Rheumatology News

The Food and Drug Administration (FDA) has approved a 10-mg dose of Roxybond (Protega Pharmaceuticals), an opioid analgesic indicated for the management of severe pain in cases where other treatments are not well-tolerated or prove ineffective.

Roxybond, an immediate-release (IR) formulation of oxycodone hydrochloride, is made with Protega’s SentryBond technology, which makes it harder for people to crush, inject, or snort, according to the company.

In a statement from Protega, Paul Howe, the company’s chief commercial officer, said the drug meets an “unmet need for an IR opioid with abuse-deterrent technology that may reduce misuse and abuse while providing pain relief to medically appropriate patients when used as indicated.”

To determine the tablet’s ability to withstand manipulation, more than 2000 in vitro tests were conducted, according to the release. The findings indicate Roxybond reduces — but does not entirely negate — the potential for intranasal and intravenous abuse.

Roxybond was previously approved in 5-, 15-, and 30-mg doses. The 10 mg option provides clinicians with the ability to better modify side effects, manage titration, and provide precision care for patients on opioid therapy, according to Protega.

“For patients, the range of doses can provide better pain control, reduce the risk of side effects, and provide a smoother transition during dosing transitions,” the company stated.

Roxybond is contraindicated in patients with significant respiratory depression, acute or severe bronchial asthma, gastrointestinal obstruction, or hypersensitivity to oxycodone. The drug is not intended for long-term use unless otherwise determined by a clinician. Roxybond also is subject to the FDA’s Risk Evaluation and Mitigation Strategies for opioids.

“The development of Roxybond with SentryBond is a step forward in fighting the national epidemic of prescription opioid overdose,” said Eric Kinzler, PhD, vice president of medical and regulatory affairs for Protega, in a release. “Protega is dedicated to our mission to block the path to abuse and work with healthcare professionals across the continuum of care to reduce misuse and abuse.”

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

The Food and Drug Administration (FDA) has approved a 10-mg dose of Roxybond (Protega Pharmaceuticals), an opioid analgesic indicated for the management of severe pain in cases where other treatments are not well-tolerated or prove ineffective.

Roxybond, an immediate-release (IR) formulation of oxycodone hydrochloride, is made with Protega’s SentryBond technology, which makes it harder for people to crush, inject, or snort, according to the company.

In a statement from Protega, Paul Howe, the company’s chief commercial officer, said the drug meets an “unmet need for an IR opioid with abuse-deterrent technology that may reduce misuse and abuse while providing pain relief to medically appropriate patients when used as indicated.”

To determine the tablet’s ability to withstand manipulation, more than 2000 in vitro tests were conducted, according to the release. The findings indicate Roxybond reduces — but does not entirely negate — the potential for intranasal and intravenous abuse.

Roxybond was previously approved in 5-, 15-, and 30-mg doses. The 10 mg option provides clinicians with the ability to better modify side effects, manage titration, and provide precision care for patients on opioid therapy, according to Protega.

“For patients, the range of doses can provide better pain control, reduce the risk of side effects, and provide a smoother transition during dosing transitions,” the company stated.

Roxybond is contraindicated in patients with significant respiratory depression, acute or severe bronchial asthma, gastrointestinal obstruction, or hypersensitivity to oxycodone. The drug is not intended for long-term use unless otherwise determined by a clinician. Roxybond also is subject to the FDA’s Risk Evaluation and Mitigation Strategies for opioids.

“The development of Roxybond with SentryBond is a step forward in fighting the national epidemic of prescription opioid overdose,” said Eric Kinzler, PhD, vice president of medical and regulatory affairs for Protega, in a release. “Protega is dedicated to our mission to block the path to abuse and work with healthcare professionals across the continuum of care to reduce misuse and abuse.”

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

The Food and Drug Administration (FDA) has approved a 10-mg dose of Roxybond (Protega Pharmaceuticals), an opioid analgesic indicated for the management of severe pain in cases where other treatments are not well-tolerated or prove ineffective.

Roxybond, an immediate-release (IR) formulation of oxycodone hydrochloride, is made with Protega’s SentryBond technology, which makes it harder for people to crush, inject, or snort, according to the company.

In a statement from Protega, Paul Howe, the company’s chief commercial officer, said the drug meets an “unmet need for an IR opioid with abuse-deterrent technology that may reduce misuse and abuse while providing pain relief to medically appropriate patients when used as indicated.”

To determine the tablet’s ability to withstand manipulation, more than 2000 in vitro tests were conducted, according to the release. The findings indicate Roxybond reduces — but does not entirely negate — the potential for intranasal and intravenous abuse.

Roxybond was previously approved in 5-, 15-, and 30-mg doses. The 10 mg option provides clinicians with the ability to better modify side effects, manage titration, and provide precision care for patients on opioid therapy, according to Protega.

“For patients, the range of doses can provide better pain control, reduce the risk of side effects, and provide a smoother transition during dosing transitions,” the company stated.

Roxybond is contraindicated in patients with significant respiratory depression, acute or severe bronchial asthma, gastrointestinal obstruction, or hypersensitivity to oxycodone. The drug is not intended for long-term use unless otherwise determined by a clinician. Roxybond also is subject to the FDA’s Risk Evaluation and Mitigation Strategies for opioids.

“The development of Roxybond with SentryBond is a step forward in fighting the national epidemic of prescription opioid overdose,” said Eric Kinzler, PhD, vice president of medical and regulatory affairs for Protega, in a release. “Protega is dedicated to our mission to block the path to abuse and work with healthcare professionals across the continuum of care to reduce misuse and abuse.”

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

For people with severe symptomatic hip osteoarthritis, total hip replacement (THR) alleviates hip pain and improves function much more effectively than a resistance training program supervised by a physiotherapist, according to the results of a randomized controlled clinical trial. 

In the PROHIP study, the mean increases in Oxford Hip Scores from baseline to 6 months were 15.9 points for THR and 4.5 points for resistance training. The 11.4-point difference in scores was both statistically and clinically significant, the study’s investigators reported in The New England Journal of Medicine. 

“Our results are clear: Surgery is superior to exercise in patients who have hip osteoarthritis and indication for surgery, and now we have finally proven that with the highest level of evidence,” corresponding author Thomas Frydendal, PT, PhD, MSc, told this news organization.

Frydendal, who was involved in the study while working on his PhD at University Hospital of Southern Denmark – Lillebaelt Hospital, Vejle, Denmark, the primary center for the trial, is now a postdoctoral researcher at the Department of Clinical Medicine, Aarhus University, and Department of Orthopedic Surgery, Aarhus University Hospital.

“We believe that our findings are pretty robust,” Frydendal added. “I think if someone in the world conducts a trial similar to ours, they will find fairly close or consistent findings, no matter what type of exercise they choose.”

Charlotte Dahl, Lillebaelt Hospital–University Hospital of Southern Denmark, Vejle Hospital

The PROHIP Study

THR is routinely recommended for the management of severe hip osteoarthritis, but since there are no clinical trial data on the effectiveness of this procedure as compared with first-line treatment such as resistance training, the PROHIP study was conceived. 

The trial was conducted at four Danish orthopedic centers and designed as a superiority study, the hypothesis being that THR would be better at alleviating self-reported hip pain and improving hip function than resistance training. 

Of a possible 1474 individuals with a clinical suspicion of hip osteoarthritis, 791 were deemed eligible for inclusion in the trial. Inclusion criteria were being aged 50 years or older and having an indication for THR based on the presence of hip pain and clinical and radiographic findings.

However, the majority (86%) declined to enter the study, with almost half (43%) deciding to have a THR and enroll in a parallel observational cohort. This meant that only 110 (14%) individuals agreed to participate and underwent randomization, which does limit the study’s generalizability, the PROHIP investigators acknowledged. 
 

Design and Study Population

The change in Oxford Hip Score from baseline to 6 months was selected as the primary outcome measure based on the findings of a prior qualitative study. This 12-item, patient-reported outcome measure gives a score ranging from 0 to 48, with higher scores indicating less hip pain and better hip function. The estimated minimal clinically important difference is a change of 5 points. 

After a baseline assessment, 53 of 109 individuals were randomly assigned to undergo THR and 56 to participate in the resistance training program. Overall, the mean age of participants was 67.6 years, and half were women. The average duration of hip pain was a median of 1.7 years. 

The median time to receipt of the allocated treatment was 2.8 months in the THR group and 0.5 months in the resistance training group. 

Those allocated to the THR group also underwent a “fast track” program that involved patient education, pain management, and early mobilization. 

The resistance training group received 12 weeks of exercise supervised by a physiotherapist and then offered 12 weeks of additional exercise conducted on their own. The physiotherapist-supervised exercise sessions were held twice weekly and lasted for 1 hour. These started with a 10-minute warm-up on a stationary bike, followed by a standard set of resistance-based exercises that included a leg press, hip extension, hip flexion, and hip abduction. 
 

‘Reassuring’ Results

In a comment, consultant orthopedic surgeon Antony Palmer, MA, BMBCh, DPhil, said: “It’s reassuring that patients with advanced symptomatic osteoarthritis do well with hip replacements.”

THR does of course come with the potential risk for complications, but “the rate of these is what you’d expect for that procedure,” Palmer said, who works for the Nuffield Orthopaedic Centre, Oxford University Hospital NHS Foundation Trust, and is a senior clinical research fellow at Oxford University in England.

Dr. Palmer

Resistance Training Role 

A notable finding was that, at 6 months, five (9%) people assigned to the THR arm had not undergone surgery, and 12 (21%) people in the resistance training group had undergone a THR.

This could suggest two things, Palmer suggested in the interview. The first is that there could be a small proportion of people assigned to THR who may not need the operation and do well with exercise therapy. And, conversely, there may be those who would do well having the surgery without first going through the intermediate stage of physical therapy. 

It’s a suggestion that “maybe we’ve got to refine that a bit better and identify the patients that really do benefit from physiotherapy and who might not need hip replacement as a result,” Palmer said.

Or in other words, “should all patients undergo a program of physiotherapy before considering surgery?” he added.
 

Authors’ View

The PROHIP investigators conclude: “These results support current recommendations for the management of hip osteoarthritis and may be used to inform and guide shared decision making in clinical practice.”

Moreover, the results “do not oppose the use of resistance training as initial treatment,” says the authors. 

Frydendal highlighted in his interview that nearly three out of four of the patients reported not to have undertaken any type of supervised exercise before entry into the study, which is a first-line, guideline-recommended option.

“If a patient tells me, ‘I haven’t done any exercise previously,’ I’d recommend starting with completing a 6- to 12-week exercise program that is tailored to your individual needs and evaluate your symptoms afterward,” he said. 

“But we should refer the patient if our first-line treatment does not offer any improvements in the patient’s symptoms, as surgery with total hip replacement is clearly a really good treatment option,” Frydendal said.

The study was funded by the Danish Rheumatism Association, among other independent bodies. Frydendal and Palmer reported no relevant financial relationships. 
 

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

For people with severe symptomatic hip osteoarthritis, total hip replacement (THR) alleviates hip pain and improves function much more effectively than a resistance training program supervised by a physiotherapist, according to the results of a randomized controlled clinical trial. 

In the PROHIP study, the mean increases in Oxford Hip Scores from baseline to 6 months were 15.9 points for THR and 4.5 points for resistance training. The 11.4-point difference in scores was both statistically and clinically significant, the study’s investigators reported in The New England Journal of Medicine. 

“Our results are clear: Surgery is superior to exercise in patients who have hip osteoarthritis and indication for surgery, and now we have finally proven that with the highest level of evidence,” corresponding author Thomas Frydendal, PT, PhD, MSc, told this news organization.

Frydendal, who was involved in the study while working on his PhD at University Hospital of Southern Denmark – Lillebaelt Hospital, Vejle, Denmark, the primary center for the trial, is now a postdoctoral researcher at the Department of Clinical Medicine, Aarhus University, and Department of Orthopedic Surgery, Aarhus University Hospital.

“We believe that our findings are pretty robust,” Frydendal added. “I think if someone in the world conducts a trial similar to ours, they will find fairly close or consistent findings, no matter what type of exercise they choose.”

Charlotte Dahl, Lillebaelt Hospital–University Hospital of Southern Denmark, Vejle Hospital

The PROHIP Study

THR is routinely recommended for the management of severe hip osteoarthritis, but since there are no clinical trial data on the effectiveness of this procedure as compared with first-line treatment such as resistance training, the PROHIP study was conceived. 

The trial was conducted at four Danish orthopedic centers and designed as a superiority study, the hypothesis being that THR would be better at alleviating self-reported hip pain and improving hip function than resistance training. 

Of a possible 1474 individuals with a clinical suspicion of hip osteoarthritis, 791 were deemed eligible for inclusion in the trial. Inclusion criteria were being aged 50 years or older and having an indication for THR based on the presence of hip pain and clinical and radiographic findings.

However, the majority (86%) declined to enter the study, with almost half (43%) deciding to have a THR and enroll in a parallel observational cohort. This meant that only 110 (14%) individuals agreed to participate and underwent randomization, which does limit the study’s generalizability, the PROHIP investigators acknowledged. 
 

Design and Study Population

The change in Oxford Hip Score from baseline to 6 months was selected as the primary outcome measure based on the findings of a prior qualitative study. This 12-item, patient-reported outcome measure gives a score ranging from 0 to 48, with higher scores indicating less hip pain and better hip function. The estimated minimal clinically important difference is a change of 5 points. 

After a baseline assessment, 53 of 109 individuals were randomly assigned to undergo THR and 56 to participate in the resistance training program. Overall, the mean age of participants was 67.6 years, and half were women. The average duration of hip pain was a median of 1.7 years. 

The median time to receipt of the allocated treatment was 2.8 months in the THR group and 0.5 months in the resistance training group. 

Those allocated to the THR group also underwent a “fast track” program that involved patient education, pain management, and early mobilization. 

The resistance training group received 12 weeks of exercise supervised by a physiotherapist and then offered 12 weeks of additional exercise conducted on their own. The physiotherapist-supervised exercise sessions were held twice weekly and lasted for 1 hour. These started with a 10-minute warm-up on a stationary bike, followed by a standard set of resistance-based exercises that included a leg press, hip extension, hip flexion, and hip abduction. 
 

‘Reassuring’ Results

In a comment, consultant orthopedic surgeon Antony Palmer, MA, BMBCh, DPhil, said: “It’s reassuring that patients with advanced symptomatic osteoarthritis do well with hip replacements.”

THR does of course come with the potential risk for complications, but “the rate of these is what you’d expect for that procedure,” Palmer said, who works for the Nuffield Orthopaedic Centre, Oxford University Hospital NHS Foundation Trust, and is a senior clinical research fellow at Oxford University in England.

Dr. Palmer

Resistance Training Role 

A notable finding was that, at 6 months, five (9%) people assigned to the THR arm had not undergone surgery, and 12 (21%) people in the resistance training group had undergone a THR.

This could suggest two things, Palmer suggested in the interview. The first is that there could be a small proportion of people assigned to THR who may not need the operation and do well with exercise therapy. And, conversely, there may be those who would do well having the surgery without first going through the intermediate stage of physical therapy. 

It’s a suggestion that “maybe we’ve got to refine that a bit better and identify the patients that really do benefit from physiotherapy and who might not need hip replacement as a result,” Palmer said.

Or in other words, “should all patients undergo a program of physiotherapy before considering surgery?” he added.
 

Authors’ View

The PROHIP investigators conclude: “These results support current recommendations for the management of hip osteoarthritis and may be used to inform and guide shared decision making in clinical practice.”

Moreover, the results “do not oppose the use of resistance training as initial treatment,” says the authors. 

Frydendal highlighted in his interview that nearly three out of four of the patients reported not to have undertaken any type of supervised exercise before entry into the study, which is a first-line, guideline-recommended option.

“If a patient tells me, ‘I haven’t done any exercise previously,’ I’d recommend starting with completing a 6- to 12-week exercise program that is tailored to your individual needs and evaluate your symptoms afterward,” he said. 

“But we should refer the patient if our first-line treatment does not offer any improvements in the patient’s symptoms, as surgery with total hip replacement is clearly a really good treatment option,” Frydendal said.

The study was funded by the Danish Rheumatism Association, among other independent bodies. Frydendal and Palmer reported no relevant financial relationships. 
 

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

For people with severe symptomatic hip osteoarthritis, total hip replacement (THR) alleviates hip pain and improves function much more effectively than a resistance training program supervised by a physiotherapist, according to the results of a randomized controlled clinical trial. 

In the PROHIP study, the mean increases in Oxford Hip Scores from baseline to 6 months were 15.9 points for THR and 4.5 points for resistance training. The 11.4-point difference in scores was both statistically and clinically significant, the study’s investigators reported in The New England Journal of Medicine. 

“Our results are clear: Surgery is superior to exercise in patients who have hip osteoarthritis and indication for surgery, and now we have finally proven that with the highest level of evidence,” corresponding author Thomas Frydendal, PT, PhD, MSc, told this news organization.

Frydendal, who was involved in the study while working on his PhD at University Hospital of Southern Denmark – Lillebaelt Hospital, Vejle, Denmark, the primary center for the trial, is now a postdoctoral researcher at the Department of Clinical Medicine, Aarhus University, and Department of Orthopedic Surgery, Aarhus University Hospital.

“We believe that our findings are pretty robust,” Frydendal added. “I think if someone in the world conducts a trial similar to ours, they will find fairly close or consistent findings, no matter what type of exercise they choose.”

Charlotte Dahl, Lillebaelt Hospital–University Hospital of Southern Denmark, Vejle Hospital

The PROHIP Study

THR is routinely recommended for the management of severe hip osteoarthritis, but since there are no clinical trial data on the effectiveness of this procedure as compared with first-line treatment such as resistance training, the PROHIP study was conceived. 

The trial was conducted at four Danish orthopedic centers and designed as a superiority study, the hypothesis being that THR would be better at alleviating self-reported hip pain and improving hip function than resistance training. 

Of a possible 1474 individuals with a clinical suspicion of hip osteoarthritis, 791 were deemed eligible for inclusion in the trial. Inclusion criteria were being aged 50 years or older and having an indication for THR based on the presence of hip pain and clinical and radiographic findings.

However, the majority (86%) declined to enter the study, with almost half (43%) deciding to have a THR and enroll in a parallel observational cohort. This meant that only 110 (14%) individuals agreed to participate and underwent randomization, which does limit the study’s generalizability, the PROHIP investigators acknowledged. 
 

Design and Study Population

The change in Oxford Hip Score from baseline to 6 months was selected as the primary outcome measure based on the findings of a prior qualitative study. This 12-item, patient-reported outcome measure gives a score ranging from 0 to 48, with higher scores indicating less hip pain and better hip function. The estimated minimal clinically important difference is a change of 5 points. 

After a baseline assessment, 53 of 109 individuals were randomly assigned to undergo THR and 56 to participate in the resistance training program. Overall, the mean age of participants was 67.6 years, and half were women. The average duration of hip pain was a median of 1.7 years. 

The median time to receipt of the allocated treatment was 2.8 months in the THR group and 0.5 months in the resistance training group. 

Those allocated to the THR group also underwent a “fast track” program that involved patient education, pain management, and early mobilization. 

The resistance training group received 12 weeks of exercise supervised by a physiotherapist and then offered 12 weeks of additional exercise conducted on their own. The physiotherapist-supervised exercise sessions were held twice weekly and lasted for 1 hour. These started with a 10-minute warm-up on a stationary bike, followed by a standard set of resistance-based exercises that included a leg press, hip extension, hip flexion, and hip abduction. 
 

‘Reassuring’ Results

In a comment, consultant orthopedic surgeon Antony Palmer, MA, BMBCh, DPhil, said: “It’s reassuring that patients with advanced symptomatic osteoarthritis do well with hip replacements.”

THR does of course come with the potential risk for complications, but “the rate of these is what you’d expect for that procedure,” Palmer said, who works for the Nuffield Orthopaedic Centre, Oxford University Hospital NHS Foundation Trust, and is a senior clinical research fellow at Oxford University in England.

Dr. Palmer

Resistance Training Role 

A notable finding was that, at 6 months, five (9%) people assigned to the THR arm had not undergone surgery, and 12 (21%) people in the resistance training group had undergone a THR.

This could suggest two things, Palmer suggested in the interview. The first is that there could be a small proportion of people assigned to THR who may not need the operation and do well with exercise therapy. And, conversely, there may be those who would do well having the surgery without first going through the intermediate stage of physical therapy. 

It’s a suggestion that “maybe we’ve got to refine that a bit better and identify the patients that really do benefit from physiotherapy and who might not need hip replacement as a result,” Palmer said.

Or in other words, “should all patients undergo a program of physiotherapy before considering surgery?” he added.
 

Authors’ View

The PROHIP investigators conclude: “These results support current recommendations for the management of hip osteoarthritis and may be used to inform and guide shared decision making in clinical practice.”

Moreover, the results “do not oppose the use of resistance training as initial treatment,” says the authors. 

Frydendal highlighted in his interview that nearly three out of four of the patients reported not to have undertaken any type of supervised exercise before entry into the study, which is a first-line, guideline-recommended option.

“If a patient tells me, ‘I haven’t done any exercise previously,’ I’d recommend starting with completing a 6- to 12-week exercise program that is tailored to your individual needs and evaluate your symptoms afterward,” he said. 

“But we should refer the patient if our first-line treatment does not offer any improvements in the patient’s symptoms, as surgery with total hip replacement is clearly a really good treatment option,” Frydendal said.

The study was funded by the Danish Rheumatism Association, among other independent bodies. Frydendal and Palmer reported no relevant financial relationships. 
 

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

When my normally adorable cat Biscuit bit my ankle in a playful stalking exercise gone wrong, I washed it with soap and some rubbing alcohol, slapped on a Band-Aid, and went about my day.

The next morning, when it was swollen, I told myself it was probably just a hematoma and went about my day.

Dr. Wilson

Dr. Wilson

Dr. Wilson

Dr. Wilson

Dr. Wilson

JAMA Network

Dr. Wilson

Dr. Wilson is associate professor of medicine and public health and director of the Clinical and Translational Research Accelerator at Yale University, New Haven, Conn. He has disclosed no relevant financial relationships.

A version of this article appeared on Medscape.com.

When my normally adorable cat Biscuit bit my ankle in a playful stalking exercise gone wrong, I washed it with soap and some rubbing alcohol, slapped on a Band-Aid, and went about my day.

The next morning, when it was swollen, I told myself it was probably just a hematoma and went about my day.

Dr. Wilson

Dr. Wilson

Dr. Wilson

Dr. Wilson

Dr. Wilson

JAMA Network

Dr. Wilson

Dr. Wilson is associate professor of medicine and public health and director of the Clinical and Translational Research Accelerator at Yale University, New Haven, Conn. He has disclosed no relevant financial relationships.

A version of this article appeared on Medscape.com.

When my normally adorable cat Biscuit bit my ankle in a playful stalking exercise gone wrong, I washed it with soap and some rubbing alcohol, slapped on a Band-Aid, and went about my day.

The next morning, when it was swollen, I told myself it was probably just a hematoma and went about my day.

Dr. Wilson

Dr. Wilson

Dr. Wilson

Dr. Wilson

Dr. Wilson

JAMA Network

Dr. Wilson

Dr. Wilson is associate professor of medicine and public health and director of the Clinical and Translational Research Accelerator at Yale University, New Haven, Conn. He has disclosed no relevant financial relationships.

A version of this article appeared on Medscape.com.

In seconds, Ravi Parikh, MD, an oncologist at the Emory University School of Medicine in Atlanta, had a summary of his patient’s entire medical history. Normally, Parikh skimmed the cumbersome files before seeing a patient. However, the artificial intelligence (AI) tool his institution was testing could list the highlights he needed in a fraction of the time.

“On the whole, I like it ... it saves me time,” Parikh said of the tool. “But I’d be lying if I told you it was perfect all the time. It’s interpreting the [patient] history in some ways that may be inaccurate,” he said.

Within the first week of testing the tool, Parikh started to notice that the large language model (LLM) made a particular mistake in his patients with prostate cancer. If their prostate-specific antigen test results came back slightly elevated — which is part of normal variation — the LLM recorded it as disease progression. Because Parikh reviews all his notes — with or without using an AI tool — after a visit, he easily caught the mistake before it was added to the chart. “The problem, I think, is if these mistakes go under the hood,” he said.

In the data science world, these mistakes are called hallucinations. And a growing body of research suggests they’re happening more frequently than is safe for healthcare. The industry promised LLMs would alleviate administrative burden and reduce physician burnout. But so far, studies show these AI-tool mistakes often create more work for doctors, not less. To truly help physicians and be safe for patients, some experts say healthcare needs to build its own LLMs from the ground up. And all agree that the field desperately needs a way to vet these algorithms more thoroughly.
 

Prone to Error

Right now, “I think the industry is focused on taking existing LLMs and forcing them into usage for healthcare,” said Nigam H. Shah, MBBS, PhD, chief data scientist for Stanford Health. However, the value of deploying general LLMs in the healthcare space is questionable. “People are starting to wonder if we’re using these tools wrong,” he told this news organization.

In 2023, Shah and his colleagues evaluated seven LLMs on their ability to answer electronic health record–based questions. For realistic tasks, the error rate in the best cases was about 35%, he said. “To me, that rate seems a bit high ... to adopt for routine use.”

A study earlier this year by the UC San Diego School of Medicine showed that using LLMs to respond to patient messages increased the time doctors spent on messages. And this summer, a study by the clinical AI firm Mendel found that when GPT-4o or Llama-3 were used to summarize patient medical records, almost every summary contained at least one type of hallucination.

“We’ve seen cases where a patient does have drug allergies, but the system says ‘no known drug allergies’ ” in the medical history summary, said Wael Salloum, PhD, cofounder and chief science officer at Mendel. “That’s a serious hallucination.” And if physicians have to constantly verify what the system is telling them, that “defeats the purpose [of summarization],” he said.
 

A Higher Quality Diet

Part of the trouble with LLMs is that there’s just not enough high-quality information to feed them. The algorithms are insatiable, requiring vast swaths of data for training. GPT-3.5, for instance, was trained on 570 GB of data from the internet, more than 300 billion words. And to train GPT-4o, OpenAI reportedly transcribed more than 1 million hours of YouTube content.

However, the strategies that built these general LLMs don’t always translate well to healthcare. The internet is full of low-quality or misleading health information from wellness sites and supplement advertisements. And even data that are trustworthy, like the millions of clinical studies and the US Food and Drug Administration (FDA) statements, can be outdated, Salloum said. And “an LLM in training can’t distinguish good from bad,” he added.

The good news is that clinicians don’t rely on controversial information in the real world. Medical knowledge is standardized. “Healthcare is a domain rich with explicit knowledge,” Salloum said. So there’s potential to build a more reliable LLM that is guided by robust medical standards and guidelines.

It’s possible that healthcare could use small language models, which are LLM’s pocket-sized cousins, and perform tasks needing only bite-sized datasets requiring fewer resources and easier fine-tuning, according to Microsoft’s website. Shah said training these smaller models on real medical data might be an option, like an LLM meant to respond to patient messages that could be trained with real messages sent by physicians.

Several groups are already working on databases of standardized human medical knowledge or real physician responses. “Perhaps that will work better than using LLMs trained on the general internet. Those studies need to be done,” Shah said.

Jon Tamir, assistant professor of electrical and computer engineering and co-lead of the AI Health Lab at The University of Texas at Austin, said, “The community has recognized that we are entering a new era of AI where the dataset itself is the most important aspect. We need training sets that are highly curated and highly specialized.

“If the dataset is highly specialized, it will definitely help reduce hallucinations,” he said.
 

Cutting Overconfidence

A major problem with LLM mistakes is that they are often hard to detect. Hallucinations can be highly convincing even if they’re highly inaccurate, according to Tamir.

When Shah, for instance, was recently testing an LLM on de-identified patient data, he asked the LLM which blood test the patient last had. The model responded with “complete blood count [CBC].” But when he asked for the results, the model gave him white blood count and other values. “Turns out that record did not have a CBC done at all! The result was entirely made up,” he said.

Making healthcare LLMs safer and more reliable will mean training AI to acknowledge potential mistakes and uncertainty. Existing LLMs are trained to project confidence and produce a lot of answers, even when there isn’t one, Salloum said. They rarely respond with “I don’t know” even when their prediction has low confidence, he added.

Healthcare stands to benefit from a system that highlights uncertainty and potential errors. For instance, if a patient’s history shows they have smoked, stopped smoking, vaped, and started smoking again. The LLM might call them a smoker but flag the comment as uncertain because the chronology is complicated, Salloum said.

Tamir added that this strategy could improve LLM and doctor collaboration by honing in on where human expertise is needed most.
 

Too Little Evaluation

For any improvement strategy to work, LLMs — and all AI-assisted healthcare tools — first need a better evaluation framework. So far, LLMs have “been used in really exciting ways but not really well-vetted ways,” Tamir said.

While some AI-assisted tools, particularly in medical imaging, have undergone rigorous FDA evaluations and earned approval, most haven’t. And because the FDA only regulates algorithms that are considered medical devices, Parikh said that most LLMs used for administrative tasks and efficiency don’t fall under the regulatory agency’s purview.

But these algorithms still have access to patient information and can directly influence patient and doctor decisions. Third-party regulatory agencies are expected to emerge, but it’s still unclear who those will be. Before developers can build a safer and more efficient LLM for healthcare, they’ll need better guidelines and guardrails. “Unless we figure out evaluation, how would we know whether the healthcare-appropriate large language models are better or worse?” Shah asked.
 

A version of this article appeared on Medscape.com.

In seconds, Ravi Parikh, MD, an oncologist at the Emory University School of Medicine in Atlanta, had a summary of his patient’s entire medical history. Normally, Parikh skimmed the cumbersome files before seeing a patient. However, the artificial intelligence (AI) tool his institution was testing could list the highlights he needed in a fraction of the time.

“On the whole, I like it ... it saves me time,” Parikh said of the tool. “But I’d be lying if I told you it was perfect all the time. It’s interpreting the [patient] history in some ways that may be inaccurate,” he said.

Within the first week of testing the tool, Parikh started to notice that the large language model (LLM) made a particular mistake in his patients with prostate cancer. If their prostate-specific antigen test results came back slightly elevated — which is part of normal variation — the LLM recorded it as disease progression. Because Parikh reviews all his notes — with or without using an AI tool — after a visit, he easily caught the mistake before it was added to the chart. “The problem, I think, is if these mistakes go under the hood,” he said.

In the data science world, these mistakes are called hallucinations. And a growing body of research suggests they’re happening more frequently than is safe for healthcare. The industry promised LLMs would alleviate administrative burden and reduce physician burnout. But so far, studies show these AI-tool mistakes often create more work for doctors, not less. To truly help physicians and be safe for patients, some experts say healthcare needs to build its own LLMs from the ground up. And all agree that the field desperately needs a way to vet these algorithms more thoroughly.
 

Prone to Error

Right now, “I think the industry is focused on taking existing LLMs and forcing them into usage for healthcare,” said Nigam H. Shah, MBBS, PhD, chief data scientist for Stanford Health. However, the value of deploying general LLMs in the healthcare space is questionable. “People are starting to wonder if we’re using these tools wrong,” he told this news organization.

In 2023, Shah and his colleagues evaluated seven LLMs on their ability to answer electronic health record–based questions. For realistic tasks, the error rate in the best cases was about 35%, he said. “To me, that rate seems a bit high ... to adopt for routine use.”

A study earlier this year by the UC San Diego School of Medicine showed that using LLMs to respond to patient messages increased the time doctors spent on messages. And this summer, a study by the clinical AI firm Mendel found that when GPT-4o or Llama-3 were used to summarize patient medical records, almost every summary contained at least one type of hallucination.

“We’ve seen cases where a patient does have drug allergies, but the system says ‘no known drug allergies’ ” in the medical history summary, said Wael Salloum, PhD, cofounder and chief science officer at Mendel. “That’s a serious hallucination.” And if physicians have to constantly verify what the system is telling them, that “defeats the purpose [of summarization],” he said.
 

A Higher Quality Diet

Part of the trouble with LLMs is that there’s just not enough high-quality information to feed them. The algorithms are insatiable, requiring vast swaths of data for training. GPT-3.5, for instance, was trained on 570 GB of data from the internet, more than 300 billion words. And to train GPT-4o, OpenAI reportedly transcribed more than 1 million hours of YouTube content.

However, the strategies that built these general LLMs don’t always translate well to healthcare. The internet is full of low-quality or misleading health information from wellness sites and supplement advertisements. And even data that are trustworthy, like the millions of clinical studies and the US Food and Drug Administration (FDA) statements, can be outdated, Salloum said. And “an LLM in training can’t distinguish good from bad,” he added.

The good news is that clinicians don’t rely on controversial information in the real world. Medical knowledge is standardized. “Healthcare is a domain rich with explicit knowledge,” Salloum said. So there’s potential to build a more reliable LLM that is guided by robust medical standards and guidelines.

It’s possible that healthcare could use small language models, which are LLM’s pocket-sized cousins, and perform tasks needing only bite-sized datasets requiring fewer resources and easier fine-tuning, according to Microsoft’s website. Shah said training these smaller models on real medical data might be an option, like an LLM meant to respond to patient messages that could be trained with real messages sent by physicians.

Several groups are already working on databases of standardized human medical knowledge or real physician responses. “Perhaps that will work better than using LLMs trained on the general internet. Those studies need to be done,” Shah said.

Jon Tamir, assistant professor of electrical and computer engineering and co-lead of the AI Health Lab at The University of Texas at Austin, said, “The community has recognized that we are entering a new era of AI where the dataset itself is the most important aspect. We need training sets that are highly curated and highly specialized.

“If the dataset is highly specialized, it will definitely help reduce hallucinations,” he said.
 

Cutting Overconfidence

A major problem with LLM mistakes is that they are often hard to detect. Hallucinations can be highly convincing even if they’re highly inaccurate, according to Tamir.

When Shah, for instance, was recently testing an LLM on de-identified patient data, he asked the LLM which blood test the patient last had. The model responded with “complete blood count [CBC].” But when he asked for the results, the model gave him white blood count and other values. “Turns out that record did not have a CBC done at all! The result was entirely made up,” he said.

Making healthcare LLMs safer and more reliable will mean training AI to acknowledge potential mistakes and uncertainty. Existing LLMs are trained to project confidence and produce a lot of answers, even when there isn’t one, Salloum said. They rarely respond with “I don’t know” even when their prediction has low confidence, he added.

Healthcare stands to benefit from a system that highlights uncertainty and potential errors. For instance, if a patient’s history shows they have smoked, stopped smoking, vaped, and started smoking again. The LLM might call them a smoker but flag the comment as uncertain because the chronology is complicated, Salloum said.

Tamir added that this strategy could improve LLM and doctor collaboration by honing in on where human expertise is needed most.
 

Too Little Evaluation

For any improvement strategy to work, LLMs — and all AI-assisted healthcare tools — first need a better evaluation framework. So far, LLMs have “been used in really exciting ways but not really well-vetted ways,” Tamir said.

While some AI-assisted tools, particularly in medical imaging, have undergone rigorous FDA evaluations and earned approval, most haven’t. And because the FDA only regulates algorithms that are considered medical devices, Parikh said that most LLMs used for administrative tasks and efficiency don’t fall under the regulatory agency’s purview.

But these algorithms still have access to patient information and can directly influence patient and doctor decisions. Third-party regulatory agencies are expected to emerge, but it’s still unclear who those will be. Before developers can build a safer and more efficient LLM for healthcare, they’ll need better guidelines and guardrails. “Unless we figure out evaluation, how would we know whether the healthcare-appropriate large language models are better or worse?” Shah asked.
 

A version of this article appeared on Medscape.com.

In seconds, Ravi Parikh, MD, an oncologist at the Emory University School of Medicine in Atlanta, had a summary of his patient’s entire medical history. Normally, Parikh skimmed the cumbersome files before seeing a patient. However, the artificial intelligence (AI) tool his institution was testing could list the highlights he needed in a fraction of the time.

“On the whole, I like it ... it saves me time,” Parikh said of the tool. “But I’d be lying if I told you it was perfect all the time. It’s interpreting the [patient] history in some ways that may be inaccurate,” he said.

Within the first week of testing the tool, Parikh started to notice that the large language model (LLM) made a particular mistake in his patients with prostate cancer. If their prostate-specific antigen test results came back slightly elevated — which is part of normal variation — the LLM recorded it as disease progression. Because Parikh reviews all his notes — with or without using an AI tool — after a visit, he easily caught the mistake before it was added to the chart. “The problem, I think, is if these mistakes go under the hood,” he said.

In the data science world, these mistakes are called hallucinations. And a growing body of research suggests they’re happening more frequently than is safe for healthcare. The industry promised LLMs would alleviate administrative burden and reduce physician burnout. But so far, studies show these AI-tool mistakes often create more work for doctors, not less. To truly help physicians and be safe for patients, some experts say healthcare needs to build its own LLMs from the ground up. And all agree that the field desperately needs a way to vet these algorithms more thoroughly.
 

Prone to Error

Right now, “I think the industry is focused on taking existing LLMs and forcing them into usage for healthcare,” said Nigam H. Shah, MBBS, PhD, chief data scientist for Stanford Health. However, the value of deploying general LLMs in the healthcare space is questionable. “People are starting to wonder if we’re using these tools wrong,” he told this news organization.

In 2023, Shah and his colleagues evaluated seven LLMs on their ability to answer electronic health record–based questions. For realistic tasks, the error rate in the best cases was about 35%, he said. “To me, that rate seems a bit high ... to adopt for routine use.”

A study earlier this year by the UC San Diego School of Medicine showed that using LLMs to respond to patient messages increased the time doctors spent on messages. And this summer, a study by the clinical AI firm Mendel found that when GPT-4o or Llama-3 were used to summarize patient medical records, almost every summary contained at least one type of hallucination.

“We’ve seen cases where a patient does have drug allergies, but the system says ‘no known drug allergies’ ” in the medical history summary, said Wael Salloum, PhD, cofounder and chief science officer at Mendel. “That’s a serious hallucination.” And if physicians have to constantly verify what the system is telling them, that “defeats the purpose [of summarization],” he said.
 

A Higher Quality Diet

Part of the trouble with LLMs is that there’s just not enough high-quality information to feed them. The algorithms are insatiable, requiring vast swaths of data for training. GPT-3.5, for instance, was trained on 570 GB of data from the internet, more than 300 billion words. And to train GPT-4o, OpenAI reportedly transcribed more than 1 million hours of YouTube content.

However, the strategies that built these general LLMs don’t always translate well to healthcare. The internet is full of low-quality or misleading health information from wellness sites and supplement advertisements. And even data that are trustworthy, like the millions of clinical studies and the US Food and Drug Administration (FDA) statements, can be outdated, Salloum said. And “an LLM in training can’t distinguish good from bad,” he added.

The good news is that clinicians don’t rely on controversial information in the real world. Medical knowledge is standardized. “Healthcare is a domain rich with explicit knowledge,” Salloum said. So there’s potential to build a more reliable LLM that is guided by robust medical standards and guidelines.

It’s possible that healthcare could use small language models, which are LLM’s pocket-sized cousins, and perform tasks needing only bite-sized datasets requiring fewer resources and easier fine-tuning, according to Microsoft’s website. Shah said training these smaller models on real medical data might be an option, like an LLM meant to respond to patient messages that could be trained with real messages sent by physicians.

Several groups are already working on databases of standardized human medical knowledge or real physician responses. “Perhaps that will work better than using LLMs trained on the general internet. Those studies need to be done,” Shah said.

Jon Tamir, assistant professor of electrical and computer engineering and co-lead of the AI Health Lab at The University of Texas at Austin, said, “The community has recognized that we are entering a new era of AI where the dataset itself is the most important aspect. We need training sets that are highly curated and highly specialized.

“If the dataset is highly specialized, it will definitely help reduce hallucinations,” he said.
 

Cutting Overconfidence

A major problem with LLM mistakes is that they are often hard to detect. Hallucinations can be highly convincing even if they’re highly inaccurate, according to Tamir.

When Shah, for instance, was recently testing an LLM on de-identified patient data, he asked the LLM which blood test the patient last had. The model responded with “complete blood count [CBC].” But when he asked for the results, the model gave him white blood count and other values. “Turns out that record did not have a CBC done at all! The result was entirely made up,” he said.

Making healthcare LLMs safer and more reliable will mean training AI to acknowledge potential mistakes and uncertainty. Existing LLMs are trained to project confidence and produce a lot of answers, even when there isn’t one, Salloum said. They rarely respond with “I don’t know” even when their prediction has low confidence, he added.

Healthcare stands to benefit from a system that highlights uncertainty and potential errors. For instance, if a patient’s history shows they have smoked, stopped smoking, vaped, and started smoking again. The LLM might call them a smoker but flag the comment as uncertain because the chronology is complicated, Salloum said.

Tamir added that this strategy could improve LLM and doctor collaboration by honing in on where human expertise is needed most.
 

Too Little Evaluation

For any improvement strategy to work, LLMs — and all AI-assisted healthcare tools — first need a better evaluation framework. So far, LLMs have “been used in really exciting ways but not really well-vetted ways,” Tamir said.

While some AI-assisted tools, particularly in medical imaging, have undergone rigorous FDA evaluations and earned approval, most haven’t. And because the FDA only regulates algorithms that are considered medical devices, Parikh said that most LLMs used for administrative tasks and efficiency don’t fall under the regulatory agency’s purview.

But these algorithms still have access to patient information and can directly influence patient and doctor decisions. Third-party regulatory agencies are expected to emerge, but it’s still unclear who those will be. Before developers can build a safer and more efficient LLM for healthcare, they’ll need better guidelines and guardrails. “Unless we figure out evaluation, how would we know whether the healthcare-appropriate large language models are better or worse?” Shah asked.
 

A version of this article appeared on Medscape.com.

From the largest healthcare companies to solo practices, just every organization in medicine faces a risk for costly cyberattacks. In recent years, hackers have threatened to release the personal information of patients and employees — or paralyze online systems — unless they’re paid a ransom.

Should companies pay? It’s not an easy answer, a pair of experts told colleagues in an American Medical Association (AMA) cybersecurity webinar on October 18. It turns out that each choice — pay or don’t pay — can end up being costly.

This is just one of the new challenges facing the American medical system on the cybersecurity front, the speakers said. Others include the possibility that hackers will manipulate patient data — turning a medical test negative, for example, when it’s actually positive — and take advantage of the powers of artificial intelligence (AI).

The AMA held the webinar to educate physicians about cybersecurity risks and defenses, an especially hot topic in the wake of February’s Change Healthcare hack, which cost UnitedHealth Group an estimated $2.5 billion — so far — and deeply disrupted the American healthcare system.

Cautionary tales abound. Greg Garcia, executive director for cybersecurity of the Health Sector Coordinating Council, a coalition of medical industry organizations, pointed to a Pennsylvania clinic that refused to pay a ransom to prevent the release of hundreds of images of patients with breast cancer undressed from the waist up. Garcia told webinar participants that the ransom was $5 million.
 

Risky Choices

While the Federal Bureau of Investigation recommends against paying a ransom, this can be a risky choice, Garcia said. Hackers released the images, and the center has reportedly agreed to settle a class-action lawsuit for $65 million. “They traded $5 million for $60 million,” Garcia added, slightly misstating the settlement amount.

Health systems have been cagey about whether they’ve paid ransoms to prevent private data from being made public in cyberattacks. If a ransom is demanded, “it’s every organization for itself,” Garcia said.

He highlighted the case of a chain of psychiatry practices in Finland that suffered a ransomware attack in 2020. The hackers “contacted the patients and said: ‘Hey, call your clinic and tell them to pay the ransom. Otherwise, we’re going to release all your psychiatric notes to the public.’ ”

Cyberattacks continue. In October, Boston Children’s Health Physicians announced that it had suffered a “ recent security incident” involving data — possibly including Social Security numbers and treatment information — regarding patients and employees. A hacker group reportedly claimed responsibility and wants the system, which boasts more than 300 clinicians, to pay a ransom or else it will release the stolen information.
 

Should Paying Ransom Be a Crime?

Christian Dameff, MD, MS, an emergency medicine physician and director of the Center for Healthcare Cybersecurity at the University of California (UC), San Diego, noted that there are efforts to turn paying ransom into a crime. “If people aren’t paying ransoms, then ransomware operators will move to something else that makes them money.”

Dameff urged colleagues to understand we no longer live in a world where clinicians only bother to think of technology when they call the IT department to help them reset their password.

New challenges face clinicians, he said. “How do we develop better strategies, downtime procedures, and safe clinical care in an era where our vital technology may be gone, not just for an hour or 2, but as is the case with these ransomware attacks, sometimes weeks to months.”

Garcia said “cybersecurity is everybody’s responsibility, including frontline clinicians. Because you’re touching data, you’re touching technology, you’re touching patients, and all of those things combine to present some vulnerabilities in the digital world.”
 

Next Frontier: Hackers May Manipulate Patient Data

Dameff said future hackers may use AI to manipulate individual patient data in ways that threaten patient health. AI makes this easier to accomplish.

“What if I delete your allergies in your electronic health record, or I manipulate your chest x-ray, or I change your lab values so it looks like you’re in diabetic ketoacidosis when you’re not so a clinician gives you insulin when you don’t need it?”

Garcia highlighted another new threat: Phishing efforts that are harder to ignore thanks to AI.

“One of the most successful way that hackers get in, disrupt systems, and steal data is through email phishing, and it’s only going to get better because of artificial intelligence,” he said. “No longer are you going to have typos in that email written by a hacking group in Nigeria or in China. It’s going to be perfect looking.”

What can practices and healthcare systems do? Garcia highlighted federal health agency efforts to encourage organizations to adopt best practices in cybersecurity.

“If you’ve got a data breach, and you can show to the US Department of Health & Human Services [HHS] you have implemented generally recognized cybersecurity controls over the past year, that you have done your best, you did the right thing, and you still got hit, HHS is directed to essentially take it easy on you,” he said. “That’s a positive incentive.”
 

Ransomware Guide in the Works

Dameff said UC San Diego’s Center for Healthcare Cybersecurity plans to publish a free cybersecurity guide in 2025 that will include specific information about ransomware attacks for medical specialties such as cardiology, trauma surgery, and pediatrics.

“Then, should you ever be ransomed, you can pull out this guide. You’ll know what’s going to kind of happen, and you can better prepare for those effects.”

Will the future president prioritize healthcare cybersecurity? That remains to be seen, but crises do have the capacity to concentrate the mind, experts said.

The nation’s capital “has a very short memory, a short attention span. The policymakers tend to be reactive,” Dameff said. “All it takes is yet another Change Healthcare–like attack that disrupts 30% or more of the nation’s healthcare system for the policymakers to sit up, take notice, and try to come up with solutions.”

In addition, he said, an estimated two data breaches/ransomware attacks are occurring per day. “The fact is that we’re all patients, up to the President of the United States and every member of the Congress is a patient.”

There’s a “very existential, very palpable understanding that cyber safety is patient safety and cyber insecurity is patient insecurity,” Dameff said.

A version of this article appeared on Medscape.com.

From the largest healthcare companies to solo practices, just every organization in medicine faces a risk for costly cyberattacks. In recent years, hackers have threatened to release the personal information of patients and employees — or paralyze online systems — unless they’re paid a ransom.

Should companies pay? It’s not an easy answer, a pair of experts told colleagues in an American Medical Association (AMA) cybersecurity webinar on October 18. It turns out that each choice — pay or don’t pay — can end up being costly.

This is just one of the new challenges facing the American medical system on the cybersecurity front, the speakers said. Others include the possibility that hackers will manipulate patient data — turning a medical test negative, for example, when it’s actually positive — and take advantage of the powers of artificial intelligence (AI).

The AMA held the webinar to educate physicians about cybersecurity risks and defenses, an especially hot topic in the wake of February’s Change Healthcare hack, which cost UnitedHealth Group an estimated $2.5 billion — so far — and deeply disrupted the American healthcare system.

Cautionary tales abound. Greg Garcia, executive director for cybersecurity of the Health Sector Coordinating Council, a coalition of medical industry organizations, pointed to a Pennsylvania clinic that refused to pay a ransom to prevent the release of hundreds of images of patients with breast cancer undressed from the waist up. Garcia told webinar participants that the ransom was $5 million.
 

Risky Choices

While the Federal Bureau of Investigation recommends against paying a ransom, this can be a risky choice, Garcia said. Hackers released the images, and the center has reportedly agreed to settle a class-action lawsuit for $65 million. “They traded $5 million for $60 million,” Garcia added, slightly misstating the settlement amount.

Health systems have been cagey about whether they’ve paid ransoms to prevent private data from being made public in cyberattacks. If a ransom is demanded, “it’s every organization for itself,” Garcia said.

He highlighted the case of a chain of psychiatry practices in Finland that suffered a ransomware attack in 2020. The hackers “contacted the patients and said: ‘Hey, call your clinic and tell them to pay the ransom. Otherwise, we’re going to release all your psychiatric notes to the public.’ ”

Cyberattacks continue. In October, Boston Children’s Health Physicians announced that it had suffered a “ recent security incident” involving data — possibly including Social Security numbers and treatment information — regarding patients and employees. A hacker group reportedly claimed responsibility and wants the system, which boasts more than 300 clinicians, to pay a ransom or else it will release the stolen information.
 

Should Paying Ransom Be a Crime?

Christian Dameff, MD, MS, an emergency medicine physician and director of the Center for Healthcare Cybersecurity at the University of California (UC), San Diego, noted that there are efforts to turn paying ransom into a crime. “If people aren’t paying ransoms, then ransomware operators will move to something else that makes them money.”

Dameff urged colleagues to understand we no longer live in a world where clinicians only bother to think of technology when they call the IT department to help them reset their password.

New challenges face clinicians, he said. “How do we develop better strategies, downtime procedures, and safe clinical care in an era where our vital technology may be gone, not just for an hour or 2, but as is the case with these ransomware attacks, sometimes weeks to months.”

Garcia said “cybersecurity is everybody’s responsibility, including frontline clinicians. Because you’re touching data, you’re touching technology, you’re touching patients, and all of those things combine to present some vulnerabilities in the digital world.”
 

Next Frontier: Hackers May Manipulate Patient Data

Dameff said future hackers may use AI to manipulate individual patient data in ways that threaten patient health. AI makes this easier to accomplish.

“What if I delete your allergies in your electronic health record, or I manipulate your chest x-ray, or I change your lab values so it looks like you’re in diabetic ketoacidosis when you’re not so a clinician gives you insulin when you don’t need it?”

Garcia highlighted another new threat: Phishing efforts that are harder to ignore thanks to AI.

“One of the most successful way that hackers get in, disrupt systems, and steal data is through email phishing, and it’s only going to get better because of artificial intelligence,” he said. “No longer are you going to have typos in that email written by a hacking group in Nigeria or in China. It’s going to be perfect looking.”

What can practices and healthcare systems do? Garcia highlighted federal health agency efforts to encourage organizations to adopt best practices in cybersecurity.

“If you’ve got a data breach, and you can show to the US Department of Health & Human Services [HHS] you have implemented generally recognized cybersecurity controls over the past year, that you have done your best, you did the right thing, and you still got hit, HHS is directed to essentially take it easy on you,” he said. “That’s a positive incentive.”
 

Ransomware Guide in the Works

Dameff said UC San Diego’s Center for Healthcare Cybersecurity plans to publish a free cybersecurity guide in 2025 that will include specific information about ransomware attacks for medical specialties such as cardiology, trauma surgery, and pediatrics.

“Then, should you ever be ransomed, you can pull out this guide. You’ll know what’s going to kind of happen, and you can better prepare for those effects.”

Will the future president prioritize healthcare cybersecurity? That remains to be seen, but crises do have the capacity to concentrate the mind, experts said.

The nation’s capital “has a very short memory, a short attention span. The policymakers tend to be reactive,” Dameff said. “All it takes is yet another Change Healthcare–like attack that disrupts 30% or more of the nation’s healthcare system for the policymakers to sit up, take notice, and try to come up with solutions.”

In addition, he said, an estimated two data breaches/ransomware attacks are occurring per day. “The fact is that we’re all patients, up to the President of the United States and every member of the Congress is a patient.”

There’s a “very existential, very palpable understanding that cyber safety is patient safety and cyber insecurity is patient insecurity,” Dameff said.

A version of this article appeared on Medscape.com.

From the largest healthcare companies to solo practices, just every organization in medicine faces a risk for costly cyberattacks. In recent years, hackers have threatened to release the personal information of patients and employees — or paralyze online systems — unless they’re paid a ransom.

Should companies pay? It’s not an easy answer, a pair of experts told colleagues in an American Medical Association (AMA) cybersecurity webinar on October 18. It turns out that each choice — pay or don’t pay — can end up being costly.

This is just one of the new challenges facing the American medical system on the cybersecurity front, the speakers said. Others include the possibility that hackers will manipulate patient data — turning a medical test negative, for example, when it’s actually positive — and take advantage of the powers of artificial intelligence (AI).

The AMA held the webinar to educate physicians about cybersecurity risks and defenses, an especially hot topic in the wake of February’s Change Healthcare hack, which cost UnitedHealth Group an estimated $2.5 billion — so far — and deeply disrupted the American healthcare system.

Cautionary tales abound. Greg Garcia, executive director for cybersecurity of the Health Sector Coordinating Council, a coalition of medical industry organizations, pointed to a Pennsylvania clinic that refused to pay a ransom to prevent the release of hundreds of images of patients with breast cancer undressed from the waist up. Garcia told webinar participants that the ransom was $5 million.
 

Risky Choices

While the Federal Bureau of Investigation recommends against paying a ransom, this can be a risky choice, Garcia said. Hackers released the images, and the center has reportedly agreed to settle a class-action lawsuit for $65 million. “They traded $5 million for $60 million,” Garcia added, slightly misstating the settlement amount.

Health systems have been cagey about whether they’ve paid ransoms to prevent private data from being made public in cyberattacks. If a ransom is demanded, “it’s every organization for itself,” Garcia said.

He highlighted the case of a chain of psychiatry practices in Finland that suffered a ransomware attack in 2020. The hackers “contacted the patients and said: ‘Hey, call your clinic and tell them to pay the ransom. Otherwise, we’re going to release all your psychiatric notes to the public.’ ”

Cyberattacks continue. In October, Boston Children’s Health Physicians announced that it had suffered a “ recent security incident” involving data — possibly including Social Security numbers and treatment information — regarding patients and employees. A hacker group reportedly claimed responsibility and wants the system, which boasts more than 300 clinicians, to pay a ransom or else it will release the stolen information.
 

Should Paying Ransom Be a Crime?

Christian Dameff, MD, MS, an emergency medicine physician and director of the Center for Healthcare Cybersecurity at the University of California (UC), San Diego, noted that there are efforts to turn paying ransom into a crime. “If people aren’t paying ransoms, then ransomware operators will move to something else that makes them money.”

Dameff urged colleagues to understand we no longer live in a world where clinicians only bother to think of technology when they call the IT department to help them reset their password.

New challenges face clinicians, he said. “How do we develop better strategies, downtime procedures, and safe clinical care in an era where our vital technology may be gone, not just for an hour or 2, but as is the case with these ransomware attacks, sometimes weeks to months.”

Garcia said “cybersecurity is everybody’s responsibility, including frontline clinicians. Because you’re touching data, you’re touching technology, you’re touching patients, and all of those things combine to present some vulnerabilities in the digital world.”
 

Next Frontier: Hackers May Manipulate Patient Data

Dameff said future hackers may use AI to manipulate individual patient data in ways that threaten patient health. AI makes this easier to accomplish.

“What if I delete your allergies in your electronic health record, or I manipulate your chest x-ray, or I change your lab values so it looks like you’re in diabetic ketoacidosis when you’re not so a clinician gives you insulin when you don’t need it?”

Garcia highlighted another new threat: Phishing efforts that are harder to ignore thanks to AI.

“One of the most successful way that hackers get in, disrupt systems, and steal data is through email phishing, and it’s only going to get better because of artificial intelligence,” he said. “No longer are you going to have typos in that email written by a hacking group in Nigeria or in China. It’s going to be perfect looking.”

What can practices and healthcare systems do? Garcia highlighted federal health agency efforts to encourage organizations to adopt best practices in cybersecurity.

“If you’ve got a data breach, and you can show to the US Department of Health & Human Services [HHS] you have implemented generally recognized cybersecurity controls over the past year, that you have done your best, you did the right thing, and you still got hit, HHS is directed to essentially take it easy on you,” he said. “That’s a positive incentive.”
 

Ransomware Guide in the Works

Dameff said UC San Diego’s Center for Healthcare Cybersecurity plans to publish a free cybersecurity guide in 2025 that will include specific information about ransomware attacks for medical specialties such as cardiology, trauma surgery, and pediatrics.

“Then, should you ever be ransomed, you can pull out this guide. You’ll know what’s going to kind of happen, and you can better prepare for those effects.”

Will the future president prioritize healthcare cybersecurity? That remains to be seen, but crises do have the capacity to concentrate the mind, experts said.

The nation’s capital “has a very short memory, a short attention span. The policymakers tend to be reactive,” Dameff said. “All it takes is yet another Change Healthcare–like attack that disrupts 30% or more of the nation’s healthcare system for the policymakers to sit up, take notice, and try to come up with solutions.”

In addition, he said, an estimated two data breaches/ransomware attacks are occurring per day. “The fact is that we’re all patients, up to the President of the United States and every member of the Congress is a patient.”

There’s a “very existential, very palpable understanding that cyber safety is patient safety and cyber insecurity is patient insecurity,” Dameff said.

A version of this article appeared on Medscape.com.

TOPLINE:

The extended-release fluticasone propionate injection (EP-104IAR) significantly reduces knee osteoarthritis (OA) pain over 12 weeks, compared with a vehicle control, with no serious treatment-related adverse events.

METHODOLOGY:

• EP-104IAR utilizes a novel diffusion-based extended-release technology to optimize the action of fluticasone propionate.
• The researchers conducted a phase 2 trial at 12 research sites in Denmark, Poland, and the Czech Republic to assess the clinical efficacy, pharmacokinetics, and safety of EP-104IAR in 318 participants (58% women; 99% White) with a diagnosis of primary knee OA.
• Eligible patients, with a score of at least 4 out of 10 on the Western Ontario and McMaster Universities Arthritis Index (WOMAC) pain rating scale, were randomly assigned to receive either 25 mg EP-104IAR (n = 163; mean age, 64 years) or a vehicle control (n = 155; mean age, 63.2 years).
• The primary outcome was the between-group difference in the change in the WOMAC pain score from baseline to week 12.

TAKEAWAY:

• The reduction in WOMAC pain scores from baseline to week 12 was significantly higher with EP-104IAR than with a vehicle control (between-group difference, −0.66; P = .0044), with the difference maintained through week 14.
• The treatment resulted in a significant improvement in WOMAC function scores (P = .014) and the area under the curve for changes in the WOMAC pain score (P < .0001) over 12 weeks.
• Treatment-emergent adverse events were noted in 9% of participants in the EP-104IAR group and 7% of participants in the vehicle control group. No serious treatment-related adverse events or discontinuations related to EP-104IAR were reported.
• Fluticasone propionate levels were maintained at around 66% to 33% of peak values between weeks 2 and 24 at near-constant levels. The effects on glucose and cortisol levels were minimal and transient.

IN PRACTICE:

“The results of this trial show that EP-104IAR has the potential for clinically meaningful benefit in reducing knee osteoarthritis pain, addressing a substantial unmet medical need,” the authors wrote. “Additionally, the stable delivery of fluticasone propionate over an extended period with fewer systemic and local side effects than other corticosteroid treatments for knee osteoarthritis support the possibility of bilateral and repeat dosing.”

SOURCE:

The study was led by Amanda Malone, PhD, Eupraxia Pharmaceuticals, Victoria, British Columbia, Canada. It was published online in The Lancet Rheumatology.

LIMITATIONS:

The study’s generalizability may be limited because of the predominantly White participant population. The success of masking was not evaluated, and the treatment was administered by an unmasked injector. Efficacy outcomes were patient-reported, with no objective measurement of knee function.

DISCLOSURES:

This study was supported by Eupraxia Pharmaceuticals. Some authors disclosed their employment with Eupraxia Pharmaceuticals or with companies contracted by Eupraxia Pharmaceuticals for clinical research and trial and data management. One author reported serving as a consultant or participating in a speakers’ bureau. Another reported being on the board of directors for Eupraxia Pharmaceuticals and receiving royalties from a medical technology company.

This article was created using several editorial tools, including artificial intelligence, as part of the process. Human editors reviewed this content before publication. A version of this article appeared on Medscape.com.

TOPLINE:

The extended-release fluticasone propionate injection (EP-104IAR) significantly reduces knee osteoarthritis (OA) pain over 12 weeks, compared with a vehicle control, with no serious treatment-related adverse events.

METHODOLOGY:

• EP-104IAR utilizes a novel diffusion-based extended-release technology to optimize the action of fluticasone propionate.
• The researchers conducted a phase 2 trial at 12 research sites in Denmark, Poland, and the Czech Republic to assess the clinical efficacy, pharmacokinetics, and safety of EP-104IAR in 318 participants (58% women; 99% White) with a diagnosis of primary knee OA.
• Eligible patients, with a score of at least 4 out of 10 on the Western Ontario and McMaster Universities Arthritis Index (WOMAC) pain rating scale, were randomly assigned to receive either 25 mg EP-104IAR (n = 163; mean age, 64 years) or a vehicle control (n = 155; mean age, 63.2 years).
• The primary outcome was the between-group difference in the change in the WOMAC pain score from baseline to week 12.

TAKEAWAY:

• The reduction in WOMAC pain scores from baseline to week 12 was significantly higher with EP-104IAR than with a vehicle control (between-group difference, −0.66; P = .0044), with the difference maintained through week 14.
• The treatment resulted in a significant improvement in WOMAC function scores (P = .014) and the area under the curve for changes in the WOMAC pain score (P < .0001) over 12 weeks.
• Treatment-emergent adverse events were noted in 9% of participants in the EP-104IAR group and 7% of participants in the vehicle control group. No serious treatment-related adverse events or discontinuations related to EP-104IAR were reported.
• Fluticasone propionate levels were maintained at around 66% to 33% of peak values between weeks 2 and 24 at near-constant levels. The effects on glucose and cortisol levels were minimal and transient.

IN PRACTICE:

“The results of this trial show that EP-104IAR has the potential for clinically meaningful benefit in reducing knee osteoarthritis pain, addressing a substantial unmet medical need,” the authors wrote. “Additionally, the stable delivery of fluticasone propionate over an extended period with fewer systemic and local side effects than other corticosteroid treatments for knee osteoarthritis support the possibility of bilateral and repeat dosing.”

SOURCE:

The study was led by Amanda Malone, PhD, Eupraxia Pharmaceuticals, Victoria, British Columbia, Canada. It was published online in The Lancet Rheumatology.

LIMITATIONS:

The study’s generalizability may be limited because of the predominantly White participant population. The success of masking was not evaluated, and the treatment was administered by an unmasked injector. Efficacy outcomes were patient-reported, with no objective measurement of knee function.

DISCLOSURES:

This study was supported by Eupraxia Pharmaceuticals. Some authors disclosed their employment with Eupraxia Pharmaceuticals or with companies contracted by Eupraxia Pharmaceuticals for clinical research and trial and data management. One author reported serving as a consultant or participating in a speakers’ bureau. Another reported being on the board of directors for Eupraxia Pharmaceuticals and receiving royalties from a medical technology company.

This article was created using several editorial tools, including artificial intelligence, as part of the process. Human editors reviewed this content before publication. A version of this article appeared on Medscape.com.

TOPLINE:

The extended-release fluticasone propionate injection (EP-104IAR) significantly reduces knee osteoarthritis (OA) pain over 12 weeks, compared with a vehicle control, with no serious treatment-related adverse events.

METHODOLOGY:

• EP-104IAR utilizes a novel diffusion-based extended-release technology to optimize the action of fluticasone propionate.
• The researchers conducted a phase 2 trial at 12 research sites in Denmark, Poland, and the Czech Republic to assess the clinical efficacy, pharmacokinetics, and safety of EP-104IAR in 318 participants (58% women; 99% White) with a diagnosis of primary knee OA.
• Eligible patients, with a score of at least 4 out of 10 on the Western Ontario and McMaster Universities Arthritis Index (WOMAC) pain rating scale, were randomly assigned to receive either 25 mg EP-104IAR (n = 163; mean age, 64 years) or a vehicle control (n = 155; mean age, 63.2 years).
• The primary outcome was the between-group difference in the change in the WOMAC pain score from baseline to week 12.

TAKEAWAY:

• The reduction in WOMAC pain scores from baseline to week 12 was significantly higher with EP-104IAR than with a vehicle control (between-group difference, −0.66; P = .0044), with the difference maintained through week 14.
• The treatment resulted in a significant improvement in WOMAC function scores (P = .014) and the area under the curve for changes in the WOMAC pain score (P < .0001) over 12 weeks.
• Treatment-emergent adverse events were noted in 9% of participants in the EP-104IAR group and 7% of participants in the vehicle control group. No serious treatment-related adverse events or discontinuations related to EP-104IAR were reported.
• Fluticasone propionate levels were maintained at around 66% to 33% of peak values between weeks 2 and 24 at near-constant levels. The effects on glucose and cortisol levels were minimal and transient.

IN PRACTICE:

“The results of this trial show that EP-104IAR has the potential for clinically meaningful benefit in reducing knee osteoarthritis pain, addressing a substantial unmet medical need,” the authors wrote. “Additionally, the stable delivery of fluticasone propionate over an extended period with fewer systemic and local side effects than other corticosteroid treatments for knee osteoarthritis support the possibility of bilateral and repeat dosing.”

SOURCE:

The study was led by Amanda Malone, PhD, Eupraxia Pharmaceuticals, Victoria, British Columbia, Canada. It was published online in The Lancet Rheumatology.

LIMITATIONS:

The study’s generalizability may be limited because of the predominantly White participant population. The success of masking was not evaluated, and the treatment was administered by an unmasked injector. Efficacy outcomes were patient-reported, with no objective measurement of knee function.

DISCLOSURES:

This study was supported by Eupraxia Pharmaceuticals. Some authors disclosed their employment with Eupraxia Pharmaceuticals or with companies contracted by Eupraxia Pharmaceuticals for clinical research and trial and data management. One author reported serving as a consultant or participating in a speakers’ bureau. Another reported being on the board of directors for Eupraxia Pharmaceuticals and receiving royalties from a medical technology company.

This article was created using several editorial tools, including artificial intelligence, as part of the process. Human editors reviewed this content before publication. A version of this article appeared on Medscape.com.

As a physician, you might be contacted by the media to provide your professional opinion and advice. Or you might be looking for media interview opportunities to market your practice or side project. And if you do research, media interviews can be an effective way to spread the word. It’s important to prepare for a media interview so that you achieve the outcome you are looking for. Here are six tips I learned from writing health articles, interviewing experts, and being interviewed myself. 

Keep your message simple. When you are a subject expert, you might think that the basics are obvious or even boring, and that the nuances are more important. However, most of the audience is looking for big-picture information that they can apply to their lives. Consider a few key takeaways, keeping in mind that your interview is likely to be edited to short sound bites or a few quotes. It may help to jot down notes so that you cover the fundamentals clearly. You could even write and rehearse a script beforehand. If there is something complicated or subtle that you want to convey, you can preface it by saying, “This is confusing but very important …” to let the audience know to give extra consideration to what you are about to say.

Avoid extremes and hyperbole. Sometimes, exaggerated statements make their way into medical discussions. Statements such as “it doesn’t matter how many calories you consume — it’s all about the quality” are common oversimplifications. But you might be upset to see your name next to a comment like this because it is not actually correct. Check the phrasing of your key takeaways to avoid being stuck defending or explaining an inaccurate statement when your patients ask you about it later. 

Ask the interviewers what they are looking for. Many medical topics have some controversial element, so it is good to know what you’re getting into. Find out the purpose of the article or interview before you decide whether it is right for you. It could be about another doctor in town who is being sued; if you don’t want to be associated with that story, it might be best to decline the interview. 

Explain your goals. You might accept or pursue an interview to raise awareness about an underrecognized condition. You might want the public to identify and get help for early symptoms, or you might want to create empathy for people coping with a disease you treat. Consider why you are participating in an interview, and communicate that to the interviewer to ensure that your objective can be part of the final product. 

Know whom you’re dealing with. It is good to learn about the publication/media channel before you agree to participate. It may have a political bias, or perhaps the interview is intended to promote a specific product. If you agree with and support their purposes, then you may be happy to lend your opinion. But learning about the “voice” of the publication in advance allows you to make an informed decision about whether you want to be identified with a particular political ideology or product endorsement.

Ask to see your quotes before publication. It’s good to have the opportunity to make corrections in case you are accidentally misquoted or misunderstood. It is best to ask to see quotes before you agree to the interview. Some reporters may agree to (or even prefer) a written question-and-answer format so that they can directly quote your responses without rephrasing your words. You could suggest this, especially if you are too busy for a call or live meeting.

As a physician, your insights and advice can be highly beneficial to others. You can also use media interviews to propel your career forward. Doing your homework can ensure that you will be pleased with the final product and how your words were used. 
 

Dr. Moawad, Clinical Assistant Professor, Department of Medical Education, Case Western Reserve University School of Medicine, Cleveland, Ohio, has disclosed no relevant financial relationships.

A version of this article appeared on Medscape.com.

As a physician, you might be contacted by the media to provide your professional opinion and advice. Or you might be looking for media interview opportunities to market your practice or side project. And if you do research, media interviews can be an effective way to spread the word. It’s important to prepare for a media interview so that you achieve the outcome you are looking for. Here are six tips I learned from writing health articles, interviewing experts, and being interviewed myself. 

Keep your message simple. When you are a subject expert, you might think that the basics are obvious or even boring, and that the nuances are more important. However, most of the audience is looking for big-picture information that they can apply to their lives. Consider a few key takeaways, keeping in mind that your interview is likely to be edited to short sound bites or a few quotes. It may help to jot down notes so that you cover the fundamentals clearly. You could even write and rehearse a script beforehand. If there is something complicated or subtle that you want to convey, you can preface it by saying, “This is confusing but very important …” to let the audience know to give extra consideration to what you are about to say.

Avoid extremes and hyperbole. Sometimes, exaggerated statements make their way into medical discussions. Statements such as “it doesn’t matter how many calories you consume — it’s all about the quality” are common oversimplifications. But you might be upset to see your name next to a comment like this because it is not actually correct. Check the phrasing of your key takeaways to avoid being stuck defending or explaining an inaccurate statement when your patients ask you about it later. 

Ask the interviewers what they are looking for. Many medical topics have some controversial element, so it is good to know what you’re getting into. Find out the purpose of the article or interview before you decide whether it is right for you. It could be about another doctor in town who is being sued; if you don’t want to be associated with that story, it might be best to decline the interview. 

Explain your goals. You might accept or pursue an interview to raise awareness about an underrecognized condition. You might want the public to identify and get help for early symptoms, or you might want to create empathy for people coping with a disease you treat. Consider why you are participating in an interview, and communicate that to the interviewer to ensure that your objective can be part of the final product. 

Know whom you’re dealing with. It is good to learn about the publication/media channel before you agree to participate. It may have a political bias, or perhaps the interview is intended to promote a specific product. If you agree with and support their purposes, then you may be happy to lend your opinion. But learning about the “voice” of the publication in advance allows you to make an informed decision about whether you want to be identified with a particular political ideology or product endorsement.

Ask to see your quotes before publication. It’s good to have the opportunity to make corrections in case you are accidentally misquoted or misunderstood. It is best to ask to see quotes before you agree to the interview. Some reporters may agree to (or even prefer) a written question-and-answer format so that they can directly quote your responses without rephrasing your words. You could suggest this, especially if you are too busy for a call or live meeting.

As a physician, your insights and advice can be highly beneficial to others. You can also use media interviews to propel your career forward. Doing your homework can ensure that you will be pleased with the final product and how your words were used. 
 

Dr. Moawad, Clinical Assistant Professor, Department of Medical Education, Case Western Reserve University School of Medicine, Cleveland, Ohio, has disclosed no relevant financial relationships.

A version of this article appeared on Medscape.com.

As a physician, you might be contacted by the media to provide your professional opinion and advice. Or you might be looking for media interview opportunities to market your practice or side project. And if you do research, media interviews can be an effective way to spread the word. It’s important to prepare for a media interview so that you achieve the outcome you are looking for. Here are six tips I learned from writing health articles, interviewing experts, and being interviewed myself. 

Keep your message simple. When you are a subject expert, you might think that the basics are obvious or even boring, and that the nuances are more important. However, most of the audience is looking for big-picture information that they can apply to their lives. Consider a few key takeaways, keeping in mind that your interview is likely to be edited to short sound bites or a few quotes. It may help to jot down notes so that you cover the fundamentals clearly. You could even write and rehearse a script beforehand. If there is something complicated or subtle that you want to convey, you can preface it by saying, “This is confusing but very important …” to let the audience know to give extra consideration to what you are about to say.

Avoid extremes and hyperbole. Sometimes, exaggerated statements make their way into medical discussions. Statements such as “it doesn’t matter how many calories you consume — it’s all about the quality” are common oversimplifications. But you might be upset to see your name next to a comment like this because it is not actually correct. Check the phrasing of your key takeaways to avoid being stuck defending or explaining an inaccurate statement when your patients ask you about it later. 

Ask the interviewers what they are looking for. Many medical topics have some controversial element, so it is good to know what you’re getting into. Find out the purpose of the article or interview before you decide whether it is right for you. It could be about another doctor in town who is being sued; if you don’t want to be associated with that story, it might be best to decline the interview. 

Explain your goals. You might accept or pursue an interview to raise awareness about an underrecognized condition. You might want the public to identify and get help for early symptoms, or you might want to create empathy for people coping with a disease you treat. Consider why you are participating in an interview, and communicate that to the interviewer to ensure that your objective can be part of the final product. 

Know whom you’re dealing with. It is good to learn about the publication/media channel before you agree to participate. It may have a political bias, or perhaps the interview is intended to promote a specific product. If you agree with and support their purposes, then you may be happy to lend your opinion. But learning about the “voice” of the publication in advance allows you to make an informed decision about whether you want to be identified with a particular political ideology or product endorsement.

Ask to see your quotes before publication. It’s good to have the opportunity to make corrections in case you are accidentally misquoted or misunderstood. It is best to ask to see quotes before you agree to the interview. Some reporters may agree to (or even prefer) a written question-and-answer format so that they can directly quote your responses without rephrasing your words. You could suggest this, especially if you are too busy for a call or live meeting.

As a physician, your insights and advice can be highly beneficial to others. You can also use media interviews to propel your career forward. Doing your homework can ensure that you will be pleased with the final product and how your words were used. 
 

Dr. Moawad, Clinical Assistant Professor, Department of Medical Education, Case Western Reserve University School of Medicine, Cleveland, Ohio, has disclosed no relevant financial relationships.

A version of this article appeared on Medscape.com.

TOPLINE:

Allogeneic bone marrow–derived mesenchymal stromal cells (BM-MSCs) are safe but do not show efficacy in treating intervertebral disc degeneration (IDD) in patients with chronic low back pain.

METHODOLOGY:

• The RESPINE trial assessed the efficacy and safety of a single intradiscal injection of allogeneic BM-MSCs in the treatment of chronic low back pain caused by single-level IDD.
• Overall, 114 patients (mean age, 40.9 years; 35% women) with IDD-associated chronic low back pain that was persistent for 3 months or more despite conventional medical therapy and without previous surgery, were recruited across four European countries from April 2018 to April 2021 and randomly assigned to receive either intradiscal injections of allogeneic BM-MSCs (n = 58) or sham injections (n = 56).
• The first co-primary endpoint was the rate of response to BM-MSC injections at 12 months after treatment, defined as improvement of at least 20% or 20 mm in the Visual Analog Scale for pain or improvement of at least 20% in the Oswestry Disability Index for functional status.
• The secondary co-primary endpoint was structural efficacy, based on disc fluid content measured by quantitative T2 MRI between baseline and month 12.

TAKEAWAY:

• At 12 months post-intervention, 74% of patients in the BM-MSC group were classified as responders compared with 68.8% in the placebo group. However, the difference between the groups was not statistically significant.
• The probability of being a responder was higher in the BM-MSC group than in the sham group; however, the findings did not reach statistical significance.
• The average change in disc fluid content, indicative of disc regeneration, from baseline to 12 months was 37.9% in the BM-MSC group and 41.7% in the placebo group, with no significant difference between the groups.
• The incidence of adverse events and serious adverse events was not significantly different between the treatment groups.

IN PRACTICE:

“BM-MSC represents a promising opportunity for the biological treatment of IDD, but only high-quality randomized controlled trials, comparing it to standard care, can determine whether it is a truly effective alternative to spine fusion or disc replacement,” the authors wrote.

SOURCE:

The study was led by Yves-Marie Pers, MD, PhD, Clinical Immunology and Osteoarticular Diseases Therapeutic Unit, CHRU Lapeyronie, Montpellier, France. It was published online on October 11, 2024, in Annals of the Rheumatic Diseases.

LIMITATIONS:

MRI results were collected from only 55 patients across both trial arms, which may have affected the statistical power of the findings. Although patients were monitored for up to 24 months, the long-term efficacy and safety of BM-MSC therapy for IDD may not have been fully captured. Selection bias could not be excluded because of the difficulty in accurately identifying patients with chronic low back pain caused by single-level IDD.

DISCLOSURES:

The study was funded by the European Union’s Horizon 2020 Research and Innovation Programme. The authors declared no conflicts of interest.

This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication. A version of this article appeared on Medscape.com.

TOPLINE:

Allogeneic bone marrow–derived mesenchymal stromal cells (BM-MSCs) are safe but do not show efficacy in treating intervertebral disc degeneration (IDD) in patients with chronic low back pain.

METHODOLOGY:

• The RESPINE trial assessed the efficacy and safety of a single intradiscal injection of allogeneic BM-MSCs in the treatment of chronic low back pain caused by single-level IDD.
• Overall, 114 patients (mean age, 40.9 years; 35% women) with IDD-associated chronic low back pain that was persistent for 3 months or more despite conventional medical therapy and without previous surgery, were recruited across four European countries from April 2018 to April 2021 and randomly assigned to receive either intradiscal injections of allogeneic BM-MSCs (n = 58) or sham injections (n = 56).
• The first co-primary endpoint was the rate of response to BM-MSC injections at 12 months after treatment, defined as improvement of at least 20% or 20 mm in the Visual Analog Scale for pain or improvement of at least 20% in the Oswestry Disability Index for functional status.
• The secondary co-primary endpoint was structural efficacy, based on disc fluid content measured by quantitative T2 MRI between baseline and month 12.

TAKEAWAY:

• At 12 months post-intervention, 74% of patients in the BM-MSC group were classified as responders compared with 68.8% in the placebo group. However, the difference between the groups was not statistically significant.
• The probability of being a responder was higher in the BM-MSC group than in the sham group; however, the findings did not reach statistical significance.
• The average change in disc fluid content, indicative of disc regeneration, from baseline to 12 months was 37.9% in the BM-MSC group and 41.7% in the placebo group, with no significant difference between the groups.
• The incidence of adverse events and serious adverse events was not significantly different between the treatment groups.

IN PRACTICE:

“BM-MSC represents a promising opportunity for the biological treatment of IDD, but only high-quality randomized controlled trials, comparing it to standard care, can determine whether it is a truly effective alternative to spine fusion or disc replacement,” the authors wrote.

SOURCE:

The study was led by Yves-Marie Pers, MD, PhD, Clinical Immunology and Osteoarticular Diseases Therapeutic Unit, CHRU Lapeyronie, Montpellier, France. It was published online on October 11, 2024, in Annals of the Rheumatic Diseases.

LIMITATIONS:

MRI results were collected from only 55 patients across both trial arms, which may have affected the statistical power of the findings. Although patients were monitored for up to 24 months, the long-term efficacy and safety of BM-MSC therapy for IDD may not have been fully captured. Selection bias could not be excluded because of the difficulty in accurately identifying patients with chronic low back pain caused by single-level IDD.

DISCLOSURES:

The study was funded by the European Union’s Horizon 2020 Research and Innovation Programme. The authors declared no conflicts of interest.

This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication. A version of this article appeared on Medscape.com.

TOPLINE:

Allogeneic bone marrow–derived mesenchymal stromal cells (BM-MSCs) are safe but do not show efficacy in treating intervertebral disc degeneration (IDD) in patients with chronic low back pain.

METHODOLOGY:

• The RESPINE trial assessed the efficacy and safety of a single intradiscal injection of allogeneic BM-MSCs in the treatment of chronic low back pain caused by single-level IDD.
• Overall, 114 patients (mean age, 40.9 years; 35% women) with IDD-associated chronic low back pain that was persistent for 3 months or more despite conventional medical therapy and without previous surgery, were recruited across four European countries from April 2018 to April 2021 and randomly assigned to receive either intradiscal injections of allogeneic BM-MSCs (n = 58) or sham injections (n = 56).
• The first co-primary endpoint was the rate of response to BM-MSC injections at 12 months after treatment, defined as improvement of at least 20% or 20 mm in the Visual Analog Scale for pain or improvement of at least 20% in the Oswestry Disability Index for functional status.
• The secondary co-primary endpoint was structural efficacy, based on disc fluid content measured by quantitative T2 MRI between baseline and month 12.

TAKEAWAY:

• At 12 months post-intervention, 74% of patients in the BM-MSC group were classified as responders compared with 68.8% in the placebo group. However, the difference between the groups was not statistically significant.
• The probability of being a responder was higher in the BM-MSC group than in the sham group; however, the findings did not reach statistical significance.
• The average change in disc fluid content, indicative of disc regeneration, from baseline to 12 months was 37.9% in the BM-MSC group and 41.7% in the placebo group, with no significant difference between the groups.
• The incidence of adverse events and serious adverse events was not significantly different between the treatment groups.

IN PRACTICE:

“BM-MSC represents a promising opportunity for the biological treatment of IDD, but only high-quality randomized controlled trials, comparing it to standard care, can determine whether it is a truly effective alternative to spine fusion or disc replacement,” the authors wrote.

SOURCE:

The study was led by Yves-Marie Pers, MD, PhD, Clinical Immunology and Osteoarticular Diseases Therapeutic Unit, CHRU Lapeyronie, Montpellier, France. It was published online on October 11, 2024, in Annals of the Rheumatic Diseases.

LIMITATIONS:

MRI results were collected from only 55 patients across both trial arms, which may have affected the statistical power of the findings. Although patients were monitored for up to 24 months, the long-term efficacy and safety of BM-MSC therapy for IDD may not have been fully captured. Selection bias could not be excluded because of the difficulty in accurately identifying patients with chronic low back pain caused by single-level IDD.

DISCLOSURES:

The study was funded by the European Union’s Horizon 2020 Research and Innovation Programme. The authors declared no conflicts of interest.

This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication. A version of this article appeared on Medscape.com.

The US Food and Drug Administration (FDA) has announced a voluntary manufacturer-initiated recall of more than 7000 bottles of duloxetine delayed-release capsules due to unacceptable levels of a potential carcinogen.

Duloxetine (Cymbalta) is a serotonin-norepinephrine reuptake inhibitor used to treat major depressive disorder, generalized anxiety disorder, fibromyalgia, chronic musculoskeletal pain, and neuropathic pain associated with diabetic peripheral neuropathy.

The recall is due to the detection of the nitrosamine impurity, N-nitroso duloxetine, above the proposed interim limit.

Nitrosamines are common in water and foods, and exposure to some levels of the chemical is common. Exposure to nitrosamine impurities above acceptable levels and over long periods may increase cancer risk, the FDA reported.

“If drugs contain levels of nitrosamines above the acceptable daily intake limits, FDA recommends these drugs be recalled by the manufacturer as appropriate,” the agency noted on its website.

The recall was initiated by Breckenridge Pharmaceutical and covers 7107 bottles of 500-count, 20 mg duloxetine delayed-release capsules. The drug is manufactured by Towa Pharmaceutical Europe and distributed nationwide by BPI.

The affected bottles are from lot number 220128 with an expiration date of 12/2024 and NDC of 51991-746-05.

The recall was initiated on October 10 and is ongoing.

“Healthcare professionals can educate patients about alternative treatment options to medications with potential nitrosamine impurities if available and clinically appropriate,” the FDA advises. “If a medication has been recalled, pharmacists may be able to dispense the same medication from a manufacturing lot that has not been recalled. Prescribers may also determine whether there is an alternative treatment option for patients.”

The FDA has labeled this a “class II” recall, which the agency defines as “a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.”

Nitrosamine impurities have prompted a number of drug recalls in recent years, including oral anticoagulants, metformin, and skeletal muscle relaxants.

The impurities may be found in drugs for a number of reasons, the agency reported. The source may be from a drug’s manufacturing process, chemical structure, or the conditions under which it is stored or packaged.
 

A version of this article appeared on Medscape.com.

The US Food and Drug Administration (FDA) has announced a voluntary manufacturer-initiated recall of more than 7000 bottles of duloxetine delayed-release capsules due to unacceptable levels of a potential carcinogen.

Duloxetine (Cymbalta) is a serotonin-norepinephrine reuptake inhibitor used to treat major depressive disorder, generalized anxiety disorder, fibromyalgia, chronic musculoskeletal pain, and neuropathic pain associated with diabetic peripheral neuropathy.

The recall is due to the detection of the nitrosamine impurity, N-nitroso duloxetine, above the proposed interim limit.

Nitrosamines are common in water and foods, and exposure to some levels of the chemical is common. Exposure to nitrosamine impurities above acceptable levels and over long periods may increase cancer risk, the FDA reported.

“If drugs contain levels of nitrosamines above the acceptable daily intake limits, FDA recommends these drugs be recalled by the manufacturer as appropriate,” the agency noted on its website.

The recall was initiated by Breckenridge Pharmaceutical and covers 7107 bottles of 500-count, 20 mg duloxetine delayed-release capsules. The drug is manufactured by Towa Pharmaceutical Europe and distributed nationwide by BPI.

The affected bottles are from lot number 220128 with an expiration date of 12/2024 and NDC of 51991-746-05.

The recall was initiated on October 10 and is ongoing.

“Healthcare professionals can educate patients about alternative treatment options to medications with potential nitrosamine impurities if available and clinically appropriate,” the FDA advises. “If a medication has been recalled, pharmacists may be able to dispense the same medication from a manufacturing lot that has not been recalled. Prescribers may also determine whether there is an alternative treatment option for patients.”

The FDA has labeled this a “class II” recall, which the agency defines as “a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.”

Nitrosamine impurities have prompted a number of drug recalls in recent years, including oral anticoagulants, metformin, and skeletal muscle relaxants.

The impurities may be found in drugs for a number of reasons, the agency reported. The source may be from a drug’s manufacturing process, chemical structure, or the conditions under which it is stored or packaged.