I don’t want to rule the world.

Some doctors do, albeit in a non–Attila-the-Hun sort of way. They want to have offices on every street corner, in every suburb of a given city, sometimes more than one city. Like the Starbucks of medicine.

That’s not me. I’m happy in my little one-office world.

Maybe I just don’t have the ambition, or the business mindset, or whatever it takes to want to do that. I understand it’s all part of wanting to be successful, and obviously those doctors are more driven in that direction than I am. The more offices, the more patients can be seen, and the more money you make.

It’s not quite that simple, though. No one can be in more than one place at the same time, so to see more patients at more places you need more doctors. To pay more doctors requires more money, which in turn requires more patients.

There’s nothing wrong with taking over the world (or at least a suburb) if you like that sort of thing. But to me, more money brings more headaches. More offices to rent, more staff to hire, more people to handle billing, IT, HR, payroll, accounting, contracts, and so on.

You can have it. I’ve taken over all the world I want, in my case a 1,200-square-foot suite on the second floor of a small-to-medium-size medical building. To some that may sound unambitious, but to me, it’s perfect.

I know where my Keurig, Sodastream, and office supplies are. Except for my secretary and her cheerfully rambunctious young daughter, I don’t have to worry about sharing stuff here, or if anyone wants a different carpet color, or what’s going on at a satellite office halfway across town.

If other doctors want to try and take over the world, more power to them, but I’m happy with this. Enough is as good as a feast.
 

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

I don’t want to rule the world.

Some doctors do, albeit in a non–Attila-the-Hun sort of way. They want to have offices on every street corner, in every suburb of a given city, sometimes more than one city. Like the Starbucks of medicine.

That’s not me. I’m happy in my little one-office world.

Maybe I just don’t have the ambition, or the business mindset, or whatever it takes to want to do that. I understand it’s all part of wanting to be successful, and obviously those doctors are more driven in that direction than I am. The more offices, the more patients can be seen, and the more money you make.

It’s not quite that simple, though. No one can be in more than one place at the same time, so to see more patients at more places you need more doctors. To pay more doctors requires more money, which in turn requires more patients.

There’s nothing wrong with taking over the world (or at least a suburb) if you like that sort of thing. But to me, more money brings more headaches. More offices to rent, more staff to hire, more people to handle billing, IT, HR, payroll, accounting, contracts, and so on.

You can have it. I’ve taken over all the world I want, in my case a 1,200-square-foot suite on the second floor of a small-to-medium-size medical building. To some that may sound unambitious, but to me, it’s perfect.

I know where my Keurig, Sodastream, and office supplies are. Except for my secretary and her cheerfully rambunctious young daughter, I don’t have to worry about sharing stuff here, or if anyone wants a different carpet color, or what’s going on at a satellite office halfway across town.

If other doctors want to try and take over the world, more power to them, but I’m happy with this. Enough is as good as a feast.
 

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

I don’t want to rule the world.

Some doctors do, albeit in a non–Attila-the-Hun sort of way. They want to have offices on every street corner, in every suburb of a given city, sometimes more than one city. Like the Starbucks of medicine.

That’s not me. I’m happy in my little one-office world.

Maybe I just don’t have the ambition, or the business mindset, or whatever it takes to want to do that. I understand it’s all part of wanting to be successful, and obviously those doctors are more driven in that direction than I am. The more offices, the more patients can be seen, and the more money you make.

It’s not quite that simple, though. No one can be in more than one place at the same time, so to see more patients at more places you need more doctors. To pay more doctors requires more money, which in turn requires more patients.

There’s nothing wrong with taking over the world (or at least a suburb) if you like that sort of thing. But to me, more money brings more headaches. More offices to rent, more staff to hire, more people to handle billing, IT, HR, payroll, accounting, contracts, and so on.

You can have it. I’ve taken over all the world I want, in my case a 1,200-square-foot suite on the second floor of a small-to-medium-size medical building. To some that may sound unambitious, but to me, it’s perfect.

I know where my Keurig, Sodastream, and office supplies are. Except for my secretary and her cheerfully rambunctious young daughter, I don’t have to worry about sharing stuff here, or if anyone wants a different carpet color, or what’s going on at a satellite office halfway across town.

If other doctors want to try and take over the world, more power to them, but I’m happy with this. Enough is as good as a feast.
 

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

Unmet medical needs are of concern to patients who experience migraine treated with triptans and there may be an undertreatment with preventive therapies whose benefit is insufficient, a new study found. The study cohort consisted of participants with ≥4 triptan dose units per month, selected from the general population. Patients were stratified into: possible Low-Frequency Episodic Migraine (pLF-EM: 4-9 triptan dose units per month), possible High-Frequency Episodic Migraine (pHF-EM: 10-14 triptan dose units per month), and possible Chronic Migraine (pCM: 14 triptan dose units per month). Researchers found:

• Of 10,270,683 adults, 8 per 1000 were triptan users and of these, 38.2% were migraineurs with unmet medical needs.
• 72.3% of patients were affected by pLF-EM, 17.4% by pHF-EM, and 10.3% by pCM.
• 19.1% of patients used oral preventive drugs.
• Triptan use reduction was found in 22.3% of patients, decreasing with the intensification of need levels.

Piccinni C, Cevoli S, Martini N. A real-world study on unmet medical needs in triptan-treated migraine: prevalence, preventive therapies and triptan use modification from a large Italian population along two years. [Published online ahead of print June 27, 2019]. J Headache Pain. doi: 10.1186/s10194-019-1027-7.

Unmet medical needs are of concern to patients who experience migraine treated with triptans and there may be an undertreatment with preventive therapies whose benefit is insufficient, a new study found. The study cohort consisted of participants with ≥4 triptan dose units per month, selected from the general population. Patients were stratified into: possible Low-Frequency Episodic Migraine (pLF-EM: 4-9 triptan dose units per month), possible High-Frequency Episodic Migraine (pHF-EM: 10-14 triptan dose units per month), and possible Chronic Migraine (pCM: 14 triptan dose units per month). Researchers found:

• Of 10,270,683 adults, 8 per 1000 were triptan users and of these, 38.2% were migraineurs with unmet medical needs.
• 72.3% of patients were affected by pLF-EM, 17.4% by pHF-EM, and 10.3% by pCM.
• 19.1% of patients used oral preventive drugs.
• Triptan use reduction was found in 22.3% of patients, decreasing with the intensification of need levels.

Piccinni C, Cevoli S, Martini N. A real-world study on unmet medical needs in triptan-treated migraine: prevalence, preventive therapies and triptan use modification from a large Italian population along two years. [Published online ahead of print June 27, 2019]. J Headache Pain. doi: 10.1186/s10194-019-1027-7.

Unmet medical needs are of concern to patients who experience migraine treated with triptans and there may be an undertreatment with preventive therapies whose benefit is insufficient, a new study found. The study cohort consisted of participants with ≥4 triptan dose units per month, selected from the general population. Patients were stratified into: possible Low-Frequency Episodic Migraine (pLF-EM: 4-9 triptan dose units per month), possible High-Frequency Episodic Migraine (pHF-EM: 10-14 triptan dose units per month), and possible Chronic Migraine (pCM: 14 triptan dose units per month). Researchers found:

• Of 10,270,683 adults, 8 per 1000 were triptan users and of these, 38.2% were migraineurs with unmet medical needs.
• 72.3% of patients were affected by pLF-EM, 17.4% by pHF-EM, and 10.3% by pCM.
• 19.1% of patients used oral preventive drugs.
• Triptan use reduction was found in 22.3% of patients, decreasing with the intensification of need levels.

Piccinni C, Cevoli S, Martini N. A real-world study on unmet medical needs in triptan-treated migraine: prevalence, preventive therapies and triptan use modification from a large Italian population along two years. [Published online ahead of print June 27, 2019]. J Headache Pain. doi: 10.1186/s10194-019-1027-7.

Hearn Jay Cho, MD, PhD, has been appointed chief medical officer of the Multiple Myeloma Research Foundation (MMRF). In this role, Dr. Cho will develop a clinical research strategy and accelerate drug development programs for the MMRF. He will also lead the Multiple Myeloma Research Consortium, a group of 25 research centers focused on multiple myeloma.

Dr. Cho will continue on as an associate professor of medicine at the Icahn School of Medicine at Mt. Sinai in New York, and as an attending physician with the multiple myeloma service at the Mt. Sinai Tisch Cancer Institute. He will also continue to manage his lab at Mt. Sinai.

Michael Jay Styler, MD, has joined the department of hematology/oncology as an associate professor in the academic clinician track as part of the bone marrow transplant program at Fox Chase Cancer Center in Philadelphia.

Dr. Styler was previously medical director of the transplant center, apheresis center, and collection center at Hahnemann University Hospital in Philadelphia, as well as medical director of the stem cell transplant program and the clinical service chief of hematology/oncology. Dr. Styler was also an associate professor at Drexel University, Philadelphia, where he served as division director of hematology/oncology and associate fellowship director of the hematology/oncology program.

Jaspreet Chahal, MD, has joined the Oncology Institute of Hope and Innovation, which has locations in Arizona, California, and Nevada. Dr. Chahal will serve patients in Tucson and Green Valley, Ariz.

Dr. Chahal has a doctor of medicine degree from St. George’s University in West Indies, Grenada. She completed her internship in hematology and oncology at Hofstra University, Hempstead, N.Y., and her residency in internal medicine at the University of Arizona in Tucson.

Marcin Chwistek, MD, has been appointed editor in chief of AAHPM Quarterly, which is published by the American Academy of Hospice and Palliative Medicine. Dr. Chwistek is an associate professor in the department of hematology/oncology at Fox Chase Cancer Center in Philadelphia, where he is also director of the pain and palliative care program.

As editor in chief of AAHPM Quarterly, Dr. Chwistek will work with other members of the editorial board to develop content related to hospice care and palliative medicine. Dr. Chwistek previously served as the associate editor in chief of AAHPM Quarterly and writes a column that appears in every issue.
 

Movers in Medicine highlights career moves and personal achievements by hematologists and oncologists. Did you switch jobs, take on a new role, climb a mountain? Tell us all about it at [email protected] , and you could be featured in Movers in Medicine.

[email protected]

Hearn Jay Cho, MD, PhD, has been appointed chief medical officer of the Multiple Myeloma Research Foundation (MMRF). In this role, Dr. Cho will develop a clinical research strategy and accelerate drug development programs for the MMRF. He will also lead the Multiple Myeloma Research Consortium, a group of 25 research centers focused on multiple myeloma.

Dr. Cho will continue on as an associate professor of medicine at the Icahn School of Medicine at Mt. Sinai in New York, and as an attending physician with the multiple myeloma service at the Mt. Sinai Tisch Cancer Institute. He will also continue to manage his lab at Mt. Sinai.

Michael Jay Styler, MD, has joined the department of hematology/oncology as an associate professor in the academic clinician track as part of the bone marrow transplant program at Fox Chase Cancer Center in Philadelphia.

Dr. Styler was previously medical director of the transplant center, apheresis center, and collection center at Hahnemann University Hospital in Philadelphia, as well as medical director of the stem cell transplant program and the clinical service chief of hematology/oncology. Dr. Styler was also an associate professor at Drexel University, Philadelphia, where he served as division director of hematology/oncology and associate fellowship director of the hematology/oncology program.

Jaspreet Chahal, MD, has joined the Oncology Institute of Hope and Innovation, which has locations in Arizona, California, and Nevada. Dr. Chahal will serve patients in Tucson and Green Valley, Ariz.

Dr. Chahal has a doctor of medicine degree from St. George’s University in West Indies, Grenada. She completed her internship in hematology and oncology at Hofstra University, Hempstead, N.Y., and her residency in internal medicine at the University of Arizona in Tucson.

Marcin Chwistek, MD, has been appointed editor in chief of AAHPM Quarterly, which is published by the American Academy of Hospice and Palliative Medicine. Dr. Chwistek is an associate professor in the department of hematology/oncology at Fox Chase Cancer Center in Philadelphia, where he is also director of the pain and palliative care program.

As editor in chief of AAHPM Quarterly, Dr. Chwistek will work with other members of the editorial board to develop content related to hospice care and palliative medicine. Dr. Chwistek previously served as the associate editor in chief of AAHPM Quarterly and writes a column that appears in every issue.
 

Movers in Medicine highlights career moves and personal achievements by hematologists and oncologists. Did you switch jobs, take on a new role, climb a mountain? Tell us all about it at [email protected] , and you could be featured in Movers in Medicine.

[email protected]

Hearn Jay Cho, MD, PhD, has been appointed chief medical officer of the Multiple Myeloma Research Foundation (MMRF). In this role, Dr. Cho will develop a clinical research strategy and accelerate drug development programs for the MMRF. He will also lead the Multiple Myeloma Research Consortium, a group of 25 research centers focused on multiple myeloma.

Dr. Cho will continue on as an associate professor of medicine at the Icahn School of Medicine at Mt. Sinai in New York, and as an attending physician with the multiple myeloma service at the Mt. Sinai Tisch Cancer Institute. He will also continue to manage his lab at Mt. Sinai.

Michael Jay Styler, MD, has joined the department of hematology/oncology as an associate professor in the academic clinician track as part of the bone marrow transplant program at Fox Chase Cancer Center in Philadelphia.

Dr. Styler was previously medical director of the transplant center, apheresis center, and collection center at Hahnemann University Hospital in Philadelphia, as well as medical director of the stem cell transplant program and the clinical service chief of hematology/oncology. Dr. Styler was also an associate professor at Drexel University, Philadelphia, where he served as division director of hematology/oncology and associate fellowship director of the hematology/oncology program.

Jaspreet Chahal, MD, has joined the Oncology Institute of Hope and Innovation, which has locations in Arizona, California, and Nevada. Dr. Chahal will serve patients in Tucson and Green Valley, Ariz.

Dr. Chahal has a doctor of medicine degree from St. George’s University in West Indies, Grenada. She completed her internship in hematology and oncology at Hofstra University, Hempstead, N.Y., and her residency in internal medicine at the University of Arizona in Tucson.

Marcin Chwistek, MD, has been appointed editor in chief of AAHPM Quarterly, which is published by the American Academy of Hospice and Palliative Medicine. Dr. Chwistek is an associate professor in the department of hematology/oncology at Fox Chase Cancer Center in Philadelphia, where he is also director of the pain and palliative care program.

As editor in chief of AAHPM Quarterly, Dr. Chwistek will work with other members of the editorial board to develop content related to hospice care and palliative medicine. Dr. Chwistek previously served as the associate editor in chief of AAHPM Quarterly and writes a column that appears in every issue.
 

Movers in Medicine highlights career moves and personal achievements by hematologists and oncologists. Did you switch jobs, take on a new role, climb a mountain? Tell us all about it at [email protected] , and you could be featured in Movers in Medicine.

[email protected]

SAN DIEGO – When weighing an offer to join a dermatology practice, don’t allow legal considerations to drive your decision making, Mathew M. Avram, MD, JD, advised at the annual Masters of Aesthetics Symposium.

“Determine your professional interests and follow them accordingly,” said Dr. Avram, director of laser, cosmetics, and dermatologic surgery at Massachusetts General Hospital in Boston. “Your decision as to whether to join a particular practice should not be based upon a contract. Make certain to determine the business end of your deal with any new employer first: the compensation, the work hours, etc. Decide that upfront before you get into the legal details.”

The way he sees it, your relationship with your employer will always be paramount. “This is very important,” said Dr. Avram, who practiced law before he became a dermatologist. “A good contract with a bad employer will not save you from an unhappy employment experience. Few contracts ever end up in litigation, and you cannot sue your way to a happier work experience. Trust your intuition about people; trust your underlying interest in potentially working with this person, and work from there.”

Whether you choose to work in an academic practice, a private practice, or a hybrid, the key issues to address include compensation, benefits, work hours, job responsibilities, and future partnership possibilities. “As an employee, you have the greatest leverage prior to signing an agreement,” he said. “This is the time to ask for what you want.” This may include special requests such as asking the employer to purchase lasers or other special equipment for your office, or to set aside dedicated clinical time for cosmetic procedures, so that you can build a cosmetic practice.

If you’re mulling over a job offer in academics, consider asking for an academic title, what the scope of your authority is, and about your ability to hire or prevent the hiring of others. “Let’s say you’re starting a laser center in your academic center,” said Dr. Avram, who is a past president of the American Society for Laser Medicine and Surgery. “You may not want to find out after you’ve signed your contract that they’ve hired five other people to do the same thing.”

If you’re considering a job offer from a private practice, ask for specifics about bonuses, partnership track, scope of practice, and device purchases. “You want to have that decided before you sign,” he said. “But these are business issues, not legal issues. An agreement needs to be made between you and your employer as to these issues. Once they’ve been agreed upon, it’s time to proceed with a contract. This is where legal advice becomes helpful.” The trick is to negotiate in good faith while maintaining your relationship with your new employer. “Do not destroy your relationship over legal points, but do not cave on crucial issues for fear of upsetting your new employer,” he said.

In law school, Dr. Avram learned that there is no such thing as a standard employment contract. Any contract can be amended, no matter how large or small the institution. “You can amend a mortgage agreement, so you can certainly amend a physician employment contract,” he said. “If the employer is not going to put their commitments in writing, they are probably not going to honor that commitment to you. Written agreements supersede all preceding oral agreements. Each key term needs to be stated explicitly. If not, you have lost all leverage to enforce your initial agreement.”

Key provisions are restrictive covenants and at-will employment. Dr. Avram defined restrictive covenants as contractual agreements that attempt to restrict an employee so as to limit that person’s ability to compete. “This can include noncompete clauses, nonsolicitation agreements, and confidentiality agreements,” he said. “A noncompete agreement prohibits a doctor from competing against their former practice within a specific geographic area for a period of time after the employment has ended. The nonsolicitation agreement restricts the manner and time during which a physician can solicit patients or employees from a practice after termination of employment. A confidentiality agreement is usually indefinite as to time and it restricts the employee from disclosing confidential practice information.”

State laws, he continued, govern restrictive covenants. Some states prohibit them. States that allow them limit their scope to prevent undue burden on the employee’s ability to make a living after termination. “Restrictive covenants in cities need to be narrower than those in rural areas,” he said. “Overly broad restrictive covenants may be unenforceable. Courts can ‘blue line’ covenants to make them more reasonable in scope.”

Next, Dr. Avram discussed involuntary termination in the workplace. Termination with cause means that termination can only result from violation of policy or ethics code violation or significantly poor performance. “In the absence of these circumstances, termination cannot legally proceed,” he said. “This protects the employee from an arbitrary termination.”

On the other hand, at-will employees can be terminated without cause. “It’s a much easier standard to terminate an at-will employee, as long as the reason is not illegal,” he said. “In academic centers, your employment as a physician may require a for-cause termination, whereas your administrative title may be without cause.”

One way to avoid potential legal trouble is to abide by your employer’s rules governing a physician’s interactions with industry. “It is foolish to break those rules,” Dr. Avram said. “Transparency ahead of time is always your best policy. Remember: Your day job is far more valuable to you than part-time work with industry. Also, know that pharma payments are publicly reported by the Centers for Medicare & Medicaid Services.” When it comes to establishing contracts with industry, “read them carefully and have your academic center approve them, if applicable,” he said. “Watch out for noncompete clauses, and some contracts require that you do not speak negatively about your findings. That’s something you should try to avoid.”

Dr. Avram also advised clinicians not to discuss intellectual property with industry representatives. “Do not give away your intellectual property to industry when you’re consulting with them,” he said. “It is easier to do than you might think. If you have a great idea, keep it to yourself or get it protected. This is much easier for an institution where they want you to do these things. They take ownership of a lot of it, but they make it easier to do. Otherwise, you have to go through the expensive process of getting a patent.”

Dr. Avram reported that he has received consulting fees from Allergan, Merz Pharma, Sciton, Soliton, and Zalea. He also reported having ownership and/or shareholder interest in Cytrellis Biosystems, InMode, and Zalea, and intellectual property rights with Cytrellis.

[email protected]

SAN DIEGO – When weighing an offer to join a dermatology practice, don’t allow legal considerations to drive your decision making, Mathew M. Avram, MD, JD, advised at the annual Masters of Aesthetics Symposium.

“Determine your professional interests and follow them accordingly,” said Dr. Avram, director of laser, cosmetics, and dermatologic surgery at Massachusetts General Hospital in Boston. “Your decision as to whether to join a particular practice should not be based upon a contract. Make certain to determine the business end of your deal with any new employer first: the compensation, the work hours, etc. Decide that upfront before you get into the legal details.”

The way he sees it, your relationship with your employer will always be paramount. “This is very important,” said Dr. Avram, who practiced law before he became a dermatologist. “A good contract with a bad employer will not save you from an unhappy employment experience. Few contracts ever end up in litigation, and you cannot sue your way to a happier work experience. Trust your intuition about people; trust your underlying interest in potentially working with this person, and work from there.”

Whether you choose to work in an academic practice, a private practice, or a hybrid, the key issues to address include compensation, benefits, work hours, job responsibilities, and future partnership possibilities. “As an employee, you have the greatest leverage prior to signing an agreement,” he said. “This is the time to ask for what you want.” This may include special requests such as asking the employer to purchase lasers or other special equipment for your office, or to set aside dedicated clinical time for cosmetic procedures, so that you can build a cosmetic practice.

If you’re mulling over a job offer in academics, consider asking for an academic title, what the scope of your authority is, and about your ability to hire or prevent the hiring of others. “Let’s say you’re starting a laser center in your academic center,” said Dr. Avram, who is a past president of the American Society for Laser Medicine and Surgery. “You may not want to find out after you’ve signed your contract that they’ve hired five other people to do the same thing.”

If you’re considering a job offer from a private practice, ask for specifics about bonuses, partnership track, scope of practice, and device purchases. “You want to have that decided before you sign,” he said. “But these are business issues, not legal issues. An agreement needs to be made between you and your employer as to these issues. Once they’ve been agreed upon, it’s time to proceed with a contract. This is where legal advice becomes helpful.” The trick is to negotiate in good faith while maintaining your relationship with your new employer. “Do not destroy your relationship over legal points, but do not cave on crucial issues for fear of upsetting your new employer,” he said.

In law school, Dr. Avram learned that there is no such thing as a standard employment contract. Any contract can be amended, no matter how large or small the institution. “You can amend a mortgage agreement, so you can certainly amend a physician employment contract,” he said. “If the employer is not going to put their commitments in writing, they are probably not going to honor that commitment to you. Written agreements supersede all preceding oral agreements. Each key term needs to be stated explicitly. If not, you have lost all leverage to enforce your initial agreement.”

Key provisions are restrictive covenants and at-will employment. Dr. Avram defined restrictive covenants as contractual agreements that attempt to restrict an employee so as to limit that person’s ability to compete. “This can include noncompete clauses, nonsolicitation agreements, and confidentiality agreements,” he said. “A noncompete agreement prohibits a doctor from competing against their former practice within a specific geographic area for a period of time after the employment has ended. The nonsolicitation agreement restricts the manner and time during which a physician can solicit patients or employees from a practice after termination of employment. A confidentiality agreement is usually indefinite as to time and it restricts the employee from disclosing confidential practice information.”

State laws, he continued, govern restrictive covenants. Some states prohibit them. States that allow them limit their scope to prevent undue burden on the employee’s ability to make a living after termination. “Restrictive covenants in cities need to be narrower than those in rural areas,” he said. “Overly broad restrictive covenants may be unenforceable. Courts can ‘blue line’ covenants to make them more reasonable in scope.”

Next, Dr. Avram discussed involuntary termination in the workplace. Termination with cause means that termination can only result from violation of policy or ethics code violation or significantly poor performance. “In the absence of these circumstances, termination cannot legally proceed,” he said. “This protects the employee from an arbitrary termination.”

On the other hand, at-will employees can be terminated without cause. “It’s a much easier standard to terminate an at-will employee, as long as the reason is not illegal,” he said. “In academic centers, your employment as a physician may require a for-cause termination, whereas your administrative title may be without cause.”

One way to avoid potential legal trouble is to abide by your employer’s rules governing a physician’s interactions with industry. “It is foolish to break those rules,” Dr. Avram said. “Transparency ahead of time is always your best policy. Remember: Your day job is far more valuable to you than part-time work with industry. Also, know that pharma payments are publicly reported by the Centers for Medicare & Medicaid Services.” When it comes to establishing contracts with industry, “read them carefully and have your academic center approve them, if applicable,” he said. “Watch out for noncompete clauses, and some contracts require that you do not speak negatively about your findings. That’s something you should try to avoid.”

Dr. Avram also advised clinicians not to discuss intellectual property with industry representatives. “Do not give away your intellectual property to industry when you’re consulting with them,” he said. “It is easier to do than you might think. If you have a great idea, keep it to yourself or get it protected. This is much easier for an institution where they want you to do these things. They take ownership of a lot of it, but they make it easier to do. Otherwise, you have to go through the expensive process of getting a patent.”

Dr. Avram reported that he has received consulting fees from Allergan, Merz Pharma, Sciton, Soliton, and Zalea. He also reported having ownership and/or shareholder interest in Cytrellis Biosystems, InMode, and Zalea, and intellectual property rights with Cytrellis.

[email protected]

SAN DIEGO – When weighing an offer to join a dermatology practice, don’t allow legal considerations to drive your decision making, Mathew M. Avram, MD, JD, advised at the annual Masters of Aesthetics Symposium.

“Determine your professional interests and follow them accordingly,” said Dr. Avram, director of laser, cosmetics, and dermatologic surgery at Massachusetts General Hospital in Boston. “Your decision as to whether to join a particular practice should not be based upon a contract. Make certain to determine the business end of your deal with any new employer first: the compensation, the work hours, etc. Decide that upfront before you get into the legal details.”

The way he sees it, your relationship with your employer will always be paramount. “This is very important,” said Dr. Avram, who practiced law before he became a dermatologist. “A good contract with a bad employer will not save you from an unhappy employment experience. Few contracts ever end up in litigation, and you cannot sue your way to a happier work experience. Trust your intuition about people; trust your underlying interest in potentially working with this person, and work from there.”

Whether you choose to work in an academic practice, a private practice, or a hybrid, the key issues to address include compensation, benefits, work hours, job responsibilities, and future partnership possibilities. “As an employee, you have the greatest leverage prior to signing an agreement,” he said. “This is the time to ask for what you want.” This may include special requests such as asking the employer to purchase lasers or other special equipment for your office, or to set aside dedicated clinical time for cosmetic procedures, so that you can build a cosmetic practice.

If you’re mulling over a job offer in academics, consider asking for an academic title, what the scope of your authority is, and about your ability to hire or prevent the hiring of others. “Let’s say you’re starting a laser center in your academic center,” said Dr. Avram, who is a past president of the American Society for Laser Medicine and Surgery. “You may not want to find out after you’ve signed your contract that they’ve hired five other people to do the same thing.”

If you’re considering a job offer from a private practice, ask for specifics about bonuses, partnership track, scope of practice, and device purchases. “You want to have that decided before you sign,” he said. “But these are business issues, not legal issues. An agreement needs to be made between you and your employer as to these issues. Once they’ve been agreed upon, it’s time to proceed with a contract. This is where legal advice becomes helpful.” The trick is to negotiate in good faith while maintaining your relationship with your new employer. “Do not destroy your relationship over legal points, but do not cave on crucial issues for fear of upsetting your new employer,” he said.

In law school, Dr. Avram learned that there is no such thing as a standard employment contract. Any contract can be amended, no matter how large or small the institution. “You can amend a mortgage agreement, so you can certainly amend a physician employment contract,” he said. “If the employer is not going to put their commitments in writing, they are probably not going to honor that commitment to you. Written agreements supersede all preceding oral agreements. Each key term needs to be stated explicitly. If not, you have lost all leverage to enforce your initial agreement.”

Key provisions are restrictive covenants and at-will employment. Dr. Avram defined restrictive covenants as contractual agreements that attempt to restrict an employee so as to limit that person’s ability to compete. “This can include noncompete clauses, nonsolicitation agreements, and confidentiality agreements,” he said. “A noncompete agreement prohibits a doctor from competing against their former practice within a specific geographic area for a period of time after the employment has ended. The nonsolicitation agreement restricts the manner and time during which a physician can solicit patients or employees from a practice after termination of employment. A confidentiality agreement is usually indefinite as to time and it restricts the employee from disclosing confidential practice information.”

State laws, he continued, govern restrictive covenants. Some states prohibit them. States that allow them limit their scope to prevent undue burden on the employee’s ability to make a living after termination. “Restrictive covenants in cities need to be narrower than those in rural areas,” he said. “Overly broad restrictive covenants may be unenforceable. Courts can ‘blue line’ covenants to make them more reasonable in scope.”

Next, Dr. Avram discussed involuntary termination in the workplace. Termination with cause means that termination can only result from violation of policy or ethics code violation or significantly poor performance. “In the absence of these circumstances, termination cannot legally proceed,” he said. “This protects the employee from an arbitrary termination.”

On the other hand, at-will employees can be terminated without cause. “It’s a much easier standard to terminate an at-will employee, as long as the reason is not illegal,” he said. “In academic centers, your employment as a physician may require a for-cause termination, whereas your administrative title may be without cause.”

One way to avoid potential legal trouble is to abide by your employer’s rules governing a physician’s interactions with industry. “It is foolish to break those rules,” Dr. Avram said. “Transparency ahead of time is always your best policy. Remember: Your day job is far more valuable to you than part-time work with industry. Also, know that pharma payments are publicly reported by the Centers for Medicare & Medicaid Services.” When it comes to establishing contracts with industry, “read them carefully and have your academic center approve them, if applicable,” he said. “Watch out for noncompete clauses, and some contracts require that you do not speak negatively about your findings. That’s something you should try to avoid.”

Dr. Avram also advised clinicians not to discuss intellectual property with industry representatives. “Do not give away your intellectual property to industry when you’re consulting with them,” he said. “It is easier to do than you might think. If you have a great idea, keep it to yourself or get it protected. This is much easier for an institution where they want you to do these things. They take ownership of a lot of it, but they make it easier to do. Otherwise, you have to go through the expensive process of getting a patent.”

Dr. Avram reported that he has received consulting fees from Allergan, Merz Pharma, Sciton, Soliton, and Zalea. He also reported having ownership and/or shareholder interest in Cytrellis Biosystems, InMode, and Zalea, and intellectual property rights with Cytrellis.

[email protected]

Variables such as disability, depression, and lack of anger control are among the key factors associated with headache chronicity in patients who experience migraine, a new study found. The cross-sectional study included a target sample of 250 patients with acute or chronic migraine. All participants filled out questionnaires related to demographic characteristics, pain intensity, disability, depression, emotional intelligence, and anger. Researchers found:

• Patients with chronic migraine experienced higher levels of disability, depression, anger, and had lower levels of emotional intelligence vs patients with acute migraine.
• Variables that had a significant effect on headache chronicity were female gender, married status, lower level of education, headache duration, disability, depression, and anger.

Emadi F, Sharif F, Shaygan M, Sharifi N, Ashjazadeh N. Comparison of pain-related and psychological variables between acute and chronic migraine patients, and factors affecting headache chronicity. Int J Community Based Nurs Midwifery. 2019;7(3):192-200. doi: 10.30476/IJCBNM.2019.44994.

Variables such as disability, depression, and lack of anger control are among the key factors associated with headache chronicity in patients who experience migraine, a new study found. The cross-sectional study included a target sample of 250 patients with acute or chronic migraine. All participants filled out questionnaires related to demographic characteristics, pain intensity, disability, depression, emotional intelligence, and anger. Researchers found:

• Patients with chronic migraine experienced higher levels of disability, depression, anger, and had lower levels of emotional intelligence vs patients with acute migraine.
• Variables that had a significant effect on headache chronicity were female gender, married status, lower level of education, headache duration, disability, depression, and anger.

Emadi F, Sharif F, Shaygan M, Sharifi N, Ashjazadeh N. Comparison of pain-related and psychological variables between acute and chronic migraine patients, and factors affecting headache chronicity. Int J Community Based Nurs Midwifery. 2019;7(3):192-200. doi: 10.30476/IJCBNM.2019.44994.

Variables such as disability, depression, and lack of anger control are among the key factors associated with headache chronicity in patients who experience migraine, a new study found. The cross-sectional study included a target sample of 250 patients with acute or chronic migraine. All participants filled out questionnaires related to demographic characteristics, pain intensity, disability, depression, emotional intelligence, and anger. Researchers found:

• Patients with chronic migraine experienced higher levels of disability, depression, anger, and had lower levels of emotional intelligence vs patients with acute migraine.
• Variables that had a significant effect on headache chronicity were female gender, married status, lower level of education, headache duration, disability, depression, and anger.

Emadi F, Sharif F, Shaygan M, Sharifi N, Ashjazadeh N. Comparison of pain-related and psychological variables between acute and chronic migraine patients, and factors affecting headache chronicity. Int J Community Based Nurs Midwifery. 2019;7(3):192-200. doi: 10.30476/IJCBNM.2019.44994.

Among preschool children with cystic fibrosis, airway disease as measured by the Perth-Rotterdam Annotated Grid Morphometric Analysis for CF (PRAGMA-CF) accurately predicts bronchiectasis in grade school, reported Nynke R. Bouma, BSc, and colleagues.

“Even though bronchiectasis is present in 60% to 80% of children with CF in school age, the extent and severity of bronchiectasis in preschool children are generally lower ... however, diffuse airway abnormalities such as airway wall thickening and mucus plugging are observed in many preschool children. It is hypothesized that these preschool airway changes reflect diffuse airway disease that eventually will result in bronchiectasis in school age,” they noted.

The PRAGMA-CF image scoring system can measure airway disease and can also be used to monitor disease progression, noted Ms. Bouma of Sophia Children’s Hospital, Rotterdam, and colleagues. The study was published in Pediatric Pulmonology. PRAGMA-CF is a composite score of airway wall thickening, mucus plugging, and bronchiectasis as percent disease (%disease). “In preschool children, %disease measured by PRAGMA-CF on chest CT allows quantification of early clinically relevant morphological features of CF airway disease and it is associated with later school-age bronchiectasis,” the team wrote. “These findings support the use of %disease as a clinically relevant outcome measure in early CF lung disease.”

The team conducted a prospective cohort study of 61 children (mean age 4 years) with cystic fibrosis, following them for a mean of 5 years. A total of 122 CT scans were available from this group, in addition to spirometry data and cystic fibrosis quality of life scores.

From preschool age to school age, the %disease on PRAGMA-CF increased significantly, from a mean of 0.7% to 1.73%. Scores on another composite measuring tool (%MUPAT, a composite score of airway wall thickening and mucus plugging) went from 0.46 to 0.58 – not a significant difference.

A multivariate analysis corrected for age in each school group and the type of scanner used to acquire the images. That analysis determined that each 1% increase in %disease at preschool age resulted in an increase of 1.18% of bronchiectasis at school age.

A cross-sectional analysis of the group at school age found significant associations between the %disease and percent of forced expiratory volume and the cystic fibrosis quality of life score.

At least one pulmonary exacerbation requiring intravenous antibiotics occurred in 19 of the patients. However, the investigators didn’t find any significant interactions between the %disease in preschool and these exacerbations..

“These findings are in line with previous studies in school‐aged children that showed that mucus plugging is associated with inflammation and airway wall thickening, and that these are thought to be risk factors for later bronchiectasis,” they concluded. “On the basis of our findings, we suggest that %disease and %MUPAT could be used as a clinically relevant outcome measure in clinical studies in preschool patients with cystic fibrosis, as these measures predict later bronchiectasis. Percent disease may be preferred as it captures all the principal features of CF airways disease including bronchiectasis.”

Ms. Bouma had no financial disclosures.

[email protected]

SOURCE: Bouma NR et al. Pediatr Pulmonol. 2019 Sep 9 doi: 10.1002/ppul.24498; Rosenow et al. Am J Respir Crit Care Med. 2015 May 15. doi: 10.1164/rccm.201501-0061OC.

Among preschool children with cystic fibrosis, airway disease as measured by the Perth-Rotterdam Annotated Grid Morphometric Analysis for CF (PRAGMA-CF) accurately predicts bronchiectasis in grade school, reported Nynke R. Bouma, BSc, and colleagues.

“Even though bronchiectasis is present in 60% to 80% of children with CF in school age, the extent and severity of bronchiectasis in preschool children are generally lower ... however, diffuse airway abnormalities such as airway wall thickening and mucus plugging are observed in many preschool children. It is hypothesized that these preschool airway changes reflect diffuse airway disease that eventually will result in bronchiectasis in school age,” they noted.

The PRAGMA-CF image scoring system can measure airway disease and can also be used to monitor disease progression, noted Ms. Bouma of Sophia Children’s Hospital, Rotterdam, and colleagues. The study was published in Pediatric Pulmonology. PRAGMA-CF is a composite score of airway wall thickening, mucus plugging, and bronchiectasis as percent disease (%disease). “In preschool children, %disease measured by PRAGMA-CF on chest CT allows quantification of early clinically relevant morphological features of CF airway disease and it is associated with later school-age bronchiectasis,” the team wrote. “These findings support the use of %disease as a clinically relevant outcome measure in early CF lung disease.”

The team conducted a prospective cohort study of 61 children (mean age 4 years) with cystic fibrosis, following them for a mean of 5 years. A total of 122 CT scans were available from this group, in addition to spirometry data and cystic fibrosis quality of life scores.

From preschool age to school age, the %disease on PRAGMA-CF increased significantly, from a mean of 0.7% to 1.73%. Scores on another composite measuring tool (%MUPAT, a composite score of airway wall thickening and mucus plugging) went from 0.46 to 0.58 – not a significant difference.

A multivariate analysis corrected for age in each school group and the type of scanner used to acquire the images. That analysis determined that each 1% increase in %disease at preschool age resulted in an increase of 1.18% of bronchiectasis at school age.

A cross-sectional analysis of the group at school age found significant associations between the %disease and percent of forced expiratory volume and the cystic fibrosis quality of life score.

At least one pulmonary exacerbation requiring intravenous antibiotics occurred in 19 of the patients. However, the investigators didn’t find any significant interactions between the %disease in preschool and these exacerbations..

“These findings are in line with previous studies in school‐aged children that showed that mucus plugging is associated with inflammation and airway wall thickening, and that these are thought to be risk factors for later bronchiectasis,” they concluded. “On the basis of our findings, we suggest that %disease and %MUPAT could be used as a clinically relevant outcome measure in clinical studies in preschool patients with cystic fibrosis, as these measures predict later bronchiectasis. Percent disease may be preferred as it captures all the principal features of CF airways disease including bronchiectasis.”

Ms. Bouma had no financial disclosures.

[email protected]

SOURCE: Bouma NR et al. Pediatr Pulmonol. 2019 Sep 9 doi: 10.1002/ppul.24498; Rosenow et al. Am J Respir Crit Care Med. 2015 May 15. doi: 10.1164/rccm.201501-0061OC.

Among preschool children with cystic fibrosis, airway disease as measured by the Perth-Rotterdam Annotated Grid Morphometric Analysis for CF (PRAGMA-CF) accurately predicts bronchiectasis in grade school, reported Nynke R. Bouma, BSc, and colleagues.

“Even though bronchiectasis is present in 60% to 80% of children with CF in school age, the extent and severity of bronchiectasis in preschool children are generally lower ... however, diffuse airway abnormalities such as airway wall thickening and mucus plugging are observed in many preschool children. It is hypothesized that these preschool airway changes reflect diffuse airway disease that eventually will result in bronchiectasis in school age,” they noted.

The PRAGMA-CF image scoring system can measure airway disease and can also be used to monitor disease progression, noted Ms. Bouma of Sophia Children’s Hospital, Rotterdam, and colleagues. The study was published in Pediatric Pulmonology. PRAGMA-CF is a composite score of airway wall thickening, mucus plugging, and bronchiectasis as percent disease (%disease). “In preschool children, %disease measured by PRAGMA-CF on chest CT allows quantification of early clinically relevant morphological features of CF airway disease and it is associated with later school-age bronchiectasis,” the team wrote. “These findings support the use of %disease as a clinically relevant outcome measure in early CF lung disease.”

The team conducted a prospective cohort study of 61 children (mean age 4 years) with cystic fibrosis, following them for a mean of 5 years. A total of 122 CT scans were available from this group, in addition to spirometry data and cystic fibrosis quality of life scores.

From preschool age to school age, the %disease on PRAGMA-CF increased significantly, from a mean of 0.7% to 1.73%. Scores on another composite measuring tool (%MUPAT, a composite score of airway wall thickening and mucus plugging) went from 0.46 to 0.58 – not a significant difference.

A multivariate analysis corrected for age in each school group and the type of scanner used to acquire the images. That analysis determined that each 1% increase in %disease at preschool age resulted in an increase of 1.18% of bronchiectasis at school age.

A cross-sectional analysis of the group at school age found significant associations between the %disease and percent of forced expiratory volume and the cystic fibrosis quality of life score.

At least one pulmonary exacerbation requiring intravenous antibiotics occurred in 19 of the patients. However, the investigators didn’t find any significant interactions between the %disease in preschool and these exacerbations..

“These findings are in line with previous studies in school‐aged children that showed that mucus plugging is associated with inflammation and airway wall thickening, and that these are thought to be risk factors for later bronchiectasis,” they concluded. “On the basis of our findings, we suggest that %disease and %MUPAT could be used as a clinically relevant outcome measure in clinical studies in preschool patients with cystic fibrosis, as these measures predict later bronchiectasis. Percent disease may be preferred as it captures all the principal features of CF airways disease including bronchiectasis.”

Ms. Bouma had no financial disclosures.

[email protected]

SOURCE: Bouma NR et al. Pediatr Pulmonol. 2019 Sep 9 doi: 10.1002/ppul.24498; Rosenow et al. Am J Respir Crit Care Med. 2015 May 15. doi: 10.1164/rccm.201501-0061OC.

ORLANDO – Patients who took romosozumab for 12 months and then switched to alendronate continued to see benefits in bone mineral density (BMD) of the lumbar spine after 12 months of therapy with alendronate, compared with patients who began taking, and continued to take, alendronate over the same time period, according to findings from a subgroup of the ARCH study presented at the annual meeting of the American Society for Bone and Mineral Research.

“These effects occurred rapidly, as early as month 6, were sustained beyond 12 months after transitioning to alendronate, and are consistent with greater fracture-risk reduction observed in ARCH with romosozumab to alendronate versus alendronate to alendronate,” Jacques P. Brown, MD, FRCPC, of Laval University, Quebec City, said in his presentation.

In the double-blinded ARCH study, 4,093 postmenopausal women with osteoporosis and a previous fracture history were randomized to receive subcutaneous monthly romosozumab 210 mg or oral weekly alendronate 70 mg for 12 months, followed by an open-label period during which romosozumab patients received oral weekly alendronate 70 mg and alendronate patients continued to receive the same dose on the same schedule for an additional 24 months (Saag KG et al. N Eng J Med. 2017 Oct 12. doi: 10.1056/NEJMoa1708322).

Dr. Brown and colleagues performed an imaging substudy of ARCH, which included examining how the romosozumab-to-alendronate and alendronate-only groups improved lumbar spine BMD and lumbar spine bone strength. Lumbar spine BMD was assessed through quantitative CT, and lumbar spine bone strength was measured with finite element analysis. The researchers received quantitative CT images from baseline and at 6 months, 12 months, and 24 months, and determined the percentage change at each of those periods to calculate integral, trabecular, and cortical lumbar spine volumetric BMD (vBMD), and to bone mineral content (BMC). They also measured areal BMD (aBMD) at baseline, 6 months, 12 months, 18 months, and 24 months with dual-energy x-ray absorptiometry.

Overall, 49 romosozumab patients and 41 alendronate patients from the ARCH study were enrolled in the imaging substudy. Of those patients, 76 had vBMD and BMC information available at baseline and one or more time periods post baseline, and 86 patients had finite element analysis data at baseline and one or more postbaseline time periods. Patients in the romosozumab and alendronate groups had similar baseline characteristics with regard to age (73.1 years vs. 72.8 years, respectively), mean lumbar spine BMD T score (–2.82 vs. –3.38), mean total hip BMD T score (–2.65 vs. –2.75), mean femoral neck T score (–2.84 vs. –2.83), mean lumbar spine integral vBMD (130.3 mg/cm³ vs. 120.5 mg/cm³), trabecular vBMD (60.1 mg/cm³ vs. 53.7 mg/cm³) and cortical vBMD (284.6 mg/cm³ vs. 270.9 mg/cm³). Patients in both groups also had similar rates of previous osteoporotic fracture at or after aged 45 years, previous vertebral fracture, and history of hip fracture.

Beginning at 6 months, there were significant least squares mean BMD improvements in both groups, but the romosozumab group had significant improvements in aBMD percentage changes, compared with the alendronate group, which persisted until 24 months (P less than .001 at all time points). Integral, trabecular, and cortical vBMD in the romosozumab group also saw significantly greater increases from baseline, compared with the alendronate group, and those results persisted in the open-label portion of the study for patients in the romosozumab group who transitioned to alendronate and patients in the alendronate to alendronate group (P less than .001 at all time points).

“The rapid and large increases in BMD with romosozumab followed by BMD consolidation where [patients were] transitioning to alendronate, support the important role of romosozumab as a first-line therapy in treating patients who are at very high risk for fracture,” Dr. Brown said.

In regard to BMC, there were larger increases in least squares mean BMC changes from baseline in the cortical compartment than the trabecular compartment, and actual change in bone strength as measured by finite element analysis was highly correlated with integral BMC in the romosozumab group.

Dr. Brown said the study was limited to the small sample size from the imaging substudy of ARCH, and quantitative CT dictated the imaging sites for the substudy, which may have affected patient selection. However, he noted that the characteristics of the ARCH imaging substudy were similar to patients in the overall ARCH study.

Amgen, UCB Pharma, and Astellas Pharma funded the study in part. Amgen and UCB Pharma assisted in the preparation of Dr. Brown’s presentation at ASBMR 2019, including funding costs associated with its development. Dr. Brown and the other coauthors reported relationships with Amgen, UCB Pharma, and other companies in the form of consultancies, grants and research support, speaker’s bureau appointments, paid employment, and stock options.

SOURCE: Brown JP et al. ASBMR 2019, Abstract 1050.

ORLANDO – Patients who took romosozumab for 12 months and then switched to alendronate continued to see benefits in bone mineral density (BMD) of the lumbar spine after 12 months of therapy with alendronate, compared with patients who began taking, and continued to take, alendronate over the same time period, according to findings from a subgroup of the ARCH study presented at the annual meeting of the American Society for Bone and Mineral Research.

“These effects occurred rapidly, as early as month 6, were sustained beyond 12 months after transitioning to alendronate, and are consistent with greater fracture-risk reduction observed in ARCH with romosozumab to alendronate versus alendronate to alendronate,” Jacques P. Brown, MD, FRCPC, of Laval University, Quebec City, said in his presentation.

In the double-blinded ARCH study, 4,093 postmenopausal women with osteoporosis and a previous fracture history were randomized to receive subcutaneous monthly romosozumab 210 mg or oral weekly alendronate 70 mg for 12 months, followed by an open-label period during which romosozumab patients received oral weekly alendronate 70 mg and alendronate patients continued to receive the same dose on the same schedule for an additional 24 months (Saag KG et al. N Eng J Med. 2017 Oct 12. doi: 10.1056/NEJMoa1708322).

Dr. Brown and colleagues performed an imaging substudy of ARCH, which included examining how the romosozumab-to-alendronate and alendronate-only groups improved lumbar spine BMD and lumbar spine bone strength. Lumbar spine BMD was assessed through quantitative CT, and lumbar spine bone strength was measured with finite element analysis. The researchers received quantitative CT images from baseline and at 6 months, 12 months, and 24 months, and determined the percentage change at each of those periods to calculate integral, trabecular, and cortical lumbar spine volumetric BMD (vBMD), and to bone mineral content (BMC). They also measured areal BMD (aBMD) at baseline, 6 months, 12 months, 18 months, and 24 months with dual-energy x-ray absorptiometry.

Overall, 49 romosozumab patients and 41 alendronate patients from the ARCH study were enrolled in the imaging substudy. Of those patients, 76 had vBMD and BMC information available at baseline and one or more time periods post baseline, and 86 patients had finite element analysis data at baseline and one or more postbaseline time periods. Patients in the romosozumab and alendronate groups had similar baseline characteristics with regard to age (73.1 years vs. 72.8 years, respectively), mean lumbar spine BMD T score (–2.82 vs. –3.38), mean total hip BMD T score (–2.65 vs. –2.75), mean femoral neck T score (–2.84 vs. –2.83), mean lumbar spine integral vBMD (130.3 mg/cm³ vs. 120.5 mg/cm³), trabecular vBMD (60.1 mg/cm³ vs. 53.7 mg/cm³) and cortical vBMD (284.6 mg/cm³ vs. 270.9 mg/cm³). Patients in both groups also had similar rates of previous osteoporotic fracture at or after aged 45 years, previous vertebral fracture, and history of hip fracture.

Beginning at 6 months, there were significant least squares mean BMD improvements in both groups, but the romosozumab group had significant improvements in aBMD percentage changes, compared with the alendronate group, which persisted until 24 months (P less than .001 at all time points). Integral, trabecular, and cortical vBMD in the romosozumab group also saw significantly greater increases from baseline, compared with the alendronate group, and those results persisted in the open-label portion of the study for patients in the romosozumab group who transitioned to alendronate and patients in the alendronate to alendronate group (P less than .001 at all time points).

“The rapid and large increases in BMD with romosozumab followed by BMD consolidation where [patients were] transitioning to alendronate, support the important role of romosozumab as a first-line therapy in treating patients who are at very high risk for fracture,” Dr. Brown said.

In regard to BMC, there were larger increases in least squares mean BMC changes from baseline in the cortical compartment than the trabecular compartment, and actual change in bone strength as measured by finite element analysis was highly correlated with integral BMC in the romosozumab group.

Dr. Brown said the study was limited to the small sample size from the imaging substudy of ARCH, and quantitative CT dictated the imaging sites for the substudy, which may have affected patient selection. However, he noted that the characteristics of the ARCH imaging substudy were similar to patients in the overall ARCH study.

Amgen, UCB Pharma, and Astellas Pharma funded the study in part. Amgen and UCB Pharma assisted in the preparation of Dr. Brown’s presentation at ASBMR 2019, including funding costs associated with its development. Dr. Brown and the other coauthors reported relationships with Amgen, UCB Pharma, and other companies in the form of consultancies, grants and research support, speaker’s bureau appointments, paid employment, and stock options.

SOURCE: Brown JP et al. ASBMR 2019, Abstract 1050.

ORLANDO – Patients who took romosozumab for 12 months and then switched to alendronate continued to see benefits in bone mineral density (BMD) of the lumbar spine after 12 months of therapy with alendronate, compared with patients who began taking, and continued to take, alendronate over the same time period, according to findings from a subgroup of the ARCH study presented at the annual meeting of the American Society for Bone and Mineral Research.

“These effects occurred rapidly, as early as month 6, were sustained beyond 12 months after transitioning to alendronate, and are consistent with greater fracture-risk reduction observed in ARCH with romosozumab to alendronate versus alendronate to alendronate,” Jacques P. Brown, MD, FRCPC, of Laval University, Quebec City, said in his presentation.

In the double-blinded ARCH study, 4,093 postmenopausal women with osteoporosis and a previous fracture history were randomized to receive subcutaneous monthly romosozumab 210 mg or oral weekly alendronate 70 mg for 12 months, followed by an open-label period during which romosozumab patients received oral weekly alendronate 70 mg and alendronate patients continued to receive the same dose on the same schedule for an additional 24 months (Saag KG et al. N Eng J Med. 2017 Oct 12. doi: 10.1056/NEJMoa1708322).

Dr. Brown and colleagues performed an imaging substudy of ARCH, which included examining how the romosozumab-to-alendronate and alendronate-only groups improved lumbar spine BMD and lumbar spine bone strength. Lumbar spine BMD was assessed through quantitative CT, and lumbar spine bone strength was measured with finite element analysis. The researchers received quantitative CT images from baseline and at 6 months, 12 months, and 24 months, and determined the percentage change at each of those periods to calculate integral, trabecular, and cortical lumbar spine volumetric BMD (vBMD), and to bone mineral content (BMC). They also measured areal BMD (aBMD) at baseline, 6 months, 12 months, 18 months, and 24 months with dual-energy x-ray absorptiometry.

Overall, 49 romosozumab patients and 41 alendronate patients from the ARCH study were enrolled in the imaging substudy. Of those patients, 76 had vBMD and BMC information available at baseline and one or more time periods post baseline, and 86 patients had finite element analysis data at baseline and one or more postbaseline time periods. Patients in the romosozumab and alendronate groups had similar baseline characteristics with regard to age (73.1 years vs. 72.8 years, respectively), mean lumbar spine BMD T score (–2.82 vs. –3.38), mean total hip BMD T score (–2.65 vs. –2.75), mean femoral neck T score (–2.84 vs. –2.83), mean lumbar spine integral vBMD (130.3 mg/cm³ vs. 120.5 mg/cm³), trabecular vBMD (60.1 mg/cm³ vs. 53.7 mg/cm³) and cortical vBMD (284.6 mg/cm³ vs. 270.9 mg/cm³). Patients in both groups also had similar rates of previous osteoporotic fracture at or after aged 45 years, previous vertebral fracture, and history of hip fracture.

Beginning at 6 months, there were significant least squares mean BMD improvements in both groups, but the romosozumab group had significant improvements in aBMD percentage changes, compared with the alendronate group, which persisted until 24 months (P less than .001 at all time points). Integral, trabecular, and cortical vBMD in the romosozumab group also saw significantly greater increases from baseline, compared with the alendronate group, and those results persisted in the open-label portion of the study for patients in the romosozumab group who transitioned to alendronate and patients in the alendronate to alendronate group (P less than .001 at all time points).

“The rapid and large increases in BMD with romosozumab followed by BMD consolidation where [patients were] transitioning to alendronate, support the important role of romosozumab as a first-line therapy in treating patients who are at very high risk for fracture,” Dr. Brown said.

In regard to BMC, there were larger increases in least squares mean BMC changes from baseline in the cortical compartment than the trabecular compartment, and actual change in bone strength as measured by finite element analysis was highly correlated with integral BMC in the romosozumab group.

Dr. Brown said the study was limited to the small sample size from the imaging substudy of ARCH, and quantitative CT dictated the imaging sites for the substudy, which may have affected patient selection. However, he noted that the characteristics of the ARCH imaging substudy were similar to patients in the overall ARCH study.

Amgen, UCB Pharma, and Astellas Pharma funded the study in part. Amgen and UCB Pharma assisted in the preparation of Dr. Brown’s presentation at ASBMR 2019, including funding costs associated with its development. Dr. Brown and the other coauthors reported relationships with Amgen, UCB Pharma, and other companies in the form of consultancies, grants and research support, speaker’s bureau appointments, paid employment, and stock options.

SOURCE: Brown JP et al. ASBMR 2019, Abstract 1050.

James Q. Del Rosso, DO, answers important questions on antibiotic resistance and what it means for the practicing dermatologist.

Questions include:

• What is the potential magnitude of concern regarding antibiotic resistance? Is it clinically relevant to dermatologists in their day-to-day practice?

• What can dermatologists do to slow the development of antibiotic resistance?

• What is the mutant selection window?

• How does the mutant selection window apply to topical antibiotics?

Click here to read the article

James Q. Del Rosso, DO, answers important questions on antibiotic resistance and what it means for the practicing dermatologist.

Questions include:

• What is the potential magnitude of concern regarding antibiotic resistance? Is it clinically relevant to dermatologists in their day-to-day practice?

• What can dermatologists do to slow the development of antibiotic resistance?

• What is the mutant selection window?

• How does the mutant selection window apply to topical antibiotics?

Click here to read the article

James Q. Del Rosso, DO, answers important questions on antibiotic resistance and what it means for the practicing dermatologist.

Questions include:

• What is the potential magnitude of concern regarding antibiotic resistance? Is it clinically relevant to dermatologists in their day-to-day practice?

• What can dermatologists do to slow the development of antibiotic resistance?

• What is the mutant selection window?

• How does the mutant selection window apply to topical antibiotics?

Click here to read the article

A very low-calorie ketogenic diet (VLCKD) has a preventive effect in overweight, episodic patients who experience migraine that appears within 1 month, a new study found. Researchers sought to determine the therapeutic effect of a very low-calorie diet in overweight, episodic patients who experience migraine during a weight-loss intervention in which participants alternated randomly between a VLCKD and a very low-calorie non-ketogenic diet (VLCnKD) each for 1 month. The primary outcomes measure was the reduction of migraine days each month compared to a 1-month pre-diet baseline. Among the findings:

• Thirty-five obese migraine sufferers were allocated blindly to 1-month successive VLCKD or VLCnKD in random order.
• During the VLCKD patients experienced ‒3.73 migraine days respect to VLCnKD.
• The 50% responder rate for migraine days was 74.28% during the VLCKD period and 8.57% during VLCnKD.
• Migraine attacks decreased by ‒3.02 during VLCKD respect to VLCnKD.

Di Lorenzo C, Pinto A, Lenca R, et al. A randomized double-blind, cross-over trial of very low-calorie diet in overweight migraine patients: A possible role for ketones? [Published online ahead of print July 28, 2019]. Nutrients. doi: 10.3390/nu11081742.

A very low-calorie ketogenic diet (VLCKD) has a preventive effect in overweight, episodic patients who experience migraine that appears within 1 month, a new study found. Researchers sought to determine the therapeutic effect of a very low-calorie diet in overweight, episodic patients who experience migraine during a weight-loss intervention in which participants alternated randomly between a VLCKD and a very low-calorie non-ketogenic diet (VLCnKD) each for 1 month. The primary outcomes measure was the reduction of migraine days each month compared to a 1-month pre-diet baseline. Among the findings:

• Thirty-five obese migraine sufferers were allocated blindly to 1-month successive VLCKD or VLCnKD in random order.
• During the VLCKD patients experienced ‒3.73 migraine days respect to VLCnKD.
• The 50% responder rate for migraine days was 74.28% during the VLCKD period and 8.57% during VLCnKD.
• Migraine attacks decreased by ‒3.02 during VLCKD respect to VLCnKD.

Di Lorenzo C, Pinto A, Lenca R, et al. A randomized double-blind, cross-over trial of very low-calorie diet in overweight migraine patients: A possible role for ketones? [Published online ahead of print July 28, 2019]. Nutrients. doi: 10.3390/nu11081742.

A very low-calorie ketogenic diet (VLCKD) has a preventive effect in overweight, episodic patients who experience migraine that appears within 1 month, a new study found. Researchers sought to determine the therapeutic effect of a very low-calorie diet in overweight, episodic patients who experience migraine during a weight-loss intervention in which participants alternated randomly between a VLCKD and a very low-calorie non-ketogenic diet (VLCnKD) each for 1 month. The primary outcomes measure was the reduction of migraine days each month compared to a 1-month pre-diet baseline. Among the findings:

• Thirty-five obese migraine sufferers were allocated blindly to 1-month successive VLCKD or VLCnKD in random order.
• During the VLCKD patients experienced ‒3.73 migraine days respect to VLCnKD.
• The 50% responder rate for migraine days was 74.28% during the VLCKD period and 8.57% during VLCnKD.
• Migraine attacks decreased by ‒3.02 during VLCKD respect to VLCnKD.

Di Lorenzo C, Pinto A, Lenca R, et al. A randomized double-blind, cross-over trial of very low-calorie diet in overweight migraine patients: A possible role for ketones? [Published online ahead of print July 28, 2019]. Nutrients. doi: 10.3390/nu11081742.

For patients with metastatic non–small cell lung cancer (NSCLC) who have disease progression on immunotherapy, adding stereotactic body radiotherapy (SBRT) could improve progression-free survival (PFS), according to investigators.

Will Pass/MDedge News

Patients with more CD8+ T cells in circulation, and those with higher tumor infiltrating lymphocyte (TIL) scores derived the most benefit from SBRT, lead author Allison Campbell, MD, PhD, of Yale Cancer Center in New Haven, Conn., and colleagues, reported at the annual meeting of the American Society for Radiation Oncology.

“In rare cases, adding radiation to immunotherapy has been shown to result in therapeutic synergy,” Dr. Campbell said. “When we give high-dose radiation to patients on immunotherapy, some tumors that were not targeted by the radiation can shrink, and this is called ‘the abscopal effect.’ ”

The investigators designed the phase 2 trial to determine if the abscopal effect would occur if high-dose radiation was delivered to a single site in patients who had progressed on checkpoint inhibitor therapy. Fifty-six patients were enrolled, all with at least two sites of metastatic NSCLC. Of these patients, 6 had already progressed on immunotherapy, while 50 were naive to immunotherapy and began pembrolizumab during the trial, with 16 eventually progressing; collectively, these 22 patients with disease progression were identified as candidates for SBRT. Almost all candidates (21 out of 22) completed SBRT, which was delivered in three or five high-dose fractions. Only one site was treated, while other sites were tracked over time with computed tomography (CT) to assess for the abscopal effect. In addition, blood was analyzed for circulating immune cell composition.

After a median follow-up of 15.2 months, the disease control rate was 57%, with some abscopal responses detected. Two patients (10%) achieved a partial response lasting more than 1 year, and 10 patients (48%) maintained stable disease after SBRT. Although programmed death-ligand 1 (PD-L1) positivity was associated with a trend toward increased PFS, this was not statistically significant. In contrast, TIL score was significantly correlated with PFS; patients with TIL scores of 2-3 had a median PFS of 6.7 months, compared with 2.2 months among those with TIL scores of 1 or less. Similarly, immune-related adverse events predicted outcome, with patients who experienced such events achieving longer median PFS than those who did not (6.5 vs 2.2 months). Furthermore, blood testing revealed that the best responders had more CD8+ killer T cells and fewer CD4+ regulatory T cells in peripheral blood compared with patients who responded poorly.

After Dr. Campbell’s presentation, Benjamin Movsas, MD, chair of radiation oncology at the Henry Ford Cancer Institute in Detroit, offered some expert insight. “[The findings from this study] suggest perhaps that radiation may be able to reinvigorate the immune system,” Dr. Movsas said. “Maybe we can get more mileage out of the immunotherapy with this approach. Could radiation kind of be like an immune vaccine of sorts? There’s a lot of exciting possibilities.”

Will Pass/MDedge News

Dr. Movsas also noted how biomarker findings may be able to guide treatment decisions, highlighting how T cell populations predicted outcomes. “This era of precision medicine is really helping us improve benefits,” he said. “The immune profile really matters.”

The investigators disclosed relationships with Genentech, AstraZeneca, Merck, and others.

SOURCE: Campbell et al. ASTRO 2019. Abstract 74.

For patients with metastatic non–small cell lung cancer (NSCLC) who have disease progression on immunotherapy, adding stereotactic body radiotherapy (SBRT) could improve progression-free survival (PFS), according to investigators.

Will Pass/MDedge News

Patients with more CD8+ T cells in circulation, and those with higher tumor infiltrating lymphocyte (TIL) scores derived the most benefit from SBRT, lead author Allison Campbell, MD, PhD, of Yale Cancer Center in New Haven, Conn., and colleagues, reported at the annual meeting of the American Society for Radiation Oncology.

“In rare cases, adding radiation to immunotherapy has been shown to result in therapeutic synergy,” Dr. Campbell said. “When we give high-dose radiation to patients on immunotherapy, some tumors that were not targeted by the radiation can shrink, and this is called ‘the abscopal effect.’ ”

The investigators designed the phase 2 trial to determine if the abscopal effect would occur if high-dose radiation was delivered to a single site in patients who had progressed on checkpoint inhibitor therapy. Fifty-six patients were enrolled, all with at least two sites of metastatic NSCLC. Of these patients, 6 had already progressed on immunotherapy, while 50 were naive to immunotherapy and began pembrolizumab during the trial, with 16 eventually progressing; collectively, these 22 patients with disease progression were identified as candidates for SBRT. Almost all candidates (21 out of 22) completed SBRT, which was delivered in three or five high-dose fractions. Only one site was treated, while other sites were tracked over time with computed tomography (CT) to assess for the abscopal effect. In addition, blood was analyzed for circulating immune cell composition.

After a median follow-up of 15.2 months, the disease control rate was 57%, with some abscopal responses detected. Two patients (10%) achieved a partial response lasting more than 1 year, and 10 patients (48%) maintained stable disease after SBRT. Although programmed death-ligand 1 (PD-L1) positivity was associated with a trend toward increased PFS, this was not statistically significant. In contrast, TIL score was significantly correlated with PFS; patients with TIL scores of 2-3 had a median PFS of 6.7 months, compared with 2.2 months among those with TIL scores of 1 or less. Similarly, immune-related adverse events predicted outcome, with patients who experienced such events achieving longer median PFS than those who did not (6.5 vs 2.2 months). Furthermore, blood testing revealed that the best responders had more CD8+ killer T cells and fewer CD4+ regulatory T cells in peripheral blood compared with patients who responded poorly.

After Dr. Campbell’s presentation, Benjamin Movsas, MD, chair of radiation oncology at the Henry Ford Cancer Institute in Detroit, offered some expert insight. “[The findings from this study] suggest perhaps that radiation may be able to reinvigorate the immune system,” Dr. Movsas said. “Maybe we can get more mileage out of the immunotherapy with this approach. Could radiation kind of be like an immune vaccine of sorts? There’s a lot of exciting possibilities.”

Will Pass/MDedge News

Dr. Movsas also noted how biomarker findings may be able to guide treatment decisions, highlighting how T cell populations predicted outcomes. “This era of precision medicine is really helping us improve benefits,” he said. “The immune profile really matters.”

The investigators disclosed relationships with Genentech, AstraZeneca, Merck, and others.

SOURCE: Campbell et al. ASTRO 2019. Abstract 74.

For patients with metastatic non–small cell lung cancer (NSCLC) who have disease progression on immunotherapy, adding stereotactic body radiotherapy (SBRT) could improve progression-free survival (PFS), according to investigators.

Will Pass/MDedge News

Patients with more CD8+ T cells in circulation, and those with higher tumor infiltrating lymphocyte (TIL) scores derived the most benefit from SBRT, lead author Allison Campbell, MD, PhD, of Yale Cancer Center in New Haven, Conn., and colleagues, reported at the annual meeting of the American Society for Radiation Oncology.

“In rare cases, adding radiation to immunotherapy has been shown to result in therapeutic synergy,” Dr. Campbell said. “When we give high-dose radiation to patients on immunotherapy, some tumors that were not targeted by the radiation can shrink, and this is called ‘the abscopal effect.’ ”

The investigators designed the phase 2 trial to determine if the abscopal effect would occur if high-dose radiation was delivered to a single site in patients who had progressed on checkpoint inhibitor therapy. Fifty-six patients were enrolled, all with at least two sites of metastatic NSCLC. Of these patients, 6 had already progressed on immunotherapy, while 50 were naive to immunotherapy and began pembrolizumab during the trial, with 16 eventually progressing; collectively, these 22 patients with disease progression were identified as candidates for SBRT. Almost all candidates (21 out of 22) completed SBRT, which was delivered in three or five high-dose fractions. Only one site was treated, while other sites were tracked over time with computed tomography (CT) to assess for the abscopal effect. In addition, blood was analyzed for circulating immune cell composition.

After a median follow-up of 15.2 months, the disease control rate was 57%, with some abscopal responses detected. Two patients (10%) achieved a partial response lasting more than 1 year, and 10 patients (48%) maintained stable disease after SBRT. Although programmed death-ligand 1 (PD-L1) positivity was associated with a trend toward increased PFS, this was not statistically significant. In contrast, TIL score was significantly correlated with PFS; patients with TIL scores of 2-3 had a median PFS of 6.7 months, compared with 2.2 months among those with TIL scores of 1 or less. Similarly, immune-related adverse events predicted outcome, with patients who experienced such events achieving longer median PFS than those who did not (6.5 vs 2.2 months). Furthermore, blood testing revealed that the best responders had more CD8+ killer T cells and fewer CD4+ regulatory T cells in peripheral blood compared with patients who responded poorly.

After Dr. Campbell’s presentation, Benjamin Movsas, MD, chair of radiation oncology at the Henry Ford Cancer Institute in Detroit, offered some expert insight. “[The findings from this study] suggest perhaps that radiation may be able to reinvigorate the immune system,” Dr. Movsas said. “Maybe we can get more mileage out of the immunotherapy with this approach. Could radiation kind of be like an immune vaccine of sorts? There’s a lot of exciting possibilities.”

Will Pass/MDedge News

Dr. Movsas also noted how biomarker findings may be able to guide treatment decisions, highlighting how T cell populations predicted outcomes. “This era of precision medicine is really helping us improve benefits,” he said. “The immune profile really matters.”

The investigators disclosed relationships with Genentech, AstraZeneca, Merck, and others.

SOURCE: Campbell et al. ASTRO 2019. Abstract 74.