This is the third in a series of columns discussing the important roles that dermatologists have played in the skin care industry. This section will discuss those dermatologists who worked behind the scenes with the cosmetic industry, rather than developing their own skin care lines.
 

Norman Orentreich, MD

Dr. Orentreich was a successful New York City dermatologist and the first to perform hair transplants. This new technique brought him fame and notoriety and arguably made him the first “celebrity dermatologist.” (He was also a member of the original advisory board of Dermatology News, at that time Skin & Allergy News, in January 1970.) Dr. Orentreich was a seminal figure in the trend to link the cosmetic industry and dermatology. In August 1967, Vogue magazine¹ published an article on him, titled “Can Great Skin be Created?” This popular article caught the attention of Leonard Lauder, of Estée Lauder, who recruited Dr. Orentreich to help create the skin care line Clinique. Clinique was intended to be a brand with a medical look that promoted its products as “allergy tested,” with packaging that has an antiseptic look and beauty counter salespeople wearing white coats.

Dr. Orentreich’s input into the development of a skin type–based skin care line was fundamental to the development of this brand. The four-question questionnaire with an iconic plastic lever that customers slide left or right instantly provided them with an assessment of their skin type at the beauty counter, with one of four skin types: Very Dry to Dry Skin (Skin Type 1), Dry Combination (Skin Type 2), Combination Oily (Skin Type 3), and Oily (Skin Type 4).

Although this skin-typing system was not scientifically accurate (there is no scientific definition of combination skin), it was reminiscent of the system developed by cosmetic company tycoon Helena Rubinstein in the 1940s that classified people into four skin types: oily, dry, combination, and sensitive. Clinique became a blockbuster skin care brand and was one of the first developed by a dermatologist – although Dr. Orentreich did not put his name on it.

In 1972, Dr. Orentreich filed a patent² for an exfoliating pad for the skin that later became known as the “Buf-Puf.” I heard years ago that he got the idea from the machines used to buff the floors in the hospital. The buffing pad had a hole in the center where the machine attached. Dr. Orentreich purportedly thought “I wonder what they do with the cut-out centers?” He looked into this, and subsequently used the centers to create the Buf-Puf. I cannot find a reference for this, but I love this story and hope it’s true. If any readers have any knowledge of this, please let me know, so I can amend my story if it is incorrect.
 

Almay

Almay, an amalgamation of the founders’ names, Alfred and Fanny May Woititz, was the first hypoallergenic brand, established in 1931, and the first to provide hypoallergenic cosmetics, long before Clinique. In addition, the company was the first skin care brand to become available by prescription only (as it was initially), fully disclose all individual ingredients in its products (well before this became mandatory in 1976), provide totally fragrance-free products, develop a hypoallergenic fragrance – and provide patch tests and other materials to physicians to identify contact allergens.

Over 90 years, the company was also the first among skin care brands to do the following:

• Provide custom formulations to individuals proven to be allergic to a specific ingredient, through their physicians.
• Perform a full range of premarket safety testing on all products for allergy and irritation, and test all its products for comedogenicity.
• Formulate cosmetics for use around the eye area (eye shadows and eyeliners) specifically for contact lens wearers.
• Formulate hypoallergenic regimens for specific skin types in the mass market.
• Provide a specific cosmetic regimen for acne-prone women, including a silicone-based makeup and active ingredients for treatment in cosmetics and skin care.

I recently interviewed Stanley Levy, MD, who was one of the consultants to Almay, and practices in Chapel Hill, N.C., where he has an academic niche related to skin care formulation and safety. He told me how Almay provided patch test materials to dermatologists to help identify contact dermatitis to cosmetic ingredients, and described Almay’s relationship with the dermatology field as follows: “From the outset, Almay was linked to dermatology. In 1930, a chemist and pharmacist in New York City, Al Woititz, was looking to compound cosmetics for his wife suffering from cosmetic allergies, Fannie May. He enlisted the counsel of the preeminent dermatologic expert in contact dermatitis at the time, Dr. Marion Sulzberger, to suggest ingredients to avoid. [Dr. Sulzberger was also a member of the original Dermatology News editorial advisory board.] Soon, dermatologists around New York City were recommending these formulations. This led to a product line free of the known allergens and a fledgling company trademarked as Almay. For the past 90 years, [the company] has kept a close relationship with dermatologists, well before that was the norm.”

The Almay research overseen by Dr. Levy and others contributed greatly to our understanding of the allergenicity of skin care.
 

Albert Kligman, MD

The turning point for the interface of dermatology with the cosmetic industry was the shift from a safety-based approach (hypoallergenic and noncomedogenic) to an emphasis on efficacy claims in the 1980s. Part of the impetus for this was the Dr. Kligman’s observation that retinoids could improve photoaging.

Dr. Kligman, a well-known dermatologist at the University of Pennsylvania, Philadelphia, showed that retinoids were an effective treatment for acne. For more about this, listen to my interview on the Dermatology Weekly podcast, with James Leyden, MD, about his work at the University of Pennsylvania with Dr. Kligman on the development of oral and topical retinoids. During Dr. Kligman’s research on acne, he noticed that wrinkles improved after treatment with tretinoin, and in 1986, he and Dr. Leyden (and several other authors) published the first article about tretinoin’s use for photoaged skin.³ This led to a double-blind study⁴ conducted by John J. Voorhees, MD, University of Michigan, Ann Arbor, and coauthors that showed statistically significant improvement of photoaged skin when treated with topical tretinoin. Dr. Voorhees and his group did many more studies on retinoids^5,6 and photoaging⁷ – so many that, at one time, he was (and maybe still is) the most widely published dermatologist in the United States. These studies showed that, not only did prescription tretinoin improve the appearance of wrinkles, but so did over-the-counter retinol.⁸ Retinoids remain the most efficacious prescription and cosmeceutical ingredients to treat wrinkled skin.

When studies conducted by Dr. Kligman, Dr. Voorhees, and by Barbara Gilcrest, MD, ^9,10 showed that retinoids improved wrinkles, a major change in the focus in the skin care industry occurred.

During the same time period, the studies on alpha hydroxy acids by Chérie Ditre, MD, Eugene Van Scott, MD, and colleages^11,12; and studies by Sheldon Pinnell, MD, on Vitamin C (see part 1 of this series) all demonstrated the efficacy of cosmetic ingredients on photoaged skin. This triggered a major change in how skin care products were marketed, with an efficacy approach rather than a safety approach.

With the shift from safety (hypoallergenic and noncomedogenic issues) to efficacy claims in the 1980s, and as nondrug active ingredients like retinol were shown to have biologic effects, the lines between the Food and Drug Administration’s definition of a drug versus a cosmetic became blurred. In 1984, Dr. Kligman suggested a new classification for the ingredients that fell in the middle, proposing the term “cosmeceutical” and thus, the concept of a cosmeceutical was introduced. To this day, cosmeceutical is not an official definition and the FDA has yet to deal with it as a quasi-drug category. FDA regulations as to what constitutes a drug versus a cosmetic date back to the 1938 Food, Drug and Cosmetic Act.

Once marketing focused on efficacy, many companies made outrageous claims. During the second half of the 1980s, the FDA issued some warning letters to some companies in an effort to control these claims.

Now efficacy claims abound and we, as dermatologists, should be the experts who back up these claims with scientific data. As the cosmeceutical market has evolved and grown, consumers are bewildered by the myriad of active ingredients being promoted and the number of products in the marketplace. As dermatologic innovation has led to more efficacious active ingredients, our patients look to us as knowledgeable and credible sources of information and for recommendations about the best skin care routines for their skin issues. This is all reflected in the fact that physician-dispensed skin care is becoming the fastest growing segment in this market. It is incumbent upon dermatologists to be knowledgeable and conversant about skin care products and skin care routines, and is particularly true for those of us who sell skin care products in our offices.

Dr. Baumann is a private practice dermatologist, researcher, author, and entrepreneur who practices in Miami. She founded the Cosmetic Dermatology Center at the University of Miami in 1997. Dr. Baumann has written two textbooks and a New York Times Best Sellers book for consumers. Dr. Baumann has received funding for advisory boards and/or clinical research trials from Allergan, Burt’s Bees, Evolus, Galderma, and Revance. She is the CEO of Skin Type Solutions, a company that independently tests skin care products and makes recommendations to physicians on which skin care technologies are best. Write to her at [email protected].

References

1. Vogue Magazine, 1967 Aug 15. “Can Great Skin be Created?”

2. https://patents.google.com/patent/US3910284.

3. Kligman AM et al. J Am Acad Dermatol. 1986 Oct;15(4 Pt 2):836-59.

4. Weiss JS et al. JAMA. 1988 Jan 22-29;259(4):527-32.

5. Goldfarb MT et al. J Am Acad Dermatol. 1989 Sep;21(3 Pt 2):645-50.

6. Ellis CN et al. J Am Acad Dermatol. 1990 Oct;23(4 Pt 1):629-37.

7. Kang S; Voorhees JJ. J Am Acad Dermatol. 1998 Aug;39(2 Pt 3):S55-61.

8. Kafi R et al. Arch Dermatol. 2007 May;143(5):606-12.

9. Gilchrest BA. J Am Acad Dermatol. 1989 Sep;21(3 Pt 2):610-3.

10. Bhawan J et al. Arch Dermatol. 1991 May;127(5):666-72.

11. Griffin TD et al. J Am Acad Dermatol. 1996 Feb;34(2 Pt 1):196-203.

12. Ditre CM et al. J Am Acad Dermatol. 1996 Feb;34(2 Pt 1):187-95.
 

This is the third in a series of columns discussing the important roles that dermatologists have played in the skin care industry. This section will discuss those dermatologists who worked behind the scenes with the cosmetic industry, rather than developing their own skin care lines.
 

Norman Orentreich, MD

Dr. Orentreich was a successful New York City dermatologist and the first to perform hair transplants. This new technique brought him fame and notoriety and arguably made him the first “celebrity dermatologist.” (He was also a member of the original advisory board of Dermatology News, at that time Skin & Allergy News, in January 1970.) Dr. Orentreich was a seminal figure in the trend to link the cosmetic industry and dermatology. In August 1967, Vogue magazine¹ published an article on him, titled “Can Great Skin be Created?” This popular article caught the attention of Leonard Lauder, of Estée Lauder, who recruited Dr. Orentreich to help create the skin care line Clinique. Clinique was intended to be a brand with a medical look that promoted its products as “allergy tested,” with packaging that has an antiseptic look and beauty counter salespeople wearing white coats.

Dr. Orentreich’s input into the development of a skin type–based skin care line was fundamental to the development of this brand. The four-question questionnaire with an iconic plastic lever that customers slide left or right instantly provided them with an assessment of their skin type at the beauty counter, with one of four skin types: Very Dry to Dry Skin (Skin Type 1), Dry Combination (Skin Type 2), Combination Oily (Skin Type 3), and Oily (Skin Type 4).

Although this skin-typing system was not scientifically accurate (there is no scientific definition of combination skin), it was reminiscent of the system developed by cosmetic company tycoon Helena Rubinstein in the 1940s that classified people into four skin types: oily, dry, combination, and sensitive. Clinique became a blockbuster skin care brand and was one of the first developed by a dermatologist – although Dr. Orentreich did not put his name on it.

In 1972, Dr. Orentreich filed a patent² for an exfoliating pad for the skin that later became known as the “Buf-Puf.” I heard years ago that he got the idea from the machines used to buff the floors in the hospital. The buffing pad had a hole in the center where the machine attached. Dr. Orentreich purportedly thought “I wonder what they do with the cut-out centers?” He looked into this, and subsequently used the centers to create the Buf-Puf. I cannot find a reference for this, but I love this story and hope it’s true. If any readers have any knowledge of this, please let me know, so I can amend my story if it is incorrect.
 

Almay

Almay, an amalgamation of the founders’ names, Alfred and Fanny May Woititz, was the first hypoallergenic brand, established in 1931, and the first to provide hypoallergenic cosmetics, long before Clinique. In addition, the company was the first skin care brand to become available by prescription only (as it was initially), fully disclose all individual ingredients in its products (well before this became mandatory in 1976), provide totally fragrance-free products, develop a hypoallergenic fragrance – and provide patch tests and other materials to physicians to identify contact allergens.

Over 90 years, the company was also the first among skin care brands to do the following:

• Provide custom formulations to individuals proven to be allergic to a specific ingredient, through their physicians.
• Perform a full range of premarket safety testing on all products for allergy and irritation, and test all its products for comedogenicity.
• Formulate cosmetics for use around the eye area (eye shadows and eyeliners) specifically for contact lens wearers.
• Formulate hypoallergenic regimens for specific skin types in the mass market.
• Provide a specific cosmetic regimen for acne-prone women, including a silicone-based makeup and active ingredients for treatment in cosmetics and skin care.

I recently interviewed Stanley Levy, MD, who was one of the consultants to Almay, and practices in Chapel Hill, N.C., where he has an academic niche related to skin care formulation and safety. He told me how Almay provided patch test materials to dermatologists to help identify contact dermatitis to cosmetic ingredients, and described Almay’s relationship with the dermatology field as follows: “From the outset, Almay was linked to dermatology. In 1930, a chemist and pharmacist in New York City, Al Woititz, was looking to compound cosmetics for his wife suffering from cosmetic allergies, Fannie May. He enlisted the counsel of the preeminent dermatologic expert in contact dermatitis at the time, Dr. Marion Sulzberger, to suggest ingredients to avoid. [Dr. Sulzberger was also a member of the original Dermatology News editorial advisory board.] Soon, dermatologists around New York City were recommending these formulations. This led to a product line free of the known allergens and a fledgling company trademarked as Almay. For the past 90 years, [the company] has kept a close relationship with dermatologists, well before that was the norm.”

The Almay research overseen by Dr. Levy and others contributed greatly to our understanding of the allergenicity of skin care.
 

Albert Kligman, MD

The turning point for the interface of dermatology with the cosmetic industry was the shift from a safety-based approach (hypoallergenic and noncomedogenic) to an emphasis on efficacy claims in the 1980s. Part of the impetus for this was the Dr. Kligman’s observation that retinoids could improve photoaging.

Dr. Kligman, a well-known dermatologist at the University of Pennsylvania, Philadelphia, showed that retinoids were an effective treatment for acne. For more about this, listen to my interview on the Dermatology Weekly podcast, with James Leyden, MD, about his work at the University of Pennsylvania with Dr. Kligman on the development of oral and topical retinoids. During Dr. Kligman’s research on acne, he noticed that wrinkles improved after treatment with tretinoin, and in 1986, he and Dr. Leyden (and several other authors) published the first article about tretinoin’s use for photoaged skin.³ This led to a double-blind study⁴ conducted by John J. Voorhees, MD, University of Michigan, Ann Arbor, and coauthors that showed statistically significant improvement of photoaged skin when treated with topical tretinoin. Dr. Voorhees and his group did many more studies on retinoids^5,6 and photoaging⁷ – so many that, at one time, he was (and maybe still is) the most widely published dermatologist in the United States. These studies showed that, not only did prescription tretinoin improve the appearance of wrinkles, but so did over-the-counter retinol.⁸ Retinoids remain the most efficacious prescription and cosmeceutical ingredients to treat wrinkled skin.

When studies conducted by Dr. Kligman, Dr. Voorhees, and by Barbara Gilcrest, MD, ^9,10 showed that retinoids improved wrinkles, a major change in the focus in the skin care industry occurred.

During the same time period, the studies on alpha hydroxy acids by Chérie Ditre, MD, Eugene Van Scott, MD, and colleages^11,12; and studies by Sheldon Pinnell, MD, on Vitamin C (see part 1 of this series) all demonstrated the efficacy of cosmetic ingredients on photoaged skin. This triggered a major change in how skin care products were marketed, with an efficacy approach rather than a safety approach.

With the shift from safety (hypoallergenic and noncomedogenic issues) to efficacy claims in the 1980s, and as nondrug active ingredients like retinol were shown to have biologic effects, the lines between the Food and Drug Administration’s definition of a drug versus a cosmetic became blurred. In 1984, Dr. Kligman suggested a new classification for the ingredients that fell in the middle, proposing the term “cosmeceutical” and thus, the concept of a cosmeceutical was introduced. To this day, cosmeceutical is not an official definition and the FDA has yet to deal with it as a quasi-drug category. FDA regulations as to what constitutes a drug versus a cosmetic date back to the 1938 Food, Drug and Cosmetic Act.

Once marketing focused on efficacy, many companies made outrageous claims. During the second half of the 1980s, the FDA issued some warning letters to some companies in an effort to control these claims.

Now efficacy claims abound and we, as dermatologists, should be the experts who back up these claims with scientific data. As the cosmeceutical market has evolved and grown, consumers are bewildered by the myriad of active ingredients being promoted and the number of products in the marketplace. As dermatologic innovation has led to more efficacious active ingredients, our patients look to us as knowledgeable and credible sources of information and for recommendations about the best skin care routines for their skin issues. This is all reflected in the fact that physician-dispensed skin care is becoming the fastest growing segment in this market. It is incumbent upon dermatologists to be knowledgeable and conversant about skin care products and skin care routines, and is particularly true for those of us who sell skin care products in our offices.

Dr. Baumann is a private practice dermatologist, researcher, author, and entrepreneur who practices in Miami. She founded the Cosmetic Dermatology Center at the University of Miami in 1997. Dr. Baumann has written two textbooks and a New York Times Best Sellers book for consumers. Dr. Baumann has received funding for advisory boards and/or clinical research trials from Allergan, Burt’s Bees, Evolus, Galderma, and Revance. She is the CEO of Skin Type Solutions, a company that independently tests skin care products and makes recommendations to physicians on which skin care technologies are best. Write to her at [email protected].

References

1. Vogue Magazine, 1967 Aug 15. “Can Great Skin be Created?”

2. https://patents.google.com/patent/US3910284.

3. Kligman AM et al. J Am Acad Dermatol. 1986 Oct;15(4 Pt 2):836-59.

4. Weiss JS et al. JAMA. 1988 Jan 22-29;259(4):527-32.

5. Goldfarb MT et al. J Am Acad Dermatol. 1989 Sep;21(3 Pt 2):645-50.

6. Ellis CN et al. J Am Acad Dermatol. 1990 Oct;23(4 Pt 1):629-37.

7. Kang S; Voorhees JJ. J Am Acad Dermatol. 1998 Aug;39(2 Pt 3):S55-61.

8. Kafi R et al. Arch Dermatol. 2007 May;143(5):606-12.

9. Gilchrest BA. J Am Acad Dermatol. 1989 Sep;21(3 Pt 2):610-3.

10. Bhawan J et al. Arch Dermatol. 1991 May;127(5):666-72.

11. Griffin TD et al. J Am Acad Dermatol. 1996 Feb;34(2 Pt 1):196-203.

12. Ditre CM et al. J Am Acad Dermatol. 1996 Feb;34(2 Pt 1):187-95.
 

This is the third in a series of columns discussing the important roles that dermatologists have played in the skin care industry. This section will discuss those dermatologists who worked behind the scenes with the cosmetic industry, rather than developing their own skin care lines.
 

Norman Orentreich, MD

Dr. Orentreich was a successful New York City dermatologist and the first to perform hair transplants. This new technique brought him fame and notoriety and arguably made him the first “celebrity dermatologist.” (He was also a member of the original advisory board of Dermatology News, at that time Skin & Allergy News, in January 1970.) Dr. Orentreich was a seminal figure in the trend to link the cosmetic industry and dermatology. In August 1967, Vogue magazine¹ published an article on him, titled “Can Great Skin be Created?” This popular article caught the attention of Leonard Lauder, of Estée Lauder, who recruited Dr. Orentreich to help create the skin care line Clinique. Clinique was intended to be a brand with a medical look that promoted its products as “allergy tested,” with packaging that has an antiseptic look and beauty counter salespeople wearing white coats.

Dr. Orentreich’s input into the development of a skin type–based skin care line was fundamental to the development of this brand. The four-question questionnaire with an iconic plastic lever that customers slide left or right instantly provided them with an assessment of their skin type at the beauty counter, with one of four skin types: Very Dry to Dry Skin (Skin Type 1), Dry Combination (Skin Type 2), Combination Oily (Skin Type 3), and Oily (Skin Type 4).

Although this skin-typing system was not scientifically accurate (there is no scientific definition of combination skin), it was reminiscent of the system developed by cosmetic company tycoon Helena Rubinstein in the 1940s that classified people into four skin types: oily, dry, combination, and sensitive. Clinique became a blockbuster skin care brand and was one of the first developed by a dermatologist – although Dr. Orentreich did not put his name on it.

In 1972, Dr. Orentreich filed a patent² for an exfoliating pad for the skin that later became known as the “Buf-Puf.” I heard years ago that he got the idea from the machines used to buff the floors in the hospital. The buffing pad had a hole in the center where the machine attached. Dr. Orentreich purportedly thought “I wonder what they do with the cut-out centers?” He looked into this, and subsequently used the centers to create the Buf-Puf. I cannot find a reference for this, but I love this story and hope it’s true. If any readers have any knowledge of this, please let me know, so I can amend my story if it is incorrect.
 

Almay

Almay, an amalgamation of the founders’ names, Alfred and Fanny May Woititz, was the first hypoallergenic brand, established in 1931, and the first to provide hypoallergenic cosmetics, long before Clinique. In addition, the company was the first skin care brand to become available by prescription only (as it was initially), fully disclose all individual ingredients in its products (well before this became mandatory in 1976), provide totally fragrance-free products, develop a hypoallergenic fragrance – and provide patch tests and other materials to physicians to identify contact allergens.

Over 90 years, the company was also the first among skin care brands to do the following:

• Provide custom formulations to individuals proven to be allergic to a specific ingredient, through their physicians.
• Perform a full range of premarket safety testing on all products for allergy and irritation, and test all its products for comedogenicity.
• Formulate cosmetics for use around the eye area (eye shadows and eyeliners) specifically for contact lens wearers.
• Formulate hypoallergenic regimens for specific skin types in the mass market.
• Provide a specific cosmetic regimen for acne-prone women, including a silicone-based makeup and active ingredients for treatment in cosmetics and skin care.

I recently interviewed Stanley Levy, MD, who was one of the consultants to Almay, and practices in Chapel Hill, N.C., where he has an academic niche related to skin care formulation and safety. He told me how Almay provided patch test materials to dermatologists to help identify contact dermatitis to cosmetic ingredients, and described Almay’s relationship with the dermatology field as follows: “From the outset, Almay was linked to dermatology. In 1930, a chemist and pharmacist in New York City, Al Woititz, was looking to compound cosmetics for his wife suffering from cosmetic allergies, Fannie May. He enlisted the counsel of the preeminent dermatologic expert in contact dermatitis at the time, Dr. Marion Sulzberger, to suggest ingredients to avoid. [Dr. Sulzberger was also a member of the original Dermatology News editorial advisory board.] Soon, dermatologists around New York City were recommending these formulations. This led to a product line free of the known allergens and a fledgling company trademarked as Almay. For the past 90 years, [the company] has kept a close relationship with dermatologists, well before that was the norm.”

The Almay research overseen by Dr. Levy and others contributed greatly to our understanding of the allergenicity of skin care.
 

Albert Kligman, MD

The turning point for the interface of dermatology with the cosmetic industry was the shift from a safety-based approach (hypoallergenic and noncomedogenic) to an emphasis on efficacy claims in the 1980s. Part of the impetus for this was the Dr. Kligman’s observation that retinoids could improve photoaging.

Dr. Kligman, a well-known dermatologist at the University of Pennsylvania, Philadelphia, showed that retinoids were an effective treatment for acne. For more about this, listen to my interview on the Dermatology Weekly podcast, with James Leyden, MD, about his work at the University of Pennsylvania with Dr. Kligman on the development of oral and topical retinoids. During Dr. Kligman’s research on acne, he noticed that wrinkles improved after treatment with tretinoin, and in 1986, he and Dr. Leyden (and several other authors) published the first article about tretinoin’s use for photoaged skin.³ This led to a double-blind study⁴ conducted by John J. Voorhees, MD, University of Michigan, Ann Arbor, and coauthors that showed statistically significant improvement of photoaged skin when treated with topical tretinoin. Dr. Voorhees and his group did many more studies on retinoids^5,6 and photoaging⁷ – so many that, at one time, he was (and maybe still is) the most widely published dermatologist in the United States. These studies showed that, not only did prescription tretinoin improve the appearance of wrinkles, but so did over-the-counter retinol.⁸ Retinoids remain the most efficacious prescription and cosmeceutical ingredients to treat wrinkled skin.

When studies conducted by Dr. Kligman, Dr. Voorhees, and by Barbara Gilcrest, MD, ^9,10 showed that retinoids improved wrinkles, a major change in the focus in the skin care industry occurred.

During the same time period, the studies on alpha hydroxy acids by Chérie Ditre, MD, Eugene Van Scott, MD, and colleages^11,12; and studies by Sheldon Pinnell, MD, on Vitamin C (see part 1 of this series) all demonstrated the efficacy of cosmetic ingredients on photoaged skin. This triggered a major change in how skin care products were marketed, with an efficacy approach rather than a safety approach.

With the shift from safety (hypoallergenic and noncomedogenic issues) to efficacy claims in the 1980s, and as nondrug active ingredients like retinol were shown to have biologic effects, the lines between the Food and Drug Administration’s definition of a drug versus a cosmetic became blurred. In 1984, Dr. Kligman suggested a new classification for the ingredients that fell in the middle, proposing the term “cosmeceutical” and thus, the concept of a cosmeceutical was introduced. To this day, cosmeceutical is not an official definition and the FDA has yet to deal with it as a quasi-drug category. FDA regulations as to what constitutes a drug versus a cosmetic date back to the 1938 Food, Drug and Cosmetic Act.

Once marketing focused on efficacy, many companies made outrageous claims. During the second half of the 1980s, the FDA issued some warning letters to some companies in an effort to control these claims.

Now efficacy claims abound and we, as dermatologists, should be the experts who back up these claims with scientific data. As the cosmeceutical market has evolved and grown, consumers are bewildered by the myriad of active ingredients being promoted and the number of products in the marketplace. As dermatologic innovation has led to more efficacious active ingredients, our patients look to us as knowledgeable and credible sources of information and for recommendations about the best skin care routines for their skin issues. This is all reflected in the fact that physician-dispensed skin care is becoming the fastest growing segment in this market. It is incumbent upon dermatologists to be knowledgeable and conversant about skin care products and skin care routines, and is particularly true for those of us who sell skin care products in our offices.

Dr. Baumann is a private practice dermatologist, researcher, author, and entrepreneur who practices in Miami. She founded the Cosmetic Dermatology Center at the University of Miami in 1997. Dr. Baumann has written two textbooks and a New York Times Best Sellers book for consumers. Dr. Baumann has received funding for advisory boards and/or clinical research trials from Allergan, Burt’s Bees, Evolus, Galderma, and Revance. She is the CEO of Skin Type Solutions, a company that independently tests skin care products and makes recommendations to physicians on which skin care technologies are best. Write to her at [email protected].

References

1. Vogue Magazine, 1967 Aug 15. “Can Great Skin be Created?”

2. https://patents.google.com/patent/US3910284.

3. Kligman AM et al. J Am Acad Dermatol. 1986 Oct;15(4 Pt 2):836-59.

4. Weiss JS et al. JAMA. 1988 Jan 22-29;259(4):527-32.

5. Goldfarb MT et al. J Am Acad Dermatol. 1989 Sep;21(3 Pt 2):645-50.

6. Ellis CN et al. J Am Acad Dermatol. 1990 Oct;23(4 Pt 1):629-37.

7. Kang S; Voorhees JJ. J Am Acad Dermatol. 1998 Aug;39(2 Pt 3):S55-61.

8. Kafi R et al. Arch Dermatol. 2007 May;143(5):606-12.

9. Gilchrest BA. J Am Acad Dermatol. 1989 Sep;21(3 Pt 2):610-3.

10. Bhawan J et al. Arch Dermatol. 1991 May;127(5):666-72.

11. Griffin TD et al. J Am Acad Dermatol. 1996 Feb;34(2 Pt 1):196-203.

12. Ditre CM et al. J Am Acad Dermatol. 1996 Feb;34(2 Pt 1):187-95.
 

I. Finding a mentor

Case

You are a 27-year-old first-year resident who is seeking mentorship. You are halfway through the year and are thinking about your goals and future. You have a general interest in hematology/oncology but have limited experience and would like to gain more experience with clinically relevant scholarship. However, you do not know anyone in the field and are not sure who to ask for guidance.

Stage 1: Seeking the right mentor

Start first with your area of interest and then look broadly. In this case the resident is interested in heme/onc. The first place to look is on the heme/onc department website or in the faculty directory. It can be helpful to look at what the potential mentor has published recently and/or look at a version of their CV on the faculty directory or website. This can help determine how productive they are and help assess whether you share similar interests, and whether they have worked with many learners in the past.

It is also important to do some background work and ask around about potential mentors. Often resident colleagues and fellows have a good sense of current projects and which faculty work well with learners. Lastly, it is important to also look at non–heme/onc physicians as there may be internal medicine physicians or surgeons who are doing hematology or oncology research that more align with your interests.

After you have assessed whether you think this person would be a strong mentor for you, it is time to reach out. People are flattered to be asked and part of their promotion criteria is their ability to mentor. Do not assume that a potential mentor is too busy! Let him or her make that decision. Remember the worst a mentor can say is “no.” Even if they do not have time or the need for a mentee at the present time, they generally will offer some assistance or direction on who to ask.

Start with a straightforward, but pleasant email. Waiting up to 2 weeks for a response is reasonable. If after 2 weeks you have not received word, feel free to reach out again asking politely if he or she would be willing to work with you. Do not be afraid to ask bluntly for their guidance and mentorship and have a specific project or area of research that you would like their assistance with.
 

II. Optimizing the mentor/mentee relationship

Case continued

Success! Your email was received with interest by a hematologist who has done several projects, comes highly recommended by other residents, and worked with students and residents in the past. The project involves anticoagulation on the inpatient service. You are set to meet with her next month.

Stage 2: Establishing expectations and goals

Now comes the hard work in establishing an excellent mentor/mentee relationship. Before you meet with your mentor, brainstorm first. What do you want out of the relationship? A publication? Career advice? Attaining a fellowship position? You should feel empowered in knowing that you as the mentee are in the driver seat, but this relationship should be mutually beneficial. Consider basing the relationship and initial discussions on these key questions:

1. My goals

• What are my goals? It is okay not to know but be ready to communicate some information to your mentor.
• Remember to also ask your mentor what their goals are for you as well.

2. Outcome

• What type of outcome are both you and your mentor looking for from the relationship?

3. Expectations

• What mentorship expectations do you have?
• What are your mentor’s expectations of you?

Once you feel you have a sense of what you are looking for out of the relationship, it is important to communicate this with the mentor to establish congruent expectations of one another. For example, think about asking your mentor if the two of you can establish a mentor/mentee contract. This is a written document that can be found online and establishes a mutual agreement of roles, responsibilities, and expectations of one another for the relationship. It can further help to open a line for honest and consistent feedback. This can also give you a formalized endpoint and agreed upon scope for the mentoring relationship. Having a check-in preestablished in a contract reduces any potentially awkward conversations about redefining the relationship down the road. (For example, what if our case resident decides to pursue GI? It could happen.)
 

Stage 3: Establishing a common goal

After you have determined the goals and expectations of the relationship together (remember, this is a relationship), it is time to start exploring possible projects and establishing goals for those projects. Having a quality improvement or research project will determine a common goal to work towards and help establish and define the relationship.

Once you have delineated broadly what the project(s) should be, develop smaller SMART (specific, measurable, achievable, relevant, time-bound) goals to move the project forward. These goals determine stopping points for evaluation and feedback, which further establish the relationship and keep the project(s) progressing. For example, one goal could be to write the first draft of the proposal for your quality improvement project within 3 weeks.
 

Stage 4: Continued communication

With any project it is important to stay on the same page as your mentor and be clear to establish “who is doing what by when.” Do not expect accountability to be the mentor’s job. Remember that you are in the driver’s seat and that you should propose how often you need to meet and what those meetings look like by developing an agenda. You can have an open discussion and allow your mentor to help determine a reasonable timeline. Remember, the more you communicate your goals, the better your mentor will be able to address them.

One pro tip is to always exceed your mentor’s expectations – if you think you need 2 weeks to complete a task, ask for 3-4 weeks. This gives you extra padding in case of unforeseen circumstances and makes you look like a “rockstar” if you hit a deadline 1-2 weeks earlier than planned.
 

III. Ending and/or redefining the relationship

Case continued

You are now a senior resident who’s published multiple articles in the past year, and have completed an anticoagulation project for inpatients with pulmonary emboli. You look back on your experience and what stands out is the extent of your gratitude and appreciation for your incredible mentor. Not only do you feel that your mentor has guided you in your career and with your scholarship, but you feel that he or she has shaped your character and talent set. At this point your mentor is both a teacher and guide, but now also a friend. While you feel there is always more that you can learn from her, you are ready to explore new interests. How do you effectively end or redefine this relationship?

Stage 5: Redefining your mentoring relationship

First, go back to the expectations or contract established early in the relationship. The check-in is a key time in the relationship to reevaluate goals and priorities. At this point you may decide to amicably end the relationship or project, or move on to a new project with a change in your role. For example, the quality improvement project may change to research, or you as the mentee have a change in focus (e.g., change in specialty or scholarly focus).

In summary, the interaction between you and your mentor should be a relationship. And the keys to a great relationship are:

1. Establish clear expectations from the beginning. This clarifies the relationship and helps the mentee and mentor to become more successful.

2. Maintain clear and open communication throughout the relationship.3. Define your goals and discuss them with your mentor early. (Have we mentioned the importance of goals enough?) After all, your goal is the reason you started pursuing this relationship in the first place.

In clinical training having guidance can greatly enhance your experience and direct your future career in unexpected ways. We hope that using these tools will guide you towards forging a strong mentor/mentee relationship.

Dr. Zimmerberg-Helms is a resident physician at the University of New Mexico, Albuquerque. Dr. Rendon is an attending hospitalist at the University of New Mexico.

I. Finding a mentor

Case

You are a 27-year-old first-year resident who is seeking mentorship. You are halfway through the year and are thinking about your goals and future. You have a general interest in hematology/oncology but have limited experience and would like to gain more experience with clinically relevant scholarship. However, you do not know anyone in the field and are not sure who to ask for guidance.

Stage 1: Seeking the right mentor

Start first with your area of interest and then look broadly. In this case the resident is interested in heme/onc. The first place to look is on the heme/onc department website or in the faculty directory. It can be helpful to look at what the potential mentor has published recently and/or look at a version of their CV on the faculty directory or website. This can help determine how productive they are and help assess whether you share similar interests, and whether they have worked with many learners in the past.

It is also important to do some background work and ask around about potential mentors. Often resident colleagues and fellows have a good sense of current projects and which faculty work well with learners. Lastly, it is important to also look at non–heme/onc physicians as there may be internal medicine physicians or surgeons who are doing hematology or oncology research that more align with your interests.

After you have assessed whether you think this person would be a strong mentor for you, it is time to reach out. People are flattered to be asked and part of their promotion criteria is their ability to mentor. Do not assume that a potential mentor is too busy! Let him or her make that decision. Remember the worst a mentor can say is “no.” Even if they do not have time or the need for a mentee at the present time, they generally will offer some assistance or direction on who to ask.

Start with a straightforward, but pleasant email. Waiting up to 2 weeks for a response is reasonable. If after 2 weeks you have not received word, feel free to reach out again asking politely if he or she would be willing to work with you. Do not be afraid to ask bluntly for their guidance and mentorship and have a specific project or area of research that you would like their assistance with.
 

II. Optimizing the mentor/mentee relationship

Case continued

Success! Your email was received with interest by a hematologist who has done several projects, comes highly recommended by other residents, and worked with students and residents in the past. The project involves anticoagulation on the inpatient service. You are set to meet with her next month.

Stage 2: Establishing expectations and goals

Now comes the hard work in establishing an excellent mentor/mentee relationship. Before you meet with your mentor, brainstorm first. What do you want out of the relationship? A publication? Career advice? Attaining a fellowship position? You should feel empowered in knowing that you as the mentee are in the driver seat, but this relationship should be mutually beneficial. Consider basing the relationship and initial discussions on these key questions:

1. My goals

• What are my goals? It is okay not to know but be ready to communicate some information to your mentor.
• Remember to also ask your mentor what their goals are for you as well.

2. Outcome

• What type of outcome are both you and your mentor looking for from the relationship?

3. Expectations

• What mentorship expectations do you have?
• What are your mentor’s expectations of you?

Once you feel you have a sense of what you are looking for out of the relationship, it is important to communicate this with the mentor to establish congruent expectations of one another. For example, think about asking your mentor if the two of you can establish a mentor/mentee contract. This is a written document that can be found online and establishes a mutual agreement of roles, responsibilities, and expectations of one another for the relationship. It can further help to open a line for honest and consistent feedback. This can also give you a formalized endpoint and agreed upon scope for the mentoring relationship. Having a check-in preestablished in a contract reduces any potentially awkward conversations about redefining the relationship down the road. (For example, what if our case resident decides to pursue GI? It could happen.)
 

Stage 3: Establishing a common goal

After you have determined the goals and expectations of the relationship together (remember, this is a relationship), it is time to start exploring possible projects and establishing goals for those projects. Having a quality improvement or research project will determine a common goal to work towards and help establish and define the relationship.

Once you have delineated broadly what the project(s) should be, develop smaller SMART (specific, measurable, achievable, relevant, time-bound) goals to move the project forward. These goals determine stopping points for evaluation and feedback, which further establish the relationship and keep the project(s) progressing. For example, one goal could be to write the first draft of the proposal for your quality improvement project within 3 weeks.
 

Stage 4: Continued communication

With any project it is important to stay on the same page as your mentor and be clear to establish “who is doing what by when.” Do not expect accountability to be the mentor’s job. Remember that you are in the driver’s seat and that you should propose how often you need to meet and what those meetings look like by developing an agenda. You can have an open discussion and allow your mentor to help determine a reasonable timeline. Remember, the more you communicate your goals, the better your mentor will be able to address them.

One pro tip is to always exceed your mentor’s expectations – if you think you need 2 weeks to complete a task, ask for 3-4 weeks. This gives you extra padding in case of unforeseen circumstances and makes you look like a “rockstar” if you hit a deadline 1-2 weeks earlier than planned.
 

III. Ending and/or redefining the relationship

Case continued

You are now a senior resident who’s published multiple articles in the past year, and have completed an anticoagulation project for inpatients with pulmonary emboli. You look back on your experience and what stands out is the extent of your gratitude and appreciation for your incredible mentor. Not only do you feel that your mentor has guided you in your career and with your scholarship, but you feel that he or she has shaped your character and talent set. At this point your mentor is both a teacher and guide, but now also a friend. While you feel there is always more that you can learn from her, you are ready to explore new interests. How do you effectively end or redefine this relationship?

Stage 5: Redefining your mentoring relationship

First, go back to the expectations or contract established early in the relationship. The check-in is a key time in the relationship to reevaluate goals and priorities. At this point you may decide to amicably end the relationship or project, or move on to a new project with a change in your role. For example, the quality improvement project may change to research, or you as the mentee have a change in focus (e.g., change in specialty or scholarly focus).

In summary, the interaction between you and your mentor should be a relationship. And the keys to a great relationship are:

1. Establish clear expectations from the beginning. This clarifies the relationship and helps the mentee and mentor to become more successful.

2. Maintain clear and open communication throughout the relationship.3. Define your goals and discuss them with your mentor early. (Have we mentioned the importance of goals enough?) After all, your goal is the reason you started pursuing this relationship in the first place.

In clinical training having guidance can greatly enhance your experience and direct your future career in unexpected ways. We hope that using these tools will guide you towards forging a strong mentor/mentee relationship.

Dr. Zimmerberg-Helms is a resident physician at the University of New Mexico, Albuquerque. Dr. Rendon is an attending hospitalist at the University of New Mexico.

I. Finding a mentor

Case

You are a 27-year-old first-year resident who is seeking mentorship. You are halfway through the year and are thinking about your goals and future. You have a general interest in hematology/oncology but have limited experience and would like to gain more experience with clinically relevant scholarship. However, you do not know anyone in the field and are not sure who to ask for guidance.

Stage 1: Seeking the right mentor

Start first with your area of interest and then look broadly. In this case the resident is interested in heme/onc. The first place to look is on the heme/onc department website or in the faculty directory. It can be helpful to look at what the potential mentor has published recently and/or look at a version of their CV on the faculty directory or website. This can help determine how productive they are and help assess whether you share similar interests, and whether they have worked with many learners in the past.

It is also important to do some background work and ask around about potential mentors. Often resident colleagues and fellows have a good sense of current projects and which faculty work well with learners. Lastly, it is important to also look at non–heme/onc physicians as there may be internal medicine physicians or surgeons who are doing hematology or oncology research that more align with your interests.

After you have assessed whether you think this person would be a strong mentor for you, it is time to reach out. People are flattered to be asked and part of their promotion criteria is their ability to mentor. Do not assume that a potential mentor is too busy! Let him or her make that decision. Remember the worst a mentor can say is “no.” Even if they do not have time or the need for a mentee at the present time, they generally will offer some assistance or direction on who to ask.

Start with a straightforward, but pleasant email. Waiting up to 2 weeks for a response is reasonable. If after 2 weeks you have not received word, feel free to reach out again asking politely if he or she would be willing to work with you. Do not be afraid to ask bluntly for their guidance and mentorship and have a specific project or area of research that you would like their assistance with.
 

II. Optimizing the mentor/mentee relationship

Case continued

Success! Your email was received with interest by a hematologist who has done several projects, comes highly recommended by other residents, and worked with students and residents in the past. The project involves anticoagulation on the inpatient service. You are set to meet with her next month.

Stage 2: Establishing expectations and goals

Now comes the hard work in establishing an excellent mentor/mentee relationship. Before you meet with your mentor, brainstorm first. What do you want out of the relationship? A publication? Career advice? Attaining a fellowship position? You should feel empowered in knowing that you as the mentee are in the driver seat, but this relationship should be mutually beneficial. Consider basing the relationship and initial discussions on these key questions:

1. My goals

• What are my goals? It is okay not to know but be ready to communicate some information to your mentor.
• Remember to also ask your mentor what their goals are for you as well.

2. Outcome

• What type of outcome are both you and your mentor looking for from the relationship?

3. Expectations

• What mentorship expectations do you have?
• What are your mentor’s expectations of you?

Once you feel you have a sense of what you are looking for out of the relationship, it is important to communicate this with the mentor to establish congruent expectations of one another. For example, think about asking your mentor if the two of you can establish a mentor/mentee contract. This is a written document that can be found online and establishes a mutual agreement of roles, responsibilities, and expectations of one another for the relationship. It can further help to open a line for honest and consistent feedback. This can also give you a formalized endpoint and agreed upon scope for the mentoring relationship. Having a check-in preestablished in a contract reduces any potentially awkward conversations about redefining the relationship down the road. (For example, what if our case resident decides to pursue GI? It could happen.)
 

Stage 3: Establishing a common goal

After you have determined the goals and expectations of the relationship together (remember, this is a relationship), it is time to start exploring possible projects and establishing goals for those projects. Having a quality improvement or research project will determine a common goal to work towards and help establish and define the relationship.

Once you have delineated broadly what the project(s) should be, develop smaller SMART (specific, measurable, achievable, relevant, time-bound) goals to move the project forward. These goals determine stopping points for evaluation and feedback, which further establish the relationship and keep the project(s) progressing. For example, one goal could be to write the first draft of the proposal for your quality improvement project within 3 weeks.
 

Stage 4: Continued communication

With any project it is important to stay on the same page as your mentor and be clear to establish “who is doing what by when.” Do not expect accountability to be the mentor’s job. Remember that you are in the driver’s seat and that you should propose how often you need to meet and what those meetings look like by developing an agenda. You can have an open discussion and allow your mentor to help determine a reasonable timeline. Remember, the more you communicate your goals, the better your mentor will be able to address them.

One pro tip is to always exceed your mentor’s expectations – if you think you need 2 weeks to complete a task, ask for 3-4 weeks. This gives you extra padding in case of unforeseen circumstances and makes you look like a “rockstar” if you hit a deadline 1-2 weeks earlier than planned.
 

III. Ending and/or redefining the relationship

Case continued

You are now a senior resident who’s published multiple articles in the past year, and have completed an anticoagulation project for inpatients with pulmonary emboli. You look back on your experience and what stands out is the extent of your gratitude and appreciation for your incredible mentor. Not only do you feel that your mentor has guided you in your career and with your scholarship, but you feel that he or she has shaped your character and talent set. At this point your mentor is both a teacher and guide, but now also a friend. While you feel there is always more that you can learn from her, you are ready to explore new interests. How do you effectively end or redefine this relationship?

Stage 5: Redefining your mentoring relationship

First, go back to the expectations or contract established early in the relationship. The check-in is a key time in the relationship to reevaluate goals and priorities. At this point you may decide to amicably end the relationship or project, or move on to a new project with a change in your role. For example, the quality improvement project may change to research, or you as the mentee have a change in focus (e.g., change in specialty or scholarly focus).

In summary, the interaction between you and your mentor should be a relationship. And the keys to a great relationship are:

1. Establish clear expectations from the beginning. This clarifies the relationship and helps the mentee and mentor to become more successful.

2. Maintain clear and open communication throughout the relationship.3. Define your goals and discuss them with your mentor early. (Have we mentioned the importance of goals enough?) After all, your goal is the reason you started pursuing this relationship in the first place.

In clinical training having guidance can greatly enhance your experience and direct your future career in unexpected ways. We hope that using these tools will guide you towards forging a strong mentor/mentee relationship.

Dr. Zimmerberg-Helms is a resident physician at the University of New Mexico, Albuquerque. Dr. Rendon is an attending hospitalist at the University of New Mexico.

Nusinersen provides continued, long-term benefits to infants with spinal muscular atrophy (SMA) who begin treatment before symptom onset, according to an analysis presented at the 2020 CNS-ICNA Conjoint Meeting, held virtually this year.

“Children are developing in a manner more consistent with normal development than that expected for children with two and three SMN2 gene copies,” said Russell Chin, MD, a neurologist at New York–Presbyterian Hospital. “These data demonstrate the durability of effect over a median of 3.8 years of follow-up, with children aged 2.8-4.8 years at the last visit.”

Many participants in the study achieved motor milestones within normal time limits, and no participant lost any major motor milestones. The investigators did not identify any new safety concerns during a maximum of 4.7 years of follow-up. They will follow participants until they reach approximately 8 years of age.
 

An ongoing open-label study

Dr. Chin presented interim results of the ongoing NURTURE study, which is examining the efficacy and safety of intrathecal nusinersen when administered to presymptomatic infants with SMA. The open-label, single-arm, phase 2 study is being conducted in various countries. Eligible participants were 6 weeks old or younger at first dose and had two or three copies of SMN2. The primary end point of NURTURE is time to death or respiratory intervention (i.e., invasive or noninvasive ventilation for 6 or more hours per day continuously for 7 or more days or tracheostomy). The natural history of SMA type 1 indicates that the median age at death or requirement for ventilation support is 13.5 months.

The investigators enrolled 25 infants: 15 with two copies of the gene and 10 with three copies. At the February 2020 interim analysis, participants had been in the study for 3.8 years and were aged 2.8-4.8 years at the last visit. No children had discontinued treatment or withdrawn from the study. All participants are alive, and four participants (all of whom have two copies of SMN2) required respiratory intervention. The latter children initiated respiratory support during an acute reversible illness. No subjects have required permanent ventilation, which the investigators define as ventilation for 16 or more hours per day for more than 21 days in the absence of an acute reversible event, or tracheostomy.
 

Treatment improved motor development

Approximately 84% of children achieved a maximum score on the Children’s Hospital of Philadelphia Infant Test of Neuromuscular Disorders (CHOP INTEND) scale. The population’s mean CHOP INTEND score increased steadily from baseline and stabilized at approximately the maximum score of 64. The population’s mean change in CHOP INTEND score from baseline to last visit was 13.6 points. The mean score at last visit was 62.0 among patients with two copies of SMN2 and 63.4 among patients with three copies. In addition, the time to first achievement of maximum CHOP INTEND score was shorter in participants with three copies of SMN2, compared with those with two. Four participants with two copies of the gene have not yet achieved a maximum CHOP INTEND score.

Many of the children in the study achieved World Health Organization motor milestones within time frames consistent with normal development. About 84% of participants became able to sit without support within the normal time frame in healthy children. Approximately 60% of children achieved walking with assistance within the normal window, and 64% achieved walking alone within the normal window. Of 25 participants, 24 are walking with assistance, and 22 of 25 (88%) can walk alone. Dr. Chin and colleagues observed that lower levels of phosphorylated neurofilament heavy chain in plasma and cerebrospinal fluid on treatment at day 64 were significantly correlated with higher total score on the Hammersmith Infant Neurological Examination at day 302 and with earlier achievement of the WHO milestone walking alone.

Nusinersen and lumbar puncture were well tolerated. No children discontinued treatment or withdrew from the study because of an adverse event. The investigators did not consider any adverse events or serious adverse events to be related to the study drug. They also did not observe any clinically relevant trends related to nusinersen in hematology, blood chemistry, urinalysis, coagulation, vital signs, or ECGs.

Dr. Chin is an employee of and holds stock in Biogen, which manufactures nusinersen and is sponsoring the study.

[email protected]

SOURCE: Chin R et al. CNS-ICNA 2020, Abstract PL78.

Nusinersen provides continued, long-term benefits to infants with spinal muscular atrophy (SMA) who begin treatment before symptom onset, according to an analysis presented at the 2020 CNS-ICNA Conjoint Meeting, held virtually this year.

“Children are developing in a manner more consistent with normal development than that expected for children with two and three SMN2 gene copies,” said Russell Chin, MD, a neurologist at New York–Presbyterian Hospital. “These data demonstrate the durability of effect over a median of 3.8 years of follow-up, with children aged 2.8-4.8 years at the last visit.”

Many participants in the study achieved motor milestones within normal time limits, and no participant lost any major motor milestones. The investigators did not identify any new safety concerns during a maximum of 4.7 years of follow-up. They will follow participants until they reach approximately 8 years of age.
 

An ongoing open-label study

Dr. Chin presented interim results of the ongoing NURTURE study, which is examining the efficacy and safety of intrathecal nusinersen when administered to presymptomatic infants with SMA. The open-label, single-arm, phase 2 study is being conducted in various countries. Eligible participants were 6 weeks old or younger at first dose and had two or three copies of SMN2. The primary end point of NURTURE is time to death or respiratory intervention (i.e., invasive or noninvasive ventilation for 6 or more hours per day continuously for 7 or more days or tracheostomy). The natural history of SMA type 1 indicates that the median age at death or requirement for ventilation support is 13.5 months.

The investigators enrolled 25 infants: 15 with two copies of the gene and 10 with three copies. At the February 2020 interim analysis, participants had been in the study for 3.8 years and were aged 2.8-4.8 years at the last visit. No children had discontinued treatment or withdrawn from the study. All participants are alive, and four participants (all of whom have two copies of SMN2) required respiratory intervention. The latter children initiated respiratory support during an acute reversible illness. No subjects have required permanent ventilation, which the investigators define as ventilation for 16 or more hours per day for more than 21 days in the absence of an acute reversible event, or tracheostomy.
 

Treatment improved motor development

Approximately 84% of children achieved a maximum score on the Children’s Hospital of Philadelphia Infant Test of Neuromuscular Disorders (CHOP INTEND) scale. The population’s mean CHOP INTEND score increased steadily from baseline and stabilized at approximately the maximum score of 64. The population’s mean change in CHOP INTEND score from baseline to last visit was 13.6 points. The mean score at last visit was 62.0 among patients with two copies of SMN2 and 63.4 among patients with three copies. In addition, the time to first achievement of maximum CHOP INTEND score was shorter in participants with three copies of SMN2, compared with those with two. Four participants with two copies of the gene have not yet achieved a maximum CHOP INTEND score.

Many of the children in the study achieved World Health Organization motor milestones within time frames consistent with normal development. About 84% of participants became able to sit without support within the normal time frame in healthy children. Approximately 60% of children achieved walking with assistance within the normal window, and 64% achieved walking alone within the normal window. Of 25 participants, 24 are walking with assistance, and 22 of 25 (88%) can walk alone. Dr. Chin and colleagues observed that lower levels of phosphorylated neurofilament heavy chain in plasma and cerebrospinal fluid on treatment at day 64 were significantly correlated with higher total score on the Hammersmith Infant Neurological Examination at day 302 and with earlier achievement of the WHO milestone walking alone.

Nusinersen and lumbar puncture were well tolerated. No children discontinued treatment or withdrew from the study because of an adverse event. The investigators did not consider any adverse events or serious adverse events to be related to the study drug. They also did not observe any clinically relevant trends related to nusinersen in hematology, blood chemistry, urinalysis, coagulation, vital signs, or ECGs.

Dr. Chin is an employee of and holds stock in Biogen, which manufactures nusinersen and is sponsoring the study.

[email protected]

SOURCE: Chin R et al. CNS-ICNA 2020, Abstract PL78.

Nusinersen provides continued, long-term benefits to infants with spinal muscular atrophy (SMA) who begin treatment before symptom onset, according to an analysis presented at the 2020 CNS-ICNA Conjoint Meeting, held virtually this year.

“Children are developing in a manner more consistent with normal development than that expected for children with two and three SMN2 gene copies,” said Russell Chin, MD, a neurologist at New York–Presbyterian Hospital. “These data demonstrate the durability of effect over a median of 3.8 years of follow-up, with children aged 2.8-4.8 years at the last visit.”

Many participants in the study achieved motor milestones within normal time limits, and no participant lost any major motor milestones. The investigators did not identify any new safety concerns during a maximum of 4.7 years of follow-up. They will follow participants until they reach approximately 8 years of age.
 

An ongoing open-label study

Dr. Chin presented interim results of the ongoing NURTURE study, which is examining the efficacy and safety of intrathecal nusinersen when administered to presymptomatic infants with SMA. The open-label, single-arm, phase 2 study is being conducted in various countries. Eligible participants were 6 weeks old or younger at first dose and had two or three copies of SMN2. The primary end point of NURTURE is time to death or respiratory intervention (i.e., invasive or noninvasive ventilation for 6 or more hours per day continuously for 7 or more days or tracheostomy). The natural history of SMA type 1 indicates that the median age at death or requirement for ventilation support is 13.5 months.

The investigators enrolled 25 infants: 15 with two copies of the gene and 10 with three copies. At the February 2020 interim analysis, participants had been in the study for 3.8 years and were aged 2.8-4.8 years at the last visit. No children had discontinued treatment or withdrawn from the study. All participants are alive, and four participants (all of whom have two copies of SMN2) required respiratory intervention. The latter children initiated respiratory support during an acute reversible illness. No subjects have required permanent ventilation, which the investigators define as ventilation for 16 or more hours per day for more than 21 days in the absence of an acute reversible event, or tracheostomy.
 

Treatment improved motor development

Approximately 84% of children achieved a maximum score on the Children’s Hospital of Philadelphia Infant Test of Neuromuscular Disorders (CHOP INTEND) scale. The population’s mean CHOP INTEND score increased steadily from baseline and stabilized at approximately the maximum score of 64. The population’s mean change in CHOP INTEND score from baseline to last visit was 13.6 points. The mean score at last visit was 62.0 among patients with two copies of SMN2 and 63.4 among patients with three copies. In addition, the time to first achievement of maximum CHOP INTEND score was shorter in participants with three copies of SMN2, compared with those with two. Four participants with two copies of the gene have not yet achieved a maximum CHOP INTEND score.

Many of the children in the study achieved World Health Organization motor milestones within time frames consistent with normal development. About 84% of participants became able to sit without support within the normal time frame in healthy children. Approximately 60% of children achieved walking with assistance within the normal window, and 64% achieved walking alone within the normal window. Of 25 participants, 24 are walking with assistance, and 22 of 25 (88%) can walk alone. Dr. Chin and colleagues observed that lower levels of phosphorylated neurofilament heavy chain in plasma and cerebrospinal fluid on treatment at day 64 were significantly correlated with higher total score on the Hammersmith Infant Neurological Examination at day 302 and with earlier achievement of the WHO milestone walking alone.

Nusinersen and lumbar puncture were well tolerated. No children discontinued treatment or withdrew from the study because of an adverse event. The investigators did not consider any adverse events or serious adverse events to be related to the study drug. They also did not observe any clinically relevant trends related to nusinersen in hematology, blood chemistry, urinalysis, coagulation, vital signs, or ECGs.

Dr. Chin is an employee of and holds stock in Biogen, which manufactures nusinersen and is sponsoring the study.

[email protected]

SOURCE: Chin R et al. CNS-ICNA 2020, Abstract PL78.

Among individuals admitted to hospitals with sepsis, statin users had a lower mortality, compared with nonstatin users, according to a recent analysis focused on a large and diverse cohort of patients in California.

Mortality hazard ratios at 30 and 90 days were lower by about 20% for statin users admitted for sepsis, compared with nonstatin users, according to results of the retrospective cohort study.

Hydrophilic and synthetic statins had more favorable mortality outcomes, compared with lipophilic and fungal-derived statins, respectively, added investigator Brannen Liang, MD, a third-year internal medicine resident at Kaiser Permanente Los Angeles Medical Center.

These findings suggest a potential benefit of statins in patients with sepsis, with certain types of statins having a greater protective effect than others, according to Dr. Liang, who presented the original research in a presentation at the annual meeting of the American College of Chest Physicians, held virtually this year.

“I think there’s potential for extending the use of statins to other indications, such as sepsis,” Dr. Liang said in an interview, though he also cautioned that the present study is hypothesis generating and more research is necessary.

Using a certain statin type over another (i.e., a hydrophilic, synthetic statin) might be a consideration for populations who are at greater risk for sepsis, such as the immunocompromised, patients with diabetes, or elderly and who also require a statin for an indication such as hyperlipidemia, he added.

While the link between statin use and sepsis mortality outcomes is not new, this study is unique in that it replicates results of earlier studies in a large and diverse real-world population, Dr. Liang said.

“Numerous studies seem to suggest that statins may play a role in attenuating the mortality of patients admitted to the hospital with sepsis, for whatever reason – whether this is due to their anti-inflammatory effects, their lipid-lowering effects, or if they truly have an antimicrobial effect, which has been studied in vitro and in animal studies,” he said in an interview.

It’s impossible to definitively conclude from retrospective studies such as this whether statins reduce sepsis-related mortality risk, but the present study at least makes the case for using certain types of statins when they are indicated in high-risk patients, said Steven Q. Simpson, MD, FCCP, professor of medicine in the division of pulmonary and critical care medicine at the University of Kansas, Kansas City.

“If you have patients at high risk for sepsis and they need a statin, you could give consideration to using a hydrophilic and synthetic statin, rather than either of the other choices,” said Dr. Simpson, CHEST president-elect and senior advisor to the Solving Sepsis initiative of the Biomedical Advanced Research and Development Authority of the Department of Health & Human Services.

The retrospective cohort study by Dr. Liang and colleagues included a total of 137,019 individuals admitted for sepsis within the Kaiser Permanente Southern California health system between 2008 and 2018. Of that group, 36,908 were taking a statin.

Overall, the mean age of patients admitted for sepsis was 66.9 years, and 50.4% were female. Nearly 50% were White, about 12% were Black, 28% were Hispanic, and 8% were Asian. A diagnosis of ischemic heart disease was reported for 43% of statin users and 23% of nonusers, while diabetes mellitus was reported for 60% of statin users and 37% of nonusers (P < .0001 for both comparisons).

Differences in mortality favored statin users, compared with nonusers, with hazard ratios of 0.79 (95% confidence interval, 0.77-0.82) at 30 days and similarly, 0.79 (95% CI, 0.77-0.81) at 90 days, Dr. Liang reported, noting that the models were adjusted for age, race, sex, and comorbidities.

Further analysis suggested a mortality advantage of lipophilic, compared with hydrophilic statins, and an advantage of fungal-derived statins over synthetic-derived statins, the investigator added.

In the comparison of lipophilic statin users and hydrophilic statin users, the 30- and 90-day mortality HRs were 1.13 (95% CI, 1.02-1.26) and 1.17 (95% CI, 1.07-1.28), respectively, the data show. For fungal-derived statin users, compared with synthetic derived statin users, 30- and 90-day mortality HRs were 1.12 (95% CI, 1.06-1.19) and 1.14 (95% CI, 1.09-1.20), respectively.

Dr. Liang and coauthors disclosed no relevant relationships with respect to the work presented at the CHEST meeting.

SOURCE: Liang B et al. CHEST 2020, Abstract A589.

Among individuals admitted to hospitals with sepsis, statin users had a lower mortality, compared with nonstatin users, according to a recent analysis focused on a large and diverse cohort of patients in California.

Mortality hazard ratios at 30 and 90 days were lower by about 20% for statin users admitted for sepsis, compared with nonstatin users, according to results of the retrospective cohort study.

Hydrophilic and synthetic statins had more favorable mortality outcomes, compared with lipophilic and fungal-derived statins, respectively, added investigator Brannen Liang, MD, a third-year internal medicine resident at Kaiser Permanente Los Angeles Medical Center.

These findings suggest a potential benefit of statins in patients with sepsis, with certain types of statins having a greater protective effect than others, according to Dr. Liang, who presented the original research in a presentation at the annual meeting of the American College of Chest Physicians, held virtually this year.

“I think there’s potential for extending the use of statins to other indications, such as sepsis,” Dr. Liang said in an interview, though he also cautioned that the present study is hypothesis generating and more research is necessary.

Using a certain statin type over another (i.e., a hydrophilic, synthetic statin) might be a consideration for populations who are at greater risk for sepsis, such as the immunocompromised, patients with diabetes, or elderly and who also require a statin for an indication such as hyperlipidemia, he added.

While the link between statin use and sepsis mortality outcomes is not new, this study is unique in that it replicates results of earlier studies in a large and diverse real-world population, Dr. Liang said.

“Numerous studies seem to suggest that statins may play a role in attenuating the mortality of patients admitted to the hospital with sepsis, for whatever reason – whether this is due to their anti-inflammatory effects, their lipid-lowering effects, or if they truly have an antimicrobial effect, which has been studied in vitro and in animal studies,” he said in an interview.

It’s impossible to definitively conclude from retrospective studies such as this whether statins reduce sepsis-related mortality risk, but the present study at least makes the case for using certain types of statins when they are indicated in high-risk patients, said Steven Q. Simpson, MD, FCCP, professor of medicine in the division of pulmonary and critical care medicine at the University of Kansas, Kansas City.

“If you have patients at high risk for sepsis and they need a statin, you could give consideration to using a hydrophilic and synthetic statin, rather than either of the other choices,” said Dr. Simpson, CHEST president-elect and senior advisor to the Solving Sepsis initiative of the Biomedical Advanced Research and Development Authority of the Department of Health & Human Services.

The retrospective cohort study by Dr. Liang and colleagues included a total of 137,019 individuals admitted for sepsis within the Kaiser Permanente Southern California health system between 2008 and 2018. Of that group, 36,908 were taking a statin.

Overall, the mean age of patients admitted for sepsis was 66.9 years, and 50.4% were female. Nearly 50% were White, about 12% were Black, 28% were Hispanic, and 8% were Asian. A diagnosis of ischemic heart disease was reported for 43% of statin users and 23% of nonusers, while diabetes mellitus was reported for 60% of statin users and 37% of nonusers (P < .0001 for both comparisons).

Differences in mortality favored statin users, compared with nonusers, with hazard ratios of 0.79 (95% confidence interval, 0.77-0.82) at 30 days and similarly, 0.79 (95% CI, 0.77-0.81) at 90 days, Dr. Liang reported, noting that the models were adjusted for age, race, sex, and comorbidities.

Further analysis suggested a mortality advantage of lipophilic, compared with hydrophilic statins, and an advantage of fungal-derived statins over synthetic-derived statins, the investigator added.

In the comparison of lipophilic statin users and hydrophilic statin users, the 30- and 90-day mortality HRs were 1.13 (95% CI, 1.02-1.26) and 1.17 (95% CI, 1.07-1.28), respectively, the data show. For fungal-derived statin users, compared with synthetic derived statin users, 30- and 90-day mortality HRs were 1.12 (95% CI, 1.06-1.19) and 1.14 (95% CI, 1.09-1.20), respectively.

Dr. Liang and coauthors disclosed no relevant relationships with respect to the work presented at the CHEST meeting.

SOURCE: Liang B et al. CHEST 2020, Abstract A589.

Among individuals admitted to hospitals with sepsis, statin users had a lower mortality, compared with nonstatin users, according to a recent analysis focused on a large and diverse cohort of patients in California.

Mortality hazard ratios at 30 and 90 days were lower by about 20% for statin users admitted for sepsis, compared with nonstatin users, according to results of the retrospective cohort study.

Hydrophilic and synthetic statins had more favorable mortality outcomes, compared with lipophilic and fungal-derived statins, respectively, added investigator Brannen Liang, MD, a third-year internal medicine resident at Kaiser Permanente Los Angeles Medical Center.

These findings suggest a potential benefit of statins in patients with sepsis, with certain types of statins having a greater protective effect than others, according to Dr. Liang, who presented the original research in a presentation at the annual meeting of the American College of Chest Physicians, held virtually this year.

“I think there’s potential for extending the use of statins to other indications, such as sepsis,” Dr. Liang said in an interview, though he also cautioned that the present study is hypothesis generating and more research is necessary.

Using a certain statin type over another (i.e., a hydrophilic, synthetic statin) might be a consideration for populations who are at greater risk for sepsis, such as the immunocompromised, patients with diabetes, or elderly and who also require a statin for an indication such as hyperlipidemia, he added.

While the link between statin use and sepsis mortality outcomes is not new, this study is unique in that it replicates results of earlier studies in a large and diverse real-world population, Dr. Liang said.

“Numerous studies seem to suggest that statins may play a role in attenuating the mortality of patients admitted to the hospital with sepsis, for whatever reason – whether this is due to their anti-inflammatory effects, their lipid-lowering effects, or if they truly have an antimicrobial effect, which has been studied in vitro and in animal studies,” he said in an interview.

It’s impossible to definitively conclude from retrospective studies such as this whether statins reduce sepsis-related mortality risk, but the present study at least makes the case for using certain types of statins when they are indicated in high-risk patients, said Steven Q. Simpson, MD, FCCP, professor of medicine in the division of pulmonary and critical care medicine at the University of Kansas, Kansas City.

“If you have patients at high risk for sepsis and they need a statin, you could give consideration to using a hydrophilic and synthetic statin, rather than either of the other choices,” said Dr. Simpson, CHEST president-elect and senior advisor to the Solving Sepsis initiative of the Biomedical Advanced Research and Development Authority of the Department of Health & Human Services.

The retrospective cohort study by Dr. Liang and colleagues included a total of 137,019 individuals admitted for sepsis within the Kaiser Permanente Southern California health system between 2008 and 2018. Of that group, 36,908 were taking a statin.

Overall, the mean age of patients admitted for sepsis was 66.9 years, and 50.4% were female. Nearly 50% were White, about 12% were Black, 28% were Hispanic, and 8% were Asian. A diagnosis of ischemic heart disease was reported for 43% of statin users and 23% of nonusers, while diabetes mellitus was reported for 60% of statin users and 37% of nonusers (P < .0001 for both comparisons).

Differences in mortality favored statin users, compared with nonusers, with hazard ratios of 0.79 (95% confidence interval, 0.77-0.82) at 30 days and similarly, 0.79 (95% CI, 0.77-0.81) at 90 days, Dr. Liang reported, noting that the models were adjusted for age, race, sex, and comorbidities.

Further analysis suggested a mortality advantage of lipophilic, compared with hydrophilic statins, and an advantage of fungal-derived statins over synthetic-derived statins, the investigator added.

In the comparison of lipophilic statin users and hydrophilic statin users, the 30- and 90-day mortality HRs were 1.13 (95% CI, 1.02-1.26) and 1.17 (95% CI, 1.07-1.28), respectively, the data show. For fungal-derived statin users, compared with synthetic derived statin users, 30- and 90-day mortality HRs were 1.12 (95% CI, 1.06-1.19) and 1.14 (95% CI, 1.09-1.20), respectively.

Dr. Liang and coauthors disclosed no relevant relationships with respect to the work presented at the CHEST meeting.

SOURCE: Liang B et al. CHEST 2020, Abstract A589.

Two recently completed analyses of highly purified cannabidiol (CBD) used to reduce seizures in Lennox Gastaut syndrome (LGS) have shown the formulation as an add-on treatment is effective in reducing seizures out to 3 years but that it can also cause thrombocytopenia in children on concurrent valproic acid therapy.

At the 2020 CNS-ICNA Conjoint Meeting, held virtually this year, Anul Patel, MD, section chief of Pediatric neurology at Nationwide Children’s and associate professor of clinical pediatrics and neurology at the Ohio State University, both in Columbus, Ohio, reported 156-week results of an open-label extension trial called GWPCARE5 that showed patients with LGS taking Epidiolex had a 60% or greater average reduction in seizures, compared with baseline. Epidiolex, a highly purified form of CBD, was approved by the Food and Drug Administration in 2018 for LGS and Dravet syndrome.

In a separate presentation, Nancy A. McNamara, MD, an assistant professor at the C.S. Mott Children’s Hospital at the University of Michigan, Ann Arbor, said that more than one-third of patients taking both Epidiolex and valproic acid (VPA) developed thrombocytopenia after starting CBD therapy. The single-center chart review she reported on included 83 patients.

Daniel Friedman, MD, an epilepsy specialist at New York University who’s researched CBD in children with autism spectrum disorder, said, “These studies show that, while purified CBD has durable effects on the most disabling seizures in children and adults with LGS, like all treatments, it is not without risks that warrant attention and monitoring.” 
 

Open-label extension study

The open-label extension study included 366 patients who participated in the two previous clinical trials. They were given varying doses of CBD titrated over 2 weeks with 20 mg/kg as the target dose, Dr. Patel said. The most common concurrent therapies they were taking were clobazam, valproate or VPA, lamotrigine, levetiracetam, and rufinamide. At weeks 145-156, 67% of patients had a 50% or greater reduction in seizures, 44% had a 75% or greater reduction, and 9% stopped having seizures altogether, Dr. Patel said.

“CBD treatment had a similar safety profile to what was observed in the completed parent randomized clinical trials,” Dr. Patel said. “Sustained reductions in drop and total seizures were observed up to the 156-week follow-up point. So these results demonstrate the potential long-term benefits of CBD treatment for patients with LGS as it relates to reduction of their seizures.”

Adverse event profiles in this analysis were similar to previous clinical trials, he noted. The three most common adverse events were diarrhea (38%), convulsion (38%) and pyrexia (34%), but high percentages of those adverse events resolved during follow-up: 78%, 80%, and 96%, respectively.

Dr. Patel also noted that 31% of patients had elevated liver enzymes (alanine aminotransferase or aspartate aminotransferase), but most of these patients – 78 of 113, or 69% – were on concomitant VPA. “Importantly, no patient met the standard criteria for severe drug-induced liver injury, known as Hy’s law,” he said.

Retention rates for patients were 81% at 1 year, 69% at 2 years and 65% at 3 years, Dr. Patel said.
 

“An urgent systemic review”

Dr. McNamara’s research drilled down into the interaction of CBD and VPA. “Over the past several months we have made observations that several patients that had been started on CBD, also known as Epidiolex, had developed thrombocytopenia, some of which were symptomatic,” she said. Symptoms included hematuria, easy bruising, and gingival bleeding.

That prompted what Dr. McNamara called “an urgent systemic review” of all patients on CBD. Of 83 patients started on CBD for LGS from January to August 2019, 9 (11%) developed thrombocytopenia. “All of these patients were on concurrent VPA and no patients started on CBD without VPA developed thrombocytopenia,” she said. In all, 23 patients were taking CBD concurrently with VPA. Four of nine cases were symptomatic.

“The thrombocytopenia was reversible in all patients with reduction of medication and one patient recovered spontaneously without intervention,” Dr. McNamara noted.

“This was an important finding because this was not something that had come out of the clinical trials prior to FDA approval,” Dr. McNamara said. “This requires closer monitoring for patients who are started on CBD who are already on VPA.”

Of the 23 patients taking concurrent VPA, 10 had low platelet counts after starting CBD. In six patients, platelet counts dropped from normal before CBD therapy to low afterward.

The study used a McNemar test to determine if an observed adverse event occurred by chance or was related to starting a drug, which yielded a P value of .125, Dr. McNamara said. “While this did not achieve statistical significance, we suggest that prescribers closely monitor platelet levels after starting CBD, particularly when a patient is also on concurrent VPA,” she said.

Her group obtained a complete blood count at baseline and then at 1, 3, and 6 months after starting the patient on CBD, along with evaluation of alanine aminotransferase and aspartate aminotransferase. “We believe that this is helpful because most of the patients that develop low platelets did so within 3 months of starting cannabidiol,” Dr. McNamara said.

She acknowledged the limits of the single-center study. “Future research will need to be done with larger cohorts with standardized surveillance labs,” she said in an interview.

Dr. Patel disclosed financial relationships with GW Research and Greenwich Biosciences. Dr. McNamara has no relevant disclosures.

Two recently completed analyses of highly purified cannabidiol (CBD) used to reduce seizures in Lennox Gastaut syndrome (LGS) have shown the formulation as an add-on treatment is effective in reducing seizures out to 3 years but that it can also cause thrombocytopenia in children on concurrent valproic acid therapy.

At the 2020 CNS-ICNA Conjoint Meeting, held virtually this year, Anul Patel, MD, section chief of Pediatric neurology at Nationwide Children’s and associate professor of clinical pediatrics and neurology at the Ohio State University, both in Columbus, Ohio, reported 156-week results of an open-label extension trial called GWPCARE5 that showed patients with LGS taking Epidiolex had a 60% or greater average reduction in seizures, compared with baseline. Epidiolex, a highly purified form of CBD, was approved by the Food and Drug Administration in 2018 for LGS and Dravet syndrome.

In a separate presentation, Nancy A. McNamara, MD, an assistant professor at the C.S. Mott Children’s Hospital at the University of Michigan, Ann Arbor, said that more than one-third of patients taking both Epidiolex and valproic acid (VPA) developed thrombocytopenia after starting CBD therapy. The single-center chart review she reported on included 83 patients.

Daniel Friedman, MD, an epilepsy specialist at New York University who’s researched CBD in children with autism spectrum disorder, said, “These studies show that, while purified CBD has durable effects on the most disabling seizures in children and adults with LGS, like all treatments, it is not without risks that warrant attention and monitoring.” 
 

Open-label extension study

The open-label extension study included 366 patients who participated in the two previous clinical trials. They were given varying doses of CBD titrated over 2 weeks with 20 mg/kg as the target dose, Dr. Patel said. The most common concurrent therapies they were taking were clobazam, valproate or VPA, lamotrigine, levetiracetam, and rufinamide. At weeks 145-156, 67% of patients had a 50% or greater reduction in seizures, 44% had a 75% or greater reduction, and 9% stopped having seizures altogether, Dr. Patel said.

“CBD treatment had a similar safety profile to what was observed in the completed parent randomized clinical trials,” Dr. Patel said. “Sustained reductions in drop and total seizures were observed up to the 156-week follow-up point. So these results demonstrate the potential long-term benefits of CBD treatment for patients with LGS as it relates to reduction of their seizures.”

Adverse event profiles in this analysis were similar to previous clinical trials, he noted. The three most common adverse events were diarrhea (38%), convulsion (38%) and pyrexia (34%), but high percentages of those adverse events resolved during follow-up: 78%, 80%, and 96%, respectively.

Dr. Patel also noted that 31% of patients had elevated liver enzymes (alanine aminotransferase or aspartate aminotransferase), but most of these patients – 78 of 113, or 69% – were on concomitant VPA. “Importantly, no patient met the standard criteria for severe drug-induced liver injury, known as Hy’s law,” he said.

Retention rates for patients were 81% at 1 year, 69% at 2 years and 65% at 3 years, Dr. Patel said.
 

“An urgent systemic review”

Dr. McNamara’s research drilled down into the interaction of CBD and VPA. “Over the past several months we have made observations that several patients that had been started on CBD, also known as Epidiolex, had developed thrombocytopenia, some of which were symptomatic,” she said. Symptoms included hematuria, easy bruising, and gingival bleeding.

That prompted what Dr. McNamara called “an urgent systemic review” of all patients on CBD. Of 83 patients started on CBD for LGS from January to August 2019, 9 (11%) developed thrombocytopenia. “All of these patients were on concurrent VPA and no patients started on CBD without VPA developed thrombocytopenia,” she said. In all, 23 patients were taking CBD concurrently with VPA. Four of nine cases were symptomatic.

“The thrombocytopenia was reversible in all patients with reduction of medication and one patient recovered spontaneously without intervention,” Dr. McNamara noted.

“This was an important finding because this was not something that had come out of the clinical trials prior to FDA approval,” Dr. McNamara said. “This requires closer monitoring for patients who are started on CBD who are already on VPA.”

Of the 23 patients taking concurrent VPA, 10 had low platelet counts after starting CBD. In six patients, platelet counts dropped from normal before CBD therapy to low afterward.

The study used a McNemar test to determine if an observed adverse event occurred by chance or was related to starting a drug, which yielded a P value of .125, Dr. McNamara said. “While this did not achieve statistical significance, we suggest that prescribers closely monitor platelet levels after starting CBD, particularly when a patient is also on concurrent VPA,” she said.

Her group obtained a complete blood count at baseline and then at 1, 3, and 6 months after starting the patient on CBD, along with evaluation of alanine aminotransferase and aspartate aminotransferase. “We believe that this is helpful because most of the patients that develop low platelets did so within 3 months of starting cannabidiol,” Dr. McNamara said.

She acknowledged the limits of the single-center study. “Future research will need to be done with larger cohorts with standardized surveillance labs,” she said in an interview.

Dr. Patel disclosed financial relationships with GW Research and Greenwich Biosciences. Dr. McNamara has no relevant disclosures.

Two recently completed analyses of highly purified cannabidiol (CBD) used to reduce seizures in Lennox Gastaut syndrome (LGS) have shown the formulation as an add-on treatment is effective in reducing seizures out to 3 years but that it can also cause thrombocytopenia in children on concurrent valproic acid therapy.

At the 2020 CNS-ICNA Conjoint Meeting, held virtually this year, Anul Patel, MD, section chief of Pediatric neurology at Nationwide Children’s and associate professor of clinical pediatrics and neurology at the Ohio State University, both in Columbus, Ohio, reported 156-week results of an open-label extension trial called GWPCARE5 that showed patients with LGS taking Epidiolex had a 60% or greater average reduction in seizures, compared with baseline. Epidiolex, a highly purified form of CBD, was approved by the Food and Drug Administration in 2018 for LGS and Dravet syndrome.

In a separate presentation, Nancy A. McNamara, MD, an assistant professor at the C.S. Mott Children’s Hospital at the University of Michigan, Ann Arbor, said that more than one-third of patients taking both Epidiolex and valproic acid (VPA) developed thrombocytopenia after starting CBD therapy. The single-center chart review she reported on included 83 patients.

Daniel Friedman, MD, an epilepsy specialist at New York University who’s researched CBD in children with autism spectrum disorder, said, “These studies show that, while purified CBD has durable effects on the most disabling seizures in children and adults with LGS, like all treatments, it is not without risks that warrant attention and monitoring.” 
 

Open-label extension study

The open-label extension study included 366 patients who participated in the two previous clinical trials. They were given varying doses of CBD titrated over 2 weeks with 20 mg/kg as the target dose, Dr. Patel said. The most common concurrent therapies they were taking were clobazam, valproate or VPA, lamotrigine, levetiracetam, and rufinamide. At weeks 145-156, 67% of patients had a 50% or greater reduction in seizures, 44% had a 75% or greater reduction, and 9% stopped having seizures altogether, Dr. Patel said.

“CBD treatment had a similar safety profile to what was observed in the completed parent randomized clinical trials,” Dr. Patel said. “Sustained reductions in drop and total seizures were observed up to the 156-week follow-up point. So these results demonstrate the potential long-term benefits of CBD treatment for patients with LGS as it relates to reduction of their seizures.”

Adverse event profiles in this analysis were similar to previous clinical trials, he noted. The three most common adverse events were diarrhea (38%), convulsion (38%) and pyrexia (34%), but high percentages of those adverse events resolved during follow-up: 78%, 80%, and 96%, respectively.

Dr. Patel also noted that 31% of patients had elevated liver enzymes (alanine aminotransferase or aspartate aminotransferase), but most of these patients – 78 of 113, or 69% – were on concomitant VPA. “Importantly, no patient met the standard criteria for severe drug-induced liver injury, known as Hy’s law,” he said.

Retention rates for patients were 81% at 1 year, 69% at 2 years and 65% at 3 years, Dr. Patel said.
 

“An urgent systemic review”

Dr. McNamara’s research drilled down into the interaction of CBD and VPA. “Over the past several months we have made observations that several patients that had been started on CBD, also known as Epidiolex, had developed thrombocytopenia, some of which were symptomatic,” she said. Symptoms included hematuria, easy bruising, and gingival bleeding.

That prompted what Dr. McNamara called “an urgent systemic review” of all patients on CBD. Of 83 patients started on CBD for LGS from January to August 2019, 9 (11%) developed thrombocytopenia. “All of these patients were on concurrent VPA and no patients started on CBD without VPA developed thrombocytopenia,” she said. In all, 23 patients were taking CBD concurrently with VPA. Four of nine cases were symptomatic.

“The thrombocytopenia was reversible in all patients with reduction of medication and one patient recovered spontaneously without intervention,” Dr. McNamara noted.

“This was an important finding because this was not something that had come out of the clinical trials prior to FDA approval,” Dr. McNamara said. “This requires closer monitoring for patients who are started on CBD who are already on VPA.”

Of the 23 patients taking concurrent VPA, 10 had low platelet counts after starting CBD. In six patients, platelet counts dropped from normal before CBD therapy to low afterward.

The study used a McNemar test to determine if an observed adverse event occurred by chance or was related to starting a drug, which yielded a P value of .125, Dr. McNamara said. “While this did not achieve statistical significance, we suggest that prescribers closely monitor platelet levels after starting CBD, particularly when a patient is also on concurrent VPA,” she said.

Her group obtained a complete blood count at baseline and then at 1, 3, and 6 months after starting the patient on CBD, along with evaluation of alanine aminotransferase and aspartate aminotransferase. “We believe that this is helpful because most of the patients that develop low platelets did so within 3 months of starting cannabidiol,” Dr. McNamara said.

She acknowledged the limits of the single-center study. “Future research will need to be done with larger cohorts with standardized surveillance labs,” she said in an interview.

Dr. Patel disclosed financial relationships with GW Research and Greenwich Biosciences. Dr. McNamara has no relevant disclosures.

In addition to screening adolescent patients at least once a year for substance use, it’s important that pediatricians build relationships with other behavioral health providers and develop a strategy for ensuring that teens with substance use issues continue returning to your practice as their medical home, according to Lucien Gonzalez, MD, assistant professor of psychiatry and behavioral sciences at the University of Minnesota, Minneapolis.

In a presentation at the annual meeting of the American Academy of Pediatrics, held virtually this year, Dr. Gonzalez discussed some of the common challenges pediatricians face in appropriately screening, diagnosing, and managing or referring youth when it comes to substance use.
 

Substance use screening

One of these included picking the right assessment tool and frequency for screening patients for substance use. A number of validated tools are out there, including the Screening to Brief Intervention (S2BI) and CRAFFT Screening Tool for Adolescent Substance Abuse. Regardless of which screening tool providers choose, “the important thing is to use a tool that is validated in the pediatric population and ideally has frequency results in it,” Dr. Gonzalez said.

In terms of frequency, screening young people at least once a year is fairly standard, but it may be necessary to screen adolescents more often or to screen them at acute visits.

“As many of you who work with adolescents know, you can’t always rely on the yearly well child visit because after a certain age, you start to see drop-off,” Dr. Gonzalez said. “They often aren’t coming for well child visits, and they often are then only showing up for acute visits.”

That means doctors need to think about how their clinics operate, how often they see their teen patients, and other factors – including how much can happen in a single year of adolescence – to ensure that screening captures these patients at least once a year, but more if that works within the practice.
 

Screening vs. diagnosis

Dr. Gonzalez also addressed the difference between screening and diagnosis, a very familiar distinction to physicians in other areas of medicine but often a source of confusion in the area of substance use.

“Screening is the presumptive identification of unrecognized disease in apparently healthy people who don’t have symptoms, using assessments that can be used rapidly,” Dr. Gonzalez said. “When we move into the diagnostic realm, these are people who present with symptoms or they have positive results on our screening test prompting further investigation.”

Sonia Khan, MD, a pediatrician and the medical director of the substance use disorder counseling program in the department of health and human services in Fremont, Calif., who heard the talk, particularly appreciated this point about screening versus diagnosis.

“As soon as you get a hint that there’s a problem with the kid, you’re no longer screening. You’re doing diagnostic investigation,” Dr. Khan, also the human relations commissioner for the city of Fremont, Calif., said in an interview. “Screening is about the kids you don’t know about. It seems like a small point to make a big deal out of, but it’s not.”

Sometimes a screening tool can serve as an introductory interview guide when beginning a clinical investigation with a patient who already shows symptoms, but that doesn’t mean it’s a screen.

Dr. Gonzalez emphasized the importance of not prescreening.

“A prescreener looks at a kid and decides whether or not they need to be screened,” Dr. Gonzalez said. “We have research that demonstrates that that doesn’t work. Physicians are not good at determining this by eyeballing it, and it’s fraught with bias. Universal screening with a validated screening tool is what works.”

Again, the idea of confronting one’s own personal biases and how they could interfere with screening really resonated with Dr. Khan.

“When it comes to the prescreening, if you’re only screening the ones you [think you] need to screen, you’re introducing bias into your screening,” she said. “It’s usually judgmental. It’s important to focus on really getting the bias out of what you’re doing because it’s a field fraught with bias and expectations.”


 

Brief interventions

Another area of confusion for many providers is what qualifies as a brief intervention and how to deliver it. The brief intervention needs to focus on increasing the patient’s knowledge, insights, and awareness when it comes to their own substance use and how it affects others. It should also support motivation in the patient to make behavioral changes. “It is always given in a nonjudgmental, supportive manner,” Dr. Gonzalez said.

Though motivational interviewing is often discussed as though it’s a brief intervention, it is actually the mechanism for delivering the intervention – not the intervention itself.

Dr. Gonzalez highly recommended that providers seek motivational interviewing training if they haven’t already. He went on to caution attendees about behavior goals in interventions: They should be the patient’s change goals, not the provider’s, and the provider is there to facilitate the teen’s clarification of those goals.

“It’s very important to use those listening skills that we have and honor their decision-making and listen to their language in establishing their own goals,” he said. It’s also important to keep cultural relevance and respect in mind when delivering the intervention. He shared a chart showing the dominant and nondominant groups along various demographic cultural influences, including age, disability status, faith, race/ethnicity, indigenous heritage, socioeconomic status, national origin, gender and sexuality.

For example, the dominant age groups are the young and middle-aged while the nondominant are children and elderly. The dominant faith in the United States is Christian or secular, and the dominant sexuality is heterosexual; the corresponding nondominant groups would be non-Christian and nonheterosexual. It’s important for providers to consider the child’s needs within that entire behavioral context to understand where they’re coming from.

“Have you ever characterized a kid’s situation with regard to substance use and diagnoses based on certain characteristics?” Dr. Gonzalez asked attendees. “We like to think that we don’t, but research on diagnostic disparities indicates otherwise.”

A way to help avoid this is to know who you are in the room and who you’re with in terms of dominant and nondominant groups. “Oftentimes a kid’s cultural make-up holds a big part of the answer to what they need,” Dr. Gonzalez said. He provided the example of a patient who was witnessing domestic violence in the home. A key part to helping him meet his goal of reducing cannabis and alcohol use was understanding his relationship with his dad, his response to trauma, and his depression, all within his cultural and religious background.
 

Preserving the medical home

Finally, when it comes to referrals, consider what are you referring a patient for and whom are you referring them to because not all programs and all clinicians are created equal. Create, build, and maintain relationships with as many behavioral health clinicians and practices as you can, he advised.

Further, it’s important to preserve the medical home, though that can require extra effort, particularly with children who have seen a lot of providers. Each physician will need to develop their own strategy for how to do this. Sometimes kids feel passed around and there’s poor communication within programs, leaving kids and their families feeling unwelcome at your practice.

“No child is a hot potato,” he said. Because they may feel like they’re being bounced around among different providers, programs, emergency departments, facilities, and such, it’s important to convey strongly that you want to continue to care for them.

“Whether we’ve been part of that or not, we become part of that,” Dr. Gonzalez said. “They may think that you don’t want to see them again. You want to keep them, and you might have to continue giving repeated messages. Sometimes we need to be very overt and repeat ourselves and say no, ‘I really, really, really want you to come back. This is your home and I want you to come back.’ ”

Dr. Gonzalez and Dr. Khan have no disclosures.

In addition to screening adolescent patients at least once a year for substance use, it’s important that pediatricians build relationships with other behavioral health providers and develop a strategy for ensuring that teens with substance use issues continue returning to your practice as their medical home, according to Lucien Gonzalez, MD, assistant professor of psychiatry and behavioral sciences at the University of Minnesota, Minneapolis.

In a presentation at the annual meeting of the American Academy of Pediatrics, held virtually this year, Dr. Gonzalez discussed some of the common challenges pediatricians face in appropriately screening, diagnosing, and managing or referring youth when it comes to substance use.
 

Substance use screening

One of these included picking the right assessment tool and frequency for screening patients for substance use. A number of validated tools are out there, including the Screening to Brief Intervention (S2BI) and CRAFFT Screening Tool for Adolescent Substance Abuse. Regardless of which screening tool providers choose, “the important thing is to use a tool that is validated in the pediatric population and ideally has frequency results in it,” Dr. Gonzalez said.

In terms of frequency, screening young people at least once a year is fairly standard, but it may be necessary to screen adolescents more often or to screen them at acute visits.

“As many of you who work with adolescents know, you can’t always rely on the yearly well child visit because after a certain age, you start to see drop-off,” Dr. Gonzalez said. “They often aren’t coming for well child visits, and they often are then only showing up for acute visits.”

That means doctors need to think about how their clinics operate, how often they see their teen patients, and other factors – including how much can happen in a single year of adolescence – to ensure that screening captures these patients at least once a year, but more if that works within the practice.
 

Screening vs. diagnosis

Dr. Gonzalez also addressed the difference between screening and diagnosis, a very familiar distinction to physicians in other areas of medicine but often a source of confusion in the area of substance use.

“Screening is the presumptive identification of unrecognized disease in apparently healthy people who don’t have symptoms, using assessments that can be used rapidly,” Dr. Gonzalez said. “When we move into the diagnostic realm, these are people who present with symptoms or they have positive results on our screening test prompting further investigation.”

Sonia Khan, MD, a pediatrician and the medical director of the substance use disorder counseling program in the department of health and human services in Fremont, Calif., who heard the talk, particularly appreciated this point about screening versus diagnosis.

“As soon as you get a hint that there’s a problem with the kid, you’re no longer screening. You’re doing diagnostic investigation,” Dr. Khan, also the human relations commissioner for the city of Fremont, Calif., said in an interview. “Screening is about the kids you don’t know about. It seems like a small point to make a big deal out of, but it’s not.”

Sometimes a screening tool can serve as an introductory interview guide when beginning a clinical investigation with a patient who already shows symptoms, but that doesn’t mean it’s a screen.

Dr. Gonzalez emphasized the importance of not prescreening.

“A prescreener looks at a kid and decides whether or not they need to be screened,” Dr. Gonzalez said. “We have research that demonstrates that that doesn’t work. Physicians are not good at determining this by eyeballing it, and it’s fraught with bias. Universal screening with a validated screening tool is what works.”

Again, the idea of confronting one’s own personal biases and how they could interfere with screening really resonated with Dr. Khan.

“When it comes to the prescreening, if you’re only screening the ones you [think you] need to screen, you’re introducing bias into your screening,” she said. “It’s usually judgmental. It’s important to focus on really getting the bias out of what you’re doing because it’s a field fraught with bias and expectations.”


 

Brief interventions

Another area of confusion for many providers is what qualifies as a brief intervention and how to deliver it. The brief intervention needs to focus on increasing the patient’s knowledge, insights, and awareness when it comes to their own substance use and how it affects others. It should also support motivation in the patient to make behavioral changes. “It is always given in a nonjudgmental, supportive manner,” Dr. Gonzalez said.

Though motivational interviewing is often discussed as though it’s a brief intervention, it is actually the mechanism for delivering the intervention – not the intervention itself.

Dr. Gonzalez highly recommended that providers seek motivational interviewing training if they haven’t already. He went on to caution attendees about behavior goals in interventions: They should be the patient’s change goals, not the provider’s, and the provider is there to facilitate the teen’s clarification of those goals.

“It’s very important to use those listening skills that we have and honor their decision-making and listen to their language in establishing their own goals,” he said. It’s also important to keep cultural relevance and respect in mind when delivering the intervention. He shared a chart showing the dominant and nondominant groups along various demographic cultural influences, including age, disability status, faith, race/ethnicity, indigenous heritage, socioeconomic status, national origin, gender and sexuality.

For example, the dominant age groups are the young and middle-aged while the nondominant are children and elderly. The dominant faith in the United States is Christian or secular, and the dominant sexuality is heterosexual; the corresponding nondominant groups would be non-Christian and nonheterosexual. It’s important for providers to consider the child’s needs within that entire behavioral context to understand where they’re coming from.

“Have you ever characterized a kid’s situation with regard to substance use and diagnoses based on certain characteristics?” Dr. Gonzalez asked attendees. “We like to think that we don’t, but research on diagnostic disparities indicates otherwise.”

A way to help avoid this is to know who you are in the room and who you’re with in terms of dominant and nondominant groups. “Oftentimes a kid’s cultural make-up holds a big part of the answer to what they need,” Dr. Gonzalez said. He provided the example of a patient who was witnessing domestic violence in the home. A key part to helping him meet his goal of reducing cannabis and alcohol use was understanding his relationship with his dad, his response to trauma, and his depression, all within his cultural and religious background.
 

Preserving the medical home

Finally, when it comes to referrals, consider what are you referring a patient for and whom are you referring them to because not all programs and all clinicians are created equal. Create, build, and maintain relationships with as many behavioral health clinicians and practices as you can, he advised.

Further, it’s important to preserve the medical home, though that can require extra effort, particularly with children who have seen a lot of providers. Each physician will need to develop their own strategy for how to do this. Sometimes kids feel passed around and there’s poor communication within programs, leaving kids and their families feeling unwelcome at your practice.

“No child is a hot potato,” he said. Because they may feel like they’re being bounced around among different providers, programs, emergency departments, facilities, and such, it’s important to convey strongly that you want to continue to care for them.

“Whether we’ve been part of that or not, we become part of that,” Dr. Gonzalez said. “They may think that you don’t want to see them again. You want to keep them, and you might have to continue giving repeated messages. Sometimes we need to be very overt and repeat ourselves and say no, ‘I really, really, really want you to come back. This is your home and I want you to come back.’ ”

Dr. Gonzalez and Dr. Khan have no disclosures.

In addition to screening adolescent patients at least once a year for substance use, it’s important that pediatricians build relationships with other behavioral health providers and develop a strategy for ensuring that teens with substance use issues continue returning to your practice as their medical home, according to Lucien Gonzalez, MD, assistant professor of psychiatry and behavioral sciences at the University of Minnesota, Minneapolis.

In a presentation at the annual meeting of the American Academy of Pediatrics, held virtually this year, Dr. Gonzalez discussed some of the common challenges pediatricians face in appropriately screening, diagnosing, and managing or referring youth when it comes to substance use.
 

Substance use screening

One of these included picking the right assessment tool and frequency for screening patients for substance use. A number of validated tools are out there, including the Screening to Brief Intervention (S2BI) and CRAFFT Screening Tool for Adolescent Substance Abuse. Regardless of which screening tool providers choose, “the important thing is to use a tool that is validated in the pediatric population and ideally has frequency results in it,” Dr. Gonzalez said.

In terms of frequency, screening young people at least once a year is fairly standard, but it may be necessary to screen adolescents more often or to screen them at acute visits.

“As many of you who work with adolescents know, you can’t always rely on the yearly well child visit because after a certain age, you start to see drop-off,” Dr. Gonzalez said. “They often aren’t coming for well child visits, and they often are then only showing up for acute visits.”

That means doctors need to think about how their clinics operate, how often they see their teen patients, and other factors – including how much can happen in a single year of adolescence – to ensure that screening captures these patients at least once a year, but more if that works within the practice.
 

Screening vs. diagnosis

Dr. Gonzalez also addressed the difference between screening and diagnosis, a very familiar distinction to physicians in other areas of medicine but often a source of confusion in the area of substance use.

“Screening is the presumptive identification of unrecognized disease in apparently healthy people who don’t have symptoms, using assessments that can be used rapidly,” Dr. Gonzalez said. “When we move into the diagnostic realm, these are people who present with symptoms or they have positive results on our screening test prompting further investigation.”

Sonia Khan, MD, a pediatrician and the medical director of the substance use disorder counseling program in the department of health and human services in Fremont, Calif., who heard the talk, particularly appreciated this point about screening versus diagnosis.

“As soon as you get a hint that there’s a problem with the kid, you’re no longer screening. You’re doing diagnostic investigation,” Dr. Khan, also the human relations commissioner for the city of Fremont, Calif., said in an interview. “Screening is about the kids you don’t know about. It seems like a small point to make a big deal out of, but it’s not.”

Sometimes a screening tool can serve as an introductory interview guide when beginning a clinical investigation with a patient who already shows symptoms, but that doesn’t mean it’s a screen.

Dr. Gonzalez emphasized the importance of not prescreening.

“A prescreener looks at a kid and decides whether or not they need to be screened,” Dr. Gonzalez said. “We have research that demonstrates that that doesn’t work. Physicians are not good at determining this by eyeballing it, and it’s fraught with bias. Universal screening with a validated screening tool is what works.”

Again, the idea of confronting one’s own personal biases and how they could interfere with screening really resonated with Dr. Khan.

“When it comes to the prescreening, if you’re only screening the ones you [think you] need to screen, you’re introducing bias into your screening,” she said. “It’s usually judgmental. It’s important to focus on really getting the bias out of what you’re doing because it’s a field fraught with bias and expectations.”


 

Brief interventions

Another area of confusion for many providers is what qualifies as a brief intervention and how to deliver it. The brief intervention needs to focus on increasing the patient’s knowledge, insights, and awareness when it comes to their own substance use and how it affects others. It should also support motivation in the patient to make behavioral changes. “It is always given in a nonjudgmental, supportive manner,” Dr. Gonzalez said.

Though motivational interviewing is often discussed as though it’s a brief intervention, it is actually the mechanism for delivering the intervention – not the intervention itself.

Dr. Gonzalez highly recommended that providers seek motivational interviewing training if they haven’t already. He went on to caution attendees about behavior goals in interventions: They should be the patient’s change goals, not the provider’s, and the provider is there to facilitate the teen’s clarification of those goals.

“It’s very important to use those listening skills that we have and honor their decision-making and listen to their language in establishing their own goals,” he said. It’s also important to keep cultural relevance and respect in mind when delivering the intervention. He shared a chart showing the dominant and nondominant groups along various demographic cultural influences, including age, disability status, faith, race/ethnicity, indigenous heritage, socioeconomic status, national origin, gender and sexuality.

For example, the dominant age groups are the young and middle-aged while the nondominant are children and elderly. The dominant faith in the United States is Christian or secular, and the dominant sexuality is heterosexual; the corresponding nondominant groups would be non-Christian and nonheterosexual. It’s important for providers to consider the child’s needs within that entire behavioral context to understand where they’re coming from.

“Have you ever characterized a kid’s situation with regard to substance use and diagnoses based on certain characteristics?” Dr. Gonzalez asked attendees. “We like to think that we don’t, but research on diagnostic disparities indicates otherwise.”

A way to help avoid this is to know who you are in the room and who you’re with in terms of dominant and nondominant groups. “Oftentimes a kid’s cultural make-up holds a big part of the answer to what they need,” Dr. Gonzalez said. He provided the example of a patient who was witnessing domestic violence in the home. A key part to helping him meet his goal of reducing cannabis and alcohol use was understanding his relationship with his dad, his response to trauma, and his depression, all within his cultural and religious background.
 

Preserving the medical home

Finally, when it comes to referrals, consider what are you referring a patient for and whom are you referring them to because not all programs and all clinicians are created equal. Create, build, and maintain relationships with as many behavioral health clinicians and practices as you can, he advised.

Further, it’s important to preserve the medical home, though that can require extra effort, particularly with children who have seen a lot of providers. Each physician will need to develop their own strategy for how to do this. Sometimes kids feel passed around and there’s poor communication within programs, leaving kids and their families feeling unwelcome at your practice.

“No child is a hot potato,” he said. Because they may feel like they’re being bounced around among different providers, programs, emergency departments, facilities, and such, it’s important to convey strongly that you want to continue to care for them.

“Whether we’ve been part of that or not, we become part of that,” Dr. Gonzalez said. “They may think that you don’t want to see them again. You want to keep them, and you might have to continue giving repeated messages. Sometimes we need to be very overt and repeat ourselves and say no, ‘I really, really, really want you to come back. This is your home and I want you to come back.’ ”

Dr. Gonzalez and Dr. Khan have no disclosures.

Multiple mouthwash and oral rinse products wiped out a human coronavirus closely related to the SARS-CoV-2 virus in a laboratory comparison study.

Listerine Antiseptic led the list of most effective mouthwashes for inactivating the coronavirus. Interestingly, a 1% nasal rinse solution of Johnson’s Baby Shampoo also worked, eliminating up to 99.9% of the viral load in the in vitro experiments.

In contrast, use of a neti pot nasal solution yielded no decrease in virus levels.

The study was published in the Journal of Medical Virology.

Because the mouthwash and hydrogen peroxide oral rinses in the study are widely available and easy to use, “I would recommend the use of the rinses on top of wearing mask and social distancing. This could add a layer of protection for yourself and others,” lead study author Craig Meyers, PhD, professor of microbiology and immunology and obstetrics and gynecology, Penn State College of Medicine in Hershey, Pennsylvania, told Medscape Medical News.

Meyers and colleagues found that efficacy aligned with duration of time the cell cultures were exposed to each mouthwash or rinse product. Although it varied, the products required at least 30 seconds to kill most of the virus. Waiting 1 or 2 minutes tended to fortify results.

“This study adds to and further confirms the recently published evidence from virologists in Germany that mouthwashes can inactivate the virus that causes COVID-19 in a test tube,” Valerie O’Donnell, PhD, co-director of the Systems Immunity Research Institute of Cardiff University, Cardiff, Wales, said when asked to comment on the study.

“While this is great to see, what is still lacking is in vivo evidence, since we know the virus will be continually shed in the mouth,” O’Donnell said. “So, the question now becomes, by how much could mouthwashes reduce viral load in the oropharynx of infected people, and if so, then for how long?”

Meyers noted that studies of people positive for COVID-19 using each product would be informative. It remains unknown, for example, if swishing, gargling, and/or spitting out mouthwash would add or decrease the efficacy demonstrated in the lab.

The investigators used the human coronavirus HCoV‐229e as a surrogate for SARS-CoV-2. They noted HCoV-229e is analogous, and SARS-CoV-2 would have been more expensive, less available, and would have required biosafety level 3 laboratory conditions.
 

Listerine Antiseptic leads the way

“Surprisingly, we found that several of these common products had strong virucidal properties, inactivating from 2 log10 [or 99%] to greater than 4 log10 [or 99.99%] of infectious human coronavirus,” the researchers note.

Timing of the essence?

Meyers and colleagues also tested a nasal rinse solution of 1% baby shampoo because it is sometimes used to treat people with chronic rhinosinusitis. They found 30 seconds led to < 90% to < 99.99% effectiveness, but that, by 2 minutes, efficacy climbed to > 99.9% to > 99.99%.

“Thirty seconds for some products just was not enough time for the efficacy to be observed,” Meyers said. “Whereas, after a minute or two the active ingredient had enough time to work. Thirty seconds may be at the border to see full efficacy.” More research is needed to confirm the timing and determine which active ingredients are driving the findings.

A future trial could test the efficacy of mouthwash products to reduce the viral load in people with COVID-19. “If we are able to get funding to continue, I would like to see a small clinical trial as the next step,” Meyers said.

Meyers and O’Donnell disclosed no relevant financial relationships.

This article first appeared on Medscape.com.

Multiple mouthwash and oral rinse products wiped out a human coronavirus closely related to the SARS-CoV-2 virus in a laboratory comparison study.

Listerine Antiseptic led the list of most effective mouthwashes for inactivating the coronavirus. Interestingly, a 1% nasal rinse solution of Johnson’s Baby Shampoo also worked, eliminating up to 99.9% of the viral load in the in vitro experiments.

In contrast, use of a neti pot nasal solution yielded no decrease in virus levels.

The study was published in the Journal of Medical Virology.

Because the mouthwash and hydrogen peroxide oral rinses in the study are widely available and easy to use, “I would recommend the use of the rinses on top of wearing mask and social distancing. This could add a layer of protection for yourself and others,” lead study author Craig Meyers, PhD, professor of microbiology and immunology and obstetrics and gynecology, Penn State College of Medicine in Hershey, Pennsylvania, told Medscape Medical News.

Meyers and colleagues found that efficacy aligned with duration of time the cell cultures were exposed to each mouthwash or rinse product. Although it varied, the products required at least 30 seconds to kill most of the virus. Waiting 1 or 2 minutes tended to fortify results.

“This study adds to and further confirms the recently published evidence from virologists in Germany that mouthwashes can inactivate the virus that causes COVID-19 in a test tube,” Valerie O’Donnell, PhD, co-director of the Systems Immunity Research Institute of Cardiff University, Cardiff, Wales, said when asked to comment on the study.

“While this is great to see, what is still lacking is in vivo evidence, since we know the virus will be continually shed in the mouth,” O’Donnell said. “So, the question now becomes, by how much could mouthwashes reduce viral load in the oropharynx of infected people, and if so, then for how long?”

Meyers noted that studies of people positive for COVID-19 using each product would be informative. It remains unknown, for example, if swishing, gargling, and/or spitting out mouthwash would add or decrease the efficacy demonstrated in the lab.

The investigators used the human coronavirus HCoV‐229e as a surrogate for SARS-CoV-2. They noted HCoV-229e is analogous, and SARS-CoV-2 would have been more expensive, less available, and would have required biosafety level 3 laboratory conditions.
 

Listerine Antiseptic leads the way

“Surprisingly, we found that several of these common products had strong virucidal properties, inactivating from 2 log10 [or 99%] to greater than 4 log10 [or 99.99%] of infectious human coronavirus,” the researchers note.

Timing of the essence?

Meyers and colleagues also tested a nasal rinse solution of 1% baby shampoo because it is sometimes used to treat people with chronic rhinosinusitis. They found 30 seconds led to < 90% to < 99.99% effectiveness, but that, by 2 minutes, efficacy climbed to > 99.9% to > 99.99%.

“Thirty seconds for some products just was not enough time for the efficacy to be observed,” Meyers said. “Whereas, after a minute or two the active ingredient had enough time to work. Thirty seconds may be at the border to see full efficacy.” More research is needed to confirm the timing and determine which active ingredients are driving the findings.

A future trial could test the efficacy of mouthwash products to reduce the viral load in people with COVID-19. “If we are able to get funding to continue, I would like to see a small clinical trial as the next step,” Meyers said.

Meyers and O’Donnell disclosed no relevant financial relationships.

This article first appeared on Medscape.com.

Multiple mouthwash and oral rinse products wiped out a human coronavirus closely related to the SARS-CoV-2 virus in a laboratory comparison study.

Listerine Antiseptic led the list of most effective mouthwashes for inactivating the coronavirus. Interestingly, a 1% nasal rinse solution of Johnson’s Baby Shampoo also worked, eliminating up to 99.9% of the viral load in the in vitro experiments.

In contrast, use of a neti pot nasal solution yielded no decrease in virus levels.

The study was published in the Journal of Medical Virology.

Because the mouthwash and hydrogen peroxide oral rinses in the study are widely available and easy to use, “I would recommend the use of the rinses on top of wearing mask and social distancing. This could add a layer of protection for yourself and others,” lead study author Craig Meyers, PhD, professor of microbiology and immunology and obstetrics and gynecology, Penn State College of Medicine in Hershey, Pennsylvania, told Medscape Medical News.

Meyers and colleagues found that efficacy aligned with duration of time the cell cultures were exposed to each mouthwash or rinse product. Although it varied, the products required at least 30 seconds to kill most of the virus. Waiting 1 or 2 minutes tended to fortify results.

“This study adds to and further confirms the recently published evidence from virologists in Germany that mouthwashes can inactivate the virus that causes COVID-19 in a test tube,” Valerie O’Donnell, PhD, co-director of the Systems Immunity Research Institute of Cardiff University, Cardiff, Wales, said when asked to comment on the study.

“While this is great to see, what is still lacking is in vivo evidence, since we know the virus will be continually shed in the mouth,” O’Donnell said. “So, the question now becomes, by how much could mouthwashes reduce viral load in the oropharynx of infected people, and if so, then for how long?”

Meyers noted that studies of people positive for COVID-19 using each product would be informative. It remains unknown, for example, if swishing, gargling, and/or spitting out mouthwash would add or decrease the efficacy demonstrated in the lab.

The investigators used the human coronavirus HCoV‐229e as a surrogate for SARS-CoV-2. They noted HCoV-229e is analogous, and SARS-CoV-2 would have been more expensive, less available, and would have required biosafety level 3 laboratory conditions.
 

Listerine Antiseptic leads the way

“Surprisingly, we found that several of these common products had strong virucidal properties, inactivating from 2 log10 [or 99%] to greater than 4 log10 [or 99.99%] of infectious human coronavirus,” the researchers note.

Timing of the essence?

Meyers and colleagues also tested a nasal rinse solution of 1% baby shampoo because it is sometimes used to treat people with chronic rhinosinusitis. They found 30 seconds led to < 90% to < 99.99% effectiveness, but that, by 2 minutes, efficacy climbed to > 99.9% to > 99.99%.

“Thirty seconds for some products just was not enough time for the efficacy to be observed,” Meyers said. “Whereas, after a minute or two the active ingredient had enough time to work. Thirty seconds may be at the border to see full efficacy.” More research is needed to confirm the timing and determine which active ingredients are driving the findings.

A future trial could test the efficacy of mouthwash products to reduce the viral load in people with COVID-19. “If we are able to get funding to continue, I would like to see a small clinical trial as the next step,” Meyers said.

Meyers and O’Donnell disclosed no relevant financial relationships.

This article first appeared on Medscape.com.

Although medical education is constantly evolving, unique and rapid developments in recent years have sparked controversy. The next generation of physicians is learning much differently from how established doctors once did. Training has shifted from an acute focus on disease to a wider approach that considers patients within the larger context of their community and society. Although many, like myself, see this as progress, others have expressed doubts about this and many other changes.

Amid the madness that is the year 2020, I’m grateful to have a moment to reflect on this subject. Five years ago, in celebration of Medscape’s 20th anniversary, I spoke with various leaders in medical education to learn how med ed had evolved since they were in school. Since then, I’ve gone from student to faculty. This year, for Medscape’s 25th anniversary, I reached out to current medical trainees to reflect on how much things have changed in such a short time.

From adjustments forced on us by COVID-19 to trends that predated the pandemic – including an increased emphasis on social justice and a decreased emphasis on other material – becoming a doctor no longer looks like it did just a half-decade ago.
 

Social justice is now in the curricula

More than ever, medical training has shifted toward humanism, population health, and social justice. Students are now being shown not only how to treat the patient in front of them but how to “treat” the larger communities they serve. Research skills around social drivers of health, such as structural racism, are increasingly becoming status quo.

In reflecting on her current experience, Emily Kahoud, a third-year medical student at New Jersey Medical School, Newark, told me about a course she took that was devoted to health equity. She applauded how her professors have incorporated this education into their courses. “It’s so nice and refreshing to be in a community that appreciates that.”

I, too, have seen this change firsthand. In addition to caring for patients and teaching at the University of North Carolina at Chapel Hill, I work with a team that develops curricula around social justice. We strive to integrate this material into existing courses and rotations. I believe that this is not only the right thing to teach trainees in order to help their future patients, but that it also reduces harm that many students experience. The “hidden curriculum” of medical school has long marginalized anyone who isn’t White and/or male.

Children, women, and the elderly were often referred to as “special populations” during my training. Even now, content about social and structural drivers of health is still most often relegated to separate courses rather than integrated into existing material. I hope to help improve this at my institution and that others are doing the same elsewhere.

If the current students I spoke with are any indication, further integration will be a welcomed change. Travis Benson, a third-year medical student at Harvard Medical School, Boston, appreciates where medical training is headed. Specifically, he is interested in inequities in the care of transgender patients. He says he has loved what his school has done with education on issues not previously considered part of med ed. “In the first week of school, we go on tours and spend time in community health centers and learn about the ‘Family Van,’ a mobile health care clinic that offers free care. I even had an opportunity to have a longitudinal clinic experience at a jail.”

While some critics argue that this learning goes too far, others argue that it has not gone far enough fast enough. In general, I consider the progress made in this area since my time in med school to be a very good thing. Medical students are now being taught to think about the science of medicine in the context of the larger human condition.
 

More technology, less preclinical time and cost

Beyond evolution in curricular content, technical and logistical changes have dramatically reshaped med ed. Since I started my training in 2012, most medical schools now no longer formally require students to attend lectures. Instead, they make them available online for students to view on demand. This undoubtedly makes schedules more flexible, allows students to learn at their own pace, and helps accommodate students with different needs.

Another big change: Preclinical years may now be as short as 1.5 years or less. This is a big draw for some students. Most choose to go to medical school to take care of patients. Shortening the preclinical years means students have more time immersed in patient care and less time dealing with medical minutiae.

That also means that they can spend more time thinking about professional development. Ramie Fathy, a fourth-year student, told me, “I came to Penn [University of Pennsylvania in Philadelphia] because of the shortened preclinical curriculum. That allowed more time on the back end to explore different specialties.” Although some established doctors worry about what scientific details may be left out, providing more hands-on experience sure seems like a good thing to me. Learning from textbooks can only take you so far in this profession.

Another, and more expected, development is the use of ever-advancing technology. Some schools now offer 3D virtual modeling for the study of anatomy, as well as a myriad of electronic visual aids for subjects like pathology and microbiology. Adapting to technological changes can be challenging, however, especially because more nontraditional students are being admitted to medical school each year.

Kahoud is one such nontraditional – older – student. She had some concerns about reliance on newer resources going in. “It [medical school] has become increasingly dependent on technology, even before COVID,” she said. “When you are not well versed in these tools it can definitely be a struggle.”

Thanks to the pandemic, remote learning is now the name of the game for many. As a result, instructors have had to amend their teaching styles to suit distance education, various untested applications and programs have been integrated into the curriculum, and students and administrators alike have had to find alternative ways to build a sense of community.

Is this a glimpse at the future for med ed? And if so, what may be lost or gained from this transition? Tino Delamerced, a third-year student at the Brown University, Providence, R.I., shared a likely very widely held hope: “If the preclinical years can be totally remote permanently, then can tuition be cheaper?”

Med ed debt keeps growing and remains a huge deterrent for potential students, especially those who are the first in their family to pursue medicine, come from a disadvantaged background, or have other people for whom they are financially responsible. Is it possible that the restrictions of COVID-19 could finally lead to cost cutting?

A bigger solution – free medical school – predated the pandemic. Institutions such as New York University have completely eliminated tuition, whereas others such as the Icahn School of Medicine at Mount Sinai (my alma mater) have limited the amount of debt with which a student graduates. You can imagine my frustration that the debt limit policy was enacted after I graduated.

Still, as optimistic as some have been at this movement that developed in the past 5 years, many think this specific evolution is little more than a “pipe dream.”
 

Current students score big with USMLE change

Beyond med school cost, another universally despised part of medical training that has seen a dramatic change is the licensing examination. My dedicated study period for the United States Medical Licensing Examination (USMLE) Step 1 was my worst time of medical school. Well, it was second to holding a retractor in the operating room for hours at a time.

Like everyone, I suspected that Step 1 would not be an accurate indicator of my ability to actually care for patients. As a practicing physician, I can now tell you for sure that this is the case. How lucky for the next generation, then, that the test is going to a pass/fail grading system.

Step 1 has always been important, as residency programs rely on the score to weed out applicants. Even if that screening emphasis simply gets shifted to scores on other examinations, this change still feels like progress. As Fathy told me, “There will likely be more emphasis on USMLE Step 2. But I think, based on practice questions I’ve done, that is more relevant to clinical abilities.” From my new vantage point, I can confirm that.

Not everyone is excited, though. Delamerced told me that he fears that the pass/fail Step 1 score may disparately affect students outside of allopathic medical schools. He said that the new scoring system “does not allow students to distinguish themselves via a standardized test score. That may hurt IMGs or DO students.”

Even then, Delamerced conceded that the change has some clear benefits. “For med students’ mental health, it’s probably a good thing.” From a population-based perspective, a medical student’s mental health often declines throughout school. Standardized exams are not the only cause, but we all know that it is a big contributor. The Step 1 switch can only help with that.
 

Finish faster or learn more?

In addition to evolution in the content and methods used to teach and assess current med students, the duration of med ed has also changed. Today’s students can choose to complete medical school in less than 4 years.

At the school where I work, the Fully Integrated Readiness for Service Training (FIRST) program allows certain students to complete their education in just 3 years. This program is for students who already know early on that they want to pursue a specialty included on our curated list. The goal of the program is to ultimately train physicians in family medicine, psychiatry, pediatrics, or general surgery in order to provide crucial care to those who need it most in our state.

Other medical schools offer accelerated MD programs for students based on various admissions criteria and specialty interest. The benefit of these programs is that shortening training time cuts down on debt for students.

Accelerated MD programs also aim to quickly increase the number of practicing physicians. This is especially important for primary care, which expects to see a growing gap in the years to come. That aim has come under some criticism, as some believe that the 4-year program was the standard for a reason. But when I reflect on it, I often wonder whether my fourth year was really worth $60,000. I spent a lot of that year traveling for residency interviews and watching Netflix between clinic electives.

Instead of finishing medical school faster, some students now have an opportunity to integrate additional training and education. Benson told me that, at Harvard, many students take a year off to pursue other opportunities. He said, “About 40% of students end up taking a fifth year to do either a master’s degree, global health, or research.” Benson said the additional learning opportunities are broad. “Some classmates even go to other schools altogether to get additional education.” Widened areas of learning are likely to produce better doctors, in my opinion.

This chance to look back on medical education has shown me that the ways in which it has changed rapidly in just the past few years are largely positive. Although COVID-19 has been an unwanted bane, it has also forced schools to integrate new technology and has placed an even brighter spotlight on health inequities and other areas in which education further improved. I hope that, when I look back on med ed in another 5 years, it has grown even more flexible and nimble in meeting the ever-changing needs of students and patients alike.

Alexa Mieses Malchuk, MD, MPH, was born and raised in Queens, New York. Social justice is what drew her to family medicine. As an academic physician at the University of North Carolina, she practices inpatient and outpatient medicine and serves as a medical educator for students and residents.
 

This article first appeared on Medscape.com.

Although medical education is constantly evolving, unique and rapid developments in recent years have sparked controversy. The next generation of physicians is learning much differently from how established doctors once did. Training has shifted from an acute focus on disease to a wider approach that considers patients within the larger context of their community and society. Although many, like myself, see this as progress, others have expressed doubts about this and many other changes.

Amid the madness that is the year 2020, I’m grateful to have a moment to reflect on this subject. Five years ago, in celebration of Medscape’s 20th anniversary, I spoke with various leaders in medical education to learn how med ed had evolved since they were in school. Since then, I’ve gone from student to faculty. This year, for Medscape’s 25th anniversary, I reached out to current medical trainees to reflect on how much things have changed in such a short time.

From adjustments forced on us by COVID-19 to trends that predated the pandemic – including an increased emphasis on social justice and a decreased emphasis on other material – becoming a doctor no longer looks like it did just a half-decade ago.
 

Social justice is now in the curricula

More than ever, medical training has shifted toward humanism, population health, and social justice. Students are now being shown not only how to treat the patient in front of them but how to “treat” the larger communities they serve. Research skills around social drivers of health, such as structural racism, are increasingly becoming status quo.

In reflecting on her current experience, Emily Kahoud, a third-year medical student at New Jersey Medical School, Newark, told me about a course she took that was devoted to health equity. She applauded how her professors have incorporated this education into their courses. “It’s so nice and refreshing to be in a community that appreciates that.”

I, too, have seen this change firsthand. In addition to caring for patients and teaching at the University of North Carolina at Chapel Hill, I work with a team that develops curricula around social justice. We strive to integrate this material into existing courses and rotations. I believe that this is not only the right thing to teach trainees in order to help their future patients, but that it also reduces harm that many students experience. The “hidden curriculum” of medical school has long marginalized anyone who isn’t White and/or male.

Children, women, and the elderly were often referred to as “special populations” during my training. Even now, content about social and structural drivers of health is still most often relegated to separate courses rather than integrated into existing material. I hope to help improve this at my institution and that others are doing the same elsewhere.

If the current students I spoke with are any indication, further integration will be a welcomed change. Travis Benson, a third-year medical student at Harvard Medical School, Boston, appreciates where medical training is headed. Specifically, he is interested in inequities in the care of transgender patients. He says he has loved what his school has done with education on issues not previously considered part of med ed. “In the first week of school, we go on tours and spend time in community health centers and learn about the ‘Family Van,’ a mobile health care clinic that offers free care. I even had an opportunity to have a longitudinal clinic experience at a jail.”

While some critics argue that this learning goes too far, others argue that it has not gone far enough fast enough. In general, I consider the progress made in this area since my time in med school to be a very good thing. Medical students are now being taught to think about the science of medicine in the context of the larger human condition.
 

More technology, less preclinical time and cost

Beyond evolution in curricular content, technical and logistical changes have dramatically reshaped med ed. Since I started my training in 2012, most medical schools now no longer formally require students to attend lectures. Instead, they make them available online for students to view on demand. This undoubtedly makes schedules more flexible, allows students to learn at their own pace, and helps accommodate students with different needs.

Another big change: Preclinical years may now be as short as 1.5 years or less. This is a big draw for some students. Most choose to go to medical school to take care of patients. Shortening the preclinical years means students have more time immersed in patient care and less time dealing with medical minutiae.

That also means that they can spend more time thinking about professional development. Ramie Fathy, a fourth-year student, told me, “I came to Penn [University of Pennsylvania in Philadelphia] because of the shortened preclinical curriculum. That allowed more time on the back end to explore different specialties.” Although some established doctors worry about what scientific details may be left out, providing more hands-on experience sure seems like a good thing to me. Learning from textbooks can only take you so far in this profession.

Another, and more expected, development is the use of ever-advancing technology. Some schools now offer 3D virtual modeling for the study of anatomy, as well as a myriad of electronic visual aids for subjects like pathology and microbiology. Adapting to technological changes can be challenging, however, especially because more nontraditional students are being admitted to medical school each year.

Kahoud is one such nontraditional – older – student. She had some concerns about reliance on newer resources going in. “It [medical school] has become increasingly dependent on technology, even before COVID,” she said. “When you are not well versed in these tools it can definitely be a struggle.”

Thanks to the pandemic, remote learning is now the name of the game for many. As a result, instructors have had to amend their teaching styles to suit distance education, various untested applications and programs have been integrated into the curriculum, and students and administrators alike have had to find alternative ways to build a sense of community.

Is this a glimpse at the future for med ed? And if so, what may be lost or gained from this transition? Tino Delamerced, a third-year student at the Brown University, Providence, R.I., shared a likely very widely held hope: “If the preclinical years can be totally remote permanently, then can tuition be cheaper?”

Med ed debt keeps growing and remains a huge deterrent for potential students, especially those who are the first in their family to pursue medicine, come from a disadvantaged background, or have other people for whom they are financially responsible. Is it possible that the restrictions of COVID-19 could finally lead to cost cutting?

A bigger solution – free medical school – predated the pandemic. Institutions such as New York University have completely eliminated tuition, whereas others such as the Icahn School of Medicine at Mount Sinai (my alma mater) have limited the amount of debt with which a student graduates. You can imagine my frustration that the debt limit policy was enacted after I graduated.

Still, as optimistic as some have been at this movement that developed in the past 5 years, many think this specific evolution is little more than a “pipe dream.”
 

Current students score big with USMLE change

Beyond med school cost, another universally despised part of medical training that has seen a dramatic change is the licensing examination. My dedicated study period for the United States Medical Licensing Examination (USMLE) Step 1 was my worst time of medical school. Well, it was second to holding a retractor in the operating room for hours at a time.

Like everyone, I suspected that Step 1 would not be an accurate indicator of my ability to actually care for patients. As a practicing physician, I can now tell you for sure that this is the case. How lucky for the next generation, then, that the test is going to a pass/fail grading system.

Step 1 has always been important, as residency programs rely on the score to weed out applicants. Even if that screening emphasis simply gets shifted to scores on other examinations, this change still feels like progress. As Fathy told me, “There will likely be more emphasis on USMLE Step 2. But I think, based on practice questions I’ve done, that is more relevant to clinical abilities.” From my new vantage point, I can confirm that.

Not everyone is excited, though. Delamerced told me that he fears that the pass/fail Step 1 score may disparately affect students outside of allopathic medical schools. He said that the new scoring system “does not allow students to distinguish themselves via a standardized test score. That may hurt IMGs or DO students.”

Even then, Delamerced conceded that the change has some clear benefits. “For med students’ mental health, it’s probably a good thing.” From a population-based perspective, a medical student’s mental health often declines throughout school. Standardized exams are not the only cause, but we all know that it is a big contributor. The Step 1 switch can only help with that.
 

Finish faster or learn more?

In addition to evolution in the content and methods used to teach and assess current med students, the duration of med ed has also changed. Today’s students can choose to complete medical school in less than 4 years.

At the school where I work, the Fully Integrated Readiness for Service Training (FIRST) program allows certain students to complete their education in just 3 years. This program is for students who already know early on that they want to pursue a specialty included on our curated list. The goal of the program is to ultimately train physicians in family medicine, psychiatry, pediatrics, or general surgery in order to provide crucial care to those who need it most in our state.

Other medical schools offer accelerated MD programs for students based on various admissions criteria and specialty interest. The benefit of these programs is that shortening training time cuts down on debt for students.

Accelerated MD programs also aim to quickly increase the number of practicing physicians. This is especially important for primary care, which expects to see a growing gap in the years to come. That aim has come under some criticism, as some believe that the 4-year program was the standard for a reason. But when I reflect on it, I often wonder whether my fourth year was really worth $60,000. I spent a lot of that year traveling for residency interviews and watching Netflix between clinic electives.

Instead of finishing medical school faster, some students now have an opportunity to integrate additional training and education. Benson told me that, at Harvard, many students take a year off to pursue other opportunities. He said, “About 40% of students end up taking a fifth year to do either a master’s degree, global health, or research.” Benson said the additional learning opportunities are broad. “Some classmates even go to other schools altogether to get additional education.” Widened areas of learning are likely to produce better doctors, in my opinion.

This chance to look back on medical education has shown me that the ways in which it has changed rapidly in just the past few years are largely positive. Although COVID-19 has been an unwanted bane, it has also forced schools to integrate new technology and has placed an even brighter spotlight on health inequities and other areas in which education further improved. I hope that, when I look back on med ed in another 5 years, it has grown even more flexible and nimble in meeting the ever-changing needs of students and patients alike.

Alexa Mieses Malchuk, MD, MPH, was born and raised in Queens, New York. Social justice is what drew her to family medicine. As an academic physician at the University of North Carolina, she practices inpatient and outpatient medicine and serves as a medical educator for students and residents.
 

This article first appeared on Medscape.com.

Although medical education is constantly evolving, unique and rapid developments in recent years have sparked controversy. The next generation of physicians is learning much differently from how established doctors once did. Training has shifted from an acute focus on disease to a wider approach that considers patients within the larger context of their community and society. Although many, like myself, see this as progress, others have expressed doubts about this and many other changes.

Amid the madness that is the year 2020, I’m grateful to have a moment to reflect on this subject. Five years ago, in celebration of Medscape’s 20th anniversary, I spoke with various leaders in medical education to learn how med ed had evolved since they were in school. Since then, I’ve gone from student to faculty. This year, for Medscape’s 25th anniversary, I reached out to current medical trainees to reflect on how much things have changed in such a short time.

From adjustments forced on us by COVID-19 to trends that predated the pandemic – including an increased emphasis on social justice and a decreased emphasis on other material – becoming a doctor no longer looks like it did just a half-decade ago.
 

Social justice is now in the curricula

More than ever, medical training has shifted toward humanism, population health, and social justice. Students are now being shown not only how to treat the patient in front of them but how to “treat” the larger communities they serve. Research skills around social drivers of health, such as structural racism, are increasingly becoming status quo.

In reflecting on her current experience, Emily Kahoud, a third-year medical student at New Jersey Medical School, Newark, told me about a course she took that was devoted to health equity. She applauded how her professors have incorporated this education into their courses. “It’s so nice and refreshing to be in a community that appreciates that.”

I, too, have seen this change firsthand. In addition to caring for patients and teaching at the University of North Carolina at Chapel Hill, I work with a team that develops curricula around social justice. We strive to integrate this material into existing courses and rotations. I believe that this is not only the right thing to teach trainees in order to help their future patients, but that it also reduces harm that many students experience. The “hidden curriculum” of medical school has long marginalized anyone who isn’t White and/or male.

Children, women, and the elderly were often referred to as “special populations” during my training. Even now, content about social and structural drivers of health is still most often relegated to separate courses rather than integrated into existing material. I hope to help improve this at my institution and that others are doing the same elsewhere.

If the current students I spoke with are any indication, further integration will be a welcomed change. Travis Benson, a third-year medical student at Harvard Medical School, Boston, appreciates where medical training is headed. Specifically, he is interested in inequities in the care of transgender patients. He says he has loved what his school has done with education on issues not previously considered part of med ed. “In the first week of school, we go on tours and spend time in community health centers and learn about the ‘Family Van,’ a mobile health care clinic that offers free care. I even had an opportunity to have a longitudinal clinic experience at a jail.”

While some critics argue that this learning goes too far, others argue that it has not gone far enough fast enough. In general, I consider the progress made in this area since my time in med school to be a very good thing. Medical students are now being taught to think about the science of medicine in the context of the larger human condition.
 

More technology, less preclinical time and cost

Beyond evolution in curricular content, technical and logistical changes have dramatically reshaped med ed. Since I started my training in 2012, most medical schools now no longer formally require students to attend lectures. Instead, they make them available online for students to view on demand. This undoubtedly makes schedules more flexible, allows students to learn at their own pace, and helps accommodate students with different needs.

Another big change: Preclinical years may now be as short as 1.5 years or less. This is a big draw for some students. Most choose to go to medical school to take care of patients. Shortening the preclinical years means students have more time immersed in patient care and less time dealing with medical minutiae.

That also means that they can spend more time thinking about professional development. Ramie Fathy, a fourth-year student, told me, “I came to Penn [University of Pennsylvania in Philadelphia] because of the shortened preclinical curriculum. That allowed more time on the back end to explore different specialties.” Although some established doctors worry about what scientific details may be left out, providing more hands-on experience sure seems like a good thing to me. Learning from textbooks can only take you so far in this profession.

Another, and more expected, development is the use of ever-advancing technology. Some schools now offer 3D virtual modeling for the study of anatomy, as well as a myriad of electronic visual aids for subjects like pathology and microbiology. Adapting to technological changes can be challenging, however, especially because more nontraditional students are being admitted to medical school each year.

Kahoud is one such nontraditional – older – student. She had some concerns about reliance on newer resources going in. “It [medical school] has become increasingly dependent on technology, even before COVID,” she said. “When you are not well versed in these tools it can definitely be a struggle.”

Thanks to the pandemic, remote learning is now the name of the game for many. As a result, instructors have had to amend their teaching styles to suit distance education, various untested applications and programs have been integrated into the curriculum, and students and administrators alike have had to find alternative ways to build a sense of community.

Is this a glimpse at the future for med ed? And if so, what may be lost or gained from this transition? Tino Delamerced, a third-year student at the Brown University, Providence, R.I., shared a likely very widely held hope: “If the preclinical years can be totally remote permanently, then can tuition be cheaper?”

Med ed debt keeps growing and remains a huge deterrent for potential students, especially those who are the first in their family to pursue medicine, come from a disadvantaged background, or have other people for whom they are financially responsible. Is it possible that the restrictions of COVID-19 could finally lead to cost cutting?

A bigger solution – free medical school – predated the pandemic. Institutions such as New York University have completely eliminated tuition, whereas others such as the Icahn School of Medicine at Mount Sinai (my alma mater) have limited the amount of debt with which a student graduates. You can imagine my frustration that the debt limit policy was enacted after I graduated.

Still, as optimistic as some have been at this movement that developed in the past 5 years, many think this specific evolution is little more than a “pipe dream.”
 

Current students score big with USMLE change

Beyond med school cost, another universally despised part of medical training that has seen a dramatic change is the licensing examination. My dedicated study period for the United States Medical Licensing Examination (USMLE) Step 1 was my worst time of medical school. Well, it was second to holding a retractor in the operating room for hours at a time.

Like everyone, I suspected that Step 1 would not be an accurate indicator of my ability to actually care for patients. As a practicing physician, I can now tell you for sure that this is the case. How lucky for the next generation, then, that the test is going to a pass/fail grading system.

Step 1 has always been important, as residency programs rely on the score to weed out applicants. Even if that screening emphasis simply gets shifted to scores on other examinations, this change still feels like progress. As Fathy told me, “There will likely be more emphasis on USMLE Step 2. But I think, based on practice questions I’ve done, that is more relevant to clinical abilities.” From my new vantage point, I can confirm that.

Not everyone is excited, though. Delamerced told me that he fears that the pass/fail Step 1 score may disparately affect students outside of allopathic medical schools. He said that the new scoring system “does not allow students to distinguish themselves via a standardized test score. That may hurt IMGs or DO students.”

Even then, Delamerced conceded that the change has some clear benefits. “For med students’ mental health, it’s probably a good thing.” From a population-based perspective, a medical student’s mental health often declines throughout school. Standardized exams are not the only cause, but we all know that it is a big contributor. The Step 1 switch can only help with that.
 

Finish faster or learn more?

In addition to evolution in the content and methods used to teach and assess current med students, the duration of med ed has also changed. Today’s students can choose to complete medical school in less than 4 years.

At the school where I work, the Fully Integrated Readiness for Service Training (FIRST) program allows certain students to complete their education in just 3 years. This program is for students who already know early on that they want to pursue a specialty included on our curated list. The goal of the program is to ultimately train physicians in family medicine, psychiatry, pediatrics, or general surgery in order to provide crucial care to those who need it most in our state.

Other medical schools offer accelerated MD programs for students based on various admissions criteria and specialty interest. The benefit of these programs is that shortening training time cuts down on debt for students.

Accelerated MD programs also aim to quickly increase the number of practicing physicians. This is especially important for primary care, which expects to see a growing gap in the years to come. That aim has come under some criticism, as some believe that the 4-year program was the standard for a reason. But when I reflect on it, I often wonder whether my fourth year was really worth $60,000. I spent a lot of that year traveling for residency interviews and watching Netflix between clinic electives.

Instead of finishing medical school faster, some students now have an opportunity to integrate additional training and education. Benson told me that, at Harvard, many students take a year off to pursue other opportunities. He said, “About 40% of students end up taking a fifth year to do either a master’s degree, global health, or research.” Benson said the additional learning opportunities are broad. “Some classmates even go to other schools altogether to get additional education.” Widened areas of learning are likely to produce better doctors, in my opinion.

This chance to look back on medical education has shown me that the ways in which it has changed rapidly in just the past few years are largely positive. Although COVID-19 has been an unwanted bane, it has also forced schools to integrate new technology and has placed an even brighter spotlight on health inequities and other areas in which education further improved. I hope that, when I look back on med ed in another 5 years, it has grown even more flexible and nimble in meeting the ever-changing needs of students and patients alike.

Alexa Mieses Malchuk, MD, MPH, was born and raised in Queens, New York. Social justice is what drew her to family medicine. As an academic physician at the University of North Carolina, she practices inpatient and outpatient medicine and serves as a medical educator for students and residents.
 

This article first appeared on Medscape.com.

Starting Nov. 2, all patients in the United States will have immediate access to clinical notes and thus will be able to read their doctors’ writings, as well as test results and reports from pathology and imaging.

FG Trade/iStock/Getty Images Plus

The 21st Century Cures Act mandates that patients have fast, electronic access to the following types of notes: consultations, discharge summaries, history, physical examination findings, imaging narratives, laboratory and pathology report narratives, and procedure and progress notes.

But this federal mandate, called “open notes” by many, is potentially confusing and frightening for patients, say some physicians. Others worry that the change will increase workload as clinicians tailor notes for patients and answer related questions.

The law means that inpatient and outpatient notes will be released immediately and that patients will have immediate access to testing and imaging results, including results from sexually transmitted disease tests, Pap tests, cancer biopsies, CT and PET scans, fetal ultrasounds, pneumonia cultures, and mammograms.

Such notes could contain sensitive information, and there is concern that patients could be shocked, confused, or annoyed by what they read, even with more run-of-the-mill notes.

Champions of open notes say that the benefits, including better provider-patient communication, greatly outweigh such risks.

“This is about convenience – a bit like online banking,” commented Charlotte Blease, PhD, resident scholar at OpenNotes, an advocacy nonprofit organization headquartered at the Beth Israel–Deaconess Medical Center in Boston. “But it’s a culture shift for doctors,” she said in an interview.

“It turns physician paternalism on its head,” said C. T. Lin, MD, chief medical information officer, UCHealth, Denver. The change requires “some letting go of old traditions” in medicine, he wrote in an August blog post, referring to the fact that a computer screen – and not a physician – may tell patients about a new health problem.

Dr. Lin summarized the experience at the University of Colorado Cancer Center, which has allowed patients to have access to oncology notes for the past 5 years: “No issues and highly appreciated by patients. We have nothing to fear but fear itself.”
 

A new audience

Other institutions have also been voluntarily implementing open notes.

UC Davis Health in Sacramento, Calif., has run an optional program for the past year. However, only about two dozen of approximately 1,000 staff physicians opted in to the program.

“This illustrates the point that it’s a new thing that physicians aren’t used to doing. They’ve traditionally written notes for the benefit of their colleagues, for billing, for their own reference,” Scott MacDonald, MD, an internist and electronic health record medical director at UC Davis Health, told this news organization.

“They’ve never –until recently – had the patient as one of the audiences for a note,” he said.

Liam Keating, MD, an otolaryngologist in Martinez, Calif., recalls that he once wrote “globus hystericus,” and the patient wanted to sue him for saying that the patient was hysterical. “I now just code ‘Globus’ (if I don’t jump straight to LPD [lateral pharyngeal diverticulum]),” he commented in response to a commentary on open notes.

Sensitive information occurs more often in certain specialties, for example, psychiatry, genetics, adolescent medicine, and oncology, experts say.

“Cancer is an area that is highly charged for patients and doctors alike,” Dr. MacDonald pointed out. When reading pathology or imaging notes, patients may learn that they have been diagnosed with cancer or that they have a recurrence “without the physician being able to contextualize it and explain things – that’s just new and scary,” he said.

California law dictates that providers cannot post cancer test results without talking with the patient first, said Dr. MacDonald, but not all states have such laws.
 

Adjustments needed – or not – with open notes

At UCHealth in Aurora, Colo., Robert Breeze, MD, vice-chair of neurosurgery, said he has adjusted his practice to accommodate open notes and to anticipate trouble spots.*

“When I order imaging or send pathology specimens, I have already discussed with the patient the possibilities, including cancer, and what we will do next. Patients deeply appreciate these discussions, before they see the results,” he commented in an institutional white paper issued in anticipation of the changes on Nov. 2.

This is called precounseling, said Trent Rosenbloom, MD, MPH, director of patient portals at Vanderbilt University Medical Center, Nashville, Tenn., which has been a pioneer in information sharing with patients. Their system does delay the release of information in the case of “complicated” results, such as from cancer biopsies, he said in an interview.

However, Christiaan Hoff, MD, PhD, a surgeon at the Medical Center Leeuwarden (the Netherlands), wonders how important it is for the physician to be present when the patient receives bad news, including news about cancer. “We may overestimate our added value in these situations,” he suggested.

“Our empathy may not outweigh” the disadvantages of the situation, and the “finer points of our explanation will often go unnoticed” by the stressed patient, he commented. Dr. Hoff was also responding to the commentary about open notes.

In that commentary, Jack West, MD, a medical oncologist at City of Hope Cancer Center, Duarte, Calif., was concerned about misunderstandings. Oncology is complex, and patients can struggle to understand their prognosis and planned treatment efficacy, especially in cases of metastatic disease, he wrote.

This concern is somewhat refuted by a study published Oct. 5 in Cancer Cell. Responses to two surveys involving 96 oncology clinicians at three U.S. centers found that almost half (44%) believed that their patients “would be confused” by open notes.

However, only 4% of the 3,418 cancer patients from the same surveys reported being confused by open notes. (A majority of participants had more than a high school education, and English was their primary language.)

“Patient and clinician views about open notes in oncology are not aligned, with patients expressing considerably more enthusiasm,” wrote the authors, led by Liz Salmi, senior strategist at OpenNotes, who has been treated for brain cancer.

“All clinicians are anxious at first,” Ms. Salmi told this news organization. “Those patients who have more serious or chronic conditions … are more likely to read their notes.”

The survey results echo the early experience reported from Sweden, where open notes was launched in 2012. “Patients have loved it from the beginning,” said Maria Haggland, PhD, of Uppsala MedTech Science Innovation Center.

However, when the scheme first launched, it was considered to be “very controversial,” and “there were a lot of complaints, from health care professionals, especially,” she added.

Over time, clinicians have embraced open notes, and the program has 7.2 million patient accounts in a country of 10 million people, she observed during an Oct. 5 webinar on open notes.
 

More work for already overworked clinicians?

An outstanding concern about open notes is that it will cause more work for health care professionals.

Traditionally, doctors have written notes using medical lexicon, including a lot of abbreviations and jargon for efficiency’s sake. Now that patients will read the notes, will clinicians have to spell out things in lay terms, alter their writing so as not to offend, and generally do more work?

William Harvey, MD, chief medical information officer, Tufts Medical Center, Boston, acknowledged that that may be the case.

In a forthcoming note to staff about the Nov. 2 start of open notes, Dr. Harvey will include a reminder to accommodate the patient as a reader. But that may or may not mean an increase in work volume, depending on the provider. “Clinical note writing is highly personal. There’s an art to it,” he said in an interview. “So it’s hard to give standard advice.”

Steven Reidbord, MD, a psychiatrist in private practice in San Francisco and a lecturer at California Pacific Medical Center, is particularly concerned about the impact of open notes on progress notes, which he calls a tool to develop strategies and make observations while working with a patient.

By watering down the language for patients, “you are trading away the technical precision and other advantages of having a professional language,” he told this news organization.

“These notes serve many masters already,” he said, referring to purposes such as utilization review and billing. “The more masters they serve, the less useful they are to get medical work done.”

Dr. MacDonald, the medical information officer, said the new law doesn’t mandate a change in writing style.

In a study published last year, researchers analyzed notes written by oncologists before and after adoption of open notes. They found that, on average, clinicians did not change their note writing. The investigators analyzed more than 100,000 clinical notes written by 35 oncologists at a single center.

Advocates for open notes emphasize that there are benefits for clinicians.

“Doctors are overworked. They’re overburdened. But empowered patients can help the doctor,” said OpenNotes’ Dr. Blease. She cited survey data that show that patients better understand their treatment plan and medication, which can cut down on physician workload.

Open notes are “what you make of it,” said Marlene Millen, MD, an internist at UC San Diego Health, which has had a pilot program for 3 years. Each day, Dr. Millen discusses a shared note with two or three patients. “I actually end all of my appointments with, ‘Don’t forget to read your note later,’ ” she told this news organization.

“I was a little afraid of this initially,” she said, but within the first 3 months of the pilot, about 15 patients gave her direct feedback on how much they appreciated her notes. “It seemed to really reassure them that they were getting good care.”

The persons quoted in this article have disclosed no relevant financial relationships.
 

Correction, 10/23/20: An earlier version of this article misstated the campus' location. 

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

Starting Nov. 2, all patients in the United States will have immediate access to clinical notes and thus will be able to read their doctors’ writings, as well as test results and reports from pathology and imaging.

FG Trade/iStock/Getty Images Plus

The 21st Century Cures Act mandates that patients have fast, electronic access to the following types of notes: consultations, discharge summaries, history, physical examination findings, imaging narratives, laboratory and pathology report narratives, and procedure and progress notes.

But this federal mandate, called “open notes” by many, is potentially confusing and frightening for patients, say some physicians. Others worry that the change will increase workload as clinicians tailor notes for patients and answer related questions.

The law means that inpatient and outpatient notes will be released immediately and that patients will have immediate access to testing and imaging results, including results from sexually transmitted disease tests, Pap tests, cancer biopsies, CT and PET scans, fetal ultrasounds, pneumonia cultures, and mammograms.

Such notes could contain sensitive information, and there is concern that patients could be shocked, confused, or annoyed by what they read, even with more run-of-the-mill notes.

Champions of open notes say that the benefits, including better provider-patient communication, greatly outweigh such risks.

“This is about convenience – a bit like online banking,” commented Charlotte Blease, PhD, resident scholar at OpenNotes, an advocacy nonprofit organization headquartered at the Beth Israel–Deaconess Medical Center in Boston. “But it’s a culture shift for doctors,” she said in an interview.

“It turns physician paternalism on its head,” said C. T. Lin, MD, chief medical information officer, UCHealth, Denver. The change requires “some letting go of old traditions” in medicine, he wrote in an August blog post, referring to the fact that a computer screen – and not a physician – may tell patients about a new health problem.

Dr. Lin summarized the experience at the University of Colorado Cancer Center, which has allowed patients to have access to oncology notes for the past 5 years: “No issues and highly appreciated by patients. We have nothing to fear but fear itself.”
 

A new audience

Other institutions have also been voluntarily implementing open notes.

UC Davis Health in Sacramento, Calif., has run an optional program for the past year. However, only about two dozen of approximately 1,000 staff physicians opted in to the program.

“This illustrates the point that it’s a new thing that physicians aren’t used to doing. They’ve traditionally written notes for the benefit of their colleagues, for billing, for their own reference,” Scott MacDonald, MD, an internist and electronic health record medical director at UC Davis Health, told this news organization.

“They’ve never –until recently – had the patient as one of the audiences for a note,” he said.

Liam Keating, MD, an otolaryngologist in Martinez, Calif., recalls that he once wrote “globus hystericus,” and the patient wanted to sue him for saying that the patient was hysterical. “I now just code ‘Globus’ (if I don’t jump straight to LPD [lateral pharyngeal diverticulum]),” he commented in response to a commentary on open notes.

Sensitive information occurs more often in certain specialties, for example, psychiatry, genetics, adolescent medicine, and oncology, experts say.

“Cancer is an area that is highly charged for patients and doctors alike,” Dr. MacDonald pointed out. When reading pathology or imaging notes, patients may learn that they have been diagnosed with cancer or that they have a recurrence “without the physician being able to contextualize it and explain things – that’s just new and scary,” he said.

California law dictates that providers cannot post cancer test results without talking with the patient first, said Dr. MacDonald, but not all states have such laws.
 

Adjustments needed – or not – with open notes

At UCHealth in Aurora, Colo., Robert Breeze, MD, vice-chair of neurosurgery, said he has adjusted his practice to accommodate open notes and to anticipate trouble spots.*

“When I order imaging or send pathology specimens, I have already discussed with the patient the possibilities, including cancer, and what we will do next. Patients deeply appreciate these discussions, before they see the results,” he commented in an institutional white paper issued in anticipation of the changes on Nov. 2.

This is called precounseling, said Trent Rosenbloom, MD, MPH, director of patient portals at Vanderbilt University Medical Center, Nashville, Tenn., which has been a pioneer in information sharing with patients. Their system does delay the release of information in the case of “complicated” results, such as from cancer biopsies, he said in an interview.

However, Christiaan Hoff, MD, PhD, a surgeon at the Medical Center Leeuwarden (the Netherlands), wonders how important it is for the physician to be present when the patient receives bad news, including news about cancer. “We may overestimate our added value in these situations,” he suggested.

“Our empathy may not outweigh” the disadvantages of the situation, and the “finer points of our explanation will often go unnoticed” by the stressed patient, he commented. Dr. Hoff was also responding to the commentary about open notes.

In that commentary, Jack West, MD, a medical oncologist at City of Hope Cancer Center, Duarte, Calif., was concerned about misunderstandings. Oncology is complex, and patients can struggle to understand their prognosis and planned treatment efficacy, especially in cases of metastatic disease, he wrote.

This concern is somewhat refuted by a study published Oct. 5 in Cancer Cell. Responses to two surveys involving 96 oncology clinicians at three U.S. centers found that almost half (44%) believed that their patients “would be confused” by open notes.

However, only 4% of the 3,418 cancer patients from the same surveys reported being confused by open notes. (A majority of participants had more than a high school education, and English was their primary language.)

“Patient and clinician views about open notes in oncology are not aligned, with patients expressing considerably more enthusiasm,” wrote the authors, led by Liz Salmi, senior strategist at OpenNotes, who has been treated for brain cancer.

“All clinicians are anxious at first,” Ms. Salmi told this news organization. “Those patients who have more serious or chronic conditions … are more likely to read their notes.”

The survey results echo the early experience reported from Sweden, where open notes was launched in 2012. “Patients have loved it from the beginning,” said Maria Haggland, PhD, of Uppsala MedTech Science Innovation Center.

However, when the scheme first launched, it was considered to be “very controversial,” and “there were a lot of complaints, from health care professionals, especially,” she added.

Over time, clinicians have embraced open notes, and the program has 7.2 million patient accounts in a country of 10 million people, she observed during an Oct. 5 webinar on open notes.
 

More work for already overworked clinicians?

An outstanding concern about open notes is that it will cause more work for health care professionals.

Traditionally, doctors have written notes using medical lexicon, including a lot of abbreviations and jargon for efficiency’s sake. Now that patients will read the notes, will clinicians have to spell out things in lay terms, alter their writing so as not to offend, and generally do more work?

William Harvey, MD, chief medical information officer, Tufts Medical Center, Boston, acknowledged that that may be the case.

In a forthcoming note to staff about the Nov. 2 start of open notes, Dr. Harvey will include a reminder to accommodate the patient as a reader. But that may or may not mean an increase in work volume, depending on the provider. “Clinical note writing is highly personal. There’s an art to it,” he said in an interview. “So it’s hard to give standard advice.”

Steven Reidbord, MD, a psychiatrist in private practice in San Francisco and a lecturer at California Pacific Medical Center, is particularly concerned about the impact of open notes on progress notes, which he calls a tool to develop strategies and make observations while working with a patient.

By watering down the language for patients, “you are trading away the technical precision and other advantages of having a professional language,” he told this news organization.

“These notes serve many masters already,” he said, referring to purposes such as utilization review and billing. “The more masters they serve, the less useful they are to get medical work done.”

Dr. MacDonald, the medical information officer, said the new law doesn’t mandate a change in writing style.

In a study published last year, researchers analyzed notes written by oncologists before and after adoption of open notes. They found that, on average, clinicians did not change their note writing. The investigators analyzed more than 100,000 clinical notes written by 35 oncologists at a single center.

Advocates for open notes emphasize that there are benefits for clinicians.

“Doctors are overworked. They’re overburdened. But empowered patients can help the doctor,” said OpenNotes’ Dr. Blease. She cited survey data that show that patients better understand their treatment plan and medication, which can cut down on physician workload.

Open notes are “what you make of it,” said Marlene Millen, MD, an internist at UC San Diego Health, which has had a pilot program for 3 years. Each day, Dr. Millen discusses a shared note with two or three patients. “I actually end all of my appointments with, ‘Don’t forget to read your note later,’ ” she told this news organization.

“I was a little afraid of this initially,” she said, but within the first 3 months of the pilot, about 15 patients gave her direct feedback on how much they appreciated her notes. “It seemed to really reassure them that they were getting good care.”

The persons quoted in this article have disclosed no relevant financial relationships.
 

Correction, 10/23/20: An earlier version of this article misstated the campus' location. 

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

Starting Nov. 2, all patients in the United States will have immediate access to clinical notes and thus will be able to read their doctors’ writings, as well as test results and reports from pathology and imaging.

FG Trade/iStock/Getty Images Plus

The 21st Century Cures Act mandates that patients have fast, electronic access to the following types of notes: consultations, discharge summaries, history, physical examination findings, imaging narratives, laboratory and pathology report narratives, and procedure and progress notes.

But this federal mandate, called “open notes” by many, is potentially confusing and frightening for patients, say some physicians. Others worry that the change will increase workload as clinicians tailor notes for patients and answer related questions.

The law means that inpatient and outpatient notes will be released immediately and that patients will have immediate access to testing and imaging results, including results from sexually transmitted disease tests, Pap tests, cancer biopsies, CT and PET scans, fetal ultrasounds, pneumonia cultures, and mammograms.

Such notes could contain sensitive information, and there is concern that patients could be shocked, confused, or annoyed by what they read, even with more run-of-the-mill notes.

Champions of open notes say that the benefits, including better provider-patient communication, greatly outweigh such risks.

“This is about convenience – a bit like online banking,” commented Charlotte Blease, PhD, resident scholar at OpenNotes, an advocacy nonprofit organization headquartered at the Beth Israel–Deaconess Medical Center in Boston. “But it’s a culture shift for doctors,” she said in an interview.

“It turns physician paternalism on its head,” said C. T. Lin, MD, chief medical information officer, UCHealth, Denver. The change requires “some letting go of old traditions” in medicine, he wrote in an August blog post, referring to the fact that a computer screen – and not a physician – may tell patients about a new health problem.

Dr. Lin summarized the experience at the University of Colorado Cancer Center, which has allowed patients to have access to oncology notes for the past 5 years: “No issues and highly appreciated by patients. We have nothing to fear but fear itself.”
 

A new audience

Other institutions have also been voluntarily implementing open notes.

UC Davis Health in Sacramento, Calif., has run an optional program for the past year. However, only about two dozen of approximately 1,000 staff physicians opted in to the program.

“This illustrates the point that it’s a new thing that physicians aren’t used to doing. They’ve traditionally written notes for the benefit of their colleagues, for billing, for their own reference,” Scott MacDonald, MD, an internist and electronic health record medical director at UC Davis Health, told this news organization.

“They’ve never –until recently – had the patient as one of the audiences for a note,” he said.

Liam Keating, MD, an otolaryngologist in Martinez, Calif., recalls that he once wrote “globus hystericus,” and the patient wanted to sue him for saying that the patient was hysterical. “I now just code ‘Globus’ (if I don’t jump straight to LPD [lateral pharyngeal diverticulum]),” he commented in response to a commentary on open notes.

Sensitive information occurs more often in certain specialties, for example, psychiatry, genetics, adolescent medicine, and oncology, experts say.

“Cancer is an area that is highly charged for patients and doctors alike,” Dr. MacDonald pointed out. When reading pathology or imaging notes, patients may learn that they have been diagnosed with cancer or that they have a recurrence “without the physician being able to contextualize it and explain things – that’s just new and scary,” he said.

California law dictates that providers cannot post cancer test results without talking with the patient first, said Dr. MacDonald, but not all states have such laws.
 

Adjustments needed – or not – with open notes

At UCHealth in Aurora, Colo., Robert Breeze, MD, vice-chair of neurosurgery, said he has adjusted his practice to accommodate open notes and to anticipate trouble spots.*

“When I order imaging or send pathology specimens, I have already discussed with the patient the possibilities, including cancer, and what we will do next. Patients deeply appreciate these discussions, before they see the results,” he commented in an institutional white paper issued in anticipation of the changes on Nov. 2.

This is called precounseling, said Trent Rosenbloom, MD, MPH, director of patient portals at Vanderbilt University Medical Center, Nashville, Tenn., which has been a pioneer in information sharing with patients. Their system does delay the release of information in the case of “complicated” results, such as from cancer biopsies, he said in an interview.

However, Christiaan Hoff, MD, PhD, a surgeon at the Medical Center Leeuwarden (the Netherlands), wonders how important it is for the physician to be present when the patient receives bad news, including news about cancer. “We may overestimate our added value in these situations,” he suggested.

“Our empathy may not outweigh” the disadvantages of the situation, and the “finer points of our explanation will often go unnoticed” by the stressed patient, he commented. Dr. Hoff was also responding to the commentary about open notes.

In that commentary, Jack West, MD, a medical oncologist at City of Hope Cancer Center, Duarte, Calif., was concerned about misunderstandings. Oncology is complex, and patients can struggle to understand their prognosis and planned treatment efficacy, especially in cases of metastatic disease, he wrote.

This concern is somewhat refuted by a study published Oct. 5 in Cancer Cell. Responses to two surveys involving 96 oncology clinicians at three U.S. centers found that almost half (44%) believed that their patients “would be confused” by open notes.

However, only 4% of the 3,418 cancer patients from the same surveys reported being confused by open notes. (A majority of participants had more than a high school education, and English was their primary language.)

“Patient and clinician views about open notes in oncology are not aligned, with patients expressing considerably more enthusiasm,” wrote the authors, led by Liz Salmi, senior strategist at OpenNotes, who has been treated for brain cancer.

“All clinicians are anxious at first,” Ms. Salmi told this news organization. “Those patients who have more serious or chronic conditions … are more likely to read their notes.”

The survey results echo the early experience reported from Sweden, where open notes was launched in 2012. “Patients have loved it from the beginning,” said Maria Haggland, PhD, of Uppsala MedTech Science Innovation Center.

However, when the scheme first launched, it was considered to be “very controversial,” and “there were a lot of complaints, from health care professionals, especially,” she added.

Over time, clinicians have embraced open notes, and the program has 7.2 million patient accounts in a country of 10 million people, she observed during an Oct. 5 webinar on open notes.
 

More work for already overworked clinicians?

An outstanding concern about open notes is that it will cause more work for health care professionals.

Traditionally, doctors have written notes using medical lexicon, including a lot of abbreviations and jargon for efficiency’s sake. Now that patients will read the notes, will clinicians have to spell out things in lay terms, alter their writing so as not to offend, and generally do more work?

William Harvey, MD, chief medical information officer, Tufts Medical Center, Boston, acknowledged that that may be the case.

In a forthcoming note to staff about the Nov. 2 start of open notes, Dr. Harvey will include a reminder to accommodate the patient as a reader. But that may or may not mean an increase in work volume, depending on the provider. “Clinical note writing is highly personal. There’s an art to it,” he said in an interview. “So it’s hard to give standard advice.”

Steven Reidbord, MD, a psychiatrist in private practice in San Francisco and a lecturer at California Pacific Medical Center, is particularly concerned about the impact of open notes on progress notes, which he calls a tool to develop strategies and make observations while working with a patient.

By watering down the language for patients, “you are trading away the technical precision and other advantages of having a professional language,” he told this news organization.

“These notes serve many masters already,” he said, referring to purposes such as utilization review and billing. “The more masters they serve, the less useful they are to get medical work done.”

Dr. MacDonald, the medical information officer, said the new law doesn’t mandate a change in writing style.

In a study published last year, researchers analyzed notes written by oncologists before and after adoption of open notes. They found that, on average, clinicians did not change their note writing. The investigators analyzed more than 100,000 clinical notes written by 35 oncologists at a single center.

Advocates for open notes emphasize that there are benefits for clinicians.

“Doctors are overworked. They’re overburdened. But empowered patients can help the doctor,” said OpenNotes’ Dr. Blease. She cited survey data that show that patients better understand their treatment plan and medication, which can cut down on physician workload.

Open notes are “what you make of it,” said Marlene Millen, MD, an internist at UC San Diego Health, which has had a pilot program for 3 years. Each day, Dr. Millen discusses a shared note with two or three patients. “I actually end all of my appointments with, ‘Don’t forget to read your note later,’ ” she told this news organization.

“I was a little afraid of this initially,” she said, but within the first 3 months of the pilot, about 15 patients gave her direct feedback on how much they appreciated her notes. “It seemed to really reassure them that they were getting good care.”

The persons quoted in this article have disclosed no relevant financial relationships.
 

Correction, 10/23/20: An earlier version of this article misstated the campus' location. 

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

Despite a variety of options, patients with relapsed/refractory acute myeloid leukemia (AML) continue to face poor prognoses, and a standard of care remains elusive, a hematologist/oncologist told colleagues.

“Clearly we have a problem with this group of patients,” Ehab Atallah, MD, professor of medicine at Medical College of Wisconsin, Milwaukee, said in a presentation at the virtual Acute Leukemia Forum of Hemedicus. In regard to treatments, he added, “we still have multiple unanswered questions.”

As Dr. Atallah noted, a 2018 study of 3,012 patients – in 9 successive ECOG‐ACRIN trials for newly diagnosed AML from 1984-2008 – showed poor outcomes for relapsed/refractory patients. At a median follow-up of 9.7 years, 59.1% reached first complete remission (CR1), and 58.9% of those relapsed. In the relapsed patients, the median overall survival from relapse was 0.5 years, and the overall survival (OS) over 5 years was 10%.

“Even among patients who relapsed with better prognostic factors – age < 40 and CR1 > 12 months – there was no significant OS difference between the studies,” the study noted. “In conclusion, this large cohort appears to confirm that the survival of AML patients post relapse continues to be dismal and has not improved during the past quarter of a century.”

There isn’t a clear standard of care, said Dr. Atallah, as shown by a 2014 phase 3 study of elacytarabine vs. investigator choice in relapsed/refractory AML patients. The investigators chose seven treatment options for the control arm.

So how can physicians make the best decisions about treatment? A 2018 report finds that some factors do offer guidance about how well relapsed patients will do, Dr. Atallah said, including worse prognoses for higher age (>50 years), time to relapse (< 1 year), number of cycles of treatment needed to achieve remission (more than 1), and unfavorable cytogenetics. And, he said, “practically no one is cured when their leukemia relapses without stem cell transplantation.”

Also keep comorbidities in mind, he said, and consider previous therapies – not just the ones implemented prior to their induction but from all treatments they received: “How much anthracycline did they get? Do they still have room to receive any more anthracycline? Do they have any pulmonary complications from GVHD [graft versus host disease]?”

Another tool may be helpful. A 2013 study found that geriatric assessment predicted survival for older adults with AML who took induction chemotherapy, he said. “I’m pretty sure that this geriatric assessment would also have significant prognostic information for patients with relapsed refractory AML.”

Molecular changes add to the complexity of treatment for relapsed/refractory AML, Dr. Atallah said, in light of new molecularly targeted drugs. He pointed to a 2019 study that showed a slight increase in median overall survival (9.3 months vs. 5.6 months) for gilteritinib vs. salvage chemotherapy in relapsed/refractory patients with FLT3-mutated AML. Other studies have shown limited effects of ID1 inhibitors, he said.

In the big picture, “there are many patient-, disease-, and prior-therapy-related variables that are involved in our decisions plus donor availability, social support, whether they have a transplant before, what kind of treatment they got before the functional assessment, and comorbidities. Even with the current choices for relapsed/refractory AML, the overall survival remains poor. Enrollment in clinical trials would be the best option for these patients.”

Dr. Atallah disclosed ties with Jazz, Abbvie, Takeda, Celgene, and Novartis.

The Acute Leukemia Forum is held by Hemedicus, which is owned by the same company as this news organization.

SOURCE: “Why Is There No Standard of Care for Relapsed AML?” Acute Leukemia Forum of Hemedicus, Oct. 15, 2020.

Despite a variety of options, patients with relapsed/refractory acute myeloid leukemia (AML) continue to face poor prognoses, and a standard of care remains elusive, a hematologist/oncologist told colleagues.

“Clearly we have a problem with this group of patients,” Ehab Atallah, MD, professor of medicine at Medical College of Wisconsin, Milwaukee, said in a presentation at the virtual Acute Leukemia Forum of Hemedicus. In regard to treatments, he added, “we still have multiple unanswered questions.”

As Dr. Atallah noted, a 2018 study of 3,012 patients – in 9 successive ECOG‐ACRIN trials for newly diagnosed AML from 1984-2008 – showed poor outcomes for relapsed/refractory patients. At a median follow-up of 9.7 years, 59.1% reached first complete remission (CR1), and 58.9% of those relapsed. In the relapsed patients, the median overall survival from relapse was 0.5 years, and the overall survival (OS) over 5 years was 10%.

“Even among patients who relapsed with better prognostic factors – age < 40 and CR1 > 12 months – there was no significant OS difference between the studies,” the study noted. “In conclusion, this large cohort appears to confirm that the survival of AML patients post relapse continues to be dismal and has not improved during the past quarter of a century.”

There isn’t a clear standard of care, said Dr. Atallah, as shown by a 2014 phase 3 study of elacytarabine vs. investigator choice in relapsed/refractory AML patients. The investigators chose seven treatment options for the control arm.

So how can physicians make the best decisions about treatment? A 2018 report finds that some factors do offer guidance about how well relapsed patients will do, Dr. Atallah said, including worse prognoses for higher age (>50 years), time to relapse (< 1 year), number of cycles of treatment needed to achieve remission (more than 1), and unfavorable cytogenetics. And, he said, “practically no one is cured when their leukemia relapses without stem cell transplantation.”

Also keep comorbidities in mind, he said, and consider previous therapies – not just the ones implemented prior to their induction but from all treatments they received: “How much anthracycline did they get? Do they still have room to receive any more anthracycline? Do they have any pulmonary complications from GVHD [graft versus host disease]?”

Another tool may be helpful. A 2013 study found that geriatric assessment predicted survival for older adults with AML who took induction chemotherapy, he said. “I’m pretty sure that this geriatric assessment would also have significant prognostic information for patients with relapsed refractory AML.”

Molecular changes add to the complexity of treatment for relapsed/refractory AML, Dr. Atallah said, in light of new molecularly targeted drugs. He pointed to a 2019 study that showed a slight increase in median overall survival (9.3 months vs. 5.6 months) for gilteritinib vs. salvage chemotherapy in relapsed/refractory patients with FLT3-mutated AML. Other studies have shown limited effects of ID1 inhibitors, he said.

In the big picture, “there are many patient-, disease-, and prior-therapy-related variables that are involved in our decisions plus donor availability, social support, whether they have a transplant before, what kind of treatment they got before the functional assessment, and comorbidities. Even with the current choices for relapsed/refractory AML, the overall survival remains poor. Enrollment in clinical trials would be the best option for these patients.”

Dr. Atallah disclosed ties with Jazz, Abbvie, Takeda, Celgene, and Novartis.

The Acute Leukemia Forum is held by Hemedicus, which is owned by the same company as this news organization.

SOURCE: “Why Is There No Standard of Care for Relapsed AML?” Acute Leukemia Forum of Hemedicus, Oct. 15, 2020.

Despite a variety of options, patients with relapsed/refractory acute myeloid leukemia (AML) continue to face poor prognoses, and a standard of care remains elusive, a hematologist/oncologist told colleagues.

“Clearly we have a problem with this group of patients,” Ehab Atallah, MD, professor of medicine at Medical College of Wisconsin, Milwaukee, said in a presentation at the virtual Acute Leukemia Forum of Hemedicus. In regard to treatments, he added, “we still have multiple unanswered questions.”

As Dr. Atallah noted, a 2018 study of 3,012 patients – in 9 successive ECOG‐ACRIN trials for newly diagnosed AML from 1984-2008 – showed poor outcomes for relapsed/refractory patients. At a median follow-up of 9.7 years, 59.1% reached first complete remission (CR1), and 58.9% of those relapsed. In the relapsed patients, the median overall survival from relapse was 0.5 years, and the overall survival (OS) over 5 years was 10%.

“Even among patients who relapsed with better prognostic factors – age < 40 and CR1 > 12 months – there was no significant OS difference between the studies,” the study noted. “In conclusion, this large cohort appears to confirm that the survival of AML patients post relapse continues to be dismal and has not improved during the past quarter of a century.”

There isn’t a clear standard of care, said Dr. Atallah, as shown by a 2014 phase 3 study of elacytarabine vs. investigator choice in relapsed/refractory AML patients. The investigators chose seven treatment options for the control arm.

So how can physicians make the best decisions about treatment? A 2018 report finds that some factors do offer guidance about how well relapsed patients will do, Dr. Atallah said, including worse prognoses for higher age (>50 years), time to relapse (< 1 year), number of cycles of treatment needed to achieve remission (more than 1), and unfavorable cytogenetics. And, he said, “practically no one is cured when their leukemia relapses without stem cell transplantation.”

Also keep comorbidities in mind, he said, and consider previous therapies – not just the ones implemented prior to their induction but from all treatments they received: “How much anthracycline did they get? Do they still have room to receive any more anthracycline? Do they have any pulmonary complications from GVHD [graft versus host disease]?”

Another tool may be helpful. A 2013 study found that geriatric assessment predicted survival for older adults with AML who took induction chemotherapy, he said. “I’m pretty sure that this geriatric assessment would also have significant prognostic information for patients with relapsed refractory AML.”

Molecular changes add to the complexity of treatment for relapsed/refractory AML, Dr. Atallah said, in light of new molecularly targeted drugs. He pointed to a 2019 study that showed a slight increase in median overall survival (9.3 months vs. 5.6 months) for gilteritinib vs. salvage chemotherapy in relapsed/refractory patients with FLT3-mutated AML. Other studies have shown limited effects of ID1 inhibitors, he said.

In the big picture, “there are many patient-, disease-, and prior-therapy-related variables that are involved in our decisions plus donor availability, social support, whether they have a transplant before, what kind of treatment they got before the functional assessment, and comorbidities. Even with the current choices for relapsed/refractory AML, the overall survival remains poor. Enrollment in clinical trials would be the best option for these patients.”

Dr. Atallah disclosed ties with Jazz, Abbvie, Takeda, Celgene, and Novartis.

The Acute Leukemia Forum is held by Hemedicus, which is owned by the same company as this news organization.

SOURCE: “Why Is There No Standard of Care for Relapsed AML?” Acute Leukemia Forum of Hemedicus, Oct. 15, 2020.