Navigating the Search for a Financial Adviser

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Changed
Fri, 05/03/2024 - 15:21

 

As gastroenterologists, we spend innumerable years in medical training with an abrupt and significant increase in our earning potential upon beginning practice. The majority of us also carry a sizeable amount of student loan debt. This combination results in a unique situation that can make us hesitant about how best to set ourselves up financially while also making us vulnerable to potentially predatory financial practices.

Although your initial steps to achieve financial wellness and build wealth can be obtained on your own with some education, a financial adviser becomes indispensable when you have significant assets, a high income, complex finances, and/or are experiencing a major life change. Additionally, as there are so many avenues to invest and grow your capital, a financial adviser can assist in designing a portfolio to best accomplish specific monetary goals. Studies have demonstrated that those working with a financial adviser reduce their single-stock risk and have more significant increase in portfolio value, reducing the total cost associated with their investments’ management.1 Those working with a financial adviser will also net up to a 3% larger annual return, compared with a standard baseline investment plan.2,3

Dr. Luthra
Dr. Anjuli K. Luthra

Based on this information, it may appear that working with a personal financial adviser would be a no-brainer. Unfortunately, there is a caveat: There is no legal regulation regarding who can use the title “financial adviser.” It is therefore crucial to be aware of common practices and terminology to best help you identify a reputable financial adviser and reduce your risk of excessive fees or financial loss. This is also a highly personal decision and your search should first begin with understanding why you are looking for an adviser, as this will determine the appropriate type of service to look for.
 

Types of Advisers

A certified financial planner (CFP) is an expert in estate planning, taxes, retirement saving, and financial planning who has a formal designation by the Certified Financial Planner Board of Standards Inc.4 They must undergo stringent licensing examinations following a 3-year course with required continuing education to maintain their credentials. CFPs are fiduciaries, meaning they must make financial decisions in your best interest, even if they may make less money with that product or investment strategy. In other words, they are beholden to give honest, impartial recommendations to their clients, and may face sanctions by the CFP Board if found to violate its Code of Ethics and Standards of Conduct, which includes failure to act in a fiduciary duty.5

CFPs evaluate your total financial picture, such as investments, insurance policies, and overall current financial position, to develop a comprehensive strategy that will successfully guide you to your financial goal. There are many individuals who may refer to themselves as financial planners without having the CFP designation; while they may offer similar services as above, they will not be required to act as a fiduciary. Hence, it is important to do your due diligence and verify they hold this certification via the CFP Board website: www.cfp.net/verify-a-cfp-professional.

An investment adviser is a legal term from the U.S. Securities and Exchange Commission (SEC) and the Financial Industry Regulatory Authority (FINRA) referring to an individual who provides recommendations and analyses for financial securities such as stock. Both of these agencies ensure investment advisers adhere to regulatory requirements designed to protect client investers. Similar to CFPs, they are held to a fiduciary standard, and their firm is required to register with the SEC or the state of practice based on the amount of assets under management.6

An individual investment adviser must also register with their state as an Investment Adviser Representative (IAR), the distinctive term referring to an individual as opposed to an investment advising firm. Investment advisers are required to pass the extensive Series 65, Uniform Investment Advisor Law Exam, or equivalent, by states requiring licensure.7 They can guide you on the selection of particular investments and portfolio management based on a discussion with you regarding your current financial standing and what fiscal ambitions you wish to achieve.

A financial adviser provides direction on a multitude of financially related topics such as investing, tax laws, and life insurance with the goal to help you reach specific financial objectives. However, this term is often used quite ubiquitously given the lack of formal regulation of the title. Essentially, those with varying types of educational background can give themselves the title of financial adviser.

If a financial adviser buys or sells financial securities such as stocks or bonds, then they must be registered as a licensed broker with the SEC and IAR and pass the Series 6 or Series 7 exam. Unlike CFPs and investment advisers, a financial adviser (if also a licensed broker) is not required to be a fiduciary, and instead works under the suitability standard.8 Suitability requires that financial recommendations made by the adviser are appropriate but not necessarily the best for the client. In fact, these recommendations do not even have to be the most suitable. This is where conflicts of interest can arise with the adviser recommending products and securities that best compensate them while not serving the best return on investment for you.

Making the search for a financial adviser more complex, an individual can be a combination of any of the above, pending the appropriate licensing. For example, a CFP can also be an asset manager and thus hold the title of a financial adviser and/or IAR. A financial adviser may also not directly manage your assets if they have a partnership with a third party or another licensed individual. Questions to ask of your potential financial adviser should therefore include the following:

 

 

  • What licensure and related education do you have?
  • What is your particular area of expertise?
  • How long have you been in practice?
  • How will you be managing my assets?

Financial Adviser Fee Schedules

Prior to working with a financial adviser, you must also inquire about their fee structure. There are two kinds of fee schedules used by financial advisers: fee-only and fee-based.

Fee-only advisers receive payment solely for the services they provide. They do not collect commissions from third parties providing the recommended products. There is variability in how this type of payment schedule is structured, encompassing flat fees, hourly rates, or the adviser charging a retainer. The Table below compares the types of fee-only structures and range of charges based on 2023 rates.9 Of note, fee-only advisers serve as fiduciaries.10

Fee-based financial advisers receive payment for services but may also receive commission on specific products they sell to you.9 Most, if not all, financial experts recommend avoiding advisers using commission-based charges given the potential conflict of interest: How can one be absolutely sure this recommended financial product is best for you, knowing your adviser has a financial stake in said item?

In addition to charging the fees above, your financial adviser, if they are actively managing your investment portfolio, will also charge an assets under management (AUM) fee. This is a percentage of the dollar amount within your portfolio. For example, if your adviser charges a 1% AUM rate for your account totaling $100,000, this equates to a $1,000 fee in that calendar year. AUM fees typically decrease as the size of your portfolio increases. As seen in the Table, there is a wide range of the average AUM rate (0.5%–2%); however, an AUM fee approaching 2% is unnecessarily high and consumes a significant portion of your portfolio. Thus, it is recommended to look for a money manager with an approximate 1% AUM fee.

Many of us delay or avoid working with a financial adviser due to the potential perceived risks of having poor portfolio management from an adviser not working in our best interest, along with the concern for excessive fees. While anyone can invest in an Exchange Traded Fund or Index Fund, we can lose on not seeking a financial adviser’s expertise to increase our asset growth and fund of financial knowledge. In many ways, it is how we counsel our patients. While they can seek medical information on their own, their best care is under the guidance of an expert: a healthcare professional. That being said, personal finance is indeed personal, so I hope this guide helps facilitate your search and increase your financial wellness.

Dr. Luthra is a therapeutic endoscopist at Moffitt Cancer Center, Tampa, Florida, and the founder of The Scope of Finance, a financial wellness education and coaching company focused on physicians. Her interest in financial well-being is thanks to the teachings of her father, an entrepreneur and former Certified Financial Planner (CFP). She can be found on Instagram (thescopeoffinance) and X (@ScopeofFinance). She reports no financial disclosures relevant to this article.

 

 

References

1. Pagliaro CA and Utkus SP. Assessing the value of advice. Vanguard. 2019 Sept.

2. Kinniry Jr. FM et al. Putting a value on your value: Quantifying Vanguard Advisor’s Alpha. Vanguard. 2022 July.

3. Horan S. What Are the Benefits of Working with a Financial Advisor? – 2021 Study. Smart Asset. 2023 July 27.

4. Kagan J. Certified Financial PlannerTM(CFP): What It Is and How to Become One. Investopedia. 2023 Aug 3.

5. CFP Board. Our Commitment to Ethical Standards. CFP Board. 2024.

6. Staff of the Investment Adviser Regulation Office Division of Investment Management, U.S. Securities and Exchange Commission. Regulation of Investment Advisers by the U.S. Securities and Exchange Commission. 2013 Mar.

7. Hicks C. Investment Advisor vs. Financial Advisor: There is a Difference. US News & World Report. 2019 June 13.

8. Roberts K. Financial advisor vs. financial planner: What is the difference? Bankrate. 2023 Nov 21.

9. Clancy D. Average Fees for Financial Advisors in 2023. Harness Wealth. 2023 May 25.

10. Palmer B. Fee- vs. Commission-Based Advisor: What’s the Difference? Investopedia. 2023 June 20.

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As gastroenterologists, we spend innumerable years in medical training with an abrupt and significant increase in our earning potential upon beginning practice. The majority of us also carry a sizeable amount of student loan debt. This combination results in a unique situation that can make us hesitant about how best to set ourselves up financially while also making us vulnerable to potentially predatory financial practices.

Although your initial steps to achieve financial wellness and build wealth can be obtained on your own with some education, a financial adviser becomes indispensable when you have significant assets, a high income, complex finances, and/or are experiencing a major life change. Additionally, as there are so many avenues to invest and grow your capital, a financial adviser can assist in designing a portfolio to best accomplish specific monetary goals. Studies have demonstrated that those working with a financial adviser reduce their single-stock risk and have more significant increase in portfolio value, reducing the total cost associated with their investments’ management.1 Those working with a financial adviser will also net up to a 3% larger annual return, compared with a standard baseline investment plan.2,3

Dr. Luthra
Dr. Anjuli K. Luthra

Based on this information, it may appear that working with a personal financial adviser would be a no-brainer. Unfortunately, there is a caveat: There is no legal regulation regarding who can use the title “financial adviser.” It is therefore crucial to be aware of common practices and terminology to best help you identify a reputable financial adviser and reduce your risk of excessive fees or financial loss. This is also a highly personal decision and your search should first begin with understanding why you are looking for an adviser, as this will determine the appropriate type of service to look for.
 

Types of Advisers

A certified financial planner (CFP) is an expert in estate planning, taxes, retirement saving, and financial planning who has a formal designation by the Certified Financial Planner Board of Standards Inc.4 They must undergo stringent licensing examinations following a 3-year course with required continuing education to maintain their credentials. CFPs are fiduciaries, meaning they must make financial decisions in your best interest, even if they may make less money with that product or investment strategy. In other words, they are beholden to give honest, impartial recommendations to their clients, and may face sanctions by the CFP Board if found to violate its Code of Ethics and Standards of Conduct, which includes failure to act in a fiduciary duty.5

CFPs evaluate your total financial picture, such as investments, insurance policies, and overall current financial position, to develop a comprehensive strategy that will successfully guide you to your financial goal. There are many individuals who may refer to themselves as financial planners without having the CFP designation; while they may offer similar services as above, they will not be required to act as a fiduciary. Hence, it is important to do your due diligence and verify they hold this certification via the CFP Board website: www.cfp.net/verify-a-cfp-professional.

An investment adviser is a legal term from the U.S. Securities and Exchange Commission (SEC) and the Financial Industry Regulatory Authority (FINRA) referring to an individual who provides recommendations and analyses for financial securities such as stock. Both of these agencies ensure investment advisers adhere to regulatory requirements designed to protect client investers. Similar to CFPs, they are held to a fiduciary standard, and their firm is required to register with the SEC or the state of practice based on the amount of assets under management.6

An individual investment adviser must also register with their state as an Investment Adviser Representative (IAR), the distinctive term referring to an individual as opposed to an investment advising firm. Investment advisers are required to pass the extensive Series 65, Uniform Investment Advisor Law Exam, or equivalent, by states requiring licensure.7 They can guide you on the selection of particular investments and portfolio management based on a discussion with you regarding your current financial standing and what fiscal ambitions you wish to achieve.

A financial adviser provides direction on a multitude of financially related topics such as investing, tax laws, and life insurance with the goal to help you reach specific financial objectives. However, this term is often used quite ubiquitously given the lack of formal regulation of the title. Essentially, those with varying types of educational background can give themselves the title of financial adviser.

If a financial adviser buys or sells financial securities such as stocks or bonds, then they must be registered as a licensed broker with the SEC and IAR and pass the Series 6 or Series 7 exam. Unlike CFPs and investment advisers, a financial adviser (if also a licensed broker) is not required to be a fiduciary, and instead works under the suitability standard.8 Suitability requires that financial recommendations made by the adviser are appropriate but not necessarily the best for the client. In fact, these recommendations do not even have to be the most suitable. This is where conflicts of interest can arise with the adviser recommending products and securities that best compensate them while not serving the best return on investment for you.

Making the search for a financial adviser more complex, an individual can be a combination of any of the above, pending the appropriate licensing. For example, a CFP can also be an asset manager and thus hold the title of a financial adviser and/or IAR. A financial adviser may also not directly manage your assets if they have a partnership with a third party or another licensed individual. Questions to ask of your potential financial adviser should therefore include the following:

 

 

  • What licensure and related education do you have?
  • What is your particular area of expertise?
  • How long have you been in practice?
  • How will you be managing my assets?

Financial Adviser Fee Schedules

Prior to working with a financial adviser, you must also inquire about their fee structure. There are two kinds of fee schedules used by financial advisers: fee-only and fee-based.

Fee-only advisers receive payment solely for the services they provide. They do not collect commissions from third parties providing the recommended products. There is variability in how this type of payment schedule is structured, encompassing flat fees, hourly rates, or the adviser charging a retainer. The Table below compares the types of fee-only structures and range of charges based on 2023 rates.9 Of note, fee-only advisers serve as fiduciaries.10

Fee-based financial advisers receive payment for services but may also receive commission on specific products they sell to you.9 Most, if not all, financial experts recommend avoiding advisers using commission-based charges given the potential conflict of interest: How can one be absolutely sure this recommended financial product is best for you, knowing your adviser has a financial stake in said item?

In addition to charging the fees above, your financial adviser, if they are actively managing your investment portfolio, will also charge an assets under management (AUM) fee. This is a percentage of the dollar amount within your portfolio. For example, if your adviser charges a 1% AUM rate for your account totaling $100,000, this equates to a $1,000 fee in that calendar year. AUM fees typically decrease as the size of your portfolio increases. As seen in the Table, there is a wide range of the average AUM rate (0.5%–2%); however, an AUM fee approaching 2% is unnecessarily high and consumes a significant portion of your portfolio. Thus, it is recommended to look for a money manager with an approximate 1% AUM fee.

Many of us delay or avoid working with a financial adviser due to the potential perceived risks of having poor portfolio management from an adviser not working in our best interest, along with the concern for excessive fees. While anyone can invest in an Exchange Traded Fund or Index Fund, we can lose on not seeking a financial adviser’s expertise to increase our asset growth and fund of financial knowledge. In many ways, it is how we counsel our patients. While they can seek medical information on their own, their best care is under the guidance of an expert: a healthcare professional. That being said, personal finance is indeed personal, so I hope this guide helps facilitate your search and increase your financial wellness.

Dr. Luthra is a therapeutic endoscopist at Moffitt Cancer Center, Tampa, Florida, and the founder of The Scope of Finance, a financial wellness education and coaching company focused on physicians. Her interest in financial well-being is thanks to the teachings of her father, an entrepreneur and former Certified Financial Planner (CFP). She can be found on Instagram (thescopeoffinance) and X (@ScopeofFinance). She reports no financial disclosures relevant to this article.

 

 

References

1. Pagliaro CA and Utkus SP. Assessing the value of advice. Vanguard. 2019 Sept.

2. Kinniry Jr. FM et al. Putting a value on your value: Quantifying Vanguard Advisor’s Alpha. Vanguard. 2022 July.

3. Horan S. What Are the Benefits of Working with a Financial Advisor? – 2021 Study. Smart Asset. 2023 July 27.

4. Kagan J. Certified Financial PlannerTM(CFP): What It Is and How to Become One. Investopedia. 2023 Aug 3.

5. CFP Board. Our Commitment to Ethical Standards. CFP Board. 2024.

6. Staff of the Investment Adviser Regulation Office Division of Investment Management, U.S. Securities and Exchange Commission. Regulation of Investment Advisers by the U.S. Securities and Exchange Commission. 2013 Mar.

7. Hicks C. Investment Advisor vs. Financial Advisor: There is a Difference. US News & World Report. 2019 June 13.

8. Roberts K. Financial advisor vs. financial planner: What is the difference? Bankrate. 2023 Nov 21.

9. Clancy D. Average Fees for Financial Advisors in 2023. Harness Wealth. 2023 May 25.

10. Palmer B. Fee- vs. Commission-Based Advisor: What’s the Difference? Investopedia. 2023 June 20.

 

As gastroenterologists, we spend innumerable years in medical training with an abrupt and significant increase in our earning potential upon beginning practice. The majority of us also carry a sizeable amount of student loan debt. This combination results in a unique situation that can make us hesitant about how best to set ourselves up financially while also making us vulnerable to potentially predatory financial practices.

Although your initial steps to achieve financial wellness and build wealth can be obtained on your own with some education, a financial adviser becomes indispensable when you have significant assets, a high income, complex finances, and/or are experiencing a major life change. Additionally, as there are so many avenues to invest and grow your capital, a financial adviser can assist in designing a portfolio to best accomplish specific monetary goals. Studies have demonstrated that those working with a financial adviser reduce their single-stock risk and have more significant increase in portfolio value, reducing the total cost associated with their investments’ management.1 Those working with a financial adviser will also net up to a 3% larger annual return, compared with a standard baseline investment plan.2,3

Dr. Luthra
Dr. Anjuli K. Luthra

Based on this information, it may appear that working with a personal financial adviser would be a no-brainer. Unfortunately, there is a caveat: There is no legal regulation regarding who can use the title “financial adviser.” It is therefore crucial to be aware of common practices and terminology to best help you identify a reputable financial adviser and reduce your risk of excessive fees or financial loss. This is also a highly personal decision and your search should first begin with understanding why you are looking for an adviser, as this will determine the appropriate type of service to look for.
 

Types of Advisers

A certified financial planner (CFP) is an expert in estate planning, taxes, retirement saving, and financial planning who has a formal designation by the Certified Financial Planner Board of Standards Inc.4 They must undergo stringent licensing examinations following a 3-year course with required continuing education to maintain their credentials. CFPs are fiduciaries, meaning they must make financial decisions in your best interest, even if they may make less money with that product or investment strategy. In other words, they are beholden to give honest, impartial recommendations to their clients, and may face sanctions by the CFP Board if found to violate its Code of Ethics and Standards of Conduct, which includes failure to act in a fiduciary duty.5

CFPs evaluate your total financial picture, such as investments, insurance policies, and overall current financial position, to develop a comprehensive strategy that will successfully guide you to your financial goal. There are many individuals who may refer to themselves as financial planners without having the CFP designation; while they may offer similar services as above, they will not be required to act as a fiduciary. Hence, it is important to do your due diligence and verify they hold this certification via the CFP Board website: www.cfp.net/verify-a-cfp-professional.

An investment adviser is a legal term from the U.S. Securities and Exchange Commission (SEC) and the Financial Industry Regulatory Authority (FINRA) referring to an individual who provides recommendations and analyses for financial securities such as stock. Both of these agencies ensure investment advisers adhere to regulatory requirements designed to protect client investers. Similar to CFPs, they are held to a fiduciary standard, and their firm is required to register with the SEC or the state of practice based on the amount of assets under management.6

An individual investment adviser must also register with their state as an Investment Adviser Representative (IAR), the distinctive term referring to an individual as opposed to an investment advising firm. Investment advisers are required to pass the extensive Series 65, Uniform Investment Advisor Law Exam, or equivalent, by states requiring licensure.7 They can guide you on the selection of particular investments and portfolio management based on a discussion with you regarding your current financial standing and what fiscal ambitions you wish to achieve.

A financial adviser provides direction on a multitude of financially related topics such as investing, tax laws, and life insurance with the goal to help you reach specific financial objectives. However, this term is often used quite ubiquitously given the lack of formal regulation of the title. Essentially, those with varying types of educational background can give themselves the title of financial adviser.

If a financial adviser buys or sells financial securities such as stocks or bonds, then they must be registered as a licensed broker with the SEC and IAR and pass the Series 6 or Series 7 exam. Unlike CFPs and investment advisers, a financial adviser (if also a licensed broker) is not required to be a fiduciary, and instead works under the suitability standard.8 Suitability requires that financial recommendations made by the adviser are appropriate but not necessarily the best for the client. In fact, these recommendations do not even have to be the most suitable. This is where conflicts of interest can arise with the adviser recommending products and securities that best compensate them while not serving the best return on investment for you.

Making the search for a financial adviser more complex, an individual can be a combination of any of the above, pending the appropriate licensing. For example, a CFP can also be an asset manager and thus hold the title of a financial adviser and/or IAR. A financial adviser may also not directly manage your assets if they have a partnership with a third party or another licensed individual. Questions to ask of your potential financial adviser should therefore include the following:

 

 

  • What licensure and related education do you have?
  • What is your particular area of expertise?
  • How long have you been in practice?
  • How will you be managing my assets?

Financial Adviser Fee Schedules

Prior to working with a financial adviser, you must also inquire about their fee structure. There are two kinds of fee schedules used by financial advisers: fee-only and fee-based.

Fee-only advisers receive payment solely for the services they provide. They do not collect commissions from third parties providing the recommended products. There is variability in how this type of payment schedule is structured, encompassing flat fees, hourly rates, or the adviser charging a retainer. The Table below compares the types of fee-only structures and range of charges based on 2023 rates.9 Of note, fee-only advisers serve as fiduciaries.10

Fee-based financial advisers receive payment for services but may also receive commission on specific products they sell to you.9 Most, if not all, financial experts recommend avoiding advisers using commission-based charges given the potential conflict of interest: How can one be absolutely sure this recommended financial product is best for you, knowing your adviser has a financial stake in said item?

In addition to charging the fees above, your financial adviser, if they are actively managing your investment portfolio, will also charge an assets under management (AUM) fee. This is a percentage of the dollar amount within your portfolio. For example, if your adviser charges a 1% AUM rate for your account totaling $100,000, this equates to a $1,000 fee in that calendar year. AUM fees typically decrease as the size of your portfolio increases. As seen in the Table, there is a wide range of the average AUM rate (0.5%–2%); however, an AUM fee approaching 2% is unnecessarily high and consumes a significant portion of your portfolio. Thus, it is recommended to look for a money manager with an approximate 1% AUM fee.

Many of us delay or avoid working with a financial adviser due to the potential perceived risks of having poor portfolio management from an adviser not working in our best interest, along with the concern for excessive fees. While anyone can invest in an Exchange Traded Fund or Index Fund, we can lose on not seeking a financial adviser’s expertise to increase our asset growth and fund of financial knowledge. In many ways, it is how we counsel our patients. While they can seek medical information on their own, their best care is under the guidance of an expert: a healthcare professional. That being said, personal finance is indeed personal, so I hope this guide helps facilitate your search and increase your financial wellness.

Dr. Luthra is a therapeutic endoscopist at Moffitt Cancer Center, Tampa, Florida, and the founder of The Scope of Finance, a financial wellness education and coaching company focused on physicians. Her interest in financial well-being is thanks to the teachings of her father, an entrepreneur and former Certified Financial Planner (CFP). She can be found on Instagram (thescopeoffinance) and X (@ScopeofFinance). She reports no financial disclosures relevant to this article.

 

 

References

1. Pagliaro CA and Utkus SP. Assessing the value of advice. Vanguard. 2019 Sept.

2. Kinniry Jr. FM et al. Putting a value on your value: Quantifying Vanguard Advisor’s Alpha. Vanguard. 2022 July.

3. Horan S. What Are the Benefits of Working with a Financial Advisor? – 2021 Study. Smart Asset. 2023 July 27.

4. Kagan J. Certified Financial PlannerTM(CFP): What It Is and How to Become One. Investopedia. 2023 Aug 3.

5. CFP Board. Our Commitment to Ethical Standards. CFP Board. 2024.

6. Staff of the Investment Adviser Regulation Office Division of Investment Management, U.S. Securities and Exchange Commission. Regulation of Investment Advisers by the U.S. Securities and Exchange Commission. 2013 Mar.

7. Hicks C. Investment Advisor vs. Financial Advisor: There is a Difference. US News & World Report. 2019 June 13.

8. Roberts K. Financial advisor vs. financial planner: What is the difference? Bankrate. 2023 Nov 21.

9. Clancy D. Average Fees for Financial Advisors in 2023. Harness Wealth. 2023 May 25.

10. Palmer B. Fee- vs. Commission-Based Advisor: What’s the Difference? Investopedia. 2023 June 20.

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Achieving Promotion for Junior Faculty in Academic Medicine: An Interview With Experts

Article Type
Changed
Fri, 05/03/2024 - 15:11

 

Academic medicine plays a crucial role at the crossroads of medical practice, education, and research, influencing the future landscape of healthcare. Many physicians aspire to pursue and sustain a career in academic medicine to contribute to the advancement of medical knowledge, enhance patient care, and influence the trajectory of the medical field. Opting for a career in academic medicine can offer benefits such as increased autonomy and scheduling flexibility, which can significantly improve the quality of life. In addition, engagement in scholarly activities and working in a dynamic environment with continuous learning opportunities can help mitigate burnout.

However, embarking on an academic career can be daunting for junior faculty members who face the challenge of providing clinical care while excelling in research and dedicating time to mentorship and teaching trainees. According to a report by the Association of American Medical Colleges, 38% of physicians leave academic medicine within a decade of obtaining a faculty position. Barriers to promotion and retention within academic medicine include ineffective mentorship, unclear or inconsistent promotion criteria, and disparities in gender/ethnic representation.

Memorial Sloan Kettering Cancer Center
Dr. Vineet Rolston


In this article, we interview two accomplished physicians in academic medicine who have attained the rank of professors. Our aim is to provide insights into the promotion process and offer recommendations for junior faculty, highlighting the key factors that contribute to success.
 

Interview with Sophie Balzora, MD

Dr. Balzora is a professor of medicine at NYU Grossman School of Medicine and a practicing gastroenterologist specializing in the care of patients with inflammatory bowel disease at NYU Langone Health. She serves as the American College of Gastroenterology’s Diversity, Equity, and Inclusion Committee Chair, on the Advisory Board of ACG’s Leadership, Ethics, and Equity (LE&E) Center, and is president and cofounder of the Association of Black Gastroenterologists and Hepatologists (ABGH). Dr. Balzora was promoted to full professor 11 years after graduating from fellowship.

NYU Langone Health
Dr. Sophie Balzora

What would you identify as some of the most important factors that led to your success in achieving a promotion to professor of medicine?

Surround yourself with individuals whose professional and personal priorities align with yours. To achieve this, it is essential to gain an understanding of what is important to you, what you envision your success to look like, and establish a timeline to achieve it. The concept of personal success and how to best achieve it will absolutely change as you grow, and that is okay and expected. Connecting with those outside of your clinical interests, at other institutions, and even outside of the medical field, can help you achieve these goals and better shape how you see your career unfolding and how you want it to look.

Historically, the proportion of physicians who achieve professorship is lower among women compared with men. What do you believe are some of the barriers involved in this, and how would you counsel women who are interested in pursuing the rank of professor?

Systemic gender bias and discrimination, over-mentorship and under-sponsorship, inconsistent parental leave, and delayed parenthood are a few of the factors that contribute to the observed disparities in academic rank. Predictably, for women from underrepresented backgrounds in medicine, the chasm grows.

 

 

What has helped me most is to keep my eyes on the prize, and to recognize that the prize is different for everyone. It’s important not to make direct comparisons to any other individual, because they are not you. Harness what makes you different and drown out the naysayers — the “we’ve never seen this done before” camp, the “it’s too soon [for someone like you] to go up for promotion” folks. While these voices are sometimes well intentioned, they can distract you from your goals and ambitions because they are rooted in bias and adherence to traditional expectations. To do something new, and to change the game, requires going against the grain and utilizing your skills and talents to achieve what you want to achieve in a way that works for you.
 

What are some practical tips you have for junior gastroenterologists to track their promotion in academia?

  • Keep your curriculum vitae (CV) up to date and formatted to your institutional guidelines. Ensure that you document your academic activities, even if it doesn’t seem important in the moment. When it’s time to submit that promotion portfolio, you want to be ready and organized.
  • Remember: “No” is a full sentence, and saying it takes practice and time and confidence. It is a skill I still struggle to adopt at times, but it’s important to recognize the power of no, for it opens opportunities to say yes to other things.
  • Lift as you climb — a critical part of changing the status quo is fostering the future of those underrepresented in medicine. A professional goal of mine that keeps me steady and passionate is to create supporting and enriching systemic and institutional changes that work to dismantle the obstacles perpetuating disparities in academic rank for women and those underrepresented in medicine. Discovering your “why” is a complex, difficult, and rewarding journey.

Interview with Mark Schattner, MD, AGAF

Dr. Schattner is a professor of clinical medicine at Weill Cornell College of Medicine and chief of the gastroenterology, hepatology, and nutrition service at Memorial Sloan Kettering Cancer Center, both in New York. He is a former president of the New York Society for Gastrointestinal Endoscopy and a fellow of the AGA and ASGE.

NYU Langone Health
Dr. Mark Schattner

In your role as chief, you serve as a mentor for early career gastroenterologists for pursuing career promotion. What advice do you have for achieving this?

Promoting junior faculty is one of the prime responsibilities of a service chief. Generally, the early steps of promotion are straightforward, with criteria becoming more stringent as you progress. I think it is critical to understand the criteria used by promotion committees and to be aware of the various available tracks. I believe every meeting a junior faculty member has with their service chief should include, at the least, a brief check-in on where they are in the promotion process and plans (both short term and long term) to move forward. Successful promotion is facilitated when done upon a solid foundation of production and accomplishment. It is very challenging or even impossible when trying to piece together a package from discordant activities.

 

 

Most institutions require or encourage academic involvement at both national and international levels for career promotion. Do you have advice for junior faculty about how to achieve this type of recognition or experience?

The easiest place to start is with regional professional societies. Active involvement in these local societies fosters valuable networking and lays the groundwork for involvement at the national or international level. I would strongly encourage junior faculty to seek opportunities for a leadership position at any level in these societies and move up the ladder as their career matures. This is also a very good avenue to network and get invited to join collaborative research projects, which can be a fruitful means to enhance your academic productivity.

In your opinion, what factors are likely to hinder or delay an individual’s promotion?

I think it is crucial to consider the career track you are on. If you are very clinically productive and love to teach, that is completely appropriate, and most institutions will recognize the value of that and promote you along a clinical-educator tract. On the other hand, if you have a passion for research and can successfully lead research and compete for grants, then you would move along a traditional tenure track. It is also critical to think ahead, know the criteria on which you will be judged, and incorporate that into your practice early. Trying to scramble to enhance your CV in a short time just for promotion will likely prove ineffective.

Do you have advice for junior faculty who have families about how to manage career goals but also prioritize time with family?

There is no one-size-fits-all approach to this. I think this requires a lot of shared decision-making with your family. Compromise will undoubtedly be required. For example, I always chose to live in close proximity to my workplace, eliminating any commuting time. This choice really allowed me spend time with my family.



In conclusion, a career in academic medicine presents both opportunities and challenges. A successful academic career, and achieving promotion to the rank of professor of medicine, requires a combination of factors including understanding institution-specific criteria for promotion, proactive engagement at the regional and national level, and envisioning your career goals and creating a timeline to achieve them. There are challenges to promotion, including navigating systemic biases and balancing career goals with family commitments, which also requires consideration and open communication. Ultimately, we hope these insights provide valuable guidance and advice for junior faculty who are navigating this complex environment of academic medicine and are motivated toward achieving professional fulfillment and satisfaction in their careers.

Dr. Rolston is based in the Department of Gastroenterology, Hepatology, and Nutrition, Memorial Sloan Kettering Cancer Center, New York. She reports no conflicts in relation this article. Dr. Balzora and Dr. Schattner are based in the Division of Gastroenterology and Hepatology, New York University Langone Health, New York. Dr. Schattner is a consultant for Boston Scientific and Novo Nordisk. Dr. Balzora reports no conflicts in relation to this article.

 

 

References

Campbell KM. Mitigating the isolation of minoritized faculty in academic medicine. J Gen Intern Med. 2023 May. doi: 10.1007/s11606-022-07982-8.

Howard-Anderson JR et al. Strategies for developing a successful career in academic medicine. Am J Med Sci. 2024 Apr. doi: 10.1016/j.amjms.2023.12.010.

Murphy M et al. Women’s experiences of promotion and tenure in academic medicine and potential implications for gender disparities in career advancement: A qualitative analysis. JAMA Netw Open. 2021 Sep 1. doi: 10.1001/jamanetworkopen.2021.25843.

Sambunjak D et al. Mentoring in academic medicine: A systematic review. JAMA. 2006 Sep 6. doi: 10.1001/jama.296.9.1103.

Shen MR et al. Impact of mentoring on academic career success for women in medicine: A systematic review. Acad Med. 2022 Mar 1. doi: 10.1097/ACM.0000000000004563.

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Academic medicine plays a crucial role at the crossroads of medical practice, education, and research, influencing the future landscape of healthcare. Many physicians aspire to pursue and sustain a career in academic medicine to contribute to the advancement of medical knowledge, enhance patient care, and influence the trajectory of the medical field. Opting for a career in academic medicine can offer benefits such as increased autonomy and scheduling flexibility, which can significantly improve the quality of life. In addition, engagement in scholarly activities and working in a dynamic environment with continuous learning opportunities can help mitigate burnout.

However, embarking on an academic career can be daunting for junior faculty members who face the challenge of providing clinical care while excelling in research and dedicating time to mentorship and teaching trainees. According to a report by the Association of American Medical Colleges, 38% of physicians leave academic medicine within a decade of obtaining a faculty position. Barriers to promotion and retention within academic medicine include ineffective mentorship, unclear or inconsistent promotion criteria, and disparities in gender/ethnic representation.

Memorial Sloan Kettering Cancer Center
Dr. Vineet Rolston


In this article, we interview two accomplished physicians in academic medicine who have attained the rank of professors. Our aim is to provide insights into the promotion process and offer recommendations for junior faculty, highlighting the key factors that contribute to success.
 

Interview with Sophie Balzora, MD

Dr. Balzora is a professor of medicine at NYU Grossman School of Medicine and a practicing gastroenterologist specializing in the care of patients with inflammatory bowel disease at NYU Langone Health. She serves as the American College of Gastroenterology’s Diversity, Equity, and Inclusion Committee Chair, on the Advisory Board of ACG’s Leadership, Ethics, and Equity (LE&E) Center, and is president and cofounder of the Association of Black Gastroenterologists and Hepatologists (ABGH). Dr. Balzora was promoted to full professor 11 years after graduating from fellowship.

NYU Langone Health
Dr. Sophie Balzora

What would you identify as some of the most important factors that led to your success in achieving a promotion to professor of medicine?

Surround yourself with individuals whose professional and personal priorities align with yours. To achieve this, it is essential to gain an understanding of what is important to you, what you envision your success to look like, and establish a timeline to achieve it. The concept of personal success and how to best achieve it will absolutely change as you grow, and that is okay and expected. Connecting with those outside of your clinical interests, at other institutions, and even outside of the medical field, can help you achieve these goals and better shape how you see your career unfolding and how you want it to look.

Historically, the proportion of physicians who achieve professorship is lower among women compared with men. What do you believe are some of the barriers involved in this, and how would you counsel women who are interested in pursuing the rank of professor?

Systemic gender bias and discrimination, over-mentorship and under-sponsorship, inconsistent parental leave, and delayed parenthood are a few of the factors that contribute to the observed disparities in academic rank. Predictably, for women from underrepresented backgrounds in medicine, the chasm grows.

 

 

What has helped me most is to keep my eyes on the prize, and to recognize that the prize is different for everyone. It’s important not to make direct comparisons to any other individual, because they are not you. Harness what makes you different and drown out the naysayers — the “we’ve never seen this done before” camp, the “it’s too soon [for someone like you] to go up for promotion” folks. While these voices are sometimes well intentioned, they can distract you from your goals and ambitions because they are rooted in bias and adherence to traditional expectations. To do something new, and to change the game, requires going against the grain and utilizing your skills and talents to achieve what you want to achieve in a way that works for you.
 

What are some practical tips you have for junior gastroenterologists to track their promotion in academia?

  • Keep your curriculum vitae (CV) up to date and formatted to your institutional guidelines. Ensure that you document your academic activities, even if it doesn’t seem important in the moment. When it’s time to submit that promotion portfolio, you want to be ready and organized.
  • Remember: “No” is a full sentence, and saying it takes practice and time and confidence. It is a skill I still struggle to adopt at times, but it’s important to recognize the power of no, for it opens opportunities to say yes to other things.
  • Lift as you climb — a critical part of changing the status quo is fostering the future of those underrepresented in medicine. A professional goal of mine that keeps me steady and passionate is to create supporting and enriching systemic and institutional changes that work to dismantle the obstacles perpetuating disparities in academic rank for women and those underrepresented in medicine. Discovering your “why” is a complex, difficult, and rewarding journey.

Interview with Mark Schattner, MD, AGAF

Dr. Schattner is a professor of clinical medicine at Weill Cornell College of Medicine and chief of the gastroenterology, hepatology, and nutrition service at Memorial Sloan Kettering Cancer Center, both in New York. He is a former president of the New York Society for Gastrointestinal Endoscopy and a fellow of the AGA and ASGE.

NYU Langone Health
Dr. Mark Schattner

In your role as chief, you serve as a mentor for early career gastroenterologists for pursuing career promotion. What advice do you have for achieving this?

Promoting junior faculty is one of the prime responsibilities of a service chief. Generally, the early steps of promotion are straightforward, with criteria becoming more stringent as you progress. I think it is critical to understand the criteria used by promotion committees and to be aware of the various available tracks. I believe every meeting a junior faculty member has with their service chief should include, at the least, a brief check-in on where they are in the promotion process and plans (both short term and long term) to move forward. Successful promotion is facilitated when done upon a solid foundation of production and accomplishment. It is very challenging or even impossible when trying to piece together a package from discordant activities.

 

 

Most institutions require or encourage academic involvement at both national and international levels for career promotion. Do you have advice for junior faculty about how to achieve this type of recognition or experience?

The easiest place to start is with regional professional societies. Active involvement in these local societies fosters valuable networking and lays the groundwork for involvement at the national or international level. I would strongly encourage junior faculty to seek opportunities for a leadership position at any level in these societies and move up the ladder as their career matures. This is also a very good avenue to network and get invited to join collaborative research projects, which can be a fruitful means to enhance your academic productivity.

In your opinion, what factors are likely to hinder or delay an individual’s promotion?

I think it is crucial to consider the career track you are on. If you are very clinically productive and love to teach, that is completely appropriate, and most institutions will recognize the value of that and promote you along a clinical-educator tract. On the other hand, if you have a passion for research and can successfully lead research and compete for grants, then you would move along a traditional tenure track. It is also critical to think ahead, know the criteria on which you will be judged, and incorporate that into your practice early. Trying to scramble to enhance your CV in a short time just for promotion will likely prove ineffective.

Do you have advice for junior faculty who have families about how to manage career goals but also prioritize time with family?

There is no one-size-fits-all approach to this. I think this requires a lot of shared decision-making with your family. Compromise will undoubtedly be required. For example, I always chose to live in close proximity to my workplace, eliminating any commuting time. This choice really allowed me spend time with my family.



In conclusion, a career in academic medicine presents both opportunities and challenges. A successful academic career, and achieving promotion to the rank of professor of medicine, requires a combination of factors including understanding institution-specific criteria for promotion, proactive engagement at the regional and national level, and envisioning your career goals and creating a timeline to achieve them. There are challenges to promotion, including navigating systemic biases and balancing career goals with family commitments, which also requires consideration and open communication. Ultimately, we hope these insights provide valuable guidance and advice for junior faculty who are navigating this complex environment of academic medicine and are motivated toward achieving professional fulfillment and satisfaction in their careers.

Dr. Rolston is based in the Department of Gastroenterology, Hepatology, and Nutrition, Memorial Sloan Kettering Cancer Center, New York. She reports no conflicts in relation this article. Dr. Balzora and Dr. Schattner are based in the Division of Gastroenterology and Hepatology, New York University Langone Health, New York. Dr. Schattner is a consultant for Boston Scientific and Novo Nordisk. Dr. Balzora reports no conflicts in relation to this article.

 

 

References

Campbell KM. Mitigating the isolation of minoritized faculty in academic medicine. J Gen Intern Med. 2023 May. doi: 10.1007/s11606-022-07982-8.

Howard-Anderson JR et al. Strategies for developing a successful career in academic medicine. Am J Med Sci. 2024 Apr. doi: 10.1016/j.amjms.2023.12.010.

Murphy M et al. Women’s experiences of promotion and tenure in academic medicine and potential implications for gender disparities in career advancement: A qualitative analysis. JAMA Netw Open. 2021 Sep 1. doi: 10.1001/jamanetworkopen.2021.25843.

Sambunjak D et al. Mentoring in academic medicine: A systematic review. JAMA. 2006 Sep 6. doi: 10.1001/jama.296.9.1103.

Shen MR et al. Impact of mentoring on academic career success for women in medicine: A systematic review. Acad Med. 2022 Mar 1. doi: 10.1097/ACM.0000000000004563.

 

Academic medicine plays a crucial role at the crossroads of medical practice, education, and research, influencing the future landscape of healthcare. Many physicians aspire to pursue and sustain a career in academic medicine to contribute to the advancement of medical knowledge, enhance patient care, and influence the trajectory of the medical field. Opting for a career in academic medicine can offer benefits such as increased autonomy and scheduling flexibility, which can significantly improve the quality of life. In addition, engagement in scholarly activities and working in a dynamic environment with continuous learning opportunities can help mitigate burnout.

However, embarking on an academic career can be daunting for junior faculty members who face the challenge of providing clinical care while excelling in research and dedicating time to mentorship and teaching trainees. According to a report by the Association of American Medical Colleges, 38% of physicians leave academic medicine within a decade of obtaining a faculty position. Barriers to promotion and retention within academic medicine include ineffective mentorship, unclear or inconsistent promotion criteria, and disparities in gender/ethnic representation.

Memorial Sloan Kettering Cancer Center
Dr. Vineet Rolston


In this article, we interview two accomplished physicians in academic medicine who have attained the rank of professors. Our aim is to provide insights into the promotion process and offer recommendations for junior faculty, highlighting the key factors that contribute to success.
 

Interview with Sophie Balzora, MD

Dr. Balzora is a professor of medicine at NYU Grossman School of Medicine and a practicing gastroenterologist specializing in the care of patients with inflammatory bowel disease at NYU Langone Health. She serves as the American College of Gastroenterology’s Diversity, Equity, and Inclusion Committee Chair, on the Advisory Board of ACG’s Leadership, Ethics, and Equity (LE&E) Center, and is president and cofounder of the Association of Black Gastroenterologists and Hepatologists (ABGH). Dr. Balzora was promoted to full professor 11 years after graduating from fellowship.

NYU Langone Health
Dr. Sophie Balzora

What would you identify as some of the most important factors that led to your success in achieving a promotion to professor of medicine?

Surround yourself with individuals whose professional and personal priorities align with yours. To achieve this, it is essential to gain an understanding of what is important to you, what you envision your success to look like, and establish a timeline to achieve it. The concept of personal success and how to best achieve it will absolutely change as you grow, and that is okay and expected. Connecting with those outside of your clinical interests, at other institutions, and even outside of the medical field, can help you achieve these goals and better shape how you see your career unfolding and how you want it to look.

Historically, the proportion of physicians who achieve professorship is lower among women compared with men. What do you believe are some of the barriers involved in this, and how would you counsel women who are interested in pursuing the rank of professor?

Systemic gender bias and discrimination, over-mentorship and under-sponsorship, inconsistent parental leave, and delayed parenthood are a few of the factors that contribute to the observed disparities in academic rank. Predictably, for women from underrepresented backgrounds in medicine, the chasm grows.

 

 

What has helped me most is to keep my eyes on the prize, and to recognize that the prize is different for everyone. It’s important not to make direct comparisons to any other individual, because they are not you. Harness what makes you different and drown out the naysayers — the “we’ve never seen this done before” camp, the “it’s too soon [for someone like you] to go up for promotion” folks. While these voices are sometimes well intentioned, they can distract you from your goals and ambitions because they are rooted in bias and adherence to traditional expectations. To do something new, and to change the game, requires going against the grain and utilizing your skills and talents to achieve what you want to achieve in a way that works for you.
 

What are some practical tips you have for junior gastroenterologists to track their promotion in academia?

  • Keep your curriculum vitae (CV) up to date and formatted to your institutional guidelines. Ensure that you document your academic activities, even if it doesn’t seem important in the moment. When it’s time to submit that promotion portfolio, you want to be ready and organized.
  • Remember: “No” is a full sentence, and saying it takes practice and time and confidence. It is a skill I still struggle to adopt at times, but it’s important to recognize the power of no, for it opens opportunities to say yes to other things.
  • Lift as you climb — a critical part of changing the status quo is fostering the future of those underrepresented in medicine. A professional goal of mine that keeps me steady and passionate is to create supporting and enriching systemic and institutional changes that work to dismantle the obstacles perpetuating disparities in academic rank for women and those underrepresented in medicine. Discovering your “why” is a complex, difficult, and rewarding journey.

Interview with Mark Schattner, MD, AGAF

Dr. Schattner is a professor of clinical medicine at Weill Cornell College of Medicine and chief of the gastroenterology, hepatology, and nutrition service at Memorial Sloan Kettering Cancer Center, both in New York. He is a former president of the New York Society for Gastrointestinal Endoscopy and a fellow of the AGA and ASGE.

NYU Langone Health
Dr. Mark Schattner

In your role as chief, you serve as a mentor for early career gastroenterologists for pursuing career promotion. What advice do you have for achieving this?

Promoting junior faculty is one of the prime responsibilities of a service chief. Generally, the early steps of promotion are straightforward, with criteria becoming more stringent as you progress. I think it is critical to understand the criteria used by promotion committees and to be aware of the various available tracks. I believe every meeting a junior faculty member has with their service chief should include, at the least, a brief check-in on where they are in the promotion process and plans (both short term and long term) to move forward. Successful promotion is facilitated when done upon a solid foundation of production and accomplishment. It is very challenging or even impossible when trying to piece together a package from discordant activities.

 

 

Most institutions require or encourage academic involvement at both national and international levels for career promotion. Do you have advice for junior faculty about how to achieve this type of recognition or experience?

The easiest place to start is with regional professional societies. Active involvement in these local societies fosters valuable networking and lays the groundwork for involvement at the national or international level. I would strongly encourage junior faculty to seek opportunities for a leadership position at any level in these societies and move up the ladder as their career matures. This is also a very good avenue to network and get invited to join collaborative research projects, which can be a fruitful means to enhance your academic productivity.

In your opinion, what factors are likely to hinder or delay an individual’s promotion?

I think it is crucial to consider the career track you are on. If you are very clinically productive and love to teach, that is completely appropriate, and most institutions will recognize the value of that and promote you along a clinical-educator tract. On the other hand, if you have a passion for research and can successfully lead research and compete for grants, then you would move along a traditional tenure track. It is also critical to think ahead, know the criteria on which you will be judged, and incorporate that into your practice early. Trying to scramble to enhance your CV in a short time just for promotion will likely prove ineffective.

Do you have advice for junior faculty who have families about how to manage career goals but also prioritize time with family?

There is no one-size-fits-all approach to this. I think this requires a lot of shared decision-making with your family. Compromise will undoubtedly be required. For example, I always chose to live in close proximity to my workplace, eliminating any commuting time. This choice really allowed me spend time with my family.



In conclusion, a career in academic medicine presents both opportunities and challenges. A successful academic career, and achieving promotion to the rank of professor of medicine, requires a combination of factors including understanding institution-specific criteria for promotion, proactive engagement at the regional and national level, and envisioning your career goals and creating a timeline to achieve them. There are challenges to promotion, including navigating systemic biases and balancing career goals with family commitments, which also requires consideration and open communication. Ultimately, we hope these insights provide valuable guidance and advice for junior faculty who are navigating this complex environment of academic medicine and are motivated toward achieving professional fulfillment and satisfaction in their careers.

Dr. Rolston is based in the Department of Gastroenterology, Hepatology, and Nutrition, Memorial Sloan Kettering Cancer Center, New York. She reports no conflicts in relation this article. Dr. Balzora and Dr. Schattner are based in the Division of Gastroenterology and Hepatology, New York University Langone Health, New York. Dr. Schattner is a consultant for Boston Scientific and Novo Nordisk. Dr. Balzora reports no conflicts in relation to this article.

 

 

References

Campbell KM. Mitigating the isolation of minoritized faculty in academic medicine. J Gen Intern Med. 2023 May. doi: 10.1007/s11606-022-07982-8.

Howard-Anderson JR et al. Strategies for developing a successful career in academic medicine. Am J Med Sci. 2024 Apr. doi: 10.1016/j.amjms.2023.12.010.

Murphy M et al. Women’s experiences of promotion and tenure in academic medicine and potential implications for gender disparities in career advancement: A qualitative analysis. JAMA Netw Open. 2021 Sep 1. doi: 10.1001/jamanetworkopen.2021.25843.

Sambunjak D et al. Mentoring in academic medicine: A systematic review. JAMA. 2006 Sep 6. doi: 10.1001/jama.296.9.1103.

Shen MR et al. Impact of mentoring on academic career success for women in medicine: A systematic review. Acad Med. 2022 Mar 1. doi: 10.1097/ACM.0000000000004563.

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Dramatic Increase in College Student Suicide Rates

Article Type
Changed
Fri, 05/03/2024 - 14:57

 

TOPLINE:

The number of suicides among US college students has doubled over the past two decades and is now the second-most common cause of death after accidents in this population, a new study by the National Collegiate Athletic Association (NCAA) found.

METHODOLOGY:

  • Investigators analyzed deaths between 2002 and 2022, using Poisson regression models to assess changes in incidence rates over time.
  • Data were drawn from the NCAA death database, which includes death from any cause, and included demographic characteristics such as age and race and sporting discipline.
  • They utilized linear and quadratic fits between year and suicide incidence for men and women.
  • Given the low incidence of suicide deaths per year, the incidence rate was multiplied by 100,000 to calculate the incidence per 100,000 athlete-years (AYs).
  •  

TAKEAWAY:

  • Of 1102 total deaths, 11.6% were due to suicide (98 men, 30 women).
  • Athletes who died by suicide ranged in age from 17 to 24 years (mean, 20 years) were predominantly men (77%) and White (59%), with the highest suicide incidence rate among male cross-country athletes (1:29 per 815 AYs).
  • The overall incidence of suicide was 1:71 per 145 AYs.
  • Over the last 10 years, suicide was the second most common cause of death after accidents, with the proportion of deaths by suicide doubling from the first to the second decades (7.6% to 15.3%).
  • Among men, the suicide incidence rate increased in a linear fashion (5-year incidence rate ratio, 1.32; 95% CI, 1.14-1.53), while among women, a quadratic association was identified (P = .002), with the incidence rate reaching its lowest point in women from 2010 to 2011 and increasing thereafter.

IN PRACTICE:

“Athletes are generally thought of as one of the healthiest populations in our society, yet the pressures of school, internal and external performance expectations, time demands, injury, athletic identity, and physical fatigue can lead to depression, mental health problems, and suicide,” the authors wrote. “Although the rate of suicide among collegiate athletes remains lower than the general population, it is important to recognize the parallel increase to ensure this population is not overlooked when assessing for risk factors and implementing prevention strategies.”

SOURCE:

Bridget M. Whelan, MPH, research scientist in the Department of Family Medicine, Sports Medicine Section, University of Washington School of Medicine, Seattle, was the lead and corresponding author on the study, which was published online in the British Journal of Sports Medicine.

LIMITATIONS:

There is no mandatory reporting system for athlete deaths in the United States, and investigators’ search identified 16 deaths with unknown causes, suggesting reported suicide incidence rates may be underestimated. Additionally, in cases of overdose that were not clearly intentional, the death was listed as “overdose,” possibly resulting in underreporting of suicide.

DISCLOSURES:

No source of study funding was listed. The authors disclosed no relevant financial relationships.

A version of this article appeared on Medscape.com.

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TOPLINE:

The number of suicides among US college students has doubled over the past two decades and is now the second-most common cause of death after accidents in this population, a new study by the National Collegiate Athletic Association (NCAA) found.

METHODOLOGY:

  • Investigators analyzed deaths between 2002 and 2022, using Poisson regression models to assess changes in incidence rates over time.
  • Data were drawn from the NCAA death database, which includes death from any cause, and included demographic characteristics such as age and race and sporting discipline.
  • They utilized linear and quadratic fits between year and suicide incidence for men and women.
  • Given the low incidence of suicide deaths per year, the incidence rate was multiplied by 100,000 to calculate the incidence per 100,000 athlete-years (AYs).
  •  

TAKEAWAY:

  • Of 1102 total deaths, 11.6% were due to suicide (98 men, 30 women).
  • Athletes who died by suicide ranged in age from 17 to 24 years (mean, 20 years) were predominantly men (77%) and White (59%), with the highest suicide incidence rate among male cross-country athletes (1:29 per 815 AYs).
  • The overall incidence of suicide was 1:71 per 145 AYs.
  • Over the last 10 years, suicide was the second most common cause of death after accidents, with the proportion of deaths by suicide doubling from the first to the second decades (7.6% to 15.3%).
  • Among men, the suicide incidence rate increased in a linear fashion (5-year incidence rate ratio, 1.32; 95% CI, 1.14-1.53), while among women, a quadratic association was identified (P = .002), with the incidence rate reaching its lowest point in women from 2010 to 2011 and increasing thereafter.

IN PRACTICE:

“Athletes are generally thought of as one of the healthiest populations in our society, yet the pressures of school, internal and external performance expectations, time demands, injury, athletic identity, and physical fatigue can lead to depression, mental health problems, and suicide,” the authors wrote. “Although the rate of suicide among collegiate athletes remains lower than the general population, it is important to recognize the parallel increase to ensure this population is not overlooked when assessing for risk factors and implementing prevention strategies.”

SOURCE:

Bridget M. Whelan, MPH, research scientist in the Department of Family Medicine, Sports Medicine Section, University of Washington School of Medicine, Seattle, was the lead and corresponding author on the study, which was published online in the British Journal of Sports Medicine.

LIMITATIONS:

There is no mandatory reporting system for athlete deaths in the United States, and investigators’ search identified 16 deaths with unknown causes, suggesting reported suicide incidence rates may be underestimated. Additionally, in cases of overdose that were not clearly intentional, the death was listed as “overdose,” possibly resulting in underreporting of suicide.

DISCLOSURES:

No source of study funding was listed. The authors disclosed no relevant financial relationships.

A version of this article appeared on Medscape.com.

 

TOPLINE:

The number of suicides among US college students has doubled over the past two decades and is now the second-most common cause of death after accidents in this population, a new study by the National Collegiate Athletic Association (NCAA) found.

METHODOLOGY:

  • Investigators analyzed deaths between 2002 and 2022, using Poisson regression models to assess changes in incidence rates over time.
  • Data were drawn from the NCAA death database, which includes death from any cause, and included demographic characteristics such as age and race and sporting discipline.
  • They utilized linear and quadratic fits between year and suicide incidence for men and women.
  • Given the low incidence of suicide deaths per year, the incidence rate was multiplied by 100,000 to calculate the incidence per 100,000 athlete-years (AYs).
  •  

TAKEAWAY:

  • Of 1102 total deaths, 11.6% were due to suicide (98 men, 30 women).
  • Athletes who died by suicide ranged in age from 17 to 24 years (mean, 20 years) were predominantly men (77%) and White (59%), with the highest suicide incidence rate among male cross-country athletes (1:29 per 815 AYs).
  • The overall incidence of suicide was 1:71 per 145 AYs.
  • Over the last 10 years, suicide was the second most common cause of death after accidents, with the proportion of deaths by suicide doubling from the first to the second decades (7.6% to 15.3%).
  • Among men, the suicide incidence rate increased in a linear fashion (5-year incidence rate ratio, 1.32; 95% CI, 1.14-1.53), while among women, a quadratic association was identified (P = .002), with the incidence rate reaching its lowest point in women from 2010 to 2011 and increasing thereafter.

IN PRACTICE:

“Athletes are generally thought of as one of the healthiest populations in our society, yet the pressures of school, internal and external performance expectations, time demands, injury, athletic identity, and physical fatigue can lead to depression, mental health problems, and suicide,” the authors wrote. “Although the rate of suicide among collegiate athletes remains lower than the general population, it is important to recognize the parallel increase to ensure this population is not overlooked when assessing for risk factors and implementing prevention strategies.”

SOURCE:

Bridget M. Whelan, MPH, research scientist in the Department of Family Medicine, Sports Medicine Section, University of Washington School of Medicine, Seattle, was the lead and corresponding author on the study, which was published online in the British Journal of Sports Medicine.

LIMITATIONS:

There is no mandatory reporting system for athlete deaths in the United States, and investigators’ search identified 16 deaths with unknown causes, suggesting reported suicide incidence rates may be underestimated. Additionally, in cases of overdose that were not clearly intentional, the death was listed as “overdose,” possibly resulting in underreporting of suicide.

DISCLOSURES:

No source of study funding was listed. The authors disclosed no relevant financial relationships.

A version of this article appeared on Medscape.com.

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FDA Approves New Antibiotic for Uncomplicated UTIs

Article Type
Changed
Mon, 05/06/2024 - 16:59

 



The US Food and Drug Administration (FDA) has approved a new treatment for uncomplicated urinary tract infections (UTIs). 

The agency on April 24 approved pivmecillinam tablets to treat women aged 18 years or older with UTIs caused by bacteria susceptible to the drug.

The beta-lactam antibiotic already is approved in Europe and has been used for more than 40 years outside of the United States to treat infections, according to the drug’s manufacturer, Utility Therapeutics. 

The drug is an aminopenicillin that rapidly converts to mecillinam, according to the company, which is marketing the medication as Pivya. 

Pivmecillinam is intended to treat UTIs caused by susceptible isolates of Escherichia coli, Proteus mirabilis, and Staphylococcus saprophyticus

Researchers studied the treatment in three clinical trials. One study found women who received the new antibiotic were more likely to have resolution of symptoms and a reduction in bacteria in urine compared with placebo (62% vs 10%). Similar results were seen in a trial that used ibuprofen as the comparator (66% vs 22%). 

In a third study that assessed two oral antibacterial drugs, 72% of women who received pivmecillinam and 76% who received the other drug achieved resolution of symptoms and a reduction in bacteria, according to the FDA. 

The most common side effects of pivmecillinam include nausea and diarrhea.

About half of all women will experience at least one UTI in their lifetime, and the infections are one the top reasons for antibiotic prescriptions, the FDA noted. 

A version of this article appeared on Medscape.com.

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The US Food and Drug Administration (FDA) has approved a new treatment for uncomplicated urinary tract infections (UTIs). 

The agency on April 24 approved pivmecillinam tablets to treat women aged 18 years or older with UTIs caused by bacteria susceptible to the drug.

The beta-lactam antibiotic already is approved in Europe and has been used for more than 40 years outside of the United States to treat infections, according to the drug’s manufacturer, Utility Therapeutics. 

The drug is an aminopenicillin that rapidly converts to mecillinam, according to the company, which is marketing the medication as Pivya. 

Pivmecillinam is intended to treat UTIs caused by susceptible isolates of Escherichia coli, Proteus mirabilis, and Staphylococcus saprophyticus

Researchers studied the treatment in three clinical trials. One study found women who received the new antibiotic were more likely to have resolution of symptoms and a reduction in bacteria in urine compared with placebo (62% vs 10%). Similar results were seen in a trial that used ibuprofen as the comparator (66% vs 22%). 

In a third study that assessed two oral antibacterial drugs, 72% of women who received pivmecillinam and 76% who received the other drug achieved resolution of symptoms and a reduction in bacteria, according to the FDA. 

The most common side effects of pivmecillinam include nausea and diarrhea.

About half of all women will experience at least one UTI in their lifetime, and the infections are one the top reasons for antibiotic prescriptions, the FDA noted. 

A version of this article appeared on Medscape.com.

 



The US Food and Drug Administration (FDA) has approved a new treatment for uncomplicated urinary tract infections (UTIs). 

The agency on April 24 approved pivmecillinam tablets to treat women aged 18 years or older with UTIs caused by bacteria susceptible to the drug.

The beta-lactam antibiotic already is approved in Europe and has been used for more than 40 years outside of the United States to treat infections, according to the drug’s manufacturer, Utility Therapeutics. 

The drug is an aminopenicillin that rapidly converts to mecillinam, according to the company, which is marketing the medication as Pivya. 

Pivmecillinam is intended to treat UTIs caused by susceptible isolates of Escherichia coli, Proteus mirabilis, and Staphylococcus saprophyticus

Researchers studied the treatment in three clinical trials. One study found women who received the new antibiotic were more likely to have resolution of symptoms and a reduction in bacteria in urine compared with placebo (62% vs 10%). Similar results were seen in a trial that used ibuprofen as the comparator (66% vs 22%). 

In a third study that assessed two oral antibacterial drugs, 72% of women who received pivmecillinam and 76% who received the other drug achieved resolution of symptoms and a reduction in bacteria, according to the FDA. 

The most common side effects of pivmecillinam include nausea and diarrhea.

About half of all women will experience at least one UTI in their lifetime, and the infections are one the top reasons for antibiotic prescriptions, the FDA noted. 

A version of this article appeared on Medscape.com.

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Routine Breast Cancer Screening Should Start at Age 40: USPSTF

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Women who are considered to be at average risk for breast cancer should have mammograms every other year starting at age 40 years until age 74, according to the latest recommendations from the US Preventive Services Task Force (USPSTF).

In its updated recommendations published April 30 in JAMA, the USPSTF also made an urgent call to address reasons why Black women are more likely to die from breast cancer than are White women and pressed for more research to address persisting questions about how best to screen for cancer in dense breasts, which about 40% of women have. The USPSTF highlighted evidence gaps on the benefits and harms of continuing mammography after age 75 years as well.

The updated USPSTF recommendations were first unveiled last year in a draft version

In 2016, the task force recommended biennial mammograms for women starting 10 years later, at age 50 years, while stressing a need for clinicians and patients to weigh the risks and benefits of screening for those in their 40s. 

The shift to a general recommendation to start at age 40 years is based on a broad review of available data on mammography, including modeling from Cancer Intervention and Surveillance Modeling Network (CISNET).

Alongside the USPSTF report, JAMA published three separate editorials — a reflection of the controversy that these breast cancer screening recommendations often generate. 

In one editorial, published in JAMA Network Open, Lydia E. Pace, MD, MPH, and Nancy L. Keating, MD, MPH, highlighted that though screening earlier will prevent more deaths from breast cancer, it will also lead to more false positive findings and increase rates of overdiagnosis. 

Dr. Pace and Dr. Keating explained that the modeling study commissioned by the USPSTF estimated that screening every 2 years starting at age 40 years would avoid an additional 1.3 breast cancer deaths compared with screening at age 50 years. Among Black women, screening every 2 years starting at age 40 years would avert an extra 1.8 breast cancer deaths per 1000 people screened. 

However, the model also found that screening every 2 years starting at age 40 years would lead to more false positive tests — a rate of about 8.5% vs 7.8% for those starting at age 50.

“Given mammography screening’s modest benefits, we feel that all women — and particularly those aged 40 to 49 years —should be counseled about the benefits and harms of mammography and supported in deciding whether the balance of benefits to harms fits with their priorities and values,” wrote Dr. Pace and Dr. Keating, who specialize in internal medicine.

In a second editorial, in JAMA, Joann G. Elmore, MD, MPH, of UCLA, and Christoph I. Lee, MD, MS, of the University of Washington, Seattle, noted that the revised recommendations “shed light on 2 major issues that demand greater attention: addressing health inequities related to breast cancer outcomes and ensuring benefits for all women amid rapid screening technological advancements.” 

The USPSTF’s decision to recommend an earlier start age for routine mammography was partly intended to begin to address the fact that Black women are about 40% more likely to die from breast cancer than are White women.

“Despite greater absolute benefits of screening for Black women, the modeling study and systematic review underscore that mammography’s benefits (ie, breast cancer deaths averted) are modest for both Black women and the general population,” wrote Dr. Elmore and Dr. Lee.

The editorialists also cautioned against adopting artificial intelligence (AI) support tools too rapidly, criticizing the USPSTF for overlooking this “pressing issue.” 

“While AI algorithms show promise for enhancing cancer detection, their impact on patient outcomes and the balance between benefit and harms remain uncertain,” the editorialists wrote.

In a third editorial, in JAMA Oncology, Wendie A. Berg, MD, PhD, a radiologist at the University of Pittsburgh, argued that though the updated recommendations are “an important step forward,” they don’t go far enough.

Dr. Berg, for instance, noted her surprise “ to see the USPSTF recommendation only for biennial, rather than annual, screening among women aged 40 to 74 years.”

Compared with no screening, annual screening would reduce rates of breast cancer mortality (35.2%) more than biennial (28.4%) screening does among women aged 40-74 years, according to the CISNET modeling that informed the USPSTF’s decision.

Plus, Dr. Berg noted, regular risk assessments should begin at age 25 years “to identify women at high risk who should start annual MRI screenings.”

The American College of Radiology (ACR) offered similar views in a statement, saying the recommendations “do not go far enough to save more women’s lives.” It urged a more aggressive screening schedule, which starts at age 40 years but occurs annually vs biennially and continues past age 74 years. Like Dr. Berg, the ACR advocated for breast cancer risk assessments to begin at age 25 years.

The American Cancer Society also recommended annual mammography screening, starting as early as age 40 years in average-risk women, with high-risk women receiving a breast MRI and a mammogram every year starting at age 30 years. 
 

 

 

Ongoing Uncertainties 

The USPSTF’s 2024 update highlighted persistent evidence gaps in several key areas. 

The USPSTF, for instance, highlighted insufficient evidence on the benefits and harms of continuing to screen women who are 75 years or older as well as the benefits and harms of supplemental screening with breast ultrasonography or MRI in women with dense breasts who had a negative screening mammogram.

In the update, USPSTF noted that it’s still clear what proportion of ductal carcinoma in situ involves lesions detected by screening would not have ultimately caused harm. 

For women with dense breasts, the USPSTF said that “research is needed to help clinicians and patients understand the best strategy for breast cancer screening in women found to have dense breasts,” which includes supplemental screening.

Women with dense breasts should still get mammograms, but there is not enough evidence for a blanket statement about which benefit they might get from additional screening, Carol Mangione, MD, past chair of USPSTF, told this news organization. 

“We don’t want to send a message that the mammogram doesn’t have value in that group, because it does have high value,” said Dr. Mangione, chief of the division of general internal medicine and health services research at UCLA Health. 

Women with dense breasts should work with primary care clinicians who can take a holistic view of their preferences and needs, allowing them to make an informed choice about additional screening, she said.

“But we can’t make a global population choice because we don’t have the studies to do that,” Dr. Mangione said.
 

A version of this article appeared on Medscape.com.

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Women who are considered to be at average risk for breast cancer should have mammograms every other year starting at age 40 years until age 74, according to the latest recommendations from the US Preventive Services Task Force (USPSTF).

In its updated recommendations published April 30 in JAMA, the USPSTF also made an urgent call to address reasons why Black women are more likely to die from breast cancer than are White women and pressed for more research to address persisting questions about how best to screen for cancer in dense breasts, which about 40% of women have. The USPSTF highlighted evidence gaps on the benefits and harms of continuing mammography after age 75 years as well.

The updated USPSTF recommendations were first unveiled last year in a draft version

In 2016, the task force recommended biennial mammograms for women starting 10 years later, at age 50 years, while stressing a need for clinicians and patients to weigh the risks and benefits of screening for those in their 40s. 

The shift to a general recommendation to start at age 40 years is based on a broad review of available data on mammography, including modeling from Cancer Intervention and Surveillance Modeling Network (CISNET).

Alongside the USPSTF report, JAMA published three separate editorials — a reflection of the controversy that these breast cancer screening recommendations often generate. 

In one editorial, published in JAMA Network Open, Lydia E. Pace, MD, MPH, and Nancy L. Keating, MD, MPH, highlighted that though screening earlier will prevent more deaths from breast cancer, it will also lead to more false positive findings and increase rates of overdiagnosis. 

Dr. Pace and Dr. Keating explained that the modeling study commissioned by the USPSTF estimated that screening every 2 years starting at age 40 years would avoid an additional 1.3 breast cancer deaths compared with screening at age 50 years. Among Black women, screening every 2 years starting at age 40 years would avert an extra 1.8 breast cancer deaths per 1000 people screened. 

However, the model also found that screening every 2 years starting at age 40 years would lead to more false positive tests — a rate of about 8.5% vs 7.8% for those starting at age 50.

“Given mammography screening’s modest benefits, we feel that all women — and particularly those aged 40 to 49 years —should be counseled about the benefits and harms of mammography and supported in deciding whether the balance of benefits to harms fits with their priorities and values,” wrote Dr. Pace and Dr. Keating, who specialize in internal medicine.

In a second editorial, in JAMA, Joann G. Elmore, MD, MPH, of UCLA, and Christoph I. Lee, MD, MS, of the University of Washington, Seattle, noted that the revised recommendations “shed light on 2 major issues that demand greater attention: addressing health inequities related to breast cancer outcomes and ensuring benefits for all women amid rapid screening technological advancements.” 

The USPSTF’s decision to recommend an earlier start age for routine mammography was partly intended to begin to address the fact that Black women are about 40% more likely to die from breast cancer than are White women.

“Despite greater absolute benefits of screening for Black women, the modeling study and systematic review underscore that mammography’s benefits (ie, breast cancer deaths averted) are modest for both Black women and the general population,” wrote Dr. Elmore and Dr. Lee.

The editorialists also cautioned against adopting artificial intelligence (AI) support tools too rapidly, criticizing the USPSTF for overlooking this “pressing issue.” 

“While AI algorithms show promise for enhancing cancer detection, their impact on patient outcomes and the balance between benefit and harms remain uncertain,” the editorialists wrote.

In a third editorial, in JAMA Oncology, Wendie A. Berg, MD, PhD, a radiologist at the University of Pittsburgh, argued that though the updated recommendations are “an important step forward,” they don’t go far enough.

Dr. Berg, for instance, noted her surprise “ to see the USPSTF recommendation only for biennial, rather than annual, screening among women aged 40 to 74 years.”

Compared with no screening, annual screening would reduce rates of breast cancer mortality (35.2%) more than biennial (28.4%) screening does among women aged 40-74 years, according to the CISNET modeling that informed the USPSTF’s decision.

Plus, Dr. Berg noted, regular risk assessments should begin at age 25 years “to identify women at high risk who should start annual MRI screenings.”

The American College of Radiology (ACR) offered similar views in a statement, saying the recommendations “do not go far enough to save more women’s lives.” It urged a more aggressive screening schedule, which starts at age 40 years but occurs annually vs biennially and continues past age 74 years. Like Dr. Berg, the ACR advocated for breast cancer risk assessments to begin at age 25 years.

The American Cancer Society also recommended annual mammography screening, starting as early as age 40 years in average-risk women, with high-risk women receiving a breast MRI and a mammogram every year starting at age 30 years. 
 

 

 

Ongoing Uncertainties 

The USPSTF’s 2024 update highlighted persistent evidence gaps in several key areas. 

The USPSTF, for instance, highlighted insufficient evidence on the benefits and harms of continuing to screen women who are 75 years or older as well as the benefits and harms of supplemental screening with breast ultrasonography or MRI in women with dense breasts who had a negative screening mammogram.

In the update, USPSTF noted that it’s still clear what proportion of ductal carcinoma in situ involves lesions detected by screening would not have ultimately caused harm. 

For women with dense breasts, the USPSTF said that “research is needed to help clinicians and patients understand the best strategy for breast cancer screening in women found to have dense breasts,” which includes supplemental screening.

Women with dense breasts should still get mammograms, but there is not enough evidence for a blanket statement about which benefit they might get from additional screening, Carol Mangione, MD, past chair of USPSTF, told this news organization. 

“We don’t want to send a message that the mammogram doesn’t have value in that group, because it does have high value,” said Dr. Mangione, chief of the division of general internal medicine and health services research at UCLA Health. 

Women with dense breasts should work with primary care clinicians who can take a holistic view of their preferences and needs, allowing them to make an informed choice about additional screening, she said.

“But we can’t make a global population choice because we don’t have the studies to do that,” Dr. Mangione said.
 

A version of this article appeared on Medscape.com.

Women who are considered to be at average risk for breast cancer should have mammograms every other year starting at age 40 years until age 74, according to the latest recommendations from the US Preventive Services Task Force (USPSTF).

In its updated recommendations published April 30 in JAMA, the USPSTF also made an urgent call to address reasons why Black women are more likely to die from breast cancer than are White women and pressed for more research to address persisting questions about how best to screen for cancer in dense breasts, which about 40% of women have. The USPSTF highlighted evidence gaps on the benefits and harms of continuing mammography after age 75 years as well.

The updated USPSTF recommendations were first unveiled last year in a draft version

In 2016, the task force recommended biennial mammograms for women starting 10 years later, at age 50 years, while stressing a need for clinicians and patients to weigh the risks and benefits of screening for those in their 40s. 

The shift to a general recommendation to start at age 40 years is based on a broad review of available data on mammography, including modeling from Cancer Intervention and Surveillance Modeling Network (CISNET).

Alongside the USPSTF report, JAMA published three separate editorials — a reflection of the controversy that these breast cancer screening recommendations often generate. 

In one editorial, published in JAMA Network Open, Lydia E. Pace, MD, MPH, and Nancy L. Keating, MD, MPH, highlighted that though screening earlier will prevent more deaths from breast cancer, it will also lead to more false positive findings and increase rates of overdiagnosis. 

Dr. Pace and Dr. Keating explained that the modeling study commissioned by the USPSTF estimated that screening every 2 years starting at age 40 years would avoid an additional 1.3 breast cancer deaths compared with screening at age 50 years. Among Black women, screening every 2 years starting at age 40 years would avert an extra 1.8 breast cancer deaths per 1000 people screened. 

However, the model also found that screening every 2 years starting at age 40 years would lead to more false positive tests — a rate of about 8.5% vs 7.8% for those starting at age 50.

“Given mammography screening’s modest benefits, we feel that all women — and particularly those aged 40 to 49 years —should be counseled about the benefits and harms of mammography and supported in deciding whether the balance of benefits to harms fits with their priorities and values,” wrote Dr. Pace and Dr. Keating, who specialize in internal medicine.

In a second editorial, in JAMA, Joann G. Elmore, MD, MPH, of UCLA, and Christoph I. Lee, MD, MS, of the University of Washington, Seattle, noted that the revised recommendations “shed light on 2 major issues that demand greater attention: addressing health inequities related to breast cancer outcomes and ensuring benefits for all women amid rapid screening technological advancements.” 

The USPSTF’s decision to recommend an earlier start age for routine mammography was partly intended to begin to address the fact that Black women are about 40% more likely to die from breast cancer than are White women.

“Despite greater absolute benefits of screening for Black women, the modeling study and systematic review underscore that mammography’s benefits (ie, breast cancer deaths averted) are modest for both Black women and the general population,” wrote Dr. Elmore and Dr. Lee.

The editorialists also cautioned against adopting artificial intelligence (AI) support tools too rapidly, criticizing the USPSTF for overlooking this “pressing issue.” 

“While AI algorithms show promise for enhancing cancer detection, their impact on patient outcomes and the balance between benefit and harms remain uncertain,” the editorialists wrote.

In a third editorial, in JAMA Oncology, Wendie A. Berg, MD, PhD, a radiologist at the University of Pittsburgh, argued that though the updated recommendations are “an important step forward,” they don’t go far enough.

Dr. Berg, for instance, noted her surprise “ to see the USPSTF recommendation only for biennial, rather than annual, screening among women aged 40 to 74 years.”

Compared with no screening, annual screening would reduce rates of breast cancer mortality (35.2%) more than biennial (28.4%) screening does among women aged 40-74 years, according to the CISNET modeling that informed the USPSTF’s decision.

Plus, Dr. Berg noted, regular risk assessments should begin at age 25 years “to identify women at high risk who should start annual MRI screenings.”

The American College of Radiology (ACR) offered similar views in a statement, saying the recommendations “do not go far enough to save more women’s lives.” It urged a more aggressive screening schedule, which starts at age 40 years but occurs annually vs biennially and continues past age 74 years. Like Dr. Berg, the ACR advocated for breast cancer risk assessments to begin at age 25 years.

The American Cancer Society also recommended annual mammography screening, starting as early as age 40 years in average-risk women, with high-risk women receiving a breast MRI and a mammogram every year starting at age 30 years. 
 

 

 

Ongoing Uncertainties 

The USPSTF’s 2024 update highlighted persistent evidence gaps in several key areas. 

The USPSTF, for instance, highlighted insufficient evidence on the benefits and harms of continuing to screen women who are 75 years or older as well as the benefits and harms of supplemental screening with breast ultrasonography or MRI in women with dense breasts who had a negative screening mammogram.

In the update, USPSTF noted that it’s still clear what proportion of ductal carcinoma in situ involves lesions detected by screening would not have ultimately caused harm. 

For women with dense breasts, the USPSTF said that “research is needed to help clinicians and patients understand the best strategy for breast cancer screening in women found to have dense breasts,” which includes supplemental screening.

Women with dense breasts should still get mammograms, but there is not enough evidence for a blanket statement about which benefit they might get from additional screening, Carol Mangione, MD, past chair of USPSTF, told this news organization. 

“We don’t want to send a message that the mammogram doesn’t have value in that group, because it does have high value,” said Dr. Mangione, chief of the division of general internal medicine and health services research at UCLA Health. 

Women with dense breasts should work with primary care clinicians who can take a holistic view of their preferences and needs, allowing them to make an informed choice about additional screening, she said.

“But we can’t make a global population choice because we don’t have the studies to do that,” Dr. Mangione said.
 

A version of this article appeared on Medscape.com.

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Gene Therapy for Dystrophic EB: Extension Study Results Reported

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Fri, 05/03/2024 - 14:23

In an extension study of patients with dystrophic epidermolysis bullosa (DEB) treated with the topical gene therapy beremagene geperpavec, wound closure rates and adverse events were similar to those seen in the phase 3 study and no new safety signals were identified.

The results were presented by Amy S. Paller, MD, during a late-breaking session at the annual meeting of the American Academy of Dermatology.

In May 2023, beremagene geperpavec, marketed as Vyjuvek (formerly known as B-VEC) was approved by the US Food and Drug Administration (FDA) for the treatment of wounds in patients 6 months of age and older with DEB, a rare genetic blistering disorder caused by COL7A1 gene variants. The therapy uses a nonreplicating herpes simplex virus type 1 (HSV-1) vector to deliver the COL7A1 gene directly to skin cells, restoring the COL7 protein fibrils that stabilize skin structure. It is designed to be used repetitively, to heal a single wound, or on more than one wound.

In the pivotal study of patients with DEB, the gene therapy, delivered in a topical gel, was administered once a week for 6 months to one wound and placebo was applied to another wound for each participant. The proportion of wounds treated with beremagene geperpavec that healed was significantly higher than among placebo-treated wounds at 3 and 6 months (68% vs. 23% at 3 months, P = .003) and 65% vs. 26% at 6 months (P = .012), with no serious adverse events related to treatment.

The prospective, open label, uncontrolled extension study included 24 patients from the phase 3 study and 23 treatment-naive patients from five US sites. Their mean age was 16 years (range, 6 months to 46 years).

Of the 47 patients, 29 (62%) were on treatment for more than 1 year (the longest was about 2 years), and the mean duration of treatment was 475 days; 5 patients withdrew from the study for reasons not related to treatment.

Their types of adverse events (AEs) were similar to those seen in the phase 3 study and were consistent with what would be expected in patients with DEB, said Dr. Paller, professor and chair of dermatology, Northwestern University, Chicago. One patient experienced two wound hemorrhages that were possibly related to treatment, but there were no treatment-related AEs, no deaths or treatment discontinuations because of an AE, and no serious AEs thought to be related to treatment.

Wounds that were evaluated in the phase 3 study showed “a high durability of closure with continued treatment,” according to Dr. Paller. There were enough data on 19 of the 24 patients who had been in the phase 3 trial to evaluate wound closure, defined as “complete wound closure based on comparison to the exact wound area selected at baseline” at the beginning of the phase 3 study.

In the extension study, wound closure rates were almost 90% at baseline, 84.2% at 3 months, 61.1% at 6 months, 82.4% at 9 months, and 62.5% at 12 months, which was comparable to the rates observed in the third (86.4%) and sixth (73.7%) months of the phase 3 study, Dr. Paller said.

Patient-reported outcomes indicated that quality of life and satisfaction with treatment were preserved with continued treatment.The extension study was terminated in July 2023, after FDA approval, when patients could be transitioned to the commercially available treatment.Dr. Paller disclosed being an investigator (funds to institution) for multiple pharmaceutical companies, including the manufacturer of beremagene geperpavec, Krystal Biotech, which funded the study.

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In an extension study of patients with dystrophic epidermolysis bullosa (DEB) treated with the topical gene therapy beremagene geperpavec, wound closure rates and adverse events were similar to those seen in the phase 3 study and no new safety signals were identified.

The results were presented by Amy S. Paller, MD, during a late-breaking session at the annual meeting of the American Academy of Dermatology.

In May 2023, beremagene geperpavec, marketed as Vyjuvek (formerly known as B-VEC) was approved by the US Food and Drug Administration (FDA) for the treatment of wounds in patients 6 months of age and older with DEB, a rare genetic blistering disorder caused by COL7A1 gene variants. The therapy uses a nonreplicating herpes simplex virus type 1 (HSV-1) vector to deliver the COL7A1 gene directly to skin cells, restoring the COL7 protein fibrils that stabilize skin structure. It is designed to be used repetitively, to heal a single wound, or on more than one wound.

In the pivotal study of patients with DEB, the gene therapy, delivered in a topical gel, was administered once a week for 6 months to one wound and placebo was applied to another wound for each participant. The proportion of wounds treated with beremagene geperpavec that healed was significantly higher than among placebo-treated wounds at 3 and 6 months (68% vs. 23% at 3 months, P = .003) and 65% vs. 26% at 6 months (P = .012), with no serious adverse events related to treatment.

The prospective, open label, uncontrolled extension study included 24 patients from the phase 3 study and 23 treatment-naive patients from five US sites. Their mean age was 16 years (range, 6 months to 46 years).

Of the 47 patients, 29 (62%) were on treatment for more than 1 year (the longest was about 2 years), and the mean duration of treatment was 475 days; 5 patients withdrew from the study for reasons not related to treatment.

Their types of adverse events (AEs) were similar to those seen in the phase 3 study and were consistent with what would be expected in patients with DEB, said Dr. Paller, professor and chair of dermatology, Northwestern University, Chicago. One patient experienced two wound hemorrhages that were possibly related to treatment, but there were no treatment-related AEs, no deaths or treatment discontinuations because of an AE, and no serious AEs thought to be related to treatment.

Wounds that were evaluated in the phase 3 study showed “a high durability of closure with continued treatment,” according to Dr. Paller. There were enough data on 19 of the 24 patients who had been in the phase 3 trial to evaluate wound closure, defined as “complete wound closure based on comparison to the exact wound area selected at baseline” at the beginning of the phase 3 study.

In the extension study, wound closure rates were almost 90% at baseline, 84.2% at 3 months, 61.1% at 6 months, 82.4% at 9 months, and 62.5% at 12 months, which was comparable to the rates observed in the third (86.4%) and sixth (73.7%) months of the phase 3 study, Dr. Paller said.

Patient-reported outcomes indicated that quality of life and satisfaction with treatment were preserved with continued treatment.The extension study was terminated in July 2023, after FDA approval, when patients could be transitioned to the commercially available treatment.Dr. Paller disclosed being an investigator (funds to institution) for multiple pharmaceutical companies, including the manufacturer of beremagene geperpavec, Krystal Biotech, which funded the study.

In an extension study of patients with dystrophic epidermolysis bullosa (DEB) treated with the topical gene therapy beremagene geperpavec, wound closure rates and adverse events were similar to those seen in the phase 3 study and no new safety signals were identified.

The results were presented by Amy S. Paller, MD, during a late-breaking session at the annual meeting of the American Academy of Dermatology.

In May 2023, beremagene geperpavec, marketed as Vyjuvek (formerly known as B-VEC) was approved by the US Food and Drug Administration (FDA) for the treatment of wounds in patients 6 months of age and older with DEB, a rare genetic blistering disorder caused by COL7A1 gene variants. The therapy uses a nonreplicating herpes simplex virus type 1 (HSV-1) vector to deliver the COL7A1 gene directly to skin cells, restoring the COL7 protein fibrils that stabilize skin structure. It is designed to be used repetitively, to heal a single wound, or on more than one wound.

In the pivotal study of patients with DEB, the gene therapy, delivered in a topical gel, was administered once a week for 6 months to one wound and placebo was applied to another wound for each participant. The proportion of wounds treated with beremagene geperpavec that healed was significantly higher than among placebo-treated wounds at 3 and 6 months (68% vs. 23% at 3 months, P = .003) and 65% vs. 26% at 6 months (P = .012), with no serious adverse events related to treatment.

The prospective, open label, uncontrolled extension study included 24 patients from the phase 3 study and 23 treatment-naive patients from five US sites. Their mean age was 16 years (range, 6 months to 46 years).

Of the 47 patients, 29 (62%) were on treatment for more than 1 year (the longest was about 2 years), and the mean duration of treatment was 475 days; 5 patients withdrew from the study for reasons not related to treatment.

Their types of adverse events (AEs) were similar to those seen in the phase 3 study and were consistent with what would be expected in patients with DEB, said Dr. Paller, professor and chair of dermatology, Northwestern University, Chicago. One patient experienced two wound hemorrhages that were possibly related to treatment, but there were no treatment-related AEs, no deaths or treatment discontinuations because of an AE, and no serious AEs thought to be related to treatment.

Wounds that were evaluated in the phase 3 study showed “a high durability of closure with continued treatment,” according to Dr. Paller. There were enough data on 19 of the 24 patients who had been in the phase 3 trial to evaluate wound closure, defined as “complete wound closure based on comparison to the exact wound area selected at baseline” at the beginning of the phase 3 study.

In the extension study, wound closure rates were almost 90% at baseline, 84.2% at 3 months, 61.1% at 6 months, 82.4% at 9 months, and 62.5% at 12 months, which was comparable to the rates observed in the third (86.4%) and sixth (73.7%) months of the phase 3 study, Dr. Paller said.

Patient-reported outcomes indicated that quality of life and satisfaction with treatment were preserved with continued treatment.The extension study was terminated in July 2023, after FDA approval, when patients could be transitioned to the commercially available treatment.Dr. Paller disclosed being an investigator (funds to institution) for multiple pharmaceutical companies, including the manufacturer of beremagene geperpavec, Krystal Biotech, which funded the study.

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Positive Phase 2 Results Reported for TYK2 Inhibitor for Patients With Moderate to Severe Psoriasis

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Fri, 05/03/2024 - 14:39

A significant proportion of patients with moderate to severe plaque psoriasis achieved at least a 75% improvement in the Psoriasis Area and Severity Score (PASI 75) compared with those on placebo after 12 weeks of treatment with an investigational oral tyrosine kinase 2 (TYK2) inhibitor, in a phase 2 study presented during a late breaker presentation at the annual meeting of the American Academy of Dermatology.

ESK-001 is a highly-selective TYK2 inhibitor that “reduces signaling through several cytokine receptors including receptors for interleukin (IL)-12, IL-23, and interferon (IFN)-alpha,” according to Alumis, the company developing ESK-001.

The STRIDE trial enrolled 228 adults (mean age, 48 years) with a mean PASI score of 17.8 at baseline, randomized to one of five doses of ESK-001, or placebo. Nearly 70% of those enrolled were men, 82.5% were White, nearly 6% were Asian, and about 4% were Black.

The proportion of patients achieving at least a PASI-75 at 12 weeks, the primary endpoint, ranged from 19.4% among those on the lower dose (10 mg a day) to 56.4% among those on 20 mg twice a day and those on 40 mg once a day, and 64.1% among those on 40 mg twice a day, the highest dose evaluated, compared with 0% of those on placebo.

In addition, 38.5% and 15.4% of those on the highest dose achieved a PASI 90 and PASI 100, respectively, at 12 weeks, according to results presented at the meeting by Kim A. Papp, MD.

Improvements in static Physician’s Global Assessment (sPGA) scores, a secondary endpoint, at 12 weeks were also observed; including 59% of those on the highest dose (40 mg twice a day) achieving an sPGA of 0/1 at 12 weeks, according to Dr. Papp, president of Probity Medical Research, in Waterloo, Ontario, and a study investigator.



Treatment was “generally safe and well tolerated” at all doses, and most treatment-emergent adverse events were “mild to moderate” and self-limited, he said.

The most frequent treatment emergent adverse events included headache and nasopharyngitis (also reported in the placebo group), and upper respiratory tract infections. No cases of treatment-related serious adverse events were reported, and there were no cases of MACE (major adverse cardiovascular events), serious infections, thromboses related to treatment, or lab or ECG findings of concern.

In an ongoing open label extension study, 165 patients on 40 mg once a day and those on 40 mg twice a day are continuing to be evaluated, and at week 16, have continued to show significant efficacy, with a favorable risk-benefit profile to date, according to Dr. Papp.

ESK-001 is also being evaluated in a phase 2b study of patients with systemic lupus erythematosus, and a phase 2 proof-of-concept study of patients with non-infectious uveitis, according to Alumis.

In addition to being an investigator for Alumis, Dr. Papp disclosed serving as an adviser, consultant, investigator, and/or speaker for multiple other pharmaceutical companies.

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A significant proportion of patients with moderate to severe plaque psoriasis achieved at least a 75% improvement in the Psoriasis Area and Severity Score (PASI 75) compared with those on placebo after 12 weeks of treatment with an investigational oral tyrosine kinase 2 (TYK2) inhibitor, in a phase 2 study presented during a late breaker presentation at the annual meeting of the American Academy of Dermatology.

ESK-001 is a highly-selective TYK2 inhibitor that “reduces signaling through several cytokine receptors including receptors for interleukin (IL)-12, IL-23, and interferon (IFN)-alpha,” according to Alumis, the company developing ESK-001.

The STRIDE trial enrolled 228 adults (mean age, 48 years) with a mean PASI score of 17.8 at baseline, randomized to one of five doses of ESK-001, or placebo. Nearly 70% of those enrolled were men, 82.5% were White, nearly 6% were Asian, and about 4% were Black.

The proportion of patients achieving at least a PASI-75 at 12 weeks, the primary endpoint, ranged from 19.4% among those on the lower dose (10 mg a day) to 56.4% among those on 20 mg twice a day and those on 40 mg once a day, and 64.1% among those on 40 mg twice a day, the highest dose evaluated, compared with 0% of those on placebo.

In addition, 38.5% and 15.4% of those on the highest dose achieved a PASI 90 and PASI 100, respectively, at 12 weeks, according to results presented at the meeting by Kim A. Papp, MD.

Improvements in static Physician’s Global Assessment (sPGA) scores, a secondary endpoint, at 12 weeks were also observed; including 59% of those on the highest dose (40 mg twice a day) achieving an sPGA of 0/1 at 12 weeks, according to Dr. Papp, president of Probity Medical Research, in Waterloo, Ontario, and a study investigator.



Treatment was “generally safe and well tolerated” at all doses, and most treatment-emergent adverse events were “mild to moderate” and self-limited, he said.

The most frequent treatment emergent adverse events included headache and nasopharyngitis (also reported in the placebo group), and upper respiratory tract infections. No cases of treatment-related serious adverse events were reported, and there were no cases of MACE (major adverse cardiovascular events), serious infections, thromboses related to treatment, or lab or ECG findings of concern.

In an ongoing open label extension study, 165 patients on 40 mg once a day and those on 40 mg twice a day are continuing to be evaluated, and at week 16, have continued to show significant efficacy, with a favorable risk-benefit profile to date, according to Dr. Papp.

ESK-001 is also being evaluated in a phase 2b study of patients with systemic lupus erythematosus, and a phase 2 proof-of-concept study of patients with non-infectious uveitis, according to Alumis.

In addition to being an investigator for Alumis, Dr. Papp disclosed serving as an adviser, consultant, investigator, and/or speaker for multiple other pharmaceutical companies.

A significant proportion of patients with moderate to severe plaque psoriasis achieved at least a 75% improvement in the Psoriasis Area and Severity Score (PASI 75) compared with those on placebo after 12 weeks of treatment with an investigational oral tyrosine kinase 2 (TYK2) inhibitor, in a phase 2 study presented during a late breaker presentation at the annual meeting of the American Academy of Dermatology.

ESK-001 is a highly-selective TYK2 inhibitor that “reduces signaling through several cytokine receptors including receptors for interleukin (IL)-12, IL-23, and interferon (IFN)-alpha,” according to Alumis, the company developing ESK-001.

The STRIDE trial enrolled 228 adults (mean age, 48 years) with a mean PASI score of 17.8 at baseline, randomized to one of five doses of ESK-001, or placebo. Nearly 70% of those enrolled were men, 82.5% were White, nearly 6% were Asian, and about 4% were Black.

The proportion of patients achieving at least a PASI-75 at 12 weeks, the primary endpoint, ranged from 19.4% among those on the lower dose (10 mg a day) to 56.4% among those on 20 mg twice a day and those on 40 mg once a day, and 64.1% among those on 40 mg twice a day, the highest dose evaluated, compared with 0% of those on placebo.

In addition, 38.5% and 15.4% of those on the highest dose achieved a PASI 90 and PASI 100, respectively, at 12 weeks, according to results presented at the meeting by Kim A. Papp, MD.

Improvements in static Physician’s Global Assessment (sPGA) scores, a secondary endpoint, at 12 weeks were also observed; including 59% of those on the highest dose (40 mg twice a day) achieving an sPGA of 0/1 at 12 weeks, according to Dr. Papp, president of Probity Medical Research, in Waterloo, Ontario, and a study investigator.



Treatment was “generally safe and well tolerated” at all doses, and most treatment-emergent adverse events were “mild to moderate” and self-limited, he said.

The most frequent treatment emergent adverse events included headache and nasopharyngitis (also reported in the placebo group), and upper respiratory tract infections. No cases of treatment-related serious adverse events were reported, and there were no cases of MACE (major adverse cardiovascular events), serious infections, thromboses related to treatment, or lab or ECG findings of concern.

In an ongoing open label extension study, 165 patients on 40 mg once a day and those on 40 mg twice a day are continuing to be evaluated, and at week 16, have continued to show significant efficacy, with a favorable risk-benefit profile to date, according to Dr. Papp.

ESK-001 is also being evaluated in a phase 2b study of patients with systemic lupus erythematosus, and a phase 2 proof-of-concept study of patients with non-infectious uveitis, according to Alumis.

In addition to being an investigator for Alumis, Dr. Papp disclosed serving as an adviser, consultant, investigator, and/or speaker for multiple other pharmaceutical companies.

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Three Conditions for Which Cannabis Appears to Help

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Changed
Wed, 05/08/2024 - 10:53

The utility of cannabinoids to treat most medical conditions remains uncertain at best, but for at least three indications the data lean in favor of effectiveness, Ellie Grossman, MD, MPH, told attendees recently at the 2024 American College of Physicians Internal Medicine meeting.

Those are neuropathic pain, chemotherapy-induced nausea or vomiting, and spasticity in people with multiple sclerosis, said Dr. Grossman, an instructor at Harvard Medical School in Boston and medical director for primary care/behavioral health integration at Cambridge Health Alliance in Somerville, Massachusetts.

Dearth of Research Persists

Research is sorely lacking and of low quality in the field for many reasons, Dr. Grossman said. Most of the products tested come from outside the United States and often are synthetic and taken orally — which does not match the real-world use when patients go to dispensaries for cannabis derived directly from plants (or the plant product itself). And studies often rely on self-report.

Chronic pain is by far the top reason patients say they use medical cannabis, Dr. Grossman said. A Cochrane review of 16 studies found only that the potential benefits of cannabis may outweigh the potential harms for chronic neuropathic pain.
 

No Evidence in OUD

Dr. Grossman said she is frequently asked if cannabis can help people quit taking opioids. The answer seems to be no. A study published earlier this year in states with legalized medical or recreational cannabis found no difference between rates of opioid overdose compared with states with no such laws. “It seems like it doesn’t do anything to help us with our opioid problem,” she said.

Nor does high-quality evidence exist showing use of cannabis can improve sleep, she said. A 2022 systematic review found fewer than half of studies showed the substance useful for sleep outcomes. “Where studies were positives, it was in people who had chronic pain,” Dr. Grossman noted. Research indicates cannabis may have substantial benefit for chronic pain compared with placebo.
 

Potential Harms

If the medical benefits of cannabis are murky, the evidence for its potential harms, at least in the short term, are clearer, according to Dr. Grossman. A simplified guideline for prescribing medical cannabinoids in primary care includes sedation, feeling high, dizziness, speech disorders, muscle twitching, hypotension, and several other conditions among the potential hazards of the drug. 

But the potential for long-term harm is uncertain. “All the evidence comes from people who have been using it for recreational reasons,” where there may be co-use of tobacco, self-reported outcomes, and recall bias, she said. The characteristics of people using cannabis recreationally often differ from those using it medicinally.
 

Use With Other Controlled Substances

Dr. Grossman said clinicians should consider whether the co-use of cannabis and other controlled substances, such as benzodiazepines, opioids, or Adderall, raises the potential risks associated with those drugs. “Ultimately it comes down to talking to your patients,” she said. If a toxicity screen shows the presence of controlled substances, ask about their experience with the drugs they are using and let them know your main concern is their safety.

Dr. Grossman reported no relevant financial conflicts of interest.

A version of this article appeared on Medscape.com.

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The utility of cannabinoids to treat most medical conditions remains uncertain at best, but for at least three indications the data lean in favor of effectiveness, Ellie Grossman, MD, MPH, told attendees recently at the 2024 American College of Physicians Internal Medicine meeting.

Those are neuropathic pain, chemotherapy-induced nausea or vomiting, and spasticity in people with multiple sclerosis, said Dr. Grossman, an instructor at Harvard Medical School in Boston and medical director for primary care/behavioral health integration at Cambridge Health Alliance in Somerville, Massachusetts.

Dearth of Research Persists

Research is sorely lacking and of low quality in the field for many reasons, Dr. Grossman said. Most of the products tested come from outside the United States and often are synthetic and taken orally — which does not match the real-world use when patients go to dispensaries for cannabis derived directly from plants (or the plant product itself). And studies often rely on self-report.

Chronic pain is by far the top reason patients say they use medical cannabis, Dr. Grossman said. A Cochrane review of 16 studies found only that the potential benefits of cannabis may outweigh the potential harms for chronic neuropathic pain.
 

No Evidence in OUD

Dr. Grossman said she is frequently asked if cannabis can help people quit taking opioids. The answer seems to be no. A study published earlier this year in states with legalized medical or recreational cannabis found no difference between rates of opioid overdose compared with states with no such laws. “It seems like it doesn’t do anything to help us with our opioid problem,” she said.

Nor does high-quality evidence exist showing use of cannabis can improve sleep, she said. A 2022 systematic review found fewer than half of studies showed the substance useful for sleep outcomes. “Where studies were positives, it was in people who had chronic pain,” Dr. Grossman noted. Research indicates cannabis may have substantial benefit for chronic pain compared with placebo.
 

Potential Harms

If the medical benefits of cannabis are murky, the evidence for its potential harms, at least in the short term, are clearer, according to Dr. Grossman. A simplified guideline for prescribing medical cannabinoids in primary care includes sedation, feeling high, dizziness, speech disorders, muscle twitching, hypotension, and several other conditions among the potential hazards of the drug. 

But the potential for long-term harm is uncertain. “All the evidence comes from people who have been using it for recreational reasons,” where there may be co-use of tobacco, self-reported outcomes, and recall bias, she said. The characteristics of people using cannabis recreationally often differ from those using it medicinally.
 

Use With Other Controlled Substances

Dr. Grossman said clinicians should consider whether the co-use of cannabis and other controlled substances, such as benzodiazepines, opioids, or Adderall, raises the potential risks associated with those drugs. “Ultimately it comes down to talking to your patients,” she said. If a toxicity screen shows the presence of controlled substances, ask about their experience with the drugs they are using and let them know your main concern is their safety.

Dr. Grossman reported no relevant financial conflicts of interest.

A version of this article appeared on Medscape.com.

The utility of cannabinoids to treat most medical conditions remains uncertain at best, but for at least three indications the data lean in favor of effectiveness, Ellie Grossman, MD, MPH, told attendees recently at the 2024 American College of Physicians Internal Medicine meeting.

Those are neuropathic pain, chemotherapy-induced nausea or vomiting, and spasticity in people with multiple sclerosis, said Dr. Grossman, an instructor at Harvard Medical School in Boston and medical director for primary care/behavioral health integration at Cambridge Health Alliance in Somerville, Massachusetts.

Dearth of Research Persists

Research is sorely lacking and of low quality in the field for many reasons, Dr. Grossman said. Most of the products tested come from outside the United States and often are synthetic and taken orally — which does not match the real-world use when patients go to dispensaries for cannabis derived directly from plants (or the plant product itself). And studies often rely on self-report.

Chronic pain is by far the top reason patients say they use medical cannabis, Dr. Grossman said. A Cochrane review of 16 studies found only that the potential benefits of cannabis may outweigh the potential harms for chronic neuropathic pain.
 

No Evidence in OUD

Dr. Grossman said she is frequently asked if cannabis can help people quit taking opioids. The answer seems to be no. A study published earlier this year in states with legalized medical or recreational cannabis found no difference between rates of opioid overdose compared with states with no such laws. “It seems like it doesn’t do anything to help us with our opioid problem,” she said.

Nor does high-quality evidence exist showing use of cannabis can improve sleep, she said. A 2022 systematic review found fewer than half of studies showed the substance useful for sleep outcomes. “Where studies were positives, it was in people who had chronic pain,” Dr. Grossman noted. Research indicates cannabis may have substantial benefit for chronic pain compared with placebo.
 

Potential Harms

If the medical benefits of cannabis are murky, the evidence for its potential harms, at least in the short term, are clearer, according to Dr. Grossman. A simplified guideline for prescribing medical cannabinoids in primary care includes sedation, feeling high, dizziness, speech disorders, muscle twitching, hypotension, and several other conditions among the potential hazards of the drug. 

But the potential for long-term harm is uncertain. “All the evidence comes from people who have been using it for recreational reasons,” where there may be co-use of tobacco, self-reported outcomes, and recall bias, she said. The characteristics of people using cannabis recreationally often differ from those using it medicinally.
 

Use With Other Controlled Substances

Dr. Grossman said clinicians should consider whether the co-use of cannabis and other controlled substances, such as benzodiazepines, opioids, or Adderall, raises the potential risks associated with those drugs. “Ultimately it comes down to talking to your patients,” she said. If a toxicity screen shows the presence of controlled substances, ask about their experience with the drugs they are using and let them know your main concern is their safety.

Dr. Grossman reported no relevant financial conflicts of interest.

A version of this article appeared on Medscape.com.

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Girls Catching Up With Boys in Substance Use

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Fri, 05/03/2024 - 13:57

Girls are catching up with and sometimes surpassing boys in terms of adolescent substance use, warned the authors of a new report detailing trends across several regions between 2018 and 2022. The latest 4-yearly Health Behaviour in School-Aged Children study, in collaboration with the World Health Organization (WHO) Regional Office for Europe, concluded that substance use remains “a crucial public health problem among adolescents” despite overall declines in smoking, alcohol, and cannabis use.

The new report: A focus on adolescent substance use in Europe, central Asia, and Canada, detailed substance use among adolescents aged 11, 13, and 15 years across 44 countries and regions in Europe, Central Asia, and Canada in the 2021-2022 school-based survey.

Principal findings included:

  • Cigarette smoking: Lifetime smoking declined between 2018 and 2022, particularly among 13-year-old boys and 15-year-old boys and girls. There was also a small but significant decrease in current smoking among 15-year-old boys.
  • Alcohol use: Lifetime use decreased overall in boys between 2018 and 2022, particularly among 15-year-olds. An increase was observed among 11- and 13-year-old girls but not 15-year-old girls. There was a small but significant decrease in the proportion of current drinkers among 15-year-old boys, with no change among 11- and 13-year-old boys. Current alcohol use increased among girls in all age groups.
  • Cannabis use: Lifetime use among 15-year-olds decreased slightly from 14% to 12% between 2018 and 2022, while 6% of 15-year-olds reported having used cannabis in the previous 30 days.
  • Vaping: In 2022 vapes (e-cigarettes) were more popular among adolescents than conventional tobacco cigarettes.

Traditional Gender Gap Narrowing or Reversing

Report coauthor Judith Brown from the University of Glasgow, Glasgow, Scotland, and a project manager for the Scottish survey, said that “there was an overall increase in current alcohol use and drunkenness among older girls” despite the overall decrease in boys’ alcohol use.

She explained: “Substance use has traditionally been more prevalent among boys, and the survey findings confirm a well-established gender difference, with higher prevalence in boys than in girls among 11-year-olds. By the age of 13, however, gender differences diminish or even disappear in many countries and regions.”

“Among 15-year-olds, girls often reported more frequent substance use than boys. While this pattern has been known for cigarette smoking in many countries and regions for about two decades, especially among 15-year-olds, it is a new phenomenon for behaviors related to other substances (such as alcohol consumption and drunkenness) in most countries and regions. Historically, prevalence for these behaviors has been higher among boys than girls.”

The new survey results highlight this gender reversal for several substances, she said. “Cannabis is the only substance for which both lifetime and current use is consistently higher in boys.”
 

Vaping Is an Emerging Public Health Concern

Dr. Brown added that the 2022 survey was the first time that vaping data had been collected from all countries. Although this is against the background of continuing decreases in smoking rates, “researchers suggest the transition to e-cigarettes, as a more popular choice than conventional cigarettes, highlights an urgent need for more targeted interventions to address this emerging public health concern.”

The report authors commented that because young people’s brains are still developing, they are “very sensitive to substances such as nicotine,” making it “easier for them to get hooked.”

Margreet de Looze, PhD, assistant professor of interdisciplinary social science at Utrecht University in Utrecht, the Netherlands, agreed with the authors’ concerns. “Vaping is extremely attractive for young people,” she said, “because the taste is more attractive than that of traditional cigarettes.” Until recently, many people were not aware of health hazards attached to vaping. “While more research is needed, vaping may function as a first step toward tobacco use and is hazardous for young people’s health. Therefore, it should be strongly discouraged.”
 

Substance Use Trends May Be Stabilizing or Rising Again

Increased awareness of the harmful effects of alcohol for adolescent development is also one postulated reason for declining adolescent alcohol consumption in both Europe and North America over the past two decades, which Dr. de Looze’s research has explored. Her work has also noted the “growing trend” of young people abstaining from alcohol altogether and some evidence of reductions in adolescent risk behaviors more generally, including early sexual initiation and juvenile crime.

“It may be good to realize that, in fact, the current generation of youth in many respects is healthier and reports less risky health behaviors as compared to previous generations,” she said.

However, “The declining trend in adolescent substance use that took place in many countries since the beginning of the 21st century seems to have stabilized, and moreover, in some countries and subgroups of adolescents, substance use appears to be on the rise again.” She cited particularly an overall increase in current alcohol use and drunkenness among older girls between 2018 and 2022. “It appears that, especially for girls, recent trends over time are less favorable as compared with boys.”
 

Multiple Influences on Adolescent Substance Abuse

Peer group influences are known to come to the fore during adolescence, and Dr. de Looze added that the early 21st century saw marked reductions in adolescent face-to-face contacts with their peers due to the rise in digital communications. “Adolescents typically use substances in the presence of peers (and in the absence of adults/parents), as it increases their status in their peer group.” Reduced in person interactions with friends may therefore have contributed to the earlier decline in substance use.

However, her team had found that adolescents who spend much time online with friends often also spend much time with friends offline. “They are what you could call the ‘social’ youth, who just spend much time with peers, be it offline or online,” she said. “More research is needed to disentangle exactly how, what kind, for whom the digital environment may be related to young people’s substance use,” she said.

“We also see that young people actively select their friends. So, if you are curious and a bit of a sensation-seeker yourself, you are more likely to become friends with youth who are just like you, and together, you may be more likely to try out substances.”

Factors underlying adolescent substance use and differences between countries are influenced by a complex interplay of factors, said Carina Ferreira-Borges, PhD, regional adviser for alcohol, illicit drugs, and prison health at the WHO Regional Office for Europe.

“Prevention measures definitely play a critical role in reducing substance use,” she said, “but other factors, such as cultural norms and socioeconomic conditions, also significantly impact these patterns.”

“Variations in substance use among countries can be attributed to different levels of implemented polices, public health initiatives, and the extent to which substance use is normalized or stigmatized within each society.”
 

Policy Efforts Must Be Targeted

“To address these disparities effectively, interventions and population-level policies need to be culturally adapted and target the specific environments where substance use is normalized among adolescents. By understanding and modifying the broader context in which young people make choices about substance use, we can better influence their behavior and health outcomes.”

Dr. de Looze cautioned, “In the past two decades, public health efforts in many countries have focused on reducing young people’s engagement in substance use. It is important that these efforts continue, as every year a new generation of youth is born. If public health efforts do not continue to focus on supporting a healthy lifestyle among young people, it should not come as a surprise that rates start or continue to rise again.”

A version of this article appeared on Medscape.com.

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Girls are catching up with and sometimes surpassing boys in terms of adolescent substance use, warned the authors of a new report detailing trends across several regions between 2018 and 2022. The latest 4-yearly Health Behaviour in School-Aged Children study, in collaboration with the World Health Organization (WHO) Regional Office for Europe, concluded that substance use remains “a crucial public health problem among adolescents” despite overall declines in smoking, alcohol, and cannabis use.

The new report: A focus on adolescent substance use in Europe, central Asia, and Canada, detailed substance use among adolescents aged 11, 13, and 15 years across 44 countries and regions in Europe, Central Asia, and Canada in the 2021-2022 school-based survey.

Principal findings included:

  • Cigarette smoking: Lifetime smoking declined between 2018 and 2022, particularly among 13-year-old boys and 15-year-old boys and girls. There was also a small but significant decrease in current smoking among 15-year-old boys.
  • Alcohol use: Lifetime use decreased overall in boys between 2018 and 2022, particularly among 15-year-olds. An increase was observed among 11- and 13-year-old girls but not 15-year-old girls. There was a small but significant decrease in the proportion of current drinkers among 15-year-old boys, with no change among 11- and 13-year-old boys. Current alcohol use increased among girls in all age groups.
  • Cannabis use: Lifetime use among 15-year-olds decreased slightly from 14% to 12% between 2018 and 2022, while 6% of 15-year-olds reported having used cannabis in the previous 30 days.
  • Vaping: In 2022 vapes (e-cigarettes) were more popular among adolescents than conventional tobacco cigarettes.

Traditional Gender Gap Narrowing or Reversing

Report coauthor Judith Brown from the University of Glasgow, Glasgow, Scotland, and a project manager for the Scottish survey, said that “there was an overall increase in current alcohol use and drunkenness among older girls” despite the overall decrease in boys’ alcohol use.

She explained: “Substance use has traditionally been more prevalent among boys, and the survey findings confirm a well-established gender difference, with higher prevalence in boys than in girls among 11-year-olds. By the age of 13, however, gender differences diminish or even disappear in many countries and regions.”

“Among 15-year-olds, girls often reported more frequent substance use than boys. While this pattern has been known for cigarette smoking in many countries and regions for about two decades, especially among 15-year-olds, it is a new phenomenon for behaviors related to other substances (such as alcohol consumption and drunkenness) in most countries and regions. Historically, prevalence for these behaviors has been higher among boys than girls.”

The new survey results highlight this gender reversal for several substances, she said. “Cannabis is the only substance for which both lifetime and current use is consistently higher in boys.”
 

Vaping Is an Emerging Public Health Concern

Dr. Brown added that the 2022 survey was the first time that vaping data had been collected from all countries. Although this is against the background of continuing decreases in smoking rates, “researchers suggest the transition to e-cigarettes, as a more popular choice than conventional cigarettes, highlights an urgent need for more targeted interventions to address this emerging public health concern.”

The report authors commented that because young people’s brains are still developing, they are “very sensitive to substances such as nicotine,” making it “easier for them to get hooked.”

Margreet de Looze, PhD, assistant professor of interdisciplinary social science at Utrecht University in Utrecht, the Netherlands, agreed with the authors’ concerns. “Vaping is extremely attractive for young people,” she said, “because the taste is more attractive than that of traditional cigarettes.” Until recently, many people were not aware of health hazards attached to vaping. “While more research is needed, vaping may function as a first step toward tobacco use and is hazardous for young people’s health. Therefore, it should be strongly discouraged.”
 

Substance Use Trends May Be Stabilizing or Rising Again

Increased awareness of the harmful effects of alcohol for adolescent development is also one postulated reason for declining adolescent alcohol consumption in both Europe and North America over the past two decades, which Dr. de Looze’s research has explored. Her work has also noted the “growing trend” of young people abstaining from alcohol altogether and some evidence of reductions in adolescent risk behaviors more generally, including early sexual initiation and juvenile crime.

“It may be good to realize that, in fact, the current generation of youth in many respects is healthier and reports less risky health behaviors as compared to previous generations,” she said.

However, “The declining trend in adolescent substance use that took place in many countries since the beginning of the 21st century seems to have stabilized, and moreover, in some countries and subgroups of adolescents, substance use appears to be on the rise again.” She cited particularly an overall increase in current alcohol use and drunkenness among older girls between 2018 and 2022. “It appears that, especially for girls, recent trends over time are less favorable as compared with boys.”
 

Multiple Influences on Adolescent Substance Abuse

Peer group influences are known to come to the fore during adolescence, and Dr. de Looze added that the early 21st century saw marked reductions in adolescent face-to-face contacts with their peers due to the rise in digital communications. “Adolescents typically use substances in the presence of peers (and in the absence of adults/parents), as it increases their status in their peer group.” Reduced in person interactions with friends may therefore have contributed to the earlier decline in substance use.

However, her team had found that adolescents who spend much time online with friends often also spend much time with friends offline. “They are what you could call the ‘social’ youth, who just spend much time with peers, be it offline or online,” she said. “More research is needed to disentangle exactly how, what kind, for whom the digital environment may be related to young people’s substance use,” she said.

“We also see that young people actively select their friends. So, if you are curious and a bit of a sensation-seeker yourself, you are more likely to become friends with youth who are just like you, and together, you may be more likely to try out substances.”

Factors underlying adolescent substance use and differences between countries are influenced by a complex interplay of factors, said Carina Ferreira-Borges, PhD, regional adviser for alcohol, illicit drugs, and prison health at the WHO Regional Office for Europe.

“Prevention measures definitely play a critical role in reducing substance use,” she said, “but other factors, such as cultural norms and socioeconomic conditions, also significantly impact these patterns.”

“Variations in substance use among countries can be attributed to different levels of implemented polices, public health initiatives, and the extent to which substance use is normalized or stigmatized within each society.”
 

Policy Efforts Must Be Targeted

“To address these disparities effectively, interventions and population-level policies need to be culturally adapted and target the specific environments where substance use is normalized among adolescents. By understanding and modifying the broader context in which young people make choices about substance use, we can better influence their behavior and health outcomes.”

Dr. de Looze cautioned, “In the past two decades, public health efforts in many countries have focused on reducing young people’s engagement in substance use. It is important that these efforts continue, as every year a new generation of youth is born. If public health efforts do not continue to focus on supporting a healthy lifestyle among young people, it should not come as a surprise that rates start or continue to rise again.”

A version of this article appeared on Medscape.com.

Girls are catching up with and sometimes surpassing boys in terms of adolescent substance use, warned the authors of a new report detailing trends across several regions between 2018 and 2022. The latest 4-yearly Health Behaviour in School-Aged Children study, in collaboration with the World Health Organization (WHO) Regional Office for Europe, concluded that substance use remains “a crucial public health problem among adolescents” despite overall declines in smoking, alcohol, and cannabis use.

The new report: A focus on adolescent substance use in Europe, central Asia, and Canada, detailed substance use among adolescents aged 11, 13, and 15 years across 44 countries and regions in Europe, Central Asia, and Canada in the 2021-2022 school-based survey.

Principal findings included:

  • Cigarette smoking: Lifetime smoking declined between 2018 and 2022, particularly among 13-year-old boys and 15-year-old boys and girls. There was also a small but significant decrease in current smoking among 15-year-old boys.
  • Alcohol use: Lifetime use decreased overall in boys between 2018 and 2022, particularly among 15-year-olds. An increase was observed among 11- and 13-year-old girls but not 15-year-old girls. There was a small but significant decrease in the proportion of current drinkers among 15-year-old boys, with no change among 11- and 13-year-old boys. Current alcohol use increased among girls in all age groups.
  • Cannabis use: Lifetime use among 15-year-olds decreased slightly from 14% to 12% between 2018 and 2022, while 6% of 15-year-olds reported having used cannabis in the previous 30 days.
  • Vaping: In 2022 vapes (e-cigarettes) were more popular among adolescents than conventional tobacco cigarettes.

Traditional Gender Gap Narrowing or Reversing

Report coauthor Judith Brown from the University of Glasgow, Glasgow, Scotland, and a project manager for the Scottish survey, said that “there was an overall increase in current alcohol use and drunkenness among older girls” despite the overall decrease in boys’ alcohol use.

She explained: “Substance use has traditionally been more prevalent among boys, and the survey findings confirm a well-established gender difference, with higher prevalence in boys than in girls among 11-year-olds. By the age of 13, however, gender differences diminish or even disappear in many countries and regions.”

“Among 15-year-olds, girls often reported more frequent substance use than boys. While this pattern has been known for cigarette smoking in many countries and regions for about two decades, especially among 15-year-olds, it is a new phenomenon for behaviors related to other substances (such as alcohol consumption and drunkenness) in most countries and regions. Historically, prevalence for these behaviors has been higher among boys than girls.”

The new survey results highlight this gender reversal for several substances, she said. “Cannabis is the only substance for which both lifetime and current use is consistently higher in boys.”
 

Vaping Is an Emerging Public Health Concern

Dr. Brown added that the 2022 survey was the first time that vaping data had been collected from all countries. Although this is against the background of continuing decreases in smoking rates, “researchers suggest the transition to e-cigarettes, as a more popular choice than conventional cigarettes, highlights an urgent need for more targeted interventions to address this emerging public health concern.”

The report authors commented that because young people’s brains are still developing, they are “very sensitive to substances such as nicotine,” making it “easier for them to get hooked.”

Margreet de Looze, PhD, assistant professor of interdisciplinary social science at Utrecht University in Utrecht, the Netherlands, agreed with the authors’ concerns. “Vaping is extremely attractive for young people,” she said, “because the taste is more attractive than that of traditional cigarettes.” Until recently, many people were not aware of health hazards attached to vaping. “While more research is needed, vaping may function as a first step toward tobacco use and is hazardous for young people’s health. Therefore, it should be strongly discouraged.”
 

Substance Use Trends May Be Stabilizing or Rising Again

Increased awareness of the harmful effects of alcohol for adolescent development is also one postulated reason for declining adolescent alcohol consumption in both Europe and North America over the past two decades, which Dr. de Looze’s research has explored. Her work has also noted the “growing trend” of young people abstaining from alcohol altogether and some evidence of reductions in adolescent risk behaviors more generally, including early sexual initiation and juvenile crime.

“It may be good to realize that, in fact, the current generation of youth in many respects is healthier and reports less risky health behaviors as compared to previous generations,” she said.

However, “The declining trend in adolescent substance use that took place in many countries since the beginning of the 21st century seems to have stabilized, and moreover, in some countries and subgroups of adolescents, substance use appears to be on the rise again.” She cited particularly an overall increase in current alcohol use and drunkenness among older girls between 2018 and 2022. “It appears that, especially for girls, recent trends over time are less favorable as compared with boys.”
 

Multiple Influences on Adolescent Substance Abuse

Peer group influences are known to come to the fore during adolescence, and Dr. de Looze added that the early 21st century saw marked reductions in adolescent face-to-face contacts with their peers due to the rise in digital communications. “Adolescents typically use substances in the presence of peers (and in the absence of adults/parents), as it increases their status in their peer group.” Reduced in person interactions with friends may therefore have contributed to the earlier decline in substance use.

However, her team had found that adolescents who spend much time online with friends often also spend much time with friends offline. “They are what you could call the ‘social’ youth, who just spend much time with peers, be it offline or online,” she said. “More research is needed to disentangle exactly how, what kind, for whom the digital environment may be related to young people’s substance use,” she said.

“We also see that young people actively select their friends. So, if you are curious and a bit of a sensation-seeker yourself, you are more likely to become friends with youth who are just like you, and together, you may be more likely to try out substances.”

Factors underlying adolescent substance use and differences between countries are influenced by a complex interplay of factors, said Carina Ferreira-Borges, PhD, regional adviser for alcohol, illicit drugs, and prison health at the WHO Regional Office for Europe.

“Prevention measures definitely play a critical role in reducing substance use,” she said, “but other factors, such as cultural norms and socioeconomic conditions, also significantly impact these patterns.”

“Variations in substance use among countries can be attributed to different levels of implemented polices, public health initiatives, and the extent to which substance use is normalized or stigmatized within each society.”
 

Policy Efforts Must Be Targeted

“To address these disparities effectively, interventions and population-level policies need to be culturally adapted and target the specific environments where substance use is normalized among adolescents. By understanding and modifying the broader context in which young people make choices about substance use, we can better influence their behavior and health outcomes.”

Dr. de Looze cautioned, “In the past two decades, public health efforts in many countries have focused on reducing young people’s engagement in substance use. It is important that these efforts continue, as every year a new generation of youth is born. If public health efforts do not continue to focus on supporting a healthy lifestyle among young people, it should not come as a surprise that rates start or continue to rise again.”

A version of this article appeared on Medscape.com.

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FDA Requests More Information for RDEB Rx Under Review

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Fri, 05/03/2024 - 13:22

 

The Food and Drug Administration (FDA) has issued a complete response letter regarding the Biologics License Application (BLA) for prademagene zamikeracel (pz-cel), which is under review for the treatment of patients with recessive dystrophic epidermolysis bullosa (RDEB), requesting more information from the manufacturer.

Pz-cel, which comprises autologous, COL7A1 gene–corrected epidermal sheets, is being evaluated for its ability to enable normal type VII collagen expression in a patient’s skin cells and to facilitate wound healing and pain reduction in wounds in patients with RDEB after a one-time application procedure. The cause of RDEB is a defect in the COL7A1 gene that “results in the inability to produce type VII collagen,” a press release from the manufacturer noted.



On April 22, 2024, the manufacturer Abeona Therapeutics announced that following a meeting with the FDA in March and in a subsequent request for information, the agency requires additional information to satisfy certain Chemistry Manufacturing and Controls requirements before the BLA for pz-cel can be approved. According to a press release from the company, the information pertains to validation requirements for certain manufacturing and release testing methods, including some that were observed during the FDA’s pre-licensing inspection.

The complete response letter did not identify any issues related to the clinical efficacy or safety data in the BLA, and the FDA did not request any new clinical trials or clinical data to support approval, according to the company.

The company anticipates completing the BLA resubmission in the third quarter of 2024. The application is supported by clinical efficacy and safety data from the pivotal phase 3 VIITAL study and a phase 1/2a study in patients with RDEB.

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

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The Food and Drug Administration (FDA) has issued a complete response letter regarding the Biologics License Application (BLA) for prademagene zamikeracel (pz-cel), which is under review for the treatment of patients with recessive dystrophic epidermolysis bullosa (RDEB), requesting more information from the manufacturer.

Pz-cel, which comprises autologous, COL7A1 gene–corrected epidermal sheets, is being evaluated for its ability to enable normal type VII collagen expression in a patient’s skin cells and to facilitate wound healing and pain reduction in wounds in patients with RDEB after a one-time application procedure. The cause of RDEB is a defect in the COL7A1 gene that “results in the inability to produce type VII collagen,” a press release from the manufacturer noted.



On April 22, 2024, the manufacturer Abeona Therapeutics announced that following a meeting with the FDA in March and in a subsequent request for information, the agency requires additional information to satisfy certain Chemistry Manufacturing and Controls requirements before the BLA for pz-cel can be approved. According to a press release from the company, the information pertains to validation requirements for certain manufacturing and release testing methods, including some that were observed during the FDA’s pre-licensing inspection.

The complete response letter did not identify any issues related to the clinical efficacy or safety data in the BLA, and the FDA did not request any new clinical trials or clinical data to support approval, according to the company.

The company anticipates completing the BLA resubmission in the third quarter of 2024. The application is supported by clinical efficacy and safety data from the pivotal phase 3 VIITAL study and a phase 1/2a study in patients with RDEB.

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

 

The Food and Drug Administration (FDA) has issued a complete response letter regarding the Biologics License Application (BLA) for prademagene zamikeracel (pz-cel), which is under review for the treatment of patients with recessive dystrophic epidermolysis bullosa (RDEB), requesting more information from the manufacturer.

Pz-cel, which comprises autologous, COL7A1 gene–corrected epidermal sheets, is being evaluated for its ability to enable normal type VII collagen expression in a patient’s skin cells and to facilitate wound healing and pain reduction in wounds in patients with RDEB after a one-time application procedure. The cause of RDEB is a defect in the COL7A1 gene that “results in the inability to produce type VII collagen,” a press release from the manufacturer noted.



On April 22, 2024, the manufacturer Abeona Therapeutics announced that following a meeting with the FDA in March and in a subsequent request for information, the agency requires additional information to satisfy certain Chemistry Manufacturing and Controls requirements before the BLA for pz-cel can be approved. According to a press release from the company, the information pertains to validation requirements for certain manufacturing and release testing methods, including some that were observed during the FDA’s pre-licensing inspection.

The complete response letter did not identify any issues related to the clinical efficacy or safety data in the BLA, and the FDA did not request any new clinical trials or clinical data to support approval, according to the company.

The company anticipates completing the BLA resubmission in the third quarter of 2024. The application is supported by clinical efficacy and safety data from the pivotal phase 3 VIITAL study and a phase 1/2a study in patients with RDEB.

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

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