Dr. Bansal recalled some psychedelic research on end-of-life anxiety and depression that he’d read about in Michael Pollan’s book on psychedelics, “How to Change Your Mind” (New York, Penguin Press, 2018).

The studies were small and the research was new, but Dr. Bansal was impressed enough with the results to take a chance. He called a lead researcher of one of the studies, a fellow New York doctor, and eventually found himself accepted into a new study.
 

Starting the journey

By the time Dr. Bansal arrived at the Bill Richards Center for Healing at the Aquilino Cancer Center in Rockville, Md., he had already been through weeks of screening.

The main requirements for the study were a cancer diagnosis and a measurable level of depression. But study participants also had to be physically fit enough to handle the medication, and psychologically free from a personal or family history of psychosis or schizophrenia. (The study also required participants to slowly wean themselves from medications like SSRIs for depression or antianxiety medications under the strict supervision of a qualified doctor.)

Dr. Bansal’s week of treatment began almost immediately on arrival at Aquilino. Everything was carefully choreographed but not rushed. From Monday to Wednesday, doctors followed his physical health with exams, ECGs, and blood work. And most importantly, they began to prepare him for the “dosing session” on Thursday when he would take the psilocybin.

This is the careful crafting of “set and setting” stressed in so many psychedelic therapies. “Set” refers to your mindset going into the drug experience. “Setting” is the space and people around you when the drug sends you into an altered state of consciousness.

Dr. Bansal met several times with at least three therapists in the days leading up to his dosing. He attended 4-plus hours of therapist-led group sessions with other people who would get a dosing on the same day. Together, they talked about what to expect during the experience and what to do in the face of fear or panic. 

He connected with a therapist who would be his personal guide. Dr. Bansal’s therapist was a military psychiatrist with over 30 years’ experience.

“He was there with me from day 1, and so we established a relationship,” Dr. Bansal said.

“He asked me a lot of personal background history – you know, my religious convictions, aspirations, all those things.”

“Trust and let go,” was a kind of mantra for the treatment repeated by his guide and other doctors.

For Dr. Bansal, a doctor and scientist accustomed to using hard facts rather than touchy-feely slogans to navigate the care of patients, it was an adjustment, to say the least.

But he did his best to set aside his doubts and embrace the journey he was about to take.
 

The day of the trip

Thursday morning finally arrived. The setting of the dosing room was warm and welcoming, more like a cozy home study than a hospital room.

This matters more than you might think. First, because it’s important that you feel safe, open, and comfortable enough to let go and enter into a therapeutic process. But also because though rare, it’s possible – especially with psilocybin – for people to lose track of where they are and what they’re doing and put themselves or others in danger.

The dose, 25 mg, had been carefully calibrated to induce a psychedelic experience sufficient for therapy. Much less than that, say 10 mg, isn’t enough for most people to enter this state. A double dose, 50 mg, though not physically unsafe, may leave you too incoherent to have the useful insights key to therapeutic value.

A doctor, the lead investigator of the study, brought the five capsules into the room in an intricately carved crucible with a small ceremonial cup that held the water with which to take it.

“It was very solemn,” Dr. Bansal said. “He sat down with me in a very calming way.”

The doctor said: “Don’t worry about it. Just trust and let go.”

And that’s just what he did.

Dr. Bansal swallowed the capsules and lay down. The doctor quietly left the room so that Dr. Bansal and his psychiatrist guide could begin their session together.

Special eye shades kept him in the pitch dark whether his eyes were open or closed. Headphones streamed a curated musical playlist – much of it Western classical like Strauss, Bach, Mozart, and Beethoven – but also modern electronica and other music from cultures around the globe.

Dr. Bansal would remain here, with his therapist-guide by his side, in largely this same position, for the next 7-and-a-half hours.

It took about 45 minutes for the medication to kick in.
 

The investigator

The doctor who brought the capsules into the dosing room was Manish Agrawal, MD, codirector of clinical research at the Aquilino Cancer Center and lead investigator of the study.

Dr. Agrawal trained at the National Cancer Institute and practiced for many years as an oncologist before developing an interest in psychedelic therapies. It was his work with cancer patients that drew him to psychedelics in the first place.

He had seen too many of his patients mentally wrecked by a cancer diagnosis, and he often felt helpless to comfort them.

“You take care of the physical aspects of the cancer, right? You talk about side effects and recommend another scan to look for recurrence.”

“But what about the psychological effects?”

They can be very serious and too often go ignored, said Dr. Agrawal. Your plans for the future suddenly become moot. You may be concerned about your ability to work or worried about the pain and suffering and financial strain that might be ahead for both you and your family. And to top it all off, you’re staring into the face of your own mortality.

So it’s no wonder, said Dr. Agrawal, that many people develop clinical levels of anxiety and depression after a cancer diagnosis.

Like Dr. Bansal, Dr. Agrawal had been impressed by early studies on psilocybin-assisted therapies for end-of-life anxiety and depression. He had tried other approaches – support groups, one-on-one therapy, religious counselors, psychiatrist-prescribed medication – but he was never really happy with the results.

To Dr. Agrawal, psilocybin-assisted therapy was the first thing that looked like it could really make a difference.

And so after his psychedelic certification at the California Institute of Integral Studies, Dr. Agrawal was determined to change his approach.

The result was the Bill Richards Center for Healing at Aquilino Cancer Center, built specifically to study psychedelic-assisted therapies for psychological distress in people with cancer. The mission of the center is to help develop safe, FDA-approved psychedelic therapies for the mental health of cancer patients, and, once approved, provide a state-of-the-art facility and staff to administer those treatments.
 

A trip into the unknown

Back in the dosing room, Dr. Bansal was starting to feel the effects of the medication. As the psilocybin kicked in, spectacular images swirled.

“It was as if a million stained glass windows had suddenly come to life and were dancing in front of my vision,” Dr. Bansal said.

There were moving landscapes and intricate swirling patterns and massive stages in the sky where he saw orchestras playing the music he was hearing.

Dr. Bansal saw himself being crushed by a huge machine and buried, dead, in the Earth. He died and returned to life several times, glided over the top of New York City with the skyscrapers just below him, and took in the vision of the entire universe.

“I saw this expanse of the sky that was limitless. And there was this prehistoric reptile creature that spanned galaxies in the sky ahead of me who was dying. I said: ‘My God, the universe is dying,’ but then after a few moments, the universe came to life again in a burst of stars exploding.”

All the while, Dr. Bansal said, he was well aware that it was simply his mind creating these images, thoughts, and ideas. He knew he was in a safe room wearing eyeshades and headphones.

And yet, he says, it felt true. “The images and feelings are so powerful that you cannot help but believe they are in some way a part of reality.”

“At one point, I saw this giant Ferris wheel coming towards me and it was full of giant crabs, clicking and clacking their pincers. And my brain told me: ‘That’s my cancer!’ ”

Dr. Bansal was terrified. But he and his therapist had arranged a system of signals before the session. “If I was feeling afraid, I would hold his hand and if I had other issues, I would raise my hand. If I was feeling good, I would give him a thumbs up.”

Dr. Bansal reached out to his therapist and grasped his hand. “I said, ‘My cancer is coming at me!’ ”

His therapist was clear about what to do: Stand firm and walk toward it.

“That’s what they tell you: If you see anything frightening, you face it. And that’s the whole point of this exercise. And so, I stood and walked forward, and it just blew off in a puff of smoke.”
 

A state of peace

Around 3 hours into the experience, Dr. Bansal started to feel an immense sense of peace, happiness, and even comfort.

“I felt like I was watching a movie or a multidimensional slideshow. I was also a part of the movie. I felt like I could tell my mind what I wanted to see, and it would show it to me. It’s almost like you can mold your own visions. It was mystical.”

After about 8 hours, as the effects of the drug wore off, Dr. Bansal removed his eyeshades and headphones. He was completely drained.

“Even though I was lying down on my back for 7 hours, I felt like I had been run over by a truck. I was exhausted beyond belief physically and mentally.”

This was partly because of the fact that he hadn’t eaten much during the session. But mostly, said Dr. Bansal, it was because of the searing emotional intensity of the experience.
 

After the journey

It’s hard to put into words, said Dr. Bansal, what this treatment has done for his life. He feels as if he has stumbled onto something very precious that had been right in front of him all along. He wrote of his change in perspective almost obsessively in his journal in the days and weeks after treatment. One passage reads:

“It seems that, as time is passing on, I’m becoming more relaxed and hopeful, more calm, and at peace. Family has become even more important to me now. Money, politics, material gains, alcohol, seem less important.”

And yet there was nothing “easy” about the experience. In fact, in some ways the experience demanded more from him. “I feel I need to be more compassionate and considerate – less irritable and angry, more understanding of others’ needs. I feel I need to be a better human being, a better patient, a better father, and a better doctor for my patients.”

The experience, he said, gave him something far more important than mere ease. It gave him a sense of meaning.

From his journal:

“I died, and I was reborn. If I survived this, then I can face anything and anybody in the cosmic scheme. I can become part of it.

“How many sorrows in the universe? My cancer is nothing. Life does not end with the end of life. What was will be again. Eternally.”

That’s not an unusual response, according to the namesake of the Bill Richards Center for Healing. Bill Richards, PhD, has worked in the world of psychedelic-assisted psychotherapy since 1963.

A psychologist with decades of experience, Dr. Richards and colleagues figure that, with few possible exceptions, he has helped treat more people with psychedelic therapies than anyone alive in Western medicine today. At Aquilino, he works directly with patients and oversees the therapy protocol that goes along with the psilocybin dosing sessions.

“It’s inspiring,” Dr. Richards said.

“You meet someone who’s very depressed and scared and isolating from family and having all kinds of physical complaints. And a few days later, you talk to the same person and they have a whole new lease on life.”

And the positive effects can extend deep into the family system, he said.

After psilocybin treatment, said Dr. Richards, the person with cancer can become a kind of social worker for the family. They’re often far better able to talk about death and loss and even money and family issues than their loved ones. It’s not uncommon after treatment to see the resolution of years-old resentments or grievances that have dogged a family for many years.

Plus, said Dr. Richards, the cancer patient often ends up as a kind model to other family members for how to approach death. “They can demonstrate how to live fully – right to the last breath – which is a real gift because those relatives and loved ones have to die someday too, you know.”

At 80 years old, Dr. Richards is still in active practice and hopes to spend the rest of his days working with people in end-of-life care.
 

After the experience

Psychedelic-assisted therapy does not end with the dosing session. Integration sessions, where you discuss what happened during the dosing session, are a key part of most treatments.

The goal is to help participants absorb and “integrate” their experience. It typically happens over two or more sessions of 60-90 minutes with a therapist. In some cases, the therapist may invite a significant other to join in the integration process.

Dr. Agrawal’s trial at the Bill Richards center added something new: group therapy. Not only did Dr. Bansal meet with his therapist, he also met with a group of three other people in the trial who had their dosing the same day.

The point, said Dr. Agrawal, is to try and determine the effect of the group on the therapy. After their private dosing sessions, they come back together to discuss their experiences.

“After the psilocybin, they feel like they’ve been to war together,” Dr. Agrawal said. “There is this profound openness and connection. They feel able to share things with each other that they wouldn’t with other people.”

It will take some time to figure out how the group affects the overall outcome, but Dr. Bansal thinks it was integral to the success of his treatment.

In fact, he continues to meet regularly with his therapy group, even though it’s long since past the requirements of the study.
 

Pradeep 2.0

Dr. Bansal still has tough days with his cancer. Recently, immunotherapy treatment for his bladder caused side effects – pain, bleeding, fever, and chills – for most of the night. He felt like he was “passing razor blades” when he peed.

“And yet it was somehow okay,” he said. “It was only pain.”

“It’s as if there is a part of me that is watching myself objectively, going through the painful process of treatments saying: ‘It’s all right. I will be with you through this journey, through this experience. Don’t worry.’”

Months after taking that one dose, Dr. Bansal still calls it as “the single most powerful experience of my life.”

The change in his mental outlook, Dr. Bansal said, was profound, particularly in regard to his cancer.

“I understood that I still had cancer and that it could kill me in a few weeks, or months, or years. But my perspective had shifted.”

Dr. Bansal was as surprised as anyone. “Had somebody told me going into this that I would come out a transformed being or a person with a completely different perspective on life, I would never have believed it.”

He even named his new outlook. “I call it Pradeep 2.0.”

A version of this article first appeared on WebMD.com.

Pradeep Bansal considered the five capsules he was about to swallow. Together they made up a 25-mg dose of a substance that, in another setting, could have landed him in federal prison.

The substance was psilocybin, the active ingredient in magic mushrooms. To be more exact, it was a synthetic form of psilocybin called COMP360, made to pharmaceutical standards by a company called COMPASS Pathways. He was taking it as part of an Food and Drug Administration–approved clinical study on mental health therapy for people with cancer.

Dr. Bansal, a New York gastroenterologist, was far more comfortable giving medical treatment than receiving it. But he was getting used to it.

He had already been through surgery and a number of other treatments to address the physical aspects of his cancer. The psilocybin was to address the mental aspects – the crushing anxiety and depression that had stuck with him after his diagnosis.

Dr. Bansal did not arrive at this moment lightly.

“I was extremely skeptical going into this process,” said Dr. Bansal, who during a long medical career had looked with distrust and even disdain at alternative therapies.

“I don’t have much patience for holistic medicine, homeopathy, acupuncture, or alternative medicines with claims of spiritual upliftment or altered states of mind.”

But Bansal had done his homework on psilocybin and was impressed.

People with late-stage cancer and other serious health conditions who got psilocybin-assisted psychotherapy had “significant decreases” in anxiety and depression as long as 12 months after the treatment, according to studies published in 2011, 2014, and 2016.

One study from Johns Hopkins University tracked the effects of a single guided dose of psilocybin in terminal cancer patients with anxiety and depression. More than 80% had a “significant decrease” in symptoms – even 6 months after treatment – with more than 60% of the group remaining in the normal mood range.

For the study Dr. Bansal joined, there had been weeks of screening and consultation and preparation in a strictly controlled scientific trial.

And yet, even with all that he had learned, even with his psychiatrist-guide by his side, he was afraid. Afraid of what he might experience under the powerful effects of psilocybin. And afraid that this was all a misguided waste of time – that his mental angst would still be there when it was all over.

He knew that psilocybin, like other psychedelic substances, could take you on a “trip” – could remove you, at least for a time, from normal conscious experience.

Maybe he would feel “funny,” he thought. Maybe he would have some hallucinations. But how would that change the reality of his cancer? How would it lift the black dread and anxiety he felt about his future?
 

Stuck in a dark place

Dr. Bansal had first noticed blood in his urine – a lot of it – in September 2019. 

Two months later, doctors diagnosed cancer in his right kidney. He would need surgery to remove the kidney and surrounding lymph nodes (an operation called radical nephrectomy).

It was a shock, said Dr. Bansal. But the diagnosis and the surgery happened so quickly that he hardly had time to think. And treatment results seemed good. The cancer was only in stage I and the CT scans showed no signs of cancer after surgery.

“We were so relieved. Everyone was so happy,” Dr. Bansal said. “They didn’t even give me chemotherapy after surgery because it seemed so early.”

But a routine scan in June 2020 revealed more cancer in his lung. Within a couple of months, it was in his bladder too.

“It was devastating,” Dr. Bansal said. “I went from thinking I was healthy again to stage IV cancer.”

As doctors scheduled surgery to remove part of his lung, Dr. Bansal started on painful immunotherapy (BCG therapy) for his bladder.

At this point, from a psychological standpoint, Dr. Bansal was reeling. As a doctor, he knew all too well the meaning of stage IV cancer.

With two adult children and a grandchild on the way, Dr. Bansal had been looking forward to retirement with his wife of almost 40 years. “Suddenly, I wasn’t sure I was going to last that long,” Bansal recalled. “I was in a very dark place. I was very anxious, very depressed from lack of sleep.”

He saw a therapist about his cancer diagnosis and maintained his regular meditation practice at home. He hired a personal trainer and tried to focus on any good news that he got about his treatment.

Those things helped, but not enough.

The basic facts were inescapable. His cancer might end everything. He couldn’t stop thinking about it. And then he couldn’t stop thinking about how he couldn’t stop thinking about it.

If the worst happened, he didn’t want to spend his last days in a state of such relentless existential angst. And it wasn’t just for himself. He wanted to be strong and mentally present for his family and his loved ones and his patients.

As he searched for something to ease his mental anguish, Dr. Bansal recalled some psychedelic research on end-of-life anxiety and depression that he’d read about in Michael Pollan’s book on psychedelics, “How to Change Your Mind” (New York, Penguin Press, 2018).

The studies were small and the research was new, but Dr. Bansal was impressed enough with the results to take a chance. He called a lead researcher of one of the studies, a fellow New York doctor, and eventually found himself accepted into a new study.
 

Starting the journey

By the time Dr. Bansal arrived at the Bill Richards Center for Healing at the Aquilino Cancer Center in Rockville, Md., he had already been through weeks of screening.

The main requirements for the study were a cancer diagnosis and a measurable level of depression. But study participants also had to be physically fit enough to handle the medication, and psychologically free from a personal or family history of psychosis or schizophrenia. (The study also required participants to slowly wean themselves from medications like SSRIs for depression or antianxiety medications under the strict supervision of a qualified doctor.)

Dr. Bansal’s week of treatment began almost immediately on arrival at Aquilino. Everything was carefully choreographed but not rushed. From Monday to Wednesday, doctors followed his physical health with exams, ECGs, and blood work. And most importantly, they began to prepare him for the “dosing session” on Thursday when he would take the psilocybin.

This is the careful crafting of “set and setting” stressed in so many psychedelic therapies. “Set” refers to your mindset going into the drug experience. “Setting” is the space and people around you when the drug sends you into an altered state of consciousness.

Dr. Bansal met several times with at least three therapists in the days leading up to his dosing. He attended 4-plus hours of therapist-led group sessions with other people who would get a dosing on the same day. Together, they talked about what to expect during the experience and what to do in the face of fear or panic. 

He connected with a therapist who would be his personal guide. Dr. Bansal’s therapist was a military psychiatrist with over 30 years’ experience.

“He was there with me from day 1, and so we established a relationship,” Dr. Bansal said.

“He asked me a lot of personal background history – you know, my religious convictions, aspirations, all those things.”

“Trust and let go,” was a kind of mantra for the treatment repeated by his guide and other doctors.

For Dr. Bansal, a doctor and scientist accustomed to using hard facts rather than touchy-feely slogans to navigate the care of patients, it was an adjustment, to say the least.

But he did his best to set aside his doubts and embrace the journey he was about to take.
 

The day of the trip

Thursday morning finally arrived. The setting of the dosing room was warm and welcoming, more like a cozy home study than a hospital room.

This matters more than you might think. First, because it’s important that you feel safe, open, and comfortable enough to let go and enter into a therapeutic process. But also because though rare, it’s possible – especially with psilocybin – for people to lose track of where they are and what they’re doing and put themselves or others in danger.

The dose, 25 mg, had been carefully calibrated to induce a psychedelic experience sufficient for therapy. Much less than that, say 10 mg, isn’t enough for most people to enter this state. A double dose, 50 mg, though not physically unsafe, may leave you too incoherent to have the useful insights key to therapeutic value.

A doctor, the lead investigator of the study, brought the five capsules into the room in an intricately carved crucible with a small ceremonial cup that held the water with which to take it.

“It was very solemn,” Dr. Bansal said. “He sat down with me in a very calming way.”

The doctor said: “Don’t worry about it. Just trust and let go.”

And that’s just what he did.

Dr. Bansal swallowed the capsules and lay down. The doctor quietly left the room so that Dr. Bansal and his psychiatrist guide could begin their session together.

Special eye shades kept him in the pitch dark whether his eyes were open or closed. Headphones streamed a curated musical playlist – much of it Western classical like Strauss, Bach, Mozart, and Beethoven – but also modern electronica and other music from cultures around the globe.

Dr. Bansal would remain here, with his therapist-guide by his side, in largely this same position, for the next 7-and-a-half hours.

It took about 45 minutes for the medication to kick in.
 

The investigator

The doctor who brought the capsules into the dosing room was Manish Agrawal, MD, codirector of clinical research at the Aquilino Cancer Center and lead investigator of the study.

Dr. Agrawal trained at the National Cancer Institute and practiced for many years as an oncologist before developing an interest in psychedelic therapies. It was his work with cancer patients that drew him to psychedelics in the first place.

He had seen too many of his patients mentally wrecked by a cancer diagnosis, and he often felt helpless to comfort them.

“You take care of the physical aspects of the cancer, right? You talk about side effects and recommend another scan to look for recurrence.”

“But what about the psychological effects?”

They can be very serious and too often go ignored, said Dr. Agrawal. Your plans for the future suddenly become moot. You may be concerned about your ability to work or worried about the pain and suffering and financial strain that might be ahead for both you and your family. And to top it all off, you’re staring into the face of your own mortality.

So it’s no wonder, said Dr. Agrawal, that many people develop clinical levels of anxiety and depression after a cancer diagnosis.

Like Dr. Bansal, Dr. Agrawal had been impressed by early studies on psilocybin-assisted therapies for end-of-life anxiety and depression. He had tried other approaches – support groups, one-on-one therapy, religious counselors, psychiatrist-prescribed medication – but he was never really happy with the results.

To Dr. Agrawal, psilocybin-assisted therapy was the first thing that looked like it could really make a difference.

And so after his psychedelic certification at the California Institute of Integral Studies, Dr. Agrawal was determined to change his approach.

The result was the Bill Richards Center for Healing at Aquilino Cancer Center, built specifically to study psychedelic-assisted therapies for psychological distress in people with cancer. The mission of the center is to help develop safe, FDA-approved psychedelic therapies for the mental health of cancer patients, and, once approved, provide a state-of-the-art facility and staff to administer those treatments.
 

A trip into the unknown

Back in the dosing room, Dr. Bansal was starting to feel the effects of the medication. As the psilocybin kicked in, spectacular images swirled.

“It was as if a million stained glass windows had suddenly come to life and were dancing in front of my vision,” Dr. Bansal said.

There were moving landscapes and intricate swirling patterns and massive stages in the sky where he saw orchestras playing the music he was hearing.

Dr. Bansal saw himself being crushed by a huge machine and buried, dead, in the Earth. He died and returned to life several times, glided over the top of New York City with the skyscrapers just below him, and took in the vision of the entire universe.

“I saw this expanse of the sky that was limitless. And there was this prehistoric reptile creature that spanned galaxies in the sky ahead of me who was dying. I said: ‘My God, the universe is dying,’ but then after a few moments, the universe came to life again in a burst of stars exploding.”

All the while, Dr. Bansal said, he was well aware that it was simply his mind creating these images, thoughts, and ideas. He knew he was in a safe room wearing eyeshades and headphones.

And yet, he says, it felt true. “The images and feelings are so powerful that you cannot help but believe they are in some way a part of reality.”

“At one point, I saw this giant Ferris wheel coming towards me and it was full of giant crabs, clicking and clacking their pincers. And my brain told me: ‘That’s my cancer!’ ”

Dr. Bansal was terrified. But he and his therapist had arranged a system of signals before the session. “If I was feeling afraid, I would hold his hand and if I had other issues, I would raise my hand. If I was feeling good, I would give him a thumbs up.”

Dr. Bansal reached out to his therapist and grasped his hand. “I said, ‘My cancer is coming at me!’ ”

His therapist was clear about what to do: Stand firm and walk toward it.

“That’s what they tell you: If you see anything frightening, you face it. And that’s the whole point of this exercise. And so, I stood and walked forward, and it just blew off in a puff of smoke.”
 

A state of peace

Around 3 hours into the experience, Dr. Bansal started to feel an immense sense of peace, happiness, and even comfort.

“I felt like I was watching a movie or a multidimensional slideshow. I was also a part of the movie. I felt like I could tell my mind what I wanted to see, and it would show it to me. It’s almost like you can mold your own visions. It was mystical.”

After about 8 hours, as the effects of the drug wore off, Dr. Bansal removed his eyeshades and headphones. He was completely drained.

“Even though I was lying down on my back for 7 hours, I felt like I had been run over by a truck. I was exhausted beyond belief physically and mentally.”

This was partly because of the fact that he hadn’t eaten much during the session. But mostly, said Dr. Bansal, it was because of the searing emotional intensity of the experience.
 

After the journey

It’s hard to put into words, said Dr. Bansal, what this treatment has done for his life. He feels as if he has stumbled onto something very precious that had been right in front of him all along. He wrote of his change in perspective almost obsessively in his journal in the days and weeks after treatment. One passage reads:

“It seems that, as time is passing on, I’m becoming more relaxed and hopeful, more calm, and at peace. Family has become even more important to me now. Money, politics, material gains, alcohol, seem less important.”

And yet there was nothing “easy” about the experience. In fact, in some ways the experience demanded more from him. “I feel I need to be more compassionate and considerate – less irritable and angry, more understanding of others’ needs. I feel I need to be a better human being, a better patient, a better father, and a better doctor for my patients.”

The experience, he said, gave him something far more important than mere ease. It gave him a sense of meaning.

From his journal:

“I died, and I was reborn. If I survived this, then I can face anything and anybody in the cosmic scheme. I can become part of it.

“How many sorrows in the universe? My cancer is nothing. Life does not end with the end of life. What was will be again. Eternally.”

That’s not an unusual response, according to the namesake of the Bill Richards Center for Healing. Bill Richards, PhD, has worked in the world of psychedelic-assisted psychotherapy since 1963.

A psychologist with decades of experience, Dr. Richards and colleagues figure that, with few possible exceptions, he has helped treat more people with psychedelic therapies than anyone alive in Western medicine today. At Aquilino, he works directly with patients and oversees the therapy protocol that goes along with the psilocybin dosing sessions.

“It’s inspiring,” Dr. Richards said.

“You meet someone who’s very depressed and scared and isolating from family and having all kinds of physical complaints. And a few days later, you talk to the same person and they have a whole new lease on life.”

And the positive effects can extend deep into the family system, he said.

After psilocybin treatment, said Dr. Richards, the person with cancer can become a kind of social worker for the family. They’re often far better able to talk about death and loss and even money and family issues than their loved ones. It’s not uncommon after treatment to see the resolution of years-old resentments or grievances that have dogged a family for many years.

Plus, said Dr. Richards, the cancer patient often ends up as a kind model to other family members for how to approach death. “They can demonstrate how to live fully – right to the last breath – which is a real gift because those relatives and loved ones have to die someday too, you know.”

At 80 years old, Dr. Richards is still in active practice and hopes to spend the rest of his days working with people in end-of-life care.
 

After the experience

Psychedelic-assisted therapy does not end with the dosing session. Integration sessions, where you discuss what happened during the dosing session, are a key part of most treatments.

The goal is to help participants absorb and “integrate” their experience. It typically happens over two or more sessions of 60-90 minutes with a therapist. In some cases, the therapist may invite a significant other to join in the integration process.

Dr. Agrawal’s trial at the Bill Richards center added something new: group therapy. Not only did Dr. Bansal meet with his therapist, he also met with a group of three other people in the trial who had their dosing the same day.

The point, said Dr. Agrawal, is to try and determine the effect of the group on the therapy. After their private dosing sessions, they come back together to discuss their experiences.

“After the psilocybin, they feel like they’ve been to war together,” Dr. Agrawal said. “There is this profound openness and connection. They feel able to share things with each other that they wouldn’t with other people.”

It will take some time to figure out how the group affects the overall outcome, but Dr. Bansal thinks it was integral to the success of his treatment.

In fact, he continues to meet regularly with his therapy group, even though it’s long since past the requirements of the study.
 

Pradeep 2.0

Dr. Bansal still has tough days with his cancer. Recently, immunotherapy treatment for his bladder caused side effects – pain, bleeding, fever, and chills – for most of the night. He felt like he was “passing razor blades” when he peed.

“And yet it was somehow okay,” he said. “It was only pain.”

“It’s as if there is a part of me that is watching myself objectively, going through the painful process of treatments saying: ‘It’s all right. I will be with you through this journey, through this experience. Don’t worry.’”

Months after taking that one dose, Dr. Bansal still calls it as “the single most powerful experience of my life.”

The change in his mental outlook, Dr. Bansal said, was profound, particularly in regard to his cancer.

“I understood that I still had cancer and that it could kill me in a few weeks, or months, or years. But my perspective had shifted.”

Dr. Bansal was as surprised as anyone. “Had somebody told me going into this that I would come out a transformed being or a person with a completely different perspective on life, I would never have believed it.”

He even named his new outlook. “I call it Pradeep 2.0.”

A version of this article first appeared on WebMD.com.

The antidepressant bupropion failed to improve sexual dysfunction in female cancer survivors, according to new findings published online in the Journal of Clinical Oncology.

Using the Female Sexual Function Index (FSFI) as a measurement tool, investigators found that desire scores were not significantly different for participants who received bupropion versus a placebo over the 9-week study period.

“Sexual health is a complex phenomenon and [our results suggest that] no one intervention is going to solve the broader issue,” lead author Debra Barton, RN, PhD, FAAN, professor in the School of Nursing at the University of Michigan, Ann Arbor, told this news organization.

Sexual dysfunction is common among cancer survivors and experienced across multiple cancer types and stages of disease. Research shows that as many as 70% of female cancer survivors report loss of desire, compared with up to one-third of the general population.

Common sexual concerns among female cancer survivors include low desire, arousal issues, lack of appropriate lubrication, difficulty in achieving orgasm, and pain with penetrative sexual activity. Additionally, these women may experience significant overlap of symptoms, and often encounter multiple sexual issues that are exacerbated by a range of cancer treatments.

“It’s a huge problem,” Maryam B. Lustberg, MD, MPH, from Yale Cancer Center, New Haven, Conn., and colleagues wrote in an accompanying editorial.

Despite the prevalence of sexual dysfunction among cancer survivors, effective treatments remain elusive. Preliminary evidence suggests that bupropion, already approved for seasonal affective disorder, major depressive disorder, and smoking cessation, may also enhance libido.

Dr. Barton and colleagues conducted this phase 2 trial to determine whether bupropion can improve sexual desire in female cancer survivors without undesirable side effects.

In the study, Dr. Barton and colleagues compared two dose levels of extended-release bupropion in a cohort of 230 postmenopausal women diagnosed with breast or gynecologic cancer and low baseline FSFI desire scores (<3.3), who had completed definitive cancer therapy.

Participants were randomized to receive either 150 mg (79 patients) or 300 mg (74 patients) once daily of extended-release bupropion, or placebo (77 patients).

Barton and colleagues then evaluated whether sexual desire significantly improved over the 9-week study period comparing the bupropion arms and the placebo group.

Overall, the authors found no significant differences (mean between-arm change for 150 mg once daily and placebo of 0.02; P = .93; mean between-arm change for 300 mg once daily and placebo of –0.02; P = .92). Mean scores at 9 weeks on the desire subscale were 2.17, 2.27, and 2.30 for 150 mg, 300 mg, and the placebo group, respectively.

In addition, none of the subscales – which included arousal, lubrication, and orgasm – or the total score showed a significant difference between arms at either 5 or 9 weeks.

Bupropion did, however, appear to be well tolerated. No grade 4-5 treatment-related adverse events occurred. In the 150-mg bupropion arm, two patients (2.6%) experienced a grade 3 event (insomnia and headache) and one patient in the 300-mg bupropion arm (1.4%) and placebo arm (1.3%) experienced a grade 3 event related to treatment (hypertension and headache, respectively).

In the accompanying editorial, Dr. Lustberg and colleagues “applaud the authors for conducting a study in this population of cancer survivors,” noting that “evidenced-based approaches have not been extensively studied.”

Dr. Lustberg and colleagues also commented that other randomized controlled clinical trials evaluating sexual desire disorder assessed outcomes using additional metrics, such as the Female Sexual Distress Scale–Revised questionnaire, which measures distress related to sexual dysfunction and low desire, in particular.

“The use of specific validated instruments for libido in place of the FSFI might have helped determine the effect of the study intervention in this reported trial,” they wrote.

Overall, according to Dr. Lustberg and colleagues, the negative results of this study indicate that a multidisciplinary clinical approach may be needed.

“As much as we would like to have one intervention that addresses this prominent issue, the evidence strongly suggests that cancer-related sexual problems may need an integrative biopsychosocial model that intervenes on biologic, psychologic, interpersonal, and social-cultural factors, not just on one factor, such as libido,” they wrote. “Such work may require access to multidisciplinary care with specialists in women’s health, pelvic floor rehabilitation, and psychosocial oncology.”

Dr. Barton said she has been developing a multicomponent approach to addressing sexual health in female cancer survivors.

However, she noted, “there is still much we do not fully understand about the broader impact of the degree of hormone deprivation in the population of female cancer survivors. A better understanding would provide clearer targets for interventions.” 

The study was supported by the National Cancer Institute and Breast Cancer Research Foundation. Dr. Barton has disclosed research funding from Merck. Dr. Lustberg reported receiving honoraria from Novartis and Biotheranostics; consulting or advising with PledPharma, Disarm Therapeutics, Pfizer; and other relationships with Cynosure/Hologic.

A version of this article first appeared on Medscape.com.

The antidepressant bupropion failed to improve sexual dysfunction in female cancer survivors, according to new findings published online in the Journal of Clinical Oncology.

Using the Female Sexual Function Index (FSFI) as a measurement tool, investigators found that desire scores were not significantly different for participants who received bupropion versus a placebo over the 9-week study period.

“Sexual health is a complex phenomenon and [our results suggest that] no one intervention is going to solve the broader issue,” lead author Debra Barton, RN, PhD, FAAN, professor in the School of Nursing at the University of Michigan, Ann Arbor, told this news organization.

Sexual dysfunction is common among cancer survivors and experienced across multiple cancer types and stages of disease. Research shows that as many as 70% of female cancer survivors report loss of desire, compared with up to one-third of the general population.

Common sexual concerns among female cancer survivors include low desire, arousal issues, lack of appropriate lubrication, difficulty in achieving orgasm, and pain with penetrative sexual activity. Additionally, these women may experience significant overlap of symptoms, and often encounter multiple sexual issues that are exacerbated by a range of cancer treatments.

“It’s a huge problem,” Maryam B. Lustberg, MD, MPH, from Yale Cancer Center, New Haven, Conn., and colleagues wrote in an accompanying editorial.

Despite the prevalence of sexual dysfunction among cancer survivors, effective treatments remain elusive. Preliminary evidence suggests that bupropion, already approved for seasonal affective disorder, major depressive disorder, and smoking cessation, may also enhance libido.

Dr. Barton and colleagues conducted this phase 2 trial to determine whether bupropion can improve sexual desire in female cancer survivors without undesirable side effects.

In the study, Dr. Barton and colleagues compared two dose levels of extended-release bupropion in a cohort of 230 postmenopausal women diagnosed with breast or gynecologic cancer and low baseline FSFI desire scores (<3.3), who had completed definitive cancer therapy.

Participants were randomized to receive either 150 mg (79 patients) or 300 mg (74 patients) once daily of extended-release bupropion, or placebo (77 patients).

Barton and colleagues then evaluated whether sexual desire significantly improved over the 9-week study period comparing the bupropion arms and the placebo group.

Overall, the authors found no significant differences (mean between-arm change for 150 mg once daily and placebo of 0.02; P = .93; mean between-arm change for 300 mg once daily and placebo of –0.02; P = .92). Mean scores at 9 weeks on the desire subscale were 2.17, 2.27, and 2.30 for 150 mg, 300 mg, and the placebo group, respectively.

In addition, none of the subscales – which included arousal, lubrication, and orgasm – or the total score showed a significant difference between arms at either 5 or 9 weeks.

Bupropion did, however, appear to be well tolerated. No grade 4-5 treatment-related adverse events occurred. In the 150-mg bupropion arm, two patients (2.6%) experienced a grade 3 event (insomnia and headache) and one patient in the 300-mg bupropion arm (1.4%) and placebo arm (1.3%) experienced a grade 3 event related to treatment (hypertension and headache, respectively).

In the accompanying editorial, Dr. Lustberg and colleagues “applaud the authors for conducting a study in this population of cancer survivors,” noting that “evidenced-based approaches have not been extensively studied.”

Dr. Lustberg and colleagues also commented that other randomized controlled clinical trials evaluating sexual desire disorder assessed outcomes using additional metrics, such as the Female Sexual Distress Scale–Revised questionnaire, which measures distress related to sexual dysfunction and low desire, in particular.

“The use of specific validated instruments for libido in place of the FSFI might have helped determine the effect of the study intervention in this reported trial,” they wrote.

Overall, according to Dr. Lustberg and colleagues, the negative results of this study indicate that a multidisciplinary clinical approach may be needed.

“As much as we would like to have one intervention that addresses this prominent issue, the evidence strongly suggests that cancer-related sexual problems may need an integrative biopsychosocial model that intervenes on biologic, psychologic, interpersonal, and social-cultural factors, not just on one factor, such as libido,” they wrote. “Such work may require access to multidisciplinary care with specialists in women’s health, pelvic floor rehabilitation, and psychosocial oncology.”

Dr. Barton said she has been developing a multicomponent approach to addressing sexual health in female cancer survivors.

However, she noted, “there is still much we do not fully understand about the broader impact of the degree of hormone deprivation in the population of female cancer survivors. A better understanding would provide clearer targets for interventions.” 

The study was supported by the National Cancer Institute and Breast Cancer Research Foundation. Dr. Barton has disclosed research funding from Merck. Dr. Lustberg reported receiving honoraria from Novartis and Biotheranostics; consulting or advising with PledPharma, Disarm Therapeutics, Pfizer; and other relationships with Cynosure/Hologic.

A version of this article first appeared on Medscape.com.

The antidepressant bupropion failed to improve sexual dysfunction in female cancer survivors, according to new findings published online in the Journal of Clinical Oncology.

Using the Female Sexual Function Index (FSFI) as a measurement tool, investigators found that desire scores were not significantly different for participants who received bupropion versus a placebo over the 9-week study period.

“Sexual health is a complex phenomenon and [our results suggest that] no one intervention is going to solve the broader issue,” lead author Debra Barton, RN, PhD, FAAN, professor in the School of Nursing at the University of Michigan, Ann Arbor, told this news organization.

Sexual dysfunction is common among cancer survivors and experienced across multiple cancer types and stages of disease. Research shows that as many as 70% of female cancer survivors report loss of desire, compared with up to one-third of the general population.

Common sexual concerns among female cancer survivors include low desire, arousal issues, lack of appropriate lubrication, difficulty in achieving orgasm, and pain with penetrative sexual activity. Additionally, these women may experience significant overlap of symptoms, and often encounter multiple sexual issues that are exacerbated by a range of cancer treatments.

“It’s a huge problem,” Maryam B. Lustberg, MD, MPH, from Yale Cancer Center, New Haven, Conn., and colleagues wrote in an accompanying editorial.

Despite the prevalence of sexual dysfunction among cancer survivors, effective treatments remain elusive. Preliminary evidence suggests that bupropion, already approved for seasonal affective disorder, major depressive disorder, and smoking cessation, may also enhance libido.

Dr. Barton and colleagues conducted this phase 2 trial to determine whether bupropion can improve sexual desire in female cancer survivors without undesirable side effects.

In the study, Dr. Barton and colleagues compared two dose levels of extended-release bupropion in a cohort of 230 postmenopausal women diagnosed with breast or gynecologic cancer and low baseline FSFI desire scores (<3.3), who had completed definitive cancer therapy.

Participants were randomized to receive either 150 mg (79 patients) or 300 mg (74 patients) once daily of extended-release bupropion, or placebo (77 patients).

Barton and colleagues then evaluated whether sexual desire significantly improved over the 9-week study period comparing the bupropion arms and the placebo group.

Overall, the authors found no significant differences (mean between-arm change for 150 mg once daily and placebo of 0.02; P = .93; mean between-arm change for 300 mg once daily and placebo of –0.02; P = .92). Mean scores at 9 weeks on the desire subscale were 2.17, 2.27, and 2.30 for 150 mg, 300 mg, and the placebo group, respectively.

In addition, none of the subscales – which included arousal, lubrication, and orgasm – or the total score showed a significant difference between arms at either 5 or 9 weeks.

Bupropion did, however, appear to be well tolerated. No grade 4-5 treatment-related adverse events occurred. In the 150-mg bupropion arm, two patients (2.6%) experienced a grade 3 event (insomnia and headache) and one patient in the 300-mg bupropion arm (1.4%) and placebo arm (1.3%) experienced a grade 3 event related to treatment (hypertension and headache, respectively).

In the accompanying editorial, Dr. Lustberg and colleagues “applaud the authors for conducting a study in this population of cancer survivors,” noting that “evidenced-based approaches have not been extensively studied.”

Dr. Lustberg and colleagues also commented that other randomized controlled clinical trials evaluating sexual desire disorder assessed outcomes using additional metrics, such as the Female Sexual Distress Scale–Revised questionnaire, which measures distress related to sexual dysfunction and low desire, in particular.

“The use of specific validated instruments for libido in place of the FSFI might have helped determine the effect of the study intervention in this reported trial,” they wrote.

Overall, according to Dr. Lustberg and colleagues, the negative results of this study indicate that a multidisciplinary clinical approach may be needed.

“As much as we would like to have one intervention that addresses this prominent issue, the evidence strongly suggests that cancer-related sexual problems may need an integrative biopsychosocial model that intervenes on biologic, psychologic, interpersonal, and social-cultural factors, not just on one factor, such as libido,” they wrote. “Such work may require access to multidisciplinary care with specialists in women’s health, pelvic floor rehabilitation, and psychosocial oncology.”

Dr. Barton said she has been developing a multicomponent approach to addressing sexual health in female cancer survivors.

However, she noted, “there is still much we do not fully understand about the broader impact of the degree of hormone deprivation in the population of female cancer survivors. A better understanding would provide clearer targets for interventions.” 

The study was supported by the National Cancer Institute and Breast Cancer Research Foundation. Dr. Barton has disclosed research funding from Merck. Dr. Lustberg reported receiving honoraria from Novartis and Biotheranostics; consulting or advising with PledPharma, Disarm Therapeutics, Pfizer; and other relationships with Cynosure/Hologic.

A version of this article first appeared on Medscape.com.

A soon-to-be medical student and former oncology ward volunteer has received a $10,000 scholarship for her education recently after tipping off a Vancouver Canucks staff member about a cancerous mole on the back of his neck during a National Hockey League game in Seattle this past October.

Sitting immediately behind the visiting team’s bench, Nadia Popovici wrote a large-font message on her cell phone and tapped the protective glass to get the attention of Brian Hamilton, assistant equipment manager for the Canucks.

“The mole on the back of your neck is possibly cancerous. Please go see a doctor!” read the message.

Mr. Hamilton acted on the tip and was eventually diagnosed with a malignant stage II melanoma, according to a report in the Seattle Times.

As noted in a Medscape Q&A, “ABCDE” is the acronym that indicates the visible, physical characteristics suggestive of melanoma. ABCDE stands for asymmetry, irregular border, color variations (especially red, white, and blue tones in a brown or black lesion), diameter greater than 6 mm, and elevated surface. The lesions may itch, bleed, ulcerate, or develop satellites.

The Canucks returned to Seattle recently for another game against the Seattle Kraken, and the visiting team posted a note on social media from Mr. Hamilton seeking the identity of the good Samaritan.

“... the message you showed me on your cell phone will forever be etched into my brain and has made a true life-changing difference for me and my family,” wrote Mr. Hamilton.

Within hours, Ms. Popovici’s mother, whose family has season tickets to the Seattle team’s games, responded to the message.

Ms. Popovici and Mr. Hamilton met up again at the Jan. 1 game, where Ms. Popovici was rewarded with a $10,000 medical school scholarship in a surprise announcement, shared on Twitter and liked more than 42,000 times.

“She didn’t take me out of a burning car like the big stories, but she took me out of a slow fire. And the words out of the doctor’s mouth were, if I ignored that for 4-5 years, I wouldn’t be here,” Mr. Hamilton said at a news conference on Jan. 1.

Ms. Popovici says she has been accepted to several medical schools and will start school in the fall, according to a press release from the National Hockey League.

More money for medical school may be on the way for Ms. Popovici after a GoFundMe page was started. With a goal of $25,000, the fund had received just over $2,500 as of Jan. 4.

“The teams made a kind gesture of giving her 10K, but I think we can do better!” Josh Doxey, a sales manager from Lehi, Utah, wrote on the page he created for Ms. Popovici.

Mr. Doxey told this news organization, “I started the GoFundMe thinking it would be a nice gesture especially for someone going into health care after 2 crazy years of COVID ... I have gotten in touch with her and her mother, and have been chatting with both. They both seem incredibly kind, grateful, and humble.”

A version of this article first appeared on Medscape.com.

A soon-to-be medical student and former oncology ward volunteer has received a $10,000 scholarship for her education recently after tipping off a Vancouver Canucks staff member about a cancerous mole on the back of his neck during a National Hockey League game in Seattle this past October.

Sitting immediately behind the visiting team’s bench, Nadia Popovici wrote a large-font message on her cell phone and tapped the protective glass to get the attention of Brian Hamilton, assistant equipment manager for the Canucks.

“The mole on the back of your neck is possibly cancerous. Please go see a doctor!” read the message.

Mr. Hamilton acted on the tip and was eventually diagnosed with a malignant stage II melanoma, according to a report in the Seattle Times.

As noted in a Medscape Q&A, “ABCDE” is the acronym that indicates the visible, physical characteristics suggestive of melanoma. ABCDE stands for asymmetry, irregular border, color variations (especially red, white, and blue tones in a brown or black lesion), diameter greater than 6 mm, and elevated surface. The lesions may itch, bleed, ulcerate, or develop satellites.

The Canucks returned to Seattle recently for another game against the Seattle Kraken, and the visiting team posted a note on social media from Mr. Hamilton seeking the identity of the good Samaritan.

“... the message you showed me on your cell phone will forever be etched into my brain and has made a true life-changing difference for me and my family,” wrote Mr. Hamilton.

Within hours, Ms. Popovici’s mother, whose family has season tickets to the Seattle team’s games, responded to the message.

Ms. Popovici and Mr. Hamilton met up again at the Jan. 1 game, where Ms. Popovici was rewarded with a $10,000 medical school scholarship in a surprise announcement, shared on Twitter and liked more than 42,000 times.

“She didn’t take me out of a burning car like the big stories, but she took me out of a slow fire. And the words out of the doctor’s mouth were, if I ignored that for 4-5 years, I wouldn’t be here,” Mr. Hamilton said at a news conference on Jan. 1.

Ms. Popovici says she has been accepted to several medical schools and will start school in the fall, according to a press release from the National Hockey League.

More money for medical school may be on the way for Ms. Popovici after a GoFundMe page was started. With a goal of $25,000, the fund had received just over $2,500 as of Jan. 4.

“The teams made a kind gesture of giving her 10K, but I think we can do better!” Josh Doxey, a sales manager from Lehi, Utah, wrote on the page he created for Ms. Popovici.

Mr. Doxey told this news organization, “I started the GoFundMe thinking it would be a nice gesture especially for someone going into health care after 2 crazy years of COVID ... I have gotten in touch with her and her mother, and have been chatting with both. They both seem incredibly kind, grateful, and humble.”

A version of this article first appeared on Medscape.com.

A soon-to-be medical student and former oncology ward volunteer has received a $10,000 scholarship for her education recently after tipping off a Vancouver Canucks staff member about a cancerous mole on the back of his neck during a National Hockey League game in Seattle this past October.

Sitting immediately behind the visiting team’s bench, Nadia Popovici wrote a large-font message on her cell phone and tapped the protective glass to get the attention of Brian Hamilton, assistant equipment manager for the Canucks.

“The mole on the back of your neck is possibly cancerous. Please go see a doctor!” read the message.

Mr. Hamilton acted on the tip and was eventually diagnosed with a malignant stage II melanoma, according to a report in the Seattle Times.

As noted in a Medscape Q&A, “ABCDE” is the acronym that indicates the visible, physical characteristics suggestive of melanoma. ABCDE stands for asymmetry, irregular border, color variations (especially red, white, and blue tones in a brown or black lesion), diameter greater than 6 mm, and elevated surface. The lesions may itch, bleed, ulcerate, or develop satellites.

The Canucks returned to Seattle recently for another game against the Seattle Kraken, and the visiting team posted a note on social media from Mr. Hamilton seeking the identity of the good Samaritan.

“... the message you showed me on your cell phone will forever be etched into my brain and has made a true life-changing difference for me and my family,” wrote Mr. Hamilton.

Within hours, Ms. Popovici’s mother, whose family has season tickets to the Seattle team’s games, responded to the message.

Ms. Popovici and Mr. Hamilton met up again at the Jan. 1 game, where Ms. Popovici was rewarded with a $10,000 medical school scholarship in a surprise announcement, shared on Twitter and liked more than 42,000 times.

“She didn’t take me out of a burning car like the big stories, but she took me out of a slow fire. And the words out of the doctor’s mouth were, if I ignored that for 4-5 years, I wouldn’t be here,” Mr. Hamilton said at a news conference on Jan. 1.

Ms. Popovici says she has been accepted to several medical schools and will start school in the fall, according to a press release from the National Hockey League.

More money for medical school may be on the way for Ms. Popovici after a GoFundMe page was started. With a goal of $25,000, the fund had received just over $2,500 as of Jan. 4.

“The teams made a kind gesture of giving her 10K, but I think we can do better!” Josh Doxey, a sales manager from Lehi, Utah, wrote on the page he created for Ms. Popovici.

Mr. Doxey told this news organization, “I started the GoFundMe thinking it would be a nice gesture especially for someone going into health care after 2 crazy years of COVID ... I have gotten in touch with her and her mother, and have been chatting with both. They both seem incredibly kind, grateful, and humble.”

A version of this article first appeared on Medscape.com.

To reduce risks of lung cancer mortality, interventions designed to improve high-risk groups’ uptake of low-dose CT (LDCT) lung cancer screening should focus on perceptions of lung cancer controllability, survival, and perceived effectiveness of changes in behavior, according to analysis of data from the SUMMIT study recently published in the Journal of Thoracic Oncology. Such an approach may be more effective than trying to change risk perceptions.

While 1-year survival among patients diagnosed with early-stage lung cancer is 88%, it is only 19% for those diagnosed with advanced disease. But only 27% of patients are diagnosed with early-stage disease. Screening high-risk asymptomatic adults using LDCT detects early-stage disease and significantly reduces lung cancer mortality, according to Samantha L. Quaife, PhD, of the Wolfson Institute of Population Health at Queen Mary University of London, and associates.

The effectiveness and equity of LDCT lung cancer screening as a population-level early detection strategy is compromised by low uptake among high-risk groups, the authors wrote.

In the United States, only 2% of eligible smokers have been screened since screening was first recommended in 2013. To provide a scientific evidence base for intervention, an understanding of factors making high-risk groups less likely to participate in LDCT screening is critical, Dr. Quaife and colleagues wrote.

Their longitudinal cohort study evaluating psychological correlates of lung cancer screening uptake included 44,000 ever-smokers (aged 55-77 years) who were invited to mail a self-regulatory questionnaire for lung cancer screening. Eligibility for LDCT lung cancer screening and inclusion in the SUMMIT study were further determined through telephone and in-person Lung Health Check (LHC) appointments. The primary outcome was uptake of the invitation to book an LHC appointment by telephone.

Of those invited, 7,966 (18.1%) returned the questionnaire with 7,730 (45% female; mean age, about 64 years) linked to screening uptake data. About 30% reported being current smokers with high tobacco dependence (60.3% smoking within 30 minutes of waking). The analysis from Dr. Quaife and colleagues looked at psychological correlates of lung cancer screening uptake using a psychometrically validated self-regulatory questionnaire for lung cancer screening (SRQ-LCS) to measure psychological constructs hypothesized to be associated with uptake which included consequences, emotional representation, coherence (lung cancer knowledge), treatment control, personal control, risk perception, perceived stigma, response efficacy of smoking cessation, early diagnosis behavioral response, survival from lung cancer, and treatment intention.

Among those who perceived early diagnosis to be more beneficial as a behavioral response, the positive association with uptake was strongest (adjusted odds ratio, 1.37; 95% confidence interval, 1.33-1.41). Those who perceived greater personal control (aOR, 1.09; 95% CI, 1.05-1.11) or believed their risk of lung cancer was high (aOR, 1.08; 95% CI, 1.05-1.10) were also more likely to respond. Other uptake increases were found for those who perceived smoking cessation as an effective means of reducing lung cancer risk or thought the chances of surviving early-stage lung cancer were good or fair (P < .01), and for those who perceived lung cancer as stigmatized (aOR, 1.26; 95% CI, 1.14-1.40). Most of these constructs were also perceived more negatively by current than former smokers.

Income, employment, education, social class, and housing conditions were significantly associated with many of the constructs. Greater affluence correlated with perceived personal control and benefit from early diagnosis, but more negative perceptions of the consequences of lung cancer. Also, those from more affluent areas were more likely to perceive lung cancer to be stigmatized and perceive smoking cessation to be less effective in reducing risk. Current daily smokers were less willing to be treated for early-stage disease, more pessimistic about survival, but had the highest-risk perception scores, at odds with their lower participation in lung screening trials. This contradiction, Dr. Quaife and colleagues suggested, may be explained by current smokers also holding more negative perceptions associated with lower uptake, including negative perceptions of lung cancer controllability, early diagnosis and survival, lower willingness to be treated, and belief that smoking cessation is less effective in reducing risk. All of these undermine positive responses to their high perceived risk.

“These findings pinpoint specific psychological targets for intervention,” the authors wrote. Experimental studies investigating the methods and mechanisms through which these perceptions could be changed are needed.

The study was funded by Cancer Research UK Population Research Fellowship (C50664/A24460) awarded to Dr. Quaife. The study investigators declared no support from financial organizations that might have an interest in the submitted work in the previous 3 years.

To reduce risks of lung cancer mortality, interventions designed to improve high-risk groups’ uptake of low-dose CT (LDCT) lung cancer screening should focus on perceptions of lung cancer controllability, survival, and perceived effectiveness of changes in behavior, according to analysis of data from the SUMMIT study recently published in the Journal of Thoracic Oncology. Such an approach may be more effective than trying to change risk perceptions.

While 1-year survival among patients diagnosed with early-stage lung cancer is 88%, it is only 19% for those diagnosed with advanced disease. But only 27% of patients are diagnosed with early-stage disease. Screening high-risk asymptomatic adults using LDCT detects early-stage disease and significantly reduces lung cancer mortality, according to Samantha L. Quaife, PhD, of the Wolfson Institute of Population Health at Queen Mary University of London, and associates.

The effectiveness and equity of LDCT lung cancer screening as a population-level early detection strategy is compromised by low uptake among high-risk groups, the authors wrote.

In the United States, only 2% of eligible smokers have been screened since screening was first recommended in 2013. To provide a scientific evidence base for intervention, an understanding of factors making high-risk groups less likely to participate in LDCT screening is critical, Dr. Quaife and colleagues wrote.

Their longitudinal cohort study evaluating psychological correlates of lung cancer screening uptake included 44,000 ever-smokers (aged 55-77 years) who were invited to mail a self-regulatory questionnaire for lung cancer screening. Eligibility for LDCT lung cancer screening and inclusion in the SUMMIT study were further determined through telephone and in-person Lung Health Check (LHC) appointments. The primary outcome was uptake of the invitation to book an LHC appointment by telephone.

Of those invited, 7,966 (18.1%) returned the questionnaire with 7,730 (45% female; mean age, about 64 years) linked to screening uptake data. About 30% reported being current smokers with high tobacco dependence (60.3% smoking within 30 minutes of waking). The analysis from Dr. Quaife and colleagues looked at psychological correlates of lung cancer screening uptake using a psychometrically validated self-regulatory questionnaire for lung cancer screening (SRQ-LCS) to measure psychological constructs hypothesized to be associated with uptake which included consequences, emotional representation, coherence (lung cancer knowledge), treatment control, personal control, risk perception, perceived stigma, response efficacy of smoking cessation, early diagnosis behavioral response, survival from lung cancer, and treatment intention.

Among those who perceived early diagnosis to be more beneficial as a behavioral response, the positive association with uptake was strongest (adjusted odds ratio, 1.37; 95% confidence interval, 1.33-1.41). Those who perceived greater personal control (aOR, 1.09; 95% CI, 1.05-1.11) or believed their risk of lung cancer was high (aOR, 1.08; 95% CI, 1.05-1.10) were also more likely to respond. Other uptake increases were found for those who perceived smoking cessation as an effective means of reducing lung cancer risk or thought the chances of surviving early-stage lung cancer were good or fair (P < .01), and for those who perceived lung cancer as stigmatized (aOR, 1.26; 95% CI, 1.14-1.40). Most of these constructs were also perceived more negatively by current than former smokers.

Income, employment, education, social class, and housing conditions were significantly associated with many of the constructs. Greater affluence correlated with perceived personal control and benefit from early diagnosis, but more negative perceptions of the consequences of lung cancer. Also, those from more affluent areas were more likely to perceive lung cancer to be stigmatized and perceive smoking cessation to be less effective in reducing risk. Current daily smokers were less willing to be treated for early-stage disease, more pessimistic about survival, but had the highest-risk perception scores, at odds with their lower participation in lung screening trials. This contradiction, Dr. Quaife and colleagues suggested, may be explained by current smokers also holding more negative perceptions associated with lower uptake, including negative perceptions of lung cancer controllability, early diagnosis and survival, lower willingness to be treated, and belief that smoking cessation is less effective in reducing risk. All of these undermine positive responses to their high perceived risk.

“These findings pinpoint specific psychological targets for intervention,” the authors wrote. Experimental studies investigating the methods and mechanisms through which these perceptions could be changed are needed.

The study was funded by Cancer Research UK Population Research Fellowship (C50664/A24460) awarded to Dr. Quaife. The study investigators declared no support from financial organizations that might have an interest in the submitted work in the previous 3 years.

To reduce risks of lung cancer mortality, interventions designed to improve high-risk groups’ uptake of low-dose CT (LDCT) lung cancer screening should focus on perceptions of lung cancer controllability, survival, and perceived effectiveness of changes in behavior, according to analysis of data from the SUMMIT study recently published in the Journal of Thoracic Oncology. Such an approach may be more effective than trying to change risk perceptions.

While 1-year survival among patients diagnosed with early-stage lung cancer is 88%, it is only 19% for those diagnosed with advanced disease. But only 27% of patients are diagnosed with early-stage disease. Screening high-risk asymptomatic adults using LDCT detects early-stage disease and significantly reduces lung cancer mortality, according to Samantha L. Quaife, PhD, of the Wolfson Institute of Population Health at Queen Mary University of London, and associates.

The effectiveness and equity of LDCT lung cancer screening as a population-level early detection strategy is compromised by low uptake among high-risk groups, the authors wrote.

In the United States, only 2% of eligible smokers have been screened since screening was first recommended in 2013. To provide a scientific evidence base for intervention, an understanding of factors making high-risk groups less likely to participate in LDCT screening is critical, Dr. Quaife and colleagues wrote.

Their longitudinal cohort study evaluating psychological correlates of lung cancer screening uptake included 44,000 ever-smokers (aged 55-77 years) who were invited to mail a self-regulatory questionnaire for lung cancer screening. Eligibility for LDCT lung cancer screening and inclusion in the SUMMIT study were further determined through telephone and in-person Lung Health Check (LHC) appointments. The primary outcome was uptake of the invitation to book an LHC appointment by telephone.

Of those invited, 7,966 (18.1%) returned the questionnaire with 7,730 (45% female; mean age, about 64 years) linked to screening uptake data. About 30% reported being current smokers with high tobacco dependence (60.3% smoking within 30 minutes of waking). The analysis from Dr. Quaife and colleagues looked at psychological correlates of lung cancer screening uptake using a psychometrically validated self-regulatory questionnaire for lung cancer screening (SRQ-LCS) to measure psychological constructs hypothesized to be associated with uptake which included consequences, emotional representation, coherence (lung cancer knowledge), treatment control, personal control, risk perception, perceived stigma, response efficacy of smoking cessation, early diagnosis behavioral response, survival from lung cancer, and treatment intention.

Among those who perceived early diagnosis to be more beneficial as a behavioral response, the positive association with uptake was strongest (adjusted odds ratio, 1.37; 95% confidence interval, 1.33-1.41). Those who perceived greater personal control (aOR, 1.09; 95% CI, 1.05-1.11) or believed their risk of lung cancer was high (aOR, 1.08; 95% CI, 1.05-1.10) were also more likely to respond. Other uptake increases were found for those who perceived smoking cessation as an effective means of reducing lung cancer risk or thought the chances of surviving early-stage lung cancer were good or fair (P < .01), and for those who perceived lung cancer as stigmatized (aOR, 1.26; 95% CI, 1.14-1.40). Most of these constructs were also perceived more negatively by current than former smokers.

Income, employment, education, social class, and housing conditions were significantly associated with many of the constructs. Greater affluence correlated with perceived personal control and benefit from early diagnosis, but more negative perceptions of the consequences of lung cancer. Also, those from more affluent areas were more likely to perceive lung cancer to be stigmatized and perceive smoking cessation to be less effective in reducing risk. Current daily smokers were less willing to be treated for early-stage disease, more pessimistic about survival, but had the highest-risk perception scores, at odds with their lower participation in lung screening trials. This contradiction, Dr. Quaife and colleagues suggested, may be explained by current smokers also holding more negative perceptions associated with lower uptake, including negative perceptions of lung cancer controllability, early diagnosis and survival, lower willingness to be treated, and belief that smoking cessation is less effective in reducing risk. All of these undermine positive responses to their high perceived risk.

“These findings pinpoint specific psychological targets for intervention,” the authors wrote. Experimental studies investigating the methods and mechanisms through which these perceptions could be changed are needed.

The study was funded by Cancer Research UK Population Research Fellowship (C50664/A24460) awarded to Dr. Quaife. The study investigators declared no support from financial organizations that might have an interest in the submitted work in the previous 3 years.

A new analysis of cardiovascular adverse drug reactions for non–small cell lung cancer (NCSLC)–targeted therapies finds that ALK and ROS1 inhibitors are associated with higher odds of conduction disease and QT prolongation than BRAF and EGFR inhibitors.

The findings are especially important because cardiovascular disease is known to be associated with NSCLC. Even before the start of therapy, 14%-22% of patients with stage I-IV NSCLC have heart failure and 26%-31% of patients have arrhythmias. No other study to date has described cardiovascular effects to this extent as a result of treatment.

The findings were published in the Journal of Thoracic Oncology.

Led by Joel W. Neal, MD, PhD, a medical oncologist at Stanford (Calif.) Health Care, researchers evaluated the association between NSCLC-targeted agents with arrhythmia and heart failure. Their findings are based on analysis of data from the World Health Organization pharmacovigilance database VigiBase. They found that of 98,765 adverse reactions, 61,383 occurred in patients treated with EGFR inhibitors, 15,540 were associated with ALK inhibitors, and 21,842 were associated with BRAF and MEK inhibitors. Arrhythmias occurred in 1,783 patients and 1,146 patients had heart failure.
 

The specifics

Strong associations with conduction disease and QT prolongation were found for ALK and ROS1 inhibitors, especially crizotinib. Of QT prolongation cases, 38.5% of patients on ceritinib and 18.4% of patients on crizotinib also had conduction disease and 7.9% of alectinib-associated conduction disease cases also had prolongation.

BRAF and MEK inhibitors had stronger associations with heart failure, while osimertinib, a third-generation EGFR tyrosine kinase inhibitor, was strongly associated with QT prolongation, supraventricular tachycardia, and heart failure.

ALK inhibitors were found to be 13 times more likely to lead to conduction disease and five times more likely to lead to lead to long QT syndrome as compared to all NSCLC-targeted therapies together. ALK inhibitor crizotinib had significantly higher odds of conduction disease, compared with all other targeted therapies, but of all ALK inhibitors, ceritinib and lorlatinib had the lowest odds of conduction disease. Crizotinib was 1.9 times more likely to lead to QT prolongation than other ALK inhibitors.

The EGFR inhibitor osimertinib was associated with 49 times more like to lead to long QT syndrome than other EGFR inhibitors and 6 times more likely as compared with all other targeted therapies. The EGFR inhibitor gefitinib was twice as likely than other EGFR inhibitors to lead to conduction disease. The third-generation EGFR inhibitor osimertinib had approximately two times higher odds of supraventricular tachycardia than other EGFR inhibitors.

Osimertinib was associated with 6.8 times higher chances of heart failure, compared with other EGFR inhibitors, and 3.6 times more than other targeted therapies. Dabrafenib and trametinib were associated with two to three times higher odds of heart failure as compared with other targeted therapies.

“There is a need for an understanding of the mechanisms underlying these toxicities and for additional studies to establish standardized guidelines for monitoring, particularly for osimertinib, crizotinib, and alectinib,” the authors wrote

The authors disclosed a number of paid advisory roles with various pharmaceutical companies.

A new analysis of cardiovascular adverse drug reactions for non–small cell lung cancer (NCSLC)–targeted therapies finds that ALK and ROS1 inhibitors are associated with higher odds of conduction disease and QT prolongation than BRAF and EGFR inhibitors.

The findings are especially important because cardiovascular disease is known to be associated with NSCLC. Even before the start of therapy, 14%-22% of patients with stage I-IV NSCLC have heart failure and 26%-31% of patients have arrhythmias. No other study to date has described cardiovascular effects to this extent as a result of treatment.

The findings were published in the Journal of Thoracic Oncology.

Led by Joel W. Neal, MD, PhD, a medical oncologist at Stanford (Calif.) Health Care, researchers evaluated the association between NSCLC-targeted agents with arrhythmia and heart failure. Their findings are based on analysis of data from the World Health Organization pharmacovigilance database VigiBase. They found that of 98,765 adverse reactions, 61,383 occurred in patients treated with EGFR inhibitors, 15,540 were associated with ALK inhibitors, and 21,842 were associated with BRAF and MEK inhibitors. Arrhythmias occurred in 1,783 patients and 1,146 patients had heart failure.
 

The specifics

Strong associations with conduction disease and QT prolongation were found for ALK and ROS1 inhibitors, especially crizotinib. Of QT prolongation cases, 38.5% of patients on ceritinib and 18.4% of patients on crizotinib also had conduction disease and 7.9% of alectinib-associated conduction disease cases also had prolongation.

BRAF and MEK inhibitors had stronger associations with heart failure, while osimertinib, a third-generation EGFR tyrosine kinase inhibitor, was strongly associated with QT prolongation, supraventricular tachycardia, and heart failure.

ALK inhibitors were found to be 13 times more likely to lead to conduction disease and five times more likely to lead to lead to long QT syndrome as compared to all NSCLC-targeted therapies together. ALK inhibitor crizotinib had significantly higher odds of conduction disease, compared with all other targeted therapies, but of all ALK inhibitors, ceritinib and lorlatinib had the lowest odds of conduction disease. Crizotinib was 1.9 times more likely to lead to QT prolongation than other ALK inhibitors.

The EGFR inhibitor osimertinib was associated with 49 times more like to lead to long QT syndrome than other EGFR inhibitors and 6 times more likely as compared with all other targeted therapies. The EGFR inhibitor gefitinib was twice as likely than other EGFR inhibitors to lead to conduction disease. The third-generation EGFR inhibitor osimertinib had approximately two times higher odds of supraventricular tachycardia than other EGFR inhibitors.

Osimertinib was associated with 6.8 times higher chances of heart failure, compared with other EGFR inhibitors, and 3.6 times more than other targeted therapies. Dabrafenib and trametinib were associated with two to three times higher odds of heart failure as compared with other targeted therapies.

“There is a need for an understanding of the mechanisms underlying these toxicities and for additional studies to establish standardized guidelines for monitoring, particularly for osimertinib, crizotinib, and alectinib,” the authors wrote

The authors disclosed a number of paid advisory roles with various pharmaceutical companies.

A new analysis of cardiovascular adverse drug reactions for non–small cell lung cancer (NCSLC)–targeted therapies finds that ALK and ROS1 inhibitors are associated with higher odds of conduction disease and QT prolongation than BRAF and EGFR inhibitors.

The findings are especially important because cardiovascular disease is known to be associated with NSCLC. Even before the start of therapy, 14%-22% of patients with stage I-IV NSCLC have heart failure and 26%-31% of patients have arrhythmias. No other study to date has described cardiovascular effects to this extent as a result of treatment.

The findings were published in the Journal of Thoracic Oncology.

Led by Joel W. Neal, MD, PhD, a medical oncologist at Stanford (Calif.) Health Care, researchers evaluated the association between NSCLC-targeted agents with arrhythmia and heart failure. Their findings are based on analysis of data from the World Health Organization pharmacovigilance database VigiBase. They found that of 98,765 adverse reactions, 61,383 occurred in patients treated with EGFR inhibitors, 15,540 were associated with ALK inhibitors, and 21,842 were associated with BRAF and MEK inhibitors. Arrhythmias occurred in 1,783 patients and 1,146 patients had heart failure.
 

The specifics

Strong associations with conduction disease and QT prolongation were found for ALK and ROS1 inhibitors, especially crizotinib. Of QT prolongation cases, 38.5% of patients on ceritinib and 18.4% of patients on crizotinib also had conduction disease and 7.9% of alectinib-associated conduction disease cases also had prolongation.

BRAF and MEK inhibitors had stronger associations with heart failure, while osimertinib, a third-generation EGFR tyrosine kinase inhibitor, was strongly associated with QT prolongation, supraventricular tachycardia, and heart failure.

ALK inhibitors were found to be 13 times more likely to lead to conduction disease and five times more likely to lead to lead to long QT syndrome as compared to all NSCLC-targeted therapies together. ALK inhibitor crizotinib had significantly higher odds of conduction disease, compared with all other targeted therapies, but of all ALK inhibitors, ceritinib and lorlatinib had the lowest odds of conduction disease. Crizotinib was 1.9 times more likely to lead to QT prolongation than other ALK inhibitors.

The EGFR inhibitor osimertinib was associated with 49 times more like to lead to long QT syndrome than other EGFR inhibitors and 6 times more likely as compared with all other targeted therapies. The EGFR inhibitor gefitinib was twice as likely than other EGFR inhibitors to lead to conduction disease. The third-generation EGFR inhibitor osimertinib had approximately two times higher odds of supraventricular tachycardia than other EGFR inhibitors.

Osimertinib was associated with 6.8 times higher chances of heart failure, compared with other EGFR inhibitors, and 3.6 times more than other targeted therapies. Dabrafenib and trametinib were associated with two to three times higher odds of heart failure as compared with other targeted therapies.

“There is a need for an understanding of the mechanisms underlying these toxicities and for additional studies to establish standardized guidelines for monitoring, particularly for osimertinib, crizotinib, and alectinib,” the authors wrote

The authors disclosed a number of paid advisory roles with various pharmaceutical companies.

Patients diagnosed with breast cancer during incarceration are unlikely to receive neoadjuvant therapy and have an increase time to surgery if they have the procedure upfront compared to other patients, suggests a new study.

The study was presented at the 2021 San Antonio Breast Cancer Symposium on Dec. 10 (Abstract P5-14-10).

Examining the records of more than 4,300 patients with breast cancer who were treated between 2014 and 2020 in North Carolina, researchers identified 34 who were either incarcerated at the time of diagnosis or who were diagnosed before they were imprisoned.

They found that neoadjuvant therapy was not given to incarcerated breast cancer patients as compared to 8% of women who were never incarcerated and 20% of women incarcerated later. Incarcerated patients treated with surgery upfront had to wait on average more than 3 weeks longer than other patients for their procedure. Their findings were followed by a recently published study in JAMA Network Open indicating that young people with a history of incarceration were significantly more likely to experience early mortality and that mortality was higher among Black prisoners.

“These findings are concerning for missed treatment opportunities within the carceral system,” wrote researchers who were led by Oluwadamilola “Lola” Fayanju, MD, MPHS, FACS, chief of breast surgery for the University of Pennsylvania Health System, Philadelphia.

Dr. Fayanju told this news organization that she was “not surprised by the finding that there was no neoadjuvant chemotherapy given to patients at all. Even in the practice of care outside of the carceral system it is striking how much variation there is in regards to treatment sequence if it is not approached in an evidence-based way. Many of the social ills that contribute to incarceration also contribute to this variation in care, and it’s not surprising that in women who are experiencing incarceration, there is geometric escalation of disparities with regards to their opportunities for treatment.”

Erica L. Mayer, MD, MPH, a medical oncologist and clinical investigator in the Breast Oncology Center at the Dana-Faber Cancer Institute, Boston, said “this is really interesting and important work showing some worrisome trends. On the one hand, this is a very small experience and such a small sample size is always vulnerable to bias or skew from factors that become more important. However, this is not the first observation that there are disparities of care in incarcerated populations,”said Dr. Mayer, who was not involved in the study. “This is a topic that has been studied in diseases outside of oncology, such as heart disease and diabetes. There is a theme that patients who are incarcerated have a disparity and inequity of care compared to those who are not.”

The current findings “fit in with general themes,” she said. As rates of cancer are expected to grow in the coming years, “understanding how to provide the best possible care in those settings is very important. This is early data but it’s an important signal and is suggesting to us that a greater understanding of health care access for incarcerated individuals is a very important area of study, and hopefully an area for which one could provide interventions that might help to reduce these disparities.”

Dr. Fayanju and associates. set out to determine the disease and treatment characteristics of individuals with breast cancer and a history of incarceration. They focused on women who had a breast cancer diagnosis at the University of North Carolina Hospitals between April 2014 and December 2020. They gathered data on patient demographics, incarceration status, disease characteristics, treatment types, and dates of receipt of treatment, but there were few data available. “It is really striking how little data there is available. This is a very small study and is the best we could glean from a large state-wide dataset,” she said.

Of 4,332 breast cancer cases, 34 (0.8%) were diagnosed while incarcerated (70.6%) or before incarceration (29.4%). Those who were diagnosed during incarceration were significantly more likely to be single (P < .001), use illicit drugs at the time of diagnosis (P = .01), and have a family history of breast cancer (P = .03) as compared with patients who were never incarcerated and those who were diagnosed before incarceration.

The results also showed that patients diagnosed with breast cancer during incarceration were significantly less likely to receive neoadjuvant therapy at 0% versus 8.2% for those who were never incarcerated, and 20% for those who were diagnosed before incarceration (P = .01 for trend).

“Further research is needed to understand the full scope of cancer inequities and identify factors that contribute to them among patients who experience incarceration,” Dr. Fayanju said.

No funding or relevant financial relationships were declared for this featured study.

Patients diagnosed with breast cancer during incarceration are unlikely to receive neoadjuvant therapy and have an increase time to surgery if they have the procedure upfront compared to other patients, suggests a new study.

The study was presented at the 2021 San Antonio Breast Cancer Symposium on Dec. 10 (Abstract P5-14-10).

Examining the records of more than 4,300 patients with breast cancer who were treated between 2014 and 2020 in North Carolina, researchers identified 34 who were either incarcerated at the time of diagnosis or who were diagnosed before they were imprisoned.

They found that neoadjuvant therapy was not given to incarcerated breast cancer patients as compared to 8% of women who were never incarcerated and 20% of women incarcerated later. Incarcerated patients treated with surgery upfront had to wait on average more than 3 weeks longer than other patients for their procedure. Their findings were followed by a recently published study in JAMA Network Open indicating that young people with a history of incarceration were significantly more likely to experience early mortality and that mortality was higher among Black prisoners.

“These findings are concerning for missed treatment opportunities within the carceral system,” wrote researchers who were led by Oluwadamilola “Lola” Fayanju, MD, MPHS, FACS, chief of breast surgery for the University of Pennsylvania Health System, Philadelphia.

Dr. Fayanju told this news organization that she was “not surprised by the finding that there was no neoadjuvant chemotherapy given to patients at all. Even in the practice of care outside of the carceral system it is striking how much variation there is in regards to treatment sequence if it is not approached in an evidence-based way. Many of the social ills that contribute to incarceration also contribute to this variation in care, and it’s not surprising that in women who are experiencing incarceration, there is geometric escalation of disparities with regards to their opportunities for treatment.”

Erica L. Mayer, MD, MPH, a medical oncologist and clinical investigator in the Breast Oncology Center at the Dana-Faber Cancer Institute, Boston, said “this is really interesting and important work showing some worrisome trends. On the one hand, this is a very small experience and such a small sample size is always vulnerable to bias or skew from factors that become more important. However, this is not the first observation that there are disparities of care in incarcerated populations,”said Dr. Mayer, who was not involved in the study. “This is a topic that has been studied in diseases outside of oncology, such as heart disease and diabetes. There is a theme that patients who are incarcerated have a disparity and inequity of care compared to those who are not.”

The current findings “fit in with general themes,” she said. As rates of cancer are expected to grow in the coming years, “understanding how to provide the best possible care in those settings is very important. This is early data but it’s an important signal and is suggesting to us that a greater understanding of health care access for incarcerated individuals is a very important area of study, and hopefully an area for which one could provide interventions that might help to reduce these disparities.”

Dr. Fayanju and associates. set out to determine the disease and treatment characteristics of individuals with breast cancer and a history of incarceration. They focused on women who had a breast cancer diagnosis at the University of North Carolina Hospitals between April 2014 and December 2020. They gathered data on patient demographics, incarceration status, disease characteristics, treatment types, and dates of receipt of treatment, but there were few data available. “It is really striking how little data there is available. This is a very small study and is the best we could glean from a large state-wide dataset,” she said.

Of 4,332 breast cancer cases, 34 (0.8%) were diagnosed while incarcerated (70.6%) or before incarceration (29.4%). Those who were diagnosed during incarceration were significantly more likely to be single (P < .001), use illicit drugs at the time of diagnosis (P = .01), and have a family history of breast cancer (P = .03) as compared with patients who were never incarcerated and those who were diagnosed before incarceration.

The results also showed that patients diagnosed with breast cancer during incarceration were significantly less likely to receive neoadjuvant therapy at 0% versus 8.2% for those who were never incarcerated, and 20% for those who were diagnosed before incarceration (P = .01 for trend).

“Further research is needed to understand the full scope of cancer inequities and identify factors that contribute to them among patients who experience incarceration,” Dr. Fayanju said.

No funding or relevant financial relationships were declared for this featured study.

Patients diagnosed with breast cancer during incarceration are unlikely to receive neoadjuvant therapy and have an increase time to surgery if they have the procedure upfront compared to other patients, suggests a new study.

The study was presented at the 2021 San Antonio Breast Cancer Symposium on Dec. 10 (Abstract P5-14-10).

Examining the records of more than 4,300 patients with breast cancer who were treated between 2014 and 2020 in North Carolina, researchers identified 34 who were either incarcerated at the time of diagnosis or who were diagnosed before they were imprisoned.

They found that neoadjuvant therapy was not given to incarcerated breast cancer patients as compared to 8% of women who were never incarcerated and 20% of women incarcerated later. Incarcerated patients treated with surgery upfront had to wait on average more than 3 weeks longer than other patients for their procedure. Their findings were followed by a recently published study in JAMA Network Open indicating that young people with a history of incarceration were significantly more likely to experience early mortality and that mortality was higher among Black prisoners.

“These findings are concerning for missed treatment opportunities within the carceral system,” wrote researchers who were led by Oluwadamilola “Lola” Fayanju, MD, MPHS, FACS, chief of breast surgery for the University of Pennsylvania Health System, Philadelphia.

Dr. Fayanju told this news organization that she was “not surprised by the finding that there was no neoadjuvant chemotherapy given to patients at all. Even in the practice of care outside of the carceral system it is striking how much variation there is in regards to treatment sequence if it is not approached in an evidence-based way. Many of the social ills that contribute to incarceration also contribute to this variation in care, and it’s not surprising that in women who are experiencing incarceration, there is geometric escalation of disparities with regards to their opportunities for treatment.”

Erica L. Mayer, MD, MPH, a medical oncologist and clinical investigator in the Breast Oncology Center at the Dana-Faber Cancer Institute, Boston, said “this is really interesting and important work showing some worrisome trends. On the one hand, this is a very small experience and such a small sample size is always vulnerable to bias or skew from factors that become more important. However, this is not the first observation that there are disparities of care in incarcerated populations,”said Dr. Mayer, who was not involved in the study. “This is a topic that has been studied in diseases outside of oncology, such as heart disease and diabetes. There is a theme that patients who are incarcerated have a disparity and inequity of care compared to those who are not.”

The current findings “fit in with general themes,” she said. As rates of cancer are expected to grow in the coming years, “understanding how to provide the best possible care in those settings is very important. This is early data but it’s an important signal and is suggesting to us that a greater understanding of health care access for incarcerated individuals is a very important area of study, and hopefully an area for which one could provide interventions that might help to reduce these disparities.”

Dr. Fayanju and associates. set out to determine the disease and treatment characteristics of individuals with breast cancer and a history of incarceration. They focused on women who had a breast cancer diagnosis at the University of North Carolina Hospitals between April 2014 and December 2020. They gathered data on patient demographics, incarceration status, disease characteristics, treatment types, and dates of receipt of treatment, but there were few data available. “It is really striking how little data there is available. This is a very small study and is the best we could glean from a large state-wide dataset,” she said.

Of 4,332 breast cancer cases, 34 (0.8%) were diagnosed while incarcerated (70.6%) or before incarceration (29.4%). Those who were diagnosed during incarceration were significantly more likely to be single (P < .001), use illicit drugs at the time of diagnosis (P = .01), and have a family history of breast cancer (P = .03) as compared with patients who were never incarcerated and those who were diagnosed before incarceration.

The results also showed that patients diagnosed with breast cancer during incarceration were significantly less likely to receive neoadjuvant therapy at 0% versus 8.2% for those who were never incarcerated, and 20% for those who were diagnosed before incarceration (P = .01 for trend).

“Further research is needed to understand the full scope of cancer inequities and identify factors that contribute to them among patients who experience incarceration,” Dr. Fayanju said.

No funding or relevant financial relationships were declared for this featured study.

The drumbeat of U.S. recalls continues for various lots of extended-release metformin because of contamination with unacceptably high levels of a nitrosamine that pose a cancer risk.

On Dec. 28, 2021, Viona Pharmaceuticals voluntarily recalled 33 lots of metformin hydrochloride extended-release tablets, USP 750 mg to the retail level, as a precautionary measure, because of possible contamination with N-nitrosodimethylamine (NDMA).

Metformin is used as an adjunct to diet and exercise to improve blood glucose control in adults with type 2 diabetes mellitus. Patients who have received impacted lots of metformin are advised to continue taking their medication and contact their physician for advice regarding an alternative treatment

The product can be identified as white to off-white, capsule shaped, uncoated tablets, debossed with “Z,” “C” on one side and “20” on the other side, and come in bottles of 100 tablets, which have been distributed nationwide. The 33 batch numbers are listed in a company statement.

The affected product was manufactured by Cadila Healthcare, Ahmedabad, India, for U.S. distribution by Viona.

In its statement, Viona said: “NDMA is classified as a probable human carcinogen (a substance that could cause cancer) based on results from laboratory tests. NDMA is a known environmental contaminant and found in water and foods, including meats, dairy products, and vegetables.”

This recall is being conducted “with the knowledge of the U.S. Food and Drug Administration,” it added.

Consumers with questions regarding this recall can contact the recall processor Eversana Life Science Services by phone at 1-888-304-5022, option 1; Monday-Friday, 8:00 a.m.–7:00 p.m. CT. Customers with medical-related questions who wish to report an adverse event or quality issues about the products being recalled should contact Viona Pharmaceuticals by phone at 888-304-5011, Monday-Friday, 8:30 p.m.–5:30 p.m., EST.
 

Latest in a long line of metformin recalls

This is the second time in 2021 that Viona has voluntarily recalled extended-release metformin tablets, 750 mg, because of potential contamination with NDMA. It recalled two lots in June, as reported by this news organization.

And in January 2021, Nostrum Laboratories recalled another lot of metformin extended-release 750-mg tablets, following on from a prior recall in November 2020.

These recalls follows 258 distinct U.S. lot recalls tracked by the FDA during the past 2 years because of unacceptably high NDMA levels in lots of metformin hydrochloride extended-release tablets.

The FDA has issued several statements about NDMA contamination of metformin formulations over the past 2 years, including a review of the methods used to detect NDMA and a summary of the information the agency had collected on excessive levels of NDMA in metformin.

According to the FDA’s 2020 summary, the agency has not yet determined how or why high levels of NDMA turn up so often in multiple batches of metformin hydrochloride extended-release tablets. However, published research attributed the contamination to certain methods of manufacturing metformin tablets.

A version of this article first appeared on Medscape.com.

The drumbeat of U.S. recalls continues for various lots of extended-release metformin because of contamination with unacceptably high levels of a nitrosamine that pose a cancer risk.

On Dec. 28, 2021, Viona Pharmaceuticals voluntarily recalled 33 lots of metformin hydrochloride extended-release tablets, USP 750 mg to the retail level, as a precautionary measure, because of possible contamination with N-nitrosodimethylamine (NDMA).

Metformin is used as an adjunct to diet and exercise to improve blood glucose control in adults with type 2 diabetes mellitus. Patients who have received impacted lots of metformin are advised to continue taking their medication and contact their physician for advice regarding an alternative treatment

The product can be identified as white to off-white, capsule shaped, uncoated tablets, debossed with “Z,” “C” on one side and “20” on the other side, and come in bottles of 100 tablets, which have been distributed nationwide. The 33 batch numbers are listed in a company statement.

The affected product was manufactured by Cadila Healthcare, Ahmedabad, India, for U.S. distribution by Viona.

In its statement, Viona said: “NDMA is classified as a probable human carcinogen (a substance that could cause cancer) based on results from laboratory tests. NDMA is a known environmental contaminant and found in water and foods, including meats, dairy products, and vegetables.”

This recall is being conducted “with the knowledge of the U.S. Food and Drug Administration,” it added.

Consumers with questions regarding this recall can contact the recall processor Eversana Life Science Services by phone at 1-888-304-5022, option 1; Monday-Friday, 8:00 a.m.–7:00 p.m. CT. Customers with medical-related questions who wish to report an adverse event or quality issues about the products being recalled should contact Viona Pharmaceuticals by phone at 888-304-5011, Monday-Friday, 8:30 p.m.–5:30 p.m., EST.
 

Latest in a long line of metformin recalls

This is the second time in 2021 that Viona has voluntarily recalled extended-release metformin tablets, 750 mg, because of potential contamination with NDMA. It recalled two lots in June, as reported by this news organization.

And in January 2021, Nostrum Laboratories recalled another lot of metformin extended-release 750-mg tablets, following on from a prior recall in November 2020.

These recalls follows 258 distinct U.S. lot recalls tracked by the FDA during the past 2 years because of unacceptably high NDMA levels in lots of metformin hydrochloride extended-release tablets.

The FDA has issued several statements about NDMA contamination of metformin formulations over the past 2 years, including a review of the methods used to detect NDMA and a summary of the information the agency had collected on excessive levels of NDMA in metformin.

According to the FDA’s 2020 summary, the agency has not yet determined how or why high levels of NDMA turn up so often in multiple batches of metformin hydrochloride extended-release tablets. However, published research attributed the contamination to certain methods of manufacturing metformin tablets.

A version of this article first appeared on Medscape.com.

The drumbeat of U.S. recalls continues for various lots of extended-release metformin because of contamination with unacceptably high levels of a nitrosamine that pose a cancer risk.

On Dec. 28, 2021, Viona Pharmaceuticals voluntarily recalled 33 lots of metformin hydrochloride extended-release tablets, USP 750 mg to the retail level, as a precautionary measure, because of possible contamination with N-nitrosodimethylamine (NDMA).

Metformin is used as an adjunct to diet and exercise to improve blood glucose control in adults with type 2 diabetes mellitus. Patients who have received impacted lots of metformin are advised to continue taking their medication and contact their physician for advice regarding an alternative treatment

The product can be identified as white to off-white, capsule shaped, uncoated tablets, debossed with “Z,” “C” on one side and “20” on the other side, and come in bottles of 100 tablets, which have been distributed nationwide. The 33 batch numbers are listed in a company statement.

The affected product was manufactured by Cadila Healthcare, Ahmedabad, India, for U.S. distribution by Viona.

In its statement, Viona said: “NDMA is classified as a probable human carcinogen (a substance that could cause cancer) based on results from laboratory tests. NDMA is a known environmental contaminant and found in water and foods, including meats, dairy products, and vegetables.”

This recall is being conducted “with the knowledge of the U.S. Food and Drug Administration,” it added.

Consumers with questions regarding this recall can contact the recall processor Eversana Life Science Services by phone at 1-888-304-5022, option 1; Monday-Friday, 8:00 a.m.–7:00 p.m. CT. Customers with medical-related questions who wish to report an adverse event or quality issues about the products being recalled should contact Viona Pharmaceuticals by phone at 888-304-5011, Monday-Friday, 8:30 p.m.–5:30 p.m., EST.
 

Latest in a long line of metformin recalls

This is the second time in 2021 that Viona has voluntarily recalled extended-release metformin tablets, 750 mg, because of potential contamination with NDMA. It recalled two lots in June, as reported by this news organization.

And in January 2021, Nostrum Laboratories recalled another lot of metformin extended-release 750-mg tablets, following on from a prior recall in November 2020.

These recalls follows 258 distinct U.S. lot recalls tracked by the FDA during the past 2 years because of unacceptably high NDMA levels in lots of metformin hydrochloride extended-release tablets.

The FDA has issued several statements about NDMA contamination of metformin formulations over the past 2 years, including a review of the methods used to detect NDMA and a summary of the information the agency had collected on excessive levels of NDMA in metformin.

According to the FDA’s 2020 summary, the agency has not yet determined how or why high levels of NDMA turn up so often in multiple batches of metformin hydrochloride extended-release tablets. However, published research attributed the contamination to certain methods of manufacturing metformin tablets.

A version of this article first appeared on Medscape.com.

In non–small cell lung cancer (NSCLC), earlier detection may be an under-appreciated factor in recent trends of declining mortality, according to a new analysis of data from the Surveillance, Epidemiology, and End Results (SEER) registries published in JAMA Network Open. Between 2006 and 2016, a stage shift occurred with an increase in stage 1 and 2 diagnoses and a decrease in stage 3 and 4 diagnoses.

While targeted therapy and immunotherapy have rightfully been credited with improved NSCLC survival, the new results underline the importance of screening, according to study author Emanuela Taioli, MD, PhD, director of the Institute for Translational Epidemiology and the associate director for population science at the Tisch Cancer Institute at Mount Sinai, New York.

She noted that the average survival for stage 1 or stage 2 patients was 57 months, but just 7 months when the stage diagnosis was 3 or 4. “So being diagnosed with stage 1 and 2 is a major driver of better survival,” said Dr. Taioli in an interview.

The study included 312,382 individuals diagnosed with NSCLC (53.4% male; median age, 68). Incidence-based, 5-year mortality declined by 3.7% (95% confidence interval, 3.4%-4.1%). Stage 1 or 2 diagnoses increased from 26.5% to 31.2% of diagnoses between 2006 and 2016 (average annual percentage change, 1.5%; 95% CI, 0.5%-2.5%).

“Immunotherapy is a very exciting field. And it is an important contributor for people who have a disease that can be treated with immunotherapy, so that’s why people focus on that. But if you can diagnose the cancer earlier, that’s the best bet,” Dr. Taioli said.

Unfortunately, many patients and physicians haven’t received that message. Even though computed tomography lung cancer screening is covered by Medicare for current or former smokers, only about 7% of eligible patients undergo annual screening. Dr. Taioli said that a belief persists that lung cancer is so deadly that early detection isn’t effective.

But advances in therapy and surgery have changed that outlook. “It’s not true anymore. People don’t know, and physicians are not educated to the idea that lung cancer can be diagnosed earlier and save lives,” she said.

People who have quit smoking may be relatively easy to convince. “They made a big step, because quitting smoking is incredibly hard. I think they will be amenable to screening because they are in a phase [of life] in which they want to take care of themselves. The physician should really explain the benefits, and I don’t think they do it very clearly now,” Dr. Taioli said.

The study is limited by its retrospective nature, and it did not include information on diagnostic method or many NSCLC risk factors.

Dr. Taioli has no relevant financial disclosures.

In non–small cell lung cancer (NSCLC), earlier detection may be an under-appreciated factor in recent trends of declining mortality, according to a new analysis of data from the Surveillance, Epidemiology, and End Results (SEER) registries published in JAMA Network Open. Between 2006 and 2016, a stage shift occurred with an increase in stage 1 and 2 diagnoses and a decrease in stage 3 and 4 diagnoses.

While targeted therapy and immunotherapy have rightfully been credited with improved NSCLC survival, the new results underline the importance of screening, according to study author Emanuela Taioli, MD, PhD, director of the Institute for Translational Epidemiology and the associate director for population science at the Tisch Cancer Institute at Mount Sinai, New York.

She noted that the average survival for stage 1 or stage 2 patients was 57 months, but just 7 months when the stage diagnosis was 3 or 4. “So being diagnosed with stage 1 and 2 is a major driver of better survival,” said Dr. Taioli in an interview.

The study included 312,382 individuals diagnosed with NSCLC (53.4% male; median age, 68). Incidence-based, 5-year mortality declined by 3.7% (95% confidence interval, 3.4%-4.1%). Stage 1 or 2 diagnoses increased from 26.5% to 31.2% of diagnoses between 2006 and 2016 (average annual percentage change, 1.5%; 95% CI, 0.5%-2.5%).

“Immunotherapy is a very exciting field. And it is an important contributor for people who have a disease that can be treated with immunotherapy, so that’s why people focus on that. But if you can diagnose the cancer earlier, that’s the best bet,” Dr. Taioli said.

Unfortunately, many patients and physicians haven’t received that message. Even though computed tomography lung cancer screening is covered by Medicare for current or former smokers, only about 7% of eligible patients undergo annual screening. Dr. Taioli said that a belief persists that lung cancer is so deadly that early detection isn’t effective.

But advances in therapy and surgery have changed that outlook. “It’s not true anymore. People don’t know, and physicians are not educated to the idea that lung cancer can be diagnosed earlier and save lives,” she said.

People who have quit smoking may be relatively easy to convince. “They made a big step, because quitting smoking is incredibly hard. I think they will be amenable to screening because they are in a phase [of life] in which they want to take care of themselves. The physician should really explain the benefits, and I don’t think they do it very clearly now,” Dr. Taioli said.

The study is limited by its retrospective nature, and it did not include information on diagnostic method or many NSCLC risk factors.

Dr. Taioli has no relevant financial disclosures.

In non–small cell lung cancer (NSCLC), earlier detection may be an under-appreciated factor in recent trends of declining mortality, according to a new analysis of data from the Surveillance, Epidemiology, and End Results (SEER) registries published in JAMA Network Open. Between 2006 and 2016, a stage shift occurred with an increase in stage 1 and 2 diagnoses and a decrease in stage 3 and 4 diagnoses.

While targeted therapy and immunotherapy have rightfully been credited with improved NSCLC survival, the new results underline the importance of screening, according to study author Emanuela Taioli, MD, PhD, director of the Institute for Translational Epidemiology and the associate director for population science at the Tisch Cancer Institute at Mount Sinai, New York.

She noted that the average survival for stage 1 or stage 2 patients was 57 months, but just 7 months when the stage diagnosis was 3 or 4. “So being diagnosed with stage 1 and 2 is a major driver of better survival,” said Dr. Taioli in an interview.

The study included 312,382 individuals diagnosed with NSCLC (53.4% male; median age, 68). Incidence-based, 5-year mortality declined by 3.7% (95% confidence interval, 3.4%-4.1%). Stage 1 or 2 diagnoses increased from 26.5% to 31.2% of diagnoses between 2006 and 2016 (average annual percentage change, 1.5%; 95% CI, 0.5%-2.5%).

“Immunotherapy is a very exciting field. And it is an important contributor for people who have a disease that can be treated with immunotherapy, so that’s why people focus on that. But if you can diagnose the cancer earlier, that’s the best bet,” Dr. Taioli said.

Unfortunately, many patients and physicians haven’t received that message. Even though computed tomography lung cancer screening is covered by Medicare for current or former smokers, only about 7% of eligible patients undergo annual screening. Dr. Taioli said that a belief persists that lung cancer is so deadly that early detection isn’t effective.

But advances in therapy and surgery have changed that outlook. “It’s not true anymore. People don’t know, and physicians are not educated to the idea that lung cancer can be diagnosed earlier and save lives,” she said.

People who have quit smoking may be relatively easy to convince. “They made a big step, because quitting smoking is incredibly hard. I think they will be amenable to screening because they are in a phase [of life] in which they want to take care of themselves. The physician should really explain the benefits, and I don’t think they do it very clearly now,” Dr. Taioli said.

The study is limited by its retrospective nature, and it did not include information on diagnostic method or many NSCLC risk factors.

Dr. Taioli has no relevant financial disclosures.

A Chicago-based medical oncologist has been charged with insider trading by the U.S. Securities and Exchange Commission, according to a Dec. 20 press release issued by the U.S. Department of Justice.

Daniel V.T. Catenacci, MD, PhD, a gastrointestinal medical oncologist and associate professor of medicine at the University of Chicago, is alleged to have used confidential information to purchase shares of California-based biotechnology company Five Prime Therapeutics before it publicly announced positive results from a clinical trial of bemarituzumab, an experimental cancer drug.

Dr. Catenacci served as the lead investigator of the clinical trial that evaluated bemarituzumab. The drug, which earned breakthrough therapy designation from the Food and Drug Administration earlier this year, is designed to target fibroblast growth factor receptor 2b (FGFR2b), overexpressed in about 30% of patients with HER2-negative gastric cancer and other solid tumors.

Bemarituzumab is being positioned as a potential frontline therapy for advanced gastric or gastroesophageal junction cancer. A recent phase 2 trial found that adding bemarituzumab to chemotherapy in this patient population improved survival over chemotherapy alone.

According to the criminal information, filed on Dec. 17 in U.S. District Court in Chicago, the charges state that, in November 2020, Dr. Catenacci “used material, non-public information about the trial results to make more than $134,000 in illegal profits from the purchase and sale of securities in the company.”

More specifically, the SEC’s complaint alleges that Dr. Catenacci received confidential information about the company and its positive clinical trial results through his position as principal investigator. Dr. Catenacci then purchased almost 8,800 shares of Five Prime Therapeutics before the company announced the positive results. Dr. Catenacci subsequently sold those shares shortly after the trial results were announced. In the interim, the shares tripled or quadrupled in value.

He has been charged with one count of securities fraud, punishable by up to 20 years in federal prison. Arraignment in federal court in Chicago has yet to be scheduled.

In addition, the federal complaint alleges that Dr. Catenacci violated the antifraud provisions of the federal securities laws. According to a press release, “Catenacci has agreed to be permanently enjoined from violations of these provisions, and to pay a civil penalty in an amount to be determined by the court later.”

Erin E. Schneider, regional director of the SEC’s San Francisco Regional Office, stated in the press release that clinical drug trials typically involve sensitive and valuable information about the viability of an experimental drug.

“As alleged in our complaint, Catenacci was required to safeguard the material nonpublic information he learned about Five Prime’s clinical trial, and not trade on it,” said Mr. Schneider.

A version of this article first appeared on Medscape.com.

A Chicago-based medical oncologist has been charged with insider trading by the U.S. Securities and Exchange Commission, according to a Dec. 20 press release issued by the U.S. Department of Justice.

Daniel V.T. Catenacci, MD, PhD, a gastrointestinal medical oncologist and associate professor of medicine at the University of Chicago, is alleged to have used confidential information to purchase shares of California-based biotechnology company Five Prime Therapeutics before it publicly announced positive results from a clinical trial of bemarituzumab, an experimental cancer drug.

Dr. Catenacci served as the lead investigator of the clinical trial that evaluated bemarituzumab. The drug, which earned breakthrough therapy designation from the Food and Drug Administration earlier this year, is designed to target fibroblast growth factor receptor 2b (FGFR2b), overexpressed in about 30% of patients with HER2-negative gastric cancer and other solid tumors.

Bemarituzumab is being positioned as a potential frontline therapy for advanced gastric or gastroesophageal junction cancer. A recent phase 2 trial found that adding bemarituzumab to chemotherapy in this patient population improved survival over chemotherapy alone.

According to the criminal information, filed on Dec. 17 in U.S. District Court in Chicago, the charges state that, in November 2020, Dr. Catenacci “used material, non-public information about the trial results to make more than $134,000 in illegal profits from the purchase and sale of securities in the company.”

More specifically, the SEC’s complaint alleges that Dr. Catenacci received confidential information about the company and its positive clinical trial results through his position as principal investigator. Dr. Catenacci then purchased almost 8,800 shares of Five Prime Therapeutics before the company announced the positive results. Dr. Catenacci subsequently sold those shares shortly after the trial results were announced. In the interim, the shares tripled or quadrupled in value.

He has been charged with one count of securities fraud, punishable by up to 20 years in federal prison. Arraignment in federal court in Chicago has yet to be scheduled.

In addition, the federal complaint alleges that Dr. Catenacci violated the antifraud provisions of the federal securities laws. According to a press release, “Catenacci has agreed to be permanently enjoined from violations of these provisions, and to pay a civil penalty in an amount to be determined by the court later.”

Erin E. Schneider, regional director of the SEC’s San Francisco Regional Office, stated in the press release that clinical drug trials typically involve sensitive and valuable information about the viability of an experimental drug.

“As alleged in our complaint, Catenacci was required to safeguard the material nonpublic information he learned about Five Prime’s clinical trial, and not trade on it,” said Mr. Schneider.

A version of this article first appeared on Medscape.com.

A Chicago-based medical oncologist has been charged with insider trading by the U.S. Securities and Exchange Commission, according to a Dec. 20 press release issued by the U.S. Department of Justice.

Daniel V.T. Catenacci, MD, PhD, a gastrointestinal medical oncologist and associate professor of medicine at the University of Chicago, is alleged to have used confidential information to purchase shares of California-based biotechnology company Five Prime Therapeutics before it publicly announced positive results from a clinical trial of bemarituzumab, an experimental cancer drug.

Dr. Catenacci served as the lead investigator of the clinical trial that evaluated bemarituzumab. The drug, which earned breakthrough therapy designation from the Food and Drug Administration earlier this year, is designed to target fibroblast growth factor receptor 2b (FGFR2b), overexpressed in about 30% of patients with HER2-negative gastric cancer and other solid tumors.

Bemarituzumab is being positioned as a potential frontline therapy for advanced gastric or gastroesophageal junction cancer. A recent phase 2 trial found that adding bemarituzumab to chemotherapy in this patient population improved survival over chemotherapy alone.

According to the criminal information, filed on Dec. 17 in U.S. District Court in Chicago, the charges state that, in November 2020, Dr. Catenacci “used material, non-public information about the trial results to make more than $134,000 in illegal profits from the purchase and sale of securities in the company.”

More specifically, the SEC’s complaint alleges that Dr. Catenacci received confidential information about the company and its positive clinical trial results through his position as principal investigator. Dr. Catenacci then purchased almost 8,800 shares of Five Prime Therapeutics before the company announced the positive results. Dr. Catenacci subsequently sold those shares shortly after the trial results were announced. In the interim, the shares tripled or quadrupled in value.

He has been charged with one count of securities fraud, punishable by up to 20 years in federal prison. Arraignment in federal court in Chicago has yet to be scheduled.

In addition, the federal complaint alleges that Dr. Catenacci violated the antifraud provisions of the federal securities laws. According to a press release, “Catenacci has agreed to be permanently enjoined from violations of these provisions, and to pay a civil penalty in an amount to be determined by the court later.”

Erin E. Schneider, regional director of the SEC’s San Francisco Regional Office, stated in the press release that clinical drug trials typically involve sensitive and valuable information about the viability of an experimental drug.

“As alleged in our complaint, Catenacci was required to safeguard the material nonpublic information he learned about Five Prime’s clinical trial, and not trade on it,” said Mr. Schneider.

A version of this article first appeared on Medscape.com.