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Biosimilar Dilemma

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Biosimilar Dilemma

 

 

The passage of the Biologics Price Competition and Innovation Act of 2009 (BPCI Act) allowed for the creation of a regulatory pathway for new, safe, and effective biosimilar agents. Although the medical community always needs new and affordable treatments, patients and physicians are aware of and concerned about the risks associated with biologics and the lack of long-term safety data for new treatments.

In contrast to generic drugs, which are chemically identical to their branded counterparts, biosimilar agents are not chemically identical to their branded biologic counterparts because as large complex molecules derived from living cells using recombinant DNA technology, biologics can never be exactly replicated due to their inherent variability.

Because of these substantial differences, the National Psoriasis Foundation released a policy in July 2013 to ensure patient safety.

The National Psoriasis Foundation recommends that the patient-provider relationship remain at the center of all treatment planning and supports a prohibition on biosimilar substitution unless all of the following minimal thresholds are met:

  1. the biosimilar has been designated by the Food and Drug Administration as interchangeable with the prescribed biologic for the specified indicated use;
  2. the biosimilar has a unique nonproprietary name to eliminate confusion, to allow providers to accurately track the therapeutic agent in a patient's permanent record, and to allow for the collection of adverse event information;
  3. the biosimilar product follows the same route of administration and dosage form as the reference product;
  4. the pharmacist notifies the prescriber in writing or electronic communication of the intention to substitute at least 24 hours prior to the substitution;
  5. if explicit permission from prescribing physician and patient is not obtained within 24 hours, then the original prescription must be filled;
  6. the patient (or patient's authorized representative) must be informed and educated about a biosimilar substitution at the point of sale; and
  7. upon notification of a substitution, the pharmacy and the prescribing physician are to retain a permanent record in the patient's medical record of the biosimilar substitution.

 

What’s the issue?

The tension between lowering costs and using trusted therapeutic options will be at the center of the debate over biosimilar agents. The National Psoriasis Foundation policy protects physicians and patients and helps maintain their autonomy. As these drugs are developed and studied, we will have more information to inform our decisions. How will you and your patients respond to the availability of biosimilar agents?

We want to know your views. Tell us what you think.

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Dr. Weinberg is from the Icahn School of Medicine at Mount Sinai, New York, New York.

Dr. Weinberg is a member of the medical board for the National Psoriasis Foundation; is a speaker for Abbott Laboratories and Amgen Inc; and has received research grants from Amgen Inc, Celgene Corporation, and LEO Pharma.

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Dr. Weinberg is from the Icahn School of Medicine at Mount Sinai, New York, New York.

Dr. Weinberg is a member of the medical board for the National Psoriasis Foundation; is a speaker for Abbott Laboratories and Amgen Inc; and has received research grants from Amgen Inc, Celgene Corporation, and LEO Pharma.

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Dr. Weinberg is from the Icahn School of Medicine at Mount Sinai, New York, New York.

Dr. Weinberg is a member of the medical board for the National Psoriasis Foundation; is a speaker for Abbott Laboratories and Amgen Inc; and has received research grants from Amgen Inc, Celgene Corporation, and LEO Pharma.

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The passage of the Biologics Price Competition and Innovation Act of 2009 (BPCI Act) allowed for the creation of a regulatory pathway for new, safe, and effective biosimilar agents. Although the medical community always needs new and affordable treatments, patients and physicians are aware of and concerned about the risks associated with biologics and the lack of long-term safety data for new treatments.

In contrast to generic drugs, which are chemically identical to their branded counterparts, biosimilar agents are not chemically identical to their branded biologic counterparts because as large complex molecules derived from living cells using recombinant DNA technology, biologics can never be exactly replicated due to their inherent variability.

Because of these substantial differences, the National Psoriasis Foundation released a policy in July 2013 to ensure patient safety.

The National Psoriasis Foundation recommends that the patient-provider relationship remain at the center of all treatment planning and supports a prohibition on biosimilar substitution unless all of the following minimal thresholds are met:

  1. the biosimilar has been designated by the Food and Drug Administration as interchangeable with the prescribed biologic for the specified indicated use;
  2. the biosimilar has a unique nonproprietary name to eliminate confusion, to allow providers to accurately track the therapeutic agent in a patient's permanent record, and to allow for the collection of adverse event information;
  3. the biosimilar product follows the same route of administration and dosage form as the reference product;
  4. the pharmacist notifies the prescriber in writing or electronic communication of the intention to substitute at least 24 hours prior to the substitution;
  5. if explicit permission from prescribing physician and patient is not obtained within 24 hours, then the original prescription must be filled;
  6. the patient (or patient's authorized representative) must be informed and educated about a biosimilar substitution at the point of sale; and
  7. upon notification of a substitution, the pharmacy and the prescribing physician are to retain a permanent record in the patient's medical record of the biosimilar substitution.

 

What’s the issue?

The tension between lowering costs and using trusted therapeutic options will be at the center of the debate over biosimilar agents. The National Psoriasis Foundation policy protects physicians and patients and helps maintain their autonomy. As these drugs are developed and studied, we will have more information to inform our decisions. How will you and your patients respond to the availability of biosimilar agents?

We want to know your views. Tell us what you think.

 

 

The passage of the Biologics Price Competition and Innovation Act of 2009 (BPCI Act) allowed for the creation of a regulatory pathway for new, safe, and effective biosimilar agents. Although the medical community always needs new and affordable treatments, patients and physicians are aware of and concerned about the risks associated with biologics and the lack of long-term safety data for new treatments.

In contrast to generic drugs, which are chemically identical to their branded counterparts, biosimilar agents are not chemically identical to their branded biologic counterparts because as large complex molecules derived from living cells using recombinant DNA technology, biologics can never be exactly replicated due to their inherent variability.

Because of these substantial differences, the National Psoriasis Foundation released a policy in July 2013 to ensure patient safety.

The National Psoriasis Foundation recommends that the patient-provider relationship remain at the center of all treatment planning and supports a prohibition on biosimilar substitution unless all of the following minimal thresholds are met:

  1. the biosimilar has been designated by the Food and Drug Administration as interchangeable with the prescribed biologic for the specified indicated use;
  2. the biosimilar has a unique nonproprietary name to eliminate confusion, to allow providers to accurately track the therapeutic agent in a patient's permanent record, and to allow for the collection of adverse event information;
  3. the biosimilar product follows the same route of administration and dosage form as the reference product;
  4. the pharmacist notifies the prescriber in writing or electronic communication of the intention to substitute at least 24 hours prior to the substitution;
  5. if explicit permission from prescribing physician and patient is not obtained within 24 hours, then the original prescription must be filled;
  6. the patient (or patient's authorized representative) must be informed and educated about a biosimilar substitution at the point of sale; and
  7. upon notification of a substitution, the pharmacy and the prescribing physician are to retain a permanent record in the patient's medical record of the biosimilar substitution.

 

What’s the issue?

The tension between lowering costs and using trusted therapeutic options will be at the center of the debate over biosimilar agents. The National Psoriasis Foundation policy protects physicians and patients and helps maintain their autonomy. As these drugs are developed and studied, we will have more information to inform our decisions. How will you and your patients respond to the availability of biosimilar agents?

We want to know your views. Tell us what you think.

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Sorting Out Supplements

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Sorting Out Supplements

 

 

In December 2013, the Annals of Internal Medicine amassed 2 original research articles, 1 review, and 1 editorial analyzing and supporting the hypothesis that vitamin and mineral supplementation may not be beneficial for many facets of total health. One study assessed daily multivitamin efficacy in older adults for prevention of cognitive decline (Ann Intern Med. 2013;159:806-814); one evaluated high-dosage daily multivitamin in myocardial infarction patients for prevention of repeated cardiovascular events (Ann Intern Med. 2013;159:797-805); and the systematic review reported all-cause mortality, cardiovascular disease, and cancer in multivitamin users (Ann Intern Med. 2013;159:824-834). All 3 concluded that there was no significant benefit, and the editorial asked that we close the book on this question (Ann Intern Med. 2013;159:850-851).

 

What’s the issue?

In dermatology, patients often inquire about supplements, dietary changes, and natural methods for aiding in their recovery and for preventing disease. This set of publications attempts to steer us to summarily discourage widespread multivitamin and supplement use. However, there are certainly instances in which dogma from medical school training, smaller patient cohorts, and anecdotal cases compel us to continue them. The first things to come to mind in dermatology (and beyond) are biotin for hair and nail growth, folic acid for preconception and pregnancy prevention of fetal neural defects, and vitamin D for bone health.

Should everyone be on a multivitamin? For which diagnoses do you routinely recommend vitamin or mineral supplementation? In fact, in which instances do you take supplementation yourself? Do you feel comfortable with the evidence that supports it? Which references do you trust in this facet?

We want to know your views. Tell us what you think.

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Dr. Rosamilia is from the Department of Dermatology, Geisinger Health System, State College, Pennsylvania.

Dr. Rosamilia reports no conflicts of interest in relation to this post.

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Dr. Rosamilia is from the Department of Dermatology, Geisinger Health System, State College, Pennsylvania.

Dr. Rosamilia reports no conflicts of interest in relation to this post.

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In December 2013, the Annals of Internal Medicine amassed 2 original research articles, 1 review, and 1 editorial analyzing and supporting the hypothesis that vitamin and mineral supplementation may not be beneficial for many facets of total health. One study assessed daily multivitamin efficacy in older adults for prevention of cognitive decline (Ann Intern Med. 2013;159:806-814); one evaluated high-dosage daily multivitamin in myocardial infarction patients for prevention of repeated cardiovascular events (Ann Intern Med. 2013;159:797-805); and the systematic review reported all-cause mortality, cardiovascular disease, and cancer in multivitamin users (Ann Intern Med. 2013;159:824-834). All 3 concluded that there was no significant benefit, and the editorial asked that we close the book on this question (Ann Intern Med. 2013;159:850-851).

 

What’s the issue?

In dermatology, patients often inquire about supplements, dietary changes, and natural methods for aiding in their recovery and for preventing disease. This set of publications attempts to steer us to summarily discourage widespread multivitamin and supplement use. However, there are certainly instances in which dogma from medical school training, smaller patient cohorts, and anecdotal cases compel us to continue them. The first things to come to mind in dermatology (and beyond) are biotin for hair and nail growth, folic acid for preconception and pregnancy prevention of fetal neural defects, and vitamin D for bone health.

Should everyone be on a multivitamin? For which diagnoses do you routinely recommend vitamin or mineral supplementation? In fact, in which instances do you take supplementation yourself? Do you feel comfortable with the evidence that supports it? Which references do you trust in this facet?

We want to know your views. Tell us what you think.

 

 

In December 2013, the Annals of Internal Medicine amassed 2 original research articles, 1 review, and 1 editorial analyzing and supporting the hypothesis that vitamin and mineral supplementation may not be beneficial for many facets of total health. One study assessed daily multivitamin efficacy in older adults for prevention of cognitive decline (Ann Intern Med. 2013;159:806-814); one evaluated high-dosage daily multivitamin in myocardial infarction patients for prevention of repeated cardiovascular events (Ann Intern Med. 2013;159:797-805); and the systematic review reported all-cause mortality, cardiovascular disease, and cancer in multivitamin users (Ann Intern Med. 2013;159:824-834). All 3 concluded that there was no significant benefit, and the editorial asked that we close the book on this question (Ann Intern Med. 2013;159:850-851).

 

What’s the issue?

In dermatology, patients often inquire about supplements, dietary changes, and natural methods for aiding in their recovery and for preventing disease. This set of publications attempts to steer us to summarily discourage widespread multivitamin and supplement use. However, there are certainly instances in which dogma from medical school training, smaller patient cohorts, and anecdotal cases compel us to continue them. The first things to come to mind in dermatology (and beyond) are biotin for hair and nail growth, folic acid for preconception and pregnancy prevention of fetal neural defects, and vitamin D for bone health.

Should everyone be on a multivitamin? For which diagnoses do you routinely recommend vitamin or mineral supplementation? In fact, in which instances do you take supplementation yourself? Do you feel comfortable with the evidence that supports it? Which references do you trust in this facet?

We want to know your views. Tell us what you think.

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Growing Ears, Noses, and Skin: The New Frontier in Dermatology and Dermatologic Surgery?

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Growing Ears, Noses, and Skin: The New Frontier in Dermatology and Dermatologic Surgery?

In an article published online in Maclean’s magazine on October 15, 2013, the concept of developing artificial body parts is discussed. The technology now exists for scientists to grow tissue organs, such as ears, noses, and fingers. Several groups of investigators, including Anthony Atala, MD (Wake Forest Institute for Regenerative Medicine, Winston-Salem, North Carolina) and Alexander Seifalian, PhD (University College London, England), are busy making ears by creating a biodegradable scaffold onto which cells—either stem cells from the patient or cells that have been harvested from the patient’s original organ—are layered and permitted to multiply. The cell-layered scaffold is then placed in a bioreactor for a couple of weeks. Once ready, the new ear is transplanted onto the patient; subsequently, the scaffold melts away.

Dr. Atala’s laboratory also is busy growing fingers. Meanwhile, Dr. Seifalian grew a nose (inside the patient’s own arm) in only 3 months after the patient lost his nose to skin cancer. He made a mold based on the patient’s original nose, created a scaffold composed of nanocomposite material, added the patient’s stem cells to the scaffold, and put the nose in a bioreactor to mature. Meanwhile, he placed a tissue expander in the patient’s arm and subsequently inserted the nose into the arm so that it could become vascularized and covered by skin. The nose was transplanted to the patient’s face; additional surgery is planned to open the nostrils, followed by seeding them with stem cells to return his sense of smell.

Marc Jeschke, MD, PhD (Ross Tilley Burn Centre, Sunnybrook Health Sciences Centre, Toronto, Ontario) is developing a bioprinter to create skin. The bioprinter dispenses different types of cells (grown from the patient’s own cells) into a hydrogel matrix in 3 dimensions. Currently, Dr. Jeschke is working with mice; however, in a few years, he anticipates treating human patients. Other investigators, such as Michael C. McAlpine (Princeton University, New Jersey), recently used a commercial 3-dimensional printer to make an ear; the “inks” included calf cells and a silver nanoparticle paste that formed a coiled antenna inside the cartilage that was capable of receiving electromagnetic signals and transmitting them to the brain.

 

What’s the issue?

The ability to grow tissue organs is going to revolutionize the surgical management of patients who need solid organ replacement; kidneys, lungs, pancreases, spleens, and tracheas have already been successfully grown. Indeed several investigators are making ears and noses. How long will it be before flaps and grafts to repair wound defects following extensive and deforming skin cancer surgery are replaced by ears and noses that are grown from the patient’s own tissue cells or stem cells? Although it seems like science fiction today, how soon will it be before a cutaneous 3-dimensional printer becomes a standard piece of equipment in the dermatologist and dermatologic surgeon’s office for use to create skin to cover postoperative sites that cannot be closed by directly bringing the wound edges together?

We want to know your views. Tell us what you think.

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Dr. Cohen reports no conflicts of interest in relation to this post.

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In an article published online in Maclean’s magazine on October 15, 2013, the concept of developing artificial body parts is discussed. The technology now exists for scientists to grow tissue organs, such as ears, noses, and fingers. Several groups of investigators, including Anthony Atala, MD (Wake Forest Institute for Regenerative Medicine, Winston-Salem, North Carolina) and Alexander Seifalian, PhD (University College London, England), are busy making ears by creating a biodegradable scaffold onto which cells—either stem cells from the patient or cells that have been harvested from the patient’s original organ—are layered and permitted to multiply. The cell-layered scaffold is then placed in a bioreactor for a couple of weeks. Once ready, the new ear is transplanted onto the patient; subsequently, the scaffold melts away.

Dr. Atala’s laboratory also is busy growing fingers. Meanwhile, Dr. Seifalian grew a nose (inside the patient’s own arm) in only 3 months after the patient lost his nose to skin cancer. He made a mold based on the patient’s original nose, created a scaffold composed of nanocomposite material, added the patient’s stem cells to the scaffold, and put the nose in a bioreactor to mature. Meanwhile, he placed a tissue expander in the patient’s arm and subsequently inserted the nose into the arm so that it could become vascularized and covered by skin. The nose was transplanted to the patient’s face; additional surgery is planned to open the nostrils, followed by seeding them with stem cells to return his sense of smell.

Marc Jeschke, MD, PhD (Ross Tilley Burn Centre, Sunnybrook Health Sciences Centre, Toronto, Ontario) is developing a bioprinter to create skin. The bioprinter dispenses different types of cells (grown from the patient’s own cells) into a hydrogel matrix in 3 dimensions. Currently, Dr. Jeschke is working with mice; however, in a few years, he anticipates treating human patients. Other investigators, such as Michael C. McAlpine (Princeton University, New Jersey), recently used a commercial 3-dimensional printer to make an ear; the “inks” included calf cells and a silver nanoparticle paste that formed a coiled antenna inside the cartilage that was capable of receiving electromagnetic signals and transmitting them to the brain.

 

What’s the issue?

The ability to grow tissue organs is going to revolutionize the surgical management of patients who need solid organ replacement; kidneys, lungs, pancreases, spleens, and tracheas have already been successfully grown. Indeed several investigators are making ears and noses. How long will it be before flaps and grafts to repair wound defects following extensive and deforming skin cancer surgery are replaced by ears and noses that are grown from the patient’s own tissue cells or stem cells? Although it seems like science fiction today, how soon will it be before a cutaneous 3-dimensional printer becomes a standard piece of equipment in the dermatologist and dermatologic surgeon’s office for use to create skin to cover postoperative sites that cannot be closed by directly bringing the wound edges together?

We want to know your views. Tell us what you think.

In an article published online in Maclean’s magazine on October 15, 2013, the concept of developing artificial body parts is discussed. The technology now exists for scientists to grow tissue organs, such as ears, noses, and fingers. Several groups of investigators, including Anthony Atala, MD (Wake Forest Institute for Regenerative Medicine, Winston-Salem, North Carolina) and Alexander Seifalian, PhD (University College London, England), are busy making ears by creating a biodegradable scaffold onto which cells—either stem cells from the patient or cells that have been harvested from the patient’s original organ—are layered and permitted to multiply. The cell-layered scaffold is then placed in a bioreactor for a couple of weeks. Once ready, the new ear is transplanted onto the patient; subsequently, the scaffold melts away.

Dr. Atala’s laboratory also is busy growing fingers. Meanwhile, Dr. Seifalian grew a nose (inside the patient’s own arm) in only 3 months after the patient lost his nose to skin cancer. He made a mold based on the patient’s original nose, created a scaffold composed of nanocomposite material, added the patient’s stem cells to the scaffold, and put the nose in a bioreactor to mature. Meanwhile, he placed a tissue expander in the patient’s arm and subsequently inserted the nose into the arm so that it could become vascularized and covered by skin. The nose was transplanted to the patient’s face; additional surgery is planned to open the nostrils, followed by seeding them with stem cells to return his sense of smell.

Marc Jeschke, MD, PhD (Ross Tilley Burn Centre, Sunnybrook Health Sciences Centre, Toronto, Ontario) is developing a bioprinter to create skin. The bioprinter dispenses different types of cells (grown from the patient’s own cells) into a hydrogel matrix in 3 dimensions. Currently, Dr. Jeschke is working with mice; however, in a few years, he anticipates treating human patients. Other investigators, such as Michael C. McAlpine (Princeton University, New Jersey), recently used a commercial 3-dimensional printer to make an ear; the “inks” included calf cells and a silver nanoparticle paste that formed a coiled antenna inside the cartilage that was capable of receiving electromagnetic signals and transmitting them to the brain.

 

What’s the issue?

The ability to grow tissue organs is going to revolutionize the surgical management of patients who need solid organ replacement; kidneys, lungs, pancreases, spleens, and tracheas have already been successfully grown. Indeed several investigators are making ears and noses. How long will it be before flaps and grafts to repair wound defects following extensive and deforming skin cancer surgery are replaced by ears and noses that are grown from the patient’s own tissue cells or stem cells? Although it seems like science fiction today, how soon will it be before a cutaneous 3-dimensional printer becomes a standard piece of equipment in the dermatologist and dermatologic surgeon’s office for use to create skin to cover postoperative sites that cannot be closed by directly bringing the wound edges together?

We want to know your views. Tell us what you think.

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OnabotulinumtoxinA Approved for Treatment of Crow’s-feet

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The US Food and Drug Administration recently approved a new use for Botox Cosmetic (onabotulinumtoxinA)(Allergan, Inc): temporary improvement in the appearance of moderate to severe crow’s-feet (lateral canthal lines). As reported in the prescribing information, 2 placebo-controlled clinical studies evaluated 833 adult participants with moderate to severe lateral canthal lines. Each participant received 4 U of onabotulinumtoxinA or placebo into 3 sites per side for a total of 24 U in the lateral orbicularis oculi muscle. The first injection was placed approximately 1.5 to 2.0 cm temporal to the lateral canthus and just temporal to the orbital rim. The second and third injection was either above and below, respectively, the first injection or both below the first injection depending on the appearance of wrinkles. Results showed that participants treated with onabotulinumtoxinA had greater improvement compared to placebo in the appearance of crow’s-feet. The most common side effect was lid edema, which occurred in 1% of participants.

 

What’s the issue?

Although dermatologists and cosmetic surgeons have been using onabotulinumtoxinA and other neurotoxins for treatment of crow’s-feet for a long time (off label), it is now approved for this indication. The volume used on label also is important because it gives guidance as to how much product can be used. Of course each patient is different and many clinicians may decide to use more or less product to achieve a desired correction. The fact that onabotulinumtoxinA is now deemed safe to be used in the crow’s-feet area also is important because it gives the physician some medical/legal protection. Will this approval really change anything that you currently do or don’t do?

We want to know your views! Tell us what you think.

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The US Food and Drug Administration recently approved a new use for Botox Cosmetic (onabotulinumtoxinA)(Allergan, Inc): temporary improvement in the appearance of moderate to severe crow’s-feet (lateral canthal lines). As reported in the prescribing information, 2 placebo-controlled clinical studies evaluated 833 adult participants with moderate to severe lateral canthal lines. Each participant received 4 U of onabotulinumtoxinA or placebo into 3 sites per side for a total of 24 U in the lateral orbicularis oculi muscle. The first injection was placed approximately 1.5 to 2.0 cm temporal to the lateral canthus and just temporal to the orbital rim. The second and third injection was either above and below, respectively, the first injection or both below the first injection depending on the appearance of wrinkles. Results showed that participants treated with onabotulinumtoxinA had greater improvement compared to placebo in the appearance of crow’s-feet. The most common side effect was lid edema, which occurred in 1% of participants.

 

What’s the issue?

Although dermatologists and cosmetic surgeons have been using onabotulinumtoxinA and other neurotoxins for treatment of crow’s-feet for a long time (off label), it is now approved for this indication. The volume used on label also is important because it gives guidance as to how much product can be used. Of course each patient is different and many clinicians may decide to use more or less product to achieve a desired correction. The fact that onabotulinumtoxinA is now deemed safe to be used in the crow’s-feet area also is important because it gives the physician some medical/legal protection. Will this approval really change anything that you currently do or don’t do?

We want to know your views! Tell us what you think.

The US Food and Drug Administration recently approved a new use for Botox Cosmetic (onabotulinumtoxinA)(Allergan, Inc): temporary improvement in the appearance of moderate to severe crow’s-feet (lateral canthal lines). As reported in the prescribing information, 2 placebo-controlled clinical studies evaluated 833 adult participants with moderate to severe lateral canthal lines. Each participant received 4 U of onabotulinumtoxinA or placebo into 3 sites per side for a total of 24 U in the lateral orbicularis oculi muscle. The first injection was placed approximately 1.5 to 2.0 cm temporal to the lateral canthus and just temporal to the orbital rim. The second and third injection was either above and below, respectively, the first injection or both below the first injection depending on the appearance of wrinkles. Results showed that participants treated with onabotulinumtoxinA had greater improvement compared to placebo in the appearance of crow’s-feet. The most common side effect was lid edema, which occurred in 1% of participants.

 

What’s the issue?

Although dermatologists and cosmetic surgeons have been using onabotulinumtoxinA and other neurotoxins for treatment of crow’s-feet for a long time (off label), it is now approved for this indication. The volume used on label also is important because it gives guidance as to how much product can be used. Of course each patient is different and many clinicians may decide to use more or less product to achieve a desired correction. The fact that onabotulinumtoxinA is now deemed safe to be used in the crow’s-feet area also is important because it gives the physician some medical/legal protection. Will this approval really change anything that you currently do or don’t do?

We want to know your views! Tell us what you think.

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Choosing Wisely

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Choosing Wisely

 

 

Along with 80 other medical societies, the American Academy of Dermatology (AAD) recently published a list of unnecessary medical tests and procedures as part of a stewardship effort called Choosing Wisely, orchestrated by the American Board of Internal Medicine (ABIM) Foundation to conserve health care resources. For dermatologists, the list includes:

  1. Don’t prescribe oral antifungal therapy for suspected nail fungus without confirmation of fungal infection.
  2. Don’t perform sentinel lymph node biopsy or other diagnostic tests for the evaluation of early, thin melanoma because they do not improve survival.
  3. Don’t treat uncomplicated, nonmelanoma skin cancer less than 1 centimeter in size on the trunk and extremities with Mohs micrographic surgery.
  4. Don’t use oral antibiotics for treatment of atopic dermatitis unless there is clinical evidence of infection.
  5. Don’t routinely use topical antibiotics on a surgical wound.

 

What’s the issue?

Read the list. Assess your current clinical practices. Note where health care waste exists. A November 2013 ABC News investigation noted that hospital charges are the largest source of medical inflation, and I thought to myself, “Yes, think of all the emergency department and inpatients who are reflexively on expensive broad-spectrum antibiotics, or think of the number of patients admitted for stable conditions.” However, from a different standpoint, some might say that dermatology costs are extravagant based on the items on this list, particularly the surgical inconsistencies. Therefore, we should try not to cast the first stone unless our own specialty’s waste is managed. What are examples of regional sources of excess that you can identify?

We want to know your views! Tell us what you think.

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Along with 80 other medical societies, the American Academy of Dermatology (AAD) recently published a list of unnecessary medical tests and procedures as part of a stewardship effort called Choosing Wisely, orchestrated by the American Board of Internal Medicine (ABIM) Foundation to conserve health care resources. For dermatologists, the list includes:

  1. Don’t prescribe oral antifungal therapy for suspected nail fungus without confirmation of fungal infection.
  2. Don’t perform sentinel lymph node biopsy or other diagnostic tests for the evaluation of early, thin melanoma because they do not improve survival.
  3. Don’t treat uncomplicated, nonmelanoma skin cancer less than 1 centimeter in size on the trunk and extremities with Mohs micrographic surgery.
  4. Don’t use oral antibiotics for treatment of atopic dermatitis unless there is clinical evidence of infection.
  5. Don’t routinely use topical antibiotics on a surgical wound.

 

What’s the issue?

Read the list. Assess your current clinical practices. Note where health care waste exists. A November 2013 ABC News investigation noted that hospital charges are the largest source of medical inflation, and I thought to myself, “Yes, think of all the emergency department and inpatients who are reflexively on expensive broad-spectrum antibiotics, or think of the number of patients admitted for stable conditions.” However, from a different standpoint, some might say that dermatology costs are extravagant based on the items on this list, particularly the surgical inconsistencies. Therefore, we should try not to cast the first stone unless our own specialty’s waste is managed. What are examples of regional sources of excess that you can identify?

We want to know your views! Tell us what you think.

 

 

Along with 80 other medical societies, the American Academy of Dermatology (AAD) recently published a list of unnecessary medical tests and procedures as part of a stewardship effort called Choosing Wisely, orchestrated by the American Board of Internal Medicine (ABIM) Foundation to conserve health care resources. For dermatologists, the list includes:

  1. Don’t prescribe oral antifungal therapy for suspected nail fungus without confirmation of fungal infection.
  2. Don’t perform sentinel lymph node biopsy or other diagnostic tests for the evaluation of early, thin melanoma because they do not improve survival.
  3. Don’t treat uncomplicated, nonmelanoma skin cancer less than 1 centimeter in size on the trunk and extremities with Mohs micrographic surgery.
  4. Don’t use oral antibiotics for treatment of atopic dermatitis unless there is clinical evidence of infection.
  5. Don’t routinely use topical antibiotics on a surgical wound.

 

What’s the issue?

Read the list. Assess your current clinical practices. Note where health care waste exists. A November 2013 ABC News investigation noted that hospital charges are the largest source of medical inflation, and I thought to myself, “Yes, think of all the emergency department and inpatients who are reflexively on expensive broad-spectrum antibiotics, or think of the number of patients admitted for stable conditions.” However, from a different standpoint, some might say that dermatology costs are extravagant based on the items on this list, particularly the surgical inconsistencies. Therefore, we should try not to cast the first stone unless our own specialty’s waste is managed. What are examples of regional sources of excess that you can identify?

We want to know your views! Tell us what you think.

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Beta-blockers and Melanoma

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I have taken beta-blockers for nearly 30 years to combat a non–life-threatening but very disconcerting supraventricular arrhythmia. Also being fair skinned and having suffered through many a blistering sunburn in my youth, I was excited to read the most recent publication regarding the relationship between beta-blocker ingestion and survival from melanoma by De Giorgi et al (Mayo Clin Proc. 2013;88:1196-1203). The Italian investigators collected data from all melanoma patients diagnosed in the dermatology department at the University of Florence (1993-2009). After excluding patients who presented with metastatic disease, they then compared the courses of the remaining patients based on whether or not they had been prescribed beta-blockers for at least 1 year before or after their cutaneous melanoma diagnosis. Of 741 consecutive patients who fit the retrospective study criteria, 79 (11%) had been taking beta-blockers and the remaining 662 (89%) had not been taking beta-blockers.

An analysis based on the multivariate Cox model indicated that the beta-blocker group had improved overall survival after a median follow-up of 4.2 years (P=.005). Looked at in another way, significantly more patients in the untreated group (8%) than the beta-blocker group (3%) experienced disease progression or death (P<.001). The “protective” effect of beta-blockers was so striking that it could be quantified; for each year of beta-blocker use, the risk for death was reduced by 38%. More notable was the fact that the beneficial effect of beta-blocker administration was consistent, even among patients with inherently unfavorable prognostic factors, such as advanced age, thicker lesions, higher frequency of mitoses and ulceration, and nodular melanoma subtype. This large study confirms the results of a much smaller study (N=121) published by the same group in 2011 (Arch Intern Med. 2011;171:779-781).

 

What’s the issue?

Why might this phenomenon occur? Perhaps blocking sympathetic nervous system neurotransmitters might help avoid the suspected immunosuppression that accompanies stress. Sympathetic neurotransmitters also are known to interact with molecular pathways implicated in abnormal cellular replication, such as the p38/MAPK pathway. Thus, blunting the effects of epinephrine and norepinephrine by blocking some of their receptors might produce a salutatory benefit in the cancer (in this case, melanoma) patient.

Before we all rush out and give all our melanoma patients daily doses of metoprolol, however, De Giorgi et al noted in the most recent study that about two-thirds of the patients were already taking a beta-blocker when their melanoma was diagnosed. Although this study suggests that beta-blockers reduce the risk for recurrence and disease-specific mortality, these drugs clearly do not prevent melanoma in the first place. Furthermore, it should be noted that the number of melanoma patients receiving beta-blockers was small, and conclusions should always be tempered in a retrospective study. The authors duly admit that their investigation indicates the strong need for a truly randomized prospective clinical trial. Of course, administration of beta-blockers is not a totally benign endeavor, as serious hypotension and/or bradycardia may occur, leading to syncope or even worse problems. Finally, the evidence of beta-blocker benefit in melanoma patients is contradictory! A Dutch cohort of 709 melanoma patients recently was studied (Eur J Cancer. 2013;49:3863-3871); this set of investigators found that exposure to beta-blockers did not impact overall melanoma survival regardless of the timing, duration, or dosage of beta-blocker use. In summary, therefore, we still need to determine many things about the relationship between beta-blockers and melanoma survival. That is, if there is a relationship at all. What do you think?

We want to know your views! Tell us what you think.

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I have taken beta-blockers for nearly 30 years to combat a non–life-threatening but very disconcerting supraventricular arrhythmia. Also being fair skinned and having suffered through many a blistering sunburn in my youth, I was excited to read the most recent publication regarding the relationship between beta-blocker ingestion and survival from melanoma by De Giorgi et al (Mayo Clin Proc. 2013;88:1196-1203). The Italian investigators collected data from all melanoma patients diagnosed in the dermatology department at the University of Florence (1993-2009). After excluding patients who presented with metastatic disease, they then compared the courses of the remaining patients based on whether or not they had been prescribed beta-blockers for at least 1 year before or after their cutaneous melanoma diagnosis. Of 741 consecutive patients who fit the retrospective study criteria, 79 (11%) had been taking beta-blockers and the remaining 662 (89%) had not been taking beta-blockers.

An analysis based on the multivariate Cox model indicated that the beta-blocker group had improved overall survival after a median follow-up of 4.2 years (P=.005). Looked at in another way, significantly more patients in the untreated group (8%) than the beta-blocker group (3%) experienced disease progression or death (P<.001). The “protective” effect of beta-blockers was so striking that it could be quantified; for each year of beta-blocker use, the risk for death was reduced by 38%. More notable was the fact that the beneficial effect of beta-blocker administration was consistent, even among patients with inherently unfavorable prognostic factors, such as advanced age, thicker lesions, higher frequency of mitoses and ulceration, and nodular melanoma subtype. This large study confirms the results of a much smaller study (N=121) published by the same group in 2011 (Arch Intern Med. 2011;171:779-781).

 

What’s the issue?

Why might this phenomenon occur? Perhaps blocking sympathetic nervous system neurotransmitters might help avoid the suspected immunosuppression that accompanies stress. Sympathetic neurotransmitters also are known to interact with molecular pathways implicated in abnormal cellular replication, such as the p38/MAPK pathway. Thus, blunting the effects of epinephrine and norepinephrine by blocking some of their receptors might produce a salutatory benefit in the cancer (in this case, melanoma) patient.

Before we all rush out and give all our melanoma patients daily doses of metoprolol, however, De Giorgi et al noted in the most recent study that about two-thirds of the patients were already taking a beta-blocker when their melanoma was diagnosed. Although this study suggests that beta-blockers reduce the risk for recurrence and disease-specific mortality, these drugs clearly do not prevent melanoma in the first place. Furthermore, it should be noted that the number of melanoma patients receiving beta-blockers was small, and conclusions should always be tempered in a retrospective study. The authors duly admit that their investigation indicates the strong need for a truly randomized prospective clinical trial. Of course, administration of beta-blockers is not a totally benign endeavor, as serious hypotension and/or bradycardia may occur, leading to syncope or even worse problems. Finally, the evidence of beta-blocker benefit in melanoma patients is contradictory! A Dutch cohort of 709 melanoma patients recently was studied (Eur J Cancer. 2013;49:3863-3871); this set of investigators found that exposure to beta-blockers did not impact overall melanoma survival regardless of the timing, duration, or dosage of beta-blocker use. In summary, therefore, we still need to determine many things about the relationship between beta-blockers and melanoma survival. That is, if there is a relationship at all. What do you think?

We want to know your views! Tell us what you think.

I have taken beta-blockers for nearly 30 years to combat a non–life-threatening but very disconcerting supraventricular arrhythmia. Also being fair skinned and having suffered through many a blistering sunburn in my youth, I was excited to read the most recent publication regarding the relationship between beta-blocker ingestion and survival from melanoma by De Giorgi et al (Mayo Clin Proc. 2013;88:1196-1203). The Italian investigators collected data from all melanoma patients diagnosed in the dermatology department at the University of Florence (1993-2009). After excluding patients who presented with metastatic disease, they then compared the courses of the remaining patients based on whether or not they had been prescribed beta-blockers for at least 1 year before or after their cutaneous melanoma diagnosis. Of 741 consecutive patients who fit the retrospective study criteria, 79 (11%) had been taking beta-blockers and the remaining 662 (89%) had not been taking beta-blockers.

An analysis based on the multivariate Cox model indicated that the beta-blocker group had improved overall survival after a median follow-up of 4.2 years (P=.005). Looked at in another way, significantly more patients in the untreated group (8%) than the beta-blocker group (3%) experienced disease progression or death (P<.001). The “protective” effect of beta-blockers was so striking that it could be quantified; for each year of beta-blocker use, the risk for death was reduced by 38%. More notable was the fact that the beneficial effect of beta-blocker administration was consistent, even among patients with inherently unfavorable prognostic factors, such as advanced age, thicker lesions, higher frequency of mitoses and ulceration, and nodular melanoma subtype. This large study confirms the results of a much smaller study (N=121) published by the same group in 2011 (Arch Intern Med. 2011;171:779-781).

 

What’s the issue?

Why might this phenomenon occur? Perhaps blocking sympathetic nervous system neurotransmitters might help avoid the suspected immunosuppression that accompanies stress. Sympathetic neurotransmitters also are known to interact with molecular pathways implicated in abnormal cellular replication, such as the p38/MAPK pathway. Thus, blunting the effects of epinephrine and norepinephrine by blocking some of their receptors might produce a salutatory benefit in the cancer (in this case, melanoma) patient.

Before we all rush out and give all our melanoma patients daily doses of metoprolol, however, De Giorgi et al noted in the most recent study that about two-thirds of the patients were already taking a beta-blocker when their melanoma was diagnosed. Although this study suggests that beta-blockers reduce the risk for recurrence and disease-specific mortality, these drugs clearly do not prevent melanoma in the first place. Furthermore, it should be noted that the number of melanoma patients receiving beta-blockers was small, and conclusions should always be tempered in a retrospective study. The authors duly admit that their investigation indicates the strong need for a truly randomized prospective clinical trial. Of course, administration of beta-blockers is not a totally benign endeavor, as serious hypotension and/or bradycardia may occur, leading to syncope or even worse problems. Finally, the evidence of beta-blocker benefit in melanoma patients is contradictory! A Dutch cohort of 709 melanoma patients recently was studied (Eur J Cancer. 2013;49:3863-3871); this set of investigators found that exposure to beta-blockers did not impact overall melanoma survival regardless of the timing, duration, or dosage of beta-blocker use. In summary, therefore, we still need to determine many things about the relationship between beta-blockers and melanoma survival. That is, if there is a relationship at all. What do you think?

We want to know your views! Tell us what you think.

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Cutaneous SCC in a Renal Transplant Patient Derived From Donor Kidney Tumor Cells: Should Donor Transplant Organs Undergo Genetic Profiling for Cancer-Associated Mutations?

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Squamous cell carcinoma (SCC) on sun-exposed sites following prolonged immunosuppression is one of the main long-term complications of allogeneic transplantations. In an article published in the Journal of Clinical Investigation (2013;123:3797-3801), the investigators demonstrated that the SCC tumor cells from a renal transplant patient had the donor genotype and harbored a TP53 (tumor-suppressing p53) mutation in codon 175; in addition, the same TP53 mutation had previously been documented 7 years earlier in p53+ cells in the renal tubules from a kidney graft biopsy. The observations in this patient provide evidence that the kidney donor can contribute to subsequent SCCs in renal transplant recipients.

 

What’s the issue?

Donor contribution to the malignant epithelium of cutaneous cancer in organ transplant recipients has several important implications. First, this observation provides additional insight into the initiation and progression of tumor carcinogenesis. Second, because there is longer survival of patients following renal transplant and therefore a prolonged duration of immunosuppression in these individuals, the development of long-term complications such as SCC of sun-exposed skin may be greater. Third, should genetic profiling of kidneys from potential donors to screen for cancer-associated mutations be performed? And fourth, is this phenomenon restricted only to patients receiving kidneys or might it be a possible complication in the recipients of other organs such as hearts, lungs, or even faces?

We want to know your views! Tell us what you think.

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Squamous cell carcinoma (SCC) on sun-exposed sites following prolonged immunosuppression is one of the main long-term complications of allogeneic transplantations. In an article published in the Journal of Clinical Investigation (2013;123:3797-3801), the investigators demonstrated that the SCC tumor cells from a renal transplant patient had the donor genotype and harbored a TP53 (tumor-suppressing p53) mutation in codon 175; in addition, the same TP53 mutation had previously been documented 7 years earlier in p53+ cells in the renal tubules from a kidney graft biopsy. The observations in this patient provide evidence that the kidney donor can contribute to subsequent SCCs in renal transplant recipients.

 

What’s the issue?

Donor contribution to the malignant epithelium of cutaneous cancer in organ transplant recipients has several important implications. First, this observation provides additional insight into the initiation and progression of tumor carcinogenesis. Second, because there is longer survival of patients following renal transplant and therefore a prolonged duration of immunosuppression in these individuals, the development of long-term complications such as SCC of sun-exposed skin may be greater. Third, should genetic profiling of kidneys from potential donors to screen for cancer-associated mutations be performed? And fourth, is this phenomenon restricted only to patients receiving kidneys or might it be a possible complication in the recipients of other organs such as hearts, lungs, or even faces?

We want to know your views! Tell us what you think.

Squamous cell carcinoma (SCC) on sun-exposed sites following prolonged immunosuppression is one of the main long-term complications of allogeneic transplantations. In an article published in the Journal of Clinical Investigation (2013;123:3797-3801), the investigators demonstrated that the SCC tumor cells from a renal transplant patient had the donor genotype and harbored a TP53 (tumor-suppressing p53) mutation in codon 175; in addition, the same TP53 mutation had previously been documented 7 years earlier in p53+ cells in the renal tubules from a kidney graft biopsy. The observations in this patient provide evidence that the kidney donor can contribute to subsequent SCCs in renal transplant recipients.

 

What’s the issue?

Donor contribution to the malignant epithelium of cutaneous cancer in organ transplant recipients has several important implications. First, this observation provides additional insight into the initiation and progression of tumor carcinogenesis. Second, because there is longer survival of patients following renal transplant and therefore a prolonged duration of immunosuppression in these individuals, the development of long-term complications such as SCC of sun-exposed skin may be greater. Third, should genetic profiling of kidneys from potential donors to screen for cancer-associated mutations be performed? And fourth, is this phenomenon restricted only to patients receiving kidneys or might it be a possible complication in the recipients of other organs such as hearts, lungs, or even faces?

We want to know your views! Tell us what you think.

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Battle of the Sexes: “Brotox”

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In the October 2013 issue of Dermatologic Surgery (2013;39:1434-1443), Keaney and Alster reviewed the use of botulinum toxin in men. Although botulinum toxin injection was the most common cosmetic procedure performed in 2011 in both sexes, men represented only 6% of participants. The authors reviewed the sexual differences in the anatomy of treatment areas. As described, men were noted to have more prominent supraorbital ridges, which contributed to a flatter eyebrow contour that was positioned lower along the orbital rim compared to women. Also the medial supraorbital ridge blended into the glabellar complex on men, giving a greater forward projection. Additionally, forehead height and width were greater in men and there was a greater backward slope compared to women. The female forehead had a greater contour and the female orbit was proportionally larger in relation to skull size. With regard to facial musculature, men were thought to have greater skeletal muscle mass. Men were reported to have greater upward vertical movement for facial expressions, which was thought to contribute to the differences in rhytide severity and distribution.

The authors also reviewed 2 published studies that accounted for sex in study design or subgroup analysis. In a study performed by Brandt et al (Dermatol Surg. 2009;35:1893-1901) of abobotulinumtoxinA for the treatment of glabellar lines, 158 participants (23 men [15%]) were randomized (2:1 ratio) to receive a single 50-U injection of abobotulinumtoxinA or placebo. This study found that women in the abobotulinumtoxinA group were more likely to respond than men, and therefore Brandt et al concluded that treatment of the male glabella required an abobotulinumtoxinA dose of more than 50 U.

 

What’s the issue?

The number of men seeking botulinum toxin injections has been increasing and therefore it is important to understand the inherent anatomic differences. There have been numerous clinical articles and trials using botulinum toxin but not all include men. It is important to consider the differences in muscle mass and anatomic differences when injecting botulinum toxin in men. Although clinical trials and studies provide guidelines on dosing, it is important to assess each patient individually according to muscle strength and mass. The standardized doses used in clinical trials may not be appropriate for all patients, especially men, because this patient population is not equally represented in these trials. Some male patients may state that botulinum toxin did not work, which may be due to inherent underdosing for the muscle size or strength. It is important to understand and appreciate these anatomic and structural differences in men when utilizing botulinum toxin. With a growing proportion of men seeking cosmetic treatments, are you equipped to assess the nuances?

We want to know your views! Tell us what you think.

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In the October 2013 issue of Dermatologic Surgery (2013;39:1434-1443), Keaney and Alster reviewed the use of botulinum toxin in men. Although botulinum toxin injection was the most common cosmetic procedure performed in 2011 in both sexes, men represented only 6% of participants. The authors reviewed the sexual differences in the anatomy of treatment areas. As described, men were noted to have more prominent supraorbital ridges, which contributed to a flatter eyebrow contour that was positioned lower along the orbital rim compared to women. Also the medial supraorbital ridge blended into the glabellar complex on men, giving a greater forward projection. Additionally, forehead height and width were greater in men and there was a greater backward slope compared to women. The female forehead had a greater contour and the female orbit was proportionally larger in relation to skull size. With regard to facial musculature, men were thought to have greater skeletal muscle mass. Men were reported to have greater upward vertical movement for facial expressions, which was thought to contribute to the differences in rhytide severity and distribution.

The authors also reviewed 2 published studies that accounted for sex in study design or subgroup analysis. In a study performed by Brandt et al (Dermatol Surg. 2009;35:1893-1901) of abobotulinumtoxinA for the treatment of glabellar lines, 158 participants (23 men [15%]) were randomized (2:1 ratio) to receive a single 50-U injection of abobotulinumtoxinA or placebo. This study found that women in the abobotulinumtoxinA group were more likely to respond than men, and therefore Brandt et al concluded that treatment of the male glabella required an abobotulinumtoxinA dose of more than 50 U.

 

What’s the issue?

The number of men seeking botulinum toxin injections has been increasing and therefore it is important to understand the inherent anatomic differences. There have been numerous clinical articles and trials using botulinum toxin but not all include men. It is important to consider the differences in muscle mass and anatomic differences when injecting botulinum toxin in men. Although clinical trials and studies provide guidelines on dosing, it is important to assess each patient individually according to muscle strength and mass. The standardized doses used in clinical trials may not be appropriate for all patients, especially men, because this patient population is not equally represented in these trials. Some male patients may state that botulinum toxin did not work, which may be due to inherent underdosing for the muscle size or strength. It is important to understand and appreciate these anatomic and structural differences in men when utilizing botulinum toxin. With a growing proportion of men seeking cosmetic treatments, are you equipped to assess the nuances?

We want to know your views! Tell us what you think.

In the October 2013 issue of Dermatologic Surgery (2013;39:1434-1443), Keaney and Alster reviewed the use of botulinum toxin in men. Although botulinum toxin injection was the most common cosmetic procedure performed in 2011 in both sexes, men represented only 6% of participants. The authors reviewed the sexual differences in the anatomy of treatment areas. As described, men were noted to have more prominent supraorbital ridges, which contributed to a flatter eyebrow contour that was positioned lower along the orbital rim compared to women. Also the medial supraorbital ridge blended into the glabellar complex on men, giving a greater forward projection. Additionally, forehead height and width were greater in men and there was a greater backward slope compared to women. The female forehead had a greater contour and the female orbit was proportionally larger in relation to skull size. With regard to facial musculature, men were thought to have greater skeletal muscle mass. Men were reported to have greater upward vertical movement for facial expressions, which was thought to contribute to the differences in rhytide severity and distribution.

The authors also reviewed 2 published studies that accounted for sex in study design or subgroup analysis. In a study performed by Brandt et al (Dermatol Surg. 2009;35:1893-1901) of abobotulinumtoxinA for the treatment of glabellar lines, 158 participants (23 men [15%]) were randomized (2:1 ratio) to receive a single 50-U injection of abobotulinumtoxinA or placebo. This study found that women in the abobotulinumtoxinA group were more likely to respond than men, and therefore Brandt et al concluded that treatment of the male glabella required an abobotulinumtoxinA dose of more than 50 U.

 

What’s the issue?

The number of men seeking botulinum toxin injections has been increasing and therefore it is important to understand the inherent anatomic differences. There have been numerous clinical articles and trials using botulinum toxin but not all include men. It is important to consider the differences in muscle mass and anatomic differences when injecting botulinum toxin in men. Although clinical trials and studies provide guidelines on dosing, it is important to assess each patient individually according to muscle strength and mass. The standardized doses used in clinical trials may not be appropriate for all patients, especially men, because this patient population is not equally represented in these trials. Some male patients may state that botulinum toxin did not work, which may be due to inherent underdosing for the muscle size or strength. It is important to understand and appreciate these anatomic and structural differences in men when utilizing botulinum toxin. With a growing proportion of men seeking cosmetic treatments, are you equipped to assess the nuances?

We want to know your views! Tell us what you think.

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Open Notes, Open Risk?

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The Journal of Medical Internet Research recently outlined a study addressing online patient access to personal medical records (OpenNotes intervention). It is the latest in a series of publications regarding this initiative’s utilization, risks, benefits, and perspectives from physicians as well as from patients. This cohort study surveyed attitudes about privacy in approximately 4000 primary care patients at baseline and 1 year after access to their own medical records via online secure portals. One-third of patients voiced concern about privacy both before and after the study period; however, it did not deter use of the portal, as nearly all participants viewed their records during the study.

 

What’s the issue?

From the standpoint of a patient, OpenNotes provides timely information gathering and transparency in reporting. From the standpoint of physicians and institutions, the same is true. And in a perfect world, all would be well. Currently, at any office, patients can access their records via telephone, fax, or mail, but OpenNotes creates a ubiquitous and rapid portal. The word portal, however, may breed thoughts of hackers, viruses, and worms to laypeople, and thoughts of lawsuits and bureaucracy to providers. This study did not prove that patients consciously trust the system after 1 year, but perhaps they do subconsciously, as they used the portal anyway. What do your patients think of this evolution in information technology, what do providers think, and where might the glitches, if any, emerge?

We want to know your views! Tell us what you think.

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The Journal of Medical Internet Research recently outlined a study addressing online patient access to personal medical records (OpenNotes intervention). It is the latest in a series of publications regarding this initiative’s utilization, risks, benefits, and perspectives from physicians as well as from patients. This cohort study surveyed attitudes about privacy in approximately 4000 primary care patients at baseline and 1 year after access to their own medical records via online secure portals. One-third of patients voiced concern about privacy both before and after the study period; however, it did not deter use of the portal, as nearly all participants viewed their records during the study.

 

What’s the issue?

From the standpoint of a patient, OpenNotes provides timely information gathering and transparency in reporting. From the standpoint of physicians and institutions, the same is true. And in a perfect world, all would be well. Currently, at any office, patients can access their records via telephone, fax, or mail, but OpenNotes creates a ubiquitous and rapid portal. The word portal, however, may breed thoughts of hackers, viruses, and worms to laypeople, and thoughts of lawsuits and bureaucracy to providers. This study did not prove that patients consciously trust the system after 1 year, but perhaps they do subconsciously, as they used the portal anyway. What do your patients think of this evolution in information technology, what do providers think, and where might the glitches, if any, emerge?

We want to know your views! Tell us what you think.

 

 

The Journal of Medical Internet Research recently outlined a study addressing online patient access to personal medical records (OpenNotes intervention). It is the latest in a series of publications regarding this initiative’s utilization, risks, benefits, and perspectives from physicians as well as from patients. This cohort study surveyed attitudes about privacy in approximately 4000 primary care patients at baseline and 1 year after access to their own medical records via online secure portals. One-third of patients voiced concern about privacy both before and after the study period; however, it did not deter use of the portal, as nearly all participants viewed their records during the study.

 

What’s the issue?

From the standpoint of a patient, OpenNotes provides timely information gathering and transparency in reporting. From the standpoint of physicians and institutions, the same is true. And in a perfect world, all would be well. Currently, at any office, patients can access their records via telephone, fax, or mail, but OpenNotes creates a ubiquitous and rapid portal. The word portal, however, may breed thoughts of hackers, viruses, and worms to laypeople, and thoughts of lawsuits and bureaucracy to providers. This study did not prove that patients consciously trust the system after 1 year, but perhaps they do subconsciously, as they used the portal anyway. What do your patients think of this evolution in information technology, what do providers think, and where might the glitches, if any, emerge?

We want to know your views! Tell us what you think.

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Shared Medical Appointments: A New Practice Model for Dermatologists?

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Shared Medical Appointments: A New Practice Model for Dermatologists?

In a recent article published online in Time magazine, “The New Group Medical Checkup,” the potential benefits of shared medical appointments are discussed. The author mentions that “[a]mong those who try shared visits, about 85% don’t go back to individual exams for everything from diabetes to weight loss and skin-related issues.”

A shared medical appointment is a group visit for the patient. For example, patients sign in and have their vital signs taken. If the visit includes a one-on-one examination by the physician, the nonphysician office personnel answers questions for the other patients. Discussion of the patients’ problems and treatments is then conducted in a group setting; additional time (eg, 90 minutes) is allocated to the visit so that the patients can learn from each other’s medical problems and have ample opportunity to ask questions.

Group visits are already being conducted by family medicine practices. It also is anticipated that additional specialties may incorporate shared medical appointments because group visits shall provide an efficient means for lowering costs when major provisions of the Patient Protection and Affordable Care Act are implemented next year.

Group visits can provide advantages for both the physician and the patient. The shared medical appointment enables the physician to streamline the delivery of care without having to repeat the same recommendations to each patient separately. The group visit encourages patients to inquire about their disease and to learn more about their condition by being able to share the experience with other patients.

 

What’s the issue?

The practice of medicine (and dermatology) continues to evolve, from sole practitioners to group practices to multispecialty groups to corporate-owned and -managed institutions. Some of the established means for interaction between the physician and the patient occur in a setting that is either private, hospital based, or concierge. However, social and financial influences are promoting another practice model: shared medical appointments. Is this approach to medical management appropriate for dermatology? If group visits are considered to be an appropriate approach to dermatology patient care, should dermatologists embrace this new concept and incorporate it into their practices?

We want to know your views! Tell us what you think.

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Dr. Cohen is from the Division of Dermatology, University of California San Diego.

Dr. Cohen reports no conflicts of interest in relation to this post.

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Author and Disclosure Information

Dr. Cohen is from the Division of Dermatology, University of California San Diego.

Dr. Cohen reports no conflicts of interest in relation to this post.

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In a recent article published online in Time magazine, “The New Group Medical Checkup,” the potential benefits of shared medical appointments are discussed. The author mentions that “[a]mong those who try shared visits, about 85% don’t go back to individual exams for everything from diabetes to weight loss and skin-related issues.”

A shared medical appointment is a group visit for the patient. For example, patients sign in and have their vital signs taken. If the visit includes a one-on-one examination by the physician, the nonphysician office personnel answers questions for the other patients. Discussion of the patients’ problems and treatments is then conducted in a group setting; additional time (eg, 90 minutes) is allocated to the visit so that the patients can learn from each other’s medical problems and have ample opportunity to ask questions.

Group visits are already being conducted by family medicine practices. It also is anticipated that additional specialties may incorporate shared medical appointments because group visits shall provide an efficient means for lowering costs when major provisions of the Patient Protection and Affordable Care Act are implemented next year.

Group visits can provide advantages for both the physician and the patient. The shared medical appointment enables the physician to streamline the delivery of care without having to repeat the same recommendations to each patient separately. The group visit encourages patients to inquire about their disease and to learn more about their condition by being able to share the experience with other patients.

 

What’s the issue?

The practice of medicine (and dermatology) continues to evolve, from sole practitioners to group practices to multispecialty groups to corporate-owned and -managed institutions. Some of the established means for interaction between the physician and the patient occur in a setting that is either private, hospital based, or concierge. However, social and financial influences are promoting another practice model: shared medical appointments. Is this approach to medical management appropriate for dermatology? If group visits are considered to be an appropriate approach to dermatology patient care, should dermatologists embrace this new concept and incorporate it into their practices?

We want to know your views! Tell us what you think.

In a recent article published online in Time magazine, “The New Group Medical Checkup,” the potential benefits of shared medical appointments are discussed. The author mentions that “[a]mong those who try shared visits, about 85% don’t go back to individual exams for everything from diabetes to weight loss and skin-related issues.”

A shared medical appointment is a group visit for the patient. For example, patients sign in and have their vital signs taken. If the visit includes a one-on-one examination by the physician, the nonphysician office personnel answers questions for the other patients. Discussion of the patients’ problems and treatments is then conducted in a group setting; additional time (eg, 90 minutes) is allocated to the visit so that the patients can learn from each other’s medical problems and have ample opportunity to ask questions.

Group visits are already being conducted by family medicine practices. It also is anticipated that additional specialties may incorporate shared medical appointments because group visits shall provide an efficient means for lowering costs when major provisions of the Patient Protection and Affordable Care Act are implemented next year.

Group visits can provide advantages for both the physician and the patient. The shared medical appointment enables the physician to streamline the delivery of care without having to repeat the same recommendations to each patient separately. The group visit encourages patients to inquire about their disease and to learn more about their condition by being able to share the experience with other patients.

 

What’s the issue?

The practice of medicine (and dermatology) continues to evolve, from sole practitioners to group practices to multispecialty groups to corporate-owned and -managed institutions. Some of the established means for interaction between the physician and the patient occur in a setting that is either private, hospital based, or concierge. However, social and financial influences are promoting another practice model: shared medical appointments. Is this approach to medical management appropriate for dermatology? If group visits are considered to be an appropriate approach to dermatology patient care, should dermatologists embrace this new concept and incorporate it into their practices?

We want to know your views! Tell us what you think.

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