Opinion

Recently, Canada announced new regulations on tobacco, with warnings printed on individual cigarettes, such as “poison in every puff.” This is on top of the packaging already required to have 75% of its space devoted to similar warnings, often with graphic pictures, of the potential consequences.

Make no mistake, I don’t like cigarettes and try to get smokers to quit.

But I have to wonder how successful this is going to be. I mean, you’d have to have lived under a rock for the last 70 years (or more) to not know that cigarettes (and tobacco in general) aren’t good for you, and can cause stroke, heart disease, and a multitude of cancers.

I suppose you could ban cigarettes, but that only opens up a black market. From 1920 to 1933 the United States set an example for the world with prohibition, showing how such an idea can backfire horribly.

Realistically, there are always going to be people making bad health decisions of one kind or another, including myself. Whether it’s tobacco, alcohol, or a cheeseburger and fries.

Tobacco, of course, has a much worse track record than that of the cheeseburger. We all have to eat, even though some choices are better than others. Tobacco has absolutely no biological necessity, as do food, air, and water.

But it’s remarkably addictive, not to mention profitable. Those factors will always guarantee it a place in society.

At this point, if people want to smoke, I have a hard time believing that they’re unaware of the health risks.

There’s a legitimate argument to be made in trying to keep people from starting. The teenage years, where we all tend to believe we’re immortal, are when a lot of habits (good and bad) form. If gruesome pictures and repeated warnings cut down on those numbers, then in the long run it’s a very good thing. Given that Canada’s goal is to cut tobacco use from 13% down to less than 5% by 2035, this could happen. Only time will tell how it plays out.

On a side note, here in the United States tobacco use is 19% of the population. This is actually somewhat surprising to me, as a brief, not particularly scientific, review of my charts for the past few weeks found that less than 5% of my patients do it. So either some are lying or (more likely), it’s just the demographics of my practice area.

But at some point it doesn’t matter how many warnings or gory pictures people see, or where they encounter them. Some will keep smoking out of habit. Some because they actually like it. Some to be defiant. Some just because they can. And no amount of warnings is going to change their minds.

Dr. Block has a solo neurology practice in Scottsdale, Ariz.

Recently, Canada announced new regulations on tobacco, with warnings printed on individual cigarettes, such as “poison in every puff.” This is on top of the packaging already required to have 75% of its space devoted to similar warnings, often with graphic pictures, of the potential consequences.

Make no mistake, I don’t like cigarettes and try to get smokers to quit.

But I have to wonder how successful this is going to be. I mean, you’d have to have lived under a rock for the last 70 years (or more) to not know that cigarettes (and tobacco in general) aren’t good for you, and can cause stroke, heart disease, and a multitude of cancers.

I suppose you could ban cigarettes, but that only opens up a black market. From 1920 to 1933 the United States set an example for the world with prohibition, showing how such an idea can backfire horribly.

Realistically, there are always going to be people making bad health decisions of one kind or another, including myself. Whether it’s tobacco, alcohol, or a cheeseburger and fries.

Tobacco, of course, has a much worse track record than that of the cheeseburger. We all have to eat, even though some choices are better than others. Tobacco has absolutely no biological necessity, as do food, air, and water.

But it’s remarkably addictive, not to mention profitable. Those factors will always guarantee it a place in society.

At this point, if people want to smoke, I have a hard time believing that they’re unaware of the health risks.

There’s a legitimate argument to be made in trying to keep people from starting. The teenage years, where we all tend to believe we’re immortal, are when a lot of habits (good and bad) form. If gruesome pictures and repeated warnings cut down on those numbers, then in the long run it’s a very good thing. Given that Canada’s goal is to cut tobacco use from 13% down to less than 5% by 2035, this could happen. Only time will tell how it plays out.

On a side note, here in the United States tobacco use is 19% of the population. This is actually somewhat surprising to me, as a brief, not particularly scientific, review of my charts for the past few weeks found that less than 5% of my patients do it. So either some are lying or (more likely), it’s just the demographics of my practice area.

But at some point it doesn’t matter how many warnings or gory pictures people see, or where they encounter them. Some will keep smoking out of habit. Some because they actually like it. Some to be defiant. Some just because they can. And no amount of warnings is going to change their minds.

Dr. Block has a solo neurology practice in Scottsdale, Ariz.

Recently, Canada announced new regulations on tobacco, with warnings printed on individual cigarettes, such as “poison in every puff.” This is on top of the packaging already required to have 75% of its space devoted to similar warnings, often with graphic pictures, of the potential consequences.

Make no mistake, I don’t like cigarettes and try to get smokers to quit.

But I have to wonder how successful this is going to be. I mean, you’d have to have lived under a rock for the last 70 years (or more) to not know that cigarettes (and tobacco in general) aren’t good for you, and can cause stroke, heart disease, and a multitude of cancers.

I suppose you could ban cigarettes, but that only opens up a black market. From 1920 to 1933 the United States set an example for the world with prohibition, showing how such an idea can backfire horribly.

Realistically, there are always going to be people making bad health decisions of one kind or another, including myself. Whether it’s tobacco, alcohol, or a cheeseburger and fries.

Tobacco, of course, has a much worse track record than that of the cheeseburger. We all have to eat, even though some choices are better than others. Tobacco has absolutely no biological necessity, as do food, air, and water.

But it’s remarkably addictive, not to mention profitable. Those factors will always guarantee it a place in society.

At this point, if people want to smoke, I have a hard time believing that they’re unaware of the health risks.

There’s a legitimate argument to be made in trying to keep people from starting. The teenage years, where we all tend to believe we’re immortal, are when a lot of habits (good and bad) form. If gruesome pictures and repeated warnings cut down on those numbers, then in the long run it’s a very good thing. Given that Canada’s goal is to cut tobacco use from 13% down to less than 5% by 2035, this could happen. Only time will tell how it plays out.

On a side note, here in the United States tobacco use is 19% of the population. This is actually somewhat surprising to me, as a brief, not particularly scientific, review of my charts for the past few weeks found that less than 5% of my patients do it. So either some are lying or (more likely), it’s just the demographics of my practice area.

But at some point it doesn’t matter how many warnings or gory pictures people see, or where they encounter them. Some will keep smoking out of habit. Some because they actually like it. Some to be defiant. Some just because they can. And no amount of warnings is going to change their minds.

Dr. Block has a solo neurology practice in Scottsdale, Ariz.

This transcript has been edited for clarity.

Hello. I am Dr. JoAnn Pinkerton, professor of obstetrics and gynecology at the University of Virginia and a North American Menopause  Society–credentialed menopause specialist.

I am excited to tell you about a brand-new, just-approved non-estrogen therapy for treatment of menopausal symptoms. Fezolinetant (brand name, Veozah), a 45-mg oral daily therapy, is the first neurokinin receptor antagonist to receive approval from the Food and Drug Administration to treat vasomotor symptoms, including hot flashes and night sweats, due to menopause. The manufacturer, Astellas, is expected to make fezolinetant available at pharmacies before the end of this year. This medication binds to and blocks the neurokinin 3 (NK3) receptor, which plays a role in regulating body temperature, leading to a reduction in hot flashes.

University of Virginia Health System

For women suffering from frequent moderate to severe hot flashes, fezolinetant is an exciting breakthrough in women’s health as it is a highly effective nonhormonal treatment that reduces hot flashes and improves quality of life.

In two phase 3 clinical trials (Johnson et al. and Lederman et al.), fezolinetant 45 mg reduced the frequency of vasomotor symptoms by about 65%, significantly more than placebo, and similar to the 75% reduction seen with hormone therapy. Fezolinetant’s efficacy becomes evident within 1 week, reducing both frequency and severity of hot flashes.

With respect to side effects, 1%-2% of the menopausal women participating in clinical trials reported adverse events, including headaches, abdominal pain, diarrhea, insomnia, back pain, hot flushes, and reversible elevated hepatic transaminases. Serious adverse events were infrequent.

Subgroup analysis of data presented at ACOG’s 2023 annual meeting noted fezolinetant’s effectiveness among diverse populations, including White or Black race, body mass index of 30 or higher, those younger or older than age 55, smokers, former smokers, and never smokers, in U.S. as well as in European trial participants.

With respect to safety, a 52-week placebo-controlled safety trial confirmed safety for this time period. Adverse effects on the endometrium were neither seen nor expected, as fezolinetant is a centrally acting non–estrogen-containing medication. In addition, no loss of bone density was seen.

Prior trials of neurokinin receptor antagonists suggested the potential for hepatotoxicity. Increases in ALT or AST noted in one of the phase 3 trials of fezolinetant were described as asymptomatic, isolated, intermittent, or transient and returned to baseline during treatment or after discontinuation. However, the FDA placed a warning about liver injury potential. Package labeling recommends baseline liver function tests before starting fezolinetant and at 3, 6, and 9 months. In addition, concomitant use of moderate CYP1A2 inhibitors, including many antidepressants and cimetidine, should be avoided.

As with other recently approved medications, I am concerned that high cost could prevent appropriate candidates from having access.

Until now, the FDA had approved only one nonhormone therapy for vasomotor symptoms, 7.5 mg paroxetine salt. However, neither this formulation nor off-label use of other SSRIs, SNRIs, gabapentinoids, oxybutynin, or clonidine are as effective as hormone therapy or fezolinetant for moderate to severe vasomotor symptoms.

For women with bothersome menopausal hot flashes who can’t or choose not to use hormone therapy, including those with estrogen-sensitive breast or uterine cancers, fezolinetant offers a much-needed, highly effective, safe, nonhormone/non-estrogen option to treat their hot flashes.

The FDA approved it for treating vasomotor symptoms of menopause (hot flashes and night sweats) but it also appears to improve sleep disruption, mood, and quality of life.

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

This transcript has been edited for clarity.

Hello. I am Dr. JoAnn Pinkerton, professor of obstetrics and gynecology at the University of Virginia and a North American Menopause  Society–credentialed menopause specialist.

I am excited to tell you about a brand-new, just-approved non-estrogen therapy for treatment of menopausal symptoms. Fezolinetant (brand name, Veozah), a 45-mg oral daily therapy, is the first neurokinin receptor antagonist to receive approval from the Food and Drug Administration to treat vasomotor symptoms, including hot flashes and night sweats, due to menopause. The manufacturer, Astellas, is expected to make fezolinetant available at pharmacies before the end of this year. This medication binds to and blocks the neurokinin 3 (NK3) receptor, which plays a role in regulating body temperature, leading to a reduction in hot flashes.

University of Virginia Health System

For women suffering from frequent moderate to severe hot flashes, fezolinetant is an exciting breakthrough in women’s health as it is a highly effective nonhormonal treatment that reduces hot flashes and improves quality of life.

In two phase 3 clinical trials (Johnson et al. and Lederman et al.), fezolinetant 45 mg reduced the frequency of vasomotor symptoms by about 65%, significantly more than placebo, and similar to the 75% reduction seen with hormone therapy. Fezolinetant’s efficacy becomes evident within 1 week, reducing both frequency and severity of hot flashes.

With respect to side effects, 1%-2% of the menopausal women participating in clinical trials reported adverse events, including headaches, abdominal pain, diarrhea, insomnia, back pain, hot flushes, and reversible elevated hepatic transaminases. Serious adverse events were infrequent.

Subgroup analysis of data presented at ACOG’s 2023 annual meeting noted fezolinetant’s effectiveness among diverse populations, including White or Black race, body mass index of 30 or higher, those younger or older than age 55, smokers, former smokers, and never smokers, in U.S. as well as in European trial participants.

With respect to safety, a 52-week placebo-controlled safety trial confirmed safety for this time period. Adverse effects on the endometrium were neither seen nor expected, as fezolinetant is a centrally acting non–estrogen-containing medication. In addition, no loss of bone density was seen.

Prior trials of neurokinin receptor antagonists suggested the potential for hepatotoxicity. Increases in ALT or AST noted in one of the phase 3 trials of fezolinetant were described as asymptomatic, isolated, intermittent, or transient and returned to baseline during treatment or after discontinuation. However, the FDA placed a warning about liver injury potential. Package labeling recommends baseline liver function tests before starting fezolinetant and at 3, 6, and 9 months. In addition, concomitant use of moderate CYP1A2 inhibitors, including many antidepressants and cimetidine, should be avoided.

As with other recently approved medications, I am concerned that high cost could prevent appropriate candidates from having access.

Until now, the FDA had approved only one nonhormone therapy for vasomotor symptoms, 7.5 mg paroxetine salt. However, neither this formulation nor off-label use of other SSRIs, SNRIs, gabapentinoids, oxybutynin, or clonidine are as effective as hormone therapy or fezolinetant for moderate to severe vasomotor symptoms.

For women with bothersome menopausal hot flashes who can’t or choose not to use hormone therapy, including those with estrogen-sensitive breast or uterine cancers, fezolinetant offers a much-needed, highly effective, safe, nonhormone/non-estrogen option to treat their hot flashes.

The FDA approved it for treating vasomotor symptoms of menopause (hot flashes and night sweats) but it also appears to improve sleep disruption, mood, and quality of life.

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

This transcript has been edited for clarity.

Hello. I am Dr. JoAnn Pinkerton, professor of obstetrics and gynecology at the University of Virginia and a North American Menopause  Society–credentialed menopause specialist.

I am excited to tell you about a brand-new, just-approved non-estrogen therapy for treatment of menopausal symptoms. Fezolinetant (brand name, Veozah), a 45-mg oral daily therapy, is the first neurokinin receptor antagonist to receive approval from the Food and Drug Administration to treat vasomotor symptoms, including hot flashes and night sweats, due to menopause. The manufacturer, Astellas, is expected to make fezolinetant available at pharmacies before the end of this year. This medication binds to and blocks the neurokinin 3 (NK3) receptor, which plays a role in regulating body temperature, leading to a reduction in hot flashes.

University of Virginia Health System

For women suffering from frequent moderate to severe hot flashes, fezolinetant is an exciting breakthrough in women’s health as it is a highly effective nonhormonal treatment that reduces hot flashes and improves quality of life.

In two phase 3 clinical trials (Johnson et al. and Lederman et al.), fezolinetant 45 mg reduced the frequency of vasomotor symptoms by about 65%, significantly more than placebo, and similar to the 75% reduction seen with hormone therapy. Fezolinetant’s efficacy becomes evident within 1 week, reducing both frequency and severity of hot flashes.

With respect to side effects, 1%-2% of the menopausal women participating in clinical trials reported adverse events, including headaches, abdominal pain, diarrhea, insomnia, back pain, hot flushes, and reversible elevated hepatic transaminases. Serious adverse events were infrequent.

Subgroup analysis of data presented at ACOG’s 2023 annual meeting noted fezolinetant’s effectiveness among diverse populations, including White or Black race, body mass index of 30 or higher, those younger or older than age 55, smokers, former smokers, and never smokers, in U.S. as well as in European trial participants.

With respect to safety, a 52-week placebo-controlled safety trial confirmed safety for this time period. Adverse effects on the endometrium were neither seen nor expected, as fezolinetant is a centrally acting non–estrogen-containing medication. In addition, no loss of bone density was seen.

Prior trials of neurokinin receptor antagonists suggested the potential for hepatotoxicity. Increases in ALT or AST noted in one of the phase 3 trials of fezolinetant were described as asymptomatic, isolated, intermittent, or transient and returned to baseline during treatment or after discontinuation. However, the FDA placed a warning about liver injury potential. Package labeling recommends baseline liver function tests before starting fezolinetant and at 3, 6, and 9 months. In addition, concomitant use of moderate CYP1A2 inhibitors, including many antidepressants and cimetidine, should be avoided.

As with other recently approved medications, I am concerned that high cost could prevent appropriate candidates from having access.

Until now, the FDA had approved only one nonhormone therapy for vasomotor symptoms, 7.5 mg paroxetine salt. However, neither this formulation nor off-label use of other SSRIs, SNRIs, gabapentinoids, oxybutynin, or clonidine are as effective as hormone therapy or fezolinetant for moderate to severe vasomotor symptoms.

For women with bothersome menopausal hot flashes who can’t or choose not to use hormone therapy, including those with estrogen-sensitive breast or uterine cancers, fezolinetant offers a much-needed, highly effective, safe, nonhormone/non-estrogen option to treat their hot flashes.

The FDA approved it for treating vasomotor symptoms of menopause (hot flashes and night sweats) but it also appears to improve sleep disruption, mood, and quality of life.

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

The overprescribing of opioid pain medications has given way to an overprescribing of anxiolytics, sedatives, and stimulants. The results are unsafe and dangerous.

When we address this problem with patients, some become immediately defensive, making it difficult to modify treatment regimens. It’s almost as if people believe that they have a “right” to their medications and nobody should dare take them away. Even when I think the interaction goes relatively smoothly, the outcome usually shows otherwise.

I will decrease gabapentin from 3,200 mg per day and they will come back with cyclobenzaprine from the urgent care center down the block.

I try to stop an abused amphetamine and dextroamphetamine, and not only do the drugs show up in the urine toxicology test a month later (from the brother’s girlfriend’s sister) but the screening will be positive for cocaine (from the sister’s boyfriend’s brother) and probably alprazolam, too. 

People want what they want, and I believe what they want is the overwhelming need not to feel, and especially to not feel our natural and uncomfortable states of pain, sadness, anxiety, fatigue, and discomfort (sometimes all at once). They will use anything orally or intravenously or nasally to make those feelings go away.

I am an addiction specialist so I write this commentary out of care and concern and recognition of how much, pain both physical and psychic, people suffer.

Perhaps we as physicians are conditioned to believe that we must prescribe “something” to the patient who is uncomfortable and sitting in front of us. In general we are sympathetic to the needs of those who come to us in distress, and we try our best to help reduce their symptoms.

I know that we cannot simply “fire” people, because these patients are ours to take care of; they are our responsibility, though this is our overused response to “difficult” patients. 

And I know that we have insufficient replacements for these medications. We stopped prescribing oxycodone and now people are on gabapentin in the highest doses, diversion is up, and so is its abuse.

Many of us regularly teach about breathing and mindfulness. I discuss trauma and talk therapy. I order physical therapy and walking regimens and podcasts. But our relationship is transactional, and in prescribing a medication, I have shown them that I am hearing them. I hate this feeling of being trapped. 

I spend much of my day negotiating and drive home at night feeling like nothing more than a vending machine.

Dr. Hambright is with the department of addiction medicine at Samaritan Daytop Village, Ellenville, N.Y., and Samadhi Recovery Community Outreach Center, Kingston, N.Y. She disclosed no relevant conflicts of interest.

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

The overprescribing of opioid pain medications has given way to an overprescribing of anxiolytics, sedatives, and stimulants. The results are unsafe and dangerous.

When we address this problem with patients, some become immediately defensive, making it difficult to modify treatment regimens. It’s almost as if people believe that they have a “right” to their medications and nobody should dare take them away. Even when I think the interaction goes relatively smoothly, the outcome usually shows otherwise.

I will decrease gabapentin from 3,200 mg per day and they will come back with cyclobenzaprine from the urgent care center down the block.

I try to stop an abused amphetamine and dextroamphetamine, and not only do the drugs show up in the urine toxicology test a month later (from the brother’s girlfriend’s sister) but the screening will be positive for cocaine (from the sister’s boyfriend’s brother) and probably alprazolam, too. 

People want what they want, and I believe what they want is the overwhelming need not to feel, and especially to not feel our natural and uncomfortable states of pain, sadness, anxiety, fatigue, and discomfort (sometimes all at once). They will use anything orally or intravenously or nasally to make those feelings go away.

I am an addiction specialist so I write this commentary out of care and concern and recognition of how much, pain both physical and psychic, people suffer.

Perhaps we as physicians are conditioned to believe that we must prescribe “something” to the patient who is uncomfortable and sitting in front of us. In general we are sympathetic to the needs of those who come to us in distress, and we try our best to help reduce their symptoms.

I know that we cannot simply “fire” people, because these patients are ours to take care of; they are our responsibility, though this is our overused response to “difficult” patients. 

And I know that we have insufficient replacements for these medications. We stopped prescribing oxycodone and now people are on gabapentin in the highest doses, diversion is up, and so is its abuse.

Many of us regularly teach about breathing and mindfulness. I discuss trauma and talk therapy. I order physical therapy and walking regimens and podcasts. But our relationship is transactional, and in prescribing a medication, I have shown them that I am hearing them. I hate this feeling of being trapped. 

I spend much of my day negotiating and drive home at night feeling like nothing more than a vending machine.

Dr. Hambright is with the department of addiction medicine at Samaritan Daytop Village, Ellenville, N.Y., and Samadhi Recovery Community Outreach Center, Kingston, N.Y. She disclosed no relevant conflicts of interest.

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

The overprescribing of opioid pain medications has given way to an overprescribing of anxiolytics, sedatives, and stimulants. The results are unsafe and dangerous.

When we address this problem with patients, some become immediately defensive, making it difficult to modify treatment regimens. It’s almost as if people believe that they have a “right” to their medications and nobody should dare take them away. Even when I think the interaction goes relatively smoothly, the outcome usually shows otherwise.

I will decrease gabapentin from 3,200 mg per day and they will come back with cyclobenzaprine from the urgent care center down the block.

I try to stop an abused amphetamine and dextroamphetamine, and not only do the drugs show up in the urine toxicology test a month later (from the brother’s girlfriend’s sister) but the screening will be positive for cocaine (from the sister’s boyfriend’s brother) and probably alprazolam, too. 

People want what they want, and I believe what they want is the overwhelming need not to feel, and especially to not feel our natural and uncomfortable states of pain, sadness, anxiety, fatigue, and discomfort (sometimes all at once). They will use anything orally or intravenously or nasally to make those feelings go away.

I am an addiction specialist so I write this commentary out of care and concern and recognition of how much, pain both physical and psychic, people suffer.

Perhaps we as physicians are conditioned to believe that we must prescribe “something” to the patient who is uncomfortable and sitting in front of us. In general we are sympathetic to the needs of those who come to us in distress, and we try our best to help reduce their symptoms.

I know that we cannot simply “fire” people, because these patients are ours to take care of; they are our responsibility, though this is our overused response to “difficult” patients. 

And I know that we have insufficient replacements for these medications. We stopped prescribing oxycodone and now people are on gabapentin in the highest doses, diversion is up, and so is its abuse.

Many of us regularly teach about breathing and mindfulness. I discuss trauma and talk therapy. I order physical therapy and walking regimens and podcasts. But our relationship is transactional, and in prescribing a medication, I have shown them that I am hearing them. I hate this feeling of being trapped. 

I spend much of my day negotiating and drive home at night feeling like nothing more than a vending machine.

Dr. Hambright is with the department of addiction medicine at Samaritan Daytop Village, Ellenville, N.Y., and Samadhi Recovery Community Outreach Center, Kingston, N.Y. She disclosed no relevant conflicts of interest.

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

This transcript has been edited for clarity.

Hi. It’s Dr. Kathy Miller from Indiana University, coming to you today from the 2023 ASCO annual meeting in Chicago.

It’s been an exciting year for breast cancer news. I want to make sure that you hear about the two studies that I find the most impactful. One is the NATALEE study looking at ribociclib in adjuvant ER-positive patients at high risk for recurrence. You saw the press release a few weeks ago, and we now have the data. There is no doubt that this is a positive trial.

The details here are important. These were pre- or postmenopausal women, and men as well. Premenopausal women and men also had an LHRH agonist in addition to an aromatase inhibitor – that could have been either letrozole or anastrozole – then randomized to ribociclib or placebo.

The dose of ribociclib that you’re used to thinking about is 600 mg daily for 3 weeks and 7 days off. That’s the approved dose in the metastatic setting. In the adjuvant trial, they used 400 mg, and that was intentional to try to reduce some of the toxicity because the plan was for 3 years of therapy. Managing toxicity and really making this tolerable for patients was crucial.

We’ve now seen the efficacy results, with a roughly 3% reduction in the risk for recurrence; 90% disease-free survival in the ribociclib arm, 87% in the control arm, some patients still having prolongation of QTc but no serious arrhythmias; some patients still with myelosuppression, but risk for serious infections was really very low.

This is going to give you a question to ponder in your high-risk, ER-positive patients who are appropriate to consider for adjuvant cyclin-dependent kinase inhibitors. Are you now on team abemaciclib or team ribociclib? We have no head-to-head trials in any setting, and I doubt that our industry colleagues are going to be interested in a head-to-head setting.

We’re going to need to pay particular attention to long-term follow-up and to quality of life and toxicity data as to which our patients prefer. We may need to think about other ways of doing those direct comparisons with public funding, where we can get the answers our patients deserve.

I also want to think about the other end of the spectrum, those patients with HER2-positive disease. We saw fantastic results from the PHERGain study from our colleagues in Spain. This was a trial that took patients with predominantly stage II and III HER2-positive breast cancer. These are patients that we would treat with neoadjuvant chemotherapy, with dual HER2-targeted therapy.

Years ago, we saw results of some small, single-arm, phase 2 studies, suggesting that some of those patients may be so sensitive to biologic therapy that they have a pathologic complete response with HER2-targeted therapy – HER2-targeted therapy with endocrine therapy if they are positive – with no chemotherapy at all. Our question has always been how to identify those patients. Can we identify them well enough that we would be comfortable not treating them with chemotherapy? Importantly, If they didn’t get chemotherapy, what’s their long-term outcome?

The PHERGain trial lets us look at all those things. The PHERGain trial gave patients two cycles of dual HER2-targeted therapy, pertuzumab and trastuzumab, hormone therapy if also ER positive, and they got an FDG-PET scan after two cycles of therapy.

If they had a significant PET response, those patients were then randomized to switch to chemotherapy, standard TCHP, or continue biologic therapy alone for a total of six cycles. They then went to surgery. If they had a pathologic complete response, whether they had gotten chemotherapy or no chemotherapy, they completed the HER2-targeted therapy. If they still had residual disease, they got chemotherapy if chemotherapy had not been administered before, and they may have gotten other HER2-targeted therapies if they had already received chemotherapy.

There were over 300 patients in this trial, and my memory is that roughly two thirds of them had a PET response. About 86 patients randomized to continue biologic therapy had a pathologic complete response, so about one-third of those for whom the PET imaging said they were responding with biologic therapy only had a pathologic complete response.

They have now been followed for 3 years. The 3-year disease-free survival results look very reassuring. Of those 86 patients, one patient had a local recurrence and no patient had a distant recurrence.

This is what we’ve been waiting for. Can we identify those patients who have an excellent prognosis with biologic therapy alone so that we can avoid the toxicities? This is really where you’ll see the research over the coming years in breast cancer, looking at additional therapies in high-risk patients who don’t do so well with our standard therapies, and better stratification of patients who do so well with our standard therapies that we may be able to do less.

This is one of the ways that we’ll be able to do that. I look forward to sharing those results with you over coming years.

Kathy D. Miller, MD, is associate director of clinical research and codirector of the breast cancer program at the Melvin and Bren Simon Cancer Center at Indiana University, Indianapolis. She disclosed no relevant conflicts of interest.

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

This transcript has been edited for clarity.

Hi. It’s Dr. Kathy Miller from Indiana University, coming to you today from the 2023 ASCO annual meeting in Chicago.

It’s been an exciting year for breast cancer news. I want to make sure that you hear about the two studies that I find the most impactful. One is the NATALEE study looking at ribociclib in adjuvant ER-positive patients at high risk for recurrence. You saw the press release a few weeks ago, and we now have the data. There is no doubt that this is a positive trial.

The details here are important. These were pre- or postmenopausal women, and men as well. Premenopausal women and men also had an LHRH agonist in addition to an aromatase inhibitor – that could have been either letrozole or anastrozole – then randomized to ribociclib or placebo.

The dose of ribociclib that you’re used to thinking about is 600 mg daily for 3 weeks and 7 days off. That’s the approved dose in the metastatic setting. In the adjuvant trial, they used 400 mg, and that was intentional to try to reduce some of the toxicity because the plan was for 3 years of therapy. Managing toxicity and really making this tolerable for patients was crucial.

We’ve now seen the efficacy results, with a roughly 3% reduction in the risk for recurrence; 90% disease-free survival in the ribociclib arm, 87% in the control arm, some patients still having prolongation of QTc but no serious arrhythmias; some patients still with myelosuppression, but risk for serious infections was really very low.

This is going to give you a question to ponder in your high-risk, ER-positive patients who are appropriate to consider for adjuvant cyclin-dependent kinase inhibitors. Are you now on team abemaciclib or team ribociclib? We have no head-to-head trials in any setting, and I doubt that our industry colleagues are going to be interested in a head-to-head setting.

We’re going to need to pay particular attention to long-term follow-up and to quality of life and toxicity data as to which our patients prefer. We may need to think about other ways of doing those direct comparisons with public funding, where we can get the answers our patients deserve.

I also want to think about the other end of the spectrum, those patients with HER2-positive disease. We saw fantastic results from the PHERGain study from our colleagues in Spain. This was a trial that took patients with predominantly stage II and III HER2-positive breast cancer. These are patients that we would treat with neoadjuvant chemotherapy, with dual HER2-targeted therapy.

Years ago, we saw results of some small, single-arm, phase 2 studies, suggesting that some of those patients may be so sensitive to biologic therapy that they have a pathologic complete response with HER2-targeted therapy – HER2-targeted therapy with endocrine therapy if they are positive – with no chemotherapy at all. Our question has always been how to identify those patients. Can we identify them well enough that we would be comfortable not treating them with chemotherapy? Importantly, If they didn’t get chemotherapy, what’s their long-term outcome?

The PHERGain trial lets us look at all those things. The PHERGain trial gave patients two cycles of dual HER2-targeted therapy, pertuzumab and trastuzumab, hormone therapy if also ER positive, and they got an FDG-PET scan after two cycles of therapy.

If they had a significant PET response, those patients were then randomized to switch to chemotherapy, standard TCHP, or continue biologic therapy alone for a total of six cycles. They then went to surgery. If they had a pathologic complete response, whether they had gotten chemotherapy or no chemotherapy, they completed the HER2-targeted therapy. If they still had residual disease, they got chemotherapy if chemotherapy had not been administered before, and they may have gotten other HER2-targeted therapies if they had already received chemotherapy.

There were over 300 patients in this trial, and my memory is that roughly two thirds of them had a PET response. About 86 patients randomized to continue biologic therapy had a pathologic complete response, so about one-third of those for whom the PET imaging said they were responding with biologic therapy only had a pathologic complete response.

They have now been followed for 3 years. The 3-year disease-free survival results look very reassuring. Of those 86 patients, one patient had a local recurrence and no patient had a distant recurrence.

This is what we’ve been waiting for. Can we identify those patients who have an excellent prognosis with biologic therapy alone so that we can avoid the toxicities? This is really where you’ll see the research over the coming years in breast cancer, looking at additional therapies in high-risk patients who don’t do so well with our standard therapies, and better stratification of patients who do so well with our standard therapies that we may be able to do less.

This is one of the ways that we’ll be able to do that. I look forward to sharing those results with you over coming years.

Kathy D. Miller, MD, is associate director of clinical research and codirector of the breast cancer program at the Melvin and Bren Simon Cancer Center at Indiana University, Indianapolis. She disclosed no relevant conflicts of interest.

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

This transcript has been edited for clarity.

Hi. It’s Dr. Kathy Miller from Indiana University, coming to you today from the 2023 ASCO annual meeting in Chicago.

It’s been an exciting year for breast cancer news. I want to make sure that you hear about the two studies that I find the most impactful. One is the NATALEE study looking at ribociclib in adjuvant ER-positive patients at high risk for recurrence. You saw the press release a few weeks ago, and we now have the data. There is no doubt that this is a positive trial.

The details here are important. These were pre- or postmenopausal women, and men as well. Premenopausal women and men also had an LHRH agonist in addition to an aromatase inhibitor – that could have been either letrozole or anastrozole – then randomized to ribociclib or placebo.

The dose of ribociclib that you’re used to thinking about is 600 mg daily for 3 weeks and 7 days off. That’s the approved dose in the metastatic setting. In the adjuvant trial, they used 400 mg, and that was intentional to try to reduce some of the toxicity because the plan was for 3 years of therapy. Managing toxicity and really making this tolerable for patients was crucial.

We’ve now seen the efficacy results, with a roughly 3% reduction in the risk for recurrence; 90% disease-free survival in the ribociclib arm, 87% in the control arm, some patients still having prolongation of QTc but no serious arrhythmias; some patients still with myelosuppression, but risk for serious infections was really very low.

This is going to give you a question to ponder in your high-risk, ER-positive patients who are appropriate to consider for adjuvant cyclin-dependent kinase inhibitors. Are you now on team abemaciclib or team ribociclib? We have no head-to-head trials in any setting, and I doubt that our industry colleagues are going to be interested in a head-to-head setting.

We’re going to need to pay particular attention to long-term follow-up and to quality of life and toxicity data as to which our patients prefer. We may need to think about other ways of doing those direct comparisons with public funding, where we can get the answers our patients deserve.

I also want to think about the other end of the spectrum, those patients with HER2-positive disease. We saw fantastic results from the PHERGain study from our colleagues in Spain. This was a trial that took patients with predominantly stage II and III HER2-positive breast cancer. These are patients that we would treat with neoadjuvant chemotherapy, with dual HER2-targeted therapy.

Years ago, we saw results of some small, single-arm, phase 2 studies, suggesting that some of those patients may be so sensitive to biologic therapy that they have a pathologic complete response with HER2-targeted therapy – HER2-targeted therapy with endocrine therapy if they are positive – with no chemotherapy at all. Our question has always been how to identify those patients. Can we identify them well enough that we would be comfortable not treating them with chemotherapy? Importantly, If they didn’t get chemotherapy, what’s their long-term outcome?

The PHERGain trial lets us look at all those things. The PHERGain trial gave patients two cycles of dual HER2-targeted therapy, pertuzumab and trastuzumab, hormone therapy if also ER positive, and they got an FDG-PET scan after two cycles of therapy.

If they had a significant PET response, those patients were then randomized to switch to chemotherapy, standard TCHP, or continue biologic therapy alone for a total of six cycles. They then went to surgery. If they had a pathologic complete response, whether they had gotten chemotherapy or no chemotherapy, they completed the HER2-targeted therapy. If they still had residual disease, they got chemotherapy if chemotherapy had not been administered before, and they may have gotten other HER2-targeted therapies if they had already received chemotherapy.

There were over 300 patients in this trial, and my memory is that roughly two thirds of them had a PET response. About 86 patients randomized to continue biologic therapy had a pathologic complete response, so about one-third of those for whom the PET imaging said they were responding with biologic therapy only had a pathologic complete response.

They have now been followed for 3 years. The 3-year disease-free survival results look very reassuring. Of those 86 patients, one patient had a local recurrence and no patient had a distant recurrence.

This is what we’ve been waiting for. Can we identify those patients who have an excellent prognosis with biologic therapy alone so that we can avoid the toxicities? This is really where you’ll see the research over the coming years in breast cancer, looking at additional therapies in high-risk patients who don’t do so well with our standard therapies, and better stratification of patients who do so well with our standard therapies that we may be able to do less.

This is one of the ways that we’ll be able to do that. I look forward to sharing those results with you over coming years.

Kathy D. Miller, MD, is associate director of clinical research and codirector of the breast cancer program at the Melvin and Bren Simon Cancer Center at Indiana University, Indianapolis. She disclosed no relevant conflicts of interest.

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

It’s common knowledge that the recommended first-line treatment for obesity is behavioral or “lifestyle” intervention, with the goal of losing a modest amount of weight to gain significant health benefits. Unfortunately, when pursuing weight loss, patients often think they need to beat themselves up to stay motivated. I’ve heard patients call themselves “weak,” saying they need to “stop being lazy” and gain some self-control in order to be less of a “failure.” They label their bodies as “disgusting” and themselves as “worthless,” all because of their weight.

Some patients may worry that if they are kind to themselves or “too accepting” of their bodies, they’ll lose motivation to stick with their health behavior goals. In many people’s minds, weight management and body- and self-acceptance are mutually exclusive.

What if patients didn’t have to choose between the two? That’s a question that my colleagues and I have explored in recent research that attempts to reduce weight stigma as part of standard weight-related care.
 

Misguided societal view drives blame game

This tendency for people to blame and disparage themselves for their weight is largely driven by the misguided societal view of body weight as an issue of personal responsibility. We’re constantly exposed to messages telling us that there’s a narrow range of acceptable body weights and sizes, and that if we have enough willpower and discipline to eat healthily and exercise, then we should be able to control our weight. These messages are prevalent in the news and in social media, but often they are communicated in health care settings too. Narratives of this kind usually ignore the complex environmental and biological factors that contribute to body size and shape, instead attributing high body weight to laziness and moral failings.

Such messages exemplify weight bias and stigma, or the negative attitudes toward and mistreatment of individuals with a high body weight. Given society’s harsh judgment of people with larger bodies, it’s no surprise that many individuals internalize these beliefs and stigmatize themselves for their weight. This internalized or self-directed stigma is known to be harmful to mental and physical health.

Contrary to beliefs that negative self-talk and self-blame can be motivators to improve health, we know that high levels of weight self-stigma are linked to unhealthy eating behaviors and less engagement in physical activity, among other poor health outcomes. Thus, ironically, internalizing weight stigma actually undermines efforts to lose weight and maintain weight loss, rather than motivating healthy behavior change.
 

Combating internalized weight stigma

How do we combat these negative weight messages in our culture and reduce, or ideally prevent, internalization of judgment and blame? Fundamental changes in policies, health care practices, and public attitudes are needed to eradicate weight stigma. While such initiatives are underway, there are many individuals who have already experienced and internalized weight stigma and need support now. Interventions such as peer support and psychological counseling may be helpful for challenging negative, internalized beliefs about weight; learning to cope with exposure to weight stigma without internalizing it; increasing self-acceptance and self-compassion; and feeling empowered to fight back against weight bias and stigma.

In our latest study, my colleagues and I tested the long-term effects of including a group intervention to address weight stigma in a standard behavioral weight management program. More than 100 adults with obesity who had experienced and internalized weight stigma were recruited for this clinical trial, which randomly assigned participants to receive either the Weight Bias Internalization and Stigma (Weight BIAS) program combined with standard behavioral weight loss treatment, or standard weight loss treatment alone.

The Weight BIAS program adapted evidence-based psychotherapy techniques to target weight self-stigma, while also providing peer support in a group treatment format. Specific topics included challenging myths and stereotypes about weight; identifying and changing negative thought patterns related to weight and how they affect emotions and behaviors; and responding to experiences of weight stigma.

For example, to challenge negative thoughts (for example, that they were a “failure” because of their weight), patients worked together to examine all of the evidence that proved these beliefs were not true, and came up with ideas for how to revise these thoughts to be less judgmental and more fair and accurate.

Other topics focused on building confidence, increasing body- and self-acceptance, and advocating for themselves and others who are mistreated because of their weight. Many patients shared examples of stigmatizing experiences in health care settings and discussed what they could say or do when facing judgment or discrimination from health care providers, as well as the importance of finding health care providers who treated them with respect. Group discussions also tied in information relevant to health behavior goals, such as overcoming self-consciousness about weight to enjoy physical activity.

Participants were offered weekly group meetings for 20 weeks, followed by a year of less frequent meetings. At the study’s end, participants in the group that received weight loss treatment with the Weight BIAS program on average lost about 7% of their starting weight, compared with an average weight loss of about 5% in the group that received weight loss treatment alone. Weight losses of these magnitudes are known to have meaningful health benefits. Results from our study showed comparable improvements in most outcomes across groups, with some added benefit of the Weight BIAS program for certain psychological and behavioral outcomes. These findings challenge the notion that reducing weight stigma and promoting body acceptance will undermine motivation to engage in healthy behaviors and lose weight. We found no such effect.
 

What did participants say?

When asked questions such as how much they liked the program, what they learned, and how they used the new skills and changed their self-perceptions, participants who received the Weight BIAS program gave higher ratings than those who received only the weight loss treatment. Positive feedback from free-response questions indicated that many participants identified social support as their favorite aspect of the program. Others highlighted how the program helped them to gain “the ability to think differently about myself and other people” and “an understanding that weight really is separate from the person.” They also described how they brought together the goals of weight loss and body and self-acceptance, saying, “I am more accepting of me and at the same time more dedicated to obtaining a healthier weight,” and “It’s okay to be happy the way I am and still want to change.”

Participants who didn’t receive the Weight BIAS program also shared positive feedback, writing that their favorite part of the program was “being part of such a supportive group of people who can relate to the things that I think and feel” and that they learned “how not to be so hard on myself.” This might suggest that even without an intervention specifically for weight stigma, providing respectful, compassionate care and peer support may help patients to feel less alone and to be kinder to themselves.

Our study results suggest that reducing negative self-talk and internalized beliefs about weight certainly won’t undermine treatment outcomes and may have some benefits beyond standard weight loss treatment. At the same time, we also all need to do our part to change how society views and treats people with larger bodies and prevent the harms of experiencing and internalizing weight stigma.

Research reported in this publication was supported by the National Heart, Lung, and Blood Institute of the National Institutes of Health under award number K23HL140176. The content is solely the responsibility of the author and does not necessarily reflect the official views of the National Institutes of Health.
 

Dr. Pearl is assistant professor, clinical and health psychology, University of Florida, Gainesville. She has disclosed no relevant financial relationships.

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

It’s common knowledge that the recommended first-line treatment for obesity is behavioral or “lifestyle” intervention, with the goal of losing a modest amount of weight to gain significant health benefits. Unfortunately, when pursuing weight loss, patients often think they need to beat themselves up to stay motivated. I’ve heard patients call themselves “weak,” saying they need to “stop being lazy” and gain some self-control in order to be less of a “failure.” They label their bodies as “disgusting” and themselves as “worthless,” all because of their weight.

Some patients may worry that if they are kind to themselves or “too accepting” of their bodies, they’ll lose motivation to stick with their health behavior goals. In many people’s minds, weight management and body- and self-acceptance are mutually exclusive.

What if patients didn’t have to choose between the two? That’s a question that my colleagues and I have explored in recent research that attempts to reduce weight stigma as part of standard weight-related care.
 

Misguided societal view drives blame game

This tendency for people to blame and disparage themselves for their weight is largely driven by the misguided societal view of body weight as an issue of personal responsibility. We’re constantly exposed to messages telling us that there’s a narrow range of acceptable body weights and sizes, and that if we have enough willpower and discipline to eat healthily and exercise, then we should be able to control our weight. These messages are prevalent in the news and in social media, but often they are communicated in health care settings too. Narratives of this kind usually ignore the complex environmental and biological factors that contribute to body size and shape, instead attributing high body weight to laziness and moral failings.

Such messages exemplify weight bias and stigma, or the negative attitudes toward and mistreatment of individuals with a high body weight. Given society’s harsh judgment of people with larger bodies, it’s no surprise that many individuals internalize these beliefs and stigmatize themselves for their weight. This internalized or self-directed stigma is known to be harmful to mental and physical health.

Contrary to beliefs that negative self-talk and self-blame can be motivators to improve health, we know that high levels of weight self-stigma are linked to unhealthy eating behaviors and less engagement in physical activity, among other poor health outcomes. Thus, ironically, internalizing weight stigma actually undermines efforts to lose weight and maintain weight loss, rather than motivating healthy behavior change.
 

Combating internalized weight stigma

How do we combat these negative weight messages in our culture and reduce, or ideally prevent, internalization of judgment and blame? Fundamental changes in policies, health care practices, and public attitudes are needed to eradicate weight stigma. While such initiatives are underway, there are many individuals who have already experienced and internalized weight stigma and need support now. Interventions such as peer support and psychological counseling may be helpful for challenging negative, internalized beliefs about weight; learning to cope with exposure to weight stigma without internalizing it; increasing self-acceptance and self-compassion; and feeling empowered to fight back against weight bias and stigma.

In our latest study, my colleagues and I tested the long-term effects of including a group intervention to address weight stigma in a standard behavioral weight management program. More than 100 adults with obesity who had experienced and internalized weight stigma were recruited for this clinical trial, which randomly assigned participants to receive either the Weight Bias Internalization and Stigma (Weight BIAS) program combined with standard behavioral weight loss treatment, or standard weight loss treatment alone.

The Weight BIAS program adapted evidence-based psychotherapy techniques to target weight self-stigma, while also providing peer support in a group treatment format. Specific topics included challenging myths and stereotypes about weight; identifying and changing negative thought patterns related to weight and how they affect emotions and behaviors; and responding to experiences of weight stigma.

For example, to challenge negative thoughts (for example, that they were a “failure” because of their weight), patients worked together to examine all of the evidence that proved these beliefs were not true, and came up with ideas for how to revise these thoughts to be less judgmental and more fair and accurate.

Other topics focused on building confidence, increasing body- and self-acceptance, and advocating for themselves and others who are mistreated because of their weight. Many patients shared examples of stigmatizing experiences in health care settings and discussed what they could say or do when facing judgment or discrimination from health care providers, as well as the importance of finding health care providers who treated them with respect. Group discussions also tied in information relevant to health behavior goals, such as overcoming self-consciousness about weight to enjoy physical activity.

Participants were offered weekly group meetings for 20 weeks, followed by a year of less frequent meetings. At the study’s end, participants in the group that received weight loss treatment with the Weight BIAS program on average lost about 7% of their starting weight, compared with an average weight loss of about 5% in the group that received weight loss treatment alone. Weight losses of these magnitudes are known to have meaningful health benefits. Results from our study showed comparable improvements in most outcomes across groups, with some added benefit of the Weight BIAS program for certain psychological and behavioral outcomes. These findings challenge the notion that reducing weight stigma and promoting body acceptance will undermine motivation to engage in healthy behaviors and lose weight. We found no such effect.
 

What did participants say?

When asked questions such as how much they liked the program, what they learned, and how they used the new skills and changed their self-perceptions, participants who received the Weight BIAS program gave higher ratings than those who received only the weight loss treatment. Positive feedback from free-response questions indicated that many participants identified social support as their favorite aspect of the program. Others highlighted how the program helped them to gain “the ability to think differently about myself and other people” and “an understanding that weight really is separate from the person.” They also described how they brought together the goals of weight loss and body and self-acceptance, saying, “I am more accepting of me and at the same time more dedicated to obtaining a healthier weight,” and “It’s okay to be happy the way I am and still want to change.”

Participants who didn’t receive the Weight BIAS program also shared positive feedback, writing that their favorite part of the program was “being part of such a supportive group of people who can relate to the things that I think and feel” and that they learned “how not to be so hard on myself.” This might suggest that even without an intervention specifically for weight stigma, providing respectful, compassionate care and peer support may help patients to feel less alone and to be kinder to themselves.

Our study results suggest that reducing negative self-talk and internalized beliefs about weight certainly won’t undermine treatment outcomes and may have some benefits beyond standard weight loss treatment. At the same time, we also all need to do our part to change how society views and treats people with larger bodies and prevent the harms of experiencing and internalizing weight stigma.

Research reported in this publication was supported by the National Heart, Lung, and Blood Institute of the National Institutes of Health under award number K23HL140176. The content is solely the responsibility of the author and does not necessarily reflect the official views of the National Institutes of Health.
 

Dr. Pearl is assistant professor, clinical and health psychology, University of Florida, Gainesville. She has disclosed no relevant financial relationships.

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

It’s common knowledge that the recommended first-line treatment for obesity is behavioral or “lifestyle” intervention, with the goal of losing a modest amount of weight to gain significant health benefits. Unfortunately, when pursuing weight loss, patients often think they need to beat themselves up to stay motivated. I’ve heard patients call themselves “weak,” saying they need to “stop being lazy” and gain some self-control in order to be less of a “failure.” They label their bodies as “disgusting” and themselves as “worthless,” all because of their weight.

Some patients may worry that if they are kind to themselves or “too accepting” of their bodies, they’ll lose motivation to stick with their health behavior goals. In many people’s minds, weight management and body- and self-acceptance are mutually exclusive.

What if patients didn’t have to choose between the two? That’s a question that my colleagues and I have explored in recent research that attempts to reduce weight stigma as part of standard weight-related care.
 

Misguided societal view drives blame game

This tendency for people to blame and disparage themselves for their weight is largely driven by the misguided societal view of body weight as an issue of personal responsibility. We’re constantly exposed to messages telling us that there’s a narrow range of acceptable body weights and sizes, and that if we have enough willpower and discipline to eat healthily and exercise, then we should be able to control our weight. These messages are prevalent in the news and in social media, but often they are communicated in health care settings too. Narratives of this kind usually ignore the complex environmental and biological factors that contribute to body size and shape, instead attributing high body weight to laziness and moral failings.

Such messages exemplify weight bias and stigma, or the negative attitudes toward and mistreatment of individuals with a high body weight. Given society’s harsh judgment of people with larger bodies, it’s no surprise that many individuals internalize these beliefs and stigmatize themselves for their weight. This internalized or self-directed stigma is known to be harmful to mental and physical health.

Contrary to beliefs that negative self-talk and self-blame can be motivators to improve health, we know that high levels of weight self-stigma are linked to unhealthy eating behaviors and less engagement in physical activity, among other poor health outcomes. Thus, ironically, internalizing weight stigma actually undermines efforts to lose weight and maintain weight loss, rather than motivating healthy behavior change.
 

Combating internalized weight stigma

How do we combat these negative weight messages in our culture and reduce, or ideally prevent, internalization of judgment and blame? Fundamental changes in policies, health care practices, and public attitudes are needed to eradicate weight stigma. While such initiatives are underway, there are many individuals who have already experienced and internalized weight stigma and need support now. Interventions such as peer support and psychological counseling may be helpful for challenging negative, internalized beliefs about weight; learning to cope with exposure to weight stigma without internalizing it; increasing self-acceptance and self-compassion; and feeling empowered to fight back against weight bias and stigma.

In our latest study, my colleagues and I tested the long-term effects of including a group intervention to address weight stigma in a standard behavioral weight management program. More than 100 adults with obesity who had experienced and internalized weight stigma were recruited for this clinical trial, which randomly assigned participants to receive either the Weight Bias Internalization and Stigma (Weight BIAS) program combined with standard behavioral weight loss treatment, or standard weight loss treatment alone.

The Weight BIAS program adapted evidence-based psychotherapy techniques to target weight self-stigma, while also providing peer support in a group treatment format. Specific topics included challenging myths and stereotypes about weight; identifying and changing negative thought patterns related to weight and how they affect emotions and behaviors; and responding to experiences of weight stigma.

For example, to challenge negative thoughts (for example, that they were a “failure” because of their weight), patients worked together to examine all of the evidence that proved these beliefs were not true, and came up with ideas for how to revise these thoughts to be less judgmental and more fair and accurate.

Other topics focused on building confidence, increasing body- and self-acceptance, and advocating for themselves and others who are mistreated because of their weight. Many patients shared examples of stigmatizing experiences in health care settings and discussed what they could say or do when facing judgment or discrimination from health care providers, as well as the importance of finding health care providers who treated them with respect. Group discussions also tied in information relevant to health behavior goals, such as overcoming self-consciousness about weight to enjoy physical activity.

Participants were offered weekly group meetings for 20 weeks, followed by a year of less frequent meetings. At the study’s end, participants in the group that received weight loss treatment with the Weight BIAS program on average lost about 7% of their starting weight, compared with an average weight loss of about 5% in the group that received weight loss treatment alone. Weight losses of these magnitudes are known to have meaningful health benefits. Results from our study showed comparable improvements in most outcomes across groups, with some added benefit of the Weight BIAS program for certain psychological and behavioral outcomes. These findings challenge the notion that reducing weight stigma and promoting body acceptance will undermine motivation to engage in healthy behaviors and lose weight. We found no such effect.
 

What did participants say?

When asked questions such as how much they liked the program, what they learned, and how they used the new skills and changed their self-perceptions, participants who received the Weight BIAS program gave higher ratings than those who received only the weight loss treatment. Positive feedback from free-response questions indicated that many participants identified social support as their favorite aspect of the program. Others highlighted how the program helped them to gain “the ability to think differently about myself and other people” and “an understanding that weight really is separate from the person.” They also described how they brought together the goals of weight loss and body and self-acceptance, saying, “I am more accepting of me and at the same time more dedicated to obtaining a healthier weight,” and “It’s okay to be happy the way I am and still want to change.”

Participants who didn’t receive the Weight BIAS program also shared positive feedback, writing that their favorite part of the program was “being part of such a supportive group of people who can relate to the things that I think and feel” and that they learned “how not to be so hard on myself.” This might suggest that even without an intervention specifically for weight stigma, providing respectful, compassionate care and peer support may help patients to feel less alone and to be kinder to themselves.

Our study results suggest that reducing negative self-talk and internalized beliefs about weight certainly won’t undermine treatment outcomes and may have some benefits beyond standard weight loss treatment. At the same time, we also all need to do our part to change how society views and treats people with larger bodies and prevent the harms of experiencing and internalizing weight stigma.

Research reported in this publication was supported by the National Heart, Lung, and Blood Institute of the National Institutes of Health under award number K23HL140176. The content is solely the responsibility of the author and does not necessarily reflect the official views of the National Institutes of Health.
 

Dr. Pearl is assistant professor, clinical and health psychology, University of Florida, Gainesville. She has disclosed no relevant financial relationships.

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

As medical practices become increasingly dependent on digital systems, protecting the data they generate becomes an increasingly relevant issue. While data protection is important in any industry, it is particularly critical in health care because in addition to the usual financial records, trade secrets, and other valuable data, confidential patient information is also at risk.

You may think that your computer vendor is responsible for safeguarding your data, but third parties can only do so much. And if your data is compromised, the ultimate responsibility is yours – not to mention the financial loss, and the damage to your practice’s reputation.

In addition to the security vulnerabilities inherent in any system, there are external vulnerabilities, such as weak passwords, viruses, and hacking (either externally or internally). And as hardware becomes more and more portable, there is the increasing risk of theft of platforms and storage media containing confidential data.

A close and ongoing relationship with your hardware and software vendors is essential to good data protection. Your office should have a permanent contact at each company, and you should talk to them regularly. Ask them what sort of firewalls, antivirus software, and other safeguards are in place to protect your system. Whenever they identify a bug or other vulnerability, you should know about it. They should tell you about each software update, what improvements it makes, and what defects it fixes. You should also know about any changes to your data encryption.

Encryption has become an essential component of data protection. It is especially important if you use portable devices such as laptops, pads, or smart phones to store and transport patient information. If you lose one of these devices, or a thumb drive or other storage media, HIPAA will probably not consider it a breach if the data it contains is encrypted.

Encryption isn’t perfect, of course. Log-in credentials can be stolen; and data that is stored in house is can be hacked with malware and phishing techniques, especially if the key to decryption is located on that server. And make sure that employees are not putting any medical data on their own private (unencrypted) devices.

Each employee should have his or her own password, and sharing should be strictly prohibited. Multifactor authentication is becoming increasingly popular for an extra level of security.

Your vendor should require you to change your passwords every few months. If it doesn’t, you need to establish a timetable to do it yourself. All passwords should be strong (no birthdays, pet names, etc.), and they shouldn’t be the same or similar to old passwords.

In some offices, I’ve been surprised to see that every employee has unrestricted access to all practice data. The vulnerabilities of such an arrangement are obvious. There is no reason why receptionists, for example, should have access to medical histories, and insurance people don’t need to know what medications a patient is on. Your vendor can help you design partitions that restrict each employee to only the information they need access to.

Ask if your vendor provides security training for employees. If not, look into hiring a security firm to do it. Regular security training can help employees to recognize data security attacks like phishing, and instills a heightened sense of security awareness and vigilance among staff. They will also gain a better understanding of the role they play in maintaining the overall security of your office.

It goes without saying that third parties, such as business vendors, payers, and managed care providers, should never have access to patient records or other personal health information.


 

Backing up data

I have written many times about the importance of regularly backing up your data. Industry statistics show that fully 10% of hard drives fail in any given year, and 43% of computer users lose one or more files every year in the form of clinical data, financial records, photos, email, documents, and other important information. Recovery of lost data, when it’s possible at all, can be very expensive.

Even if your EHR vendor backs up your data, you should consider making a separate backup of your own. Backup drives have been known to fail too; and if you decide to switch computer vendors, you don’t want to be at the mercy of the old company that might be reluctant to transfer your data without a hefty payment.

The first rule of backing up is to store your backup drives in a different location from your computers. Unfortunately, that’s a pain; and external drives can be lost or stolen, creating a HIPAA nightmare. So an increasingly popular alternative is automatic remote backup. Several companies offer that service, and the cost is very reasonable for individual computers. Backing up an entire office costs more, depending on how many computers and/or servers you have, but it’s still very reasonable and includes other services, such as operating system and network share support.

The procedure is simple: You create an account and tell the service which files you want copied. Your first backup can take a long time, often days, depending on how much data you are sending and how fast your Internet connection runs. After that the program runs in the background, copying only those files that have changed since the previous backup. Files are encrypted before leaving your computer, and they remain encrypted at the service’s data center, making them HIPAA compliant and, theoretically, only accessible by you.

Dr. Eastern practices dermatology and dermatologic surgery in Belleville, N.J. He is the author of numerous articles and textbook chapters, and is a longtime monthly columnist for Dermatology News. Write to him at [email protected].

As medical practices become increasingly dependent on digital systems, protecting the data they generate becomes an increasingly relevant issue. While data protection is important in any industry, it is particularly critical in health care because in addition to the usual financial records, trade secrets, and other valuable data, confidential patient information is also at risk.

You may think that your computer vendor is responsible for safeguarding your data, but third parties can only do so much. And if your data is compromised, the ultimate responsibility is yours – not to mention the financial loss, and the damage to your practice’s reputation.

In addition to the security vulnerabilities inherent in any system, there are external vulnerabilities, such as weak passwords, viruses, and hacking (either externally or internally). And as hardware becomes more and more portable, there is the increasing risk of theft of platforms and storage media containing confidential data.

A close and ongoing relationship with your hardware and software vendors is essential to good data protection. Your office should have a permanent contact at each company, and you should talk to them regularly. Ask them what sort of firewalls, antivirus software, and other safeguards are in place to protect your system. Whenever they identify a bug or other vulnerability, you should know about it. They should tell you about each software update, what improvements it makes, and what defects it fixes. You should also know about any changes to your data encryption.

Encryption has become an essential component of data protection. It is especially important if you use portable devices such as laptops, pads, or smart phones to store and transport patient information. If you lose one of these devices, or a thumb drive or other storage media, HIPAA will probably not consider it a breach if the data it contains is encrypted.

Encryption isn’t perfect, of course. Log-in credentials can be stolen; and data that is stored in house is can be hacked with malware and phishing techniques, especially if the key to decryption is located on that server. And make sure that employees are not putting any medical data on their own private (unencrypted) devices.

Each employee should have his or her own password, and sharing should be strictly prohibited. Multifactor authentication is becoming increasingly popular for an extra level of security.

Your vendor should require you to change your passwords every few months. If it doesn’t, you need to establish a timetable to do it yourself. All passwords should be strong (no birthdays, pet names, etc.), and they shouldn’t be the same or similar to old passwords.

In some offices, I’ve been surprised to see that every employee has unrestricted access to all practice data. The vulnerabilities of such an arrangement are obvious. There is no reason why receptionists, for example, should have access to medical histories, and insurance people don’t need to know what medications a patient is on. Your vendor can help you design partitions that restrict each employee to only the information they need access to.

Ask if your vendor provides security training for employees. If not, look into hiring a security firm to do it. Regular security training can help employees to recognize data security attacks like phishing, and instills a heightened sense of security awareness and vigilance among staff. They will also gain a better understanding of the role they play in maintaining the overall security of your office.

It goes without saying that third parties, such as business vendors, payers, and managed care providers, should never have access to patient records or other personal health information.


 

Backing up data

I have written many times about the importance of regularly backing up your data. Industry statistics show that fully 10% of hard drives fail in any given year, and 43% of computer users lose one or more files every year in the form of clinical data, financial records, photos, email, documents, and other important information. Recovery of lost data, when it’s possible at all, can be very expensive.

Even if your EHR vendor backs up your data, you should consider making a separate backup of your own. Backup drives have been known to fail too; and if you decide to switch computer vendors, you don’t want to be at the mercy of the old company that might be reluctant to transfer your data without a hefty payment.

The first rule of backing up is to store your backup drives in a different location from your computers. Unfortunately, that’s a pain; and external drives can be lost or stolen, creating a HIPAA nightmare. So an increasingly popular alternative is automatic remote backup. Several companies offer that service, and the cost is very reasonable for individual computers. Backing up an entire office costs more, depending on how many computers and/or servers you have, but it’s still very reasonable and includes other services, such as operating system and network share support.

The procedure is simple: You create an account and tell the service which files you want copied. Your first backup can take a long time, often days, depending on how much data you are sending and how fast your Internet connection runs. After that the program runs in the background, copying only those files that have changed since the previous backup. Files are encrypted before leaving your computer, and they remain encrypted at the service’s data center, making them HIPAA compliant and, theoretically, only accessible by you.

Dr. Eastern practices dermatology and dermatologic surgery in Belleville, N.J. He is the author of numerous articles and textbook chapters, and is a longtime monthly columnist for Dermatology News. Write to him at [email protected].

As medical practices become increasingly dependent on digital systems, protecting the data they generate becomes an increasingly relevant issue. While data protection is important in any industry, it is particularly critical in health care because in addition to the usual financial records, trade secrets, and other valuable data, confidential patient information is also at risk.

You may think that your computer vendor is responsible for safeguarding your data, but third parties can only do so much. And if your data is compromised, the ultimate responsibility is yours – not to mention the financial loss, and the damage to your practice’s reputation.

In addition to the security vulnerabilities inherent in any system, there are external vulnerabilities, such as weak passwords, viruses, and hacking (either externally or internally). And as hardware becomes more and more portable, there is the increasing risk of theft of platforms and storage media containing confidential data.

A close and ongoing relationship with your hardware and software vendors is essential to good data protection. Your office should have a permanent contact at each company, and you should talk to them regularly. Ask them what sort of firewalls, antivirus software, and other safeguards are in place to protect your system. Whenever they identify a bug or other vulnerability, you should know about it. They should tell you about each software update, what improvements it makes, and what defects it fixes. You should also know about any changes to your data encryption.

Encryption has become an essential component of data protection. It is especially important if you use portable devices such as laptops, pads, or smart phones to store and transport patient information. If you lose one of these devices, or a thumb drive or other storage media, HIPAA will probably not consider it a breach if the data it contains is encrypted.

Encryption isn’t perfect, of course. Log-in credentials can be stolen; and data that is stored in house is can be hacked with malware and phishing techniques, especially if the key to decryption is located on that server. And make sure that employees are not putting any medical data on their own private (unencrypted) devices.

Each employee should have his or her own password, and sharing should be strictly prohibited. Multifactor authentication is becoming increasingly popular for an extra level of security.

Your vendor should require you to change your passwords every few months. If it doesn’t, you need to establish a timetable to do it yourself. All passwords should be strong (no birthdays, pet names, etc.), and they shouldn’t be the same or similar to old passwords.

In some offices, I’ve been surprised to see that every employee has unrestricted access to all practice data. The vulnerabilities of such an arrangement are obvious. There is no reason why receptionists, for example, should have access to medical histories, and insurance people don’t need to know what medications a patient is on. Your vendor can help you design partitions that restrict each employee to only the information they need access to.

Ask if your vendor provides security training for employees. If not, look into hiring a security firm to do it. Regular security training can help employees to recognize data security attacks like phishing, and instills a heightened sense of security awareness and vigilance among staff. They will also gain a better understanding of the role they play in maintaining the overall security of your office.

It goes without saying that third parties, such as business vendors, payers, and managed care providers, should never have access to patient records or other personal health information.


 

Backing up data

I have written many times about the importance of regularly backing up your data. Industry statistics show that fully 10% of hard drives fail in any given year, and 43% of computer users lose one or more files every year in the form of clinical data, financial records, photos, email, documents, and other important information. Recovery of lost data, when it’s possible at all, can be very expensive.

Even if your EHR vendor backs up your data, you should consider making a separate backup of your own. Backup drives have been known to fail too; and if you decide to switch computer vendors, you don’t want to be at the mercy of the old company that might be reluctant to transfer your data without a hefty payment.

The first rule of backing up is to store your backup drives in a different location from your computers. Unfortunately, that’s a pain; and external drives can be lost or stolen, creating a HIPAA nightmare. So an increasingly popular alternative is automatic remote backup. Several companies offer that service, and the cost is very reasonable for individual computers. Backing up an entire office costs more, depending on how many computers and/or servers you have, but it’s still very reasonable and includes other services, such as operating system and network share support.

The procedure is simple: You create an account and tell the service which files you want copied. Your first backup can take a long time, often days, depending on how much data you are sending and how fast your Internet connection runs. After that the program runs in the background, copying only those files that have changed since the previous backup. Files are encrypted before leaving your computer, and they remain encrypted at the service’s data center, making them HIPAA compliant and, theoretically, only accessible by you.

Dr. Eastern practices dermatology and dermatologic surgery in Belleville, N.J. He is the author of numerous articles and textbook chapters, and is a longtime monthly columnist for Dermatology News. Write to him at [email protected].

This transcript has been edited for clarity.

Welcome to Impact Factor, your weekly dose of commentary on a new medical study. I’m Dr. F. Perry Wilson of the Yale School of Medicine.

There was a time when I would have had to explain to you what an N95 mask is, how it is designed to filter out 95% of fine particles, defined as stuff in the air less than 2.5 microns in size.

But of course, you know that now. The N95 had its moment – a moment that seemed to be passing as the concentration of airborne coronavirus particles decreased.

Wikimedia Commons

JAMA Network Open

JAMA Network Open

JAMA Network Open

F. Perry Wilson, MD, MSCE, is an associate professor of medicine and director of Yale’s Clinical and Translational Research Accelerator. He reported no conflicts of interest.

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

This transcript has been edited for clarity.

Welcome to Impact Factor, your weekly dose of commentary on a new medical study. I’m Dr. F. Perry Wilson of the Yale School of Medicine.

There was a time when I would have had to explain to you what an N95 mask is, how it is designed to filter out 95% of fine particles, defined as stuff in the air less than 2.5 microns in size.

But of course, you know that now. The N95 had its moment – a moment that seemed to be passing as the concentration of airborne coronavirus particles decreased.

Wikimedia Commons

JAMA Network Open

JAMA Network Open

JAMA Network Open

F. Perry Wilson, MD, MSCE, is an associate professor of medicine and director of Yale’s Clinical and Translational Research Accelerator. He reported no conflicts of interest.

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

This transcript has been edited for clarity.

Welcome to Impact Factor, your weekly dose of commentary on a new medical study. I’m Dr. F. Perry Wilson of the Yale School of Medicine.

There was a time when I would have had to explain to you what an N95 mask is, how it is designed to filter out 95% of fine particles, defined as stuff in the air less than 2.5 microns in size.

But of course, you know that now. The N95 had its moment – a moment that seemed to be passing as the concentration of airborne coronavirus particles decreased.

Wikimedia Commons

JAMA Network Open

JAMA Network Open

JAMA Network Open

F. Perry Wilson, MD, MSCE, is an associate professor of medicine and director of Yale’s Clinical and Translational Research Accelerator. He reported no conflicts of interest.

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

Not everyone will suffer an episode of posttraumatic stress disorder, even though everyday American life is characterized by a lot of uncertainty these days, particularly considering the proliferation of gun violence.

Robert T. London

Also, everyone who does experience a traumatic event will not suffer an episode of PTSD – just as not everyone develops a heart attack or cancer, nor will everyone get every illness.

The data suggest that of those exposed to trauma, up to 25% of people will develop PTSD, according to Massachusetts General/McLean Hospital, Belmont, psychiatrist Kerry J. Ressler, MD, PhD, chief of the division of depression and anxiety disorders.

As I wrote in December 2022, our “kids” are not all right and psychiatry can help. I would say that many adolescents, and adults as well, may not be all right as we are terrorized not only by mass school shootings, but shootings happening almost anywhere and everywhere in our country: in supermarkets, hospitals, and shopping malls, at graduation parties, and on the streets.

According to a report published in Clinical Psychiatry News, a poll conducted by the American Psychiatric Association showed that most American adults [70%] reported that they were anxious or extremely anxious about keeping themselves or their families safe. APA President Rebecca W. Brendel, MD, JD, pointed out that there is “a lot of worry out there about economic uncertainty, about violence and how we are going to come out of this time period.”

Meanwhile, PTSD is still defined in the DSM-5 as exposure to actual or threatened death, serious injury, or sexual violence experienced directly, witnessing the traumatic event as it occurs to others, learning that a traumatic event occurred to a close family member or friend, or experiencing of traumatic events plus extreme exposure to aversive details of the event.

Examples of traumatic events can be numerous. They include natural disasters, man-made disasters, various types of assaults, war trauma, and severe illness with ICU experiences. I would add encounters with racism and bigotry – including homophobia when one fears for their very life or physical injury. This list includes only a few triggers that may invoke this disorder.

Interestingly, the DSM-5 excludes aversive exposure through electronic media, television, movies, or pictures. Including these aspects of trauma exposure would indeed increase PTSD diagnoses, and I believe this type of exposure needs to be included, especially considering how different people process information. Some viewers of media remain “outside” the events depicted on television, movies, or electronic media while others fit directly “into” the film or TV show. Even, for example, a news program, as evidenced by those people suffering from PTSD after viewing the Sept. 11, 2001, disaster on TV.

I have interviewed numerous people who witnessed Sept. 11 tragedies on TV, some during and some after the event, and they genuinely had experienced key factors of PTSD, including nightmares and intrusive recollections of the event. It’s important to include the ways in which people process information and events in order to make a correct diagnosis, in that “one [diagnostic] size does not fit all.”
 

PTSD at school

In my December column, I noted the fear of death that my generation and beyond experienced with the endless threat of nuclear war, which by its very nature meant death, and if not, the saying went “the living would envy the dead” – that is, in post–nuclear war.

As I pointed out in the column, that war never came and hopefully never will, yet the intensity of those many decades of threatened terror with regular school exercises of “hide under the desk” and “don’t look at the flash” left some with intrusive fearful thoughts, nightmares, and even visualization of atomic destruction, as well as the many scenes of destruction portrayed in news casts and films of nuclear explosions.

Clearly, most U.S. school children who participate in school lockdown drills will not suffer from PTSD episodes, but some will. If that “some” approaches 20% or even 10% or less, that will amount to a lot of kids.

I decided to interview two of my grandchildren, each living in different communities and attending different school systems, but both experiencing “lockdown drills.”

Jack, who is 13 and going into eighth grade, was quite clear regarding the drills and reported that in his age group, both he and the kids in his class felt scared while in lockdown. He told me some kids looked nervous. He mentioned that they were taught in school that if the “real thing” happened, the message was “hide, run, and fight.” I was curious and asked why not run first. He was quick to answer and said if you run, you might run into danger, so it’s better to hide and wait for help to arrive. I said to myself, if not PTSD, then being scared or nervous may also lead to anxiety or even to an anxiety disorder.

Next, I interviewed almost 11-year-old Charley, who is going into sixth grade. She was very clear about not at all being fearful or nervous during these drills and was confident that her classmates felt the same way. Then she explained that the school did a great job with a security officer and had locked doors all around that only opened from the inside. She was proud of the school and not fearful or worried at all.

The diverse views of these two young people surprised me but confirm that PTSD is not at all a given based on what is occurring in society. However, it should always be considered by clinicians if a child or adolescent begins to show signs consistent with PTSD.

These two interviews were quite short, but after I finished talking with Charley, she reported spontaneously that while she and her classmates were neither worried nor scared, some of their teachers did look nervous and seemed scared.

I was quite impressed with her sharpness and nuanced observation, and as noted, adults as well may be adversely affected by the entire concept of school lockdowns, as the awareness of their purpose rests in the forefront of their minds.
 

The way forward

So how do we prepare kids and adolescents for potential emotional problems like PTSD arising from lockdowns, even though most children or adults will not suffer any of these PTSD issues?

First, I believe that as we develop and teach health education in schools, mental health issues should be included according to grade level without generating fear or worry. Second, it is important that school children be aware that if they feel bad in any way emotionally, they should speak to their parents, guardians, teachers, or school nurses.

Clearly, communicating simple problems without embarrassment or shame can lead to solutions, often quickly. Larger, more complicated issues may need professional intervention. Equally important, many mental health interventions need not be long in duration but client-centered, focused, and short term.

But what needs to be emphasized is that speaking and addressing what’s going on, if your thoughts and emotions are troubling, are in themselves therapeutic. Talk therapy works – especially if you get a new perspective on the old set of problems.

Dr. London is a practicing psychiatrist and has been a newspaper columnist for 35 years, specializing in and writing about short-term therapy, including cognitive-behavioral therapy and guided imagery. He is author of “Find Freedom Fast” (New York: Kettlehole Publishing, 2019). He has no conflicts of interest.

Not everyone will suffer an episode of posttraumatic stress disorder, even though everyday American life is characterized by a lot of uncertainty these days, particularly considering the proliferation of gun violence.

Robert T. London

Also, everyone who does experience a traumatic event will not suffer an episode of PTSD – just as not everyone develops a heart attack or cancer, nor will everyone get every illness.

The data suggest that of those exposed to trauma, up to 25% of people will develop PTSD, according to Massachusetts General/McLean Hospital, Belmont, psychiatrist Kerry J. Ressler, MD, PhD, chief of the division of depression and anxiety disorders.

As I wrote in December 2022, our “kids” are not all right and psychiatry can help. I would say that many adolescents, and adults as well, may not be all right as we are terrorized not only by mass school shootings, but shootings happening almost anywhere and everywhere in our country: in supermarkets, hospitals, and shopping malls, at graduation parties, and on the streets.

According to a report published in Clinical Psychiatry News, a poll conducted by the American Psychiatric Association showed that most American adults [70%] reported that they were anxious or extremely anxious about keeping themselves or their families safe. APA President Rebecca W. Brendel, MD, JD, pointed out that there is “a lot of worry out there about economic uncertainty, about violence and how we are going to come out of this time period.”

Meanwhile, PTSD is still defined in the DSM-5 as exposure to actual or threatened death, serious injury, or sexual violence experienced directly, witnessing the traumatic event as it occurs to others, learning that a traumatic event occurred to a close family member or friend, or experiencing of traumatic events plus extreme exposure to aversive details of the event.

Examples of traumatic events can be numerous. They include natural disasters, man-made disasters, various types of assaults, war trauma, and severe illness with ICU experiences. I would add encounters with racism and bigotry – including homophobia when one fears for their very life or physical injury. This list includes only a few triggers that may invoke this disorder.

Interestingly, the DSM-5 excludes aversive exposure through electronic media, television, movies, or pictures. Including these aspects of trauma exposure would indeed increase PTSD diagnoses, and I believe this type of exposure needs to be included, especially considering how different people process information. Some viewers of media remain “outside” the events depicted on television, movies, or electronic media while others fit directly “into” the film or TV show. Even, for example, a news program, as evidenced by those people suffering from PTSD after viewing the Sept. 11, 2001, disaster on TV.

I have interviewed numerous people who witnessed Sept. 11 tragedies on TV, some during and some after the event, and they genuinely had experienced key factors of PTSD, including nightmares and intrusive recollections of the event. It’s important to include the ways in which people process information and events in order to make a correct diagnosis, in that “one [diagnostic] size does not fit all.”
 

PTSD at school

In my December column, I noted the fear of death that my generation and beyond experienced with the endless threat of nuclear war, which by its very nature meant death, and if not, the saying went “the living would envy the dead” – that is, in post–nuclear war.

As I pointed out in the column, that war never came and hopefully never will, yet the intensity of those many decades of threatened terror with regular school exercises of “hide under the desk” and “don’t look at the flash” left some with intrusive fearful thoughts, nightmares, and even visualization of atomic destruction, as well as the many scenes of destruction portrayed in news casts and films of nuclear explosions.

Clearly, most U.S. school children who participate in school lockdown drills will not suffer from PTSD episodes, but some will. If that “some” approaches 20% or even 10% or less, that will amount to a lot of kids.

I decided to interview two of my grandchildren, each living in different communities and attending different school systems, but both experiencing “lockdown drills.”

Jack, who is 13 and going into eighth grade, was quite clear regarding the drills and reported that in his age group, both he and the kids in his class felt scared while in lockdown. He told me some kids looked nervous. He mentioned that they were taught in school that if the “real thing” happened, the message was “hide, run, and fight.” I was curious and asked why not run first. He was quick to answer and said if you run, you might run into danger, so it’s better to hide and wait for help to arrive. I said to myself, if not PTSD, then being scared or nervous may also lead to anxiety or even to an anxiety disorder.

Next, I interviewed almost 11-year-old Charley, who is going into sixth grade. She was very clear about not at all being fearful or nervous during these drills and was confident that her classmates felt the same way. Then she explained that the school did a great job with a security officer and had locked doors all around that only opened from the inside. She was proud of the school and not fearful or worried at all.

The diverse views of these two young people surprised me but confirm that PTSD is not at all a given based on what is occurring in society. However, it should always be considered by clinicians if a child or adolescent begins to show signs consistent with PTSD.

These two interviews were quite short, but after I finished talking with Charley, she reported spontaneously that while she and her classmates were neither worried nor scared, some of their teachers did look nervous and seemed scared.

I was quite impressed with her sharpness and nuanced observation, and as noted, adults as well may be adversely affected by the entire concept of school lockdowns, as the awareness of their purpose rests in the forefront of their minds.
 

The way forward

So how do we prepare kids and adolescents for potential emotional problems like PTSD arising from lockdowns, even though most children or adults will not suffer any of these PTSD issues?

First, I believe that as we develop and teach health education in schools, mental health issues should be included according to grade level without generating fear or worry. Second, it is important that school children be aware that if they feel bad in any way emotionally, they should speak to their parents, guardians, teachers, or school nurses.

Clearly, communicating simple problems without embarrassment or shame can lead to solutions, often quickly. Larger, more complicated issues may need professional intervention. Equally important, many mental health interventions need not be long in duration but client-centered, focused, and short term.

But what needs to be emphasized is that speaking and addressing what’s going on, if your thoughts and emotions are troubling, are in themselves therapeutic. Talk therapy works – especially if you get a new perspective on the old set of problems.

Dr. London is a practicing psychiatrist and has been a newspaper columnist for 35 years, specializing in and writing about short-term therapy, including cognitive-behavioral therapy and guided imagery. He is author of “Find Freedom Fast” (New York: Kettlehole Publishing, 2019). He has no conflicts of interest.

Not everyone will suffer an episode of posttraumatic stress disorder, even though everyday American life is characterized by a lot of uncertainty these days, particularly considering the proliferation of gun violence.

Robert T. London

Also, everyone who does experience a traumatic event will not suffer an episode of PTSD – just as not everyone develops a heart attack or cancer, nor will everyone get every illness.

The data suggest that of those exposed to trauma, up to 25% of people will develop PTSD, according to Massachusetts General/McLean Hospital, Belmont, psychiatrist Kerry J. Ressler, MD, PhD, chief of the division of depression and anxiety disorders.

As I wrote in December 2022, our “kids” are not all right and psychiatry can help. I would say that many adolescents, and adults as well, may not be all right as we are terrorized not only by mass school shootings, but shootings happening almost anywhere and everywhere in our country: in supermarkets, hospitals, and shopping malls, at graduation parties, and on the streets.

According to a report published in Clinical Psychiatry News, a poll conducted by the American Psychiatric Association showed that most American adults [70%] reported that they were anxious or extremely anxious about keeping themselves or their families safe. APA President Rebecca W. Brendel, MD, JD, pointed out that there is “a lot of worry out there about economic uncertainty, about violence and how we are going to come out of this time period.”

Meanwhile, PTSD is still defined in the DSM-5 as exposure to actual or threatened death, serious injury, or sexual violence experienced directly, witnessing the traumatic event as it occurs to others, learning that a traumatic event occurred to a close family member or friend, or experiencing of traumatic events plus extreme exposure to aversive details of the event.

Examples of traumatic events can be numerous. They include natural disasters, man-made disasters, various types of assaults, war trauma, and severe illness with ICU experiences. I would add encounters with racism and bigotry – including homophobia when one fears for their very life or physical injury. This list includes only a few triggers that may invoke this disorder.

Interestingly, the DSM-5 excludes aversive exposure through electronic media, television, movies, or pictures. Including these aspects of trauma exposure would indeed increase PTSD diagnoses, and I believe this type of exposure needs to be included, especially considering how different people process information. Some viewers of media remain “outside” the events depicted on television, movies, or electronic media while others fit directly “into” the film or TV show. Even, for example, a news program, as evidenced by those people suffering from PTSD after viewing the Sept. 11, 2001, disaster on TV.

I have interviewed numerous people who witnessed Sept. 11 tragedies on TV, some during and some after the event, and they genuinely had experienced key factors of PTSD, including nightmares and intrusive recollections of the event. It’s important to include the ways in which people process information and events in order to make a correct diagnosis, in that “one [diagnostic] size does not fit all.”
 

PTSD at school

In my December column, I noted the fear of death that my generation and beyond experienced with the endless threat of nuclear war, which by its very nature meant death, and if not, the saying went “the living would envy the dead” – that is, in post–nuclear war.

As I pointed out in the column, that war never came and hopefully never will, yet the intensity of those many decades of threatened terror with regular school exercises of “hide under the desk” and “don’t look at the flash” left some with intrusive fearful thoughts, nightmares, and even visualization of atomic destruction, as well as the many scenes of destruction portrayed in news casts and films of nuclear explosions.

Clearly, most U.S. school children who participate in school lockdown drills will not suffer from PTSD episodes, but some will. If that “some” approaches 20% or even 10% or less, that will amount to a lot of kids.

I decided to interview two of my grandchildren, each living in different communities and attending different school systems, but both experiencing “lockdown drills.”

Jack, who is 13 and going into eighth grade, was quite clear regarding the drills and reported that in his age group, both he and the kids in his class felt scared while in lockdown. He told me some kids looked nervous. He mentioned that they were taught in school that if the “real thing” happened, the message was “hide, run, and fight.” I was curious and asked why not run first. He was quick to answer and said if you run, you might run into danger, so it’s better to hide and wait for help to arrive. I said to myself, if not PTSD, then being scared or nervous may also lead to anxiety or even to an anxiety disorder.

Next, I interviewed almost 11-year-old Charley, who is going into sixth grade. She was very clear about not at all being fearful or nervous during these drills and was confident that her classmates felt the same way. Then she explained that the school did a great job with a security officer and had locked doors all around that only opened from the inside. She was proud of the school and not fearful or worried at all.

The diverse views of these two young people surprised me but confirm that PTSD is not at all a given based on what is occurring in society. However, it should always be considered by clinicians if a child or adolescent begins to show signs consistent with PTSD.

These two interviews were quite short, but after I finished talking with Charley, she reported spontaneously that while she and her classmates were neither worried nor scared, some of their teachers did look nervous and seemed scared.

I was quite impressed with her sharpness and nuanced observation, and as noted, adults as well may be adversely affected by the entire concept of school lockdowns, as the awareness of their purpose rests in the forefront of their minds.
 

The way forward

So how do we prepare kids and adolescents for potential emotional problems like PTSD arising from lockdowns, even though most children or adults will not suffer any of these PTSD issues?

First, I believe that as we develop and teach health education in schools, mental health issues should be included according to grade level without generating fear or worry. Second, it is important that school children be aware that if they feel bad in any way emotionally, they should speak to their parents, guardians, teachers, or school nurses.

Clearly, communicating simple problems without embarrassment or shame can lead to solutions, often quickly. Larger, more complicated issues may need professional intervention. Equally important, many mental health interventions need not be long in duration but client-centered, focused, and short term.

But what needs to be emphasized is that speaking and addressing what’s going on, if your thoughts and emotions are troubling, are in themselves therapeutic. Talk therapy works – especially if you get a new perspective on the old set of problems.

Dr. London is a practicing psychiatrist and has been a newspaper columnist for 35 years, specializing in and writing about short-term therapy, including cognitive-behavioral therapy and guided imagery. He is author of “Find Freedom Fast” (New York: Kettlehole Publishing, 2019). He has no conflicts of interest.

Unlike many of you, maybe even most of you, I can recall when my office records were handwritten, some would say scribbled, on pieces of paper. They were decipherable by a select few. Some veteran assistants never mastered the skill. Pages were sometimes lavishly illustrated with drawings of body parts, often because I couldn’t remember or spell the correct anatomic term. When I needed to send a referring letter to another provider I typed it myself because dictating never quite suited my personality.

When I joined a small primary care group, the computer-savvy lead physician and a programmer developed our own homegrown EHR. It relied on scanning documents, as so many of us still generated handwritten notes. Even the most vociferous Luddites among us loved the system from day 2.

However, for a variety of reasons, some defensible some just plain bad, our beloved system needed to be replaced after 7 years. We then invested in an off-the-shelf EHR system that promised more capabilities. We were told there would be a learning curve but the plateau would come quickly and we would enjoy our new electronic assistant.

You’ve lived the rest of the story. The learning curve was steep and long and the plateau was a time gobbler. I was probably the most efficient provider in the group, and after 6 months I was leaving the office an hour later than I had been and was seeing the same number of patients. Most of my coworkers were staying and/or working on the computer at home for an extra 2 hours. This change could be easily documented by speaking with our spouses and children. I understand from my colleagues who have stayed in the business that over the ensuing decade and a half since my first experience with the EHR, its insatiable appetite for a clinician’s time has not abated.

The authors of a recent article in Annals of Family Medicine offer up some advice on how this tragic situation might be brought under control. First, the investigators point out that the phenomenon of after-hours EHR work, sometimes referred to as WOW (work outside of work), has not gone unnoticed by health system administrators and vendors who develop and sell the EHRs. However, analyzing the voluminous data necessary is not any easy task and for the most part has resulted in metrics that cannot be easily applied over a variety of practice scenarios. Many health care organizations, even large ones, have simply given up and rely on the WOW data and recommendations provided by the vendors, obviously lending the situation a faint odor of conflict of interest.

The bottom line is that after a couple of decades, there is no well defined way of quantifying the time-gobbling effect of an EHR system. It would seem to me just asking the spouses and significant others of the clinicians would be sufficient. But, authors of the paper have more specific recommendations. First, they suggest that time working on the computer outside of scheduled time with patients should be separated from any other calculation of EHR usage. They encourage vendors and time-management researchers to develop standardized and validated methods for measuring active EHR use. And, finally they recommend that all EHR work done outside of time scheduled with patients be attributed to WOW. They feel that clearly labeling it work outside of work offers health care organizations a better chance of developing policies that will address the scourge of burnout.

This, unfortunately, is another tragic example of how clinicians have lost control of our work environments. The fact that 20 years have passed and there is still no standardized method for determining how much time we spend on the computer is more evidence we need to raise our voices.
 

Dr. Wilkoff practiced primary care pediatrics in Brunswick, Maine, for nearly 40 years. He has authored several books on behavioral pediatrics, including “How to Say No to Your Toddler.” Other than a Littman stethoscope he accepted as a first-year medical student in 1966, Dr. Wilkoff reports having nothing to disclose. Email him at [email protected].

Unlike many of you, maybe even most of you, I can recall when my office records were handwritten, some would say scribbled, on pieces of paper. They were decipherable by a select few. Some veteran assistants never mastered the skill. Pages were sometimes lavishly illustrated with drawings of body parts, often because I couldn’t remember or spell the correct anatomic term. When I needed to send a referring letter to another provider I typed it myself because dictating never quite suited my personality.

When I joined a small primary care group, the computer-savvy lead physician and a programmer developed our own homegrown EHR. It relied on scanning documents, as so many of us still generated handwritten notes. Even the most vociferous Luddites among us loved the system from day 2.

However, for a variety of reasons, some defensible some just plain bad, our beloved system needed to be replaced after 7 years. We then invested in an off-the-shelf EHR system that promised more capabilities. We were told there would be a learning curve but the plateau would come quickly and we would enjoy our new electronic assistant.

You’ve lived the rest of the story. The learning curve was steep and long and the plateau was a time gobbler. I was probably the most efficient provider in the group, and after 6 months I was leaving the office an hour later than I had been and was seeing the same number of patients. Most of my coworkers were staying and/or working on the computer at home for an extra 2 hours. This change could be easily documented by speaking with our spouses and children. I understand from my colleagues who have stayed in the business that over the ensuing decade and a half since my first experience with the EHR, its insatiable appetite for a clinician’s time has not abated.

The authors of a recent article in Annals of Family Medicine offer up some advice on how this tragic situation might be brought under control. First, the investigators point out that the phenomenon of after-hours EHR work, sometimes referred to as WOW (work outside of work), has not gone unnoticed by health system administrators and vendors who develop and sell the EHRs. However, analyzing the voluminous data necessary is not any easy task and for the most part has resulted in metrics that cannot be easily applied over a variety of practice scenarios. Many health care organizations, even large ones, have simply given up and rely on the WOW data and recommendations provided by the vendors, obviously lending the situation a faint odor of conflict of interest.

The bottom line is that after a couple of decades, there is no well defined way of quantifying the time-gobbling effect of an EHR system. It would seem to me just asking the spouses and significant others of the clinicians would be sufficient. But, authors of the paper have more specific recommendations. First, they suggest that time working on the computer outside of scheduled time with patients should be separated from any other calculation of EHR usage. They encourage vendors and time-management researchers to develop standardized and validated methods for measuring active EHR use. And, finally they recommend that all EHR work done outside of time scheduled with patients be attributed to WOW. They feel that clearly labeling it work outside of work offers health care organizations a better chance of developing policies that will address the scourge of burnout.

This, unfortunately, is another tragic example of how clinicians have lost control of our work environments. The fact that 20 years have passed and there is still no standardized method for determining how much time we spend on the computer is more evidence we need to raise our voices.
 

Dr. Wilkoff practiced primary care pediatrics in Brunswick, Maine, for nearly 40 years. He has authored several books on behavioral pediatrics, including “How to Say No to Your Toddler.” Other than a Littman stethoscope he accepted as a first-year medical student in 1966, Dr. Wilkoff reports having nothing to disclose. Email him at [email protected].

Unlike many of you, maybe even most of you, I can recall when my office records were handwritten, some would say scribbled, on pieces of paper. They were decipherable by a select few. Some veteran assistants never mastered the skill. Pages were sometimes lavishly illustrated with drawings of body parts, often because I couldn’t remember or spell the correct anatomic term. When I needed to send a referring letter to another provider I typed it myself because dictating never quite suited my personality.

When I joined a small primary care group, the computer-savvy lead physician and a programmer developed our own homegrown EHR. It relied on scanning documents, as so many of us still generated handwritten notes. Even the most vociferous Luddites among us loved the system from day 2.

However, for a variety of reasons, some defensible some just plain bad, our beloved system needed to be replaced after 7 years. We then invested in an off-the-shelf EHR system that promised more capabilities. We were told there would be a learning curve but the plateau would come quickly and we would enjoy our new electronic assistant.

You’ve lived the rest of the story. The learning curve was steep and long and the plateau was a time gobbler. I was probably the most efficient provider in the group, and after 6 months I was leaving the office an hour later than I had been and was seeing the same number of patients. Most of my coworkers were staying and/or working on the computer at home for an extra 2 hours. This change could be easily documented by speaking with our spouses and children. I understand from my colleagues who have stayed in the business that over the ensuing decade and a half since my first experience with the EHR, its insatiable appetite for a clinician’s time has not abated.

The authors of a recent article in Annals of Family Medicine offer up some advice on how this tragic situation might be brought under control. First, the investigators point out that the phenomenon of after-hours EHR work, sometimes referred to as WOW (work outside of work), has not gone unnoticed by health system administrators and vendors who develop and sell the EHRs. However, analyzing the voluminous data necessary is not any easy task and for the most part has resulted in metrics that cannot be easily applied over a variety of practice scenarios. Many health care organizations, even large ones, have simply given up and rely on the WOW data and recommendations provided by the vendors, obviously lending the situation a faint odor of conflict of interest.

The bottom line is that after a couple of decades, there is no well defined way of quantifying the time-gobbling effect of an EHR system. It would seem to me just asking the spouses and significant others of the clinicians would be sufficient. But, authors of the paper have more specific recommendations. First, they suggest that time working on the computer outside of scheduled time with patients should be separated from any other calculation of EHR usage. They encourage vendors and time-management researchers to develop standardized and validated methods for measuring active EHR use. And, finally they recommend that all EHR work done outside of time scheduled with patients be attributed to WOW. They feel that clearly labeling it work outside of work offers health care organizations a better chance of developing policies that will address the scourge of burnout.

This, unfortunately, is another tragic example of how clinicians have lost control of our work environments. The fact that 20 years have passed and there is still no standardized method for determining how much time we spend on the computer is more evidence we need to raise our voices.
 

Dr. Wilkoff practiced primary care pediatrics in Brunswick, Maine, for nearly 40 years. He has authored several books on behavioral pediatrics, including “How to Say No to Your Toddler.” Other than a Littman stethoscope he accepted as a first-year medical student in 1966, Dr. Wilkoff reports having nothing to disclose. Email him at [email protected].

This transcript has been edited for clarity.

This is Dr. JoAnn Manson, professor of medicine at Harvard Medical School and Brigham and Women’s Hospital. I’d like to talk with you about a recent randomized clinical trial suggesting that multivitamins may improve memory and slow cognitive aging, compared with placebo, known as COSMOS (Cocoa Supplement and Multivitamins Outcome Study). This is the second COSMOS trial to show a benefit of multivitamins on memory and cognition. This trial involved a collaboration between Brigham and Columbia University and was published in the American Journal of Clinical Nutrition. I’d like to acknowledge that I am a coauthor of this study, together with Dr. Howard Sesso, who co-leads the main COSMOS trial with me.

Preserving memory and cognitive function is of critical importance to older adults. Nutritional interventions play an important role because we know the brain requires several nutrients for optimal health, and deficiencies in one or more of these nutrients may accelerate cognitive decline. Some of the micronutrients that are known to be important for brain health include vitamin B12, thiamin, other B vitamins, lutein, magnesium, and zinc, among others.

The current trial included 3,500 participants aged 60 or older, looking at performance on a web-based memory test. The multivitamin group did significantly better than the placebo group on memory tests and word recall, a finding that was estimated as the equivalent of slowing age-related memory loss by about 3 years. The benefit was first seen at 1 year and was sustained across the 3 years of the trial.

Intriguingly, in both COSMOS and COSMOS-Web, and the earlier COSMOS-Mind study, which was done in collaboration with Wake Forest, the participants with a history of cardiovascular disease showed the greatest benefits from multivitamins, perhaps due to lower nutrient status. But the basis for this finding needs to be explored further.

A few important caveats need to be emphasized. First, multivitamins and other dietary supplements will never be a substitute for a healthy diet and healthy lifestyle and should not distract from those goals. But multivitamins may have a role as a complementary strategy. Another caveat is that the randomized trials tested recommended dietary allowances and not megadoses of these micronutrients. In fact, randomized trials of high doses of isolated micronutrients have not clearly shown cognitive benefits, and this suggests that more is not necessarily better and may be worse. High doses also may be associated with toxicity, or they may interfere with absorption or bioavailability of other nutrients.

In COSMOS, over the average 3.6 years of follow-up and in the earlier Physicians’ Health Study II,  over 1 year of supplementation, multivitamins were found to be safe without any clear risks or safety concerns. A further caveat is that although Centrum Silver was tested in this trial, we would not expect that this is a brand-specific benefit, and other high-quality multivitamin brands would be expected to confer similar benefits. Of course, it’s important to check bottles for quality-control documentation such as the seals of the U.S. Pharmacopeia, National Science Foundation, ConsumerLab.com, and other auditors.

Overall, the finding that a daily multivitamin improved memory and slowed cognitive decline in two separate COSMOS randomized trials is exciting, suggesting that multivitamin supplementation holds promise as a safe, accessible, and affordable approach to protecting cognitive health in older adults. Further research will be needed to understand who is most likely to benefit and the biological mechanisms involved. Expert committees will have to look at the research and decide whether any changes in guidelines are indicated in the future.

Dr. Manson is Professor of Medicine and the Michael and Lee Bell Professor of Women’s Health, Harvard Medical School and director of the Division of Preventive Medicine, Brigham and Women’s Hospital, both in Boston. She reported receiving funding/donations from Mars Symbioscience.

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

This transcript has been edited for clarity.

This is Dr. JoAnn Manson, professor of medicine at Harvard Medical School and Brigham and Women’s Hospital. I’d like to talk with you about a recent randomized clinical trial suggesting that multivitamins may improve memory and slow cognitive aging, compared with placebo, known as COSMOS (Cocoa Supplement and Multivitamins Outcome Study). This is the second COSMOS trial to show a benefit of multivitamins on memory and cognition. This trial involved a collaboration between Brigham and Columbia University and was published in the American Journal of Clinical Nutrition. I’d like to acknowledge that I am a coauthor of this study, together with Dr. Howard Sesso, who co-leads the main COSMOS trial with me.

Preserving memory and cognitive function is of critical importance to older adults. Nutritional interventions play an important role because we know the brain requires several nutrients for optimal health, and deficiencies in one or more of these nutrients may accelerate cognitive decline. Some of the micronutrients that are known to be important for brain health include vitamin B12, thiamin, other B vitamins, lutein, magnesium, and zinc, among others.

The current trial included 3,500 participants aged 60 or older, looking at performance on a web-based memory test. The multivitamin group did significantly better than the placebo group on memory tests and word recall, a finding that was estimated as the equivalent of slowing age-related memory loss by about 3 years. The benefit was first seen at 1 year and was sustained across the 3 years of the trial.

Intriguingly, in both COSMOS and COSMOS-Web, and the earlier COSMOS-Mind study, which was done in collaboration with Wake Forest, the participants with a history of cardiovascular disease showed the greatest benefits from multivitamins, perhaps due to lower nutrient status. But the basis for this finding needs to be explored further.

A few important caveats need to be emphasized. First, multivitamins and other dietary supplements will never be a substitute for a healthy diet and healthy lifestyle and should not distract from those goals. But multivitamins may have a role as a complementary strategy. Another caveat is that the randomized trials tested recommended dietary allowances and not megadoses of these micronutrients. In fact, randomized trials of high doses of isolated micronutrients have not clearly shown cognitive benefits, and this suggests that more is not necessarily better and may be worse. High doses also may be associated with toxicity, or they may interfere with absorption or bioavailability of other nutrients.

In COSMOS, over the average 3.6 years of follow-up and in the earlier Physicians’ Health Study II,  over 1 year of supplementation, multivitamins were found to be safe without any clear risks or safety concerns. A further caveat is that although Centrum Silver was tested in this trial, we would not expect that this is a brand-specific benefit, and other high-quality multivitamin brands would be expected to confer similar benefits. Of course, it’s important to check bottles for quality-control documentation such as the seals of the U.S. Pharmacopeia, National Science Foundation, ConsumerLab.com, and other auditors.

Overall, the finding that a daily multivitamin improved memory and slowed cognitive decline in two separate COSMOS randomized trials is exciting, suggesting that multivitamin supplementation holds promise as a safe, accessible, and affordable approach to protecting cognitive health in older adults. Further research will be needed to understand who is most likely to benefit and the biological mechanisms involved. Expert committees will have to look at the research and decide whether any changes in guidelines are indicated in the future.

Dr. Manson is Professor of Medicine and the Michael and Lee Bell Professor of Women’s Health, Harvard Medical School and director of the Division of Preventive Medicine, Brigham and Women’s Hospital, both in Boston. She reported receiving funding/donations from Mars Symbioscience.

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

This transcript has been edited for clarity.

This is Dr. JoAnn Manson, professor of medicine at Harvard Medical School and Brigham and Women’s Hospital. I’d like to talk with you about a recent randomized clinical trial suggesting that multivitamins may improve memory and slow cognitive aging, compared with placebo, known as COSMOS (Cocoa Supplement and Multivitamins Outcome Study). This is the second COSMOS trial to show a benefit of multivitamins on memory and cognition. This trial involved a collaboration between Brigham and Columbia University and was published in the American Journal of Clinical Nutrition. I’d like to acknowledge that I am a coauthor of this study, together with Dr. Howard Sesso, who co-leads the main COSMOS trial with me.

Preserving memory and cognitive function is of critical importance to older adults. Nutritional interventions play an important role because we know the brain requires several nutrients for optimal health, and deficiencies in one or more of these nutrients may accelerate cognitive decline. Some of the micronutrients that are known to be important for brain health include vitamin B12, thiamin, other B vitamins, lutein, magnesium, and zinc, among others.

The current trial included 3,500 participants aged 60 or older, looking at performance on a web-based memory test. The multivitamin group did significantly better than the placebo group on memory tests and word recall, a finding that was estimated as the equivalent of slowing age-related memory loss by about 3 years. The benefit was first seen at 1 year and was sustained across the 3 years of the trial.

Intriguingly, in both COSMOS and COSMOS-Web, and the earlier COSMOS-Mind study, which was done in collaboration with Wake Forest, the participants with a history of cardiovascular disease showed the greatest benefits from multivitamins, perhaps due to lower nutrient status. But the basis for this finding needs to be explored further.

A few important caveats need to be emphasized. First, multivitamins and other dietary supplements will never be a substitute for a healthy diet and healthy lifestyle and should not distract from those goals. But multivitamins may have a role as a complementary strategy. Another caveat is that the randomized trials tested recommended dietary allowances and not megadoses of these micronutrients. In fact, randomized trials of high doses of isolated micronutrients have not clearly shown cognitive benefits, and this suggests that more is not necessarily better and may be worse. High doses also may be associated with toxicity, or they may interfere with absorption or bioavailability of other nutrients.

In COSMOS, over the average 3.6 years of follow-up and in the earlier Physicians’ Health Study II,  over 1 year of supplementation, multivitamins were found to be safe without any clear risks or safety concerns. A further caveat is that although Centrum Silver was tested in this trial, we would not expect that this is a brand-specific benefit, and other high-quality multivitamin brands would be expected to confer similar benefits. Of course, it’s important to check bottles for quality-control documentation such as the seals of the U.S. Pharmacopeia, National Science Foundation, ConsumerLab.com, and other auditors.

Overall, the finding that a daily multivitamin improved memory and slowed cognitive decline in two separate COSMOS randomized trials is exciting, suggesting that multivitamin supplementation holds promise as a safe, accessible, and affordable approach to protecting cognitive health in older adults. Further research will be needed to understand who is most likely to benefit and the biological mechanisms involved. Expert committees will have to look at the research and decide whether any changes in guidelines are indicated in the future.

Dr. Manson is Professor of Medicine and the Michael and Lee Bell Professor of Women’s Health, Harvard Medical School and director of the Division of Preventive Medicine, Brigham and Women’s Hospital, both in Boston. She reported receiving funding/donations from Mars Symbioscience.

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